Impact of Sheath Type on Vascular and Bleeding Complications After Transcatheter Aortic Valve Replacement: A Post Hoc Analysis From the MARVEL Registry Study.

Abstract

Background: Vascular and bleeding complications remain a concern after transfemoral transcatheter aortic valve replacement (TAVR). The impact of the sheath type on these complications remains unclear.

Methods: The prospective MARVEL registry study analyzed enrolled 500 patients undergoing large-bore transfemoral procedures and arteriotomy closure with the MANTA vascular closure device from 10 hospitals in Europe and Canada. We stratified these patients according to type of sheath used (expandable or conventional). A propensity-matched analysis was performed using VARC-2 major or minor vascular and bleeding complications as the primary endpoint. The secondary endpoint was time to hemostasis.

Results: We identified 196 propensity-matched pairs. Major vascular complications occurred in 3.6% in the expandable sheath group and 4.1% in the conventional sheath group (p = 1.0). Minor vascular complications occurred in 5.6% in the expandable sheath group and 4.6% in the conventional sheath group (p = 0.819). There were no significant differences in bleeding complications between groups. Time to hemostasis after MANTA closure was significantly shorter in the expandable sheath group (30 vs. 60 s, p < 0.001).

Conclusions: A propensity-matched analysis demonstrated no significant differences in vascular complication rates with MANTA arteriotomy closure after removal of large bore expandable or conventional sheaths. Time to hemostasis was significantly shorter in the expandable sheath group.