1-Year Outcomes of Transcatheter Aortic Valve Replacement Using a Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valve.

Abstract

Background: Mid-term comparative data for the self-expanding ACURATE neo2 transcatheter heart valve and the balloon-expandable SAPIEN 3 Ultra are lacking.

Objectives: The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement of these 2 valves.

Methods: A total of 2,106 patients from 3 centers (neo2, n = 1,166; Ultra, n = 940) undergoing transfemoral transcatheter aortic valve replacement were analyzed retrospectively. The primary endpoint was the composite of all-cause mortality, stroke, and rehospitalization at 1 year. Secondary endpoints were the individual components of the primary endpoint at 1 year. To adjust for baseline differences, nearest neighbor propensity score matching was used.

Results: After matching (702 pairs), baseline characteristics were similar between groups. Device success was more common in the neo2 group (87.5% vs 82.3%; P = 0.007), irrespective of matching. DP mean after the procedure was higher for Ultra (13 mm Hg [Q1-Q3: 10-15 mm Hg] vs 8 mm Hg [Q1-Q3: 6-11] mm Hg; P < 0.001). Rates of paravalvular leakage, device embolization, and multiple valve implantations were more common in the neo2 arm, whereas major cardiac structural complications and major vascular complications occurred more frequently in the Ultra group. All other in-hospital complication rates were similar between the 2 groups. At 1 year, the cumulative incidence of the primary endpoint (14.1% for neo2 vs 14.5% for Ultra; P = 0.819) was similar between the groups. Likewise, the individual components showed no difference between the groups.

Conclusions: Despite differing immediate results, the outcomes at 1 year, including the composite of all-cause mortality, stroke, or hospitalization, were similar for neo2 and Ultra transcatheter heart valves.