Department of Rhythmology, University Heart Center Lübeck, University Clinic Schleswig-Holstein, Ratzeburger Allee 160, D-23538 Luebeck, Germany.
German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Luebeck, Germany.
Europace. 2024 May 2;26(5). doi: 10.1093/europace/euae105.
Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)].
This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group.
Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.
简化的肺静脉隔离（PVI）消融技术在全球范围内越来越多地应用。PVI 后最常见的并发症之一是血管通路相关并发症。最近，静脉闭合系统（VCS）已被引入临床实践，旨在减少卧床时间，增加患者舒适度，并减少血管通路相关并发症。本研究旨在比较单次 PVI 后使用 VCS 达到止血与实际标准治疗[8 字形缝合和手动压迫（MC）]的安全性和有效性。
这是一项在德国三个中心进行的前瞻性、多中心、随机、对照、开放标签试验。患者按 1:1 随机分为 VCS 组（VCS 组）或 8 字形缝合和 MC 组（F8 组）进行止血。主要疗效终点是下床活动时间，主要安全性终点是主要围手术期不良事件的发生率，直至出院。共纳入 125 例患者。两组的基线特征相似。VCS 组下床活动时间更短[109.0（82.0，160.0）vs. 269.0（243.8，340.5）min；P<0.001]，止血时间更短[1（1，2）vs. 5（2，10）min；P<0.001]，出院资格时间更短[270（270，270）vs. 340（300，458）min；P<0.001]。两组均未报告重大血管通路相关并发症。与对照组相比，VCS 组在手术当天观察到轻微血管通路相关并发症的发生率较低[7（11.1%）vs. 15（24.2%）；P=0.063]。
在房颤消融后，使用 VCS 可显著缩短下床活动、止血和出院资格时间。未发现重大血管通路相关并发症。MC 和 8 字形缝合的使用显示出轻微血管通路相关并发症发生率较高的趋势。
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