|
|
NewsletterEffect of lung volume reduction surgery in patients with severe emphysema. D Geddes, M Davies, H Koyama, D Hansell, U Pastorino, J Pepper, P Agent, P Cullinan, S MacNeill, P Goldstraw. N Engl J Med 2000; 343: 239-45.
Reviewer: Rose Christopherson, MD, PhD
Background: To date, no randomized, controlled trial of lung volume reduction surgery vs. good medical management has determined whether survival is affected, although many studies have shown improvements in lung function and quality of life. Also, patients with isolated bullae, who are known to benefit from such surgery, have been included in previous studies, thus making it harder to determine whether there is a benefit for patients without isolated bullae. Methods: Patients with isolated bullae were excluded from this trial. Prior to enrollment, patients were given intensive medical treatment, smoking-cessation assistance, and six weeks of outpatient rehabilitation. They were then randomized to either surgical or further medical management. Because 5 of the first 15 patients randomized died, enrollment criteria were changed. Patients with carbon monoxide gas transfer values less than 30% of predicted, as well as those who were not able to walk 150 meters, were excluded subsequently. The followup period was 6-12 months. Results: Of 174 patients initially assessed, 98 patients were randomized, 24 to medical and 24 to surgical treatment. Both groups had a median FEV1 of 0.75 liter and a median shuttle walking distance of 215 meters. There was no significant difference in mortality, with 5 patients dying in the surgical group (21%) compared to 3 patients in the medical group (12%, P = 0.43). After 6 months, the median FEV1 increased by 70 ml in the surgical group and decreased by 80 ml in the medical group (P = 0.02). There were similar changes at 12 months, and similar changes with respect to quality of life. However, 5 of the 19 patients who survived in the surgical group had no improvement. Conclusions: The authors concluded that for patients with severe emphysema but without isolated bullae, lung-volume reduction surgery can improve FEV1, walking distance, and quality of life. However, they were unable to make a conclusion related to reduced mortality. Comments: The investigators calculated the power of their study based upon a change in FEV1, which they were able to show. This study was too small to show a difference in mortality. They have shown successfully, however, that FEV1, walking distance, and quality of life improve for patients who have lung volume reduction surgery even if they do not have isolated bullae. Their study also suggests that mortality is extremely high among patients with carbon monoxide gas transfer values less than 30% of predicted and among those with shuttle walking distances less than 150 meters, regardless of whether they receive surgical or medical treatment. Four of the 6 high risk patients assigned to the surgery group died prior to discharge from the hospital after surgery. It would be interesting to know the results
of surgical vs. medical treatment in the group which excluded these highest
risk patients. The authors did state that operative mortality was 6% (1 of 18
patients) among those who met the modified criteria. It would be interesting
to know whether on longer followup the surgical patients in the lower risk group
may have had improved survival compared to those randomized to medical management.
|