One-Year Follow-Up after Endobronchial Valve Treatment in Patients with Emphysema without Collateral Ventilation Treated in the STELVIO Trial

Abstract

Background: One-way endobronchial valve (EBV) treatment has shown safety and efficacy at 6 months after treatment in patients with severe emphysema and confirmed absence of interlobar collateral ventilation. Longer follow-up in this subgroup is not available.

Objectives: To investigate the efficacy and safety of EBV treatment of the STELVIO cohort at a 1-year follow-up.

Methods: Emphysema patients who have been treated with EBV in the STELVIO trial were invited for a voluntary 1-year follow-up visit. Both the original treatment group and the control group who crossed over to treatment have been included. Analyses are performed on the patients who attended the 1-year follow-up visit.

Results: Sixty-four patients received EBV treatment. At 1 year, 40 patients (26 female; mean age 59 ± 8 years; FEV1 0.86 ± 0.29 L; RV 4.56 ± 1.00 L; 6MWD 367 ± 78 m; and SGRQ 56 ± 13 points) visited the hospital. Significant improvements (p < 0.001) were found for FEV1 (+17%, 95% CI, 11 to 24), RV (-687 mL, 95% CI, -918 to -456), 6MWD (+61 m, 95% CI, 42 to 80), and SGRQ (-11 points, 95% CI, -17 to -6). Two patients died: 1 after 58 days due to progressive respiratory failure and 1 after 338 days of follow-up due to a myocardial infarction. Seventeen percent of the patients underwent valve replacement and 22% of the initially treated patients had permanent valve removal. In 22% of the patients, pneumothoraces occurred before 6 months, and none occurred between 6 and 12 months.

Conclusions: EBV treatment results in clinically relevant benefits at 1 year of follow-up. Maintenance bronchoscopies to achieve this are needed. This study supports the use of EBV treatment in carefully selected patients with severe emphysema without collateral ventilation.

© 2016 The Author(s) Published by S. Karger AG, Basel.

Figures

Fig. 1

Study flowchart. EBV, endobronchial valve.

Fig. 2

Efficacy outcomes compared to baseline at the 1-year follow-up of the patients who attended the 1-year follow-up visit (n = 40). The data are presented as mean change from baseline to 1 year of follow-up for 5 different groups: complete group (n = 40), homogeneous distribution (n = 21), heterogeneous distribution (n = 19), upper lobe treatment (n = 22), and lower lobe treatment (n = 18). Horizontal bars represent the MCID value for each outcome. FEV1, forced expiratory volume in 1 s; 6MWD, 6-min walk distance; RV, residual volume; SGRQ, St. George's Respiratory Questionnaire.

Fig. 3

Individual patient outcomes compared to baseline at 6 months and 1 year of follow-up of the patients who attended the voluntary 1-year follow-up visit (n = 40). The data are presented as change from baseline to 6 months and 1 year of follow-up. FEV1, forced expiratory volume in 1 s; 6MWD, 6-min walk distance, RV, residual volume; SGRQ, St. George's Respiratory Questionnaire.