Predictors and mid-term outcomes of vascular complications after large-bore plug-based access-site closure in patients undergoing transfemoral TAVI: A CHOICE-CLOSURE substudy

A. Roeßler (Leipzig)¹, O. Dumpies (Leipzig)¹, P. Hartung (Leipzig)¹, J. Rotta Detto Loria (Leipzig)¹, I. Richter (Leipzig)², N. Lankisch (Leipzig)¹, H.-J. Feistritzer (Leipzig)¹, N. Majunke (Leipzig)¹, P. Kiefer (Leipzig)³, T. Noack (Leipzig)³, S. Desch (Leipzig)¹, H. Thiele (Leipzig)¹, M. Abdel-Wahab (Leipzig)^1
1Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; ²Helios Park-Klinikum Leipzig Klinik für Innere Medizin I - Kardiologie, Angiologie Leipzig, Deutschland; ³Herzzentrum Leipzig - Universität Leipzig Universitätsklinik für Herzchirurgie Leipzig, Deutschland

Background
The plug-based MANTA (Teleflex, Pennsylvania, USA) vascular closure device (VCD) is an alternative to suture-based VCDs for large-bore arterial closure after transcatheter aortic valve implantation (TAVI), but has been associated with higher rates of vascular complications. Predictors and outcomes of these complications are not well-analyzed, especially regarding the self-resorbing characteristics of the MANTA VCD.

Objectives
To identify predictors of access-site related vascular complications following transfemoral TAVI with the MANTA VCD, and to assess mid-term outcomes and late-onset events (after 30 days) in affected patients.

Methods
This prospective substudy of the CHOICE-CLOSURE trial included all patients randomized to vascular closure with the MANTA VCD at the Leipzig Heart Center. Patients with vascular complications, defined according to the Valve Academic Research Consortium (VARC)-2 criteria, underwent additional clinical and ultrasound follow-up, at least 6 months after the index procedure. Predictors of vascular complications were assessed through multivariable analysis.

Results
Of 237 patients treated with the MANTA VCD, 46 (19.4%) had an access-site related vascular complication. Pre-procedural dual antiplatelet therapy (DAPT) was the only independent predictor in multivariable analysis (odds ratio 2.86, 95% confidence interval 1.02–7.98, p=0.045). At a mean follow-up of 13.5 months, no new vascular complications occurred. Patients with an over-stented MANTA VCD (n= 5) had no in-stent stenosis, and stent diameters further expanded by 12.5% to 20.0%.

Conclusion
Pre-procedural DAPT independently predicted vascular complications after TAVI in MANTA patients. Patients with vascular complications had no further access-site late-onset events, and endovascular stenting of a MANTA VCD appeared safe.