Key result
SAPIEN 3 Ultra linked to ~70% lower mild PVL at 30 days vs SAPIEN 3.
Why the study?
The incidence of paravalvular leak after TAVR has declined with iterative valve improvements, but the effect of a fourth-generation valve with enhanced skirt compared to a third-generation valve was not established.
Does a fourth-generation balloon-expandable transcatheter valve with an enhanced skirt reduce the incidence of paravalvular leak compared to a third-generation valve in patients undergoing TAVR?
Cohort (n=260)
No
Does a fourth-generation balloon-expandable transcatheter valve with an enhanced skirt reduce the incidence of paravalvular leak compared to a third-generation valve in patients undergoing TAVR?
Absolute Event Rate: 10.8% vs 36.5%
p-value: p=< .0001
The use of a fourth-generation balloon-expandable transcatheter valve with an enhanced skirt significantly reduces the incidence of mild and moderate paravalvular leak at 30 days post-TAVR compared to the third-generation valve.
May inform TAVR valve selection to limit mild PVL; leaves open effects on outcomes and need for randomized confirmation.
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.
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Welle et al. (2020) conducted a cohort in Aortic valve disease requiring TAVR (n=260). Fourth-generation balloon-expandable transcatheter valve (4G-BEV) vs. Third-generation balloon-expandable transcatheter valve (3G-BEV) was evaluated on Mild paravalvular leak at 30 days (p=< .0001). The fourth-generation transcatheter valve (SAPIEN 3 Ultra) was associated with lower mild paravalvular leak at 30 days compared to the third-generation valve (10.8% vs 36.5%; p<0.0001).
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