Background and Purpose-To describe the safety and effectiveness of a self-expanding and fully retrievable stent (Solitaire AB; ev3 Inc, Plymouth, MN) in revascularization of patients with acute ischemic stroke. Methods-Prospective, single-center study of 20 patients with an acute ischemic stroke attributable to a large artery occlusion of the anterior circulation within the first 8 hours from symptoms onset (median National Institutes of Health Stroke Scale, 19 [interquartile range,[15][16][17][18][19][20][21][22][23]). The occlusion site was middle cerebral artery in 12 patients, proximal internal carotid artery/middle cerebral artery tandem occlusion in 3 patients, and terminus internal carotid artery in 5 patients. Thrombectomy was used as rescue therapy in 2 patients who were refractory to intra-arterial plasminogen activator, and in 3 patients in whom successful recanalization with the MERCI retriever was not achieved. Results-Successful revascularization defined as thrombosis in cerebral ischemia grade 2b or 3 was achieved in 18 of 20 (90%) treated vessels, and 16 patients showed immediate restoration of flow after stent deployment. The mean number of passes for maximal recanalization was 1.4, and the median (quartiles) time from groin puncture to recanalization was 50 (38 -71) minutes. No case required adjuvant therapy after deployment of the embolectomy device. No significant procedural events occurred. Symptomatic intracranial hemorrhage was found in 2 (10%) patients, 4 (20%) patients died during the 90-day follow-up period, and 45% of patients showed good functional outcome at 3 months (modified Rankin Scale score Յ2). Conclusions-These results suggest that the Solitaire AB device can rapidly, safely, and effectively retrieve clots from the middle cerebral artery and terminus internal carotid artery within 8 hours from symptoms onset. (Stroke. 2010;41:1836-1840.)Key Words: acute Ⅲ embolectomy Ⅲ interventional neuroradiology Ⅲ reperfusion Ⅲ stroke Ⅲ thrombectomy T he Solitaire AB (ev3 Inc, Plymouth, MN) is a selfexpanding stent that offers the unique capability of being able to be fully deployed and then completely retrieved if it has not been detached. 1,2 In this pilot study, we tested whether the Solitaire AB stent could be used as a novel mechanical embolectomy device for large artery occlusions of the anterior circulation in patients presenting within 8 hours from the onset of an acute ischemic stroke.
Materials and MethodsWe treated 20 consecutive patients refractory or ineligible for the use of intravenous tissue plasminogen activator who met the following criteria: age 80 years or younger, National Institutes of Health Stroke Scale (NIHSS) score Ն8 or lower if there was a fluctuating neurological deficit, time from symptoms onset to the endovascular procedure of Ͻ8 hours, absence of large signs of ischemia (defined as an Alberta Stroke Program 3 early CT score of Ͻ7 or MR diffusion-weighted lesion Ͼ50% of the middle cerebral artery territory), and an angiographically proven occlusion of the ante...
Campbell, B. C.V. et al. (2019) Penumbral imaging and functional outcome in patients with anterior circulation ischaemic stroke treated with endovascular thrombectomy versus medical therapy: a meta-analysis of individual patient-level data.ABSTRACT Background: CT-perfusion (CTP) and MRI may assist patient selection for endovascular thrombectomy. We aimed to establish whether imaging assessments of ischaemic core and penumbra volumes were associated with functional outcomes and treatment effect.
Background and Purpose
Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire FR in patients with acute ischemic stroke.
Methods
STAR was an international, multicenter, prospective, single-arm study of Solitaire FR thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary endpoint was the revascularization rate (3TICI 2b) of the occluded vessel as determined by an independent core lab. The secondary endpoint was the rate of good functional outcome (defined as 90-day modified Rankin scale (mRS) 0–2).
Results
A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale (NIHSS) was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and/or procedure related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic.
Conclusions
In this single arm study, treatment with the Solitaire™ FR device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days.
Clinical Trial Registration
This study is registered with ClinicalTrials.gov, number NCT01327989.
Campbell, B. C. V. et al. (2018) Effect of general anaesthesia on functional outcome in patients with anterior circulation ischaemic stroke having endovascular thrombectomy versus standard care: a meta-analysis of individual patient data. Lancet Neurology, 17(1), pp. 47-53. (doi:10.1016/S1474-4422(17)30407-6) This is the author's final accepted version.There may be differences between this version and the published version. You are advised to consult the publisher's version if you wish to cite from it.http://eprints.gla.ac.uk/149670/ variables. An alternative approach using propensity-score stratification was also used. To account for between-trial variance we used mixed-effects modeling with a random effect for trial incorporated in all models. Bias was assessed using the Cochrane tool.Findings: Of 1764 patients in 7 trials, 871 were allocated to endovascular thrombectomy. After exclusion of 74 patients (72 who did not undergo the procedure and 2 with missing data on anaesthetic strategy), 236/797 (30%) of endovascular patients were treated under GA. At baseline, GA patients were younger and had shorter time to randomisation but similar pre-treatment clinical severity compared to non-GA. Endovascular thrombectomy improved functional outcome at 3 months versus standard care in both GA (adjusted common odds ratio (cOR) 1·52, 95%CI 1·09-2·11, p=0·014) and non-GA (adjusted cOR 2·33, 95%CI 1·75-3·10, p<0·001) patients. However, outcomes were significantly better for those treated under non-GA versus GA (covariate-adjusted cOR 1·53, 95%CI 1·14-2·04, p=0·004; propensitystratified cOR 1·44 95%CI 1·08-1·92, p=0·012). The risk of bias and variability among studies was assessed to be low.Interpretation: Worse outcomes after endovascular thrombectomy were associated with GA, after adjustment for baseline prognostic variables. These data support avoidance of GA whenever possible. The procedure did, however, remain effective versus standard care in patients treated under GA, indicating that treatment should not be withheld in those who require anaesthesia for medical reasons.
Funding:The HERMES collaboration was funded by an unrestricted grant from Medtronic to the University of Calgary.
Research in contextEvidence before this study between abolition of the thrombectomy treatment effect in MR CLEAN and no effect in THRACE. Three single-centre randomised trials of general anaesthesia versus conscious sedation found either no difference in functional outcome between groups or a slight benefit of general anaesthesia.
Added value of this studyThese data from contemporary, high quality randomised trials form the largest study to date of the association between general anesthesia and the benefit of endovascular thrombectomy versus standard care. We used two different approaches to adjust for baseline imbalances (multivariable logistic regression and propensity-score stratification). We found that GA for endovascular thrombectomy, as practiced in contemporary clinical care across a wide range of expert centres during the rand...
Key PointsQuestionDoes the use of adjunct intra-arterial thrombolysis following an angiographically successful thrombectomy improve functional outcomes in patients with large vessel occlusion acute ischemic stroke?FindingsIn this randomized clinical trial that included 121 adults, treatment with intra-arterial alteplase compared with placebo resulted in a modified Rankin Scale score of 0 or 1 in 59.0% vs 40.4% of patients at 90 days. This difference was statistically significant.MeaningAmong patients with large vessel occlusion acute ischemic stroke and successful reperfusion following thrombectomy, the use of adjunct intra-arterial alteplase compared with placebo resulted in a greater likelihood of excellent neurological outcome at 90 days; however, the findings should be considered preliminary until replicated.
Background and Purpose-A progressive decline in the odds of favorable outcome as time to reperfusion increases is well known. However, the impact of specific workflow intervals is not clear.
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