Background-Low testosterone is an independent predictor of reduced exercise capacity and poor clinical outcomes in patients with heart failure (HF). We sought to determine whether testosterone therapy improves exercise capacity in patients with stable chronic HF. Methods and Results-We searched Medline, Embase, Web of Science, and Cochrane Central Register of Controlled Trials (1980Trials ( -2010. Eligible studies included randomized controlled trials (RCTs) reporting the effects of testosterone on exercise capacity in patients with HF. Reviewers determined the methodological quality of studies and collected descriptive, quality, and outcome data. Four trials (nϭ198; men, 84%; mean age, 67 years) were identified that reported the 6-minute walk test (2 RCTs), incremental shuttle walk test (2 RCTs), or peak oxygen consumption (2 RCTs) to assess exercise capacity after up to 52 weeks of treatment. Testosterone therapy was associated with a significant improvement in exercise capacity compared with placebo. The mean increase in the 6-minute walk test, incremental shuttle walk test, and peak oxygen consumption between the testosterone and placebo groups was 54.0 m (95% CI, 43.0 -65.0 m), 46.7 m (95% CI, 12.6 -80.9 m), and 2.70 mL/kg per min (95% CI, 2.68 -2.72 mL/kg per min), respectively. Testosterone therapy was associated with a significant increase in exercise capacity as measured by units of pooled SDs (net effect, 0.52 SD; 95% CI, 0.10 -0.94 SD). No significant adverse cardiovascular events were noted. Conclusions-Given the unmet clinical needs, testosterone appears to be a promising therapy to improve functional capacity in patients with HF. Adequately powered RCTs are required to assess the benefits of testosterone in this high-risk population with regard to quality of life, clinical events, and safety. (Circ Heart Fail. 2012;5:315-321.)

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Objectives To assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of three commonly used VCDs. Background VCDs are commonly used following percutaneous coronary intervention (PCI) on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared to manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications. Methods From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug-based (n=18,533) or nitinol clip-based (n=2,284) or suture-based (n=2,996) VCD between 06/2005 and 12/2007 were identified. We defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis. Results Among 23,813 procedures, VCD failed in 781 (3.3%) procedures (2.1% of collagen plug-based, 6.1% of suture-based, 9.5% of nitinol clip-based). Patients with VCD failure had excess risk of ‘any’ (7.7% versus 2.8%; P<0.001), major (3.3% versus 0.8%; P<0.001), or minor (5.8% versus 2.1%; P<0.001) vascular complications compared with successful VCD deployment. In a propensity-score adjusted analysis, when compared with collagen plug-based VCD (Reference OR =1.0), nitinol clip-based VCD had 2-fold increased risk (OR 2.0, 95% CI: 1.8–2.3, p<0.001) and suture-based VCD had 1.25-fold increased risk (OR 1.25, 95% CI: 1.2–1.3, p<0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug-based VCD and nitinol clip-based VCD, but not for suture-based VCD. Conclusion VCD failure rates vary depending upon the types of VCD used and are associated with significantly higher vascular complications as compared to deployment successes.

Background-Post-market medical product safety surveillance is a complex task requiring standardized data collection, prompt adverse event reporting mechanisms and appropriate methodologies to identify low frequency safety threats and risk communication.