Authors
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
Published in
Expert review of medical devices. Jul 25, 2026. Epub Jul 25, 2026.
Abstract
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.
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).
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).
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.
PMID:
42500855
Bibliographic data and abstract were imported from PubMed on 25 Jul 2026.
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