Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient‐Level Study

Background Cerebrovascular events remain one of the most devastating complications of transcatheter aortic valve implantation (TAVI). Data from real‐world contemporary cohorts on longitudinal trends and outcomes remain limited. The aim of this study was to assess incidence, temporal trends, predicto...

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Main Authors: Astrid C. van Nieuwkerk, Hugo M. Aarts, Kimberley I. Hemelrijk, Cristobal Urbano Carrillo, Didier Tchétché, Fabio S. de Brito, Marco Barbanti, Ran Kornowski, Azeem Latib, Augusto D'Onofrio, Flavio Ribichini, Sergio García‐Blas, Nicolas Dumonteil, Alexandre Abizaid, Samantha Sartori, Paola D'Errigo, Giuseppe Tarantini, Mattia Lunardi, Katia Orvin, Matteo Pagnesi, Felipe Navarro, George Dangas, Roxana Mehran, Ronak Delewi
Format: Article
Language:English
Published: Wiley 2024-09-01
Series:Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
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Online Access:https://www.ahajournals.org/doi/10.1161/JAHA.123.032901
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author Astrid C. van Nieuwkerk
Hugo M. Aarts
Kimberley I. Hemelrijk
Cristobal Urbano Carrillo
Didier Tchétché
Fabio S. de Brito
Marco Barbanti
Ran Kornowski
Azeem Latib
Augusto D'Onofrio
Flavio Ribichini
Sergio García‐Blas
Nicolas Dumonteil
Alexandre Abizaid
Samantha Sartori
Paola D'Errigo
Giuseppe Tarantini
Mattia Lunardi
Katia Orvin
Matteo Pagnesi
Felipe Navarro
George Dangas
Roxana Mehran
Ronak Delewi
author_facet Astrid C. van Nieuwkerk
Hugo M. Aarts
Kimberley I. Hemelrijk
Cristobal Urbano Carrillo
Didier Tchétché
Fabio S. de Brito
Marco Barbanti
Ran Kornowski
Azeem Latib
Augusto D'Onofrio
Flavio Ribichini
Sergio García‐Blas
Nicolas Dumonteil
Alexandre Abizaid
Samantha Sartori
Paola D'Errigo
Giuseppe Tarantini
Mattia Lunardi
Katia Orvin
Matteo Pagnesi
Felipe Navarro
George Dangas
Roxana Mehran
Ronak Delewi
author_sort Astrid C. van Nieuwkerk
collection DOAJ
description Background Cerebrovascular events remain one of the most devastating complications of transcatheter aortic valve implantation (TAVI). Data from real‐world contemporary cohorts on longitudinal trends and outcomes remain limited. The aim of this study was to assess incidence, temporal trends, predictors, and outcomes of cerebrovascular events following transfemoral TAVI. Methods and Results The CENTER2 (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon‐Expandable Valves Versus Self‐Expandable Valves 2) study includes patients undergoing TAVI between 2007 and 2022. The database contains pooled patient‐level data from 10 clinical studies. A total of 24 305 patients underwent transfemoral TAVI (mean age 81.5±6.7 years, 56% women, median Society of Thoracic Surgeon Predicted Risk of Mortality 4.9% [3.1%–8.5%]). Of these patients, 2.2% (n=534) experienced stroke in the first 30 days after TAVI, and 40 (0.4%) had a transient ischemic attack. Stroke rates remained stable during the treatment period (2007–2010: 2.1%, 2011–2014: 2.5%, 2015–2018: 2.1%, 2019–2022: 2.1%; Ptrend=0.28). Moreover, 30‐day cerebrovascular event rates were similar across Society of Thoracic Surgeon Predicted Risk of Mortality risk categories: 2.1% in low‐risk, 2.6% in intermediate‐risk, and 2.5% in high‐risk patients (P=0.21). Mortality was higher in patients with 30‐day stroke than without at 30 days (20.3% versus 4.7%; odds ratio, 5.1 [95% CI, 4.1–6.5]; P<0.001) and at 1 year (44.1% versus 15.0%; hazard ratio, 3.5 [95% CI, 3.0–4.2]; P<0.001). One‐year mortality rates for stroke did not decline over time (2007–2010: 46.9%, 2011–2014: 46.0%, 2015–2018: 43.0%, 2019–2022: 39.1%; Ptrend=0.32). At 1 year, 7.0% of patients undergoing TAVI had a stroke. Conclusions In 24 305 patients who underwent transfemoral TAVI, 30‐day cerebrovascular event incidence remained ≈ 2.2% between 2007 and 2022. Thirty‐day stroke rates were similar throughout Society of Thoracic Surgeon Predicted Risk of Mortality risk categories. Mortality rates after stroke remain high. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03588247.
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spelling doaj-art-dfc0db0abb1345f1998bb5a413dd6a3c2024-11-28T12:39:45ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802024-09-01131710.1161/JAHA.123.032901Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient‐Level StudyAstrid C. van Nieuwkerk0Hugo M. Aarts1Kimberley I. Hemelrijk2Cristobal Urbano Carrillo3Didier Tchétché4Fabio S. de Brito5Marco Barbanti6Ran Kornowski7Azeem Latib8Augusto D'Onofrio9Flavio Ribichini10Sergio García‐Blas11Nicolas Dumonteil12Alexandre Abizaid13Samantha Sartori14Paola D'Errigo15Giuseppe Tarantini16Mattia Lunardi17Katia Orvin18Matteo Pagnesi19Felipe Navarro20George Dangas21Roxana Mehran22Ronak Delewi23Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences Amsterdam the NetherlandsDepartment of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences Amsterdam the NetherlandsDepartment of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences Amsterdam the NetherlandsHospital Regional Universitario de Málaga Malaga SpainClinique Pasteur Toulouse FranceHeart Institute, University of São Paulo Medical School São Paulo BrazilUniversità degli Studi di Enna “Kore” Enna ItalyCardiology Department Rabin Medical Center Petach Tikva IsraelDepartment of Cardiology Montefiore Medical Center New York NY USADivision of Cardiac Surgery University of Padova Padova ItalyDivision of Cardiology, Department of Medicine University of Verona Verona ItalyClínico Universitario de Valencia Valencia SpainClinique Pasteur Toulouse FranceHeart Institute, University of São Paulo Medical School São Paulo BrazilThe Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY USANational Centre for Global Health—Istituto Superiore di Sanità Rome ItalyDivision of Cardiac Surgery University of Padova Padova ItalyDivision of Cardiology, Department of Medicine University of Verona Verona ItalyCardiology Department Rabin Medical Center Petach Tikva IsraelDepartment of Medical and Surgical Specialties, Institute of Cardiology, Radiological Sciences and Public Health, ASST Spedali Civili University of Brescia Brescia ItalyFundacion Jimenez Diaz Ute Madrid SpainThe Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY USAThe Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY USADepartment of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences Amsterdam the NetherlandsBackground Cerebrovascular events remain one of the most devastating complications of transcatheter aortic valve implantation (TAVI). Data from real‐world contemporary cohorts on longitudinal trends and outcomes remain limited. The aim of this study was to assess incidence, temporal trends, predictors, and outcomes of cerebrovascular events following transfemoral TAVI. Methods and Results The CENTER2 (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon‐Expandable Valves Versus Self‐Expandable Valves 2) study includes patients undergoing TAVI between 2007 and 2022. The database contains pooled patient‐level data from 10 clinical studies. A total of 24 305 patients underwent transfemoral TAVI (mean age 81.5±6.7 years, 56% women, median Society of Thoracic Surgeon Predicted Risk of Mortality 4.9% [3.1%–8.5%]). Of these patients, 2.2% (n=534) experienced stroke in the first 30 days after TAVI, and 40 (0.4%) had a transient ischemic attack. Stroke rates remained stable during the treatment period (2007–2010: 2.1%, 2011–2014: 2.5%, 2015–2018: 2.1%, 2019–2022: 2.1%; Ptrend=0.28). Moreover, 30‐day cerebrovascular event rates were similar across Society of Thoracic Surgeon Predicted Risk of Mortality risk categories: 2.1% in low‐risk, 2.6% in intermediate‐risk, and 2.5% in high‐risk patients (P=0.21). Mortality was higher in patients with 30‐day stroke than without at 30 days (20.3% versus 4.7%; odds ratio, 5.1 [95% CI, 4.1–6.5]; P<0.001) and at 1 year (44.1% versus 15.0%; hazard ratio, 3.5 [95% CI, 3.0–4.2]; P<0.001). One‐year mortality rates for stroke did not decline over time (2007–2010: 46.9%, 2011–2014: 46.0%, 2015–2018: 43.0%, 2019–2022: 39.1%; Ptrend=0.32). At 1 year, 7.0% of patients undergoing TAVI had a stroke. Conclusions In 24 305 patients who underwent transfemoral TAVI, 30‐day cerebrovascular event incidence remained ≈ 2.2% between 2007 and 2022. Thirty‐day stroke rates were similar throughout Society of Thoracic Surgeon Predicted Risk of Mortality risk categories. Mortality rates after stroke remain high. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03588247.https://www.ahajournals.org/doi/10.1161/JAHA.123.032901aortic valve stenosismortalitystroketranscatheter aortic valve replacement
spellingShingle Astrid C. van Nieuwkerk
Hugo M. Aarts
Kimberley I. Hemelrijk
Cristobal Urbano Carrillo
Didier Tchétché
Fabio S. de Brito
Marco Barbanti
Ran Kornowski
Azeem Latib
Augusto D'Onofrio
Flavio Ribichini
Sergio García‐Blas
Nicolas Dumonteil
Alexandre Abizaid
Samantha Sartori
Paola D'Errigo
Giuseppe Tarantini
Mattia Lunardi
Katia Orvin
Matteo Pagnesi
Felipe Navarro
George Dangas
Roxana Mehran
Ronak Delewi
Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient‐Level Study
Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
aortic valve stenosis
mortality
stroke
transcatheter aortic valve replacement
title Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient‐Level Study
title_full Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient‐Level Study
title_fullStr Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient‐Level Study
title_full_unstemmed Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient‐Level Study
title_short Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient‐Level Study
title_sort cerebrovascular events in patients undergoing transfemoral transcatheter aortic valve implantation a pooled patient level study
topic aortic valve stenosis
mortality
stroke
transcatheter aortic valve replacement
url https://www.ahajournals.org/doi/10.1161/JAHA.123.032901
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