Peri-procedural vs. post-procedural mortality after endobronchial valve treatment for severe emphysema: a systematic review and meta-analysis of randomized controlled trials.

IF 2.7
Expert review of medical devices Pub Date : 2026-09-01 Epub Date: 2026-07-27 DOI:10.1080/17434440.2026.2710806
Pier-Valerio Mari, Simone Ielo, Angelo Coppola, Alberto Ricci, Maria Angela Licata, Roberto Lipsi, Meridiana Dodaj, Francesco Gennari, Eugenio De Corso, Veronica Ojetti, Raffaele Scala, Stefano Baglioni, Michela Bezzi, Lorenzo Carriera
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Abstract

Introduction: Endobronchial valve (EBV) treatment improves functional outcomes in severe emphysema, but its effect on mortality remains uncertain. Recent evidence suggested increased mid-term mortality with EBV, without distinguishing early peri-procedural deaths from later post-procedural mortality.

Methods: PubMed, Embase, Cochrane CENTRAL, and Web of Science were systematically searched from database inception through March 2026 for randomized controlled trials comparing EBV with standard of care (SoC) in patients with severe emphysema. The main outcome was overall mortality, further stratified into peri-procedural mortality (≤90 days) and post-procedural mortality (>90 days).

Results: Six randomized controlled trials involving 819 patients (515 EBV, 304 SoC) were included. Peri-procedural mortality was significantly higher with EBV (Peto OR 3.70, 95% CI 1.07-12.84; p = 0.03). Post-procedural mortality was not significantly increased (Peto OR 0.50, 95% CI 0.12-2.09; p = 0.33). Overall mortality did not differ significantly between groups (Peto OR 1.57, 95% CI 0.61-4.04; p = 0.35).

Conclusions: In randomized trials, the mortality signal associated with EBV appears confined to the peri-procedural period and is largely driven by pneumothorax-related deaths. No excess mortality was observed beyond 90 days. These findings may inform patient counseling, peri-procedural management, and future trials with survival endpoints.

严重肺气肿支气管内瓣膜治疗前后的死亡率:随机对照试验的系统回顾和荟萃分析
简介:支气管内瓣膜(EBV)治疗改善了严重肺气肿的功能结局,但其对死亡率的影响仍不确定。最近的证据表明,EBV的中期死亡率增加,但没有区分早期手术期间死亡和后期手术后死亡。方法:系统检索PubMed、Embase、Cochrane CENTRAL和Web of Science从数据库建立到2026年3月的随机对照试验,比较EBV与标准护理(SoC)在严重肺气肿患者中的疗效。主要转归为总死亡率,并进一步分为术中死亡率(≤90天)和术后死亡率(≤90天)。结果:纳入6项随机对照试验,共819例患者(EBV 515例,SoC 304例)。EBV患者的手术期死亡率明显更高(Peto OR 3.70, 95% CI 1.07-12.84; p = 0.03)。术后死亡率无显著升高(Peto OR 0.50, 95% CI 0.12-2.09; p = 0.33)。两组间总死亡率无显著差异(Peto OR 1.57, 95% CI 0.61-4.04; p = 0.35)。结论:在随机试验中,与EBV相关的死亡率信号似乎局限于围手术期,并且主要由气胸相关死亡驱动。超过90天未观察到额外死亡率。这些发现可以为患者咨询、围手术期管理和未来的生存终点试验提供信息。
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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