Publications by authors named "Robert J Mentz"

362 Publications

Patient Phenotypes and SGLT-2 Inhibition in Type 2 Diabetes: Insights From the EMPA-REG OUTCOME Trial.

JACC Heart Fail 2021 Aug;9(8):568-577

Duke University School of Medicine, Durham, North Carolina, USA.

Objectives: Using latent class analysis (LCA) of EMPA-REG OUTCOME (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients), this study identified distinct phenotypes in subjects with type 2 diabetes (T2D) and cardiovascular (CV) disease and explored treatment effects across phenotypes.

Background: In the EMPA-REG OUTCOME trial, empagliflozin reduced risk of CV death or hospitalization for heart failure (HHF) by 34% in subjects with T2D and CV disease. Among such subjects, there has been limited evaluation of clinical phenotypes.

Methods: Overall, 7,020 participants were treated with empagliflozin 25 mg, 10 mg, or placebo. For this post hoc analysis, participants were randomly separated into training (two-thirds of patients) and validation (remaining one-third) sets. LCA identified 3 phenotype groups (n = 6,639 with complete data). The phenotype association with CV death or HHF and empagliflozin treatment effect across groups was explored by Cox regression (in training and validation sets).

Results: In the training set, phenotype group 1 (n = 1,463; 33.1%) included younger patients with shorter T2D duration and the highest estimated glomerular filtration rate (eGFR). Phenotype group 2 (n = 1,172; 26.5%) included more women with non-coronary artery disease. Phenotype group 3 (n = 1,785; 40.4%) included older patients with advanced coronary disease and the lowest eGFR. The risk of CV death varied across phenotypes (group 2 vs. 1: hazard ratio [HR]; 1.83; 95% confidence interval [CI]: 1.23 to 2.71; group 3 vs. 1: HR: 1.86; 95% CI: 1.30 to 2.67) with similar patterns for CV death or HHF. Consistent treatment effects of empagliflozin were seen across phenotypes in the training and validation sets (interaction p > 0.30).

Conclusions: Among participants with T2D, this study identified 3 phenotypes with varying CV risk. The treatment effect across phenotypes reaffirms the robustness of CV death or HHF reduction with empagliflozin. (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients [EMPA-REG OUTCOME]; NCT01131676).
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http://dx.doi.org/10.1016/j.jchf.2021.03.003DOI Listing
August 2021

A Case for Re-Gifting.

JACC Case Rep 2021 Jul 2;3(7):1010-1012. Epub 2021 Jun 2.

Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.

Many patients die while waiting for a heart transplant. Therefore, it is vital that all suitable organs are used for transplantation. We present a case of an allograft that was transplanted twice and outline considerations regarding tissue typing, the impact of repeated ischemic time, and ethical considerations with allograft retransplantation. ().
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http://dx.doi.org/10.1016/j.jaccas.2021.03.025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311369PMC
July 2021

Sleep quality, depressive symptoms, and transplant outcomes: Follow-up analyses from the ADAPT prospective pilot study.

Gen Hosp Psychiatry 2021 Jun 29;72:53-58. Epub 2021 Jun 29.

Duke University Medical Center, Department of Medicine, Durham, NC, United States of America; Duke Clinical Research Institute, Durham, NC, United States of America.

Background: Previous studies suggested that depressive symptoms and sleep quality may be important for long-term clinical outcomes following cardiothoracic transplant. Few studies, however, have systematically examined objective markers of these behavioral factors among ambulatory transplant recipients, or their association with clinical outcomes.

Methods: We examined sleep quality and depressive symptoms with subsequent clinical outcomes (hospitalizations and death) in a sample of 66 lung or heart transplant recipients using a single-center, prospective cohort study. Recipients were assessed at approximately 6 months post-transplant and completed one week of actigraphy assessment to examine sleep quality and self-report measures of mood (Centers for Epidemiologic Studies of Depression [CESD]). Recipients were followed for clinical outcomes.

Results: At 6-months following transplantation, recipients spent the majority of daytime activity at a sedentary level (61% of daily activity [SD = 10]) and elevated depressive symptoms were common (subclinical = 17%, mild = 12%, or moderate = 8%). Over a median follow-up of 4.5 years (IQR = 0.9, 5.1), 51 participants (77%) had at least one unplanned hospitalization and 11 (17%) participants died. In addition, sleep efficiency measurements suggested that a subset of participants exhibited suboptimal sleep (mean efficiency = 87% [SD = 7]). Poorer sleep quality, indexed by lower sleep efficiency and greater sleep fragmentation, was associated with greater depressive symptoms (r's = 0.37-0.50, P < .01). Better sleep quality at 6-months (HR = 0.75 [0.60, 0.95], P = .015), including sleep efficiency (HR = 0.74 [0.56, 0.99], P = .041) and sleep fragmentation (HR = 0.71 [0.53, 0.95], P = .020) were associated with lower risk of hospitalization or death. Compared with individuals without elevated depressive symptoms or sleep difficulties, individuals with either factor (HR = 1.72 [1.05, 2.81], P = .031) or both factors (HR = 2.37 [1.35, 4.18], P = .003) exhibited greater risk of clinical events in adjusted analyses.

Conclusions: Sleep quality is associated with depressive symptoms among cardiothoracic transplant recipients and enhances the prognostic association between biobehavioral risk factors and clinical outcomes.
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http://dx.doi.org/10.1016/j.genhosppsych.2021.06.011DOI Listing
June 2021

Sex-Differences in Cause of Death for Patients Hospitalized for Heart Failure With Reduced Versus Preserved Ejection Fraction (from the ASCEND-HF Trial).

Am J Cardiol 2021 Jul 17. Epub 2021 Jul 17.

Division of Cardiology, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.

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http://dx.doi.org/10.1016/j.amjcard.2021.06.006DOI Listing
July 2021

Representativeness of the VICTORIA Trial Population in Clinical Practice: Analysis of the PINNACLE Registry.

J Card Fail 2021 Jul 13. Epub 2021 Jul 13.

Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham NC, USA.

Background: . In the VICTORIA trial, vericiguat reduced the risk of cardiovascular mortality and heart failure (HF) hospitalization among patients with heart failure with reduced ejection fraction (HFrEF) and a recent worsening heart failure event (WHFE). The representativeness of VICTORIA population to patients with WHFE in clinical practice is unknown.

Methods And Results: . Patients with HF and ejection fraction <45% were identified in the PINNACLE registry and stratified by the occurrence of WHFE. Characteristics and outcomes of PINNACLE patients with and without a WHFE were compared to the VICTORIA population. Of the 14,180 PINNACLE patients with HFrEF identified, 26.5% had a WHFE. The VICTORIA population was similar to PINNACLE patients with a WHFE in mean age (67.3 vs. 66.7), ejection fraction (28.9% vs. 28.3%), body mass index (26.8 vs. 27.6), and comorbidity burden. The rate of HF hospitalization at 1 year was 29.6% in the placebo group of VICTORIA, compared to 35.8% in PINNACLE patients with a WHFE and 13.3% in patients without a WHFE.

Conclusions: . The PINNACLE patients with a WHFE meeting the VICTORIA definition resembled the VICTORIA population in characteristics and outcomes, suggesting that VICTORIA's population may be generalizable to patients with a WHFE in clinical practice.
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http://dx.doi.org/10.1016/j.cardfail.2021.06.019DOI Listing
July 2021

Rehabilitation Intervention in Older Patients With Acute Heart Failure With Preserved Versus Reduced Ejection Fraction.

JACC Heart Fail 2021 Jun 29. Epub 2021 Jun 29.

Section on Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA; Sections on Geriatrics, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA. Electronic address:

Objectives: This study assessed for treatment interactions by ejection fraction (EF) subgroup (≥45% [preserved EF (HFpEF); vs <45% [reduced EF; (HFrEF)]).

Background: The REHAB-HF trial showed that an early multidomain rehabilitation intervention improved physical function, frailty, quality-of-life, and depression in older patients hospitalized with acute decompensated heart failure (ADHF).

Methods: Three-month outcomes were: Short Physical Performance Battery (SPPB), 6-min walk distance (6MWD), and Kansas City Cardiomyopathy Questionnaire (KCCQ). Six-month end points included all-cause rehospitalization and death and a global rank of death, all-cause rehospitalization, and SPPB. Prespecified significance level for interaction was P ≤ 0.1.

Results: Among 349 total participants, 185 (53%) had HFpEF and 164 (47%) had HFrEF. Compared with HFrEF, HFpEF participants were more often women (61% vs 43%) and had significantly worse baseline physical function, frailty, quality of life, and depression. Although interaction P values for 3-month outcomes were not significant, effect sizes were larger for HFpEF vs HFrEF: SPPB +1.9 (95% CI: 1.1-2.6) vs +1.1 (95% CI: 0.3-1.9); 6MWD +40 meters (95% CI: 9 meters-72 meters) vs +27 (95% CI: -6 meters to 59 meters); KCCQ +9 (2-16) vs +6 (-2 to 14). All-cause rehospitalization rate was nominally lower with intervention in HFpEF but not HFrEF [effect size 0.83 (95% CI: 0.64-1.09) vs 0.99 (95% CI: 0.74-1.33); interaction P = 0.40]. There were significantly greater treatment benefits in HFpEF vs HFrEF for all-cause death [interaction P = 0.08; intervention rate ratio 0.63 (95% CI: 0.25-1.61) vs 2.21 (95% CI: 0.78-6.25)], and the global rank end point (interaction P = 0.098) with benefit seen in HFpEF [probability index 0.59 (95% CI: 0.50-0.68)] but not HFrEF.

Conclusions: Among older patients hospitalized with ADHF, compared with HFrEF those with HFpEF had significantly worse impairments at baseline and may derive greater benefit from the intervention. (A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients [REHAB-HF]; NCT02196038).
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http://dx.doi.org/10.1016/j.jchf.2021.05.007DOI Listing
June 2021

Regional Adiposity and Risk of Heart Failure and Mortality: The Jackson Heart Study.

J Am Heart Assoc 2021 Jul 9;10(14):e020920. Epub 2021 Jul 9.

Duke Clinical Research Institute Duke University School of Medicine Durham NC.

Background Visceral adipose tissue (VAT) is associated with incident heart failure (HF) and HF with preserved ejection fraction, yet it is unknown how pericardial and abdominal adiposity affect HF and mortality risks in Black individuals. We examined the associations of pericardial adipose tissue (PAT), VAT, and subcutaneous adipose tissue (SAT) with incident HF hospitalization and all-cause mortality in a large community cohort of Black participants. Methods and Results Among the 2882 Jackson Heart Study Exam 2 participants without prevalent HF who underwent body computed tomography, we used Cox proportional hazards models to examine associations between computed tomography-derived regional adiposity and incident HF hospitalization and all-cause mortality. Fully adjusted models included demographics and cardiovascular disease risk factors. Median follow-up was 10.6 years among participants with available VAT (n=2844), SAT (n=2843), and PAT (n=1386). Fully adjusted hazard ratios (95% CIs) of distinct computed tomography-derived adiposity measures (PAT per 10 cm, VAT or SAT per 100 cm) were as follows: for incident HF, PAT 1.08 (95% CI, 1.02-1.14) and VAT 1.04 (95% CI, 1.01-1.08); for HF with preserved ejection fraction, PAT 1.13 (95% CI, 1.04-1.21) and VAT 1.07 (95% CI, 1.01-1.13); for mortality, PAT 1.07 (95% CI, 1.03-1.12) and VAT 1.01 (95% CI, 0.98-1.04). SAT was not associated with either outcome. Conclusions High PAT and VAT, but not SAT, were associated with incident HF and HF with preserved ejection fraction, and only PAT was associated with mortality in the fully adjusted models in a longitudinal community cohort of Black participants. Future studies may help understand whether changes in regional adiposity improves HF, particularly HF with preserved ejection fraction, risk predictions. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00005485.
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http://dx.doi.org/10.1161/JAHA.121.020920DOI Listing
July 2021

Clinical Outcome Predictions for the VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) Trial.

J Card Fail 2021 Jun 24. Epub 2021 Jun 24.

Duke Clinical Research Institute, Duke University, Durham, North Carolina.

Background: The prediction of outcomes in patients with heart failure (HF) may inform prognosis, clinical decisions regarding treatment selection, and new trial planning. The VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction included high-risk patients with HF with reduced ejection fraction and a recent worsening HF event. The study participants had a high event rate despite the use of contemporary guideline-based therapies. To provide generalizable predictive data for a broad population with a recent worsening HF event, we focused on risk prognostication in the placebo group.

Methods And Results: Data from 2524 participants randomized to placebo with chronic HF (New York Heart Association functional class II-IV) and an ejection fraction of less than 45% were studied and backward variable selection was used to create Cox proportional hazards models for clinical end points, selecting from 66 candidate predictors. Final model results were produced, accounting for missing data, and nonlinearities. Optimism-corrected c-indices were calculated using 200 bootstrap samples. Over a median follow-up of 10.4 months, the primary outcome of HF hospitalization or cardiovascular death occurred in 972 patients (38.5%). Independent predictors of increased risk for the primary end point included HF characteristics (longer HF duration and worse New York Heart Association functional class), medical history (prior myocardial infarction), and laboratory values (higher N-terminal pro-hormone B-type natriuretic peptide, bilirubin, urate; lower chloride and albumin). Optimism-corrected c-indices were 0.68 for the HF hospitalization/cardiovascular death model, 0.68 for HF hospitalization/all-cause death, 0.72 for cardiovascular death, and 0.73 for all-cause death.

Conclusions: Predictive models developed in a large diverse clinical trial with comprehensive clinical and laboratory baseline data-including novel measures-performed well in high-risk patients with HF who were receiving excellent guideline-based clinical care.

Clinical Trial Registration: Clinicaltrials.gov identifier, NCT02861534.Lay Summary: Patients with heart failure may benefit from tools that help clinicians to better understand a patient's risk for future events like hospitalization. Relatively few risk models have been created after the worsening of heart failure in a contemporary cohort. We provide insights on the risk factors for clinical events from a recent, large, global trial of patients with worsening heart failure to help clinicians better understand and communicate prognosis and select treatment options.
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http://dx.doi.org/10.1016/j.cardfail.2021.05.016DOI Listing
June 2021

Clinical Outcome Predictions for the VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA) Trial: VICTORIA Outcomes Model.

J Card Fail 2021 May 26. Epub 2021 May 26.

Duke Clinical Research Institute, Duke University, Durham, NC.

Background: Prediction of outcomes in patients with heart failure (HF) may inform prognosis, clinical decisions regarding treatment selection, and new trial planning. The VICTORIA trial included high-risk patients with HF and reduced ejection fraction and a recent worsening HF event. The study participants had an unusually high event rate despite usage of contemporary guideline-based therapies. To provide generalizable predictive data for a broad population with a recent worsening HF event, we focused on risk prognostication in the placebo group.

Methods: Data from 2524 participants randomized to placebo with chronic HF (New York Heart Association class [NYHA] II-IV) and ejection fraction <45% were studied and backward variable selection was used to create Cox proportional hazards models for clinical endpoints, selecting from 66 candidate predictors. Final model results were produced, accounting for missing data, non-linearities, and interactions with treatment. Optimism-corrected c-indices were calculated using 200 bootstrap samples.

Results: During a median follow-up of 10.4 months, the primary outcome of HF hospitalization or cardiovascular death occurred in 972 (38.5%) patients. Independent predictors of increased risk for the primary endpoint included HF characteristics (longer HF duration and worse NYHA class), medical history (prior myocardial infarction), and laboratory values (higher N-terminal pro-hormone B-type natriuretic peptide, bilirubin, urate; lower chloride and albumin). Optimism-corrected c-indices were 0.68 for the HF hospitalization/cardiovascular death model, 0.68 for HF hospitalization/all-cause death, 0.72 for cardiovascular death, and 0.73 for all-cause death.

Conclusions: Predictive models developed in a large diverse clinical trial with comprehensive clinical and laboratory baseline data-including novel measures-performed well in high-risk HF patients who were receiving excellent guideline-based clinical care.

Clinical Trial Registration: Clinicaltrials.gov identifier, NCT02861534.

Lay Summary: Patients with heart failure may benefit from tools that help clinicians better understand patient's risk for future events like hospitalization. Relatively few risk models have been created after worsening of heart failure in a contemporary cohort. We provide insights on risk factors for clinical events from a recent large, global trial of patients with worsening heart failure to help clinicians better understand and communicate prognosis and select treatment options.
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http://dx.doi.org/10.1016/j.cardfail.2021.05.016DOI Listing
May 2021

Drugs of Abuse and Heart Failure.

J Card Fail 2021 Jun 13. Epub 2021 Jun 13.

Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.

Substance use is common among those with heart failure (HF) and is associated with worse clinical outcomes. Alcohol, tobacco, cannabis, and cocaine are commonly abused substances that can contribute to the development and worsening of HF. Heavy alcohol consumption can lead to dilated cardiomyopathy, whereas moderate intake may decrease incident HF. Tobacco increases the risk of HF through coronary artery disease and coronary artery disease-independent mechanisms. Continued smoking worsens outcomes for those with HF and cessation is associated with an improved risk of major adverse cardiac events. Cannabis has complex interactions on the cardiovascular system depending on the method of consumption, amount consumed, and content of cannabinoids. Delta-9-tetrahydrocannabinol can increase sympathetic tone, cause vascular dysfunction, and may increase the risk of myocardial infarction. Cannabidiol is cardioprotective in preclinical studies and is a potential therapeutic target. Cocaine increases sympathetic tone and is a potent proarrhythmogenic agent. It increases the risk of myocardial infarction and can also lead to a dilated cardiomyopathy. The use of beta-blockers in those with HF and cocaine use is likely safe and effective. Future studies are needed to further elucidate the impact of these substances both on the development of HF and their effects on those who have HF.
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http://dx.doi.org/10.1016/j.cardfail.2021.05.023DOI Listing
June 2021

Physical Activity, Subclinical Myocardial Injury, and Risk of Heart Failure Subtypes in Black Adults.

JACC Heart Fail 2021 Jul 9;9(7):484-493. Epub 2021 Jun 9.

Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA. Electronic address:

Objectives: This study sought to evaluate the independent associations and interactions between high-sensitivity cardiac troponin I (hs-cTnI) and physical activity (PA) with risk of heart failure (HF) subtypes, HF with preserved ejection fraction (HFpEF) and HF with reduced ejection fraction (HFrEF).

Background: Black adults are at high risk for developing HF. Physical inactivity and subclinical myocardial injury, as assessed by hs-cTnI concentration, are independent risk factors for HF.

Methods: Black adults from the Jackson Heart Study without prevalent HF who had hs-cTnI concentration and self-reported PA assessed at baseline were included. Adjusted Cox models were used to evaluate the independent and joint associations and interaction between hs-cTnI concentrations and PA with risk of HFpEF and HFrEF.

Results: Among 3,959 participants, 25.1% had subclinical myocardial injury (hs-cTnI ≥4 and ≥6 ng/l in women and men, respectively), and 48.2% were inactive (moderate-to-vigorous PA = 0 min/week). Over 12.0 years of follow-up, 163 and 150 participants had an incident HFpEF and HFrEF event, respectively. In adjusted analysis, higher hs-cTnI concentration (per 1-U log increase) was associated with higher risk of HFpEF (hazard ratio [HR]: 1.47; 95% confidence interval [CI]: 1.25 to 1.72]) and HFrEF (HR: 1.57; 95% CI: 1.35 to 1.83]). In contrast, higher PA (per 1-U log increase) was associated with a lower risk of HFpEF (HR: 0.93; 95% CI: 0.88 to 0.99]) but not HFrEF. There was a significant interaction between hs-cTnI and PA for risk of HFpEF (p interaction = 0.04) such that inactive participants with subclinical myocardial injury were at higher risk of HFpEF but active participants were not.

Conclusions: Among Black adults with subclinical myocardial injury, higher levels of PA were associated with attenuated risk of HFpEF.
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http://dx.doi.org/10.1016/j.jchf.2021.04.003DOI Listing
July 2021

Remembering the Calling - Where Patients and Caregivers Are Front and Center.

J Card Fail 2021 Jun;27(6):621

Duke University Medical Center and Duke Clinical Research Institute, Durham, NC, USA.

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http://dx.doi.org/10.1016/j.cardfail.2021.05.001DOI Listing
June 2021

Growth differentiation factor-15, treatment with liraglutide, and clinical outcomes among patients with heart failure.

ESC Heart Fail 2021 Aug 1;8(4):2608-2616. Epub 2021 Jun 1.

Duke Clinical Research Institute, Duke University, 200 Morris Street, Durham, NC, 27701, USA.

Aims: Associations between growth differentiation factor-15 (GDF-15), cardiovascular outcomes, and exercise capacity among patients with a recent hospitalization for heart failure (HHF) and heart failure with reduced ejection fraction (HFrEF) are unknown. We utilized data from the 'Functional Impact of GLP-1 for Heart Failure Treatment' (FIGHT) study to address these knowledge gaps.

Methods And Results: FIGHT was a randomized clinical trial testing the effect of liraglutide (vs. placebo) among 300 participants with HFrEF and a recent HHF. Multivariable regression models evaluated associations between baseline GDF-15 and change in GDF-15 (per 1000 pg/mL increase from baseline to 30 days) with clinical outcomes (at 180 days) and declines in exercise capacity (6 min walk distance ≥ 45 m). At baseline (n = 249), median GDF-15 value was 3221 pg/mL (interquartile range 1938-5511 pg/mL). Participants in the highest tertile of baseline GDF-15 were more likely to be male and have more co-morbidities. After adjustment, an increase in GDF-15 over 30 days was associated with higher risk of death or HHF [hazard ratio 1.35, 95% confidence interval (CI) 1.11-1.64]. In addition, higher baseline GDF-15 (per 1000 pg/mL until 6000 pg/mL) and an increase in GDF-15 over 30 days were associated with declining 6 min walk distance (odds ratio 1.26, 95% CI 1.02-1.55 and odds ratio 1.37, 95% CI 1.12-1.69, respectively). GDF-15 levels remained stable among participants randomized to liraglutide.

Conclusions: An increase in GDF-15 over 30 days among patients in HFrEF was independently associated with an increased risk of cardiovascular events and declining exercise capacity. These results support the value of longitudinal GDF-15 trajectory in informing risk of heart failure disease progression.
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http://dx.doi.org/10.1002/ehf2.13348DOI Listing
August 2021

Early diuretic strategies and the association with In-hospital and Post-discharge outcomes in acute heart failure.

Am Heart J 2021 Sep 27;239:110-119. Epub 2021 May 27.

Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Duke University Medical Center, Durham, NC.

Background: Decongestion is a primary goal during hospitalizations for decompensated heart failure (HF). However, data surrounding the preferred route and strategy of diuretic administration are limited with varying results in prior studies.

Methods: This is a retrospective analysis using patients from ASCEND-HF with a stable diuretic strategy in the first 24 hours following randomization. Patients were divided into three groups: intravenous (IV) continuous, IV bolus and oral strategy. Baseline characteristics, in-hospital outcomes, 30-day composite cardiovascular mortality or HF rehospitalization and 180-day all-cause mortality were compared across groups. Inverse propensity weighted modeling was used for adjustment.

Results: Among 5,738 patients with a stable diuretic regimen in the first 24 hours (80% of overall ASCEND trial), 3,944 (68.7%) patients received IV intermittent bolus administration of diuretics, 799 (13.9%) patients received IV continuous therapy and 995 (17.3%) patients with oral administration. Patients in the IV continuous group had a higher baseline creatinine (IV continuous 1.4 [1.1-1.7]; intermittent bolus 1.2 [1.0-1.6]; oral 1.2 [1.0-1.4] mg/dL; P <0.001) and high NTproBNP (IV continuous 5,216 [2,599-11,603]; intermittent bolus 4,944 [2,339-9,970]; oral 3,344 [1,570-7,077] pg/mL; P <0.001). There was no difference between IV continuous and intermittent bolus group in weight change, total urine output and change in renal function till 10 days/discharge (adjusted P >0.05 for all). There was no difference in 30 day mortality and HF readmission (adjusted OR 1.08 [95%CI: 0.74, 1.57]; P = 0.701) and 180 days mortality (adjusted OR 1.04 [95%CI: 0.75, 1.43]; P = 0.832).

Conclusion: In a large cohort of patients with decompensated HF, there were no significant differences in diuretic-related in-hospital, or post-discharge outcomes between IV continuous and intermittent bolus administration. Tailoring appropriate diuretic strategy to different states of acute HF and congestion phenotypes needs to be further investigated.
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http://dx.doi.org/10.1016/j.ahj.2021.05.011DOI Listing
September 2021

Randomized Placebo-Controlled Trial of Ferric Carboxymaltose in Heart Failure With Iron Deficiency: Rationale and Design.

Circ Heart Fail 2021 May 18;14(5):e008100. Epub 2021 May 18.

Duke Clinical Research Institute, Durham, NC (R.J.M., F.R., J.G., M.D.S., D.L., A.F.H.).

Background: Iron deficiency (ID) has a prevalence of ≈40% to 50% among patients in heart failure (HF) with reduced ejection fraction and is associated with worse prognosis. Several trials demonstrated that intravenous ferric carboxymaltose leads to early and sustained improvement in patient-reported outcomes and functional capacity in patients with HF with reduced ejection fraction with ID, yet morbidity and mortality data are limited.

Methods: The objective of the HEART-FID trial (Ferric Carboxymaltose in Heart Failure With Iron Deficiency) is to assess efficacy and safety of ferric carboxymaltose compared with placebo as treatment for symptomatic HF with reduced ejection fraction with ID. HEART-FID is a multicenter, randomized, double-blind, placebo-controlled trial enrolling ≈3014 patients at ≈300 international centers. Eligible patients are aged ≥18 years in stable chronic HF with New York Heart Association functional class II to IV symptoms, ejection fraction ≤40%, ID (ferritin <100 ng/mL or ferritin 100-300 ng/mL with a transferrin saturation <20%), and documented HF hospitalization or elevated N-terminal pro-brain natriuretic peptide. Consented patients are assigned to ferric carboxymaltose or placebo at baseline, with repeated visits/assessments every 6 months for additional study drug based on hemoglobin and iron indices for the trial duration. The primary end point is a hierarchical composite of death and HF hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance.

Conclusions: The HEART-FID trial will inform clinical practice by clarifying the role of long-term treatment with intravenous ferric carboxymaltose, added to usual care, in ambulatory patients with symptomatic HF with reduced ejection fraction with ID. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03037931.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.120.008100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8136455PMC
May 2021

Physical Rehabilitation for Older Patients Hospitalized for Heart Failure.

N Engl J Med 2021 07 16;385(3):203-216. Epub 2021 May 16.

From the Department of Internal Medicine, Sections of Cardiovascular Medicine (D.W.K., M.B.N., B.U.) and Gerontology and Geriatric Medicine (D.W.K., M.A.E.), and the Departments of Neurology (P.D.) and Biostatistics and Data Science (H.C., M.A.E.), Wake Forest School of Medicine, Winston-Salem, the Department of Orthopedic Surgery, Doctor of Physical Therapy Division (A.M.P.), the Department of Medicine, Division of Cardiology (R.J.M.), and the Department of Population Health Sciences (S.D.R.), Duke University School of Medicine, Durham, and Novant Health Heart and Vascular Institute, Charlotte (G.R.R.) - all in North Carolina; the Department of Medicine, Sidney Kimmel Medical College at Thomas Jefferson University (D.J.W.), and the Department of Physical Therapy, Jefferson College of Rehabilitation Sciences at Thomas Jefferson University (L.A.H.) - both in Philadelphia; and Inova Heart and Vascular Institute, Fairfax, VA (C.M.O.).

Background: Older patients who are hospitalized for acute decompensated heart failure have high rates of physical frailty, poor quality of life, delayed recovery, and frequent rehospitalizations. Interventions to address physical frailty in this population are not well established.

Methods: We conducted a multicenter, randomized, controlled trial to evaluate a transitional, tailored, progressive rehabilitation intervention that included four physical-function domains (strength, balance, mobility, and endurance). The intervention was initiated during, or early after, hospitalization for heart failure and was continued after discharge for 36 outpatient sessions. The primary outcome was the score on the Short Physical Performance Battery (total scores range from 0 to 12, with lower scores indicating more severe physical dysfunction) at 3 months. The secondary outcome was the 6-month rate of rehospitalization for any cause.

Results: A total of 349 patients underwent randomization; 175 were assigned to the rehabilitation intervention and 174 to usual care (control). At baseline, patients in each group had markedly impaired physical function, and 97% were frail or prefrail; the mean number of coexisting conditions was five in each group. Patient retention in the intervention group was 82%, and adherence to the intervention sessions was 67%. After adjustment for baseline Short Physical Performance Battery score and other baseline characteristics, the least-squares mean (±SE) score on the Short Physical Performance Battery at 3 months was 8.3±0.2 in the intervention group and 6.9±0.2 in the control group (mean between-group difference, 1.5; 95% confidence interval [CI], 0.9 to 2.0; P<0.001). At 6 months, the rates of rehospitalization for any cause were 1.18 in the intervention group and 1.28 in the control group (rate ratio, 0.93; 95% CI, 0.66 to 1.19). There were 21 deaths (15 from cardiovascular causes) in the intervention group and 16 deaths (8 from cardiovascular causes) in the control group. The rates of death from any cause were 0.13 and 0.10, respectively (rate ratio, 1.17; 95% CI, 0.61 to 2.27).

Conclusions: In a diverse population of older patients who were hospitalized for acute decompensated heart failure, an early, transitional, tailored, progressive rehabilitation intervention that included multiple physical-function domains resulted in greater improvement in physical function than usual care. (Funded by the National Institutes of Health and others; REHAB-HF ClinicalTrials.gov number, NCT02196038.).
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http://dx.doi.org/10.1056/NEJMoa2026141DOI Listing
July 2021

Temporal Trends and Factors Associated With Cardiac Rehabilitation Participation Among Medicare Beneficiaries With Heart Failure.

JACC Heart Fail 2021 Jul 12;9(7):471-481. Epub 2021 May 12.

Ahmanson-UCLA Cardiomyopathy Center, University of California, Los Angeles, California, USA. Electronic address:

Objectives: The purpose of this study was to assess temporal trends and factors associated with cardiac rehabilitation (CR) enrollment and participation among Medicare beneficiaries after the 2014 Medicare coverage expansion.

Background: CR improves exercise capacity, quality of life, and clinical outcomes in heart failure (HF) with reduced ejection fraction (HFrEF). In 2014, Medicare coverage for CR was expanded to include chronic HFrEF.

Methods: Among Medicare beneficiaries from quarter (Q) 1 2014 to Q2 2016, 11,696 patients from 14,258 hospitalizations with primary discharge diagnosis of HF were identified. Patients with HF with preserved ejection fraction were excluded. Quarterly CR participation rates among hospitalized HF patients within 6 months of discharge were identified through outpatient administrative claims. The predictors of CR participation were assessed with the use of a multivariable logistic regression model that included patient- and hospital-level characteristics. A secondary analysis to assess participation rates of CR after outpatient encounters for HF was performed.

Results: Overall, only 611 (4.3%) and 349 (2.2%) eligible patients participated CR after primary hospitalization or outpatient visit for HF, respectively. There was a modest, statistically significant increase in CR participation after HF admissions (2.8% in Q1 2014; 5.0% in Q2 2016; p < 0.001) without significant increase after outpatient visits for HF (2.6% to 3.8%; p = 0.21). Younger age, male sex, nonblack race, previous cardiovascular procedures, and hospitalization at hospitals with available CR facilities were all independently associated with CR participation.

Conclusions: CR participation among eligible Medicare beneficiaries with HFrEF was low with minimal increase since 2014 Medicare coverage decision. Sex, race, and institution-dependent variables were independent predictors of CR participation.
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http://dx.doi.org/10.1016/j.jchf.2021.02.006DOI Listing
July 2021

Physical Functioning in Heart Failure With Preserved Ejection Fraction.

J Card Fail 2021 May 12. Epub 2021 May 12.

Division of Cardiology, Duke University School of Medicine; Duke Clinical Research Institute, Durham, North Carolina. Electronic address:

Heart failure with preserved ejection fraction (HFpEF) is increasingly prevalent, yet interventions and therapies to improve outcomes remain limited. There has been increasing attention towards the impact of comorbidities and physical functioning (PF) on poor clinical outcomes within this population. In this review, we summarize and discuss the literature on PF in HFpEF, its association with clinical and patient-centered outcomes, and future advances in the care of HFpEF with respect to PF. Multiple PF metrics have been demonstrated to provide prognostic value within HFpEF, yet the data are less robust compared with other patient populations, highlighting the need for further investigation. The evaluation and detection of poor PF provides a potential strategy to improve care in HFpEF, and future studies are needed to understand if modulating PF improves clinical and/or patient-reported outcomes. LAY SUMMARY: • Patients with heart failure with preserved ejection fraction (HFpEF) commonly have impaired physical functioning (PF) demonstrated by limitations across a wide range of common PF metrics.• Impaired PF metrics demonstrate prognostic value for both clinical and patient-reported outcomes in HFpEF, making them plausible therapeutic targets to improve outcomes.• Clinical trials are ongoing to investigate novel methods of detecting, monitoring, and improving impaired PF to enhance HFpEF care.Heart failure with preserved ejection fraction (HFpEF) is increasingly prevalent, yet interventions and therapies to improve outcomes remain limited. As such, there has been increasing focus on the impact of physical performance (PF) on clinical and patient-centered outcomes. In this review, we discuss the state of PF in patients with HFpEF by examining the multitude of PF metrics available, their respective strengths and limitations, and their associations with outcomes in HFpEF. We highlight future advances in the care of HFpEF with respect to PF, particularly regarding the evaluation and detection of poor PF.
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http://dx.doi.org/10.1016/j.cardfail.2021.04.013DOI Listing
May 2021

Estimated Glomerular Filtration Rate Variability in Patients With Heart Failure and Chronic Kidney Disease.

J Card Fail 2021 May 10. Epub 2021 May 10.

Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. Electronic address:

Background: Greater variability in the estimated glomerular filtration rate (eGFR) is associated with higher mortality in patients with chronic kidney disease (CKD). Heart failure (HF) is common in CKD and may increase variability through changes in hemodynamic and volume regulation. We sought to determine if patients with vs without HF have higher kidney function variability in CKD, and to define the association with mortality.

Methods And Results: Patients undergoing coronary angiography from 2003 to 2013 with an eGFR of less than 60 mL/min/1.73 m were evaluated from the Duke Databank for Cardiovascular Disease. Variability in the eGFR, measured as the coefficient of variation (CV) of residuals from the regression of eGFR vs time, was calculated spanning 3 months to 2 years after catheterization. Mortality was assessed 2 to 7 years after catheterization. Patients were grouped into 3 HF phenotypes: HF with reduced ejection fraction, HF with preserved ejection, and no HF. Regression was used to evaluate associations between HF phenotypes and variability in the eGFR and between variability in the eGFR and mortality rate with stratification by HF phenotype. Among 3767 participants, the median eGFR at baseline was 45 mL/min/1.73 m (interquartile range 33-53 mL/min/1.73 m), and longitudinal measures of eGFR over 21 months had within-patient residual variability (CV) of 14% (9%-20%). In adjusted analyses, variability in the eGFR was greater in those with HF with preserved ejection (n = 695, CV difference 0.98%, 95% confidence interval 0.14%-1.81%) or HF with reduced ejection fraction (n = 800, CV difference 2.51%, 95% confidence interval 1.66%-3.37%) relative to no HF (n = 2272). In 3068 participants eligible for mortality analysis, the presence of HF and greater variability in the eGFR were each associated independently with higher mortality, but there was no evidence of interaction between variability in the eGFR and any HF phenotype (all P for interaction ≥.49).

Conclusions: Variability in the eGFR is greater in patients with HF and associated with mortality. Prediction algorithms and classification schemes should consider not only static, but also dynamic eGFR variability in HF and CKD prognostication.
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http://dx.doi.org/10.1016/j.cardfail.2021.04.016DOI Listing
May 2021

Early Identification of Patients at Risk for Incident Heart Failure With Preserved Ejection Fraction: Novel Approach to Echocardiographic Trends.

J Card Fail 2021 May 7. Epub 2021 May 7.

Division of Cardiology, Duke University School of Medicine, Durham, North Carolina; Division of Cardiology, Duke Molecular Physiology Institute, Durham, North Carolina.

Background: Heart failure with preserved ejection fraction (HFpEF) continues to increase in prevalence with a 50% mortality rate within 3 years of diagnosis, but lacking effective evidence-based therapies. Specific echocardiographic markers are not typically used to trigger alarm before acute HFpEF decompensation. The goal of this study was to retrospectively track changes in echocardiographic markers leading to the time of incident HFpEF hospitalization.

Methods And Results: In a single-center, retrospective analysis, patients with HFpEF admitted between 2007 and 2014 were identified using the International Classification of Diseases, 9th Revision with search refined using the European Society of Cardiology HFpEF guidelines. Using linear mixed effects models, changes in echocardiographic markers preceding acute HF decompensation owing to incident HFpEF were analyzed. We report on an incident HFpEF cohort of 242 patients, extending 18 years retrospectively, and including 675 echocardiograms analyzed from the overall sample at 14 distinct time intervals before acute decompensation. The regression models demonstrated 3 echocardiographic markers with statistically significant increases across multiple time intervals including, arterial elastance (P = .006), right atrial pressure estimate (P < .001), and right ventricular systolic pressure (P = .006). Other echocardiographic markers had individual time intervals with significant increases before acute decompensation, including (a) left atrial diameter, 8 to 10 years before HFpEF diagnosis, (b) left ventricular filling pressure 2 to 6 years before HFpEF diagnosis, (c) ventricular elastance 3 to 6 months before HFpEF diagnosis, and (d) ventricular elastance/arterial elastance as early as 10 to 20 years and as late as 3 to 6 months before HFpEF diagnosis. Furthermore, African Americans presented with incident HFpEF at an average younger age than White patients (65.6 ± 15.2 years vs. 76.7 years ± 11.7, P < .001).

Conclusions: Noninvasive echocardiographic markers associated with incident HFpEF diagnosis showed long, mid, and acute range, significant changes as far back as 10 to 20 years and as close as 3 to 6 months before acute HFpEF decompensation. Including a diverse study cohort is critical to understanding the phenotypic differences of HFpEF. This hypothesis-generating study identified a novel approach to identifying trends in echocardiographic markers that may be used as a signal of impending incident HFpEF.
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http://dx.doi.org/10.1016/j.cardfail.2021.03.013DOI Listing
May 2021

Reaping from Reciprocity: the Mentor-Mentee Relationship.

J Card Fail 2021 May;27(5):507-508

Duke University Medical Center and Duke Clinical Research Institute, Durham, NC, USA.

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http://dx.doi.org/10.1016/j.cardfail.2021.04.007DOI Listing
May 2021

Quality outcomes, healthcare resource utilization and costs in Medicare patients with chronic heart failure with reduced ejection fraction with and without a worsening event.

J Med Econ 2021 Jan-Dec;24(1):698-705

Merck & Co., Inc, Kenilworth, NJ, USA.

Aims: The study compared quality outcomes, resource utilization, and costs in Medicare beneficiaries with chronic heart failure with reduced ejection fraction (HFrEF) with and without a worsening heart failure event (WHFE).

Methods: This retrospective observational study evaluated claims data for two cohorts of Medicare beneficiaries with chronic HFrEF who were enrolled in Medicare fee-for-service (FFS) or Medicare advantage (MA) plans. The index date was the first claim of HFrEF between October 2015 and September 2017. Patients with WHFE were identified if they had IV diuretic use or hospitalization for HF during 12 months after index date; with remaining patients classified as non-WHFE. During follow-up, starting from the 13 month after HFrEF index date to end of follow-up, generalized linear models were used to adjust for patient characteristics to compare mean per patient per year (PPPY) quality outcomes, resource utilization, and costs between HFrEF patients with and without WHFE.

Results: Of the 1,182,509 FFS and 28,645 MA patients with HFrEF, 34.2% and 32.5% developed WHFE, respectively. Compared to patients without WHFE, patients with WHFE had higher rates of all-cause 30-day readmissions (FFS: 42% vs. 31%; MA: 41% vs. 31%), hospitalizations (FFS: 2.27 vs. 1.36; MA: 1.47 vs. 0.78 PPPY) and ED visits (FFS: 1.82 vs. 1.25; MA: 1.43 vs. 0.96 PPPY); all comparisons  < .05. Mortality rates in FFS patients were higher among patients with WHFE (34.3%) compared to those without (23.4%). All-cause total PPPY costs were higher for patients with WHFE compared to those without by $20,825 in FFS and $15,974 in MA. Similar trends were observed for HF-related outcomes.

Conclusion: Medicare patients with chronic HFrEF experiencing a WHFE had worse quality outcomes as well as higher resource utilization and costs compared to those without WHFE, thus, suggesting the need for better treatments and interventions to manage these patients.
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http://dx.doi.org/10.1080/13696998.2021.1922195DOI Listing
April 2021

Development and Validation of Machine Learning-Based Race-Specific Models to Predict 10-Year Risk of Heart Failure: A Multicohort Analysis.

Circulation 2021 Jun 13;143(24):2370-2383. Epub 2021 Apr 13.

Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (M.W.S., K.V.P., A.C., C.A., S.R., J.A.d.L., A.P.).

Background: Heart failure (HF) risk and the underlying risk factors vary by race. Traditional models for HF risk prediction treat race as a covariate in risk prediction and do not account for significant parameters such as cardiac biomarkers. Machine learning (ML) may offer advantages over traditional modeling techniques to develop race-specific HF risk prediction models and to elucidate important contributors of HF development across races.

Methods: We performed a retrospective analysis of 4 large, community cohort studies (ARIC [Atherosclerosis Risk in Communities], DHS [Dallas Heart Study], JHS [Jackson Heart Study], and MESA [Multi-Ethnic Study of Atherosclerosis]) with adjudicated HF events. The study included participants who were >40 years of age and free of HF at baseline. Race-specific ML models for HF risk prediction were developed in the JHS cohort (for Black race-specific model) and White adults from ARIC (for White race-specific model). The models included 39 candidate variables across demographic, anthropometric, medical history, laboratory, and electrocardiographic domains. The ML models were externally validated and compared with prior established traditional and non-race-specific ML models in race-specific subgroups of the pooled MESA/DHS cohort and Black participants of ARIC. The Harrell C-index and Greenwood-Nam-D'Agostino χ tests were used to assess discrimination and calibration, respectively.

Results: The ML models had excellent discrimination in the derivation cohorts for Black (n=4141 in JHS, C-index=0.88) and White (n=7858 in ARIC, C-index=0.89) participants. In the external validation cohorts, the race-specific ML model demonstrated adequate calibration and superior discrimination (Black individuals, C-index=0.80-0.83; White individuals, C-index=0.82) compared with established HF risk models or with non-race-specific ML models derived with race included as a covariate. Among the risk factors, natriuretic peptide levels were the most important predictor of HF risk across both races, followed by troponin levels in Black and ECG-based Cornell voltage in White individuals. Other key predictors of HF risk among Black individuals were glycemic parameters and socioeconomic factors. In contrast, prevalent cardiovascular disease and traditional cardiovascular risk factors were stronger predictors of HF risk in White adults.

Conclusions: Race-specific and ML-based HF risk models that integrate clinical, laboratory, and biomarker data demonstrated superior performance compared with traditional HF risk and non-race-specific ML models. This approach identifies distinct race-specific contributors of HF.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.053134DOI Listing
June 2021

Worsening Heart Failure Events in HFpEF: Underlying Biology Not Treatment Location.

JACC Heart Fail 2021 May 7;9(5):383-385. Epub 2021 Apr 7.

Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA.

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http://dx.doi.org/10.1016/j.jchf.2021.02.001DOI Listing
May 2021

Relationship of physical function with quality of life in older patients with acute heart failure.

J Am Geriatr Soc 2021 Jul 10;69(7):1836-1845. Epub 2021 Apr 10.

Section of Cardiovascular Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, United States.

Background: Older patients with acute decompensated heart failure (ADHF) have severely impaired physical function (PF) and quality of life (QOL). However, relationships between impairments in PF and QOL are unknown but are relevant to clinical practice and trial design.

Methods: We assessed 202 consecutive patients hospitalized with ADHF in the multicenter Rehabilitation Therapy in Older Acute HF Patients (REHAB-HF) Trial. PF measures included Short Physical Performance Battery (SPPB) and 6-min walk distance (6MWD). Disease-specific QOL was assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). General QOL was assessed by the Short Form-12 (SF-12) and EuroQol-5D-5L. PF was evaluated as a predictor of QOL using stepwise regression adjusted for age, sex, race, and New York Heart Association class.

Results: Participants were 72 ± 8 years, 54% women, 55% minority race, 52% with reduced ejection fraction, and body mass index 33 ± 9 kg/m . Participants had severe impairments in PF (6MWD 185 ± 99 m, SPPB 6.0 ± 2.5 units) and disease-specific QOL (KCCQ Overall Score 41 ± 21 and Physical Score 47 ± 24) and general QOL (SF-12 Physical Score 28 ± 9 and EuroQol Visual Analog Scale 57 ± 23). There were modest, statistically significant correlations between 6MWD and KCCQ Overall, KCCQ Physical Limitation, and SF-12 Physical Scores (r = 0.23, p < 0.001; r = 0.30, p < 0.001; and r = 0.24, p = 0.001, respectively); and between SPPB and KCCQ Physical and SF-12 Physical Scores (r = 0.20, p = 0.004, and r = 0.19, p = 0.007, respectively). Both 6MWD and SPPB were correlated with multiple components of the EuroQol-5D-5L. 6MWD was a significant, weak predictor of KCCQ Overall Score and SF-12 Physical Score (estimate = 0.05 ± 0.01, p < 0.001 and estimate = 0.05 ± 0.02, p = 0.012, respectively). SPPB was a significant, weak predictor of KCCQ Physical Score and SF-12 Physical Score (estimate = 1.37 ± 0.66, p = 0.040 and estimate = 0.54 ± 0.25, p = 0.030, respectively).

Conclusion: In older, hospitalized ADHF patients, PF and QOL are both severely impaired but are only modestly related, suggesting that PF and QOL provide complementary information and assessment of both should be considered to fully assess clinically meaningful patient-oriented outcomes.
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http://dx.doi.org/10.1111/jgs.17156DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8273137PMC
July 2021

Update on the Impact of Comorbidities on the Efficacy and Safety of Heart Failure Medications.

Curr Heart Fail Rep 2021 06 9;18(3):132-143. Epub 2021 Apr 9.

Division of Cardiology, Duke University School of Medicine, Durham, NC, USA.

Purpose Of Review: Multiple newer medications benefit patients with heart failure with reduced ejection fraction (HFrEF). While these therapies benefit the broad population with HFrEF, the efficacy and safety of these therapies have been less well characterized in patients with significant comorbidities.

Recent Findings: Common comorbidities of high interest in heart failure (HF) include diabetes mellitus, chronic kidney disease (CKD), atrial fibrillation, and obesity, and each has potential implications for clinical management. As the burden of comorbidities increases in HF populations, risk-benefit assessments of HF therapies in the context of different comorbidities are increasingly relevant for clinical practice. This review summarizes data regarding the core HFrEF therapies in the context of comorbidities, with specific attention to sodium-glucose cotransporter 2 inhibitors, sacubitril/valsartan, mineralocorticoid receptor antagonists (MRAs), and beta-blockers. In general, studies support consistent treatment effects with regard to clinical outcome benefits in the presence of comorbidities. Likewise, safety profiles are relatively consistent irrespective of comorbidities, with the exception of heightened risk of hyperkalemia with MRA therapy in patients with severe CKD. In conclusion, while HF management is complex in the context of multiple comorbidities, the totality of evidence strongly supports guideline-directed medical therapies as foundational for improving outcomes in these high-risk patients.
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http://dx.doi.org/10.1007/s11897-021-00512-3DOI Listing
June 2021

Prognostic Role of Prior Heart Failure Hospitalization Among Patients Hospitalized for Worsening Chronic Heart Failure.

Circ Heart Fail 2021 Apr 29;14(4):e007871. Epub 2021 Mar 29.

Division of Cardiology, Duke University School of Medicine, Durham, NC (V.B., R.J.M., A.F.H., S.J.G.).

Background: Hospitalization for heart failure (HF) is associated with increased risk of death among patients with chronic HF. The degree to which hospitalization for HF is a distinct biologic entity with independent prognostic value versus a marker of higher risk chronic HF patients is unclear.

Methods: After excluding patients with new-onset HF, the ASCEND-HF trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) included 4205 patients hospitalized for worsening chronic HF with reduced or preserved ejection fraction. The present analysis compared patients by presence or absence of prior HF hospitalization within 12 months and by timing of prior HF hospitalization relative to index hospitalization. Associations with 180-day all-cause mortality were assessed, including adjustment for 27 prespecified clinical factors.

Results: Overall, 2241 (53.3%) patients had a HF hospitalization within the prior 12 months and 1964 (46.7%) did not. Mortality rates at 180 days were 15.5% and 11.9%, respectively. In unadjusted analyses, prior HF hospitalization was associated with increased risk of 180-day mortality (HR, 1.35 [95% CI, 1.14-1.59]; <0.01). After adjustment, the point estimate was attenuated and the association not statistically significant (HR, 1.18 [95% CI, 0.99-1.40]; =0.064). Similarly, after adjustment, compared with patients without prior hospitalization, prior HF hospitalization was not associated with mortality, irrespective of timing (0-4 months: HR, 1.10 [95% CI, 0.87-1.39], =0.41; 4-8 months: HR, 0.95 [95% CI, 0.70-1.27]; =0.72; 8-12 months: HR, 1.06 [95% CI, 0.74-1.51], =0.77; >12 months: HR, 0.81 [95% CI, 0.63-1.06], =0.12).

Conclusions: In this cohort of patients hospitalized for worsening HF, prior HF hospitalization was not associated with 180-day mortality after comprehensively accounting for patient characteristics measured during the index patient visit. Clinical confounders measured at the point-of-care may explain previously observed associations between prior HF hospitalization and mortality, and these clinical factors may be a more direct means of predicting patient survival. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00475852.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.120.007871DOI Listing
April 2021

Cigarette Smoking, Incident Coronary Heart Disease, and Coronary Artery Calcification in Black Adults: The Jackson Heart Study.

J Am Heart Assoc 2021 Apr 23;10(7):e017320. Epub 2021 Mar 23.

Department of Medicine University of Mississippi Medical Center Jackson MS.

Background Although Black adults are more likely to die from coronary heart disease (CHD) compared with White adults, few studies have examined the relationship between cigarette smoking and CHD risk among Black adults. We evaluated the relationship between cigarette smoking, incident CHD, and coronary artery calcification in the JHS (Jackson Heart Study). Methods and Results We classified JHS participants without a history of CHD (n=4432) by self-reported baseline smoking status into current, former (smoked at least 400 cigarettes/life) or never smokers at baseline (2000-2004). We further classified current smokers by smoking intensity (number of cigarettes smoked per day [1-19 or ≥20]) and followed for incident CHD (through 2016). Hazard ratios (HR) for incident CHD for each smoking group compared with never smokers were estimated with adjusted Cox proportional hazard regression models. At baseline, there were 548 (12.4%) current, 782 (17.6%) former, and 3102 (70%) never smokers. During follow-up (median, 13.8 years), 254 participants developed CHD. After risk factor adjustment, CHD risk was significantly higher in current smokers compared with never smokers (HR, 2.11; 95% CI, 1.39-3.18); the difference between former smokers and never smokers (HR, 1.37; 95% CI, 1.0-1.90) did not achieve statistical significance. Among current smokers, we did not observe a dose-response effect for CHD risk. Additionally, in multivariable logistic regression models with a subset of our analytic cohort, current smokers had greater odds of coronary artery calcification score >0 compared with never smokers (odds ratio, 2.63; 95% CI, 1.88-3.68). Conclusions In a large prospective cohort of Black adults, current smoking was associated with a >2-fold increased risk of CHD over a median follow-up of greater than a decade.
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http://dx.doi.org/10.1161/JAHA.120.017320DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8174312PMC
April 2021
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