Differences in provider approach to initiating and titrating guideline directed medical therapy in heart failure with reduced ejection fraction.

BACKGROUND: Despite the strong evidence supporting guideline-directed medical therapy (GDMT) in patients with heart failure with reduced ejection fraction (HFrEF), prescription rates in clinical practice are still lacking. METHODS: A survey containing 20 clinical vignettes of patients with HFrEF was answered by a national sample of 127 cardiologists and 68 internal/family medicine physicians. Each vignette had 4-5 options for adjusting GDMT and the option to make no medication changes. Survey respondents could only select one option. For analysis, responses were dichotomized to the answer of interest. RESULTS: Cardiologists were more likely to make GDMT changes than general medicine physicians (91.8% vs. 82.0%; OR 1.84 [1.07-3.19]; p = 0.020). Cardiologists were more likely to initiate beta-blockers (46.3% vs. 32.0%; OR 2.38 [1.18-4.81], p = 0.016), angiotensin receptor blocker/neprilysin inhibitor (ARNI) (63.8% vs. 48.1%; OR 1.76 [1.01-3.09], p = 0.047), and hydralazine and isosorbide dinitrate (HYD/ISDN) (38.2% vs. 23.7%; OR 2.47 [1.48-4.12], p < 0.001) compared to general medicine physicians. No differences were found in initiating angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARBs), initiating mineralocorticoid receptor antagonist (MRA), sodium-glucose transporter protein 2 (SGLT2) inhibitors, digoxin, or ivabradine. CONCLUSIONS: Our results demonstrate cardiologists were more likely to adjust GDMT than general medicine physicians. Future focus on improving GDMT prescribing should target providers other than cardiologists to improve care in patients with HFrEF.

The prognostic value of positron emission tomography in the evaluation of suspected cardiac sarcoidosis.

OBJECTIVES: To assess the prognostic value of positron emission tomography (PET) imaging in patients undergoing evaluation for known or suspected cardiac sarcoidosis (CS) while not on active immunotherapy. BACKGROUND: Previous studies have attempted to identify the value of PET imaging to aid in risk stratification of patients with CS, however, most cohorts have included patients currently on immunosuppression, which may confound scan results by suppressing positive findings. METHODS: We retrospectively analyzed 197 patients not on immunosuppression who underwent 18F-fluorodeoxyglucose (FDG) PET scans for evaluation of known or suspected CS. The primary endpoint of the study was time to ventricular arrhythmia (VT/VF), or death. Candidate predictors were identified by univariable Cox proportional hazards regression. Independent predictors were identified by performing multivariable Cox regression with stepwise forward selection. RESULTS: Median follow-up time was 531 [IQR 309, 748] days. 41 patients met the primary endpoint. After stepwise forward selection, left ventricular ejection fraction (LVEF) (HR 0.98, 95% CI 0.96-0.99, P = 0.02), history of VT/VF (HR 4.19, 95% CI 2.15-8.17, P < 0.001), and summed rest score (SRS) (HR 1.06, 95% CI 1.02-1.12, P = 0.01) were predictive of the primary endpoint. Quantitative and qualitative measures of FDG uptake on PET were not predictive of clinical events. CONCLUSIONS: Among untreated patients who underwent PET scans to evaluate known or suspected CS, LVEF, history of VT/VF, and SRS were associated with adverse clinical outcomes.

Interleukin-1 blockade in cardiac sarcoidosis: study design of the multimodality assessment of granulomas in cardiac sarcoidosis: Anakinra Randomized Trial (MAGiC-ART).

BACKGROUND: Sarcoidosis is an inflammatory disease characterized by the formation of granulomas, which involve the heart in up to 25% of patients. Cardiac sarcoidosis can lead to life threatening arrhythmias and heart failure. While corticosteroids have been used as a treatment for over 50 years, they are associated with hypertension, diabetes, and weight gain, further increasing cardiovascular risk. Interleukin-1 (IL-1) is the prototypical proinflammatory cytokine that works to activate the nuclear transcription factor NF-kB, one of the targets of glucocorticoids. IL-1 also plays an important role also in the pathophysiology of heart disease including atherosclerosis, myocardial infarction, and myocarditis. METHODS: Building on a network of research collaborators developed in the Cardiac Sarcoidosis Consortium, we will investigate the feasibility and tolerability of treatment of CS with anakinra at two National Institute of Health Clinical and Translational Science Award (CTSA) hubs with expertise in cardiac sarcoidosis. In this pilot study, up to 28 patients with cardiac sarcoidosis will be recruited to compare the administration of an IL-1 blocker, anakinra, 100 mg daily on top of standard of care versus standard of care only for 28 days and followed for 180 days. Utilizing surrogate endpoints of changes in systemic inflammatory biomarkers and cardiac imaging, we aim to determine whether IL-1 blockade with anakinra can combat systemic and cardiac inflammation in patients with cardiac sarcoidosis. DISCUSSION: The current trial demonstrates an innovative collaborative approach to clinical trial development in a rare, understudied disease that disproportionately affects females and minorities. Trial Registration The trial was registered prospectively with ClinicalTrials.gov on July 12, 2019, identifier NCT04017936.

Resting Oxygen Consumption and Heart Failure: Importance of Measurement for Determination of Cardiac Output With the Use of the Fick Principle.

BACKGROUND: Resting oxygen consumption (VO2) is often estimated and frequently used to guide therapeutic decisions in symptomatic heart failure (HF) patients. The relationship between resting VO2 and symptomatic HF and the accuracy of estimations of VO2 in this population are unknown. METHODS AND RESULTS: We performed a cross-sectional study of HF patients (n = 691) and healthy control subjects (n = 77). VO2 was measured with the use of a metabolic cart, and estimated VO2 was calculated with the use of the Dehmer, LaFarge, and Bergstra formulas and the thermodilution method. The measured and estimated VO2 were compared and the potential impact of estimations determined. In the multivariable model, resting VO2 decreased with increasing New York Heart Association (NYHA) functional class in a stepwise fashion (ß NYHA functional class IV vs control = -36 mL O2/min; P < .001). Estimations of VO2 with the use of derived equations diverged from measured values, particularly for patients with NYHA functional class IV limitations. The percentage difference of measured VO2 versus estimated VO2 was >25% in 39% (n = 271), 25% (n = 170), 82% (n = 566), and 39% (n = 271) of HF patients when using the Dehmer, LaFarge, Bergstra, and thermodilution-derived estimations of VO2 respectively. CONCLUSIONS: Resting VO2 decreases with increasing NYHA functional class and is lower than in control subjects. Using estimations of VO2 to calculate CO may introduce clinically important error.

Safety of regadenoson positron emission tomography stress testing in orthotopic heart transplant patients.

OBJECTIVES: We sought to determine the safety of regadenoson (REG) stress testing in patients who have undergone orthotopic heart transplantation (OHT). BACKGROUND: Routine screening for cardiac allograft vasculopathy (CAV) is necessary after OHT. Adenosine stress is contraindicated after heart transplantation due to supersensitivity in denervated hearts. Safety of regadenoson stress following OHT has not been well studied. METHODS: We retrospectively reviewed data from OHT patients (N = 123) who were referred to REG stress testing. Medical records were reviewed to determine hemodynamic and ECG response to regadenoson and to identify adverse reactions. RESULTS: No serious adverse events occurred. No life-threatening arrhythmias or hemodynamic changes occurred. Common side-effects related to regadenoson were observed, dyspnea being the most frequent (66.7%). On average the heart rate rose from 82.8 ± 12 to 95.7 ± 13.4 bpm (P < 0.001), systolic blood pressure decreased from 138.7 ± 20.9 to 115.9 ± 23.9 mmHg (P < 0.001) and mean arterial pressure decreased from 103.5 ± 14.1 to 84.72 ± 15.90 mmHg (P < 0.001) during stress protocol. There was no sustained ventricular tachycardia, ventricular fibrillation, or second-or third-degree atrioventricular block. CONCLUSION: Regadenoson stress testing appears to be well tolerated and safe in OHT patients.

Construct Validity of the Multi-Source Interference Task to Examine Attention in Heart Failure.

BACKGROUND: Patients with heart failure (HF) are at risk of cognitive dysfunction, including decreased directed attention. Directed attention is critical for performing daily activities including HF self-care by facilitating one to follow instructions or train-of-thought when there are interferences in which presented stimuli are in conflict with one another. The Multi-Source Interference Task (MSIT) is a computerized neuropsychological test that examines the function of the dorsal anterior cingulate cortex, the neurological substrate for directed attention. However, the MSIT has not been used in past HF studies. OBJECTIVE: The purpose of the study was to examine construct validity of the MSIT in HF. METHODS: Baseline data were obtained from a cognitive intervention study among patients with HF (n = 22) and age- and education-matched healthy adults (n = 20). Construct validity was evaluated using t tests to examine differences between patients with HF and healthy adults and congruent and incongruent MSIT trials. Pearson's correlations were computed to examine relationships between the MSIT and Trail-Making Test, Stroop Test, and Attentional Function Index. RESULTS: Compared with healthy adults, patients with HF demonstrated worse performance (i.e., slower response times and higher error rates) on MSIT. Patients with HF had worse performance on MSIT incongruent trials than congruent trials. Interference z scores of MSIT did not correlate with Trail-Making Tests A and B and Stroop Test interference z scores, but the MSIT interference z scores correlated with perceived attention function measured by Attentional Function Index. DISCUSSION: Construct validity of the MSIT was supported, in part, among patients with HF. The MSIT is a sensitive measure of detecting worse directed attention among patients with HF compared with healthy adults. The preliminary findings support the use of the MSIT as a measure of directed attention in HF. Confirmation is warranted for current findings in larger samples.

Randomized Crossover Study of the Natural Restorative Environment Intervention to Improve Attention and Mood in Heart Failure.

BACKGROUND: In heart failure (HF), attention may be decreased because of lowered cerebral blood flow and increased attentional demands needed for self-care. OBJECTIVE: Guided by the Attention Restoration Theory, the objective was to test the efficacy of the natural restorative environment (NRE) intervention on improving attention and mood among HF patients and healthy adults. METHODS: A randomized crossover pilot study was conducted among 20 HF patients and an age- and education-matched comparison group of 20 healthy adults to test the efficacy of the NRE intervention compared with an active control intervention. Neuropsychological tests were administered to examine attention, particularly attention span, sustained attention, directed attention, and attention switching, at before and after the intervention. Mood was measured with the Positive and Negative Affect Schedule. RESULTS: No significant differences were found in attention and mood after the NRE intervention compared with the control intervention among the HF patients and the healthy adults. In analyses with HF patients and healthy adults combined (n = 40), significant differences were found. Compared with the control intervention, sustained attention improved after the NRE intervention (P = .001) regardless of the presence of HF. Compared with the healthy adults, HF patients performed significantly worse on attention switching after the control intervention (P = .045). CONCLUSIONS: The NRE intervention may be efficacious in improving sustained attention in HF patients. Future studies are needed to enhance the NRE intervention to be more efficacious and tailored for HF patients and test the efficacy in a larger sample of HF patients.

Refusal to participate in heart failure studies: do age and gender matter?

AIMS AND OBJECTIVES: The objective of this retrospective study was to evaluate reasons heart failure patients decline study participation, to inform interventions to improve enrollment. BACKGROUND: Failure to enrol older heart failure patients (age > 65) and women in studies may lead to sampling bias, threatening study validity. DESIGN: This study was a retrospective analysis of refusal data from four heart failure studies that enrolled 788 patients in four states. METHODS: Chi-Square and a pooled t-test were computed to analyse refusal data (n = 300) obtained from heart failure patients who were invited to participate in one of the four studies but declined. RESULTS: Refusal reasons from 300 patients (66% men, mean age 65·33) included: not interested (n = 163), too busy (n = 64), travel burden (n = 50), too sick (n = 38), family problems (n = 14), too much commitment (n = 13) and privacy concerns (n = 4). Chi-Square analyses showed no differences in frequency of reasons (p > 0·05) between men and women. Patients who refused were older, on average, than study participants. CONCLUSIONS: Some reasons were patient-dependent; others were study-dependent. With 'not interested' as the most common reason, cited by over 50% of patients who declined, recruitment measures should be targeted at stimulating patients' interest. Additional efforts may be needed to recruit older participants. However, reasons for refusal were consistent regardless of gender. RELEVANCE TO CLINICAL PRACTICE: Heart failure researchers should proactively approach a greater proportion of women and patients over age 65. With no gender differences in type of reasons for refusal, similar recruitment strategies can be used for men and women. However, enrolment of a representative proportion of women in heart failure studies has proven elusive and may require significant effort from researchers. Employing strategies to stimulate interest in studies is essential for recruiting heart failure patients, who overwhelmingly cited lack of interest as the top reason for refusal.

Nurse-Enhanced Computerized Cognitive Training Increases Serum Brain-Derived Neurotropic Factor Levels and Improves Working Memory in Heart Failure.

BACKGROUND: Memory loss is common in heart failure (HF) patients, but few interventions have been tested to treat it. The objective of this study was to evaluate efficacy of a cognitive training intervention, Brain Fitness, to improve memory, serum brain-derived neurotropic factor (BDNF) levels, working memory, processing speed, executive function, instrumental activities of daily living, mobility, depressive symptoms, and health-related quality of life. METHODS AND RESULTS: Twenty-seven HF patients were randomly assigned to Brain Fitness and health education active control interventions. Data were collected at baseline and 8 and 12 weeks. Linear mixed models analyses were completed. Patients in the Brain Fitness group were older with lower ejection fraction. At 12 weeks, a group by time interaction effect was found for serum BDNF levels (P = .011): serum BDNF levels increased among patients who completed Brain Fitness and decreased among patients who completed health education. No differences were found in memory, but a group by time interaction (P = .046) effect was found for working memory. CONCLUSIONS: Findings support efficacy of Brain Fitness in improving working memory and serum BDNF levels as a biomarker of intervention response. A randomized controlled study is needed among a larger more diverse group of HF patients.

A web application for self-monitoring improves symptoms in chronic systolic heart failure.

OBJECTIVE: The objective of this study was to determine if a Web application that promoted mindfulness of the progress of the chronic disease through self-monitoring improved quality of life in heart failure. MATERIALS AND METHODS: This was a prospective single-center single-group study. Participants were instructed how to use the Web application and to perform self-monitoring daily for 12 weeks. A comprehensive physical exam, assessment of New York Heart Association (NYHA) class, the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and an evaluation of self-management were performed in person at baseline and at 12 weeks. RESULTS: Participants consisted of older (mean, 59 years), predominantly female (63%) adults with NYHA class II or III symptoms. NYHA classification (preintervention versus postintervention, 2.5±0.13 versus 2.0±0.13; p=0.0032) and MLHFQ score (55.7±4.6 versus 42.6±5.1, respectively; p=0.0078) improved over 12 weeks of self-monitoring. A trend toward improvement was also demonstrated in weight (preintervention versus postintervention, 209±9.6 pounds versus 207±9.4 pounds; by paired t test, p=0.389), number of times exercised per week (1.29±0.5 versus 2.5±0.6, respectively; p=0.3), and walk distance (572±147 yards versus 845±187 yards, respectively; p=0.119). Jugular venous distention (preintervention versus postintervention, 8.1±0.6 cm versus 6.7±0.3 cm; p=0.083) and peripheral edema (29.2% versus 16.7%, respectively; p=0.375) decreased after 12 weeks of self-monitoring via the Web application. CONCLUSIONS: A Web application for self-monitoring heart failure over 12 weeks improved both NYHA classification and MLHFQ score. The trend in improved physical activity and physical exam support these outcomes. The number of patients reporting a sodium-restricted diet increased over the 12 weeks, which may have led to the positive findings.

Risk stratification for death and all-cause hospitalization in heart failure clinic outpatients.

BACKGROUND: Most heart failure (HF) risk stratification models were developed for inpatient use, and available outpatient models use a complex set of variables. We hypothesized that routinely collected clinical data could predict the 6-month risk of death and all-cause medical hospitalization in HF clinic outpatients. METHODS AND RESULTS: Using a quality improvement database and multivariable Cox modeling, we derived the Heart Failure Patient Severity Index (HFPSI) in the University of Michigan HF clinic (UM cohort, n = 1,536; 314 reached primary outcome). We externally validated the HFPSI in the Ann Arbor Veterans' Affairs HF clinic (VA cohort, n = 445; 106 outcomes) and explored "real-time" HFPSI use (VA-RT cohort, n = 486; 141 outcomes) by tracking VA patients for 6 months from their most recently calculated HFPSI, rather than using an arbitrary start date for the cohort. The HFPSI model included blood urea nitrogen, B-type natriuretic peptide, New York Heart Association class, diabetes status, history of atrial fibrillation/flutter, and all-cause hospitalization within the prior 1 and 2 to 6 months. The concordance c statistics in the UM/VA/VA-RT cohorts were 0.71/0.68/0.74. Kaplan-Meier curves and log-rank testing demonstrated excellent risk stratification, particularly between a large, low-risk group (40% of patients, 6-month event rates in the UM/VA/VA-RT cohorts 8%/12%/12%) and a small, high-risk group (10% of patients, 6-month event rates in the UM/VA/VA-RT cohorts 57%/58%/79%). CONCLUSIONS: The HFPSI uses readily available data to predict the 6-month risk of death and/or all-cause medical hospitalization in HF clinic outpatients and could potentially help allocate specialized HF resources within health systems.

Clinical utility of auditory memory testing in a heart failure population.

BACKGROUND: The self-care regimen necessary in heart failure (HF) is notably complex. A complication to integrating new knowledge and behaviors is that impaired cognition has been frequently reported in patients with HF, which significantly impacts patients' health, admission and mortality rates, and instrumental activities of daily living. OBJECTIVE: The identification of reliable cognitive screening tools to assess potential difficulties in performing self-care for cardiac populations is essential. As such, the current purposes were to evaluate the validity and stability of the International Shopping List (ISL) auditory learning subtest from the computerized CogState battery as a screening tool in HF populations, determine the ISL's ability to predict functional declines, and evaluate the task's sensitivity in myocardial infarction. METHODS: Forty patients with chronic HF were enrolled in a longitudinal study evaluating the impact of a cognitive training intervention. Baseline neuropsychological and behavioral measurements before treatment were used in the current study, including measures of auditory memory, orientation, verbal fluency, processing speed, and activities of daily living, and a subset of patients (n = 17) received repeat testing at 8 weeks on some tasks. Analyses also were performed with patients organized based on myocardial infarction status. RESULTS: The current study indicated that the ISL performed comparably with an established measure of auditory memory (Hopkins Verbal Learning Test-Revised; r = 0.70, P < .001), displayed adequate coefficients of stability (r = 0.53-0.68), and successfully predicted declines over time in daily functioning (ß = .47, P < .001) in our HF sample. CONCLUSIONS: The computerized CogState auditory memory subtest, the ISL, seems to be a beneficial tool in evaluating cognitive change in HF patients. Particularly given its cross-cultural sensitivity and ease of administration and scoring, this task may provide assistance to quickly and reliably monitor memory functioning in these vulnerable patients and gauge their potential for self-care behaviors.

A Computable Algorithm for Medication Optimization in Heart Failure With Reduced Ejection Fraction.

Background: Guideline-directed medical therapy (GDMT) optimization can improve outcomes in heart failure with reduced ejection fraction. Objectives: The objective of this study was to determine if a novel computable algorithm appropriately recommended GDMT. Methods: Clinical trial data from the GUIDE-IT (Guiding Evidence-Based Therapy Using Biomarker Intensified Treatment in Heart Failure) and HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trials were evaluated with a computable medication optimization algorithm that outputs GDMT recommendations and a medication optimization score (MOS). Algorithm-based recommendations were compared to medication changes. A Cox proportional-hazards model was used to estimate the associations between MOS and the composite primary end point for both trials. Results: The algorithm recommended initiation of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, beta-blockers, and mineralocorticoid receptor antagonists in 52.8%, 34.9%, and 68.1% of GUIDE-IT visits, respectively, when not prescribed the drug. Initiation only occurred in 20.8%, 56.9%, and 15.8% of subsequent visits. The algorithm also identified dose titration in 48.8% of visits for angiotensin-converting enzyme inhibitor/angiotensin receptor blockers and 39.4% of visits for beta-blockers. Those increases only occurred in 24.3% and 36.8% of subsequent visits. A higher baseline MOS was associated with a lower risk of cardiovascular death or heart failure hospitalization (HR: 0.41; 95% CI: 0.21-0.80; P = 0.009) in GUIDE-IT and all-cause death and hospitalization (HR: 0.61; 95% CI: 0.44-0.84; P = 0.003) in HF-ACTION. Conclusions: The algorithm accurately identified patients for GDMT optimization. Even in a clinical trial with robust protocols, GDMT could have been further optimized in a meaningful number of visits. The algorithm-generated MOS was associated with a lower risk of clinical outcomes. Implementation into clinical care may identify and address suboptimal GDMT in patients with heart failure with reduced ejection fraction.

Model for end-stage liver disease score predicts left ventricular assist device operative transfusion requirements, morbidity, and mortality.

BACKGROUND: The Model for End-Stage Liver Disease (MELD) predicts events in cirrhotic subjects undergoing major surgery and may offer similar prognostication in left ventricular assist device candidates with comparable degrees of multisystem dysfunction. METHODS AND RESULTS: Preoperative MELD scores were calculated for subjects enrolled in the University of Michigan Health System (UMHS) mechanical circulatory support database. Univariate and multiple regression analyses were performed to investigate the ability of patient characteristics, laboratory data (including MELD scores), and hemodynamic measurements to predict total perioperative blood product exposure and operative mortality. The ability of preoperative MELD scores to predict operative mortality was evaluated in subjects enrolled in the Interagency Registry of Mechanically Assisted Circulatory Support (INTERMACS), and results were compared with those from the UMHS cohort. The mean+/-SD MELD scores for the UMHS (n=211) and INTERMACS (n=324) cohorts were 13.7+/-6.1 and 15.2+/-5.8, respectively, with 29 (14%) and 19 (6%) perioperative deaths. In the UMHS cohort, median total perioperative blood product exposure was 74 units (25th and 75th percentiles, 44 and 120 units). Each 5-unit MELD score increase was associated with 15.1+/-3.8 units (beta+/-SE) of total perioperative blood product exposure. Each 10-unit increase in total perioperative blood product exposure increased the odds of operative death (odds ratio, 1.05; 95% confidence interval, 1.01 to 1.10). Odds ratios, measuring the ability of MELD scores to predict perioperative mortality, were 1.5 (95% confidence interval, 1.1 to 2.0) and 1.5 (95% confidence interval, 1.1 to 2.1) per 5 MELD units for the UMHS and INTERMACS cohorts, respectively. When MELD scores were dichotomized as >or=17 and <17, risk-adjusted Cox proportional-hazard ratios for 6-month mortality were 2.5 (95% confidence interval, 1.2 to 5.3) and 2.5 (95% confidence interval, 1.1 to 5.4) for the UMHS and INTERMACS cohorts, respectively. CONCLUSIONS: The MELD score identified left ventricular assist device candidates at high risk for perioperative bleeding and mortality.

Nurse-Enhanced Memory Intervention in Heart Failure: the MEMOIR study.

BACKGROUND: Many patients with heart failure (HF) have cognitive deficits, including memory loss. OBJECTIVES: The aim of this study was to evaluate the efficacy of a cognitive training intervention on memory (primary outcome), working memory, psychomotor speed, executive function, and performance of cognitive activities and instrumental activities of daily living (IADLs). METHODS AND RESULTS: Forty patients with HF were randomly assigned to the computerized plasticity-based cognitive training intervention called Brain Fitness or to the health education active control intervention. Advanced practice nurses made weekly home visits to assess symptoms and monitor intervention adherence. Patients completed demographic and clinical data (baseline), neuropsychologic tests (baseline and 8 and 12 weeks), and measures of cognitive and IADLs performance (baseline and 12 weeks) and satisfaction (12 weeks). Linear mixed models analyses indicated a significant group by time interaction for delayed recall memory (P = .032) and a significant time effect for total (list learning) (P < .001) and delayed (P = .015) recall memory, psychomotor speed (P = .029), and performance of IADLs (P = .006). Intervention adherence and patient satisfaction were high. CONCLUSIONS: To our knowledge, this was the first test of Brain Fitness in HF. Although it was a preliminary study with limitations, results support the need for a larger randomized controlled trial to determine whether the memory loss of HF is amenable to plasticity-based interventions.

The Effects of the ManageHF4Life Mobile App on Patients With Chronic Heart Failure: Randomized Controlled Trial.

BACKGROUND: The successful management of heart failure (HF) involves guideline-based medical therapy as well as self-management behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE: The aim of this paper was to evaluate the efficacy of enhanced self-management via a mobile app intervention on health-related quality of life, self-management, and HF readmissions. METHODS: A single-center randomized controlled trial was performed. Participants older than 45 years and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group ("app group") used a mobile app, and the intervention prompted daily self-monitoring and promoted self-management. The control group ("no-app group") received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire score and recurrent HF admissions. RESULTS: A total of 83 participants were enrolled and completed all baseline assessments. Baseline characteristics were similar between the groups except for the prevalence of ischemic HF. The app group had a reduced MLHFQ at 6 weeks (mean 37.5, SD 3.5 vs mean 48.2, SD 3.7; P=.04) but not at 12 weeks (mean 44.2, SD 4 vs mean 45.9, SD 4; P=.78), compared to the no-app group. There was no effect of the app on the SCHFI at 6 or 12 weeks. The time to first HF readmission was not statistically different between the app group and the no-app group (app group 11/42, 26% vs no-app group 12/41, 29%; hazard ratio 0.89, 95% CI 0.39-2.02; P=.78) over 12 weeks. CONCLUSIONS: The adaptive mobile app intervention, which focused on promoting self-monitoring and self-management, improved the MLHFQ at 6 weeks but did not sustain its effects at 12 weeks. No effect was seen on HF self-management measured by self-report. Further research is needed to enhance engagement in the app for a longer period and to determine if the app can reduce HF readmissions in a larger study. TRIAL REGISTRATION: ClinicalTrials.gov NCT03149510; https://clinicaltrials.gov/ct2/show/NCT03149510.

Measured Versus Estimated Resting Metabolic Rate in Heart Failure With Preserved Ejection Fraction.

BACKGROUND: Obesity is common in heart failure with preserved ejection fraction (HFpEF), and a hypocaloric diet can improve functional capacity. Malnutrition, sarcopenia, and frailty are also frequently present, and calorie restriction could harm some patients. Resting metabolic rate (RMR) is an essential determinant of caloric needs; however, it is rarely measured in clinical practice. The accuracy of commonly used predictive equations in HFpEF is unknown. METHODS: RMR was measured with indirect calorimetry in 43 patients with HFpEF undergoing right heart catheterization at the University of Michigan, and among 49 participants in the SECRET trial (Study of the Effects of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction); SECRET patients also had dual-energy X-ray absorptiometry body composition measures. Measured RMR was compared with RMR estimated using the Harris Benedict, Mifflin-St Jeor, World Health Organization, and Academy for Nutrition and Dietetics equations. RESULTS: All predictive equations overestimated RMR (by >10%, P<0.001 for all), with mean (95% CI) differences Harris Benedict equation +250 (186-313), Mifflin-St. Jeor equation +169 (110-229), World Health Organization equation +300 (239-361), and Academy for Nutrition and Dietetics equation +794 (890-697) kcal/day. Results were similar across both patient groups, and the discrepancy between measured and estimated RMR tended to increase with body mass index. In SECRET, measured RMR was closely associated with lean body mass (ρ=0.74; by linear regression adjusted for age and sex: ß=27 [95% CI, 18-36] kcal/day per kg, P<0.001; r2=0.56). CONCLUSIONS: Commonly used predictive equations systematically overestimate measured RMR in patients with HFpEF. Direct measurement of RMR may be needed to effectively tailor dietary guidance in this population. Registration: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT00959660.

Aortic Valve Repair Versus Replacement Associated With Durable Left Ventricular Assist Devices.

BACKGROUND: Aortic valve (AV) repair (AVr) using a central coaptation stitch or bioprosthetic AV replacement (AVR) are most commonly performed at the time of durable left ventricular assist device implant to address AV insufficiency (AI). METHODS: Prospective data collection on 46 patients undergoing left ventricular assist device implant from 2007 through 2018 who received concomitant AVr (n = 40) or AVR (n = 6) was retrospectively analyzed to assess freedom from recurrent aortic insufficiency. Paired Wilcoxon rank-sum test was used to compare echocardiographic findings. Mantel-Cox statistics were used to analyze survival. RESULTS: For AVr, central coaptation led to a mean decrease in AI severity by 2.1 ± 1.0 grades (P < .001). Three patients (7.5%) had recurrence of at least moderate AI by 3 years. In comparison, all patients in the AVR group had mild or less AI on subsequent follow-up. Success of AVr in downgrading AI severity was associated with a smaller aortic root diameter (P = .011) and sinotubular junction diameter (P = .003). An aortic root diameter greater than 3.5 cm was predictive of less improvement in AI severity compared with 3.5 cm or less (1.83 ± 1.03 versus 2.47 ± 0.80 grades of improvement; P = .038). Duration of cardiopulmonary bypass was 32 minutes longer and duration of aortic cross-clamp was 38 minutes longer for AVR versus AVr cohorts. No difference in 30-day (P = .418) or overall survival (P = .572) between the AVr and AVR groups was seen. CONCLUSIONS: Aortic valve repair for addressing AI has a recurrence rate of 7.5% at 3 years. Success in downgrading AI is more likely with a smaller aortic root. No difference in survival was observed between AVr and AVR.