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.

The REACH Trial: A Randomized Controlled Trial Assessing the Safety and Effectiveness of the Spiration® Valve System in the Treatment of Severe Emphysema

“…The FEV 1 responder rate in our study (47.6% at the 3-month primary endpoint) was comparable with that in the BeLieVeR-HIFi [9] (47% when collateral ventilation-positive patients were excluded) and STELVIO (59%) [10] single-center studies and the multicenter TRANSFORM [19] (55% using a ≥12% improvement threshold) and LIBERATE [20] (47.7% at 12 months) studies. Moreover, QCT was sufficient to screen responders, without the need for adjunctive collateral ventilation assessments, as required in other studies [9, 10].…”

“…Moreover, QCT was sufficient to screen responders, without the need for adjunctive collateral ventilation assessments, as required in other studies [9, 10]. …”

“…The initial bronchoscopic valve studies were promising, but failed to meet their endpoints; however, subgroup analysis of the data did identify a subset of patients with complete interlobar fissure (i.e., little or no collateral ventilation) and heterogeneous distribution of emphysema in whom there was clinically significant benefit with valve therapy [8]. Subsequent studies (BeLieVeR-HIFi, STELVIO) have demonstrated effectiveness in this selected emphysema population [9, 10] and have provided compelling enough results to warrant the inclusion of bronchoscopic lung volume reduction as a treatment option in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines [1]. …”

Endoscopic Lung Volume Reduction: An Expert Panel Recommendation - Update 2017

“…An update of the STELVIO trial [25] has been published in the last few months. In the STELVIO trial, the best responder criteria to EBV treatment were evaluated in a randomized controlled trial, using the Chartis system as primary treatment assessment tool [26] .…”

Bronchoscopic Lung Volume Reduction Treatment Using Endobronchial Valves for Emphysema: Emerging Questions

“…To date, results have been published on safety and efficacy of the endobronchial valve treatment up to 1 year after treatment [8]. Currently, about 3 out of 4 treated patients retain the valves 1 year later.…”