|
1
|
Gittess D, Anderson RD. Editorial: Response to "Outcomes in transcatheter aortic valve replacement (TAVR) patients requiring red blood cell transfusion: A nationwide perspective". CARDIOVASCULAR REVASCULARIZATION MEDICINE 2025; 70:54-55. [PMID: 39191614 DOI: 10.1016/j.carrev.2024.08.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2024] [Accepted: 08/13/2024] [Indexed: 08/29/2024]
Affiliation(s)
- David Gittess
- University of Florida, Department of Internal Medicine, United States of America
| | - R David Anderson
- University of Florida, Division of Cardiovascular Medicine, United States of America.
| |
Collapse
|
|
2
|
Barth S, Ahmed M, Hautmann MB, Reents W, Zacher M, Kerber S, Lüsebrink U, Schmandra TC. Prognostic benefits of early vascular surgical intervention in patients with major peripheral vascular complications following transcatheter aortic valve implantation. Hellenic J Cardiol 2024; 77:1-12. [PMID: 37611868 DOI: 10.1016/j.hjc.2023.08.007] [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: 06/29/2023] [Revised: 08/08/2023] [Accepted: 08/11/2023] [Indexed: 08/25/2023] Open
Abstract
OBJECTIVES This study aimed to analyze the incidence, surgical management of major vascular complications, and outcomes in patients undergoing transfemoral (TF) transcatheter aortic valve replacement (TAVR) at our center after strict selection of the access route, carefully considering all known major predictors. METHODS Data of 494 consecutive patients with pre-interventional multi-slice computed tomography (CT) of the aorta who had undergone TF TAVR from 2009 to 2019 were analyzed. RESULTS In total, 23/494 (4.7%) patients had major vascular and access-related complications of peripheral vessels and/or infrarenal aorta. These included hematomas that met the Valve Academic Research Consortium 3-criteria of major vascular complications (7/494, 1.4%), arterial dissections (3/494, 0.6%), pseudoaneurysm (6/494, 1.2%), thrombus of the external iliac artery leading to acute limb ischemia (1/494, 0.2%), fistula (1/494, 0.2%), and perforation (5/494, 1.0%). In total, 17/23 (73.9%) major vascular complications required immediate endovascular and/or open surgery. In 16/17 (94%) cases, only 1 surgical procedure was performed. The long-term survival of patients with and without major vascular complications of the peripheral vessels was determined after 2 years. CONCLUSIONS Early vascular surgery intervention reversed the mortality disadvantage in patients with major complications of the peripheral vessels after TAVR. This underscores the importance of immediate vascular surgery stand-by as an indispensable requirement.
Collapse
Affiliation(s)
- Sebastian Barth
- Cardiovascular Center Bad Neustadt/Saale, Department of Cardiology, Bad Neustadt/Saale, Germany.
| | - Mohammed Ahmed
- Cardiovascular Center Bad Neustadt/Saale, Department of Cardiology, Bad Neustadt/Saale, Germany
| | - Martina B Hautmann
- Cardiovascular Center Bad Neustadt/Saale, Department of Cardiology, Bad Neustadt/Saale, Germany
| | - Wilko Reents
- Cardiovascular Center Bad Neustadt/Saale, Department Cardiac Surgery, Bad Neustadt/Saale, Germany
| | - Michael Zacher
- Department of Medical Documentation, Bad Neustadt/Saale, Germany
| | - Sebastian Kerber
- Cardiovascular Center Bad Neustadt/Saale, Department of Cardiology, Bad Neustadt/Saale, Germany
| | | | - Thomas C Schmandra
- Cardiovascular Center Bad Neustadt/Saale, Department of Vascular Surgery, Bad Neustadt/Saale, Germany
| |
Collapse
|
|
3
|
Memon S, Goldman S, Rodriguez R, Ramlawi B, Coady PM, Gnall EM. Alternative Application Technique for the MANTA Vascular Closure Device for Percutaneous Large-Bore Arterial Access Closure: The Fluoroscopic DOT Technique. J Endovasc Ther 2023; 30:885-891. [PMID: 35766367 DOI: 10.1177/15266028221105187] [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] [Indexed: 11/17/2022]
Abstract
BACKGROUND Vascular complications are a cause of increased morbidity and mortality when performing percutaneous procedures requiring large-bore arterial access. MANTA vascular closure device (VCD) is currently the only large-bore VCD using an intraluminal foot plate and an extraluminal collagen plug. The traditional depth locator approach might be compromised in; emergent cases without the required measurements, cases of hematoma formation, or other patient, procedure, or operator-specific variables. Furthermore, this technique can be used for postclosure in cases without the required measurement of depth. We describe vascular outcomes using fluoroscopy (fluoroscopic DOT technique) rather than traditional depth locator approach for vascular closure with the MANTA VCD. METHODS Fifty patients who underwent transcatheter aortic valve implantation (TAVI) were retrospectively analyzed using fluoroscopic DOT technique with 18F MANTA VCD between May and August 2021. All patients >18 years of age who qualified for transfemoral TAVI were included. Access was obtained with ultrasound guidance with vessel diameter of at least > 6 mm and free from anterior vessel wall calcification. Patient related factors and primary outcomes of access site bleeding and acute flow-limited limb ischemia requiring intervention were prospectively analyzed. Furthermore, 1 patient who failed hemostasis with suture-mediated VCD had successful hemostasis with fluoroscopic DOT technique as dry postclosure after balloon aortic valvuloplasty. RESULTS In total, 50 patients were analyzed with a mean age of 81 years and majority were male (56%). Majority had comorbidities of hypertension (88%) and hyperlipidemia (94%), 24% had peripheral arterial disease, 38% coronary artery disease, and 58% were former smokers. Importantly, 40% were obese with an average body mass index (BMI) of 29 kg/m2. There were no bleeding or ischemic limb complications post MANTA VCD deployment using the fluoroscopic DOT technique. Furthermore, none of the patients required peripheral intervention from index procedure to 1 month post verified during their 1-month post TAVR follow-up. CONCLUSION Fluoroscopic DOT technique using the MANTA VCD is highly reproducible and allows hemostasis in a predictable manner for procedures requiring large-bore arterial access in the absence of MANTA depth measurement.
Collapse
Affiliation(s)
- Sehrish Memon
- Division of Cardiovascular Diseases, Lankenau Medical Center, Lankenau Institute of Medical Research, Wynnewood, PA, USA
| | - Scott Goldman
- Division of Cardiothoracic Surgery, Lankenau Medical Center, Lankenau Institute of Medical Research, Wynnewood, PA, USA
| | - Roberto Rodriguez
- Division of Cardiothoracic Surgery, Lankenau Medical Center, Lankenau Institute of Medical Research, Wynnewood, PA, USA
| | - Basel Ramlawi
- Division of Cardiothoracic Surgery, Lankenau Medical Center, Lankenau Institute of Medical Research, Wynnewood, PA, USA
| | - Paul M Coady
- Division of Cardiovascular Diseases, Lankenau Medical Center, Lankenau Institute of Medical Research, Wynnewood, PA, USA
| | - Eric M Gnall
- Division of Cardiovascular Diseases, Lankenau Medical Center, Lankenau Institute of Medical Research, Wynnewood, PA, USA
| |
Collapse
|
|
4
|
Carande EJ, Salim TS, Chase A, Sekar B, Aldalati O, Hailan A, Khurana A, Smith D, Obaid DR. Computed tomography defined femoral artery plaque composition predicts vascular complications during transcatheter aortic valve implantation. Br J Radiol 2023; 96:20230296. [PMID: 37747290 PMCID: PMC10646661 DOI: 10.1259/bjr.20230296] [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: 03/30/2023] [Revised: 07/16/2023] [Accepted: 07/25/2023] [Indexed: 09/26/2023] Open
Abstract
OBJECTIVE Vascular and bleeding complications after transcatheter aortic valve implantation (TAVI) are common and lead to increased morbidity and mortality. Analysis of plaque at the arterial access site may improve prediction of complications. METHODS We investigated the association between demographic and procedural risk factors for Valve Academic Research Consortium (VARC-3) vascular complications in patients undergoing transfemoral TAVI with use of a vascular closure device (ProGlide® or MANTA®) in this retrospective cohort study. The ability of pre-procedure femoral CT angiography to predict complications was investigated including a novel method of quantifying plaque composition of the common femoral artery using plaque maps created with patient specific X-ray attenuation cut-offs. RESULTS 23 vascular complications occurred in the 299 patients in the study group (7.7%). There were no demographic risk factors associated with vascular complications and no statistical difference between use of closure device (ProGlide® vs MANTA®) and vascular complications. Vascular complications after TAVI were associated with sheath size (OR 1.36, 95% CI 1.08-1.76, P 0.01) and strongly associated with CT-derived necrotic core volume in the common femoral artery of the procedural side (OR 17.49, 95% CI 1.21-226.60, P 0.03). CONCLUSION Plaque map analysis of the common femoral artery by CT angiography reveals patients with greater necrotic core are at increased risk of VARC-3 vascular complications. ADVANCES IN KNOWLEDGE The novel measurement of necrotic core volume in the common femoral artery on the procedural side by CT analysis was associated with post-TAVI vascular complications, which can be used to highlight increased risk.
Collapse
Affiliation(s)
- Elliott J. Carande
- Cwm Taff Morgannwg University Health Board, Princess of Wales Hospital, Coity Road, Bridgend, United Kingdom
| | - Tarik S Salim
- Swansea Bay University Health Board, Morriston Hospital, Swansea, United Kingdom
| | - Alexander Chase
- Swansea Bay University Health Board, Morriston Hospital, Swansea, United Kingdom
| | - Baskar Sekar
- Swansea Bay University Health Board, Morriston Hospital, Swansea, United Kingdom
| | - Omar Aldalati
- Swansea Bay University Health Board, Morriston Hospital, Swansea, United Kingdom
| | - Ahmed Hailan
- Swansea Bay University Health Board, Morriston Hospital, Swansea, United Kingdom
| | - Ayush Khurana
- Swansea Bay University Health Board, Morriston Hospital, Swansea, United Kingdom
| | - Dave Smith
- Swansea Bay University Health Board, Morriston Hospital, Swansea, United Kingdom
| | | |
Collapse
|
|
5
|
Fukutomi M, Onishi T, Ando T, Higuchi R, Hagiya K, Saji M, Takamisawa I, Iguchi N, Takayama M, Shimizu A, Shimizu J, Doi S, Okazaki S, Sato K, Tamura H, Yokoyama H, Takanashi S, Tobaru T. Impact of periprocedural bleeding on mid-term outcome in nonagenarians who underwent transcatheter aortic valve implantation: insights from LAPLACE registry. J Thromb Thrombolysis 2023:10.1007/s11239-023-02800-2. [PMID: 37061662 DOI: 10.1007/s11239-023-02800-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 03/26/2023] [Indexed: 04/17/2023]
Abstract
Data from several recent studies have demonstrated the safety and efficacy of transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) even in nonagenarians. However, the impact of periprocedural bleeding following TAVI on their outcome remains unclear. In the aLliAnce for exPloring cLinical prospects of AortiC valvE disease (LAPLACE) registry, we compared outcomes between the bleeding and no-bleeding groups among 1953 patients < 90 years old (mean age, 83.0 ± 4.6 years old) and 316 nonagenarians (mean age, 91.7 ± 1.9 years old) who underwent TAVI with a median follow-up period of 628 days. The group with any periprocedural bleeding showed a higher 30-day mortality than the no-bleeding group in patients < 90 years old (3.3% vs. 0.5%, p = 0.001) and nonagenarians (7.9% vs. 0.7%, p = 0.001). In patients < 90 years old, severe periprocedural bleeding (n = 85) was associated with a higher mid-term all-cause mortality rate than no severe bleeding (n = 1,868), even after adjusting for covariates (hazard ratio [HR], 1.994; 95% confidence interval [CI] 1.287-2.937; p = 0.002). On the other hand, in nonagenarians, any periprocedural bleeding (n = 38) was associated with a higher mid-term cardiovascular (CV) mortality rate (21.1% vs. 4.3%, log-rank p = 0.014) than no bleeding (n = 278), even after adjusting for covariates (HR, 3.104; 95% CI 1.140-8.449; p = 0.027). In conclusion, any periprocedural bleeding after TAVI was associated with mid-term CV mortality in nonagenarians, whereas severe bleeding was associated with mid-term all-cause mortality in patients < 90 years old.
Collapse
Affiliation(s)
- Motoki Fukutomi
- Department of Cardiology, Kawasaki Saiwai Hospital, 31-27, Kawasaki, Kanagawa, 212-0014, Japan.
| | - Takayuki Onishi
- Department of Cardiology, Kawasaki Saiwai Hospital, 31-27, Kawasaki, Kanagawa, 212-0014, Japan
| | - Tomo Ando
- Department of Cardiology, Kawasaki Saiwai Hospital, 31-27, Kawasaki, Kanagawa, 212-0014, Japan
| | - Ryosuke Higuchi
- Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan
| | - Kenichi Hagiya
- Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan
| | - Mike Saji
- Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan
| | - Itaru Takamisawa
- Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan
| | - Nobuo Iguchi
- Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan
| | | | - Atsushi Shimizu
- Department of Cardiovascular Surgery, Sakakibara Heart Institute, Tokyo, Japan
| | - Jun Shimizu
- Department of Anesthesiology, Sakakibara Heart Institute, Tokyo, Japan
| | - Shinichiro Doi
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Shinya Okazaki
- Department of Cardiovascular Biology and Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan
| | - Kei Sato
- Department of Cardiology, Mie University Hospital, Thu, Japan
| | - Harutoshi Tamura
- Department of Cardiology, Pulmonology and Nephrology, Yamagata University Hospital, Yamagata, Japan
| | - Hiroaki Yokoyama
- Department of Cardiology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan
| | | | - Tetsuya Tobaru
- Department of Cardiology, Kawasaki Saiwai Hospital, 31-27, Kawasaki, Kanagawa, 212-0014, Japan
| |
Collapse
|
|
6
|
Savvoulidis P, Nadir AM, Mechery A, Doshi SN. A very rare vascular complication of the Edwards expandable eSheath during transcatheter aortic valve replacement. Catheter Cardiovasc Interv 2023; 101:660-667. [PMID: 36640417 DOI: 10.1002/ccd.30557] [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: 10/06/2022] [Revised: 12/03/2022] [Accepted: 01/02/2023] [Indexed: 01/15/2023]
Abstract
Transcatheter aortic valve replacement (TAVR) has revolutionized the management of severe symptomatic aortic valve stenosis. TAVR is now indicated as an alternative to surgical replacement in a wide risk profile ranging from high to low surgical risk. Although vascular complications have decreased in frequency over time, with the introduction of lower profile delivery systems and sheaths, they remain one of the most frequently encountered and serious complications of TAVR. Patient-specific predisposing factors have been well characterized. However, much less is known about device-specific complications. Awareness of the possible device-related complications may lead to earlier identification, prompt management, and better outcomes. We report a previously unreported complication of the Edwards expandable eSheath that lead to avulsion of the external iliac artery following successful TAVR with a 29-mm Edwards Sapien 3 transcatheter heart valve. Bleeding was promptly controlled with an occlusion balloon and emergency surgical repair was required with a favorable outcome.
Collapse
Affiliation(s)
- Panagiotis Savvoulidis
- Department of Cardiology, Queen Elizabeth University Hospital, Edgbaston, Birmingham, UK
| | - Adnan M Nadir
- Department of Cardiology, Queen Elizabeth University Hospital, Edgbaston, Birmingham, UK.,Institute for Cardiovascular Sciences, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK
| | - Anthony Mechery
- Department of Cardiology, Queen Elizabeth University Hospital, Edgbaston, Birmingham, UK
| | - Sagar N Doshi
- Department of Cardiology, Queen Elizabeth University Hospital, Edgbaston, Birmingham, UK.,Institute for Cardiovascular Sciences, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK
| |
Collapse
|
|
7
|
Doshi R, Vasudev R, Guragai N, Patel KN, Kumar A, Majmundar M, Doshi P, Patel P, Shah K, Santana M, Roman S, Vallabhajosyula S, Virk H, Bikkina M, Shamoon F. Clinical outcomes of MANTA vs suture-based vascular closure devices after transcatheter aortic valve replacement: An updated meta-analysis. Indian Heart J 2023; 75:59-67. [PMID: 36640840 PMCID: PMC9986740 DOI: 10.1016/j.ihj.2023.01.007] [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: 08/26/2022] [Revised: 01/08/2023] [Accepted: 01/09/2023] [Indexed: 01/13/2023] Open
Abstract
OBJECTIVE A recently published randomized control trial showed different results with suture-based vascular closure device (VCD) than plug-based VCD in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The learning curve for MANTA device is steep, while the learning curve for suture based VCD is shallow as the devices are quite different. In this meta-analysis, we have compared suture-based (ProGlide and Prostar XL) vs plug-based VCDs (MANTA). METHODS We performed a meta-analysis of all published studies (using PubMed/Medline and Cochrane databases) reporting the clinical outcome of plug-based vs suture-based VCDs in transfemoral TAVR patients. RESULTS We included nine studies with a total of 2865 patients (plug-based n = 1631, suture-based n = 1234). There was no significant difference in primary outcome of all bleeding when using plug-based as opposed to suture-based VCDs (RR 1.14 [0.62-2.06] I2 = 72%). There was no significant difference in the incidence of secondary outcomes between two groups including major life threatening bleeding (RR 1.16 [0.38-3.58] I2 = 65%), major vascular complications (RR 0.84 [0.35-2.00] I2 = 55%), minor vascular complications (RR 1.05 [0.56-1.95] I2 = 42%), pseudo aneurysm (RR 1.84 [0.11-29.98] I2 = 44%), stenosis-dissection (RR 0.98 [0.66-1.47] I2 = 0%), VCD failure (RR 1.71 [0.96-3.04] I2 = 0%), and blood transfusion (RR 1.01 [0.38-2.71], I2 = 61%). CONCLUSION Large bore arteriotomy closure with plug-based VCD was not superior to suture-based VCDs in this transfemoral TAVR population. There was very frequent use of secondary VCDs in suture-based VCD group which is not practical when using MANTA. Additional high-powered studies are required to determine the safety and efficacy of MANTA device.
Collapse
Affiliation(s)
- Rajkumar Doshi
- Department of Cardiology, St Joseph University Medical Center, Paterson, NJ, USA.
| | - Rahul Vasudev
- Department of Cardiology, St Joseph University Medical Center, Paterson, NJ, USA
| | - Nirmal Guragai
- Department of Cardiology, St Joseph University Medical Center, Paterson, NJ, USA
| | - Kunal Nitinkumar Patel
- Department of Internal Medicine, Saint Peter's University Hospital, New Brunswick, NJ, USA
| | - Ashish Kumar
- Department of Internal Medicine Cleveland Clinic Akron General, Akron, OH, USA
| | - Monil Majmundar
- Department of Cardiology, University of Kansas Medical Center, Kansas City, KS, USA
| | - Preet Doshi
- Department of Medicine, MS Ramaiah Medical College, Bengaluru, India
| | - Prem Patel
- Department of Cardiology, St Joseph University Medical Center, Paterson, NJ, USA
| | - Kalpesh Shah
- Department of Cardiology, St Joseph University Medical Center, Paterson, NJ, USA
| | - Melvin Santana
- Department of Cardiology, St Joseph University Medical Center, Paterson, NJ, USA
| | - Sherif Roman
- Department of Cardiology, St Joseph University Medical Center, Paterson, NJ, USA
| | - Saraschandra Vallabhajosyula
- Section of Cardiovascular Medicine, Department of Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, USA
| | - Hartaj Virk
- Department of Cardiology, St Joseph University Medical Center, Paterson, NJ, USA
| | - Mahesh Bikkina
- Department of Cardiology, St Joseph University Medical Center, Paterson, NJ, USA
| | - Fayez Shamoon
- Department of Cardiology, St Joseph University Medical Center, Paterson, NJ, USA
| |
Collapse
|
|
8
|
Cakal B, Cakal S, Karaca O, Yilmaz FK, Gunes HM, Yildirim A, Ulas Ozcan O, Guler Y, Boztosun B. Angio-Seal Used as a Bailout for Incomplete Hemostasis After Dual Perclose ProGlide Deployment in Transcatheter Aortic Valve Implantation. Tex Heart Inst J 2022; 49:489290. [PMID: 36515932 PMCID: PMC9809091 DOI: 10.14503/thij-21-7684] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
BACKGROUND The failure rate of vascular closure devices remains a significant cause of major vascular complications in contemporary transcatheter aortic valve implantation practice. METHODS This research aimed to evaluate use of the Angio-Seal device in a bailout context in the setting of incomplete hemostasis following use of dual Perclose ProGlide devices in patients undergoing transfemoral transcatheter aortic valve implantation. A total of 185 patients undergoing transfemoral transcatheter aortic valve implantation with either dual Per-close ProGlide (n = 139) or a combination of dual Perclose ProGlide and Angio-Seal (n = 46) were retrospectively analyzed. The baseline, procedural characteristics, and all outcomes (defined according to Valve Academic Research Consortium-2 criteria) were compared. RESULTS No significant differences were seen between the dual Perclose ProGlide vs dual Perclose ProGlide+Angio-Seal groups with regard to the in-hospital Valve Academic Research Consortium-2 primary end points of major vascular complications (n = 13 [9.4%] vs n = 2 [4.3%]; P = .36), minor vascular complications (n = 13 [9.4%] vs n = 8 [14.7%]; P = .14), major bleeding (n = 16 [11.5%] vs n = 2 [4.3%]; P = .25), and minor bleeding (n = 9 [6.5%] vs n = 5 [10.9%]; P = .34), with higher rates of hematoma in the dual Perclose ProGlide+Angio-Seal group (n = 4 [2.9%] vs n = 5 [10.9%]; P = .044). CONCLUSION Finding from the current study suggest that adjunctive Angio-Seal deployment may be feasible and safe, especially in patients with incomplete hemostasis following dual Perclose ProGlide use, and can be an optimal "bailout" procedure.
Collapse
Affiliation(s)
- Beytullah Cakal
- Department of Cardiology, Faculty of Medicine, Istanbul Medipol University, Bağcilar, Istanbul, Turkey
| | - Sinem Cakal
- Haseki Training and Research Hospital, Cardiology Clinic, Istanbul, Turkey
| | - Oguz Karaca
- Department of Cardiology, Faculty of Medicine, Istanbul Medipol University, Bağcilar, Istanbul, Turkey
| | - Filiz Kizilirmak Yilmaz
- Department of Cardiology, Faculty of Medicine, Istanbul Medipol University, Bağcilar, Istanbul, Turkey
| | - Haci Murat Gunes
- Department of Cardiology, Faculty of Medicine, Istanbul Medipol University, Bağcilar, Istanbul, Turkey
| | - Arzu Yildirim
- Department of Cardiology, Faculty of Medicine, Istanbul Medipol University, Bağcilar, Istanbul, Turkey
| | - Ozgur Ulas Ozcan
- Department of Cardiology, Faculty of Medicine, Istanbul Medipol University, Bağcilar, Istanbul, Turkey
| | - Yeliz Guler
- Department of Cardiology, Faculty of Medicine, Istanbul Medipol University, Bağcilar, Istanbul, Turkey
| | - Bilal Boztosun
- Department of Cardiology, Faculty of Medicine, Istanbul Medipol University, Bağcilar, Istanbul, Turkey
| |
Collapse
|
|
9
|
Lu C, Zhang Y. Gastrointestinal bleeding during the transcatheter aortic valve replacement perioperative period: A Review. Medicine (Baltimore) 2022; 101:e31953. [PMID: 36482568 PMCID: PMC9726417 DOI: 10.1097/md.0000000000031953] [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: 12/13/2022] Open
Abstract
With the aging of the population, the incidence of senile degenerative valvular heart disease is expected to increase. Transcatheter aortic valve replacement (TAVR) has been used for patients at lower surgical risk with symptomatic severe aortic valve stenosis. Because of the improvements in TAVR technology and increasing experience of the operators, TAVR is regarded as a safe and feasible procedure. Bleeding events during the TAVR perioperative period, especially gastrointestinal (GI) bleeding, have been proven to be related to the long-term prognosis and mortality. Elderly patients with valvular heart disease are susceptible to GI bleeding because of their use of antithrombotic drugs, physical damage of coagulation factors, and GI angiodysplasia. Frequent GI bleeding and low levels of preoperative hemoglobin increase the risk of TAVR, especially for elderly patients. Because of these risks, which are easily overlooked, we should focus more attention on the perioperative management of TAVR. Reasonable screening tools, including blood examinations, risk evaluation scales, and endoscopy, are beneficial to the prevention of complications that can occur during the perioperative period. Additionally, medical therapy can safely help patients at high-risk for bleeding patients throughout the perioperative period. This study aimed to characterize the pathology of TAVR patients and discuss treatment strategies for GI bleeding during the perioperative period.
Collapse
Affiliation(s)
- Chuan Lu
- From the Second Hospital of Dalian Medicial University, Shahekou District, Dalian City, China
| | - Yue Zhang
- From the Second Hospital of Dalian Medicial University, Shahekou District, Dalian City, China
- * Correspondence: Yue Zhang, From the Second Hospital of Dalian Medicial University, 467 Zhongshan Road, Shahekou District, Dalian city, China (e-mail: )
| |
Collapse
|
|
10
|
Tchetche D, Boiago M. Understanding Women Specificities: The Right Way to Improve Their Outcomes. JACC Cardiovasc Interv 2022; 15:1661-1663. [PMID: 35981840 DOI: 10.1016/j.jcin.2022.07.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/10/2022] [Accepted: 07/13/2022] [Indexed: 10/15/2022]
|
|
11
|
Garot P, Neylon A, Morice MC, Tamburino C, Bleiziffer S, Thiele H, Scholtz S, Schramm R, Cockburn J, Cunnington M, Wolf A, Barbanti M, Tchetché D, Pagnotta P, Gilard M, Bedogni F, Van Belle E, Vasa-Nicotera M, Chieffo A, Bogaerts K, Hengstenberg C, Capodanno D. Bleeding risk differences after TAVR according to the ARC-HBR criteria: insights from SCOPE 2. EUROINTERVENTION 2022; 18:503-513. [PMID: 35450838 PMCID: PMC10241269 DOI: 10.4244/eij-d-21-01048] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/02/2021] [Accepted: 03/16/2022] [Indexed: 11/23/2022]
Abstract
BACKGROUND The Academic Research Consortium - High Bleeding Risk (ARC-HBR) initiative defined conditions associated with percutaneous coronary intervention (PCI)-related bleeding. AIMS We sought to further explore these HBR conditions in the setting of transcatheter aortic valve replacement (TAVR). METHODS Patients from the SCOPE 2 trial were stratified by their bleeding risk status based on the ARC-HBR definitions. Baseline and procedural characteristics, as well as key clinical outcomes including Bleeding Academic Research Consortium (BARC) 3-5 bleeding, were compared in ARC-HBR positive (HBR+) and ARC-HBR negative (HBR-) patients. RESULTS Of 787 patients randomised in SCOPE 2 and included in this study, 633 were HBR+ (80.4%). Compared with HBR- patients, those HBR+ were older and more frequently presented with diabetes, a history of coronary artery disease, atrial fibrillation, prior cerebrovascular accident, and a Society of Thoracic Surgeons predicted risk of 30-day mortality (STS-PROM) (4.9±2.9% vs 3.3%±2.1%; p<0.0001). In addition, HBR+ patients were more frequently on oral anticoagulation therapy. At 1 year, HBR+ patients had higher rates of all-cause death (12.4% vs 4.3%, respectively, risk difference 8.09%; 95% confidence interval [CI]: 3.76-12.41; p=0.0002); the rates of BARC 3-5 type bleeding were relatively high but not statistically different compared with HBR- patients (7.7% vs 6.1%, risk difference 1.67%; 95% CI: -2.72 to 6.06; p=0.46). Subgroup analyses for bleeding events showed no significant interaction in terms of STS-PROM score, age, or medications. CONCLUSIONS The ARC-HBR criteria failed to isolate a subgroup of patients at higher bleeding risk in TAVR patients from a randomised trial. These findings have potential implications, especially for the selection of post-TAVR antithrombotic regimens based on individual bleeding-risk profiles. Specific HBR criteria should be defined for TAVR patients.
Collapse
Affiliation(s)
- Philippe Garot
- Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Ramsay-Santé, Massy, France
| | - Antoinette Neylon
- Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Ramsay-Santé, Massy, France
| | - Marie-Claude Morice
- Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques Cartier, Ramsay-Santé, Massy, France
| | - Corrado Tamburino
- Division of Cardiology Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele" University of Catania, Catania, Italy
| | - Sabine Bleiziffer
- Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhein-Westfalia, University Hospital, Ruhr-University Bochum, Bad Oeynhausen, Germany
| | - Holger Thiele
- Department of Cardiology, Leipzig Heart Center, University of Leipzig, Leipzig, Germany
| | - Smita Scholtz
- Department of Interventional Cardiology, Heart and Diabetes Center North Rhine Westfalia, Bad Oeynhausen, Germany
| | - Rene Schramm
- Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhein-Westfalia, University Hospital, Ruhr-University Bochum, Bad Oeynhausen, Germany
| | - James Cockburn
- Department of Cardiology, Brighton & Sussex University Hospitals NHS Trust, Brighton, United Kingdom
| | - Michael Cunnington
- Department of Cardiology, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
| | - Alexander Wolf
- Department of Interventional Cardiology, Elisabeth Hospital Essen, Essen, Germany
| | - Marco Barbanti
- Department of Cardio-Thoracic-Vascular diseases and transplantation, Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico-San Marco", Catania, Italy
| | - Didier Tchetché
- Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France
| | - Paolo Pagnotta
- Department of Cardiovascular Medicine, Humanitas Clinical and Research Center, Milano, Italy
| | - Martine Gilard
- Department of Cardiology, Brest University Hospital, Brest, France
| | | | - Eric Van Belle
- Department of Cardiology, Lille University Hospital, Lille, France
| | - Mariuca Vasa-Nicotera
- Department of Cardiology, Goethe University Hospital Frankfurt, Frankfurt am Main, Germany
| | - Alaide Chieffo
- Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy
| | - Kris Bogaerts
- KU Leuven, Faculty of Medicine, I-BioStat, Leuven, Belgium and UHasselt, I-BioStat, Hasselt, Belgium
| | | | - Davide Capodanno
- Division of Cardiology Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele" University of Catania, Catania, Italy
| |
Collapse
|
|
12
|
Nguyen Q, Luc JG, MacGillivray TE, Preventza OA. Transcatheter Versus Surgical Aortic Valve Replacement in Young, Low-risk Patients with Severe Aortic Stenosis. US CARDIOLOGY REVIEW 2022; 16:e18. [PMID: 39600837 PMCID: PMC11588169 DOI: 10.15420/usc.2022.08] [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: 02/18/2022] [Accepted: 04/13/2022] [Indexed: 11/04/2022] Open
Abstract
Aortic stenosis is a common form of acquired degenerative valvular disease associated with poor survival after the onset of symptoms. Treatment options for patients with aortic stenosis in addition to medical therapy include surgical aortic valve replacement (SAVR) with either tissue or mechanical valves, or transcatheter aortic valve replacement (TAVR) with either balloon-expandable or self-expanding valves via either transfemoral or alternative access routes. In this review, the authors discuss the current evidence and special considerations regarding the use of TAVR versus SAVR in the management of severe aortic stenosis in young (<65 years of age), low-risk patients, highlighting the history of aortic stenosis treatment, the current guidelines and recommendations, and important issues that remain to be addressed. Ultimately, until ongoing clinical trials with long-term follow-up data shed light on whether interventions for aortic stenosis can be broadened to a low-risk population, TAVR in young, low-risk patients should be undertaken with caution and with guidance from a multidisciplinary heart team.
Collapse
Affiliation(s)
- Quynh Nguyen
- Faculty of Medicine and Dentistry, University of Alberta Edmonton, Canada
| | - Jessica Gy Luc
- Division of Cardiovascular Surgery, Department of Surgery, University of British Columbia Vancouver, Canada
| | - Thomas E MacGillivray
- Division of Cardiac Surgery and Thoracic Transplantation Surgery, Houston Methodist DeBakey Heart and Vascular Center Houston, TX
| | - Ourania A Preventza
- Division of Cardiothoracic Surgery, Michael E DeBakey Department of Surgery, Baylor College of Medicine Houston, TX
- Department of Cardiovascular Surgery, Texas Heart Institute Houston, TX
| |
Collapse
|
|
13
|
Iacovelli F, Desario P, Cafaro A, Pignatelli A, Alemanni R, Montesanti R, Bortone AS, De Cillis E, De Palo M, Bardi L, Martinelli GL, Tesorio T, Cassese M, Contegiacomo G. The hemodynamic performance of balloon-expandable aortic bioprostheses in the elderly: a comparison between rapid deployment and transcatheter implantation. Hellenic J Cardiol 2022; 68:9-16. [PMID: 35863727 DOI: 10.1016/j.hjc.2022.07.006] [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: 03/13/2022] [Revised: 07/01/2022] [Accepted: 07/11/2022] [Indexed: 11/16/2022] Open
Abstract
BACKGROUND Surgical aortic valve replacement with a rapid deployment valve (RDV) is a relatively recent treatment option. Aim of this study was to compare the hemodynamic performance of balloon-expandable (BE)-RDVs and BE-transcatheter heart valves (THVs) in a high surgical risk and frail-elderly population. METHODS BE-THVs and BE-RDVs were respectively implanted in 138 and 47 patients, all older than 75 years and with a Canadian Study of Health and Aging category of 5 or above. Echocardiographic assessment was performed at discharge and at six months. RESULTS At discharge, transprosthetic pressure gradients and indexed effective orifice area (iEOA) were similar in both cohorts. At six-month follow-up, BE-RDV showed lower peak (14.69 vs 20.86 mmHg; p <0.001) and mean (7.82 vs 11.83 mmHg; p <0.001) gradients, as well as larger iEOA (1.05 vs 0.84 cm2/m2; p <0.001). Similar findings were also shown considering only small sized valves. Moderate-to-severe paravalvular leakage was more prevalent in BE-THVs at discharge (14.49 vs 0.00%; p=0.032) and, considering exclusively small prostheses, at six months too (57.69 vs 15.00%; p=0.014). Nevertheless, BE-THVs determined amelioration in left ventricular ejection fraction (53.79 vs 60.14%; p <0.001), pulmonary artery systolic pressure (35.81 vs 33.15 mmHg; p=0.042) and tricuspid regurgitation severity (40.58 vs 19.57%; p=0.031) from discharge to mid-term follow-up. CONCLUSIONS BE-RDVs showed better hemodynamic performance, especially when implanted in small annulus. Despite their worse baseline conditions, transcatheter patients still exhibited a greater improvement of their echocardiographic profile at mid-term follow-up.
Collapse
Affiliation(s)
- Fortunato Iacovelli
- Division of University Cardiology, Cardiothoracic Department, Policlinico University Hospital, Piazza Giulio Cesare 11, 70124 Bari, Italy; Division of Cardiology, "SS. Annunziata" Hospital, Via Francesco Bruno 1, 74121 Taranto, Italy.
| | - Paolo Desario
- Division of University Cardiology, Cardiothoracic Department, Policlinico University Hospital, Piazza Giulio Cesare 11, 70124 Bari, Italy.
| | - Alessandro Cafaro
- Division of Cardiology, "V. Fazzi" Hospital, Piazza Filippo Muratore, 73100 Lecce, Italy.
| | - Antonio Pignatelli
- Interventional Cardiology Service, "Anthea" Clinic, GVM Care & Research, Via Camillo Rosalba 35/37, 70124 Bari, Italy.
| | - Rossella Alemanni
- Division of Heart Surgery, Emergency and Critical Care Department, "Casa Sollievo della Sofferenza" Research Hospital, Viale Cappuccini, 71013 San Giovanni Rotondo, Italy.
| | - Rosamaria Montesanti
- Division of Heart Surgery, Emergency and Critical Care Department, "Casa Sollievo della Sofferenza" Research Hospital, Viale Cappuccini, 71013 San Giovanni Rotondo, Italy.
| | - Alessandro Santo Bortone
- Division of University Heart Surgery, Cardiothoracic Department, Policlinico University Hospital, Piazza Giulio Cesare 11, 70124 Bari, Italy.
| | - Emanuela De Cillis
- Division of University Heart Surgery, Cardiothoracic Department, Policlinico University Hospital, Piazza Giulio Cesare 11, 70124 Bari, Italy.
| | - Micaela De Palo
- Division of University Heart Surgery, Cardiothoracic Department, Policlinico University Hospital, Piazza Giulio Cesare 11, 70124 Bari, Italy.
| | - Luca Bardi
- Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples "Federico II", Via Sergio Pansini 5, 80131 Naples, Italy.
| | - Gian Luca Martinelli
- Division of Heart Surgery, Cardiovascular Department, "MultiMedica" Research Hospital, Via Milanese 300, 20099 Sesto San Giovanni, Italy.
| | - Tullio Tesorio
- Interventional Cardiology Service, "Montevergine" Clinic, Via Mario Malzoni, 83013 Mercogliano, Italy.
| | - Mauro Cassese
- Division of Heart Surgery, Emergency and Critical Care Department, "Casa Sollievo della Sofferenza" Research Hospital, Viale Cappuccini, 71013 San Giovanni Rotondo, Italy.
| | - Gaetano Contegiacomo
- Interventional Cardiology Service, "Anthea" Clinic, GVM Care & Research, Via Camillo Rosalba 35/37, 70124 Bari, Italy.
| |
Collapse
|
|
14
|
Rouleau SG, Brady WJ, Koyfman A, Long B. Transcatheter aortic valve replacement complications: A narrative review for emergency clinicians. Am J Emerg Med 2022; 56:77-86. [DOI: 10.1016/j.ajem.2022.03.042] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/20/2022] [Revised: 03/11/2022] [Accepted: 03/20/2022] [Indexed: 02/07/2023] Open
|
|
15
|
Tomey MI. Intensive Care after Transcatheter Aortic Valve Replacement. Interv Cardiol 2022. [DOI: 10.1002/9781119697367.ch60] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/10/2022] Open
|
|
16
|
Tauriainen T, Juvonen T, Anttila V, Maaranen P, Niemelä M, Eskola M, Ahvenvaara T, Husso A, Virtanen MP, Kinnunen EM, Dahlbacka S, Jalava M, Laine M, Valtola A, Raivio P, Vento A, Airaksinen J, Mäkikallio T, Biancari F. Perioperative Bleeding Requiring Blood Transfusions Is Associated with Increased Risk of Stroke after Transcatheter and Surgical Aortic Valve Replacement. J Cardiothorac Vasc Anesth 2022; 36:3057-3064. [DOI: 10.1053/j.jvca.2022.04.029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/03/2022] [Revised: 04/15/2022] [Accepted: 04/22/2022] [Indexed: 11/11/2022]
|
|
17
|
Dietrich L, Kibler M, Matsushita K, Marchandot B, Trimaille A, Reydel A, Diop B, Truong PD, Trung AM, Trinh A, Carmona A, Hess S, Jesel L, Ohlmann P, Morel O. Impact of Primary Hemostasis Disorders on Late Major Bleeding Events among Anticoagulated Atrial Fibrillation Patients Treated by TAVR. J Clin Med 2021; 11:212. [PMID: 35011952 PMCID: PMC8746148 DOI: 10.3390/jcm11010212] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/14/2021] [Revised: 12/21/2021] [Accepted: 12/29/2021] [Indexed: 11/16/2022] Open
Abstract
BACKGROUND Bleeding events are among the striking complications following transcatheter aortic valve replacement (TAVR), and bleeding prediction models are crucially warranted. Several studies have highlighted that primary hemostasis disorders secondary to persistent loss of high-molecular-weight (HMW) multimers of the von Willebrand factor (vWF) and assessed by adenosine diphosphate closure time (CT-ADP) may be a strong predictor of late major/life-threatening bleeding complications (MLBCs). Pre-existing atrial fibrillation (AF) is a frequent comorbidity in TAVR patients and potentially associated with increased bleeding events after the procedure. OBJECTIVES This study evaluated the impact of ongoing primary hemostasis disorders, as assessed by post-procedural CT-ADP > 180 s, on clinical events after TAVR among anticoagulated AF patients. METHODS An ongoing primary hemostasis disorder was defined by post-procedure CT-ADP > 180 s. Bleeding complications were assessed according to the Valve Academic Research Consortium-2 (VARC-2) criteria. The primary endpoint was the occurrence of late MLBCs at one-year follow-up. The secondary endpoint was a composite of mortality, stroke, myocardial infarction, and rehospitalization for heart failure. RESULTS In total, 384 TAVR patients were included in the analysis. Of these patients, 57 patients (14.8%) had a prolongated CT-ADP > 180 s. Increased MLBCs were observed in patients with CT-ADP > 180 s (35.1% versus 1.2%; p < 0.0001). Conversely, the occurrence of the composite endpoint did not differ between the groups. Multivariate analysis identified CT-ADP > 180 s (HR 28.93; 95% CI 9.74-85.95; p < 0.0001), bleeding history, paradoxical aortic stenosis (AS), and major vascular complications following TAVR as independent predictors of late MLBCs. CONCLUSION Among patients with anticoagulated AF, a post-procedural CT-ADP > 180 s was identified as a strong independent predictor of late MLBCs. These findings suggest that persistent primary hemostasis disorders contribute to a higher risk of late bleeding events and should be considered for a tailored, risk-adjusted antithrombotic therapy after TAVR.
Collapse
Affiliation(s)
- Laurent Dietrich
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
| | - Marion Kibler
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
| | - Kensuke Matsushita
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
- Institut National de la Santé et de la Recherche Médicale (INSERM), Nano Médecine Régénérative, Unité Mixte de Recherche 1260, Faculté de Pharmacie, Université de Strasbourg, 67400 Illkirch, France
| | - Benjamin Marchandot
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
| | - Antonin Trimaille
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
| | - Antje Reydel
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
| | - Bamba Diop
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
| | - Phi Dinh Truong
- Vietnam National Heart Institute, Bach Mai Hospital, Hanoi 100000, Vietnam; (P.D.T.); (A.M.T.)
| | - Anh Mai Trung
- Vietnam National Heart Institute, Bach Mai Hospital, Hanoi 100000, Vietnam; (P.D.T.); (A.M.T.)
| | - Annie Trinh
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
| | - Adrien Carmona
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
| | - Sébastien Hess
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
| | - Laurence Jesel
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
- Institut National de la Santé et de la Recherche Médicale (INSERM), Nano Médecine Régénérative, Unité Mixte de Recherche 1260, Faculté de Pharmacie, Université de Strasbourg, 67400 Illkirch, France
| | - Patrick Ohlmann
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
| | - Olivier Morel
- Centre Hospitalier Universitaire, Pôle d’Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Université de Strasbourg, 67000 Strasbourg, France; (L.D.); (K.M.); (B.M.); (A.T.); (A.R.); (B.D.); (A.T.); (A.C.); (S.H.); (L.J.); (P.O.); (O.M.)
- Institut National de la Santé et de la Recherche Médicale (INSERM), Nano Médecine Régénérative, Unité Mixte de Recherche 1260, Faculté de Pharmacie, Université de Strasbourg, 67400 Illkirch, France
| |
Collapse
|
|
18
|
Sousa ALS, Carvalho LAF, Salgado CG, Oliveira RLD, Lima LCCLE, Mattos NDFGD, Fagundes FES, Colafranceschi AS, Mesquita ET. C-reactive Protein as a Prognostic Marker of 1-Year Mortality after Transcatheter Aortic Valve Implantation in Aortic Stenosis. Arq Bras Cardiol 2021; 117:1018-1027. [PMID: 34817012 PMCID: PMC8682084 DOI: 10.36660/abc.20190715] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/28/2019] [Accepted: 12/02/2020] [Indexed: 01/15/2023] Open
Abstract
Fundamento: A proteína C-reativa (PCR) é um biomarcador de inflamação preditor de eventos adversos em procedimentos cardiovasculares. Na avaliação do implante da válvula aórtica transcateter (transcatheter aortic valve implantation, TAVI) em relação ao prognóstico de longo prazo ainda é incipiente. Objetivo: Avaliar a PCR como marcador prognóstico no primeiro ano pós-TAVI na estenose aórtica (EAo). Métodos: A PCR foi avaliada na primeira semana do peroperatório numa coorte de casos retrospectiva com EAo. Correlacionou-se a PCR pré- e pós-TAVI com a mortalidade e foram pesquisados fatores preditores de mortalidade em 1 ano. Realizada regressão de Cox multivariada para identificar os preditores independentes de óbito em 1 ano. Resultados: Estudados 130 pacientes submetidos a TAVI, com mediana de idade de 83 anos, sendo 49% deles do sexo feminino. A PCR pré-TAVI elevada (> 0,5 mg/dL) ocorreu em 34,5% dos casos. O pico de PCR foi 7,0 (5,3-12,1) mg/dL no quarto dia. A mortalidade em 1 ano foi 14,5% (n = 19), sendo maior nos grupos com PCR pré-TAVI elevada (68,8% vs 29,1%; p = 0,004) e pico de PCR ≥ 10,0 mg/dL (64,7% vs 30,8%; p = 0,009). Os fatores preditores independentes de mortalidade foram insuficiência renal aguda (IRA) [razão de risco (RR) = 7,43; intervalo de confiança de 95% (IC95%), 2,1-24,7; p = 0,001], PCR pré-TAVI elevada [RR = 4,15; IC95%, 1,3-12,9; p=0,01] e hemotransfusão volumosa [HR = 4,68; 1,3-16,7; p = 0,02]. Conclusões: A PCR pré-TAVI elevada mostrou-se fator preditor independente de mortalidade no primeiro ano, assim como a ocorrência de IRA e hemotransfusões volumosas.
Collapse
Affiliation(s)
- André Luiz Silveira Sousa
- Universidade Federal Fluminense - Hospital Antonio Pedro - Cardiologia, Niterói, RJ - Brasil.,Hospital Pró-Cardíaco - Hemodinâmica, Rio de Janeiro, RJ - Brasil
| | | | | | | | | | | | | | | | - Evandro Tinoco Mesquita
- Universidade Federal Fluminense - Hospital Antonio Pedro - Cardiologia, Niterói, RJ - Brasil
| |
Collapse
|
|
19
|
In-hospital outcomes of transapical versus surgical aortic valve replacement: from the U.S. national inpatient sample. J Geriatr Cardiol 2021; 18:702-710. [PMID: 34659376 PMCID: PMC8501380 DOI: 10.11909/j.issn.1671-5411.2021.09.005] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022] Open
Abstract
OBJECTIVE To compare the outcomes of transapical transcatheter aortic valve replacement (TA-TAVR) and surgical aortic valve replacement (SAVR) using a large US population sample. METHODS The U.S. National Inpatient Sample was queried for all patients who underwent TA-TAVR or SAVR during the years 2016-2017. The primary outcome was all-cause in-hospital mortality. Secondary outcomes were in-hospital stroke, pericardiocentesis, pacemaker insertion, mechanical ventilation, vascular complications, major bleeding, acute kidney injury, length of stay, and cost of hospitalization. Outcomes were modeled using multi-variable logistic regression for binary outcomes and generalized linear models for continuous outcomes. RESULTS A total of 1560 TA-TAVR and 44,280 SAVR patients were included. Patients who underwent TA-TAVR were older and frailer. Compared to SAVR, TA-TAVR correlated with a higher mortality (4.5% vs. 2.7%, effect size (SMD) = 0.1) and higher periprocedural complications. Following multivariable analysis, both TA-TAVR and SAVR had a similar adjusted risk for in-hospital mortality. TA-TAVR correlated with lower odds of bleeding with (adjusted OR (aOR) = 0.26; 95% CI: 0.18-0.38;P < 0.001), and a shorter length of stay (adjusted mean ratio (aMR) = 0.77; 95% CI: 0.69-0.84; P < 0.001), but higher cost (aMR = 1.18; 95% CI: 1.10-1.28; P < 0.001). No significant differences in other study outcomes. In subgroup analysis, TA-TAVR in patients with chronic lung disease had higher odds for mortality (aOR = 3.11; 95%CI: 1.37-7.08; P = 0.007). CONCLUSION The risk-adjusted analysis showed that TA-TAVR has no advantage over SAVR except for patients with chronic lung disease where TA-TAVR has higher mortality.
Collapse
|
|
20
|
Zahid S, Ullah W, Khan MU, Salama A, Krupica T, Khan MZ. Predictors of Acute Kidney Injury After Transcatheter Aortic Valve Implantation (From National Inpatient Sample [2011-2018]). Am J Cardiol 2021; 151:120-122. [PMID: 34006370 DOI: 10.1016/j.amjcard.2021.04.003] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/19/2021] [Revised: 03/30/2021] [Accepted: 04/02/2021] [Indexed: 02/07/2023]
|
|
21
|
Ciardetti N, Ciatti F, Nardi G, Di Muro FM, Demola P, Sottili E, Stolcova M, Ristalli F, Mattesini A, Meucci F, Di Mario C. Advancements in Transcatheter Aortic Valve Implantation: A Focused Update. MEDICINA (KAUNAS, LITHUANIA) 2021; 57:711. [PMID: 34356992 PMCID: PMC8306774 DOI: 10.3390/medicina57070711] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 06/23/2021] [Revised: 07/09/2021] [Accepted: 07/12/2021] [Indexed: 01/07/2023]
Abstract
Transcatheter aortic valve implantation (TAVI) has become the leading technique for aortic valve replacement in symptomatic patients with severe aortic stenosis with conventional surgical aortic valve replacement (SAVR) now limited to patients younger than 65-75 years due to a combination of unsuitable anatomies (calcified raphae in bicuspid valves, coexistent aneurysm of the ascending aorta) and concerns on the absence of long-term data on TAVI durability. This incredible rise is linked to technological evolutions combined with increased operator experience, which led to procedural refinements and, accordingly, to better outcomes. The article describes the main and newest technical improvements, allowing an extension of the indications (valve-in-valve procedures, intravascular lithotripsy for severely calcified iliac vessels), and a reduction of complications (stroke, pacemaker implantation, aortic regurgitation).
Collapse
Affiliation(s)
| | | | | | | | | | | | | | | | | | | | - Carlo Di Mario
- Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Clinica Medica, Room 124, Careggi University Hospital, Largo Brambilla 3, 50139 Florence, Italy; (N.C.); (F.C.); (G.N.); (F.M.D.M.); (P.D.); (E.S.); (M.S.); (F.R.); (A.M.); (F.M.)
| |
Collapse
|
|
22
|
Khan H, Gilani A, Qayum I, Khattak T, Haq F, Zahid Anwar M, Khan MA, Asjad SJ, Abbas S, Inayat A. An Analysis of the Predictors of Major Bleeding After Transcatheter Aortic Valve Transplantation Using the National Inpatient Sample (2015-2018). Cureus 2021; 13:e16022. [PMID: 34336511 PMCID: PMC8319189 DOI: 10.7759/cureus.16022] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/28/2021] [Indexed: 12/13/2022] Open
Abstract
Background Transcatheter aortic valve replacement (TAVR) is now a common procedure to treat and improve quality of life, clinical outcomes, and self-sufficiency in high-risk patients with aortic stenosis, and its use has been expanding rapidly in younger and low-risk populations. The aim of this study was to evaluate the outcomes, trends, and predictors of major bleeding in patients undergoing TAVR. Methodology We utilized the National Inpatient Sample (NIS) data from the year 2015 to 2018. International Classification of Disease 10 codes were utilized to extract data. Baseline characteristics were compared using Pearson's chi-square test for categorical variables and independent samples t-test for continuous variables. A multivariable logistic regression model was used to evaluate the predictors of major bleeding. Propensity matching was done for adjusted analysis to compare outcomes in TAVR with and without major bleeding. The outcomes of interest in this study were (1) predictors of major bleeding after TAVR; (2) in-hospital mortality; and (3) resource utilization in terms of cost and length of stay. Results A total of 34,752 weighted hospitalizations for TAVR were included in the analysis. Of the patients undergoing the procedure, 2,294 (6.6%) had a major bleed while 32,458 (93.3%) did not. At baseline, patients with coagulopathy (odds ratio [OR]: 2.03; 95% confidence interval [CI]: 1.82-2.27), congestive heart failure (OR: 1.26; 95% CI: 1.13-1.40), chronic obstructive pulmonary disease (OR: 1.41; 95% CI: 1.29-1.55), liver disease (OR: 1.96; 95% CI: 1.61-2.39), peripheral vascular disease (OR: 1.29; 95% CI: 1.17-1.43), cerebrovascular disease (OR: 1.22; 95% CI: 1.07-1.38), end-stage renal disease (ESRD) (OR: 2.17; 95% CI: 1.82-2.59), and coronary artery disease (OR: 1.17; 95% Cl: 1.06-1.30) had higher adjusted rates of odds of major bleeding. Patients who had major bleeding had a higher median cost of stay (US$60,326 vs. US$45490) and length of stay (seven vs. three days). Conclusions Mortality is higher in patients with major bleeding, and at baseline, coagulopathy and ESRD are significant predictors of a major bleed in patients undergoing TAVR.
Collapse
Affiliation(s)
- Henna Khan
- Medicine, Khyber Girls Medical College, Peshawar, PAK
| | - Asma Gilani
- Medicine, Khyber Girls Medical College, Peshawar, PAK
| | - Ihtisham Qayum
- Internal Medicine, Khyber Teaching Hospital Peshawar, Peshawar, PAK
| | - Taif Khattak
- Emergency Medicine, Hamad General Hospital, Doha, QAT
| | - Furqan Haq
- Medicine, Khyber Medical College, Peshawar, PAK
| | | | - Muhammad Atif Khan
- Internal Medicine, Texas Tech University Health Sciences Center, Amarillo, USA
| | | | - Sakina Abbas
- Medicine, Dow University of Health Sciences, Karachi, PAK
| | - Arslan Inayat
- Internal Medicine, University at Buffalo, Catholic Health System, Buffalo, USA
| |
Collapse
|
|
23
|
Zahid S, Ullah W, Khan MU, Abbas S, Ud Din MT, Uddin MF, Inayat A, Ubaid A, Salman F, Thakkar S, Salama A, Khan MZ. Trends, predictors, and outcomes of major bleeding after transcatheter aortic valve implantation, from national inpatient sample (2011-2018). Expert Rev Cardiovasc Ther 2021; 19:557-563. [PMID: 33926363 DOI: 10.1080/14779072.2021.1924678] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Abstract
INTRODUCTION Major bleeding remains one of the most frequent complications seen in transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate outcomes, trends, and predictors of major bleeding in patients undergoing TAVI. METHODS We utilized the National Inpatient Sample (NIS) data from the year 2011 to 2018. Baseline characteristics were compared using a Pearsonχ2 test for categorical variables and Mann-Whitney U-Test for continuous variables. A multivariable logistic regression model was used to evaluate predictors of major bleeding. Propensity Matching was done for adjusted analysis to compare outcomes in TAVI with and without major bleeding. RESULTS A total of 215,938 weighted hospitalizations for TAVI were included in the analysis. Of the patient undergoing the procedure, 20,102 (9.3%) had major bleeding and 195,836 (90.7%) patients did not have in-hospital bleeding events. Patients in the major bleeding cohort were older and had greater female gender representation. At baseline patients with thrombocytopenia (Odds Ratio [OR], 1.47[confidence interval (CI), 1.36-1.59]), colon cancer (OR, 1.70[CI, 1.27-2.28]), coagulopathy (OR, 1.17[CI, 1.08-1.27]), liver disease (OR, 1.31[CI, 1.21-1.41]), chronic obstructive pulmonary disease (OR, 1.29[CI, 1.25-1.33]), congestive heart failure (OR, 1.12[CI, 1.08-1.16]), and end-stage renal disease (ESRD) (OR, 1.47[CI, 1.38-1.57]) had higher adjusted rates of major bleeding. The percentage of adjusted in-hospital mortality (14.4% vs. 4.2%, P < 0.01) was significantly higher in the major bleeding group Patients with major bleeding had higher median cost of stay ($235,274 vs. $177,920) and length of stay (7 vs 3 days). CONCLUSION In conclusion, we report that mortality is higher in patients with major bleeding and that baseline comorbidities like ESRD, liver disease, coagulopathy and colonic malignancy are important predictors of this adverse event.
Collapse
Affiliation(s)
- Salman Zahid
- Department of Medicine, Rochester General Hospital, Rochester,NY,USA
| | - Waqas Ullah
- Department of Medicine, Abington Jefferson Health, PA, USA
| | - Muhammad Usman Khan
- Department of Cardiology, Division of Cardiovascular Medicine, West Virginia University Heart & Vascular Institute, Morgantown, WV, USA
| | - Sakina Abbas
- Department of Medicine, Dow Medical College, Karachi, PK
| | | | | | - Arslan Inayat
- Department of Medicine, Internal Medicine, University at Buffalo, Catholic Health System, Buffalo, NY, USA
| | - Aamer Ubaid
- Department of Medicine, Internal Medicine, University of Missouri- Kansas City, Kansas City, MO
| | - Fnu Salman
- Department of Medicine, Mercy Health St. Vincent Medical Center, Toledo, USA
| | | | - Amr Salama
- Department of Medicine, Rochester General Hospital, Rochester,NY,USA
| | - Muhammad Zia Khan
- Department of Medicine, West Virginia University, Medicine, Morgantown, WV, USA
| |
Collapse
|
|
24
|
Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J 2021; 42:1825-1857. [DOI: 10.1093/eurheartj/ehaa799] [Citation(s) in RCA: 126] [Impact Index Per Article: 31.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/12/2020] [Revised: 06/22/2020] [Accepted: 09/24/2020] [Indexed: 12/17/2022] Open
Abstract
Abstract
Aims
The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.
Methods and results
Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs.
Conclusions
Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.
Collapse
Affiliation(s)
| | - Philippe Généreux
- Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ, USA
| | - Nicolo Piazza
- McGill University Health Centre, Montreal, QC, Canada
| | - Maria C Alu
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, NY, USA
| | - Tamim Nazif
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, NY, USA
| | - Rebecca T Hahn
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, NY, USA
| | - Philippe Pibarot
- Quebec Heart & Lung Institute, Laval University, Quebec, QC, Canada
| | - Jeroen J Bax
- Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Jonathon A Leipsic
- Department of Radiology, St. Paul's Hospital and University of British Columbia, Vancouver, BC, Canada
| | - Philipp Blanke
- Department of Radiology, St. Paul's Hospital and University of British Columbia, Vancouver, BC, Canada
| | - Eugene H Blackstone
- Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic and Department of Quantitative Health Sciences, Research Institute, Cleveland Clinic, Cleveland, OH, USA
| | - Matthew T Finn
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, NY, USA
| | - Samir Kapadia
- Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA
| | | | - Michael J Mack
- Baylor Scott & White Heart Hospital Plano, Plano, TX, USA
| | - Raj Makkar
- Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA
| | - Roxana Mehran
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA
| | | | | | | | | | - John G Webb
- Department of Cardiology, St. Paul's Hospital and University of British Columbia, Vancouver, BC, Canada
| | - David J Cohen
- University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA
| | - Martin B Leon
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, NY, USA
| |
Collapse
|
|
25
|
Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol 2021; 77:2717-2746. [PMID: 33888385 DOI: 10.1016/j.jacc.2021.02.038] [Citation(s) in RCA: 596] [Impact Index Per Article: 149.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
AIMS The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. METHODS AND RESULTS Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs. CONCLUSIONS Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.
Collapse
Affiliation(s)
| | - Philippe Généreux
- Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey, USA
| | - Nicolo Piazza
- McGill University Health Centre, Montreal, Quebec, Canada
| | - Maria C Alu
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York, USA
| | - Tamim Nazif
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York, USA
| | - Rebecca T Hahn
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York, USA
| | - Philippe Pibarot
- Quebec Heart & Lung Institute, Laval University, Quebec, Quebec, Canada
| | - Jeroen J Bax
- Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands
| | - Jonathon A Leipsic
- Department of Radiology, St. Paul's Hospital and University of British Columbia, Vancouver, British Columbia, Canada
| | - Philipp Blanke
- Department of Radiology, St. Paul's Hospital and University of British Columbia, Vancouver, British Columbia, Canada
| | - Eugene H Blackstone
- Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic and Department of Quantitative Health Sciences, Research Institute, Cleveland Clinic, Cleveland, Ohio, USA
| | - Matthew T Finn
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York, USA
| | - Samir Kapadia
- Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA
| | | | - Michael J Mack
- Baylor Scott & White Heart Hospital Plano, Plano, Texas, USA
| | - Raj Makkar
- Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA
| | - Roxana Mehran
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Jeffrey J Popma
- Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
| | - Michael Reardon
- Methodist DeBakey Heart & Vascular Center, Houston, Texas, USA
| | - Josep Rodes-Cabau
- Quebec Heart & Lung Institute, Laval University, Quebec, Quebec, Canada
| | | | - John G Webb
- Department of Cardiology, St. Paul's Hospital and University of British Columbia, Vancouver, British Columbia, Canada
| | - David J Cohen
- University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, USA
| | - Martin B Leon
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and Cardiovascular Research Foundation, New York, New York, USA.
| |
Collapse
|
|
26
|
Mangieri A, Laricchia A, Montalto C, Palena ML, Fisicaro A, Cereda A, Sticchi A, Latib A, Giannini F, Khokhar AA, Colombo A. Patient selection, procedural planning and interventional guidance for transcatheter aortic valve intervention. Minerva Cardiol Angiol 2021; 69:671-683. [PMID: 33703862 DOI: 10.23736/s2724-5683.21.05573-0] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Transcatheter aortic valve replacement (TAVR) is an established treatment for severe aortic stenosis across a broad spectrum of patient risk profiles. Pre-procedural planning using multislice computed tomography (MSCT) is a fundamental component to ensure acute and long-term procedural success. MSCT can establish the procedural feasibility, the type vascular of approach as well as the device which is more likely to give a good result. Moreover, MSCT is a key tool to estimate the risk of potentially life-threatening complications. In this review, the role of MSCT for pre-procedural TAVR planning will be discussed providing a panoramic overview of the key elements that should be considered when performing TAVR. Additionally, the adjunctive role of fluoroscopy and echocardiography to plan and guide a TAVR procedure will also be discussed.
Collapse
Affiliation(s)
- Antonio Mangieri
- Cardiovascular Department, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy -
| | - Alessandra Laricchia
- Cardiovascular Department, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy
| | - Claudio Montalto
- Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
| | - Mariano L Palena
- Cardiovascular Department, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy
| | - Andrea Fisicaro
- Cardiovascular Department, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy
| | - Alberto Cereda
- Cardiovascular Department, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy
| | - Alessandro Sticchi
- Cardiovascular Department, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy
| | - Azeem Latib
- Division of Cardiology, Montefiore Medical Center, New York, NY, USA
| | - Francesco Giannini
- Cardiovascular Department, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy
| | - Arif A Khokhar
- Cardiovascular Department, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy
| | - Antonio Colombo
- Cardiovascular Department, GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy
| |
Collapse
|
|
27
|
Sex based analysis of the impact of red blood cell transfusion and vascular or bleeding complications related to TAVI - The TRITAVI-Women Study. Int J Cardiol 2021; 333:69-76. [PMID: 33662485 DOI: 10.1016/j.ijcard.2021.02.066] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/22/2020] [Revised: 02/19/2021] [Accepted: 02/22/2021] [Indexed: 11/24/2022]
Abstract
BACKGROUND Women present specific risks for transcatheter aortic valve replacement (TAVI) but there are scarce sex-based analysis. The aim of this study was to explore the risk of vascular/bleeding complications in females vs. males that underwent TAVI and the impact of red blood cell (RBC) transfusion. METHODS TRITAVI-Women is a retrospective analysis in 13 European institutions. Propensity score based on pairs of different sex was performed and global outcomes, vascular/bleeding risk factors were determined. Afterwards, the female population of the study was divided into two groups according to the need of RBC transfusion and the risk for mortality, AKI, MI, stroke at 30-days and at 1-year were compared as a combined endpoint (primary endpoint) and separately (secondary endpoints). RESULTS The global study population included 5837 patients. Females presented more advanced NYHA class, chronic kidney disease, and baseline anemia. Vascular/bleeding complications and RBC transfusion were more common in women. However, 1-year mortality was lower for women in the matched cohort (8.1% vs.10.3%, p = 0.028). The need for RBC transfusion was an independent predictor of higher incidence of the primary endpoint at 30-day and 1-year. The main predictor of RBC transfusion in women was the presence of baseline anemia. CONCLUSIONS Women present lower risk of mortality than men at 1-year follow up, but not at 30-day due to higher rates of vascular/bleeding complications. RBC transfusion was also more often required in women and was an independent predictor or poorer outcomes. The treatment of pre-existing anemia before TAVI might improve the short-term results in women.
Collapse
|
|
28
|
Megaly M, Sedhom R, Abdelmaseeh P, ElBebawy B, Goel SS, Karam J, Pershad A, Brilakis ES, Garcia S. Complications of the MANTA closure device. Insights from MAUDE database. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2021; 34:75-79. [PMID: 33612411 DOI: 10.1016/j.carrev.2021.02.013] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/21/2021] [Revised: 02/06/2021] [Accepted: 02/10/2021] [Indexed: 12/20/2022]
Abstract
BACKGROUND The collagen-based MANTA device (Teleflex, PA, USA) is used for closure of large-bore vascular access. There is a paucity of data on complications associated with its use in a real-life setting. METHODS We queried the "Manufacturer and User Facility Device Experience" MAUDE database between February 2019 and December 2020 for reports on MANTA device. RESULTS We identified 250 reports in the MAUDE database from February 2019 through December 2020. The most common failure complication of MANTA is persistent bleeding (48.8%) and vessel occlusion or stenosis (29.6%). Most complications were managed successfully with an endovascular approach (48.4%), but a high number of patients required surgical intervention (40.4%). The most commonly reported failure mechanism was the failure of deployment (22%) followed by subcutaneous deployment (7.6%), intraluminal deployment (4.8%) amd detachment of collagen (2.8%). Access site infection was rare (1.2%). The 18 Fr. MANTA was associated with a lower risk of failure of deployment compared with the 14 Fr. device but was associated with a higher risk of vessel occlusion or stenosis (32.4% vs. 16.3%, p = 0.04) and thrombosis (11.6% vs 0%, p = 0.03). CONCLUSIONS The most common complication of the MANTA device reported to the MAUDE registry was persistent bleeding (48.8% of reports) followed by vessel occlusion (29.6%). These complications were managed successfully using an endovascular approach in 48.4% of the reports.
Collapse
Affiliation(s)
- Michael Megaly
- Division of Cardiology, Banner University Medical Center, University of Arizona, Phoenix, AZ, USA
| | - Ramy Sedhom
- Department of Medicine, Albert Einstein Medical Center, Philadelphia, PA, USA
| | - Peter Abdelmaseeh
- Department of Medicine, Albert Einstein Medical Center, Philadelphia, PA, USA
| | - Bishoy ElBebawy
- Division of Cardiology, Arnot Ogden Medical Center- Lake Erie College of Medicine, Elmira, NY, USA
| | - Sachin S Goel
- Department of Cardiology, Houston Methodist DeBakey Heart & Vascular Center, Houston, TX, USA
| | - Joseph Karam
- Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA
| | - Ashish Pershad
- Division of Cardiology, Banner University Medical Center, University of Arizona, Phoenix, AZ, USA
| | | | - Santiago Garcia
- Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA.
| |
Collapse
|
|
29
|
Zimarino M, Barbanti M, Dangas GD, Testa L, Capodanno D, Stefanini GG, Radico F, Marchioni M, Amat-Santos I, Piva T, Saia F, Reimers B, De Innocentiis C, Picchi A, Toro A, Rodriguez-Gabella T, Nicolini E, Moretti C, Gallina S, Maddestra N, Bedogni F, Tamburino C. Early Adverse Impact of Transfusion After Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the TRITAVI Registry. Circ Cardiovasc Interv 2020; 13:e009026. [PMID: 33272037 DOI: 10.1161/circinterventions.120.009026] [Citation(s) in RCA: 22] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND There is no consensus on the benefit of red blood cell (RBC) transfusion after transcatheter aortic valve replacement. METHODS The multicenter Transfusion Requirements in Transcatheter Aortic Valve Implantation (TRITAVI) registry retrospectively included patients after transfemoral transcatheter aortic valve replacement; propensity score-matching identified pairs of patients with and without RBC transfusion. The primary end point was 30-day mortality; nonfatal myocardial infarction, cerebrovascular accident, and stage 2 to 3 acute kidney injury at 30 days were secondary end points. We repeated propensity score-matching according to the hemoglobin nadir, hemoglobin drop, and in the subgroup of uncomplicated patients, without major vascular complications or major bleeding. RESULTS Among 2587 patients, RBC transfusion was administered in 421 cases (16%). The primary end point occurred in 104 (4.0%) patients, myocardial infarction in 9 (0.4%), cerebrovascular accident in 38 (1.5%), and acute kidney injury in 125 (4.8%) cases. In the 842 propensity-matched patients, RBC transfusion was associated with increased mortality (hazard ratio, 2.07 [95% CI, 1.06-4.05]; P=0.034) and acute kidney injury (hazard ratio, 4.35 [95% CI, 2.21-8.55]; P<0.001). Interaction testing between RBC transfusion and mortality was not statistically significant in the above-mentioned subgroups, and such association was not documented in the corresponding propensity score-matched cohorts. In the multivariable Cox proportional hazards regression model, major vascular complications (P=0.044), major bleeding (P=0.041), and RBC transfusion (P=0.048) were independent correlates of 30-day mortality. CONCLUSIONS RBC transfusion correlates with increased mortality and acute kidney injury early after transcatheter aortic valve replacement and is an independent predictor of 30-day mortality, irrespective of periprocedural major bleeding and vascular complications. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03740425.
Collapse
Affiliation(s)
- Marco Zimarino
- Institute of Cardiology (M.Z., F.R., A.T., S.G.), "G. d'Annunzio" University Chieti-Pescara, Italy.,Interventional Cath Lab, ASL 2 Abruzzo, Chieti, Italy (M.Z., N.M.)
| | - Marco Barbanti
- Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., D.C., A.P., C.T.)
| | - George D Dangas
- The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D.)
| | - Luca Testa
- Department of Cardiology, IRCCS Pol. S. Donato, S. Donato Milanese Milan, Italy (L.T., F.B.)
| | - Davide Capodanno
- Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., D.C., A.P., C.T.)
| | - Giulio G Stefanini
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy (G.G.S., B.R.).,Humanitas Clinical and Research Center IRCCS, Rozzano-Milan, Italy (G.G.S., B.R.)
| | - Francesco Radico
- Institute of Cardiology (M.Z., F.R., A.T., S.G.), "G. d'Annunzio" University Chieti-Pescara, Italy
| | - Michele Marchioni
- Department of Medical, Oral and Biotechnological Sciences, Laboratory of Biostatistics (M.M.), "G. d'Annunzio" University Chieti-Pescara, Italy
| | - Ignacio Amat-Santos
- CIBERCV, Hospital Clínico Universitario de Valladolid, Spain (I.A.-S., T.R.-G.)
| | - Tommaso Piva
- Interventional Cardiology, Ospedali Riuniti di Ancona, Ancona, Italy (T.P., E.N.)
| | - Francesco Saia
- Division of Cardiology, Cardiothoracic and Vascular Department, S. Orsola Hospital, Bologna University, Bologna, Italy (F.S., C.M.)
| | - Bernhard Reimers
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele-Milan, Italy (G.G.S., B.R.).,Humanitas Clinical and Research Center IRCCS, Rozzano-Milan, Italy (G.G.S., B.R.)
| | | | - Andrea Picchi
- Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., D.C., A.P., C.T.)
| | - Alessandro Toro
- Institute of Cardiology (M.Z., F.R., A.T., S.G.), "G. d'Annunzio" University Chieti-Pescara, Italy
| | | | - Elisa Nicolini
- Interventional Cardiology, Ospedali Riuniti di Ancona, Ancona, Italy (T.P., E.N.)
| | - Carolina Moretti
- Division of Cardiology, Cardiothoracic and Vascular Department, S. Orsola Hospital, Bologna University, Bologna, Italy (F.S., C.M.)
| | - Sabina Gallina
- Institute of Cardiology (M.Z., F.R., A.T., S.G.), "G. d'Annunzio" University Chieti-Pescara, Italy
| | - Nicola Maddestra
- Interventional Cath Lab, ASL 2 Abruzzo, Chieti, Italy (M.Z., N.M.)
| | - Francesco Bedogni
- Department of Cardiology, IRCCS Pol. S. Donato, S. Donato Milanese Milan, Italy (L.T., F.B.)
| | - Corrado Tamburino
- Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy (M.B., D.C., A.P., C.T.)
| |
Collapse
|
|
30
|
Apostolidou E, Kolte D, Kennedy KF, Beale CE, Abbott JD, Ehsan A, Gurm HS, Carson JL, Mamdani S, Aronow HD. Institutional Red Blood Cell Transfusion Rates Are Correlated Following Endovascular and Surgical Cardiovascular Procedures: Evidence That Local Culture Influences Transfusion Decisions. J Am Heart Assoc 2020; 9:e016232. [PMID: 33140685 PMCID: PMC7763716 DOI: 10.1161/jaha.119.016232] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
Background The relationship between local hospital culture and transfusion rates following endovascular and surgical cardiovascular procedures has not been well studied. Methods and Results Patients undergoing coronary revascularization, aortic valve replacement, lower extremity peripheral vascular intervention, or carotid artery revascularization from up to 852 US hospitals in the Nationwide Readmissions Database were identified. Crude and risk‐standardized red blood cell transfusion rates were determined for each procedure. Pearson correlation coefficients were calculated between respective procedural transfusion rates. Median odds ratios were estimated to reflect between‐hospital variability in red blood cell transfusion rates following the same procedure for a given patient. There was wide variation in red blood cell transfusion rates across different procedures, from 2% following carotid endarterectomy to 29% following surgical aortic valve replacement. For surgical and endovascular modalities, transfusion rates at the same hospital were highly correlated for aortic valve replacement (r=0.67; P<0.001), moderately correlated for coronary revascularization (r=0.56; P<0.001) and peripheral vascular intervention (r=0.51; P<0.001), and weakly correlated for carotid artery revascularization (r=0.19, P<0.001). Median odds ratios were all >2, highest for coronary artery bypass graft surgery and surgical aortic valve replacement, indicating substantial site variation in transfusion rates. Conclusions After adjustment for patient‐related factors, wide variation in red blood cell transfusion rates remained across surgical and endovascular procedures employed for the same cardiovascular condition. Transfusion rates following these procedures are highly correlated at individual hospitals and vary widely across hospitals. In aggregate, these findings suggest that local institutional culture significantly influences the decision to transfuse following invasive cardiovascular procedures and highlight the need for randomized data to inform such decisions.
Collapse
Affiliation(s)
- Eirini Apostolidou
- Division of Cardiology Alpert Medical School of Brown University Providence RI
| | - Dhaval Kolte
- Division of Cardiology Massachusetts General Hospital and Harvard Medical School Boston MA
| | - Kevin F Kennedy
- Statistical Consultant to the Cardiovascular Institute Kansas City MO
| | | | - J Dawn Abbott
- Division of Cardiology Alpert Medical School of Brown University Providence RI
| | - Afshin Ehsan
- Division of Cardiothoracic Surgery Alpert Medical School of Brown University Providence RI
| | | | - Jeffrey L Carson
- Division of Internal Medicine Robert Wood Johnson University Hospital New Brunswick NJ
| | - Shafiq Mamdani
- Division of Cardiology Alpert Medical School of Brown University Providence RI
| | - Herbert D Aronow
- Division of Cardiology Alpert Medical School of Brown University Providence RI
| |
Collapse
|
|
31
|
Bendayan M, Messas N, Perrault LP, Asgar AW, Lauck S, Kim DH, Arora RC, Langlois Y, Piazza N, Martucci G, Lefèvre T, Noiseux N, Lamy A, Peterson MD, Labinaz M, Popma JJ, Webb JG, Afilalo J. Frailty and Bleeding in Older Adults Undergoing TAVR or SAVR: Insights From the FRAILTY-AVR Study. JACC Cardiovasc Interv 2020; 13:1058-1068. [PMID: 32381184 DOI: 10.1016/j.jcin.2020.01.238] [Citation(s) in RCA: 41] [Impact Index Per Article: 8.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/06/2019] [Revised: 01/21/2020] [Accepted: 01/22/2020] [Indexed: 01/01/2023]
Abstract
OBJECTIVES The aim of this study was to examine the value of frailty to predict in-hospital major bleeding and determine its impact on mid-term mortality following transcatheter (TAVR) or surgical (SAVR) aortic valve replacement. BACKGROUND Bleeding complications are harbingers of mortality and major morbidity in patients undergoing TAVR or SAVR. Despite the high prevalence of frailty in this population, little is known about its effects on bleeding risk. METHODS A post hoc analysis was performed of the multinational FRAILTY-AVR (Frailty Aortic Valve Replacement) cohort study, which prospectively enrolled older adults ≥70 years of age undergoing TAVR or SAVR. Trained researchers assessed frailty using a questionnaire and physical performance battery pre-procedure and ascertained clinical data from the electronic health record. The primary endpoint was major or life-threatening bleeding during the index hospitalization, and the secondary endpoint was units of packed red blood cells transfused. RESULTS The cohort consisted of 1,195 patients with a mean age of 81.3 ± 6.0 years. The incidence of life-threatening bleeding, major bleeding with a clinically apparent source, and major bleeding without a clinically apparent source was, respectively, 3%, 6%, and 9% in the TAVR group and 8%, 10%, and 31% in the SAVR group. Frailty measured using the Essential Frailty Toolset was an independent predictor of major bleeding and packed red blood cell transfusions in both groups. Major bleeding was associated with a 3-fold increase in 1-year mortality following TAVR (odds ratio: 3.40; 95% confidence interval: 2.22 to 5.21) and SAVR (odds ratio: 2.79; 95% confidence interval: 1.25 to 6.21). CONCLUSIONS Frailty is associated with post-procedural major bleeding in older adults undergoing TAVR and SAVR, which is in turn associated with a higher risk for mid-term mortality.
Collapse
Affiliation(s)
- Melissa Bendayan
- Division of Experimental Medicine, McGill University, Montreal, Quebec, Canada; Centre for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute for Medical Research, Montreal, Quebec, Canada
| | - Nathan Messas
- Division of Cardiology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
| | - Louis P Perrault
- Division of Cardiac Surgery, Institut de Cardiologie de Montréal, Université de Montréal, Montreal, Quebec, Canada
| | - Anita W Asgar
- Division of Cardiology, Institut de Cardiologie de Montréal, Université de Montréal, Montreal, Quebec, Canada
| | - Sandra Lauck
- Centre for Heart Valve Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada
| | - Dae H Kim
- Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard University, Boston, Massachusetts
| | - Rakesh C Arora
- Divisions of Cardiac Surgery and Critical Care, St. Boniface Hospital, University of Manitoba, Winnipeg, Manitoba
| | - Yves Langlois
- Division of Cardiac Surgery, Jewish General Hospital, McGill University, Montreal, Quebec, Canada
| | - Nicolo Piazza
- Division of Cardiology, McGill University Health Center, Montreal, Quebec, Canada
| | - Giuseppe Martucci
- Division of Cardiology, McGill University Health Center, Montreal, Quebec, Canada
| | - Thierry Lefèvre
- Division of Cardiology, Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France
| | - Nicolas Noiseux
- Division of Cardiac Surgery, Center Hospitalier de l'Université de Montréal, Centre de Recherche du CHUM, Montreal, Quebec
| | - Andre Lamy
- Division of Cardiac Surgery, Hamilton Health Sciences, Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada
| | - Mark D Peterson
- Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada
| | - Marino Labinaz
- Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
| | - Jeffrey J Popma
- Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard University, Boston, Massachusetts
| | - John G Webb
- Centre for Heart Valve Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada
| | - Jonathan Afilalo
- Division of Experimental Medicine, McGill University, Montreal, Quebec, Canada; Centre for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute for Medical Research, Montreal, Quebec, Canada; Division of Cardiology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.
| |
Collapse
|
|
32
|
Megaly M, Buda KG, Brilakis ES, Pershad A, Louka B, Saad M, Abdelaziz HK, Anantha Narayanan M, Syed M, Mentias A, Omer M, Alexander J, Titus J, Garcia S. Outcomes with MANTA Device for Large-Bore Access Closure after Transcatheter Aortic Valve Replacement: A Meta-Analysis. STRUCTURAL HEART 2020; 4:420-426. [DOI: 10.1080/24748706.2020.1809755] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/26/2020] [Revised: 06/30/2020] [Accepted: 08/05/2020] [Indexed: 11/24/2024]
|
|
33
|
Matsushita K, Marchandot B, Trimaille A, Kibler M, Heger J, Peillex M, Hess S, Grunebaum L, Reydel A, Kindo M, Hoang MT, Sato C, De Poli F, Leddet P, Ohana M, Jesel L, Ohlmann P, Susen S, Morel O. Paradoxical Increase of Stroke in Patients with Defect of High Molecular Weight Multimers of the von Willebrand Factors following Transcatheter Aortic Valve Replacement. Thromb Haemost 2020; 120:1330-1338. [PMID: 32726854 DOI: 10.1055/s-0040-1713424] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
Abstract
BACKGROUND Stroke is a major cause of disability after transcatheter aortic valve replacement (TAVR) and stroke prediction models and data are crucially needed. Following TAVR, high molecular weight (HMW) multimers defect of von Willebrand factor (VWF) as assessed by closure time of adenosine diphosphate (CT-ADP) value > 180 seconds is an independent predictor of bleeding events. This study sought to identify predictors of ischemic neurological events in patients who underwent TAVR and the specific impact of HMW multimers defect of VWF. METHODS Patients were prospectively enrolled between November 2012 and May 2018 at our institution. The CT-ADP, a point-of-care measure of hemostasis, was assessed the day before and 24 hours after the procedures. The rate of ischemic stroke and transient ischemic attack (TIA) was recorded up to 30 days after the procedures. RESULTS Of 565 TAVR patients, ischemic stroke/TIA was observed in 21 (3.7%) patients within 30 days. Ischemic stroke/TIA was associated with major/life-threatening bleeding complications (MLBCs) (9 [43%] vs. 88 [16%], p = 0.002) and postprocedure CT-ADP > 180 seconds (10 [48%] vs. 116 [21%], p = 0.01). By multivariate analysis, MLBCs (odds ratio [OR]: 3.58; 95% confidence interval [CI]: 1.45-8.84; p = 0.006) and postprocedure CT-ADP > 180 seconds (OR: 3.38; 95% CI: 1.38-8.25; p = 0.008) were evidenced as independent predictors of ischemic stroke/TIA. CONCLUSION MLBCs and CT-ADP > 180 seconds were identified as predictors for ischemic stroke or TIA. The present study suggests that the defects of HMW multimers of the VWFs may contribute not only to bleeding events but also to thrombotic events.
Collapse
Affiliation(s)
- Kensuke Matsushita
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France.,UMR1260 INSERM, Nanomédecine Régénérative, Faculté de Pharmacie, Université de Strasbourg, Illkirch, France
| | - Benjamin Marchandot
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France
| | - Antonin Trimaille
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France
| | - Marion Kibler
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France
| | - Joe Heger
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France
| | - Marilou Peillex
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France
| | - Sebastien Hess
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France
| | - Lelia Grunebaum
- Department of Haemostasis, Centre Hospitalier Universitaire, Strasbourg, France
| | - Antje Reydel
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France
| | - Michel Kindo
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France
| | - Minh Tam Hoang
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France
| | - Chisato Sato
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France
| | - Fabien De Poli
- Department of Cardiology, Centre Hospitalier de Haguenau, Haguenau, France
| | - Pierre Leddet
- Department of Cardiology, Centre Hospitalier de Haguenau, Haguenau, France
| | - Mickael Ohana
- Department of Radiology, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Strasbourg, France
| | - Laurence Jesel
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France.,UMR1260 INSERM, Nanomédecine Régénérative, Faculté de Pharmacie, Université de Strasbourg, Illkirch, France
| | - Patrick Ohlmann
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France
| | - Sophie Susen
- INSERM U1011 - EGID, Institut Pasteur de Lille, University of Lille, Lille, France.,Hematology Transfusion, CHU Lille, Lille, France
| | - Olivier Morel
- Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, Université de Strasbourg, Strasbourg, France.,UMR1260 INSERM, Nanomédecine Régénérative, Faculté de Pharmacie, Université de Strasbourg, Illkirch, France
| |
Collapse
|
|
34
|
Abstract
Background. Little research has been conducted to explore the postoperative outcomes of obese patients after transfemoral transcatheter aortic valve replacement (TF-TAVR). Objective. We investigated the influence of body mass index (BMI) on 1-year outcomes after TF-TAVR. Methods. We included retrospectively 1609 high- and intermediate-risk TAVR patients (mean EuroSCORE II 21 ± 11) operated under general anesthesia between March 2014 and March 2018 in central hospital, Bad Berka, Germany. We stratified the patients according to BMI. Results. Our demographic data analysis showed 41% of patients were male and the mean age was 78 (range, 61–92 years). According to the WHO classification, 33% patients had normal weight, 42% were defined as overweight, and 22% were obese. Obese patients showed statistically significant difference in their clinical parameters as having higher incidence of hypertension, diabetes mellitus, pulmonary hypertension, and chronic obstructive pulmonary disease; on the contrary, obese patients were found to be younger than others. We found no differences in valve types and sizes among the different BMI categories. Our mortality rate during the 1-year follow-up period was 17.8% (287 patients). Mortality was significantly higher in patients with BMI < 25 kg/m2 (1 year mortality 149 patients 28.2% in patients with BMI < 25 kg/m2 vs. 138 patients 12.6% in patients with BMI ≥ 25 kg/m2; P=0.0001). Even after considering the confounding risk factors, BMI ≥ 25 kg/m2 was independently associated with reduced 1 year mortality (odds ratio (OR): 0.36, 95% confidence interval (CI): 0.21–0.6; P=0.01) in multivariate logistic regression analysis. The rate of vascular complication was higher in patients with BMI ≥ 25 kg/m2. However, the rate of blood transfusion was higher in patients with BMI < 25 kg/m2. All other serious complications occurred with equal distribution in both groups. Conclusion. In our single-center study, BMI ≥ 25 kg/m2 was independently associated with lower 1 year mortality after TF-TAVR.
Collapse
|
|
35
|
Vincent F, Spillemaeker H, Kyheng M, Belin-Vincent C, Delhaye C, Piérache A, Denimal T, Verdier B, Debry N, Moussa M, Schurtz G, Porouchani S, Cosenza A, Juthier F, Pamart T, Richardson M, Coisne A, Hertault A, Sobocinski J, Modine T, Pontana F, Duhamel A, Labreuche J, Van Belle E. Ultrasound Guidance to Reduce Vascular and Bleeding Complications of Percutaneous Transfemoral Transcatheter Aortic Valve Replacement: A Propensity Score-Matched Comparison. J Am Heart Assoc 2020; 9:e014916. [PMID: 32172643 PMCID: PMC7335526 DOI: 10.1161/jaha.119.014916] [Citation(s) in RCA: 39] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/08/2023]
Abstract
Background Ultrasound (US) guidance provides the unique opportunity to control the puncture zone of the artery during transfemoral transcatheter aortic valve replacement and may decrease major vascular complications (VC) and life-threatening or major bleeding complications. This study aimed to evaluate the clinical impact of US guidance using a propensity score-matched comparison. Methods and Results US guidance was implemented as the default approach for all transfemoral transcatheter aortic valve replacement cases in our institution in June 2013. We defined 3 groups of consecutive patients according to the method of puncture (fluoroscopic/US guidance) and the use of a transcatheter heart valve. Patients in the US-guided second-generation group (Sapien XT [Edwards Lifesciences, Irvine, CA], Corevalve [Medtronic, Dublin, Ireland]) were successfully 1:1 matched with patients in the fluoroscope-guided second-generation group (n=95) with propensity score matching. In a second analysis we described the consecutive patients of the US-guided third-generation group (Evolut-R [Medtronic], Sapien 3 [Edwards Lifesciences], n=308). All vascular and bleeding complications were reduced in the US-guided second-generation group compared with the fluoroscope-guided second-generation group: VC (16.8% versus 6.3%; P=0.023); life-threatening or major bleeding (22.1% versus 6%; P=0.004); and VC related to vascular access (12.6% versus 4.2%; P=0.052). In the US-guided third-generation group the rates of major VC and life-threatening or major bleeding were 3.2% (95% CI, 1.6% to 5.9%) and 3.6% (95% CI, 1.8% to 6.3%). In the overall population (n=546), life-threatening or major bleeding was associated with a 1.7-fold increased mortality risk (P=0.02). Conclusions We demonstrated that US guidance effectively reduced VC and bleeding complications for transfemoral transcatheter aortic valve replacement and should be considered the standard puncture method. Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02628509.
Collapse
Affiliation(s)
- Flavien Vincent
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France.,Inserm U1011 Institut Pasteur de Lille EGID Lille France.,Université de Lille France
| | - Hugues Spillemaeker
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France.,Inserm U1011 Institut Pasteur de Lille EGID Lille France.,Université de Lille France
| | - Maéva Kyheng
- EA 2694-Santé Publique: Épidémiologie et Qualité des Soins CHU Lille University of Lille France
| | - Cassandre Belin-Vincent
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France
| | - Cédric Delhaye
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France
| | - Adeline Piérache
- EA 2694-Santé Publique: Épidémiologie et Qualité des Soins CHU Lille University of Lille France
| | - Tom Denimal
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France.,Inserm U1011 Institut Pasteur de Lille EGID Lille France.,Université de Lille France
| | - Basile Verdier
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France.,Inserm U1011 Institut Pasteur de Lille EGID Lille France.,Université de Lille France
| | - Nicolas Debry
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France.,Inserm U1011 Institut Pasteur de Lille EGID Lille France.,Université de Lille France
| | - Mouhamed Moussa
- Anesthésie et Réanimation Cardio-Vasculaire CHU Lille Lille France.,Inserm U1011 Institut Pasteur de Lille EGID Lille France.,Université de Lille France
| | - Guillaume Schurtz
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France
| | - Sina Porouchani
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France
| | - Alessandro Cosenza
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France
| | - Francis Juthier
- Chirurgie Cardiaque CHU Lille Lille France.,Inserm U1011 Institut Pasteur de Lille EGID Lille France.,Université de Lille France
| | - Thibault Pamart
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France.,Inserm U1011 Institut Pasteur de Lille EGID Lille France.,Université de Lille France
| | - Marjorie Richardson
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France
| | - Augustin Coisne
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France.,Inserm U1011 Institut Pasteur de Lille EGID Lille France.,Université de Lille France
| | | | | | - Thomas Modine
- Chirurgie Cardiaque CHU Lille Lille France.,Inserm U1011 Institut Pasteur de Lille EGID Lille France.,Université de Lille France
| | | | - Alain Duhamel
- EA 2694-Santé Publique: Épidémiologie et Qualité des Soins CHU Lille University of Lille France
| | - Julien Labreuche
- EA 2694-Santé Publique: Épidémiologie et Qualité des Soins CHU Lille University of Lille France
| | - Eric Van Belle
- Cardiology Department of Interventional Cardiology for Coronary, Valves, and Structural Heart Diseases Institut Coeur Poumon CHU Lille Lille France.,Inserm U1011 Institut Pasteur de Lille EGID Lille France.,Université de Lille France
| |
Collapse
|
|
36
|
Noubouossie DF, Henderson MW, Mooberry M, Ilich A, Ellsworth P, Piegore M, Skinner SC, Pawlinski R, Welsby I, Renné T, Hoffman M, Monroe DM, Key NS. Red blood cell microvesicles activate the contact system, leading to factor IX activation via 2 independent pathways. Blood 2020; 135:755-765. [PMID: 31971571 PMCID: PMC7059516 DOI: 10.1182/blood.2019001643] [Citation(s) in RCA: 63] [Impact Index Per Article: 12.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2019] [Accepted: 01/08/2020] [Indexed: 01/01/2023] Open
Abstract
Storage lesion-induced, red cell-derived microvesicles (RBC-MVs) propagate coagulation by supporting the assembly of the prothrombinase complex. It has also been reported that RBC-MVs initiate coagulation via the intrinsic pathway. To elucidate the mechanism(s) of RBC-MV-induced coagulation activation, the ability of storage lesion-induced RBC-MVs to activate each zymogen of the intrinsic pathway was assessed in a buffer system. Simultaneously, the thrombin generation (TG) assay was used to assess their ability to initiate coagulation in plasma. RBC-MVs directly activated factor XII (FXII) or prekallikrein, but not FXI or FIX. RBC-MVs initiated TG in normal pooled plasma and in FXII- or FXI-deficient plasma, but not in FIX-deficient plasma, suggesting an alternate pathway that bypasses both FXII and FXI. Interestingly, RBC-MVs generated FIXa in a prekallikrein-dependent manner. Similarly, purified kallikrein activated FIX in buffer and initiated TG in normal pooled plasma, as well as FXII- or FXI-deficient plasma, but not FIX-deficient plasma. Dual inhibition of FXIIa by corn trypsin inhibitor and kallikrein by soybean trypsin inhibitor was necessary for abolishing RBC-MV-induced TG in normal pooled plasma, whereas kallikrein inhibition alone was sufficient to abolish TG in FXII- or FXI-deficient plasma. Heating RBC-MVs at 60°C for 15 minutes or pretreatment with trypsin abolished TG, suggesting the presence of MV-associated proteins that are essential for contact activation. In summary, RBC-MVs activate both FXII and prekallikrein, leading to FIX activation by 2 independent pathways: the classic FXIIa-FXI-FIX pathway and direct kallikrein activation of FIX. These data suggest novel mechanisms by which RBC transfusion mediates inflammatory and/or thrombotic outcomes.
Collapse
Affiliation(s)
| | - Michael W Henderson
- UNC Blood Research Center, and
- Department of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC
| | | | - Anton Ilich
- Department of Medicine
- UNC Blood Research Center, and
| | - Patrick Ellsworth
- Department of Medicine
- Department of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC
| | - Mark Piegore
- Department of Medicine
- UNC Blood Research Center, and
| | - Sarah C Skinner
- Department of Medicine
- UNC Blood Research Center, and
- Department of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC
| | | | - Ian Welsby
- Department of Anesthesiology, Duke University, Durham, NC
| | - Thomas Renné
- Institute of Clinical Chemistry and Laboratory Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; and
| | - Maureane Hoffman
- Department of Pathology, Veteran Affairs Medical Center, Durham, NC
| | | | - Nigel S Key
- Department of Medicine
- UNC Blood Research Center, and
- Department of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC
| |
Collapse
|
|
37
|
Junquera L, Urena M, Latib A, Muñoz-Garcia A, Nombela-Franco L, Faurie B, Veiga-Fernandez G, Alperi A, Serra V, Regueiro A, Fischer Q, Himbert D, Mangieri A, Colombo A, Muñoz-García E, Vera-Urquiza R, Jiménez-Quevedo P, de la Torre JM, Pascual I, Garcia Del Blanco B, Sabaté M, Mohammadi S, Freitas-Ferraz AB, Guimarães L, Couture T, Côté M, Rodés-Cabau J. Comparison of Transfemoral Versus Transradial Secondary Access in Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv 2020; 13:e008609. [PMID: 32089002 DOI: 10.1161/circinterventions.119.008609] [Citation(s) in RCA: 19] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
BACKGROUND Transfemoral approach has been commonly used as secondary access in transcatheter aortic valve replacement (TAVR). Scarce data exist on the use and potential clinical benefits of the transradial approach as secondary access during TAVR procedures. The objective of the study is to determine the occurrence of vascular complications (VC) and clinical outcomes according to secondary access (transfemoral versus transradial) in patients undergoing TAVR. METHODS This was a multicenter study including 4949 patients who underwent TAVR (mean age, 81±8 years, mean Society of Thoracic Surgeons score, 4.9 [3.3-7.5]). Transfemoral and transradial approaches were used as secondary access in 4016 (81.1%) and 933 (18.9%) patients, respectively. The 30-day clinical events (vascular and bleeding complications, stroke, acute kidney injury, and mortality) were evaluated and defined according to Valve Academic Research Consortium-2 criteria. Clinical outcomes were analyzed according to the secondary access (transfemoral versus transradial) in the overall population and in a propensity score-matched population involving 2978 transfemoral and 928 transradial patients. RESULTS Related-access VC occurred in 834 (16.9%) patients (major VC, 5.7%) and were related to the secondary access in 172 (3.5%) patients (major VC, 1.3%). The rate of VC related to the secondary access was higher in the transfemoral group (VC, 4.1% versus 0.9%, P<0.001; major VC, 1.6% versus 0%, P<0.001). In the propensity score-matched population, VC related to the secondary access remained higher in the transfemoral group (4.7% versus 0.9%, P<0.001; major VC, 1.8% versus 0%, P<0.001), which also exhibited a higher rate of major/life-threatening bleeding events (1.0% versus 0%, P<0.001). Significant differences between secondary access groups were observed regarding the rates of 30-day stroke (transfemoral: 3.1%, transradial: 1.6%; P=0.043), acute kidney injury (transfemoral: 9.9%, transradial: 5.7%; P<0.001), and mortality (transfemoral: 4.0%, transradial: 2.4%, P=0.047). CONCLUSIONS The use of transradial approach as secondary access in TAVR procedures was associated with a significant reduction in vascular and bleeding complications and improved 30-day outcomes. Future randomized studies are warranted.
Collapse
Affiliation(s)
- Lucía Junquera
- Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada (L.J., S.M., A.B.F.-F., L.G., T.C., M.C., J.R.-C.)
| | - Marina Urena
- Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France (M.U., Q.F., D.H.)
| | - Azeem Latib
- San Raffaele Scientific Institute, Milan, Italy (A.L., A.M., A.C.).,Montefiore Medical Center, New York, NY (A.L.)
| | | | - Luis Nombela-Franco
- Instituto Cardiovascular, Hospital Clinico San Carlos, IdISSC, Madrid, Spain (L.N.-F., R.V.U., P.J.-Q.)
| | - Benjamin Faurie
- Groupe Hospitalier Mutualiste de Grenoble, Institut Cardiovasculaire,Grenoble, France (B.F.)
| | | | - Alberto Alperi
- Hospital Universitario Central de Asturias, Spain (A.A., I.P.)
| | - Vicenç Serra
- Hospital Universitari Vall d'Hebron, Barcelona, Spain (V.S., B.G.d.B.)
| | - Ander Regueiro
- Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (A.R., M.S.)
| | - Quentin Fischer
- Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France (M.U., Q.F., D.H.)
| | - Dominique Himbert
- Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France (M.U., Q.F., D.H.)
| | - Antonio Mangieri
- San Raffaele Scientific Institute, Milan, Italy (A.L., A.M., A.C.).,Maria Cecilia GVM Hospital, Cotignola, Italy (A.M., A.C.)
| | - Antonio Colombo
- San Raffaele Scientific Institute, Milan, Italy (A.L., A.M., A.C.).,Maria Cecilia GVM Hospital, Cotignola, Italy (A.M., A.C.)
| | - Erika Muñoz-García
- Hospital Universitario Virgen de la Victoria, Málaga, Spain (A.M.-G., E.M.-G.)
| | - Rafael Vera-Urquiza
- Instituto Cardiovascular, Hospital Clinico San Carlos, IdISSC, Madrid, Spain (L.N.-F., R.V.U., P.J.-Q.)
| | - Pilar Jiménez-Quevedo
- Instituto Cardiovascular, Hospital Clinico San Carlos, IdISSC, Madrid, Spain (L.N.-F., R.V.U., P.J.-Q.)
| | | | - Isaac Pascual
- Hospital Universitario Central de Asturias, Spain (A.A., I.P.)
| | | | - Manel Sabaté
- Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (A.R., M.S.)
| | - Siamak Mohammadi
- Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada (L.J., S.M., A.B.F.-F., L.G., T.C., M.C., J.R.-C.)
| | - Afonso B Freitas-Ferraz
- Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada (L.J., S.M., A.B.F.-F., L.G., T.C., M.C., J.R.-C.)
| | - Leonardo Guimarães
- Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada (L.J., S.M., A.B.F.-F., L.G., T.C., M.C., J.R.-C.)
| | - Thomas Couture
- Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada (L.J., S.M., A.B.F.-F., L.G., T.C., M.C., J.R.-C.)
| | - Melanie Côté
- Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada (L.J., S.M., A.B.F.-F., L.G., T.C., M.C., J.R.-C.)
| | - Josep Rodés-Cabau
- Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada (L.J., S.M., A.B.F.-F., L.G., T.C., M.C., J.R.-C.)
| |
Collapse
|
|
38
|
Maaranen P, Husso A, Tauriainen T, Lahtinen A, Valtola A, Ahvenvaara T, Virtanen M, Laakso T, Kinnunen EM, Dahlbacka S, Juvonen T, Mäkikallio T, Jalava MP, Jaakkola J, Airaksinen J, Vasankari T, Rosato S, Savontaus M, Laine M, Raivio P, Niemelä M, Mennander A, Eskola M, Biancari F. Blood Transfusion and Outcome After Transfemoral Transcatheter Aortic Valve Replacement. J Cardiothorac Vasc Anesth 2019; 33:2949-2959. [DOI: 10.1053/j.jvca.2019.06.038] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2019] [Revised: 06/21/2019] [Accepted: 06/26/2019] [Indexed: 11/11/2022]
|
|
39
|
Scarsini R, De Maria GL, Joseph J, Fan L, Cahill TJ, Kotronias RA, Burzotta F, Newton JD, Kharbanda R, Prendergast B, Ribichini F, Banning AP. Impact of Complications During Transfemoral Transcatheter Aortic Valve Replacement: How Can They Be Avoided and Managed? J Am Heart Assoc 2019; 8:e013801. [PMID: 31522627 PMCID: PMC6818016 DOI: 10.1161/jaha.119.013801] [Citation(s) in RCA: 53] [Impact Index Per Article: 8.8] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Affiliation(s)
- Roberto Scarsini
- Oxford Heart Centre Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom.,Division of Cardiology Department of Medicine University of Verona Italy
| | - Giovanni L De Maria
- Oxford Heart Centre Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom
| | - Jubin Joseph
- Oxford Heart Centre Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom.,Guy's and St.Thomas' Hospitals NHS Foundation Trust London United Kingdom
| | - Lampson Fan
- Oxford Heart Centre Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom
| | - Thomas J Cahill
- Oxford Heart Centre Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom
| | - Rafail A Kotronias
- Oxford Heart Centre Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom.,Department of Cardiovascular Medicine University of Oxford United Kingdom
| | | | - James D Newton
- Oxford Heart Centre Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom
| | - Rajesh Kharbanda
- Oxford Heart Centre Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom
| | | | - Flavio Ribichini
- Division of Cardiology Department of Medicine University of Verona Italy
| | - Adrian P Banning
- Oxford Heart Centre Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom
| |
Collapse
|
|
40
|
Apostolidou E, Aronow HD, Beale CE, Kolte D, Kennedy KF, Sellke FW, Gordon PC, Sharaf B, Ehsan A. Association Between Red Blood Cell Transfusion and Clinical Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement. Ann Thorac Surg 2019; 107:1791-1798. [DOI: 10.1016/j.athoracsur.2018.11.022] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/19/2018] [Revised: 10/06/2018] [Accepted: 11/05/2018] [Indexed: 11/27/2022]
|
|
41
|
Takagi H, Hari Y, Kawai N, Kuno T, Ando T. Meta-analysis of prognostic impact of blood transfusion on survival after transcatheter aortic valve implantation. THE JOURNAL OF CARDIOVASCULAR SURGERY 2019; 60:535-539. [PMID: 31089078 DOI: 10.23736/s0021-9509.19.10822-1] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/28/2023]
Affiliation(s)
- Hisato Takagi
- Department of Cardiovascular Surgery, Shizuoka Medical Center, Shizuoka, Japan - .,Department of Cardiovascular Surgery, Kitasato University School of Medicine, Sagamihara, Japan -
| | - Yosuke Hari
- Department of Cardiovascular Surgery, Shizuoka Medical Center, Shizuoka, Japan.,Department of Cardiovascular Surgery, Kitasato University School of Medicine, Sagamihara, Japan
| | - Norikazu Kawai
- Department of Cardiovascular Surgery, Shizuoka Medical Center, Shizuoka, Japan
| | - Toshiki Kuno
- Department of Medicine, Mount Sinai Beth Israel Medical Center, New York, NY, USA
| | - Tomo Ando
- Department of Cardiology, Detroit Medical Center, Detroit, MI, USA
| | | |
Collapse
|
|
42
|
Kitahara H, Edelman JJ, Thourani VH. Commentary: Blood transfusions in transcatheter aortic valve replacement-Less is more. J Thorac Cardiovasc Surg 2019; 159:112-113. [PMID: 31101351 DOI: 10.1016/j.jtcvs.2019.03.108] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/25/2019] [Accepted: 03/26/2019] [Indexed: 11/19/2022]
Affiliation(s)
- Hiroto Kitahara
- Department of Cardiac Surgery, MedStar Heart and Vascular Institute, Georgetown University, Washington, DC
| | - J James Edelman
- Department of Cardiac Surgery, MedStar Heart and Vascular Institute, Georgetown University, Washington, DC
| | - Vinod H Thourani
- Department of Cardiac Surgery, MedStar Heart and Vascular Institute, Georgetown University, Washington, DC.
| |
Collapse
|
|
43
|
Abbasi D, Vanhook JE, Salartash K, Levite H. Diagnosis and Management of Rare Case of Mesenteric Hematoma Rupture after Transcatheter Aortic Valve Replacement (TAVR): A Case Report and Review of the Literature. Case Rep Vasc Med 2018; 2018:6273538. [PMID: 30584489 PMCID: PMC6280234 DOI: 10.1155/2018/6273538] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/26/2018] [Revised: 10/22/2018] [Accepted: 10/30/2018] [Indexed: 11/17/2022] Open
Abstract
We present a case of a 78-year-old female with history of diastolic heart failure and paroxysmal atrial fibrillation on apixaban presenting with worsening shortness of breath. She underwent transesophageal echocardiogram showing severe aortic stenosis with a valve area of 0.8 cm2. Coronary angiography did not reveal significant coronary artery disease. CT of chest, abdomen, and pelvis did not show any evidence of hematoma or dissection. Patient was scheduled for transfemoral TAVR. Patient's apixaban was discontinued prior to the procedure. She received heparin during the procedure. She successfully underwent left transfemoral aortic valve replacement. Shortly after the procedure, she complained of abdominal pain and became hypotensive. Blood pressure was 76/44 mm of Hg (MAP 58). Hemoglobin dropped to 8.1 g/dl (baseline 13). Stat CT abdomen and pelvis showed a large volume of hemorrhage in the peritoneal cavity. CTA of abdomen showed no evidence of aortic aneurysm or dissection but active extravasation below the inferior aspect of the spleen. Catheterization of the superior mesenteric artery (SMA) identified ileal branch of SMA as the source of bleeding. Embolization using gel foam slurry followed by a coil insertion was performed. Repeat angiogram demonstrated continued extravasation through arcade collaterals. A rapid exploration of the abdominal cavity revealed ruptured mesenteric hematoma. Evacuation of hematoma was performed. Portion of small ileum and bleeding mesenteric branch vessel was resected. Her condition stabilized with no postoperative bleeding and she was discharged on warfarin postoperatively. Use of antithrombotic therapy increases risk of bleeding in TAVR patients. Mesenteric hematoma rupture if not identified can be life-threatening. We believe that this is the first reported case of mesenteric hematoma rupture after a TAVR procedure.
Collapse
Affiliation(s)
| | | | - Khashayar Salartash
- Lewis Katz School of Medicine at Temple University, Department of Medicine, USA
| | - Howard Levite
- AtlantiCare Regional Medical Center, USA
- American Heart Association for Central and Southern, New Jersey, USA
| |
Collapse
|
|
44
|
Impact of gender on outcomes after transcatheter aortic valve implantation. JOURNAL OF GERIATRIC CARDIOLOGY : JGC 2018; 15:394-400. [PMID: 30108610 PMCID: PMC6087513 DOI: 10.11909/j.issn.1671-5411.2018.06.013] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 01/09/2023]
Abstract
Backgound The influence of gender on clinical outcomes following transcatheter aortic valve implantation (TAVI) was considerably discrepant in previous studies. We aimed to investigate the impact of gender in our registry. Methods The study is a retrospective observational analysis of a prospectively designed cohort (546 consecutive patients treated at the University Hospital Zurich who were enrolled in Swiss TAVI Cohort from May 2008 to April 2014). The Study took place in University Heart Centre at University Hospital Zurich, Switzerland. Results Both genders were equally represented with 51.5 % (n = 281) of the populations being females, who were significantly older and had a more pronounced history of hypertension (P < 0.001). Males on the other hand showed a higher incidence of diabetes (P = 0.004), coronary artery disease (P < 0.001), chronic obstructive pulmonary disease (P < 0.001) and renal failure requiring renal replacement therapy (P = 0.018). Patients were followed up for a median of 391 days with a 100% complete follow-up at one year. The primary outcome (all-cause mortality) occurred in 6.8% (n = 37) and 15% (n = 82) of patients at 30 days and one year, respectively. The 30-day all-cause mortality outcome did not significantly differ between females (7.5%) and males (6.0%) (P = 0.619), but one year all-cause mortality occurred significantly more in males than in females (18.7% vs. 11.7%, P < 0.037). Conclusion After TAVI implantation for severe aortic stenosis, males have a less favorable long-term (one year) mortality outcome than females.
Collapse
|
|
45
|
Panoulas VF, Francis DP, Ruparelia N, Malik IS, Chukwuemeka A, Sen S, Anderson J, Nihoyannopoulos P, Sutaria N, Hannan EL, Samadashvili Z, D'Errigo P, Schymik G, Mehran R, Chieffo A, Latib A, Presbitero P, Mehilli J, Petronio AS, Morice MC, Tamburino C, Thyregod HGH, Leon M, Colombo A, Mikhail GW. Female-specific survival advantage from transcatheter aortic valve implantation over surgical aortic valve replacement: Meta-analysis of the gender subgroups of randomised controlled trials including 3758 patients. Int J Cardiol 2018; 250:66-72. [PMID: 29169764 DOI: 10.1016/j.ijcard.2017.05.047] [Citation(s) in RCA: 38] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/28/2017] [Revised: 03/05/2017] [Accepted: 05/09/2017] [Indexed: 01/09/2023]
Abstract
Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) is the first area of interventional cardiology where women are treated as often as men. In this analysis of the gender specific results of randomised controlled trials (RCTs) comparing TAVI with surgical aortic valve replacement (SAVR) we aimed to determine whether gender affects the survival comparison between TAVI and SAVR. We identified all RCTs comparing TAVI versus SAVR for severe AS and reporting 1 and/or 2year survival. Summary odds ratios (ORs) were obtained using a random-effects model. Heterogeneity was assessed using the Q statistic and I2. Four RCTs met the criteria, totalling 3758 patients, 1706 women and 2052 men. Amongst females, TAVI recipients had a significantly lower mortality than SAVR recipients, at 1year (OR 0.68; 95%CI 0.50 to 0.94) and at 2years (OR 0.74; 95%CI 0.58 to 0.95). Amongst males there was no difference in mortality between TAVI and SAVR, at 1year (OR 1.09; 95%CI 0.86 to 1.39) or 2years (OR 1.05; 95%CI 0.85 to 1.3). The difference in treatment effect between genders was significant at both 1year (pinteraction=0.02) and 2years (pinteraction=0.04). In women TAVI has a 26 to 31% lower mortality odds than SAVR. In men, there is no difference in mortality between TAVI and SAVR.
Collapse
Affiliation(s)
- Vasileios F Panoulas
- Cardiovascular Sciences, National Heart and Lung Institute, Imperial College London, London, UK; Cardiology Department, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK.
| | - Darrel P Francis
- Cardiovascular Sciences, National Heart and Lung Institute, Imperial College London, London, UK
| | - Neil Ruparelia
- Cardiology Department, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK
| | - Iqbal S Malik
- Cardiovascular Sciences, National Heart and Lung Institute, Imperial College London, London, UK; Cardiology Department, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK
| | - Andrew Chukwuemeka
- Cardiothoracic Department, Hammersmith Hospital, Imperial College Healthcare NHS Trust
| | - Sayan Sen
- Cardiovascular Sciences, National Heart and Lung Institute, Imperial College London, London, UK; Cardiology Department, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK
| | - Jonathan Anderson
- Cardiothoracic Department, Hammersmith Hospital, Imperial College Healthcare NHS Trust
| | - Petros Nihoyannopoulos
- Cardiovascular Sciences, National Heart and Lung Institute, Imperial College London, London, UK; Cardiology Department, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK
| | - Nilesh Sutaria
- Cardiovascular Sciences, National Heart and Lung Institute, Imperial College London, London, UK
| | - Edward L Hannan
- School of Public Health, University at Albany, State University of New York, Albany, NY, USA
| | - Zaza Samadashvili
- School of Public Health, University at Albany, State University of New York, Albany, NY, USA
| | - Paola D'Errigo
- National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy
| | - Gerhard Schymik
- Medical Clinic IV, Department of Cardiology, Municipal Hospital Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Freiburg, Germany
| | - Roxana Mehran
- Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, United States
| | - Alaide Chieffo
- Cardiology department, San Raffaele Scientific Institute, Milan, Italy
| | - Azeem Latib
- Cardiology department, San Raffaele Scientific Institute, Milan, Italy
| | - Patrizia Presbitero
- Hemodynamic and Invasive Cardiology Unit, IRCCS Istituto Clinico Humanitas, Milan, Italy
| | - Julinda Mehilli
- Munich University Clinic, Ludwig-Maximilians University, Munich, Germany,; Munich Heart Alliance at Deutsches Zentrum für Herz-Kreislauf-Forschung, Munich, Germany
| | | | - Marie-Claude Morice
- RAMSAY, Génerale de Santé,ICPS, Institut Cardiovasculaire Paris Sud, Massy, France
| | - Corrado Tamburino
- Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy; ETNA Foundation, Catania, Italy
| | - Hans G H Thyregod
- Department of Cardiothoracic Surgery, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
| | - Martin Leon
- Columbia University Medical Center, New York, USA
| | - Antonio Colombo
- Cardiology department, San Raffaele Scientific Institute, Milan, Italy
| | - Ghada W Mikhail
- Cardiovascular Sciences, National Heart and Lung Institute, Imperial College London, London, UK; Cardiology Department, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK
| |
Collapse
|
|
46
|
Ahmad Y, Demir O, Rajkumar C, Howard JP, Shun-Shin M, Cook C, Petraco R, Jabbour R, Arnold A, Frame A, Sutaria N, Ariff B, Kanaganayagam G, Francis D, Mayet J, Mikhail G, Malik I, Sen S. Optimal antiplatelet strategy after transcatheter aortic valve implantation: a meta-analysis. Open Heart 2018; 5:e000748. [PMID: 29387433 PMCID: PMC5786926 DOI: 10.1136/openhrt-2017-000748] [Citation(s) in RCA: 32] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/09/2017] [Revised: 12/13/2017] [Accepted: 12/29/2017] [Indexed: 01/09/2023] Open
Abstract
Objective International guidelines recommend the use of dual antiplatelet therapy (DAPT) after transcatheter aortic valve implantation (TAVI). The recommended duration of DAPT varies between guidelines. In this two-part study, we (1) performed a structured survey of 45 TAVI centres from around the world to determine if there is consensus among clinicians regarding antiplatelet therapy after TAVI; and then (2) performed a systematic review of all suitable studies (randomised controlled trials (RCTs) and registries) to determine if aspirin monotherapy can be used instead of DAPT. Methods A structured electronic survey regarding antiplatelet use after TAVI was completed by 45 TAVI centres across Europe, Australasia and the USA. A systematic review of TAVI RCTs and registries was then performed comparing DAPT duration and incidence of stroke, bleeding and death. A variance weighted least squared metaregression was then performed to determine the relationship of antiplatelet therapy and adverse events. Results 82.2% of centres routinely used DAPT after TAVI. Median duration was 3 months. 13.3% based their practice on guidelines. 11 781 patients (26 studies) were eligible for the metaregression. There was no benefit of DAPT over aspirin monotherapy for stroke (P=0.49), death (P=0.72) or bleeding (P=0.91). Discussion Aspirin monotherapy appears to be as safe and effective as DAPT after TAVI.
Collapse
Affiliation(s)
- Yousif Ahmad
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Ozan Demir
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Christopher Rajkumar
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - James P Howard
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Matthew Shun-Shin
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Christopher Cook
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Ricardo Petraco
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Richard Jabbour
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Ahran Arnold
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Angela Frame
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Nilesh Sutaria
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Ben Ariff
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Gajen Kanaganayagam
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Darrel Francis
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Jamil Mayet
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Ghada Mikhail
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Iqbal Malik
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| | - Sayan Sen
- International Centre for Circulatory Health, Hammersmith Hospital, Imperial College London, London, UK
| |
Collapse
|
|
47
|
Koniari I, Kounis NG, Hahalis G. Antithrombotic treatment following transcatheter valve replacement: current considerations. J Thorac Dis 2017; 9:4251-4259. [PMID: 29268485 DOI: 10.21037/jtd.2017.10.34] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Affiliation(s)
- Ioanna Koniari
- Department of Cardiology, Royal Bromptom Hospital, London, England
| | - Nicholas G Kounis
- Department of Cardiology, University of Patras Medical School, Rion, Patras, Achaia, Greece
| | - George Hahalis
- Department of Cardiology, University of Patras Medical School, Rion, Patras, Achaia, Greece
| |
Collapse
|
|
48
|
Nijenhuis VJ, Bennaghmouch N, Kuijk JPV, Capodanno D, ten Berg JM. Antithrombotic treatment in patients undergoing transcatheter aortic valve implantation (TAVI). Thromb Haemost 2017; 113:674-85. [DOI: 10.1160/th14-10-0821] [Citation(s) in RCA: 26] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/02/2014] [Accepted: 11/27/2014] [Indexed: 12/31/2022]
Abstract
SummaryTranscatheter aortic valve implantation (TAVI) is an established treatment option for symptomatic patients with severe aortic valvular disease who are not suitable for conventional surgical aortic valve replacement. Despite improving experience and techniques, ischaemic and bleeding complications after TAVI remain prevalent and impair survival in this generally old and comorbid-rich population. Due to changing aetiology of complications over time, antiplatelet and anticoagulant therapy after TAVI should be carefully balanced. Empirically, a dual antiplatelet strategy is generally used after TAVI for patients without an indication for oral anticoagulation (OAC; e. g. atrial fibrillation, mechanical mitral valve prosthesis), including aspirin and a thienopyridine. For patients on OAC, a combination of OAC and aspirin or thienopyridine is generally used. This review shows that current registries are unfit to directly compare antithrombotic regimens. Small exploring studies suggest that additional clopidogrel after TAVI only affects bleeding and not ischemic complications. However, these studies are lack in quality in terms of Cochrane criteria. Currently, three randomised controlled trials are recruiting to gather more knowledge about the effects of clopidogrel after TAVI.
Collapse
|
|
49
|
Mayr NP, Wiesner G, Hapfelmeier A, van der Starre P, Husser O, Bleiziffer S, Schunkert H, Lange R, Tassani-Prell P, Martin K. Periprocedural transfusion in patients undergoing transfemoral transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2017; 92:141-148. [PMID: 29130582 DOI: 10.1002/ccd.27382] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2017] [Revised: 09/13/2017] [Accepted: 09/28/2017] [Indexed: 12/19/2022]
Abstract
OBJECTIVES The aim of this investigation was to identify patient's characteristics and periprocedural variables related to periprocedural transfusion in transfemoral Transcatheter Aortic Valve Implantation (tf-TAVI). BACKGROUND Transfusion of allogenic red-blood cells (RBC) in tf-TAVI and the number of transfused units has been linked to an increased 30-day mortality. In line with the trend of minimization and cost-effectiveness, transfusion should be avoided, wherever possible. METHODS Between 2007 and 2015, 1,734 procedures were analyzed from our prospective registry for RBC-transfusion. Multiple logistic regression analysis was used to identify the dependent variables. RESULTS Transfusion was considered necessary in 14% (n = 243) of the patients. Female gender (OR [95% CI]) (1.680 [1.014-2.783]) and preprocedural moderate (7.594 [4.404-13.095]) and severe anemia (8.202 [0.900-74.752]) according to WHO were the most important preprocedural variables. Periprocedural, pericardial effusion (12.109 [3.753-39.063]), emergency extracorporeal circulation (54.5288 [6.178-481.259]) and major vascular injury (2.647 [1.412-4.962]) were related to transfusion. The same applies to moderate (4.255 [1.859-9.740]) and severe anemia (31.567 [8.560-116.416]) as well as periprocedural experience (0.072 [0.035-0.149] - 0.141[0.079-0.251], P < 0.001) CONCLUSION: Procedural experience, serious adverse events, low pre- and periprocedural Hb levels and female gender were the main variables relating to transfusion. Even in experienced high-volume centers, transfusion is still necessary in a considerable number of patients.
Collapse
Affiliation(s)
- N Patrick Mayr
- Institut für Anästhesiologie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, Munich, D-80636, Germany
| | - Gunther Wiesner
- Institut für Anästhesiologie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, Munich, D-80636, Germany
| | - Alexander Hapfelmeier
- Institut für Medizinische Statistik und Epidemiologie, Klinikum Rechts der Isar, Technische Universität München, Ismaningerstr. 22, Munich, D-81675, Germany
| | - Pieter van der Starre
- Department of Anesthesiology and Perioperative Medicine, Stanford University School of Medicine, 300 Pasteur Drive, MC 5640, Stanford, California, 94305
| | - Oliver Husser
- Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, Munich, D-80636, Germany
| | - Sabine Bleiziffer
- Klinik für Herz- und Gefäßchirurgie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, Munich, D-80636, Germany
| | - Heribert Schunkert
- Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, Munich, D-80636, Germany.,DZHK, partner site Munich Heart Alliance, Munich, Germany
| | - Rüdiger Lange
- Klinik für Herz- und Gefäßchirurgie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, Munich, D-80636, Germany.,DZHK, partner site Munich Heart Alliance, Munich, Germany
| | - Peter Tassani-Prell
- Institut für Anästhesiologie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, Munich, D-80636, Germany
| | - Klaus Martin
- Institut für Anästhesiologie, Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München, Lazarettstr. 36, Munich, D-80636, Germany
| |
Collapse
|
|
50
|
Prognostic impact of anemia and iron-deficiency anemia in a contemporary cohort of patients undergoing transcatheter aortic valve implantation. Int J Cardiol 2017. [DOI: 10.1016/j.ijcard.2017.06.024] [Citation(s) in RCA: 32] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/21/2022]
|