Treatment Outcomes of Endovascular Embolization Only in Patients with Unruptured Brain Arteriovenous Malformations: A Subgroup Analysis of ARUBA (A Randomized Trial of Unruptured Brain Arteriovenous Malformations).

BACKGROUND AND PURPOSE: Endovascular embolization only has been advocated for treatment of brain arteriovenous malformations in recent trials. Our aim was to evaluate the results of embolization only in a cohort of patients who were enrolled in the A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA) study at 39 clinical sites in 9 countries. MATERIALS AND METHODS: We analyzed the rates and severity of stroke and death in patients who underwent embolization only. Events were identified through in-person neurologic follow-up visits performed at 6-month intervals during the first 2 years and annually, with telephone contact every 6 months thereafter. All event-related data were reviewed by independent adjudicators. RESULTS: Among 30 patients who had embolization planned, 26 underwent embolization only. A total of 13 stroke events were reported in the follow-up period among 26 subjects (ischemic, hemorrhagic, or both in 4, 7, and 2 subjects, respectively). The adverse event occurred after the first embolization in 11 of 13 patients. One patient had a major motor deficit, and 2 patients developed major visual field deficits. One event was fatal. The modified Rankin Scale score was 0-2 at last follow-up in 11 of the 12 stroke survivors. Estimated stroke-free survival was 46% at 12 months. CONCLUSIONS: Although the rates of stroke and/or death were high in patients treated with embolization only in ARUBA, the rates of favorable outcomes following stroke were high during follow-up.

Racial disparity in estrogen receptor positive breast cancer patients receiving trimodality therapy.

INTRODUCTION: We assessed racial differences in progression-free survival (PFS) and overall survival (OS) in relation to subtype in uniformly treated stage II-III breast cancer patients. METHODS: We reviewed records of 582 patients receiving post-mastectomy radiation (PMRT) between 1/1999 and 12/2009 and evaluated the effect of demographic, tumor, and treatment characteristics on PFS and OS. RESULTS: Median follow up was 44.7 months. 24% of patients were black and 76% white. All had mastectomy and PMRT; 98% had chemotherapy; Estrogen receptor (ER)+ patients received endocrine therapy. Black patients were more likely to have ER- (56% vs. 38%, p=0.0001), progesterone receptor (PR)- (69% vs. 54%, p = 0.002), and triple negative (TN) (46% vs. 24%, p < 0.0001) tumors. Overall, black patients had worse PFS (60.6% vs. 78.3%, p = 0.001) and OS (72.8% vs. 87.7%, p < 0.0001). There was no racial difference in PFS (p = 0.229 and 0.273 respectively) or OS (p = 0.113 and 0.097 respectively) among ER- or TN. Among ER+, black patients had worse PFS (55% vs. 81%, p < 0.001) and OS (73% vs. 91%, p < 0.0001). The difference in PFS was seen in the ER+/PR+/HER2- subgroup (p = 0.002) but not ER+/PR-/HER2- (p = 0.129), and in the post-menopausal ER+/HER2- subgroup (p = 0.004) but not pre/peri-menopausal ER+/HER2- (p = 0.150). CONCLUSIONS: Black women had worse survival outcomes in this cohort. This disparity was driven by (1) a higher proportion of ER- and TN tumors in black women and (2) worse outcome of similarly treated black women with ER+ breast cancer. The underlying causes of racial disparity within hormone receptor categories must be further examined.

Risk of locoregional recurrence by receptor status in breast cancer patients receiving modern systemic therapy and post-mastectomy radiation.

We assessed differences in locoregional outcome based on receptor status combinations in a cohort of stage II-III breast cancer patients treated with modern trimodality therapy. Medical records of 582 consecutively treated patients receiving post-mastectomy radiation (PMRT) between 1/1999 and 12/2009 were reviewed. Rate of local regional recurrence (LRR) was estimated by the method of cumulative incidence allowing for competing risks. The effect of prognostic factors was examined by Gray's test and by Fine and Gray's modeling approach. Median follow-up was 44.7 months. Five-year progression-free survival (PFS) was 73.9% and overall survival (OS) was 84%. The cumulative 5-year incidence of LRR as first site of failure was 6.2% (95% CI 4.2-8.7). Five-year cumulative incidence of LRR was 8.6 versus 4.4% for estrogen receptor (ER) negative versus ER positive (P = 0.017), 8.5 versus 3.4% for progesterone receptor (PR) negative versus PR positive (P = 0.011), and 1.7 versus 7.5% for HER2 positive (86% received trastuzamab) versus HER2 negative (P = 0.032). Five-year cumulative incidence of LRR was 11.8% for the triple negative subtype and 3.9% for other receptor combinations (P < 0.001). Among patients whose disease is ER positive, 5-year LRR rate was 7.8 versus 3.4% for PR negative versus PR positive (P = 0.130). The prognostic value of the triple negative and HER2 negative subtypes was maintained on multivariate analysis. In the era of HER-2 targeted therapy, tumors that are HER-2 over expressing and are treated with trastuzumab have a very low rate of LRR. ER negative, PR negative, and triple negative status are associated with increased risk of LRR.

Efficacy of rapid IV administration of valproic acid for status epilepticus.

Although not approved by the US Food and Drug Administration for the treatment of status epilepticus (SE), valproic acid (VPA) is an emerging option for this purpose. The authors reviewed 63 patients (30 men) with SE treated with IV VPA (average dose, 31.5 mg/kg). Analysis of demographic, clinical, and treatment information indicated an overall efficacy of 63.3% and favorable tolerance of rapid administration.

Assessment: transcranial Doppler ultrasonography: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology.

OBJECTIVE: To review the use of transcranial Doppler ultrasonography (TCD) and transcranial color-coded sonography (TCCS) for diagnosis. METHODS: The authors searched the literature for evidence of 1) if TCD provides useful information in specific clinical settings; 2) if using this information improves clinical decision making, as reflected by improved patient outcomes; and 3) if TCD is preferable to other diagnostic tests in these clinical situations. RESULTS: TCD is of established value in the screening of children aged 2 to 16 years with sickle cell disease for stroke risk (Type A, Class I) and the detection and monitoring of angiographic vasospasm after spontaneous subarachnoid hemorrhage (Type A, Class I to II). TCD and TCCS provide important information and may have value for detection of intracranial steno-occlusive disease (Type B, Class II to III), vasomotor reactivity testing (Type B, Class II to III), detection of cerebral circulatory arrest/brain death (Type A, Class II), monitoring carotid endarterectomy (Type B, Class II to III), monitoring cerebral thrombolysis (Type B, Class II to III), and monitoring coronary artery bypass graft operations (Type B to C, Class II to III). Contrast-enhanced TCD/TCCS can also provide useful information in right-to-left cardiac/extracardiac shunts (Type A, Class II), intracranial occlusive disease (Type B, Class II to IV), and hemorrhagic cerebrovascular disease (Type B, Class II to IV), although other techniques may be preferable in these settings.

Microbiological study of external otitis in Rosario City, Argentina.

Mycological and/or bacteriological studies were performed on 294 samples isolated from the external auditory control (EAC). It was observed that 185 (81.5%) of the mycological analysis were negative while 42 (18.5%) were positive with the following distribution: 22 Candida (9.7%), 15 Aspergillus (6.5%) and five associations of Aspergillus and Candida (2.2%). The bacteriological studies were negative in 52 cases (23.6%) and the frequency of the bacterial agents (75.5%) isolated were as follows: 41 Pseudomonas aeruginosa (18.6%), 24 Proteus mirabilis (10.9%), 24 Staphylococcus aureus (10.9%), and three associations of Ps. aeruginosa and Pr. mirabilis (1.4%). Pseudomonas aeruginosa, which was the most frequent bacterial species isolated, did not present associations with any fungus.

Transesophageal echocardiography in patients with ischemic stroke accurately detects significant coronary artery stenosis and often changes management.

OBJECTIVES: TEE is performed in many patients with ischemic stroke, and it is possible to examine the proximal coronaries by TEE in these patients. Our purpose was to (1) determine the accuracy of transesophageal echocardiography (TEE) in the diagnosis of proximal coronary stenosis in patients with ischemic stroke and (2) show that TEE detection of proximal coronary stenosis changed management in a substantial number of patients. METHODS: Thirty-two patients with ischemic stroke undergoing TEE, in whom the proximal coronaries were examined and who had angiographic results available, were studied. RESULTS: Proximal coronaries were visualized as follows: left main (LM) in 31 (97%), left anterior descending (LAD) in 32 (100%), left circumflex (LCx) in 30 (94%) and right coronary artery (RCA) in 21 (66%). The sensitivity and specificity of TEE in diagnosing significant coronary stenosis in visualized vessels were as follows: LM 100% and 100%, LAD 100% and 95%, LCx 100% and 96%, and RCA 100% and 100%, respectively. When visualized and nonvisualized segments were considered, TEE detected significant stenosis as follows: 4 of 5 in the LM (80%), 13 of 13 in the LAD (100%), 2 of 3 in the LCx (66%), and 2 of 8 in the RCA (25%). Of the 32 patients, TEE results changed management in 17 patients (53%). Angiographic findings resulted in 10 of the 17 patients (59%) undergoing revascularization. CONCLUSIONS: TEE was very accurate in diagnosing significant coexisting coronary artery disease in patients with ischemic stroke. TEE diagnosis of these lesions prompted coronary angiography and subsequent revascularization in a substantial number of patients.

Controversies about tissue plasminogen activator: extending the window of therapy.

The management of stroke has undergone significant development over the past 15 years. Perhaps the single most important landmark has been the approval by the Food and Drug Administration of intravenous (IV) tissue plasminogen activator (t-PA) for the treatment of ischemic stroke. However, the approval of this drug has not met with unanimous support by the medical community and, at present, only a minority of stroke patients receive t-PA. Although this is partly due to the fact that many patients do not meet criteria for treatment with IV t-PA, others simply do not arrive at medical facilities sufficiently early to be safely managed using thrombolysis. The appropriate use of IV t-PA in the treatment of ischemic stroke requires proper selection of patients and strict adherence to clinical protocols of treatment. The ideal stroke patient for treatment with IV t-PA is one who suffers occlusion of a small artery that leads to a disabling deficit.

Carotid angioplasty and stenting: new horizons.

Advances in technology have made it possible for lesions that affect the carotid artery, both extra-and intracranially, to be treated by endovascular means. Depending upon the type and location of the pathology, as well as the existing comorbidities in any given patient, angioplasty and stenting may be considered an alternative to traditional methods of revascularization. In fact, in some instances, endovascular therapy may be the procedure of choice. For patients whose lesions can be treated either surgically or endovascularly, future randomized trials will help define the role of each type of procedure.

Carotid stent placement for extracranial carotid artery disease: current state of the art.

Percutaneous revascularization techniques have dramatically altered traditional approaches to the management of both coronary and peripheral vascular disease. Their major advantage is that they are less invasive than conventional surgical procedures, offering revascularization without the risk of general anesthesia and with lesser procedural morbidity and mortality, shorter hospital stay, and lower cost. In patients with comorbidities that increase their risk of surgical complications, percutaneous revascularization techniques are the procedures of choice. The Achilles heel of balloon angioplasty, the higher risk of lesion recurrence, restenosis, has been markedly reduced with the use of endovascular stents. Over the past 20 years, percutaneous angioplasty and stenting have become accepted alternatives to surgical revascularization of aortoiliac, renal, femoropopliteal, subclavian, brachiocephalic, and dialysis access lesions. The most recent application of percutaneous intervention has been to explore its clinical utility and safety for stroke prevention in stenotic extracranial carotid arteries. Cathet. Cardiovasc. Intervent. 51:339-346, 2000.

Safety, efficacy, and durability of carotid artery stenting for restenosis following carotid endarterectomy: a multicenter study.

PURPOSE: To present the results of a multicenter registry established to collect data on carotid stent procedures in patients with restenosis following carotid endarterectomy. METHODS: The procedural details, outcomes, and late follow-up results were collected from 14 centers in the United States. Thirty-day and late stroke and death rates were analyzed. RESULTS: Three hundred and thirty-eight patients (201 men; 71 +/- 8 years) underwent carotid stenting in 358 arteries. The average duration from carotid endarterectomy was 5.5 +/- 7.3 years. Sixty-one percent of the patients were asymptomatic. The overall 30-day stroke and death rate was 3.7%. The minor stroke rate was 1.7% (6/358), and the major nonfatal stroke rate was 0.8% (3/358). The fatal stroke rate was 0.3% (1/358), and the nonstroke-related death rate was 0.9% (3/338). There was 1 (0.3%) fatal and 1 (0.3%) nonfatal stroke during the follow-up period. The overall 3-year rate of freedom from all fatal and nonfatal strokes was 96% +/- 1% (+/- SE). CONCLUSIONS: Carotid artery stenting can be performed in patients with restenosis following carotid endarterectomy with 30-day complication rates comparable to those of most published studies on repeat carotid endarterectomy. Results of late follow-up suggest that this technique is durable and efficacious.

Emergency endovascular treatment of cerebral sinus thrombosis with a rheolytic catheter device.

Severe thrombosis of the superior sagittal, transverse, and straight sinuses developed in a 53-year-old woman. This resulted in extensive multifocal hemorrhagic venous infarction and severe intracranial hypertension refractory to intensive management. Endovascular therapy using a rheolytic catheter device in combination with a small amount of fibrinolytic agent led to rapid normalization of the intracranial pressure, allowing optimization of the cerebral perfusion pressures and was followed by steady, albeit protracted, clinical improvement. The patient not only survived but also left the hospital with minimal neurologic deficit. The rheolytic catheter endovascular treatment is, in the opinion of the authors, the treatment of choice for patients with life-threatening cerebral sinus thrombosis.

Global experience in cervical carotid artery stent placement.

The purpose of this article is to review and update the current status of carotid artery stent placement in the world. Surveys to major interventional centers in Europe, North and South America, and Asia were initially completed in June 1997. Subsequent information from these 24 centers in addition to 12 new centers has been obtained to update the information. The survey asked the various questions regarding the patients enrolled, procedure techniques, and results of carotid stenting, including complications and restenosis. The total number of endovascular carotid stent procedures that have been performed worldwide to date included 5,210 procedures involving 4,757 patients. There was a technical success of 98.4% with 5,129 carotid arteries treated. Complications that occurred during the carotid stent placement or within a 30-day period following placement were recorded. Overall, there were 134 transient ischemic attacks (TIAs) for a rate of 2.82%. Based on the total patient population, there were 129 minor strokes with a rate of occurrence of 2.72%. The total number of major strokes was 71 for a rate of 1.49%. There were 41 deaths within a 30-day postprocedure period resulting in a mortality rate of 0.86%. The combined minor and major strokes and procedure-related death rate was 5.07%. Restenosis rates of carotid stenting have been 1.99% and 3.46% at 6 and 12 months, respectively. The rate of neurologic events after stent placement has been 1.42% at 6-12-month follow-up. Endovascular stent treatment of carotid artery atherosclerotic disease is growing as an alternative for vascular surgery, especially for patients that are high risk for standard carotid endarterectomy. The periprocedure risks for major and minor strokes and death are generally acceptable at this early stage of development and have not changed significantly since the first survey results. Cathet. Cardiovasc. Intervent. 50:160-167, 2000.

Elective stenting of symptomatic middle cerebral artery stenosis.

Percutaneous balloon angioplasty has been found to be useful for the treatment of intracranial atherosclerotic arterial stenosis. Nonetheless, an ongoing risk of this procedure is arterial dissection, which increases the hazards of acute closure, stroke, and restenosis. Stenting of the intracranial vasculature recently has been shown to be feasible in a variety of circumstances. To our knowledge, however, stenting of the middle cerebral artery has not been possible until now primarily because of difficulty with tracking stents across the carotid siphon. We describe the successful treatment of a symptomatic middle cerebral artery stenosis achieved using a balloon-expandable flexible coronary stent.

Transcranial Doppler ultrasonography: year 2000 update.

In this update, the main clinical applications of transcranial Doppler ultrasonography are reassessed. A specific format for technology assessment, personal experience, and an extensive review of the literature form the basis of the evaluation. The document is approved by the American Society of Neuroimaging and the Neurosonology Research Group of the World Federation of Neurology.

Carotid stenting for severe radiation-induced extracranial carotid artery occlusive disease.

PURPOSE: To present our experience with carotid artery stenting as an alternative treatment to endarterectomy in patients with radiation-induced carotid artery occlusive disease. METHODS AND RESULTS: Fourteen patients (10 males; mean age 61 years, range 52 to 79) underwent percutaneous stenting of 15 carotid arteries for severe radiation-induced extracranial stenoses. Technical success was achieved in all patients, with reduction of the mean stenosis from 77% +/- 6% to 8% +/- 2%. In 2 patients, ipsilateral vertebral artery lesions were stented concomitantly. One patient had a minor stroke after the procedure but recovered fully in 2 days. No other complications were encountered. Nine (64%) patients had 6-month follow-up imaging (angiography or duplex scanning) that showed no evidence of restenoses (obstruction > or = 50%). At 18 +/- 2 months, 3 (21%) patients had died from unrelated causes. No neurological events occurred, and no repeat carotid artery interventions were required in the remaining patients. CONCLUSIONS: Carotid stenting is an effective treatment option for severe radiation-induced carotid artery occlusive disease.

Elective stenting of symptomatic basilar artery stenosis.

BACKGROUND AND PURPOSE: Percutaneous angioplasty of the intracranial arteries still carries the risk of dissection, with acute closure and embolization. Stenting has been shown to improve the safety and durability of angioplasty in every circulatory bed in which it has been applied. However, stenting of the intracranial arteries has been limited by the availability of stents that can be reliably deployed intracranially. METHODS: Twelve patients underwent elective stenting of the basilar artery after episodes of vertebrobasilar ischemia. In all patients, either medical therapy had failed or the patient had a contraindication for long-term anticoagulation. Information from independent neurological examinations, quantitative angiography, and clinical follow-up was collected. Differences between pretreatment and posttreatment degree of stenoses were subjected to 1-way ANOVA for repeated measures. RESULTS: There were 10 men and 2 women, all white, aged 40 to 82 years (mean age, 62.6 years). Stent placement was successful in all patients, leading to statistically significant changes in the degree of stenosis, from 71. 4% (range, 53% to 90%) to 10.3% (range, 0% to 36%) (P<0.0001). There were no deaths, stent thromboses, perforations, ruptures, or myocardial infarctions. Clinical follow-up was available for 0.5 to 16 months (mean, 5.9 months). One patient had nonspecific symptoms, and another had a transient ischemic attack. All other patients remained asymptomatic. CONCLUSIONS: Elective stenting of the basilar artery is feasible, with minimal risk to the patient. Its impact on long-term stroke prevention and its durability are unknown and will require further study.