TY - JOUR
T1 - Twelve-month positive outcomes of Zephyr endobronchial valves in severe emphysema patients
T2 - 28th International Congress of the European-Respiratory-Society (ERS)
AU - Slebos, Dirk-Jan
AU - Wright, Shawn
AU - Sue, Richard
AU - Dransfield, Mark
AU - Rivas-Perez, Hiram
AU - Wiese, Tanya
AU - Sciurba, Frank
AU - Shah, Pallav
AU - Wahidi, Momen
AU - De Oliviera, Hugo
AU - Morrissey, Brian
AU - Cardoso, Paulo
AU - Hays, Steven
AU - Majid, Adnan
AU - Pastis, Nicholas
AU - Kopas, Lisa
AU - Vollenweider, Mark
AU - Mcfadden, Paul M.
AU - Machuzak, Michael
AU - Hsia, David
AU - Sung, Arthur
AU - Jarad, Nabil
AU - Kornaszewska, Malgorzata
AU - Hazelrigg, Stephen
AU - Krishna, Ganesh
AU - Ten Hacken, Nick
AU - Shargill, Narinder
AU - Criner, Gerard
PY - 2018/9/15
Y1 - 2018/9/15
N2 - 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. 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.
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. 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.
U2 - 10.1183/13993003.congress-2018.OA4932
DO - 10.1183/13993003.congress-2018.OA4932
M3 - Meeting Abstract
SN - 0903-1936
VL - 52
JO - European Respiratory Journal
JF - European Respiratory Journal
IS - Suppl.62
Y2 - 15 September 2018 through 19 September 2018
ER -