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Preliminary findings from the National Emphysema Treatment Trial, the multicenter trial evaluating the efficacy of a controversial lung-reduction procedure vs. conventional medical treatment, have found significantly higher mortality rates in some high-risk patients who received the surgery, according to an early report of an article to be published in the New England Journal of Medicine.1
The findings seem to support Medicare’s decision in 1996 to restrict coverage of the procedure to subjects enrolled in a clinical trial, wrote Jeffrey M. Drazen, MD, in an editorial accompanying the article. At the time, many emphysema patients and proponents of the surgery denounced the decision because it forced patients who wanted lung-volume reduction to either participate in research trials (where they risked assignment to the non-surgical control group) or pay for the procedure themselves. (See "When should experimental surgery end?" Medical Ethics Advisor, September, 1998, p. 99.)
"These findings are important," Drazen states. "Some patients who were disappointed when they discovered they were in the control group can now be thankful that this assignment may have saved their lives. Indeed, in my opinion it does not make sense for anyone to undergo lung-volume reduction surgery outside a controlled trial."
Developed in the mid-1990s, lung-volume reduction surgery was a controversial procedure designed to improve the quality of life for patients with advanced stage emphysema. During the procedure, areas of emphysematous lung tissue were removed, reducing the overall size of the lung, theoretically improving lung function. Following the 1996 publication in the Journal of Thoracic and Cardiovascular Surgery2 of one group’s success with the procedure, many other centers began performing the surgery. Within months of publication of the original article, Medicare paid claims for 700 such procedures.
However, some patients did well after undergoing the procedure while other patients inexplicably did poorly. One of the goals of the national treatment trial is to determine which patients could be expected to do well with the procedure.
Preliminary results of the trial found that a subset of patients — those with a forced expiratory volume in the first second (FEV1) that was 20% or less of their predicted value and either a carbon monoxide diffusing capacity that was 20% or less of their predicted value or evidence on computed tomography of a uniform pattern of emphysema throughout the lungs — had a 30-day mortality rate of 16% compared with a zero mortality rate when compared with medically treated patients with similar characteristics. And patients with these clinical criteria who survived after 30 days post-surgery did not appear to experience significant benefits from the procedure.
1. National Emphysema Treatment Trial Research Group. Patients at high-risk of death following lung-volume reduction surgery. N Engl J Med Advance web publication, Aug. 14, 2001. Accessed: August 15, 2001. To be published in print October 11, 2001.
2. Cooper JD, Patterson GA, Sundaresan RS, et al. Results of 150 consecutive bilateral lung-volume reduction procedures in patients with severe emphysema. J Thorac Cardiovasc Surg 1996; 112:1,319-1,329.