OBJECTIVE: To contribute to the knowledge on the therapeutic value of lung volume reduction surgery (LVRS). DESIGN: Two similar, independently conceived and conducted, multicenter, randomized clinical trials. SETTING: The Canadian Lung Volume Reduction (CLVR) study and the Overholt-Blue Cross Emphysema Surgery Trial (OBEST). METHODS: Using a fixed-effects meta-analysis, the 6-month results produced by the addition of LVRS to optimal medical therapy were compared to those obtained from optimal medical therapy alone. Patients were required to have severe emphysema, marked airflow limitation (ie, FEV(1), 15 to 40% predicted), hyperinflation (total lung capacity [TLC], > 120% predicted), CO(2), < 55 mm Hg, and measurable dyspnea (chronic respiratory disease questionnaire [CRDQ] scores </= 4 for the CLVR study, or Medical Research Council dyspnea scale >/= 1 for the OBEST). Optimal medical therapy included pulmonary rehabilitation in both arms of both studies. RESULTS: The CLVR study randomized 58 patients and the OBEST randomized 35 patients for a total of 93 patients. Of these, 54 patients were randomized to undergo surgery, and 39 patients were randomized to receive medical treatment. The 6-month mortality rate (including operative mortality) in the surgical and medical cohorts was similar (5.6% vs 5.1%, respectively). A comparison of the medical and surgical arms of the combined CLVR study/OBEST population showed that LVRS was associated with a higher FEV(1) (167 mL or 24% predicted; 95% confidence interval [CI], 29 to 304; p = 0.017), lower residual volume (-1,342 mL or 24.5% predicted; 95% CI, -1,844 to -840; p < 0.001), lower TLC (-1,044 mL or 13% predicted; 95% CI, -1483 to -605; p < 0.001), and higher 6-min walk distance (148.8 feet; 95% CI, 24.3 to 273.2; p = 0.019). Each domain of the CRDQ showed statistically significant improvement in the surgical arm of the study, but not in the medical arm. The summary physical component scale of the Medical Outcomes Study 36-item short form (SF-36) was also more favorable in the LVRS cohort (6.9; 95% CI, 2.86 to 10.90; p < 0.001). The summary mental component scale of the SF-36 did not show a statistically significant difference between the two groups. CONCLUSION: Six months after randomization, LVRS produced better palliation than optimal medical therapy in patients with advanced emphysema.
RCT Entities:
OBJECTIVE: To contribute to the knowledge on the therapeutic value of lung volume reduction surgery (LVRS). DESIGN: Two similar, independently conceived and conducted, multicenter, randomized clinical trials. SETTING: The Canadian Lung Volume Reduction (CLVR) study and the Overholt-Blue Cross Emphysema Surgery Trial (OBEST). METHODS: Using a fixed-effects meta-analysis, the 6-month results produced by the addition of LVRS to optimal medical therapy were compared to those obtained from optimal medical therapy alone. Patients were required to have severe emphysema, marked airflow limitation (ie, FEV(1), 15 to 40% predicted), hyperinflation (total lung capacity [TLC], > 120% predicted), CO(2), < 55 mm Hg, and measurable dyspnea (chronic respiratory disease questionnaire [CRDQ] scores </= 4 for the CLVR study, or Medical Research Council dyspnea scale >/= 1 for the OBEST). Optimal medical therapy included pulmonary rehabilitation in both arms of both studies. RESULTS: The CLVR study randomized 58 patients and the OBEST randomized 35 patients for a total of 93 patients. Of these, 54 patients were randomized to undergo surgery, and 39 patients were randomized to receive medical treatment. The 6-month mortality rate (including operative mortality) in the surgical and medical cohorts was similar (5.6% vs 5.1%, respectively). A comparison of the medical and surgical arms of the combined CLVR study/OBEST population showed that LVRS was associated with a higher FEV(1) (167 mL or 24% predicted; 95% confidence interval [CI], 29 to 304; p = 0.017), lower residual volume (-1,342 mL or 24.5% predicted; 95% CI, -1,844 to -840; p < 0.001), lower TLC (-1,044 mL or 13% predicted; 95% CI, -1483 to -605; p < 0.001), and higher 6-min walk distance (148.8 feet; 95% CI, 24.3 to 273.2; p = 0.019). Each domain of the CRDQ showed statistically significant improvement in the surgical arm of the study, but not in the medical arm. The summary physical component scale of the Medical Outcomes Study 36-item short form (SF-36) was also more favorable in the LVRS cohort (6.9; 95% CI, 2.86 to 10.90; p < 0.001). The summary mental component scale of the SF-36 did not show a statistically significant difference between the two groups. CONCLUSION: Six months after randomization, LVRS produced better palliation than optimal medical therapy in patients with advanced emphysema.
Authors: Wei Huang; Wen R Wang; Bo Deng; You Q Tan; Guang Y Jiang; Hai Jing Zhou; Yong He Journal: J Cardiothorac Surg Date: 2011-11-10 Impact factor: 1.637
Authors: Denis E O'Donnell; Shaw Aaron; Jean Bourbeau; Paul Hernandez; Darcy D Marciniuk; Meyer Balter; Gordon Ford; Andre Gervais; Rogers Goldstein; Rick Hodder; Alan Kaplan; Sean Keenan; Yves Lacasse; Francois Maltais; Jeremy Road; Graeme Rocker; Don Sin; Tasmin Sinuff; Nha Voduc Journal: Can Respir J Date: 2007-09 Impact factor: 2.409