Vascular Closure Devices After Femoral Access in Adult EP Procedures: Updated Systematic Review and Meta-Analysis.

IF 1.3
Hasnain Wajeeh Saqib, Mohamed Nasser Elshabrawi, Arpitha Sirichandana Baggu, Vikramjit Purewal, Shaiza Maryam, Aneek Ghosh, Syeda Vilay Zehra Rizvi, Neel Ajit Doshi, Hrishikesh Kommu, Yasar Sattar, Ashesh Das, Utkarsh Kohli
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引用次数: 0

Abstract

Background: Femoral vascular access is integral to diagnostic and therapeutic electrophysiology (EP) procedures but is associated with bleeding and access-site complications. Manual compression and figure-of-eight sutures remain widely used for hemostasis; however, they are resource intensive and delay ambulation. Vascular closure devices (VCDs) have been introduced to facilitate rapid hemostasis and improve procedural efficiency, yet evidence specific to adult EP procedures remain conflicting.

Objectives: To systematically evaluate the safety and efficacy of vascular closure devices compared with manual compression or figure-of-eight sutures for femoral access-site closure in adult electrophysiology procedures.

Methods: A systematic review and meta-analysis were conducted in accordance with PRISMA 2020 guidelines. PubMed/MEDLINE, Embase, Cochrane CENTRAL, and Scopus were searched from inception through January 2026. Randomized controlled trials and observational studies enrolling adults (≥ 18 years) undergoing diagnostic electrophysiology studies or catheter ablation with femoral access were included. Structural and valvular interventions were excluded. Random-effects meta-analyses were performed. Safety outcomes were summarized using risk ratios (RRs), and efficiency outcomes using standardized mean differences (SMDs) with 95% confidence intervals (CIs).

Results: Eighteen studies (10 randomized controlled trials and 8 observational studies) involving 40,632 patients were included. Compared with manual compression, VCD was associated with significantly lower risks of access-site hematoma (RR, 0.59; 95% CI, 0.46-0.71), major bleeding (RR, 0.72; 95% CI, 0.55-0.88), minor bleeding (RR, 0.55; 95% CI, 0.17-0.93), and pseudoaneurysm formation (RR, 0.69; 95% CI, 0.54-0.83), with minimal heterogeneity for these outcomes. Absolute risk reductions were modest (number needed to treat: 90 for hematoma; 430 for pseudoaneurysm). VCDs significantly reduced time to hemostasis (SMD, -2.90; 95% CI, -3.71 to -2.08), time to ambulation (SMD, -1.84; 95% CI, -2.45 to -1.24), and time to hospital discharge (SMD, -1.12; 95% CI, -1.66 to -0.58), although heterogeneity for time-based outcomes was high. No significant differences were observed in infection or hospital readmission rates.

Conclusions: In adult electrophysiology procedures, vascular closure devices are associated with modest reductions in access-site complications and substantial improvements in procedural efficiency. These findings support selective adoption of VCDs to optimize patient recovery and workflow, particularly in high-volume EP centers.

成人EP手术中股骨通路后血管闭合装置:更新的系统回顾和荟萃分析。
背景:股血管通路是诊断和治疗性电生理(EP)手术不可或缺的一部分,但与出血和通路部位并发症相关。手动按压和八字缝合仍然广泛用于止血;然而,它们是资源密集型的,并且延迟了移动。血管关闭装置(vcd)已被引入以促进快速止血和提高手术效率,但针对成人EP手术的证据仍然存在冲突。目的:在成人电生理手术中,系统评价血管闭合装置与手动加压或8字形缝合线进行股骨通路闭合的安全性和有效性。方法:根据PRISMA 2020指南进行系统评价和荟萃分析。PubMed/MEDLINE、Embase、Cochrane CENTRAL和Scopus从成立到2026年1月进行了检索。随机对照试验和观察性研究纳入了接受诊断性电生理学研究或经股骨通路导管消融的成人(≥18岁)。排除了结构和瓣膜干预。进行随机效应荟萃分析。使用风险比(rr)总结安全性结果,使用95%置信区间(ci)的标准化平均差异(SMDs)总结效率结果。结果:纳入18项研究(10项随机对照试验和8项观察性研究),涉及40,632例患者。与手工按压相比,VCD与通路部位血肿(RR, 0.59; 95% CI, 0.46-0.71)、大出血(RR, 0.72; 95% CI, 0.55-0.88)、小出血(RR, 0.55; 95% CI, 0.17-0.93)和假性动脉瘤形成(RR, 0.69; 95% CI, 0.54-0.83)的风险显著降低相关,这些结果的异质性最小。绝对风险的降低是适度的(需要治疗的人数:血肿90人;假性动脉瘤430人)。vcd显著缩短了止血时间(SMD, -2.90; 95% CI, -3.71至-2.08)、活动时间(SMD, -1.84; 95% CI, -2.45至-1.24)和出院时间(SMD, -1.12; 95% CI, -1.66至-0.58),尽管基于时间的结果异质性很高。在感染和再入院率方面没有观察到显著差异。结论:在成人电生理手术中,血管闭合装置与通路部位并发症的适度减少和手术效率的显著提高有关。这些发现支持选择性地采用vcd来优化患者恢复和工作流程,特别是在高容量的心电中心。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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