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.

Risk scores for major bleeding from direct oral anticoagulants: comparing predictive performance in patients with atrial fibrillation.

Background: Despite direct oral anticoagulants (DOACs) being safer than warfarin for stroke prevention in atrial fibrillation (AF), major bleeding concerns persist. Most bleeding risk scores predate DOAC approval. Objectives: This study aimed to compare the Age, history of Bleeding, and non-bleeding related Hospitalisation [ABH] score's performance-derived for DOAC-treated patients-with those of 5 other scores (Anticoagulation and Risk Factors in Atrial Fibrillation [ATRIA], Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly [>65 years], Drugs/alcohol concomitantly [HAS-BLED], Hepatic, Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke [HEMORR2HAGES], Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF], and Congestive heart failure, Hypertension, Age ≥75 [doubled], Diabetes, Stroke [doubled]-Vascular disease, Age 65-74, Sex category [CHA2DS2-VASc]) in predicting DOAC-related major bleeding in patients with AF. Methods: In this retrospective study of 2364 patients with nonvalvular AF on rivaroxaban or apixaban (median age, 68.3 years; 32.1% women), International Society on Thrombosis and Haemostasis-defined major bleeding (incidence, 4.1%; n = 97) was analyzed. C-statistics from time-dependent receiver operating characteristic (ROC) curves for continuous risk scores were the primary comparison metric, but other metrics, such as decision curves, were also compared. Results: At 100 days, C-statistics were highest for ORBIT-AF and ATRIA (0.62 and 0.61, respectively, with other scores having an area under the ROC curve of <0.60); some significant differences favored ORBIT-AF. At 1100 days, C-statistics remained highest for ORBIT-AF and ATRIA (0.62 and 0.61, respectively, with other scores having an area under the ROC curve of <0.60 again), and ORBIT-AF had significantly higher C-statistics than those for all other risk scores (P < .05), except for ATRIA. At 2100 days, all C-statistics were <0.60 with no significant differences. Decision curves showed the greatest net benefit for ORBIT-AF and ATRIA at 100 days and for ATRIA at 1100 days, with no discernible net benefit for any of the scores at 2100 days. Conclusion: ORBIT-AF and ATRIA provided the best bleeding risk prediction within the first 1100 days. None of the 6 bleeding risk scores provided predictive benefit over 2100 days of DOAC treatment.

A Physical Activity and Diet Just-in-Time Adaptive Intervention to Reduce Blood Pressure: The myBPmyLife Study Rationale and Design.

BACKGROUND: Smartphone applications and wearable devices are promising mobile health interventions for hypertension self-management. However, most mobile health interventions fail to use contextual data, potentially diminishing their impact. The myBPmyLife Study is a just-in-time adaptive intervention designed to promote personalized self-management for patients with hypertension. METHODS AND RESULTS: The study is a 6-month prospective, randomized-controlled, remotely administered trial. Participants were recruited from the University of Michigan Health in Ann Arbor, Michigan or the Hamilton Community Health Network, a federally qualified health center network in Flint, Michigan. Participants were randomized to a mobile application with a just-in-time adaptive intervention promoting physical activity and lower-sodium food choices as well as weekly goal setting or usual care. The mobile study application encourages goal attainment through a central visualization displaying participants' progress toward their goals for physical activity and lower-sodium food choices. Participants in both groups are followed for up for 6 months with a primary end point of change in systolic blood pressure. Exploratory analyses will examine the impact of notifications on step count and self-reported lower-sodium food choices. The study launched on December 9, 2021, with 484 participants enrolled as of March 31, 2023. Enrollment of participants was completed on July 3, 2023. After 6 months of follow-up, it is expected that results will be available in the spring of 2024. CONCLUSIONS: The myBPmyLife study is an innovative mobile health trial designed to evaluate the effects of a just-in-time adaptive intervention focused on improving physical activity and dietary sodium intake on blood pressure in diverse patients with hypertension. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05154929.

Use of Human-Centered Design Methodology to Develop a Digital Toolkit to Optimize Heart Failure Guideline-Directed Medical Therapy.

BACKGROUND: Guideline-directed medical therapies (GDMTs) improve quality of life and health outcomes for patients with heart failure (HF). However, GDMT utilization is suboptimal among patients with HF. OBJECTIVE: The aims of this study were to engage key stakeholders in semistructured, virtual human-centered design sessions to identify challenges in GDMT optimization posthospitalization and inform the development of a digital toolkit aimed at optimizing HF GDMTs. METHODS: For the human-centered design sessions, we recruited (a) clinicians who care for patients with HF across 3 hospital systems, (b) patients with HF with reduced ejection fraction (ejection fraction ≤ 40%) discharged from the hospital within 30 days of enrollment, and (c) caregivers. All participants were 18 years or older, English speaking, with Internet access. RESULTS: A total of 10 clinicians (median age, 37 years [interquartile range, 35-41], 12 years [interquartile range, 10-14] of experience caring for patients with HF, 80% women, 50% White, 50% nurse practitioners) and three patients and one caregiver (median age 57 years [IQR: 53-60], 75% men, 50% Black, 75% married) were included. Five themes emerged from the clinician sessions on challenges to GDMT optimization (eg, barriers to patient buy-in). Six themes on challenges (eg, managing medications), 4 themes on motivators (eg, regaining independence), and 3 themes on facilitators (eg, social support) to HF management arose from the patient and caregiver sessions. CONCLUSIONS: The clinician, patient, and caregiver insights identified through human-centered design will inform a digital toolkit aimed at optimizing HF GDMTs, including a patient-facing smartphone application and clinician dashboard. This digital toolkit will be evaluated in a multicenter, clinical trial.

Role of Individual Clinician Authority in the Implementation of Informatics Tools for Population-Based Medication Management: Qualitative Semistructured Interview Study.

BACKGROUND: Direct oral anticoagulant (DOAC) medications are frequently associated with inappropriate prescribing and adverse events. To improve the safe use of DOACs, health systems are implementing population health tools within their electronic health record (EHR). While EHR informatics tools can help increase awareness of inappropriate prescribing of medications, a lack of empowerment (or insufficient empowerment) of nonphysicians to implement change is a key barrier. OBJECTIVE: This study examined how the individual authority of clinical pharmacists and anticoagulation nurses is impacted by and changes the implementation success of an EHR DOAC Dashboard for safe DOAC medication prescribing. METHODS: We conducted semistructured interviews with pharmacists and nurses following the implementation of the EHR DOAC Dashboard at 3 clinical sites. Interview transcripts were coded according to the key determinants of implementation success. The intersections between individual clinician authority and other determinants were examined to identify themes. RESULTS: A high level of individual clinician authority was associated with high levels of key facilitators for effective use of the DOAC Dashboard (communication, staffing and work schedule, job satisfaction, and EHR integration). Conversely, a lack of individual authority was often associated with key barriers to effective DOAC Dashboard use. Positive individual authority was sometimes present with a negative example of another determinant, but no evidence was found of individual authority co-occurring with a positive instance of another determinant. CONCLUSIONS: Increased individual clinician authority is a necessary antecedent to the effective implementation of an EHR DOAC Population Management Dashboard and positively affects other aspects of implementation. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13012-020-01044-5.

Facilitators and barriers to blood pressure telemonitoring: A mixed-methods study.

Background: Telemonitoring of blood pressure (BP) may improve BP control. However, many patients are not using BP telemonitoring due to personal, technological, and health system barriers. Individuals are required to have electronic health literacy (e-HL), defined as knowledge and skills to use technology services effectively, such as BP telemonitoring. Objective: The objective was to determine the facilitators and barriers experienced by patients with hypertension in telemonitoring of BP using the e-HL framework (e-HLF). Methods: This study was a prospective mixed-methods study using a convergent design. We recruited a convenience sample of 21 patients with hypertension. The qualitative section was online or phone individual in-depth interviews based on the e-HLF, which has seven domains. The quantitative section was an online survey consisting of demographics, an e-HL questionnaire, and patient-provider communication preferences. A joint display was used in the mixed-methods analysis. Results: Five themes including knowledge, motivation, skills, systems, and behaviors along with 28 subthemes comprising facilitators or barriers of BP telemonitoring were identified. The mixed-methods results showed concordance between the participants' e-HL status and their experiences in the ability to actively engage with BP monitoring and managing digital services (domain 3) of the e-HLF. Other e-HL domains showed discordance. Conclusion: Patients may engage with BP telemonitoring when they feel the usefulness of concurrent access to telemonitoring services that suit their needs.

A Community Participatory Approach to Creating Contextually Tailored mHealth Notifications: myBPmyLife Project.

Just-in-time adaptive interventions (JITAIs) are a novel approach to mobile health (mHealth) interventions, sending contextually tailored behavior change notifications to participants when they are more likely to engage, determined by data from wearable devices. We describe a community participatory approach to JITAI notification development for the myBPmyLife Project, a JITAI focused on decreasing sodium consumption and increasing physical activity to reduce blood pressure. Eighty-six participants were interviewed, 50 at a federally qualified health center (FQHC) and 36 at a university clinic. Participants were asked to provide encouraging physical activity and low-sodium diet notifications and provided feedback on researcher-generated notifications to inform revisions. Participant notifications were thematically analyzed using an inductive approach. Participants noted challenging vocabulary, phrasing, and culturally incongruent suggestions in some of the researcher-generated notifications. Community-generated notifications were more direct, used colloquial language, and contained themes of grace. The FQHC participants' notifications expressed more compassion, religiosity, and addressed health-related social needs. University clinic participants' notifications frequently focused on office environments. In summary, our participatory approach to notification development embedded a distinctive community voice within our notifications. Our approach may be generalizable to other communities and serve as a model to create tailored mHealth notifications to their focus population.

Nationwide Implementation of a Population Management Dashboard for Monitoring Direct Oral Anticoagulants: Insights From the Veterans Affairs Health System.

BACKGROUND: Direct oral anticoagulants are first-line therapy for common thrombotic conditions, including atrial fibrillation and venous thromboembolism. Despite their strong efficacy and safety profile, evidence-based prescribing can be challenging given differences in dosing based on indication, renal function, and drug-drug interactions. The Veterans Health Affairs developed and implemented a population management dashboard to support pharmacist review of anticoagulant prescribing. The dashboard includes information about direct oral anticoagulants and dose prescribed, renal function, age, and weight, potential interacting medications, and the need for direct oral anticoagulant medication refills. It is a stand-alone system. METHODS: Using login data from the dashboard, nationwide implementation was evaluated using elements from the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. RESULTS: Between August 2016 and June 2020, 150/164 sites within the Veterans Health Affairs system used the dashboard, averaging 1875 patients per site. The dashboard was made available to sites on a staggered basis. Moderate or high adoption, defined as at least one login on at least 2 separate days per month, began slowly with 3/5 sites in the pilot phase but rapidly grew to 142/150 (94.7%) sites by June 2020. The average number of unique users per site increased from 2.4 to 7.5 over the study period. Moderate to high adoption of the dashboard's use was maintained for > 6 months in 126/150 (84.0%) sites by the end of the study period. CONCLUSIONS: There was rapid and sustained implementation and adoption of a population health dashboard for evidence-based anticoagulant prescribing across the national United States Veterans Health Administration health system. The impact of this tool on clinical outcomes and strategies to replicate this care model in other health systems will be important for broad dissemination and uptake.

Consumer perceptions of the OTC Coach: A clinical decision support system aimed at improving the safe use of over-the-counter medications.

BACKGROUND: There are more than 300,000 over-the-counter (OTC) medications on the market making it challenging for consumers to select safe and effective products to treat their minor ailments. OBJECTIVE: We sought to identify consumer perceptions about the use of a clinical decision support system, OTC Coach, to help them make informed decisions about OTC medications. METHODS: We developed a prototype of the OTC Coach that focused on treating fever in adults. We recruited community members who were 18 years and older via our institutional research website. Participants completed a 30- to 45-minute video interview in which they initially discussed their perceptions and experiences of using OTC medications. We subsequently shared the OTC Coach prototype and sought feedback related to the content and format of the tool. We asked participants to rate their likelihood of using the tool to treat a new symptom (10-point Likert scale, 1 = not at all to 10 = extremely likely) and conducted a qualitative and quantitative analysis of these findings. RESULTS: Among 20 participants, 11 (55%) were female, 10 (50%) were white, and the mean age was 47.9 years (range 18-81 years). Participants reported that the tool was easy to understand. The questions reported as being extremely important by most participants were allergies (n = 17, 85%), increased risk of bleeding (n = 15, 75%), temperature (n = 12, 60%), and duration of symptoms (n = 12, 60%). Three-fourths of participants (n = 15) selected a score of 7 or higher when asked about their likelihood of using this tool for a new symptom. Concerns that were raised included ensuring that the tool accounted for their personal health history, data storage, and accessibility. CONCLUSION: Consumers were interested in using an electronic tool to determine if their symptoms can be self-treated and, if so, which medications are appropriate.

Eight pharmacokinetic genetic variants are not associated with the risk of bleeding from direct oral anticoagulants in non-valvular atrial fibrillation patients.

Background: Atrial fibrillation (AF) is the leading cause of ischemic stroke and treatment has focused on reducing this risk through anticoagulation. Direct Oral Anticoagulants (DOACs) are the first-line guideline-recommended therapy since they are as effective and overall safer than warfarin in preventing AF-related stroke. Although patients bleed less from DOACs compared to warfarin, bleeding remains the primary safety concern with this therapy. Hypothesis: Genetic variants known to modify the function of metabolic enzymes or transporters involved in the pharmacokinetics (PK) of DOACs could increase the risk of bleeding. Aim: To assess the association of eight, functional PK-related single nucleotide variants (SNVs) in five genes (ABCB1, ABCG2, CYP2J2, CYP3A4, CYP3A5) with the risk of bleeding from DOACs in non-valvular AF patients. Methods: A retrospective cohort study was carried out with 2,364 self-identified white non-valvular AF patients treated with either rivaroxaban or apixaban. Genotyping was performed with Illumina Infinium CoreExome v12.1 bead arrays by the Michigan Genomics Initiative biobank. The primary endpoint was a composite of major and clinically relevant non-major bleeding. Cox proportional hazards regression with time-varying analysis assessed the association of the eight PK-related SNVs with the risk of bleeding from DOACs in unadjusted and covariate-adjusted models. The pre-specified primary analysis was the covariate-adjusted, additive genetic models. Six tests were performed in the primary analysis as three SNVs are in the same haplotype, and thus p-values below the Bonferroni-corrected level of 8.33e-3 were considered statistically significant. Results: In the primary analysis, none of the SNVs met the Bonferroni-corrected level of statistical significance (all p > 0.1). In exploratory analyses with other genetic models, the ABCB1 (rs4148732) GG genotype tended to be associated with the risk of bleeding from rivaroxaban [HR: 1.391 (95%CI: 1.019-1.900); p = 0.038] but not from apixaban (p = 0.487). Conclusion: Eight functional PK-related genetic variants were not significantly associated with bleeding from either rivaroxaban or apixaban in more than 2,000 AF self-identified white outpatients.

Patient self-assessment of urine dipsticks to estimate sodium intake in patients with hypertension.

BACKGROUND & AIMS: Dietary sodium restriction is recommended by current guidelines to reduce blood pressure and decrease the risk of cardiovascular disease. Current methods to assess sodium intake such as dietary questionnaires and 24-h urine collection are cumbersome, and the results are not readily available to patients. In this analysis, we evaluated using chloride and creatinine dipsticks as a convenient method to monitor sodium intake, in addition to patients' ability to practice this method independently. METHODS: This is a post-hoc analysis of a previously published trial, LowSalt4Life, that measured change in sodium consumption over 8 weeks to evaluate the effect of a just-in-time adaptive mobile application intervention. Participants were instructed on how to complete and interpret Quantab® chloride and Multistix® PRO 10 LS creatinine dipstick measurements at home and upload a picture of their results. A pharmacy student interpreted the chloride dipsticks, and intraclass correlation coefficients (ICC) were calculated to assess interrater reliability between the participant and pharmacy student. Predicted 24-h sodium values were calculated by the Kawasaki and Mann methods and compared to actual 24-h sodium excretion. RESULTS: There was a strong interobserver correlation between interpretations of the chloride dipsticks, with the ICC values 0.90, 0.97, 0.99, and 0.98 at weeks 2, 4, 6, and 8, respectively. There was a moderate correlation between the dipstick predicted 24-h sodium excretion and actual 24-h sodium excretion at baseline (r = 0.506; P < 0.001), and a weak correlation at week 8 (r = 0.187; P = 0.217). When corrected creatinine values were used, the dipstick predicted 24-h sodium excretion correlated with the actual 24-h sodium excretion at baseline and week 8 (r = 0.512; P < 0.001 and r = 0.451; P = 0.002). CONCLUSIONS: Our analysis suggests that chloride and creatinine dipsticks have the potential to predict total daily excretion of sodium. This method provides patients with an easy, convenient, and accurate method to assess sodium excretion at home. Further research is needed to identify the optimal timing of performing the dipstick analysis as well as ways to improve the creatinine measurement of the urine samples. TRIAL REGISTRATION: ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343.

A Physical Activity Just-in-time Adaptive Intervention Designed in Partnership With a Predominantly Black Community: Virtual, Community-Based Participatory Design Approach.

BACKGROUND: Black people are disproportionally impacted by hypertension. New approaches for encouraging healthy lifestyles are needed to reduce hypertension and promote health equity in Black communities. OBJECTIVE: In this report, we describe the early-stage, virtual design of a just-in-time adaptive intervention (JITAI) to increase physical activity in partnership with members of a low-income, predominantly Black community. METHODS: The hallmark of JITAIs is highly contextualized mobile app push notifications. Thus, understanding participants' context and determinants of physical activity are critical. During the height of the COVID-19 pandemic, we conducted virtual discovery interviews and analysis guided by the Behavior Change Wheel (which focuses on participants' capacity, opportunity, and motivation to engage in physical activity), as well as empathy mapping. We then formed a community-academic participatory design team that partnered in the design sprint, storyboarding, and paper prototyping. RESULTS: For this study, 5 community members participated in the discovery interviews, 12 stakeholders participated in the empathy mapping, 3 community members represented the community on the design team, and 10 community members provided storyboard or paper prototyping feedback. Only one community member had used videoconferencing prior to partnering with the academic team, and none had design experience. A set of 5 community-academic partner design principles were created: (1) keep users front and center, (2) tailor to the individual, (3) draw on existing motivation, (4) make physical activity feel approachable, and (5) make data collection transparent yet unobtrusive. To address community-specific barriers, the community-academic design team decided that mobile app push notifications will be tailored to participants' baseline mobility level and community resources (eg, local parks and events). Push notifications will also be tailored based on the day (weekday versus weekend), time of day, and weather. Motivation will be enhanced via adaptive goal setting with supportive feedback and social support via community-generated notifications. CONCLUSIONS: We completed early-stage virtual design of a JITAI in partnership with community participants and a community design team with limited design and videoconferencing experience. We found that designing JITAIs with the community enables these interventions to address community-specific needs, which may lead to a more meaningful impact on users' health.

Predictors of Smartphone and Tablet Use Among Patients With Hypertension: Secondary Analysis of Health Information National Trends Survey Data.

BACKGROUND: Uncontrolled hypertension leads to significant morbidity and mortality. The use of mobile health technology, such as smartphones, for remote blood pressure (BP) monitoring has improved BP control. An increase in BP control is more significant when patients can remotely communicate with their health care providers through technologies and receive feedback. Little is known about the predictors of remote BP monitoring among hypertensive populations. OBJECTIVE: The objective of this study is to quantify the predictors of smartphone and tablet use in achieving health goals and communicating with health care providers via SMS text messaging among hypertensive patients in the United States. METHODS: This study was a cross-sectional, secondary analysis of the 2017 and 2018 Health Information National Trends Survey 5, cycles 1 and 2 data. A total of 3045 respondents answered "Yes" to the question "Has a doctor or other healthcare provider ever told you that you had high blood pressure or hypertension?", which defined the subpopulation used in this study. We applied the Health Information National Trends Survey full sample weight to calculate the population estimates and 50 replicate weights to calculate the SEs of the estimates. We used design-adjusted descriptive statistics to describe the characteristics of respondents who are hypertensive based on relevant survey items. Design-adjusted multivariable logistic regression models were fitted to estimate predictors of achieving health goals with the help of smartphone or tablet and sending or receiving an SMS text message to or from a health care provider in the last 12 months. RESULTS: An estimated 36.9%, SE 0.9% (183,285,150/497,278,883) of the weighted adult population in the United States had hypertension. The mean age of the hypertensive population was 58.3 (SE 0.48) years. Electronic communication with the doctor or doctor's office through email or internet (odds ratio 2.93, 95% CI 1.85-4.63; P<.001) and having a wellness app (odds ratio 1.82, 95% CI 1.16-2.86; P=.02) were significant predictors of using SMS text message communication with a health care professional, adjusting for other demographic and technology-related variables. The odds of achieving health-related goals with the help of a tablet or smartphone declined significantly with older age (P<.001) and ownership of basic cellphones (P=.04). However, they increased significantly with being a woman (P=.045) or with being married (P=.03), having a wellness app (P<.001), using devices other than smartphones or tablets to monitor health (P=.008), making health treatment decisions (P=.048), and discussing with a provider (P=.02) with the help of a tablet or smartphone. CONCLUSIONS: Intervention measures accounting for age, gender, marital status, and the patient's technology-related health behaviors are required to increase smartphone and tablet use in self-care and SMS text message communication with health care providers.

Survival Association of Angiotensin Inhibitors in Heart Failure With Reduced Ejection Fraction: Comparisons Using Self-Identified Race and Genomic Ancestry.

BACKGROUND: It remains unclear whether there is a racial disparity in the response to angiotensin inhibitors in patients with heart failure with reduced ejection fraction (HFrEF) and whether the role of genomic ancestry plays a part. Therefore, we compared survival rates associated with angiotensin inhibitors in patients with HFrEF by self-identified race and proportion of West African genomic ancestry. METHODS: Three datasets totaling 1153 and 1480 self-identified Black and White patients, respectively, with HFrEF were meta-analyzed (random effects model) for race-based analyses. One dataset had genomic data for ancestry analyses (416 and 369 self-identified Black and White patients, respectively). Cox proportional hazards regression, adjusted for propensity scores, assessed the association of angiotensin inhibitor exposure with all-cause mortality by self-identified race or proportion of West African genomic ancestry. RESULTS: In meta-analysis of self-identified race, adjusted hazard ratios (95% CI) for exposure to angiotensin inhibitors were similar in self-identified Black and White patients with HFrEF: 0.52 (0.31-0.85) P = 0.006 and 0.54 (0.42-0.71) P = 0.001, respectively. Results were similar when the proportion of West African genomic ancestry was > 80% or < 5%: 0.66 (0.34-1.25) P = 0.200 and 0.56 (0.26-1.23) P = 0.147, respectively. CONCLUSIONS: Among self-identified Black and White patients with HFrEF, reduction in all-cause mortality associated with exposure to angiotensin inhibitors was similar regardless of self-identified race or proportion of West African genomic ancestry.

Tacrolimus time in therapeutic range and long-term outcomes in heart transplant recipients.

STUDY OBJECTIVE: Little is known about the association between tacrolimus time in therapeutic range (TTR) within the guideline-recommended targets and heart transplant (HT) patient outcomes. This study evaluated the association of early tacrolimus TTR with rejection and other clinical outcomes during an extended follow-up after HT. DESIGN: This was a single-center retrospective cohort study. SETTING: The study was conducted at Michigan Medicine (1/1/2006-12/31/2017). PATIENTS: HT recipients ≥18 years of age were included. MEASUREMENT: The primary end point was the effect of tacrolimus TTR on time to rejection over the entire follow-up period. MAIN RESULTS: A total of 137 patients were included with a median follow-up of 53 months. Based on the median TTR of 58%, the patients were divided into the low tacrolimus TTR (n = 68) and high tacrolimus TTR (n = 69) cohort. The high tacrolimus TTR was associated with a significantly lower risk of rejection compared to the low tacrolimus TTR cohort (hazard ratio [HR] 0.63, 95% confidence interval [CI] 0.41-0.98; p = 0.04). A post hoc analysis revealed associations between rejection and TTR when high and low TTR groups were created at different levels. TTR <30% was associated with a 7-fold higher risk of rejection (HR 7.56; 95% CI 1.76-37.6; p < 0.01) and TTR >75% was associated with a 77% lower risk of rejection (HR 0.23; 95% CI 0.08-0.627; p < 0.01). CONCLUSIONS: Patients in the higher tacrolimus TTR cohort had a lower risk of rejection. We observed correlations between higher risk of rejection with TTR <30% and lower risk of rejection with TTR >75%. Future studies should focus on validating the optimal TTR cutoff while also exploring a cutoff to delineate high-risk patients for which early interventions to improve tacrolimus TTR may be beneficial.

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.

Comparative performance of the two pooled cohort equations for predicting atherosclerotic cardiovascular disease.

BACKGROUND AND AIMS: Multivariable algorithms have been developed to predict the risk of atherosclerotic cardiovascular disease (ASCVD) to identify high-risk patients. Shortly after the introduction of the AHA/ACC Pooled Cohort Equations (PCE), a systematic overestimation of risk was identified. As such, a revised PCE was proposed to more accurately assess ASCVD risk. This study aims to compare the accuracy of both PCE in predicting ASCVD risk within a large, real-world patient sample in the US. METHODS: This retrospective cohort study identified 20,843 patients aged between 40 and 75 years with no previous ASCVD in an academic healthcare system. Model fit, calibration, and discrimination were compared between PCE using Bayesian Information Criterion (BIC), Hosmer-Lemeshow test, area under the ROC curves (AUC), Brier score, and precision-recall analysis. In addition, we examined race and sex subgroups for effect modification. RESULTS: Both PCE showed poor calibration (Hosmer-Lemeshow χ2 > 20; p < 0.05) and discrimination (AUC<0.7). The lack of improvement in discrimination of the revised PCE (AUC: 0.677 vs 0.679; p = 0.357) was confirmed with the AUC precision-recall curves (AUCPR: 0.0717 vs 0.0698). In contrast, the AHA/ACC PCE showed a strong positive risk prediction (ΔBIC>10) compared to the revised PCE, although calibration curves had overlapped. CONCLUSIONS: In this single center analysis, both PCE had poor calibration and discrimination of ASCVD risk in a large, real-world patient sample followed up for over 2 years. There was no evidence of improvement in the accuracy of the revised PCE in assessing the risk of ASCVD in relation to the AHA/ACC PCE.