Angio-Seal plug-based versus dual ProGlide for transfemoral hemostasis in transcatheter aortic valve replacement: a systematic review and meta-analysis

Abstract

Transcatheter aortic valve replacement (TAVR) carries risks of vascular and bleeding complications. We aimed to study the effectiveness of Angio-Seal combined with Perclose ProGlide versus dual Perclose ProGlide following transfemoral TAVR. We searched PubMed, Cochrane Library, Scopus, and WOS from inception until November 2024 for studies comparing Parclose ProGlide with Angio-Seal versus dual Parclose ProGlide in transfemoral TAVR. The primary outcome was major vascular complications, while other secondary outcomes were bleeding complications, the need for additional vascular closure device (VCD), minor vascular complications, unplanned surgical intervention, mortality, hematoma, pseudoaneurysm, and dissection. Dichotomous outcomes were pooled and analyzed using odds ratio (OR) with 95% confidence interval (CI) via the DerSimonian-Laird random-effect model. Seven studies (two RCTs and five observational studies) comprising 1,766 patients were included. In RCT-only analyses, single Perclose ProGlide combined with Angio-Seal showed no significant difference compared with dual Perclose ProGlide in major vascular complications (OR = 0.54, 95% CI [0.28-1.04], P = 0.07) or major/life-threatening bleeding (OR = 0.66, 95% CI [0.25-1.74], P = 0.40). However, it significantly reduced the need for additional vascular closure devices (OR = 0.11, 95% CI [0.05-0.24], P < 0.01) and minor vascular complications (OR = 0.52, 95% CI [0.38-0.72], P < 0.01). For dual Perclose ProGlide combined with Angio-Seal, no RCTs were available; observational evidence suggested a reduction in major/life-threatening bleeding compared to dual Perclose ProGlide (OR = 0.43, 95% CI [0.21 to0.92], p = 0.03), while there was no significant difference between the two groups upon excluding Costa et al. (EuroIntervention, 17:728-735, 2021) (OR = 0.56, 95% CI [0.26 to 1.21], p = 0.14). Based on the available RCTs, the combination of single Perclose ProGlide with Angio-Seal during transfemoral TAVR significantly reduces the need for additional vascular closure devices. It may also reduce minor vascular complications, but this effect is not consistently robust. The pooled analysis of observational studies suggests a potential benefit of dual Perclose ProGlide combined with Angio-Seal for major/life-threatening bleeding. However, this finding was not robust in sensitivity analyses and no RCTs have evaluated this strategy.