Keele Research Repository

Background
Studies comparing plug-based (i.e., MANTA) with suture-based (i.e., ProStar XL and ProGlide) vascular closure devices (VCDs) for large-bore access closure after transcatheter aortic valve replacement (TAVR) have yielded mixed results.

Aims
To examine the comparative safety and efficacy of both types of VCDs among TAVR recipients.

Methods
An electronic database search was performed through March 2022 for studies comparing access-site related vascular complications with plug-based versus suture-based VCDs for large-bore access site closure after transfemoral (TF) TAVR.

Results
Ten studies (2 randomized controlled trials [RCTs] and 8 observational studies) with 3113 patients (MANTA = 1358, ProGlide/ProStar XL = 1755) were included. There was no difference between plug-based and suture-based VCD in the incidence of access-site major vascular complications (3.1% vs. 3.3%, odds ratio [OR]: 0.89; 95% confidence interval [CI]: 0.52−1.53). The incidence of VCD failure was lower in plug-based VCD (5.2% vs. 7.1%, OR: 0.64; 95% CI: 0.44−0.91). There was a trend toward a higher incidence of unplanned vascular intervention in plug-based VCD (8.2% vs. 5.9%, OR: 1.35; 95% CI: 0.97−1.89). Length of stay was shorter with MANTA. Subgroup analyses suggested significant interaction based on study designs such that there was higher incidence of access-site vascular complications and bleeding events with plug-based versus suture-based VCD among RCTs.

Conclusion
In patients undergoing TF-TAVR, large-bore access site closure with plug-based VCD was associated with a similar safety profile as suture-based VCD. However, subgroup analysis showed that plug-based VCD was associated with higher incidence of vascular and bleeding complications in RCTs.