A Prospective Multicenter Trial of the TransForm Occlusion Balloon Catheter: Trial Design and Results.

BACKGROUND AND PURPOSE: Adjunctive treatments like balloon-assisted coil embolization (BACE) and stent-assisted coil embolization play a major role in the treatment of wide-neck and large intracranial aneurysms. The TransForm™ Occlusion Balloon Catheter (TOBC) registry is intended to evaluate the safety, efficacy, and efficiency of BACE using the TOBC. METHOD AND STUDY DESIGN: The TOBC registry is a prospective multicenter registry trial. Seven sites in the USA and 1 site in Spain participated and enrolled 81 patients. RESULTS: The performance and safety of the TOBC was evaluated based on scoring for different variables. Scores were measured using a semiquantitative rating scale (1 = excellent, 5 = poor). The mean scores for these variables were as follows: visibility under fluoroscopy, 1.8; ability to reach the intended site, 1.6; stability during first positioning, 1.5; stability during inflation, 1.6; stability during deflation, 1.6; ability to temporarily stop flow, 1.6; and ability to assist in coil embolization, 1.7. The mean inflation and deflation times were 4.9 and 5.6 s, respectively. Complete obliteration of the aneurysm (Raymond class I) was achieved in 69.4% of the BACE cases. Thrombus formation occurred in 4/81 (4.8%) of the cases. In all cases, the thrombus resolved with medications, no patient suffered an infarction, and an underlying hypercoagulable state from subarachnoid hemorrhage was considered a contributing factor. Vessel rupture occurred in 1/81 (1.2%) of the cases, but was unrelated to TOBC use. CONCLUSION: BACE using the TOBC is safe and effective. All variables assessed for performance showed good-to-excellent results.

Treatment of Intracranial Aneurysms With the SILK Embolization Device in a Multicenter Study. A Retrospective Data Analysis.

BACKGROUND: Flow-diverter technology has become an important stent-based embolization tool in the treatment of complex cerebrovascular pathology. We report here the experience of 4 Spanish centers with using the SILK flow-diverter (SFD) device. OBJECTIVE: To evaluate the safety and efficacy of using the SFD in the endovascular treatment of intracranial aneurysms with complex morphology. METHODS: We retrospectively examined a prospectively maintained database of patients treated with SFD devices between July 2008 and December 2013 at 1 of 4 institutions in Spain. Data regarding patient demographics, aneurysm characteristics, and technical procedure were analyzed. Angiographic and clinical findings were recorded during the procedure and at 12 months postoperatively. RESULTS: A total of 175 SFD devices were implanted in 157 patients (women/men: 119/38; mean, median, and range of age: 56.2, 56.7, and 19-80 years, respectively), who were treated in a delayed manner (3-6 months from the event) for 180 aneurysms (165 unruptured and 15 ruptured). Adverse events (acute and delayed) were observed in 28.7% of cases (45/157), and most were resolved (19.1%; 30/157). Six months after the procedure, total morbidity and mortality were 9.6% (15/157) and 3.2% (5/157), respectively. Long-term imaging follow-up showed complete occlusion, neck remnants, and residual aneurysm in 78.1% (100/128), 14.0% (18/128), and 7.8% (10/128) of cases, respectively. CONCLUSIONS: The SFD device is an effective tool for the treatment of challenging aneurysms, and allows complete occlusion within a year of the procedure in most patients, with morbidity and mortality comparable to those previously reported for similar devices.

Initial experience using the 3MAX cerebral reperfusion catheter in the endovascular treatment of acute ischemic stroke of distal arteries.

INTRODUCTION: The advancement of technology has allowed the development of new catheters that may provide safe intracranial navigation. OBJECTIVE: To report our first experience with the direct aspiration first pass technique in small arteries as the primary method for recanalization with the Penumbra 3MAX cerebral reperfusion catheter. METHODS: A retrospective case series analysis study of patients with acute ischemic stroke endovascularly treated with the direct aspiration technique using the 3MAX reperfusion catheter in our hospital in the past year. RESULTS: We treated six patients in our hospital for acute ischemic stroke using the 3MAX aspiration catheter as first choice. The patients had a median National Institutes of Health Strokes Scale (NIHSS) score of 12 (range 10-17) at admission, with occlusions of an M2 segment of a middle cerebral artery (MCA) treated through an anterior communicating artery, pericallosal artery, P2 artery, and M2-MCA and M3-MCA arteries. Recanalization (TICI 2b-3) was achieved in all cases and no complications occurred. It was not necessary to combine treatment with a stent retriever in any of the patients. All the patients showed early neurological improvement. The median NIHSS score at discharge was 1 (0-3) and 5/6 (83%) patients had a modified Rankin Scale score 0-2 at discharge. CONCLUSIONS: Our initial experience suggests that treatment of distal cerebrovascular occlusions with the 3MAX catheter is feasible. We achieved complete recanalization in all cases without unexpected complications while obtaining good clinical results. However, larger studies are necessary to establish its benefits and its safety.

Control metabólico y pérdida de peso en pacientes con obesidad y diabetes mellitus tipo 2 tratados con exenatida / Metabolic control and weight loss in patients with obesity and type 2 diabetes mellitus, treated with exenatide

Fundamento y objetivo. Exenatida es un análogo de GLP1 diseñado para mejorar el control glucémico en pacientes con obesidad y diabetes mellitus tipo 2 (DM2). Además, presenta otras acciones de control metabólico. El objetivo de este estudio fue valorar si exenatida ayuda a conseguir objetivos de control metabólico en pacientes con obesidad y DM2 tras 24 semanas de tratamiento. Pacientes y método. Ensayo clínico abierto en 102 pacientes, 69 mujeres y 33 varones, con edades comprendidas entre 19-77 años (media [DE] de 53,2 [1,1] años, con DM2 de evolución media de 4,88 [0,5] años (extremos entre 1 y 20 años) en tratamiento con antidiabéticos orales (ADO) y obesidad. Resultados. Se observó una diferencia significativa de la glucosa basal, con reducción promedio de 19,7 (7,1) mg/dl, y de hemoglobina glucosilada (HbA1c) de 0,33 (0,17)%, siendo esta última mayor en pacientes con mal control previo al tratamiento (HbA1c>8,5%), en los que la disminución fue de una media del 2,12 (0,53)%. Se tomó como objetivo establecido respecto a HbA1c < 7%, alcanzado en un 14% más de los pacientes tratados que de los controles (43,6 frente a 57,9; p < 0,05). El peso disminuyó en 4,4 (0,8) kg y el índice de masa corporal en 1,7 (0,3) kg/m2. Se redujeron de forma no significativa el colesterol total (una media de 4,9 [1,5] mg/dl), el colesterol unido a lipoproteínas de baja densidad (colesterol LDL) (una media de 3,2 [3,4] mg/dl, el colesterol unido a lipoproteínas de no alta densidad (de 8,6 [5,6] mg/dl) y el colesterol unido a lipoproteínas de alta densidad (de 2,5 [1,4] mg/dl). En pacientes fuera de objetivo (colesterol LDL>100mg/dl y/o triglicéridos>150mg/dl) sí se observaron diferencias significativas en el colesterol LDL y los triglicéridos. En cuanto a la presión arterial (PA), solo se obtuvieron diferencias significativas en las cifras de PA diastólica (descenso medio de 18,9 [5,7] mmHg), mientras que la PA sistólica se redujo de forma no significativa. Se tomó como objetivo establecido respecto a HbA1c<7%, alcanzado en un 14% más de los pacientes tratados que de los controles (43,6 frente a 57,9; p<0,05). Conclusiones. Exenatida es un fármaco efectivo no solo para el control de la glucemia (HbA1c), sino también para otros parámetros como perfil lipídico, PA y peso corporal(AU)

Background and objective. Exenatide is an analogue of GLP1 designed to improve the glycemic control in patients with obesity and type 2 diabetes. It may control other metabolic processes as well. We aimed to evaluate whether exenatide helps to achieve metabolic control goals in patients with obesity and type 2 diabetes (T2DM) after 24 weeks of treatment. Patients and method. Open clinical trial in 102 obese patients, with age between 19-77 years (mean [ED] 53,2 [1,1] years), T2DM with mean evolution of 4,88 [0,5] years (range 1 to 20 years) with oral antidiabetic treatment. Results. There was a reduction of 19.7±7.1mg/dl in the fasting glucose average and of 0.33±0.17% in glycated hemoglobin (HbA1c). These last values were higher (2.12±0.53%) in patients with bad control prior to treatment (HbA1c>8.5%). The desirable threshold of HbA1c<7% was fulfilled by 14% more treated than control patients (43.6 vs. 57.9, P<.05). Reductions of 4.4±0.8kg average weight and of 1.7±0.3kg/m2 body mass index were recorded. Although there was not a significant reduction in the overall lipid profile, a decrease of 4.9±5.1mg/dl total cholesterol, 3.2±4.3mg/dl LDL-C, 8.6±5.6mg/dl noHDL-C and 2.5±1, 4mg/dl HDL-C was observed. Patients outside target (LDL>100 and/or triglycerides>150mg/dl) showed significant differences in their concentrations of LDL-C and triglycerides. With respect to blood pressure (BP), significant differences were observed in diastolic BP (-18.9±5.7mmHg) but not in systolic BP (P<.05). Conclusions. Exenatide is an effective drug not only for glycemic control but also for the overall metabolic control of HbA1c, lipid profile, BP and body weight(AU)

[Metabolic control and weight loss in patients with obesity and type 2 diabetes mellitus, treated with exenatide]. / Control metabólico y pérdida de peso en pacientes con obesidad y diabetes mellitus tipo 2 tratados con exenatida.

BACKGROUND AND OBJECTIVE: Exenatide is an analogue of GLP1 designed to improve the glycemic control in patients with obesity and type 2 diabetes. It may control other metabolic processes as well. We aimed to evaluate whether exenatide helps to achieve metabolic control goals in patients with obesity and type 2 diabetes (T2DM) after 24 weeks of treatment. PATIENTS AND METHOD: Open clinical trial in 102 obese patients, with age between 19-77 years (mean [ED] 53,2 [1,1] years), T2DM with mean evolution of 4,88 [0,5] years (range 1 to 20 years) with oral antidiabetic treatment. RESULTS: There was a reduction of 19.7±7.1mg/dl in the fasting glucose average and of 0.33±0.17% in glycated hemoglobin (HbA(1c)). These last values were higher (2.12±0.53%) in patients with bad control prior to treatment (HbA(1c)>8.5%). The desirable threshold of HbA(1c)<7% was fulfilled by 14% more treated than control patients (43.6 vs. 57.9, P<.05). Reductions of 4.4±0.8kg average weight and of 1.7±0.3kg/m(2) body mass index were recorded. Although there was not a significant reduction in the overall lipid profile, a decrease of 4.9±5.1mg/dl total cholesterol, 3.2±4.3mg/dl LDL-C, 8.6±5.6mg/dl noHDL-C and 2.5±1, 4mg/dl HDL-C was observed. Patients outside target (LDL>100 and/or triglycerides>150mg/dl) showed significant differences in their concentrations of LDL-C and triglycerides. With respect to blood pressure (BP), significant differences were observed in diastolic BP (-18.9±5.7mmHg) but not in systolic BP (P<.05). CONCLUSIONS: Exenatide is an effective drug not only for glycemic control but also for the overall metabolic control of HbA(1c), lipid profile, BP and body weight.

Using ankle-brachial index to detect peripheral arterial disease: prevalence and associated risk factors in a random population sample.

BACKGROUND AND AIM: The ankle-brachial index (ABI) is being used increasingly to diagnose peripheral arterial disease (PAD) that predicts cardiovascular morbidity and mortality. The aim of this study is to determine the prevalence of PAD and associated risk factors in a Spanish random population sample of age > or =40. METHODS AND RESULTS: PAD is defined as an ABI<0.9 in either leg. 784 participants of age > or =40 were randomly selected in a Spanish province. 55.4% of them were female. The prevalence of PAD in this sample was 10.5% (95% confidence interval (CI) 8.4-12.8); 9.7% in females and 11.4% in males. In logistic regression analyses, adjusted for age and gender, smoking per 10 pack-years (odds ratio (OR) 1.40, 95% CI 1.23-1.58), hypertension (OR 1.85, 95% CI 1.05-3.28), hypercholesterolemia (OR 1.76, 95% CI 1.04-2.98), and diabetes (OR 1.80, 95% CI 1.04-3.11) were positively associated with prevalent PAD. More than 91% of persons with PAD had one or more cardiovascular disease risk factors. CONCLUSIONS: We conclude that in our study hypertension, hypercholesterolemia, diabetes mellitus and smoking are associated with PAD. The majority of individuals with PAD had at least one important cardiovascular risk factor advanced enough to be considered eligible for an aggressive treatment.

Home-based self-measurement of blood pressure: a proposal using new reference values (the PURAS study).

OBJECTIVES: To establish reference values for blood pressure by means of self-measurement of blood pressure (BP) conducted at home. DESIGN: Descriptive study of the distribution of self-measured BP at home and its correspondence with clinic-based measurements of BP. METHODS: The aim of this study is to define the home BP levels that correspond to clinic BP thresholds 140/90 mmHg (hypertension) and 130/85 mmHg (normality). The sample consisting of 1411 randomly selected adults stratified by age and gender. A pre-calibrated electronic device (Omron 705CP) was used for BP and heart rate (HR) measurements and a trained nurse performed clinic-based sphygmomanometer measurements. The same nurse provided tutorials for the subjects on how to obtain 12 self-measured BP values at home using the Omron device in a single day. RESULTS: Of the 1184 volunteers that attended the appointment, 195 were known as hypertensives and were excluded from the study. The average age of the remaining 989 subjects (50.4% females) was 44.3 years. Clinic BP values were significantly higher than self-measured BP at home regardless of age and gender. Both had good correlations (systolic BP, r=0.84 and diastolic BP, r=0.77). Using linear regression, the self-measured BP at home hypertension threshold would be 131/82 mmHg and the limit of normality 123/78 mmHg. Using corresponding percentiles, these values would be 134/85 and 124/80 mmHg, respectively. CONCLUSIONS: The self-measured BP at home values found in this study, when defining hypertension, are lower than values currently accepted (135/85 mmHg). Long-term studies are necessary to confirm these results.