Lung Volume Reduction with Vapor Ablation in the Presence of Incomplete Fissures: 12-Month Results from the STEP-UP Randomized Controlled Study

Abstract

Background: Emphysema patients with collateral ventilation (CV) will not benefit from valve therapy, the most common endoscopic lung volume reduction procedure. A recent randomized controlled trial (STEP-UP) of the alternative bronchoscopic thermal vapor ablation (BTVA) included patients with (CV+) and without interlobar CV (CV-). Objectives: This analysis evaluated the efficacy and safety of the CV+ population following BTVA. Method: A post hoc fissure analysis of the baseline computed tomography of all treatment and control patients was performed with the VIDA Diagnostics Apollo software. A patient was considered to be CV+ if either of the treated upper lobes was adjacent to a fissure that was <90% complete. The primary endpoints, forced expiratory volume in 1 s (FEV₁) and St. George's Respiratory Questionnaire (SGRQ-C), were calculated for these CV+ patients following BTVA and safety results summarized. Results: 78% (35/45) of the patients in the treatment arm and 79% (19/24) of the patients in the control arm were found to be CV+. At 12 months, the FEV₁ improvement of the treatment arm was 9.2%, as compared with a decrease of 5.4% in the control group, resulting in a mean between-group difference of 14.6% (p = 0.0137). The improvement in SGRQ-C of the treatment arm as compared to the control arm was 8.4 points (p = 0.0712). An increase in respiratory related serious adverse events was observed immediately following treatment, but most resolved with routine care. Conclusion: BTVA can achieve safe and clinically meaningful improvement in pulmonary function and quality of life in patients with CV. These randomized controlled trial subgroup results offer proof of a viable solution for CV+ patients.

Bronchoscopic Thermal Vapor Ablation: Best Practice Recommendations from an Expert Panel on Endoscopic Lung Volume Reduction

“…Improvements in quality of life (SGRQ) in contrast appeared to further increase over time. Importantly, interlobar fissure integrity, an independent predictor of response to bronchoscopic volume reduction therapy with one-way valves, did not influence outcomes with BTVA in both above mentioned multicenter studies [8, 9]. With regards to the safety profile, patients in the intervention group experienced a higher pneumonia (18 vs. 8%) and COPD exacerbation rate (24 vs. 4%) at 6 months after treatment compared with controls; however, all events were managed with standard medical treatment representing an improvement over previous lobar-based studies.…”

“…The system also provides possible target locations for treatment and the dose of calorific energy required. As the efficacy of BTVA is independent of interlobar CV, BTVA can be used irrespective of fissure integrity [8, 9]. Nevertheless, for each patient who is considered for any ELVR treatment, an assessment of interlobar CV is crucial as the degree of CV influences the choice of the ELVR method.…”

Bronchoscopic lung volume reduction: recent updates

“…A sub study of the STEP-UP study evaluated patients with collateral ventilation (39). A post-hoc fissure analysis of all treated and control patients was performed and patients with collateral ventilation were identified if adjacent fissures were <90% complete.…”

Importance of bronchoscopic lung volume reduction coil therapy in potential candidates for lung transplantation

“…In recent years, bronchoscopic lung volume reduction (BLVR) has become an alternative and promising treatment modality for selected severe emphysema patients (6). The loss of elastic recoil and hyperinflation caused by the emphysema can be treated with BLVR using the coil, valve, or thermal vapor ablation method (7)(8)(9). The main indications of this treatment modality are a forced expiration volume in one second (FEV 1 ) of 15-45% and an RV of more than 175% in patients with emphysema diagnosed by computed tomography (CT).…”