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Mizoguchi T, Kawada Y, Shintani Y, Yokoi M, Yamabe S, Mori K, Kikuchi S, Ito T, Kitada S, Goto T, Seo Y. Central blood pressure profile variability and prognostic impact of transcatheter aortic valve implantation. Heart Vessels 2025; 40:484-495. [PMID: 39560717 DOI: 10.1007/s00380-024-02488-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/22/2024] [Accepted: 11/06/2024] [Indexed: 11/20/2024]
Abstract
Transcatheter aortic valve implantation (TAVI) is a proven treatment for severe aortic stenosis (AS); however, the effects of TAVI on central blood pressure (CBP) and clinical outcomes remain unclear. We assessed CBP indices before and after TAVI and their prognostic value. Seventy-six patients with severe AS who underwent TAVI were retrospectively evaluated, and CBP was estimated noninvasively 1 day before and after TAVI. The following indices were measured: augmentation index corrected for heart rate (HR) (AIx@HR75), peak pressure of the forward wave (Pf) and backward wave (Pb), time to peak pressure of the forward wave corrected for HR (Tfc) and the backward wave corrected for HR (Tbc), and ejection duration (ED). The primary endpoint was the composite outcome of all-cause mortality and hospitalized heart failure. The median follow-up period was 1135 (844-1404) days. Tfc, Tbc, ED, Pb, and AIx@HR75 decreased despite no significant changes in Pf after TAVI. The univariable Cox proportional hazards model showed that ED 1 day after TAVI was associated with composite outcomes (hazard ratio: 1.02; 95% confidence interval [CI]: 1.01-1.04; P = 0.002). When the patients were divided into two groups by the cutoff value determining composite outcomes by receiver operating characteristic curve analysis, a long ED 1 day after TAVI was significantly associated with composite outcomes by Kaplan-Meier curve analysis (log-rank test, P < 0.001). The multivariable Cox proportional hazards model showed that a long ED 1 day after TAVI was associated with composite outcomes (adjusted hazard ratio: 12.12; 95% CI 2.41-60.81; P = 0.002). In conclusion, a long ED 1 day after TAVI was associated with adverse clinical outcomes.
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Affiliation(s)
- Tatsuya Mizoguchi
- Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.
| | - Yu Kawada
- Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
| | - Yasuhiro Shintani
- Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
| | - Masashi Yokoi
- Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
| | - Sayuri Yamabe
- Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
| | - Kento Mori
- Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
| | - Shohei Kikuchi
- Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
| | - Tsuyoshi Ito
- Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
| | - Shuichi Kitada
- Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
| | - Toshihiko Goto
- Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
| | - Yoshihiro Seo
- Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan
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2
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Feng J, Wei H, Zhang S, Li Y, Liu H, Wu Y. Efficacy and safety of transfemoral TAVR in pure aortic regurgitation patients: a single center study. Sci Rep 2025; 15:17951. [PMID: 40410432 PMCID: PMC12102353 DOI: 10.1038/s41598-025-03214-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/16/2024] [Accepted: 05/19/2025] [Indexed: 05/25/2025] Open
Abstract
The objective of this study was to evaluate the efficacy of transcatheter aortic valve replacement (TAVR) via the femoral approach in patients with pure aortic regurgitation (AR), with a focus on mortality, adverse event rates, cardiac function, and clinical symptom improvement. The study utilised a single-centre experience to provide insights and offer guidance for the management of TAVR in AR patients. Patients with aortic valve pathology who underwent TAVR at the Second Affiliated Hospital of Nanchang University, from January 2018 to March 2023 were enrolled. They were classified into two groups: pure AR and aortic stenosis (AS) based on preoperative transthoracic echocardiography. We compared baseline characteristics, imaging data, surgical outcomes, and follow-up conditions between them. We focused on the safety and efficacy of TAVR in patients with AR and evaluated these results using regression analysis. The study cohort comprised 87 patients, with 21 in the AR group and 63 in the AS group. We revealed that AR patients exhibited low mortality and adverse event rates following transfemoral TAVR, with notable improvements in postoperative cardiac function and substantial symptom relief. However, the rates of paravalvular leak (PVL), permanent pacemaker (PPM) implantation, and valve-in-valve procedures were relatively elevated. While these findings suggest that TAVR may represent a viable therapeutic option for patients with AR, the elevated rates of PVL, PPM implantation, and readmission underscore the need for further investigation, with larger cohorts and extended follow-up, to more robustly evaluate the long-term safety and efficacy of this approach.
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Affiliation(s)
- Jie Feng
- Department of Cardiology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, 330006, China
| | - Haixia Wei
- Department of Cardiology, Shangrao People's Hospital, Shangrao, 334000, Jiangxi Province, China
| | - Shiyuan Zhang
- Department of Cardiology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, 330006, China
| | - Yao Li
- Department of Cardiology, The Affiliated Hospital of Jiujiang College, Jiujiang, 332000, Jiangxi Province, China
| | - Hangyu Liu
- Department of Cardiology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, 330006, China
| | - Yanqing Wu
- Department of Cardiology, The Second Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, 330006, China.
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3
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Makkar RR, Ramana RK, Gnall E, Ramlawi B, Cheng W, Diamantouros P, Potluri S, Kleinman N, Gupta A, Chakravarty T, Samy S, Rassi A, Rajagopal V, Yakubov S, Sorajja P, Patel D, Garcia S, Yadav P, Thourani V, Wang J, Rinaldi M, Kapadia S, Waksman R, Webb J, Ren CB, Gregson J, Modolo R, Sathananthan J, Reardon MJ, ACURATE IDE study investigators. ACURATE neo2 valve versus commercially available transcatheter heart valves in patients with severe aortic stenosis (ACURATE IDE): a multicentre, randomised, controlled, non-inferiority trial. Lancet 2025:S0140-6736(25)00319-8. [PMID: 40412426 DOI: 10.1016/s0140-6736(25)00319-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/08/2024] [Revised: 02/10/2025] [Accepted: 02/14/2025] [Indexed: 05/27/2025]
Abstract
BACKGROUND ACURATE neo2 is an open-cell, supra-annular, self-expanding transcatheter heart valve that is commercially available in over 50 countries but has not previously been evaluated in a randomised trial. ACURATE-IDE aimed to prospectively evaluate the safety and efficacy of transcatheter aortic valve replacement (TAVR) with the ACURATE neo2 valve compared with commercially available valves for the treatment of severe symptomatic aortic stenosis. METHODS In this multicentre, randomised, controlled, non-inferiority trial, patients with symptomatic severe aortic stenosis and any level of surgical risk were recruited from 71 medical centres in the USA and Canada. Eligible patients were randomly assigned (1:1) to TAVR with ACURATE neo2 or one of the control valves, SAPIEN 3 (SAPIEN 3 or SAPIEN 3 Ultra) or Evolut, using permuted block randomisation with a pseudo-random number generator, and stratified by the clinical investigation site and type of control valve. All devices were implanted according to the manufacturer's instructions. The primary endpoint was a composite of all-cause mortality, all stroke, and rehospitalisation at 1 year, tested for non-inferiority using a Bayesian approach. The primary analysis was performed in the intention-to-treat population and sensitivity analyses were done in the implanted population. The non-inferiority margin was 8·0%. This study is registered with ClinicalTrials.gov, NCT03735667, and is ongoing. FINDINGS Between June 10, 2019, and April 19, 2023, 1500 patients were recruited, of whom 752 were randomly assigned to the ACURATE neo2 group and 748 to the control group. The median age of participants was 79 years (IQR 74-83). 778 (51·9%) of 1500 patients were female and 721 (48·1%) were male. At 1 year, the posterior median probability of the primary composite endpoint was higher in the ACURATE neo2 group (16·2% [95% Bayesian credible interval 13·4-19·1) than in the control group (9·5% [7·5-11·9]; between-group difference 6·6% [3·0-10·2]). The upper bound of treatment difference exceeded the prespecified non-inferiority margin of 8%, with a posterior probability of treatment difference of >0·999. At 1 year, the ACURATE neo2 group, had significantly higher Kaplan-Meier rates of the composite endpoint of all-cause mortality, all stroke, and rehospitalisation (14·8% [95% CI 12·5-17·6] vs 9·1% [7·2-11·4]; hazard ratio [HR] 1·71 [95% CI 1·26-2·33]; p=0·0005). At 1 year, all-cause mortality occurred in 36 of 752 patients in the ACURATE neo2 group versus 28 of 748 patients in the control group (HR 1·30 [95% CI 0·80-2·14]), stroke in 41 patients versus 25 patients (1·68 [1·02-2·75]), and rehospitalisation in 38 patients versus 25 patients (1·57 [0·95-2·61]). Cardiovascular mortality (3·7% vs 1·8%, p=0·024) and spontaneous myocardial infarction at 1 year (2·4% vs 0·7%, p=0·0092) were more frequent in the ACURATE neo2 group than in the control group. Prosthetic valve aortic regurgitation (central plus paravalvular) at 1 year was significantly more frequent in the ACURATE neo2 group than in the control group (mild aortic regurgitation 42·5% vs 24·8%, p<0·0001; moderate 4·4% vs 1·8%, p=0·0070; severe 0·5% vs 0%; p=0·12). INTERPRETATION In patients with symptomatic severe aortic stenosis, TAVR with ACURATE neo2 did not meet non-inferiority and resulted in significantly worse outcomes with respect to the primary endpoint of composite of all-cause mortality, all stroke, and rehospitalisation at 1 year when compared with commercial valves. FUNDING Boston Scientific.
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Affiliation(s)
- Raj R Makkar
- Cedars-Sinai Medical Center, Los Angeles, CA, USA.
| | | | - Eric Gnall
- Advocate Christ Medical Center, Mokena, IL, USA
| | | | - Wen Cheng
- Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | | | | | | | | | | | | | | | | | - Steven Yakubov
- OhioHealth Research and Innovation Institute-Riverside Methodist Hospital, Columbus, OH, USA
| | - Paul Sorajja
- Abbott Northwestern Hospital, Minneapolis, MN, USA
| | | | - Santiago Garcia
- Lindner Center for Research and Education at Christ Hospital, Cincinnati, OH, USA
| | | | | | - John Wang
- Union Memorial Hospital, Baltimore, MD, USA
| | | | | | - Ron Waksman
- Washington Hospital Center, Washington, DC, USA
| | - John Webb
- Providence Health-St Paul's Hospital, Vancouver, BC, Canada
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Nakase M, Draxler DF, Tomii D, Heg D, Okuno T, Samim D, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Incidence, predictors and clinical impact of upper gastrointestinal bleeding after transcatheter aortic valve replacement. Heart 2025:heartjnl-2024-325359. [PMID: 40348411 DOI: 10.1136/heartjnl-2024-325359] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/04/2024] [Accepted: 04/06/2025] [Indexed: 05/14/2025] Open
Abstract
BACKGROUND Upper gastrointestinal (GI) bleeding following transcatheter aortic valve replacement (TAVR) is common in patients with aortic stenosis due to the combination of acquired type 2A von Willebrand disease and aspirin-based antiplatelet therapy. We aimed to investigate the incidence, predictors and clinical outcomes of late upper GI bleeding in patients undergoing TAVR. METHODS In a prospective TAVR registry, patients were stratified according to upper GI bleeding within 1 year of discharge. RESULTS Among the 3144 eligible patients, 54 (1.7%) experienced upper GI bleeding after discharge. Of these, 40 patients had major or life-threatening bleeding, while 14 had minor bleeding events. The presence of atrial fibrillation or atrial flutter (HRadjusted 2.98; 95% CI 1.65 to 5.38) and previous upper GI bleeding (HRadjusted 3.51; 95% CI 1.51 to 8.19) were independent predictors of upper GI bleeding, while the use of proton pump inhibitors at discharge (HRadjusted 0.49; 95% CI 0.27 to 0.89) and higher haemoglobin levels (1 g/dL increase) (HRadjusted 0.73; 95% CI 0.62 to 0.87) were protective. Patients who experienced major or life-threatening upper GI bleeding had a higher all-cause (73.7% vs 11.4%, HR 5.84; 95% CI 3.41 to 10.02) and cardiovascular mortality (31.6% vs 7.3%, HR 3.87; 95% CI 1.72 to 8.70) compared with those without upper GI bleeding. CONCLUSIONS Among patients who underwent TAVR, 1.7% of patients experienced upper GI bleeding within 1 year of discharge. Major or life-threatening upper GI bleeding was associated with an increased risk of all-cause and cardiovascular mortality. TRIAL REGISTRATION NUMBER NCT01368250.
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Affiliation(s)
- Masaaki Nakase
- Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Dominik F Draxler
- Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Daijiro Tomii
- Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Dik Heg
- Department of Clinical Research, University of Bern, Bern, Switzerland
| | - Taishi Okuno
- Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Daryoush Samim
- Department of Cardiac Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Jonas Lanz
- Department of Cardiac Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Stefan Stortecky
- Department of Cardiac Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - David Reineke
- Department of Cardiac Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Stephan Windecker
- Department of Cardiac Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Thomas Pilgrim
- Department of Cardiac Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
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5
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Yildirim A, Genc O, Evlice M, Erdogan A, Pacaci E, Ozderya A, Yerlikaya MG, Sezici E, Guler Y, Sen O, Guler A, Akyuz AR, Korkmaz L, Kurt IH. Predictive power of ALBI score-based nomogram for 30-day mortality following transcatheter aortic valve implantation. Biomark Med 2025; 19:305-316. [PMID: 40159704 PMCID: PMC12051588 DOI: 10.1080/17520363.2025.2483157] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/05/2024] [Accepted: 03/19/2025] [Indexed: 04/02/2025] Open
Abstract
AIM This retrospective, multi-center study evaluates the relationships between novel liver function scoring systems - Albumin-Bilirubin (ALBI) score, EZ-ALBI, PALBI, and MELD-XI - and outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). Feature importance was assessed with SHAP-values via the XGBoost-algorithm. RESULTS The ALBI score exhibited the strongest association with 30-day mortality after TAVI (AUC = 0.723, p < 0.001), outperforming other scores in this regard and consistently demonstrating predictive power across various subgroup populations. Higher 30-day mortality rates were observed in the higher tertiles of the ALBI score compared to the lower tertiles (log-rank p-value = 0.004). The ALBI-based nomogram (C-index = 0.81, 95% CI:0.73-0.86, p = 0 < 001) demonstrated superior predictive power for 30-day mortality post-TAVI compared to the STS (C-index = 0.71, 95% CI :0.64-0.77, p = 0 < 001). In addition, the nomogram showed a significant improvement in reclassification (69.3%, p < 0.001) and a stronger discrimination 15.2%, p < 0.001) compared to the STS. It integrates nine variables, first ALBI score (SHAP:1.165), including NYHA class (0.594), body mass index (0.510), glomerular filtration rate, creatinine, hemoglobin, gender, predilatation requirement, presence of chronic kidney disease, and providing a comprehensive risk assessment tool. CONCLUSION This study exhibits the significance of liver dysfunction with AS patients and suggests incorporating liver function parameters in pre-operative risk assessments for better clinical outcomes in TAVI procedures.
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Affiliation(s)
- Abdullah Yildirim
- Department of Cardiology, University of Health Sciences, Adana City Training and Research Hospital, Adana, TÜRKIYE
| | - Omer Genc
- Department of Cardiology, University of Health Sciences, Basaksehir Cam & Sakura City Hospital, Istanbul, TÜRKIYE
| | - Mert Evlice
- Department of Cardiology, University of Health Sciences, Adana City Training and Research Hospital, Adana, TÜRKIYE
| | - Aslan Erdogan
- Department of Cardiology, University of Health Sciences, Basaksehir Cam & Sakura City Hospital, Istanbul, TÜRKIYE
| | - Emre Pacaci
- Department of Cardiology, University of Health Sciences, Adana City Training and Research Hospital, Adana, TÜRKIYE
| | - Ahmet Ozderya
- Department of Cardiology, University of Health Sciences, Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Trabzon, TÜRKIYE
| | - Murat Gokhan Yerlikaya
- Department of Cardiology, University of Health Sciences, Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Trabzon, TÜRKIYE
| | - Emre Sezici
- Department of Cardiology, University of Health Sciences, Adana City Training and Research Hospital, Adana, TÜRKIYE
| | - Yeliz Guler
- Department of Cardiology, University of Health Sciences, Basaksehir Cam & Sakura City Hospital, Istanbul, TÜRKIYE
| | - Omer Sen
- Department of Cardiology, University of Health Sciences, Adana City Training and Research Hospital, Adana, TÜRKIYE
| | - Ahmet Guler
- Department of Cardiology, University of Health Sciences, Basaksehir Cam & Sakura City Hospital, Istanbul, TÜRKIYE
| | - Ali Riza Akyuz
- Department of Cardiology, University of Health Sciences, Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Trabzon, TÜRKIYE
| | - Levent Korkmaz
- Department of Cardiology, University of Health Sciences, Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Trabzon, TÜRKIYE
| | - Ibrahim Halil Kurt
- Department of Cardiology, University of Health Sciences, Adana City Training and Research Hospital, Adana, TÜRKIYE
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6
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Wang C, Hamid N, Bapat V, Cavalcante JL, Lesser JR, Walser-Kuntz E, Stanberry L, Enriquez-Sarano M, Sorajja P. Incidence, predictors and outcomes of tricuspid regurgitation progression after left-sided valvular intervention. Heart 2025:heartjnl-2024-325194. [PMID: 40312105 DOI: 10.1136/heartjnl-2024-325194] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/07/2024] [Accepted: 03/31/2025] [Indexed: 05/03/2025] Open
Abstract
BACKGROUND Tricuspid regurgitation (TR) progression following left-sided valvular heart disease (VHD) correction is a critical clinical concern. This study aimed to determine the incidence, predictors and outcomes of TR progression in a contemporary cohort. METHODS We analysed 1644 patients (mean age 73 years, 62% men) without severe TR who underwent surgical or transcatheter treatment for aortic or mitral disease between 2014 and 2018. TR progression was defined as an increase in TR grade to moderate or severe on follow-up echocardiography. RESULTS At 5 years, TR progression incidence was 12.0% (95% CI 10.5% to 13.7%). Baseline factors associated with TR progression included older age, female sex, atrial fibrillation, prior pacemaker implantation and larger tricuspid annular diameter (TAD). The relationship between TAD and TR progression was linear (HR 1.08; 95% CI 1.04 to 1.11; p<0.001), with sex differences mitigated by indexing TAD to body surface area. TR progression was associated with increased all-cause mortality (adjusted HR 2.77; 95% CI 2.16 to 3.56; p<0.001) and a combined endpoint of death or heart failure hospitalisation (adjusted HR 2.91; 95% CI 2.21 to 3.82; p<0.001). CONCLUSIONS TR progression is common after left-sided VHD correction and is associated with adverse outcomes. Indexing TAD to body surface area mitigates sex differences in risk assessment. These findings suggest that lower thresholds for prophylactic tricuspid intervention may be warranted in high-risk patients.
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Affiliation(s)
- Cheng Wang
- Center for Structural Heart Disease, Fuwai Hospital, CAMS and PUMC, Beijing, China
- Valve Science Center, Minneapolis Heart Institute, Minneapolis, Minnesota, USA
| | - Nadira Hamid
- Valve Science Center, Minneapolis Heart Institute, Minneapolis, Minnesota, USA
- Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota, USA
| | - Vinayak Bapat
- Valve Science Center, Minneapolis Heart Institute, Minneapolis, Minnesota, USA
- Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota, USA
| | - Joao L Cavalcante
- Valve Science Center, Minneapolis Heart Institute, Minneapolis, Minnesota, USA
- Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota, USA
| | - John R Lesser
- Valve Science Center, Minneapolis Heart Institute, Minneapolis, Minnesota, USA
- Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota, USA
| | - Evan Walser-Kuntz
- Valve Science Center, Minneapolis Heart Institute, Minneapolis, Minnesota, USA
| | - Larissa Stanberry
- Valve Science Center, Minneapolis Heart Institute, Minneapolis, Minnesota, USA
- Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota, USA
| | | | - Paul Sorajja
- Valve Science Center, Minneapolis Heart Institute, Minneapolis, Minnesota, USA
- Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota, USA
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7
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Kolte D, Marquis-Gravel G, Stebbins A, Vekstein AM, Vemulapalli S, Elmariah S. Temporal Trends in 1-Year Cause-Specific Mortality After TAVR: Insights From the STS/ACC TVT Registry. JACC Cardiovasc Interv 2025; 18:1013-1024. [PMID: 40117414 DOI: 10.1016/j.jcin.2024.12.016] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/04/2024] [Revised: 12/11/2024] [Accepted: 12/17/2024] [Indexed: 03/23/2025]
Abstract
BACKGROUND The impact of changing patient demographics and risk profiles on cause-specific mortality after transcatheter aortic valve replacement (TAVR) remains unclear. OBJECTIVES The aim of this study was to examine causes of death (CoDs) and temporal trends and predictors of cause-specific mortality after TAVR. METHODS Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were analyzed to identify patients who underwent isolated TAVR between January 2012 and October 2022 who had available information on 1-year CoD. The primary outcome was cause-specific (cardiac and noncardiac) mortality at 1 year. Fine and Gray subdistribution hazard models were used to account for the competing risk for cause-specific death. RESULTS Of 36,877 patients who died within 1 year after TAVR and had available information on CoD, 11,560 (31.3%) had cardiac death and 25,317 (68.7%) had noncardiac death. There was an initial decline in the risk-adjusted hazards of 1-year cardiac and noncardiac death after TAVR from 2012 to 2017 (adjusted HR per year: 0.95 [95% CI: 0.92-0.97] and 0.92 [95% CI: 0.90-0.93], respectively), followed by an increase from 2018 to 2022 (adjusted HR per year: 1.07 [95% CI: 1.05-1.09] and 1.22 [95% CI: 1.20-1.24], respectively). Age >80 years, comorbidities, poor functional status, nonelective procedure, nonfemoral access, and in-hospital complications were identified as independent predictors of both cardiac and noncardiac death after TAVR. CONCLUSIONS Noncardiac causes account for two-thirds of deaths within 1 year after TAVR. Further studies are needed to examine whether the COVID-19 pandemic, the rapid expansion in the number of TAVR sites, or other patient and hospital characteristics contributed to the increased risk for cardiac and noncardiac death after TAVR in recent years.
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Affiliation(s)
- Dhaval Kolte
- Cardiology Division, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.
| | - Guillaume Marquis-Gravel
- Duke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA
| | - Amanda Stebbins
- Duke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA
| | - Andrew M Vekstein
- Duke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA
| | - Sreekanth Vemulapalli
- Duke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA
| | - Sammy Elmariah
- Division of Cardiology, University of California-San Francisco, Medical Center, San Francisco, California, USA
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8
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Mengi S, Nombela-Franco L, Cepas-Guillén P, Lerakis S, Makkar R, Chakravarty T, Babaliaros V, Ribeiro HB, Pelletier-Beaumont E, Pibarot P, Rodés-Cabau J. Temporal Trends in Transcatheter Aortic Valve Replacement Outcomes in Patients With Low-Flow, Low-Gradient Aortic Stenosis: Insights From the TOPAS-TAVI Registry. Can J Cardiol 2025:S0828-282X(25)00318-6. [PMID: 40287133 DOI: 10.1016/j.cjca.2025.04.015] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2025] [Revised: 04/14/2025] [Accepted: 04/16/2025] [Indexed: 04/29/2025] Open
Abstract
BACKGROUND Transcatheter aortic valve replacement (TAVR) technology and techniques have continuously improved, but data on their impact in low-flow, low-gradient aortic stenosis (LFLG-AS) remain limited. In particular, scarce data exist comparing the results of TAVR with new-generation devices vs early-generation devices in these patients. This study evaluated the temporal trends in TAVR practices among LFLG-AS patients. METHODS This multicentre registry included 424 LFLG-AS patients undergoing TAVR from 2007 to 2023, stratified by device generation: new-generation devices (n = 193) and early-generation devices (n = 231). All-cause mortality or heart failure hospitalization (HFH) at 1-year follow-up was the primary end point. RESULTS The median Society of Thoracic Surgeons score was lower in the new-generation group (5.3% [interquartile range [IQR] 3.4%-8.2%] vs 7.4% [IQR 5.0%-12.1%]; P < 0.001), whereas left ventricular ejection fractions (LVEFs) were similar (new: 31.2 ± 8.3%; early: 30.0 ± 8.8%; P = 0.16). New-generation devices were associated with a significant reduction in moderate-to-severe paravalvular leak after TAVR (2.6% vs 9.1%; P = 0.005), although 30-day mortality was similar (new: 1.6%; early: 3.9%; P = 0.15). At 1 year, new-generation devices were associated with a greater LVEF improvement (43.8 ± 12.5% vs 39.8 ± 11.5%; P = 0.003), but without a significant reduction in all-cause mortality or HFH (new: 23.8%; early: 28.1%; P = 0.32). Chronic kidney disease and low hemoglobin independently predicted worse outcomes (P < 0.05). CONCLUSIONS Despite procedural improvements with new-generation TAVR devices, clinical outcomes in LFLG-AS patients remain suboptimal. LVEF significantly improved after TAVR with new-generation devices but failed to translate into improved clinical outcomes. These findings suggest that TAVR alone may not suffice in this population and underscore the need for a comprehensive therapeutic approach that integrates TAVR with optimized medical management and cardiac rehabilitation.
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Affiliation(s)
- Siddhartha Mengi
- Québec Heart and Lung Institute, Laval University, Québec City, Québec, Canada
| | - Luis Nombela-Franco
- Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain
| | - Pedro Cepas-Guillén
- Québec Heart and Lung Institute, Laval University, Québec City, Québec, Canada
| | | | - Raj Makkar
- Cedars-Sinai Medical Center, Los Angeles, California, USA
| | | | | | - Henrique Barbosa Ribeiro
- Québec Heart and Lung Institute, Laval University, Québec City, Québec, Canada; Instituto do Coração (InCor), Sao Paulo, Brazil
| | | | - Philippe Pibarot
- Québec Heart and Lung Institute, Laval University, Québec City, Québec, Canada
| | - Josep Rodés-Cabau
- Québec Heart and Lung Institute, Laval University, Québec City, Québec, Canada.
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9
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Liu R, Li Y, Zhang L, Lu Z, Fu Z, Modine T, Jilahawi H, Pocock S, Wu Y, Song G. Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve Replacement. J Am Heart Assoc 2025; 14:e039350. [PMID: 40118800 DOI: 10.1161/jaha.124.039350] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2024] [Accepted: 01/28/2025] [Indexed: 03/23/2025]
Abstract
BACKGROUND Current guidelines and expert consensus recommend lifelong single antiplatelet therapy for patients undergoing transcatheter aortic valve replacement who have no indication for anticoagulation or dual antiplatelet therapy. However, there is no direct evidence from randomized controlled trials supporting this practice. Furthermore, the optimal duration of antiplatelet therapy in this population has not been adequately investigated. METHODS AND RESULTS CREATE (A Multicenter Randomized Controlled Study to Evaluate Cessation of Antithrombotic Therapy at 1 Year in TAVR Patients-The CREATE Study) is a prospective, multicenter, open-label, randomized controlled trial for patients who have undergone successful transcatheter aortic valve replacement and have no indication for long-term oral anticoagulation or antiplatelet therapy. Eligible patients are free from major bleeding and ischemic events for 1 year postprocedure before being randomized 1:1 to single antiplatelet therapy (control group) or no antiplatelet therapy (experimental group). The primary efficacy end point is the incidence of bleeding events, defined by the VARC-3 (Valve Academic Research Consortium-3) criteria, at 1-year postrandomization. The primary safety end point is a composite of cardiac death, myocardial infarction, and ischemic stroke at 1 year. The trial is powered for both superiority in efficiency and noninferiority in safety. Accordingly, a total of 3380 patients will be enrolled. CONCLUSIONS The CREATE trial aims to assess if stopping antiplatelet therapy at 1-year after transcatheter aortic valve replacement reduces bleeding risk without increasing ischemic events in patients not requiring chronic antithrombotic therapy. REGISTRATION URL: https://www.chictr.org.cn; Unique identifier: ChiCTR2400087454.
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Affiliation(s)
- Ran Liu
- Interventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing China
| | - Yang Li
- Interventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing China
| | - Lihua Zhang
- Cardiovascular Disease Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China
| | - Zhinan Lu
- Interventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing China
| | - Zhaolin Fu
- Interventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing China
| | - Thomas Modine
- Department of Cardiology and Cardio-Vascular Surgery Hôpital Cardiologique de Haut-Leveque, Bordeaux University Hospital Bordeaux France
| | - Hasan Jilahawi
- Cedars-Sinai Medical Center Smidt Heart Institute Los Angeles CA USA
| | - Stuart Pocock
- London School of Hygiene and Tropical Medicine London United Kingdom
| | - Yongjian Wu
- Cardiovascular Disease Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China
| | - Guangyuan Song
- Interventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing China
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10
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Tomii D, Heg D, Nakase M, Samim D, Lanz J, Praz F, Stortecky S, Reineke D, Windecker S, Pilgrim T. Flow Status-Based Predicted Prosthesis-Patient Mismatch in Patients Undergoing Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve. STRUCTURAL HEART : THE JOURNAL OF THE HEART TEAM 2025; 9:100379. [PMID: 40321306 PMCID: PMC12047503 DOI: 10.1016/j.shj.2024.100379] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 07/16/2024] [Revised: 10/17/2024] [Accepted: 10/24/2024] [Indexed: 05/08/2025]
Abstract
Background Effective orifice area (EOA) is flow dependent. However, established methods for the assessment of predicted prosthesis-patient mismatch (PPM) do not consider flow status and therefore may underestimate the rate and impact of PPM in patients with abnormal flow status. This study aimed to investigate the clinical impact of flow status-based predicted PPM in patients undergoing transcatheter aortic valve replacement (TAVR). Methods Patients undergoing TAVR in a prospective TAVR registry were stratified by the presence of moderate or severe PPM (EOA index to body surface area [EOAi]: 0.65-0.85 or ≤0.65 and 0.55-0.70 or ≤0.55 cm2/m2 if obese). PPM was defined according to echocardiographically measured EOAi (measured PPM) or predicted or flow status-based predicted EOAi. Predicted EOAs were based on reference values of EOA for each valve generation and size (predicted PPMTHV) or native aortic annulus dimension (predicted PPMCT). Results Among 1510 patients included (August 2007-June 2022), rates of moderate or severe PPM differed according to method of assessment: 27.0 and 8.7% according to measured PPM, 11.3 and 1.2% according to predicted PPMTHV, 12.0 and 0.1% according to PPMCT, 21.6 and 0.2% according to flow status-based predicted PPMTHV, and 25.1 and 0.4% according to flow status-based predicted PPMCT. Five-year mortality was comparable in patients with and without flow status-based predicted PPM defined by either method. These results were consistent when patients were stratified by flow status. Conclusions Rates of PPM differ considerably when flow status is considered. There was no consistent signal of increased risk of adverse events up to 5 years in patients with flow status-based predicted PPM. Clinical Trial Registration https://www.clinicaltrials.gov. NCT01368250.
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Affiliation(s)
- Daijiro Tomii
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - Dik Heg
- Department of Clinical Research, University of Bern, Bern, Switzerland
| | - Masaaki Nakase
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - Daryoush Samim
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - Jonas Lanz
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - Fabien Praz
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - Stefan Stortecky
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - David Reineke
- Department of Cardiovascular Surgery, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - Stephan Windecker
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - Thomas Pilgrim
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
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11
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Mas-Peiro S, Lhermusier T, Urena M, Nombela-Franco L, Vilalta V, Muñoz-Garcia A, Amat-Santos I, Atienza F, Kleiman N, Chamandi C, Serra V, Deyell MW, Campelo-Parada F, Mondoly P, Suc G, Canadas-Godoy V, Fernandez-Nofrerias E, Castrodeza J, Elizaga J, Baudinaud P, Francisco Pascual J, Webb JG, Pelletier-Beaumont E, Philippon F, Rodés-Cabau J. Late arrhythmic burden in patients with left bundle branch block after TAVR with the Evolut valve. Europace 2025; 27:euaf057. [PMID: 40103312 PMCID: PMC11983392 DOI: 10.1093/europace/euaf057] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/28/2024] [Revised: 03/04/2025] [Accepted: 03/06/2025] [Indexed: 03/20/2025] Open
Abstract
AIMS Arrhythmic burden after discharge in patients with new-onset persistent left bundle branch block (NOP-LBBB) following transcatheter aortic valve replacement (TAVR) with Evolut devices remains largely unknown. The aim of this study is to assess the incidence and type of arrhythmias at 2-year follow-up in patients with NOP-LBBB post-TAVR. METHODS AND RESULTS This is a prospective multicentre study including 88 patients with LBBB persisting for ≥3 days post-implantation. Before discharge, an implantable loop recorder (REVEAL XT/LINQ) was implanted; patients had continuous monitoring for 2 years. Arrhythmic events were adjudicated in a central core lab. Of the arrhythmic events, 411 were detected in 58 patients [65.9%; 2 (1-4) events per patient]. Symptoms were reported in 12/58 (20.7%), and therapy was changed in 25/58 (43.1%). There were 101 bradyarrhythmic events in 33 patients [35 high-grade atrioventricular block (HAVB) and 66 severe bradycardia]. The HAVB incidence was higher in the early (4-week) phase and remained stable over time, whereas severe bradycardia increased after 1 year. Permanent pacemaker was required in 11 (12.5%) patients (6.8% and 5.7% in the first and second year, respectively). There were 310 tachyarrhythmic events in 29 patients (120 AF/AFL, 111 AT, 72 SVT, 6 NSVT, and 1 VT); its incidence decreased throughout the 2 years. New AF/AFL episodes occurred in 20/69 patients [29%; symptomatic in 2/20 (10%)]. CONCLUSION Patients with NOP-LBBB post-TAVR with Evolut devices exhibited a high burden of late arrhythmias, with events occurring in two-thirds of patients and leading to treatment changes in about half of them. These data should inform future studies on cardiac monitoring devices for follow-up and treatment optimization in this challenging population.
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Affiliation(s)
- Silvia Mas-Peiro
- Department of Cardiology, Quebec Heart & Lung Institute, Laval University, 2725 Chemin Ste-Foy, Quebec City, Quebec, Canada G1V4G5
| | - Thibault Lhermusier
- Department of Cardiology, Hôpital Universitaire de Toulouse, Toulouse, France
| | - Marina Urena
- Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat-Claude Bernard, Paris, France
| | - Luis Nombela-Franco
- Instituto Cardiovascular, Hospital Clinico San Carlos, IdISSC, Madrid, Spain
| | - Victoria Vilalta
- Department of Cardiology, Hospital Germans Trias i Pujol, Badalona, Spain
| | | | - Ignacio Amat-Santos
- Department of Cardiology, Hospital Universitario de Valladolid, Valladolid, Spain
| | - Felipe Atienza
- Department of Cardiology, Hospital Gregorio Marañón, Madrid, Spain
| | - Neal Kleiman
- Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA
| | | | - Vicenç Serra
- Department of Cardiology, Hospital Universitari Vall d’Hebron, CIBER-CV, Barcelona, Spain
| | - Marc W Deyell
- Department of Cardiology, St Paul’s Hospital, Vancouver, Canada
| | | | - Pierre Mondoly
- Department of Cardiology, Hôpital Universitaire de Toulouse, Toulouse, France
| | - Gaspard Suc
- Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat-Claude Bernard, Paris, France
| | | | | | - Javier Castrodeza
- Department of Cardiology, Hospital Universitario de Valladolid, Valladolid, Spain
| | - Jaime Elizaga
- Department of Cardiology, Hospital Gregorio Marañón, Madrid, Spain
| | - Pierre Baudinaud
- Department of Cardiology, Hôpital Européen George Pompidou, Paris, France
| | | | - John G Webb
- Department of Cardiology, St Paul’s Hospital, Vancouver, Canada
| | - Emilie Pelletier-Beaumont
- Department of Cardiology, Quebec Heart & Lung Institute, Laval University, 2725 Chemin Ste-Foy, Quebec City, Quebec, Canada G1V4G5
| | - François Philippon
- Department of Cardiology, Quebec Heart & Lung Institute, Laval University, 2725 Chemin Ste-Foy, Quebec City, Quebec, Canada G1V4G5
| | - Josep Rodés-Cabau
- Department of Cardiology, Quebec Heart & Lung Institute, Laval University, 2725 Chemin Ste-Foy, Quebec City, Quebec, Canada G1V4G5
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12
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Papadopoulos GE, Ninios I, Leptopoulos E, Papazoglou K, Konstantinidis K, Evangelou S, Ioannides A, Ninios V. Comparative analysis of percutaneous vs. surgical access in transfemoral TAVR: a propensity-matched cohort study. Hellenic J Cardiol 2025:S1109-9666(25)00053-3. [PMID: 40058643 DOI: 10.1016/j.hjc.2025.03.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/06/2024] [Accepted: 03/03/2025] [Indexed: 03/29/2025] Open
Abstract
OBJECTIVE Transcatheter aortic valve replacement (TAVR) is a proven treatment for severe aortic stenosis. Transfemoral access is the most prevalent method, achieved either surgically or percutaneously. This study compared in-hospital outcomes and length of stay between surgical cut-down and fully percutaneous approaches. METHODS This retrospective, propensity-matched study analyzed medical records of all patients who underwent transfemoral TAVR at our center from January 2019 to December 2023. Outcomes were assessed based on Valve Academic Research Consortium-2 (VARC-2) consensus criteria. RESULTS A total of 251 TAVR patients (77 propensity score-matched pairs) were included (55% female) with a median (IQR) age of 80 (11) years. Surgical cut-down showed fewer vascular complications, bleeding, and transfusions. No death was reported in this group. Fewer mean hospitalization days were observed in the total cohort over the years (p < 0.001). This reduction was more pronounced after 2021 when the surgical approach was adopted. Mean hospitalization days were 6.40 ± 6.46 for percutaneous and 4.34 ± 1.61 for surgical groups (p < 0.001). CONCLUSION Surgical cut-down for TAVR femoral access yields superior outcomes and shorter hospital stays compared to fully percutaneous methods.
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Affiliation(s)
| | - Ilias Ninios
- 2nd Cardiology Department, Interbalkan Medical Center, Thessaloniki, Greece
| | | | | | | | - Sotirios Evangelou
- 2nd Cardiology Department, Interbalkan Medical Center, Thessaloniki, Greece
| | - Andreas Ioannides
- 2nd Cardiology Department, Interbalkan Medical Center, Thessaloniki, Greece
| | - Vlasis Ninios
- 2nd Cardiology Department, Interbalkan Medical Center, Thessaloniki, Greece.
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13
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Stolte T, Lopez-Ayala P, Reichl J, Pfenniger A, Allegra G, Leibundgut G, Kaiser C, Boeddinghaus J, Mahfoud F, Mueller C, Nestelberger T. The impact of myocardial injury on outcomes in TAVI patients. Clin Res Cardiol 2025; 114:385-394. [PMID: 39663248 PMCID: PMC11913931 DOI: 10.1007/s00392-024-02585-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/20/2024] [Accepted: 11/29/2024] [Indexed: 12/13/2024]
Abstract
BACKGROUND Peri-procedural myocardial injury (PPMI) has been commonly reported after transcatheter aortic valve implantation (TAVI) and may have a potential impact on outcomes. The recent update to the Valve Academic Research Consortium (VARC)-3 criteria for PPMI warrants a comparison with the preceding VARC-2 criteria to understand its implications on patient outcomes. AIMS To assess the prognostic significance of PPMI as defined by VARC-3 versus VARC-2 in TAVI patients and evaluate the predictive value of high-sensitivity cardiac troponin T (hs-cTnT) for adverse outcomes within 1 year post-TAVI. METHODS Consecutive patients undergoing TAVI in a tertiary university hospital between December 2011 and June 2023, with hs-cTnT concentrations pre- and post-procedurally, were enrolled. The primary outcome was all-cause mortality at 1 year. Secondary outcomes were major cardiac adverse events (MACE), defined as a composite end point including all-cause mortality, unplanned reintervention, stroke, myocardial infarction, or major bleeding at 30 days and 1 year. RESULTS Of 653 patients, 535 (82%) had elevated baseline serum hs-cTnT. It was a significant predictor of 1-year mortality and MACE, whereas post-TAVI hs-cTnT concentrations did not predict outcomes (HR: 1.5, p = 0.21 and HR: 0.943, p = 0.54). 367 (56%) of all patients met VARC-2 PPMI criteria, while only 24 (3.7%) met VARC-3 criteria. Patients meeting VARC-3 criteria had significantly more comorbidities and higher 1-year mortality (25% vs. 9%; p = 0.0047). VARC-2 criteria did not predict higher mortality (9% vs. 9%; p = 0.69). CONCLUSIONS Baseline hs-cTnT concentrations strongly predicted 1-year mortality and MACE, while post-procedure levels did not. VARC-3 criteria provided better prognostic discrimination than VARC-2.
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Affiliation(s)
- Thorald Stolte
- Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Petersgraben 4, CH-4031, Basel, Switzerland
- Department of Health Sciences and Technology, Swiss Federal Institute of Technology, Zurich, Switzerland
| | - Pedro Lopez-Ayala
- Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Petersgraben 4, CH-4031, Basel, Switzerland
| | - Jakob Reichl
- Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Petersgraben 4, CH-4031, Basel, Switzerland
| | - Anna Pfenniger
- Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Petersgraben 4, CH-4031, Basel, Switzerland
| | - Giampiero Allegra
- Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Petersgraben 4, CH-4031, Basel, Switzerland
| | - Gregor Leibundgut
- Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Petersgraben 4, CH-4031, Basel, Switzerland
| | - Christoph Kaiser
- Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Petersgraben 4, CH-4031, Basel, Switzerland
| | - Jasper Boeddinghaus
- Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Petersgraben 4, CH-4031, Basel, Switzerland
| | - Felix Mahfoud
- Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Petersgraben 4, CH-4031, Basel, Switzerland
| | - Christian Mueller
- Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Petersgraben 4, CH-4031, Basel, Switzerland
| | - Thomas Nestelberger
- Department of Cardiology and Cardiovascular Research Institute Basel (CRIB), University Hospital Basel, University of Basel, Petersgraben 4, CH-4031, Basel, Switzerland.
- Department of Cardiac Surgery, University Hospital Basel, University of Basel, Basel, Switzerland.
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14
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Bay B, Gitto M, Sartori S, Vogel B, Tchetche D, Petronio AS, Mehilli J, Di Muro FM, Lefevre T, Presbitero P, Capranzano P, Oliva A, Iadanza A, Leone PP, Sardella G, van Mieghem NM, Kim CJ, Meliga E, Feng Y, Dumonteil N, Fraccaro C, Trabattoni D, Mikhail G, Ferrer-Gracia MC, Naber C, Sharma SK, Watanabe Y, Morice MC, Dangas GD, Chieffo A, Mehran R. Clinical Outcomes According to the Extent of Atherosclerotic Disease in Female Patients Undergoing Transcatheter Aortic Valve Replacement: An Analysis From the WIN-TAVI Registry. Catheter Cardiovasc Interv 2025; 105:891-899. [PMID: 39776285 DOI: 10.1002/ccd.31395] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/11/2024] [Revised: 10/23/2024] [Accepted: 12/22/2024] [Indexed: 01/11/2025]
Abstract
BACKGROUND Limited data exist on the impact of polyvascular disease (PolyVD) on clinical outcomes in female patients undergoing transcatheter aortic valve replacement (TAVR). We therefore sought to investigate clinical outcomes in women with versus without PolyVD undergoing TAVR. METHODS Female participants from the multicentre Women's International Transcatheter Aortic Valve Implantation (WIN-TAVI) registry were categorized based on the presence or absence of PolyVD. The PolyVD population was defined as the presence of atherosclerotic disease affecting ≥ 2 arterial systems from coronary, cerebral, or lower limb peripheral vessels, whilst patients with either no atherosclerosis or atherosclerotic disease in one vascular system were included in the non-PolyVD population. The primary endpoint was the Valve Academic Research Consortium-2 consensus (VARC-2) efficacy endpoint at 1 year, whilst secondary endpoints included VARC-2 safety events, VARC-2 major bleeding and major vascular complications. Cox regression analysis were computed adjusting for various cofounders. RESULTS Among 996 participants, 543 (54.5%) had PolyVD, while 453 (45.5%) did not. Across the subgroups no differences in age was noted, whilst patients with PolyVD were more likely to have a history of hypercholesterolemia and a previous cardiac surgery. The incidence of the primary endpoint was higher in the PolyVD group (19.4%) compared to the non-PolyVD group (13.3%, plog-rank = 0.014), though the difference was attenuated after multivariable adjustments (p = 0.093). Of note, no statistically significant differences concerning incident VARC-2 safety events, VARC-2 major bleeding and major vascular complications were noted according to PolyVD status. CONCLUSION PolyVD is a common comorbidity and is associated with elevated rates of adverse clinical events, but no increase in safety events, vascular complications, or bleeding among women undergoing TAVR.
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Affiliation(s)
- Benjamin Bay
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Department of Cardiology, University Heart & Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
| | - Mauro Gitto
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
| | - Samantha Sartori
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Birgit Vogel
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | | | | | - Julinda Mehilli
- Medizinische Klinik I, Landshut-Achdorf Hospital, Landshut, Germany
- Klinikum der Universität München, Ludwig-Maximilians-Universität, Munich, Germany
- German Centre for Cardiovascular Research (DZHK), partner site Munich Heart Alliance, Munich, Germany
| | - Francesca Maria Di Muro
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Clinica Medica, Careggi University Hospital, Florence, Italy
| | - Thierry Lefevre
- Institut Hospitalier Jacques Cartier, Ramsay Générale de Santé, Massy, France
| | | | - Piera Capranzano
- Cardiology, Policlinico Hospital, University of Catania, Catania, Italy
| | - Angelo Oliva
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
| | - Alessandro Iadanza
- Azienda Ospedaliera Universitaria Senese, Policlinico Le Scotte, Siena, Italy
| | - Pier Pasquale Leone
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Gennaro Sardella
- Policlinico Umberto I "Sapienza," University of Rome, Rome, Italy
| | | | - Chan Joon Kim
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
- Division of Cardiology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea
| | | | - Yihan Feng
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | | | | | | | - Ghada Mikhail
- Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, UK
| | | | - Christoph Naber
- Contilia Heart and Vascular Centre, Elisabeth Krankenhaus, Essen, Germany
| | - Samin K Sharma
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Yusuke Watanabe
- Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan
| | - Marie-Claude Morice
- Institut Cardiovasculaire Paris-Sud (ICPS), Hôpital privé Jacques Cartier, Ramsay-Santé, Massy, France
| | - George D Dangas
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | | | - Roxana Mehran
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
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15
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Tomii D, Lanz J, Heg D, Möllmann H, Kim WK, Burgdorf C, Linke A, Redwood S, Hilker M, Joner M, Thiele H, Conradi L, Kerber S, Thilo C, Toggweiler S, Prendergast B, Walther T, Windecker S, Pilgrim T. The Impact of Frailty on VARC-3 Integrated Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement. JACC. ADVANCES 2025; 4:101594. [PMID: 39954343 PMCID: PMC11872499 DOI: 10.1016/j.jacadv.2025.101594] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/05/2024] [Revised: 12/23/2024] [Accepted: 01/03/2025] [Indexed: 02/17/2025]
Abstract
BACKGROUND TAVR is preferred over surgical aortic valve replacement in frail patients with aortic stenosis. The assessment of the treatment benefit of TAVR in this population is however equivocal. OBJECTIVES The purpose of this study was to investigate the impact of frailty on clinical and patient-reported outcomes in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS Patients in the SCOPE I (Safety and Efficacy of the ACURATE Neo/TF Compared to the SAPIEN 3 Bioprosthesis) trial were stratified according to frailty, defined as a multicomponent index that included loss of independence criteria based on activities of daily living, lean body mass, serum albumin, and cognitive impairment or dementia. The outcomes of interest included an endpoint integrating vital and patient-reported disease-specific health status, as well as clinical efficacy according to the Valve Academic Research Consortium (VARC)-3 definition. RESULTS Among 739 randomized patients, 122 patients (16.5%) met the definition of frailty. Mean age, comorbidities, and surgical risk were comparable between groups. Patients with and without frailty had similar improvement in patient-reported health status measures after TAVR, while patients with frailty had an increased risk of VARC-3 unfavorable outcome (risk ratio: 1.38, 95% CI: towards reduced VARC-3 clinical efficacy (risk ratio: 0.82; 95% CI: 0.65-1.03) at 3 years after TAVR. CONCLUSIONS More than 1 in 6 patients with severe aortic stenosis undergoing TAVR were considered frail in the SCOPE I trial. Patients with frailty had a similar improvement in patient-reported health status measures after TAVR, but a higher risk of unfavorable outcomes throughout 3 years of follow-up.
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Affiliation(s)
- Daijiro Tomii
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - Jonas Lanz
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - Dik Heg
- Department of Clinical Research, University of Bern, Bern, Switzerland
| | - Helge Möllmann
- Department of Internal Medicine I, St-Johannes-Hospital, Dortmund, Germany
| | - Won-Keun Kim
- Department of Cardiology, Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany
| | - Christof Burgdorf
- Department of Cardiology, Heart, and Vascular Center, Bad Bevensen, Germany
| | - Axel Linke
- Department of Internal Medicine and Cardiology, Heart Centre Dresden, Technische Universität Dresden, Dresden, Germany
| | - Simon Redwood
- Department of Cardiology, St Thomas' Hospital & Cleveland Clinic, London, United Kingdom
| | - Michael Hilker
- Department of Cardiothoracic Surgery, University Medical Centre, Regensburg, Germany
| | - Michael Joner
- German Heart Centre, Technical University of Munich, Munich, Germany
| | - Holger Thiele
- Department of Cardiology, Heart Center Leipzig, Leipzig, Germany
| | - Lenard Conradi
- Department of Cardiovascular Surgery, University Heart Centre Hamburg, Hamburg, Germany
| | - Sebastian Kerber
- Department of Cardiology, Cardiovascular Centre Bad Neustadt, Bad Neustadt, Germany
| | - Christian Thilo
- Department of Internal Medicine I, RoMed Klinikum, Rosenheim, Germany
| | | | - Bernard Prendergast
- Department of Cardiology, St Thomas' Hospital & Cleveland Clinic, London, United Kingdom
| | - Thomas Walther
- Department of Cardiac, Thoracic and Thoracic Vascular Surgery, University Hospital Frankfurt, Frankfurt, Germany
| | - Stephan Windecker
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland
| | - Thomas Pilgrim
- Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.
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16
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Al Said S, Kaier K, Nury E, Alsaid D, Gibson CM, Bax J, Westermann D, Meerpohl JJ. Non-vitamin K antagonist oral anticoagulants (NOACs) after transcatheter aortic valve replacement (TAVR): a network meta-analysis. Cochrane Database Syst Rev 2025; 2:CD013745. [PMID: 39991882 PMCID: PMC11848970 DOI: 10.1002/14651858.cd013745.pub2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/25/2025]
Abstract
BACKGROUND Balancing the risk of thromboembolism and bleeding after transcatheter aortic valve replacement (TAVR) remains clinically challenging. Questions regarding the efficacy and safety of non-vitamin K oral anticoagulants (NOACs) after TAVR still need to be definitively answered. OBJECTIVES To evaluate the efficacy and safety of NOACs after TAVR in individuals with and without indication for anticoagulation. SEARCH METHODS We searched CENTRAL, MEDLINE, Embase, Web of Science, ClinicalTrials.gov, and WHO ICTRP on 7 October 2023 together with reference checking and citation searching to identify additional studies. SELECTION CRITERIA We searched for randomised controlled trials (RCTs) that compared NOACs versus antiplatelet therapy or vitamin K antagonists (VKAs) after TAVR in adults with or without an indication for anticoagulation. DATA COLLECTION AND ANALYSIS We used standard Cochrane methods and conducted random-effects pair-wise analyses and network meta-analyses (NMAs). Our primary outcomes were all-cause mortality, cardiovascular mortality, stroke, and major bleeding. We used GRADE to assess the certainty of evidence. MAIN RESULTS We included four RCTs with 4808 participants in the NMA. Of these, one compared rivaroxaban versus antiplatelet therapy in people without an indication for anticoagulation after TAVR; one compared apixaban versus antiplatelet therapy in people without an indication for anticoagulation or versus VKA in people with an indication for anticoagulation after TAVR; one compared edoxaban versus VKA in people with an indication for anticoagulation after TAVR; and one compared edoxaban with antiplatelet therapy in people without an indication for anticoagulation after TAVR. The mean age of trial participants was 81 years. Follow-up duration ranged from 6 to 18 months. Overall, we judged the risk of bias in the included trials to be low in all domains except for blinding, which was assessed as high in all four studies. No studies evaluated dabigatran. In people without an indication for anticoagulation, rivaroxaban and apixaban may increase all-cause mortality after TAVR as compared to antiplatelet therapy (rivaroxaban: risk ratio (RR) 1.67, 95% confidence interval (CI) 1.13 to 2.46; studies = 1, participants = 1644; moderate-certainty evidence; apixaban: RR 1.71, 95% CI 0.97 to 3.02; studies = 1, participants = 1049; low-certainty evidence), while edoxaban may result in little or no difference (RR 1.59, 95% CI 0.27 to 9.36; studies = 1, participants = 229; low-certainty evidence). Low-certainty evidence suggests little or no difference between rivaroxaban, apixaban, or edoxaban and antiplatelet therapy in cardiovascular mortality (rivaroxaban: RR 1.28, 95% CI 0.78 to 2.10; studies = 1, participants = 1644; apixaban: RR 1.30, 95% CI 0.64 to 2.65; studies = 1, participants = 1049; edoxaban: RR 7.44, 95% CI 0.39 to 142.38; studies = 1, participants = 229) and between rivaroxaban or edoxaban and antiplatelets in stroke (rivaroxaban: RR 1.19, 95% CI 0.71 to 2.00; studies = 1, participants = 1644; edoxaban: RR 1.06, 95% CI 0.15 to 7.42; studies = 1, participants = 229). While rivaroxaban versus antiplatelets probably increases major bleeding after TAVR (RR 1.98, 95% CI 1.07 to 3.65; studies = 1, participants = 1644; moderate-certainty evidence), there may be little or no difference between apixaban and antiplatelet therapy (RR 1.07, 95% CI 0.70 to 1.64; studies = 1, participants = 1049; low-certainty evidence). It is unclear if edoxaban has an effect on major bleeding, although the point estimate suggests increased bleeding (versus antiplatelets: RR 2.13, 95% CI 0.54 to 8.30; studies = 1, participants = 229; low-certainty evidence). In people with an indication for anticoagulation, low-certainty evidence suggests apixaban or edoxaban may result in little to no difference in our predefined primary efficacy outcomes after TAVR when compared to VKA (all-cause mortality: apixaban: RR 1.02, 95% CI 0.59 to 1.77; studies = 1, participants = 451; edoxaban: RR 0.91, 95% CI 0.69 to 1.20; studies = 1, participants = 1426; cardiovascular mortality: apixaban: RR 1.43, 95% CI 0.76 to 2.70; studies = 1, participants = 451; edoxaban: RR 1.07, 95% CI 0.72 to 1.57; studies = 1, participants = 1426; stroke: apixaban: RR 1.28, 95% CI 0.35 to 4.70; studies = 1, participants = 451; edoxaban: RR 0.83, 95% CI 0.51 to 1.34; studies = 1, participants = 1426). While apixaban may result in a similar rate of bleeding as VKA in this population, edoxaban probably increases major bleeding after TAVR in people with an indication for anticoagulation (apixaban: RR 0.90, 95% CI 0.53 to 1.54; studies = 1, participants = 451; low-certainty evidence; edoxaban: RR 1.44, 95% CI 1.08 to 1.93; studies = 1, participants = 1426; moderate-certainty evidence). AUTHORS' CONCLUSIONS In people without an indication for oral anticoagulation, rivaroxaban and apixaban may increase all-cause mortality when compared to antiplatelet therapy, while edoxaban may result in little or no difference. There might be little or no difference between rivaroxaban, apixaban, or edoxaban and antiplatelet therapy in cardiovascular mortality, and between rivaroxaban or edoxaban and antiplatelets in stroke. While rivaroxaban probably increases major bleeding following TAVR, there might be little or no difference between apixaban and antiplatelet therapy, and the effect of edoxaban on major bleeding remains unclear. In people with an indication for anticoagulation, apixaban and edoxaban may be as effective as VKA in preventing all-cause mortality, cardiovascular death, and stroke. Apixaban may lead to a similar rate of major bleeding as VKA in this population. However, edoxaban probably increases major bleeding following TAVR when compared to VKA. Our NMA did not show superiority of one NOAC over another for any of the primary outcomes. Head-to-head trials directly comparing NOACs against each other are required to increase the certainty of the evidence.
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Affiliation(s)
- Samer Al Said
- Department of Cardiology and Angiology, University Heart Center Freiburg Bad Krozingen, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
| | - Klaus Kaier
- Institute for Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany
| | - Edris Nury
- Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
- Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
| | - Dima Alsaid
- Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
| | - C Michael Gibson
- Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
| | - Jeroen Bax
- Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands
| | - Dirk Westermann
- Department of Cardiology and Angiology, University Heart Center Freiburg Bad Krozingen, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
| | - Joerg J Meerpohl
- Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
- Cochrane Germany, Cochrane Germany Foundation, Freiburg, Germany
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17
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Yamanaka F, Shishido K, Moriyama N, Ochiai T, Miyashita H, Yokoyama H, Sugiyama Y, Yashima F, Ohno Y, Nishina H, Izumo M, Asami M, Naganuma T, Mizutani K, Yamawaki M, Tada N, Shirai S, Noguchi M, Ueno H, Takagi K, Watanabe Y, Yamamoto M, Saito S, Hayashida K, OCEAN-TAVI Investigators. Incidence and Prognosis of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement for Bicuspid Aortic Stenosis. JACC Cardiovasc Interv 2025; 18:492-502. [PMID: 39797833 DOI: 10.1016/j.jcin.2024.10.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/31/2024] [Revised: 09/26/2024] [Accepted: 10/01/2024] [Indexed: 01/13/2025]
Abstract
BACKGROUND Evidence regarding the incidence of prosthesis-patient mismatch (PPM) and long-term mortality after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS) is scarce. OBJECTIVES This study sought to assess the incidence and prognostic impact of PPM after TAVR for bicuspid AS compared with that for tricuspid AS. METHODS In total, 7,393 patients who underwent TAVR were prospectively enrolled in the OCEAN-TAVI (Optimized Catheter Valvular Intervention Transcatheter Aortic Valve Implantation) registry, an ongoing Japanese, multicenter registry. We analyzed 7,051 patients (median age = 85 years, 68.4% women) and identified 503 (7.1%) with bicuspid AS. We compared the incidence of PPM and long-term mortality in 497 patients with and 497 without bicuspid AS after one-to-one propensity score matching analysis. RESULTS Among the 7,051 patients, moderate and severe PPM were observed in 756 (10.7%) and 92 (1.3%) patients, respectively. Upon Kaplan-Meier curve analysis of the overall cohort, severe PPM appeared to be associated with long-term mortality (log-rank test, P = 0.065). After propensity score matching analysis, moderate and severe PPM were more frequently observed among patients with tricuspid AS than patients with bicuspid AS (moderate PPM, 11.7% vs 4.4%; severe PPM, 1.4% vs 1.0%; P = 0.0001). CONCLUSIONS Severe PPM appeared to be associated with all-cause mortality. Moderate and severe PPM were more frequently observed in patients with tricuspid AS than patients with bicuspid AS.
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Affiliation(s)
- Futoshi Yamanaka
- Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan.
| | - Koki Shishido
- Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan
| | - Noriaki Moriyama
- Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan
| | - Tomoki Ochiai
- Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan
| | - Hirokazu Miyashita
- Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan
| | - Hiroaki Yokoyama
- Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan
| | - Yoichi Sugiyama
- Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan
| | - Fumiaki Yashima
- Department of Cardiology, Saiseikai Utsunomiya Hospital, Tochigi, Japan
| | - Yohei Ohno
- Department of Cardiology, Tokai University School of Medicine, Isehara, Japan
| | - Hidetaka Nishina
- Department of Cardiology, Tsukuba Medical Center Hospital, Tsukuba, Japan
| | - Masaki Izumo
- Department of Cardiology, St Marianna University, Kawasaki, Japan
| | - Masahiko Asami
- Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
| | - Toru Naganuma
- Department of Cardiology, New Tokyo Hospital, Matsudo, Japan
| | - Kazuki Mizutani
- Division of Cardiology, Department of Medicine, Kindai University, Osaka, Japan
| | - Masahiro Yamawaki
- Department of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan
| | - Norio Tada
- Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan
| | - Shinichi Shirai
- Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan
| | - Masahiko Noguchi
- Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu, Japan
| | - Hiroshi Ueno
- Department of Cardiology, Toyama University Hospital, Toyama, Japan
| | - Kensuke Takagi
- Department of Cardiology, National Cerebral and Cardiovascular Center, Osaka, Japan
| | - Yusuke Watanabe
- Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan
| | - Masanori Yamamoto
- Department of Cardiology, Toyohashi Heart Center, Toyohashi, Japan; Department of Cardiology, Nagoya Heart Center, Nagoya, Japan; Department of Cardiology, Gifu Heart Center, Gifu, Japan
| | - Shigeru Saito
- Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan
| | - Kentaro Hayashida
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
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18
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Zhou D, Dai H, Sheng W, Zheng R, Fan J, Yidilisi A, Aihemaiti A, Liu Q, Chen J, He Y, Guo Y, Zhu Q, Yang S, Wei Y, Wang J, Liu X. Evaluation of aortic arch calcification to predict prognosis after transcatheter aortic valve replacement. Sci Rep 2025; 15:6396. [PMID: 39984474 PMCID: PMC11845605 DOI: 10.1038/s41598-024-83536-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2024] [Accepted: 12/16/2024] [Indexed: 02/23/2025] Open
Abstract
Few centers routinely report aortic arch calcification (AAC) due to the lack of an easy and effective evaluation method. The association between AAC and the clinical prognosis of patients who undergo transcatheter aortic valve replacement (TAVR) is unclear. We aimed to develop a rapid method to evaluate AAC in patients who underwent TAVR and to further assess their prognosis. We enrolled 464 consecutive patients with aortic stenosis who underwent TAVR. Patients with severe (11.2%), moderate (18.5%), mild (58.2%), and no (12.1%) AAC had an estimated 3-year all-cause mortality incidence of 39.6%, 20.8%, 13.4%, and 6.7% (log rank p < 0.001), respectively. Patients with severe AAC had a significantly higher incidence of both cardiovascular (log rank p = 0.002) and non-cardiovascular mortality (log rank p = 0.009), whereas patients with moderate AAC had a higher incidence of only non-cardiovascular mortality (p = 0.003) compared with patients with no/mild AAC. Moderate/severe AAC was an independent predictor of 3-year all-cause mortality in univariate (hazard ratio [HR]: 2.39, 95% confidence interval [CI]: 1.41-4.03; p = 0.001) and multivariate COX regression analyses (HR: 1.78, 95%CI: 1.04-3.06; p = 0.037). Our rapid semi-quantitative method to evaluate AAC is highly reproducible and can be used to assess AAC in patients who undergo TAVR.
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Affiliation(s)
- Dao Zhou
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
- State Key Laboratory of Transvascular Implantation Devices, Hangzhou, 310009, China
| | - Hanyi Dai
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
- State Key Laboratory of Transvascular Implantation Devices, Hangzhou, 310009, China
| | - Wenjing Sheng
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
- State Key Laboratory of Transvascular Implantation Devices, Hangzhou, 310009, China
| | - Rongrong Zheng
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
| | - Jiaqi Fan
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
- State Key Laboratory of Transvascular Implantation Devices, Hangzhou, 310009, China
| | - Abuduwufuer Yidilisi
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
- State Key Laboratory of Transvascular Implantation Devices, Hangzhou, 310009, China
| | - Ailifeire Aihemaiti
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
| | - Qiong Liu
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
| | - Jun Chen
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
| | - Yuxin He
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
- State Key Laboratory of Transvascular Implantation Devices, Hangzhou, 310009, China
| | - Yuchao Guo
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
- State Key Laboratory of Transvascular Implantation Devices, Hangzhou, 310009, China
| | - Qifeng Zhu
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
- State Key Laboratory of Transvascular Implantation Devices, Hangzhou, 310009, China
| | - Shuangshuang Yang
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
- State Key Laboratory of Transvascular Implantation Devices, Hangzhou, 310009, China
| | - Yanxia Wei
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China
| | - Jian'an Wang
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China.
- State Key Laboratory of Transvascular Implantation Devices, Hangzhou, 310009, China.
| | - Xianbao Liu
- Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310009, China.
- State Key Laboratory of Transvascular Implantation Devices, Hangzhou, 310009, China.
- Heart Regeneration and Repair Key Laboratory of Zhejiang province, Hangzhou, 310009, China.
- Binjiang Institute of Zhejiang University, Hangzhou, 310052, Zhejiang, China.
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19
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Kurmanaliyev A, Sutiene K, Braukylienė R, Aldujeli A, Jurenas M, Kregzdyte R, Braukyla L, Zhumagaliyev R, Aitaliyev S, Zhanabayev N, Botabayeva R, Orazymbetov Y, Unikas R. An Integrative Machine Learning Model for Predicting Early Safety Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation. MEDICINA (KAUNAS, LITHUANIA) 2025; 61:374. [PMID: 40142184 PMCID: PMC11943591 DOI: 10.3390/medicina61030374] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 01/24/2025] [Revised: 02/18/2025] [Accepted: 02/19/2025] [Indexed: 03/28/2025]
Abstract
Background: Early safety outcomes following transcatheter aortic valve implantation (TAVI) for severe aortic stenosis are critical for patient prognosis. Accurate prediction of adverse events can enhance patient management and improve outcomes. Aim: This study aimed to develop a machine learning model to predict early safety outcomes in patients with severe aortic stenosis undergoing TAVI. Methods: We conducted a retrospective single-centre study involving 224 patients with severe aortic stenosis who underwent TAVI. Seventy-seven clinical and biochemical variables were collected for analysis. To handle unbalanced classification problems, an adaptive synthetic (ADASYN) sampling approach was used. A fined-tuned random forest (RF) machine learning model was developed to predict early safety outcomes, defined as all-cause mortality, stroke, life-threatening bleeding, acute kidney injury (stage 2 or 3), coronary artery obstruction requiring intervention, major vascular complications, and valve-related dysfunction requiring repeat procedures. Shapley Additive Explanations (SHAPs) were used to explain the output of the machine learning model by attributing each variable's contribution to the final prediction of early safety outcomes. Results: The random forest model identified left femoral artery diameter and aortic valve calcification volume as the most influential predictors of early safety outcomes. SHAPs analysis demonstrated that smaller left femoral artery diameter and higher aortic valve calcification volume were associated with poorer early safety prognoses. Conclusions: The machine learning model highlights of early safety outcomes after TAVI. These findings suggest that incorporating these variables into pre-procedural assessments may improve risk stratification and inform clinical decision-making to enhance patient care.
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Affiliation(s)
- Abilkhair Kurmanaliyev
- Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (A.K.); (R.B.); (A.A.); (M.J.); (R.K.); (L.B.); (R.U.)
| | - Kristina Sutiene
- Department of Mathematical Modeling, Kaunas University of Technology, Studentų Str. 50–143, LT-50009 Kaunas, Lithuania;
| | - Rima Braukylienė
- Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (A.K.); (R.B.); (A.A.); (M.J.); (R.K.); (L.B.); (R.U.)
| | - Ali Aldujeli
- Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (A.K.); (R.B.); (A.A.); (M.J.); (R.K.); (L.B.); (R.U.)
- CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, 1 University Road Str., H91 TK33 Galway, Ireland
| | - Martynas Jurenas
- Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (A.K.); (R.B.); (A.A.); (M.J.); (R.K.); (L.B.); (R.U.)
| | - Rugile Kregzdyte
- Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (A.K.); (R.B.); (A.A.); (M.J.); (R.K.); (L.B.); (R.U.)
| | - Laurynas Braukyla
- Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (A.K.); (R.B.); (A.A.); (M.J.); (R.K.); (L.B.); (R.U.)
| | - Rassul Zhumagaliyev
- Department of Cardiac, Thoracic and Vascular Surgery, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (R.Z.); (Y.O.)
| | - Serik Aitaliyev
- Department of Cardiac, Thoracic and Vascular Surgery, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (R.Z.); (Y.O.)
- Faculty of Medicine and Health Care, Al-Farabi Kazakh National University, 71 Al-Farabi Ave., Almaty 050040, Kazakhstan
| | - Nurlan Zhanabayev
- South Kazakhstan Medical Academy, 1 Al-Farabi Square, Shymkent 160019, Kazakhstan; (N.Z.); (R.B.)
| | - Rauan Botabayeva
- South Kazakhstan Medical Academy, 1 Al-Farabi Square, Shymkent 160019, Kazakhstan; (N.Z.); (R.B.)
| | - Yerlan Orazymbetov
- Department of Cardiac, Thoracic and Vascular Surgery, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (R.Z.); (Y.O.)
- National Scientific Medical Center, 42 Abylaikhan Avenue, Astana 010009, Kazakhstan
| | - Ramunas Unikas
- Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (A.K.); (R.B.); (A.A.); (M.J.); (R.K.); (L.B.); (R.U.)
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20
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Hu X, Zhao Z, Wang C, Feng D, Chen Y, Niu G, Zhou Z, Zhang H, Li Z, Ye Y, Wang M, Wu Y. Predictors and Prognostic Effects of Perioperative Myocardial Injury After Transcatheter Aortic Valve Replacement According to VARC-3 Criteria. Clin Interv Aging 2025; 20:125-135. [PMID: 39959308 PMCID: PMC11829743 DOI: 10.2147/cia.s505174] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/07/2024] [Accepted: 02/04/2025] [Indexed: 02/18/2025] Open
Abstract
Purpose The impact of periprocedural myocardial injury (PPMI) according to VARC-3 criteria in patients undergoing transcatheter aortic valve replacement (TAVR) remains unclear. This study aimed to investigate the incidence, risk factors, and prognosis of PPMI in patients with severe aortic who underwent TAVR in China. Materials and Methods Between September 2012 and November 2021, 516 patients with severe aortic stenosis who underwent TAVR at the Fuwai Hospital were consecutively enrolled. PPMI was defined according to the VARC-3 criteria as a 70-fold increase of upper reference limit in cardiac troponin I (cTnI) levels. We compared the baseline characteristics, perioperative conditions, and in-hospital and long-term endpoints between the PPMI and non-PPMI groups. Logistic regression analysis was used to determine the predictors of PPMI. Survival probabilities for outcomes between the PPMI and non-PPMI groups were estimated using the Kaplan-Meier method. Results Of the enrolled patients (mean age: 75.5±7.2 years, 57.5% male), the incidence of PPMI was 20.5%. The median cTnI was 24.9 (interquartile range: 11.4-60.2) times the upper reference limit. After multivariable adjustment, female sex (odds ratio [OR]: 3.01, 95% confidence interval [CI]: 1.88-4.82, P < 0.001), anticoagulant use (OR: 0.27, 95% CI: 0.08-0.96, P = 0.043), balloon-expandable valve (OR: 0.27, 95% CI: 0.09-0.79, P = 0.017), and secondary valve implantation (OR: 2.66, 95% CI: 1.40-5.03, P = 0.003) were significantly associated with PPMI. Patients with PPMI had short- and long-term outcomes similar to those without PPMI. Conclusion Female sex and secondary valve implantation are predictors of an increased risk of PPMI, whereas baseline anticoagulant use and the use of balloon-expandable valves are protective factors. The presence of PPMI does not seem to indicate poor short- or long-term prognosis in patients undergoing TAVR.
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Affiliation(s)
- Xiangming Hu
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China
| | - Zhenyan Zhao
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China
| | - Can Wang
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China
| | - Dejing Feng
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China
| | - Yang Chen
- Department of Cardiology, Peking University People’s Hospital, Beijing, People’s Republic of China
| | - Guannan Niu
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China
| | - Zheng Zhou
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China
| | - Hongliang Zhang
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China
| | - Zhe Li
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China
| | - Yunqing Ye
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China
| | - Moyang Wang
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China
| | - Yongjian Wu
- Department of Cardiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China
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21
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Van Mieghem NM, Windecker S, Manoharan G, Lancellotti P, Tamburino C, Kornowski R, Thiele H, Danenberg H, Fiorina C, Scholtz W, Brecker S, Ruge H, Opdahl A, Amoroso G, Bedogni F, Petronio AS, Nickenig G, Harnath A, Kempfert J, Oh JK, Eisenberg RE, Grube E. Three-Year Outcomes With a Supra-Annular, Self-Expanding Bioprosthesis and a Pericardial Wrap-The FORWARD PRO Study. Catheter Cardiovasc Interv 2025; 105:577-587. [PMID: 39686582 PMCID: PMC11831722 DOI: 10.1002/ccd.31335] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2024] [Revised: 09/24/2024] [Accepted: 11/22/2024] [Indexed: 12/18/2024]
Abstract
BACKGROUND The self-expanding, supra-annular Evolut valve is an established platform for Transcatheter Aortic Valve Implantation (TAVI). Evolut PRO introduced an outer sealing wrap to mitigate paravalvular leakage. We evaluated the 3-year clinical outcomes and valve performance of the Evolut PRO in standard clinical practice for severe aortic stenosis (AS) patients at intermediate or higher risk for surgery. METHODS The FORWARD PRO prospective, single-arm, multicentre, post-market clinical study enrolled 638 patients with native aortic valve stenosis or failed surgical bioprosthetic aortic valve undergoing TAVI, at intermediate or high risk, with the Evolut PRO valve. Clinical and serial echocardiographic outcomes were followed-up for 3 years. RESULTS TAVI using Evolut PRO was attempted in 629 AS patients (implanted in 97%) (mean age 81.7 years; STS PROM score, 4.7%). At 3 years all-cause mortality was 25.0%, disabling stroke 6.5% (all-cause mortality or disabling stroke, 28.5%) and rate of new permanent pacemaker implantation 24.7%. Excellent valve haemodynamics were maintained (mean gradient 8.8 ± 4.7 mm Hg; mean effective orifice area 2.0 ± 0.5 cm2) at 3 years. In a paired analysis of patients with ≥ mild paravalvular leakage (PVL) at discharge, more than two-thirds demonstrated improved PVL at 3 years. Patients with ≥ mild PVL at discharge had higher median total calcium volume than those with no/trace PVL (p < 0.001). CONCLUSIONS In clinical practice TAVI with the Evolut PRO valve is associated with favorable clinical outcomes and excellent haemodynamic performance out to 3 years. The observation of improvements in PVL over time warrants further research.
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Affiliation(s)
- Nicolas M. Van Mieghem
- Department of CardiologyCardiovascular Institute, Erasmus University Medical Center RotterdamRotterdamThe Netherlands
| | - Stephan Windecker
- Department of Cardiology, InselspitalBern University HospitalBernSwitzerland
| | - Ganesh Manoharan
- Department of CardiologyRegional Health Centre, Royal Victoria HospitalBelfastUK
| | | | - Corrado Tamburino
- Cardiothoracic, Transplantation and Vascular Surgery DepartmentAzienda Policlinico‐Vittorio Emanuele, Universita di CataniaCataniaItaly
| | - Ran Kornowski
- Cardiology DivisionRabin Medical CenterPetach TikvaIsrael
| | - Holger Thiele
- Department of Internal Medicine, CardiologyHeart Center Leipzig at University of LeipzigLeipzigGermany
| | - Haim Danenberg
- Interventional CardiologyWolfson Medical CenterTel AvivIsrael
| | - Claudia Fiorina
- Cardiothoracic DepartmentSpedali Civili di BresciaBresciaItaly
| | - Werner Scholtz
- Clinic for General and Interventional Cardiology, AngiologyHerz‐ und Diabeteszentrum Nordrhein‐Westfalen, Universitätsklinik der Ruhr‐Universität BochumBad OeynhausenGermany
| | | | - Hendrik Ruge
- Department of Cardiovascular SurgeryDeutsches Herzzentrum MünchenMunichGermany
| | - Anders Opdahl
- Department of CardiologyOslo University Hospital RikshospitaletOsloNorway
| | | | - Francesco Bedogni
- Clinical Cardiology, Inverventional Cardiology and Coronary Intesive Care UnitsIRCCS Policlinico San DonatoMilanItaly
| | | | | | - Axel Harnath
- Cardiology DepartmentSana Heart CenterCottbusGermany
| | - Joerg Kempfert
- Department of Cardiothoracic and Vascular SurgeryGerman Heart Institute Charité BerlinBerlinGermany
| | - Jae K. Oh
- Echocardiography Core LaboratoryMayo ClinicRochesterMinnesotaUSA
| | | | - Eberhard Grube
- Center of Innovative Interventions in CardiologyUniversity Hospital BonnBonnGermany
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22
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Lauten P, Kreutz J, Costello-Boerrigter LC, Schreiber M, Boerrigter G, Albert C, El Garhy M, Göbel B, Schieffer B, Lapp H, Owais T, Kuntze T, Markus B. Impact of porcelain aorta on outcomes in transfemoral aortic valve implantation (TAVI) with balloon-expandable valves. Open Heart 2025; 12:e003069. [PMID: 39884740 PMCID: PMC11784204 DOI: 10.1136/openhrt-2024-003069] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/20/2024] [Accepted: 12/31/2024] [Indexed: 02/01/2025] Open
Abstract
BACKGROUND Current guidelines recommend transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis and porcelain aorta (PA). Neurological outcomes of patients with PA undergoing TAVI with modern valves require clarification as most trials examined balloon-expandable valves (BEV) and self-expandable valves in intermediate or high-risk patients, but not specifically in patients with PA. Our aim was to compare outcomes, including stroke and mortality, in well-matched patients with and without PA who received BEV during transfemoral TAVI procedures. METHODS Consecutive patients undergoing TAVI were entered into a registry. For this single-centre (Zentralklinik Bad Berka, Germany), retrospective analysis, we only selected patients who received BEV. PA diagnosis was made when non-contrast axial CT images fulfilled Valve Academic Research Consortium-2 criteria for PA. There was 2:1 nearest neighbour matching of patients without and with PA. The primary outcome measure was 30-day mortality or stroke within 72 hours. Secondary outcome measures were 30-day mortality, stroke within 72 hours, technical success and 30-day device success. RESULTS After matching patients with (n=141) and without PA (n=282), the primary outcome of mortality at <30 days or stroke within 72 hours was higher in PA versus non-PA (7.8% vs 2.5%; OR 3.32 (95% CI 1.25 to 8.85); p=0.019). With regard to secondary outcomes, PA was not associated with mortality at 30 days (4.3% vs 2.1%; OR 2.04 (95% CI 0.65 to 6.48); p=0.23); however, stroke within 72 hours was significantly higher in PA versus non-PA (3.5% vs 0.4%; OR 10.33 (95% CI 1.17 to 91.12); p=0.017). Technical and device success were uninfluenced by PA. CONCLUSIONS Transfemoral TAVI with BEV in patients with PA was associated with a higher risk of the primary combined endpoint of mortality at 30 days or stroke within 72 hours, which was primarily driven by stroke within 72 hours. These findings might influence cerebral embolic protection device use in patients with PA.
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Affiliation(s)
- Philipp Lauten
- Heart Center/Structural Heart, Zentralklinik Bad Berka, Bad Berka, Germany
- Philipps University of Marburg, Marburg, Germany
| | - Julian Kreutz
- Philipps University of Marburg, Marburg, Germany
- Department of Cardiology, Angiology, and Intensive Care Medicine, University Hospital of Giessen and Marburg, Marburg, Germany
| | - Lisa C Costello-Boerrigter
- Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka, Bad Berka, Germany
- Clinical Research Rhön-Klinikum, Bad Neustadt, Germany
| | - Mathias Schreiber
- Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka, Bad Berka, Germany
| | - Guido Boerrigter
- Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka, Bad Berka, Germany
| | - Christian Albert
- Department of Nephrology, Zentralklinik Bad Berka, Bad Berka, Germany
- Otto von Guericke University Magdeburg, Magdeburg, Germany
| | - Mohammad El Garhy
- Department of Cardiology, Klinikum Hersfeld-Rotenburg, Bad Hersfeld, Germany
| | - Björn Göbel
- Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka, Bad Berka, Germany
| | - Bernhard Schieffer
- Philipps University of Marburg, Marburg, Germany
- Department of Cardiology, Angiology, and Intensive Care Medicine, University Hospital of Giessen and Marburg, Marburg, Germany
| | - Harald Lapp
- Philipps University of Marburg, Marburg, Germany
- Department of Cardiology and Intensive Care Medicine, Zentralklinik Bad Berka, Bad Berka, Germany
| | - Tamer Owais
- Cardiac Surgery, Zentralklinik Bad Berka, Augsburg, Germany
- Cardiac Surgery, Cairo University, Cairo, Egypt
| | - Thomas Kuntze
- Department of Cardiac Surgery, Central Hospital Bad Berka, Bad Berka, Germany
| | - Birgit Markus
- Philipps University of Marburg, Marburg, Germany
- Department of Cardiology, Angiology, and Intensive Care Medicine, University Hospital of Giessen and Marburg, Marburg, Germany
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23
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Aurigemma C, Trani C, D’Errigo P, Barbanti M, Biancari F, Tarantini G, Ussia GP, Ranucci M, Badoni G, Baglio G, Rosato S. Long-Term Clinical Impact of Paravalvular Leak Following Transcatheter Aortic Valve Implantation. J Clin Med 2025; 14:605. [PMID: 39860611 PMCID: PMC11765977 DOI: 10.3390/jcm14020605] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2024] [Revised: 01/08/2025] [Accepted: 01/13/2025] [Indexed: 01/27/2025] Open
Abstract
Background: Paravalvular leak (PVL) was initially recognized as one of the most common complications after transcatheter aortic valve implantation (TAVI) and has been linked to adverse clinical outcomes, including mortality. This study aims to assess the long-term clinical effects of PVL in patients undergoing TAVI with the latest generation of transcatheter aortic valves, as part of the national observational prospective multicenter study OBSERVANT II. Methods: OBSERVANT II included all consecutive patients with severe aortic stenosis who underwent TAVI across 28 Italian centers from December 2016 to September 2018. A total of 2125 patients were included in this analysis and stratified according to the presence of moderate-to-severe PVL (significant PVL, n = 155) versus no/trace-to-mild PVL (no significant PVL, n = 1970). The primary endpoint was 5-year major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, stroke, myocardial infarction, and coronary revascularization. Five-year all cause death and re-hospitalization for heart failure (HF) were the secondary endpoints. Results: In our cohort, the incidence of moderate-to-severe PVL was 7%. Age, aortic anulus perimeter, and self-expandable valves were determinants of PVL. The risk of MACCE, all-cause death, and re-hospitalization for HF at the 5-year follow-up were not different between the study groups [HR = 1.07 (95% CI: 0.85-1.34) p = 0.571; HR = 1.10 (95% CI: 0.87-1.39) p = 0.435; HR = 1.20 (95% CI: 0.88-1.62) p = 0.245, respectively]. Conclusions: In this analysis of the OBSERVANT II study, moderate/severe PVL was not associated with a higher incidence of MACCE and re-hospitalization for heart failure at the 5-year follow-up.
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Affiliation(s)
- Cristina Aurigemma
- Department of Cardiovascular Science CUORE Fondazione Policlinico Universitario, IRCCS, A. Gemelli, 00168 Rome, Italy;
| | - Carlo Trani
- Department of Cardiovascular Science CUORE Fondazione Policlinico Universitario, IRCCS, A. Gemelli, 00168 Rome, Italy;
- Università Cattolica del Sacro Cuore, 00168 Rome, Italy
| | - Paola D’Errigo
- National Center for Global Health, Istituto Superiore di Sanitá, 00161 Rome, Italy; (P.D.); (G.B.); (S.R.)
| | - Marco Barbanti
- Faculty of Medicine and Surgery, Università degli Studi di Enna “Kore”, 94100 Enna, Italy;
| | - Fausto Biancari
- Department of Cardiovascular Surgery, Centro Cardiologico Monzino, IRCCS, 20138 Milan, Italy;
| | - Giuseppe Tarantini
- Division of Cardiology, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, 35122 Padova, Italy;
| | - Gian Paolo Ussia
- Department of Cardiology Science, Università Campus Bio-Medico, 00128 Rome, Italy;
| | - Marco Ranucci
- Anesthesia and Cardiovascular Intensive Care Unit, IRCCS Policlinico San Donato, 20097 Milan, Italy;
| | - Gabriella Badoni
- National Center for Global Health, Istituto Superiore di Sanitá, 00161 Rome, Italy; (P.D.); (G.B.); (S.R.)
| | - Giovanni Baglio
- Italian National Agency for Regional Healthcare Services, 00187 Rome, Italy;
| | - Stefano Rosato
- National Center for Global Health, Istituto Superiore di Sanitá, 00161 Rome, Italy; (P.D.); (G.B.); (S.R.)
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24
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Schlömicher M, Prümmer K, Haldenwang P, Moustafine V, Berres D, Bechtel M, Strauch JT. Conduction Disorders after Rapid Deployment Aortic Valve Replacement Compared to Conventional Aortic Valve Replacement. Thorac Cardiovasc Surg 2025. [PMID: 39515780 DOI: 10.1055/a-2464-2727] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2024]
Abstract
OBJECTIVES We evaluated and compared early postprocedural and midterm incidence and evolution of atrioventricular and intraventricular conduction disorders following rapid deployment aortic valve replacement (RDAVR) and conventional aortic valve replacement (AVR). MATERIALS AND METHODS One hundred and forty-seven patients who underwent isolated rapid deployment AVR between 2017 and 2021 as well as 128 patients after conventional biological AVR in the same period were included in this study. ECGs recorded at baseline, discharge, and 12 months were retrospectively analyzed. Intrinsic rhythm, PQ interval, QRS duration, and atrioventricular and intraventricular conduction were evaluated and compared between both groups. RESULTS Patients in both groups had comparable Society of Thoracic surgeons risc (STS) scores (2.9 ± 1.6 vs. 3.1 ± 2.2, p = 0.32) and comparable baseline characteristics. The mean age was 73.4 ± 5.7 years in the RDAVR group and 74.2 ± 5.9 years in the AVR group, respectively. At baseline, the mean QRS width was 95.7 ± 25.5 ms in the RDAVR group, and 97.3 ± 23.5 ms in the AVR group, respectively (p = 0.590). At discharge, the mean QRS width in the RDAVR group was significantly increased with 117.4 ± 28.6 ms and a mean ΔQRS width of 21.7 ± 26.3 ms (p < 0.001) compared with baseline. No significant changes in QRS width were found in the AVR group with a mean value of 101.2 ± 24.1 ms and a mean ΔQRS width of 3.9 ± 23.9 ms at discharge (p = 0.193). The left bundle branch block (LBBB) was increased in the RDAVR group after 12 months (19.3% vs. 5.1%, p < 0.001). Permanent pacemaker implantation (PPI) rates were significantly higher in the RDAVR group after 12 months (hazard ratio (HR): 4.68; 95% CI: 2.23-7.43, p < 0.001). Mortality did not differ between both groups after 12 months (HR: 1.09; 95% CI: 0.46-1.83, p = 0.835) CONCLUSION: Patients after RDAVR showed significantly higher rates of LBBB and PPI after 12 months. However, higher mortality was not observed in the RDAVR group.
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Affiliation(s)
- Markus Schlömicher
- Department of Cardiothoracic Surgery, Ruhr University Hospital Bergmannsheil Bochum, Bochum, Nordrhine Westphalia, Germany
| | - Katrin Prümmer
- Department of Anesthesiology, Ruhr-University Bochum, Bochum, Nordrhin-Westphalia, Germany
| | - Peter Haldenwang
- Department of Cardiothoracic Surgery, Ruhr University Hospital Bergmannsheil Bochum, Bochum, Nordrhine Westphalia, Germany
| | - Vadim Moustafine
- Department of Cardiothoracic Surgery, Ruhr University Hospital Bergmannsheil Bochum, Bochum, Nordrhine Westphalia, Germany
| | - Dinah Berres
- Department of Cardiothoracic Surgery, Ruhr University Hospital Bergmannsheil Bochum, Bochum, Nordrhine Westphalia, Germany
| | - Matthias Bechtel
- Department of Cardiothoracic Surgery, Ruhr University Hospital Bergmannsheil Bochum, Bochum, Nordrhine Westphalia, Germany
| | - Justus T Strauch
- Department of Cardiothoracic Surgery, Ruhr University Hospital Bergmannsheil Bochum, Bochum, Nordrhine Westphalia, Germany
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25
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Yashima F, Yamamoto M, Shirai S, Tada N, Naganuma T, Yamawaki M, Yamanaka F, Mizutani K, Noguchi M, Ueno H, Takagi K, Ohno Y, Izumo M, Nishina H, Suzuyama H, Yamasaki K, Nishioka K, Hachinohe D, Fuku Y, Otsuka T, Asami M, Watanabe Y, Hayashida K. Initial Findings Concerning the Latest Self-Expandable Evolut FX Valve: A Report Using OCEAN-TAVI Registry Data. Am J Cardiol 2025; 235:59-66. [PMID: 39461400 DOI: 10.1016/j.amjcard.2024.10.015] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/25/2024] [Revised: 10/02/2024] [Accepted: 10/14/2024] [Indexed: 10/29/2024]
Abstract
Data concerning the clinical effect of the latest-generation self-expandable transcatheter heart valve (Evolut FX) remain limited. We aimed to assess the in-hospital outcomes of 3 bioprosthetic valves (Evolut EPO, PRO+, and FX). We analyzed data from a Japanese multicenter registry involving 634 consecutive patients who underwent transcatheter aortic valve replacement with Evolut FX up until October 2023. Patients who underwent transcatheter aortic valve replacement with Evolut EPO between 2018 and 2020 (n = 1,128), and those with Evolut EPO+ between 2020 and 2023 (n = 1,696) served as the control groups. The exclusion criteria comprised patients on dialysis with a history of infective endocarditis or with insufficient data. Unmatched comparisons among the 3 valves were conducted, followed by a propensity score-matched comparison between Evolut EPO+ and FX. In the unmatched cohort, among the Evolut EPO, PRO+, and FX groups, all vascular complications (7.8% vs 5.2% vs 4.5%, respectively, p <0.01) and new pacemaker implantation rates (11.2% vs 6.1% vs 7.7%, respectively, p <0.01) differed significantly. In the propensity score-matched analysis, the rate of all bleeding events was significantly higher in the Evolut EPO+ group (11.0%) than in the FX group (7.0%) (p = 0.02), whereas all vascular complications (4.6% vs 4.6%, respectively, p = 1.00) and new pacemaker implantation (5.9% vs 7.6%, respectively, p = 0.28) rates were comparable. The incidence of stroke in the FX group was approximately half that of the EP+ group (3.7% vs 1.9%, p = 0.095), without statistical significance. In conclusion, compared with the Evolut EPO+, Evolut FX was associated with a lower incidence of in-hospital bleeding complications and may reduce the incidence of in-hospital stroke.
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Affiliation(s)
- Fumiaki Yashima
- Department of Cardiology, Saiseikai Utsunomiya Hospital, Tochigi, Japan.
| | - Masanori Yamamoto
- Department of Cardiology, Toyohashi Heart Center, Toyohashi, Japan; Department of Cardiology, Nagoya Heart Center, Nagoya, Japan; Department of Cardiology, Gifu Heart Center, Gifu, Japan
| | - Shinichi Shirai
- Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan
| | - Norio Tada
- Department of Cardiology, Sendai Kosei Hospital, Sendai, Japan
| | - Toru Naganuma
- Department of Cardiology, New Tokyo Hospital, Chiba, Japan
| | - Masahiro Yamawaki
- Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan
| | - Futoshi Yamanaka
- Department of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan
| | - Kazuki Mizutani
- Division of Cardiology, Department of Medicine, Kindai University, Osaka, Japan
| | - Masahiko Noguchi
- Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu, Japan
| | - Hiroshi Ueno
- Second Department of Internal Medicine, Toyama University Hospital, Toyama, Japan
| | - Kensuke Takagi
- Department of Cardiology, National Cerebral and Cardiovascular Center, Oasaka, Japan
| | - Yohei Ohno
- Department of Cardiology, Tokai University School of Medicine, Isehara, Japan
| | - Masaki Izumo
- Department of Cardiology, St Marianna University School of Medicine, Tokyo, Japan
| | - Hidetaka Nishina
- Department of Cardiology, Tsukuba Medical Center Hospital, Tsukuba, Japan
| | - Hiroto Suzuyama
- Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan
| | - Kazumasa Yamasaki
- Department of Cardiology, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan
| | - Kenji Nishioka
- Department of Cardiology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan
| | - Daisuke Hachinohe
- Cardiovascular Medicine, Sapporo Heart Center, Sapporo Cardiovascular Clinic, Sapporo, Japan
| | - Yasushi Fuku
- Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan
| | - Toshiaki Otsuka
- Department of Hygiene and Public Health, Nippon Medical School, Tokyo, Japan; Center for Clinical Research, Nippon Medical School Hospital, Tokyo, Japan
| | - Masahiko Asami
- Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
| | - Yusuke Watanabe
- Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan
| | - Kentaro Hayashida
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
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26
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Kurmanaliyev A, Braukylienė R, Aldujeli A, Zhumagaliyev R, Aitaliyev S, Unikas R. Evaluating the Impacts of Procedural and Patient-Specific Factors on the Outcomes of Transcatheter Aortic Valve Implantation (TAVI). MEDICINA (KAUNAS, LITHUANIA) 2025; 61:94. [PMID: 39859076 PMCID: PMC11766704 DOI: 10.3390/medicina61010094] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/10/2024] [Revised: 01/02/2025] [Accepted: 01/07/2025] [Indexed: 01/27/2025]
Abstract
Background: Transcatheter aortic valve implantation (TAVI) has emerged as a pivotal intervention for managing severe aortic stenosis in high-risk surgical patients. Objective: This study aimed to evaluate the impacts of procedural factors and patient characteristics on TAVI outcomes, with a focus on survival rates, cardiac mortality, and associated complications. Methods: A retrospective, single-center study involving 224 patients who underwent TAVI at the Lithuanian University of Health Sciences from September 2021 to April 2023 was conducted. Data encompassing demographic characteristics, medical history, procedural specifics, and follow-up outcomes were analyzed. Survival and adverse events were assessed at 30 days, 6 months, and 12 months post-TAVI. Results: The study included 224 patients. The mean age in the non-death group was 80 ± 6.17 years (range, 49-91), while that in the cardiac death group was 81.5 ± 6.14 years (range, 70-94; p = 0.079). Males accounted for 37.7% of the non-death group and 50% of the cardiac death group (p = 0.304). Statistical analyses identified factors significantly associated with mortality and complications. The overall survival rate was 88.8%, with cardiac-related mortality observed in 8% of patients. Increased fluoroscopy time (p < 0.001), a higher contrast volume (p = 0.005), and less improvement in aortic valve velocity post-TAVI (p = 0.031) were significantly associated with cardiac mortality. Advanced age and a reduced left ventricular ejection fraction (<50%) were prominent predictors of adverse outcomes. Patients with non-coronary cusp calcification exhibited lower cardiac mortality (p = 0.005), while mitral valve regurgitation was linked to poorer outcomes (p = 0.015). Logistic regression analysis underscored the incremental risks posed by procedural complexities and comorbidities. Conclusions: Procedural factors such as fluoroscopy duration and contrast volume, along with patient-specific attributes including age, left ventricular function, and valve calcification patterns, critically influence TAVI outcomes. These findings emphasize the need for tailored procedural strategies and patient management protocols to mitigate risks and enhance the efficacy of TAVI interventions.
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Affiliation(s)
- Abilkhair Kurmanaliyev
- Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (A.K.); (R.B.); (A.A.); (R.U.)
| | - Rima Braukylienė
- Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (A.K.); (R.B.); (A.A.); (R.U.)
| | - Ali Aldujeli
- Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (A.K.); (R.B.); (A.A.); (R.U.)
- CORRIB Research Centre for Advanced Imaging and Core Laboratory, University of Galway, 1 University Road Str., H91 TK33 Galway, Ireland
| | - Rassul Zhumagaliyev
- Department of Cardiac, Thoracic and Vascular Surgery, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania;
| | - Serik Aitaliyev
- Department of Cardiac, Thoracic and Vascular Surgery, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania;
- Faculty of Medicine and Health Care, Al-Farabi Kazakh National University, 71 Al-Farabi Ave., 050040 Almaty, Kazakhstan
| | - Ramunas Unikas
- Department of Cardiology, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Lithuanian University of Health Sciences, 2 Eivenių Str., LT-50009 Kaunas, Lithuania; (A.K.); (R.B.); (A.A.); (R.U.)
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Wischmann P, Stern M, Baasen S, Schillings M, Schremmer J, Oliver Stern M, Klein K, Jung C, Zeus T, Heiss C, Kelm M, Busch L. Importance of pseudoaneurysms after TAVI - a retrospective analysis of 2063 patients. VASA 2025; 54:50-58. [PMID: 39017671 DOI: 10.1024/0301-1526/a001135] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 07/18/2024]
Abstract
Background: Bifemoral arterial access is common in patients undergoing transcatheter aortic valve implantation (TAVI), with a primary treatment access (TAVI access) and a secondary non-TAVI access. Pseudoaneurysm (PSA) is an important complication of femoral arterial puncture. Major vascular complications after TAVI are well described, but little is known about PSA. Patients and methods: A total of 2063 patients underwent transfemoral TAVI between January 2014 and January 2020. Vascular ultrasound of the common femoral artery was assessed before and after TAVI. We compared patient characteristics, periprocedural risk scores, procedural characteristics, and access site bleeding events according to Valve Academic Research Consortium 3 (VARC-3) criteria, length of stay (LOS), and all-cause mortality at one year between patients with (46) and without (2017) PSA. Results: The incidence of PSA after TAVI was 2.2% (46/2063). All PSA were successfully treated with ultrasound-guided manual compression (UGMC) or thrombin injection (UGTI) without complications. Patients with PSA had lower platelet counts (210×1000/μl vs. 234×1000/μl; p<0.05), more heart failure symptoms on admission (91% vs. 25%; p<0.05), were more often treated with (N)OACs for atrial fibrillation (AF; 54% vs. 38%; p <0.05), and were less often treated with aspirin (35% vs. 51%; p<0.03). Multivariate analysis identified secondary access site (odds ratio [OR] 8.11; p<0.001) and (N)OAC therapy (OR 1.31; p = 0.037) as risk factors for PSA development. PSA is associated with VARC-3 type 1-3 access site bleeding and longer LOS (15.2 ± 11.3 d vs. 11.6 ± 8.9 d; p<0.01), but this did not affect one year mortality (17% vs. 14%; p = 0.53). Conclusions: Pseudoaneurysms are an important complication after TAVI and are associated with access site bleeding and prolonged hospital stay. (N)OAC therapy and secondary access are important risk factors. Pseudoaneurysms can be safely and effectively treated with thrombin injection and do not affect one-year mortality.
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Affiliation(s)
- Patricia Wischmann
- Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany
- CARID, Cardiovascular Research Institute Düsseldorf, Medical Faculty, and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany
| | - Manuel Stern
- Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany
| | - Sven Baasen
- Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany
| | - Miriam Schillings
- Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany
| | - Johanna Schremmer
- Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany
| | - Marc Oliver Stern
- Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany
| | - Kathrin Klein
- Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany
| | - Christian Jung
- Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany
- CARID, Cardiovascular Research Institute Düsseldorf, Medical Faculty, and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany
| | - Tobias Zeus
- Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany
| | - Christian Heiss
- Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, United Kingdom
- Department of Vascular Medicine, Surrey and Sussex NHS Healthcare Trust, Redhill, United Kingdom
| | - Malte Kelm
- Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany
- CARID, Cardiovascular Research Institute Düsseldorf, Medical Faculty, and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Germany
| | - Lucas Busch
- Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany
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Abadie BQ, Wang TKM. Contemporary Multi-modality Imaging of Prosthetic Aortic Valves. Rev Cardiovasc Med 2025; 26:25339. [PMID: 39867176 PMCID: PMC11759978 DOI: 10.31083/rcm25339] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/22/2024] [Revised: 10/08/2024] [Accepted: 10/23/2024] [Indexed: 01/28/2025] Open
Abstract
With the aging of the general population and the rise in surgical and transcatheter aortic valve replacement, there will be an increase in the prevalence of prosthetic aortic valves. Patients with prosthetic aortic valves can develop a wide range of unique pathologies compared to the general population. Accurate diagnosis is necessary in this population to generate a comprehensive treatment plan. Transthoracic echocardiography is often insufficient alone to diagnose many prosthetic valve pathologies. The integration of many imaging modalities, including transthoracic echocardiography, transesophageal echocardiography, cardiac computed tomography, cardiac magnetic resonance imaging, and nuclear imaging, is necessary to care for patients with prosthetic valves. The purpose of this review is to describe the strengths, limitations, and contemporary use of the different imaging modalities necessary to diagnose prosthetic valve dysfunction.
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Affiliation(s)
- Bryan Q Abadie
- Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH 44195, USA
| | - Tom Kai Ming Wang
- Section of Cardiovascular Imaging, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH 44195, USA
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29
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Butala NM, Lalani C, Tale A, Song Y, Kolte D, Baron S, Strom J, Cohen DJ, Yeh RW. Use of Claims to Assess Outcomes and Treatment Effects in the Evolut Low Risk Trial. Circ Cardiovasc Interv 2025; 18:e014592. [PMID: 39836743 PMCID: PMC11748901 DOI: 10.1161/circinterventions.124.014592] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/17/2024] [Accepted: 11/18/2024] [Indexed: 01/23/2025]
Abstract
BACKGROUND Food and Drug Administration-mandated postmarket studies for transcatheter aortic valve replacement in low-risk populations plan to use passively collected registry data linked to claims for long-term follow-up out to 10 years. Therefore, it is critically important to understand the validity of these claims-based end points. We sought to evaluate the ability of administrative claims with International Classification of Diseases-Tenth Revision (ICD-10) codes to identify trial-adjudicated end points and reproduce treatment comparisons of aortic valve replacement in the Evolut Low Risk Trial. METHODS We linked Evolut Low Risk trial patients to the Medicare Provider Analysis and Review database. We calculated sensitivity, specificity, positive predictive value, negative predictive value, and κ agreement statistic of claims to detect clinical end points through 2 years in trial patients. We additionally compared end points across treatment arms using trial-adjudicated outcomes versus claims-based outcomes. RESULTS Trial-adjudicated deaths were perfectly identified by claims. Claims had good performance in identifying trial-adjudicated disabling stroke (sensitivity 68.8%, specificity 99.0%, positive predictive value 64.7%, negative predictive value 99.1%, κ=0.66) and pacemaker placement (sensitivity 85.2%, specificity 98.4%, positive predictive value 90.4%, negative predictive value 97.5%, κ=0.86), but more modest performance in identifying trial-adjudicated myocardial infarction (κ=0.46) and vascular complications (κ=0.45). There was no difference between treatment arms for the primary end point of death or disabling stroke using trial data (hazard ratio, 0.83 [95% CI, 0.41-1.68]) or claims data (hazard ratio, 0.89 [95% CI, 0.43-1.81]; interaction P=0.71). CONCLUSIONS Claims-based end points performed well in ascertaining death, disabling stroke, and pacemaker placement and were able to reproduce principal trial findings. These results support the selective use of claims-based end points for transcatheter aortic valve replacement postmarketing surveillance. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283.
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Affiliation(s)
- Neel M. Butala
- Division of Cardiology, Department of Medicine, Rocky Mountain Regional VA Medical Center, Aurora, CO (N.M.B.)
- Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora (N.M.B.)
| | - Christina Lalani
- Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.L., A.T., Y.S., J.S., R.W.Y.)
| | - Archana Tale
- Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.L., A.T., Y.S., J.S., R.W.Y.)
| | - Yang Song
- Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.L., A.T., Y.S., J.S., R.W.Y.)
| | - Dhaval Kolte
- Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (D.K., S.B.)
- Harvard Medical School, Boston, MA (D.K., S.B., J.S., R.W.Y.)
| | - Suzanne Baron
- Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (D.K., S.B.)
- Harvard Medical School, Boston, MA (D.K., S.B., J.S., R.W.Y.)
| | - Jordan Strom
- Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.L., A.T., Y.S., J.S., R.W.Y.)
- Harvard Medical School, Boston, MA (D.K., S.B., J.S., R.W.Y.)
| | - David J. Cohen
- Cardiovascular Research Foundation, New York City, NY (D.J.C.)
- St. Francis Hospital and Heart Center, Roslyn, NY (D.J.C.)
| | - Robert W. Yeh
- Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.L., A.T., Y.S., J.S., R.W.Y.)
- Harvard Medical School, Boston, MA (D.K., S.B., J.S., R.W.Y.)
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30
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Shiri I, Balzer S, Baj G, Bernhard B, Hundertmark M, Bakula A, Nakase M, Tomii D, Barbati G, Dobner S, Valenzuela W, Rominger A, Caobelli F, Siontis GCM, Lanz J, Pilgrim T, Windecker S, Stortecky S, Gräni C. Multi-modality artificial intelligence-based transthyretin amyloid cardiomyopathy detection in patients with severe aortic stenosis. Eur J Nucl Med Mol Imaging 2025; 52:485-500. [PMID: 39307861 PMCID: PMC11732884 DOI: 10.1007/s00259-024-06922-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2024] [Accepted: 09/14/2024] [Indexed: 09/28/2024]
Abstract
PURPOSE Transthyretin amyloid cardiomyopathy (ATTR-CM) is a frequent concomitant condition in patients with severe aortic stenosis (AS), yet it often remains undetected. This study aims to comprehensively evaluate artificial intelligence-based models developed based on preprocedural and routinely collected data to detect ATTR-CM in patients with severe AS planned for transcatheter aortic valve implantation (TAVI). METHODS In this prospective, single-center study, consecutive patients with AS were screened with [99mTc]-3,3-diphosphono-1,2-propanodicarboxylic acid ([99mTc]-DPD) for the presence of ATTR-CM. Clinical, laboratory, electrocardiogram, echocardiography, invasive measurements, 4-dimensional cardiac CT (4D-CCT) strain data, and CT-radiomic features were used for machine learning modeling of ATTR-CM detection and for outcome prediction. Feature selection and classifier algorithms were applied in single- and multi-modality classification scenarios. We split the dataset into training (70%) and testing (30%) samples. Performance was assessed using various metrics across 100 random seeds. RESULTS Out of 263 patients with severe AS (57% males, age 83 ± 4.6years) enrolled, ATTR-CM was confirmed in 27 (10.3%). The lowest performances for detection of concomitant ATTR-CM were observed in invasive measurements and ECG data with area under the curve (AUC) < 0.68. Individual clinical, laboratory, interventional imaging, and CT-radiomics-based features showed moderate performances (AUC 0.70-0.76, sensitivity 0.79-0.82, specificity 0.63-0.72), echocardiography demonstrated good performance (AUC 0.79, sensitivity 0.80, specificity 0.78), and 4D-CT-strain showed the highest performance (AUC 0.85, sensitivity 0.90, specificity 0.74). The multi-modality model (AUC 0.84, sensitivity 0.87, specificity 0.76) did not outperform the model performance based on 4D-CT-strain only data (p-value > 0.05). The multi-modality model adequately discriminated low and high-risk individuals for all-cause mortality at a mean follow-up of 13 months. CONCLUSION Artificial intelligence-based models using collected pre-TAVI evaluation data can effectively detect ATTR-CM in patients with severe AS, offering an alternative diagnostic strategy to scintigraphy and myocardial biopsy.
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Affiliation(s)
- Isaac Shiri
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Sebastian Balzer
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Giovanni Baj
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
- Biostatistics Unit, Department of Medical Sciences, University of Trieste, Trieste, Italy
| | - Benedikt Bernhard
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Moritz Hundertmark
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Adam Bakula
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Masaaki Nakase
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Daijiro Tomii
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Giulia Barbati
- Biostatistics Unit, Department of Medical Sciences, University of Trieste, Trieste, Italy
| | - Stephan Dobner
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Waldo Valenzuela
- University Institute for Diagnostic and Interventional Neuroradiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse, Bern, 3010, Switzerland
| | - Axel Rominger
- Department of Nuclear Medicine, Inselspital Bern University Hospital, University of Bern, Bern, Switzerland
| | - Federico Caobelli
- Department of Nuclear Medicine, Inselspital Bern University Hospital, University of Bern, Bern, Switzerland
| | - George C M Siontis
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Jonas Lanz
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Thomas Pilgrim
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Stephan Windecker
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Stefan Stortecky
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland
| | - Christoph Gräni
- Department of Cardiology, Inselspital Bern University Hospital, University of Bern, Freiburgstrasse, Bern, CH - 3010, Switzerland.
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Yokoyama H, Yamanaka F, Shishido K, Moriyama N, Ochiai T, Miyashita H, Sugiyama Y, Yashima F, Ohno Y, Nishina H, Izumo M, Asami M, Naganuma T, Mizutani K, Yamawaki M, Tada N, Shirai S, Noguchi M, Ueno H, Takagi K, Watanabe Y, Yamamoto M, Saito S, Hayashida K. Difference in cardiac response after transcatheter aortic valve implantation according to flow and gradient pattern. Eur Heart J Cardiovasc Imaging 2024; 26:107-117. [PMID: 39255370 DOI: 10.1093/ehjci/jeae235] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/27/2024] [Revised: 07/17/2024] [Accepted: 08/23/2024] [Indexed: 09/12/2024] Open
Abstract
AIMS In patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS), data on the differences in subsequent cardiac structure and function among stratified groups with flow gradient patterns through the aortic valve are insufficient. METHODS AND RESULTS In this large multicenter study, 4523 patients undergoing TAVI for severe AS between 2013 and 2019 were divided into three groups according to the following criteria: (i) high-gradient AS (HG-AS) [mean pressure gradient (MPG) ≥ 40 mmHg], (ii) classical low-flow low-gradient AS (cLFLG-AS) [MPG < 40 mmHg, left ventricular (LV) ejection fraction (LVEF) <50%], and (iii) paradoxical low-flow low-gradient AS (pLFLG-AS) [MPG < 40 mmHg, LVEF ≥ 50% but stroke volume index (SVi) <35 mL/m2]. Echocardiography was performed at baseline, post-procedure, and 1 year post-TAVI. 3697, 507, and 319 patients had HG-AS, cLFLG-AS, and pLFLG-AS, respectively. After adjusting for clinical factors, cLFLG-AS and pLFLG-AS had an ∼1.5-fold higher 2-year all-cause mortality compared with HG-AS. During 1 year following TAVI, compared with HG-AS, cLFLG-AS showed greater reduction of LV systolic diameter (LVDs) and LV diastolic diameter (LVDd) and greater increase of LVEF (P < 0.001 for all), and changes in LV mass index (LVMi) and SVi were comparable (P = 0.915 and P = 0.821, respectively). However, pLFLG-AS demonstrated less reduction of LVDs and LVDd (P = 0.039 and P = 0.001, respectively), less improvement of LVEF and LVMi (P = 0.045 and P < 0.001, respectively), and comparable change in SVi (P = 0.364). CONCLUSION During 1 year post-TAVI, compared with HG-AS, cLFLG-AS achieves smaller LV diameters, greater increase in LVEF, and comparable regression of LVMi, whereas pLFLG-AS does not.
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Affiliation(s)
- Hiroaki Yokoyama
- Department of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Okamoto 1370-1, Kamakura City 247-8533, Japan
| | - Futoshi Yamanaka
- Department of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Okamoto 1370-1, Kamakura City 247-8533, Japan
| | - Koki Shishido
- Department of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Okamoto 1370-1, Kamakura City 247-8533, Japan
| | - Noriaki Moriyama
- Department of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Okamoto 1370-1, Kamakura City 247-8533, Japan
| | - Tomoki Ochiai
- Department of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Okamoto 1370-1, Kamakura City 247-8533, Japan
| | - Hirokazu Miyashita
- Department of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Okamoto 1370-1, Kamakura City 247-8533, Japan
| | - Yoichi Sugiyama
- Department of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Okamoto 1370-1, Kamakura City 247-8533, Japan
| | - Fumiaki Yashima
- Department of Cardiology, Saiseikai Utsunomiya Hospital, Tochigi, Japan
| | - Yohei Ohno
- Department of Cardiology, Tokai University School of Medicine, Isehara, Japan
| | - Hidetaka Nishina
- Department of Cardiology, Tsukuba Medical Center Hospital, Tsukuba, Japan
| | - Masaki Izumo
- Department of Cardiology, St Marianna University, Kawasaki, Japan
| | - Masahiko Asami
- Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
| | - Toru Naganuma
- Department of Cardiology, New Tokyo Hospital, Matsudo, Japan
| | - Kazuki Mizutani
- Division of Cardiology, Department of Medicine, Kindai University, Osaka, Japan
| | - Masahiro Yamawaki
- Department of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan
| | - Norio Tada
- Department of Cardiology, Sendai Kousei Hospital, Sendai, Japan
| | - Shinichi Shirai
- Department of Cardiology, Kokura Memorial Hospital, Kokura, Japan
| | - Masahiko Noguchi
- Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu, Japan
| | - Hiroshi Ueno
- Department of Cardiology, Toyama University Hospital, Toyama, Japan
| | - Kensuke Takagi
- Department of Cardiology, National Cerebral and Cardiovascular Center, Oasaka, Japan
| | - Yusuke Watanabe
- Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan
| | - Masanori Yamamoto
- Department of Cardiology, Toyohashi Heart Center, Toyohashi, Japan
- Department of Cardiology, Nagoya Heart Center, Nagoya, Japan
- Department of Cardiology, Gifu Heart Center, Gifu, Japan
| | - Shigeru Saito
- Department of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Okamoto 1370-1, Kamakura City 247-8533, Japan
| | - Kentaro Hayashida
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
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32
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Gonzálvez-García A, Cepas-Guillén P, Ternacle J, Urena M, Alperi A, Cheema AN, Veiga-Fernández G, Nombela-Franco L, Vilalta V, Esposito G, Campelo-Parada F, Idolfi C, Del Trigo M, Muñoz-García A, Maneiro N, Asmarats L, Regueiro A, Del Val D, Serra V, Auffret V, Jonveaux M, Bonnet G, Mesnier J, Gaspard S, Avanzas P, Rezaei E, Fradejas-Sastre V, Tirado-Conte G, Fernández-Nofrerías E, Franzone A, Guitteny T, Sorrentino S, Oteo JF, Díez-Delhoyo F, Gutiérrez-Alonso L, Vidal P, Alfonso F, Monastyrski A, Nolf M, Pelletier-Beaumont E, Avvedimento M, Rodés-Cabau J. Early safety after TAVR according to VARC-3 criteria: incidence, predictors, and clinical impact. REVISTA ESPANOLA DE CARDIOLOGIA (ENGLISH ED.) 2024:S1885-5857(24)00363-3. [PMID: 39722415 DOI: 10.1016/j.rec.2024.12.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/28/2024] [Accepted: 12/09/2024] [Indexed: 12/28/2024]
Abstract
INTRODUCTION AND OBJECTIVES The Valve Academic Research Consortium (VARC)-3 definition of the early safety (ES) composite endpoint after transcatheter aortic valve replacement (TAVR) lacks clinical validation. The aim of this study was to determine the incidence, predictors, and clinical impact of ES after TAVR as defined by VARC-3 criteria. METHODS We performed a multicenter study including 10 078 patients with severe aortic stenosis undergoing transarterial TAVR. According to VARC-3 criteria, ES at 30 days was defined as freedom from all-cause mortality, stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complications, acute kidney injury stages 3-4, moderate or severe aortic regurgitation, new permanent pacemaker implantation, and surgery or intervention related to the device. Baseline, procedural, and follow-up data were prospectively collected in a dedicated database. RESULTS ES was achieved in 6598 patients (65.5%). The main factors associated with a lack of ES were the occurrence of type 2-4 bleeding (18.9%), and new pacemaker implantation (13.6%). Advanced age, peripheral artery disease, chronic kidney disease, and balloon postdilation were associated with an increased risk of no-ES (P<.01 for all). Failure to achieve ES was associated with higher all-cause mortality up to 1-year after TAVR (HR, 3.17; 95%CI, 2.76-3.65; P<.001). CONCLUSIONS VARC-3 ES was not achieved in up to one-third of contemporary TAVR patients, which was associated with worse mid-term outcomes. The factors associated with increased risk were advanced age, baseline comorbidities, and some procedural features (postdilation). These findings highlight the importance of continued efforts to minimize the risk of TAVR-related procedural complications.
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Affiliation(s)
- Ariana Gonzálvez-García
- Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada; Servicio de Cardiología, Hospital Universitario La Paz, Madrid, Spain. https://x.com/@ari_gonzalvez
| | - Pedro Cepas-Guillén
- Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. https://x.com/@pedro_cepas
| | - Julien Ternacle
- Département de Cardiologie, Hôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, Bordeaux, France
| | - Marina Urena
- Département de Cardiologie(,) Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
| | - Alberto Alperi
- Servicio de Cardiología, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
| | - Asim N Cheema
- Cardiology Department, Southlake Regional Health Centre Newmarket, Ontario, Canada
| | - Gabriela Veiga-Fernández
- Servicio de Cardiología, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Valdecilla (IDIVAL), Santander, Cantabria, Spain
| | - Luis Nombela-Franco
- Servicio de Cardiología, Instituto Cardiovascular Hospital Clínico San Carlos, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), Madrid, Spain
| | - Victoria Vilalta
- Servicio de Cardiología, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
| | - Giovanni Esposito
- Dipartimento di Scienze Biomediche Avanzate, Università di Napoli Federico II, Naples, Italy
| | | | - Ciro Idolfi
- Dipartimento di Cardiologia, Università di 'Magna Graecia', Catanzaro, Italy
| | - María Del Trigo
- Servicio de Cardiología, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
| | | | - Nicolás Maneiro
- Servicio de Cardiología, Hospital Universitario 12 de Octubre, Madrid, Spain
| | - Luis Asmarats
- Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
| | - Ander Regueiro
- Servei de Cardiologia, Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain
| | - David Del Val
- Servicio de Cardiología, Hospital Universitario de La Princesa, Madrid, Spain
| | - Vicenç Serra
- Servicio de Cardiología, Hospital Univesitario Vall d'Hebron, Barcelona, Spain
| | - Vincent Auffret
- Département de Cardiologie, Centre Hospitalier Universitaire de Rennes, Rennes, France
| | - Melchior Jonveaux
- Département de Cardiologie, Hôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, Bordeaux, France
| | - Guillaume Bonnet
- Département de Cardiologie, Hôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, Bordeaux, France
| | - Jules Mesnier
- Département de Cardiologie(,) Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
| | - Suc Gaspard
- Département de Cardiologie(,) Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
| | - Pablo Avanzas
- Servicio de Cardiología, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
| | - Effat Rezaei
- Cardiology Department, Southlake Regional Health Centre Newmarket, Ontario, Canada
| | - Víctor Fradejas-Sastre
- Servicio de Cardiología, Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Valdecilla (IDIVAL), Santander, Cantabria, Spain
| | - Gabriela Tirado-Conte
- Servicio de Cardiología, Instituto Cardiovascular Hospital Clínico San Carlos, Instituto de Investigación Sanitaria Hospital Clínico San Carlos (IdISSC), Madrid, Spain
| | | | - Anna Franzone
- Dipartimento di Scienze Biomediche Avanzate, Università di Napoli Federico II, Naples, Italy
| | - Thibaut Guitteny
- Département de Cardiologie, Centre Hospitalier Universitaire de Toulouse, Toulouse, France
| | - Sabato Sorrentino
- Dipartimento di Cardiologia, Università di 'Magna Graecia', Catanzaro, Italy
| | - Juan Francisco Oteo
- Servicio de Cardiología, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
| | - Felipe Díez-Delhoyo
- Servicio de Cardiología, Hospital Universitario 12 de Octubre, Madrid, Spain
| | | | - Pablo Vidal
- Servei de Cardiologia, Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain
| | - Fernando Alfonso
- Servicio de Cardiología, Hospital Universitario de La Princesa, Madrid, Spain
| | - Andrea Monastyrski
- Servicio de Cardiología, Hospital Univesitario Vall d'Hebron, Barcelona, Spain
| | - Maxime Nolf
- Département de Cardiologie, Centre Hospitalier Universitaire de Rennes, Rennes, France
| | - Emilie Pelletier-Beaumont
- Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
| | - Marisa Avvedimento
- Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. https://x.com/@MAvvedimento
| | - Josep Rodés-Cabau
- Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada; Department of Research and Innovation, Clínic Barcelona, Barcelona, Spain.
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Lønborg J, Jabbari R, Sabbah M, Veien KT, Niemelä M, Freeman P, Linder R, Ioanes D, Terkelsen CJ, Kajander OA, Koul S, Savontaus M, Karjalainen P, Erglis A, Minkkinen M, Sørensen R, Tilsted HH, Holmvang L, Bieliauskas G, Ellert J, Piuhola J, Eftekhari A, Angerås O, Rück A, Christiansen EH, Jørgensen T, Özbek BT, Glinge C, Søndergaard L, De Backer O, Engstrøm T. PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med 2024; 391:2189-2200. [PMID: 39216095 DOI: 10.1056/nejmoa2401513] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/04/2024]
Abstract
BACKGROUND The benefit of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease and severe aortic stenosis who are undergoing transcatheter aortic-valve implantation (TAVI) remains unclear. METHODS In an international trial, we randomly assigned, in a 1:1 ratio, patients with severe symptomatic aortic stenosis and at least one coronary-artery stenosis with a fractional flow reserve of 0.80 or less or a diameter stenosis of at least 90% either to undergo PCI or to receive conservative treatment, with all patients also undergoing TAVI. The primary end point was a major adverse cardiac event, defined as a composite of death from any cause, myocardial infarction, or urgent revascularization. Safety, including bleeding events and procedural complications, was assessed. RESULTS A total of 455 patients underwent randomization: 227 to the PCI group and 228 to the conservative-treatment group. The median age of the patients was 82 years (interquartile range, 78 to 85), and the median Society of Thoracic Surgeons-Predicted Risk of Mortality score (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after the procedure) was 3% (interquartile range, 2 to 4). At a median follow-up of 2 years (interquartile range, 1 to 4), a major adverse cardiac event (primary end point) had occurred in 60 patients (26%) in the PCI group and in 81 (36%) in the conservative-treatment group (hazard ratio, 0.71; 95% confidence interval [CI], 0.51 to 0.99; P = 0.04). A bleeding event occurred in 64 patients (28%) in the PCI group and in 45 (20%) in the conservative-treatment group (hazard ratio, 1.51; 95% CI, 1.03 to 2.22). In the PCI group, 7 patients (3%) had PCI procedure-related complications. CONCLUSIONS Among patients with coronary artery disease who were undergoing TAVI, PCI was associated with a lower risk of a composite of death from any cause, myocardial infarction, or urgent revascularization at a median follow-up of 2 years than conservative treatment. (Funded by Boston Scientific and the Danish Heart Foundation; NOTION-3 ClinicalTrials.gov number, NCT03058627.).
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Affiliation(s)
- Jacob Lønborg
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Reza Jabbari
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Muhammad Sabbah
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Karsten T Veien
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Matti Niemelä
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Phillip Freeman
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Rickard Linder
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Dan Ioanes
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Christian J Terkelsen
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Olli A Kajander
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Sasha Koul
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Mikko Savontaus
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Pasi Karjalainen
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Andrejs Erglis
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Mikko Minkkinen
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Rikke Sørensen
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Hans-Henrik Tilsted
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Lene Holmvang
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Gintautas Bieliauskas
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Julia Ellert
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Jarkko Piuhola
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Ashkan Eftekhari
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Oskar Angerås
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Andreas Rück
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Evald H Christiansen
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Troels Jørgensen
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Burcu T Özbek
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Charlotte Glinge
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Lars Søndergaard
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Ole De Backer
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
| | - Thomas Engstrøm
- From the Department of Cardiology, Copenhagen University Hospital-Rigshospitalet (J.L., R.J., M. Sabbah, M.M., R.S., H.-H.T., L.H., G.B., T.J., B.T.Ö., C.G., L.S., O.D.B., T.E.), the Department of Clinical Medicine, University of Copenhagen (J.L., R.S., L.H., L.S., O.D.B., T.E.), and the Danish Heart Foundation (C.J.T.), Copenhagen, the Department of Cardiology, Odense University Hospital, Odense (K.T.V., J.E.), the Department of Cardiology, Aalborg University Hospital, Aalborg (P.F., A. Eftekhari), and the Department of Cardiology, Aarhus University Hospital, Aarhus (C.J.T., E.H.C.) - all in Denmark; the Research Unit of Biomedicine and Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu (M.N., J.P.), the Heart Hospital, Tampere University Hospital, Well-being Services County of Pirkanmaa, and the Faculty of Medicine and Health Technology, Tampere University, Tampere (O.A.K.), the Heart Center, Turku University Hospital, Turku (M. Savontaus), and the Heart and Lung Center, Helsinki University Hospital and Helsinki University, Helsinki (P.K., M.M.) - all in Finland; the Department of Medicine, and the Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institute, Danderyd University Hospital, Stockholm (R.L., A.R.), the Department of Cardiology, Sahlgrenska University Hospital, Gothenburg (D.I., O.A.), and the Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund (S.K.) - all in Sweden; and the University of Latvia, Riga (A. Erglis)
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Amoey D, Samy M, Elbasha K, Alali A, Landt M, Kurniadi A, Nef H, Tölg R, Richardt G, Mankerious N. Predictors and Outcomes of Inappropriate Dosing of Direct Oral Anticoagulants in Patients Receiving Transcatheter Aortic Valve Implantation. Cardiol Ther 2024; 13:761-773. [PMID: 39495243 DOI: 10.1007/s40119-024-00387-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/09/2024] [Accepted: 09/24/2024] [Indexed: 11/05/2024] Open
Abstract
INTRODUCTION Direct oral anticoagulant (DOAC) dose adjustment is based on age, renal function, and body weight. There is a paucity of data describing the factors associated with the prescription of inappropriate dosage and their impact on clinical outcomes among patients receiving transcatheter aortic valve implantation (TAVI). METHODS In a single-center study, 432 patients who were on long-term DOAC therapy and underwent TAVI between 2015 and 2022 were included. We analyzed the predictors and outcomes of inappropriate dosing of DOACs; namely apixaban, dabigatran, edoxaban, and rivaroxaban. A composite endpoint, including all-cause mortality, life-threatening/major bleeding, stroke, peripheral thromboembolic complications, or myocardial infarction, was assessed after 1 year. RESULTS In this TAVI cohort, inappropriate DOAC dosing was observed in 20.6% of patients. Inappropriate DOAC dosage was related to female gender (adj. odds ratio [OR] 2.72, 95% confidence interval [CI] 1.64-4.51, p < 0.001) as well as lower estimated glomerular filtration rate (eGFR) (adj. OR 0.99, 95% CI 0.98-1.00, p = 0.019), and to the administration of non-rivaroxaban DOACs (adj. OR 0.28, 95% CI 0.16-0.50, p < 0.001). After 1 year, patients on both appropriate and inappropriate DOAC dosage exhibited comparable rates of the composite endpoint (OR 0.88, 95% CI 0.53-1.46, p = 0.622). Old age (adj. OR 1.05, 95% CI 1.01-1.10, p = 0.018) as well as anemia (adj. OR 0.86, 95% CI 0.75-0.99, p = 0.031) emerged as independent predictors of the composite endpoint. CONCLUSIONS In this TAVI cohort, female gender and renal insufficiency were associated with inappropriate DOAC dosage, whereas rivaroxaban was linked to appropriate dosing. Inadequate DOAC dosage did not translate into a worse outcome in our TAVI population. TRIAL REGISTRATION Prospective Segeberg TAVI Registry (ClinicalTrials.gov identifier: NCT03192774).
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Affiliation(s)
- Danial Amoey
- Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany
| | - Mohamed Samy
- Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany
- Cardiology Department, Zagazig University, Sharkia, Egypt
| | - Karim Elbasha
- Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany
- Cardiology Department, Zagazig University, Sharkia, Egypt
| | - Ahmad Alali
- Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany
| | - Martin Landt
- Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany
| | - Arief Kurniadi
- Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany
| | - Holger Nef
- Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany
| | - Ralph Tölg
- Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany
- Zentrum für Herz-, Gefäss- und Diabetesmedizin, Asklepios Klinik Bad Oldesloe, Bad Oldesloe, Germany
- Medizinische Fakultät der Christian-Albrechts-Universität zu Kiel, Kiel, Germany
| | - Gert Richardt
- Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany
- Zentrum für Herz-, Gefäss- und Diabetesmedizin, Asklepios Klinik Bad Oldesloe, Bad Oldesloe, Germany
| | - Nader Mankerious
- Heart Center, Segeberger Kliniken GmbH, Am Kurpark 1, 23795, Bad Segeberg, Germany.
- Cardiology Department, Zagazig University, Sharkia, Egypt.
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Alperi A, Ptaszynski R, Pascual I, Del Valle R, Hernández-Vaquero D, Almendárez M, Antuna P, Ludeña R, Morís C, Avanzas P. Late bleeding events in TAVI patients receiving vitamin K antagonists or direct oral anticoagulants. REVISTA ESPANOLA DE CARDIOLOGIA (ENGLISH ED.) 2024; 77:976-984. [PMID: 38701880 DOI: 10.1016/j.rec.2024.03.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/27/2023] [Accepted: 03/14/2024] [Indexed: 05/05/2024]
Abstract
INTRODUCTION AND OBJECTIVES The optimal chronic antithrombotic regimen for patients with atrial fibrillation undergoing transcatheter aortic valve implantation (TAVI) remains uncertain. Our aim was to compare the incidence of late bleeding events between patients on direct oral anticoagulants (DOACs) and those on vitamin-K antagonists (VKA). METHODS This single-center observational study included TAVI patients requiring oral anticoagulation at discharge between 2015 and 2021. The primary endpoint was any clinically significant bleeding event. Secondary endpoints were stroke, heart failure, and all-cause mortality. RESULTS A total of 702 TAVI procedures were performed, with 297 patients requiring oral anticoagulation at discharge. Among them, 206 (69.4%) received VKA and 91 (30.6%) received DOAC. Baseline clinical, procedural and in-hospital characteristics did not significantly differ between groups, except for better renal function among DOAC patients. The median length of follow-up was 2.8 years. The risk of bleeding events was higher in patients receiving DOACs than in those receiving VKA (HR, 2.27; 95%CI, 1.21-4.26; incidence of 9.7 and 4.2 events per 100 patient-years of follow-up for DOAC and VKA patients, respectively). There were no statistically significant differences in the rates of stroke (HR, 1.28; 95%CI, 0.4-4.3), heart failure hospitalization (HR, 0.92; 95%CI, 0.46-1.86), or all-cause mortality (HR, 1.02; 95%CI, 0.68-1.55). CONCLUSIONS In older patients undergoing TAVI and receiving anticoagulant therapy for atrial fibrillation, the use of DOAC was associated with a higher risk of late bleeding events than VKA.
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Affiliation(s)
- Alberto Alperi
- Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain; Instituto de Investigación Sanitaria del Principado de Asturias, ISPA, Asturias, Spain
| | - Raul Ptaszynski
- Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
| | - Isaac Pascual
- Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain; Instituto de Investigación Sanitaria del Principado de Asturias, ISPA, Asturias, Spain; Universidad de Oviedo, Oviedo, Asturias, Spain
| | - Raquel Del Valle
- Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain; Instituto de Investigación Sanitaria del Principado de Asturias, ISPA, Asturias, Spain
| | - Daniel Hernández-Vaquero
- Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain; Instituto de Investigación Sanitaria del Principado de Asturias, ISPA, Asturias, Spain; Universidad de Oviedo, Oviedo, Asturias, Spain
| | - Marcel Almendárez
- Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
| | - Paula Antuna
- Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
| | - Raul Ludeña
- Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
| | - César Morís
- Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain; Instituto de Investigación Sanitaria del Principado de Asturias, ISPA, Asturias, Spain; Universidad de Oviedo, Oviedo, Asturias, Spain
| | - Pablo Avanzas
- Área del Corazón, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain; Instituto de Investigación Sanitaria del Principado de Asturias, ISPA, Asturias, Spain; Universidad de Oviedo, Oviedo, Asturias, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.
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Tomii D, Okuno T, Nakase M, Praz F, Stortecky S, Reineke D, Windecker S, Lanz J, Pilgrim T. Renin-Angiotensin System Inhibition and Cardiac Damage in Patients Undergoing Transcatheter Aortic Valve Replacement. Can J Cardiol 2024; 40:2592-2602. [PMID: 39067618 DOI: 10.1016/j.cjca.2024.07.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/27/2024] [Revised: 06/23/2024] [Accepted: 07/21/2024] [Indexed: 07/30/2024] Open
Abstract
BACKGROUND The optimal medical treatment strategy after transcatheter aortic valve replacement (TAVR) has not been established, and might be affected by the extent of extravalvular cardiac damage. We aimed to investigate the prognostic association of renin-angiotensin system (RAS) inhibitors in TAVR patients stratified according to the extent of extravalvular cardiac damage. METHODS In a prospective TAVR registry, patients were retrospectively evaluated for baseline cardiac damage and classified into 5 stages of cardiac damage (0-4) according to established criteria. Clinical outcomes at 1 year were compared according to RAS inhibitor prescription at discharge. RESULTS Among 2247 eligible patients who underwent TAVR between August 2007 and June 2021, 1634 (72.7%) were prescribed RAS inhibitors at discharge. Eighty-three patients (3.7%) were classified as stage 0, 276 (12.3%) as stage 1, 889 (39.6%) as stage 2, 489 (21.8%) as stage 3, and 510 (22.7%) as stage 4. RAS inhibitor prescription after TAVR was associated with a reduced risk of 1-year mortality (adjusted hazard ratio [HRadjusted], 0.59; 95% confidence interval [CI], 0.45-0.77). The protective association was accentuated among patients with cardiac stages 3 and 4 (HRadjusted, 0.54 [95% CI, 0.32-0.92]; and HRadjusted, 0.58 [95% CI, 0.36-0.92], respectively), but not statistically significant in for those with stage 2 (HRadjusted, 0.70; 95% CI, 0.43-1.14). CONCLUSIONS In patients who underwent TAVR, we found a strong association of RAS inhibitor prescription and improved clinical outcome in the overall population, and there were no signs of heterogeneity across stages of cardiac damage. CLINICAL TRIAL REGISTRATION NCT01368250.
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Affiliation(s)
- Daijiro Tomii
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Taishi Okuno
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Masaaki Nakase
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Fabien Praz
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Stefan Stortecky
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - David Reineke
- Department of Cardiac Surgery, Inselspital, University of Bern, Bern, Switzerland
| | - Stephan Windecker
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Jonas Lanz
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Thomas Pilgrim
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.
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Vasileios C, Ilias K, George F, Eutyxia S, Euaggelos L, Antonios M, Athanasios P, Ioannis M, Athanasios S, Anna K, Letsas K, Georgiadou P, Vasileios V, Efremidis M, Ioannis I. Vascular complications in TAVI procedures: assessment, management, and outcomes-a retrospective study. Hellenic J Cardiol 2024:S1109-9666(24)00225-2. [PMID: 39510250 DOI: 10.1016/j.hjc.2024.10.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2024] [Revised: 09/29/2024] [Accepted: 10/27/2024] [Indexed: 11/15/2024] Open
Abstract
OBJECTIVE Transcatheter Aortic Valve Implantation (TAVI) has emerged as a pivotal therapeutic modality for aortic stenosis, predominantly in the elderly population. Despite its clinical success, the incidence and implications of vascular complications during TAVI remain a subject of critical concern. METHODS A retrospective analysis was conducted on 140 patients who experienced vascular complications during TAVI procedures from a total cohort of 1343 cases. Patient demographics, clinical profiles, and procedural characteristics were scrupulously examined. Vascular complications, both intraoperative and postoperative, were identified through various diagnostic modalities. Statistical analyses were employed to discern associations and significance levels. Comparative assessments with international literature were performed to gain broader insights. RESULTS The study unveiled an overall incidence of vascular complications at approximately 10.44%. Coronary Artery Disease (CAD)-p-value (0.013), choice of valve type-p-value (0.016), and access point-p-value (0.027) demonstrated significant correlations with these complications. Complication incidences in TAVI procedures included pseudoaneurysms (4.76%), arteriovenous fistulas (1.49%), hematomas (0.37%), dissections (2.24%), arterial perforations (0.15%), stenosis/occlusion (0.37%), and closure device failures (1.94%). Over 70% of complications at the valve entry point result from dissections and closure device failures, while the pigtail entry point is predominantly linked to over 70% of pseudoaneurysms. Extended hospitalization (7.84 ± SD 3.14) was observed for patients experiencing vascular complications, underlining the importance of vigilant postprocedural care. CONCLUSION This study provides comprehensive insights into vascular complications during TAVI procedures, shedding light on their incidence, risk factors, clinical presentations, diagnostic methodologies, and management strategies.
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Lee YT, Yin WH, Tsao TP, Lee KC, Lin HC, Liu CT, Hsiung MC, Wei J. Comparable efficacy and safety for bicuspid aortic valve stenosis patients undergoing transcatheter aortic valve replacement with balloon-expandable or self-expanding valves using Wei's sizing method. J Chin Med Assoc 2024; 87:993-1001. [PMID: 39161202 DOI: 10.1097/jcma.0000000000001155] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 08/21/2024] Open
Abstract
BACKGROUND The present study aimed to investigate whether proper sizing can improve the procedural and clinical outcomes of transcatheter aortic valve replacement (TAVR) with new-generation self-expanding valves (SEVs) and balloon-expandable valves (BEVs) for treating bicuspid aortic stenosis (BAS). METHODS We retrospectively evaluated consecutive patients who underwent TAVR with Sapien 3 valves (Edwards Lifesciences, Irvine, CA) or Evolut R/PRO valves (Medtronic, Minneapolis, MN) for severe BAS from 2017 to 2022. The primary endpoints were device success rate and major adverse cardiac and cerebral events (MACCEs), including mortality, nonfatal myocardial infarction or disabling stroke, transcatheter heart valve failure, or clinically relevant valve thrombosis during follow-up. Our team used a complementary approach of supraannular sizing in addition to the conventional annular sizing method (Wei's method) to guide the TAVR procedures. RESULTS We recruited a total of 75 consecutive patients, of whom 43 (57%) were treated with BEVs from October 2017 to June 2021, and 32 (43%) were treated with SEVs from July 2021 to December 2022. Device success was similar between the BEV and SEV groups (93% vs 94%; p > 0.99), and no cases of annular rupture occurred in either group. Similar rates of moderate-to-severe paravalvular leak were observed in the BEV and SEV groups (5% vs 6%, p > 0.99). At a median follow-up of 464 days, the MACCE rates were comparable between the two groups. In multivariate analysis, the presence of previous percutaneous coronary interventions (hazard ratio: 5.43; p = 0.039) and New York Heart Association functional class III/IV heart failure at 30 days of follow-up after TAVR (hazard ratio: 9.90; p = 0.037) were independently associated with long-term MACCEs. CONCLUSION Our results demonstrated comparable efficacy and safety for BAS patients undergoing TAVR using either BEVs or SEVs when using Wei's sizing method.
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Affiliation(s)
- Yung-Tsai Lee
- Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan, ROC
- Department of Exercise and Health Science, National Taipei University of Nursing and Healthy Science, Taipei, Taiwan, ROC
| | - Wei-Hsian Yin
- Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan, ROC
- Faculty of Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC
| | - Tien-Ping Tsao
- Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan, ROC
- Faculty of Medicine, National Defense Medical Center, Taipei, Taiwan, ROC
| | - Kuo-Chen Lee
- Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan, ROC
| | - Huan-Chiu Lin
- Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan, ROC
- Faculty of Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC
| | - Chun-Ting Liu
- Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan, ROC
| | | | - Jeng Wei
- Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan, ROC
- Faculty of Medicine, National Defense Medical Center, Taipei, Taiwan, ROC
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Nakase M, Tomii D, Samim D, Gräni C, Praz F, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Impact of Severity and Extent of Iliofemoral Atherosclerosis on Clinical Outcomes in Patients Undergoing TAVR. JACC Cardiovasc Interv 2024; 17:2353-2363. [PMID: 39387783 DOI: 10.1016/j.jcin.2024.07.009] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/02/2024] [Revised: 06/29/2024] [Accepted: 07/02/2024] [Indexed: 10/15/2024]
Abstract
BACKGROUND Vascular complications remain a major concern in transfemoral transcatheter aortic valve replacement (TAVR). The Hostile score has been proposed to stratify risk in TAVR patients with peripheral artery disease. OBJECTIVES The authors aimed to assess the validity of the Hostile score in predicting iliofemoral vascular complications after TAVR. METHODS In a prospective TAVR registry, we validated the Hostile score for the prediction of puncture and non-puncture site vascular complications. This scoring system integrates the extent (number of lesions, lesion length, and minimum lumen diameter) and complexity (tortuosity, calcification, and the presence of obstruction) of iliofemoral atherosclerosis. RESULTS Of 2,023 patients who underwent transfemoral TAVR with contemporary devices between March 2014 and June 2022, 106 (5.2%) patients experienced puncture site vascular complications and 28 (1.4%) patients experienced non-puncture site vascular complications. The Hostile score was higher in patients with vascular complications than those without complications (1.00 [Q1-Q3: 0-5.00] vs 1.00 [Q1-Q3: 0-4.00]; P < .001). A higher body mass index (OR: 1.23; 95% CI: 1.04-1.50) and the use of Prostar (OR: 6.03; 95% CI: 2.23-16.30) or MANTA (OR: 6.18; 95% CI: 2.67-14.27) compared with ProGlide were independent predictors of puncture site vascular complications, whereas a higher Hostile score (OR: 1.91; 95% CI: 1.55-2.35) and female sex (OR: 2.69; 95% CI: 1.12-6.42) were independent predictors of non-puncture site vascular complications. The area under the receiver-operating characteristic curves for the prediction of puncture site and non-puncture site vascular complications were 0.554 and 0.829, respectively. CONCLUSIONS The Hostile score proved useful in predicting non-puncture site vascular complications after TAVR. (SwissTAVI Registry; NCT01368250).
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Affiliation(s)
- Masaaki Nakase
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Daijiro Tomii
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Daryoush Samim
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Christoph Gräni
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Fabien Praz
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Jonas Lanz
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Stefan Stortecky
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - David Reineke
- Department of Cardiac Surgery, Inselspital, University of Bern, Bern, Switzerland
| | - Stephan Windecker
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Thomas Pilgrim
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.
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Hasegawa H, Nakama T, Senoo M, Hoshina M, Obunai K, Tabata M, Fujita H, Watanabe H. Clinical implications of Sokolow-Lyon voltage less than 3.5 mV in patients who have undergone transcatheter aortic valve replacement. Minerva Cardiol Angiol 2024; 72:444-452. [PMID: 39254954 DOI: 10.23736/s2724-5683.24.06450-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/11/2024]
Abstract
BACKGROUND Degenerative severe aortic valve stenosis (AS) is increasingly prevalent in the aging population, leading to the adoption of transcatheter aortic valve replacement (TAVR) as a less invasive alternative. While TAVR indications have expanded, the procedure is associated with a substantial incidence of major adverse cardiac events (MACE). The study aims to establish a preoperative risk-stratification system for TAVR candidates based on Sokolow-Lyon voltage (SLV) and other relevant factors. METHODS A total of 181 consecutive patients who underwent TAVR were retrospectively reviewed. Baseline characteristics, preoperative electrocardiogram (ECG) and echocardiography findings, and TAVR procedures were assessed. Low SLV (<3.5 mV) was defined based on ECG measurements. RESULTS Baseline characteristics revealed a mean age of 84 years, with 71.8% females. The two-year incidence of MACE defined as a composite of cardiac death and hospitalization due to heart failure, was 11.6%, significantly higher in the low SLV group. Low SLV emerged as an independent prognostic factor. The Tokyo Bay Risk (TBR) Score, including low SLV, Body Mass Index <18.5 kg/m2, and previous coronary artery disease, effectively stratified MACE risk. Higher TBR scores (2 or 3) correlated with increased MACE risk. CONCLUSIONS Patients with low SLV in pre-procedural ECG demonstrated a heightened risk of two-year MACE. The TBR score, incorporating low SLV, proved valuable for preoperative risk assessment. Careful consideration of TAVR indications, along with TBR score integration, is crucial for optimizing outcomes.
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Affiliation(s)
- Hiroko Hasegawa
- Department of Cardiology, Tokyo Bay Medical Center, Urayasu, Japan
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan
| | - Tatsuya Nakama
- Department of Cardiology, Tokyo Bay Medical Center, Urayasu, Japan -
- Division of Vascular Surgery, Department of Surgery, The Jikei University School of Medicine, Tokyo, Japan
| | - Maiko Senoo
- Department of Cardiology, Tokyo Bay Medical Center, Urayasu, Japan
| | - Mizuho Hoshina
- Department of Cardiology, Tokyo Bay Medical Center, Urayasu, Japan
| | - Kotaro Obunai
- Department of Cardiology, Tokyo Bay Medical Center, Urayasu, Japan
| | - Minoru Tabata
- Department of Cardiovascular Surgery, Juntendo University School of Medicine, Tokyo, Japan
| | - Hideo Fujita
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan
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Ravani LV, Ribeiro HB, Calomeni P, de Brito FS, Bernardi F, Lemos P, Feres F, Siqueira DA, Costa R, Sarmento-Leite R, Mangione F, Mangione JA, Thiago LEKS, de Lima VC, Oliveira ADD, Marino MA, Cardoso CJF, Caramori PRA, Tumelero RT, Portela ALF, Prudente ML, Henriques LA, de Freitas Souza FS, Bezerra CG, de Almeida Prado Junior GF, de Freitas LZF, Nogueira EF, Meirelle GCX, Pope RB, Guérios ÊE, de Andrade PB, de Moura Santos L, de Sá Marchi MF, Esteves VBC, Abizaid A. Clinical impact of sex differences and procedural setting in transcatheter aortic valve implantation. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2024:S1553-8389(24)00675-4. [PMID: 39362818 DOI: 10.1016/j.carrev.2024.09.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/26/2024] [Revised: 08/26/2024] [Accepted: 09/23/2024] [Indexed: 10/05/2024]
Abstract
BACKGROUND Transcatheter aortic valve implantation (TAVI) is a well-established treatment for symptomatic patients with aortic stenosis. Yet, the impact of sex differences and public vs. private procedural setting on TAVI outcomes remain uncertain. METHODS The RIBAC-NT (Brazilian Registry for Evaluation of Transcatheter Aortic Valve Replacement Outcomes) dataset included 3194 TAVI patients from 2009 to 2021. This retrospective analysis explored disparities in baseline characteristics, procedural and in-hospital outcomes stratifying patients by sex and procedural setting. Temporal trends were also investigated. RESULTS We included 1551 (49 %) female and 1643 (51 %) male patients. Women were older (83 [78-87] vs. 81 [75-85] years; p < 0.01) but had a lower prevalence of diabetes mellitus (30.2 % vs. 36.3 %, p < 0.01) and coronary artery disease (39.0 % vs. 52.2 %, p < 0.01). However, women had a 3-fold higher higher risk of life-threatening bleeding (6.1 % vs. 2.4 %, p < 0.01). Women presented higher procedural and in-hospital mortality rates (4.4 % vs. 2.5 % and 7.7 % vs. 4.5 %, all p < 0.01, respectively). Although public hospitals presented ~2-fold higher procedural mortality rate compared with private settings (5.0 % vs. 2.7 %, p < 0.01), after multivariable analysis procedural setting was not independently associated with in-hospital mortality. CONCLUSIONS Women had higher procedural and in-hospital mortality rates after TAVI as compared with men, while facing higher life-threatening bleeding and adverse events rates. Although public hospitals exhibited higher mortality rates than private centers, procedural setting was not independently associated with in-hospital mortality.
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Affiliation(s)
- Lis Victória Ravani
- Department of Interventional Cardiology, Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
| | - Henrique Barbosa Ribeiro
- Department of Interventional Cardiology, Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
| | - Pedro Calomeni
- Department of Interventional Cardiology, Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
| | - Fábio Sandoli de Brito
- Department of Interventional Cardiology, Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
| | - Fernando Bernardi
- Department of Interventional Cardiology, Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
| | - Pedro Lemos
- Hospital Israelita Albert Eistein, São Paulo, Brazil
| | - Fausto Feres
- Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
| | | | - Ricardo Costa
- Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | - Mauricio Felippi de Sá Marchi
- Department of Interventional Cardiology, Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
| | | | - Alexandre Abizaid
- Department of Interventional Cardiology, Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
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Merdler I, Rogers T, Case BC, Zhang C, Gordon P, Ehsan A, Parikh P, Bilfinger T, Buchbinder M, Roberts D, Hanna N, Ben-Dor I, Reddy PK, Sawant V, Satler LF, Waksman R. Two-year follow-up of transcatheter aortic valve replacement in low-risk patients with symptomatic severe bicuspid aortic valve stenosis. Catheter Cardiovasc Interv 2024; 104:583-590. [PMID: 39109463 DOI: 10.1002/ccd.31170] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/05/2024] [Revised: 06/30/2024] [Accepted: 07/20/2024] [Indexed: 11/15/2024]
Abstract
BACKGROUND In 2019, the US Food and Drug Administration (FDA) approved transcatheter aortic valve replacement (TAVR) for low-risk patients with symptomatic severe tricuspid aortic stenosis. However, bicuspid aortic valve (BAV) patients were included only in single-arm registries of pivotal low-risk TAVR trials, resulting in limited data for this subgroup. METHODS The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and the first FDA-approved investigational device exemption trial to evaluate the feasibility of TAVR with balloon-expandable or self-expanding valves in low-risk patients with symptomatic severe BAV stenosis. This analysis reports 2-year follow-up, assessing the primary outcome of all-cause mortality and evaluating clinical outcomes. RESULTS From 2016 to 2019, a total of 72 low-risk patients diagnosed with symptomatic, severe BAV stenosis underwent TAVR across six centers. Six patients were lost to follow-up. At 2-year follow-up, mortality was 1.5% (1 of 66 patients). Among the remaining 65 patients, four experienced nondisabling strokes (6.2%), while 2 (3.1%) developed infective endocarditis. No new permanent pacemakers were required beyond the 30-day follow-up, and no patients, including those with endocarditis, needed aortic valve re-intervention. At the 2-year echocardiography follow-up (n = 65), 27.8% of BAV patients showed mild aortic regurgitation, with none exhibiting moderate or severe regurgitation. The mean aortic gradient was 12.1 ± 4.1 mmHg, and the mean valve area was 1.7 ± 0.5 cm². CONCLUSION The 2-year follow-up confirms commendable clinical outcomes of TAVR in patients with bicuspid aortic stenosis, establishing its evident safety.
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Affiliation(s)
- Ilan Merdler
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, USA
| | - Toby Rogers
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, USA
- Cardiovascular Branch, Division of Intramural Research, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA
| | - Brian C Case
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, USA
| | - Cheng Zhang
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, USA
| | - Paul Gordon
- Division of Cardiology, Lifespan Cardiovascular Institute, Providence, Rhode Island, USA
| | - Afshin Ehsan
- Division of Cardiothoracic Surgery, Lifespan Cardiovascular Institute, Providence, Rhode Island, USA
| | - Puja Parikh
- Department of Medicine, Stony Brook Hospital, Stony Brook, New York, USA
| | - Thomas Bilfinger
- Department of Surgery, Stony Brook Hospital, Stony Brook, New York, USA
| | - Maurice Buchbinder
- Foundation for Cardiovascular Medicine, Stanford University, Stanford, California, USA
| | - David Roberts
- Sutter Medical Center, Sacramento, Sutter Heart and Vascular Institute, Research, Sacramento, California, USA
| | - Nicholas Hanna
- St. John Heart Institute Cardiovascular Consultants, St. John Health System, Tulsa, Oklahoma, USA
| | - Itsik Ben-Dor
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, USA
| | - Pavan K Reddy
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, USA
| | - Vaishnavi Sawant
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, USA
| | - Lowell F Satler
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, USA
| | - Ron Waksman
- Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, USA
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Tomii D, Heg D, Lanz J, Nakase M, Samim D, Stortecky S, Reineke D, Windecker S, Pilgrim T. Renin-Angiotensin System Inhibition in Patients With Myocardial Injury Complicating Transcatheter Aortic Valve Replacement. JACC. ADVANCES 2024; 3:101212. [PMID: 39253713 PMCID: PMC11381816 DOI: 10.1016/j.jacadv.2024.101212] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 01/01/2024] [Revised: 06/18/2024] [Accepted: 07/08/2024] [Indexed: 09/11/2024]
Abstract
Background Periprocedural myocardial injury impacts clinical outcome after transcatheter aortic valve replacement (TAVR). The optimal medical management strategy for TAVR-related periprocedural myocardial injury has not been established. Objectives The authors aimed to investigate the prognostic association of renin-angiotensin system (RAS) inhibitors in patients with periprocedural myocardial injury after TAVR. Methods In a prospective TAVR registry, patients were retrospectively stratified according to Valve Academic Research Consortium (VARC)-3 periprocedural myocardial injury and RAS inhibitor prescription after TAVR. The main outcomes of interest were prevalence of myocardial injury and cardiovascular death. Logistic and Cox proportional hazards regression were used to analyze outcomes of interest. Results Among 2,083 eligible patients undergoing TAVR between August 2007 and June 2023, 283 patients (13.8%) developed VARC-3 periprocedural myocardial injury. RAS inhibitors were prescribed in 197 patients (70%) with periprocedural myocardial injury and in 1,251 patients (71.2%) without injury. Compared with patients without periprocedural myocardial injury, patients with myocardial injury had an increased risk of cardiovascular death at 1 year (HRadjusted: 2.08; 95% CI: 1.39-3.11). The use of RAS inhibitors after TAVR was associated with a reduced risk of cardiovascular death in patients with and without periprocedural myocardial injury (HRadjusted: 0.46; 95% CI: 0.22-0.95, and HRadjusted: 0.44; 95% CI: 0.30-0.65, respectively). Conclusions One out of 7 patients undergoing TAVR experienced periprocedural myocardial injury. VARC-3 periprocedural myocardial injury was associated with a 2-fold increased risk of cardiovascular death at 1 year after TAVR. The favorable association of RAS inhibitor prescription was consistent in patients with and without periprocedural myocardial injury. (SwissTAVI Registry; NCT01368250).
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Affiliation(s)
- Daijiro Tomii
- Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Dik Heg
- Department of Clinical Research, University of Bern, Switzerland
| | - Jonas Lanz
- Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Masaaki Nakase
- Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Daryoush Samim
- Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Stefan Stortecky
- Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - David Reineke
- Department of Cardiac Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Stephan Windecker
- Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
| | - Thomas Pilgrim
- Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
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Butala NM, Kapadia SR, Yeh RW, Cohen DJ. Use of Discharge Disposition to Determine Stroke Severity After TAVR. Circ Cardiovasc Interv 2024; 17:e013698. [PMID: 38837149 PMCID: PMC11408091 DOI: 10.1161/circinterventions.123.013698] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/08/2023] [Accepted: 05/13/2024] [Indexed: 06/06/2024]
Affiliation(s)
- Neel M Butala
- Division of Cardiology, Rocky Mountain Regional VA Medical Center, Aurora, CO (N.M.B.)
- Division of Cardiology, University of Colorado School of Medicine, Aurora (N.M.B.)
| | | | - Robert W Yeh
- Division of Cardiovascular Medicine, Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.)
| | - David J Cohen
- Cardiovascular Research Foundation, New York, NY (D.J.C.)
- St. Francis Hospital and Heart Center, Roslyn, NY (D.J.C.)
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Parma R, Joner M, Saia F, Cuisset T, Delgado V, Rodes-Cabau J, Modine T, Van Belle E, Fovino LN, Landes U, Alvarez-Covarrubias HA, Abdel-Wahab M, Zamorano JL, Eden M, Cademartiri F, Skipirzepa JN, Kurucova J, Greinert D, Bramlage P, Tarantini G. Procedural and clinical outcomes of patients undergoing a TAVI in TAVI procedure: Rationale and design of the multicentre, prospective, observational ReTAVI registry. Eur J Clin Invest 2024; 54:e14241. [PMID: 38767226 DOI: 10.1111/eci.14241] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2024] [Revised: 04/26/2024] [Accepted: 05/01/2024] [Indexed: 05/22/2024]
Abstract
BACKGROUND Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI-transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI. METHODS The ReTAVI Prospective observational registry is an investigator-initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon-expandable SAPIEN prosthesis to evaluate procedural and short-term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high-volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30-day and 12-month follow-up. The estimated study completion is 2025. CONCLUSIONS The registry will collect pre-, peri-, postoperative and 12-months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC-3-defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis.
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Affiliation(s)
- Radoslaw Parma
- Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
| | - Michael Joner
- DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
- Department of Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Munich, Germany
| | - Francesco Saia
- Cardiology Unit, Cardio-Thoraco-Vascular Department, Policlinico S. Orsola-Malpighia, University Hospital of Bologn, Bologna, Italy
| | - Thomas Cuisset
- Département de Cardiologie, Centre Hospitalier Universitaire de Timone, Marseille, France
- Aix Marseille Université, INSERM, INRA, C2VN & Faculté de Médecine, Marseille, France
| | - Victoria Delgado
- Department of Cardiology, University Hospital Germans Trias i Pujol, Badalona, Spain
| | - Josep Rodes-Cabau
- Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Québec, Canada
| | - Thomas Modine
- Department of Cardiology, Hopital Haut Levêque-Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
| | - Eric Van Belle
- Interventional Cardiology, Centre Hospitalier Universitaire de Lille, Lille, France
| | - Luca Nai Fovino
- Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy
| | - Uri Landes
- Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel
| | - Hector Alfonso Alvarez-Covarrubias
- DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
- Department of Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Munich, Germany
| | - Mohamed Abdel-Wahab
- Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
| | | | - Matthias Eden
- Heidelberg University Clinic, Department Internal Medicine III (Cardiology, Angiology, Pneumology), Heidelberg, Germany
| | | | - Joanna Nawara Skipirzepa
- Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
| | | | - Daniel Greinert
- IPPMed-Institute for Pharmacology and Preventive Medicine GmbH, Cloppenburg, Germany
| | - Peter Bramlage
- IPPMed-Institute for Pharmacology and Preventive Medicine GmbH, Cloppenburg, Germany
| | - Giuseppe Tarantini
- Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy
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Turgeon RD, Ellis UM, Barry AR. Antithrombotic therapy in patients after transcatheter aortic valve implantation: a network meta-analysis. EUROPEAN HEART JOURNAL. CARDIOVASCULAR PHARMACOTHERAPY 2024; 10:454-464. [PMID: 38081213 DOI: 10.1093/ehjcvp/pvad101] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/12/2023] [Revised: 09/18/2023] [Accepted: 12/08/2023] [Indexed: 08/15/2024]
Abstract
AIMS The optimal antithrombotic therapy to balance the risk of thrombosis and bleeding in patients who undergo transcatheter aortic valve implantation (TAVI) is unknown. This systematic review/network meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the efficacy and safety of different oral anticoagulant (OAC) and antiplatelet regimens in patients post-TAVI. METHODS AND RESULTS MEDLINE, Embase, CENTRAL, and ClinicalTrials.gov were searched from inception to April 2023. Co-primary outcomes were all-cause death and major bleeding. We conducted Bayesian network meta-analyses to compare all interventions simultaneously. For each outcome, we generated odds ratios (ORs) with 95% credible intervals using a random-effects model with informative priors, and ranked interventions based on mean surface under the cumulative ranking curve. We included 11 RCTs (n = 6415), including 1 unpublished RCT. Three trials enrolled patients with an indication for an OAC. Overall risk of bias was low or with some concerns. Median age was 81 years. Median follow-up was 6 months. The combination of OAC plus single antiplatelet therapy (SAPT) increased the risk of all-cause death compared with dual antiplatelet therapy (DAPT) (OR 1.78, 95% credible interval 1.15-2.77). No other comparisons for all-cause death were significantly different. For major bleeding, SAPT reduced the risk compared with DAPT, direct-acting OAC, and OAC + SAPT (OR 0.20-0.40), and DAPT reduced the risk compared with OAC + SAPT. SAPT and DAPT ranked best for all-cause death, while SAPT ranked best for major bleeding. CONCLUSION In post-TAVI patients, SAPT may provide the optimal balance of reducing thrombotic events while minimizing the risk of bleeding.
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Affiliation(s)
- Ricky D Turgeon
- Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, V6T 1Z3, Canada
- St. Paul's Hospital, Vancouver, British Columbia, V6Z 1Y6, Canada
| | - Ursula M Ellis
- Woodward Library, University of British Columbia, Vancouver, British Columbia, V6T 1Z3, Canada
| | - Arden R Barry
- Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, V6T 1Z3, Canada
- Jim Pattison Outpatient Care and Surgery Centre, Lower Mainland Pharmacy Services, Surrey, British Columbia, V3T 0G9, Canada
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Mesnier J, Cruz-González I, Guedeney P, Arzamendi D, Freixa X, Nombela-Franco L, Peral V, Caneiro-Queija B, Mangieri A, Trejo-Velasco B, Asmarats L, Cepas-Guillén P, Salinas P, Siquier-Padilla J, Estevez-Loureiro R, Laricchia A, O'Hara G, Montalescot G, Rodés-Cabau J. Early Nonprocedural Bleeding After Left Atrial Appendage Occlusion. JACC Cardiovasc Interv 2024; 17:1765-1776. [PMID: 39023452 DOI: 10.1016/j.jcin.2024.05.032] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/19/2024] [Revised: 05/07/2024] [Accepted: 05/21/2024] [Indexed: 07/20/2024]
Abstract
BACKGROUND Patients treated with left atrial appendage occlusion (LAAO) are at high bleeding risk. Intensive antithrombotic treatment is recommended after the procedure to prevent device-related thrombosis. OBJECTIVES This study sought to evaluate the incidence, consequences, and predictors of early nonprocedural bleeding after LAAO. METHODS This was a multicenter study including 1,649 patients undergoing LAAO in 9 centers. Early nonprocedural bleeding was defined as bleeding unrelated to the procedure occurring within 3 months after device implantation. The severity of bleeding was defined by the Valve Academic Research Consortium-2 classification. A sensitivity analysis was performed at 45 days. RESULTS A total of 121 (7.3%) patients experienced early nonprocedural bleeding events, and 69 (57.0%) were classified as major bleeding (4.2% of patients). Independent predictors of early nonprocedural bleeding were dual antiplatelet therapy (DAPT) at discharge (adjusted HR [aHR]: 1.61; 95% CI: 1.12-2.33; P = 0.01), prior gastrointestinal bleeding (aHR: 2.15; 95% CI: 1.38-3.35; P < 0.001), and multiple locations of prior bleeding (aHR: 2.33; 95% CI: 1.34-4.05; P < 0.001). DAPT at discharge was predictive of both all and major nonprocedural bleeding at 3 months and 45 days. After a median follow-up of 2.3 years (Q1-Q3: 1.1-4.1 years), early nonprocedural bleeding was independently associated with an increased risk of all-cause death (aHR: 1.53; 95% CI: 1.15-2.06; P < 0.001). This heightened mortality risk was similar at 45 days. CONCLUSIONS Early nonprocedural bleeding after LAAO occurred in ∼7% of patients within 3 months, with more than one-half being classified as major bleeding. Regardless of severity, early nonprocedural bleeding was associated with increased mortality. DAPT at discharge determined an increased risk of early nonprocedural bleeding after LAAO. These results emphasize the importance of bleeding risk for determining antithrombotic strategies after LAAO.
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Affiliation(s)
- Jules Mesnier
- Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
| | | | - Paul Guedeney
- Sorbonne Université, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie (AP-HP), Paris, France
| | | | - Xavier Freixa
- Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer, Barcelona, Spain
| | | | - Vicente Peral
- Servicio de Cardiología, Hospital Universitari Son Espases, Institut d'Investigació Sanitària Illes Balears, Palma, Balearic Islands, Spain
| | | | - Antonio Mangieri
- Cardiocenter, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
| | | | | | - Pedro Cepas-Guillén
- Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer, Barcelona, Spain
| | - Pablo Salinas
- Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain
| | - Joan Siquier-Padilla
- Servicio de Cardiología, Hospital Universitari Son Espases, Institut d'Investigació Sanitària Illes Balears, Palma, Balearic Islands, Spain
| | | | - Alessandra Laricchia
- GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy; ASST Fatebenefratelli Sacco, Milan, Italy
| | - Gilles O'Hara
- Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
| | - Gilles Montalescot
- Sorbonne Université, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie (AP-HP), Paris, France
| | - Josep Rodés-Cabau
- Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada; Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer, Barcelona, Spain.
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Möllmann H, Noack T, Hilker M, Conradi L, Toggweiler S, Hofmann B, Joner M, Modolo R, Allocco DJ, Kim WK. Five-year outcomes of transcatheter aortic valve implantation with the ACURATE neo2 valve system. EUROINTERVENTION 2024; 20:e951-e953. [PMID: 39099375 PMCID: PMC11285037 DOI: 10.4244/eij-d-23-00852] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/06/2023] [Accepted: 04/15/2024] [Indexed: 08/06/2024]
Affiliation(s)
- Helge Möllmann
- Department of Internal Medicine I, St.-Johannes-Hospital, Dortmund, Germany
| | - Thilo Noack
- University Department of Cardiac Surgery, Heart Center Leipzig, Leipzig, Germany
| | - Michael Hilker
- Klinik für Herz-, Thorax und Herznahe Gefäßchirurgie, Universität Regensburg, Regensburg, Germany
| | - Lenard Conradi
- Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany
| | - Stefan Toggweiler
- Department of Cardiology, Luzerner Kantonsspital, LUKS, Luzern, Switzerland
| | - Britt Hofmann
- Department of Cardiac Surgery, University Hospital Halle, Halle, Germany
| | - Michael Joner
- Deutsches Herzzentrum München, Technische Universität München, Munich, Germany
- DZHK (German Centre for Cardiovascular Research), Munich Heart Alliance, Munich, Germany
| | | | | | - Won-Keun Kim
- Department of Cardiology/Cardiac Surgery, Kerckhoff Heart Centre, Bad Nauheim, Germany
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Palmier M, Amarouche H, Teniere T, Bernard G, Pochulu B, Fares Y, Miranda S, Plissonnier D. Enhancing Arterial Closure in Endovascular Aortic Procedures: The Efficacy of Echo-Guided ProGlide Technique. Ann Vasc Surg 2024; 105:125-131. [PMID: 38588952 DOI: 10.1016/j.avsg.2024.02.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/28/2023] [Revised: 01/27/2024] [Accepted: 02/06/2024] [Indexed: 04/10/2024]
Abstract
BACKGROUND Endovascular aortic surgery is increasingly becoming the standard treatment. Percutaneous access preclosing systems appear to be effective and notably the Proglide (PG). We aimed to prospectively assess the clinical effectiveness of combining ultrasound-guided femoral puncture with ultrasound-guided PG deployment. METHODS Our single-center study consecutively included patients managed at a tertiary center from May to September 2023, undergoing endovascular aortic surgery. The placement of PG was performed under ultrasound guidance. Preoperative patient characteristics were evaluated using preoperative computed tomography scans. Clinical and technical success were defined, respectively, as the ability to achieve complete hemostasis confirmed by ultrasound 48 hr postprocedure and as the successful placement of a PG under ultrasound guidance contributing to final hemostasis. RESULTS Twenty patients were included over a 6-month period, totaling 34 common femoral arteries (CFAs). Fourteen were male, with an average age of 72.8 ± 8.2 years. Among the 34 CFA, CFA had diameter of 12.05 ± 2.4 mm and a depth of 38.0 ± 13.4 mm. The mean introducer sheath diameter was 6.2 ± 1.5 mm with a sheath to femoral artery ratio of 0.54 ± 0.18. Successful Proglide placement under ultrasound guidance was achieved in 100% of cases. No PG failure occurred. Clinical and technical success were, respectively, of 95% and 100%. One small pseudoaneurysm was observed at 48 hr treated medically. No CFA access reintervention was required. CONCLUSIONS The technique of ultrasound-guided PG deployment in aortic surgery is a safe and effective method for achieving hemostasis. It effectively prevents PG failures at a lower cost.
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Affiliation(s)
- Mickael Palmier
- Department of Vascular Surgery, Rouen University Hospital, Rouen, France.
| | - Hossam Amarouche
- Department of Vascular Medicine, Rouen University Hospital, Rouen, France
| | - Tom Teniere
- Department of Vascular Surgery, Rouen University Hospital, Rouen, France
| | - Geoffrey Bernard
- Department of Vascular Surgery, Rouen University Hospital, Rouen, France
| | - Bruno Pochulu
- Department of Vascular Surgery, Rouen University Hospital, Rouen, France
| | - Yara Fares
- Department of Vascular Medicine, Rouen University Hospital, Rouen, France
| | - Sebastien Miranda
- Department of Vascular Medicine, Rouen University Hospital, Rouen, France
| | - Didier Plissonnier
- Department of Vascular Surgery, Rouen University Hospital, Rouen, France
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50
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Zierer A, De Paulis R, Bakhtiary F, Ahmad AES, Andreas M, Autschbach R, Benedikt P, Binder K, Bonaros N, Borger M, Bourguignon T, Canovas S, Coscioni E, Dagenais F, Demers P, Dewald O, Feyrer R, Geißler HJ, Grabenwöger M, Grünenfelder J, Kueri S, Lam KY, Langanay T, Laufer G, Van Leeuwen W, Leyh R, Liebold A, Mariscalco G, Massoudy P, Mehdiani A, Pessotto R, Pollari F, Polvani G, Ricci A, Roussel JC, Salamate S, Siepe M, Stefano P, Strauch J, Theron A, Vötsch A, Weber A, Wendler O, Thielmann M, Eden M, Botta B, Bramlage P, Meuris B. Sex-related differences among patients undergoing surgical aortic valve replacement-a propensity score matched study. INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY 2024; 39:ivae140. [PMID: 39128016 PMCID: PMC11341123 DOI: 10.1093/icvts/ivae140] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/02/2024] [Accepted: 08/08/2024] [Indexed: 08/13/2024]
Abstract
OBJECTIVES We investigated the sex-related difference in characteristics and 2-year outcomes after surgical aortic valve replacement (SAVR) by propensity-score matching (PSM). METHODS Data from 2 prospective registries, the INSPIRIS RESILIA Durability Registry (INDURE) and IMPACT, were merged, resulting in a total of 933 patients: 735 males and 253 females undergoing first-time SAVR. The PSM was performed to assess the impact of sex on the SAVR outcomes, yielding 433 males and 243 females with comparable baseline characteristics. RESULTS Females had a lower body mass index (median 27.1 vs 28.0 kg/m2; P = 0.008), fewer bicuspid valves (52% vs 59%; P = 0.036), higher EuroSCORE II (mean 2.3 vs 1.8%; P < 0.001) and Society of Thoracic Surgeons score (mean 1.6 vs 0.9%; P < 0.001), were more often in New York Heart Association functional class III/IV (47% vs 30%; P < 0.001) and angina Canadian Cardiovascular Society III/IV (8.2% vs 4.4%; P < 0.001), but had a lower rate of myocardial infarction (1.9% vs 5.2%; P = 0.028) compared to males. These differences vanished after PSM, except for the EuroSCORE II and Society of Thoracic Surgeons scores, which were still significantly higher in females. Furthermore, females required smaller valves (median diameter 23.0 vs 25.0 mm, P < 0.001). There were no differences in the length of hospital stay (median 8 days) or intensive care unit stay (median 24 vs 25 hours) between the 2 sexes. At 2 years, post-SAVR outcomes were comparable between males and females, even after PSM. CONCLUSIONS Despite females presenting with a significantly higher surgical risk profile, 2-year outcomes following SAVR were comparable between males and females.
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Affiliation(s)
- Andreas Zierer
- Department of Cardiac, Vascular and Thoracic Surgery, Kepler University Hospital Linz, Linz, Austria
- Department of Cardiac, Vascular and Thoracic Surgery, Hospital Wels-Grieskirchen, Wels, Austria
| | | | - Farhad Bakhtiary
- Department of Cardiac Surgery, University Hospital Bonn, Bonn, Germany
| | | | - Martin Andreas
- Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria
| | - Rüdiger Autschbach
- Department of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen, Germany
| | - Peter Benedikt
- Department of Cardiac, Vascular and Thoracic Surgery, Kepler University Hospital Linz, Linz, Austria
- Department of Cardiac, Vascular and Thoracic Surgery, Hospital Wels-Grieskirchen, Wels, Austria
| | - Konrad Binder
- Department of Cardiac Surgery, University Hospital St Poelten, St Poelten, Austria
| | - Nikolaos Bonaros
- Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria
| | - Michael Borger
- Department of Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany
| | - Thierry Bourguignon
- Department of Cardiology and Cardiac Surgery, Tours University Hospital, Tours, France
| | - Sergio Canovas
- Cardiovascular Surgery Department, Hospital University Virgen de la Arrixaca, Murcia, Spain
| | - Enrico Coscioni
- Department of Cardiac Surgery, University Hospital San Giovanni di Dio e Ruggi d'Aragona, Salerno, Italy
| | - Francois Dagenais
- Department of Cardiac Surgery, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec City, Québec, Canada
| | - Philippe Demers
- Department of Surgery, Montreal Heart Institute, University of Montreal, Montreal, Canada
| | - Oliver Dewald
- Department of Pediatric Cardiac Surgery, University Hospital Erlangen, Erlangen, Germany
| | - Richard Feyrer
- Department of Cardiac Surgery, Clinic for Cardiovascular Surgery, Central Military Hospital, Koblenz, Germany
| | - Hans-Joachim Geißler
- Department of Cardiac, Vascular and Thoracic Surgery, Kepler University Hospital Linz, Linz, Austria
- Department of Cardiac, Vascular and Thoracic Surgery, Hospital Wels-Grieskirchen, Wels, Austria
| | - Martin Grabenwöger
- Department of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria
| | - Jürg Grünenfelder
- Department of Cardiac Surgery, Heart Clinic Zurich, Hirslanden Klinik, Zurich, Switzerland
| | - Sami Kueri
- Department of Cardiovascular Surgery, University Heart Center Freiburg Bad Krozingen, Bad Krozingen, Germany
| | - Ka Yan Lam
- Department of Cardiothoracic Surgery, Catharina Hospital Eindhoven, Eindhoven, Netherlands
| | - Thierry Langanay
- Department of Thoracic and Cardiovascular Surgery, Rennes University Hospital Center, Rennes, France
| | - Günther Laufer
- Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria
| | - Wouter Van Leeuwen
- Department of Cardiothoracic Surgery, Erasmus MC University Medical Center, Rotterdam, Netherlands
| | - Rainer Leyh
- Department of Thoracic and Cardiovascular Surgery, University of Wuerzburg, Wuerzburg, Germany
| | - Andreas Liebold
- Department of Cardiac Surgery, University of Ulm Medical Center, Ulm, Germany
| | - Giovanni Mariscalco
- Department of Cardiac Surgery, National Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, UK
| | - Parwis Massoudy
- Department of Cardiac Surgery, Klinikum Passau, Passau, Germany
| | - Arash Mehdiani
- Department of Cardiac Surgery, University Hospital Duesseldorf, Duesseldorf, Germany
- Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center, University Duisburg-Essen, Essen, Germany
| | - Renzo Pessotto
- Department of Cardiothoracic Surgery, Royal Infirmary of Edinburgh, Edinburgh, UK
| | - Francesco Pollari
- Department of Cardiac Surgery, Klinikum Nürnberg-Paracelsus Medical University, Nuremberg, Germany
| | - Gianluca Polvani
- Department of Cardiovascular Surgery, Centro Cardiologico Monzino IRCCS, Milan, Italy
| | | | | | - Saad Salamate
- Department of Cardiac Surgery, University Hospital Bonn, Bonn, Germany
| | - Matthias Siepe
- Department of Cardiovascular Surgery, University Heart Center Freiburg Bad Krozingen, Bad Krozingen, Germany
- Department of Cardiac Surgery, University Hospital Bern, University of Bern, Bern, Switzerland
| | - Pierluigi Stefano
- Department of Cardiothoracic and Vascular Surgery, Careggi University Hospital, Florence, Italy
| | - Justus Strauch
- Department of Cardiothoracic Surgery, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Bochum, Nordrhein-Westfalen, Germany
| | - Alexis Theron
- Cardio-Thoracic Surgery Department, Hospital de la Timone, Marseille, France
| | - Andreas Vötsch
- Department of Cardiovascular and Endovascular Surgery, Paracelsus Medical University, Salzburg, Austria
| | - Alberto Weber
- Department of Cardiovascular Surgery, Heart Center Hirslanden, Zurich, Switzerland
| | - Olaf Wendler
- Department of Cardiothoracic Surgery, King’s College Hospital NHS Foundation Trust, London, UK
| | - Matthias Thielmann
- Department of Thoracic and Cardiovascular Surgery, West-German Heart and Vascular Center, University Duisburg-Essen, Essen, Germany
| | - Matthias Eden
- Department of Medicine III: Cardiology, Angiology, and Pneumology, Heidelberg University, Heidelberg, Germany
| | - Beate Botta
- Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany
| | - Peter Bramlage
- Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany
| | - Bart Meuris
- Department of Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium
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