Luca Testa1, Azeem Latib2, Nedy Brambilla1, Federico De Marco1, Claudia Fiorina3, Marianna Adamo3, Cristina Giannini4, Marco Angelillis4, Marco Barbanti5, Carmelo Sgroi5, Arnaldo Poli6, Erica Ferrara6, Giuseppe Bruschi7, Claudio Francesco Russo7, Montorfano Matteo2, Francesco De Felice8, Carmine Musto8, Salvatore Curello3, Antonio Colombo2, Corrado Tamburino5, Anna Sonia Petronio4, Francesco Bedogni1. 1. Department of Cardiology, IRCCS Policlinico S. Donato, San Donato Milanese, 20149 Milan, Italy. 2. Department of Cardiology, Interventional Cardiology Unit, San Raffaele Scientific Institute, Via Olgettina Milano, 58, 20132 Milano MI, Italy. 3. Cardiothoracic Department, Spedali Civili Brescia, Piazzale Spedali Civili, 1, Brescia, Italy. 4. Catheterisation Laboratory, Cardiothoracic and Vascular Department, University of Pisa, Via Piero Trivella, 56124 Pisa, Italy. 5. Division of Cardiology, Ferrarotto Hospital, University of Catania, Via S. Sofia, Catania, Italy. 6. Department of Cardiology, Interventional Cardiology Unit, ASST Ovest Milanese, Legnano Hospital, Via Papa Giovanni Paolo II, 20025 Legnano, Italy. 7. Department of Cardiology, "De Gasperis" Cardio Center, ASST Niguarda Metropolitan Hospital, Piazza Ospedale Maggiore, 3 Milano, Italy. 8. Department of Cardiology, Interventional Cardiology Unit, S. Camillo Forlanini Hospital, Circonvallazione Gianicolense, 87, 00152 Roma, Italy.
Abstract
AIMS: In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU). METHODS AND RESULTS: Nine hundred and ninety inoperable or high-risk patients were treated with the CoreValve TAV in eight Italian Centres from June 2007 to December 2011. The median FU was 4.4 years (interquartile range 1.4-6.7 years). Longest FU reached 11 years. A total of 728 died within 8-year FU (78.3% mortality from Kaplan-Meier curve analysis). A significant functional improvement was observed in the majority of patients and maintained over time, with 79.3% of surviving patients still classified New York Heart Association class ≤ II at 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years in paired analysis (P = 0.164). Structural valve deterioration (SVD) and late bioprosthetic valve failure (BVF) were defined according to a modification of the 2017 EAPCI/ESC/EACTS criteria. In cumulative incidence functions at 8 years, moderate and severe SVD were 3.0% [95% confidence interval (CI) 2.1-4.3%] and 1.6% (95% CI 0.6-3.9%), respectively, while late BVF was 2.5% (95% CI 1.2-5%). CONCLUSION: While TAVs are questioned about long-term performance and durability, the results of the present research provide reassuring 8-year evidence on the CoreValve first-generation self-expandable bioprosthesis. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU). METHODS AND RESULTS: Nine hundred and ninety inoperable or high-risk patients were treated with the CoreValve TAV in eight Italian Centres from June 2007 to December 2011. The median FU was 4.4 years (interquartile range 1.4-6.7 years). Longest FU reached 11 years. A total of 728 died within 8-year FU (78.3% mortality from Kaplan-Meier curve analysis). A significant functional improvement was observed in the majority of patients and maintained over time, with 79.3% of surviving patients still classified New York Heart Association class ≤ II at 8 years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9 ± 4 mmHg at discharge, 9 ± 5 mmHg at 8 years, P = 0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ≥5 years in paired analysis (P = 0.164). Structural valve deterioration (SVD) and late bioprosthetic valve failure (BVF) were defined according to a modification of the 2017 EAPCI/ESC/EACTS criteria. In cumulative incidence functions at 8 years, moderate and severe SVD were 3.0% [95% confidence interval (CI) 2.1-4.3%] and 1.6% (95% CI 0.6-3.9%), respectively, while late BVF was 2.5% (95% CI 1.2-5%). CONCLUSION: While TAVs are questioned about long-term performance and durability, the results of the present research provide reassuring 8-year evidence on the CoreValve first-generation self-expandable bioprosthesis. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Faizus Sazzad; Jimmy Kim Fatt Hon; Kollengode Ramanathan; Jie Hui Nah; Zhi Xian Ong; Lian Kah Ti; Roger Foo; Edgar Tay; Theo Kofidis Journal: Front Cardiovasc Med Date: 2022-02-24
Authors: Luca Testa; Matteo Casenghi; Enrico Criscione; Nicolas M Van Mieghem; Didier Tchétché; Anita W Asgar; Ole De Backer; Azeem Latib; Bernhard Reimers; Giulio Stefanini; Carlo Trani; Francesco Giannini; Antonio Bartorelli; Wojtek Wojakowski; Maciej Dabrowski; Dariusz Jagielak; Adrian P Banning; Rajesh Kharbanda; Raul Moreno; Joachim Schofer; Christina Brinkmann; Niels van Royen; Duane Pinto; Antoni Serra; Amit Segev; Arturo Giordano; Nedy Brambilla; Mauro Agnifili; Antonio Popolo Rubbio; Mattia Squillace; Jacopo Oreglia; Rudolph Tanja; James M McCabe; Alexander Abizaid; Michiel Voskuil; Rui Teles; Giuseppe Biondi Zoccai; Lars Sondergaard; Francesco Bedogni Journal: Front Cardiovasc Med Date: 2022-07-29