Gender-specific 30-day outcomes after carotid endarterectomy and carotid artery stenting in the Society for Vascular Surgery Vascular Registry

ObjectiveAlthough the optimal treatment of carotid stenosis remains unclear, available data suggest that women have higher risk of adverse events after carotid revascularization. We used data from the Society for Vascular Surgery Vascular Registry to determine the effect of gender on outcomes after carotid endarterectomy (CEA) and carotid artery stenting (CAS).MethodsThere were 9865 patients (40.6% women) who underwent CEA (n = 6492) and CAS (n = 3373). The primary end point was a composite of death, stroke, and myocardial infarction at 30 days.ResultsThere was no difference in age and ethnicity between genders, but men were more likely to be symptomatic (41.6% vs 38.6%; P < .003). There was a higher prevalence of hypertension and chronic obstructive pulmonary disease in women, whereas men had a higher prevalence of coronary artery disease, history of myocardial infarction, and smoking history. For disease etiology in CAS, restenosis was more common in women (28.7% vs 19.7%; P < .0001), and radiation was higher in men (6.2% vs 2.6%; P < .0001). Comparing by gender, there were no statistically significant differences in the primary end point for CEA (women, 4.07%; men, 4.06%) or CAS (women, 6.69%; men, 6.80%). There remains no difference after stratification by symptomatology and multivariate risk adjustment.ConclusionsIn this large, real-world analysis, women and men demonstrated similar results after CEA or CAS. These data suggest that, contrary to previous reports, women do not have a higher risk of adverse events after carotid revascularization

Impact of Spironolactone on Longitudinal Changes in Health-Related Quality of Life in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial

BACKGROUND: Heart failure (HF) with preserved ejection fraction patients have equally impaired health-related quality of life (HRQL) compared with those with HF with reduced ejection fraction, but limited studies have evaluated the impact of therapies on changes in HRQL. METHODS AND RESULTS: Patients ≥50 years of age, with symptomatic HF and left ventricular ejection fraction ≥45%, were enrolled in Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) and randomized to spironolactone or placebo. Patients completed the Kansas City Cardiomyopathy Questionnaire (KCCQ), which was the primary HRQL instrument, and EQ5D visual analog scale at baseline, 4 months, 12 months, and annually thereafter. McMaster Overall Treatment Evaluation was assessed at 4 and 12 months to assess global change scores. Change scores (+SD) were calculated to determine between-group differences, and multivariable repeated-measures models were created to identify other factors associated with change scores. Paired KCCQ data were available for 91.7% of 3445 TOPCAT patients. By 4 months, the mean change in KCCQ was 7.7±16 and mean change in EQ5D visual analog scale was 4.7±16. Adjusted mean changes in KCCQ for the spironolactone group were significantly better than those for the placebo group at 4-month (1.54 better; P=0.002), 12-month (1.35 better; P=0.02), and 36-month (1.86 better; P=0.02) visits. No between-group differences in EQ5D visual analog scale change scores or McMaster Overall Treatment Evaluation were noted. Older age, obesity, current smoking, New York Heart Association class III/IV, and comorbid illnesses were associated with declines in KCCQ scores. Use of spironolactone was an independent predictor of improved KCCQ scores. CONCLUSIONS: In symptomatic HF with preserved ejection fraction patients, use of spironolactone was associated with an improvement in HF-specific HRQL. Several modifiable risk factors were associated with HRQL deterioration. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00094302

Spironolactone for heart failure with preserved ejection fraction

BACKGROUND: Mineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction. We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction. METHODS: In this randomized, double-blind trial, we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45% or more to receive either spironolactone (15 to 45 mg daily) or placebo. The primary outcome was a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. RESULTS: With a mean follow-up of 3.3 years, the primary outcome occurred in 320 of 1722 patients in the spironolactone group (18.6%) and 351 of 1723 patients in the placebo group (20.4%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.77 to 1.04; P = 0.14). Of the components of the primary outcome, only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group (206 patients [12.0%] vs. 245 patients [14.2%]; hazard ratio, 0.83; 95% CI, 0.69 to 0.99, P = 0.04). Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone. Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia (18.7%, vs. 9.1% in the placebo group) but reduced hypokalemia. With frequent monitoring, there were no significant differences in the incidence of serious adverse events, a serum creatinine level of 3.0 mg per deciliter (265 μmol per liter) or higher, or dialysis. CONCLUSIONS: In patients with heart failure and a preserved ejection fraction, treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure

Society for Vascular Surgery Vascular Registry evaluation of stent cell design on carotid artery stenting outcomes

ObjectiveThe Society for Vascular Surgery (SVS) Vascular Registry (VR) collects data on outcomes of carotid endarterectomy and carotid artery stenting (CAS). The purpose of this study was to evaluate the impact of open vs closed cell stent design on the in-hospital and 30-day outcome of CAS.MethodsThe VR collects provider-reported data on patients using a Web-based database. Data were analyzed both in-hospital and at 30 days postprocedure. The primary outcome is combined death/stroke/myocardial infarction (MI).ResultsAs of October 14, 2009, there were 4337 CAS with discharge data and 2397 with 30-day data. Open cell stents (OPEN) were used in 3451 patients (79.6%), and closed cell stents (CLOSED) were used in 866 patients (20.4%). Baseline demographics showed no differences in age, gender, race, and ethnicity. However, the OPEN group had more patients with atherosclerosis (74.5% vs 67.4%; P = .0003) as the etiology of carotid artery disease. The OPEN group also had a higher prevalence of preprocedural stroke (25.8% vs 21.4%; P = .0079), chronic obstructive pulmonary disease (COPD; 21.0% vs 17.6%; P = .0277), cardiac arrhythmia (14.7% vs 11.4%; P = .0108), valvular heart disease (7.4% vs 3.7%; P < .0001), peripheral vascular disease (PVD; 40.0% vs 35.3%; P = .0109), and smoking history (59.0% vs 54.1%; P = .0085). There are no statistically significant differences in the in-hospital or 30-day outcomes between the OPEN and CLOSED patients. Further subgroup analyses demonstrated symptomatic patients had a higher event rate than the asymptomatic cohort in both the OPEN and CLOSED groups. Among symptomatic patients, the OPEN patients had a lower (0.43% vs 1.41%; P = .0349) rate of in-hospital mortality with no difference in stroke or transient ischemic attack (TIA). There were no differences in 30-day event rates. In asymptomatic patients, there were also no statistically significant differences between the OPEN and CLOSED groups. After risk adjustment, there remained no statistically significant differences between groups of the primary endpoint (death/stroke/MI) during in-hospital or 30 days.ConclusionIn-hospital and 30-day outcomes after CAS were not significantly influenced by stent cell design. Symptomatic patients had higher adverse event rates compared to the asymptomatic cohort. As there is no current evidence of differential outcome between the use of open and closed cell stents, physicians should continue to use approved stent platforms based on criteria other than stent cell design

The impact of Centers for Medicare and Medicaid Services high-risk criteria on outcome after carotid endarterectomy and carotid artery stenting in the SVS Vascular Registry

ObjectiveThe Centers for Medicare and Medicaid Services (CMS) require high-risk (HR) criteria for carotid artery stenting (CAS) reimbursement. The impact of these criteria on outcomes after carotid endarterectomy (CEA) and CAS remains uncertain. Additionally, if these HR criteria are associated with more adverse events after CAS, then existing comparative effectiveness analysis of CEA vs CAS may be biased. We sought to elucidate this using data from the SVS Vascular Registry.MethodsWe analyzed 10,107 patients undergoing CEA (6370) and CAS (3737), stratified by CMS HR criteria. The primary endpoint was composite death, stroke, and myocardial infarction (MI) (major adverse cardiovascular event [MACE]) at 30 days. We compared baseline characteristics and outcomes using univariate and multivariable analyses.ResultsCAS patients were more likely to have preoperative stroke (26% vs 21%) or transient ischemic attack (23% vs 19%) than CEA. Although age ≥80 years was similar, CAS patients were more likely to have all other HR criteria. For CEA, HR patients had higher MACEs than normal risk in both symptomatic (7.3% vs 4.6%; P < .01) and asymptomatic patients (5% vs 2.2%; P < .0001). For CAS, HR status was not associated with a significant increase in MACE for symptomatic (9.1% vs 6.2%; P = .24) or asymptomatic patients (5.4% vs 4.2%; P = .61). All CAS patients had MACE rates similar to HR CEA. After multivariable risk adjustment, CAS had higher rates than CEA for MACE (odds ratio [OR], 1.2; 95% confidence interval [CI], 1.0-1.5), death (OR, 1.5; 95% CI, 1.0-2.2), and stroke (OR, 1.3; 95% CI,1.0-1.7), whereas there was no difference in MI (OR, 0.8; 95% CI, 0.6-1.3). Among CEA patients, age ≥80 (OR, 1.4; 95% CI, 1.02-1.8), congestive heart failure (OR, 1.7; 95% CI, 1.03-2.8), EF <30% (OR, 3.5; 95% CI, 1.6-7.7), angina (OR, 3.9; 95% CI, 1.6-9.9), contralateral occlusion (OR, 3.2; 95% CI, 2.1-4.7), and high anatomic lesion (OR, 2.7; 95% CI, 1.33-5.6) predicted MACE. Among CAS patients, recent MI (OR, 3.2; 95% CI, 1.5-7.0) was predictive, and radiation (OR, 0.6; 95% CI, 0.4-0.8) and restenosis (OR, 0.5; 95% CI, 0.3-0.96) were protective for MACE.ConclusionsAlthough CMS HR criteria can successfully discriminate a group of patients at HR for adverse events after CEA, certain CMS HR criteria are more important than others. However, CEA appears safer for the majority of patients with carotid disease. Among patients undergoing CAS, non-HR status may be limited to restenosis and radiation

Physical activity and body mass index: the contribution of age and workplace characteristics

The workplace is an important domain for adults, and many effective interventions targeting physical activity and weight reduction have been implemented in the workplace. However, the U.S. workforce is aging, and few studies have examined the relationship of BMI, physical activity, and age as they relate to workplace characteristics. This paper reports on the distribution of physical activity and BMI by age in a population of hospital-based healthcare workers and investigates the relationships among workplace characteristics, physical activity, and BMI. Data from a survey of patient care workers in two large academic hospitals in the Boston area were collected in late 2009 and analyzed in early 2013. In multivariate models, workers reporting greater decision latitude (OR=1.02, 95% CI=1.01, 1.03) and job flexibility (OR=1.05, 95% CI=1.01, 1.10) reported greater physical activity. Overweight and obesity increased with age (p<0.01), even after adjusting for workplace characteristics. Sleep deficiency (OR=1.56, 95% CI=1.15, 2.12) and workplace harassment (OR=1.62, 95% CI=1.20, 2.18) were also associated with obesity. These findings underscore the persistent impact of the work environment for workers of all ages. Based on these results, programs or policies aimed at improving the work environment, especially decision latitude, job flexibility, and workplace harassment should be included in the design of worksite-based health promotion interventions targeting physical activity or obesity