BackgroundThe hybrid strategy combining plug‐based and suture‐based vascular closure devices (VCD) was introduced as a promising technique for vascular access hemostasis after transcatheter aortic valve implantation (TAVI) with satisfactory outcomes. However, data comparing two plug‐based VCDs each in the combination with a suture‐based VCD, namely ProGlide/AngioSeal (P/AS) with ProGlide/FemoSeal (P/FS) VCDs, is still lacking.AimsTo compare the 30‐day outcome of the hybrid strategy using P/AS versus P/FS for vascular access site closure after TAVI.MethodsA retrospective single‐center observational study included 608 patients recruited from a prospective TAVI registry between 2016 and 2022. The composite endpoint was defined as any VCD‐related major vascular complications and/or bleeding more than type 1 according to Valve Academic Research Consortium criteria.ResultsThe current study reported a significantly higher rate of composite endpoint in P/AS group, which was driven by a higher rate of major bleeding (5.4% vs. 1.4%, p = 0.036). We also found a higher rate of VCD‐related minor bleeding in P/AS group (16.3% vs. 8.1%, p = 0.013). Successful access site hemostasis was achieved in 71.7% of P/AS group versus 83.1% in P/FS group (p = 0.006). The presence of anterior wall calcification at the access site was significantly associated with the composite endpoint (adj odds ratio 2.49; 95% confidence interval (1.08–5.75), p = 0.032).ConclusionThe hybrid strategy for large bore vascular access closure using P/FS showed a potentially better 30‐day outcomes compared with P/AS. The presence of anterior calcification at the access site carries a significant risk of VCD‐related complications.

中文翻译：

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ProGlide-AngioSeal 与 ProGlide-FemoSeal 用于经导管主动脉瓣植入术后血管通路止血的比较


背景结合基于塞子和基于缝合线的血管闭合装置 （VCD） 的混合策略被引入，作为经导管主动脉瓣植入术 （TAVI） 后血管通路止血的一种有前途的技术，结果令人满意。然而，仍然缺乏比较两种基于插头的 VCD 与基于缝合的 VCD 的组合的数据，即 ProGlide/AngioSeal （P/AS） 与 ProGlide/FemoSeal （P/FS） VCD。目的比较使用 P/AS 与 P/FS 的混合策略在 TAVI 后血管通路部位闭合的 30 天结果。方法一项回顾性单中心观察性研究包括 608 年至 2016 年间从前瞻性 TAVI 登记处招募的 2022 名患者。根据 Valve Academic Research Consortium 标准，复合终点定义为任何与 VCD 相关的主要血管并发症和/或超过 1 型的出血。结果目前的研究报道了 P/AS 组复合终点率显着升高，这是由较高的大出血率驱动的 （5.4% vs. 1.4%，p = 0.036）。我们还发现 P/AS 组 VCD 相关轻微出血的发生率更高 （16.3% vs. 8.1%，p = 0.013）。P/AS 组 71.7% 成功进入部位止血，而 P/FS 组为 83.1% （p = 0.006）。入路部位前壁钙化的存在与复合终点显著相关 （调整比值比 2.49;95% 置信区间 （1.08-5.75），p = 0.032）。结论与 P/AS 相比，使用 P/FS 的大口径血管通路闭合混合策略显示可能更好的 30 天结局。入路部位前钙化存在 VCD 相关并发症的重大风险。