Vascular Closure Device in TAVI with a Dedicated Endovascular Plug-Based Device – Experience from a High-Volume Tertiary Center

Abstract Background Vascular complications at the access site are important adverse events during transcatheter aortic valve implantation (TAVI). Effective, reproducible, and safe closure of large bore arteriotomies remains challenging as management strategies vary among centers and operators. MANTAÒ is a dedicated plug-based vascular closure device (VCD) recently approved for percutaneous access site closure. This study aimed to describe our experience and to determine the safety and effectiveness of MANTAÒ for large bore arteriotomies during transfemoral TAVI. Methods Single center retrospective analysis on prospectively collected data of all consecutive patients who underwent transfemoral TAVI from 2018 to 2020. The primary safety outcomes were access-related vascular injury and bleeding complications according to VARC-3 criteria. Technical success was defined as puncture closure obtained with MANTAÒ without the use of unplanned endovascular or surgical intervention. A secondary analysis according to center experience was performed. Results Of the 535 patients that underwent transfemoral TAVI during the study period (median age = 84 [IQR 80–87], 39.4% male; median EuroSCORE II of 3.89% [IQR 2.62–5.39]), MANTAÒ VCD was deployed in 320 (59.8%). Overall, 32 (10.0%) patients suffered an access-related vascular injury and 22 (6.6%) had a bleeding complication (Figure 1A). Technical success was achieved in most cases (n=298; 93.1%). 30-day mortality rate was 1.6% (n=5). Since the first deployment in mid-2018, the rates of MANTA-related complications decreased with increasing experience and a steep learning curve effect was noted (Figure 1B). Conclusions MANTAÒ was rapidly adopted as the default strategy for vascular access site closure after TAVI at our center. A relatively steep learning was observed, suggesting that few procedures are required to acquire device proficiency. In addition, our results suggest that MANTA Ò can effectively close large bore arteriotomies with a low risk of severe complications. Funding Acknowledgement Type of funding sources: None.