Hutchinson PJ, Kolias AG, Timofeev IS, Corteen EA, Czosnyka
M, Timothy J, Anderson I, Bulters DO, Belli A, Eynon CA, Wadley J,
Mendelow AD, Mitchell PM, Wilson MH, Critchley G, Sahuquillo J, Unterberg A, Servadei
F, Teasdale GM, Pickard JD, Menon DK, Murray GD, Kirkpatrick PJ; RESCUEicp
Trial Collaborators. Trial of Decompressive Craniectomy for Traumatic
Intracranial Hypertension. N Engl J Med. 2016 Sep 7. [Epub ahead of print]
BACKGROUND
The effect of decompressive craniectomy on clinical outcomes
in patients with refractory traumatic intracranial hypertension remains
unclear.
METHODS
From 2004 through 2014, we randomly assigned 408 patients,
10 to 65 years of age, with traumatic brain injury and refractory elevated
intracranial pressure (>25 mm Hg) to undergo decompressive craniectomy or
receive ongoing medical care. The primary outcome was the rating on the
Extended Glasgow Outcome Scale (GOS-E) (an 8-point scale, ranging from death to
“upper good recovery” [no injury-related problems]) at 6 months. The
primary-outcome measure was analyzed with an ordinal method based on the
proportional-odds model. If the model was rejected, that would indicate a
significant difference in the GOS-E distribution, and results would be reported
descriptively.
RESULTS
The GOS-E distribution differed between the two groups
(P<0.001). The proportional-odds assumption was rejected, and therefore
results are reported descriptively. At 6 months, the GOS-E distributions were
as follows: death, 26.9% among 201 patients in the surgical group versus 48.9%
among 188 patients in the medical group; vegetative state, 8.5% versus 2.1%;
lower severe disability (dependent on others for care), 21.9% versus 14.4%;
upper severe disability (independent at home), 15.4% versus 8.0%; moderate
disability, 23.4% versus 19.7%; and good recovery, 4.0% versus 6.9%. At 12 months,
the GOS-E distributions were as follows: death, 30.4% among 194 surgical
patients versus 52.0% among 179 medical patients; vegetative state, 6.2% versus
1.7%; lower severe disability, 18.0% versus 14.0%; upper severe disability,
13.4% versus 3.9%; moderate disability, 22.2% versus 20.1%; and good recovery,
9.8% versus 8.4%. Surgical patients had fewer hours than medical patients with
intracranial pressure above 25 mm Hg after randomization (median, 5.0 vs. 17.0
hours; P<0.001) but had a higher rate of adverse
CONCLUSIONS
At 6 months, decompressive craniectomy in patients with
traumatic brain injury and refractory intracranial hypertension resulted in
lower mortality and higher rates of vegetative state, lower severe disability,
and upper severe disability than medical care. The rates of moderate disability
and good recovery were similar in the two groups. (Funded by the Medical
Research Council and others; RESCUEicp Current Controlled Trials number,
ISRCTN66202560.)
___________________________________________________________________
"This is groundbreaking as it is the first intervention
that has shown a major difference in outcome in this population — in particular
a large and dramatic survival benefit," lead author, neurosurgeon Peter
Hutchinson, FRCS, commented to Medscape Medical News.
Mortality was reduced from 48.9% in the control group to
26.9% in the surgery group.
However, the concern is that patients whose lives have been
saved by this procedure are generally left with a severe level of disability,
with more patients in a vegetative state or with lower severe disability
(dependent on others for care) or upper severe disability (able to live
independently but requiring support to go out), Professor Hutchinson added.
The rates of moderate disability and good recovery were
similar in the two groups, he said, "so the big question is, 'Is it worth
it?' That is the fundamental issue."
"There is no doubt this surgery saves lives — but we
have to look very carefully at the quality of survival to give information to
families on the pros and cons of performing this surgery," he said.
"This is not a black and white decision. This surgery is already taking
place in practice, but now we have more information to guide our decisions. The
data are now out there and can be discussed, and the neurosurgeons need to
interpret it for themselves. I believe some will take this study as a reason to
do more of these procedures. Others may be more concerned about the increase in
patients left in a vegetative state and decide to do less."…
So far, no treatment has shown evidence of benefit in terms
of outcome for these patients, he said. "We try to bring intracranial
pressure down with drugs such as barbiturates, but this has not been tested in
an outcomes study. Decompressive surgery is also performed in some cases, but
again there has been no evidence of benefit until now in an outcomes
study."…
A previous trial of decompressive surgery in trauma patients
— DECRA — did not show a benefit. "In DECRA, the mortality was the same
and there were more unfavorable outcomes in the surgery group," Professor
Hutchinson commented. "But they had different inclusion criteria and
timing of surgery — in our study the threshold for intracranial pressure was
higher and surgery was performed later. It is possible that in DECRA the
surgery was performed too early and some patients therefore received it who did
not need it but still experienced the complications of surgery."…
This is a similar procedure that is sometimes performed in
patients who have had a very large stroke. Professor Hutchinson noted that
stroke patients normally have just one side of the skull removed, but in this
trial individual surgeons decided whether to perform unilateral or bifrontal
surgery; 63% chose bifrontal.
"The patients were also much younger than stroke
patients, and a subgroup analysis showed a tendency to a better outcome with
surgery in those aged under 40," he added.
"This is groundbreaking as it is the first intervention
that has shown a major difference in outcome in this population — in particular
a large and dramatic survival benefit," lead author, neurosurgeon Peter
Hutchinson, FRCS, commented to Medscape Medical News.
Mortality was reduced from 48.9% in the control group to
26.9% in the surgery group.
However, the concern is that patients whose lives have been
saved by this procedure are generally left with a severe level of disability,
with more patients in a vegetative state or with lower severe disability
(dependent on others for care) or upper severe disability (able to live
independently but requiring support to go out), Professor Hutchinson added.
The rates of moderate disability and good recovery were
similar in the two groups, he said, "so the big question is, 'Is it worth
it?' That is the fundamental issue."
"There is no doubt this surgery saves lives — but we
have to look very carefully at the quality of survival to give information to
families on the pros and cons of performing this surgery," he said.
"This is not a black and white decision. This surgery is already taking
place in practice, but now we have more information to guide our decisions. The
data are now out there and can be discussed, and the neurosurgeons need to
interpret it for themselves. I believe some will take this study as a reason to
do more of these procedures. Others may be more concerned about the increase in
patients left in a vegetative state and decide to do less."…
So far, no treatment has shown evidence of benefit in terms
of outcome for these patients, he said. "We try to bring intracranial
pressure down with drugs such as barbiturates, but this has not been tested in
an outcomes study. Decompressive surgery is also performed in some cases, but
again there has been no evidence of benefit until now in an outcomes
study."…
A previous trial of decompressive surgery in trauma patients
— DECRA — did not show a benefit. "In DECRA, the mortality was the same
and there were more unfavorable outcomes in the surgery group," Professor
Hutchinson commented. "But they had different inclusion criteria and
timing of surgery — in our study the threshold for intracranial pressure was
higher and surgery was performed later. It is possible that in DECRA the
surgery was performed too early and some patients therefore received it who did
not need it but still experienced the complications of surgery."…
This is a similar procedure that is sometimes performed in
patients who have had a very large stroke. Professor Hutchinson noted that
stroke patients normally have just one side of the skull removed, but in this
trial individual surgeons decided whether to perform unilateral or bifrontal
surgery; 63% chose bifrontal.
"The patients were also much younger than stroke
patients, and a subgroup analysis showed a tendency to a better outcome with
surgery in those aged under 40," he added.
http://www.medscape.com/viewarticle/868589#vp_1
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