Impact of Direct Transcatheter Aortic Valve Replacement Without Balloon Aortic Valvuloplasty on Procedural and Clinical Outcomes: Insights From the FRANCE TAVI Registry.

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.