Effect of a fourth‐generation transcatheter valve enhanced skirt on paravalvular leak

Abstract Objectives The aim of this study was to assess the 30 day incidence of paravalvular leak (PVL) and need for aortic valve reintervention of a fourth generation balloon expandable transcatheter valve with enhanced skirt (4G‐BEV) (SAPIEN 3 Ultra) compared with a third generation balloon expandable transcatheter valve (3G‐BEV) (SAPIEN 3). Background The incidence of PVL has steadily declined with iterative improvements in transcatheter aortic valve replacement (TAVR) technology and implantation strategies. Methods Patients who underwent TAVR at Mayo Clinic from 7/2018 to 7/2019 were included in a prospective institutional registry. 4G‐BEV has been utilized since 2/2019, and, after this date, 3G‐BEV and 4G‐BEV were simultaneously used. 4G‐BEV had three sizes (20, 23, and 26 mm) while 3G‐BEV included four sizes (20, 23, 26, and 29 mm). Both cohorts were evaluated at 30 days post‐TAVR with a transthoracic echocardiogram to assess for PVL. Results A total of 260 consecutive patients were included. Of these, 101 patients received a 4G‐BEV and 159 patients received a 3G‐BEV. There were more females ( p = .0005) and a lower aortic valve calcium score ( p = .02) in the 4G‐BEV cohort at baseline. Age, STS risk score, NYHA Class, and aortic valve mean gradient did not differ between groups. 4G‐BEV was associated with a lower incidence of mild PVL (10.8 vs. 36.5%; p < .0001) and moderate PVL (0 vs. 5.8%) compared to the 3G‐BEV at 30 days. There was no association between PVL and valve size in either cohort. Conclusions Utilization of 4G‐BEV is associated with reduced PVL at 30 days post‐TAVR compared with 3G‐BEV.