Sex differences in long-term outcomes following acute heart failure hospitalization: Findings from the Get With The Guidelines-Heart Failure registry.

AIMS: Sex differences in long-term outcomes following hospitalization for heart failure (HF) across ejection fraction (EF) subtypes are not well described. In this study, we evaluated the risk of mortality and rehospitalization among males and females across the spectrum of EF over 5 years of follow-up following an index HF hospitalization event. METHODS AND RESULTS: Patients hospitalized with HF between 1 January 2006 and 31 December 2014 from the American Heart Association's Get With The Guidelines-Heart Failure registry with available 5-year follow-up using Medicare Part A claims data were included. The association between sex and risk of mortality and readmission over a 5-year follow-up period for each HF subtype (HF with reduced EF [HFrEF, EF ≤40%], HF with mildly reduced EF [HFmrEF, EF 41-49%], and HF with preserved EF [HFpEF, EF >50%]) was assessed using adjusted Cox models. The effect modification by the HF subtype for the association between sex and outcomes was assessed by including multiplicative interaction terms in the models. A total of 155 670 patients (median age: 81 years, 53.4% female) were included. Over 5-year follow-up, males and females had comparably poor survival post-discharge; however, females (vs. males) had greater years of survival lost to HF compared with the median age- and sex-matched US population (HFpEF: 17.0 vs. 14.6 years; HFrEF: 17.3 vs. 15.1 years; HFmrEF: 17.7 vs. 14.6 years for age group 65-69 years). In adjusted analysis, females (vs. males) had a lower risk of 5-year mortality (adjusted hazard ratio [aHR] 0.89, 95% confidence interval [CI] 0.87-0.90, p < 0.0001), and the risk difference was most pronounced among patients with HFrEF (aHR 0.87, 95% CI 0.85-0.89; pinteraction [sex*HF subtype] = 0.04). Females (vs. males) had a higher adjusted risk of HF readmission over 5-year follow-up (aHR 1.06, 95% CI 1.04-1.08, p < 0.0001), with the risk difference most pronounced among patients with HFpEF (aHR 1.11, 95% CI 1.07-1.14; pinteraction [sex*HF subtype] = 0.001). CONCLUSIONS: While females (vs. males) had lower adjusted mortality, females experienced a significantly greater loss in survival time than the median age- and sex-matched US population and had a greater risk of rehospitalization over 5 years following HF hospitalization.

Gender differences in outcomes after surgical ablation of atrial fibrillation.

BACKGROUND: Gender disparities have been established in patients who have atrial fibrillation (AF), and in their outcomes after medical treatment for AF. This study evaluated differences in outcome by gender in patients who underwent surgical treatment for AF. METHODS: From April 2004 to December 2012, a total of 936 patients had surgical treatment for AF. Outcomes were analyzed by gender using propensity score-matching methods. RESULTS: Of the 936 subjects, 571 (61%) were men; women were older (aged 68.6 ± 11.3 vs 66.9 ± 11.9 years; P = .033), had more heart failure (44% vs 37%; P = .024), more mitral valve surgery (72% vs 50%; P < .001) and more tricuspid valve surgery (41% vs 18%; P < .001). Men underwent more coronary artery bypass surgery (37% vs 19%; P < .001) and aortic valve surgery (38% vs 31%; P = .029). Women had higher late stroke rate per 10 person-years (0.15 vs 0.07; P = .035), fewer catheter ablations (6.0% vs 9.8%; P = .017), and a trend toward fewer cardioversions for recurrent AF (15.7% vs 19.2%; P = .20). After propensity-score matching, late stroke rates per 10 person-years trended higher in women (0.12 vs 0.04; P = .13). No significant gender differences were found in overall survival (5-year survival: 78.8% in men, and 81.0% in women; P = .40) or freedom from AF without antiarrhythmic drugs at last follow-up (71.8% in men vs 73.6% in women, P = .59). CONCLUSIONS: Women sought surgery treatment at older ages and with more heart failure. No gender-based differences were found in stroke, overall survival, or procedure success, after propensity-score matching.

Globalization of clinical research by the pharmaceutical industry.

Drug companies' quest for speedy results has led to a boom in trials based in developing countries, where ethical standards may be lax and the impoverished sick abundant. According to the U.S. Department of Health and Human Services Inspector General's office, the number of researchers based outside the United States seeking new drug approvals has increased 16-fold over the last decade. In this article, a 1996 Pfizer trial in Nigeria--the subject of a controversial class-action suit--illustrates the dangers.