A multicenter study of the safety and effectiveness of mechanical thrombectomy for patients with acute ischemic stroke not meeting top-tier evidence criteria

2017 ◽  
Vol 10 (1) ◽  
pp. 10-16 ◽  
Author(s):  
Nitin Goyal ◽  
Georgios Tsivgoulis ◽  
Donald Frei ◽  
Aquilla Turk ◽  
Blaise Baxter ◽  
...  

BackgroundWhile mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke (AIS) with emergent large-vessel occlusions (ELVO), recently published guidelines appropriately award top-tier evidence to the same selective criteria that were employed in completed clinical trials. We sought to evaluate the safety and effectiveness of MT in patients with AIS with ELVO who do not meet top-tier evidence criteria (TTEC).MethodsWe conducted an observational study on consecutive patients with AIS with ELVO who underwent MT at six high-volume endovascular centers. Standard safety outcomes (3-month mortality, symptomatic intracranial hemorrhage) and effectiveness outcomes (3-month functional independence: modified Rankin Scale scores of 0–2) were compared between patients meeting and failing TTEC.ResultsThe sample consisted of 349 (60%) controls fulfilling TTEC and 234 (40%) non-TTEC patients. Control patients meeting TTEC for MT tended to have higher functional independence rates at 3 months (47% vs 39%; p=0.055), while the rates of symptomatic intracerebral hemorrhage (sICH) were similar (9%) in both groups (p=0.983). In multivariable logistic regression models, adherence to TTEC for MT was not independently related to any safety outcome (sICH: OR 0.71, 95% CI 0.30 to 1.68, p=0.434; 3-month mortality: OR 1.27, 95% CI 0.69 to 2.33, p=0.448) or effectiveness outcome (3-month functional independence: OR 0.81, 95% CI 0.48 to 1.37, p=0.434; 3-month functional improvement: OR 0.73, 95% CI 0.48 to 1.11, p=0.138) after adjusting for potential confounders.ConclusionsApproximately 40% of patients with AIS with ELVO offered MT do not fulfill TTEC for MT. Patients who did not meet TTEC had high rates of good clinical outcome and low complication rates.

Neurology ◽  
2021 ◽  
Vol 97 (20 Supplement 2) ◽  
pp. S178-S184
Author(s):  
Shashvat M. Desai ◽  
Ruchira M. Jha ◽  
Italo Linfante

Purpose of the ReviewMechanical thrombectomy (MT)–mediated endovascular recanalization has dramatically transformed treatment and outcomes after acute ischemic stroke caused by a large vessel occlusion (LVO). Current guidelines recommend MT up to 24 hours from stroke onset in carefully selected patients based on favorable clinical and imaging parameters. Despite optimal patient selection and low complication rates with current recanalization technology, approximately 1 in 2 patients with LVO stroke do not achieve functional independence at 3 months. This ceiling effect of MT efficacy may be explained by ischemic core expansion into the ischemic penumbra before recanalization and neuronal loss occurring after recanalization. Factors affecting the efficacy of MT, or the degree of irreversible injury, include time from symptom onset to recanalization, collateral circulation status, and differences in neuronal vulnerability. The purpose of this brief review is to discuss potential targets for neuroprotection, present and future potential pharmacologic and nonpharmacologic agents, and the data available in the literature.Recent FindingsIn experimental ischemia models, several authors reported that pharmacologic and nonpharmacologic agents are able to slow the progression of ischemic core expansion. However, in the era of unsuccessful recanalization of the occluded artery, several neuroprotective agents that were promising in the preclinical stage failed phase II/III clinical trials.SummaryProviding neuroprotection before and after recanalization of an LVO may play an important role in improving outcomes in the era of MT. Neuroprotection is classically defined as a process that results in the salvage, recovery, or regeneration of neuronal (and other supporting CNS cell) structure or function. The advent of successful recanalization of acute LVO by MT in the majority of patients may spur the growth of effective neuroprotection.


2017 ◽  
Vol 10 (5) ◽  
pp. 434-439 ◽  
Author(s):  
Jens Altenbernd ◽  
Oliver Kuhnt ◽  
Svenja Hennigs ◽  
Ruediger Hilker ◽  
Christian Loehr

BackgroundAfter a series of positive studies for mechanical thrombectomy in large vessel occlusion acute ischemic stroke, the question remains, can symptomatic patients with distal vessel occlusion benefit from mechanical thrombectomy?PurposeTo assess the safety and efficacy of the 3MAX reperfusion system as frontline therapy for M2 and M3 occlusions.MethodsThis study retrospectively collected data on 58 patients treated for M2 and M3 occlusions between January and September 2016. Of these 58 patients, 31 had an isolated M2 or M3 occlusion. Eligible patients were treated with 3MAX by adirect first pass aspiration (ADAPT) technique within 6 hours following stroke onset. Effectiveness was defined by functional independence (90-day modified Rankin Scale core 0–2) and revascularization to modified Thrombolysis in Cerebral Infarction (mTICI) 2b–3 scores adjudicated by a core laboratory, while complication rates were used to determine safety of the device and the procedure.ResultsPatients with an isolated M2 or M3 occlusion had a mean age of 68.6±13.3 years (range 18–90 years), a median National Institutes of Health Stroke Score of 15 (IQR 9–19), and ASPECTS score of 9 (IQR 8–10). After intervention, 100% (31/31) of patients were revascularized to mTICI 2b–3; 77.4% (24/31) of patients showed revascularization to mTICI 3. Aspiration alone led to revascularization in 83.9% (26/31) of patients. At 90 days, 96.8% (30/31) of patients had achieved functional independence. The incidence of symptomatic intracranial hemorrhage was 0% (0/31).ConclusionsResults suggest that the 3MAX reperfusion system is safe and effective in achieving successful revascularization and functional independence for patients with acute ischemic stroke secondary to M2 and M3 occlusions using ADAPT, either as frontline monotherapy, or in combination with adjunctive devices.


2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Lili Zhao ◽  
Yating Jian ◽  
Tao Li ◽  
Heying Wang ◽  
Zhang Lei ◽  
...  

Introduction. Limited comparative studies have reported the safety and efficacy of tirofiban in acute ischemic stroke (AIS) patients after mechanical thrombectomy (MT). Additionally, the available studies are inconsistent with each other, which makes application of tirofiban unclear in neuro-intervention. Here, we performed a comparative retrospective study to investigate whether tirofiban combined with MT improves short- and long-term prognosis in AIS patients and whether its use is associated with complications. Method. Retrospective data were collected for AIS patients admitted between January 2013 and January 2019 at three stroke centers. According to whether tirofiban was used during the operation, patients were divided into tirofiban group and control group. Multivariate and COX regression analyses were performed to determine the association of tirofiban treatment with safety and efficiency in subjects treated with MT. Result. A total of 174 patients were analyzed, of whom 89 (51.1%) were treated with tirofiban. There were no differences in the incidence of symptomatic intracerebral hemorrhage (10.2% vs. 10.6%, p=0.918), parenchymal hemorrhage type 2 (18.0% vs. 16.5%, p=0.793), and reocclusion at 24 h (3.4% vs. 10.6%, p=0.060) between the tirofiban group and control group. Multivariate regression showed that tirofiban was not associated with intracerebral hemorrhage, early neurological deterioration, neurological improvement at 7 days, functional independence at 3-month and 9-month follow-up, or death at 9-month follow-up (adjusted p>0.05 for all). However, AIS patients treated with MT + tirofiban showed a trend towards acquiring faster functional independence, with a median time to acquire functional independence of 4.0 months compared with 6.5 months in the control group (risk ratio = 1.49, 95% confidence interval 0.98–2.27; long rank p=0.066). Conclusion. Tirofiban may help AIS patients given MT to gain functional independence faster, without increasing the risk of complications.


Author(s):  
Anna Lambrinos ◽  
Alexis K. Schaink ◽  
Irfan Dhalla ◽  
Timo Krings ◽  
Leanne K. Casaubon ◽  
...  

AbstractAlthough intravenous thrombolysis increases the probability of a good functional outcome in carefully selected patients with acute ischemic stroke, a substantial proportion of patients who receive thrombolysis do not have a good outcome. Several recent trials of mechanical thrombectomy appear to indicate that this treatment may be superior to thrombolysis. We therefore conducted a systematic review and meta-analysis to evaluate the clinical effectiveness and safety of new-generation mechanical thrombectomy devices with intravenous thrombolysis (if eligible) compared with intravenous thrombolysis (if eligible) in patients with acute ischemic stroke caused by a proximal intracranial occlusion. We systematically searched seven databases for randomized controlled trials published between January 2005 and March 2015 comparing stent retrievers or thromboaspiration devices with best medical therapy (with or without intravenous thrombolysis) in adults with acute ischemic stroke. We assessed risk of bias and overall quality of the included trials. We combined the data using a fixed or random effects meta-analysis, where appropriate. We identified 1579 studies; of these, we evaluated 122 full-text papers and included five randomized control trials (n=1287). Compared with patients treated medically, patients who received mechanical thrombectomy were more likely to be functionally independent as measured by a modified Rankin score of 0-2 (odds ratio, 2.39; 95% confidence interval, 1.88-3.04; I2=0%). This finding was robust to subgroup analysis. Mortality and symptomatic intracerebral hemorrhage were not significantly different between the two groups. Mechanical thrombectomy significantly improves functional independence in appropriately selected patients with acute ischemic stroke.


2020 ◽  
Vol 132 (4) ◽  
pp. 1182-1187 ◽  
Author(s):  
Carrie E. Andrews ◽  
Nikolaos Mouchtouris ◽  
Evan M. Fitchett ◽  
Fadi Al Saiegh ◽  
Michael J. Lang ◽  
...  

OBJECTIVEMechanical thrombectomy (MT) is now the standard of care for acute ischemic stroke (AIS) secondary to large-vessel occlusion, but there remains a question of whether elderly patients benefit from this procedure to the same degree as the younger populations enrolled in the seminal trials on MT. The authors compared outcomes after MT of patients 80–89 and ≥ 90 years old with AIS to those of younger patients.METHODSThe authors retrospectively analyzed records of patients undergoing MT at their institution to examine stroke severity, comorbid conditions, medical management, recanalization results, and clinical outcomes. Univariate and multivariate logistic regression analysis were used to compare patients < 80 years, 80–89 years, and ≥ 90 years old.RESULTSAll groups had similar rates of comorbid disease and tissue plasminogen activator (tPA) administration, and stroke severity did not differ significantly between groups. Elderly patients had equivalent recanalization outcomes, with similar rates of readmission, 30-day mortality, and hospital-associated complications. These patients were more likely to have poor clinical outcome on discharge, as defined by a modified Rankin Scale (mRS) score of 3–6, but this difference was not significant when controlled for stroke severity, tPA administration, and recanalization results.CONCLUSIONSOctogenarians, nonagenarians, and centenarians with AIS have similar rates of mortality, hospital readmission, and hospital-associated complications as younger patients after MT. Elderly patients also have the capacity to achieve good functional outcome after MT, but this potential is moderated by stroke severity and success of treatment.


2021 ◽  
pp. 174749302110473
Author(s):  
Jin Pyeong Jeon ◽  
Chih-Hao Chen ◽  
Fon-Yih Tsuang ◽  
Jianming Liu ◽  
Michael D Hill ◽  
...  

Background. The impact of renal impairment (RI) on the outcomes of patients with acute ischemic stroke (AIS) treated with endovascular thrombectomy (EVT) was relatively limited and contradictory. We performed a systematic review and meta-analysis to investigate this. Aims. We registered a protocol on September 2020 and searched MEDLINE, EMBASE, and Google Scholar accordingly. RI was defined as an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2. Predefined outcomes included functional independence (defined as a modified Rankin Scale of 0, 1, or 2) at 3 months, successful reperfusion, mortality, and symptomatic intracerebral hemorrhage (sICH). Summary of review. Eleven studies involving 3453 patients were included. For the unadjusted outcomes, RI was associated with fewer functional independence (odds ratio (OR), 0.49; 95% confidence interval (CI), 0.39–0.62) and higher mortality (OR, 2.55; 95% CI, 2.03–3.21). RI was not associated with successful reperfusion (OR, 0.80; 95% CI 0.63–1.00) and sICH (OR, 1.41; 95% CI, 0.95–2.10). For the adjusted outcomes, results derived from a multivariate meta-analysis were consistent with the respective unadjusted outcomes: functional independence (OR, 0.59; 95% CI, 0.45–0.77), mortality (OR, 2.23, 95% CI, 1.45–3.43), and sICH (OR, 1.34; 95% CI, 0.85–2.10). Conclusions. We presented the first systematic review to demonstrate that RI is associated with fewer functional independence and higher mortality. Future EVT studies should publish complete renal eGFR data to facilitate prognostic studies and permit eGFR to be analyzed in a continuous variable. Systematic Review Registration: PROSPERO CRD42020191309


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Ameer E Hassan ◽  
Mahmoud Dibas ◽  
Amr Ehab El-Qushayri ◽  
Sherief Ghozy ◽  
Adam A Dmytriw ◽  
...  

Background: Mechanical thrombectomy (MT) has significantly improved outcomes of acute ischemic stroke (AIS) patients due to large vessel occlusion (LVO). The first-pass effect (FPE), defined as achieving complete reperfusion (mTICI3/2c) with a single pass, was reported to be associated with higher functional independence rates following EVT and has been emphasized as an important procedural target. We compared MT outcomes in patients who achieved FPE to those who did not in a real world large database. Method: A retrospective analysis of LVO pts who underwent MT from a single center prospectively collected database. Patients were stratified into those who achieved FPE and non-FPE. The primary outcome (discharge and 90 day mRS 0-2) and safety (sICH, mortality and neuro-worsening) were compared between the two groups. Results: Of 580 pts, 261 (45%) achieved FPE and 319 (55%) were non-FPE. Mean age was (70 vs 71, p=0.051) and mean initial NIHSS (16 vs 17, p=0.23) and IV tPA rates (37% bs 36%, p=0.9) were similar between the two groups. Other baseline characteristics were similar. Non-FPE pts required more stenting (15% vs 25%, p=0.003), and angioplasty (19% vs 29%, p=0.01). The FPE group had significantly more instances of discharge (33% vs 17%, p<0.001), and 90-day mRS score 0-2 (29% vs 20%, p<0.001), respectively. Additionally, the FPE group had a significant lower mean discharge NIHSS score (12 vs 17, p<0.001). FPE group had better safety outcomes with lower mortality (14.2% vs 21.6%, p=0.03), sICH (5.7% vs 13.5, p=0.004), and neurological worsening (71.3% vs 78.4%, p=0.02), compared to the non-FPE group. Conclusion: Patients with first pass complete or near complete reperfusion with MT had higher functional independence rates, reduced mortality, symptomatic hemorrhage and neurological worsening. Improvement in MT devices and techniques is vital to increase first pass effect and improve clinical outcomes.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Stephanie Chen ◽  
David McCarthy ◽  
Vasu Saini ◽  
Marie Brunet ◽  
Eric Peterson ◽  
...  

Background: Obesity is an established risk factor for acute ischemic stroke (AIS), but its impact on clinical outcomes and mortality after AIS remains controversial. In this study, we evaluate the association of body mass index (BMI) on outcomes after mechanical thrombectomy (MT) for large vessel occlusion acute ischemic stroke (LVOS). Methods: We reviewed our prospective MT database for LVOS between 2015 and 2018. BMI was analyzed as a continuous and categorical variable with underweight BMI <18.5, normal BMI 18.5-24.9, overweight BMI 25-29.9, and obese BMI>30. Multivariate analysis was used to determine predictors of outcome. Results: 335 patients underwent MT with 7 (2.1%) patients classified as underweight, 107 (31.9%) normal, 141 (42.1%) overweight, and 80 (23.9%) obese. Compared to normal weight (reference), obese patients had higher rates of hypertension and hyperlipidemia, while underweight patients had higher rates of previous stroke and presentation NIHSS. The time from symptom onset to puncture, procedural techniques, and reperfusion success (>TICI 2b) was not significantly different between BMI categories. There was a significant inverse linear correlation between BMI and symptomatic hemorrhagic. In patients with successful reperfusion (>TICI 2b), there was also a significant bell-shaped relationship between BMI and functional independence (mRS < 3) with both low and high BMIs associated with worse outcomes. In patients without post-procedural symptomatic hemorrhage, there was a significant linear correlation between BMI and inpatient mortality. Conclusion: In LVOS patients treated with MT, BMI is inversely related with post-procedural symptomatic hemorrhage. Yet in those whom reperfusion is achieved, both lower and higher than normal BMI were associated with worse functional outcomes. Thus, the obesity paradox does not appear to pertain to mechanical thrombectomy, although larger prospective studies are necessary.


Author(s):  
Azalea T. Pajo ◽  
Jose Danilo B. Diestro ◽  
Adrian I. Espiritu ◽  
Adam A. Dmytriw ◽  
Alejandro Enriquez-Marulanda ◽  
...  

ABSTRACT:Background:Intravenous tissue-type plasminogen activator (IVtPA) is a proven treatment for acute ischemic stroke; however, diabetes mellitus (DM) and previous cerebral infarction (PCI) were considered relative contraindications for thrombolysis within the 3–4.5 h period.Objective:The study aimed to determine the safety and efficacy of IVtPA among diabetic patients with PCI presenting with acute ischemic stroke.Methods:Studies which evaluated the outcome of IVtPA in terms of symptomatic intracerebral hemorrhage (sICH), functional outcome in modified Rankin scale, and death among diabetic patients with PCI presenting with acute ischemic stroke within the 3–4.5 h period were systematically searched until July 2019. Screening and eligibility criteria were applied. Risk of bias was evaluated using the Newcastle–Ottawa Scale. Odds ratios (ORs) with 95% confidence interval (CI) were used to compare measures of treatment effect. Mantel–Haenszel method and random-effects model were also employed.Results:Four registry-based studies with a total of 44,572 patients were included for quantitative synthesis. Giving IVtPA among DM+/PCI+ patients did not result in significantly increased rate of sICH (OR, 1.09; 95% CI, 0.88, 1.36) compared to No DM+/PCI+ patients. However, there was significantly higher mortality (OR, 1.81; 95% CI, 1.60, 2.06) in the DM+/PCI+ group. Conversely, among those who survived, the DM+/PCI+ patients were more functionally independent at 3 months (OR, 0.76; 95% CI, 0.61, 0.94).Conclusion:Limited evidence suggests that thrombolysis in DM+/PCI+ patients does not result in significantly higher incidence of sICH and may improve functional independence. However, the significantly higher mortality in this group warrants an assessment of the individualized risk–benefit ratio in the use of IVtPA.


Stroke ◽  
2019 ◽  
Vol 50 (4) ◽  
pp. 880-888 ◽  
Author(s):  
Johannes Kaesmacher ◽  
Panagiotis Chaloulos-Iakovidis ◽  
Leonidas Panos ◽  
Pasquale Mordasini ◽  
Patrik Michel ◽  
...  

Background and Purpose— If anterior circulation large vessel occlusion acute ischemic stroke patients presenting with ASPECTS 0–5 (Alberta Stroke Program Early CT Score) should be treated with mechanical thrombectomy remains unclear. Purpose of this study was to report on the outcome of patients with ASPECTS 0–5 treated with mechanical thrombectomy and to provide data regarding the effect of successful reperfusion on clinical outcomes and safety measures in these patients. Methods— Multicenter, pooled analysis of 7 institutional prospective registries: Bernese-European Registry for Ischemic Stroke Patients Treated Outside Current Guidelines With Neurothrombectomy Devices Using the SOLITAIRE FR With the Intention for Thrombectomy (Clinical Trial Registration—URL: https://www.clinicaltrials.gov . Unique identifier: NCT03496064). Primary outcome was defined as modified Rankin Scale 0–3 at day 90 (favorable outcome). Secondary outcomes included rates of day 90 modified Rankin Scale 0–2 (functional independence), day 90 mortality and occurrence of symptomatic intracerebral hemorrhage. Multivariable logistic regression analyses were performed to assess the association of successful reperfusion with clinical outcomes. Outputs are displayed as adjusted Odds Ratios (aOR) and 95% CI. Results— Two hundred thirty-seven of 2046 patients included in this registry presented with anterior circulation large vessel occlusion and ASPECTS 0–5. In this subgroup, the overall rates of favorable outcome and mortality at day 90 were 40.1% and 40.9%. Achieving successful reperfusion was independently associated with favorable outcome (aOR, 5.534; 95% CI, 2.363–12.961), functional independence (aOR, 5.583; 95% CI, 1.964–15.873), reduced mortality (aOR, 0.180; 95% CI, 0.083–0.390), and lower rates of symptomatic intracerebral hemorrhage (aOR, 0.235; 95% CI, 0.062–0.887). The mortality-reducing effect remained in patients with ASPECTS 0–4 (aOR, 0.167; 95% CI, 0.056–0.499). Sensitivity analyses did not change the primary results. Conclusions— In patients presenting with ASPECTS 0–5, who were treated with mechanical thrombectomy, successful reperfusion was beneficial without increasing the risk of symptomatic intracerebral hemorrhage. Although the results do not allow for general treatment recommendations, formal testing of mechanical thrombectomy versus best medical treatment in these patients in a randomized controlled trial is warranted.


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