Temporal Trends in Transcatheter Aortic Valve Replacement in France FRANCE 2 to FRANCE TAVI

被引:302
作者
Auffret, Vincent [1 ]
Lefevre, Thierry [2 ]
Van Belle, Eric [3 ]
Eltchaninoff, Helene [4 ]
Iung, Bernard [5 ,6 ]
Koning, Rene [7 ]
Motreff, Pascal [8 ]
Leprince, Pascal [9 ]
Verhoye, Jean Philippe [10 ]
Manigold, Thibaut [11 ]
Souteyrand, Geraud [8 ]
Boulmier, Dominique [1 ]
Joly, Patrick [12 ]
Pinaud, Frederic [13 ]
Himbert, Dominique [5 ,6 ]
Collet, Jean Philippe [14 ]
Rioufol, Gilles [15 ]
Ghostine, Said [16 ]
Bar, Olivier [17 ]
Dibie, Alain [18 ]
Champagnac, Didier [19 ]
Leroux, Lionel [20 ]
Collet, Frederic [21 ]
Teiger, Emmanuel [22 ]
Darremont, Olivier [23 ]
Folliguet, Thierry [24 ]
Leclercq, Florence [25 ]
Lhermusier, Thibault [26 ]
Olhmann, Patrick [27 ]
Huret, Bruno [28 ]
Lorgis, Luc [29 ]
Drogoul, Laurent [30 ]
Bertrand, Bernard [31 ]
Spaulding, Christian [32 ]
Quilliet, Laurent [33 ]
Cuisset, Thomas [34 ]
Delomez, Maxence [35 ]
Beygui, Farzin [36 ]
Claudel, Jean-Philippe [37 ]
Hepp, Alain [38 ]
Jegou, Arnaud [39 ]
Gommeaux, Antoine [40 ]
Mirode, Anfani [41 ]
Christiaens, Luc [42 ]
Christophe, Charles [43 ]
Cassat, Claude [44 ]
Metz, Damien [45 ]
Mangin, Lionel [46 ]
Isaaz, Karl [47 ]
Jacquemin, Laurent [48 ]
机构
[1] Univ Rennes 1, Signal & Image Treatment Lab LTSI,Natl Inst Hlth, Pontchaillou Univ Hosp Ctr,Ctr Clin Invest 804, Cardiol & Vasc Dis Serv,U1099, Rennes, France
[2] Jacques Cartier Private Hosp, Paris South Cardiovasc Inst, Massy, France
[3] Univ Lille 2, Natl Inst Hlth & Med Res,U1011, Dept Cardiol,Reg Univ Hosp Ctr Lille, Univ Hosp Federat Integra, Lille, France
[4] Rouen Charles Nicolle Univ Hosp Ctr, Natl Inst Hlth & Med Res, U644, Cardiol Serv, Rouen, France
[5] Univ Hosp Dept Fire, Dept Cardiol, Paris, France
[6] Paris Diderot Univ, Bichat Hosp, AP HP, Paris, France
[7] St Hilaire Clin, Cardiol Serv, Rouen, France
[8] Univ Auvergne, Natl Sci Res Ctr,UMR 6284, Dept Cardiol,Gabriel Montpied Univ Hosp Ctr, Image Sci Intervent Tech,Cardiovasc Intervent The, Clermont Ferrand, France
[9] Sorbonne Pierre & Marie Curie Univ, Publ Assistance Hosp Paris, GHPS, Cardiac Surg, Paris, France
[10] Univ Rennes 1, Natl Inst Hlth & Med Res,U1099, Thorac & Cardiovasc Surg Serv,Pontchaillou Univ H, Signal & Image Treatment Lab LTSI, Rennes, France
[11] Guillaume & Rene Laennec Univ, Ctr Hosp, Cardiol Serv, Thorac Inst, Nantes, France
[12] St Joseph Hosp, Cardiol Federat, Marseille, France
[13] Univ Angers, Univ Hosp Ctr Angers,Cardiac Surg Serv, Natl Sci Res Ctr,UMR6214, Natl Inst Hlth & Med Res,U1083, Angers, France
[14] Publ Assistance Hosp Paris, Pitie La Salpetriere Univ Hosp Ctr, Cardiol Serv, Paris, France
[15] Louis Pradel Univ Hosp Ctr, Ctr Clin Invest Lyon, Div Cardiol, Bron, France
[16] Marie Lannelongue Ctr, Dept Cardiol, Le Plessis Robinson, France
[17] St Gatien Clin, Cardiol Serv, Tours, France
[18] Montsouris Mutualist Inst, Dept Cardiol, Paris, France
[19] Clin Tonkin, Cardiol Serv, Villeurbanne, France
[20] Univ Bordeaux, Cardiol Hosp Haut Leveque, Dept Intervent Cardiol, Pessac, France
[21] Clairval Private Hosp, Cardiol Serv, Marseille, France
[22] Henri Mondor Hosp, AP HP, Dept Cardiol, Creteil, France
[23] St Augustin Clin, Cardiol Serv, Bordeaux, France
[24] Univ Hosp Ctr Nancy, Cardiovasc Surg Serv, Vandoeuvre Les Nancy, France
[25] Arnaud de Villeneuve Univ Hosp Ctr, Cardiol Serv, Montpellier, France
[26] Univ Toulouse 3, Natl Inst Hlth & Med Res,U1048, Univ Hosp Ctr Toulouse, Dept Cardiol, Toulouse, France
[27] Univ Strasbourg, New Civil Hosp, Univ Hosp Ctr Strasbourg, Dept Cardiol, Strasbourg, France
[28] St Martin Private Hosp, Cardiol Serv, Caen, France
[29] Univ Burgundy, Natl Inst Hlth & Med Res,U866, Pharmacol & Cardiometab Physiopathol Lab, Dept Cardiol,Univ Hosp Ctr Dijon, Dijon, France
[30] Arnaud Tzanck Inst, Cardiol Serv, St Laurent Du Var, France
[31] Univ Hosp Ctr Grenoble, Univ Cardiol Clin, Grenoble, France
[32] Paris Descartes Univ, Natl Inst Hlth & Med Res,U970, Publ Assistance Hosp Paris,Ctr Expertise Sudden, Dept Cardiol,Georges Pompidou European Hosp, Paris, France
[33] Francois Rabelais Univ, Trousseau Univ Hosp Ctr, Heart Thorax & Vasc Ctr, Cardiol Serv, Tours, France
[34] Univ Aix Marseille, Natl Inst Hlth & Med Res,UMR1062, French Natl Inst Agr Res,UMR 1260,Dept Cardiol, La Timone Univ Hosp Ctr,Publ Assistance Hosp Mars, Marseille, France
[35] Polyclin Bois, Cardiol Serv, Lille, France
[36] Cote Nacre Univ Hosp Ctr, Cardiol Serv, Caen, France
[37] Protestant Infirm Lyon, Cardiol Serv, Caluire Et Cuire, France
[38] Clin Sauvegarde, Cardiovasc Surg Serv, Lyon, France
[39] Parly 2 Private Hosp, Cardiol Serv, Le Chesnay, France
[40] Bois Bernard Private Hosp, Cardiol Serv, Bois Bernard, France
[41] Univ Hosp Ctr Amiens, Dept Cardiol, Amiens, France
[42] La Miletrie Univ Hosp Ctr, Dept Cardiol, Poitiers, France
[43] Claude Bernard Hosp Clin, Cardiol Serv, Metz, France
[44] Dupuytren Univ Hosp Ctr, Cardiol Serv, Limoges, France
[45] Robert Debre Univ Hosp Ctr, Cardiol & Vasc Pathol Serv, Reims, France
[46] Hosp Ctr Annecy Genevois, Cardiol Serv, Metz, France
[47] Univ Hosp Ctr St Etienne, Dept Cardiol, St Etienne, France
[48] Hosp Grp Mulhouse & South Alsace Reg, Emile Muller Hosp, Cardiol Serv, Mulhouse, France
[49] Cardiol Ctr North, Dept Intervent Cardiol, St Denis, Reunion, France
[50] St Clotilde Clin, Cardiol Serv, St Denis La Reunion, La Reunion, France
关键词
national registry; outcomes; pacemaker; transfemoral; LONG-TERM OUTCOMES; TRANSFEMORAL TRANSCATHETER; CLINICAL-OUTCOMES; IMPLANTATION; RISK; PREDICTORS; STENOSIS; REGISTRY; TRIAL; PLACEMENT;
D O I
10.1016/j.jacc.2017.04.053
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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) (C) 2017 by the American College of Cardiology Foundation.
引用
收藏
页码:42 / 55
页数:14
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