Description: Background— The most frequent complications associated with implantable cardioverter-defibrillators (ICDs) involve the transvenous leads. A subcutaneous implantable cardioverter-defibrillator (S-ICD) has been developed as an alternative system. This study evaluated the safety and effectiveness of the S-ICD System (Cameron Health/Boston Scientific) for the treatment of life-threatening ventricular arrhythmias (ventricular tachycardia/ventricular fibrillation). Methods and Results— This prospective, nonrandomized, multicenter trial included adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The primary safety end point was the 180-day S-ICD System complication-free rate compared with a prespecified performance goal of 79%. The primary effectiveness end point was the induced ventricular fibrillation conversion rate compared with a prespecified performance goal of 88%, with success defined as 2 consecutive ventricular fibrillation conversions of 4 attempts. Detection and conversion of spontaneous episodes were also evaluated. Device implantation was attempted in 321 of 330 enrolled patients, and 314 patients underwent successful implantation. The cohort was followed for a mean duration of 11 months. The study population was 74% male with a mean age of 52±16 years and mean left ventricular ejection fraction of 36±16%. A previous transvenous ICD had been implanted in 13%. Both primary end points were met: The 180-day system complication-free rate was 99%, and sensitivity analysis of the acute ventricular fibrillation conversion rate was 〉90% in the entire cohort. There were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded in 21 patients (6.7%), all of which successfully converted. Forty-one patients (13.1%) received an inappropriate shock. Conclusions— The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01064076.

Description: We aimed to prospectively examine the association between the glycemic index and glycemic load of foods consumed and the dietary intakes of carbohydrates, sugars, fiber, and principal carbohydrate-containing food groups (eg, breads, cereals, and sugary drinks) with changes in blood pressure during adolescence. A total of 858 students aged 12 years at baseline (422 girls and 436 boys) were examined from 2004–2005 to 2009–2011. Dietary data were assessed from validated semiquantitative food frequency questionnaires. Blood pressure was measured using a standard protocol. In girls, after adjusting for age, ethnicity, parental education, parental history of hypertension, baseline height, baseline blood pressure, change in body mass index, and time spent in physical and sedentary activities, each 1-SD (1-SD=7.10 g/d) increase in baseline dietary intake of total fiber was associated with a 0.96-, 0.62-, and 0.75-mmHg decrease in mean systolic ( P =0.02), diastolic ( P =0.01), and arterial blood pressures ( P =0.002), respectively, 5 years later. In girls, each 1-SD increase in dietary glycemic index, glycemic load, carbohydrate, and fructose was concurrently related to increases of 1.81 ( P =0.001), 4.02 ( P =0.01), 4.74 ( P =0.01), and 1.80 mm Hg ( P =0.03) in systolic blood pressure, respectively, 〉5 years. Significant associations between carbohydrate nutrition variables and blood pressure were not observed among boys. Excessive dietary intake of carbohydrates, specifically from high glycemic index/glycemic load foods, could adversely influence blood pressure, particularly in girls, whereas fiber-rich diets may be protective against elevated blood pressure during adolescence.