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Intracranial thrombectomy using the Solitaire stent: a historical vignette.

ABSTRACT: The endovascular treatment of acute ischemic stroke has been revolutionized in the past years by the introduction of new devices for mechanical thrombectomy. Several tools were already available in 2008. The majority allowed the recanalization of acutely occluded intracranial arteries with acceptable levels of safety and efficacy, and with occasional failures.On 3 March 2008, a 67-year-old woman was treated 3.5 h after the clinical onset of a right hemispheric stroke due to an embolic middle cerebral artery (MCA) M1 occlusion. The National Institutes of Health Stroke Scale (NIHSS) score prior to treatment was 10. Mechanical thrombectomy with a microbrush yielded a significant amount of thrombotic material without recanalization. Given the urgency of the situation, the uncertain outcome in the case of a persistent occlusion of the right M1 segment and the fact that no other device was available, a Solitaire stent was deployed within the occluded right M1 segment. After several minutes of incubation, the expanded stent was slowly withdrawn under continuous aspiration with instantaneous removal of the entire thrombus and complete recanalization of the right MCA with reperfusion of the whole MCA supply territory. Digital subtraction angiography showed neither peripheral emboli nor vasospasm. The patient made a complete clinical recovery with an NIHSS score of 0 at the 30 day follow-up.The Solitaire stent was initially developed for the endovascular treatment of wide necked intracranial aneurysms but has been demonstrated to be safe and efficacious for intracranial thrombectomy. This was the first successful human clinical use of a Solitaire stent for this purpose and the ignition spark for the development of a whole generation of new devices, now called stent retrievers.

SUBMITTER: Perez MA

PROVIDER: S-EPMC3465948 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature

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Intracranial thrombectomy using the Solitaire stent: a historical vignette.

Pérez Marta Aguilar MA Miloslavski Elina E Fischer Sebastian S Bäzner Hansjörg H Henkes Hans H

Journal of neurointerventional surgery 20111214 6

<h4>Introduction</h4>The endovascular treatment of acute ischemic stroke has been revolutionized in the past years by the introduction of new devices for mechanical thrombectomy. Several tools were already available in 2008. The majority allowed the recanalization of acutely occluded intracranial arteries with acceptable levels of safety and efficacy, and with occasional failures.<h4>Case presentation</h4>On 3 March 2008, a 67-year-old woman was treated 3.5 h after the clinical onset of a right ...[more]

PMID: 22170823

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Project description:ImportanceStent retriever-based thrombectomy is highly beneficial in large vessel occlusion (LVO) strokes. Many stent retriever designs are currently available, but comparison of these technologies in well-conducted studies is lacking.ObjectiveTo determine whether thrombectomy for LVO stroke with the pRESET stent retriever is noninferior to treatment with the Solitaire stent retriever.Design, setting, and participantsThis study was a multicenter, prospective, randomized, controlled, open-label, adaptive, noninferiority trial with blinded primary end point evaluation. Between October 2019 and February 2022, multicenter participation occurred across 19 research hospitals and/or universities in the US and 5 in Germany. Patients with LVO stroke were enrolled and included up to 8 hours after symptom onset.InterventionsPatients underwent 1:1 randomization to thrombectomy with the pRESET or Solitaire stent retriever.Main outcomes and measuresThe primary outcome was the difference in the rate of 90-day functional independence across the 2 devices, using a -12.5% noninferiority margin for the lower bound of the 1-sided 95% CI of the difference between pRESET and Solitaire retrievers.ResultsOf 340 randomized patients, 170 (50.0%) were female, and the median (IQR) age was 73.0 (64.0-82.0) years. The study procedure was completed in 322 of the 340 randomized patients. The primary end point of 90-day functional independence was achieved by 95 patients (54.9%; 95% CI, 48.7-61.1) in the pRESET group and in 96 (57.5%; 95% CI, 51.2-63.8) in the Solitaire group (absolute difference, -2.57%; 95% CI, -11.42 to 6.28). As the lower bound of the 95% CI was greater than -12.5%, the pRESET retriever was deemed noninferior to the Solitaire retriever. The noninferiority of pRESET over Solitaire was also observed in the secondary clinical end point (90-day shift in modified Rankin Scale score) and in both angiographic end points (Expanded Treatment in Cerebral Infarction [eTICI] score of 2b50 or greater within 3 passes: 146 of 173 [84.4%] vs 149 of 167 [89.2%]; absolute difference, -4.83%; 95% CI, -10.84 to 1.19; eTICI of 2c or greater following the first pass: 76 of 173 [43.7%] vs 74 of 167 [44.3%]; absolute difference, -0.63%; 95% CI, -9.48 to 8.21). Symptomatic intracranial hemorrhage occurred in 0 patients in the pRESET group and 2 (1.2%) in the Solitaire group. Mortality occurred in 25 (14.5%) in the pRESET group and in 24 (14.4%) in the Solitaire group at 90 days. Findings of the per-protocol and as-treated analyses were in concordance with findings of the intention-to-treat analysis.Conclusions and relevanceIn this study, among patients with LVO stroke, thrombectomy with the pRESET stent retriever was noninferior to thrombectomy with the Solitaire stent retriever. Findings suggest that pRESET offers a safe and effective option for flow restoration and disability reduction in patients with LVO stroke.

Project description:Background and purposeIntracranial hemorrhage is the most dreaded complication of neurothrombectomy therapy for acute ischemic stroke. The determinants of intracranial hemorrhage and its impact on clinical course remain incompletely delineated. The purpose of this study is to further investigate the clinical and procedural factors leading to intracranial hemorrhage and to define the clinical impact of different hemorrhagic subtypes.Materials and methodsWe analyzed data prospectively collected in the Solitaire FR With Intention for Thrombectomy randomized clinical trial. A multivariable logistic regression model was used to identify independent clinical, imaging, and procedural predictors of any intracranial hemorrhage and of 7 intracranial hemorrhage subtypes. Univariate analysis was used to determine the impact of each of the intracranial hemorrhage subtypes on clinical outcome.ResultsAmong the 144 enrolled patients, any radiologic intracranial hemorrhage (21.3% versus 38.2%, P = .035), symptomatic intracranial hemorrhage (1.1% versus 10.9%, P = .012), and subarachnoid hemorrhage (2.2% versus 12.7%, P = .027) occurred less frequently in the Solitaire FR than in the Merci retriever arms. The most common independent determinant of hemorrhage occurrence was rescue therapy with intra-arterial rtPA, which was associated with any intracranial hemorrhage and 4 subtypes and tended to be used more frequently in the Merci group (10.9% versus 3.4%; P = .09). Among the hemorrhage subtypes, basal ganglionic hemorrhage had the strongest impact on good clinical outcome at 90 days (OR, 0.30; P = .025) and was associated with higher reperfusion, prolonged time to treatment, and rescue therapy with intra-arterial rtPA.ConclusionsIntracranial hemorrhage, especially subarachnoid and symptomatic intracerebral hemorrhage, occurs less frequently with the Solitaire FR than the Merci retriever, in part due to less frequent use of rescue therapy with intra-arterial rtPA. Basal ganglionic hemorrhage strongly affects clinical outcome and is distinctively related to late reperfusion.

Project description:BackgroundAlthough stent retriever (SR) is recommended as a frontline device of endovascular treatment (EVT) for embolic large artery occlusion causing acute ischemic stroke, contact aspiration (CA) device showed similar efficacy in the recent trials. However, the efficacy of the both devices as first-line therapy for intracranial atherosclerotic stenosis (ICAS)-related large vessel occlusion has not yet been established. Therefore, we compared the immediate effects and final outcomes of SR and CA as first-line devices for treating ICAS-related occlusions.MethodsWe retrospectively analyzed the data of patients who underwent EVT for acute ischemic stroke from the registry of three Korean hospitals. Patients with ICAS-related occlusion who were treated within 24 h of onset of the symptoms were included. We investigated immediate reperfusion performance, immediate safety outcomes, and 3-month clinical outcomes for the two first-line devices.ResultsOf the 720 registered patients, 111 were eligible for this study. Forty-nine patients (44.1%) used SR and 62 (55.9%) used CA as the first-line device. Achieving successful reperfusion immediately after first-line thrombectomy was more frequent in the SR group than that in the CA group (77.6% vs. 43.5%, p = 0.001), with fewer additional rescue treatments (12.2% vs. 59.7%, p < 0.001). The incidence of iatrogenic dissection or rupture was lower in the SR group than that in the CA group (8.2% vs. 29.0%, p = 0.012). After additional rescue treatments, however, the final successful reperfusion rate did not differ between the two groups (SR 87.8% vs. CA 77.4%, p = 0.247), and there was no significant difference in the 3-month good outcomes (modified Rankin Scale, p = 0.524).ConclusionsFirst-line SR thrombectomy showed higher immediate reperfusion and less vessel injury for ICAS-related occlusions than CA. However, there was no significant difference in the final reperfusion status or 3-month outcomes from additional rescue treatments.

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Intracranial thrombectomy using the Solitaire stent: a historical vignette.

Publications

Intracranial thrombectomy using the Solitaire stent: a historical vignette.

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