Emphysema Surgery May Harm Advanced-Stage Patients
Researchers conducting a study on a controversial surgical treatment for emphysema announced yesterday that the procedure may prove "dangerous" and "even deadly" for patients in advanced stages of the disease, the AP/Richmond Times-Dispatch reports (AP/Richmond Times-Dispatch, 8/15). According to researchers, 16% of patients with severe and diffuse lung damage from emphysema who underwent lung volume reduction surgery died within a month, while no patients treated only with drugs died. Researchers also said that patients in advanced stages of emphysema "were four times more likely to die" over an 18 month period after undergoing the procedure than those who received non-surgical treatment. In lung volume reduction surgery, introduced in 1994, a surgeon removes overinflated and damaged tissue from a patient's lungs, which reduces the volume of the lungs by up to one-third. This effect increases the "elastic properties" of the chest and allows an emphysema patient to "move more air in and out of the lungs." Researchers conducting the study -- called the National Emphysema Treatment Trial -- have stopped enrollment of patients with severe and diffuse lung damage from emphysema (Brown, Washington Post, 8/15). They called the mortality rate among those patients "unacceptable" (Sutherland, Los Angeles Times, 8/15). "I think this is a very important finding," Dr. Gail Weinmann, an NIH physician who has helped to run the study, said, adding, "This is the most severely disabled group, and the one that is most looking for an intervention will improve their quality of life. I think there was a lot of hope that this was group might get some benefit from the procedure" (Washington Post, 8/15).
In 1995, the
Centers for Medicare and Medicaid Services, formerly HCFA, decided to stop covering the procedure, which costs between $25,000 and $60,000, a move that subjected the agency to "intense criticism." According to CMS officials, "there was no firm evidence the procedure worked," but advocacy groups "accused" the government of denying patients the treatment "simply to save money." Instead, CMS, along with the NIH, agreed to sponsor the "randomized, controlled" study to determine whether lung reduction surgery "worked," which emphysema patients "benefited the most" and "how much they improved" (Washington Post, 8/15). The New York Times reports that "if the operation turns out to help" most patients in the study, Medicare could "face a huge bill." Medicare reimburses hospitals $30,000 for the procedure, and with two million emphysema patients nationwide, most 65 or older, the procedure could cost up to $20 billion for the program. However, Dr. Joel Cooper, a lung surgeon at Washington University who introduced the surgery about 10 years ago, said that a "high price tag is no excuse" for Medicare to refuse to cover the procedure (New York Times, 8/15). He added that Medicare officials, by funding the study, hope to find "justification to limit, delay or deny coverage" for the surgery. A CMS official, however, said that the agency "didn't interfere with the scientific decision making" in the study (AP/Richmond Times-Dispatch, 8/15).Doctors who perform lung volume reduction surgery have estimated that the procedure offers emphysema patients on average a 70% improvement in their condition (Los Angeles Times, 8/15). To view the study findings, go to http://nejm.org/earlyrelease/feature.asp?strxmlfilename=2001/20011011/01101101. To view an accompanying NEJM editorial, go to http://nejm.org/earlyrelease/feature.asp?strxmlfilename=2001/20011011/01101102.