PubMed1997
Since the early 1900s, a variety of operations have been suggested for emphysema but, with the exception of giant bullectomy, an option in only a small fraction of patients, none has proven effective. Data collected by a number of academic medical centers indicate that LVRS may ameliorate symptoms and improve pulmonary physiology, function, and quality of life in appropriately selected patients with emphysema. Accordingly, LVRS may provide an opportunity to intervene in a rapid, effective, and, possibly, cost-effective manner in a debilitating, chronic disease. That is an extraordinarily attractive proposition for both patients and physicians alike. But a number of questions remain: (1) What is the effect of LVRS compared with maximal medical therapy? (2) What is the duration of any beneficial effect of LVRS? (3) What is the best operative approach? (4) What patient characteristics predict good and bad outcomes? (5) What is the role of pre- and, possibly, postoperative pulmonary rehabilitation? (6) Does LVRS adversely affect the rate of loss of lung function over time, as some have suggested? (7) What is the cost of LVRS compared with standard medical therapy? (8) Can the procedure be performed safely in nontransplant centers? (9) What is the effect on disease-specific quality of life? (10) Does it affect mortality? A prospective, randomized controlled trial involving 18 selected centers will begin in the fall of 1997 under the sponsorship of the Health Care Financing Corporation (the administrators of Medicare) and the National Institutes of Health. We strongly support the creative, collaborative approach that has been taken by those two government agencies to stimulate this study. The need for controlled trials of new therapies cannot be overstated; only with such trials can the questions enumerated above be answered with certainty.