Pierre Deharo1, Nicolas Jaussaud2, Dominique Grisoli2, Olivier Camus3, Noemie Resseguier4, Herve Le Breton5, Vincent Auffret5, Jean Philippe Verhoye6, René Koning7, Thierry Lefevre8, Eric Van Belle9, Helene Eltchaninoff10, Martine Gilard11, Pascal Leprince12, Bernard Iung13, Marc Lambert14, Frédéric Collart15, Thomas Cuisset16. 1. Département de Cardiologie, CHU Timone, Marseille, France; UMR MD2, Aix Marseille University, Marseille, France; Faculté de Médecine, Aix-Marseille Université, Marseille, France. 2. Service de Chirurgie Cardiaque, CHU Timone, Marseille, France. 3. Hôpital d'Instructions des Armées Laveran, Marseille, France. 4. Department of Public Health, Research Unit EA 3279, Aix-Marseille University, Marseille, France. 5. CHU Rennes, Service de Cardiologie, INSERM, U1099, Université de Rennes 1, Signal and Image Treatment Laboratory, Rennes, France. 6. Thoracic and Cardiovascular Surgery Service, Pontchaillou University Hospital Center, University of Rennes 1, Signal and Image Treatment Laboratory, National Institute of Health and Medical Research U1099, Rennes, France. 7. Cardiology Service, Saint Hilaire Clinic, Rouen, France. 8. Paris South Cardiovascular Institute, Jacques-Cartier Private Hospital, Massy, France. 9. 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. 10. Cardiology Service, Rouen-Charles-Nicolle University Hospital Center, National Institute of Health and Medical Research U644, Rouen, France. 11. 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. 12. Sorbonne-Pierre-et-Marie-Curie University, Public Assistance Hospitals of Paris, Groupe Hospitalier de la Pitié Salpêtrière, Cardiac Surgery, Paris, France. 13. Department of Cardiology, University Hospital Department Fire and Paris-Diderot University, Public Assistance Hospitals of Paris, Bichat Hospital, Paris, France. 14. Département de Cardiologie, CHU Timone, Marseille, France; Faculté de Médecine, Aix-Marseille Université, Marseille, France. 15. Faculté de Médecine, Aix-Marseille Université, Marseille, France; Service de Chirurgie Cardiaque, CHU Timone, Marseille, France. 16. Département de Cardiologie, CHU Timone, Marseille, France; Faculté de Médecine, Aix-Marseille Université, Marseille, France; Aix Marseille University, Inserm, Inra, C2VN, Marseille, France. Electronic address: thomas.cuisset@ap-hm.fr.
Abstract
OBJECTIVES: This study sought to describe the current practices and compare outcomes according to the use of balloon aortic valvuloplasty (BAV) or not during transcatheter aortic valve replacement (TAVR). BACKGROUND: Since its development, aortic valve pre-dilatation has been an essential step of TAVR procedures. However, the feasibility of TAVR without systematic BAV has been described. METHODS: TAVR performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (Registry of Aortic Valve Bioprostheses Established by Catheter) registry. We compared outcomes according to BAV during the TAVR procedure. RESULTS: A total of 5,784 patients have been included in our analysis, corresponding to 2,579 (44.6%) with BAV avoidance and 3,205 (55.4%) patients with BAV performed. We observed a progressive decline in the use of BAV over time (78% of procedures in 2013 and 49% in the last trimester of 2015). Avoidance of BAV was associated with similar device implantation success (97.3% vs. 97.6%; p = 0.40). TAVR procedures without BAV were quicker (fluoroscopy 17.2 ± 9.1 vs. 18.5 ± 8.8 min; p < 0.01) and used lower amounts of contrast (131.5 ± 61.6 vs. 141.6 ± 61.5; p < 0.01) and radiation (608.9 ± 576.3 vs. 667.0 ± 631.3; p < 0.01). The rates of moderate to severe aortic regurgitation were lower with avoidance of BAV (8.3% vs. 12.2%; p < 0.01) and tamponade rates (1.5% vs. 2.3%; p = 0.04). CONCLUSIONS: We confirmed that TAVR without BAV is frequently performed in France with good procedural results. This procedure is associated with procedural simplification and lower rates of residual aortic regurgitation.
OBJECTIVES: This study sought to describe the current practices and compare outcomes according to the use of balloon aortic valvuloplasty (BAV) or not during transcatheter aortic valve replacement (TAVR). BACKGROUND: Since its development, aortic valve pre-dilatation has been an essential step of TAVR procedures. However, the feasibility of TAVR without systematic BAV has been described. METHODS: TAVR performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (Registry of Aortic Valve Bioprostheses Established by Catheter) registry. We compared outcomes according to BAV during the TAVR procedure. RESULTS: A total of 5,784 patients have been included in our analysis, corresponding to 2,579 (44.6%) with BAV avoidance and 3,205 (55.4%) patients with BAV performed. We observed a progressive decline in the use of BAV over time (78% of procedures in 2013 and 49% in the last trimester of 2015). Avoidance of BAV was associated with similar device implantation success (97.3% vs. 97.6%; p = 0.40). TAVR procedures without BAV were quicker (fluoroscopy 17.2 ± 9.1 vs. 18.5 ± 8.8 min; p < 0.01) and used lower amounts of contrast (131.5 ± 61.6 vs. 141.6 ± 61.5; p < 0.01) and radiation (608.9 ± 576.3 vs. 667.0 ± 631.3; p < 0.01). The rates of moderate to severe aortic regurgitation were lower with avoidance of BAV (8.3% vs. 12.2%; p < 0.01) and tamponade rates (1.5% vs. 2.3%; p = 0.04). CONCLUSIONS: We confirmed that TAVR without BAV is frequently performed in France with good procedural results. This procedure is associated with procedural simplification and lower rates of residual aortic regurgitation.
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