JACC: Cardiovascular Interventions
Impact of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty on Procedural and Clinical OutcomesInsights From the FRANCE TAVI Registry
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Author + information
- Pierre Deharo, MDa,b,c,
- Nicolas Jaussaud, MDd,
- Dominique Grisoli, MDd,
- Olivier Camus, MDe,
- Noemie Resseguier, MDf,
- Herve Le Breton, MDg,
- Vincent Auffret, MDg,
- Jean Philippe Verhoye, MD, PhDh,
- René Koning, MDi,
- Thierry Lefevre, MDj,
- Eric Van Belle, MD, PhDk,
- Helene Eltchaninoff, MD, PhDl,
- Martine Gilard, MD, PhDm,
- Pascal Leprince, MDn,
- Bernard Iung, MD, PhDo,
- Marc Lambert, MDa,c,
- Frédéric Collart, MDc,d and
- Thomas Cuisset, MD, PhDa,c,p,∗ (thomas.cuisset{at}ap-hm.fr)
- aDépartement de Cardiologie, CHU Timone, Marseille, France
- bUMR MD2, Aix Marseille University, Marseille, France
- cFaculté de Médecine, Aix-Marseille Université, Marseille, France
- dService de Chirurgie Cardiaque, CHU Timone, Marseille, France
- eHôpital d’Instructions des Armées Laveran, Marseille, France
- fDepartment of Public Health, Research Unit EA 3279, Aix-Marseille University, Marseille, France
- gCHU Rennes, Service de Cardiologie, INSERM, U1099, Université de Rennes 1, Signal and Image Treatment Laboratory, Rennes, France
- hThoracic 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
- iCardiology Service, Saint Hilaire Clinic, Rouen, France
- jParis South Cardiovascular Institute, Jacques-Cartier Private Hospital, Massy, France
- kDepartment 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
- lCardiology Service, Rouen–Charles-Nicolle University Hospital Center, National Institute of Health and Medical Research U644, Rouen, France
- mDepartment 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
- nSorbonne–Pierre-et-Marie-Curie University, Public Assistance Hospitals of Paris, Groupe Hospitalier de la Pitié Salpêtrière, Cardiac Surgery, Paris, France
- oDepartment of Cardiology, University Hospital Department Fire and Paris-Diderot University, Public Assistance Hospitals of Paris, Bichat Hospital, Paris, France
- pAix Marseille University, Inserm, Inra, C2VN, Marseille, France
- ↵∗Address for correspondence:
Prof. Thomas Cuisset, Department of Cardiology, Hopital la Timone, 265 Rue Saint Pierre, 13005 Marseille, France.
Graphical abstract
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.
Footnotes
Edwards Lifesciences and Medtronic partially funded the FRANCE TAVI registry. Edwards Lifesciences and Medtronic had no role in data management, data analysis, or writing of the manuscript. Dr. Le Breton has received speaker fees from Edwards Lifesciences and Medtronic. Dr. Auffret has received research grants from Edwards Lifesciences, Medtronic, and Abbott. Dr. Koning has clinical research relationships with Boehringer Ingelheim, Boston Scientific, Abbott, Biosensor, and Biotronik. Dr. Lefevre has served as a proctor for Edwards Lifesciences and Abbott. Dr. Eltchaninoff has served as a proctor for and received lecture fees from Edwards Lifesciences. Dr. Leprince has served as a proctor for Medtronic. Dr. Iung has received consulting fees from Boehringer Ingelheim; and has received a speaker fee from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 4, 2018.
- Revision received June 7, 2018.
- Accepted June 13, 2018.
- 2018 American College of Cardiology Foundation
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