Background The MANTA vascular closure device (VCD) is a novel collagen plug-based VCD for large bore arteriotomies. The current literature regarding complication rates of this device is quite variable and mostly limited to relatively small case series.

Methods This study is retrospective analysis of the MANTA VCD-related main access site complications according to Valve Academic Research Consortium-2 (VARC-2) criteria during the hospital stay. Particular attention was paid to the detailed analysis of multislice computed tomography with regard to the anatomy of the access vessel and the puncture site itself.

Results A total of 524 patients underwent transfemoral transcatheter aortic valve implantation (TF TAVI) including the use of the MANTA device (18F) for percutaneous vascular closure. A group of 22 patients was excluded from the study due to incomplete imaging data. During the study period, we observed 28 major (5.6%) and five minor (1.0%) MANTA device-related vascular complications. There was no patient death related to these adverse events. Female gender, vessel angulation at the puncture site, and at least moderate calcification of the dorsal vessel segment were identified as independent predictors for major complications.

Conclusions The MANTA device is a feasible option for vascular closure of large bore arteriotomies in patients undergoing TF TAVI or other percutaneous transfemoral interventions. Furthermore, we have identified novel predictors for device failure/complications that should be taken into account for selection of the appropriate closure device. To our knowledge, this report is one of the largest case series analyzing the use of the MANTA VCD.

背景 MANTA 血管闭合装置 (VCD) 是一种新型的基于胶原塞的 VCD，用于大口径动脉切开术。目前关于该装置并发症发生率的文献变化很大，并且大多局限于相对较小的病例系列。

方法 本研究是根据 Valve Academic Research Consortium-2 (VARC-2) 标准在住院期间对 MANTA VCD 相关主要通路部位并发症的回顾性分析。特别注意了关于通路血管和穿刺部位本身的解剖学的多层计算机断层扫描的详细分析。

结果 共有 524 名患者接受了经股动脉经导管主动脉瓣植入术 (TF TAVI)，包括使用 MANTA 装置 (18F) 进行经皮血管闭合术。由于成像数据不完整，一组 22 名患者被排除在研究之外。在研究期间，我们观察到 28 例主要 (5.6%) 和 5 例轻微 (1.0%) MANTA 装置相关血管并发症。没有与这些不良事件相关的患者死亡。女性、穿刺部位的血管角度和背侧血管段的至少中度钙化被确定为主要并发症的独立预测因子。

结论 MANTA 装置是接受 TF TAVI 或其他经皮经股动脉介入治疗患者大口径动脉切开术血管闭合的可行选择。此外，我们已经确定了装置故障/并发症的新预测因素，在选择合适的闭合装置时应考虑这些因素。据我们所知，这份报告是分析 MANTA VCD 使用情况的最大案例系列之一。