Suture-based versus plug-based closure for large-bore arterial access: an individual patient-level meta-analysis of randomized trials

O. Dumpies (Leipzig)¹, M. van Wiechen (Rotterdam)², A. Jobs (Leipzig)¹, A. Abdelhafez (Leipzig)¹, J. Rotta Detto Loria (Leipzig)¹, I. Richter (Leipzig)³, H.-J. Feistritzer (Leipzig)¹, N. Majunke (Leipzig)¹, T. Noack (Leipzig)⁴, S. Desch (Leipzig)¹, H. Thiele (Leipzig)¹, N. Dumonteil (Toulouse)⁵, D. Tchétché (Toulouse)⁵, N. M. Van Mieghem (Rotterdam)⁶, M. Abdel-Wahab (Leipzig)^1
1Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; ²Erasmus University Medical Center Department of Cardiology Rotterdam, Niederlande; ³Helios Park-Klinikum Leipzig Klinik für Innere Medizin I - Kardiologie, Angiologie Leipzig, Deutschland; ⁴Herzzentrum Leipzig - Universität Leipzig Universitätsklinik für Herzchirurgie Leipzig, Deutschland; ⁵Clinique Pasteur Department of Cardiology Toulouse, Frankreich; ⁶Erasmus Medical Center Department of Interventional Cardiology Rotterdam, Niederlande

Background:
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.