Key result
Newer generation transcatheter heart valves showed no difference in the 30-day early safety composite endpoint compared to early generation devices (HR 0.98; 95% CI 0.72-1.33; P=0.88).
Why the study?
Do newer generation transcatheter heart valve devices improve safety and efficacy compared to early generation devices in patients undergoing TAVI?
Observational (n=782)
No
Do newer generation transcatheter heart valve devices improve safety and efficacy compared to early generation devices in patients undergoing TAVI?
Hazard Ratio: 0.98 (95% CI 0.72–1.33)
Absolute Event Rate: 20.8% vs 21.2%
p-value: p=0.88
While overall 30-day safety composite outcomes were similar, newer generation TAVI devices demonstrated reduced rates of valve embolization, paravalvular regurgitation, and bleeding, albeit with a slight increase in annulus rupture compared to early generation devices.
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No difference in 30-day safety composite with newer THVs; leaves open device-specific benefits pending randomized trials.
Pilgrim et al. (2018) conducted an observational in Transcatheter aortic valve implantation (TAVI) (n=782). Newer generation transcatheter heart valve (THV) devices vs. Early generation THV devices was evaluated on Valve Academic Research Consortium (VARC)-2 early safety composite end point at 30 days (HR 0.98, 95% CI 0.72-1.33, p=0.88). Newer generation transcatheter heart valves showed no difference in the 30-day early safety composite endpoint compared to early generation devices (HR 0.98; 95% CI 0.72-1.33; P=0.88).