Multicenter evaluation of transcatheter aortic valve replacement using either SAPIEN XT or CoreValve: Degree of device oversizing by computed-tomography and clinical outcomes.

OBJECTIVE: To analyze the association between computed-tomography-derived degrees of device oversizing and clinical outcomes during transcatheter aortic valve replacement (TAVR).

BACKGROUND: Previous reports suggest that different devices reach optimal results with different degrees of device oversizing. Therefore, similar sized devices of different types (SAPIEN XT and CoreValve) may be favored in different annular ranges and a case considered borderline between two sizes of a specific device might be within a favorable range of another.

METHODS AND RESULTS: A multicenter registry of 615 consecutive transfemoral TAVR procedures using either SAPIEN XT or CoreValve was analyzed. A first group of 190 patients had annular sizes for which only moderate oversizing degree was feasible (5-20% by area or 2.5-9.5% by perimeter). A second group included 178 patients that had annulus size for which only large oversizing degree was feasible (20.1-35% by area or 9.6-16.2% by perimeter). In the "only large oversizing feasible group" there were more annular rupture events in patients treated by SAPIEN XT valve as compared to those treated by CoreValve (3.4% vs. 0%, P = 0.04). In the "only moderate oversizing feasible group", those treated by CoreValve had more post balloon dilatation and 30-day major stroke in comparison with those treated by SAPIEN XT (16.1% vs. 7.7%, P = 0.04 and 8% vs. 1.3%, P = 0.02, respectively).

CONCLUSIONS: Optimal clinical performance of CoreValve and SAPIEN XT appears to be reached with different degrees of oversizing. Certain annular sizes that allow for only moderate or large oversizing, but not both, appear to benefit from a device specific approach.