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Rationale and design of the national emphysema treatment trial. A prospective randomized trial of lung volume reduction surgery. The national emphysema treatment trial research group

The National Emphysema Treatment Trial is a multicenter, randomized clinical trial of medical therapy vs medical therapy plus lung volume reduction surgery (LVRS) for the treatment of patients with severe bilateral emphysema. LVRS will be accomplished by bilateral stapled excision via median sternotomy or video-assisted thoracoscopic surgery. Every patient will complete 6 to 10 weeks of pulmonary rehabilitation prior to randomization and will participate in a maintenance program of pulmonary rehabilitation after randomization. The primary outcome to be assessed by the trial is survival. Additional outcomes to be assessed are maximum exercise capacity, pulmonary function, oxygen requirement, distance walked in 6 min, quality of life, respiratory symptoms, and health-care utilization and costs. In addition, selected clinics will evaluate lung mechanics and respiratory muscle function, partial and maximal flow-volume curves, gas exchange during maximal exercise, and right heart function. The trial is targeted to enroll patients with severe emphysema who have no significant comorbid conditions; each patient will be randomized to one of the two treatment groups. The study duration is 4.5 years with a close-out period of 6 months.

Journal Article↗

Bullous emphysema versus diffuse emphysema: a functional and radiologic comparison.

The contribution of bullous emphysema (BE) to the functional impairment of patients with concomitant diffuse emphysema (DE) and the confounding effects of BE on functional measurements were investigated. Twenty-nine patients (Group I), with BE and DE were compared with a group of patients without BE matched, among other criteria, for radiographic extent of DE (Group II). Group I showed significantly lower PaO2, FEV1 and DLCO values and higher MRC score than Group II. In Group I the radiographic extent of BE and the extent of DE did not predict the functional impairment. The FEV1/FVC ratio in the subgroup with BE extent > 25% of total lung volume was higher than in subgroups with BE extent > 20% and 15%, respectively. In the same subgroups the correlation between DE and DLCO increased with the extent of BE. We conclude that BE contributes to the functional impairment of patients with concomitant DE. The confounding functional effect of bullae depends on BE extent: relatively milder obstruction can be observed with severe BE, whereas moderate BE causes modest deterioration of diffusing capacity, explaining the lack of functional-radiologic correlations in Group I. Therefore the computed tomographic scan is very useful in the work-up of BE with DE associated.

Aged↗

Results of lung volume reduction surgery in patients with emphysema. The Washington University Emphysema Surgery Group.

Between January 1993 and April 1995, 84 patients with emphysema underwent bilateral lung volume reduction surgery at Barnes Hospital, Fifty-three patients had completed 3 months; 37 patients, 6 months; and 19 patients, 1 year of follow-up. Significant improvement was observed in spirometric parameters, oxygenation, 6-minute walking distance, dyspnea indices, and quality-of-life scores. The average increases in FEV1 were 52%, 51%, and 61%, at 3,6, and 12 months, respectively, after surgery. The most common postoperative complication, prolonged ( > 7 days) chest tube drainage, was present in 63% of the cases, and the mean duration of hospitalization in the survivors was 15 days (range 5 to 49 days). This has been reduced to 11 days (median 7.5 days) for the subsequent 40 patients. Five postoperative deaths occurred, 2 in the first, 2 in the third, and 1 in the fifth postoperative month, respectively. The overall mortality in the 84 patients was 6%, and the actuarial survival at 1 year was 93%. Volume reduction surgery is a promising therapeutic option for patients with an appropriate pattern of emphysema. Improvement has been sustained for more than 1 year, and long-term follow-up is planned to ascertain the duration of the benefits.

Activities of Daily Living↗

Evaluation of patients with emphysema for lung volume reduction surgery. Washington University Emphysema Surgery Group.

Lung volume reduction surgery (LVRS) is performed to alleviate the dyspnea of patients with emphysema and improve performance in the activities of daily living. Removing diseased and functionless lung may improve the function of remaining, less diseased lung by (1) increasing elastic recoil pressure, thereby increasing expiratory airflow rates, (2) decreasing the degree of hyperinflation resulting in improved diaphragm and chest wall mechanics, and (3) decreasing inhomogeneity resulting in decreased work of breathing and improved alveolar gas exchange. The guidelines used for patient assessment were (1) airflow limitation with a forced expiratory volume in 1 second (FEV1) less than 35%, (2) hyperinflation and air trapping with total lung capacity more than 125% and respiratory volume more than 250% predicted, and (3) regional heterogeneity of the emphysematous process providing target areas for resection. We sought to exclude patients with the following: (1) obliteration of the pleural space by previous disease or surgery, (2) severe structural abnormalities of the thoracic cage, (3) PaCo2 greater than 55 mm Hg. (4) mean pulmonary artery pressure greater than 35 mm Hg. (5) predominant airway disease such as asthma, bronchiectasis, or chronic bronchitis with persistent excessive purulent secretions, (6) significant coexisting disease, and (7) maintenance corticosteroid therapy in excess of 10 mg prednisone per day. The assessment process continues to be evaluated by analysis of patient outcome.

Activities of Daily Living↗