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© 2015 Bentham Science Publishers.For decades, it has been recognized that men have a higher age-adjusted risk of ischemic cardiovascular (CVD) events compared to women, thus generating hypotheses that sex steroids contribute to CVD risk. Potential mechani

Context: Medical devices are common in clinical practice and have important effects on morbidity and mortality, yet there has not been a systematic examination of evidence used by the US Food and Drug Administration (FDA) for device approval.Objectives: To study premarket approval (PMA)--the most stringent FDA review process--of cardiovascular devices and to characterize the type and strength of evidence on which it is based.Data Sources and Study Selection: Systematic review of 78 summaries of safety and effectiveness data for 78 PMAs for high risk cardiovascular devices that received PMA between January 2000 and December 2007 [corrected].Data Extraction: Examination of the methodological characteristics considered essential to minimize confounding and bias, as well as the primary end points of the 123 studies supporting the PMAs.Results: Thirty-three of 123 studies (27%) used to support recent FDA approval of cardiovascular devices were randomized and 17 of 123 (14%) were blinded. Fifty-one of 78 PMAs (65%) were based on a single study. One hundred eleven of 213 primary end points (52%) were compared with controls and 34 of 111 controls (31%) were retrospective. One hundred eighty-seven of 213 primary end points (88%) were surrogate measures and 122 of 157 (78%) had a discrepancy between the number of patients enrolled in the study and the number analyzed.Conclusion: Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias. [ABSTRACT FROM AUTHOR]

As the volume, complexity, and cost of new medical technology increase, the need for evaluating benefits and risks becomes increasingly important. Once the formal requirements for Food and Drug Administration approval and insurance coverage are met, however, few systematic criteria are applied to ensure patient benefit. A more systematic policy approach regarding new technologies is needed, with input from balanced groups reviewing evidence of clinical outcomes data to determine patient benefit. This paper examines cardiac computed tomography angiography as a case study; it proposes procedures designed to ensure that the benefits of new technologies justify their costs. [ABSTRACT FROM AUTHOR]

Although women with coronary heart disease (CHD) present with a higher rate of atypical anginal symptoms than men, both women and men most commonly have typical chest pain.Age is the most important risk factor for CHD in women, with increasing age directly increasing the likelihood of CHD when chest pain is present.Differential diagnoses include ischemic chest pain, nonischemic cardiac causes, and noncardiac causes.Although treadmill exercise testing remains the gold standard for the evaluation of chest pain, it is only moderately accurate in women as compared with men.Exercise time and heart rate recovery on treadmill testing may be more helpful than ST-segment depression for predicting-term outcomes in asymptomatic women.Risk stratification aids in both the diagnostic workup and the treatment of women presenting it chest pain. [ABSTRACT FROM AUTHOR]

The FRS, the predominant method of determining cardiovascular disease (CVD) risk in asymptomatic patients, estimates 10-year risk based on 5 simple criteria and provides initial risk stratification.While the approach to low- and high-risk patients is relatively clearly established, further stratification of the intermediate group may be necessary to clarify therapeutic strategies.The ankle/brachial index is an inexpensive way of identifying subclinical CVD in an office setting and is effective for further risk stratification.C-reactive protein (CRP) is a marker for inflammation that is predictive of CVD, but testing for CRP does not provide much risk information beyond that of the Framingham Risk Score.Electron beam CT for evaluating coronary calcium is useful for intermediate-risk stratification, but its use is limited by its high cost.Testing for microalbuminuria may be an appropriate (and low-cost) stratification test for patients at higher risk for developing diabetes or metabolic syndrome. [ABSTRACT FROM AUTHOR]

Context: The value of exercise testing in women has been questioned.Objective: To determine the prognostic value of exercise testing in a population-based cohort of asymptomatic women followed up for 20 years.Design and Setting: Near-maximal Bruce-protocol treadmill test data from the Lipid Research Clinics Prevalence Study (1972-1976) with follow-up through 1995.Participants: A total of 2994 asymptomatic North American women, aged 30 to 80 years, without known cardiovascular disease.Main Outcome Measures: Cardiovascular and all-cause mortality.Results: There were 427 (14%) deaths during 20 years of follow-up, of which 147 were due to cardiovascular causes. Low exercise capacity, low heart rate recovery (HRR), and not achieving target heart rate were independently associated with increased all-cause and cardiovascular mortality. There was no increased cardiovascular death risk for exercise-induced ST-segment depression (age-adjusted hazard ratio, 1.02; 95% confidence interval [CI], 0.57-1.80; P =.96). The age-adjusted hazard ratio for cardiovascular death for every metabolic equivalent (MET) decrement in exercise capacity was 1.20 (95% CI, 1.18-1.30; P<.001); for every 10 beats per minute decrement in HRR, the hazard ratio was 1.36 (95% CI, 1.19-1.55; P<.001). After adjusting for multiple other risk factors, women who were below the median for both exercise capacity and HRR had a 3.5-fold increased risk of cardiovascular death (95% CI, 1.57-7.86; P =.002) compared with those above the median for both variables. Among women with low risk Framingham scores, those with below median levels of both exercise capacity and HRR had significantly increased risk compared with women who had above median levels of these 2 exercise variables, 44.5 and 3.5 cardiovascular deaths per 10 000 person-years, respectively (hazard ratio for cardiovascular death, 12.93; 95% CI, 5.62-29.73; P<.001).Conclusion: The prognostic value of exercise testing in asymptomatic women derives not from electrocardiographic ischemia but from fitness-related variables. [ABSTRACT FROM AUTHOR]

Coronary artery disease is the underdiagnosed number 1 killer of women in the United States. More aggressive evaluation of chest pain in women is important to ensure an optimal outcome. [ABSTRACT FROM AUTHOR]