Abstract
BACKGROUND: Percutaneous large-bore arteriotomy closure devices are either suture- or plug-based. The comparative efficacy and safety of both techniques and optimal patient selection remain controversial. AIMS: We aimed to conduct a patient-level meta-analysis of randomised trials comparing suture-based ProGlide versus plug-based MANTA large-bore vascular closure devices (VCDs). METHODS: We searched PubMed, the Cochrane Central Register of Controlled Trials, and Google Scholar for randomised controlled trials comparing vascular closure with the ProGlide-based and the MANTA-based technique. The primary endpoint of this analysis was access site-related vascular complications defined according to the Valve Academic Research Consortium-3 criteria. RESULTS: We identified 2 trials that enrolled a total of 722 patients undergoing transcatheter aortic valve implantation. The primary endpoint was significantly less common after vascular closure with the ProGlide-based technique (odds ratio [OR] 0.54, 95% confidence interval [CI]: 0.35-0.82). Access site-related bleeding events were also less common with the ProGlide-based technique (OR 0.41, 95% CI: 0.18-0.94). Prespecified subgroup analyses did not reveal any subgroup favouring the plug-based technique. Clinical outcomes with the MANTA-based technique were better in larger-sized vessels. Patients who received the ProGlide-based technique were less likely to undergo endovascular stenting or vascular surgery (OR 0.22, 95% CI: 0.06-0.79). CONCLUSIONS: In this patient-level meta-analysis of randomised trials, the ProGlide-based technique for large-bore arterial access was superior to the MANTA-based technique in terms of vascular and bleeding complications.