Lung Volume Reductions Surgery (LVRS) Study
Lung Volume Reductions Surgery (LVRS) Study
The main objectives of this study are to see if a type of lung surgery, known as lung
 reduction surgery, in addition to standard medical treatment improves the quality of life,
 lung function, and reduces the high mortality associated with severe emphysema when compared
 to standard medical treatment alone. Another goal of this study is to better identify the
 patients most likely to benefit from this surgical treatment. The information obtained in
 this study is important because lung reduction surgery is being done in several centers
 around the country but its long term benefits, if any, over standard medical treatment, are
 not known.
Chronic obstructive pulmonary disease is a major cause of mortality and morbidity in the US.
 Although medical therapy may delay disability and death, there has been no definitive therapy
 to improve pulmonary function in these patients. The resection of emphysematous lung
 parenchyma, lung volume reduction surgery (LVRS), has been reported in uncontrolled studies
 in highly selected emphysema patients to substantially improve parameters of pulmonary
 function, dyspnea, and quality of life. Numerous case series have reported significant
 short-term benefits. Current LVRS data regarding outcomes is limited by study design lacking
 parallel control groups and lack of long term data.

 The main objectives of this proposal are: 1) To study the effects of LVRS in addition to
 maximal medical therapy when compared to maximal medical therapy alone in terms of
 improvement of physiology and quality of life. 2) To better define preoperative selection
 criteria to determine which patients would benefit from this surgical intervention. To
 accomplish these objectives, patients who meet clinical criteria and complete a pulmonary
 rehabilitation-program will be randomized into 2 groups: 1) Continuing optimal medical care
 or 2) bilateral LVRS via median sternotomy in addition to medical therapy.

 The Houston Veterans Affairs Medical Center is currently performing LVRS under a protocol
 supported by Merit Review funding (1996-200O, Effects of lung volume reduction surgery in the
 treatment of severe emphysema) in selected patients with severe emphysema. This controlled
 study is designed to determine patient selection criteria, as well as, both the short and
 long term benefits of operated and non-operated patients with severe emphysema receiving
 maximal medical therapy. Given the strict selection criteria and unexpectedly high survival
 in both treatment groups to date, it is unlikely in a study of this size that survival
 differences will be detected.

 In 1997 the National Heart, Lung, and Blood Institute and Health Care Financing
 Administration organized a national registry and a controlled, multicenter clinical trial to
 compare bilateral LVRS to maximal medical treatment (NETT, National Emphysema Treatment
 Trial).

 Both our on-going LVRS study and the NETT have been hindered by an underestimation of the
 difficulty in recruiting patients who qualify for this invasive study. Both studies have
 evaluated/recruited to date approximately 50% of the projected number of subjects required to
 achieve statistical power to draw significant clinical conclusions. In fact, the NIH is
 investing additional funds in the national "marketing" of the NETT and LVRS. We believe that
 this national marketing effort, as well as changes and enhancement of local recruiting
 strategies will allow us to enroll adequate patients for study completion. This controlled
 clinical trial will provide data to address crucial clinical and potential economic
 implications of this surgical intervention in patients with severe emphysema.
1. Post-bronchodilator FEV I < 40% and > 15% of predicted

 2. TLC > 120% of predicted*

 3. Carbon monoxide diffusing capacity by the single breath technique (DLCOSB) < 50% of
 predicted

 4. PaCO2 < 55 mmHg

 5. Age 75 years or younger

 -  TLC will be determined by body plethysmography using slow inspiratory effort to
 determine thoracic gas lume because of the overestimation of lung volumes by high
 frequency panting in patients with COPD.