[en] [en] BACKGROUND: The self-expanding, supra-annular Evolut valve is an established platform for Transcatheter Aortic Valve Implantation (TAVI). Evolut PRO introduced an outer sealing wrap to mitigate paravalvular leakage. We evaluated the 3-year clinical outcomes and valve performance of the Evolut PRO in standard clinical practice for severe aortic stenosis (AS) patients at intermediate or higher risk for surgery.
METHODS: The FORWARD PRO prospective, single-arm, multicentre, post-market clinical study enrolled 638 patients with native aortic valve stenosis or failed surgical bioprosthetic aortic valve undergoing TAVI, at intermediate or high risk, with the Evolut PRO valve. Clinical and serial echocardiographic outcomes were followed-up for 3 years.
RESULTS: TAVI using Evolut PRO was attempted in 629 AS patients (implanted in 97%) (mean age 81.7 years; STS PROM score, 4.7%). At 3 years all-cause mortality was 25.0%, disabling stroke 6.5% (all-cause mortality or disabling stroke, 28.5%) and rate of new permanent pacemaker implantation 24.7%. Excellent valve haemodynamics were maintained (mean gradient 8.8 ± 4.7 mm Hg; mean effective orifice area 2.0 ± 0.5 cm2) at 3 years. In a paired analysis of patients with ≥ mild paravalvular leakage (PVL) at discharge, more than two-thirds demonstrated improved PVL at 3 years. Patients with ≥ mild PVL at discharge had higher median total calcium volume than those with no/trace PVL (p < 0.001).
CONCLUSIONS: In clinical practice TAVI with the Evolut PRO valve is associated with favorable clinical outcomes and excellent haemodynamic performance out to 3 years. The observation of improvements in PVL over time warrants further research.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Van Mieghem, Nicolas M ; Department of Cardiology, Cardiovascular Institute, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands
Windecker, Stephan; Department of Cardiology, Inselspital, Bern University Hospital, Bern, Switzerland
Manoharan, Ganesh; Department of Cardiology, Regional Health Centre, Royal Victoria Hospital, Belfast, UK
Lancellotti, Patrizio ; Université de Liège - ULiège > Département des sciences cliniques > Cardiologie - Pathologie spéciale et réhabilitation
Tamburino, Corrado; Cardiothoracic, Transplantation and Vascular Surgery Department, Azienda Policlinico-Vittorio Emanuele, Universita di Catania, Catania, Italy
Kornowski, Ran ; Cardiology Division, Rabin Medical Center, Petach Tikva, Israel
Thiele, Holger; Department of Internal Medicine, Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
Danenberg, Haim; Interventional Cardiology, Wolfson Medical Center, Tel Aviv, Israel
Fiorina, Claudia; Cardiothoracic Department, Spedali Civili di Brescia, Brescia, Italy
Scholtz, Werner; Clinic for General and Interventional Cardiology, Angiology, Herz- und Diabeteszentrum Nordrhein-Westfalen, Universitätsklinik der Ruhr-Universität Bochum, Bad Oeynhausen, Germany
Brecker, Stephen; Department of Cardiology, Saint George's Hospital, London, UK
Ruge, Hendrik; Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Munich, Germany
Opdahl, Anders; Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway
Amoroso, Giovanni; Department of Cardiology, OLVG, Amsterdam, The Netherlands
Bedogni, Francesco ; Clinical Cardiology, Inverventional Cardiology and Coronary Intesive Care Units, IRCCS Policlinico San Donato, Milan, Italy
Petronio, Anna Sonia; CardioThoracic and Vascular Department, University Hospital, Pisa, Italy
Nickenig, Georg; Heart Center Bonn, University Hospital Bonn, Bonn, Germany
Harnath, Axel; Cardiology Department, Sana Heart Center, Cottbus, Germany
Kempfert, Joerg; Department of Cardiothoracic and Vascular Surgery, German Heart Institute Charité Berlin, Berlin, Germany
Oh, Jae K; Echocardiography Core Laboratory, Mayo Clinic, Rochester, Minnesota, USA
Eisenberg, Ruth E; Structural Heart and Aortic, Medtronic, Minneapolis, Minnesota, USA
Grube, Eberhard; Center of Innovative Interventions in Cardiology, University Hospital Bonn, Bonn, Germany
Panagiota Kopsiafti, BSc (Hons), MSc, MPH drafted the methods and results, created all tables and figures, and formatted the paper for journal style under the direction of the lead author. Maarten Hollander, MSc and Linda Schepers, MSc from Medtronic Bakken Research Center (Maastricht, the Netherlands) were responsible for overall study management. The authors would like to thank Fen Wang, MS for the quantitative calcification analysis. All are employees of Medtronic Plc. Medtronic (Bakken Research Center BV) funded the FORWARD PRO Study. ClinicalTrials.gov Identifier NCT03417011.
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