RT Journal Article
SR Electronic
T1 Twelve-month positive outcomes of Zephyr endobronchial valves in severe emphysema patients: LIBERATE trial
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP OA4932
DO 10.1183/13993003.congress-2018.OA4932
VO 52
IS suppl 62
A1 Dirk-Jan Slebos
A1 Shawn Wright
A1 Richard Sue
A1 Mark Dransfield
A1 Hiram Rivas-Perez
A1 Tanya Wiese
A1 Frank Sciurba
A1 Pallav Shah
A1 Momen Wahidi
A1 Hugo De Oliviera
A1 Brian Morrissey
A1 Paulo Cardoso
A1 Steven Hays
A1 Adnan Majid
A1 Nicholas Pastis
A1 Lisa Kopas
A1 Mark Vollenweider
A1 Paul M. Mcfadden
A1 Michael Machuzak
A1 David Hsia
A1 Arthur Sung
A1 Nabil Jarad
A1 Malgorzata Kornaszewska
A1 Stephen Hazelrigg
A1 Ganesh Krishna
A1 Nick Ten Hacken
A1 Narinder Shargill
A1 Gerard Criner
YR 2018
UL http://erj.ersjournals.com/content/52/suppl_62/OA4932.abstract
AB Introduction: Zephyr® Endobronchial Valve (EBV®) treatment in severe emphysema patients, improves lung function, exercise capacity and quality of life.Objective: Evaluate effectiveness and safety of EBV treatment in severe emphysema.Methods: 190 severe heterogeneous emphysema subjects (M47%/F53%) with hyperinflation (FEV1 27.4 %pred; RV 224.5 %pred) and absent collateral ventilation (Chartis®) were randomized 2:1 (EBV:Standard-of-Care (SoC). Responders were classified according to established Minimal Clinically Important Differences for outcome measures.Results: At 12-months 84.2% EBV subjects had a target lobe volume reduction ≥350mL. Between group differences (ΔEBV–SoC) for mean changes from baseline were significant (p<0.05) at 12 months: ΔFEV1= +0.106L (17.6%); ΔSGRQ= -7.1 points; ΔBODE Index= -1.2 points; and Δ6MWD= +39.3m. Responder rates significantly favored EBV over SoC for all measures (Figure).Major serious adverse events in the EBV group <45 days post-procedure were pneumothorax (EBV 26.6% vs SoC 0%), COPD exacerbations (7.8% vs 4.8%), and death (3.1% vs 0%). Between 45-days out to 12-months, these were COPD exacerbations (23.0% vs 30.6%) and death (0.8% vs 1.6%).Conclusions: Zephyr EBV treatment provides durable, clinically meaningful improvements in lung function, exercise capacity, dyspnea and quality of life in hyperinflated, severe emphysema patients with absent collateral ventilation.FootnotesCite this article as: European Respiratory Journal 2018 52: Suppl. 62, OA4932.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).