April 29, 2008 (Chicago, Illinois) — Early decompressive surgery significantly improves outcomes and reduces complication rates in patients with spinal cord injury (SCI), a large multicenter study suggests.
Presented here at the American Association of Neurological Surgeons (AANS) 76th Annual Meeting, preliminary, 1-year results from the Surgical Treatment of Acute Spinal Cord Injury Study (STASCIS) showed 24% of patients who received decompressive surgery within 24 hours of their injury experienced a 2-grade or greater improvement on the American Spinal Injury Association (ASIA) scale, compared with 4% of those in the delayed-treatment group.
"A 2-grade improvement is a large change that is, without question, of clinical importance. It is still not a home run and far from a cure, but what it means is that 1 in 5 individuals is walking away from an injury they wouldn't normally walk away from," principal investigator Michael Fehlings, MD, PhD, head of the Krembil Neuroscience Centre at the University Health Network, in Toronto, Ontario, told Medscape Neurology & Neurosurgery.
Furthermore, he said, complication rates among individuals who received early intervention were about 20% lower than in those whose treatment was delayed.
According to Dr. Fehlings, the role and timing of decompression in SCI is controversial. In large part, he said, the debate centers on whether timing of surgery makes any difference to outcomes.
"Many people believe that it is better to stabilize patients first and that the timing of the intervention doesn't really matter. This prevailing attitude is based on the idea that all of the damage occurs during the initial trauma," he said.
However, he added, there is now strong evidence to suggest there is a biologic rationale for using decompressive surgery early on to mitigate progressive secondary injury.
"During the primary injury, the blood vessels in the spinal cord are mechanically disrupted, but then there are chemical reactions that occur that cause further damage. This secondary injury initiates a cascade of events that includes the release of calcium and sodium, which causes further damage and leads to cell death," said Dr. Fehlings.
Lower Complication Rate
To determine whether early surgical intervention would limit spinal cord damage and improve outcomes, the investigators recruited 170 consecutive patients from 10 centers in Canada and the United States who had subaxial cervical SCI and imaging evidence of spinal cord compression.
The investigators chose 24 hours as the cutoff point for early decompression based on pilot data indicating that it may be an optimal time point for the prevention of secondary injury.
According to Dr. Fehlings, whether patients were in the "early" or "delayed" group was determined by natural variations in the length of time it took them to reach the study center.
Patients were eligible for the study only if they were enrolled within 24 hours of injury and had to undergo surgery within 7 days of SCI. Outcomes were assessed at 6 months and 1 year postinjury.
In addition to an average 2-grade or greater improvement in ASIA scores, Dr. Fehlings said, the investigators found that complications, particularly those involving the cardiopulmonary system and urinary tract, were lower in the early surgery group — 37.1% vs 48.6%.
"Going into this study, I was prepared that we might not see a difference in outcomes. But I think that the fact that we are seeing reductions in complications and improved neurological outcomes is amazing," said Dr. Fehlings.
"Our initial estimates of a sample size required to show a difference was on the order of around 400 patients, and the fact that we saw any difference at all, particularly with 170 patients, was a bit of a surprise," he added.
A Medical Emergency
While further study is required to validate these findings, Dr. Fehlings said the results suggest that, like stroke, where timing of treatment is critical to outcome, SCI should be considered a medical emergency.
In fact, he said, based on the current literature and emerging data from STASCIS, the Spine Study Trauma Group, a consensus-based group of the world's 40 top spine surgeons, has recommended that patients with an acute SCI, without other life-threatening conditions, should have early decompression surgery within 24 hours of injury.
Furthermore, he noted, early intervention offers clinicians the opportunity to apply other, so-called regenerative treatments that may augment the effect of surgery and further improve recovery in SCI patients.
One such treatment may be Cethrin (Alseres Pharmaceuticals), a recombinant protein antagonist of a molecule known as Rho, which inhibits nerve cell regeneration and repair, which is showing "very promising results" in SCI patients.
A second study presented at the AANS meeting by Dr. Fehlings and colleagues shows that this so-called regenerative treatment is safe and well-tolerated and has potential neurological benefit.
"With the emergence of the era of regenerative medicine and the resulting treatments that are now finding their way into the clinic, we have an opportunity to optimize the milieu for recovery in spinal cord injury patients," he said.
The study was supported by the Spine Trauma Study Group, the North American Clinical Trials Network, the Cervical Spine Research Society, the American Association of Neurological Surgeons and Congress of Neurological Surgeons, the Krembil Foundation, and the Canadian Spinal Cord Injury Translational Research Network. The authors have no relevant conflicts to report.
American Association of Neurological Surgeons 76th Annual Meeting: Abstract 600. Presented April 28, 2008.
Medscape Medical News © 2008 Medscape
Cite this: Caroline Cassels. STASCIS: Early Surgery in Spinal Cord Injury Improves Outcomes, Lowers Complications - Medscape - Apr 29, 2008.