Meta-analysis of short- and long-term clinical outcomes of the self-expanding Evolut R/pro valve versus the balloon-expandable Sapien 3 valve for transcatheter aortic valve implantation

Abstract

Background: The Evolut R/Pro and the Sapien 3 are the most commonly valve systems used today for transcatheter aortic valve implantation (TAVI). However, there is a still uncertainty regarding the efficacy and safety comparison of these two valves.

Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies comparing the Evolut R/Pro versus the Sapien 3. The primary outcome was all-cause mortality (short and long-term). The secondary outcomes were stroke, bleeding, permanent pacemaker implantation (PPI), acute kidney injury (AKI), major vascular complication, device success, moderate- severe aortic regurgitation (AR), and pressure gradients.

Results: Twenty-one publications totaling 35,248 patients were included in the analysis. Evolut R/Pro was associated with higher risk of short-term all-cause mortality (OR = 1.31;95% CI 1.15-1.49, p < 0.001) and a trend of higher long-term mortality (OR = 1.07;95% CI 1.00-1.16, p = 0.06). The Evolut R/Pro was associated with higher risk of PPI and AR and lower risk for bleeding, major vascular complication, and pressure gradients. There was no significant difference between the groups regarding the risk of stroke, AKI and device success.

Conclusions: The Evolut R/Pro valve system compared to the Sapien 3 is associated with higher risk of short-term mortality, significant AR and PPI while providing the advantage of lower risk of bleeding, major vascular complication, and lower residual transvalvular gradients.

Keywords: Balloon-expandable valve; Evolut Pro; Evolut R; Sapien 3; Self-expanding valve; TAVI.