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Background: Acute decompensation of heart failure (HF) is often marked by fluid retention, and weight loss is a marker of successful diuresis. We examined the relationship between in-hospital weight loss and post-discharge outcomes in patients with HF., Methods: We conducted a propensity score-matched study of 8830 patients hospitalized for decompensated HF in the Medicare-linked Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF) registry, in which 4415 patients in the weight-loss group and 4415 patients in the no-weight-loss group were balanced on 75 baseline characteristics. We defined weight loss as an admission-to-discharge weight loss of 1-30 kilograms, and we defined no weight loss as a weight gain or loss of < 1 kilogram. Hazard ratios (HRs) and 95% confidence intervals (CIs) for outcomes associated with weight loss were estimated., Results: Patients had a mean age of 78 years, 57% were women, and 11% were African American. The median weight loss in the weight-loss group was 3.6 (interquartile range, 2.0-6.0) kilograms. HRs and 95% CIs for 30-day all-cause mortality, all-cause readmission and HF readmission associated with weight loss were 0.75 (0.63-0.90), 0.90 (0.83-0.99) and 0.83 (0.72-0.96), respectively. Respective 60-day HRs (95% CIs) were 0.80 (0.70-0.92), 0.91 (0.85-0.98) and 0.88 (0.79-0.98). These associations were attenuated and lost significance during 6 months of follow-up., Conclusions: Among older patients hospitalized for decompensated HF, in-hospital weight loss was associated with a lower risk of mortality and hospital readmission. These findings suggest that in-hospital weight loss, a marker of successful diuresis and decongestion, is also a marker of improved clinical outcomes., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Sugammadex produces recovery from neuromuscular blockade more rapidly and reliably than neostigmine. We sought to determine if sugammadex is associated with improved perioperative efficiency when compared to traditional neuromuscular blockade reversal with neostigmine, potentially offsetting the higher medication cost. This retrospective analysis involved patients receiving either neostigmine or sugammadex for reversal of neuromuscular blockade at a single academic tertiary care hospital. The final propensity-matched groups consisted of 4060 in each group (neostigmine or sugammadex). The primary outcome measured was total time in the operating room. Secondary outcomes included specific measures of perioperative efficiency as well as postoperative pulmonary failure. The average operating room time for patients was 169.59 [1.27] minutes for neostigmine and 157.06 [1.33] minutes for sugammadex ( P  < 0.001). The difference was primarily accounted for by shorter surgical times (121.45 [1.18] vs 109.62 [1.22] minutes, P  < 0.011). Sugammadex was also associated with a shorter post-anesthesia care unit length of stay (102.47 [1.04] vs 98.67 [1.02] minutes, P  < 0.001). For 8120 patients, sugammadex use was associated with shorter operating room and surgical durations as well as shorter post-anesthesia care unit stay. The favorable pharmacodynamic profile of sugammadex may improve surgical and perioperative efficiency and offset higher medication cost., (Copyright © 2022 Baylor University Medical Center.)

Background: A low right ventricular ejection fraction (RVEF) is a marker of poor outcomes in patients with heart failure with reduced ejection fraction (HFrEF). Beta-blockers improve outcomes in HFrEF, but whether this effect is modified by RVEF is unknown., Methods and Results: Of the 2798 patients in Beta-Blocker Evaluation of Survival Trial (BEST), 2008 had data on baseline RVEF (mean 35%, median 34%). Patients were categorized into an RVEF of less than 35% (n = 1012) and an RVEF of 35% or greater (n = 996). We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) within each RVEF subgroup and formally tested for interactions between bucindolol and RVEF. The effect of bucindolol on all-cause mortality in 2008 patients with baseline RVEF (HR 0.88, 95% CI 0.75-1.02) is consistent with that in 2798 patients in the main trial (HR 0.90, 95% CI 0.78-1.02). Bucindolol use was associated with a lower risk of all-cause mortality in patients with an RVEF of 35% or greater (HR 0.70, 95% CI 0.55-0.89), but not in those with an RVEF of less than 35% (HR 1.02, 95% CI 0.83-1.24, P for interaction = .022). Similar variations were observed for cardiovascular mortality (P for interaction = .009) and sudden cardiac death (P for interaction = .018), but not for pump failure death (P for interaction = .371) or HF hospitalization (P for interaction = .251)., Conclusions: The effect of bucindolol on mortality in patients with HFrEF was modified by the baseline RVEF. If these hypothesis-generating findings can be replicated using approved beta-blockers in contemporary patients with HFrEF, then RVEF may help to risk stratify patients with HFrEF for optimization of beta-blocker therapy., Competing Interests: Declaration of Competing Interest The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Department of Veterans Affairs. Dr Fonarow reports consulting with Abbott, Amgen, Astra Zeneca, Bayer, CHF Solutions, Janssen, Medtronic, Merck, and Novartis, and was the Principal Investigator of OPTIMIZE-HF. Dr Filippatos participated in committees of trials and registries sponsored by Medtronic, Vifor, BI, and Servier, and has received research grants from the European Union. None of the other authors report any conflicts of interest related to this article., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Heart failure (HF) and breast cancer are 2 of the leading causes of death in postmenopausal women. The temporal association between HF and breast cancer in postmenopausal women has not been described., Objectives: This study sought to examine the temporal association between HF and breast cancer., Methods: Postmenopausal women within the WHI (Women's Health Initiative) cohort were studied. All prevalent HF and prevalent breast cancer at enrollment were self-reported. Incident hospitalized HF and breast cancer diagnoses were adjudicated through 2017., Results: Among a cohort of 44,174 women (mean age 63 ± 7 years), 2,188 developed incident invasive breast cancer and 2,416 developed incident hospitalized HF over a median follow-up of 14 and 15 years, respectively. When compared with a breast cancer- and HF-free cohort, there was no association between prevalent HF and incident invasive breast cancer and similarly, there was no association between prevalent breast cancer and incident hospitalized HF. Across the entire cohort, the median survival after incident hospitalized HF was worse compared with an incident invasive breast cancer diagnosis (5 and 19 years, respectively). In women with incident invasive breast cancer, prevalent HF was associated with an increased risk of mortality (hazard ratio: 2.28; 95% confidence interval: 1.31 to 3.95). In women with incident hospitalized HF, prevalent breast cancer was associated with an increased risk of mortality (hazard ratio: 1.66; 95% confidence interval: 1.03 to 2.68). Cause of death after incident HF was different only in women with prevalent and interim breast cancer compared with those without prevalent and interim breast cancer., Conclusions: In postmenopausal women, prevalent HF was not associated with a higher incidence of breast cancer and vice versa. However, the presence of incident invasive breast cancer or incident HF in those with prevalent HF or prevalent breast cancer, respectively, was associated with increased mortality., Competing Interests: Dr. Nohria has received research support from Amgen, Inc.; and has consulted for Takeda Oncology. Dr. Fonarow has consulted for Abbott, Amgen, Bayer, Janssen, Novartis, and Medtronic. Dr. Chlebowski has consulted for Novartis, AstraZeneca, Genentech, Merck, and Immunomedics; and has received honorarium from Novartis and AstraZeneca. Dr. Mohammed serves on the Advisory Board for Pfizer; and has received research support from CardioCell, Abbott, Actelion, Corvia, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2020 The Authors.)

Objective: Epidural anesthesia for the parturient is often provided in a clinical context where rapid onset of segmental analgesia is important; however, little is published on the ideal local anesthetic to safely achieve this onset. To fi ll this gap in knowledge, we studied bupivacaine and lidocaine, two local anesthetics (LA) commonly used for labor epidural activation, either as a single drug or in combination to determine the onset of epidural analgesia., Methods: In this double-blinded study, seventy-five patients were randomized into three groups (n = 25 each) for labor epidural activation: 10 mL of 0.25% bupivacaine, 10 mL of 1% lidocaine, or 5 mL of 0.25% bupivacaine plus 5 mL of 1% lidocaine. Patients were assessed for the fi rst 20 min after drug administration at 5-min intervals. Data collected included sensory level to pinprick, maternal blood pressure, vasopressor administration, and peak motor blockade., Results: Data were analyzed on 71 of 75 patients. Time to loss of sensation to pinprick at the T10 dermatome in the bupivacaine group was signifi cantly longer than the lidocaine group (p = 0.006), but the time to loss of sensation to pinprick at the T10 dermatome did not signifi cantly differ in the bupivacaine plus lidocaine group when compared to both the bupivacaine (p = 0.114) as well as the lidocaine (p = 0.203) groups. Phenylephrine usage did not signifi cantly differ amongst the three groups (p = 0.062)., Conclusion: Lidocaine provides statistically signifi cant faster onset of epidural analgesia when compared to bupivacaine only. Combining the two LA did not signifi cantly affect onset.

Background: Digoxin use has been associated with a lower risk of 30-day all-cause admission and readmission in patients with heart failure and reduced ejection fraction (HFrEF)., Hypothesis: Digoxin use will be associated with improved outcomes in patients with HFrEF receiving β-blockers., Methods: Of the 3076 hospitalized Medicare beneficiaries with HFrEF (EF <45%), 1046 received a discharge prescription for β-blockers, of which 634 were not on digoxin. Of the 634, 204 received a new discharge prescription for digoxin. Propensity scores for digoxin use, estimated for each of the 634 patients, were used to assemble a matched cohort of 167 pairs of patients receiving and not receiving digoxin, balanced on 30 baseline characteristics. Matched patients (n = 334) had a mean age of 74 years and were 46% female and 30% African American., Results: 30-day all-cause readmission occurred in 15% and 27% of those receiving and not receiving digoxin, respectively (hazard ratio [HR]: 0.51, 95% confidence interval [CI]: 0.31-0.83, P = 0.007). This beneficial association persisted during 4 years of follow-up (HR: 0.72, 95% CI: 0.57-0.92, P = 0.008). Digoxin use was also associated with a lower risk of the combined endpoint of all-cause readmission or all-cause mortality at 30 days (HR: 0.54, 95% CI: 0.34-0.86, P = 0.009) and at 4 years (HR: 0.76, 95% CI: 0.61-0.96, P = 0.020)., Conclusions: In hospitalized patients with HFrEF receiving β-blockers, digoxin use was associated with a lower risk of 30-day all-cause readmission but not mortality, which persisted during longer follow-up., (© 2018 Wiley Periodicals, Inc.)

In this review I discuss the appropriateness of various statistical methods for use with small sample sizes. I review the assumptions and limitations of these methods and provide recommendations for figures and statistical tests., (Copyright © 2017 the American Physiological Society.)

Aims: Octogenarians have the highest incidence of heart failure (HF) that is not fully explained by traditional risk factors. We explored whether lack of pneumococcal vaccination is associated with higher risk of incident HF among octogenarians., Methods and Results: In the Cardiovascular Health Study (CHS), 5290 community-dwelling adults, ≥65 years of age, were free of baseline HF and had data on pneumococcal vaccination. Of these, 851 were octogenarians, of whom, 593 did not receive pneumococcal vaccination. Multivariable-adjusted hazard ratios (aHR) and 95% confidence intervals (CI) for associations of lack of pneumococcal vaccination with incident HF and other outcomes during 13 years of follow-up were estimated using Cox regression models, adjusting for demographics and other HF risk factors including influenza vaccination. Octogenarians had a mean (±SD) age of 83 (±3) years; 52% were women and 17% African American. Overall, 258 participants developed HF and 662 died. Lack of pneumococcal vaccination was associated with higher relative risk of incident HF (aHR, 1.37; 95% CI, 1.01-1.85; P  = 0.044). There was also higher risk for all-cause mortality (aHR, 1.23; 95% CI, 1.02-1.49; P  = 0.028), which was mostly driven by cardiovascular mortality (aHR, 1.45; 95% CI, 1.06-1.98; P  = 0.019). Octogenarians without pneumococcal vaccination had a trend toward higher risk of hospitalization due to pneumonia (aHR, 1.34; 95% CI, 0.99-1.81; P  = 0.059). These associations were not observed among those 65-79 years of age., Conclusions: Among community-dwelling octogenarians, lack of pneumococcal vaccination was associated with a significantly higher independent risk of incident HF and mortality, and trend for higher pneumonia hospitalization.

Background: According to the 2004 Surgeon General's Report on Health Consequences of Smoking, after >15 years of abstinence, the cardiovascular risk of former smokers becomes similar to that of never-smokers. Whether this health benefit of smoking cessation varies by amount and duration of prior smoking remains unclear., Methods and Results: Of the 4482 adults ≥65 years without prevalent heart failure (HF) in the Cardiovascular Health Study, 2556 were never-smokers, 629 current smokers, and 1297 former smokers with >15 years of cessation, of whom 312 were heavy smokers (highest quartile; ≥32 pack-years). Age-sex-race-adjusted hazard ratios (aHR) and 95% confidence intervals (CI) for centrally adjudicated incident HF and mortality during 13 years of follow-up were estimated using Cox regression models. Compared with never-smokers, former smokers as a group had similar risk for incident HF (aHR, 0.99; 95% CI, 0.85-1.16) and all-cause mortality (aHR, 1.08; 95% CI, 0.96-1.20), but former heavy smokers had higher risk for both HF (aHR, 1.45; 95% CI, 1.15-1.83) and mortality (aHR, 1.38; 95% CI, 1.17-1.64). However, when compared with current smokers, former heavy smokers had lower risk of death (aHR, 0.64; 95% CI, 0.53-0.77), but not of HF (aHR, 0.97; 95% CI, 0.74-1.28)., Conclusions: After >15 years of smoking cessation, the risk of HF and death for most former smokers becomes similar to that of never-smokers. Although this benefit of smoking cessation is not extended to those with ≥32 pack-years of prior smoking, they have lower risk of death relative to current smokers., (© 2015 American Heart Association, Inc.)

Background: Clinical intuition suggests that a sharp increase in the number of enhancing lesions should signal an increased risk of relapse. The 'rule of five' recommends that subjects exhibiting at least five lesions over the baseline level be referred for closer monitoring. This rule has been used as an informal safety criterion with limited formal evaluation., Objective: The purpose of this study was to determine the best threshold for the rule and to demonstrate its predictive validity for risk of subsequent relapses for multiple sclerosis (MS) trials., Methods: We used logistic regression modeling to apply the rule to patient data from a phase II clinical trial. Predictive validity was ascertained using rate ratios and receiver operating characteristic (ROC) curves., Results: We found that, for these data, a threshold of five lesions over the baseline constituted the best definition of a threshold. Overall, 35% of subjects broke the rule at least once. Breaking the rule increased the odds of imminent relapse by a factor of 3.2 (95% confidence interval (CI): 1.8-5.5)., Conclusion: Breaking the rule of five was found to be a significant predictor of an imminent relapse. Length of follow-up and the number of lesions discovered via magnetic resonance imaging (MRI) were also significant predictors of relapse.