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

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