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  • 1
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    Effect of Direct Transportation to Thrombectomy-Capable Center vs Local Stroke Center on Neurological Outcomes in Patients With Suspected Large-Vessel Occlusion Stroke in Nonurban Areas : The RACECAT Randomized Clinical Trial
    American Medical Association (AMA) ; 2022
    In:  JAMA Vol. 327, No. 18 ( 2022-05-10), p. 1782-
    Details
    In: JAMA, American Medical Association (AMA), Vol. 327, No. 18 ( 2022-05-10), p. 1782-
    Abstract: In nonurban areas with limited access to thrombectomy-capable centers, optimal prehospital transport strategies in patients with suspected large-vessel occlusion stroke are unknown. Objective To determine whether, in nonurban areas, direct transport to a thrombectomy-capable center is beneficial compared with transport to the closest local stroke center. Design, Setting, and Participants Multicenter, population-based, cluster-randomized trial including 1401 patients with suspected acute large-vessel occlusion stroke attended by emergency medical services in areas where the closest local stroke center was not capable of performing thrombectomy in Catalonia, Spain, between March 2017 and June 2020. The date of final follow-up was September 2020. Interventions Transportation to a thrombectomy-capable center (n = 688) or the closest local stroke center (n = 713). Main Outcomes and Measures The primary outcome was disability at 90 days based on the modified Rankin Scale (mRS; scores range from 0 [no symptoms] to 6 [death] ) in the target population of patients with ischemic stroke. There were 11 secondary outcomes, including rate of intravenous tissue plasminogen activator administration and thrombectomy in the target population and 90-day mortality in the safety population of all randomized patients. Results Enrollment was halted for futility following a second interim analysis. The 1401 enrolled patients were included in the safety analysis, of whom 1369 (98%) consented to participate and were included in the as-randomized analysis (56% men; median age, 75 [IQR, 65-83] years; median National Institutes of Health Stroke Scale score, 17 [IQR, 11-21] ); 949 (69%) comprised the target ischemic stroke population included in the primary analysis. For the primary outcome in the target population, median mRS score was 3 (IQR, 2-5) vs 3 (IQR, 2-5) (adjusted common odds ratio [OR], 1.03; 95% CI, 0.82-1.29). Of 11 reported secondary outcomes, 8 showed no significant difference. Compared with patients first transported to local stroke centers, patients directly transported to thrombectomy-capable centers had significantly lower odds of receiving intravenous tissue plasminogen activator (in the target population, 229/482 [47.5%] vs 282/467 [60.4%]; OR, 0.59; 95% CI, 0.45-0.76) and significantly higher odds of receiving thrombectomy (in the target population, 235/482 [48.8%] vs 184/467 [39.4%]; OR, 1.46; 95% CI, 1.13-1.89). Mortality at 90 days in the safety population was not significantly different between groups (188/688 [27.3%] vs 194/713 [27.2%]; adjusted hazard ratio, 0.97; 95% CI, 0.79-1.18). Conclusions and Relevance In nonurban areas in Catalonia, Spain, there was no significant difference in 90-day neurological outcomes between transportation to a local stroke center vs a thrombectomy-capable referral center in patients with suspected large-vessel occlusion stroke. These findings require replication in other settings. Trial Registration ClinicalTrials.gov Identifier: NCT02795962
    Type of Medium: Online Resource
    ISSN: 0098-7484
    URL: Article
    DOI: 10.1001/jama.2022.4404
    RVK:
    XA 10000
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2022
    detail.hit.zdb_id: 2958-0
    detail.hit.zdb_id: 2018410-4
    SSG: 5,21
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  • 2
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    Workflows and Outcomes in Patients With Suspected Large Vessel Occlusion Stroke Triaged in Urban and Nonurban Areas
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Stroke Vol. 53, No. 12 ( 2022-12), p. 3728-3740
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 53, No. 12 ( 2022-12), p. 3728-3740
    Abstract: We aim to compare the outcome of patients from urban areas, where the referral center is able to perform thrombectomy, with patients from nonurban areas enrolled in the RACECAT trial (Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion). Methods: Patients with suspected large vessel occlusion stroke, as evaluated by a Rapid Arterial Occlusion Evaluation score of ≥5, from urban catchment areas of thrombectomy-capable centers during RACECAT trial enrollment period were included in the Stroke Code Registry of Catalonia. Primary outcome was disability at 90 days, as assessed by the shift analysis on the modified Rankin Scale score, in patients with an ischemic stroke. Secondary outcomes included mortality at 90 days, rate of thrombolysis and thrombectomy, time from onset to thrombolysis, and thrombectomy initiation. Propensity score matching was used to assemble a cohort of patients with similar characteristics. Results: The analysis included 1369 patients from nonurban areas and 2502 patients from urban areas. We matched 920 patients with an ischemic stroke from urban areas and nonurban areas based on their propensity scores. Patients with ischemic stroke from nonurban areas had higher degrees of disability at 90 days (median [interquartle range] modified Rankin Scale score, 3 [2–5] versus 3 [1–5], common odds ratio, 1.25 [95% CI, 1.06–1.48] ); the observed average effect was only significant in patients with large vessel stroke (common odds ratio, 1.36 [95% CI, 1.08–1.65]). Mortality rate was similar between groups(odds ratio, 1.02 [95% CI, 0.81–1.28] ). Patients from nonurban areas had higher odds of receiving thrombolysis (odds ratio, 1.36 [95% CI, 1.16–1.67]), lower odds of receiving thrombectomy(odds ratio, 0.61 [95% CI, 0.51–0.75] ), and longer time from stroke onset to thrombolysis (mean difference 38 minutes [95% CI, 25–52]) and thrombectomy(mean difference 66 minutes [95% CI, 37–95] ). Conclusions: In Catalonia, Spain, patients with large vessel occlusion stroke triaged in nonurban areas had worse neurological outcomes than patients from urban areas, where the referral center was able to perform thrombectomy. Interventions aimed at improving organizational practices and the development of thrombectomy capabilities in centers located in remote areas should be pursued. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02795962.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.122.040768
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
    detail.hit.zdb_id: 1467823-8
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  • 3
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    Association of Time of Day With Outcomes Among Patients Triaged for a Suspected Severe Stroke in Nonurban Catalonia
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Stroke Vol. 54, No. 3 ( 2023-03), p. 770-780
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 54, No. 3 ( 2023-03), p. 770-780
    Abstract: We aim to assess whether time of day modified the treatment effect in the RACECAT trial (Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion Trial), a cluster-randomized trial that did not demonstrate the benefit of direct transportation to a thrombectomy-capable center versus nearest local stroke center for patients with a suspected large vessel stroke triaged in nonurban Catalonia between March 2017 and June 2020. Methods: We performed a post hoc analysis of RACECAT to evaluate if the association between initial transport routing and functional outcome differed according to trial enrollment time: daytime (8:00 am –8:59 pm ) and nighttime (9:00 pm –7:59 am ). Primary outcome was disability at 90 days, as assessed by the shift analysis on the modified Rankin Scale score, in patients with ischemic stroke. Subgroup analyses according to stroke subtype were evaluated. Results: We included 949 patients with an ischemic stroke, of whom 258 patients(27%) were enrolled during nighttime. Among patients enrolled during nighttime, direct transport to a thrombectomy-capable center was associated with lower degrees of disability at 90 days (adjusted common odds ratio [acOR] , 1.620 [95% CI, 1.020–2.551]); no significant difference between trial groups was present during daytime (acOR, 0.890 [95% CI, 0.680–1.163] ; P interaction =0.014). Influence of nighttime on the treatment effect was only evident in patients with large vessel occlusion(daytime, acOR 0.766 [95% CI, 0.548–1.072]; nighttime, acOR, 1.785 [95% CI, 1.024–3.112] ; P interaction 〈 0.01); no heterogeneity was observed for other stroke subtypes ( P interaction 〉 0.1 for all comparisons). We observed longer delays in alteplase administration, interhospital transfers, and mechanical thrombectomy initiation during nighttime in patients allocated to local stroke centers. Conclusions: Among patients evaluated during nighttime for a suspected acute severe stroke in non-urban areas of Catalonia, direct transport to a thrombectomy-capable center was associated with lower degrees of disability at 90 days. This association was only evident in patients with confirmed large vessel occlusion on vascular imaging. Time delays in alteplase administration and interhospital transfers might mediate the observed differences in clinical outcome. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02795962.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.122.041013
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
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  • 4
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    Predictors of Functional Outcome After Thrombectomy in Patients With Prestroke Disability in Clinical Practice
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Stroke Vol. 53, No. 3 ( 2022-03), p. 845-854
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 53, No. 3 ( 2022-03), p. 845-854
    Abstract: Mechanical thrombectomy (MT) in ischemic stroke patients with poor prestroke conditions remains controversial. We aimed to analyze the frequency of previously disabled patients treated with MT in clinical practice, the safety and clinical response to MT of patients with preexisting disability, and the disabled patient characteristics associated with a better response to MT. Methods: We studied all consecutive patients with anterior circulation occlusion treated with MT from January 2017 to December 2019 included in the Codi Ictus Catalunya registry—a government-mandated, prospective, hospital-based data set. Prestroke disability was defined as modified Rankin Scale score 2 or 3. Functional outcome at 90 days was centrally assessed by a blinded evaluator of the Catalan Stroke Program. Favorable outcome (to return at least to prestroke modified Rankin Scale at 90 days) and safety and secondary outcomes were compared with patients without previous disability. Logistic regression analysis was used to assess the association between prestroke disability and outcomes and to identify a disabled patient profile with favorable outcome after MT. Results: Of 2487 patients included in the study, 409 (17.1%) had prestroke disability (313 modified Rankin Scale score 2 and 96 modified Rankin Scale score 3). After adjustment for covariates, prestroke disability was not associated with a lower chance of achieving favorable outcome at 90 days (24% versus 30%; odds ratio, 0.79 [0.57–1.08]), whereas it was independently associated with a higher risk of symptomatic intracranial hemorrhage (5% versus 3%; odds ratio, 2.04 [1.11–3.72] ) and long-term mortality (31% versus 18%; odds ratio, 1.74 [1.27–2.39]) compared with patients without disability. Prestroke disabled patients without diabetes, Alberta Stroke Program Early CT Score 〉 8 and National Institutes of Health Stroke Scale score 〈 17 showed similar safety and outcome results after MT as patients without prestroke disability. Conclusions: Despite a higher mortality and risk of symptomatic intracranial hemorrhage, prestroke-disabled patients return as often as independent patients to their prestroke level of function, especially those nondiabetic patients with favorable early ischemic signs profile. These data support a potential benefit of MT in patients with previous mild or moderate disability after large anterior vessel occlusion stroke.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.121.034960
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
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  • 5
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    Abstract TMP89: Thrombus Cellular Composition Predicts Unexpected Early Intracranial Reocclusion After Successful Mechanical Thrombectomy
    Ovid Technologies (Wolters Kluwer Health) ; 2024
    In:  Stroke Vol. 55, No. Suppl_1 ( 2024-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 55, No. Suppl_1 ( 2024-02)
    Abstract: Introduction: Our objective is to identify thrombus composition and related factors associated with unexpected early intracranial reoclussion ( EIR) after successful mechanical thrombectomy ( MT). Methods: Endovascular treatments of patients with acute intracranial or extracranial stenting were excluded. A total of 206 patients with successful reperfusion ( mTICI ≥ 2b) were included . Each intracranial thrombi obtained by MT were analyzed by Flow Cytometry analysis to provide proportion of main leukocyte composition: granulocytes, monocytes and lymphocyte populations. Thrombi analysis, antithrombotic treatment, etiology , reperfusion treatment features, neuroimaging and other baseline variables were analyzed to identify predictors of early reoclussion in the first 48 hours after thrombectomy . Results: EIT were observed in 5.8 %( 12/206) of successfully reperfused strokes. Patients with EIR were younger [ 67 years ( 47-80) vs. 76 years ( 66-84) ; p = 0.046] with lower basal NIHSS [ 17 ( 10-21) vs. 18 ( 11-21) ; p = 0.022] . Thrombi from patients with EIR had higher proportion of lymphocytes B [1.41 % ( 0.48-2.42) vs. 0.44 %(0.16-1.19) ;p = 0.018] in comparison to cases without reoclussion. Basilar artery occlusion ( BAO) [ 2 (15.4%) vs. 8 (4,3%) ; p 0.081 ] and active smoking [ 4( 30.8%) vs. 24 (12.4%) p =0.062] presented a positive trend with EIR cases . In the logistic regression analysis adjusted by age, previous use of intravenous fibrinolysis, number of endovascular passes , proportion of Lymphocytes B, BAO and active smoking , the independent predictor of early reoclussion was the proportion of Lymphocyte B in intracranial thrombus ( aOR 1.363 , 95% CI 1.060- 1.753). Conclusions: Rich B-Lymphocyte- Thrombus predicts unexpected early intracranial reoclusion after successful mechanical thrombectomy
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.55.suppl_1.TMP89
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2024
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  • 6
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    Abstract WMP62: High Linfocytes B Cells In Intracranial Thrombi Represent A Biomarker Of Atherothrombotic Stroke
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Stroke Vol. 51, No. Suppl_1 ( 2020-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 51, No. Suppl_1 ( 2020-02)
    Abstract: Approximately 30% of strokes are cryptogenic despite an exhaustive in-hospital work-up Analysis of clot composition following endovascular treatment could provide insight into stroke etiology. Objective: To evaluate different population of lymphocytes in the clot analyses obtained in the hyper acute phase of stroke, as an early marker of etiology of ischemic stroke. Material and Methods: Consecutively, intracranial clots were obtained in the hyper acute phase of stroke in endovascular treatment with solitaire device and analyzed by flow cytometry quantifying the relative proportion ( RP ) of main leukocyte, monocyte, granulocyte and total lymphocyte populations and lymphocyte sub populations of B line (CD19), T line (CD3, CD4, CD8), Cytotoxic and Natural Killer. The results were expressed as percentages (%). All patients included were studied with complete diagnostic work up that included at least complete arteriography , aortic Angio CT , complete cardiac holter monitoring until one month form hospital discharge and transthoracic echocardiography , The etiology of stroke was categorized: cardiomebolic ( major structural heart disease and Atrial Fibrillation) atherosclerotic ( AT) (severe symptomatic arterial stenosis or complicated aortic atheromatosis ulceration confirmed by trans esophageal echocardiography ) ,infrequent causes or unknown etiology . Results: 80 patients were included. 22, 5% AT (n = 18) strokes were associated with higher RP lymphocytes PR (16.55 % vs. 5. 37 % p 〈 0,001), CD4 RP (5.74% vs. 2.03 % p = 0.001) and RP CD 19 (2.26 % vs. 0.37 % p 〈 0,001) in clot cytometry Analysis than rest of of strokes etiologies (n= 72). Multivariate logistic regression analysis showed that RP CD 19 (OR 3.51; 95% CI, 1, 81-6.81) was an independent predictor of atherosclerotic stroke .The ROC curve showed AUC (0.83) (95% CI, 0.72-0.95) for RP CD 19 for diagnosis of atherosclerotic strokes with flow cytometry of the clot ,obtained in emergent endovascular treatment. Conclusion: High expression of lymphocytes B in intracranial thrombi is a marker of atherosclerotic etiology.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.51.suppl_1.WMP62
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
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  • 7
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    Abstract TP255: Lymphocytes And Platelets In Extracted Thrombus May Indicate The Etiology Of The Thrombus. Results From The Itacat Multicentric Registry.
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Stroke Vol. 53, No. Suppl_1 ( 2022-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 53, No. Suppl_1 ( 2022-02)
    Abstract: Aim: We performed a histological and immune analysis of the clot in acute stroke patients to detect surrogates of stroke etiology. Methods: We conducted a prospective observational study of consecutive patients with acute stroke who underwent thrombectomy that obtained extracted thrombus (ITACAT study). Several staining were performed to evaluate red blood cells/fibrin (hematoxylin/eosin), platelets (CD61) and leucocytes (CD4, CD8 and CD20). All patients received CT angio to detect extra/intracranial vascular stenosis and 30-day cardiac monitoring to diagnose AF. According to TOAST classification the thrombi were classified in cardioembolic etiology CE (T-CE), due to symptomatic atherosclerosis (T-AT) and without any cause (T-CRYP). We excluded strokes due to double cause or incomplete workup. Results: Of the 117 patients: 30 were T-AT, 55 were T-CE and 32 were T-CRYP. T-AT patients were younger: T-AT 68 years (60-77) Vs. T-CE 75 years (68-80) Vs. T-CRYP 72 years (55-81) (p=0.034). T-AT group had higher percentage of CD4: T-AT 6.52% (4-13) Vs. T-CE (3.31% (12.9) Vs .T-CRYP 3.72% (1.5-12) (p=0.015) and lower percentage of CD61: T-AT 51.18% (34-68) Vs. CE 64.70% (19.56) Vs. CRYP 70.3% (19) (p=0.001). There were no correlation between CD4 and platelets. Both CD4 OR 1.05 (1-1.10) (p=0.020) and CD61 (OR 0.96 (0.94-0.98) (p=0.01) independently predicted T-AT from the age. Final analysis (n=400 cases) will be ended in September 2021. Conclusions: Patients with high percentage of CD4 and low percentage of CD61 are related to atherosclerosis etiology.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.53.suppl_1.TP255
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
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  • 8
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    Abstract 95: High Proportion Of Granulocytes Form Intracranial Thrombus Is Associated With Increased Stiffness And Resistance To Endovascular Recanalization
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Stroke Vol. 54, No. Suppl_1 ( 2023-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 54, No. Suppl_1 ( 2023-02)
    Abstract: Hypothesis: We aim to identify a profile of intracranial thrombus resistant to recanalization by standard mechanical thrombectomy (MT) in acute stroke treatment. Methods: First extracted clot of each MT were analyzed by Flow Cytometry obtaining composition of main leukocyte populations: granulocytes, monocytes and lymphocytes. Demographics, reperfusion treatment and grade of recanalization were registered. MT Failure ( MTF) was defined as final Thrombolysis in Cerebral Infarction score IIa or lower and/ or need of permanent intracranial stenting as a rescue therapy after standard MT. In other cohort of cases, unconfined compression tests were performed to explore stiffness of retrieved clots . We looked for correlation between mechanical characterization tests and clot composition. Results: Among 225 patients, there were 13 % of MTF that were significantly associated to atherosclerosis etiology ( 33.3% vs. 15.9% ; p 0.021) , more passes ( 3 vs. 2; p 〈 0.001), higher proportion of clot granulocytes ( 82.46% vs. 68.90% ; p 〈 0.001) and lower proportion of clot monocytes ( 9.18% vs.17.34% ; p 〈 0.001). The proportion of clot granulocytes (aOR 1.07; 95% CI 1.01-1.14) remained as an independent marker of MTF. Among Thirty eight clots tested by unconfined compression median clot stiffness was 30.2 (IQR, 18.9-42.7) kPa. There was a positive correlation between granulocyte proportion and thrombi stiffness (Pearson’s r=0.35, p=0.032). Conclusions: There is a positive correlation between granulocyte proportion and thrombi stiffness that may explain endovascular resistance to recanalization. Influence of granulocytes within thrombus may be a target for future reperfusion treatments.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.54.suppl_1.95
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
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  • 9
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    Abstract P779: Monocyte to Lymphocyte Ratio in Clot Analysis is a Marker of Cardioembolic Stroke Etiology
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Stroke Vol. 52, No. Suppl_1 ( 2021-03)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 52, No. Suppl_1 ( 2021-03)
    Abstract: Methods: We analyzed data from 190 patients in a prospective unicentric study. Thrombi obtained in emergent endovascular treatment ( EVT) were analyzed by MFC order to calculate the percentage of granulocytes , monocytes and lymphocytes, over total leukocyte population as well as monocyte-to-lymphocyte ratio ( MLR) Clinical and interventional parameters were recorded for each patient. Stroke subtypes were defined by the Trial of ORG 10172 in Acute Stroke Treatment classification. We tested MFC predictors of high risk cardioembolic strokes (HR CE) in patients with undetermined stroke etiology . MFC predictor was obtained by comparison of clots due to Large Arterial Atherosclerosis compared with clots due to HR CE. Results: Among 190 clots retrieved, 163 cases were properly analized. 91 cases with known stroke etiology after EVT and 72 cases of Undetermined stroke. In a demographic (age, gender) and EVT matched (time, tpa, number of passes) case -control study of 56 patients: HR CE strokes (28 cases) and LAA strokes (28 cases), the proportion of monocytes ( OR 1.06 , 95% CI 1.01- 1.11) and MLR ( OR 1.83 , 95% CI 1.12- 2.98) independently predicted HR CE detection. A cut-off point of 1.77% in a receiver operating characteristic curve predicted cardiomebolic etiology with sensitivity of 71% and specificity of 82%. Among Undetermined Strokes (n=72) the percentage of HR CE detection was higher in patients with high MLR (n=40 ; 74%) compared with low MLR (n=6; 33%) ( p 〈 0.001). Patients with high MLR were older than low MLR cases, although MLR 〉 1.77 independently predicted HR CE detection among Undetermined strokes (OR, 4.50 ,95% CI 1.35-15.04) in a multivariate model adjusted for age. Conclusion: Measurement of monocyte to lymphocyte ratio in clots by multiparametric flow cytometry detected patients at high risk of hidden cardioembolic origin among undetermined stroke population.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.52.suppl_1.P779
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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  • 10
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    Sphenopalatine Ganglion Stimulation to Augment Cerebral Blood Flow : A Randomized, Sham-Controlled Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Stroke Vol. 50, No. 8 ( 2019-08), p. 2108-2117
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 50, No. 8 ( 2019-08), p. 2108-2117
    Abstract: Many patients with acute ischemic stroke are not eligible for thrombolysis or mechanical reperfusion therapies due to contraindications, inaccessible vascular occlusions, late presentation, or large infarct core. Sphenopalatine ganglion (SPG) stimulation to enhance collateral flow and stabilize the blood-brain barrier offers an alternative, potentially more widely deliverable, therapy. Methods— In a randomized, sham-controlled, double-masked trial at 41 centers in 7 countries, patients with anterior circulation ischemic stroke not treated with reperfusion therapies within 24 hours of onset were randomly allocated to active SPG stimulation or sham control. The primary efficacy outcome was improvement beyond expectations on the modified Rankin Scale of global disability at 90 days (sliding dichotomy), assessed in the modified intention-to-treat population. The initial planned sample size was 660 patients, but the trial was stopped early when technical improvements in device placement occurred, so that analysis of accumulated experience could be conducted to inform a successor trial. Results— Among 303 enrolled patients, 253 received at least one active SPG or sham stimulation, constituting the modified intention-to-treat population (153 SPG stimulation and 100 sham control). Age was median 73 years (interquartile range, 64–79), 52.6% were female, deficit severity on the National Institutes of Health Stroke Scale was median 11 (interquartile range, 9–15), and time from last known well median 18.6 hours (interquartile range, 14.5–22.5). For the primary outcome, improved 3-month disability beyond expectations, rates in the SPG versus sham treatment groups were 49.7% versus 40.0%; odds ratio, 1.48 (95% CI, 0.89–2.47); P =0.13. A significant treatment interaction with stroke location (cortical versus noncortical) was noted, P =0.04. In the 87 patients with confirmed cortical involvement, rates of improvement beyond expectations were 50.0% versus 27.0%; odds ratio, 2.70 (95% CI, 1.08–6.73); P =0.03. Similar response patterns were observed for all prespecified secondary efficacy outcomes. No differences in mortality or serious adverse event safety end points were observed. Conclusions— SPG stimulation within 24 hours of onset is safe in acute ischemic stroke. SPG stimulation was not shown to statistically significantly improve 3-month disability above expectations, though favorable outcomes were nominally higher with SPG stimulation. Beneficial effects may distinctively be conferred in patients with confirmed cortical involvement. The results of this study need to be confirmed in a larger pivotal study. Clinical Trial Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT03767192.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.118.024582
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
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