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1.
N Engl J Med ; 378(1): 11-21, 2018 01 04.
Artículo en Inglés | MEDLINE | ID: mdl-29129157

RESUMEN

BACKGROUND: The effect of endovascular thrombectomy that is performed more than 6 hours after the onset of ischemic stroke is uncertain. Patients with a clinical deficit that is disproportionately severe relative to the infarct volume may benefit from late thrombectomy. METHODS: We enrolled patients with occlusion of the intracranial internal carotid artery or proximal middle cerebral artery who had last been known to be well 6 to 24 hours earlier and who had a mismatch between the severity of the clinical deficit and the infarct volume, with mismatch criteria defined according to age (<80 years or ≥80 years). Patients were randomly assigned to thrombectomy plus standard care (the thrombectomy group) or to standard care alone (the control group). The coprimary end points were the mean score for disability on the utility-weighted modified Rankin scale (which ranges from 0 [death] to 10 [no symptoms or disability]) and the rate of functional independence (a score of 0, 1, or 2 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating more severe disability) at 90 days. RESULTS: A total of 206 patients were enrolled; 107 were assigned to the thrombectomy group and 99 to the control group. At 31 months, enrollment in the trial was stopped because of the results of a prespecified interim analysis. The mean score on the utility-weighted modified Rankin scale at 90 days was 5.5 in the thrombectomy group as compared with 3.4 in the control group (adjusted difference [Bayesian analysis], 2.0 points; 95% credible interval, 1.1 to 3.0; posterior probability of superiority, >0.999), and the rate of functional independence at 90 days was 49% in the thrombectomy group as compared with 13% in the control group (adjusted difference, 33 percentage points; 95% credible interval, 24 to 44; posterior probability of superiority, >0.999). The rate of symptomatic intracranial hemorrhage did not differ significantly between the two groups (6% in the thrombectomy group and 3% in the control group, P=0.50), nor did 90-day mortality (19% and 18%, respectively; P=1.00). CONCLUSIONS: Among patients with acute stroke who had last been known to be well 6 to 24 hours earlier and who had a mismatch between clinical deficit and infarct, outcomes for disability at 90 days were better with thrombectomy plus standard care than with standard care alone. (Funded by Stryker Neurovascular; DAWN ClinicalTrials.gov number, NCT02142283 .).


Asunto(s)
Accidente Cerebrovascular/cirugía , Trombectomía , Anciano , Anciano de 80 o más Años , Teorema de Bayes , Infarto Cerebral/complicaciones , Infarto Cerebral/diagnóstico por imagen , Terapia Combinada , Evaluación de la Discapacidad , Procedimientos Endovasculares , Femenino , Fibrinolíticos/uso terapéutico , Humanos , Hemorragias Intracraneales/etiología , Masculino , Persona de Mediana Edad , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular/mortalidad , Trombectomía/métodos , Tiempo de Tratamiento
2.
N Engl J Med ; 372(24): 2285-95, 2015 Jun 11.
Artículo en Inglés | MEDLINE | ID: mdl-25882376

RESUMEN

BACKGROUND: 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. METHODS: 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]). RESULTS: 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). CONCLUSIONS: 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.).


Asunto(s)
Fibrinolíticos/uso terapéutico , Accidente Cerebrovascular/terapia , Trombectomía/métodos , Activador de Tejido Plasminógeno/uso terapéutico , Enfermedad Aguda , Administración Intravenosa , Anciano , Isquemia Encefálica/terapia , Terapia Combinada , Procedimientos Endovasculares , Femenino , Fibrinolíticos/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Stents , Accidente Cerebrovascular/tratamiento farmacológico , Trombectomía/efectos adversos , Trombectomía/instrumentación , Activador de Tejido Plasminógeno/efectos adversos , Resultado del Tratamiento
3.
N Engl J Med ; 372(11): 1019-30, 2015 Mar 12.
Artículo en Inglés | MEDLINE | ID: mdl-25671798

RESUMEN

BACKGROUND: Among patients with a proximal vessel occlusion in the anterior circulation, 60 to 80% of patients die within 90 days after stroke onset or do not regain functional independence despite alteplase treatment. We evaluated rapid endovascular treatment in addition to standard care in patients with acute ischemic stroke with a small infarct core, a proximal intracranial arterial occlusion, and moderate-to-good collateral circulation. METHODS: We randomly assigned participants to receive standard care (control group) or standard care plus endovascular treatment with the use of available thrombectomy devices (intervention group). Patients with a proximal intracranial occlusion in the anterior circulation were included up to 12 hours after symptom onset. Patients with a large infarct core or poor collateral circulation on computed tomography (CT) and CT angiography were excluded. Workflow times were measured against predetermined targets. The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. A proportional odds model was used to calculate the common odds ratio as a measure of the likelihood that the intervention would lead to lower scores on the modified Rankin scale than would control care (shift analysis). RESULTS: The trial was stopped early because of efficacy. At 22 centers worldwide, 316 participants were enrolled, of whom 238 received intravenous alteplase (120 in the intervention group and 118 in the control group). In the intervention group, the median time from study CT of the head to first reperfusion was 84 minutes. The rate of functional independence (90-day modified Rankin score of 0 to 2) was increased with the intervention (53.0%, vs. 29.3% in the control group; P<0.001). The primary outcome favored the intervention (common odds ratio, 2.6; 95% confidence interval, 1.7 to 3.8; P<0.001), and the intervention was associated with reduced mortality (10.4%, vs. 19.0% in the control group; P=0.04). Symptomatic intracerebral hemorrhage occurred in 3.6% of participants in intervention group and 2.7% of participants in control group (P=0.75). CONCLUSIONS: Among patients with acute ischemic stroke with a proximal vessel occlusion, a small infarct core, and moderate-to-good collateral circulation, rapid endovascular treatment improved functional outcomes and reduced mortality. (Funded by Covidien and others; ESCAPE ClinicalTrials.gov number, NCT01778335.).


Asunto(s)
Procedimientos Endovasculares , Accidente Cerebrovascular/terapia , Trombectomía , Anciano , Anciano de 80 o más Años , Angiografía de Substracción Digital , Isquemia Encefálica/diagnóstico por imagen , Isquemia Encefálica/terapia , Hemorragia Cerebral/inducido químicamente , Terapia Combinada , Femenino , Fibrinolíticos/uso terapéutico , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Reperfusión , Método Simple Ciego , Stents , Accidente Cerebrovascular/mortalidad , Trombectomía/instrumentación , Activador de Tejido Plasminógeno/uso terapéutico , Tomografía Computarizada por Rayos X
4.
Circulation ; 133(23): 2279-86, 2016 Jun 07.
Artículo en Inglés | MEDLINE | ID: mdl-27076599

RESUMEN

BACKGROUND: The Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial used innovative imaging and aggressive target time metrics to demonstrate the benefit of endovascular treatment in patients with acute ischemic stroke. We analyze the impact of time on clinical outcome and the effect of patient, hospital, and health system characteristics on workflow within the trial. METHODS AND RESULTS: Relationship between outcome (modified Rankin Scale) and interval times was modeled by using logistic regression. Association between time intervals (stroke onset to arrival in endovascular-capable hospital, to qualifying computed tomography, to groin puncture, and to reperfusion) and patient, hospital, and health system characteristics were modeled by using negative binomial regression. Every 30-minute increase in computed tomography-to-reperfusion time reduced the probability of achieving a functionally independent outcome (90-day modified Rankin Scale 0-2) by 8.3% (P=0.006). Symptom onset-to-imaging time was not associated with outcome (P>0.05). Onset-to-endovascular hospital arrival time was 42% (34 minutes) longer among patients receiving intravenous alteplase at the referring hospital (drip and ship) versus direct transfer (mothership). Computed tomography-to-groin puncture time was 15% (8 minutes) shorter among patients presenting during work hours versus off hours, 41% (24 minutes) shorter in drip-ship patients versus mothership, and 43% (22 minutes) longer when general anesthesia was administered. The use of a balloon guide catheter during endovascular procedures shortened puncture-to-reperfusion time by 21% (8 minutes). CONCLUSIONS: Imaging-to-reperfusion time is a significant predictor of outcome in the ESCAPE trial. Inefficiencies in triaging, off-hour presentation, intravenous alteplase administration, use of general anesthesia, and endovascular techniques offer major opportunities for improvement in workflow. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01778335.


Asunto(s)
Isquemia Encefálica/terapia , Procedimientos Endovasculares , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/terapia , Trombectomía , Terapia Trombolítica , Estudios de Tiempo y Movimiento , Tiempo de Tratamiento , Flujo de Trabajo , Administración Intravenosa , Atención Posterior , Anestesia General , Isquemia Encefálica/diagnóstico por imagen , Isquemia Encefálica/mortalidad , Angiografía Cerebral/métodos , Angiografía por Tomografía Computarizada , Evaluación de la Discapacidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Fibrinolíticos/administración & dosificación , Humanos , Valor Predictivo de las Pruebas , Punciones , Factores de Riesgo , Accidente Cerebrovascular/diagnóstico por imagen , Trombectomía/efectos adversos , Trombectomía/mortalidad , Terapia Trombolítica/efectos adversos , Terapia Trombolítica/mortalidad , Factores de Tiempo , Activador de Tejido Plasminógeno/administración & dosificación , Resultado del Tratamiento , Triaje
5.
Ann Neurol ; 79(1): 76-89, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-26476022

RESUMEN

OBJECTIVE: Within the context of a prospective randomized trial (SWIFT PRIME), we assessed whether early imaging of stroke patients, primarily with computed tomography (CT) perfusion, can estimate the size of the irreversibly injured ischemic core and the volume of critically hypoperfused tissue. We also evaluated the accuracy of ischemic core and hypoperfusion volumes for predicting infarct volume in patients with the target mismatch profile. METHODS: Baseline ischemic core and hypoperfusion volumes were assessed prior to randomized treatment with intravenous (IV) tissue plasminogen activator (tPA) alone versus IV tPA + endovascular therapy (Solitaire stent-retriever) using RAPID automated postprocessing software. Reperfusion was assessed with angiographic Thrombolysis in Cerebral Infarction scores at the end of the procedure (endovascular group) and Tmax > 6-second volumes at 27 hours (both groups). Infarct volume was assessed at 27 hours on noncontrast CT or magnetic resonance imaging (MRI). RESULTS: A total of 151 patients with baseline imaging with CT perfusion (79%) or multimodal MRI (21%) were included. The median baseline ischemic core volume was 6 ml (interquartile range= 0-16). Ischemic core volumes correlated with 27-hour infarct volumes in patients who achieved reperfusion (r = 0.58, p < 0.0001). In patients who did not reperfuse (<10% reperfusion), baseline Tmax > 6-second lesion volumes correlated with 27-hour infarct volume (r = 0.78, p = 0.005). In target mismatch patients, the union of baseline core and early follow-up Tmax > 6-second volume (ie, predicted infarct volume) correlated with the 27-hour infarct volume (r = 0.73, p < 0.0001); the median absolute difference between the observed and predicted volume was 13 ml. INTERPRETATION: Ischemic core and hypoperfusion volumes, obtained primarily from CT perfusion scans, predict 27-hour infarct volume in acute stroke patients who were treated with reperfusion therapies.


Asunto(s)
Isquemia Encefálica/diagnóstico por imagen , Circulación Cerebrovascular/fisiología , Evaluación de Resultado en la Atención de Salud , Accidente Cerebrovascular/diagnóstico por imagen , Tomografía Computarizada por Rayos X/métodos , Anciano , Anciano de 80 o más Años , Isquemia Encefálica/terapia , Infarto Cerebral/diagnóstico por imagen , Infarto Cerebral/terapia , Medios de Contraste , Procedimientos Endovasculares , Femenino , Fibrinolíticos/uso terapéutico , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Accidente Cerebrovascular/terapia , Activador de Tejido Plasminógeno/uso terapéutico
6.
Stroke ; 47(3): 782-8, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-26888533

RESUMEN

BACKGROUND AND PURPOSE: Patients with posterior circulation strokes have been excluded from recent randomized endovascular stroke trials. We reviewed the recent multicenter experience with endovascular treatment of posterior circulation strokes to identify the clinical, radiographic, and procedural predictors of successful recanalization and good neurological outcomes. METHODS: We performed a multicenter retrospective analysis of consecutive patients with posterior circulation strokes, who underwent thrombectomy with stent retrievers or primary aspiration thrombectomy (including A Direct Aspiration First Pass Technique [ADAPT] approach). We correlated clinical and radiographic outcomes with demographic, clinical, and technical characteristics. RESULTS: A total of 100 patients were included in the final analysis (mean age, 63.5±14.2 years; mean admission National Institutes of Health Stroke Scale score, 19.2±8.2). Favorable clinical outcome at 3 months (modified Rankin Scale score ≤2) was achieved in 35% of patients. Successful recanalization and shorter time from stroke onset to the start of the procedure were significant predictors of favorable clinical outcome at 90 days. Stent retriever and aspiration thrombectomy as primary treatment approaches showed comparable procedural and clinical outcomes. None of the baseline advanced imaging modalities (magnetic resonance imaging, computed tomographic perfusion, or computed tomography angiography assessment of collaterals) showed superiority in selecting patients for thrombectomy. CONCLUSIONS: Time to the start of the procedure is an important predictor of clinical success after thrombectomy in patients with posterior circulation strokes. Both stent retriever and aspiration thrombectomy as primary treatment approaches are effective in achieving successful recanalization.


Asunto(s)
Circulación Cerebrovascular/fisiología , Procedimientos Endovasculares/métodos , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/terapia , Anciano , Circulación Cerebrovascular/efectos de los fármacos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Trombectomía/métodos , Activador de Tejido Plasminógeno/administración & dosificación , Resultado del Tratamiento
7.
Stroke ; 47(3): 777-81, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-26892284

RESUMEN

BACKGROUND AND PURPOSE: The goal of reperfusion therapy in acute ischemic stroke is to limit brain infarction. The objective of this study was to investigate whether the beneficial effect of endovascular treatment on functional outcome could be explained by a reduction in post-treatment infarct volume. METHODS: The Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial was a multicenter randomized open-label trial with blinded outcome evaluation. Among 315 enrolled subjects (endovascular treatment n=165; control n=150), 314 subject's infarct volumes at 24 to 48 hours on magnetic resonance imaging (n=254) or computed tomography (n=60) were measured. Post-treatment infarct volumes were compared by treatment assignment and recanalization/reperfusion status. Appropriate statistical models were used to assess relationship between baseline clinical and imaging variables, post-treatment infarct volume, and functional status at 90 days (modified Rankin Scale). RESULTS: Median post-treatment infarct volume in all subjects was 21 mL (interquartile range =65 mL), in the intervention arm, 15.5 mL (interquartile range =41.5 mL), and in the control arm, 33.5 mL (interquartile range =84 mL; P<0.01). Baseline National Institute of Health Stroke Scale (P<0.01), site of occlusion (P<0.01), baseline noncontrast computed tomographic scan Alberta Stroke Program Early CT score (ASPECTS) (P<0.01), and recanalization (P<0.01) were independently associated with post-treatment infarct volume, whereas age, sex, treatment type, intravenous alteplase, and time from onset to randomization were not (P>0.05). Post-treatment infarct volume (P<0.01) and delta National Institute of Health Stroke Scale (P<0.01) were independently associated with 90-day modified Rankin Scale, whereas laterality (left versus right) was not. CONCLUSIONS: These results support the primary results of the ESCAPE trial and show that the biological underpinning of the success of endovascular therapy is a reduction in infarct volume. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01778335.


Asunto(s)
Infarto Cerebral/diagnóstico , Infarto Cerebral/tratamiento farmacológico , Procedimientos Endovasculares/tendencias , Infusiones Intraarteriales/tendencias , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/tratamiento farmacológico , Procedimientos Endovasculares/métodos , Femenino , Estudios de Seguimiento , Humanos , Infusiones Intraarteriales/métodos , Masculino , Método Simple Ciego , Terapia Trombolítica/métodos , Terapia Trombolítica/tendencias , Activador de Tejido Plasminógeno/administración & dosificación , Resultado del Tratamiento
8.
Stroke ; 47(12): 2993-2998, 2016 12.
Artículo en Inglés | MEDLINE | ID: mdl-27834743

RESUMEN

BACKGROUND AND PURPOSE: Infarct in a new previously unaffected territory (INT) is a potential complication of endovascular treatment. We applied a recently proposed methodology to identify and classify INTs in the ESCAPE randomized controlled trial (Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times). METHODS: The core laboratory identified INTs on 24-hour follow-up imaging, blinded to treatment allocation, after assessing all baseline imaging. INTs were classified into 3 types (I-III) and 2 subtypes (A/B) based on size and if catheter manipulation was likely performed across the vessel territory ostium. Logistic regression was used to understand the effect of multiple a priori identified variables on INT occurrence. Ordinal logistic regression was used to analyze the effect of INTs on modified Rankin Scale shift at 90 days. RESULTS: From 308 patients included, 14 INTs (4.5% overall; 2.8% on follow-up noncontrast computed tomography, 11.7% on follow-up magnetic resonance imaging) were identified (5.0% in endovascular treatment arm versus 4.0% in control arm [P=0.7]). The use of intravenous alteplase was associated with a 68% reduction in the odds of INT occurrence (3.0% with versus 9.1% without; odds ratio, 0.32; 95% confidence interval, 0.11-0.96; adjusted for age, sex, and treatment type). No other variables were associated with INTs. INT occurrence was associated with reduced probability of good clinical outcome (common odds ratio, 0.25; 95% confidence interval, 0.09-0.74; adjusted for age, type of treatment, and follow-up scan). CONCLUSIONS: INTs are uncommon, detected more frequently on follow-up magnetic resonance imaging, and affect clinical outcome. In experienced centers, endovascular treatment is likely not causal, whereas intravenous alteplase may be therapeutic. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01778335.


Asunto(s)
Infarto Cerebral/diagnóstico por imagen , Infarto Cerebral/terapia , Fibrinolíticos/uso terapéutico , Terapia Trombolítica/métodos , Activador de Tejido Plasminógeno/uso terapéutico , Infarto Cerebral/clasificación , Fibrinolíticos/efectos adversos , Humanos , Terapia Trombolítica/efectos adversos , Activador de Tejido Plasminógeno/efectos adversos
9.
Ann Vasc Surg ; 29(1): 125.e1-11, 2015 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-25194548

RESUMEN

Severe acute stroke patients with critical carotid stenosis or occlusion without intracranial thrombus typically do not undergo emergent carotid thromboendarterectomy (CEA) because of the risk of reperfusion-related intracranial hemorrhage. Past studies have not consistently demonstrated benefit of early operative intervention. Cerebral computed tomography (CT), cervical and cerebral CT angiography (CTA), and cerebral CT perfusion (CTP) imaging may identify a subset of acute stroke patients without intracranial thrombus who may benefit from emergent CEA. Acute stroke patients underwent unenhanced brain CT imaging to exclude pathology that would contraindicate emergent therapy. Emergent CTAs of the intracranial and extracranial vessels were utilized to identify patients who presented with stroke symptoms based on the presence of isolated extracranial carotid disease in the absence of intracranial thromboembolism. CTP was then used to assess the extent of potentially reversible cerebral ischemia (penumbral tissue). Patients with isolated extracranial carotid lesions with significant reversible ischemia in the absence of large areas of irreversible cerebral damage underwent emergent CEA to salvage ischemic penumbra. In 1 year, 3 patients presented with large acute strokes in which CTA disclosed symptomatic extracranial internal carotid artery preocclusive or occlusive lesions without intracranial thromboembolic occlusions. CTP indicated a large area of ischemic penumbra with limited permanent injury. Mean age, time to presentation, and National Institutes of Health stroke score (NIHSS) were 66 years, 4.2 hr, and 19.3. All patients underwent emergent CEA with cervical carotid thrombectomy. Average time from stroke symptom onset to revascularization was 12.5 (range 5.9-19.0) hr. There were no perioperative deaths. At day 5, the mean NIHSS decreased to 7.6 and at day 30 was 4.7. The modified Rankin scale score dropped from a poststroke, preoperative level of 5 to 2.3 by day 30. Emergent CEA should be considered in patients presenting with large acute strokes based on favorable CT, CTA, and CTP findings. Emergent clot localization and physiological assessment of brain "tissue at risk" relative to irreversible cerebral infarction using CT, CTA, and CTP is now available. Utilization of this information by an experienced stroke team of neurologists, radiologists, and surgeons may aid in the recognition of a select group of patients in which emergent CEA may drive to improved outcomes.


Asunto(s)
Arteria Carótida Interna/diagnóstico por imagen , Arteria Carótida Interna/cirugía , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/cirugía , Angiografía Cerebral/métodos , Circulación Cerebrovascular , Endarterectomía Carotidea , Tomografía Computarizada Multidetector/métodos , Imagen de Perfusión/métodos , Accidente Cerebrovascular/diagnóstico por imagen , Anciano , Arteria Carótida Interna/fisiopatología , Estenosis Carotídea/complicaciones , Estenosis Carotídea/fisiopatología , Evaluación de la Discapacidad , Urgencias Médicas , Humanos , Masculino , Persona de Mediana Edad , Selección de Paciente , Valor Predictivo de las Pruebas , Recuperación de la Función , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/fisiopatología , Trombectomía , Factores de Tiempo , Resultado del Tratamiento
10.
J Neurointerv Surg ; 15(e1): e148-e153, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36150897

RESUMEN

BACKGROUND: Chronological heterogeneity in neurological improvement after endovascular thrombectomy (EVT) for large vessel occlusion (LVO) stroke is commonly observed in clinical practice. Understanding the temporal progression of functional independence after EVT, especially delayed functional independence in patients who do not improve early, is essential for prognostication and rehabilitation. We aim to determine the incidence of early functional independence (EFI) and delayed functional independence (DFI), identify associated predictors after EVT, and develop the Delayed Functional Independence After Neurothrombectomy (DEFIANT) score. METHODS: Demographic, clinical, radiological, treatment, and procedural information were analyzed from the Trevo Registry (patients undergoing EVT due to anterior LVO using the Trevo stent retriever). Incidence and predictors of EFI (modified Rankin Scale (mRS) score 0-2 at discharge) and DFI (mRS score 0-2 at 90 days in non-EFI patients) were analyzed. RESULTS: A total of 1623 patients met study criteria. EFI was observed in 45% (730) of patients. Among surviving non-EFI patients (884), DFI was observed in 35% (308). Younger age (p=0.003), lower discharge National Institutes of Health Stroke Scale (NIHSS) score (p<0.0001), and absence of any hemorrhage (p=0.021) were independent predictors of DFI. After age 60, the probability of DFI declines significantly with 5 year age increments (approximately 7% decline for every 5 years; p(DFI)= 1.3559-0.0699, p for slope=0.001). The DEFIANT score is available online (https://bit.ly/3KZRVq5). CONCLUSION: Approximately 45% of patients experience EFI. About one-third of non-early improvers experience DFI. Younger age, lower discharge NIHSS score, and absence of any hemorrhage were independent predictors of DFI among non-early improvers.


Asunto(s)
Isquemia Encefálica , Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Persona de Mediana Edad , Preescolar , Isquemia Encefálica/terapia , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/cirugía , Accidente Cerebrovascular/epidemiología , Estado Funcional , Resultado del Tratamiento , Trombectomía , Sistema de Registros
12.
J Neurointerv Surg ; 14(2): 126-132, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33632884

RESUMEN

BACKGROUND: The PerfusiOn imaging Selection of Ischemic sTroke patIents for endoVascular thErapy (POSITIVE) trial was designed to evaluate functional outcome in patients with emergent large vessel occlusion (ELVO) presenting within 0-12 hours with pre-specified bifurcated arms of early and late window presentation, who were selected for endovascular thrombectomy with non-vendor specific commercially available perfusion imaging software. Recent trials demonstrating the benefit of thrombectomy up to 16-24 hours following ELVO removed equipoise to randomize late window ELVO patients and therefore the trial was halted. METHODS: Up to 200 patients were to be enrolled in this FDA-cleared, prospective, randomized, multicenter international trial to compare thrombectomy and best medical management in patients with ELVO ineligible for or refractory to treatment with IV tissue plasminogen activator (IV-tPA) selected with perfusion imaging and presenting within 0-12 hours of last seen normal. The primary outcome was 90-day clinical outcome as measured by the raw modified Rankin Scale (mRS) with scores 5 and 6 collapsed (mRS shift analysis). RESULTS: The POSITIVE trial suspended enrollment with the release of results from the DAWN trial and was stopped after the release of the DEFUSE 3 trial results. Thirty-three patients were enrolled (21 for medical management and 12 for thrombectomy). Twelve of the 33 patients were enrolled in the 6-12 hour cohort. Despite the early cessation, the primary outcome demonstrated statistically significant superior clinical outcomes for patients treated with thrombectomy (P=0.0060). The overall proportion of patients achieving an mRS score of 0-2 was 75% in the thrombectomy cohort and 43% in the medical management cohort (OR 4.00, 95% CI 0.84 to 19.2). CONCLUSION: POSITIVE supports the already established practice of delayed thrombectomy for appropriately selected patients presenting within 0-12 hours selected by perfusion imaging from any vendor. The results of the POSITIVE trial are consistent with other thrombectomy trials. The statistically significant effect on functional improvement, despite the small number of patients, reinforces the robust benefits of thrombectomy. CLINICAL TRIAL REGISTRATION: NCT01852201.


Asunto(s)
Isquemia Encefálica , Procedimientos Endovasculares , Accidente Cerebrovascular Isquémico , Isquemia Encefálica/diagnóstico por imagen , Isquemia Encefálica/cirugía , Humanos , Accidente Cerebrovascular Isquémico/diagnóstico por imagen , Accidente Cerebrovascular Isquémico/cirugía , Imagen de Perfusión , Estudios Prospectivos , Trombectomía , Activador de Tejido Plasminógeno , Resultado del Tratamiento
13.
J Neurointerv Surg ; 14(10): 992-996, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34649935

RESUMEN

BACKGROUND: There is conflicting evidence on the utility of intravenous (IV) alteplase in patients with emergent large vessel occlusion (ELVO) treated with mechanical thrombectomy (MT). METHODS: This was a post hoc analysis of the COMPASS: a trial of aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion. We compared clinical, procedural and angiographic outcomes of patients with and without prior IV alteplase administration. RESULTS: In the COMPASS trial, 235 patients had presented to the hospital within the first 4 hours of stroke symptom onset and were eligible for analysis. On univariate analysis, administration of IV alteplase prior to MT was found to be significantly associated with favorable outcomes (modified Rankin scale (mRS) 0-2 at 3 months; 55.6% vs 40.0% in the MT-only group, P=0.037). However, on multivariate analysis, only baseline (pre-stroke) mRS, admission National Institutes of Health Stroke Scale (NIHSS) score and age were identified as independent predictors of favorable outcomes at 3 months. We found higher final thrombolysis in cerebral infarction (TICI) 2b/3 rates in patients without the use of alteplase prior to the aspiration first approach (100.0% vs 87.9% in IV altepase +aspiration first MT, P=0.03). In the stent retriever first group, final TICI 2b/3 rates were identical in patients with and without IV alteplase administration (87.5% and 87.5%, P=1.0). CONCLUSIONS: Prior administration of IV alteplase may adversely affect the efficacy of aspiration, but does not seem to influence the stent retriever first approach to MT in patients with anterior circulation ELVO.


Asunto(s)
Accidente Cerebrovascular , Trombectomía , Activador de Tejido Plasminógeno , Isquemia Encefálica/etiología , Infarto Cerebral/etiología , Humanos , Lactante , Recién Nacido , Estudios Retrospectivos , Stents/efectos adversos , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular/cirugía , Trombectomía/efectos adversos , Trombectomía/métodos , Activador de Tejido Plasminógeno/uso terapéutico , Resultado del Tratamiento
14.
J Neurointerv Surg ; 13(4): 307-310, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32561658

RESUMEN

BACKGROUND: Prior studies evaluating the Wingspan stent for treatment of symptomatic intracranial atherosclerotic disease have included patients with a spectrum of both on-label and off-label indications for the stent. The WEAVE trial assessed 152 patients stented with the Wingspan stent strictly by its current on-label indication and found a 2.6% periprocedural stroke and death rate. OBJECTIVE: This WOVEN study assesses the 1-year follow-up from this cohort. METHODS: Twelve of the original 24 sites enrolling patients in the WEAVE trial performed follow-up chart review and imaging analysis up to 1 year after stenting. Assessment of delayed stroke and death was made in 129 patients, as well as vascular imaging follow-up to assess for in-stent re-stenosis. RESULTS: In the 1-year follow-up period, seven patients had a stroke (six minor, one major). Subsequent to the periprocedural period, no deaths were recorded in the cohort. Including the four patients who had periprocedural events in the WEAVE study, there were 11 strokes or deaths of the 129 patients (8.5%) at the 1-year follow-up. CONCLUSIONS: The WOVEN study provides the 1-year follow-up on a cohort of 129 patients who were stented according to the current on-label use. It provides a more homogeneous patient group for analysis than prior studies, and demonstrates a relatively low 8.5% 1-year stroke and death rate in stented patients.


Asunto(s)
Arteriosclerosis Intracraneal/terapia , Enfermedades del Sistema Nervioso/etiología , Stents/tendencias , Accidente Cerebrovascular/terapia , Anciano , Estudios de Cohortes , Constricción Patológica/diagnóstico por imagen , Constricción Patológica/etiología , Constricción Patológica/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Arteriosclerosis Intracraneal/diagnóstico por imagen , Arteriosclerosis Intracraneal/mortalidad , Masculino , Persona de Mediana Edad , Mortalidad/tendencias , Enfermedades del Sistema Nervioso/diagnóstico por imagen , Enfermedades del Sistema Nervioso/mortalidad , Stents/efectos adversos , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/mortalidad , Resultado del Tratamiento
15.
J Neurointerv Surg ; 13(11): 979-984, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-33323503

RESUMEN

BACKGROUND: There is a paucity of data regarding mechanical thrombectomy (MT) in distal arterial occlusions (DAO). We aim to evaluate the safety and efficacy of MT in patients with DAO and compare their outcomes with proximal arterial occlusion (PAO) strokes. METHODS: The Trevo Registry was a prospective open-label MT registry including 2008 patients from 76 sites across 12 countries. Patients were categorized into: PAO: intracranial ICA, and MCA-M1; and DAO: MCA-M2, MCA-M3, ACA, and PCA. Baseline and outcome variables were compared across the PAO vs DAO patients with pre-morbid mRS 0-2. RESULTS: Among 407 DAOs including 350 (86.0%) M2, 25 (6.1%) M3, 10 (2.5%) ACA, and 22 (5.4%) PCA occlusions, there were 376 DAO with pre-morbid mRS 0-2 which were compared with 1268 PAO patients. The median baseline NIHSS score was lower in DAO (13 [8-18] vs 16 [12-20], P<0.001). There were no differences in terms of age, sex, IV-tPA use, co-morbidities, or time to treatment across DAO vs PAO. The rates of post-procedure reperfusion, symptomatic intracranial hemorrhage (sICH), and 90-mortality were comparable between both groups. DAO showed significantly higher rates of 90-day mRS 0-2 (68.3% vs 56.5%, P<0.001). After adjustment for potential confounders, the level of arterial occlusion was not associated with the chances of excellent outcome (DAO for 90-day mRS 0-1: OR; 1.18, 95% CI [0.90 to 1.54], P=0.225), successful reperfusion or SICH. However, DAO patients were more likely to be functionally independent (mRS 0-2: OR; 1.45, 95% CI [1,09 to 1.92], P=0.01) or dead (OR; 1.54, 95% CI [1.06 to 2.27], P=0.02) at 90 days. CONCLUSION: Endovascular therapy in DAO appears to result in a comparable safety and technical success profile as in PAO. The potential benefits of DAO thrombectomy should be investigated in future randomized trials.


Asunto(s)
Procedimientos Endovasculares , Accidente Cerebrovascular , Humanos , Sistema de Registros , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/cirugía , Trombectomía , Resultado del Tratamiento
16.
J Neurointerv Surg ; 13(6): 509-514, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-32680875

RESUMEN

BACKGROUND: Clot density (Hounsfield units, HU) and perviousness (post-contrast increase in the HU of clot) are thought to be associated with clot composition. We evaluate whether these imaging characteristics were associated with angiographic outcomes of aspiration and stent retriever thrombectomy in COMPASS: a trial of aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion. METHODS: Clot density and perviousness were measured by two independent operators who were blind to all the final angiographic and clinical outcomes. The association of clot density and perviousness with the Thrombolysis In Cerebral Infarction (TICI) scale after first pass was assessed using univariate and multivariate analysis. RESULTS: Among all patients enrolled in COMPASS, 165 were eligible for the post-hoc analysis (81 patients in the aspiration first and 84 in the stent retriever first groups). Overall mean perviousness of clot was significantly higher in patient with mTICI 2b-3 after first pass (28.6±22.9 vs 20.3±19.2, p=0.017). Mean perviousness among patients who achieved TICI 2c/3 versus TICI 2b versus TICI 0-2a in the aspiration first group varied significantly (32.6±26.1, 35.3±24.4, and 17.7±13.1, p=0.013). The association of perviousness with first pass success was not significant in the stent retriever group. Using multivariate analysis, high perviousness (defined as cut-off >27.6) was an independent predictor of TICI 2b-3 (OR 3.82, 95% CI 1.10 to 13.19; p=0.034). CONCLUSIONS: Clot perviousness is associated with first pass angiographic success in patients treated with the aspiration first approach for thrombectomy.


Asunto(s)
Stents , Trombectomía/métodos , Trombosis/diagnóstico por imagen , Trombosis/cirugía , Anciano , Anciano de 80 o más Años , Infarto Cerebral/diagnóstico por imagen , Infarto Cerebral/etiología , Infarto Cerebral/cirugía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Stents/tendencias , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/cirugía , Trombosis/complicaciones , Resultado del Tratamiento
17.
Int J Stroke ; 16(5): 593-601, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-32515694

RESUMEN

BACKGROUND: Some patients with ischemic stroke have poor outcomes despite small infarcts after endovascular thrombectomy, while others with large infarcts sometimes fare better. AIMS: We explored factors associated with such discrepancies between post-treatment infarct volume (PIV) and functional outcome. METHODS: We identified patients with small PIV (volume ≤ 25th percentile) and large PIV (volume ≥ 75th percentile) on 24-48-h CT/MRI in the ESCAPE randomized-controlled trial. Demographics, comorbidities, baseline, and 24-48-h stroke severity (NIHSS), stroke location, treatment type, post-stroke complications, and other outcome scales like Barthel Index, and EQ-5D were compared between "discrepant cases" - those with 90-day modified Rankin Scale(mRS) ≤ 2 despite large PIV or mRS ≥ 3 despite small PIV - and "non-discrepant cases". Multi-variable logistic regression was used to identify pre-treatment and post-treatment factors associated with small-PIV/mRS ≥ 3 and large-PIV/mRS ≤ 2. Sensitivity analyses used different definitions of small/large PIV and good/poor outcome. RESULTS: Among 315 patients, median PIV was 21 mL; 27/79 (34.2%) patients with PIV ≤ 7 mL (25th percentile) had mRS ≥ 3; 12/80 (15.0%) with PIV ≥ 72 mL (75th percentile) had mRS ≤ 2. Discrepant cases did not differ by CT versus MRI-based PIV ascertainment, or right versus left-hemisphere involvement (p = 0.39, p = 0.81, respectively, for PIV ≤ 7 mL/mRS ≥ 3). Pre-treatment factors independently associated with small-PIV/mRS ≥ 3 included older age (p = 0.010), cancer, and vascular risk-factors; post-treatment factors included 48-h NIHSS (p = 0.007) and post-stroke complications (p = 0.026). Absence of vascular risk-factors (p = 0.004), CT-based lentiform nucleus sparing (p = 0.002), lower 24-hour NIHSS (p = 0.001), and absence of complications (p = 0.013) were associated with large-PIV/mRS ≤ 2. Sensitivity analyses yielded similar results. CONCLUSIONS: Discrepancies between functional ability and PIV are likely explained by differences in age, comorbidities, and post-stroke complications, emphasizing the need for high-quality post-thrombectomy stroke care. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01778335.


Asunto(s)
Isquemia Encefálica , Accidente Cerebrovascular , Anciano , Isquemia Encefálica/complicaciones , Isquemia Encefálica/terapia , Humanos , Infarto , Factores de Riesgo , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/terapia , Trombectomía , Resultado del Tratamiento
18.
J Neurointerv Surg ; 12(3): 256-259, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-31363043

RESUMEN

BACKGROUND AND PURPOSE: Differences in the treatment practice of female and male physicians have been shown in several medical subspecialties. It is currently not known whether this also applies to endovascular stroke treatment. The purpose of this study was to explore whether there are differences in endovascular treatment decisions made by female and male stroke physicians and neurointerventionalists. METHODS: In an international survey, stroke physicians and neurointerventionalists were randomly assigned 10 case scenarios and asked how they would treat the patient: (A) assuming there were no external constraints and (B) given their local working conditions. Descriptive statistics were used to describe baseline demographics, and the adjusted OR for physician gender as a predictor of endovascular treatment decision was calculated using logistic regression. RESULTS: 607 physicians (97 women, 508 men, 2 who did not wish to declare) participated in this survey. Physician gender was neither a significant predictor for endovascular treatment decision under assumed ideal conditions (endovascular therapy was favored by 77.0% of female and 79.3% of male physicians, adjusted OR 1.03, P=0.806) nor under current local resources (endovascular therapy was favored by 69.1% of female and 76.9% of male physicians, adjusted OR 1.03, P=0.814). CONCLUSION: Endovascular therapy decision making between male and female physicians did not differ under assumed ideal conditions or under current local resources.


Asunto(s)
Toma de Decisiones Clínicas/métodos , Procedimientos Endovasculares/métodos , Internacionalidad , Médicos/normas , Accidente Cerebrovascular/terapia , Encuestas y Cuestionarios , Adulto , Anciano , Estudios Transversales , Procedimientos Endovasculares/tendencias , Femenino , Humanos , Masculino , Persona de Mediana Edad , Médicos/tendencias , Distribución Aleatoria , Factores Sexuales , Accidente Cerebrovascular/epidemiología , Resultado del Tratamiento
19.
J Neurointerv Surg ; 12(2): 122-126, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-31285376

RESUMEN

BACKGROUND AND PURPOSE: The decision to proceed with endovascular thrombectomy should ideally be made independent of inconvenience factors, such as daytime. We assessed the influence of patient presentation time on endovascular therapy decision making under current local resources and assumed ideal conditions in acute ischemic stroke with level 2B evidence for endovascular treatment. METHODS AND MATERIALS: In an international cross sectional survey, 607 stroke physicians from 38 countries were asked to give their treatment decisions to 10 out of 22 randomly assigned case scenarios. Eleven scenarios had level 2B evidence for endovascular treatment: 7 daytime scenarios (7:00 am-5:00 pm) and four night time cases (5:01 pm- 6:59 am). Participants provided their treatment approach assuming (A) there were no practice constraints and (B) under their current local resources. Endovascular treatment decisions in the 11 scenarios were analyzed according to presentation time with adjustment for patient and physician characteristics. RESULTS: Participants selected endovascular therapy in 74.2% under assumed ideal conditions, and 70.7% under their current local resources of night time scenarios, and in 67.2% and 63.8% of daytime scenarios. Night time presentation did not increase the probability of a treatment decision against endovascular therapy under current local resources or assumed ideal conditions. CONCLUSION: Presentation time did not influence endovascular treatment decision making in stroke patients in this international survey.


Asunto(s)
Isquemia Encefálica/terapia , Toma de Decisiones Clínicas/métodos , Procedimientos Endovasculares/métodos , Médicos , Accidente Cerebrovascular/terapia , Encuestas y Cuestionarios , Anciano , Anciano de 80 o más Años , Isquemia Encefálica/epidemiología , Ritmo Circadiano/fisiología , Estudios Transversales , Procedimientos Endovasculares/tendencias , Femenino , Humanos , Internacionalidad , Masculino , Persona de Mediana Edad , Médicos/tendencias , Accidente Cerebrovascular/epidemiología , Trombectomía/métodos , Trombectomía/tendencias , Factores de Tiempo , Resultado del Tratamiento
20.
J Neurointerv Surg ; 12(12): 1199-1204, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-32245843

RESUMEN

BACKGROUND: Burnout takes a heavy toll on healthcare providers. We sought to assess the prevalence and risk factors for burnout among neurointerventional (NI) non-physician procedural staff (nurses and technologists) given increasing thrombectomy demands. METHODS: A 41-question online survey containing questions including the Maslach Burnout Inventory-Human Services Survey for Medical Personnel was distributed to NI nurses and radiology technologists at 20 US endovascular capable stroke centers. RESULTS: 244 responses were received (64% response rate). Median (IQR) composite scores for emotional exhaustion were 25 (15-35), depersonalization 6 (2-11), and personal accomplishment 39 (35-43). Fifty-one percent of respondents met established criteria for burnout. There was no significant relationship between hospital thrombectomy volume, call frequency, call cases covered, or length of commute. On multiple logistic regression analysis, feeling under-appreciated by hospital leadership (OR 4.1; P<0.001) and working with difficult/unpleasant physicians (OR 1.2; P=0.05) were strongly associated with burnout. At participating centers, nurse and technologist attrition was 25% over the previous year. Over 50% of respondents indicated they had strongly considered leaving their position over the last 2 years. CONCLUSIONS: This survey of US NI non-physician procedural staff demonstrates a self-reported burnout prevalence of 51%. This was driven more by interaction with leadership and physician staff than by thrombectomy procedural volume and stroke call. Attrition among NI non-physician procedural staff is high.


Asunto(s)
Agotamiento Profesional/psicología , Personal de Salud/psicología , Satisfacción en el Trabajo , Médicos , Encuestas y Cuestionarios , Trombectomía/psicología , Adulto , Agotamiento Profesional/epidemiología , Femenino , Personal de Salud/tendencias , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Trombectomía/tendencias
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