Vincent Auffret1, Thierry Lefevre2, Eric Van Belle3, Hélène Eltchaninoff4, Bernard Iung5, René Koning6, Pascal Motreff7, Pascal Leprince8, Jean Philippe Verhoye9, Thibaut Manigold10, Geraud Souteyrand7, Dominique Boulmier1, Patrick Joly11, Frédéric Pinaud12, Dominique Himbert5, Jean Philippe Collet13, Gilles Rioufol14, Said Ghostine15, Olivier Bar16, Alain Dibie17, Didier Champagnac18, Lionel Leroux19, Frédéric Collet20, Emmanuel Teiger21, Olivier Darremont22, Thierry Folliguet23, Florence Leclercq24, Thibault Lhermusier25, Patrick Olhmann26, Bruno Huret27, Luc Lorgis28, Laurent Drogoul29, Bernard Bertrand30, Christian Spaulding31, Laurent Quilliet32, Thomas Cuisset33, Maxence Delomez34, Farzin Beygui35, Jean-Philippe Claudel36, Alain Hepp37, Arnaud Jegou38, Antoine Gommeaux39, Anfani Mirode40, Luc Christiaens41, Charles Christophe42, Claude Cassat43, Damien Metz44, Lionel Mangin45, Karl Isaaz46, Laurent Jacquemin47, Philippe Guyon48, Christophe Pouillot49, Serge Makowski50, Vincent Bataille51, Josep Rodés-Cabau52, Martine Gilard53, Hervé Le Breton54. 1. Cardiology and Vascular Diseases Service, Pontchaillou University Hospital Center, Center for Clinical Investigation 804, University of Rennes 1, Signal and Image Treatment Laboratory (LTSI), National Institute of Health and Medical Research U1099, Rennes, France. 2. Paris South Cardiovascular Institute, Jacques-Cartier Private Hospital, Massy, France. 3. Department of Cardiology, University of Lille 2, Regional University Hospital Center of Lille, National Institute of Health and Medical Research U1011, University Hospital Federation Integra, Lille, France. 4. Cardiology Service, Rouen-Charles-Nicolle University Hospital Center, National Institute of Health and Medical Research U644, Rouen, France. 5. Department of Cardiology, University Hospital Department Fire and Paris-Diderot University, Public Assistance Hospitals of Paris, Bichat Hospital, Paris, France. 6. Cardiology Service, Saint Hilaire Clinic, Rouen, France. 7. Department of Cardiology, Gabriel Montpied University Hospital Center, Image Science for Interventional Techniques, Cardiovascular Interventional Therapy and Imaging, National Scientific Research Center Unité Mixte de Recherche (UMR) 6284, University of the Auvergne, Clermont-Ferrand, France. 8. Sorbonne-Pierre-et-Marie-Curie University, Public Assistance Hospitals of Paris, Groupe Hospitalier de la Pitié Salpêtrière (GHPS), Cardiac Surgery, Paris, France. 9. Thoracic and Cardiovascular Surgery Service, Pontchaillou University Hospital Center, University of Rennes 1, Signal and Image Treatment Laboratory (LTSI), National Institute of Health and Medical Research U1099, Rennes, France. 10. Cardiology Service, Thoracic Institute, Guillaume et René Laennec University Hospital Center, Nantes, France. 11. Cardiology Federation, Saint Joseph Hospital, Marseille, France. 12. Cardiac Surgery Service, University Hospital Center of Angers, National Scientific Research Center UMR 6214, National Institute of Health and Medical Research 1083, University of Angers, Angers, France. 13. Cardiology Service, La Pitié-Salpêtrière University Hospital Center, Public Assistance Hospitals of Paris, Paris, France. 14. Division of Cardiology, Center for Clinical Investigation of Lyon, Louis Pradel University Hospital Center, Bron, France. 15. Department of Cardiology, Marie Lannelongue Center, Le Plessis Robinson, France. 16. Cardiology Service, Saint Gatien Clinic, Tours, France. 17. Department of Cardiology, Montsouris Mutualist Institute, Paris, France. 18. Cardiology Service, Clinic of the Tonkin, Villeurbanne, France. 19. Department of Interventional Cardiology, Cardiology Hospital of the Haut-Lévêque, University of Bordeaux, Pessac, France. 20. Cardiology Service, Clairval Private Hospital, Marseille, France. 21. Department of Cardiology, Henri-Mondor Hospital, Public Assistance Hospitals of Paris, Créteil, France. 22. Cardiology Service, Saint Augustin Clinic, Bordeaux, France. 23. Cardiovascular Surgery Service, University Hospital Center of Nancy, Vandœuvre-lès-Nancy, France. 24. Cardiology Service, Arnaud de Villeneuve University Hospital Center, Montpellier, France. 25. Department of Cardiology, University Hospital Center of Toulouse, National Institute of Health and Medical Research U1048, University of Toulouse 3, Toulouse, France. 26. Department of Cardiology, University Hospital Center of Strasbourg, New Civil Hospital, University of Strasbourg, Strasbourg, France. 27. Cardiology Service, Saint Martin Private Hospital, Caen, France. 28. Department of Cardiology, Pharmacology and Cardiometabolic Physiopathology Laboratory, University Hospital Center of Dijon, National Institute of Health and Medical Research U866, University of Burgundy, Dijon, France. 29. Cardiology Service, Arnaud Tzanck Institute, Saint Laurent du Var, France. 30. University Cardiology Clinics, University Hospital Center of Grenoble, Grenoble, France. 31. Department of Cardiology, Georges Pompidou European Hospital, Public Assistance Hospitals of Paris, Center for Expertise on Sudden Death, National Institute of Health and Medical Research U970, Paris Descartes University, Paris, France. 32. Cardiology Service, Heart, Thorax, and Vascular Center, Trousseau University Hospital Center, François Rabelais University, Tours, France. 33. Department of Cardiology, La Timone University Hospital Center, Public Assistance Hospitals of Marseille, National Institute of Health and Medical Research UMR1062, French National Institute for Agricultural Research UMR 1260, University of Aix-Marseille, Marseille, France. 34. Cardiology Service, Polyclinic du Bois, Lille, France. 35. Cardiology Service, Côte de Nacre University Hospital Center, Caen, France. 36. Cardiology Service, Protestant Infirmary of Lyon, Caluire et Cuire, France. 37. Cardiovascular Surgery Service, Clinic of the Sauvegarde, Lyon, France. 38. Cardiology Service, Parly 2 Private Hospital, Le Chesnay, France. 39. Cardiology Service, Bois Bernard Private Hospital, Bois-Bernard, France. 40. Department of Cardiology, University Hospital Center of Amiens, Amiens, France. 41. Department of Cardiology, La Miletrie University Hospital Center, Poitiers, France. 42. Cardiology Service, Claude Bernard Hospital Clinic, Metz, France. 43. Cardiology Service, Dupuytren University Hospital Center, Limoges, France. 44. Cardiology and Vascular Pathology Service, Robert Debré University Hospital Center, Reims, France. 45. Cardiology Service, Hospital Center of Annecy-Genevois, Metz-Tessy, France. 46. Department of Cardiology, University Hospital Center of Saint-Etienne, Saint-Etienne, France. 47. Cardiology Service, Emile Müller Hospital, Hospital Group of the Mulhouse and South Alsace Region, Mulhouse, France. 48. Department of Interventional Cardiology, Cardiology Center of the North, Saint-Denis, France. 49. Cardiology Service, Saint Clotilde Clinic, Saint Denis de La Réunion, La Réunion, France. 50. Cardiac Surgery Service, Ambroise Paré Clinic, Neuilly-sur-Seine, France. 51. Department of Epidemiology and Public Health, University of Toulouse 3, National Institute of Health and Medical Research UMR 1027, University Hospital Center of Toulouse, Toulouse, France. 52. University Institute of Cardiology and Pulmonology, Laval University, Québec City, Québec, Canada. 53. Department of Cardiology, La Cavale Blanche University Hospital Center, Optimization of Physiological Regulations, Science and Technical Training and Research Unit, University of Western Brittany, Brest, France. 54. Cardiology and Vascular Diseases Service, Pontchaillou University Hospital Center, Center for Clinical Investigation 804, University of Rennes 1, Signal and Image Treatment Laboratory (LTSI), National Institute of Health and Medical Research U1099, Rennes, France. Electronic address: herve.le.breton@chu-rennes.fr.
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).
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).
Authors: Richard Tanner; Barbara Moran; Ronan Margey; Gavin Blake; Catherine McGorrian; Jacqueline Geraghty; Susan Groarke; Jana Boleckova; John Hurley; Andrew Roy; David Barton; Declan Sugrue; Ivan P Casserly Journal: Ir J Med Sci Date: 2019-06-13 Impact factor: 1.568