Background

In the randomized CHOICE-CLOSURE trial, access-site or access-related vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) were more common with a pure plug-based vascular closure technique (MANTA, Teleflex) compared to a primary suture-based technique (ProGlide, Abbott). This was partly attributed to a higher incidence of pseudoaneurysm (PSA) formation with the MANTA-based strategy. We therefore sought to analyze clinical characteristics, predictors and outcome of PSA formation after arterial access-site closure with the MANTA-based technique.

Methods

Five hundred and sixteen patients undergoing transfemoral TAVI were enrolled and randomized in the CHOICE CLOSURE trial at 3 centers in Germany between June 2020 and June 2021. Of these, 258 patients randomized to the MANTA-based technique were included in the current post-hoc analysis. Baseline characteristics and procedural details were compared between patients who developed a PSA at the main access site after TAVI and those who did not.  Development of a PSA was further characterized according to the timing of diagnosis, management and outcomes.

Results

PSA after arterial access site closure with MANTA occurred in 16 patients (6.2%). Patients who developed a PSA had a higher atherosclerotic disease burden (history of coronary artery disease, previous percutaneous coronary or peripheral intervention), were more commonly on a dual antiplatelet regimen (37.5% vs. 8.7%, p<0.001), and had a significantly lower platelet count at baseline (184 ± 45 x 10⁹/L vs 218 ± 70 x 10⁹/L, p=0.029) and 24 hours post-TAVI (141 ± 41 x 10⁹/L vs 176 ± 60 x 10⁹/L, p=0.020) compared to patients without a PSA. There were no significant differences between both groups regarding severity (18.8% vs 11.6%, p=0.437) or location of calcification (anterior in 25% vs 32.6%, p=0.588), femoral bifurcation height, puncture technique, sheath size, or sheath-to-femoral artery ratio.

Six patients (37.5%) were diagnosed during the index procedure, and the remaining 10 patients were diagnosed at a median of 1 day after TAVI. Of patients diagnosed during the index procedure, 4 were successfully treated with manual compression only and 2 required an additional peripheral intervention. On the other hand, patients with delayed diagnosis of PSA were more likely to be treated with Thrombin injection (n=6) and/or additional endovascular interventions (n=3). One patient in each group had a main access site-related major bleeding event independently adjudicated according to the Valve Academic Research Consortium-2 definition.

Conclusions

Patients undergoing vascular access site closure after transfemoral TAVI with the plug-based MANTA device are more likely to develop a PSA if they have history of atherosclerosis, low platelet count prior to or after TAVI, or receive dual antiplatelet treatment. Careful intraprocedural assessment to exclude a PSA after MANTA appears justified, as these patients are less likely to require invasive treatment compared to those with a delayed diagnosis.