Patients at High Risk of Death after Lung-Volume-Reduction Surgery

doi:10.1056/NEJMoa11798

Volume 345:1075-1083		October 11, 2001		Number 15

Patients at High Risk of Death after Lung-Volume–Reduction Surgery

National Emphysema Treatment Trial Research Group

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Editorial
by Drazen, J. M.

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ABSTRACT

Background Lung-volume–reduction surgery is a proposedtreatment for emphysema, but optimal selection criteria havenot been defined. The National Emphysema Treatment Trial isa randomized, multicenter clinical trial comparing lung-volume–reductionsurgery with medical treatment.

Methods After evaluation and pulmonary rehabilitation, we randomlyassigned patients to undergo lung-volume–reduction surgeryor receive medical treatment. Outcomes were monitored by anindependent data and safety monitoring board.

Results A total of 1033 patients had been randomized by June2001. For 69 patients who had a forced expiratory volume inone second (FEV₁) that was no more than 20 percent of theirpredicted value and either a homogeneous distribution of emphysemaon computed tomography or a carbon monoxide diffusing capacitythat was no more than 20 percent of their predicted value, the30-day mortality rate after surgery was 16 percent (95 percentconfidence interval, 8.2 to 26.7 percent), as compared witha rate of 0 percent among 70 medically treated patients (P<0.001).Among these high-risk patients, the overall mortality rate washigher in surgical patients than medical patients (0.43 deathsper person-year vs. 0.11 deaths per person-year; relative risk,3.9; 95 percent confidence interval, 1.9 to 9.0). As comparedwith medically treated patients, survivors of surgery had smallimprovements at six months in the maximal workload (P=0.06),the distance walked in six minutes (P=0.03), and FEV₁ (P<0.001),but a similar health-related quality of life. The results ofthe analysis of functional outcomes for all patients, whichaccounted for deaths and missing data, did not favor eithertreatment.

Conclusions Caution is warranted in the use of lung-volume–reductionsurgery in patients with emphysema who have a low FEV₁ and eitherhomogeneous emphysema or a very low carbon monoxide diffusingcapacity. These patients are at high risk for death after surgeryand also are unlikely to benefit from the surgery.

Source Information

The writing committee of the National Emphysema Treatment Trial (Alfred Fishman, M.D., University of Pennsylvania, Philadelphia; Henry Fessler, M.D., Johns Hopkins University, Baltimore; Fernando Martinez, M.D., University of Michigan, Ann Arbor; Robert J. McKenna, Jr., M.D., Cedars–Sinai Medical Center, Los Angeles; Keith Naunheim, M.D., St. Louis University, St. Louis; Steven Piantadosi, M.D., Ph.D., Johns Hopkins University, Baltimore; Gail Weinmann, M.D., National Heart, Lung, and Blood Institute, Bethesda, Md.; and Robert Wise, M.D., Johns Hopkins University, Baltimore) takes responsibility for the content of this article.

Because of its possible clinical implications, this article was published at www.nejm.org on August 14, 2001.

Address reprint requests to Dr. Piantadosi at the NETT Coordinating Center, 615 N. Wolfe St., Rm. 5010, Baltimore, MD 21205.

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