Indications for thrombectomy Aamodt, Anne Hege; Kurz, Martin; Jacobsen, Eva A ...
Tidsskrift for den Norske Lægeforening,
10/2018, Letnik:
138, Številka:
17
Journal Article
The benefits of endovascular revascularization using the contact aspiration technique vs the stent retriever technique in patients with acute ischemic stroke remain uncertain because of lack of ...evidence from randomized trials.
To compare efficacy and adverse events using the contact aspiration technique vs the standard stent retriever technique as a first-line endovascular treatment for successful revascularization among patients with acute ischemic stroke and large vessel occlusion.
The Contact Aspiration vs Stent Retriever for Successful Revascularization (ASTER) study was a randomized, open-label, blinded end-point clinical trial conducted in 8 comprehensive stroke centers in France (October 2015-October 2016). Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation within 6 hours of symptom onset were included.
Patients were randomly assigned to first-line contact aspiration (n = 192) or first-line stent retriever (n = 189) immediately prior to mechanical thrombectomy.
The primary outcome was the proportion of patients with successful revascularization defined as a modified Thrombolysis in Cerebral Infarction score of 2b or 3 at the end of all endovascular procedures. Secondary outcomes included degree of disability assessed by overall distribution of the modified Rankin Scale (mRS) score at 90 days, change in National Institutes of Health Stroke Scale (NIHSS) score at 24 hours, all-cause mortality at 90 days, and procedure-related serious adverse events.
Among 381 patients randomized (mean age, 69.9 years; 174 women 45.7%), 363 (95.3%) completed the trial. Median time from symptom onset to arterial puncture was 227 minutes (interquartile range, 180-280 minutes). For the primary outcome, the proportion of patients with successful revascularization was 85.4% (n = 164) in the contact aspiration group vs 83.1% (n = 157) in the stent retriever group (odds ratio, 1.20 95% CI, 0.68-2.10; P = .53; difference, 2.4% 95% CI, -5.4% to 9.7%). For the clinical efficacy outcomes (change in NIHSS score at 24 hours, mRS score at 90 days) and adverse events, there were no significant differences between groups.
Among patients with ischemic stroke in the anterior circulation undergoing thrombectomy, first-line thrombectomy with contact aspiration compared with stent retriever did not result in an increased successful revascularization rate at the end of the procedure.
clinicaltrials.gov Identifier: NCT02523261.
Achieving first-pass recanalization (FPR) has become the primary procedural objective during thrombectomy in acute ischemic stroke patients as it correlates with the best clinical outcome. ...Understanding factors contributing to FPR failures is essential to enhance FPR success rates. As the central target of thrombectomy, the thrombus itself may be a significant factor influencing FPR.
This study aimed to investigate the association between thrombus composition and FPR success rates.
In total, thrombi from 267 ischemic stroke patients were collected in the AZ Groeninge Hospital (Kortrijk, Belgium). Thrombus composition was determined via detailed histologic analysis of red blood cells (RBCs), fibrin, von Willebrand factor, platelets, leukocytes, citrullinated histone 3 (marker for neutrophil extracellular traps), and intracellular and extracellular DNA. FPR was defined as obtaining a modified thrombolysis in cerebral infarction (mTICI) score of 2c/3 after the first pass.
An mTICI score of 2c/3 was obtained in 180 patients, which was achieved via a successful FPR procedure in 126 cases or after multiple passes in 54 cases. Interestingly, thrombi from FPR cases had a different composition from thrombi that needed multiple passes to obtain an mTICI score of 2c/3. FPR thrombi contained significantly more RBCs (P = .0264), less fibrin (P = .0196), and less extracellular DNA (P = .0457).
Our results indicate that thrombi characterized by lower RBC content, higher fibrin levels, and increased extracellular DNA are less likely to result in an FPR. These results are important to guide future research aiming at improving procedures or technologies to obtain FPR rates in RBC-poor thrombi.
Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, less than 40% regain functional independence when treated with intravenous tissue ...plasminogen activator (t-PA) alone. Thrombectomy with the use of a stent retriever, in addition to intravenous t-PA, increases reperfusion rates and may improve long-term functional outcome.
We randomly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone (control group) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset (intervention group). Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions. The primary outcome was the severity of global disability at 90 days, as assessed by means of the modified Rankin scale (with scores ranging from 0 no symptoms to 6 death).
The study was stopped early because of efficacy. At 39 centers, 196 patients underwent randomization (98 patients in each group). In the intervention group, the median time from qualifying imaging to groin puncture was 57 minutes, and the rate of substantial reperfusion at the end of the procedure was 88%. Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale (P<0.001). The rate of functional independence (modified Rankin scale score, 0 to 2) was higher in the intervention group than in the control group (60% vs. 35%, P<0.001). There were no significant between-group differences in 90-day mortality (9% vs. 12%, P=0.50) or symptomatic intracranial hemorrhage (0% vs. 3%, P=0.12).
In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation, thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days. (Funded by Covidien; SWIFT PRIME ClinicalTrials.gov number, NCT01657461.).
We aimed to assess the safety and efficacy of thrombectomy for the treatment of stroke in a trial embedded within a population-based stroke reperfusion registry.
During a 2-year period at four ...centers in Catalonia, Spain, we randomly assigned 206 patients who could be treated within 8 hours after the onset of symptoms of acute ischemic stroke to receive either medical therapy (including intravenous alteplase when eligible) and endovascular therapy with the Solitaire stent retriever (thrombectomy group) or medical therapy alone (control group). All patients had confirmed proximal anterior circulation occlusion and the absence of a large infarct on neuroimaging. In all study patients, the use of alteplase either did not achieve revascularization or was contraindicated. The primary outcome was the severity of global disability at 90 days, as measured on the modified Rankin scale (ranging from 0 no symptoms to 6 death). Although the maximum planned sample size was 690, enrollment was halted early because of loss of equipoise after positive results for thrombectomy were reported from other similar trials.
Thrombectomy reduced the severity of disability over the range of the modified Rankin scale (adjusted odds ratio for improvement of 1 point, 1.7; 95% confidence interval CI, 1.05 to 2.8) and led to higher rates of functional independence (a score of 0 to 2) at 90 days (43.7% vs. 28.2%; adjusted odds ratio, 2.1; 95% CI, 1.1 to 4.0). At 90 days, the rates of symptomatic intracranial hemorrhage were 1.9% in both the thrombectomy group and the control group (P=1.00), and rates of death were 18.4% and 15.5%, respectively (P=0.60). Registry data indicated that only eight patients who met the eligibility criteria were treated outside the trial at participating hospitals.
Among patients with anterior circulation stroke who could be treated within 8 hours after symptom onset, stent retriever thrombectomy reduced the severity of post-stroke disability and increased the rate of functional independence. (Funded by Fundació Ictus Malaltia Vascular through an unrestricted grant from Covidien and others; REVASCAT ClinicalTrials.gov number, NCT01692379.).
Endovascular thrombectomy is a highly efficacious treatment for large vessel occlusion (LVO). LVO prediction instruments, based on stroke signs and symptoms, have been proposed to identify stroke ...patients with LVO for rapid transport to endovascular thrombectomy-capable hospitals. This evidence review committee was commissioned by the American Heart Association/American Stroke Association to systematically review evidence for the accuracy of LVO prediction instruments.
Medline, Embase, and Cochrane databases were searched on October 27, 2016. Study quality was assessed with the Quality Assessment of Diagnostic Accuracy-2 tool.
Thirty-six relevant studies were identified. Most studies (21 of 36) recruited patients with ischemic stroke, with few studies in the prehospital setting (4 of 36) and in populations that included hemorrhagic stroke or stroke mimics (12 of 36). The most frequently studied prediction instrument was the National Institutes of Health Stroke Scale. Most studies had either some risk of bias or unclear risk of bias. Reported discrimination of LVO mostly ranged from 0.70 to 0.85, as measured by the C statistic. In meta-analysis, sensitivity was as high as 87% and specificity was as high as 90%, but no threshold on any instruments predicted LVO with both high sensitivity and specificity. With a positive LVO prediction test, the probability of LVO could be 50% to 60% (depending on the LVO prevalence in the population), but the probability of LVO with a negative test could still be ≥10%.
No scale predicted LVO with both high sensitivity and high specificity. Systems that use LVO prediction instruments for triage will miss some patients with LVO and milder stroke. More prospective studies are needed to assess the accuracy of LVO prediction instruments in the prehospital setting in all patients with suspected stroke, including patients with hemorrhagic stroke and stroke mimics.
Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain tissue, who were randomly ...assigned beyond 6 h and (depending on study protocol) up to 24 h from time last seen well. We aimed to estimate the benefit of thrombectomy overall and in prespecified subgroups through individual patient data meta-analysis.
We did a systematic review and individual patient data meta-analysis between Jan 1, 2010, and March 1, 2021, of randomised controlled trials of endovascular stroke therapy. In the Analysis Of Pooled Data From Randomized Studies Of Thrombectomy More Than 6 Hours After Last Known Well (AURORA) collaboration, the primary outcome was disability on the modified Rankin Scale (mRS) at 90 days, analysed by ordinal logistic regression. Key safety outcomes were symptomatic intracerebral haemorrhage and mortality within 90 days.
Patient level data from 505 individuals (n=266 intervention, n=239 control; mean age 68·6 years SD 13·7, 259 51·3% women) were included from six trials that met inclusion criteria of 17 screened published randomised trials. Primary outcome analysis showed a benefit of thrombectomy with an unadjusted common odds ratio (OR) of 2·42 (95% CI 1·76–3·33; p<0·0001) and an adjusted common OR (for age, gender, baseline stroke severity, extent of infarction on baseline head CT, and time from onset to random assignment) of 2·54 (1·83–3·54; p<0·0001). Thrombectomy was associated with higher rates of independence in activities of daily living (mRS 0–2) than best medical therapy alone (122 45·9% of 266 vs 46 19·3% of 238; p<0·0001). No significant difference between intervention and control groups was found when analysing either 90-day mortality (44 16·5% of 266 vs 46 19·3% of 238) or symptomatic intracerebral haemorrhage (14 5·3% of 266 vs eight 3·3% of 239). No heterogeneity of treatment effect was noted across subgroups defined by age, gender, baseline stroke severity, vessel occlusion site, baseline Alberta Stroke Program Early CT Score, and mode of presentation; treatment effect was stronger in patients randomly assigned within 12–24 h (common OR 5·86 95% CI 3·14–10·94) than those randomly assigned within 6–12 h (1·76 1·18–2·62; pinteraction=0·0087).
These findings strengthen the evidence for benefit of endovascular thrombectomy in patients with evidence of reversible cerebral ischaemia across the 6–24 h time window and are relevant to clinical practice. Our findings suggest that in these patients, thrombectomy should not be withheld on the basis of mode of presentation or of the point in time of presentation within the 6–24 h time window.
Stryker Neurovascular.
Acute limb ischemia (ALI) remains a vascular emergency with high morbidity and mortality. While the JETi Hydrodynamic Thrombectomy System (Abbott) offers a percutaneous approach to fragment and ...aspirate the thrombus in patients with arterial occlusions, data on its efficacy and safety are limited. This study reports our early experience using the JETi device to treat ALI at our institution.
This is a single-center, retrospective review of patients with ALI treated with the JETi device between September 2020 and December 2022. Patients were included if the JETi device was used either as a primary intervention or as an adjunct procedure. The primary endpoint was technical success defined as <50% residual thrombus after intervention. Secondary endpoints included achieving complete resolution of the thrombus on angiogram, acute kidney injury (AKI), major bleeding, 30-day major amputation, and 30-day mortality.
A total of 59 JETi procedures for ALI (median age 62 years interquartile range: 56-71 years) were performed on 39 male and 20 female patients. The median time from onset of symptoms to hospitalization was 24 hours (interquartile range: 4-168 hours). Rutherford classifications were I (10), IIa (27), IIb (14), and undocumented (8). Etiology of ALI was native vessel thrombosis (27), embolism (16), graft/stent thrombosis (14), and iatrogenic (2). A total of 124 vessels were treated, with an average of 2.1 vessels per procedure. The primary outcome was achieved in 86% (107/124) of the arteries, with 82% (102/124) successfully opened using the JETi device alone without the need for any adjunctive therapy. Complete resolution of the thrombus using JETi was achieved in 81% (101/124) arteries, with or without the use of adjunctive therapy. A total of 6.7% (4/59) patients required a major limb amputation within 30 days despite successful recanalization, and one 30-day mortality was recorded. Complications included distal embolization (5), access site hematoma (2), and AKI (4). No major bleeding, hemolysis-induced AKI, or vessel dissection or perforation was observed.
The JETi device appears to be a safe and effective percutaneous treatment option in the management of ALI. It provides definitive treatment with a high technical success rate of 86% and a good safety profile.
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