Mechanical thrombectomy with a self-expanding retrievable intracranial stent (Solitaire AB): experience in 26 patients with acute cerebral artery occlusion.
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ABSTRACT: Background and purpose
Patients with stroke unsuitable for IV thrombolysis may be considered for endovascular revascularization, particularly when baseline imaging suggests proximal cerebral vessel occlusion associated with minimal established infarction. This retrospective review describes the use of a self-expanding retrievable intracranial stent (Solitaire AB) for thrombectomy in acute ischemic stroke.Materials and methods
Twenty-six consecutive patients with stroke treated endovascularly by using the Solitaire stent were identified, followed by detailed review of data extracted from their imaging and clinical records.Results
Recanalization (TIMI grade ≥2) was achieved with Solitaire thrombectomy as the single treatment technique in 16 patients and in combination with urokinase or the Penumbra device in 9 of the remaining 10 patients. Two patients had symptomatic intracranial hemorrhage. A favorable clinical outcome (mRS score of ≤2) was seen in 3 of 5 patients with MCA occlusion, 6 of 11 (55%) patients with ICA occlusion, and 2 of 10 patients with BA occlusion.Conclusions
Mechanical thrombectomy by using the Solitaire stent appears to be safe and is capable of achieving a high rate of recanalization and favorable clinical outcomes in patients presenting with proximal cerebral vessel occlusion.
SUBMITTER: Miteff F
PROVIDER: S-EPMC8013140 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description: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.
| S-EPMC3465948 | biostudies-literature
Project description:OBJECTIVE:Large vessel occlusion in acute ischemic stroke is associated with low recanalization rates under intravenous thrombolysis. We evaluated the safety and efficacy of the Solitaire AB stent in treating acute ischemic stroke. METHODS:Patients presenting with acute ischemic stroke were prospectively evaluated. The neurological outcomes were assessed using the National Institutes of Health Stroke Scale and the modified Rankin Scale. Time was recorded from the symptom onset to the recanalization and procedure time. Recanalization was assessed using the thrombolysis in cerebral infarction score. RESULTS:Twenty-one patients were evaluated. The mean patient age was 65, and the National Institutes of Health Stroke Scale scores ranged from 7 to 28 (average 17 ± 6.36) at presentation. The vessel occlusions occurred in the middle cerebral artery (61.9%), distal internal carotid artery (14.3%), tandem carotid occlusion (14.3%), and basilarartery (9.5%). Primary thrombectomy, rescue treatment and a bridging approach represented 66.6%, 28.6%, and 4.8% of the performed procedures, respectively. The mean time from symptom onset to recanalization was 356.5 ± 107.8 minutes (range, 80-586 minutes). The mean procedure time was 60.4 ± 58.8 minutes (range, 14-240 minutes). The overall recanalization rate (thrombolysis in cerebral infarction scores of 3 or 2b) was 90.4%, and the symptomatic intracranial hemorrhage rate was 14.2%. The National Institutes of Health Stroke Scale scores at discharge ranged from 0 to 25 (average 6.9 ± 7). At three months, 61.9% of the patients had a modified Rankin Scale score of 0 to 2, with an overall mortality rate of 9.5%. CONCLUSIONS:Intra-arterial thrombectomy with the Solitaire AB device appears to be safe and effective. Large randomized trials are necessary to confirm the benefits of this approach in acute ischemic stroke.
| S-EPMC3521799 | biostudies-literature
Project description:Background: Sporadic data showed hyperglycemia at presentation is associated with poor outcomes in patients with acute ischemic stroke (AIS) under mechanical thrombectomy (MT) treatment. Objective: This study aims to evaluate the relationship of admission hyperglycemia and outcomes in patients treated with solitaire stent thrombectomy. Methods: This multicenter prospective study registered patients with AIS due to anterior circulation large vessel occlusion (LVO) suitable for MT with Solitaire stent retriever. We analyzed the influence of admission hyperglycemia (?7.8 mmol/L) and serum glucose on functional independence which is defined as modified Rankin Scale score (mRS) of 0-2, symptomatic intracranial hemorrhage (sICH) and several outcomes of interest using univariable and multiple logistic regression analysis. Results: This study involved 17 stroke centers across China and consecutively recruited 149 patients. Patients with hyperglycemia at presentation less frequently exhibited a functional independence at 3 months than patients without hyperglycemia (22.2 vs. 66.4%; odds ratio 0.75, 95% confidence interval 0.61-0.92; P = 0.005). Higher glucose levels were correlated with worse outcome (per 1 mmol/L increase in glucose: odds ratio for mRS score 0-2 at 3 months 0.17, 95% confidence interval 0.06-0.45; P < 0.001) at 3 months and sICH (per 1 mmol/L increase in glucose: odds ratio for sICH was 8.2, 95% confidence interval 1.13-29.57; P < 0.001) after thrombectomy. Conclusions: Higher admission serum glucose and hyperglycemia were independently correlated with lower functional independence at 3 months in patients treated with Solitaire stent thrombectomy of anterior circulation LVO. Higher admission serum glucose was also associated with sICH after thrombectomy.
| S-EPMC6390827 | biostudies-literature
Project description:PURPOSE:In recent years, mechanical thrombectomy using Solitaire stent retrieval has been tried for treating acute ischemic stroke with a large artery occlusion. We systematically reviewed published articles to appraise the evidence that supports the safety and efficacy of the mechanical thrombectomy in acute strokes with Solitaire stent. MATERIALS AND METHODS:Systematic searches using Medline and Scopus were performed for studies evaluating mechanical thrombectomy using a Solitaire stent in acute ischemic stroke. Articles were included if they were published since 2008, contained at least 5 subjects, and provided clinical results. RESULTS:Thirteen articles (262 cases) were included in this review. The mean time of the procedures ranged from 37 to 95.6 minutes in 10 studies. The success of recanalization was achieved in 89.7% and the recanalization rate varied from 66.7% to 100% in all 13 studies. The overall rates of the symptomatic hemorrhagic complications and mortality were 6.8% and 11.1%, respectively. A favorable outcome of mRS 2 or under was 47.3%. Procedure-induced complications developed in 3.4%. CONCLUSION:The present review suggested that mechanical thrombectomy using a Solitaire stent in acute ischemic stroke was effective in recanalizing the occluded artery. The rate of procedural complications was small.
| S-EPMC3299943 | biostudies-literature
Project description:Background and purposeStent placement may be an effective and last resort method for recanalization of recalcitrant intracranial artery occlusion. The purpose of this study was to evaluate the safety and efficacy of a self-expanding stent for the recanalization of acute embolic or dissecting intracranial artery occlusion.Materials and methodsNine patients (mean age, 66 years; NIHSS score, 10-23) with acute embolic (n = 8) or dissecting occlusion (n = 1) of the intracranial arteries (ICA terminus in 5, MCA in 3, and BA in 1) were treated with a recapturable self-expanding stent. The safety and efficacy of the stent for recanalization were evaluated retrospectively.ResultsThe emboli were entrapped against the vessel wall by the stent, resulting in immediate recanalization (TIMI 2) in all embolic occlusions. The dissecting occlusion was recanalized completely (TIMI 3). Adjunctive thrombolytics (n = 8, urokinase, 100,000-300,000 U) and/or GP IIb/IIIa antagonist (n = 7, tirofiban, 0.5-1 mg) were administered intra-arterially, and the degree of recanalization further improved in 4 embolic occlusions (TIMI 3). Acute in-stent thrombosis occurred in 2 patients, who received only urokinase without GP IIb/IIIa antagonist. Both of the reoccluded arteries were reopened, by stent recapture in 1 and by intra-arterial administration of GP IIb/IIIa antagonist in the other. Recapture was attempted in 7 cases, of which there were 3 successful outcomes. There was 1 asymptomatic hemorrhagic conversion at the infarction site. The mean improvement of the NIHSS score between baseline and discharge was 12.3 (range, 3-22).ConclusionsPreliminary results of this study suggest that a self-expanding stent may be safe and efficient for recanalization of acute embolic or dissecting intracranial artery occlusion.
| S-EPMC7963979 | biostudies-literature
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.
| S-EPMC10762632 | biostudies-literature
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.
| S-EPMC7368707 | biostudies-literature
Project description:BackgroundTigertriever (Rapid Medical, Sunrise, FL) is an adjustable-diameter stent retriever that is being tested in an investigational device exemption clinical trial, Treatment with Intent to Generate Reperfusion (TIGER). The retriever is available in three lengths with corresponding adjustable diameters; however, a single device cannot be used for multiple thrombectomy attempts. A clicker-based expansion mechanism allows incremental expansion of the retriever and step-wise increase in radial force to the parent vessel diameter. The clicker mechanism is used to expand the stent retriever until it is apposed with the vessel walls. Rest of the procedure is similar to a mechanical thrombectomy performed with a conventional stent retriever and is demonstrated in the video.Case descriptionWe present a case of a 59-year-old woman who presented with left-upper extremity weakness, facial droop, and hemineglect. Perfusion imaging demonstrated increased time-to-peak. Angiography showed right internal carotid artery terminus occlusion. The patient underwent successful mechanical thrombectomy (Thrombolysis in Cerebral Infarction 2b reperfusion) using the Tigertriever and was discharged home without any perioperative complications.ConclusionAn adjustable, expandable stent retriever allows operator to size the stent retriever to match the target artery diameter. The expandable design of stent retriever has potential implications for distal vessel occlusion mechanical thrombectomy.
| S-EPMC7771483 | biostudies-literature
Project description:BackgroundThe Catfish stent retriever is a newly developed mechanical thrombectomy device for rapid recanalisation in emergent large vessel occlusion (ELVO) stroke. The current trial aimed to assess whether the Catfish stent retriever is non-inferior to the Solitaire stent retriever in terms of outcomes in ELVO stroke.MethodsThis was a randomised, prospective, parallel-group, multicentre, open-label, non-inferiority study conducted at 18 sites in China. The primary outcome was the proportion of cases with successful recanalisation (modified thrombolysis in cerebral infarction score of 2b or 3) following the procedure. Secondary efficacy outcomes included the National Institutes of Health Stroke Scale scores at 24 hours and 7 days or discharge if earlier, time from artery puncture to successful recanalisation and good clinical outcome (modified Rankin scale score ≤2) at 90 days. Safety outcomes included symptomatic intracranial haemorrhage, all cause-death and severe adverse events at 90 days.ResultsBetween 3 March 2019 and 5 June 2021, 118 and 120 patients were randomly allocated to the Catfish and Solitaire groups, respectively. The primary endpoint after all endovascular procedures was non-inferior in the Catfish group (88.5%, 100/113) than in the Solitaire group (87.7%, 100/114), with a rate difference (RD) of 0.78% (95% CI -7.64 to -9.20; p=0.001). Sensitivity analysis only considering the per-protocol set also yielded similar results, with an RD of 0.83% (95% CI -7.03 to -8.70; p<0.001). Additionally, the proportions of cases with good clinical outcomes (47.8% vs 50.0%, p=0.739) and all-cause death rates (17.7% vs 18.8%, p=0.700) were similar in both groups at 90 days.ConclusionsThe Catfish stent retriever is an effective and safe device for endovascular recanalisation in ELVO stroke.Trial registration numberNCT03820882.
| S-EPMC10800261 | biostudies-literature
Project description:Background and purposeLittle is known about the consequences of arterial wall damage that may be due to mechanical endovascular thrombectomy. Our aim was to perform 1-year MR angiographic and clinical follow-up of patients treated with mechanical endovascular thrombectomy using the Solitaire device.Materials and methodsPatients with stroke treated between August 2010 and July 2012 were prospectively evaluated with a minimum follow-up of 1 year after mechanical endovascular thrombectomy. Angiographic follow-up was performed on a 3T MR imaging scanner and included intracranial artery TOF MRA and supra-aortic artery gadolinium-enhanced MRA. Images were assessed to detect arterial abnormalities (stenosis, occlusion, dilation) and were compared with the final post-mechanical endovascular thrombectomy run to differentiate delayed and pre-existing abnormalities. Clinical evaluation was performed with the mRS and the 36-Item Short-Form Health Survey questionnaire quality-of-life scale.ResultsThirty-nine patients were angiographically assessed at the mean term of 19 ± 4 months. MRA showed intracranial artery abnormalities in 10 patients, including 5 delayed intracranial artery abnormalities in 4 patients (4 stenoses and 1 dilation), 4 cases of pre-existing intracranial artery stenosis, and 2 occlusions. Pre-existing etiologic cervical artery stenosis or occlusion was observed in 2 patients. All these patients remained asymptomatic during the follow-up period. A significant clinical improvement was observed at 1-year follow-up in comparison with 3-month follow-up (P < .0001), with a good outcome achieved in 62.5% of patients and an acceptable quality of life restored.ConclusionsOne-year follow-up identifies delayed asymptomatic arterial abnormalities in patients treated with the Solitaire device.
| S-EPMC7965909 | biostudies-literature