This systematic review examines the level and prevalence of spin in presenting findings that are not statistically significant in published reports of cardiovascular randomized clinical trials (RCTs).

Background Although sodium restriction is advised for patients with heart failure (HF), data on sodium restriction and HF outcomes are inconsistent. Objective We sought to evaluate the impact of sodium restriction on HF outcomes. Methods We analyzed data from the multi-hospital, Heart Failure Adherence and Retention Trial which enrolled 902 NYHA class II/III HF patients and followed them for a median of 36 months. Sodium intake was serially assessed by a food frequency questionnaire. Based on the mean daily sodium intake prior to the first event of death or HF hospitalization, patients were classified into sodium restricted (<2,500 mg/day) and unrestricted (≥2,500 mg/day) groups. Study groups were propensity score-matched according to plausible baseline confounders. The primary outcome was a composite of death or HF hospitalization. The secondary outcomes were cardiac death and HF hospitalization. Results Sodium intake data were available for 833 subjects (145 sodium restricted, 688 sodium unrestricted), of whom 260 were propensity-matched into sodium restricted (n=130) and sodium unrestricted (n=130) groups. Sodium restriction was associated with significantly higher risk of death or HF hospitalization (42.3% vs. 26.2%; hazard ratio [HR], 1.83; 95% confidence interval [CI], 1.21–2.84; P=0.004), derived from an increase in the rate of HF hospitalization (32.3% vs. 20.0%; HR, 1.82; CI, 1.11–2.96; P=0.015) and a non-significant increase in the rate of cardiac death (HR, 1.62; CI, 0.70–3.73; P=0.257) and all-cause mortality (P=0.074). Exploratory subgroup analyses suggested that sodium restriction was associated with increased risk of death or HF hospitalization in patients not receiving angiotensin converting-enzyme inhibitor or angiotensin receptor blocker (HR, 5.78; CI, 1.93–17.27; P=0.002). Conclusions In symptomatic patients with chronic HF, sodium restriction may have a detrimental impact on outcome. A randomized clinical trial is needed to definitively address the role of sodium restriction in HF management.

Background-Appropriate use criteria (AUC) have been developed to aid in the optimal use of single-photon emission computed tomography (SPECT)-myocardial perfusion imaging (MPI), a technique that is a mainstay of risk assessment for ischemic heart disease. The impact of appropriate use on the prognostic value of SPECT-MPI is unknown. Methods and Results-A prospective cohort study of 1511 consecutive patients undergoing outpatient, community-based SPECT-MPI was conducted. Subjects were stratified on the basis of the 2009 AUC for SPECT-MPI into an appropriate or uncertain appropriateness group and an inappropriate group. Patients were prospectively followed up for 27±10 months for major adverse cardiac events of death, death or myocardial infarction, and cardiac death or myocardial infarction. In the entire cohort, the 167 subjects (11%) with an abnormal scan experienced significantly higher rates of major adverse cardiac events and coronary revascularization than those with normal MPI. Among the 823 subjects (54.5%) whose MPIs were classified as appropriate (779, 51.6%) or uncertain (44, 2.9%), an abnormal scan predicted a multifold increase in the rates of death (9.2% versus 2.6%; hazard ratio, 3.1; P=0.004), death or myocardial infarction (11.8% versus 3.3%; hazard ratio, 3.3; P=0.001), cardiac death or myocardial infarction (6.7% versus 1.7%; hazard ratio, 3.7; P=0.006), and revascularization (24.7% versus 2.7%; hazard ratio, 11.4; P<0.001). Among the 688 subjects (45.5%) with MPI classified as inappropriate, an abnormal MPI failed to predict major adverse cardiac events, although it was associated with a high revascularization rate. Furthermore, appropriate MPI use provided incremental prognostic value beyond myocardial perfusion and ejection fraction data. Conclusions-When performed for appropriate indications, SPECT-MPI continues to demonstrate high prognostic value.However, inappropriate use lacks effectiveness for risk stratification, further emphasizing the need for optimal patient selection for cardiac testing. (Circulation. 2013;128:1634-1643.)

Background: To investigate sex differences in coronavirus disease 2019 outcomes in a large Illinois-based cohort. Methods: A multicenter retrospective cohort study compared males versus females with COVID-19 infections from March 1, 2020, to June 21, 2020, in the Rush University System. We analyzed sex differences in rates of hospitalization, intensive care unit (ICU) admission, vasopressor use, endotracheal intubation, and death in this cohort. A multivariable model correcting for age and sum of comorbidities was used to explore associations between sex and COVID-19-related outcomes. Results: There were 8108 positive COVID-19 patients-4300 (53.0%) females and 3808 (47.0%) males. Males had higher rates of hospitalization (19% vs. 13%; p < 0.001), ICU transfer (8% vs. 4%; p < 0.001), vasopressor support (4% vs. 2%; p < 0.001), and endotracheal intubation (5% vs. 2%; p < 0.001). Of those who died, 92 were males and 64 were females (2% vs. 1%; p = 0.003). A multivariable model correcting for age and sum of comorbidities showed a significant association between male sex and mortality in the total cohort (odds ratio, 1.96; 95% confidence interval, 1.34-2.90; p = 0.001). Conclusion:Male sex was independently associated with death, hospitalization, ICU admissions, and need for vasopressors or endotracheal intubation, after correction for important covariates.

The impact of physical inactivity on heart failure (HF) mortality is unclear. We analyzed data from the HF Adherence and Retention Trial (HART) which enrolled 902 NYHA class II/III HF patients, with preserved or reduced ejection fraction, who were followed for 36 months. Based upon mean self-reported weekly exercise duration, patients were classified into inactive (0 min/week) and active (≥ 1 min/week) groups and then propensity-score matched according to 34 baseline covariates in 1:2 ratio. Sedentary activity was determined according to self-reported daily television screen time (<2 h/day, 2–4 h/day; >4 h/day). The primary outcome was all-cause death. Secondary outcomes were cardiac death and HF hospitalization. There were 196 inactive patients, of whom 171 were propensity matched to 342 active patients. Physical inactivity was associated with higher risk of all-cause death (HR, 2.01; CI, 1.47 – 3.00; P < 0.001) and cardiac death (HR, 2.01; CI, 1.28 – 3.17; P = 0.002), but no significant difference in HF hospitalization (P = 0.548). Modest exercise (1–89 min/week) was associated with a significant reduction in the rate of death (P = 0.003) and cardiac death (P = 0.050). Independent of exercise duration and baseline covariates, television screen time (>4 h/day versus <2 h/day) was associated with all-cause death (HR, 1.65; CI, 1.10 – 2.48; P = 0.016; incremental χ2= 6.05; P = 0.049). In conclusion, among symptomatic chronic HF patients, physical inactivity is associated with higher all-cause and cardiac mortality. Failure to exercise and television screen time are additive in their effects on mortality. Even modest exercise was associated with survival benefit.

These data indicate that BNP is an independent predictor of LAAT in AF and may complement the role of the CHADS2 score in predicting stroke risk.

Aims  Patients with acute pulmonary embolism (PE) at low risk for short-term death are candidates for home treatment or short-hospital stay. We aimed at determining whether the assessment of right ventricle dysfunction (RVD) or elevated troponin improves identification of low-risk patients over clinical models alone. Methods and results  Individual patient data meta-analysis of studies assessing the relationship between RVD or elevated troponin and short-term mortality in patients with acute PE at low risk for death based on clinical models (Pulmonary Embolism Severity Index, simplified Pulmonary Embolism Severity Index or Hestia). The primary study outcome was short-term death defined as death occurring in hospital or within 30 days. Individual data of 5010 low-risk patients from 18 studies were pooled. Short-term mortality was 0.7% [95% confidence interval (CI) 0.4–1.3]. RVD at echocardiography, computed tomography or B-type natriuretic peptide (BNP)/N-terminal pro BNP (NT-proBNP) was associated with increased risk for short-term death (1.5 vs. 0.3%; OR 4.81, 95% CI 1.98–11.68), death within 3 months (1.6 vs. 0.4%; OR 4.03, 95% CI 2.01–8.08), and PE-related death (1.1 vs. 0.04%; OR 22.9, 95% CI 2.89–181). Elevated troponin was associated with short-term death (OR 2.78, 95% CI 1.06–7.26) and death within 3 months (OR 3.68, 95% CI 1.75–7.74). Conclusion   RVD assessed by echocardiography, computed tomography, or elevated BNP/NT-proBNP levels and increased troponin are associated with short-term death in patients with acute PE at low risk based on clinical models. RVD assessment, mainly by BNP/NT-proBNP or echocardiography, should be considered to improve identification of low-risk patients that may be candidates for outpatient management or short hospital stay.

BackgroundLeft ventricular diastolic impairment and consequently elevated filling pressure may contribute to stasis leading to left atrial appendage thrombus (LAAT) in nonvalvular atrial fibrillation (AF). We investigated whether transthoracic echocardiographic parameters can predict LAAT independent of traditional clinical predictors.MethodsWe conducted a retrospective cohort study of 297 consecutive nonvalvular AF patients who underwent transthoracic echocardiogram followed by a transesophageal echocardiogram within one year. Multivariate logistic regression analysis models were used to determine factors independently associated with LAAT.ResultsNineteen subjects (6.4%) were demonstrated to have LAAT by transesophageal echocardiography. These patients had higher mean CHADS2 scores [2.6 ± 1.2 vs. 1.9 ± 1.3, P = 0.009], higher E:e’ ratios [16.6 ± 6.1 vs. 12.0 ± 5.4, P = 0.001], and lower mean e’ velocities [6.5 ± 2.1 cm/sec vs. 9.1 ± 3.2 cm/sec, P = 0.001]. Both E:e’ and e’ velocity were associated with LAAT formation independent of the CHADS2 score, warfarin therapy, left ventricular ejection fraction (LVEF), and left atrial volume index (LAVI) [E:e’ odds-ratio = 1.14 (95% confidence interval = 1.03 – 1.3), P = 0.009; e’ velocity odds-ratio = 0.68 (95% confidence interval = 0.5 – 0.9), P = 0.007]. Similarly, diastolic function parameters were independently associated with spontaneous echo contrast.ConclusionThe diastolic function indices E:e’ and e’ velocity are independently associated with LAAT in nonvalvular AF patients and may help identify patients at risk for LAAT.