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BACKGROUND: Timely heart failure (HF) diagnosis can lead to earlier intervention and reduced morbidity. Among historically marginalized patients, new-onset HF diagnosis is more likely to occur in acute care settings (emergency department or inpatient hospitalization) than outpatient settings. Whether inequity within outpatient clinician practices affects diagnosis settings is unknown. METHODS: We determined the setting of incident HF diagnosis among Medicare fee-for-service beneficiaries between 2013 and 2017. We identified sociodemographic and medical characteristics associated with HF diagnosis in the acute care setting. Within each outpatient clinician practice, we compared acute care diagnosis rates across sociodemographic characteristics: female versus male sex, non-Hispanic White versus other racial and ethnic groups, and dual Medicare-Medicaid eligible (a surrogate for low income) versus nondual-eligible patients. Based on within-practice differences in acute diagnosis rates, we stratified clinician practices by equity (high, intermediate, and low) and compared clinician practice characteristics. RESULTS: Among 315 439 Medicare patients with incident HF, 173 121 (54.9%) were first diagnosed in acute care settings. Higher adjusted acute care diagnosis rates were associated with female sex (6.4% [95% CI, 6.1%-6.8%]), American Indian (3.6% [95% CI, 1.1%-6.1%]) race, and dual eligibility (4.1% [95% CI, 3.7%-4.5%]). These differences persisted within clinician practices. With clinician practice adjustment, dual-eligible patients had a 4.9% (95% CI, 4.5%-5.4%) greater acute care diagnosis rate than nondual-eligible patients. Clinician practices with greater equity across dual eligibility also had greater equity across sex and race and ethnicity and were more likely to be composed of predominantly primary care clinicians. CONCLUSIONS: Differences in HF diagnosis rates in the acute care setting between and within clinician practices highlight an opportunity to improve equity in diagnosing historically marginalized patients. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

BACKGROUND: Coronary artery disease (CAD) testing remains underutilized in patients with newly diagnosed heart failure (HF). The longitudinal clinical impact of early CAD testing has not been well-characterized. We investigated changes in clinical management and long-term outcomes after early CAD evaluation in patients with incident HF. METHODS: We identified Medicare patients with incident HF from 2006 to 2018. The exposure variable was early CAD testing within 1 month of initial HF diagnosis. Covariate-adjusted rates of cardiovascular interventions after testing, including CAD-related management, were modeled using mixed-effects regression with clinician as a random intercept. We assessed mortality and hospitalization outcomes using landmark analyses with inverse probability-weighted Cox proportional hazards models. Falsification end points and mediation analysis were employed for bias assessment. RESULTS: Among 309 559 patients with new-onset HF without prior CAD, 15.7% underwent early CAD testing. Patients who underwent prompt CAD evaluation had higher adjusted rates of subsequent antiplatelet/statin prescriptions and revascularization, guideline-directed therapy for HF, and stroke prophylaxis for atrial fibrillation/flutter than controls. In weighted Cox models, 1-month CAD testing was associated with significantly reduced all-cause mortality (hazard ratio, 0.93 [95% CI, 0.91–0.96]). Mediation analyses indicated that ≈70% of this association was explained by CAD management, largely from new statin prescriptions. Falsification end points (outpatient diagnoses of urinary tract infection and hospitalizations for hip/vertebral fracture) were nonsignificant. CONCLUSIONS: Early CAD testing after incident HF was associated with a modest mortality benefit, driven mostly by subsequent statin therapy. Further investigation on clinician barriers to testing and treating high-risk patients may improve adherence to guideline-recommended cardiovascular interventions. [ABSTRACT FROM AUTHOR]

Keywords: Editorials; health care; outcome assessment; quality indicators; racial groups EN Editorials health care outcome assessment quality indicators racial groups 1134 1136 3 04/10/23 20230411 NES 230411 Measuring the performance of our health care system, our hospitals, and our clinicians is important for multiple reasons. For example, a hospital that provided great care to White patients but not to Black patients could have the same composite rating as a hospital that was providing average care to both. However, it did have the expected beneficial effect of better aligning hospital performance classification with the hospital's outcomes among Black patients while slightly decreasing the alignment between hospital outcomes (mortality) and White patients. [Extracted from the article]

Aim: The "2022 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 on 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. Structure: 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 with high-quality published economic analyses. [ABSTRACT FROM AUTHOR]

Aim: The "2022 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 on 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. Structure: 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 with high-quality published economic analyses. [ABSTRACT FROM AUTHOR]

Following the adoption of an acuity-adaptable unit model in an academic medical center, a $13M increase in cost of intermediate intensive care unit (IICU) accommodations was observed. The authors followed A3 methodology to determine the root cause of this increase and developed a 3-prong intervention centered on physician engagement, given that physicians have the ability to order a patient's level of care. This intervention consisted of: (1) identifying physician champions to promote appropriate IICU use, (2) visual changes to essential electronic medical record tools, and (3) data-driven feedback to physician champions. In the year following intervention deployment, average IICU length of stay decreased from 1.08 to 0.62 days and average IICU use decreased from 21.4% to 12.3%, corresponding to ~$5.7M cost savings with no significant change in balancing measures observed. Together, these results demonstrate that a multicomponent intervention aimed at engaging physicians reduced inappropriate IICU use with no increase in adverse events. [ABSTRACT FROM AUTHOR]

BACKGROUND: Early heart failure (HF) recognition can reduce morbidity, yet HF is often initially diagnosed only after a patient clinically worsens. We sought to identify characteristics that predict diagnosis in the acute care setting versus the outpatient setting. METHODS: We estimated the proportion of incident HF diagnosed in the acute care setting (inpatient hospital or emergency department) versus outpatient setting based on diagnostic codes from a claims database covering commercial insurance and Medicare Advantage between 2003 and 2019. After excluding new-onset HF potentially caused by a concurrent acute cause (eg, acute myocardial infarction), we identified demographic, clinical, and socioeconomic predictors of diagnosis setting. Patients were linked to their primary care clinicians to evaluate diagnosis setting variation across clinicians. RESULTS: Of 959 438 patients with new HF, 38% were diagnosed in acute care. Of these, 46% had potential HF symptoms in the prior 6 months. Over time, the relative odds of acute care diagnosis increased by 3.2% annually after adjustment for patient characteristics (95% CI, 3.1%-3.3%). Acute care diagnosis setting was more likely for women compared with men (adjusted odds ratio, 1.11 [95% CI, 1.10-1.12]) and for Black patients compared with White patients (adjusted odds ratio, 1.18 [95% CI, 1.16-1.19]). The proportion of acute care diagnosis varied substantially (interquartile range: 24%-39%) among clinicians after adjusting for patient-level risk factors. CONCLUSIONS: A large proportion of first HF diagnoses occur in the acute care setting, particularly among women and Black patients, yet many had potential HF symptoms in the months before acute care visits. These results raise concerns that many HF diagnoses are missed in the outpatient setting. Earlier diagnosis could allow for timelier high-value interventions, addressing disparities and reducing the progression of HF. [ABSTRACT FROM AUTHOR]

Background: Heart failure (HF) management requires the participation of patients, their significant others, and clinical providers. Each group may face barriers to HF management that may be unique or may overlap. Objective: The aim of this study was to compare the barriers and facilitators of HF management as perceived by patients, significant others, and clinical providers. Methods: Participants were recruited from a Veterans Health Administration facility. Eligible patients had a diagnosis of HF(ICD9 code428.XX), 1 or more HF-related visit in the previous year, and a significant other who was their primary caregiver. Significant others were adults with no history of cognitive impairments caring for patients with HF. Providers were eligible if they cared for patients with HF. All participants completed semistructured interviews designed to elicit barriers to managing HF and strategies that they used to overcome these barriers. Interviews were transcribed and analyzed using latent thematic analysis, and recruitment continued until thematic saturation was attained. Results: A total of 17 couples and 12 providers were recruited. All 3 groups identified poor communication as a key barrier to HF management, including communication between patients and their significant other, between couples and providers, and providers with each other. Significant others noted that the lack of direct communication with clinical providers hindered their efforts to care for the patient. All 3 groups emphasized the importance of family members in optimizing adherence to HF self-management recommendations. Conclusions: Providers, patients, and significant others all play important and distinct roles in the management of HF. Tools to enhance communication and collaboration for all 3 and supporting the needs of significant others are missing components of current HF care. [ABSTRACT FROM AUTHOR]

BACKGROUND: Patients with atrial fibrillation (AF) treated with percutaneous coronary intervention (PCI) require multiple antithrombotic therapies. The optimal strategy is debated suggesting increased treatment variation. This study sought to characterize site-level variation in antithrombotic therapies in AF patients after PCI and determine the association with outcomes. METHODS: Using the retrospective TREAT-AF study (The Retrospective Evaluation and Assessment of Therapies in AF) from the Veterans Health Administration, patients with newly diagnosed, nonvalvular AF between 2004 and 2015 followed by a PCI with a P2Y12-antagonist prescription were identified. Patients were grouped according to the therapy dispensed 7 days before until 30 days after the PCI: oral anticoagulation plus platelet inhibition (OAC+PI) or platelet inhibition only. A combined outcome of death, myocardial infarction, stroke, or major bleeding was assessed 1 year after PCI and Cox regression was performed to estimate hazard ratios. RESULTS: Of 230 762 patients with newly diagnosed AF, 4042 (1.8%) underwent PCI and received a P2Y12-antagonist during the observation period (age, 67±9 years; CHA2DS2-VASc, 2.7±1.7; HAS-BLED, 2.6±1.2). Among these, 47% were prescribed OAC+PI, and 53% platelet inhibition only 7 days before until 30 days after the PCI. Across 63 sites, the use of OAC+PI ranged from 19% to 66%. Prescription of OAC+PI was independently associated with a reduction in the combined outcome of death, myocardial infarction, stroke, or major bleeding compared with platelet inhibition only (adjusted hazard ratio, 0.85; 95% CI, 0.73-0.99; P=0.033). CONCLUSIONS: In patients with established AF undergoing PCI, the use of OAC+PI varied substantially across sites in the 30 days post-PCI. Anticoagulation appeared to be underutilized but was associated with improved outcomes. Strategies to promote OAC+PI and minimize site variation may be useful, particularly in light of recent randomized trials. [ABSTRACT FROM AUTHOR]

Keywords: health expenditures; health policy; heart failure; prescription drugs EN health expenditures health policy heart failure prescription drugs 1073 1075 3 04/15/21 20210316 NES 210316 Background Heart failure with reduced ejection fraction has seen remarkable advances with multiple medical therapies that reduce mortality. For these 2 drugs, the combined average annual 2018 Medicare cost was $10 802 with out-of-pocket costs of $895 among patients with prescription plans.[1] This is not only unaffordable for patients without prescription plans, the cost sharing also creates financial strain for insured patients. [Extracted from the article]

BACKGROUND: Numerous quality metrics for heart failure (HF) care now exist based on process and outcome. What remains unclear, however, is if the correct quality metrics are being emphasized. To determine the validity of certain measures, we compared correlations between measures and reliability over time. Measures assessed include guideline-recommended β-blocker (BB), any BB, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker, mineralocorticoid receptor antagonist, and hydralazine/isosorbide dinitrate (in blacks) use among candidates, 30-day mortality, 1-year mortality, and 30-day readmission. METHODS AND RESULTS: This was an observational cohort analysis using chart review and electronic resources for 55 735 patients from 102 Veterans Affairs medical centers hospitalized with HF from 2008 to 2013. Assessments of convergent validity and reliability were performed. Significant correlations were found between in-hospital rates of ACE inhibitor use and the following measures: BB use, 30-day mortality, and 1-year mortality. Guideline-recommended BB use was also significantly correlated with mineralocorticoid receptor antagonists, 30-day mortality, and 1-year mortality. There was no correlation between 30-day readmission rates and any therapy or mortality. Measure reliability over time was seen for guideline-recommended BBs (r=0.57), mineralocorticoid receptor antagonists (r=0.50), 30-day mortality (r=0.29), and 1-year mortality (r=0.31). ACE inhibitor and readmission rates were not reliable measures over time. CONCLUSIONS: BB use, ACE inhibitor use, mortality, and mineralocorticoid receptor antagonist use are valid measures of HF quality. Thirty-day readmission rate did not seem to be a valid measure of HF quality of care. If the goal is to identify high-quality HF care, the emphasis on decreasing readmission rates might be better directed towards improving usage of the recommended therapies. [ABSTRACT FROM AUTHOR]

Background: The outcomes from pulmonary vein isolation (PVI) for atrial fibrillation (AF) are suboptimal, but the benefits of additional lesion sets remain unproven. Recent studies propose ablation of AF drivers improves outcomes over PVI, yet with conflicting reports in the literature. We undertook a systematic literature review and meta-analysis to determine outcomes from ablation of AF drivers in addition to PVI or as a stand-alone procedure.Methods: Database search was done using the terms atrial fibrillation and ablation or catheter ablation and driver or rotor or focal impulse or FIRM (Focal Impulse and Rotor Modulation). We pooled data using random effects model and assessed heterogeneity with I2 statistic.Results: Seventeen studies met inclusion criteria, in a cohort size of 3294 patients. Adding AF driver ablation to PVI reported freedom from AF of 72.5% (confidence interval [CI], 62.1%-81.8%; P<0.01) and from all arrhythmias of 57.8% (CI, 47.5%-67.7%; P<0.01). AF driver ablation when added to PVI or as stand-alone procedure compared with controls produced an odds ratio of 3.1 (CI, 1.3-7.7; P=0.02) for freedom from AF and an odds ratio of 1.8 (CI, 1.2-2.7; P<0.01) for freedom from all arrhythmias in 4 controlled studies. AF termination rate was 40.5% (CI, 30.6%-50.9%) and predicted favorable outcome from ablation(P<0.05).Conclusions: In controlled studies, the addition of AF driver ablation to PVI supports the possible benefit of a combined approach of AF driver ablation and PVI in improving single-procedure freedom from all arrhythmias. However, most studies are uncontrolled and are limited by substantial heterogeneity in outcomes. Large multicenter randomized trials are needed to precisely define the benefits of adding driver ablation to PVI. [ABSTRACT FROM AUTHOR]

BACKGROUND: Early ambulation (EA) is associated with improved outcomes for mechanically ventilated and stroke patients. Whether the same association exists for patients hospitalized with acute heart failure is unknown. We sought to determine whether EA among patients hospitalized with heart failure is associated with length of stay, discharge disposition, 30-day post discharge readmissions, and mortality. METHODS AND RESULTS: The study population included 369 hospitals and 285 653 patients with heart failure enrolled in the Get With The Guidelines-Heart Failure registry. We used multivariate logistic regression with generalized estimating equations at the hospital level to identify predictors of EA and determine the association between EA and outcomes. Sixty-five percent of patients ambulated by day 2 of the hospital admission. Patient-level predictors of EA included younger age, male sex, and hospitalization outside of the Northeast (P<0.01 for all). Hospital size and academic status were not predictive. Hospital-level analysis revealed that those hospitals with EA rates in the top 25% were less likely to have a long length of stay (defined as >4 days) compared with those in the bottom 25% (odds ratio, 0.83; confidence interval, 0.73-0.94; P=0.004). Among a subgroup of fee-for-service Medicare beneficiaries, we found that hospitals in the highest quartile of rates of EA demonstrated a statistically significant 24% lower 30-day readmission rates (P<0.0001). Both end points demonstrated a dose-response association and statistically significant P for trend test. CONCLUSIONS: Multivariable-adjusted hospital-level analysis suggests an association between EA and both shorter length of stay and lower 30-day readmissions. Further prospective studies are needed to validate these findings. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcomes (PROs) may improve care for patients with heart failure. The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a patient survey that captures symptom frequency, symptom burden, physical limitations, social limitations, and quality of life. Despite the utility of PROs and the KCCQ-12, the implementation and routine use of these measures can be difficult. We conducted an evaluation of clinician perceptions of the KCCQ-12 to identify barriers and facilitators to implementation into clinical practice. Methods: We conducted interviews with cardiologists from 4 institutions across the United States and Canada (n=16) and observed clinic visits at 1 institution in Northern California (n=5). Qualitative analysis was conducted in 2 rounds: (1) rapid analysis constructed around major themes related to the aims of the study and (2) content analysis with codes derived from the rapid analysis and implementation science. Results: Most heart failure physicians and advanced practice clinicians reported that the KCCQ-12 was acceptable, appropriate, and useful in clinical care. Clinician engagement efforts, trialability, and the straightforward design of the KCCQ-12 facilitated its use in clinical care. Further opportunities identified to facilitate implementation include more streamlined integration into the electronic health record and comprehensive staff education on PROs. Participants highlighted that the KCCQ-12 was useful in clinic visits to improve the consistency of patient history taking, focus patient-clinician conversations, collect a more accurate account of patient quality of life, track trends in patient well-being over time, and refine clinical decision-making. Conclusions: In this qualitative study, clinicians reported that the KCCQ-12 enhanced several aspects of heart failure patient care. Use of the KCCQ-12 was facilitated by a robust clinician engagement campaign and the design of the KCCQ-12 itself. Future implementation of PROs in heart failure clinic should focus on streamlining electronic health record integration and providing additional staff education on the value of PROs. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04164004. [ABSTRACT FROM AUTHOR]

Background: Clinicians typically estimate heart failure health status using the New York Heart Association Class, which is often discordant with patient-reported health status. It is unknown whether collecting patient-reported health status improves the accuracy of clinician assessments. Methods: The PRO-HF trial (Patient-Reported Outcomes in Heart Failure Clinic) is a randomized, nonblinded trial evaluating routine Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) collection in heart failure clinic. Patients with a scheduled visit to Stanford heart failure clinic between August 30, 2021 and June 30, 2022 were enrolled and randomized to KCCQ-12 assessment or usual care. In this prespecified substudy, we evaluated whether access to the KCCQ-12 improved the accuracy of clinicians' New York Heart Association assessment or patients' perspectives on their clinician interaction. We surveyed clinicians regarding their patients' New York Heart Association Class, quality of life, and symptom frequency. Clinician responses were compared with patients' KCCQ-12 responses. We surveyed patients regarding their clinician interactions. Results: Of the 1248 enrolled patients, 1051 (84.2%) attended a visit during the substudy. KCCQ-12 results were given to the clinicians treating the 528 patients in the KCCQ-12 arm; the 523 patients in the usual care arm completed the KCCQ-12 without the results being shared. The correlation between New York Heart Association Class and KCCQ-12 Overall Summary Score was stronger when clinicians had access to the KCCQ-12 (r=−0.73 versus r=−0.61, P <0.001). More patients in the KCCQ-12 arm strongly agreed that their clinician understood their symptoms (95.2% versus 89.7% of respondents [odds ratio‚ 2.27; 95% CI‚ 1.32–3.87]). However, patients in both arms reported similar quality of clinician communication and therapeutic alliance. Conclusions: Collecting the KCCQ-12 in heart failure clinic improved clinicians' accuracy of health status assessment; correspondingly, patients believed their clinicians better understood their symptoms. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04164004. [ABSTRACT FROM AUTHOR]

Background: Rising drug costs have increased interest in performance-linked reimbursement (PLR) contracts that tie payment to patient outcomes. PLR is theoretically attractive to payers interested in reducing the risk of overpaying for expensive drugs, to manufacturers working to improve early drug adoption, and to patients seeking improved access. Multiple PLR contracts were developed for sacubitril-valsartan. We evaluated how the characteristics of a PLR contract influence its performance.Methods: We used a published cost-effectiveness model of sacubitril-valsartan. We evaluated hypothetical PLR contracts that adjusted drug payment based on observed therapy effectiveness. Ideally, these contracts reduce the uncertainty around the value obtained with purchasing sacubitril-valsartan. By reducing the financial risk in covering an ineffective therapy, PLR incentivizes insurers to increase patient access. We measured the uncertainty in value as the SD of the incremental net monetary benefit (INMB), an estimate of therapy value incorporating costs and clinical benefits. We evaluated the change in INMB SD under a variety of different assumptions regarding contract design, therapy effectiveness, and population characteristics.Results: Over 2 years, sacubitril-valsartan led to 0.042 additional quality-adjusted life-years at an incremental cost of $4916. Using a willingness-to-pay of $150 000 per quality-adjusted life-year, this led to a mean INMB across simulations of $1416 (SD, $1720). A PLR contract that adjusted payment based on cardiovascular mortality reduced the INMB SD moderately by 20.7% while a contract based on all-cause mortality was more effective (INMB SD reduction of 27.3%). A contract based on heart failure hospitalization reduction was ineffective. PLR effectiveness increased with greater uncertainty regarding therapy effectiveness or in sicker cohorts (eg, New York Heart Association Class III/IV heart failure). Contracts required precise estimates of treatment effect in addition to trust or verifiability between manufacturers and payers concerning patient selection.Conclusions: The development of accurate prospective estimates of treatment effectiveness using actual enrollee characteristics will be critical for successful PLR. If able to meet these requirements, PLRs could incentivize insurers to expand access to expensive treatments by reducing financial risk. [ABSTRACT FROM AUTHOR]

Background: Generic medications cost less than brand-name medications and are similarly effective, but brand-name medications are still prescribed. We evaluated patterns in generic cardiovascular medication fills and estimated the potential cost savings with increased substitution of generic for brand-name medications.Methods: This was a cross-sectional study of cardiovascular therapies using the Medicare Part D database of prescription medications in 2017. We evaluated drug fill patterns for therapies with available brand-name and generic options. We determined the generic substitution ratio and estimated the potential savings with increased generic substitution at the national, state, and clinician level. We compared states with laws related to mandatory pharmacist generic substitution and patient consent for substitution.Results: Of ≈$22.9 billion spent on cardiovascular drugs in Medicare Part D prescription programs in 2017, ≈$11.0 billion was spent on medications with both brand-name and generic options. Although only 2.4% of medication fills were for the brand-name choice, they made up 21.2% of total spending. Accounting for estimated brand-name rebates, generic substitution for these medications would save $641 million, including $135 million in costs shouldered by patients. Furthermore, the minority of clinicians with the lowest generic utilization was responsible for a large proportion of the potential cost savings.Conclusions: There are substantial potential cost savings from substituting brand-name medications with generic medications. These savings would be primarily driven by lower use of brand-name therapies by the minority of clinicians who prescribe them at increased rates. [ABSTRACT FROM AUTHOR]

Background: Despite increasing awareness regarding evidence-based guidelines, considerable gaps exist for heart failure (HF) quality of care at teaching hospitals (TH) and nonteaching hospitals (NTH). We analyzed data from Get With The Guidelines (GWTG)-HF to compare the rates and trends of guideline-recommended care at TH and NTH for patients with HF.Method and Results: Baseline patient characteristics, performance measures, and in-hospital outcomes were compared between 197 187 HF patients admitted to TH and 106 924 patients admitted to NTH between 2005 and 2014. Patients treated in TH were younger and were more likely to be black and uninsured. Defect-free care (defined as 100% compliance with performance measures) was similar in both group of hospitals (crude rates: 88% at TH versus 86% at NTH, adjusted odds ratio 0.99, 95% confidence interval 0.73-1.34) as were individual performance measures: discharge instruction, documentation of ejection fraction, use of angiotensin-converting enzyme inhibitors/angiotensin receptor antagonists, use of β-blocker, and smoking cessation counseling. During the study period, there was improvement in adherence with performance measures over time, with no significant difference at TH (adjusted odds ratio 1.20, 95% confidence interval 1.11-1.30; P<0.01) and NTH (adjusted odds ratio 1.09, 95% confidence interval 1.02-1.17; P=0.01; interaction P value 0.07).Conclusions: Data from the GWTG-HF program suggest that there was improving and comparable adherence with HF performance measures and use of guideline-recommended therapies irrespective of hospital teaching status. [ABSTRACT FROM AUTHOR]

Background: Hospital to Home (H2H) is a national quality improvement initiative sponsored by the Institute for Healthcare Improvement and the American College of Cardiology, with the goal of reducing readmission for patients hospitalized with heart disease. We sought to determine the impact of H2H within the Veterans Affairs (VA) health care system. Methods: Using a controlled interrupted time series, we determined the association of VA hospital enrollment in H2H with the primary outcome of 30-day all-cause readmission following a heart failure hospitalization. VA heart failure providers were surveyed to determine quality improvement projects initiated in response to H2H. Secondary outcomes included initiation of recommended H2H projects, follow-up within 7 days, and total hospital days at 30 days and 1 year. Results: Sixty-five of 104 VA hospitals (66%) enrolled in the national H2H initiative. Hospital characteristic associated with H2H enrollment included provision of tertiary care, academic affiliation, and greater use of home monitoring. There was no significant difference in mean 30-day readmission rates (20.0% ± 5.0% for H2H vs 19.3% ± 5.9% for non-H2H hospitals; P= .48) The mean fraction of patients with a cardiology visit within 7 days was slightly higher for H2H hospitals (3.0% ± 2.4% for H2H vs 2.0% ± 1.9% for non-H2H hospitals; P = .05). Patients discharged from H2H hospitals had fewer mean hospitals days during the following year (7.6% ± 2.6% for H2H vs 9.2% ± 3.0 for non-H2H; P = .01) early after launch of H2H, but the effect did not persist. Conclusions: VA hospitals enrolling in H2H had slightly more early follow-up in cardiology clinic but no difference in 30-day readmission rates compared with hospitals not enrolling in H2H. [ABSTRACT FROM AUTHOR]

Background--Reducing hospital readmissions for patients with heart failure is a national priority, and quality improvement campaigns are targeting reductions of =20%. However, there are limited data on whether such targets have been met. Methods and Results--We analyzed data from the American Heart Association's Get With The Guidelines-Heart Failure registry linked to Medicare claims between 2009 and 2012 to describe trends and relative reduction of rates of 30-day all-cause readmission among patients with heart failure. A total of 21,264 patients with heart failure were included from 70 US sites from January 2009 to October 2012. Overall hospital-level, risk-adjusted, 30-day all-cause readmission rates declined slightly, from 20.0% (SD, 1.3%) in 2009 to 19.0% (SD, 1.2%) in 2012 (P=0.001). Only 1 in 70 (1.4%) hospitals achieved the 20% relative reduction in 30-day risk-adjusted readmission rates. A multivariable linear regression model was used to determine hospital-level factors associated with relative improvements in 30-day risk-adjusted readmissions between 2009 and 2012. Teaching hospitals had higher relative readmission rates as compared with their peers, and hospitals that used postdischarge heart failure disease management programs had lower relative readmission rates. Conclusions--Although there has been slight improvement in 30-day all-cause readmission rates during the past 4 years in patients with heart failure, few hospitals have seen large success. [ABSTRACT FROM AUTHOR]

Background: Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost effectiveness compared with anticoagulation has not been evaluated using all available contemporary trial data.Methods and Results: We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation (PROTECT AF) and Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation (PREVAIL) randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios compared with warfarin and dabigatran were $20 486 and $23 422 per quality-adjusted life year, respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 quality-adjusted life years, respectively) and more costly. At a willingness-to-pay threshold of $50 000 per quality-adjusted life year, LAA closure was cost effective 90% and 9% of the time under PROTECT AF and PREVAIL assumptions, respectively. These results were sensitive to the rates of ischemic stroke and intracranial hemorrhage for LAA closure and medical anticoagulation.Conclusions: Using data from the PROTECT AF trial, LAA closure with the Watchman device was cost effective; using PREVAIL trial data, Watchman was more costly and less effective than warfarin and dabigatran. PROTECT AF enrolled more patients and has substantially longer follow-up time, allowing greater statistical certainty with the cost-effectiveness results. However, longer-term trial results and postmarketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice. [ABSTRACT FROM AUTHOR]

Background--In clinical trials, hydralazine-isosorbide dinitrate (H-ISDN) for heart failure with reduced ejection fraction reduced morbidity and mortality among black patients and patients with intolerance to angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers. The effectiveness of H-ISDN in clinical practice is unknown. Methods and Results--Using data from a clinical registry linked with Medicare claims, we examined the use and outcomes of H-ISDN between 2005 and 2011 among older patients hospitalized with heart failure and reduced ejection fraction. We adjusted for demographic and clinical characteristics using Cox proportional hazards models and inverse probability weighting. Among 4663 eligible patients, 22.7% of black patients and 18.2% of patients not on an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker were newly prescribed H-ISDN therapy at discharge. By 3 years, the cumulative incidence rates of mortality and readmission were similar between treated and untreated patients. After multivariable adjustment, 3-year outcomes remained similar for mortality [black patients: hazard ratio (HR), 0.92; 95% confidence interval (CI), 0.75-1.13; other patients: HR, 0.93; 95% CI, 0.79-1.09], all-cause readmission (black patients: HR, 0.98; 95% CI, 0.84-1.13; other patients: HR, 1.02; 95% CI, 0.90-1.17), and cardiovascular readmission (black patients: HR, 0.99; 95% CI, 0.82-1.19; other patients: HR, 0.94; 95% CI, 0.81-1.09). A post hoc analysis of Medicare Part D data revealed low postdischarge adherence to therapy. Conclusions--Guideline-recommended initiation of H-ISDN therapy at hospital discharge was uncommon, and adherence was low. For both black patients and patients of other races, there were no differences in outcomes between those treated and untreated at discharge. [ABSTRACT FROM AUTHOR]

Background--Previous data demonstrate early follow-up (ie, within 7 days of discharge) after a hospitalization for heart failure is associated with a lower risk of readmission, yet is uncommon and varies widely across hospitals. Limited data exist on whether the use of early follow-up after discharge has improved over time. Methods and Results--We used data from Get With The Guidelines-Heart Failure (GWTG-HF) linked to Medicare claims to examine temporal trends in early follow-up and to assess for patient and hospital characteristics associated with early scheduled follow-up. In the overall GWTG-HF cohort, we studied 52438 patients discharged from 239 hospitals from 2009 to 2012. Scheduled early follow-up at the time of hospital discharge rose from 51% to 65% over time (P<0.001). After multivariable adjustment, patients with older age (odds ratio, 1.04; 95% confidence interval, 1.01-1.07), certain comorbidities (anemia, diabetes mellitus, and chronic kidney disease), and the use of anticoagulation at discharge (odds ratio, 1.16; 95% confidence interval, 1.11-1.22) were associated with greater likelihood for early scheduled follow-up. Patients treated in hospitals located in the Midwest (odds ratio, 0.67; 95% confidence interval, 0.50-0.91) were less likely to have early scheduled follow-up. In a subset of patients with linked Medicare claims, we observed smaller improvements in actual early follow-up visits over time from 26% to 30% (P=0.005). Conclusions--From 2009 to 2012, there was improvement in early scheduled outpatient follow-up and, in the subset analyzed, improvement in actual early follow-up visits for hospitalized patients with heart failure. However, substantial opportunities remain for improving heart failure transitional care. [ABSTRACT FROM AUTHOR]

Background: Reducing hospital length of stay (LOS) has been identified as an important lever for minimizing the burden of heart failure hospitalization, yet the impact of social and structural determinants of health on LOS has received little attention. We investigated disparities in LOS across race/ethnicity and their possible drivers. Methods: We analyzed patients hospitalized for heart failure from 2017 to 2020 using the Get With The Guidelines-Heart Failure registry. We characterized LOS differences across race/ethnicity by insurance and disposition, adjusting for demographics, comorbidities, and clinical severity. Effects of hospital-level clustering on LOS across race/ethnicity were assessed using hierarchical mixed-effects models. We evaluated the association between LOS and discharge rates of guideline-directed medical therapy. Results: Three thousand three seven hundred thirty patients hospitalized for heart failure were identified. After excluding inpatient deaths, the adjusted LOS for Black (5.72 days [95% CI, 5.62–5.82]), Hispanic (5.94 days [95% CI, 5.79–6.08]), and Indigenous American/Pacific Islander (6.06 days [95% CI, 5.85–6.27]) patients remained significantly longer compared with non-Hispanic White patients (5.32 days [95% CI, 5.25–5.39]). This pattern was driven by LOS differences among patients discharged to hospice or nursing facilities. After accounting for variability between hospitals, associations of race/ethnicity with LOS either were attenuated or reversed in direction. Guideline-directed medical therapy rates on discharge did not differ significantly across race/ethnicity despite longer LOS for Black, Hispanic, and Indigenous American/Pacific Islander patients. Conclusions: Differences between hospitals drive LOS disparities across race/ethnicity. Longer LOS among Black, Hispanic, and Indigenous American/Pacific Islander patients was not associated with improved quality of care. [ABSTRACT FROM AUTHOR]

Background: Racial and ethnic minorities are under-represented in clinical trials of primary prevention implantable cardioverter-defibrillators (ICDs). This analysis investigates the association between primary prevention ICDs and mortality among Medicare, racial/ethnic minority patients.Methods and Results: Data from Get With The Guidelines-Heart Failure Registry and National Cardiovascular Data Registry's ICD Registry were used to perform an adjusted comparative effectiveness analysis of primary prevention ICDs in Medicare, racial/ethnic minority patients (nonwhite race or Hispanic ethnicity). Mortality data were obtained from the Medicare denominator file. The relationship of ICD with survival was compared between minority and white non-Hispanic patients. Our analysis included 852 minority patients, 426 ICD and 426 matched non-ICD patients, and 2070 white non-Hispanic patients (1035 ICD and 1035 matched non-ICD patients). Median follow-up was 3.1 years. Median age was 73 years, and median ejection fraction was 23%. Adjusted 3-year mortality rates for minority ICD and non-ICD patients were 44.9% (95% confidence interval [CI], 44.2%-45.7%) and 54.3% (95% CI, 53.4%-55.1%), respectively (adjusted hazard ratio, 0.79; 95% CI, 0.63-0.98; P=0.034). White non-Hispanic patients receiving an ICD had lower adjusted 3-year mortality rates of 47.8% (95% CI, 47.3%-48.3%) compared with 57.3% (95% CI, 56.8%-57.9%) for those with no ICD (adjusted hazard ratio, 0.75; 95% CI, 0.67%-0.83%; P<0.0001). There was no significant interaction between race/ethnicity and lower mortality risk with ICD (P=0.70).Conclusions: Primary prevention ICDs are associated with lower mortality in nonwhite and Hispanic patients, similar to that seen in white, non-Hispanic patients. These data support a similar approach to ICD patient selection, regardless of race or ethnicity. [ABSTRACT FROM AUTHOR]