The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Cardiology Department, Algemeen Stedelijk Ziekenhuis, Aalst, Belgium.
EuroIntervention. 2024 Mar 18;20(6):e354-e362. doi: 10.4244/EIJ-D-23-00725.
Despite transcatheter aortic valve implantation (TAVI) having become a routine procedure, access site bleeding and vascular complications are still a concern which contribute to procedure-related morbidity and mortality.
The TAVI-MultiCLOSE study aimed to assess the safety and efficacy of a new vascular closure algorithm for percutaneous large-bore arterial access closure following transfemoral (TF)-TAVI.
All consecutive TF-TAVI cases in which the MultiCLOSE vascular closure algorithm was used were prospectively included in a multicentre, observational study. This stepwise algorithm entails the reinsertion of a 6-8 Fr sheath (primary access) following the initial preclosure with one or two suture-based vascular closure devices (VCDs). This provides the operator with the opportunity to perform a quick and easy angiographic control and tailor the final vascular closure with either an additional suture- or plug-based VCD, or neither of these.
Among 630 patients who underwent TF-TAVI utilising the MultiCLOSE algorithm, complete arterial haemostasis was achieved in 616 patients (98%). VCD failure occurred in 14 patients (2%), treated with either balloon inflation (N=1), covered stent (N=12) or surgical repair (N=1). Overall, this vascular closure approach resulted in a minor and major vascular complication rate of 2.2% and 0.6%, respectively. At 30 days, only one new minor vascular complication (0.2%) was noted. In-hospital and 30-day all-cause mortality rates were 0.2% and 1.0%, respectively.
Use of the MultiCLOSE vascular closure algorithm was demonstrated to contribute to an easy, safe, efficacious and durable vascular closure after TF-TAVI, resulting in a major vascular complication rate of less than 1%.
尽管经导管主动脉瓣植入术（TAVI）已成为常规手术，但入路部位出血和血管并发症仍然令人担忧，这导致了与手术相关的发病率和死亡率。
TAVI-MultiCLOSE 研究旨在评估一种新的血管闭合算法在经股动脉（TF）-TAVI 后经皮大口径动脉入路闭合中的安全性和有效性。
所有连续的 TF-TAVI 病例，其中使用了 MultiCLOSE 血管闭合算法，前瞻性地纳入了一项多中心、观察性研究。该逐步算法涉及在最初使用一个或两个基于缝合的血管闭合装置（VCD）进行预闭合后，重新插入 6-8 Fr 鞘（主要入路）。这为操作者提供了进行快速简便的血管造影控制的机会，并可通过额外的基于缝合或基于塞子的 VCD，或者两者都不使用，对最终的血管闭合进行定制。
在 630 例使用 MultiCLOSE 算法进行 TF-TAVI 的患者中，616 例（98%）实现了完全动脉止血。14 例（2%）患者发生 VCD 失败，采用球囊充气（N=1）、覆膜支架（N=12）或手术修复（N=1）治疗。总的来说，这种血管闭合方法导致轻微和主要血管并发症的发生率分别为 2.2%和 0.6%。在 30 天时，仅注意到 1 例新的轻微血管并发症（0.2%）。住院期间和 30 天全因死亡率分别为 0.2%和 1.0%。
使用 MultiCLOSE 血管闭合算法可有助于在 TF-TAVI 后实现简便、安全、有效且持久的血管闭合，主要血管并发症发生率低于 1%。
