The National Heart, Lung, and Blood Institute (NHLBI) and the Health Care Financing Administration (HCFA) today announced the selection of the 18 medical centers and the data coordinating center that will conduct the first multi-center clinical trial of lung volume reduction surgery (LVRS).
The LVRS study is designed to show whether lung volume reduction surgery is a safe and effective procedure for patients in the last stages of emphysema, a chronic lung condition usually caused by smoking that is a major cause of death and disability in the United States. The procedure involves surgical removal of about 20 to 30 percent of each lung.
The study will be conducted by the NHLBI, and HCFA will cover the patient care costs for the Medicare beneficiaries who participate.
"We are pleased to be working with HCFA on this study," said NHLBI Director Dr. Claude Lenfant. "For although LVRS has been reported to improve lung function and quality of life in some cases, there still are many questions about its benefits and risks that should be answered before it is used widely. This study should provide the answers to these questions."
"We need to know whether Medicare should cover this procedure," said HCFA Administrator Bruce C. Vladeck. "The LVRS study should provide the data that we need to determine whether it is effective. And we hope the study will be a model for future collaborations between HCFA and NIH."
As a first step, a registry of all emphysema patients referred to the participating medical centers will be created. Approximately 2,600 patients from the registry who meet specific inclusion criteria will be invited to participate in the randomized trial. All participants in the trial will receive intensive medical therapy and rehabilitation. Half will also be selected randomly to undergo LVRS. It is expected that the first patients will be enrolled in the registry starting late in the summer of 1997, and enrollment will continue at least until the summer of 1999.
All participants will be evaluated for exercise ability, lung function, quality of life, illness and survival, and the results for the patients who underwent LVRS will be compared with those for the other patients. Although it has been estimated that it will take seven years to complete the study, treatment recommendations may be made sooner than that if the data, which are reviewed every three months by an independent panel of experts, show clear-cut benefits or risks.
The decision to undertake the study grew out of two independent assessments. One, an NHLBI workshop of medical experts, held in September 1995, recommended that systematic evaluation of long-term outcomes of LVRS and of patient selection criteria was urgently needed before the procedure became more widely practiced. A separate, but simultaneous, assessment of the procedure, conducted for HCFA by the federal Agency for Health Care Policy and Research, found that the current data on the risks and benefits of LVRS were too inconclusive to justify unrestricted Medicare reimbursement for the procedure. A clinical trial evaluating the effectiveness of the surgery was recommended. In April 1996, the NHLBI and HCFA announced that they would collaborate on the study.
Approximately 2 million Americans, most of them over age 50, have been diagnosed with emphysema. Current treatment for patients in the end stages of emphysema is largely supportive, including nutritional supplementation and exercise rehabilitation. Lung transplantation may be an option for some patients under age 60, but donor lungs are scarce, and the procedure is expensive. The LVRS study will show whether this procedure can provide another treatment option for some of these patients.
NOTE: People with emphysema who want to participate in the study should discuss this with their doctors and ask for a referral to one of the participating centers, or call the patient coordinator at the nearest participating center.