Lung volume reduction surgery in pulmonary emphysema; results of a randomised, controlled trial

There are substantial uncertainties regarding the safety and efficacy of Lung Volume Reduction surgery (LVRS). To address this, we have conducted a randomised, controlled trial, in patients with severe emphysema, assessing the outcome of LVRS plus rehabilitation compared to rehabilitation and intensive medical treatment. Between April 1996 and February 1999, 174 subjects were assessed. Following initial investigations and a run-in period of pulmonary rehabilitation, 48 patients were randomised to the surgical or medical group: Mean age 60.4 ± 3 years, FEV₁ 0.82 ± 0.03L, shuttle walk distance (SWD) 249 ± 15m. Those patients randomised to the medical treatment group were informed that they would proceed to surgery if the trial showed significant benefit after interim or final analysis. Mortality was 5/23 in the surgical group and 3/23 in the medical group (NS). There were 3 early deaths in the surgical group in patients with TL_CO <30% predicted and SWD <150m. Entry criteria were therefore modified to exclude such patients after the first 15 patients were randomised. At 3 months, there was an increase in FEV₁ in the LVRS arm of 0.25 ± 0.09L in contrast to a slight fall in FEV₁ in the medical group (-0.04 ± 0.02L) (p