Multicenter clinical experience in over 125 patients with the Penumbra Separator 3D for mechanical thrombectomy in acute ischemic stroke

BackgroundThe aim of this study was to assess reperfusion and clinical outcome of treatment with the self-expanding retrievable Separator 3D in revascularization of acute ischemic stroke. The three-dimensional (3D) device secures thrombus with direct aspiration and supports debulking of the clot.MethodsAt two centers, 129 consecutive stroke patients with National Institutes of Health Stroke Scale (NIHSS) scores ≥5 were treated with mechanical thrombectomy using the Separator 3D as a component of the Penumbra System within 8 h of symptom onset; modified Treatment in Cerebral Infarction (mTICI) revascularization scores, NIHSS score on admission and discharge, mortality rates, and modified Rankin Scale (mRS) outcomes at 90 days were evaluated.ResultsA total of 129 vessels in 129 patients were treated. Occlusions were located in the middle cerebral artery (MCA, 48%), internal carotid artery (ICA, 33%), cervical ICA–MCA (3%), and vertebrobasilar arteries (16%). Intravenous thrombolytic therapy with recombinant tissue plasminogen activator was given to 78% of patients. Median NIHSS was 15 prior to treatment. Reperfusion to mTICI 2b or 3 was successful in 96/129 (74%) target arterial lesions, with more than half of cases (51%) achieving mTICI 3. The mean time from arterial puncture to revascularization was 65 min. At 90 days, the symptomatic intracranial hemorrhage rate was 4%, all cause mortality was 32%, and 43/99 patients (43%) achieved functional independence with an mRS score of ≤2.ConclusionsThe results suggest that the Separator 3D enables safe and effective revascularization of occluded large arteries in acute stroke intervention, leading to a high rate of functional independence at 90 days.

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Frontline ADAPT therapy to treat patients with symptomatic M2 and M3 occlusions in acute ischemic stroke: initial experience with the Penumbra ACE and 3MAX reperfusion system

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2017-013233 ◽

2017 ◽

Vol 10 (5) ◽

pp. 434-439 ◽

Cited By ~ 30

Author(s):

Jens Altenbernd ◽

Oliver Kuhnt ◽

Svenja Hennigs ◽

Ruediger Hilker ◽

Christian Loehr

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Mechanical Thrombectomy ◽

Functional Independence ◽

National Institutes Of Health ◽

Complication Rates ◽

Vessel Occlusion ◽

First Pass ◽

Symptomatic Intracranial Hemorrhage ◽

Distal Vessel

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.

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Mechanical thrombectomy of acute ischemic stroke with a new intermediate aspiration catheter: preliminary results

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2017-013679 ◽

2018 ◽

Vol 10 (10) ◽

pp. 975-977 ◽

Cited By ~ 5

Author(s):

Fabrizio Sallustio ◽

Enrico Pampana ◽

Alessandro Davoli ◽

Stefano Merolla ◽

Giacomo Koch ◽

...

Keyword(s):

Ischemic Stroke ◽

Endovascular Treatment ◽

Acute Ischemic Stroke ◽

Intracranial Hemorrhage ◽

Mechanical Thrombectomy ◽

Functional Independence ◽

Stroke Patients ◽

Frequent Site ◽

Symptomatic Intracranial Hemorrhage ◽

Procedural Outcomes

Background and purposeTo report clinical and procedural outcomes of acute ischemic stroke patients after endovascular treatment with the new thromboaspiration catheter AXS Catalyst 6.MethodsPatients with anterior and posterior circulation stroke were selected. Successful reperfusion defined as a Thrombolysis in Cerebral Infarction (TICI) score ≥2 b and 3-month functional independence defined as a modified Rankin Scale (mRS) ≤2 were the main efficacy outcomes. Symptomatic intracranial hemorrhage and mortality were the main safety outcomes.Results107 patients were suitable for analysis. Mean age was 73.18±12.62 year and median baseline NIHSS was 17 (range: 3–32). The most frequent site of occlusion was the middle cerebral artery (MCA) (60.7%). 76.6% of patients were treated with AXS Catalyst 6 alone without the need for rescue devices or thromboaspiration catheters. Successful reperfusion was achieved in 84.1%, functional independence in 47.6%, symptomatic intracranial hemorrhage occurred in 3.7%, and mortality in 21.4%.ConclusionsEndovascular treatment with AXS Catalyst 6 proved to be safe, technically feasible, and effective. Comparison analyses with other devices for mechanical thrombectomy are needed.

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Association of admission leukocyte count with clinical outcomes in acute ischemic stroke patients undergoing intravenous thrombolysis with recombinant tissue plasminogen activator

Current Neurovascular Research ◽

10.2174/1567202617999201125201616 ◽

2020 ◽

Vol 17 ◽

Author(s):

Jie Chen ◽

Fu-Liang Zhang ◽

Shan Lv ◽

Hang Jin ◽

Yun Luo ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Plasminogen Activator ◽

Tissue Plasminogen Activator ◽

Leukocyte Count ◽

Intravenous Thrombolysis ◽

Recombinant Tissue Plasminogen Activator ◽

Functional Independence ◽

Tissue Plasminogen ◽

Poor Outcomes

Objective:: Increased leukocyte count are positively associated with poor outcomes and all-cause mortality in coronary heart disease, cancer, and ischemic stroke. The role of leukocyte count in acute ischemic stroke (AIS) remains important. We aimed to investigate the association between admission leukocyte count before thrombolysis with recombinant tissue plasminogen activator (rt-PA) and 3-month outcomes in AIS patients. Methods:: This retrospective study included consecutive AIS patients who received intravenous (IV) rt-PA within 4.5 h of symptom onset between January 2016 and December 2018. We assessed outcomes including short-term hemorrhagic transformation (HT), 3-month mortality, and functional independence (modified Rankin Scale [mRS] score of 0–2 or 0–1). Results:: Among 579 patients who received IV rt-PA, 77 (13.3%) exhibited HT at 24 h, 43 (7.4%) died within 3 months, and 211 (36.4%) exhibited functional independence (mRS score: 0–2). Multivariable logistic regression revealed admission leukocyte count as an independent predictor of good and excellent outcomes at 3 months. Each 1-point increase in admission leukocyte count increased the odds of poor outcomes at 3 months by 7.6% (mRS score: 3–6, odds ratio (OR): 1.076, 95% confidence interval (CI): 1.003–1.154, p=0.041) and 7.8% (mRS score: 2–6, OR: 1.078, 95% CI: 1.006–1.154, p=0.033). Multivariable regression analysis revealed no association between HT and 3-month mortality. Admission neutrophil and lymphocyte count were not associated with 3-month functional outcomes or 3-month mortality. Conclusion:: Lower admission leukocyte count independently predicts good and excellent outcomes at 3 months in AIS patients undergoing rt-PA treatment.

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Abstract T P48: Intravenous Thrombolysis Using Low-Dose Alteplase for Nonagenarians with Acute Ischemic Stroke: The SAMURAI rtPA Registry

Stroke ◽

10.1161/str.45.suppl_1.tp48 ◽

2014 ◽

Vol 45 (suppl_1) ◽

Author(s):

Mikito Hayakawa ◽

Masatoshi Koga ◽

Shoichiro Sato ◽

Shoji Arihiro ◽

Yoshiaki Shiokawa ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Low Dose ◽

Intravenous Thrombolysis ◽

Functional Independence ◽

Efficacy And Safety ◽

Multivariate Adjustment ◽

Potential Efficacy ◽

Symptomatic Intracranial Hemorrhage ◽

Baseline Characteristics

Objective: Although intravenous thrombolysis (IVT) using alteplase for octogenarians with acute ischemic stroke becomes relatively familiar, it is unclear whether IVT for nonagenarians is a futile intervention. The purpose of this study is to clarify the efficacy and safety of IVT using low-dose alteplase (0.6 mg/kg) for nonagenarians compared with octogenarians. Methods: Stroke Acute Management with Urgent Risk-factor Assessment and Improvement (SAMURAI) rtPA registry retrospectively collected 600 consecutive acute stroke patients receiving IVT from 10 Japanese stroke centers between October 2005 and July 2008. We extracted all octogenarians (O group) and nonagenarians (N group) from the registry. We compared baseline characteristics, symptomatic intracranial hemorrhage (SICH), and 3-month outcomes between the groups. 3-month outcomes include; functional independence (FI) defined as a mRS score 0-2, good outcome (GO) as a mRS score 0-2 or same as the premorbid mRS, poor outcome (PO) defined as a mRS score 5-6, and death. Results: Twenty-five nonagenarians (mean age, 93 years) and 124 octogenarians (mean age, 84 years) were included. N group was more female-predominant (76% versus 56%, p=0.06) and premorbidly dependent (44% versus 14%, p<0.001) than O group. There were no significant differences of median baseline NIHSS score (16 versus 14, p=0.95) and Alberta Stroke Program Early CT Score (9 versus 9, p=0.36) between the groups. The rate of FI tended to be lower in N group than O group (16% versus 36%, p=0.06), otherwise, the differences of the rates of GO (28% versus 37%, p=0.39), PO (40% versus 36%, p=0.73), death (20% versus 11%, p=0.23) and SICH (0% versus 2.4%, p=1.00) were not significant between the groups. In comparison with O group, N group was not associated with 3-month clinical outcomes (FI; OR 0.61; 95% CI, 0.15-2.42, GO; 0.98; 0.31-3.07, PO; 0.63; 0.15-2.70, death; 3.18; 0.62-16.3) and SICH (0.68; 0.17-2.69) after multivariate adjustment. Conclusions: IVT using low-dose alteplase for N group resulted in less frequent achievement of FI mainly because of more premorbid dependency than O group, however, showed at least a similar safety and a potential efficacy.

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Safety and efficacy of mechanical thrombectomy in acute ischemic stroke of anticoagulated patients

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2017-013714 ◽

2018 ◽

Vol 10 (12) ◽

pp. e29-e29 ◽

Cited By ~ 10

Author(s):

Vincent L’Allinec ◽

Marielle Ernst ◽

Mathieu Sevin-Allouet ◽

Nathalie Testard ◽

Béatrice Delasalle-Guyomarch ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Intracranial Hemorrhage ◽

Mechanical Thrombectomy ◽

Univariate Analysis ◽

Recombinant Tissue Plasminogen Activator ◽

Reperfusion Therapy ◽

Safety And Efficacy ◽

Risk Of Death ◽

Anticoagulated Patients

BackgroundAnticoagulated patients (APs) are currently excluded from acute ischemic stroke reperfusion therapy with intravenous recombinant tissue plasminogen activator (IV-rtPA); however, these patients could benefit from mechanical thrombectomy (MT). Evidence for MT in this condition remains scarce. The aim of this study was to analyze the safety and efficacy of MT in APs.MethodsWe analyzed three patient groups from two prospective registries: APs with MT (AP-MT group), non-anticoagulated patients treated with MT (NAP-MT group), and non-anticoagulated patients treated with IV-rtPA and MT (NAP-IVTMT group). Univariate and multivariate logistic regression were used to evaluate treatment efficacy with modified Rankin Scale (mRS) ≤2 and safety (radiologic intracranial hemorrhage (rICH), symptomatic intracranial hemorrhage (sICH) and death rate at 3 months) between groups.Results333 patients were included in the study, with 44 (12%) in the AP-MT group, 105 (31%) in the NAP-MT group, and 188 (57%) in the NAP-IVTMT group. Univariate analysis showed that the AP-MT group was older (P<0.001), more often had atrial fibrillation (P<0001), and had a higher ASPECTS (P<0.006 and P<0.002) compared with the NAP-MT group and NAP-IVTMT groups, respectively. Multivariate analysis showed that the AP-MT group had a lower risk of rICH (OR 2.77, 95% CI 1.01 to 7.61, P=0.05) but a higher risk of death at 3 months (OR 0.26, 95% CI 0.09 to 0.76, P=0.01) compared with the NAP-IVTMT group. No difference was found between the AP-MT and NAP-MT groups.ConclusionsWith regard to intracranial bleeding and functional outcome at 3 months, MT in APs seems as safe and efficient as in NAPs. However, there is a higher risk of death at 3 months in the AP-MT group compared with the NAP-IVTMT group.

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Abstract P488: The Impact of First Pass Effect on Acute Ischemic Stroke Clinical Outcomes: Why We Need to Continue to Improve Mechanical Thrombectomy?

Stroke ◽

10.1161/str.52.suppl_1.p488 ◽

2021 ◽

Vol 52 (Suppl_1) ◽

Author(s):

Ameer E Hassan ◽

Mahmoud Dibas ◽

Amr Ehab El-Qushayri ◽

Sherief Ghozy ◽

Adam A Dmytriw ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Clinical Outcomes ◽

Mechanical Thrombectomy ◽

Functional Independence ◽

Vessel Occlusion ◽

First Pass Effect ◽

Improved Outcomes ◽

First Pass ◽

The Impact

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.

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Abstract WP25: The Impact of Body Mass Index on Outcomes of Mechanical Thrombectomy for Acute Ischemic Stroke

Stroke ◽

10.1161/str.51.suppl_1.wp25 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Stephanie Chen ◽

David McCarthy ◽

Vasu Saini ◽

Marie Brunet ◽

Eric Peterson ◽

...

Keyword(s):

Body Mass Index ◽

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Body Mass ◽

Linear Correlation ◽

Mechanical Thrombectomy ◽

Functional Independence ◽

Normal Weight ◽

Vessel Occlusion ◽

The Impact

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.

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Thrombectomy for acute ischemic stroke in nonagenarians compared with octogenarians

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2019-015147 ◽

2019 ◽

Vol 12 (3) ◽

pp. 266-270 ◽

Cited By ~ 7

Author(s):

Eric S Sussman ◽

Blake Martin ◽

Michael Mlynash ◽

Michael P Marks ◽

David Marcellus ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Functional Independence ◽

Inclusion Criteria ◽

Related Factors ◽

Vessel Occlusion ◽

Endovascular Thrombectomy ◽

Improved Outcomes ◽

Symptomatic Intracranial Hemorrhage ◽

The Difference

IntroductionMultiple randomized trials have shown that endovascular thrombectomy (EVT) leads to improved outcomes in acute ischemic stroke (AIS) due to large vessel occlusion (LVO). Elderly patients were poorly represented in these trials, and the efficacy of EVT in nonagenarian patients remains uncertain.MethodsWe performed a retrospective cohort study at a single center. Inclusion criteria were: age 80–99, LVO, core infarct <70 mL, and salvageable penumbra. Patients were stratified into octogenarian (80–89) and nonagenarian (90–99) cohorts. The primary outcome was the ordinal score on the modified Rankin Scale (mRS) at 90 days. Secondary outcomes included dichotomized functional outcome (mRS ≤2 vs mRS ≥3), successful revascularization, symptomatic intracranial hemorrhage (ICH), and mortality.Results108 patients met the inclusion criteria, including 79 octogenarians (73%) and 29 nonagenarians (27%). Nonagenarians were more likely to be female (86% vs 58%; p<0.01); there were no other differences between groups in terms of demographics, medical comorbidities, or treatment characteristics. Successful revascularization (TICI 2b–3) was achieved in 79% in both cohorts. Median mRS at 90 days was 5 in octogenarians and 6 in nonagenarians (p=0.09). Functional independence (mRS ≤2) at 90 days was achieved in 12.5% and 19.7% of nonagenarians and octogenarians, respectively (p=0.54). Symptomatic ICH occurred in 21.4% and 6.4% (p=0.03), and 90-day mortality rate was 63% and 40.9% (p=0.07) in nonagenarians and octogenarians, respectively.ConclusionsNonagenarians may be at higher risk of symptomatic ICH than octogenarians, despite similar stroke- and treatment-related factors. While there was a trend towards higher mortality and worse functional outcomes in nonagenarians, the difference was not statistically significant in this relatively small retrospective study.

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Hyperacute Stenting for Acute Ischemic Stroke Is Associated with a High Rate of Symptomatic Intracranial Hemorrhage (P02.200)

Neurology ◽

10.1212/wnl.78.1_meetingabstracts.p02.200 ◽

2012 ◽

Vol 78 (Meeting Abstracts 1) ◽

pp. P02.200-P02.200

Author(s):

A. Fong ◽

E. Bershad ◽

H. Morsi ◽

H. Shaltoni ◽

M. Mawad ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Intracranial Hemorrhage ◽

High Rate ◽

Symptomatic Intracranial Hemorrhage

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Trends in mortality following mechanical thrombectomy for the treatment of acute ischemic stroke in the USA

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2015-011674 ◽

2015 ◽

Vol 8 (5) ◽

pp. 457-460 ◽

Cited By ~ 4

Author(s):

Mark R Villwock ◽

David J Padalino ◽

Eric M Deshaies

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Mechanical Thrombectomy ◽

Temporal Trends ◽

Rank Correlation ◽

Binary Logistic Regression ◽

Recombinant Tissue Plasminogen Activator ◽

Therapeutic Benefit ◽

Primary Diagnosis ◽

Inhospital Mortality

Background and purposeMechanical thrombectomy (MT) for the treatment of acute ischemic stroke has been growing in popularity while the therapeutic benefit of MT has been increasingly debated. Our objective was to examine national trends in mortality following MT.MethodsWe analyzed the National Inpatient Sample (2012) and the Nationwide Inpatient Sample (2008–2011) for patients with a primary diagnosis of acute ischemic stroke that received MT. Temporal trends in mortality were examined using Spearman's rank correlation. To account for confounding factors, mortality was further analyzed in binary logistic regression.ResultsHospitals performing MT comprised 8% of all hospitals treating ischemic stroke. The percentage of stroke cases treated with MT increased from 0.6% of cases in 2008 to 1.1% in 2012, totaling 16 307 MT cases in a 5 year period. Inhospital mortality decreased over the study period from 25.4% in 2008 to 16.1% in 2012 (r=−0.081, p<0.001). This finding was supported by regression analysis as each incremental year reduced the odds of mortality by 20% (OR=0.832, p<0.001). Administration of recombinant tissue plasminogen activator was associated with a decrease in the odds of mortality (OR=0.805, p<0.001).ConclusionsUtilization of MT represents a small percentage of stroke cases, although the trend is increasing. Mortality following MT has been showing a steady decline over the past 5 years. This may be a result of a learning curve, improved patient selection, and/or device improvements. Randomized trials remain essential to evaluate the potential benefit of endovascular devices and identify the most appropriate patients.

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