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Cepas-Guillén P, Avvedimento M, Ternacle J, Urena M, Alperi A, Cheema AN, Veiga-Fernandez G, Nombela-Franco L, Vilalta V, Esposito G, Indolfi C, Trigo MD, Muñoz-Garcia A, Maneiro N, Asmarats L, Regueiro A, Val DD, Serra V, Gonzálvez-García A, Bonnet G, Di Renzo A, Mesnier J, Suc G, Avanzas P, Rezaei E, Fradejas-Sastre V, Chavez Solsol JF, Fernández-Nofrerias E, Angellotti D, Sorrentino S, Oteo JF, Diez-Delhoyo F, Gutiérrez-Alonso L, Ruberti A, Alfonso F, Monastyrski A, Pelletier-Beaumont E, Rodés-Cabau J. Vascular Complications in Patients Undergoing Transcatheter Aortic Valve Replacement With Contemporary Devices. Can J Cardiol 2025:S0828-282X(25)00244-2. [PMID: 40204013 DOI: 10.1016/j.cjca.2025.03.034] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/03/2024] [Revised: 03/24/2025] [Accepted: 03/29/2025] [Indexed: 04/11/2025] Open
Abstract
BACKGROUND Vascular complications (VCs) remain a major concern after transcatheter aortic valve replacement (TAVR). However, their occurrence in patients treated with newer generation devices has been scarcely studied. Therefore, the aim of this study was to determine the incidence, management, predictors, and clinical impact of VCs in patients undergoing TAVR with contemporary devices. METHODS Multicenter study including 8815 patients that underwent transfemoral TAVR. VCs were classified based on the Valve Academic Research Consortium-3 criteria. Baseline, procedural, and follow-up data were prospectively collected in a dedicated database. RESULTS VCs occurred in 1464 patients (16.5%), being major and minor in 44.7% and 55.3% of cases, respectively, and most of them related to primary access (87%). Vascular injury (75.2%) and device closure failure (21.2%) were the most predominant subtypes. Major VCs were independently associated with a substantial increase in 1-year mortality (hazard ratio [HR] 2.33, 95% confidence interval [CI] 1.92-2.82, P = 0.001). However, this association was absent in minor VCs, even if an unplanned intervention occurred. Female sex, dual-antiplatelet therapy, access-related anatomic factors, and use of large plug-based vascular closure were associated with an increased risk of major VCs (P < 0.05 for all), with echocardiography-guided access and secondary radial access emerging as protective factors (P < 0.01 for all). CONCLUSIONS VCs persist as a major issue in patients undergoing TAVR with contemporary devices, with multiple modifiable factors determining a higher risk. Major, but not minor VCs were associated with poorer short- and long-term survival. Given their negative impact on clinical outcomes, every effort should be made to minimize the occurrence of VCs after TAVR.
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Affiliation(s)
- Pedro Cepas-Guillén
- Cardiology Department, Québec Heart & Lung Institute, Laval University, Québec City, Québec, Canada
| | - Marisa Avvedimento
- Cardiology Department, Québec Heart & Lung Institute, Laval University, Québec City, Québec, Canada
| | - Julien Ternacle
- Cardiology Department, Hôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, Bordeaux, France
| | - Marina Urena
- Cardiology Department, Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
| | - Alberto Alperi
- Cardiology Department, Hospital Universitario Central de Asturias, Oviedo, Spain
| | - Asim N Cheema
- Cardiology Department, Southlake Regional Health Centre Newmarket, Newmarket, Ontario, Canada
| | - Gabriela Veiga-Fernandez
- Cardiology Department, Hospital Marques de Valdecilla, Instituto de Investigación Valdecilla, Santander, Spain
| | - Luis Nombela-Franco
- Cardiology Department, Instituto Cardiovascular, Hospital Clinico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico de San Carlos, Madrid, Spain
| | - Victoria Vilalta
- Cardiology Department, Hospital Germans Trias i Pujol, Badalona, Spain
| | - Giovanni Esposito
- Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
| | - Ciro Indolfi
- Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro, Italy
| | - Maria Del Trigo
- Cardiology Department, Hospital Puerta de Hierro, Madrid, Spain
| | | | - Nicolas Maneiro
- Cardiology Department, Hospital Doce de Octubre, Madrid, Spain
| | - Lluis Asmarats
- Cardiology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
| | - Ander Regueiro
- Cardiology Department, Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain
| | - David Del Val
- Cardiology Department, Hospital de La Princesa, Madrid, Spain
| | - Vicenç Serra
- Cardiology Department, Vall d'Hebron University Hospital, Barcelona, Spain
| | - Ariana Gonzálvez-García
- Cardiology Department, Québec Heart & Lung Institute, Laval University, Québec City, Québec, Canada; Cardiology Department, Hospital Universitario La Paz, Madrid, Spain
| | - Guillaume Bonnet
- Cardiology Department, Hôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, Bordeaux, France
| | - Antonio Di Renzo
- Cardiology Department, Hôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, Bordeaux, France
| | - Jules Mesnier
- Cardiology Department, Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
| | - Gaspard Suc
- Cardiology Department, Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France
| | - Pablo Avanzas
- Cardiology Department, Southlake Regional Health Centre Newmarket, Newmarket, Ontario, Canada
| | - Effat Rezaei
- Cardiology Department, Southlake Regional Health Centre Newmarket, Newmarket, Ontario, Canada
| | - Victor Fradejas-Sastre
- Cardiology Department, Hospital Marques de Valdecilla, Instituto de Investigación Valdecilla, Santander, Spain
| | | | | | - Domenico Angellotti
- Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
| | - Sabato Sorrentino
- Division of Cardiology, Department of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro, Italy
| | | | | | | | - Andrea Ruberti
- Cardiology Department, Institut Clínic Cardiovascular, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain
| | | | - Andrea Monastyrski
- Cardiology Department, Vall d'Hebron University Hospital, Barcelona, Spain
| | | | - Josep Rodés-Cabau
- Cardiology Department, Québec Heart & Lung Institute, Laval University, Québec City, Québec, Canada; Department of Research and Innovation, Clínic Barcelona, Barcelona, Spain.
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Nakase M, Tomii D, Samim D, Gräni C, Praz F, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Impact of Severity and Extent of Iliofemoral Atherosclerosis on Clinical Outcomes in Patients Undergoing TAVR. JACC Cardiovasc Interv 2024; 17:2353-2363. [PMID: 39387783 DOI: 10.1016/j.jcin.2024.07.009] [Citation(s) in RCA: 4] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/02/2024] [Revised: 06/29/2024] [Accepted: 07/02/2024] [Indexed: 10/15/2024]
Abstract
BACKGROUND Vascular complications remain a major concern in transfemoral transcatheter aortic valve replacement (TAVR). The Hostile score has been proposed to stratify risk in TAVR patients with peripheral artery disease. OBJECTIVES The authors aimed to assess the validity of the Hostile score in predicting iliofemoral vascular complications after TAVR. METHODS In a prospective TAVR registry, we validated the Hostile score for the prediction of puncture and non-puncture site vascular complications. This scoring system integrates the extent (number of lesions, lesion length, and minimum lumen diameter) and complexity (tortuosity, calcification, and the presence of obstruction) of iliofemoral atherosclerosis. RESULTS Of 2,023 patients who underwent transfemoral TAVR with contemporary devices between March 2014 and June 2022, 106 (5.2%) patients experienced puncture site vascular complications and 28 (1.4%) patients experienced non-puncture site vascular complications. The Hostile score was higher in patients with vascular complications than those without complications (1.00 [Q1-Q3: 0-5.00] vs 1.00 [Q1-Q3: 0-4.00]; P < .001). A higher body mass index (OR: 1.23; 95% CI: 1.04-1.50) and the use of Prostar (OR: 6.03; 95% CI: 2.23-16.30) or MANTA (OR: 6.18; 95% CI: 2.67-14.27) compared with ProGlide were independent predictors of puncture site vascular complications, whereas a higher Hostile score (OR: 1.91; 95% CI: 1.55-2.35) and female sex (OR: 2.69; 95% CI: 1.12-6.42) were independent predictors of non-puncture site vascular complications. The area under the receiver-operating characteristic curves for the prediction of puncture site and non-puncture site vascular complications were 0.554 and 0.829, respectively. CONCLUSIONS The Hostile score proved useful in predicting non-puncture site vascular complications after TAVR. (SwissTAVI Registry; NCT01368250).
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Affiliation(s)
- Masaaki Nakase
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Daijiro Tomii
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Daryoush Samim
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Christoph Gräni
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Fabien Praz
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Jonas Lanz
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Stefan Stortecky
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - David Reineke
- Department of Cardiac Surgery, Inselspital, University of Bern, Bern, Switzerland
| | - Stephan Windecker
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland
| | - Thomas Pilgrim
- Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.
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Basman C, Kodra A, Mustafa A, Wang D, Cinelli M, Onyebeke K, Rutkin B, Mehla P, Maniatis G, Pirelli L, Goldberg Y, Liu S, Uttar S, Wilson S, Kalimi R, Brinster D, Gandotra P, Koss E, Meraj P, Mihelis E, Supariwala A, Hartman A, Scheinerman SJ, Kliger C, Northwell TAVR Investigators. Collagen-Based Bailout Compared to Suture-Mediated Vascular Closure Alone During Transcatheter Aortic Valve Replacement. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2024; 3:101929. [PMID: 39132601 PMCID: PMC11307645 DOI: 10.1016/j.jscai.2024.101929] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 12/19/2023] [Revised: 02/22/2024] [Accepted: 03/01/2024] [Indexed: 08/13/2024]
Abstract
Background Hemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized. Methods Data were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone ("legacy strategy") and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria. Results A total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; P < .001). Both minor (3.92% vs 1.12%; P = .002) and major (1.14% vs 0.19%; P = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; P < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD. Conclusions A contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR.
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Affiliation(s)
- Craig Basman
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Arber Kodra
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Ahmad Mustafa
- Department of Cardiovascular & Thoracic Surgery, Staten Island University Hospital/Northwell Health, New York, New York
| | - Denny Wang
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Michael Cinelli
- Department of Cardiovascular & Thoracic Surgery, Staten Island University Hospital/Northwell Health, New York, New York
| | - Kenenna Onyebeke
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Bruce Rutkin
- Department of Cardiovascular & Thoracic Surgery, Northshore University Hospital/Northwell Health, New York, New York
| | - Priti Mehla
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Gregory Maniatis
- Department of Cardiovascular & Thoracic Surgery, Staten Island University Hospital/Northwell Health, New York, New York
| | - Luigi Pirelli
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Ythan Goldberg
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Shangyi Liu
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Sridhar Uttar
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Sean Wilson
- Department of Cardiovascular & Thoracic Surgery, Northshore University Hospital/Northwell Health, New York, New York
| | - Robert Kalimi
- Department of Cardiovascular & Thoracic Surgery, Southside Hospital/Northwell Health, New York, New York
| | - Derek Brinster
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Puneet Gandotra
- Department of Cardiovascular & Thoracic Surgery, Northshore University Hospital/Northwell Health, New York, New York
| | - Elana Koss
- Department of Cardiovascular & Thoracic Surgery, Northshore University Hospital/Northwell Health, New York, New York
| | - Perwaiz Meraj
- Department of Cardiovascular & Thoracic Surgery, Northshore University Hospital/Northwell Health, New York, New York
| | - Efstathia Mihelis
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Azhar Supariwala
- Department of Cardiovascular & Thoracic Surgery, Southside Hospital/Northwell Health, New York, New York
| | - Alan Hartman
- Department of Cardiovascular & Thoracic Surgery, Northshore University Hospital/Northwell Health, New York, New York
| | - S. Jacob Scheinerman
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Chad Kliger
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
| | - Northwell TAVR Investigators
- Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York
- Department of Cardiovascular & Thoracic Surgery, Staten Island University Hospital/Northwell Health, New York, New York
- Department of Cardiovascular & Thoracic Surgery, Northshore University Hospital/Northwell Health, New York, New York
- Department of Cardiovascular & Thoracic Surgery, Southside Hospital/Northwell Health, New York, New York
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Dumpies O, Abdelhafez A, Rotta Detto Loria J, Richter I, Feistritzer HJ, Majunke N, Desch S, Noack T, Thiele H, Abdel-Wahab M. A study of bailout plug-based closure after failed suture-based closure in patients undergoing transfemoral TAVI. EUROINTERVENTION 2024; 20:e344-e353. [PMID: 38506741 PMCID: PMC10941667 DOI: 10.4244/eij-d-23-00750] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/02/2023] [Accepted: 11/21/2023] [Indexed: 03/21/2024]
Abstract
BACKGROUND Percutaneous suture-based arterial access site closure (ProGlide) is commonly applied in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). However, the failure of a suture-based vascular closure device (VCD) may require additional treatment. AIMS We aimed to evaluate the efficacy and safety of bailout access site closure using a large-bore plug-based device (MANTA) in patients with failed suture-based closure during transfemoral TAVI. METHODS Patients undergoing a bailout attempt with the MANTA VCD were identified from a prospectively enrolling, institutional registry. Efficacy was defined as haemostasis at the access site without the need for alternative treatment other than manual compression or endovascular ballooning. Safety was defined as freedom from vascular dissection, stenosis and occlusion requiring intervention. RESULTS Of 2,505 patients, 66 underwent a bailout attempt with MANTA as a result of ProGlide failure, which occurred before the large-bore sheath insertion in 16.7% of patients and after the sheath removal in 83.3% of patients. Bailout MANTA was deemed effective in 75.8% of patients (50/66), and the technique was considered safe in 86.4% (57/66) of patients. Failure of bailout MANTA occurred because of its superficial application, resulting in persistent bleeding in 18.2% of patients (12/66), and because of its deep application, resulting in stenosis or occlusion in 6.1% of patients (4/66). Operator experience with the technique (odds ratio [OR] 12.29, 95% confidence interval [CI]: 1.99-75.99; p=0.007) and prior use of three ProGlides (OR 0.02, 95% CI: <0.01-0.39; p=0.010) were the only independent predictors of the efficacy endpoint. CONCLUSIONS Bailout MANTA after ProGlide failure was effective and safe, but operator experience seems to be crucial. Further technological refinements to facilitate accurate placement appear necessary.
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Affiliation(s)
- Oliver Dumpies
- Department of Structural Heart Disease/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
| | - Ahmed Abdelhafez
- Department of Structural Heart Disease/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
| | - Johannes Rotta Detto Loria
- Department of Structural Heart Disease/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
| | - Ines Richter
- Department of Structural Heart Disease/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
| | - Hans-Josef Feistritzer
- Department of Structural Heart Disease/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
| | - Nicolas Majunke
- Department of Structural Heart Disease/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
| | - Steffen Desch
- Department of Structural Heart Disease/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
| | - Thilo Noack
- Department of Structural Heart Disease/Cardiac Surgery, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
| | - Holger Thiele
- Department of Structural Heart Disease/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
| | - Mohamed Abdel-Wahab
- Department of Structural Heart Disease/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
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Androshchuk V, Chehab O, Prendergast B, Rajani R, Patterson T, Redwood S. Computed tomography derived anatomical predictors of vascular access complications following transfemoral transcatheter aortic valve implantation: A systematic review. Catheter Cardiovasc Interv 2024; 103:169-185. [PMID: 37994240 PMCID: PMC10915898 DOI: 10.1002/ccd.30918] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/15/2023] [Revised: 10/17/2023] [Accepted: 11/12/2023] [Indexed: 11/24/2023]
Abstract
BACKGROUND Vascular complications after percutaneous transfemoral transcatheter aortic valve implantation (TAVI) are associated with adverse clinical outcomes and remain a significant challenge. AIMS The purpose of this review is to synthesize the existing evidence regarding the iliofemoral artery features predictive of vascular complications after TAVI on pre-procedural contrast-enhanced multidetector computed tomography (MDCT). METHODS A systematic search was performed in Embase and Medline (Pubmed) databases. Studies of patients undergoing transfemoral TAVI with MDCT were included. Studies with only valve-in-valve TAVI, planned surgical intervention and those using fluoroscopic assessment were excluded. Data on study cohort, procedural characteristics and significant predictors of vascular complications were extracted. RESULTS We identified 23 original studies involving 8697 patients who underwent TAVI between 2006 and 2020. Of all patients, 8514 (97.9%) underwent percutaneous transfemoral-TAVI, of which 8068 (94.8%) had contrast-enhanced MDCT. The incidence of major vascular complications was 6.7 ± 4.1% and minor vascular complications 26.1 ± 7.8%. Significant independent predictors of major and minor complications related to vessel dimensions were common femoral artery depth (>54 mm), sheath-to-iliofemoral artery diameter ratio (>0.91-1.19), sheath-to-femoral artery diameter ratio (>1.03-1.45) and sheath-to-femoral artery area ratio (>1.35). Substantial iliofemoral vessel tortuosity predicted 2-5-fold higher vascular risk. Significant iliofemoral calcification predicted 2-5-fold higher risk. The iliac morphology score was the only hybrid scoring system with predictive value. CONCLUSIONS Independent iliofemoral predictors of access-site complications in TAVI were related to vessel size, depth, calcification and tortuosity. These should be considered when planning transfemoral TAVI and in the design of future risk prediction models.
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Affiliation(s)
- Vitaliy Androshchuk
- School of Cardiovascular Medicine & Sciences, Faculty of Life Sciences & MedicineKing's College LondonLondonUK
- Department of CardiologySt Thomas’ Hospital, King's College LondonLondonUK
| | - Omar Chehab
- School of Cardiovascular Medicine & Sciences, Faculty of Life Sciences & MedicineKing's College LondonLondonUK
- Department of CardiologySt Thomas’ Hospital, King's College LondonLondonUK
| | | | - Ronak Rajani
- Department of CardiologySt Thomas’ Hospital, King's College LondonLondonUK
- School of Biomedical Engineering and Imaging Sciences, Faculty of Life Sciences & MedicineKing's College LondonLondonUK
| | - Tiffany Patterson
- School of Cardiovascular Medicine & Sciences, Faculty of Life Sciences & MedicineKing's College LondonLondonUK
- Department of CardiologySt Thomas’ Hospital, King's College LondonLondonUK
| | - Simon Redwood
- School of Cardiovascular Medicine & Sciences, Faculty of Life Sciences & MedicineKing's College LondonLondonUK
- Department of CardiologySt Thomas’ Hospital, King's College LondonLondonUK
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6
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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.
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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
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7
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Naoum I, Eitan A, Galili O, Hayeq H, Shiran A, Zissman K, Sliman H, Jaffe R. Strategy for Totally Percutaneous Management of Vascular Injury in Combined Transfemoral Transcatheter Aortic Valve Replacement and Endovascular Aortic Aneurysm Repair Procedures. Am J Cardiol 2023; 207:130-136. [PMID: 37738782 DOI: 10.1016/j.amjcard.2023.08.148] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/25/2023] [Revised: 08/21/2023] [Accepted: 08/21/2023] [Indexed: 09/24/2023]
Abstract
Minimally invasive treatment of severe aortic stenosis by transcatheter aortic valve replacement (TAVR) and infrarenal abdominal aortic aneurysm by endovascular aortic aneurysm repair (EVAR) requires large-bore vascular access. These percutaneous transfemoral interventions may be performed as a combined procedure, however, vascular injury may necessitate surgical vascular repair. We implemented a strategy designed to enable percutaneous vascular repair, with stent-graft implantation, if necessary, after these combined procedures. We identified all combined percutaneous TAVR and EVAR procedures which were performed at our institution. Patient and procedural characteristics and clinical outcomes were analyzed. Six consecutive patients underwent total percutaneous combined TAVR and EVAR procedures. In all cases, TAVR was performed first and was followed by EVAR. Both common femoral arteries served as primary access sites for delivery of the implanted devices and hemostasis was achieved by deployment of vascular closure devices. Secondary access sites included the right brachial artery in all patients and superficial femoral arteries in 50% of the patients. In all cases an "0.014" 300-cm length "safety" wire was delivered to the common femoral artery or descending aorta by way of a secondary access site to facilitate stent graft delivery. Successful device implantation was achieved in all cases. Vascular closure device failure occurred in 2 patients and was treated by stent graft implantation by way of the brachial and superficial femoral arteries, without need for surgical vascular repair. A strategy designed to facilitate percutaneous vascular repair after combined EVAR and TAVR procedures may enable a truly minimally invasive procedure.
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Affiliation(s)
| | | | - Offer Galili
- Department of Vascular & Endovascular Surgery, Carmel Medical Center, Haifa, Israel
| | - Hashem Hayeq
- Department of Vascular & Endovascular Surgery, Carmel Medical Center, Haifa, Israel
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Zornitzki L, Zahler D, Frydman S, Itach T, Ben-Shoshan J, Halkin A, Bazan S, Arbel Y, Konigstein M, Finkelstein A, Banai S, Steinvil A. Vascular Complications in Transcatheter Aortic Valve Replacement With Plug-Based vs Suture-Based Closure Devices. Can J Cardiol 2023; 39:1528-1534. [PMID: 37419247 DOI: 10.1016/j.cjca.2023.06.425] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/06/2023] [Revised: 06/27/2023] [Accepted: 06/29/2023] [Indexed: 07/09/2023] Open
Abstract
BACKGROUND There are conflicting data regarding the efficacy and safety of suture vs plug-based vascular closure devices (VCDs) for large-bore catheter management in patients undergoing transcatheter aortic valve replacement (TAVR). We compared the rates of vascular complications (VCs) associated with 2 commonly used VCDs in a large cohort of patients undergoing TAVR. METHODS We conducted a single-centre, all-comer, prospective registry study, enrolling patients undergoing TAVR for symptomatic severe aortic stenosis (AS) between the years 2009 and 2022. Clinical outcomes were compared between patients undergoing closure of the femoral access point using the MANTA VCD (M-VCD) (Teleflex, Wayne, PA) vs the ProGlide VCD (P-VCD) (Abbott Vascular, Abbott Park, IL). The main outcome measures were researcher adjudicated events of VARC-2 defined major and minor VCs. RESULTS Overall, 2368 patients were enrolled in the registry; 1315 (51.0% male, 81.0 ± 7.0 years) patients were included in the current analysis. P-VCD was used in 813 patients, whereas M-VCD was used in 502 patients. In-hospital VCs were more frequent in the M-VCD vs the P-VCD group (17.3% vs 9.8%; P < 0.001). This outcome was mainly driven by elevated rates of minor VCs in the M-VCD group, whereas no significant difference was observed for major VCs (15.1% vs 8.4%; P < 0.001 and 2.2% vs 1.5%; P = 0.33, respectively). CONCLUSIONS In patients undergoing TAVR for severe AS, M-VCD was associated with higher rates of VCs. This outcome was mainly driven by minor VCs. The rate of major VCs was low in both groups.
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Affiliation(s)
- Lior Zornitzki
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Internal Medicine B, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel.
| | - David Zahler
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Shir Frydman
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Internal Medicine B, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Tamar Itach
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Jeremy Ben-Shoshan
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Amir Halkin
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Samuel Bazan
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Yaron Arbel
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Maayan Konigstein
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Ariel Finkelstein
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Shmuel Banai
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Arie Steinvil
- Department of Cardiology, Tel Aviv Sourasky Medical Center, affiliated with the School of Medicine, Tel Aviv University, Tel Aviv, Israel
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9
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Daghem M, Weidinger F, Achenbach S. Computed tomography to guide transcatheter aortic valve implantation. Herz 2023; 48:359-365. [PMID: 37594503 DOI: 10.1007/s00059-023-05203-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/11/2023] [Indexed: 08/19/2023]
Abstract
Since its introduction in 2022, transcatheter aortic valve implantation (TAVI) has revolutionized the treatment and prognosis of patients with aortic stenosis. Robust clinical trial data and a wealth of scientific evidence support its efficacy and safety. One of the key factors for success of the TAVI procedure is careful preprocedural planning using imaging. Computed tomography (CT) has developed into the standard imaging method for comprehensive patient assessment in this context. Suitability of the femoral and iliac arteries for transfemoral access, exact measurement of aortic annulus size and geometry as the basis for prosthesis selection, quantification of the spatial relationship of the coronary ostia to the aortic annular plane, and identification of optimal fluoroscopic projection angles for the implantation procedure are among the most important information that can be gained from preprocedural CT. Further research is aimed at improving risk stratification, for example, with respect to annular perforation, periprosthetic aortic regurgitation, and need for postprocedural implantation of a permanent pacemaker.
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Affiliation(s)
- Marwa Daghem
- Medizinische Klinik 2, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, 91054, Erlangen, Germany
| | - Florian Weidinger
- Medizinische Klinik 2, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, 91054, Erlangen, Germany
| | - Stephan Achenbach
- Medizinische Klinik 2, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, 91054, Erlangen, Germany.
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10
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Hosseini M, Lahr BD, Greason KL, Arghami A, Gulati R, Eleid MF, Crestanello JA. Obesity and vascular complication in percutaneous transfemoral transcatheter aortic valve insertion. Catheter Cardiovasc Interv 2023; 101:1221-1228. [PMID: 37036273 DOI: 10.1002/ccd.30658] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/23/2022] [Revised: 02/01/2023] [Accepted: 03/19/2023] [Indexed: 04/11/2023]
Abstract
BACKGROUND Obesity has been associated with an increased risk of vascular complication during percutaneous coronary intervention, but there are no data on the risk of vascular complication during percutaneous transfemoral transcatheter aortic valve insertion (TAVI). OBJECTIVES We hypothesized there would be a similar increased risk associated with TAVI. METHODS We reviewed the records of 1176 patients who received percutaneous transfemoral transcatheter aortic valve insertion from September 2015 to September 2020. All patients received 1) preoperative computed tomoraphy angiography assessment of the abdomen and pelvis to delineate iliofemoral artery anatomy, 2) ultrasound-guided percutaneous femoral arterial access, and 3) pre-closure of the delivery sheath femoral access site. Vascular complication was recorded based on definitions set forth by Valve Academic Research Consortium 3. RESULTS The median age of patients was 81 years, and 60% were men. The median body mass index (BMI) was 29 kg/m2 (range, 11-67), and 91 (8%) patients had a value ≥40 kg/m2 (i.e., morbid obesity). Delivery sheath size was 14-French in 859 (73%) patients, 16-French in 311 (26%), and 18-French in 6 (1%). Vascular complication occurred in 53 (5%) patients, including 39 (7%) among the first half of procedures and 14 (2%) among the second half (p < 0.001). When stratified by obesity status (BMI < or ≥30 kg/m2 , p < 0.001), the complication rate was 4% in nonobese patients and 5% in obese patients. Multivariable analysis showed no overall association between risk of vascular complication and BMI categories (p = 0.583)BMI continuous values (p = 0.529), or sheath size (p = 0.217). CONCLUSIONS Obesity is not associated with a vascular complication during percutaneous transfemoral transcatheter aortic valve insertion. The operation should not be denied in obese patients.
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Affiliation(s)
- Motahar Hosseini
- Department of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota, USA
| | - Brian D Lahr
- Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA
| | - Kevin L Greason
- Department of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota, USA
| | - Arman Arghami
- Department of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota, USA
| | - Rajiv Gulati
- Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota, USA
| | - Mackram F Eleid
- Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota, USA
| | - Juan A Crestanello
- Department of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota, USA
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11
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Avvedimento M, Nuche J, Farjat-Pasos JI, Rodés-Cabau J. Bleeding Events After Transcatheter Aortic Valve Replacement: JACC State-of-the-Art Review. J Am Coll Cardiol 2023; 81:684-702. [PMID: 36792284 DOI: 10.1016/j.jacc.2022.11.050] [Citation(s) in RCA: 28] [Impact Index Per Article: 14.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/25/2022] [Accepted: 11/21/2022] [Indexed: 02/15/2023]
Abstract
Transcatheter aortic valve replacement (TAVR) has gained over time a major reduction in procedural complications. Despite this, clinically relevant bleeding still occurs in a non-negligible proportion of patients and adversely affects prognosis. Patients with severe aortic stenosis are at heightened risk for spontaneous bleeding due to advanced age and a high comorbidity burden. Also, procedural factors and antithrombotic management contribute to define individual bleeding susceptibility. Bleeding prevention represents an emerging area for improving patient care. Because of the tight hemorrhagic/ischemic balance, a tailored approach based on individual bleeding-risk profile, such as a less invasive antithrombotic regimen or appropriate diagnostic preprocedural evaluation, should be pursued to avoid bleeding events. This review aims to provide an in-depth overview of bleeding events in the TAVR field, including definitions, timing and the extent of risk, and clinical impact, as well as updates on antithrombotic management and its potential influence on bleeding complications.
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Affiliation(s)
- Marisa Avvedimento
- Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada
| | - Jorge Nuche
- Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada
| | | | - Josep Rodés-Cabau
- Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
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Costa G, Reddavid C, Dipietro E, Barbanti M. Managing complications after transcatheter aortic valve implantation. Expert Rev Med Devices 2022; 19:599-612. [PMID: 36150162 DOI: 10.1080/17434440.2022.2129009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2022]
Abstract
INTRODUCTION Although transcatheter aortic valve implantation (TAVI) has become a streamlined and standardized procedure, different complications still remain and need the operators to be properly trained about their management. AREAS COVERED This review article aims at offering a practical overview of the most impactful TAVI complications, analyzing, and discussing the potential risk factors, and focusing on the available strategies for their management. EXPERT OPINION Complications following TAVI have been decreasing thanks to technical advancements and operators experience. The thorough knowledge of potential complications and their prevention played a key role in the decreasing of complications rates. Pre-procedural, computed tomography angiography assessment of patient's anatomical characteristics, allows to properly choose and tailor the best strategy for managing complications in most of cases. Nevertheless, further research is required to shed lights about the optimal strategies to adopt for managing TAVI complications.
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Affiliation(s)
- Giuliano Costa
- Division of Cardiology, C.A.S.T., Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico - San Marco", University of Catania, Catania, Italy
| | - Claudia Reddavid
- Division of Cardiology, C.A.S.T., Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico - San Marco", University of Catania, Catania, Italy
| | - Elena Dipietro
- Division of Cardiology, C.A.S.T., Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico - San Marco", University of Catania, Catania, Italy
| | - Marco Barbanti
- Division of Cardiology, C.A.S.T., Azienda Ospedaliero-Universitaria Policlinico "G. Rodolico - San Marco", University of Catania, Catania, Italy
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13
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Pledget-assisted hemostasis to fix residual access-site bleedings after double pre-closure technique. World J Cardiol 2022. [DOI: 10.4330/wjc.v14.i5.296] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
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14
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Burzotta F, Aurigemma C, Kovacevic M, Romagnoli E, Cangemi S, Bianchini F, Nesta M, Bruno P, Trani C. Pledget-assisted hemostasis to fix residual access-site bleedings after double pre-closure technique. World J Cardiol 2022; 14:297-306. [PMID: 35702322 PMCID: PMC9157605 DOI: 10.4330/wjc.v14.i5.297] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/17/2021] [Revised: 02/06/2022] [Accepted: 04/24/2022] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND The use of pre-closure suture-based devices represents a widely access-site hemostasis technique in percutaneous transfemoral transcatheter-aortic-valve-replacement (TF-TAVR); yet this technique is associated with the risk of a device failure that may result in clinically relevant residual bleeding. Thus, a bailout intervention is needed. So far, the best management of pre-closure device failure has not been recognized. AIM To report the first clinical results obtained using a novel bailout hemostasis technique for patients with double suture-based vascular closure device failure in the setting of TF-TAVR. METHODS We developed a "pledget-assisted hemostasis" technique to manage residual access-site bleeding. This consists of the insertion of a surgical, non-absorbable, polytetrafluoroethylene pledget over the sutures of the two ProGlide (Abbott Vascular, CA, United States). The ProGlide's knot-pushers are used to push down the pledget and the hand-made slipknot to seal the femoral artery leak. This technique was used as a bailout strategy in patients undergoing TF-TAVR with a systematic double pre-closure technique. Post-procedural access-site angiography was systematically performed. In-hospital complications were systematically detected and classified according to Valve Academic Research Consortium-2 criteria. RESULTS Out of 136 consecutive patients who underwent TF-TAVR, 15 patients (mean age 80.0 ± 7.2 years, 66.7% female) with access-site bleeding after double pre-closure technique failure were treated by pledget-assisted hemostasis. In the majority of patients, 16F sheath was used (n = 12; 80%). In 2 cases (13%), a peripheral balloon was also inflated in the iliac artery to limit blood loss during pledget preparation. Angiography-confirmed hemostasis (primary efficacy endpoint) was achieved in all patients. After the procedure, 1 patient required blood transfusion (2 units), and no other bleeding or major ischemic complication was noticed. CONCLUSION The "pledget assisted hemostasis" might be considered as a possible bailout technique to treat patients with residual access site bleeding. Further studies are needed to compare this approach with other bail-out techniques.
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Affiliation(s)
- Francesco Burzotta
- Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome 00168, Italy.
| | - Cristina Aurigemma
- Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome 00168, Italy
| | - Mila Kovacevic
- Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia
| | - Enrico Romagnoli
- Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome 00168, Italy
| | - Stefano Cangemi
- Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome 00168, Italy
| | - Francecso Bianchini
- Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome 00168, Italy
| | - Marialisa Nesta
- Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome 00168, Italy
| | - Piergiorgio Bruno
- Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome 00168, Italy
| | - Carlo Trani
- Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome 00168, Italy
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Eitan A, Sliman H, Shiran A, Jaffe R. Strategies for Facilitating Totally Percutaneous Transfemoral TAVR Procedures. J Clin Med 2022; 11:2104. [PMID: 35456197 PMCID: PMC9028438 DOI: 10.3390/jcm11082104] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2022] [Revised: 04/05/2022] [Accepted: 04/05/2022] [Indexed: 02/01/2023] Open
Abstract
Transcatheter aortic valve replacement (TAVR) has transformed the treatment of aortic stenosis and should ideally be performed as a totally percutaneous procedure via the transfemoral (TF) approach. Peripheral vascular disease may impede valve delivery, and vascular access site complications are associated with adverse clinical outcome and increased mortality. We review strategies aimed to facilitate TF valve delivery in patients with hostile vascular anatomy and achieve percutaneous management of vascular complications.
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Affiliation(s)
| | | | | | - Ronen Jaffe
- Department of Cardiology, Carmel Medical Center, Haifa 3436212, Israel; (A.E.); (H.S.); (A.S.)
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Sliman H, Eitan A, Shiran A, Zafrir B, Jaffe R. Transbrachial Secondary Vascular Access in Transcatheter Aortic Valve Replacement Procedures: A Single-Centre Retrospective Analysis. Heart Lung Circ 2022; 31:1023-1028. [PMID: 35277348 DOI: 10.1016/j.hlc.2022.01.013] [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] [Received: 09/18/2021] [Revised: 11/30/2021] [Accepted: 01/27/2022] [Indexed: 12/19/2022]
Abstract
BACKGROUND Transfemoral transcatheter aortic valve replacement (TAVR) procedures require secondary vascular access for inserting accessory catheters and performing percutaneous repair of femoral artery injury. Use of the transbrachial approach for secondary vascular access in TAVR procedures has not been reported. METHODS This study identified 48 patients at the current institution who had undergone transfemoral TAVR utilising transbrachial secondary vascular access. Efficacy and safety of this strategy for achieving a successful totally percutaneous procedure were examined. Study endpoints were occurrence of vascular complications and bleeding related to transbrachial access, as well as periprocedural and 1-year mortality. RESULTS Mean patient age was 80±7 years and Society of Thoracic Surgeons Predicted Risk of Mortality score was 10.6±3.1. Sizes of sheaths inserted into the brachial artery were 6 Fr (85%), 8 Fr (2%), and 9 Fr (13%). Transbrachial access was used for delivering stent grafts to the femoral artery in 13% of the patients, inflation of an occlusive balloon within the iliac artery in 10%, and treatment of iatrogenic femoral artery stenosis in 2%. Successful valve replacement was achieved in all cases. Brachial sheaths were removed by manual compression following administration of protamine sulfate. There were no major access site complications or VARC-3 type ≥2 bleeding related to the brachial vascular access. Brachial artery occlusion occurred in two patients (4%) who underwent surgical vascular repair. Two (2) additional patients developed mild arm ischaemia, which was treated conservatively. Periprocedural mortality was 0% and early mortality was 8%. CONCLUSIONS Transbrachial secondary access in TAVR procedures was feasible and enabled percutaneous vascular repair in cases of femoral artery injury.
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Affiliation(s)
- Hussein Sliman
- Department of Cardiology, Carmel Medical Center, Haifa, Israel
| | - Amnon Eitan
- Department of Cardiology, Carmel Medical Center, Haifa, Israel
| | - Avinoam Shiran
- Department of Cardiology, Carmel Medical Center, Haifa, Israel
| | - Barak Zafrir
- Department of Cardiology, Carmel Medical Center, Haifa, Israel
| | - Ronen Jaffe
- Department of Cardiology, Carmel Medical Center, Haifa, Israel.
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Heitzinger G, Brunner C, Koschatko S, Dannenberg V, Mascherbauer K, Halavina K, Doná C, Koschutnik M, Spinka G, Nitsche C, Mach M, Andreas M, Wolf F, Loewe C, Neumayer C, Gschwandtner M, Willfort-Ehringer A, Winter MP, Lang IM, Bartko PE, Hengstenberg C, Goliasch G. A Real World 10-Year Experience With Vascular Closure Devices and Large-Bore Access in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation. Front Cardiovasc Med 2022; 8:791693. [PMID: 35127860 PMCID: PMC8814307 DOI: 10.3389/fcvm.2021.791693] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/08/2021] [Accepted: 12/17/2021] [Indexed: 12/19/2022] Open
Abstract
Transcatheter aortic valve replacement (TAVR) has established itself as a safe and efficient treatment option in patients with severe aortic valve stenosis, regardless of the underlying surgical risk. Widespread adoption of transfemoral procedures led to more patients than ever being eligible for TAVR. This increase in procedural volumes has also stimulated the use of vascular closure devices (VCDs) for improved access site management. In a single-center examination, we investigated 871 patients that underwent transfemoral TAVR from 2010 to 2020 and assessed vascular complications according to the Valve Academic Research Consortium (VARC) III recommendations. Patients were grouped by the VCD and both, vascular closure success and need for intervention were analyzed. In case of a vascular complication, the type of intervention was investigated for all VCDs. The Proglide VCD was the most frequently used device (n = 670), followed by the Prostar device (n = 112). Patients were old (median age 83 years) and patients suffered from high comorbidity burden (60% coronary artery disease, 30% type II diabetes, 40% atrial fibrillation). The overall rate of major complications amounted to 4.6%, it was highest in the Prostar group (9.6%) and lowest in the Manta VCD group (1.1% p = 0.019). The most frequent vascular complications were bleeding and hematoma (n = 110, 13%). In case a complication occurred, 72% of patients did not need any further intervention other than manual compression or pressure bandages. The rate of surgical intervention after complication was highest in the Prostar group (n = 15, 29%, p = 0.001). Temporal trends in VCD usage highlight the rapid adoption of the Proglide system after introduction at our institution. In recent years VCD alternatives, utilizing other closure techniques, such as the Manta device emerged and increased vascular access site management options. This 10-year single-center experience demonstrates high success rates for all VCDs. Despite successful closure, a significant number of patients does experience minor vascular complications, in particular bleeding and hematoma. However, most complications do not require surgical or endovascular intervention. Temporal trends display a marked increase in TAVR procedures and highlight the need for more refined vascular access management strategies.
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Affiliation(s)
- Gregor Heitzinger
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Christina Brunner
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Sophia Koschatko
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Varius Dannenberg
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Katharina Mascherbauer
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Kseniya Halavina
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Carolina Doná
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Matthias Koschutnik
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Georg Spinka
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Christian Nitsche
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Markus Mach
- Department of Cardiothoracic Surgery, Medical University of Vienna, Vienna, Austria
| | - Martin Andreas
- Department of Cardiothoracic Surgery, Medical University of Vienna, Vienna, Austria
| | - Florian Wolf
- Department of Cardiovascular and Interventional Radiology, Medical University of Vienna, Vienna, Austria
| | - Christian Loewe
- Department of Cardiovascular and Interventional Radiology, Medical University of Vienna, Vienna, Austria
| | - Christoph Neumayer
- Department of Vascular Surgery, Medical University of Vienna, Vienna, Austria
| | - Michael Gschwandtner
- Division for Angiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Andrea Willfort-Ehringer
- Division for Angiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Max-Paul Winter
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Irene M. Lang
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Philipp E. Bartko
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Christian Hengstenberg
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
| | - Georg Goliasch
- Division for Cardiology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
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Prevalence of Posttranscatheter Aortic Valve Implantation Vascular Complications in Real Life. J Interv Cardiol 2021; 2021:5563486. [PMID: 34729054 PMCID: PMC8526196 DOI: 10.1155/2021/5563486] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2021] [Revised: 09/13/2021] [Accepted: 09/21/2021] [Indexed: 11/18/2022] Open
Abstract
Background Vascular complications (VCs) are commonly observed after transfemoral transcatheter aortic valve implantation (TAVI) procedures. Closure devices for the access site were developed to reduce their incidence. We aim to evaluate the prevalence, predictors, and outcomes of the occurrence of post-TAVI VCs. Materials and Methods A retrospective study was conducted on 1336 consecutive patients who underwent TAVI at the University Hospital of Toulouse, France, between January 2016 and March 2020. All included procedures were performed through the common femoral artery, and ProGlide® was the used closure device. The studied population was divided into two groups depending on the occurrence of VCs defined according to Valve Academic Research Consortium-2 criteria. Results The mean age of the studied population was 84.4 ± 6.9, and 48% were male. 90% of TAVI interventions were performed through the right femoral artery. The prevalence of VCs was 18.8%, and 3.7% were major. Prolonged procedure duration was an independent predictor of VCs. Using the right access site and smaller introducer size (14 Fr) were preventive factors. No significant difference in mortality rate was detected between the two groups. Conclusion This study showed a low prevalence for post-TAVI VCs, especially for the major type. An increase in bleeding events and prolonged cardiac care unit stay were the common adverse outcomes.
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Costa G, Valvo R, Picci A, Criscione E, Reddavid C, Motta S, Strazzieri O, Deste W, Giuffrida A, Garretto V, Cannizzaro M, Inserra C, Veroux P, Giaquinta A, Sgroi C, Tamburino C, Barbanti M. An upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation. EUROINTERVENTION 2021; 17:728-735. [PMID: 33589411 PMCID: PMC9724957 DOI: 10.4244/eij-d-20-01125] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
BACKGROUND Vascular complications still represent an important issue after transcatheter aortic valve implantation (TAVI). AIMS The aim of this study was to evaluate the effectiveness of upfront use of an adjunctive Angio-Seal (AS) plug-based system on top of suture-based devices (SBDs) for endovascular haemostasis after transfemoral (TF) TAVI. METHODS From January 2019 to April 2020, 332 consecutive patients with preprocedural computed tomography angiography (CTA) assessment underwent fully percutaneous TF-TAVI. The primary outcomes were 30-day major vascular complications and major or life-threatening (LT) bleeding due to endovascular closure system failure. A total of 246 TF-TAVI patients (123 pairs), undergoing either isolated SBD or SBD+AS, were matched using the propensity-score method. RESULTS At 30 days, patients receiving SBD+AS had lower rates of major/LT bleeding (1.6% vs 8.9%, odds ratio [OR] 0.17, 95% confidence interval [CI]: 0.04-0.78; p<0.01) and major vascular complications (1.6% vs 8.9%, OR 0.17, 95% CI: 0.04-0.78; p<0.01). In addition, the use of SBD+AS was associated with a significant cost saving related to the vascular event (mean difference -315.3 € per patient, 95% CI: -566.4 € to -64.1 €; p=0.01), and a higher probability of next-day discharge (NDD) after TAVI (30.9% vs 16.3%, OR 2.30, 95% CI: 1.25-4.25; p<0.01). No difference in all-cause 30-day mortality was observed (3.3% vs 1.6% for SBD and SBD+AS groups, respectively, OR 0.49, 95% CI: 0.09-2.74; p=0.41). CONCLUSIONS An upfront combined strategy with an additional AS plug-based device on top of SBDs was shown to reduce major vascular complications and major/LT bleeding due to closure system failure after TF-TAVI. This approach was associated with a cost saving and with a higher probability of NDD compared to the use of isolated SBD. Visual summary. Effectiveness of the upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation using Angio-Seal on top of a suture-based device (SBD) versus the isolated use of SBD. LT: life-threatening; TF-TAVI: transfemoral transcatheter aortic valve implantation.
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Affiliation(s)
- Giuliano Costa
- Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Roberto Valvo
- Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Andrea Picci
- Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Enrico Criscione
- Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Claudia Reddavid
- Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Silvia Motta
- Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Orazio Strazzieri
- Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Wanda Deste
- Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Angelo Giuffrida
- Division of Cardiac Surgery, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Valeria Garretto
- Division of Radiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Maria Cannizzaro
- Division of Radiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Cristina Inserra
- Division of Radiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Pierfrancesco Veroux
- Division of Vascular Surgery, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Alessia Giaquinta
- Division of Vascular Surgery, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Carmelo Sgroi
- Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Corrado Tamburino
- Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy
| | - Marco Barbanti
- Division of Cardiology, Policlinico-Vittorio Emanuele Hospital, University of Catania, Via Santa Sofia 78, 95123 Catania, Italy
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Totally Percutaneous Transfemoral Transcatheter Aortic Valve Replacement Despite Failure to Deploy a Vascular Closure Device: A Single-Center Case Series. Heart Lung Circ 2021; 31:390-394. [PMID: 34607752 DOI: 10.1016/j.hlc.2021.09.005] [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] [Received: 05/15/2021] [Revised: 07/27/2021] [Accepted: 09/09/2021] [Indexed: 02/08/2023]
Abstract
BACKGROUND Transcatheter aortic valve replacement (TAVR) is preferably performed as a completely percutaneous procedure via transfemoral access. Suture-mediated vascular closure devices are deployed prior to sheath insertion (pre-closure). Inability to perform pre-closure may necessitate surgical vascular repair of the femoral artery. Patients at increased risk of vascular surgery complications may benefit from a percutaneous method for achieving access site haemostasis. Stent graft implantation is commonly used for treating access site injury following TAVR. This study assessed the feasibility of a strategy of planned stent graft implantation within the femoral artery for achieving access site haemostasis in patients undergoing transfemoral TAVR and in whom vascular pre-closure was not possible. METHODS A prospective institutional TAVR registry was retrospectively analysed and a cohort of patients were identified who were selected for transfemoral valve delivery and in whom pre-closure failed and access site haemostasis was achieved by stent graft implantation. RESULTS This strategy was used for achieving access site haemostasis in 11 patients (1.5% of 744 patients undergoing transfemoral TAVR). These patients were considered to be at increased risk of vascular surgery complications due to advanced age, frailty, comorbidities, or immobility. Stent graft implantation achieved access site haemostasis in all patients. During follow-up, 30-day mortality was zero, 1-year mortality was 27%, and none of the patients required additional vascular interventions. CONCLUSION The preliminary data suggest that planned stent graft implantation within the femoral artery may achieve access site haemostasis and enable a totally percutaneous TAVR procedure, despite failure to perform pre-closure with a suture-based vascular closure device.
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21
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Oral Anticoagulation Continuation Throughout TAVR: High Risk-High Reward or Marginal Gains? JACC Cardiovasc Interv 2020; 14:145-148. [PMID: 33358646 DOI: 10.1016/j.jcin.2020.10.026] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/12/2020] [Accepted: 10/20/2020] [Indexed: 10/22/2022]
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22
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Reply: Transcatheter Aortic Valve Implantation During COVID-19 Pandemic: The Device Also Matters. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2020; 26:68. [PMID: 33129686 PMCID: PMC7833004 DOI: 10.1016/j.carrev.2020.09.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/01/2020] [Accepted: 09/02/2020] [Indexed: 11/22/2022]
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Abd Alamir M, Nazir S, Alani A, Golub I, Gilchrist IC, Aslam F, Dhawan P, Changal K, Ostra C, Soni R, Elzanaty A, Budoff M. Multidetector computed tomography in transcatheter aortic valve replacement: an update on technological developments and clinical applications. Expert Rev Cardiovasc Ther 2020; 18:709-722. [PMID: 33063552 DOI: 10.1080/14779072.2020.1837624] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/23/2022]
Abstract
INTRODUCTION Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with underlying sever aortic valve stenosis across all spectrum of the disease. CT imaging is so crucial to the pre procedural planning, to incorporate the information from the CT imaging in the decision making intraprocedurally and to predict and identity the post procedural complications.Areas covered: In this article, we review available studies on CT role in TAVR procedure and provide update on the technological developments and clinical applications.Expert opinion: CT imaging, with its high resolution, and in particular its utilization in aortic annular measurements, bicuspid aortic valve assessment, hypoattenuated leaflet thickening and valve in valve therapy proved to be the ideal approach to study the mechanisms of aortic stenosis, detection of high-risk anatomy, more accurate risk stratification and thus to allow a personalized catheter based intervention of the affected patients.
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Affiliation(s)
- Moshrik Abd Alamir
- Department of Cardiology, Stony Brook University Hospital, Health Sciences Tower , Stony Brook, NY, USA
| | - Salik Nazir
- Department of Cardiology, University of Toledo , Toledo, OH, USA
| | - Anas Alani
- Loma Linda University , Loma Linda, CA, USA
| | - Ilana Golub
- Department of Cardiology, Lundquist Institute , Torrance, CA, USA
| | - Ian C Gilchrist
- Department of Cardiology, Stony Brook University Hospital, Health Sciences Tower , Stony Brook, NY, USA
| | - Faisal Aslam
- Department of Cardiology, Stony Brook University Hospital, Health Sciences Tower , Stony Brook, NY, USA
| | - Puneet Dhawan
- David Geffen School of Medicine at UCLA, Department of Surgery, Los Angeles County Harbor-UCLA Medical Center , Torrance, CA, USA
| | - Khalid Changal
- Department of Cardiology, University of Toledo , Toledo, OH, USA
| | - Carson Ostra
- Department of Cardiology, University of Toledo , Toledo, OH, USA
| | - Ronak Soni
- Department of Cardiology, University of Toledo , Toledo, OH, USA
| | - Ahmad Elzanaty
- Department of Cardiology, University of Toledo , Toledo, OH, USA
| | - Matthew Budoff
- Department of Cardiology, Lundquist Institute , Torrance, CA, USA
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Danenberg HD. Pay Attention on the Road: TAVR and Vascular Complications. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2020; 21:1074-1075. [PMID: 32732149 DOI: 10.1016/j.carrev.2020.06.037] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/30/2020] [Accepted: 06/30/2020] [Indexed: 11/19/2022]
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