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1.
J Cardiovasc Electrophysiol ; 31(6): 1289-1297, 2020 06.
Artículo en Inglés | MEDLINE | ID: mdl-32270538

RESUMEN

INTRODUCTION: The VICTORY AF Study was designed to evaluate the risk of the procedure and/or device-related strokes in patients with PersAF on warfarin undergoing ablation with a phased radiofrequency (RF) system. METHODS: The VICTORY AF trial was a prospective, multicenter, single-arm, investigational study. PersAF patients on vitamin K antagonism without major structural heart disease or history of stroke/transient ischemic attack undergoing phased RF ablation for atrial fibrillation (AF) were included. The primary outcome was the incidence of the procedure and/or device-related stroke within 30 days of the ablation by a board-certified neurologist's assessment. The secondary outcomes were an acute procedural success, 6 months effectiveness (defined as the reduction in AF/atrial flutter episodes lasting ≥10 minutes by 48-hour Holter 6 months postablation) and the number of patients with pulmonary vein (PV) stenosis. RESULTS: A total of 129 (108 PersAF, 21 long-standing PersAF) patients were treated (mean age: 60.6 ± 7.7; 79.8% male, 54.3% CHA2Ds2-VASc score ≥ 2). Two nondisabling strokes were reported (1.6%); one before discharge and the second diagnosed at the 30-day visit. Due to slow enrollment, the study was terminated before reaching the 95% one-sided upper confidence boundary for stroke incidence. Acute procedural success was 93.8%, and at 6 months, 72.8% of patients demonstrated ≥90% reduction in AF burden, 78.9% were off all antiarrhythmic drugs. There were no patients with PV stenosis of greater than 70%. CONCLUSIONS: VICTORY AF demonstrated a 1.6% incidence of stroke in PersAF undergoing ablation with a phased RF system which did not meet statistical confidence due to poor enrollment. The secondary outcomes suggest comparable efficacy to phased RF in the tailored treatment of permanent AF trial. Rigorous clinical evaluation of the stroke risk of new AF ablation technologies as well as restriction to Vitamin K antagonist anticoagulation appears to be unachievable goals in a clinical multicenter IDE trial of AF ablation in the current era.


Asunto(s)
Fibrilación Atrial/cirugía , Catéteres Cardíacos , Ablación por Catéter/efectos adversos , Ablación por Catéter/instrumentación , Electrodos , Accidente Cerebrovascular Hemorrágico/epidemiología , Accidente Cerebrovascular Isquémico/epidemiología , Potenciales de Acción , Anciano , Anticoagulantes/uso terapéutico , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/fisiopatología , Femenino , Frecuencia Cardíaca , Accidente Cerebrovascular Hemorrágico/diagnóstico , Accidente Cerebrovascular Hemorrágico/prevención & control , Humanos , Incidencia , Accidente Cerebrovascular Isquémico/diagnóstico , Accidente Cerebrovascular Isquémico/prevención & control , Masculino , Persona de Mediana Edad , América del Norte/epidemiología , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Warfarina/uso terapéutico
2.
Eur Heart J ; 39(19): 1687-1697, 2018 05 14.
Artículo en Inglés | MEDLINE | ID: mdl-28171522

RESUMEN

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.


Asunto(s)
Procedimientos Quirúrgicos Cardiovasculares/efectos adversos , Ensayos Clínicos como Asunto , Enfermedades del Sistema Nervioso/diagnóstico , Enfermedades del Sistema Nervioso/etiología , Cateterismo/efectos adversos , Determinación de Punto Final , Humanos , Enfermedades del Sistema Nervioso/clasificación , Examen Neurológico , Complicaciones Posoperatorias , Medición de Riesgo
4.
JAMA ; 313(12): 1240-8, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-25803346

RESUMEN

IMPORTANCE: Intracranial stenosis is one of the most common etiologies of stroke. To our knowledge, no randomized clinical trials have compared balloon-expandable stent treatment with medical therapy in symptomatic intracranial arterial stenosis. OBJECTIVE: To evaluate the efficacy and safety of the balloon-expandable stent plus medical therapy vs medical therapy alone in patients with symptomatic intracranial stenosis (≥70%). DESIGN, SETTING, AND PATIENTS: VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial is an international, multicenter, 1:1 randomized, parallel group trial that enrolled patients from 27 sites (January 2009-June 2012) with last follow-up in May 2013. INTERVENTIONS: Patients (N = 112) were randomized to receive balloon-expandable stent plus medical therapy (stent group; n = 59) or medical therapy alone (medical group; n = 53). PRIMARY OUTCOME MEASURE: a composite of stroke in the same territory within 12 months of randomization or hard transient ischemic attack (TIA) in the same territory day 2 through month 12 postrandomization. A hard TIA was defined as a transient episode of neurological dysfunction caused by focal brain or retinal ischemia lasting at least 10 minutes but resolving within 24 hours. Primary safety measure: a composite of any stroke, death, or intracranial hemorrhage within 30 days of randomization and any hard TIA between days 2 and 30 of randomization. Disability was measured with the modified Rankin Scale and general health status with the EuroQol-5D, both through month 12. RESULTS: Enrollment was halted by the sponsor after negative results from another trial prompted an early analysis of outcomes, which suggested futility after 112 patients of a planned sample size of 250 were enrolled. The 30-day primary safety end point occurred in more patients in the stent group (14/58; 24.1% [95% CI, 13.9%-37.2%]) vs the medical group (5/53; 9.4% [95% CI, 3.1%-20.7%]) (P = .05). Intracranial hemorrhage within 30 days occurred in more patients in the stent group (5/58; 8.6% [95% CI, 2.9%-19.0%]) vs none in the medical group (95% CI, 0%-5.5%) (P = .06). The 1-year primary outcome of stroke or hard TIA occurred in more patients in the stent group (21/58; 36.2% [95% CI, 24.0-49.9]) vs the medical group (8/53; 15.1% [95% CI, 6.7-27.6]) (P = .02). Worsening of baseline disability score (modified Rankin Scale) occurred in more patients in the stent group (14/58; 24.1% [95% CI, 13.9%-37.2%]) vs the medical group (6/53; 11.3% [95% CI, 4.3%-23.0%]) (P = .09).The EuroQol-5D showed no difference in any of the 5 dimensions between groups at 12-month follow-up. CONCLUSIONS AND RELEVANCE: Among patients with symptomatic intracranial arterial stenosis, the use of a balloon-expandable stent compared with medical therapy resulted in an increased 12-month risk of added stroke or TIA in the same territory, and increased 30-day risk of any stroke or TIA. These findings do not support the use of a balloon-expandable stent for patients with symptomatic intracranial arterial stenosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00816166.


Asunto(s)
Estenosis Carotídea/terapia , Stents/efectos adversos , Accidente Cerebrovascular/prevención & control , Insuficiencia Vertebrobasilar/terapia , Adulto , Anciano , Estenosis Carotídea/complicaciones , Femenino , Humanos , Hemorragias Intracraneales/etiología , Masculino , Persona de Mediana Edad , Riesgo , Accidente Cerebrovascular/etiología , Resultado del Tratamiento , Insuficiencia Vertebrobasilar/complicaciones
5.
Stroke ; 44(12): 3382-93, 2013 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-24222046

RESUMEN

BACKGROUND AND PURPOSE: Many patients with an acute stroke live in areas without ready access to a Primary or Comprehensive Stroke Center. The formation of care facilities that meet the needs of these patients might improve their care and outcomes and guide them and emergency responders to such centers within a stroke system of care. METHODS: The Brain Attack Coalition conducted an electronic search of the English medical literature from January 2000 to December 2012 to identify care elements and processes shown to be beneficial for acute stroke care. We used evidence grading and consensus paradigms to synthesize recommendations for Acute Stroke-Ready Hospitals (ASRHs). RESULTS: Several key elements for an ASRH were identified, including acute stroke teams, written care protocols, involvement of emergency medical services and emergency department, and rapid laboratory and neuroimaging testing. Unique aspects include the use of telemedicine, hospital transfer protocols, and drip and ship therapies. Emergent therapies include the use of intravenous tissue-type plasminogen activator and the reversal of coagulopathies. Although many of the care elements are similar to those of a Primary Stroke Center, compliance rates of ≥67% are suggested in recognition of the staffing, logistical, and financial challenges faced by rural facilities. CONCLUSIONS: ASRHs will form the foundation for acute stroke care in many settings. Recommended elements of an ASRH build on those proven to improve care and outcomes at Primary Stroke Centers. The ASRH will be a key component for patient care within an evolving stroke system of care.


Asunto(s)
Servicios Médicos de Urgencia , Necesidades y Demandas de Servicios de Salud , Hospitales , Accidente Cerebrovascular/terapia , Diagnóstico por Imagen , Humanos , Transferencia de Pacientes , Accidente Cerebrovascular/diagnóstico
6.
J Stroke Cerebrovasc Dis ; 22(7): 1131-9, 2013 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-23261207

RESUMEN

BACKGROUND: Patients with high-grade symptomatic intracranial stenosis (≥ 70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or anticoagulant therapy. Intracranial stenting has been proposed as a viable treatment option for this high-risk patient population; however, evaluation of this therapy in randomized multicenter trials is needed. In this article, we present the design and methods of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial for symptomatic intracranial stenosis. METHODS: The VISSIT trial is a randomized control study designed to evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse neurovascular balloon-expandable stent system plus medical therapy versus medical therapy alone in patients with cerebral or retinal ischemia due to neurovascular stenosis (≥ 70%) for preventing the primary composite end point: stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization or hard transient ischemic attack in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 postrandomization. RESULTS: Enrollment began in February 2009 and was halted in January 2012 with 112 subjects enrolled into the study. Clinical follow-up will continue for the planned period of 12 months postrandomization. CONCLUSIONS: The VISSIT trial may provide valuable insight into the use of balloon-expandable intracranial stent as a treatment option for high-risk patients. Lessons learned from this trial may better guide future clinical trial design on best patient selection, stenting techniques, and periprocedural management.


Asunto(s)
Arteriosclerosis Intracraneal/cirugía , Stents/efectos adversos , Accidente Cerebrovascular/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Protocolos Clínicos , Constricción Patológica/cirugía , Femenino , Humanos , Arteriosclerosis Intracraneal/complicaciones , Masculino , Persona de Mediana Edad , Proyectos de Investigación , Accidente Cerebrovascular/etiología
7.
Neurocrit Care ; 17(1): 139-45, 2012 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-22610823

RESUMEN

There is a need for real-time non-invasive, continuous monitoring of cerebral blood flow (CBF) during surgery, in intensive care units and clinical research. We investigated a new non-invasive hybrid technology employing ultrasound tagged near infrared spectroscopy (UT-NIRS) that may estimate changes in CBF using a cerebral blood flow index (CFI). Changes over time for UT-NIRS CFI and 133Xenon single photon emission computer tomography (133Xe-SPECT) CBF data were assessed in 10 healthy volunteers after an intravenous bolus of acetazolamide. UT-NIRS CFI was measured continuously and SPECT CBF was measured at baseline, 15 and 60 min after acetazolamide. We found significant changes over time in CFI by UT-NIRS and CBF by SPECT after acetazolamide (P ≤ 0.001). Post hoc tests showed a significant increase in CFI (P = 0.011) and SPECT CBF (P < 0.001) at 15 min after acetazolamide injection. There was a significant correlation between CFI and SPECT CBF values (r = 0.67 and P ≤ 0.033) at 15 min, but not at 60 min (P ≥ 0.777). UT-NIRS detected an increase in CFI following an acetazolamide bolus, which correlated with CBF measured with 133Xe-SPECT. This study demonstrates that UT-NIRS technology may be a promising new technique for non-invasive and real-time bedside CBF monitoring.


Asunto(s)
Circulación Cerebrovascular/fisiología , Cuidados Críticos/métodos , Espectroscopía Infrarroja Corta/métodos , Tomografía Computarizada de Emisión de Fotón Único/métodos , Ultrasonografía/métodos , Acetazolamida , Adulto , Anticonvulsivantes , Circulación Cerebrovascular/efectos de los fármacos , Femenino , Humanos , Masculino , Monitoreo Fisiológico/instrumentación , Monitoreo Fisiológico/métodos , Curva ROC , Valores de Referencia , Sensibilidad y Especificidad , Radioisótopos de Xenón , Adulto Joven
8.
Stroke ; 42(9): 2651-65, 2011 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-21868727

RESUMEN

BACKGROUND AND PURPOSE: The formation and certification of Primary Stroke Centers has progressed rapidly since the Brain Attack Coalition's original recommendations in 2000. The purpose of this article is to revise and update our recommendations for Primary Stroke Centers to reflect the latest data and experience. METHODS: We conducted a literature review using MEDLINE and PubMed from March 2000 to January 2011. The review focused on studies that were relevant for acute stroke diagnosis, treatment, and care. Original references as well as meta-analyses and other care guidelines were also reviewed and included if found to be valid and relevant. Levels of evidence were added to reflect current guideline development practices. RESULTS: Based on the literature review and experience at Primary Stroke Centers, the importance of some elements has been further strengthened, and several new areas have been added. These include (1) the importance of acute stroke teams; (2) the importance of Stroke Units with telemetry monitoring; (3) performance of brain imaging with MRI and diffusion-weighted sequences; (4) assessment of cerebral vasculature with MR angiography or CT angiography; (5) cardiac imaging; (6) early initiation of rehabilitation therapies; and (7) certification by an independent body, including a site visit and disease performance measures. CONCLUSIONS: Based on the evidence, several elements of Primary Stroke Centers are particularly important for improving the care of patients with an acute stroke. Additional elements focus on imaging of the brain, the cerebral vasculature, and the heart. These new elements may improve the care and outcomes for patients with stroke cared for at a Primary Stroke Center.


Asunto(s)
Servicio de Urgencia en Hospital/organización & administración , Servicio de Urgencia en Hospital/normas , Accidente Cerebrovascular/terapia , Angiografía Cerebral/métodos , Angiografía Cerebral/normas , Femenino , Humanos , MEDLINE , Angiografía por Resonancia Magnética/métodos , Angiografía por Resonancia Magnética/normas , Masculino , Rehabilitación/métodos , Rehabilitación/organización & administración , Rehabilitación/normas , Accidente Cerebrovascular/diagnóstico por imagen , Telemetría/normas
9.
Neurocrit Care ; 15(2): 270-4, 2011 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-21751101

RESUMEN

Hypovolemia is common after subarachnoid hemorrhage, and fluid imbalance negatively affects clinical outcome. Standard bedside volume measures fail to adequately assess fluid status after subarachnoid hemorrhage. An electronic literature search of original research studies evaluating fluid status after subarachnoid hemorrhage was conducted for English language articles published through October 2010. Sixteen articles were included in this review, with seven articles produced by two research groups. These studies highlight that fluid status is often affected and difficult to assess after subarachnoid hemorrhage. Both non-invasive and invasive monitors may be used to more accurately define volume status.


Asunto(s)
Determinación del Volumen Sanguíneo/métodos , Volumen Sanguíneo , Cuidados Críticos/métodos , Monitoreo Fisiológico/métodos , Hemorragia Subaracnoidea/terapia , Enfermedad Aguda , Humanos , Hipovolemia/diagnóstico , Hipovolemia/etiología , Hemorragia Subaracnoidea/complicaciones
10.
Neurocrit Care ; 15(2): 211-40, 2011 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-21773873

RESUMEN

Subarachnoid hemorrhage (SAH) is an acute cerebrovascular event which can have devastating effects on the central nervous system as well as a profound impact on several other organs. SAH patients are routinely admitted to an intensive care unit and are cared for by a multidisciplinary team. A lack of high quality data has led to numerous approaches to management and limited guidance on choosing among them. Existing guidelines emphasize risk factors, prevention, natural history, and prevention of rebleeding, but provide limited discussion of the complex critical care issues involved in the care of SAH patients. The Neurocritical Care Society organized an international, multidisciplinary consensus conference on the critical care management of SAH to address this need. Experts from neurocritical care, neurosurgery, neurology, interventional neuroradiology, and neuroanesthesiology from Europe and North America were recruited based on their publications and expertise. A jury of four experienced neurointensivists was selected for their experience in clinical investigations and development of practice guidelines. Recommendations were developed based on literature review using the GRADE system, discussion integrating the literature with the collective experience of the participants and critical review by an impartial jury. Recommendations were developed using the GRADE system. Emphasis was placed on the principle that recommendations should be based not only on the quality of the data but also tradeoffs and translation into practice. Strong consideration was given to providing guidance and recommendations for all issues faced in the daily management of SAH patients, even in the absence of high quality data.


Asunto(s)
Cuidados Críticos/normas , Hemorragia Subaracnoidea/mortalidad , Hemorragia Subaracnoidea/terapia , Vasoespasmo Intracraneal/mortalidad , Vasoespasmo Intracraneal/terapia , Enfermedad Aguda , Humanos , Incidencia , Prevención Secundaria
11.
Neurocrit Care ; 12(3): 395-9, 2010 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-20066515

RESUMEN

BACKGROUND: Central hypoventilation syndrome ("Ondine's Curse") is an infrequent disorder that can lead to serious acute or chronic health consequences. This syndrome, especially in adults, is rare, and even less frequent in the absence of clear pathogenic lesions on MRI. In addition, we are not aware of any previously reported cases with associated cranial nerve neuralgias. METHODS: We describe a patient with baseline trigeminal and glossopharyngeal neuralgia, admitted with episodes of severe hypoventilatory failure of central origin, consistent with "Ondine's Curse". After evaluation, she was found to have a medullary capillary telangiectasia, thought to be the causative lesion, and which could explain her complete neurologic and hypoventilatory syndrome. The patient was treated with placement of a diaphragmatic pacing system, which has been effective thus far. RESULTS: This case illustrates the need for investigation of centrally mediated apnea, especially when co-occurring cranial nerve neuralgia is present and cardiopulmonary evaluation is negative. It provides an example of capillary telangiectasia as the causative lesion, one that to our knowledge has not been reported before. CONCLUSIONS: Placement of a diaphragmatic pacing system was warranted and became lifesaving as the patient was deemed to be severely incapacitated by chronic ventilatory insufficiency.


Asunto(s)
Malformaciones Vasculares del Sistema Nervioso Central/diagnóstico , Enfermedades del Nervio Glosofaríngeo/etiología , Bulbo Raquídeo/irrigación sanguínea , Apnea Central del Sueño/etiología , Neuralgia del Trigémino/etiología , Anciano , Malformaciones Vasculares del Sistema Nervioso Central/complicaciones , Malformaciones Vasculares del Sistema Nervioso Central/terapia , Cuidados Críticos , Diagnóstico Diferencial , Diafragma/inervación , Terapia por Estimulación Eléctrica , Electroencefalografía , Femenino , Enfermedades del Nervio Glosofaríngeo/diagnóstico , Enfermedades del Nervio Glosofaríngeo/terapia , Humanos , Hipoventilación/diagnóstico , Hipoventilación/etiología , Hipoventilación/terapia , Imagen por Resonancia Magnética , Recurrencia , Respiración Artificial , Apnea Central del Sueño/diagnóstico , Apnea Central del Sueño/terapia , Neuralgia del Trigémino/diagnóstico , Neuralgia del Trigémino/terapia
13.
Stroke ; 39(1): 120-5, 2008 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-18048860

RESUMEN

BACKGROUND AND PURPOSE: The primary purpose of intracranial aneurysm treatment is to prevent rupture. Risk factors for rupture after aneurysm treatment have not been clearly established, and the need to completely occlude aneurysms is debated. METHODS: The Cerebral Aneurysm Rerupture After Treatment (CARAT) study is an ambidirectional cohort study of all patients with ruptured intracranial aneurysms treated with coil embolization or surgical clipping at 9 high-volume centers in the United States from 1996 to 1998. All subjects were followed through 2005, and all potential reruptures were adjudicated by a panel of 3 specialists without knowledge of the initial treatment or aneurysm characteristics. Degree of aneurysm occlusion post-treatment was evaluated as a predictor of nonprocedural rerupture in univariate Kaplan-Meier analysis (log-rank test) and in a Cox proportional-hazards model after adjustment for potential confounders and censoring at time of retreatment. RESULTS: Among 1001 patients during a mean of 4.0 years follow-up, there were 19 postprocedural reruptures; median time to rerupture was 3 days and 58% led to death. The degree of aneurysm occlusion after treatment was strongly associated with risk of rerupture (overall risk: 1.1% for complete occlusion, 2.9% for 91% to 99% occlusion, 5.9% for 70% to 90%, 17.6% for <70%; P<0.0001 in univariate and multivariable analysis). Overall risk of rerupture tended to be greater after coil embolization compared with surgical clipping (3.4% versus 1.3%; P=0.092), but the difference did not persist after adjustment (P=0.83). CONCLUSIONS: Degree of aneurysm occlusion after the initial treatment is a strong predictor of the risk of subsequent rupture in patients presenting with subarachnoid hemorrhage, which justifies attempts to completely occlude aneurysms.


Asunto(s)
Aneurisma Roto/epidemiología , Aneurisma Intracraneal/patología , Hemorragia Subaracnoidea/patología , Hemorragia Subaracnoidea/cirugía , Adulto , Anciano , Aneurisma Roto/cirugía , Estudios de Cohortes , Embolización Terapéutica , Femenino , Humanos , Aneurisma Intracraneal/cirugía , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Factores de Riesgo , Prevención Secundaria , Hemorragia Subaracnoidea/diagnóstico , Instrumentos Quirúrgicos , Resultado del Tratamiento , Estados Unidos/epidemiología
15.
Int J Stroke ; 12(6): 641-652, 2017 08.
Artículo en Inglés | MEDLINE | ID: mdl-28569123

RESUMEN

Rationale Efficacy of mechanical thrombectomy for acute stroke due to large vessel occlusion initiated beyond 6 h of time last seen well has not been demonstrated in randomized trials. Aim To establish whether subjects considered to have substantial areas of salvageable brain based on age-adjusted clinical core mismatch who can undergo endovascular treatment within 6-24 h from time last seen well (TLSW) have better outcomes at three months compared to subjects treated with standard medical therapy alone. Age-adjusted clinical core mismatch is defined by age (≤80 or >80 years), baseline National Institutes of Health Stroke Scale (NIHSS) (10-20 or ≥21), and core size (0-20 cm3 in subjects older than 80 and, in subjects younger than 80, 0-30 cm3 with NIHSS 10-20 and 31-50 cm3 with NIHSS ≥21). Design Prospective, randomized, multicenter, Bayesian adaptive-enrichment, open label trial with blinded endpoint assessment. For the purpose of enrolment, ischemic core size will be evaluated by CT perfusion or magnetic resonance imaging-diffusion-weighted imaging measured by automated software (RAPID). Procedures Subjects with acute ischemic stroke due to computed tomography angiography- or magnetic resonance angiogram-proven arterial occlusion of the intracranial internal carotid and/or proximal middle cerebral artery (M1) with age-adjusted clinical core mismatch in whom treatment can be initiated between 6 and 24 h from TSLW are randomized in a 1:1 ratio to receive mechanical embolectomy with the Trevo device or medical management alone. Sequential interim analyses allowing adaptation of enrolment criteria or stopping new enrolment for futility or predicted success will occur in every 50 randomized patients starting at 150 to a maximum of 500 patients. Study outcomes The primary endpoint is the modified Rankin Scale score at 90 days. The primary safety outcome is stroke-related mortality at 90 days. Analysis The primary endpoint, expressed as a utility-weighted modified Rankin Scale score is analyzed using a Bayesian posterior probability with adjustment for ischemic core size. For regulatory reasons, a nested co-primary endpoint analysis was added consisting of the proportion of subjects with modified Rankin Scale 0-2 between the active and control groups also analyzed using a Bayesian model.


Asunto(s)
Isquemia Encefálica/diagnóstico por imagen , Imagen de Difusión por Resonancia Magnética , Fibrinolíticos/uso terapéutico , Accidente Cerebrovascular/diagnóstico por imagen , Anciano , Anciano de 80 o más Años , Isquemia Encefálica/tratamiento farmacológico , Imagen de Difusión por Resonancia Magnética/métodos , Procedimientos Endovasculares/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Accidente Cerebrovascular/tratamiento farmacológico , Trombectomía/métodos , Resultado del Tratamiento , Triaje
16.
J Am Coll Cardiol ; 69(6): 679-691, 2017 Feb 14.
Artículo en Inglés | MEDLINE | ID: mdl-28183511

RESUMEN

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies.


Asunto(s)
Enfermedades Cardiovasculares/terapia , Determinación de Punto Final/normas , Enfermedades Cardiovasculares/complicaciones , Enfermedades Cardiovasculares/diagnóstico , Ensayos Clínicos como Asunto , Humanos , Enfermedades del Sistema Nervioso/diagnóstico , Proyectos de Investigación
17.
J Neurosurg ; 105(1): 15-20, 2006 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-16871878

RESUMEN

OBJECT: Subarachnoid hemorrhage (SAH) has been associated with cardiac injury and left ventricular (LV) dysfunction. The incidence and natural history of neurocardiogenic injury after SAH remains poorly understood. The objective of this study was to describe the incidence, time course, recovery rate, and segmental patterns of LV dysfunction after SAH. METHODS: Echocardiography was performed three times over a 7-day period in 173 patients with SAH. The incidence of global (ejection fraction [EF] < 50%) and segmental (any regional wall-motion abnormality [RWMA]) LV dysfunction was measured. The time course of LV dysfunction was determined by comparing the prevalence of LVEF less than 50% and RWMA at 0 to 2, 3 to 5, and 6 to 8 days after SAH. The recovery rate was defined as the proportion of patients with partial or complete normalization of function. The distribution of RWMAs among 16 LV segments was also determined. An LVEF less than 50% was found in 15% of patients, and 13% had an RWMA with a normal LVEF. There was a trend toward increased dysfunction at 0 to 2 days after SAH, compared with 3 to 8 days after SAH. Recovery of LV function was observed in 66% of patients. The most frequently abnormal LV segments were the basal and middle ventricular portions of the anteroseptal and anterior walls. The apex was rarely affected. CONCLUSIONS: Left ventricular systolic dysfunction occurs frequently after SAH and usually improves over time. The observed segmental patterns of LV dysfunction often do not correlate with coronary artery distributions.


Asunto(s)
Recuperación de la Función/fisiología , Hemorragia Subaracnoidea/complicaciones , Disfunción Ventricular Izquierda/epidemiología , Disfunción Ventricular Izquierda/fisiopatología , Adulto , Anciano , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Volumen Sistólico/fisiología , Factores de Tiempo , Ultrasonografía , Disfunción Ventricular Izquierda/diagnóstico por imagen
18.
Stroke ; 34(12): 2894-8, 2003 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-14615614

RESUMEN

BACKGROUND AND PURPOSE: Current guidelines recommend the use of head CT in the evaluation of patients with transient ischemic attack (TIA), but data supporting its value are sparse. METHODS: Patients who presented to 1 of 16 emergency departments of a large Northern California health maintenance organization and received a diagnosis of TIA from November 1997 through February 1998 were enrolled and followed up for 90 days. Clinical, demographic, and outcome data were obtained from computerized databases and medical records. Physicians blinded to patient characteristics and outcomes abstracted head CT findings from radiology reports. Abstracted findings included evidence of old or new infarct, periventricular white-matter disease, cerebral atrophy, cerebral vascular calcification, and nonischemic lesions. RESULTS: Head CT was performed in 67% of eligible patients (n=322) diagnosed with TIA. Evidence of a new infarct was seen on head CT in 13 patients (4%). A nonischemic cause of TIA symptoms was found in 4 patients (1.2%). During follow-up, 10.9% of TIA patients experienced subsequent stroke. After adjustment for confounders, risk for stroke during follow-up was significantly higher in those with a new infarct on head CT compared with others with TIA (odds ratio, 4.06; 95% confidence interval, 1.16 to 14.14; P=0.028). Old infarction, periventricular white-matter disease, cerebral atrophy, and cerebral vascular calcification were not predictors of subsequent risk of stroke. CONCLUSIONS: Evidence of a new infarct on head CT in patients presenting with TIA is associated with increased short-term risk for stroke. Head CT appears to have prognostic value in patients with TIA and, for this reason alone, may be justified in their evaluation.


Asunto(s)
Infarto Cerebral/diagnóstico , Cabeza/diagnóstico por imagen , Ataque Isquémico Transitorio/diagnóstico , Accidente Cerebrovascular/epidemiología , Tomografía Computarizada por Rayos X , Adulto , Anciano , Anciano de 80 o más Años , California/epidemiología , Infarto Cerebral/epidemiología , Estudios de Cohortes , Comorbilidad , Supervivencia sin Enfermedad , Servicios Médicos de Urgencia , Femenino , Estudios de Seguimiento , Cabeza/irrigación sanguínea , Humanos , Ataque Isquémico Transitorio/epidemiología , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Pronóstico , Estudios Retrospectivos , Medición de Riesgo
19.
Stroke ; 33(7): 1851-6, 2002 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-12105365

RESUMEN

BACKGROUND AND PURPOSE: Studies of several complex medical conditions have shown that outcomes are better at hospitals that treat more cases. We tested the hypothesis that patients with subarachnoid hemorrhage treated at high-volume hospitals have better outcomes. METHODS: Using a database of all admissions to nonfederal hospitals in California from 1990 to 1999, we obtained discharge abstracts for patients with a primary diagnosis of subarachnoid hemorrhage who were admitted through the emergency department. Hospital volume, defined as the average number of subarachnoid hemorrhage cases admitted each year, was divided into quartiles. Rates of mortality, adverse outcomes (death or discharge to long-term care), length of stay, and hospital charges were computed by univariate analysis and by multivariable general estimating equations, with adjustment for demographic and admission characteristics. RESULTS: A total of 12 804 patients were admitted for subarachnoid hemorrhage through the emergency departments of 390 hospitals. Hospital volumes varied from 0 to 8 cases per year in the first quartile to 19 to 70 cases per year in the fourth quartile. The mortality rate in the lowest volume quartile (49%) was larger than that in the highest volume quartile (32%, P<0.001). In multivariable analysis, the difference persisted (odds ratio comparing highest with lowest volume quartiles 0.57, 95% CI 0.48 to 0.67; P<0.001). At higher volume hospitals, lengths of stay were longer, and hospital charges were greater in univariate and multivariable models (all P<0.001). Only 4.8% of those admitted to hospitals in the lowest volume quartile were transferred to hospitals in the highest quartile. CONCLUSIONS: In this study of discharge abstracts in California, hospitals that treated more cases of subarachnoid hemorrhage had substantially lower rates of in-hospital mortality. Few patients with subarachnoid hemorrhage are being transferred to high-volume centers.


Asunto(s)
Hospitales/estadística & datos numéricos , Hospitales/normas , Evaluación de Resultado en la Atención de Salud , Admisión del Paciente/estadística & datos numéricos , Hemorragia Subaracnoidea/terapia , Revisión de Utilización de Recursos , California , Estudios de Cohortes , Sistemas de Administración de Bases de Datos , Demografía , Femenino , Precios de Hospital/estadística & datos numéricos , Mortalidad Hospitalaria/tendencias , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Oportunidad Relativa , Transferencia de Pacientes/estadística & datos numéricos , Derivación y Consulta/tendencias , Programas Médicos Regionales/tendencias , Hemorragia Subaracnoidea/economía , Hemorragia Subaracnoidea/mortalidad
20.
Stroke ; 35(2): 548-51, 2004 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-14739408

RESUMEN

BACKGROUND AND PURPOSE: Subarachnoid hemorrhage (SAH) frequently results in myocardial necrosis with release of cardiac enzymes. Historically, this necrosis has been attributed to coronary artery disease, coronary vasospasm, or oxygen supply-demand mismatch. Experimental evidence, however, indicates that excessive release of norepinephrine from the myocardial sympathetic nerves is the most likely cause. We hypothesized that myocardial necrosis after SAH is a neurally mediated process that is dependent on the severity of neurological injury. METHODS: Consecutive patients admitted with SAH were enrolled prospectively. Predictor variables reflecting demographic (age, sex, body surface area), hemodynamic (heart rate, systolic blood pressure), treatment (phenylephrine dose), and neurological (Hunt-Hess score) factors were recorded. Serial cardiac troponin I measurements and echocardiography were performed on days 1, 3, and 6 after enrollment. Troponin level was treated as a dichotomous outcome variable. We performed univariate and multivariate analyses on the relationships between the predictor variables and troponin level. RESULTS: The study included 223 patients with an average age of 54 years. Twenty percent of the subjects had troponin I levels >1.0 microg/L (range, 0.3 to 50 microg/L). By multivariate logistic regression, a Hunt-Hess score >2, female sex, larger body surface area and left ventricular mass, lower systolic blood pressure, and higher heart rate and phenylephrine dose were independent predictors of troponin elevation. CONCLUSIONS: The degree of neurological injury as measured by the Hunt-Hess grade is a strong, independent predictor of myocardial necrosis after SAH. This finding supports the hypothesis that cardiac injury after SAH is a neurally mediated process.


Asunto(s)
Cardiomiopatías/diagnóstico , Cardiomiopatías/etiología , Corazón/fisiopatología , Hemorragia Subaracnoidea/complicaciones , Troponina I/sangre , Adulto , Anciano , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/etiología , Arritmias Cardíacas/fisiopatología , Biomarcadores/sangre , Cardiomiopatías/fisiopatología , Estudios de Cohortes , Ecocardiografía , Electrocardiografía , Epinefrina/sangre , Femenino , Pruebas de Función Cardíaca , Frecuencia Cardíaca , Humanos , Hipertensión/diagnóstico , Hipertensión/etiología , Masculino , Persona de Mediana Edad , Miocardio/metabolismo , Necrosis , Norepinefrina/sangre , Valor Predictivo de las Pruebas , Estudios Prospectivos , Factores de Riesgo , Volumen Sistólico , Disfunción Ventricular Izquierda/diagnóstico , Disfunción Ventricular Izquierda/etiología , Disfunción Ventricular Izquierda/fisiopatología
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