Introduction: The recent multi-center STEP-UP RCT1 showed statistically significant and clinically meaningful improvements in lung function and quality of life at 12-months with a low rate of major complications in patients with severe emphysema treated with BTVA. Other recent endoscopic lung volume reduction studies suggest superior results following treatment in patients with more severe hyperinflation compared with mild-to-moderate degrees of hyperinflation.2
Objective: To assess efficacy and safety of BTVA in patients with severe hyperinflation (RV =225%), compared to mild-to-moderate hyperinflation (RV =150% to <225%).
Methods: A subgroup analysis of the primary endpoints of the STEP-UP RCT was performed post-hoc on all patients using the baseline RV. Major complications included any pneumothorax, hemoptysis, or event requiring ICU stay, and death.
Results: Patients with RV= 225% had a better response to BTVA treatment compared with patients with RV= 150% to <225%.
Multi-Center STEP-UP RCT RV Analysis
Mild-to-Moderate Hyperinflation (RV =150% to <225%)
Treatment n=20Control n=10
P-value
Severe Hyperinflation (RV =225%)
Treatment n=24Control n=13
FEV1%(95% CI) 12-mo change from Control
SGRQ points(95% CI) 12-mo change from Control
Major Complications% (patients)
NA - Not Applicable
Conclusion: BTVA in emphysema patients with severe hyperinflation have significant and clinically meaningful improvements in FEV1 and SGRQ with a low rate of pneumothorax or other major complications.