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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., Competing Interests: Under a license agreement between Corrie Health and Johns Hopkins University, the university owns equity in Corrie Health. The university, F.A.M. and S.S.M. are entitled to royalty distributions related to Corrie Health. In addition, F.A.M. and S.S.M. are co-founders of and hold equity in Corrie Health. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. F.A.M. and S.S.M. have also received research and material support from Apple and iHealth. Furthermore, S.S.M. is on the Advisory Board for Care Access and reports personal consulting fees from Amgen, AstraZeneca, Chroma, Kaneka, NewAmsterdam, Novartis, Novo Nordisk, Sanofi, and 89bio. E.M.S. reports personal consulting fees from Corrie Health. A.S. reports consulting fees from Lexicon Pharmaceuticals, Reprieve Cardiovascular, and Cleerly Health. N.A.G. reports consulting fees from Kiniksa Pharmaceuticals. All other authors declare no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Although methamphetamine use associated heart failure (MU-HF) is increasing, data on its clinical course are limited due to a preponderance of single center studies and significant heterogeneity in the definition of MU-HF in the published literature. Our objective was to evaluate left ventricular ejection fraction (LVEF) distribution, methamphetamine use treatment engagement and postdischarge healthcare utilization among Veterans with heart failure hospitalization in the department of Veterans Affairs (VA) medical centers for MU-HF versus HF not associated with methamphetamine use (other-HF)., Methods: Observational study including a cohort of Veterans with a first heart failure hospitalization during 2007 - 2020 using data in the VA Corporate Data Warehouse. MU-HF was identified based on the presence of an ICD-code for methamphetmaine use or positive toxicology results within 1-year of heart failure hospitalization. LVEF values entered in the medical record were identified using a validated natural language processing algorithm. Healthcare utilization data was obtained using clinic stop-codes and hosptilaization records., Results: Of 203,005 first-time heart failure hospitlaizations, 4080 were categorized as MU-HF. Median (interquartile range) of LVEF was 30 (20-45) % for MU-HF versus 40 (25-55)% for other-HF (P < .0001). Eighteen percent of MU-HF had LVEF ≥ 50% compared to 28% in other-HF. Discharge against medical advice was higher in MU-HF (8% vs 2%). Among Veterans with MU-HF, post hospital discharge methamphetamine use treatment engagement was low (18% at 30 days post discharge), with higher follow-up in primary care (76% at 30 days). Post discharge emergency department visits (33% versus 22% at 30 days) and rehospitalizations (24% versus 18% at 30 days) were higher in MU-HF compared to other-HF., Conclusions: While the majority of MU-HF hospitalizations are HFrEF, a sizeable minority have HFpEF. This finding has implications for accurate MU-HF classification, treatment, and prognosis. Patients with MU-HF have low addiction treatment receipt and high postdischarge unplanned healthcare utilization. Increasing substance use disorder treatment in this population must be a priority to improve health outcomes. Care-coordination and linkage interventions are urgently needed to increase post-hospitalization addiction treatment and follow-up in an effort to increase evidence-base care and mitigate unplanned healthcare utilization., (Published by Elsevier Inc.)

Heart failure (HF) poses a significant economic burden in the US, with costs projected to reach $70 billion by 2030. Cost-effectiveness analyses play a pivotal role in assessing the economic value of HF therapies. In this review, we overview the cost-effectiveness of HF therapies and discuss ways to improve patient access. Based on current costs, guideline directed medical therapies for HF with reduced ejection fraction provide high economic value except for sodium-glucose cotransporter-2 inhibitors, which provide intermediate economic value. Combining therapy with the four pillars of medical therapy also has intermediate economic value, with incremental cost-effectiveness ratios ranging from $73,000 to $98,500/ quality adjusted life-years. High economic value procedures include cardiac resynchronization devices, implantable cardioverter-defibrillators, and coronary artery bypass surgery. In contrast, advanced HF therapies have previously demonstrated intermediate to low economic value, but newer data appear more favorable. Given the affordability challenges of HF therapies, additional efforts are needed to ensure optimal care for patients. The recent Inflation Reduction Act contains provisions to reform policy pertaining to drug price negotiation and out-of-pocket spending, as well as measures to increase access to existing programs, including the Medicare low-income subsidy. On a patient level, it is also important to encourage patient and physician awareness and discussions surrounding medical costs. Overall, a broad approach to improving available therapies and access to care is needed to reduce the growing clinical and economic morbidity of HF., Competing Interests: Declaration of competing interest ATS is supported by the National Heart, Lung, and Blood Institute (1K23HL151672-04) and the American Heart Association. ATS has received consulting fees from Lexicon Pharmaceuticals and Reprieve Cardiovascular., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Current risk scores using clinical risk factors for predicting ischemic heart disease (IHD) events-the leading cause of global mortality-have known limitations and may be improved by imaging biomarkers. While body composition (BC) imaging biomarkers derived from abdominopelvic computed tomography (CT) correlate with IHD risk, they are impractical to measure manually. Here, in a retrospective cohort of 8139 contrast-enhanced abdominopelvic CT examinations undergoing up to 5 years of follow-up, we developed multimodal opportunistic risk assessment models for IHD by automatically extracting BC features from abdominal CT images and integrating these with features from each patient's electronic medical record (EMR). Our predictive methods match and, in some cases, outperform clinical risk scores currently used in IHD risk assessment. We provide clinical interpretability of our model using a new method of determining tissue-level contributions from CT along with weightings of EMR features contributing to IHD risk. We conclude that such a multimodal approach, which automatically integrates BC biomarkers and EMR data, can enhance IHD risk assessment and aid primary prevention efforts for IHD. To further promote research, we release the Opportunistic L3 Ischemic heart disease (OL3I) dataset, the first public multimodal dataset for opportunistic CT prediction of IHD., (© 2023. The Author(s).)

Clinician payment is transitioning from fee-for-service to value-based payment, with reimbursement tied to health care quality and cost. However, the overarching goals of value-based payment-to improve health care quality, lower costs, or both-have been largely unmet. This policy statement reviews the current state of value-based payment and provides recommended best practices for future design and implementation. The policy statement is divided into sections that detail different aspects of value-based payment: (1) key program design features (patient population, quality measurement, cost measurement, and risk adjustment), (2) the role of equity during design and evaluation, (3) adjustment of payment, and (4) program implementation and evaluation. Each section introduces the topic, describes important considerations, and lists examples from existing programs. Each section includes recommended best practices for future program design. The policy statement highlights 4 key themes for successful value-based payment. First, programs should carefully weigh the incentives between lowering cost and improving quality of care and ensure that there is adequate focus on quality of care. Second, the expansion of value-based payment should be a tool for improving equity, which is central to quality of care and should be a focal point of program design and evaluation. Third, value-based payment should continue to move away from fee for service toward more flexible funding that allows clinicians to focus resources on the interventions that best help patients. Last, successful programs should find ways to channel clinicians' intrinsic motivation to improve their performance and the care for their patients. These principles should guide the future development of clinician value-based payment models.

Background: Sotalol and dronedarone are both used for maintenance of sinus rhythm for patients with atrial fibrillation. However, while sotalol requires initial monitoring for QT prolongation and proarrhythmia, dronedarone does not. These treatments can be used in comparable patients, but their safety and effectiveness have not been compared head to head. Therefore, we retrospectively evaluated the effectiveness and safety using data from a large health care system., Methods: Using Veterans Health Administration data, we identified 11 296 antiarrhythmic drug-naive patients with atrial fibrillation prescribed dronedarone or sotalol in 2012 or later. We excluded patients with prior conduction disease, pacemakers or implantable cardioverter-defibrillators, ventricular arrhythmia, cancer, renal failure, liver disease, or heart failure. We used natural language processing to identify and compare baseline left ventricular ejection fraction between treatment arms. We used 1:1 propensity score matching, based on patient demographics, comorbidities, and medications, and Cox regression to compare strategies. To evaluate residual confounding, we performed falsification analysis with nonplausible outcomes., Results: The matched cohort comprised 6212 patients (3106 dronedarone and 3106 sotalol; mean [±SD] age, 71±10 years; 2.5% female; mean [±SD] CHA 2 DS 2 -VASC, 2±1.3). The mean (±SD) left ventricular ejection fraction was 55±11 and 58±10 for dronedarone and sotalol users, correspondingly. Dronedarone, compared with sotalol, did not demonstrate a significant association with risk of cardiovascular hospitalization (hazard ratio, 1.03 [95% CI, 0.88-1.21]) or all-cause mortality (hazard ratio, 0.89 [95% CI, 0.68-1.16]). However, dronedarone was associated with significantly lower risk of ventricular proarrhythmic events (hazard ratio, 0.53 [95% CI, 0.38-0.74]) and symptomatic bradycardia (hazard ratio, 0.56 [95% CI, 0.37-0.87]). The primary findings were stable across sensitivity analyses. Falsification analyses were not significant., Conclusions: Dronedarone, compared with sotalol, was associated with a lower risk of ventricular proarrhythmic events and conduction disorders while having no difference in risk of incident cardiovascular hospitalization and mortality. These observational data provide the basis for prospective efficacy and safety trials., Competing Interests: Disclosures Dr Pundi reports research grants from the American Heart Association and the American College of Cardiology and is a consultant for Evidently and 100Plus. Dr Kabadi is an employee and shareholder at Sanofi. Dr Blomström-Lundqvist reports personal fees from Bayer, Medtronic, CathPrint, Octopus, Sanofi Aventis, Boston Sci, Merck Sharp & Dohme, Abbotts, and Philips. Dr John Camm reports personal fees from Bayer, Daiichi Sankyo, Pfizer/BMS, Medtronic Abbott, Boston Scientific, Menarini, and Sanofi. Dr Kowey is an ad hoc consultant for Sanofi. Dr Singh is a consultant for Abbott, Biotronik, Boston Sci, Cardiologs, Medtronic, Implicity, Cardiac Rhythm Group, Sanofi, EBR, Microport, Biosense Webster, Sanofi, and Orchestra BioMed. Dr Rashkin is an employee at Sanofi. Dr Wieloch is an employee and shareholder at Sanofi. Dr Turakhia reports research grants from Bristol Myers Squibb, American Heart Association, Apple, Inc, Bayer, and the Food and Drug Administration and is a consultant for Medtronic, Abbott, Biotronik, Sanofi, Pfizer, Myokardia, Johnson & Johnson, Milestone, InCarda, 100Plus, Alivecor, Acutus Medical, and BrightInsight. Dr Sandhu reports research grant 1K23HL151672-01 from the National Heart, Lung, and Blood Institute. The other authors report no conflicts.

Competing Interests: Disclosures Dr Rodriguez reports consulting relationships with HealthPals, Novartis, Amgen, NovoNordisk (CEC), and AstraZeneca. The remaining authors have nothing to disclose.

Background: Traditional approaches to guideline-directed medical therapy (GDMT) management often lead to delayed initiation and titration of therapies in patients with heart failure. This study sought to characterize alternative models of care involving nonphysician provider-led GDMT interventions and their associations with therapy use and clinical outcomes., Methods: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies comparing nonphysician provider-led GDMT initiation and/or uptitration interventions vs usual physician care (PROSPERO ID: CRD42022334661). We queried PubMed, Embase, the Cochrane Library, and the World Health Organization International Clinical Trial Registry Platform for peer-reviewed studies from database inception to July 31, 2022. In the meta-analysis, we used RCT data only and leveraged random-effects models to estimate pooled outcomes. Primary outcomes were GDMT initiation and titration to target dosages by therapeutic class. Secondary outcomes included all-cause mortality and HF hospitalizations., Results: We reviewed 33 studies, of which 17 (52%) were randomized controlled trials with median follow-ups of 6 months; 14 (82%) trials evaluated nurse interventions, and the remainder assessed pharmacists' interventions. The primary analysis pooled data from 16 RCTs, which enrolled 5268 patients. Pooled risk ratios (RR) for renin-angiotensin system inhibitor (RASI) and beta-blocker initiation were 2.09 (95% CI 1.05-4.16; I 2  = 68%) and 1.91 (95% CI1.35-2.70; I 2  = 37%), respectively. Outcomes were similar for uptitration of RASI (RR 1.99, 95% CI 1.24-3.20; I 2  = 77%) and beta-blocker (RR 2.22, 95% CI 1.29-3.83; I 2  = 66%). No association was found with mineralocorticoid receptor antagonist initiation (RR 1.01, 95% CI 0.47-2.19). There were lower rates of mortality (RR 0.82, 95% CI 0.67-1.04; I 2  = 12%) and hospitalization due to HF (RR 0.80, 95% CI 0.63-1.01; I 2  = 25%) across intervention arms, but these differences were small and not statistically significant. Prediction intervals were wide due to moderate-to-high heterogeneity across trial populations and interventions. Subgroup analyses by provider type did not show significant effect modification., Conclusions: Pharmacist- and nurse-led interventions for GDMT initiation and/or uptitration improved guideline concordance. Further research evaluating newer therapies and titration strategies integrated with pharmacist- and/or nurse-based care may be valuable., Competing Interests: Disclosures None., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: While transthoracic echocardiography (TTE) is responsible for more Medicare spending than any other cardiovascular imaging procedure, little is known about its commercial cost footprint. The 2021 Hospital Price Transparency Final Rule mandated that U.S. hospitals publish their insurer-negotiated and self-pay prices for services. This study sought to characterize and assess factors contributing to variation in TTE prices., Methods: We used a commercial database containing hospital-disclosed prices to characterize variation in TTE prices within and across hospitals. We linked these price data to hospital and regional characteristics using Medicare Facility IDs., Results: A total of 1,949 hospitals reported commercial prices. Among reporting hospitals, median commercial and self-pay prices were 2.93 and 3.06 times greater than the median Medicare price ($1,313 and $1,422, respectively, vs $464). Within hospitals, the 90th percentile payer-negotiated rate was 2.78 (interquartile range, 1.80-5.09) times the 10th percentile rate (within-center ratio). Across hospitals within the same hospital referral region, the median price at the 90th percentile hospital was 2.47 (interquartile range, 1.69-3.75) times that at the 10th percentile hospital (across-center ratio). On univariate analysis, for-profit (P = .04), teaching (P < .01), investor-owned (P < .01), and higher-rated hospitals (P < .01) charged higher prices, whereas rural referral centers (P = .01) and disproportionate share hospitals (P < .01) charged less. On multivariate analysis, the association between these characteristics and TTE prices persisted, except for investor ownership and rural referral centers., Conclusions: Self-pay and commercial TTE prices were higher than Medicare prices and varied significantly within and across hospitals. For-profit, teaching, and higher-rated hospitals had higher prices, in contrast to DSH hospitals. A better understanding of the relationship between this cost variation and quality of care is critical given the impact of cost on health care access and affordability., (Copyright © 2023 American Society of Echocardiography. All rights reserved.)

Objective: To characterize the development and performance of a cataract surgery episode-based cost measure for the Medicare Quality Payment Program., Design: Claims-based analysis., Participants: Medicare clinicians with cataract surgery claims between June 1, 2016, and May 31, 2017., Methods: We limited the analysis to claims with procedure code 66984 (routine cataract surgery), excluding cases with relevant ocular comorbidities. We divided episodes into subgroups by surgery location (Ambulatory Surgery Center [ASC] or Hospital Outpatient Department [HOPD]) and laterality (bilateral when surgeries were within 30 days apart). For the episode-based cost measure, we calculated costs occurring between 60 days before surgery and 90 days after surgery, limited to services identified by an expert committee as related to cataract surgery and under the influence of the cataract surgeon. We attributed costs to the clinician submitting the cataract surgery claim, categorized costs into clinical themes, and calculated episode cost distribution, reliability in detecting clinician-dependent cost variation, and costs with versus without complications. We compared episode-based cost scores with hypothetical "nonselective" cost scores (total Medicare beneficiary costs between 60 days before surgery and 90 days after surgery)., Main Outcome Measures: Episode costs with and without complications, clinician-dependent variation (proportion of total cost variance), and proportion of costs from cataract surgery-related clinical themes., Results: We identified 583 356 cataract surgery episodes attributed to 10 790 clinicians and 8189 with ≥ 10 episodes during the measurement period. Most surgeries were performed in an ASC (71%) and unilateral (66%). The mean episode cost was $2876. The HOPD surgeries had higher costs; geography and episodes per clinician did not substantially affect costs. The proportion of cost variation from clinician-dependent factors was higher in episode-based compared with nonselective cost measures (94% vs. 39%), and cataract surgery-related clinical themes represented a higher proportion of total costs for episode-based measures. Episodes with complications had higher costs than episodes without complications ($3738 vs. $2276)., Conclusions: The cataract surgery episode-based cost measure performs better than a comparable nonselective measure based on cost distribution, clinician-dependent variance, association with cataract surgery-related clinical themes, and quality alignment (higher costs in episodes with complications). Cost measure maintenance and refinement will be important to maintain clinical validity and reliability., Financial Disclosures: Proprietary or commercial disclosure may be found after the references.

Background: In older patients with atrial fibrillation (AF), frailty is frequently prevalent. However, the prognostic value of frailty for adverse events after initiation of oral anticoagulants (OACs) is unclear., Objectives: We assessed whether frailty at the time of OAC initiation is associated with subsequent bleeding or embolic events., Methods: We extracted patients aged ≥65 years with nonvalvular AF in whom OACs were initiated from a universal administrative claims database incorporating primary and hospital care records in Shizuoka, Japan, between 2012 and 2018. Frailty was assessed using the electronic frailty index (eFI). The association of frailty with bleeding events and ischemic stroke/transient ischemic attack were evaluated using the Fine-Gray model and restricted cubic spline model., Results: Among 12,585 patients with AF, 7.8% were categorized as fit, 31.5% as mildly frail, 34.8% as moderately frail, and 25.9% as severely frail. The risk of bleeding was associated with a higher eFI (adjusted subdistribution hazard ratio [95% CI] for fit or mild frailty: 1.15 [1.02-1.30]; moderate frailty: 1.42 [1.24-1.61]; and severe frailty: 1.86 [1.61-2.15]), whereas the association was weaker for ischemic stroke/transient ischemic attack. The spline models demonstrated that the relative hazard for bleeding increased steeply with increasing eFI., Conclusion: Patients with frailty in whom OAC therapy is initiated have higher risk of bleeding, highlighting the importance of discussing this increased risk with patients with AF who have frailty and assessing frailty at the time of OAC initiation., (© 2023 The Authors.)

Background: Early recognition of heart failure (HF) can reduce morbidity, yet HF is often diagnosed only after symptoms require urgent treatment., Objectives: The authors sought to describe predictors of HF diagnosis in the acute care vs outpatient setting within the Veterans Health Administration (VHA)., Methods: The authors estimated whether incident HF diagnoses occurred in acute care (inpatient hospital or emergency department) vs outpatient settings within the VHA between 2014 and 2019. After excluding new-onset HF potentially caused by acute concurrent conditions, they identified sociodemographic and clinical variables associated with diagnosis setting and assessed variation across 130 VHA facilities using multivariable regression analysis., Results: The authors identified 303,632 patients with new HF, with 160,454 (52.8%) diagnosed in acute care settings. In the prior year, 44% had HF symptoms and 11% had a natriuretic peptide tested, 88% of which were elevated. Patients with housing insecurity and high neighborhood social vulnerability had higher odds of acute care diagnosis (adjusted odds ratio: 1.22 [95% CI: 1.17-1.27] and 1.17 [95% CI: 1.14-1.21], respectively) adjusting for medical comorbidities. Better outpatient quality of care (blood pressure control and cholesterol and diabetes monitoring within the prior 2 years) predicted a lower odds of acute care diagnosis. Likelihood of acute care HF diagnosis varied from 41% to 68% across facilities after adjusting for patient-level risk factors., Conclusions: Many first HF diagnoses occur in the acute care setting, especially among socioeconomically vulnerable populations. Better outpatient care was associated with lower rates of an acute care diagnosis. These findings highlight opportunities for timelier HF diagnosis that may improve patient outcomes., Competing Interests: Funding Support and Author Disclosures Supported by the Veterans Administration (VA) Office of Academic Affairs Advanced Fellowship in Health Services Research (RLT). ATS receives research support from the National Heart, Lung, and Blood Institute (1K23HL151672-01). The views expressed in this article are those of the authors and do not necessarily reflect the position or policies of the Department of Veterans Affairs or the United States government. Dr Sandhu consults for Acumen, LLC. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background: There are sociodemographic disparities in outcomes of heart failure with reduced ejection fraction (HFrEF), but disparities in guideline-directed medical therapy (GDMT) remain poorly characterized., Objectives: This study aimed to analyze GDMT treatment rates in eligible patients with recently diagnosed HFrEF, and to determine how rates vary by sociodemographic characteristics., Methods: This retrospective cohort study included patients diagnosed with HFrEF at Veterans Affairs (VA) hospitals from 2013 to 2019. The authors analyzed GDMT treatment rates and doses, excluding patients with contraindications. Therapies of interest were evidence-based beta-blockers (BBs), renin-angiotensin system inhibitors (RASIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and mineralocorticoid antagonists (MRAs). The authors compared adjusted treatment rates by race and ethnicity, neighborhood social vulnerability, rurality, distance to medical care, and sex., Results: The cohort comprised 126,670 VA patients with recently diagnosed HFrEF. The study found that racial and ethnic minorities had similar or higher treatment rates than White patients. Patients residing in socially vulnerable neighborhoods had 3.4% lower ARNI (95% CI: 1.9%-5.0%) treatment rates. Patients residing farther from specialty care had similar rates of GDMT therapy overall, but were less likely to be taking at least 50% of the target doses of either BBs (4.0% less likely; 95% CI: 3.1%-5.0%) or RASIs (5.0% less likely; 95% CI: 4.1%-6.0%) compared with those closer to care., Conclusions: Among VA patients with recently diagnosed HFrEF, the authors did not find that racial and ethnic minority patients were less likely to receive GDMT. However, appropriate dose up-titration may occur less frequently in more remote patients., Competing Interests: Funding Support and Author Disclosures Support for VA/CMS data was provided by the Department of Veterans Affairs, VA Health Services Research and Development Service, VA. Information Resource Center (Project Numbers SDR 02-237 and 98-004). Dr Tisdale is supported by a Veterans Administration Office of Academic Affairs Advanced Fellowship in Health Services Research. Dr Sandhu has received research support from the National Heart, Lung, and Blood Institute (1K23HL151672-01). Dr Sandhu consults for Acumen. Dr Kohsaka has received unrestricted grants from Daiichi Sankyo; and lecture fees from Bristol-Myers Squibb outside of the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background: Among patients with heart failure (HF), patient-reported health status provides information beyond standard clinician assessment. Although HF management guidelines recommend collecting patient-reported health status as part of routine care, there is minimal data on the impact of this intervention., Study Design: The Patient-Reported Outcomes in Heart Failure Clinic (PRO-HF) trial is a pragmatic, randomized, implementation-effectiveness trial testing the hypothesis that routine health status assessment via the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) leads to an improvement in patient-reported health status among patients treated in a tertiary health system HF clinic. PRO-HF has completed randomization of 1,248 participants to routine KCCQ-12 assessment or usual care. Patients randomized to the KCCQ-12 arm complete KCCQ-12 assessments before each HF clinic visit with the results shared with their treating clinician. Clinicians received education regarding the interpretation and potential utility of the KCCQ-12. The primary endpoint is the change in KCCQ-12 over 1 year. Secondary outcomes are HF therapy patterns and health care utilization, including clinic visits, testing, hospitalizations, and emergency department visits. As a sub-study, PRO-HF will also evaluate the impact of routine KCCQ-12 assessment on patient experience and the accuracy of clinician-assessed health status. In addition, clinicians completed semi-structured interviews to capture their perceptions on the trial's implementation of routine KCCQ-12 assessment in clinical practice., Conclusions: PRO-HF is a pragmatic, randomized trial based in a real-world HF clinic to determine the feasibility of routinely assessing patient-reported health status and the impact of this intervention on health status, care delivery, patient experience, and the accuracy of clinician health status assessment., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: The 2022 American College of Cardiology/American Heart Association/Heart Failure Society of America (AHA/ACC/HFSA) Guideline for the Management of Heart Failure replaces the 2013 ACCF/AHA Guideline for the Management of Heart Failure and the 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose and manage patients with heart failure., Methods: A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews and other evidence conducted in human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies published through September 2021 were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021., Results and Conclusions: Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients' interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments that have high-quality published economic analyses., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Measuring the quality of care has been central for improving the outcomes of patients undergoing percutaneous coronary intervention (PCI). This study described the performance rates and regional variations in quality metrics for PCI using a representative national Japanese registry., Methods: Overall, 760,854 patients across 714 institutions (2016-2018) were analysed. Quality metrics included preprocedural antiplatelet therapy use, door-to-balloon time ≤90 min for ST-elevation myocardial infarction, transradial approach, and preprocedural noninvasive stress testing for elective cases in 47 Japanese prefectures. Coronary computed tomography angiography (CCTA) and fractional flow reserve (FFR) were also evaluated. Factors associated with preprocedural testing rates were evaluated using multivariable linear regression., Findings: Rates of preprocedural antiplatelet therapy use were high with low variations (96·4% [94·7-97·2%]), but there was still substantial room for improvement in the rates of door-to-balloon time (74·7% [71·2-78·9%]) and transradial approach use (70·9% [65·1-73·4%]). Rates of preprocedural noninvasive stress testing were low with substantial variation (36·6% [27·1-49·7%]). Additionally, we found substantial variations in CCTA (50·0% [39·5-55·1%]) and FFR measurement (15·7% [113·-18·3%]) rates. The number of scintigraphy scanners/ prefecture was associated with the performance of noninvasive stress testing (13·4% [95% CI, 2·45-24·4%] increase for every 1/100,000 population increase in scanners)., Interpretations: We observed substantial regional variation in the use of preprocedural testing, and its performance was directly related to nuclear-scanner availability. These findings suggest the need for targeted efforts in improving testing rates, whether by optimising resource allocation or additional education or feedback mechanisms., Funding: This study was funded by the Japan Society for the Promotion of Science (Grant Nos. 20H03915, 16H05215, 16KK0186, and 20K22883) and by the Ministry of Health, Labor and Welfare Grants-in-Aid for Scientific Research Program (Grant No. 21FA1015). The J-PCI registry is led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics., Competing Interests: Kohsaka has received investigator-initiated grant funding from Daiichi-Sankyo and Bristol-Myers Squibb and has received personal fees from Bristol-Myers Squibb. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2022 The Author(s).)

The cost of heart failure care is high owing to the cost of hospitalization and chronic treatments. Heart failure treatments vary in their benefit and cost. The cost effectiveness of therapies can be determined by comparing the cost of treatment required to obtain a certain benefit, often defined as an increase in 1 year of life. This review was sponsored by the Heart Failure Society of America and describes the growing economic burden of heart failure for patients and the health care system in the United States. It also provides a summary of the cost effectiveness of drugs, devices, diagnostic tests, hospital care, and transitions of care for patients with heart failure. Many medications that are no longer under patent are inexpensive and highly cost-effective. These include angiotensin-converting enzyme inhibitors, beta-blockers and mineralocorticoid receptor antagonists. In contrast, more recently developed medications and devices, vary in cost effectiveness, and often have high out-of-pocket costs for patients., Competing Interests: Declaration of competing interest None., (Copyright © 2022. Published by Elsevier Inc.)

Background: The advent of direct-acting antiviral therapy for Hepatitis C (HCV) has made using HCV-viremic donors a viable strategy to address the donor shortage in heart transplantation. We employed a large-scale simulation to evaluate the impact and cost-effectiveness of using HCV-viremic donors for heart transplant., Methods: We simulated detailed histories from time of listing until death for the real-world cohort of all adults listed for heart transplant in the United States from July 2014 to June 2019 (n = 19,346). This population was imputed using historical data and captures "real-world" heterogeneity in geographic and clinical characteristics. We estimated the impact of an intervention in which all candidates accept HCV+ potential donors (n = 472) on transplant volume, waitlist outcomes, and lifetime costs and quality-adjusted life years (QALYs)., Results: The intervention produced 232 more transplants, 132 fewer delistings due to deterioration, and 50 fewer waitlist deaths within this 5-year cohort and reduced wait times by 3% to 11% (varying by priority status). The intervention was cost-effective, adding an average of 0.08 QALYs per patient at a cost of $124 million ($81,892 per QALY). DAA therapy and HCV care combined account for 11% this cost, with the remainder due to higher costs of transplant procedures and routine post-transplant care. The impact on transplant volume varied by blood type and region and was correlated with donor-to-candidate ratio (ρ = 0.71)., Conclusions: Transplanting HCV+ donor hearts is likely to be cost-effective and improve waitlist outcomes, particularly in regions and subgroups experiencing high donor scarcity., Competing Interests: Disclosure statement Dr Teuteberg has relationships with Abbott (consulting), Abiomed (advisory board), Medtronic (speaking, advisory board), CareDx (speaking, advisory board), Paragonix (speaking). Other authors have no disclosures., (Copyright © 2021 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) are known to impact the functional receptor for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The association between chronic therapy with these medications and infection risk remains unclear., Objectives: The objective was to determine the association between prior ACEI or ARB therapy and SARS-CoV-2 infection among patients with hypertension in the U.S. Veteran's Affairs health system., Methods: We compared the odds of SARS-CoV-2 infection among three groups: patients treated with ACEI, treated with ARB, or treated with alternate first-line anti-hypertensives without ACEI/ARB. We excluded patients with alternate indications for ACEI or ARB therapy. We performed an augmented inverse propensity weighted analysis with adjustment for demographics, region, comorbidities, vitals, and laboratory values., Results: Among 1,724,723 patients with treated hypertension, 659,180 were treated with ACEI, 310,651 with ARB, and 754,892 with neither. Before weighting, patients treated with ACEI or ARB were more likely to be diabetic and use more anti-hypertensives. There were 13,278 SARS-CoV-2 infections (0.8%) between February 12, 2020 and August 19, 2020. Patients treated with ACEI had lower odds of SARS-CoV-2 infection (odds ratio [OR] 0.93; 95% CI: 0.89-0.97) while those treated with ARB had similar odds (OR 1.02; 95% CI: 0.96-1.07) compared with patients treated with alternate first-line anti-hypertensives without ACEI/ARB. In falsification analyses, patients on ACEI did not have a difference in their odds of unrelated outcomes., Conclusions: Our results suggest the safety of continuing ACEI and ARB therapy. The association between ACEI therapy and lower odds of SARS-CoV-2 infection requires further investigation., (Copyright © 2021. Published by Elsevier Inc.)

Introduction: Evaluation of health status benefits, cost-effectiveness, and value of new heart failure therapies is critical for supporting their use. The Kansas City Cardiomyopathy Questionnaire (KCCQ) measures patients' heart failure-specific health status but does not provide utilities needed for cost-effectiveness analyses. We mapped the KCCQ scores to EQ-5D scores so that estimates of societal-based utilities can be generated to support economic analyses., Methods: Using data from two US cohort studies, we developed models for predicting EQ-5D utilities (3L and 5L versions) from the KCCQ (23- and 12-item versions). In addition to predicting scores directly, we considered predicting the five EQ-5D health state items and deriving utilities from the predicted responses, allowing different countries' health state valuations to be used. Model validation was performed internally via bootstrap and externally using data from two clinical trials. Model performance was assessed using R2, mean prediction error, mean absolute prediction error, and calibration of observed vs. predicted values., Results: The EQ-5D-3L models were developed from 1000 health status assessments in 547 patients with heart failure and reduced ejection fraction (HFrEF), while the EQ-5D-5L model was developed from 3925 patients with HFrEF. For both versions, models predicting individual EQ-5D items performed as well as those predicting utilities directly. The selected models for the 3L had internally validated R2 of 48.4-50.5% and 33.7-45.6% on external validation. The 5L version had validated R2 of 57.7%., Conclusion: Mappings from the KCCQ to the EQ-5D can yield the estimates of societal-based utilities to support cost-effectiveness analyses when EQ-5D data are not available., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Coronary artery disease (CAD), the most common manifestation of cardiovascular disease, remains the most common cause of mortality in the United States. Risk assessment is key for primary prevention of coronary events and coronary artery calcium (CAC) scoring using computed tomography (CT) is one such non-invasive tool. Despite the proven clinical value of CAC, the current clinical practice implementation for CAC has limitations such as the lack of insurance coverage for the test, need for capital-intensive CT machines, specialized imaging protocols, and accredited 3D imaging labs for analysis (including personnel and software). Perhaps the greatest gap is the millions of patients who undergo routine chest CT exams and demonstrate coronary artery calcification, but their presence is not often reported or quantitation is not feasible. We present two deep learning models that automate CAC scoring demonstrating advantages in automated scoring for both dedicated gated coronary CT exams and routine non-gated chest CTs performed for other reasons to allow opportunistic screening. First, we trained a gated coronary CT model for CAC scoring that showed near perfect agreement (mean difference in scores = -2.86; Cohen's Kappa = 0.89, P < 0.0001) with current conventional manual scoring on a retrospective dataset of 79 patients and was found to perform the task faster (average time for automated CAC scoring using a graphics processing unit (GPU) was 3.5 ± 2.1 s vs. 261 s for manual scoring) in a prospective trial of 55 patients with little difference in scores compared to three technologists (mean difference in scores = 3.24, 5.12, and 5.48, respectively). Then using CAC scores from paired gated coronary CT as a reference standard, we trained a deep learning model on our internal data and a cohort from the Multi-Ethnic Study of Atherosclerosis (MESA) study (total training n = 341, Stanford test n = 42, MESA test n = 46) to perform CAC scoring on routine non-gated chest CT exams with validation on external datasets (total n = 303) obtained from four geographically disparate health systems. On identifying patients with any CAC (i.e., CAC ≥ 1), sensitivity and PPV was high across all datasets (ranges: 80-100% and 87-100%, respectively). For CAC ≥ 100 on routine non-gated chest CTs, which is the latest recommended threshold to initiate statin therapy, our model showed sensitivities of 71-94% and positive predictive values in the range of 88-100% across all the sites. Adoption of this model could allow more patients to be screened with CAC scoring, potentially allowing opportunistic early preventive interventions.

Background: The Hospital Readmission Reduction Program (HRRP), announced in 2010, penalizes hospitals with high readmissions for multiple conditions including heart failure., Methods: We compared heart failure readmission and mortality rates in hospitals exposed to HRRP financial penalties with critical access hospitals (CAHs) not subject to the penalty between 2005 and 2016 using 3-year moving averages from Hospital Compare., Results: After HRRP introduction, CAHs experienced a 0.60% annual decrease (95% CI: -0.61 to -0.59%) in heart failure readmissions. HRRP-exposed hospitals experienced an additional 0.13% annual decrease (95% CI: -0.14 to -0.12%) compared with CAHs. The association between HRRP penalties and mortality varied with model specifications., Conclusions: Using CAHs as a control group, we found the introduction of financial penalties was only associated with modest reductions in readmissions and an uncertain association with mortality. Cluster-randomized rollouts of health care policy interventions will allow us to better evaluate the impact of our interventions., (Copyright © 2018 Elsevier Inc. All rights reserved.)