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* From McMaster University (Drs. Miller, Goldsmith, Higgins, and Cox), Hamilton, ON, Canada; the Harvard Medical School (Drs. Berger, Ingenito, and Wright), Boston, MA; the University of Western Ontario (Dr. Malthaner), London, ON, Canada; Tufts University School of Medicine (Dr. Celli), Boston, MA; and the University of Massachusetts School of Medicine (Dr. Bagley), Worcester, MA.
A list of centers and individuals participating in the CLVR-OBEST Study Group is located in the Appendix.
Correspondence to: Robert L. Berger, MD, 60 Heath St, Brookline, MA 02445; e-mail: robert_berger{at}hms.harvard.edu
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, FEV1, 15 to 40% predicted), hyperinflation (total lung capacity [TLC], > 120% predicted), CO2, < 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 FEV1 (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.
Key Words: chronic obstructive lung disease COPD emphysema lung volume reduction pneumectomy quality of life randomized multicentered clinical trial surgery
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