Efficacy and safety of the dual-layer flow-diverting stent (FRED) for the treatment of intracranial aneurysms.

PURPOSE: To describe the efficacy and complications of treating cerebral aneurysms with the Flow Re-direction Endoluminal Device (FRED) and to identify predictors for aneurysm occlusion. METHODS: A prospective observational registry including all consecutive aneurysms treated with FRED between December 2015 and July 2018 was designed in one therapeutic neuroangiography department. The primary endpoint for treatment efficacy was complete or near-complete occlusion (O'Kelly-Marotta (OKM) C-D), assessed by three-dimensional digital subtraction angiography. Major (all symptomatics) and minor complications were described and those with modified Rankin Scale scores 3-6 were considered clinically relevant. Univariate and multivariate analyses were performed to identify predictors of efficacy. RESULTS: A total of 185 aneurysms were analyzed in 150 patients (mean age 54.3±11.5 years). Mean follow-up was 18.99±11.32 months (range 0-43). Efficacy was evaluated in 156 (84.32%) cases: 132 (84.6%) had OKM C-D occlusion, 31/47 (66%) within the first year and 101/109 (92.7%) later on. Major complications were observed in 12 (6.5%) cases: three strokes (one transient ischemic accident, two minor strokes), six intra-stent thrombosis, and three with bleeding, but only one (0.5%) was clinically relevant. Minor complications (all asymptomatic) were observed in 10 (5.4%) cases: three shortening/repositioning of stent; two arterial dissection, two arterial occlusion, and three intra-stent stenosis. Independent predictors of occlusion were immediate OKM grade B-C-D (OR 4.01, 95% CI 1.51 to 10.62), single aneurysm (OR 3.29, 95% CI 1.05 to 10.32), and small size aneurysm (OR 4.74, 95% CI 1.57 to 14.30). CONCLUSION: The FRED stent fully complied with efficacy and safety requirements for treatment of intracranial aneurysms. Three predictors of aneurysm occlusion were identified.

Predictors of neurological deficit after endovascular treatment of cerebral arteriovenous malformations and functional repercussions in prospective follow-up.

Endovascular therapy is a well-established approach to the treatment of cerebral arteriovenous malformations (AVMs). The objective of this study was to determine the predictive factors of neurological deficit following endovascular procedures. Seventy-one patients with cerebral AVMs who underwent 147 embolization sessions from 2006 to 2011 were followed up prospectively (average 31.1 ± 17.5 months). Functional neurological condition was documented by means of the modified Rankin scale. Factors found to be predictors of neurological deficit were the partial obstruction of drainage veins (OR = 197.6; IC = 2.76 -1416.0; P = 0.015), a positive result in the Propofol test (OR = 50.2; IC = 6.18 - 566.5; P = 0.000), AVM diameter under 3 cm (OR = 21.3; IC: 1.71 - 265.6; P = 0.018), the presence of intranidal aneurysms (OR = 11.2; IC = 1.09 - 114.2; P = 0.042), the absence of post-procedure hypotension (OR = 10.2; IC = 1.35 - 77.7; P = 0.003), deep venous drainage (OR = 7.14; IC = 1.15 - 44.4; P = 0.035), and devascularization in excess of 40% per session (OR = 3.3; IC = 1.11 - 16.8; P = 0.056). Fifty-six patients (78.9%) did not experience changes in their neurological condition after the treatment and 13 patients (18.3%) showed a new neurological deficit related to the treatment; 95.8 % of the patients did not show significant long-term incapacity. Partial obstruction of drainage veins, small AVMs, intranidal aneurysms, faulty hemodynamic control and extensive devascularization were found to be predictors of neurological deficit. A significant number of patients with neurological deficit improved in the long term.

Predictors of total obliteration in endovascular treatment of cerebral arteriovenous malformations.

Endovascular therapy is a therapeutic option that can achieve total obliteration of cerebral arteriovenous malformations (AVMs). The objective of this study was to determine the predictive factors of total obliteration in the endovascular treatment of AVMs. A prospective study was carried out in 71 patients with cerebral AVMs having undergone 147 embolization sessions with n-BCA, performed between 2006 and 2011. A univariate analysis was carried out, followed by a logistic regression analysis to determine the predictive factors of total obliteration. Total obliteration was achieved in 18.3% of the patients and angiographic control after 12 months showed the permanency of total occlusion in 100% of the AVMs with initial total obliteration. Angiographic characteristics found favorable for total eradication were: AVM size under 3 cm and the presence of a single arterial pedicle. Predictive factors of total obliteration were an AVM diameter smaller than 3 cm (OR: 50.9; IC: 7.41 - 349, 0; P = 0.000), and opposing factors, a 3-6 cm diameter (OR: 11.7; IC: 2.49 - 55, 4; P = 0.002) and afferences of more than two vessels of the Willis polygon (OR: 7.0; IC: 1.12-43.9; P = 0.038). An AVM diameter smaller than 3 cm is a predictive factor of total obliteration. Total postembolization obliteration persisted in 100% of the cases after 12 months.

Predictors of hemorrhagic complications from endovascular treatment of cerebral arteriovenous malformations.

Post-embolization hemorrhage is the most severe, dramatic and morbidity-mortality-related complication in the treatment of endovascular arteriovenous malformations (AVMs). The objective of this study was to determine predictive factors of post-embolization hemorrhage. This is a retrospective study in 71 patients with cerebral AVMs having undergone 147 embolization sessions with n-butyl cyanoacrylate (n-BCA), carried out between 2006 and 2011. Clinical-demographic, morphological and treatment data as well as results were recorded. The relationship of post-procedure hemorrhage with demographic and morphological factors, percentage devascularization per session, venous drainage and whether or not post-procedure hypotension had been induced was investigated. Six post-embolization hemorrhages occurred, all in sessions characterized by extensive devascularization without the induction of post-procedure hypotension; which disappeared after a limit to the extent of devascularization per session and post-procedure hypotension were introduced. In the multivariate analysis, hemorrhage predictors were: nidus diameter < 3 cm (OR= 45.02; CI=95%:1.17-203.79; P=0.005); devascularization > 40% (OR=32.4; CI=95%: 3.142- 518.6; P=0.009) per session; intranidal aneurysms (OR=7.5; CI=95%:1.19-341.3; P=0.041) and lack of post-procedure hypotension (OR=16.51; CI=95%:1.81-324.4; P=0.049) and the association of sessions with devascularization exceeding 40% with lack of post-procedure hypotension, showed an increase in the risk of hemorrhage (OR=36.4; CI=95%:3.67-362.4; P=0.002). Extensive devascularization and the absence of post-procedure hypotension increase the risk of hemorrhage. We suggest partial, 25-30%, devascularization per session and the induction of post-procedure hypotension, which produces a 20% decrease of the basal mean arterial pressure (MAP).

Dementia and other chronic diseases in older adults in Havana and Matanzas: the 10/66 study in Cuba.

INTRODUCTION: Chronic non-communicable diseases are the leading cause of death worldwide, except in Sub-Saharan Africa. Nonetheless, one of these conditions, dementia, is the major contributor to disability-adjusted life years in people aged ≥60 years. Few epidemiological studies exist of the prevalence and impact of dementia and selected chronic diseases in older adults in Latin America. OBJECTIVE: Describe prevalence of dementia, other chronic vascular diseases and cardiovascular risk factors, as well as resulting disabilities and care needs generated in adults aged ≥65 years in Havana City and Matanzas provinces, Cuba. METHODS: The 10/66 study is a prospective longitudinal study involving a cohort of 3015 adults aged ≥65 years in municipalities of Havana City and Matanzas provinces, divided into two phases: a cross-sectional door-to-door study conducted in 2003-2006, and a follow-up and assessment phase in 2007-2010. This article reports findings from the first phase. Hypertension diagnosis was based on criteria from the International Society for Hypertension; diabetes mellitus on American Diabetes Association criteria; stroke according to WHO definitions; and dementia according to criteria of the American Psychiatric Society's Diagnostic and Statistical Manual of Mental Disorders DSM-IV and the 10/66 International Dementia Research Group. Ischemic heart disease was defined by self-report of previous physician diagnosis. Study variables included age, sex, educational level, substance use (alcohol, tobacco) and dietary habits. A structured physical and neurological exam, including blood pressure measurement, was performed on all participants. Laboratory tests included complete blood count, fasting blood glucose, total cholesterol and lipoprotein fractions, triglycerides and apolipoprotein E genotype. Prevalence and standardized morbidity ratios (crude and adjusted) were calculated for chronic diseases studied with 95% confidence intervals, using a Poisson regression model and indirect standardization. RESULTS: The study assessed 2944 older adults (response rate 97.6%) and found high prevalence of vascular risk factors and of chronic non-communicable diseases: hypertension 73.0% (95% CI 71.4-74.7), diabetes mellitus 24.8% (95% CI 22.9-26.5), ischemic heart disease 14.1% (95% CI 12.9-15.4), dementia 10.8% (95% CI 9.7-12.0) and stroke 7.8% (95% CI 6.9-8.8). The majority of participants (85%) had more than one cardiovascular risk factor. The main cause of disability and dependency in the study population was dementia. CONCLUSION: The high prevalence of chronic diseases observed in the elderly--with the consequent morbidity, disability and dependency--highlights the need for prevention, early diagnosis and risk factor control, particularly given the demographic and epidemiologic transition faced by Cuba and other developing countries.

Prevalence of stroke and associated risk factors in older adults in Havana City and Matanzas Provinces, Cuba (10/66 population-based study).

INTRODUCTION: Cerebrovascular disease (CVD) is the third cause of death and second cause of disability and dementia in adults aged>or=65 years worldwide. The few epidemiological studies of stroke in Latin America generally report lower prevalence and different patterns than developed countries. OBJECTIVE: Estimate the prevalence of stroke and associated risk factors in adults aged>or=65 years in Havana City and Matanzas provinces, Cuba. METHODS: Single phase, cross-sectional, door-to-door study of 3015 adults aged>or=65 years in selected municipalities of Havana City and Matanzas provinces. Variables studied were age, sex, educational level, and self-report and description of chronic disease (stroke, heart attack, angina, and diabetes mellitus), substance use (alcohol, tobacco), and dietary habits. Respondents were given a structured physical and neurological exam, and blood pressure was measured. Laboratory tests comprised complete blood count, fasting glucose, total cholesterol and fractions, triglycerides, and apolipoprotein E (APOE) genotype. Diagnosis of stroke was based on the World Health Organization's definition. Stroke prevalence ratios (crude and adjusted), with 95% confidence intervals (CI), were calculated for the variables studied using a Poisson regression model. Risk association was analyzed using multiple logistic regression for dichotomous responses. RESULTS: Assessments were made of 2944 older adults (97.6% response rate). Prevalence of stroke was 7.8% (95% CI 6.9-8.8), and was higher in men. The risk profile for this population group included history of hypertension (OR 2.8; 95% CI 2.0-4.0), low HDL cholesterol (OR 2.6; 95% CI 1.7-3.9), male sex (OR 1.7; 95% CI 1.2-2.5), anemia (OR 1.6; 95% CI 1.1-2.5), history of ischemic heart disease (OR 1.5; 95% CI 1.0-2.3), carrier of one or two apolipoprotein E4 genotype (APOE E4) alleles (OR 1.4; 95% CI 1.0-2.0), and advanced age (OR 1.3; 95% CI 1.1-1.9). CONCLUSIONS: Stroke prevalence in this study is similar to that reported for Europe and North America, and higher than that observed in other Latin American countries. The risk profile identified includes classic risk factors plus anemia and APOE E genotype.