Clinical Outcomes With a Repositionable Self-Expanding Transcatheter Aortic Valve Prosthesis: The International FORWARD Study
Eberhard Grube, Nicolas M Van Mieghem, Sabine Bleiziffer, Thomas Modine, Johan Bosmans, Ganesh Manoharan, Axel Linke, Werner Scholtz, Didier Tchétché, Ariel Finkelstein, Ramiro Trillo, Claudia Fiorina, Antony Walton, Christopher J Malkin, Jae K Oh, Hongyan Qiao, Stephan Windecker, FORWARD Study Investigators, Eberhard Grube, Stephan Windecker, Johan Bosmans, Sabine Bleiziffer, Ganesh Manoharan, Thomas Modine, Nicolas Van Mieghem, Ajay Sinhal, Robert Gooley, Tony Walton, Gerald Yong, Johan Bosmans, John Webb, Michael Chu, Sam Radhakrishnan, Antonio Dager, Marian Branny, Didier Tchetche, Thomas Modine, Emmanuel Teiger, Bernard Chevalier, Dominique Himbert, Gerhard Schymik, Tobias Zeus, Christoph Jensen, Tienush Rassaf, Stephan Fichtlscherer, Georg Nickenig, Axel Linke, Sabine Bleiziffer, Jörg Kempfert, Werner Scholtz, Axel Harnath, Ruth Strasser, Christian Frerker, Konstantinos Spargias, Béla Peter Merkely, Ariel Finkelstein, Corrado Tamburino, Antonio Colombo, Anna Sonia Petronio, Claudia Fiorina, Francesco Bedogni, Giovanni Amoroso, Jan van der Heijden, Nicolas Van Mieghem, Pim Tonino, Pedro Echeverria Beliz, Adam Witkowski, Vasco Gama Ribeiro, Moheeb Al Abdullah, Hellmuth Weich, Ramiro Trillo, José Maria Hernández García, Cesar Moris, Anders Lars Jönsson, Christopher J Malkin, Saib Khogali, David Hildick-Smith, Ganesh Manoharan, Eberhard Grube, Nicolas M Van Mieghem, Sabine Bleiziffer, Thomas Modine, Johan Bosmans, Ganesh Manoharan, Axel Linke, Werner Scholtz, Didier Tchétché, Ariel Finkelstein, Ramiro Trillo, Claudia Fiorina, Antony Walton, Christopher J Malkin, Jae K Oh, Hongyan Qiao, Stephan Windecker, FORWARD Study Investigators, Eberhard Grube, Stephan Windecker, Johan Bosmans, Sabine Bleiziffer, Ganesh Manoharan, Thomas Modine, Nicolas Van Mieghem, Ajay Sinhal, Robert Gooley, Tony Walton, Gerald Yong, Johan Bosmans, John Webb, Michael Chu, Sam Radhakrishnan, Antonio Dager, Marian Branny, Didier Tchetche, Thomas Modine, Emmanuel Teiger, Bernard Chevalier, Dominique Himbert, Gerhard Schymik, Tobias Zeus, Christoph Jensen, Tienush Rassaf, Stephan Fichtlscherer, Georg Nickenig, Axel Linke, Sabine Bleiziffer, Jörg Kempfert, Werner Scholtz, Axel Harnath, Ruth Strasser, Christian Frerker, Konstantinos Spargias, Béla Peter Merkely, Ariel Finkelstein, Corrado Tamburino, Antonio Colombo, Anna Sonia Petronio, Claudia Fiorina, Francesco Bedogni, Giovanni Amoroso, Jan van der Heijden, Nicolas Van Mieghem, Pim Tonino, Pedro Echeverria Beliz, Adam Witkowski, Vasco Gama Ribeiro, Moheeb Al Abdullah, Hellmuth Weich, Ramiro Trillo, José Maria Hernández García, Cesar Moris, Anders Lars Jönsson, Christopher J Malkin, Saib Khogali, David Hildick-Smith, Ganesh Manoharan
Abstract
Background: Clinical outcomes in large patient populations from real-world clinical practice with a next-generation self-expanding transcatheter aortic valve are lacking.
Objectives: This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement (TAVR) with a next-generation, self-expanding transcatheter heart valve (THV) system in patients with severe symptomatic aortic stenosis (AS) in routine clinical practice.
Methods: The FORWARD (CoreValve Evolut R FORWARD) study is a prospective, single-arm, multinational, multicenter, observational study. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. An independent echocardiographic core laboratory evaluated all echocardiograms. From January 2016 to December 2016, TAVR with the next-generation self-expanding THV was attempted in 1,038 patients with symptomatic, severe AS at 53 centers on 4 continents.
Results: Mean age was 81.8 ± 6.2 years, 64.9% were women, the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5%, and 33.9% of patients were deemed frail. The repositioning feature of the THV was applied in 25.8% of patients. A single valve was implanted in the proper anatomic location in 98.9% of patients. The mean aortic valve gradient was 8.5 ± 5.6 mm Hg, and moderate or severe aortic regurgitation was 1.9% at discharge. All-cause mortality was 1.9%, and disabling stroke occurred in 1.8% at 30 days. The expected-to-observed early surgical mortality ratio was 0.35. A pacemaker was implanted in 17.5% of patients.
Conclusions: TAVR using the next-generation THV is clinically safe and effective for treating older patients with severe AS at increased operative risk. (CoreValve Evolut R FORWARD Study [FORWARD]; NCT02592369).
Keywords: aortic stenosis; degenerative valve; transcatheter aortic valve replacement.
Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed