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1.
J Neurointerv Surg ; 13(10): 930-934, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-33298509

RESUMEN

BACKGROUND: No randomized trial of intracranial aneurysm coiling has compared long-term efficacy of polymer-modified coils to bare metal coils (BMCs). We report 5-year results comparing Matrix2 coils to BMCs. The primary objective was to compare the rates of target aneurysm recurrence (TAR) at 12 months. Secondary objectives included angiographic outcomes at TAR or 12 months and TAR at 5 years. METHODS: A total of 626 patients were randomized to BMCs or Matrix2 coils. Detailed methods and 1-year results have been published previously. RESULTS: Of 580 patients eligible for 5-year follow-up, 431 (74.3%) completed follow-up or reached TAR. Matrix2 coils were non-inferior to BMCs (P=0.8) but did not confer any benefit. Core lab reported post-treatment residual aneurysm filling (Raymond III) correlated with TAR (P<0.0001) and with aneurysm hemorrhage after treatment (P<0.008). Repeat aneurysmal hemorrhage after treatment, but before hospital discharge, occurred in three patients treated for acutely ruptured aneurysms. Additionally, two patients treated for unruptured aneurysms experienced a first hemorrhage during follow-up. All five hemorrhages resulted from aneurysms with Raymond III residual aneurysm filling persisting after initial treatment. After 5 years follow-up, 2/626 (0.3%) patients are known to have had target aneurysm rupture following hospital discharge. The annualized rate of delayed hemorrhage after coiling was 2/398/5=0.001 (0.1%) per year for unruptured aneurysms and 0 for ruptured aneurysms. CONCLUSIONS: After 5 years Matrix2 coils were non-inferior to BMCs but no benefit was demonstrated. Post-treatment residual angiographic aneurysm filling (Raymond III) is strongly associated with TAR (P<0.0001) and post-treatment aneurysmal hemorrhage (P=0.008).


Asunto(s)
Aneurisma Roto , Embolización Terapéutica , Aneurisma Intracraneal , Aneurisma Roto/terapia , Embolización Terapéutica/efectos adversos , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Resultado del Tratamiento
2.
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
3.
Stroke ; 46(3): 775-9, 2015 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25593135

RESUMEN

BACKGROUND AND PURPOSE: Stenting has been used as a rescue therapy in patients with intracranial arterial stenosis and a transient ischemic attack or stroke when on antithrombotic therapy (AT). We determined whether the stenting versus aggressive medical therapy for intracranial arterial stenosis (SAMMPRIS) trial supported this approach by comparing the treatments within subgroups of patients whose qualifying event (QE) occurred on versus off of AT. METHODS: The primary outcome, 30-day stroke and death and later strokes in the territory of the qualifying artery, was compared between (1) percutaneous transluminal angioplasty and stenting plus aggressive medical therapy (PTAS) versus aggressive medical management therapy alone (AMM) for patients whose QE occurred on versus off AT and between (2) patients whose QE occurred on versus off AT separately for the treatment groups. RESULTS: Among the 284/451 (63%) patients who had their QE on AT, the 2-year primary end point rates were 15.6% for those randomized to AMM (n=140) and 21.6% for PTAS (n=144; P=0.043, log-rank test). In the 167 patients not on AT, the 2-year primary end point rates were 11.6% for AMM (n=87) and 18.8% for PTAS (n=80; P=0.31, log-rank test). Within both treatment groups, there was no difference in the time to the primary end point between patients who were on or off AT (AMM, P=0.96; PTAS, P=0.52; log-rank test). CONCLUSIONS: SAMMPRIS results indicate that the benefit of AMM over PTAS is similar in patients on versus off AT at the QE and that failure of AT is not a predictor of increased risk of a primary end point. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00576693.


Asunto(s)
Interpretación Estadística de Datos , Fibrinolíticos/uso terapéutico , Arteriosclerosis Intracraneal/tratamiento farmacológico , Stents , Anciano , Angioplastia/métodos , Constricción Patológica/tratamiento farmacológico , Constricción Patológica/cirugía , Quimioterapia Combinada/efectos adversos , Femenino , Fibrinolíticos/efectos adversos , Humanos , Arteriosclerosis Intracraneal/cirugía , Ataque Isquémico Transitorio/tratamiento farmacológico , Ataque Isquémico Transitorio/cirugía , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
4.
Lancet ; 383(9914): 333-41, 2014 Jan 25.
Artículo en Inglés | MEDLINE | ID: mdl-24168957

RESUMEN

BACKGROUND: Early results of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial showed that, by 30 days, 33 (14·7%) of 224 patients in the stenting group and 13 (5·8%) of 227 patients in the medical group had died or had a stroke (percentages are product limit estimates), but provided insufficient data to establish whether stenting offered any longer-term benefit. Here we report the long-term outcome of patients in this trial. METHODS: We randomly assigned (1:1, stratified by centre with randomly permuted block sizes) 451 patients with recent transient ischaemic attack or stroke related to 70-99% stenosis of a major intracranial artery to aggressive medical management (antiplatelet therapy, intensive management of vascular risk factors, and a lifestyle-modification programme) or aggressive medical management plus stenting with the Wingspan stent. The primary endpoint was any of the following: stroke or death within 30 days after enrolment, ischaemic stroke in the territory of the qualifying artery beyond 30 days of enrolment, or stroke or death within 30 days after a revascularisation procedure of the qualifying lesion during follow-up. Primary endpoint analysis of between-group differences with log-rank test was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT 00576693. FINDINGS: During a median follow-up of 32·4 months, 34 (15%) of 227 patients in the medical group and 52 (23%) of 224 patients in the stenting group had a primary endpoint event. The cumulative probability of the primary endpoints was smaller in the medical group versus the percutaneous transluminal angioplasty and stenting (PTAS) group (p=0·0252). Beyond 30 days, 21 (10%) of 210 patients in the medical group and 19 (10%) of 191 patients in the stenting group had a primary endpoint. The absolute differences in the primary endpoint rates between the two groups were 7·1% at year 1 (95% CI 0·2 to 13·8%; p=0·0428), 6·5% at year 2 (-0·5 to 13·5%; p=0·07) and 9·0% at year 3 (1·5 to 16·5%; p=0·0193). The occurrence of the following adverse events was higher in the PTAS group than in the medical group: any stroke (59 [26%] of 224 patients vs 42 [19%] of 227 patients; p=0·0468) and major haemorrhage (29 [13%]of 224 patients vs 10 [4%] of 227 patients; p=0·0009). INTERPRETATION: The early benefit of aggressive medical management over stenting with the Wingspan stent for high-risk patients with intracranial stenosis persists over extended follow-up. Our findings lend support to the use of aggressive medical management rather than PTAS with the Wingspan system in high-risk patients with atherosclerotic intracranial arterial stenosis. FUNDING: National Institute of Neurological Disorders and Stroke (NINDS) and others.


Asunto(s)
Angioplastia/métodos , Arteriosclerosis Intracraneal/terapia , Inhibidores de Agregación Plaquetaria/uso terapéutico , Stents , Adulto , Anciano , Anciano de 80 o más Años , Angioplastia/efectos adversos , Aspirina/uso terapéutico , Estenosis Carotídea/complicaciones , Estenosis Carotídea/terapia , Clopidogrel , Femenino , Estudios de Seguimiento , Humanos , Arteriosclerosis Intracraneal/complicaciones , Ataque Isquémico Transitorio/etiología , Ataque Isquémico Transitorio/prevención & control , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/efectos adversos , Prevención Secundaria , Método Simple Ciego , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Ticlopidina/análogos & derivados , Ticlopidina/uso terapéutico , Resultado del Tratamiento
5.
J Neurosurg ; 120(2): 365-74, 2014 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-24320006

RESUMEN

OBJECT: Delayed ipsilateral intraparenchymal hemorrhage has been observed following aneurysm treatment with the Pipeline Embolization Device (PED). The relationship of this phenomenon to the device and/or procedure remains unclear. The authors present the results of histopathological analyses of the brain sections from 3 patients in whom fatal ipsilateral intracerebral hemorrhages developed several days after uneventful PED treatment of supraclinoid aneurysms. METHODS: Microscopic analyses revealed foreign material occluding small vessels within the hemorrhagic area in all patients. Further analyses of the embolic materials using Fourier transform infrared (FTIR) spectroscopy was conducted on specimens from 2 of the 3 patients. Although microscopically identical, the quantity of material recovered from the third patient was insufficient for FTIR spectroscopy. RESULTS: FTIR spectroscopy showed that the foreign material was polyvinylpyrrolidone (PVP), a substance that is commonly used in the coatings of interventional devices. CONCLUSIONS: These findings are suggestive of a potential association between intraprocedural foreign body emboli and post-PED treatment-delayed ipsilateral intraparenchymal hemorrhage.


Asunto(s)
Embolización Terapéutica/efectos adversos , Embolización Terapéutica/instrumentación , Aneurisma Intracraneal/complicaciones , Aneurisma Intracraneal/cirugía , Hemorragias Intracraneales/etiología , Complicaciones Posoperatorias/etiología , Anciano , Anticoagulantes/uso terapéutico , Autopsia , Materiales Biocompatibles , Arteria Carótida Interna/patología , Angiografía Cerebral , Resultado Fatal , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedades del Sistema Nervioso/etiología , Procedimientos Neuroquirúrgicos/métodos , Complicaciones Posoperatorias/fisiopatología , Povidona , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Espectroscopía Infrarroja por Transformada de Fourier
7.
J Vasc Surg ; 58(4): 1076-9, 2013 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-23465174

RESUMEN

Rotational vertebral artery occlusion, or bow hunter's stroke, is reversible, positional symptomatic vertebrobasilar ischemia. The typical mechanism of action is obstruction of a dominant vertebral artery with contralateral head rotation in the setting of baseline ipsilateral vertebral artery stenosis or occlusion. Here we present a rare case of mechanical occlusion of bilateral patent vertebral arteries manifesting as near syncope with rightward head rotation. Diagnostic cerebral angiography showed dynamic right C5 vertebral occlusion and left C2 vertebral occlusion. The patient underwent right C4/5 transverse process decompression. Postoperative angiogram showed patent flow through the right vertebral artery in neutral position and with head turn with resultant resolution of symptoms.


Asunto(s)
Movimientos de la Cabeza , Insuficiencia Vertebrobasilar/etiología , Angiografía Cerebral , Vértebras Cervicales/cirugía , Descompresión Quirúrgica/métodos , Humanos , Masculino , Persona de Mediana Edad , Rotación , Síncope/etiología , Resultado del Tratamiento , Ultrasonografía Doppler en Color , Insuficiencia Vertebrobasilar/diagnóstico , Insuficiencia Vertebrobasilar/cirugía
8.
J Neurointerv Surg ; 5(1): 62-8, 2013 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-22146571

RESUMEN

BACKGROUND: Lumboperitoneal shunt (LPS), ventriculoperitoneal shunt (VPS) and optic nerve sheath fenestration (ONSF) are accepted surgical therapies for medically refractory idiopathic intracranial hypertension (IIH). In the subset of patients with IIH and venous sinus stenosis, dural venous sinus stenting has emerged as an alternative surgical approach. METHODS: All cases of dural stents for IIH at our institution were retrospectively reviewed. Eligibility criteria included medically refractory IIH with documented papilledema and dural venous sinus stenosis of the dominant venous outflow system (gradient ≥10 mm Hg). RESULTS: Fifteen cases (all women) of mean age 34 years were identified. All had failed medical therapy and six had failed surgical intervention. Technical success was achieved in all patients without major periprocedural complications. The mean preprocedural gradient across the venous stenosis was reduced from 24 mm Hg before the procedure to 4 mm Hg after the procedure. Headache resolved or improved in 10 patients. Papilledema resolved in all patients and visual acuity stabilized or improved in 14 patients. There were no instances of restenosis among the 14 patients with follow-up imaging. CONCLUSION: In this small case series, dural sinus stenting for IIH was performed safely with a high degree of technical success and with excellent clinical outcomes. These results suggest that angioplasty and stenting for the treatment of medically refractory IIH in patients with dural sinus stenosis warrants further investigation as an alternative to LPS, VPS and ONSF.


Asunto(s)
Angioplastia/instrumentación , Angioplastia/métodos , Senos Craneales/diagnóstico por imagen , Seudotumor Cerebral/diagnóstico por imagen , Seudotumor Cerebral/terapia , Stents , Adulto , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Radiografía , Estudios Retrospectivos , Adulto Joven
9.
J Neurointerv Surg ; 5(6): 528-33, 2013 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-22977278

RESUMEN

BACKGROUND AND PURPOSE: To investigate the relationship between physician and site experience and the risk of 30 day hemorrhagic and ischemic strokes in the stenting arm of the Stenting and Aggressive Medical Management for the Prevention of Recurrent Ischemic Stroke (SAMMPRIS) trial. METHODS: Study records and an investigator survey were examined for physician and site related factors, including: number of Wingspan and aneurysm stents submitted for credentialing, number of study procedures performed in SAMMPRIS, years in practice after training, primary specialty, and site enrollment. Bivariate and multivariate analyses were performed to determine if these factors were associated with the 30 day rate of cerebrovascular events after angioplasty and stenting. RESULTS: 213 patients underwent angioplasty alone (n=5) or angioplasty and stenting (n=208) with study devices by 63 interventionists at 48 sites. For credentialing, the median number of Wingspan and similar aneurysm stent cases submitted by study interventionists were 10 and 6, respectively. Interventionists with higher numbers (>10) of Wingspan cases submitted for credentialing tended to have higher rates of 30 day events (19.0% vs 9.9%) than those with <10 cases. High enrolling sites in the trial tended to have lower rates of hemorrhagic stroke (9.8% at sites enrolling <12 patients vs 2.7% at sites enrolling >12 patients). CONCLUSIONS: Interventionists credentialed with less Wingspan experience were not responsible for the high rate of periprocedural stroke in SAMMPRIS. Hemorrhagic stroke may be related to low enrollment in the trial but not previous Wingspan experience.


Asunto(s)
Angioplastia/métodos , Isquemia Encefálica/cirugía , Procedimientos Neuroquirúrgicos/métodos , Stents , Accidente Cerebrovascular/cirugía , Angioplastia/efectos adversos , Isquemia Encefálica/terapia , Hemorragia Cerebral/epidemiología , Hemorragia Cerebral/etiología , Infarto Cerebral/epidemiología , Infarto Cerebral/etiología , Competencia Clínica , Habilitación Profesional , Estudios de Seguimiento , Humanos , Análisis Multivariante , Neurocirugia , Procedimientos Neuroquirúrgicos/efectos adversos , Seguridad del Paciente , Complicaciones Posoperatorias/epidemiología , Estudios Prospectivos , Prevención Secundaria , Accidente Cerebrovascular/terapia , Resultado del Tratamiento
10.
J Neurointerv Surg ; 5(1): 15-9, 2013 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-22170820

RESUMEN

BACKGROUND: Due to anatomic features, including wide necks and incorporation of important branches, endovascular coiling of middle cerebral artery (MCA) aneurysms has proved challenging. Stent assisted embolization may increase the likelihood of successful treatment. METHODS: Consecutive patients undergoing stent assisted coil embolization utilizing the Neuroform stent from 2004 to 2009 were identified by hospital billing records. Procedural and clinical information-including procedure related mortality and morbidity and long term outcomes-were then obtained by retrospective chart review. RESULTS: Treatment was successful in 22/23 (96%) patients. Median age was 61 years and 16/22 (73%) were women. Aneurysm size was: <5 mm in 5/22 (23%); 5-9 mm in 14/22 (64%); and ≥10 mm in 3/22 (14%) patients. There were four periprocedural complications (including one stroke and one intraprocedural rupture), none associated with neurological dysfunction. Angiographic follow-up was available in 18/22 (82%) and clinical follow-up in 19/22 (86%) patients, both at a median of 1 year (mean 1.2 years) after coiling. Aneurysm occlusion was complete in 12/18 (67%), a neck remnant was present in 3/18 (17%) and persistent aneurysmal filling was present in 3/18 (17%) patients, requiring retreatment in 1/18 (6%) patient. In-stent stenosis of 50%, which was asymptomatic, occurred in 1/18 (6%) patient. No subarachnoid hemorrhages and no ischemic events related to the procedure were observed during follow-up. CONCLUSION: In this small series, the technical success rate was 96%, there were no transient or permanent neurological complications and complete aneurysmal occlusion was achieved in two-thirds of treated aneurysms on follow-up angiography. These results suggest that in appropriately selected patients, stent assisted coil embolization of MCA aneurysms can be performed with a high degree of safety and acceptable durability.


Asunto(s)
Embolización Terapéutica/métodos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Stents , Femenino , Humanos , Masculino , Persona de Mediana Edad , Radiografía , Estudios Retrospectivos
11.
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
12.
Stroke ; 43(10): 2682-8, 2012 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-22984008

RESUMEN

BACKGROUND AND PURPOSE: Enrollment in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial was halted due to the high risk of stroke or death within 30 days of enrollment in the percutaneous transluminal angioplasty and stenting arm relative to the medical arm. This analysis focuses on the patient and procedural factors that may have been associated with periprocedural cerebrovascular events in the trial. METHODS: Bivariate and multivariate analyses were performed to evaluate whether patient and procedural variables were associated with cerebral ischemic or hemorrhagic events occurring within 30 days of enrollment (termed periprocedural) in the percutaneous transluminal angioplasty and stenting arm. RESULTS: Of 224 patients randomized to percutaneous transluminal angioplasty and stenting, 213 underwent angioplasty alone (n=5) or with stenting (n=208). Of these, 13 had hemorrhagic strokes (7 parenchymal, 6 subarachnoid), 19 had ischemic stroke, and 2 had cerebral infarcts with temporary signs within the periprocedural period. Ischemic events were categorized as perforator occlusions (13), embolic (4), mixed perforator and embolic (2), and delayed stent occlusion (2). Multivariate analyses showed that higher percent stenosis, lower modified Rankin score, and clopidogrel load associated with an activated clotting time above the target range were associated (P ≤ 0.05) with hemorrhagic stroke. Nonsmoking, basilar artery stenosis, diabetes, and older age were associated (P ≤ 0.05) with ischemic events. CONCLUSIONS: Periprocedural strokes in SAMMPRIS had multiple causes with the most common being perforator occlusion. Although risk factors for periprocedural strokes could be identified, excluding patients with these features from undergoing percutaneous transluminal angioplasty and stenting to lower the procedural risk would limit percutaneous transluminal angioplasty and stenting to a small subset of patients. Moreover, given the small number of events, the present data should be used for hypothesis generation rather than to guide patient selection in clinical practice. Clinical Trial Registration Information- URL: http://clinicaltrials.gov. Unique Identifier: NCT00576693.


Asunto(s)
Angioplastia/efectos adversos , Constricción Patológica/cirugía , Periodo Perioperatorio , Stents/efectos adversos , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/prevención & control , Anciano , Angioplastia/instrumentación , Angioplastia/métodos , Constricción Patológica/complicaciones , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Análisis Multivariante , Recurrencia , Factores de Riesgo , Accidente Cerebrovascular/etiología , Factores de Tiempo , Resultado del Tratamiento
13.
Acta Neurochir (Wien) ; 154(10): 1855-9, 2012 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-22865057

RESUMEN

BACKGROUND: High-grade dural arteriovenous fistulas (DAVFs) with retrograde cortical leptomeningeal drainage are formidable lesions because of their risk for intracranial hemorrhage. Treatment is aimed at occluding venous outflow to achieve obliteration of the fistula. In DAVFs that involve a large dural venous sinus (transverse sigmoid sinus or superior sagittal sinus), occluding venous outflow can be accomplished endovascularly with transvenous embolization. However, in some cases of DAVFs with reflux into cortical leptomeningeal veins, there may be venous restrictive disease downstream, such as occlusive thrombosis, which can prohibit endovascular access via the transfemoral or transjugular routes. In these instances, a transcranial approach can be performed to expose the large dural venous sinus distal to the site of occlusion for direct catheterization of the venous outflow for transvenous embolization. This combined surgical and endovascular strategy provides direct access to the venous outflow and bypasses the site of thrombotic obstruction. METHODS: In this report, we describe our technique of single stage surgically-assisted transvenous embolization in three patients with high-grade DAVFs involving a large dural sinus. RESULTS: All patients achieved complete obliteration of their DAVFs without any venous related complications. CONCLUSION: Our technique of surgically-assisted direct transvenous embolization of high-grade DAVFs can be successfully performed as a single stage in the operating room with intraoperative angiography and stereotactic image guidance.


Asunto(s)
Malformaciones Vasculares del Sistema Nervioso Central/cirugía , Senos Craneales/cirugía , Embolización Terapéutica/métodos , Procedimientos Neuroquirúrgicos/métodos , Senos Transversos/cirugía , Anciano , Angiografía Cerebral , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
14.
J Neurointerv Surg ; 3(2): 151-5, 2011 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-21990808

RESUMEN

BACKGROUND: Randomized clinical trials supporting the use of intra-arterial administration of thrombolytics (IAT) for the treatment of stroke due to middle cerebral artery (MCA) occlusion have been positive on some, but not all, endpoints. A meta-analysis was performed to estimate with more precision the effect of IAT on several key clinical endpoints. METHODS: All randomized trials of IAT in the treatment of MCA stroke were identified by PUBMED search and by hand search of potentially relevant references. Trial methodologies were assessed for compatibility in study protocols and statistical analysis. A meta-analysis was performed evaluating the effect of IAT on functional outcome at 90 days and symptomatic intracranial hemorrhage (SICH) within 24 h. RESULTS: Three trials met the criteria for the meta-analysis. IAT treated patients were significantly more likely to have a modified Rankin scale (mRS) ≤ 1 (31% vs 20%, OR 2.0, 95% CI 1.2 to 3.4, p=0.01); mRS ≤ 2 (43% vs 31%, OR 1.9, 95% CI 1.2 to 3.0, p=0.01); and NIH Stroke Scale score 0 or 1 (23% vs 12%, OR 2.4, 95% CI 1.3 to 4.4, p=0.007) at the 90 day follow-up. There was no effect on mortality at 90 days (20% vs 19%, OR 0.84, 95% CI 0.5 to 1.5). The risk of SICH was significantly increased in the active treatment arms (11% vs 2%, OR 4.6, 95% CI 1.3 to 16, p=0.02). CONCLUSIONS: Our meta-analysis demonstrates that all standard functional endpoints for stroke trials were substantially improved in the active treatment arms. Despite an increased risk of SICH, there was no effect on mortality. These results support endovascular treatment of acute ischemic stroke due to MCA occlusion with intra-arterial thrombolytics.


Asunto(s)
Fibrinolíticos/uso terapéutico , Infarto de la Arteria Cerebral Media/tratamiento farmacológico , Terapia Trombolítica , Fibrinolíticos/administración & dosificación , Humanos , Infusiones Intraarteriales , Ensayos Clínicos Controlados Aleatorios como Asunto , Terapia Trombolítica/métodos
15.
N Engl J Med ; 365(11): 993-1003, 2011 Sep 15.
Artículo en Inglés | MEDLINE | ID: mdl-21899409

RESUMEN

BACKGROUND: Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke. However, PTAS has not been compared with medical management in a randomized trial. METHODS: We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days. RESULTS: Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non-stroke-related death, 0.4%) (P=0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of follow-up, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P=0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group. CONCLUSIONS: In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected. (Funded by the National Institute of Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov number, NCT00576693.).


Asunto(s)
Arteriosclerosis Intracraneal/terapia , Ataque Isquémico Transitorio/terapia , Stents , Accidente Cerebrovascular/prevención & control , Anciano , Antihipertensivos/uso terapéutico , Aspirina/uso terapéutico , Clopidogrel , Terapia Combinada , Femenino , Estudios de Seguimiento , Conductas Relacionadas con la Salud , Humanos , Arteriosclerosis Intracraneal/tratamiento farmacológico , Hemorragias Intracraneales/epidemiología , Hemorragias Intracraneales/etiología , Ataque Isquémico Transitorio/tratamiento farmacológico , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/uso terapéutico , Stents/efectos adversos , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/terapia , Ticlopidina/análogos & derivados , Ticlopidina/uso terapéutico
16.
Neurosurgery ; 69(1): 27-37; discussion 37, 2011 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-21311379

RESUMEN

BACKGROUND: Anterior communicating artery (A-comm) aneurysm is one of the most common intracranial aneurysms. Treatments include neurosurgical clipping or endovascular embolization. OBJECTIVE: To retrospectively examine the long-term results of Neuroform stent-assisted coil embolization of incidental A-comms, with a focus on stent-associated stenosis, long-term angiographic aneurysm occlusion outcome, delayed stent-related thromboembolus, subsequent subarachnoid hemorrhage from the treated aneurysm, and procedural complications. METHODS: Between January 7, 2003 and June 16, 2009, 44 Neuroform stents were placed as an adjunct to embolization of A-comms. Patient charts were reviewed retrospectively. Angiographic follow-up of at least 3 months (up to 6.5 years, mean 65 weeks) was available for 33 patients. Aneurysm occlusion success was determined using the Raymond classification for aneurysm remnants. RESULTS: Referencing the last angiogram in the follow-up course, complete occlusion, dog-ear residual, residual neck, and residual aneurysm were found in 24, 2, 3, and 4 patients, respectively. Stenosis (45% and asymptomatic) of the artery where the stent had been placed was found in 1 patient. One patient had delayed transient ischemic attack after dual antiplatelet therapy was stopped prematurely. Retreatment based on the presence of residual aneurysm was performed or recommended in 2 patients. In 2 patients with residual or recurrent aneurysm filling, their age or clinical condition did not warrant retreatment. CONCLUSION: Neuroform stent-assisted embolization provides long-term control of A-comms with a low incidence of aneurysm growth after treatment. The need for retreatment is uncommon, and retreatment is safe if performed. Subsequent bleeding from treated aneurysms was not observed in this study.


Asunto(s)
Embolización Terapéutica/instrumentación , Embolización Terapéutica/métodos , Aneurisma Intracraneal/terapia , Stents , Adulto , Anciano , Anciano de 80 o más Años , Angiografía Cerebral , Femenino , Lateralidad Funcional/fisiología , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Retratamiento , Estudios Retrospectivos , Resultado del Tratamiento
17.
Curr Cardiol Rep ; 12(1): 20-8, 2010 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-20425180

RESUMEN

Intracranial stenosis accounts for 8-10% of all ischemic strokes in North America, a frequency slightly less than that of extracranial carotid stenosis. Among patients presenting with transient ischemic attack or stroke due to intracranial stenosis, the risk of recurrent stroke in the first year after initial symptoms is about 14%. Those with high-risk features (recent stroke and severe stenosis) have up to a 23% rate of recurrent stroke in the year after their initial event. Angioplasty with stenting has emerged as a potential treatment strategy, particularly in high-risk patients, although evidence is currently limited to uncontrolled prospective trials and retrospective case series. In this article, we critically review the clinical results supporting the use of stenting and highlight some key considerations in the application of this technology, including patient selection, procedural management, technical issues, and risk factors for complications and in-stent restenosis.


Asunto(s)
Arterias Carótidas/patología , Estenosis Carotídea/prevención & control , Stents Liberadores de Fármacos , Arteriosclerosis Intracraneal/prevención & control , Angioplastia de Balón , Arterias Carótidas/cirugía , Estenosis Carotídea/patología , Estenosis Carotídea/cirugía , Humanos , Arteriosclerosis Intracraneal/patología , Arteriosclerosis Intracraneal/cirugía , Inhibidores de Agregación Plaquetaria/uso terapéutico , Medición de Riesgo , Prevención Secundaria
20.
J Neurosurg ; 110(5): 913-20, 2009 May.
Artículo en Inglés | MEDLINE | ID: mdl-19199500

RESUMEN

OBJECT: Surgical intervention may be required if endovascular embolization is insufficient to completely obliterate intracranial dural arteriovenous fistulas (DAVFs). The authors report their 14-year experience with 23 patients harboring diverse intracranial DAVFs that required surgical intervention. METHODS: Between 1993 and 2007, 23 patients underwent surgery for intracranial DAVFs. The following types of DAVFs were treated: superior petrosal sinus (in 10 patients); parietooccipital (in 3); confluence of sinuses and ethmoidal (in 2 each); and tentorial, falcine, occipital, transverse-sigmoid, superior sagittal, and cavernous sinuses (in 1 patient each). In all cases, the authors' goal was to obliterate the DAVF venous outflow by direct surgical interruption of the leptomeningeal venous drainage. Transarterial embolization was used primarily as an adjunct to decrease flow to the DAVF prior to definitive treatment. RESULTS: Complete angiographic obliteration of the DAVF was achieved in all cases. There were no complications of venous hypertension, venous infarction, or perioperative death. There were no recurrences and no further clinical events (new hemorrhages or focal neurological deficits) after a mean follow-up of 45 months. CONCLUSIONS: The authors' experience emphasizes the importance of occluding venous outflow to obliterate intracranial DAVFs. Those that drain purely through leptomeningeal veins can be safely obliterated by surgically clipping the arterialized draining vein as it exits the dura. Radical excision of the fistula is not necessary.


Asunto(s)
Venas Cerebrales/cirugía , Duramadre/irrigación sanguínea , Malformaciones Arteriovenosas Intracraneales/cirugía , Adulto , Anciano , Malformaciones Vasculares del Sistema Nervioso Central/diagnóstico por imagen , Angiografía Cerebral , Embolización Terapéutica , Femenino , Humanos , Malformaciones Arteriovenosas Intracraneales/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Procedimientos Neuroquirúrgicos/métodos
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