Propensity matched analysis of vascular complications using integrated or expandable sheaths for TAVR

Abstract

Objectives: Vascular access site complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR).

Background: Medtronic's EnVeo PRO® low-profile sheath concept and Edwards' expandable eSheath® aim to lower vascular trauma and access site complications. This study aims to compare Valve Academic Research Consortium (VARC)-3 defined access-related vascular complications using the two different transcatheter heart valve (THV) delivery concepts.

Methods: We performed a retrospective, propensity-matched study to compare access site vascular complications in 756 consecutive patients who underwent a transfemoral TAVR using a Medtronic Evolut-R®/Evolut-PRO® or an Edwards Sapien3®/Sapien3ultra® THV.

Results: Propensity score matching resulted in 275 patient pairs. The primary endpoint of major VARC-3 vascular complication was 7.6% in the Medtronic group and 12.7% in the Edwards group (p = 0.066). Minor VARC-3 vascular complications were 9.1% and 8%, respectively (p = 0.76). VARC-3 bleeding complications (8.4% vs. 12.7%, p = 0.129) length of hospital stay (7.6 + 5.4 vs. 7.5 + 3.7 days, p = 0.783) and in-hospital mortality (1.1% vs. 0.4%, p = 0.624) were comparable between both groups.

Conclusions: In a propensity-matched TAVR population, patients treated with the integrated sheath showed a trend towards fewer major vascular complications than patients treated with an expandable sheath, however, the difference was not statistically significant.

Keywords: aortic valve disease; ascular access; complicationsv; percutaneous intervention; transcatheter valve implantation.