Single Perclose Plus Plug Based Device versus Double Perclose for Percutaneous Large Bore Arterial Access: An Systematic Review and Meta-analysis

Abstract

Background: Vascular Closure primarily utilizing suture-based devices (SBDs) are frequently used for large bore percutaneous arterial access in patients undergoing Transcatheter Aortic Valve Implantation and Endovascular Aneurysm Repair. Little is known about the intentional combination of SBD with plug-based device (PBD). Main objective was to determine the efficacy of adopting a combined SBD and PBD strategy compared to double SBD for large bore arterial access.

Methods: We searched randomized and observational studies comparing both strategies and that reported the outcomes of major vascular and vascular complications, major bleeding, all bleeding events, need for surgical or endovascular interventions, device failure, additional device, and pseudoaneurysm. A meta-analysis was conducted, with heterogeneity assessed using the I² statistic and a random-effects model applied to all outcomes. In addition, trial sequential analysis was performed.

Results: We included 3 randomized trials and 4 observational studies with 2,064 access. Sheath size ranged from 13Fr to 24 Fr. Vascular complications (relative risk [RR] 0.54; P < 0.01), major vascular complications (RR 0.55; P = 0.04), major bleeding (RR 0.49; P = 0.02), need for surgical intervention (RR 0.25; P = 0.01), and additional device (RR 0.12; P < 0.01) were significantly less common in patients treated with the SBD and PBD technique. Pseudoaneurysm (RR 1.13; P = 0.71), all bleeding events (RR 0.59; P = 0.1), and endovascular intervention (RR 0.65; P = 0.26) were not significantly different between groups.

Conclusion: These findings suggest that 1 SBD, combined with PBD, was associated with less femoral access complications when compared to the exclusive double SBD as a vascular closure strategy in patients with large bore arterial access.