Publications

BACKGROUND: Risk stratification in patients with nonischemic dilated cardiomyopathy (DCM) remains challenging. Although late gadolinium enhancement (LGE) cardiovascular magnetic resonance is recognized as a major risk factor for ventricular tachycardia/ventricular fibrillation (VT/VF), the prognostic value of LGE radiomics is unknown.

OBJECTIVES: The purpose of this study was to investigate if radiomic analysis of LGE images can improve arrhythmia risk stratification in patients with DCM beyond current clinical and imaging markers.

METHODS: In a 2-center retrospective study, patients with DCM were identified among those who received primary prevention implantable cardioverter-defibrillators (ICDs) according to the clinical guidelines and had a cardiovascular magnetic resonance before ICD implantation. The study included patients with DCM from the Cleveland Clinic Foundation for model development and patients with DCM from Beth Israel Deaconess Medical Center for external validation. Left ventricular myocardial radiomic features were extracted from LGE images. The primary outcome was appropriate ICD intervention defined as shock or antitachycardia pacing for VT/VF. Consensus clustering and pairwise correlation were used to identify the radiomic signature. To assess the prognostic value of LGE radiomics, we built 2 logistic regression models using the development data: 1) model 1, including clinical risk factors and scar presence and 2) model 2, which combines model 1 and LGE radiomics.

RESULTS: In total, 270 patients with DCM (61% male, age 58 ± 13 years) in development data and 113 patients with DCM (71% male, age 55 ± 14 years) in external validation were included. VT/VF occurred in 40 (15%) patients in development and 16 (15%) in external validation cohorts over a median follow-up period of 4.0 (IQR: 2.5-6.1) and 2.6 (IQR: 1.2-4.1) years, respectively. Consensus clustering and pairwise correlation revealed 3 distinct radiomic features. Model 2 showed a higher C-statistic than model 1 (0.71 [95% CI: 0.62-0.80] vs 0.61 [95% CI: 0.53-0.71]; P = 0.028 in development and 0.70 [95% CI: 0.59-0.85] vs 0.61 [95% CI: 0.46-0.77]; P = 0.025 in external validation). This also significantly improved risk stratification with a continuous net reclassification index of 0.60 [95% CI: 0.29-0.91; P < 0.001] in development and of 0.29 [95% CI: 0.26-0.56; P = 0.03] in external validation. Additionally, 1 radiomic feature, namely the gray level co-occurrence matrix autocorrelation, was an independent predictor of VT/VF in both development (HR: 1.45 [95% CI: 1.10-1.91]; P = 0.01) and in external validation (HR: 2.38 [95% CI: 1.28-4.42]; P = 0.01).

CONCLUSIONS: In this proof-of-concept study, radiomic analysis of LGE images provides additional prognostic value beyond LGE presence in predicting arrhythmia in patients with DCM.

Glucagon-like peptide 1 receptor agonists (GLP1-RA) are anti-diabetes agents recently approved for weight loss. Obesity is an established risk factor for venous thromboembolism (VTE). Moreover, preclinical studies have shown that GLP1-RA may attenuate thromboxaneinduced platelet activation. Therefore, we hypothesized that GLP1-RA use may reduce the risk of VTE. We performed a target trial emulation using a population-based database of electronic health records to evaluate whether GLP1-RA use is associated with a reduction in VTE in patients with type 2 diabetes mellitus (T2DM) compared with dipeptidyl peptidas e-4 inhibitors (DPP4i). Patients who were newly initiated on GLP1-RA were propensity scorematched to patients who were newly initiated on DPP4i. We evaluated the primary outcome, composite VTE, identified using ICD-10 codes, within 12 months of the initiation of GLP1-RA or DPP4i. The study cohort comprised 540,258 patients with 270,129 individuals receiving either GLP1-RA or DPP4i. Over 12 months of follow-up, patients who received GLP1-RA had a lower incidence of VTE compared with patients who received DPP4i (6.1 vs. 7.6 events per 1000 patient-years, hazard ratio [HR], 0.78 [95% CI: 0.73-0.83]). This was similar for PE (2.9 vs. 3.8 events per 1000 patient-years, HR, 0.74 [95% CI: 0.68-0.82]) and DVT (3.9 vs. 4.7 events per 1000 patient-years, HR, 0.81 [95% CI: 0.75-0.88]). In this propensity scorematched, target trial emulation study, patients with T2DM who received a GLP1-RA had a lower risk of VTE at one year compared with patients who received DPP4i.

BACKGROUND: The American Heart Association (AHA), in conjunction with the National Institutes of Health, annually reports the most up-to-date statistics related to heart disease, stroke, and cardiovascular risk factors, including core health behaviors (smoking, physical activity, nutrition, sleep, and obesity) and health factors (cholesterol, blood pressure, glucose control, and metabolic syndrome) that contribute to cardiovascular health. The AHA Heart Disease and Stroke Statistical Update presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, brain health, complications of pregnancy, kidney disease, congenital heart disease, rhythm disorders, sudden cardiac arrest, subclinical atherosclerosis, coronary heart disease, cardiomyopathy, heart failure, valvular disease, venous thromboembolism, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs).

METHODS: The AHA, through its Epidemiology and Prevention Statistics Committee, continuously monitors and evaluates sources of data on heart disease and stroke in the United States and globally to provide the most current information available in the annual Statistical Update with review of published literature through the year before writing. The 2025 AHA Statistical Update is the product of a full year's worth of effort in 2024 by dedicated volunteer clinicians and scientists, committed government professionals, and AHA staff members. This year's edition includes a continued focus on health equity across several key domains and enhanced global data that reflect improved methods and incorporation of ≈3000 new data sources since last year's Statistical Update.

RESULTS: Each of the chapters in the Statistical Update focuses on a different topic related to heart disease and stroke statistics.

CONCLUSIONS: The Statistical Update represents a critical resource for the lay public, policymakers, media professionals, clinicians, health care administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions.

IMPORTANCE: The Southern Community Cohort Study (SCCS) Polypill Trial showed that a cardiovascular polypill (a single pill containing a statin and 3 half-standard dose antihypertensive medications) effectively controls cardiovascular disease (CVD) risk factors in a majority Black race and low-income population. The cost-effectiveness of polypill treatment in this population has not been previously studied.

OBJECTIVE: To determine the cost-effectiveness of the cardiovascular polypill.

DESIGN, SETTING, AND PARTICIPANTS: A discrete-event simulation version of the well-established CVD policy model simulated clinical and economic outcomes of the SCCS Polypill Trial from a health care sector perspective. A time horizon of 10 years was adopted. Polypill treatment was priced at $463 per year in the base-case analysis. Model input data were derived from the National Health and Nutrition Examination Survey, Medical Expenditure Panel Survey, pooled longitudinal cohort studies, the SCCS Polypill Trial, and published literature. Two cohorts were analyzed: an SCCS Polypill Trial-representative cohort of 100 000 individuals and all trial-eligible non-Hispanic Black US adults. Study parameters and model inputs were varied extensively in 1-way and probabilistic sensitivity analysis.

EXPOSURES: Polypill treatment or usual care.

MAIN OUTCOME AND MEASURES: Primary outcomes were direct health care costs (US dollar 2023) and quality-adjusted life-years (QALYs), both discounted 3% annually, and the incremental cost per QALY gained.

RESULTS: In the trial-representative cohort of 100 000 individuals (mean [SD] age, 56.9 [5.9] years; 61 807 female [61.8%]), polypill treatment was projected to yield a mean of 1190 (95% uncertainty interval, 287-2159) additional QALYs compared with usual care, at a cost of approximately $10 152 000. Hence, polypill treatment was estimated to cost $8560 per QALY gained compared with usual care and was high value (<$50 000 per QALY gained) in 99% of simulations. Polypill treatment was estimated to be high value when priced at $559 or less per year and cost saving when priced at $443 or less per year. In almost all sensitivity analyses, polypill treatment remained high value. In a secondary analysis of 3 602 427 trial-eligible non-Hispanic Black US adults (mean [SD] age, 55.4 [7.6] years; 2 006 597 female [55.7%]), polypill treatment was high value, with an estimated cost of $13 400 per QALY gained.

CONCLUSIONS AND RELEVANCE: Results of this economic evaluation suggest that polypill treatment could be a high value intervention for a low-income, majority Black population with limited access to health care services. It could additionally reduce health disparities.

PURPOSE: Cardiac rehabilitation (CR) is a valuable secondary preventive intervention for Veterans given their increased risk of cardiovascular disease. Adults cared for in the Veterans Affairs (VA) healthcare system are a unique population that receives healthcare from the largest integrated care network in the United States. Yet, this group faces distinct challenges in utilizing CR. In this review, we evaluated the existing data regarding CR utilization and outcomes among U.S. Veterans.

REVIEW METHODS: A literature search was conducted using PubMed and Scopus for cardiac rehabilitation and U.S. Veterans.

SUMMARY: Veterans have 3 potential options for attending CR: in-person at their local VA medical centers, home-based CR through their local VA medical centers, and in-person at community CR centers. However, participation remains low. A significant barrier to participation is transportation to in-person CR. Home-based CR shows promise in addressing this barrier and has demonstrated resilience in the face of pandemic restrictions. Cardiac rehabilitation outcomes among Veterans who participate include improved exercise capacity, fewer depressive symptoms, and decreased mortality. Despite its benefits for secondary prevention among Veterans, there remains a paucity of data about the current uptake of CR, the impact of mental health on uptake, possible sex-based or racial disparities, and long-term outcomes.

BACKGROUND: Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction remains underused. The role of direct-to-physician marketing in accelerating uptake of GDMT is unknown.

OBJECTIVES: The authors investigated the association between industry marketing meals and GDMT prescribing rates under Medicare Part D.

METHODS: The authors linked Medicare data sets to identify general and advanced heart failure (AHF) cardiologists' prescriptions for angiotensin receptor-neprilysin inhibitors (ARNIs), sodium-glucose cotransporter 2 inhibitors (SGLT2is), angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, mineralocorticoid receptor antagonists (MRAs), and beta-blockers from 2019 to 2021. Using negative binomial regression analyses, they examined the association between marketing meals and prescribing rates of marketed and un-marketed classes of GDMT.

RESULTS: Of 11,277 general and 329 AHF cardiologists, 60% received marketing payments for ARNI and 50% for SGLT2i from 2019 to 2021. Among general cardiologists, but not AHF cardiologists, exposure to ARNI marketing meals in 2020 was associated with a greater prescribing volume of ARNI in 2021 (1-4 ARNI meals; relative ratio: 1.43 [95% CI: 1.34-1.53]; 5-9 ARNI meals; relative ratio: 1.69 [95% CI: 1.48-1.93]; ≥10 ARNI meals; relative ratio: 2.09 [95% CI: 1.80-2.43]). Findings were similar for SGLT2i. The association between marketing and prescribing of other pillars of GDMT was inconsistent across drug classes. Neither ARNI nor SGLT2i marketing was consistently associated with increased prescribing of MRAs.

CONCLUSIONS: Industry marketing to general cardiologists is associated with increased uptake of ARNIs and SGLT2is, but not with increased uptake of all pillars of GDMT. Improvements in comprehensive therapy for heart failure will require other mechanisms to accelerate uptake of MRAs and beta-blockers, as well as ARNIs and SGLT2is once multiple generic formulations become available in the United States.

INTRODUCTION: A four-drug regimen of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) is underused, in part due to prescriber inertia and low patient adherence. Although fixed-dose combination pills ('polypills') have improved adherence and clinical outcomes for other conditions, there are no polypills available that combine multiple classes of GDMT for HFrEF. Pharmacy-level over-encapsulation, in which several tablets are combined into one capsule, offers an opportunity to create customised HFrEF polypills with the goal of improving delivery of HFrEF therapies.

METHODS AND ANALYSIS: In the COMBO-HF-X pilot crossover randomised clinical trial, we will enrol 30-40 patients with HFrEF in a safety-net public healthcare system in San Francisco, California. Participants will be randomised 1:1 to receive GDMT as individual tablets or as a customised, over-encapsulated HFrEF polypill. After 1 month, participants will cross over to the other formulation (individual tablets or a HFrEF polypill). Participants will attend in-person visits at 0, 4 and 8 weeks. GDMT will be initiated and titrated by study physicians as clinically indicated in accordance with HFrEF treatment guidelines. The primary outcome will be adherence to GDMT by pill count. Key feasibility outcomes will include the successful recruitment of 30-40 participants and completion of study procedures for at least 20 participants. Implementation outcomes will include the cost and time required for HFrEF polypill preparation, which will be performed by a community pharmacy partner. Exploratory clinical outcomes will include change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level and Kansas City Cardiomyopathy Questionnaire. Acceptability will be assessed through a patient exit survey and semistructured exit interviews with patients, their primary care and cardiology providers, and pharmacy staff.

ETHICS AND DISSEMINATION: Study findings will be published in peer-reviewed journals. The protocol of this study was approved by the Institutional Review Board of the University of California, San Francisco. Written informed consent for COMBO-HF-X was obtained from all participants.

TRIAL REGISTRATION NUMBER: NCT06029712.

BACKGROUND: Use of pulmonary vein isolation (PVI) to treat atrial fibrillation continues to increase. Despite great interest in leveraging administrative data for real-world analyses, contemporary procedural codes for identifying PVI have not been evaluated.

METHODS AND RESULTS: In this observational retrospective cohort study, inpatient PVIs were identified among US Medicare fee-for-service beneficiaries using Current Procedural Terminology (CPT) code 93656 in Carrier Line Files. Each patient was matched with their claims from Medicare Provider Analysis and Review to compare CPT with International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS) claims submitted by health care facilities to bill for PVIs. We performed the reverse for commonly matched ICD-10-PCS codes, to identify corresponding CPT-billed procedures. Finally, we reviewed institutional cases for additional comparison of CPT and ICD-10-PCS assignation for PVI. We identified 25 617 inpatient PVIs from January 2017 to December 2021, of which 18 165 (71%) were linked to Medicare Provider Analysis and Review. Of these, 16 672 (92%) were billed as ICD-10-PCS 02583ZZ: "Destruction of Conduction Mechanism, Percutaneous Approach." The reverse process yielded heterogeneous results: among 75 003 procedures billed as ICD-10-PCS 02583ZZ, only 15 691 (21%) matched with CPT 93656 (PVI), as several other unrelated procedures were billed under this ICD-10-PCS code. Institutional case review confirmed the greater specificity of CPT codes.

CONCLUSIONS: The ICD-10-PCS code associated with CPT-billed PVI procedures actually referred to ablation of the atrioventricular junction. Yet this ICD-10-PCS code also matched with a wide range of other procedures distinct from PVI. We conclude that ICD-10-PCS codes alone are not sensitive nor specific for identifying PVI in claims and cannot be reliably used in isolation for health services research on this important procedure.