Prospective randomized trial comparing bilateral lung volume reduction surgery to pulmonary rehabilitation in severe chronic obstructive pulmonary disease

Several uncontrolled studies report improvement in lung function, gas excha nge, and exercise capacity after bilateral lung volume reduction surgery (L VRS). We recruited 200 patients with severe chronic obstructive pulmonary d isease (COPD) for a prospective randomized trial of pulmonary rehabilitatio n versus bilateral LVRS with stapling resection of 20 to 40% of each lung. Pulmonary function tests, gas exchange, 6-min walk distance, and symptom-li mited maximal exercise testing were done in all patients at baseline and af ter 8 wk of rehabilitation. Patients were then randomized to either 3 addit ional months of rehabilitation or LVRS. Thirty-seven patients met study cri teria and were enrolled into the trial. Eighteen patients were in the medic al arm; 15 of 18 patients completed 3 mo of additional pulmonary rehabilita tion. Thirty-two patients underwent LVRS (19 in the surgical arm, 13 crosso ver from the medical arm). After 8 wk of pulmonary rehabilitation, pulmonar y function tests remained unchanged compared with baseline data. However, t here was a trend toward a higher 6-min walk distance (285 +/- 96 versus 269 +/- 91 m, p = 0.14) and total exercise time on maximal exercise test was s ignificantly longer compared with baseline values (7.4 +/- 2.1 versus 5.8 /- 1.7 min, p < 0.001). In 15 patients who completed 3 mo of additional reh abilitation, there was a trend to a higher maximal oxygen consumption (Vo(2 )max) (13.3 +/- 3.0 versus 12.6 +/- 3.3, p < 0.08). In contrast, at 3 mo po st-LVRS, FVC (2.79 +/- 0.59 versus 2.36 +/- 0.55 L, p < 0.001) and FEV1 (0. 85 +/- 0.3 versus 0.65 +/- 0.16 L, p < 0.005) increased whereas TLC (6.53 /- 1.3 versus 7.65 +/- 2.1 L, p < 0.001) and residual volume (RV) (3.7 +/- 1.2 versus 4.9 +/- 1.1 L, p < 0.001) decreased when compared with 8 wk post rehabilitation data. In addition, Pa-CO2 decreased significantly 3 mo post- LVRS compared with 8 wk postrehabilitation. Six-minute walk distance (6MWD) , total exercise time, and Vo(2)max were higher after LVRS but did not reac h statistical significance. However, when 13 patients who crossed over from the medical to the surgical arm were included in the analysis, the increas es in 6MWD (337 +/- 99 versus 282 +/- 100 m, p < 0.001) and iio,max (13.8 /- 4 versus 12.0 +/- 3 ml/kg/min, p < 0.01) 3 mo post-LVRS were highly sign ificant when compared with postrehabilitation data. The Sickness Impact Pro file (SIP), a generalized measure of quality of life (QOL), was significant ly improved after 8 wk of rehabilitation and was maintained after 3 mo of a dditional rehabilitation. A further improvement in QOL was observed 3 mo af ter LVRS compared with the initial improvement gained after 8 wk of rehabil itation. There were 3 (9.4%) postoperative deaths, and one patient died bef ore surgery (2.7%). We conclude that bilateral LVRS, in addition to pulmona ry rehabilitation, improves static lung function, gas exchange, and QOL com pared with pulmonary rehabilitation alone. Further studies need to evaluate the risks, benefits, and durability of LVRS over time.