https://doi.org/10.1007/s00392-025-02625-4
1Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; 2Erasmus University Medical Center Department of Cardiology Rotterdam, Niederlande; 3Herzzentrum Leipzig - Universität Leipzig Universitätsklinik für Herzchirurgie Leipzig, Deutschland; 4Clinique Pasteur Department of Cardiology Toulouse, Frankreich
Percutaneous large-bore arteriotomy closure devices are either suture- or plug-based. Comparative efficacy and safety of both techniques and optimal patient selection remain controversial.
Aims:
To conduct a patient-level meta-analysis of randomized trials comparing suture-based ProGlide versus plug-based MANTA large-bore vascular closure devices (VCD).
Methods:
We searched MEDLINE, the Cochrane Central Register of Controlled Trials and Google scholar for randomized 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 favoring the plug-based technique. Clinical outcomes with the MANTA-based technique improved in larger sized vessels. VCD failure was comparable between both groups (OR 0.94, 95%CI: 0.47-1.85), but patients with the MANTA-based technique were more 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 randomized trials, the ProGlide-based technique for large-bore arterial access was superior to the MANTA-based technique in terms of vascular and bleeding complications.