Crossover balloon occlusion technique for access closure during transcatheter aortic valve implantation: a multicenter observational study

The ProGlide system represents the most common approach to close the main access site during transcatheter aortic valve implantation (TAVI). A crossover balloon occlusion technique (CBOT) has been reported in small case-series to possibly provide a controlled, safe, and successful hemostasis during TAVI. We sought to investigate the comparative performance of a combined (CBOT + ProGlide) compared with a ProGlide only approach. Primary endpoint was VARC-3 type ≥ 2 bleeding. Secondary outcomes included red blood cells transfusion, vascular complications, acute kidney injury (AKI), length of hospital stay (LOS), and death. Our study retrospectively included 229 consecutive patients admitted to "Villa Verde" Clinic (Taranto, Italy) and "Mater Dei" Hospital (Bari, Italy) and treated with TAVI. The study population was divided based on the access closure strategy in two groups: the combined and the ProGlide suture only group. The CBOT + ProGlide treated group presented lower incidence of primary endpoint, as well as less red blood cells transfusions, AKI stages ≥ 2, and shorter LOS. After propensity-score matching, the CBOT + ProGlide group confirmed lower incidence of primary endpoint (2 (2.4%) vs. 10 (11.9%), p = 0.016), of AKI stage ≥ 2 (0 vs. 5 (6%), p = 0.029), and shorter LOS (6.9 ± 4.0 vs. 8.9 ± 6.1, p = 0.015); moreover, the multivariate logistic regression analysis confirmed the protective role of the combined approach against VARC-3 type ≥ 2 bleeding (CI 0.04-0.99; OR 0.2; p = 0.05). Data from this multicenter comparative study highlight that a routinary percutaneous closure of the main TAVI access with ProGlide coupled with CBOT is possible and safe. Moreover, this combined approach seems promising in terms of reduced bleeding, RBC transfusions, AKI incidence, and shortening of hospitalizations.