Neurothrombectomy devices for the treatment of acute ischemic stroke: state of the evidence.
BACKGROUND
Acute ischemic strokes are associated with poor outcomes and high health care burden. Evidence exists evaluating the use of neurothrombectomy devices in patients receiving currently recommended treatments that may have limited efficacy.


OBJECTIVE
To describe the state of the evidence supporting use of neurothrombectomy devices in the treatment of acute ischemic stroke.


METHODS
MEDLINE, SCOPUS, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Web of Science were searched, without language restrictions, from their inception through May 2010. The MEDLINE and Cochrane Central Register of Controlled Trials searches were updated through November 2010.


METHODS
Two independent investigators screened citations for human studies of any design or case series or case reports of patients with an acute ischemic stroke that evaluated a neurothrombectomy device and reported at least 1 clinical effectiveness outcome or harm.


METHODS
Using standardized protocols, 2 independent investigators extracted information about study characteristics and outcomes, and a third reviewer resolved disagreement.


RESULTS
87 articles met eligibility criteria, including 18 prospective single-group studies, 7 noncomparative retrospective studies, and 62 case series or case reports. Two U.S. Food and Drug Administration (FDA)-cleared devices, the MERCI Retriever (Concentric Medical, Mountain View, California) (40%) and the Penumbra System (Penumbra, Alameda, California) (9%), represented a large portion of the available data. All prospective and retrospective studies provided data on successful recanalization with widely varying rates (43% to 78% with the MERCI Retriever and 83% to 100% with the Penumbra System). Rates of harms, including symptomatic (16 studies; 0% to 10% with the MERCI Retriever and 0% to 11% with the Penumbra System) or asymptomatic (13 studies; 28% to 43% and 1% to 30%, respectively) intracranial hemorrhage and vessel perforation or dissection (11 studies; 0% to 7% and 0% to 5%, respectively), also varied by device. Predictors of harm included older age, history of stroke, and higher baseline stroke severity scores, whereas successful recanalization was the sole predictor of good outcomes.


CONCLUSIONS
Most available data are from single-group, noncomparative studies. In addition, the patient population most likely to benefit from these devices is undetermined.


CONCLUSIONS
Currently available neurothrombectomy devices offer intriguing treatment options in patients with acute ischemic stroke. Future trials should use a randomized design, with adequate power to show equivalency or noninferiority between competing strategies or devices, and strive to identify populations that are most likely to benefit from use of neurothrombectomy devices.


BACKGROUND
Agency for Healthcare Research and Quality.
University of Connecticut/Hartford Hospital Evidence-based Practice Center, 06102-5037, USA.
William L
WL
Baker
Jennifer A
JA
Colby
Vanita
V
Tongbram
Ripple
R
Talati
Isaac E
IE
Silverman
C Michael
CM
White
Jeffrey
J
Kluger
Craig I
CI
Coleman
D002545:Brain Ischemia / Q000601:surgery*; D002536:Cerebral Arteries / Q000293:injuries; D004869:Equipment Safety; D019317:Evidence-Based Medicine; D006801:Humans; D020300:Intracranial Hemorrhages / Q000209:etiology; D020521:Stroke / Q000601:surgery*; D017131:Thrombectomy / Q000009:adverse effects / Q000145:classification / Q000295:instrumentation*; D016896:Treatment Outcome