A randomized clinical trial of lung volume reduction surgery versus best medical care for patients with advanced emphysema: a two-year study from Canada.

BACKGROUND: We present a summary report evaluating the efficacy of lung volume reduction surgery (LVRS) in patients with advanced emphysema in the Canadian setting.
METHODS: Quality of Life measures assessed the efficacy of adding LVRS to best medical care including rehabilitation in this blinded randomized multicentered controlled trial with 2 years of follow-up. Health utility and quality-adjusted life years (QALY) were outcomes central to our economic assessment.
RESULTS: None of the 32 patients randomized to the LVRS arm or 30 patients in the best medical care (BMC) arm crossed-over and no patients were lost to follow-up. Overall surgical mortality was 16% at 2 years while the overall medical mortality was 13% (p = 0.914). There were no 30-day postoperative deaths but 2 deaths (6%) occurred within 90 days of randomization. Surgery reduced the residual volume measured at 6 months by 23% (5,385 mL to 4,322 mL, p = 0.007). There was an increase in forced expiratory volume in 1 second (FEV1) of 30% (265 mL, p = 0.013) from baseline, an improvement in the six minute walk test (6MWT) of 78 meters (p = 0.045), and an increase in Health Utility Index 3 (HUI3) which peaked at 6 months with a difference of 0.16 (p = 0.129). There was a gain in QALYs of 0.21 (p = 0.19) in the LVRS-arm over the BMC-arm. The LVRS costs an additional 28,119 Canadian dollars (CAD) compared with BMC or 133,900 CAD/QALY gained.
CONCLUSIONS: The addition of LVRS to best medical care including pulmonary rehabilitation improves pulmonary function, exercise activity, and quality of life in selected patients with advanced emphysema. Cost is high but in keeping with other treatment modalities currently available.

RCT Entities:   Population Interventions Outcomes