ARTICLE IN BRIEF
Researchers reported that hemicraniectomy increased survival without severe disability in patients, 61 years old and older, with a malignant middle-cerebral-artery infarction, but most survivors required assistance with most bodily needs.
Decompressive hemicraniectomy reduces mortality among patients 61 and older with malignant middle-cerebral-artery infarction, but most who survive are unable to walk or attend to bodily needs without assistance, according to a new randomized, controlled study.
Hemicraniectomy surgery is used as a life-saving measure in patients up to age 60 with ischemic brain swelling, but many surgeons are reluctant to do the surgery in older patients because up to now there was a lack of information on whether it would be beneficial in that group.
The study from Germany provides some answers, but at the same time the results raise questions about whether survival is necessarily the best outcome for patients who have suffered a stroke so large that they will experience profound disability the rest of their lives.
“When you are dealing with a life-and-death situation some families are going to opt for intervention thinking some life is better than no life,” said Alejandro A. Rabinstein, MD, FAAN, professor of neurology and director of the neuroscience intensive care unit (ICU) at the Mayo Clinic in Rochester, MN, who was not involved with the study. He said the new study— which compared hemicraniectomy with standard ICU care in older stroke patients — should help inform conversations between doctors and patients and their families because it spells out the degree of disability faced by those who survive, whether they have the operation or not.
One year after stroke, half of surviving patients in both treatment groups continued to have a modified Rankin scale score of 4 (unable to walk without assistance and unable to attend to own bodily needs without assistance) and an additional one third of patients in both groups had a score of 5 (bedridden, incontinent, and requiring constant nursing care and attention),” wrote Allan H. Ropper, MD, FAAN, executive vice chair of neurology at Brigham and Women's Hospital in Boston, in an editorial that accompanied the study in the March 20 edition of The New England Journal of Medicine (NEJM).
The study, conducted at the University Hospital of Heidelberg and other German medical centers, involved 112 patients, ages 61 years or older, who had a malignant middle-cerebral-artery infarction — half of whom were randomly assigned to hemicraniectomy and the other half to conservative treatment in the ICU. Assignments were made within 48 hours of the onset of clinical symptoms, and all of the participants met set criteria used for stroke evaluation: scores higher than 14 (in patients with an infarction in the nondominant hemisphere) or higher than 19 (in patients with an infarction in the dominant hemisphere) with reduced levels of consciousness on the National Institutes of Health Stroke Scale (NIHSS). [NIHSS range from 0 to 42, with higher scores indicating more severe stroke). An additional criterion for inclusion was ischemic infarction of at least two thirds of the middle-cerebral-artery territory, including the basal ganglia, on brain imaging.
Surgical treatment consisted of a large hemicraniectomy (with a diameter of at last 12 cm) and duroplasty. Conservative treatment included basic therapy in the ICU for stroke; osmotherapy with the use of mannitol, glycerol or hypertonic hydroxyethyl starch; sedation; hyperventilation; and administration of buffer solutions.
Data were collected during hospitalization and at follow-up visits at six and 12 months. The primary endpoint was survival without severe disability at six months, which was defined by a score of 0 to 6 on the modified Rankin scale. (The scores on the scale range from 0, indicating no symptoms to 6, indicating death.)
“Hemicraniectomy improved the primary outcome,” the researchers reported. “The proportion of patients who survived without severe disability was 38 percent in the hemicraniectomy group, as compared with 18 percent in the control group [odds ratio, 291; 95% confidence interval, 1.06 to 7.49; p=0.04).
BETTER SURVIVAL DROVE NUMBERS
The researchers said the difference resulted from lower mortality in the surgery group — 33 percent versus 70 percent for the controls.
Specifically, no patients in either group had a modified Rankin score of 0 to 2 (no disability or slight disability); 7 percent of the surgery group and 3 percent of the controls had a score of 3 (moderate disability); 32 percent of the surgery group and 15 percent of controls had a score of 4 (moderately severe disability, meaning needs assistance with most bodily needs); and 28 percent of the surgery group and 13 percent of controls had a score of 5 (severe disability.)
In terms of complications, infections were more frequent in the hemicraniectomy group, while herniation was more frequent in the control group. The researchers also assessed the stroke patients at 12 months using standardized scales, including one to measure depression, and the numbers weren't encouraging for either group.
“In many large referral centers hemicraniectomy was already state of the art for patients under 60 years old; major uncertainty existed over age 60,” Werner Hacke, MD, PhD, a study coauthor and a neurologist and neurocritical care specialist at the University of Heidelberg told Neurology Today in an e-mail. He said the study provides evidence that the surgery does improve the chances for survival, “but among older patients more survivors remain disabled.”
Dr. Rabinstein, of the Mayo Clinic, said that while he welcomes the information provided in the new study, he still questions the benefits of hemicraniectomy for older patients.
“How you are going to interpret those numbers depends on your values, your principles, and your experiences,” he said.
He said that earlier in his career he was more enthusiastic about the procedure in patients of all ages, but when he began to track what happened to older patients afterward he was troubled.
“We could save their lives but it was essentially keeping them alive in poor functional shape,” said Dr. Rabinstein, who coauthored a paper in Neurology in 2006 that examined which factors were predictive of a better outcome with hemicraniectomy. Younger patients did better.
Edward Manno, MD, FAAN, head of neurocritical care at the Cleveland Clinic, said the results from this latest study clearly show that older stroke patients who undergo hemicraniectomy do not fare as well as younger patients, probably because they have comorbidities and younger patients may have better chances for neurologic recovery.
In previous studies of hemicraniectomy, he said, younger patients “not only had an improvement in survival, but those who survived did better,” than older patients.
Dr. Manno said the decision on whether to do a hemicraniectomy is difficult for families, in part because it must be made quickly.
“In my experience, when push comes to shove and people have to make an urgent decision, they usually are going to err on the side of ‘Let's do everything we can and see where the dust settles,’” Dr. Manno said.
The NEJM editorial noted that, as was the case with this study, the “majority of patients in previous studies answered affirmatively that they were satisfied with the outcome after hemicraniectomy and would have consented to the procedure again if they had to do it over, but so did most of the control group in this trial.”
“People seem to be content to escape with their lives,” Dr. Ropper wrote. “Such is the inconclusive nature of statistical outcomes applied to this primal and ultimate choice.”
Kevin Sheth, MD, chief of the division of critical care and emergency neurology at Yale University and director of the neuroscience ICU, who also serves on the Neurology Today editorial advisory board, said there needs to be better therapy to prevent brain edema in stroke patients and to identify patients early on who may be most at risk.
“People need to get to a center that has the experience and resources to deal with these problems,” he told Neurology Today.
He said the statistics from the new study will allow him to better frame conversations with families, but in the end, he said, individual values will continue to play a large role.
“For some people, surviving with severe disability is a fate worse than death,” Dr. Sheth said. “For others, it's not the life you pictured, but it's still worth living.”