Impact of closure devices on vascular complication and mortality rates in TAVI procedures.

Background: Currently two closure devices are available for the vascular access in TAVI procedures. Their impact on vascular complications and mid-term mortality is yet unknown.

Methods: Between 2009 and 2014, 398 patients underwent TAVI TF procedures in which two different closure devices were used, Prostar® XL (n=215) and Perclose-Proglide® (n=183). In the cases with Prostar we used one device and in cases with Perclose-Proglide, two devices. The two groups were compared with respect to the criteria of the Valve Academic Research Consortium (VARC) II. The mean follow-up period was 679.7±481.8 (727) days.

Results: There were no significant differences in the baseline characteristics of both patient groups. In the Prostar® group, complications were more frequent (26.6% vs. 12.6%, p=0.005); in detail, these were bleeding (14.9% vs. 7.1%, [p]=0.02), suture rupture (4.7% vs. 1.3%, p=0.04), and pseudoaneurysms (10.2% vs. 1.2%, p<0.001). Multivariate regression analysis revealed two predictors for vascular complications: female sex (OR 2.3; 95% CI 1.3-3.8, p=0.002) and closure devices (OR 0.5; 95% CI 0.3-0.8, p=0.007) in favour of Proglide®. There was no significant difference in 30-day mortality (Prostar: 5.6±1.6% vs. Proglide: 4.9±1.6%). However, Kaplan-Meier survival analysis showed a significantly higher survival rate over the entire follow-up period for the Proglide® group (p=0.03).

Conclusion: Vascular complications occurred more often in the Prostar® group. Although 30-day mortality showed no significant difference between the groups, the mortality over complete follow-up was significantly lower in the Proglide® group.