SAN FRANCISCO -- Early surgery to relieve intracranial pressure after a malignant middle cerebral artery infarction cuts mortality in half without increasing the number of severely disabled survivors, researchers said here. But survivors may have a higher risk of moderate disabilities.
SAN FRANCISCO, Feb. 13 -- Early surgery to relieve intracranial pressure after a malignant middle cerebral artery (MCA) infarction cuts mortality in half without increasing the number of severely disabled survivors, German researchers said here.
The technique, which involves removing a hand-sized portion of the skull and dura, yielded 25% absolute reduction in the risk of severe disability in a pooled analysis, reported Werner Hacke, M.D., Ph.D., of the Ruprecht Karls University of Heidelberg, during at the American Stroke Association meeting.
However, the results, published simultaneously online in The Lancet Neurology, showed a high proportion of survivors with moderate disability who needed assistance in their daily lives.
Middle cerebral artery infarction, an uncontrollable increase in intracerebral pressure that occurs in about 5% of ischemic strokes, is fatal in 80% of cases when untreated and typically leaves survivors severely disabled.
Decompressive surgery has been occasionally used in such cases for years on the basis of small uncontrolled studies because "medical therapy constantly fails," Dr. Hacke said.
However, the quality of survival was a major concern, focusing on the fear of leaving patients in a poor or vegetative state, particularly when the dominant hemisphere is involved, he said.
So to test survival and quality of life, three randomized trials were started in Europe (DECIMAL in France, DESTINY in Germany, and HAMLET in The Netherlands).
However, slow accrual led the investigators of all three to opt for an independent, pooled analysis without unblinding the individual trials. The analysis included 93 patients randomized to surgery or conservative therapy within 30, 36 or 99 hours of stroke. Inclusion was based on CT or MRI imaging of the brain.
They found an absolute reduction of 51.2% in risk of complete dependency or death as measured by a modified Rankin Score of 0 to 4 points versus 5 or 6 points (95% confidence interval 33.9% to 68.5%).
For the secondary endpoint of severe handicap, dependency or death, they also found a significant, 22.7% absolute risk reduction measured by a modified Rankin Score of 0 to 3 points versus 4 to 6 points (95% CI 4.6% to 40.9%).
The number-needed-to-treat was two to prevent complete dependency or death and four to prevent severe handicap, dependency or death.
These results were the same regardless of age, time to surgery (before 24 hours or 24 to 48 hours), or aphasia status.
"The decision to perform decompressive surgery should, however, be made on an individual basis in every patient," he said.
Although the risk of severe disability was not increased by decompressive surgery, the probability of surviving with moderate disability that requires assistance from others (modified Rankin Scale score of 4) increased more than 10 times from 2% without surgery to 31% with surgery.
"The choice of performing decompressive surgery in an individual patient with space-occupying hemispheric infarction will therefore depend on the willingness to accept survival with moderate disability," Dr. Hacke and colleagues noted in the paper.
Dr. Hacke said that while the sample size was small there was a major effect size and adjusting for baseline differences in patient characteristics between trials essentially did not alter the results.