Pan Emily, Kroon Herbert G, Tonino Pim A L, Amoroso Giovanni, Laine Mika, Christiansen Evald H, Toggweiler Stefan, Ten Berg Jur, Malmberg Markus, Slagboom Ton, Moriyama Noriaki, Terkelsen Christian J, Moccetti Federico, Gheorghe Livia, Bigelow Darra, Webb John, Wood David, Van Mieghem Nicholas, Savontaus Mikko
Department of Surgery, Central Finland Hospital Nova, Jyväskylä, Finland.
Department of Cardiology, Turku University Hospital, Turku, Finland.
Catheter Cardiovasc Interv. 2025 Mar;105(4):787-794. doi: 10.1002/ccd.31396. Epub 2025 Jan 3.
Vascular and bleeding complications remain a concern after transfemoral transcatheter aortic valve replacement (TAVR). The impact of the sheath type on these complications remains unclear.
The prospective MARVEL registry study analyzed enrolled 500 patients undergoing large-bore transfemoral procedures and arteriotomy closure with the MANTA vascular closure device from 10 hospitals in Europe and Canada. We stratified these patients according to type of sheath used (expandable or conventional). A propensity-matched analysis was performed using VARC-2 major or minor vascular and bleeding complications as the primary endpoint. The secondary endpoint was time to hemostasis.
We identified 196 propensity-matched pairs. Major vascular complications occurred in 3.6% in the expandable sheath group and 4.1% in the conventional sheath group (p = 1.0). Minor vascular complications occurred in 5.6% in the expandable sheath group and 4.6% in the conventional sheath group (p = 0.819). There were no significant differences in bleeding complications between groups. Time to hemostasis after MANTA closure was significantly shorter in the expandable sheath group (30 vs. 60 s, p < 0.001).
A propensity-matched analysis demonstrated no significant differences in vascular complication rates with MANTA arteriotomy closure after removal of large bore expandable or conventional sheaths. Time to hemostasis was significantly shorter in the expandable sheath group.
经股动脉经导管主动脉瓣置换术（TAVR）后，血管及出血并发症仍是令人担忧的问题。鞘管类型对这些并发症的影响尚不清楚。
前瞻性MARVEL注册研究分析了来自欧洲和加拿大10家医院的500例接受大口径经股动脉手术并使用MANTA血管闭合装置进行动脉切开闭合的患者。我们根据所使用鞘管的类型（可扩张型或传统型）对这些患者进行分层。以VARC-2主要或次要血管及出血并发症作为主要终点进行倾向匹配分析。次要终点为止血时间。
我们确定了196对倾向匹配的病例。可扩张鞘管组主要血管并发症发生率为3.6%，传统鞘管组为4.1%（p = 1.0）。可扩张鞘管组次要血管并发症发生率为5.6%，传统鞘管组为4.6%（p = 0.819）。两组间出血并发症无显著差异。可扩张鞘管组在MANTA闭合后止血时间明显更短（30秒对60秒，p < 0.001）。
倾向匹配分析表明，在拔除大口径可扩张或传统鞘管后，使用MANTA动脉切开闭合术时血管并发症发生率无显著差异。可扩张鞘管组的止血时间明显更短。
