Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI
Vincent Auffret, Thierry Lefevre, Eric Van Belle, Hélène Eltchaninoff, Bernard Iung, René Koning, Pascal Motreff, Pascal Leprince, Jean Philippe Verhoye, Thibaut Manigold, Geraud Souteyrand, Dominique Boulmier, Patrick Joly, Frédéric Pinaud, Dominique Himbert, Jean Philippe Collet, Gilles Rioufol, Said Ghostine, Olivier Bar, Alain Dibie, Didier Champagnac, Lionel Leroux, Frédéric Collet, Emmanuel Teiger, Olivier Darremont, Thierry Folliguet, Florence Leclercq, Thibault Lhermusier, Patrick Olhmann, Bruno Huret, Luc Lorgis, Laurent Drogoul, Bernard Bertrand, Christian Spaulding, Laurent Quilliet, Thomas Cuisset, Maxence Delomez, Farzin Beygui, Jean-Philippe Claudel, Alain Hepp, Arnaud Jegou, Antoine Gommeaux, Anfani Mirode, Luc Christiaens, Charles Christophe, Claude Cassat, Damien Metz, Lionel Mangin, Karl Isaaz, Laurent Jacquemin, Philippe Guyon, Christophe Pouillot, Serge Makowski, Vincent Bataille, Josep Rodés-Cabau, Martine Gilard, Hervé Le Breton, FRANCE TAVI Investigators
Abstract
Background: Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited.
Objectives: The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period.
Methods: TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers.
Results: A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased.
Conclusions: The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).
Keywords: national registry; outcomes; pacemaker; transfemoral.
Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed