Basman Craig, Kodra Arber, Mustafa Ahmad, Wang Denny, Cinelli Michael, Onyebeke Kenenna, Rutkin Bruce, Mehla Priti, Maniatis Gregory, Pirelli Luigi, Goldberg Ythan, Liu Shangyi, Uttar Sridhar, Wilson Sean, Kalimi Robert, Brinster Derek, Gandotra Puneet, Koss Elana, Meraj Perwaiz, Mihelis Efstathia, Supariwala Azhar, Hartman Alan, Scheinerman S Jacob, Kliger Chad
Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York.
Department of Cardiovascular & Thoracic Surgery, Staten Island University Hospital/Northwell Health, New York, New York.
J Soc Cardiovasc Angiogr Interv. 2024 Apr 3;3(6):101929. doi: 10.1016/j.jscai.2024.101929. eCollection 2024 Jun.
Hemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized.
Data were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone ("legacy strategy") and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria.
A total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; < .001). Both minor (3.92% vs 1.12%; = .002) and major (1.14% vs 0.19%; = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD.
A contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR.
经股动脉经导管主动脉瓣置换术（TAVR）的止血通常在插入大口径鞘管之前使用缝线介导的血管闭合装置（VCD）来实现（预闭合技术）。最近，在止血失败的情况下，采用了一种混合闭合技术，即在预闭合技术的基础上，在拔除鞘管后加用胶原塞VCD。
数据收集自诺斯韦尔TAVR注册中心，包括3个高容量TAVR中心。我们评估了单纯使用缝线介导的血管闭合的预闭合策略（“传统策略”）和标准补救技术，以及缝线介导闭合与胶原介导闭合补救的当代混合策略。主要终点是VARC-3标准定义的主要或次要血管并发症。
共纳入1327例患者，其中791例患者仅接受缝线介导闭合的TAVR，536例采用当代策略。当代策略的主要终点（主要或次要血管并发症）更低（5.44%对1.31%；P<.001）。当代策略中次要（3.92%对1.12%；P=.002）和主要（1.14%对0.19%；P=.0196）血管并发症均减少，住院总时长也更短（中位数3天对2天；P<.0001）。通过多变量分析，我们观察到，在对鞘管尺寸、外周动脉疾病、颈动脉疾病和手术部位进行调整后，血管管理策略显著改善了复合主要结局。在当代组中，68例患者（12.69%）使用了带Angio-Seal（泰尔茂医疗）的补救性胶原塞VCD，4例患者（0.75%）需要使用补救性MANTA（泰利福）。接受补救性胶原塞VCD的患者中没有主要或次要血管并发症。
缝线介导闭合与胶原介导闭合补救的当代混合策略可降低经股动脉TAVR患者的血管并发症风险。
