Dual ProGlide versus ProGlide and Angio-Seal for Femoral Access Hemostasis after Transcatheter Aortic Valve Replacement: A Randomized Comparative Trial

Abstract

Background: Vascular complications increase morbidity and mortality after transcatheter aortic valve replacements(TAVR), often related to failures in vascular closure devices(VCD). We intended to compare the dual Perclose ProGlide(PP) strategy to the hybrid combination of PP and Angio-Seal(AS) for femoral access hemostasis after TAVR.

Methods: A randomized controlled trial with 257 patients comparing dual PP to one PP and one AS(AS+PP) for vascular closure after transfemoral TAVR was conducted. The primary endpoint was the composite of TAVR access site-related vascular complications and life-threatening type 2/3 or 1 bleeding according to VARC-3. Secondary endpoints included additional VCD use and significant peripheral ischemia related to arteriotomy closure within one year. Modified VCD failure, defined as failure to achieve hemostasis within 5 minutes or requiring additional endovascular maneuvers, was also recorded.

Results: The AS+PP combination yielded lower rates of the primary endpoint(18.2% vs 29.8%; p = 0.0381), vascular complication(18.2% vs 29.8%; p = 0.0381), additional VCD usage(0.8% vs 19.0%; p < 0.0001), and modified VCD failure(9.9% vs 33.1%; p < 0.0001) than the dual PP. Bleeding complication rates were similar between the two groups. Three-month follow-up vascular duplex tests showed similar common femoral artery(CFA) diameters and peak systolic velocities(PSV) between the two groups, but additional intervention had higher PSV and smaller CFA diameters than those without.

Conclusions: The combined PP+AS for large-bore femoral access hemostasis following TAVR promises to be more effective and safer than dual PP in terms of vascular complications. Moreover, additional intervention for vascular complications resulted in smaller CFA diameters(ClinicalTrials.gov number, NCT05491070).