Bundled Payments for Care Improvement and Quality of Care and Outcomes in Heart Failure.

Importance: The Centers for Medicare & Medicaid Services (CMS) Bundled Payments for Care Improvement (BPCI) program was launched in 2013 with a goal to improve care quality while lowering costs to Medicare. Objective: To compare changes in the quality and outcomes of care for patients hospitalized with heart failure according to hospital participation in the BPCI program. Design, Setting, and Participants: This cross-sectional study used a difference-in-difference approach to evaluate the BPCI program in 18 BPCI hospitals vs 211 same-state non-BPCI hospitals for various process-of-care measures and outcomes using American Heart Association Get With The Guidelines-Heart Failure registry and CMS Medicare claims data from November 1, 2008, to August 31, 2018. Data were analyzed from May 2022 to May 2023. Exposures: Hospital participation in CMS BPCI Model 2 Heart Failure, which paid hospitals in a fee-for-service process and then shared savings or required reimbursement depending on how the total cost of an episode of care compared with a target price. Main Outcomes and Measures: Primary end points included 7 quality-of-care measures. Secondary end points included 9 outcome measures, including in-hospital mortality and hospital-level risk-adjusted 30-day and 90-day all-cause readmission rate and mortality rate. Results: During the study period, 8721 patients were hospitalized in the 23 BPCI hospitals and 94 530 patients were hospitalized in the 224 same-state non-BPCI hospitals. Less than a third of patients (30 723 patients, 29.8%) were 75 years or younger; 54 629 (52.9%) were female, and 48 622 (47.1%) were male. Hospital participation in BPCI Model 2 was not associated with significant differential changes in the odds of various process-of-care measures, except for a decreased odds of evidence-based ß-blocker at discharge (adjusted odds ratio [aOR], 0.63; 95% CI, 0.41-0.98; P = .04). Participation in the BPCI was not associated with a significant differential change in the odds of receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or angiotensin receptor-neprilysin inhibitors at discharge, receiving an aldosterone antagonist at discharge, having a cardiac resynchronization therapy (CRT)-defibrillator or CRT pacemaker placed or prescribed at discharge, having implantable cardioverter-defibrillator (ICD) counseling or an ICD placed or prescribed at discharge, heart failure education being provided among eligible patients, or having a follow-up visit within 7 days or less. Participation in the BPCI was associated with a significant decrease in odds of in-hospital mortality (aOR, 0.67; 95% CI, 0.51-0.86; P = .002). Participation was not associated with a significant differential change in hospital-level risk-adjusted 30-day or 90-day all-cause readmission rate and 30-day or 90-day all-cause mortality rate. Conclusion and Relevance: In this study, hospital participation in the BPCI Model 2 Heart Failure program was not associated with improvement in process-of-care quality measures or 30-day or 90-day risk-adjusted all-cause mortality and readmission rates.

Integrating Cost into Shared Decision-Making for Heart Failure with Reduced Ejection Fraction (POCKET-COST-HF): A Trial Providing Out-of-Pocket Costs for Heart Failure Medications during Clinical Encounters.

BACKGROUND: Evidence-based medical therapy for heart failure with reduced ejection fraction (HFrEF) often entails substantial out-of-pocket costs that can vary appreciably between patients. This has raised concerns regarding financial toxicity, equity, and adherence to medical therapy. In spite of these concerns, cost discussions in the HFrEF population appear to be rare, partly because out-of-pocket costs are generally unavailable during clinical encounters. In this trial, out-of-pocket cost information is given to patients and clinicians during outpatient encounters with the aim to assess the impact of providing this information on medication discussions and decisions. HYPOTHESIS: Cost-informed decision-making will be facilitated by providing access to patient-specific out-of-pocket cost estimates at the time of clinical encounter. DESIGN: Integrating Cost into Shared Decision-Making for Heart Failure with Reduced Ejection Fraction (POCKET-COST-HF) is a multicenter trial based at Emory Healthcare and University of Colorado Health. Adapting an existing patient activation tool from the EPIC-HF trial, patients and clinicians are presented a checklist with medications approved for treatment of HFrEF with or without patient-specific out-of-pocket costs (obtained from a financial navigation firm). Clinical encounters are audio-recorded, and patients are surveyed about their experience. The trial utilizes a stepped-wedge cluster randomized design, allowing for each site to enroll control and intervention group patients while minimizing contamination of the control arm. DISCUSSION: This trial will elucidate the potential impact of robust cost disclosure efforts and key information regarding patient and clinician perspectives related to cost and cost communication. It also will reveal important challenges associated with providing out-of-pocket costs for medications during clinical encounters. Acquiring medication costs for this trial requires an involved process and outsourcing of work. In addition, costs may change throughout the year, raising questions regarding what specific information is most valuable. These data will represent an important step towards understanding the role of integrating cost discussions into heart failure care. GOV IDENTIFIER: NCT04793880.

The Economic Burden of Heart Failure with Reduced Ejection Fraction: Living Longer but Poorer?

Treatment of heart failure with reduced ejection fraction (HFrEF) has benefitted from a proliferation of new medications and devices. These treatments carry important clinical benefits, but also come with costs relevant to payers, providers, and patients. Patient out-of-pocket costs have been implicated in the avoidance of medical care, nonadherence to medications, and the exacerbation of health care disparities. In the absence of major health care policy and payment redesign, high-quality HFrEF care delivery requires transparent integration of cost considerations into system design, patient-clinician interactions, and medical decision making.

Sex differences in long-term outcomes following acute heart failure hospitalization: Findings from the Get With The Guidelines-Heart Failure registry.

AIMS: Sex differences in long-term outcomes following hospitalization for heart failure (HF) across ejection fraction (EF) subtypes are not well described. In this study, we evaluated the risk of mortality and rehospitalization among males and females across the spectrum of EF over 5 years of follow-up following an index HF hospitalization event. METHODS AND RESULTS: Patients hospitalized with HF between 1 January 2006 and 31 December 2014 from the American Heart Association's Get With The Guidelines-Heart Failure registry with available 5-year follow-up using Medicare Part A claims data were included. The association between sex and risk of mortality and readmission over a 5-year follow-up period for each HF subtype (HF with reduced EF [HFrEF, EF ≤40%], HF with mildly reduced EF [HFmrEF, EF 41-49%], and HF with preserved EF [HFpEF, EF >50%]) was assessed using adjusted Cox models. The effect modification by the HF subtype for the association between sex and outcomes was assessed by including multiplicative interaction terms in the models. A total of 155 670 patients (median age: 81 years, 53.4% female) were included. Over 5-year follow-up, males and females had comparably poor survival post-discharge; however, females (vs. males) had greater years of survival lost to HF compared with the median age- and sex-matched US population (HFpEF: 17.0 vs. 14.6 years; HFrEF: 17.3 vs. 15.1 years; HFmrEF: 17.7 vs. 14.6 years for age group 65-69 years). In adjusted analysis, females (vs. males) had a lower risk of 5-year mortality (adjusted hazard ratio [aHR] 0.89, 95% confidence interval [CI] 0.87-0.90, p < 0.0001), and the risk difference was most pronounced among patients with HFrEF (aHR 0.87, 95% CI 0.85-0.89; pinteraction [sex*HF subtype] = 0.04). Females (vs. males) had a higher adjusted risk of HF readmission over 5-year follow-up (aHR 1.06, 95% CI 1.04-1.08, p < 0.0001), with the risk difference most pronounced among patients with HFpEF (aHR 1.11, 95% CI 1.07-1.14; pinteraction [sex*HF subtype] = 0.001). CONCLUSIONS: While females (vs. males) had lower adjusted mortality, females experienced a significantly greater loss in survival time than the median age- and sex-matched US population and had a greater risk of rehospitalization over 5 years following HF hospitalization.

Comparative Outcomes of Sacubitril/Valsartan Use After Hospitalization for Heart Failure Among Medicare Beneficiaries Naïve to Renin-Angiotensin System Inhibitors.

Sacubitril/valsartan improves outcomes in patients with heart failure with reduced ejection fraction (HFrEF) compared with angiotensin-converting enzyme inhibitors (ACEis). However, data on postdischarge outcomes in renin-angiotensin system inhibitor (RASi)-naïve patients are limited. We included Medicare beneficiaries aged ≥65 years who were hospitalized for HFrEF in the Get With The Guidelines-Heart Failure registry between October 2015 and June 2019, had part D prescription coverage, and were not on RASi therapy during the 6 months before hospital admission. We examined the associations between sacubitril/valsartan prescription at hospital discharge and outcomes at 30 days and 1 year after discharge using overlap-weighted median regression and Cox proportional hazards models. The end points included "home time" (defined as days alive and out of any health care institution), mortality, and rehospitalization. Among 3,572 patients with HFrEF and who are naïve to RASi therapy, at discharge, 290 (8.1%) were prescribed sacubitril/valsartan and 1,390 (38.9%) were prescribed ACEis and angiotensin receptor blockers. After adjusting for baseline characteristics, patients prescribed sacubitril/valsartan had a longer median home time (parameter estimate 27.0 days, 95% confidence interval [CI] 12.40 to 41.6, p <0.001) and lower all-cause mortality (hazard ratio [HR] 0.74, 95% CI 0.61 to 0.91, p = 0.004) at 1 year than patients not prescribed sacubitril/valsartan. The prescription of sacubitril/valsartan was not significantly associated with all-cause rehospitalization (HR 0.87, 95% CI 0.74 to 1.03, p = 0.10) or heart failure rehospitalization (HR 0.87, 95% CI 0.70 to 1.07, p = 0.19). In a restricted comparison of patients discharged on sacubitril/valsartan versus ACEis and angiotensin receptor blockers, there were no significant differences in the outcomes. In conclusion, in this contemporary population of RASi-naïve patients with HFrEF from routine clinical practice, compared with not initiating, the initiation of sacubitril/valsartan at discharge was associated with longer home time and improvements in overall survival.

Patterns of Referral and Postdischarge Utilization of Cardiac Rehabilitation Among Patients Hospitalized With Heart Failure: An Analysis From the GWTG-HF Registry.

BACKGROUND: Coverage for cardiac rehabilitation (CR) for patients with heart failure with reduced ejection fraction was expanded in 2014, but contemporary referral and participation rates remain unknown. METHODS: Patients hospitalized for heart failure with reduced ejection fraction (≤35%) in the American Heart Association Get With The Guidelines-Heart Failure registry from 2010 to 2020 were included, and CR referral status was described as yes, no, or not captured. Temporal trends in CR referral were assessed in the overall cohort. Patient and hospital-level predictors of CR referral were assessed using multivariable-adjusted logistic regression models. Additionally, CR referral and proportional utilization of CR within 1-year of referral were evaluated among patients aged >65 years with available Medicare administrative claims data who were clinically stable for 6-weeks postdischarge. Finally, the association of CR referral with the risk of 1-year death and readmission was evaluated using multivariable-adjusted Cox models. RESULTS: Of 69,441 patients with heart failure with reduced ejection fraction who were eligible for CR (median age 67 years; 33% women; 30% Black), 17,076 (24.6%) were referred to CR, and referral rates increased from 8.1% in 2010 to 24.1% in 2020 (Ptrend<0.001). Of 8310 patients with Medicare who remained clinically stable 6-weeks after discharge, the CR referral rate was 25.8%, and utilization of CR among referred patients was 4.1% (mean sessions attended: 6.7). Patients not referred were more likely to be older, of Black race, and with a higher burden of comorbidities. In adjusted analysis, eligible patients with heart failure with reduced ejection fraction who were referred to CR (versus not referred) had a lower risk of 1-year death (hazard ratio, 0.84 [95% CI, 0.70-1.00]; P=0.049) without significant differences in 1-year readmission. CONCLUSIONS: CR referral rates have increased from 2010 to 2020. However, only 1 in 4 patients are referred to CR. Among eligible patients who received CR referral, participation was low, with <1 of 20 participating in CR.

Clinical Profile, Health Care Costs, and Outcomes of Patients Hospitalized for Heart Failure With Severely Reduced Ejection Fraction.

Background Many patients with heart failure (HF) have severely reduced ejection fraction but do not meet threshold for consideration of advanced therapies (ie, stage D HF). The clinical profile and health care costs associated with these patients in US practice is not well described. Methods and Results We examined patients hospitalized for worsening chronic heart failure with reduced ejection fraction ≤40% from 2014 to 2019 in the GWTG-HF (Get With The Guidelines-Heart Failure) registry, who did not receive advanced HF therapies or have end-stage kidney disease. Patients with severely reduced EF defined as EF ≤30% were compared with those with EF 31% to 40% in terms of clinical profile and guideline-directed medical therapy. Among Medicare beneficiaries, postdischarge outcomes and health care expenditure were compared. Among 113 348 patients with EF ≤40%, 69% (78 589) had an EF ≤30%. Patients with severely reduced EF ≤30% tended to be younger and were more likely to be Black. Patients with EF ≤30% also tended to have fewer comorbidities and were more likely to be prescribed guideline-directed medical therapy ("triple therapy" 28.3% versus 18.2%, P<0.001). At 12-months postdischarge, patients with EF ≤30% had significantly higher risk of death (HR, 1.13 [95% CI, 1.08-1.18]) and HF hospitalization (HR, 1.14 [95% CI, 1.09-1.19]), with similar risk of all-cause hospitalizations. Health care expenditures were numerically higher for patients with EF ≤30% (median US$22 648 versus $21 392, P=0.11). Conclusions Among patients hospitalized for worsening chronic heart failure with reduced ejection fraction in US clinical practice, most patients have severely reduced EF ≤30%. Despite younger age and modestly higher use of guideline-directed medical therapy at discharge, patients with severely reduced EF face heightened postdischarge risk of death and HF hospitalization.

Quality of Care and Clinical Outcomes for Patients With Heart Failure at Hospitals Caring for a High Proportion of Black Adults: Get With The Guidelines-Heart Failure Registry.

Importance: Black adults with heart failure (HF) disproportionately experience higher population-level mortality than White adults with HF. Whether quality of care for HF differs at hospitals with high proportions of Black patients compared with other hospitals is unknown. Objective: To compare quality and outcomes for patients with HF at hospitals with high proportions of Black patients vs other hospitals. Design, Setting, and Participants: Patients hospitalized for HF at Get With The Guidelines (GWTG) HF sites from January 1, 2016, through December 1, 2019. These data were analyzed from May 2022 through November 2022. Exposures: Hospitals caring for high proportions of Black patients. Main Outcomes and Measures: Quality of HF care based on 14 evidence-based measures, overall defect-free HF care, and 30-day readmissions and mortality in Medicare patients. Results: This study included 422 483 patients (224 270 male [53.1%] and 284 618 White [67.4%]) with a mean age of 73.0 years. Among 480 hospitals participating in GWTG-HF, 96 were classified as hospitals with high proportions of Black patients. Quality of care was similar between hospitals with high proportions of Black patients compared with other hospitals for 11 of 14 GWTG-HF measures, including use of angiotensin-converting enzyme inhibitors/angiotensin receptor blocker/angiotensin receptor neprilysin inhibitors for left ventricle systolic dysfunction (high-proportion Black hospitals: 92.7% vs other hospitals: 92.4%; adjusted odds ratio [OR], 0.91; 95% CI, 0.65-1.27), evidence-based ß-blockers (94.7% vs 93.7%; OR, 1.02; 95% CI, 0.82-1.28), angiotensin receptor neprilysin inhibitors at discharge (14.3% vs 16.8%; OR, 0.74; 95% CI, 0.54-1.02), anticoagulation for atrial fibrillation/flutter (88.8% vs 87.5%; OR, 1.05; 95% CI, 0.76-1.45), and implantable cardioverter-defibrillator counseling/placement/prescription at discharge (70.9% vs 71.0%; OR, 0.75; 95% CI, 0.50-1.13). Patients at high-proportion Black hospitals were less likely to be discharged with a follow-up visit made within 7 days or less (70.4% vs 80.1%; OR, 0.68; 95% CI, 0.53-0.86), receive cardiac resynchronization device placement/prescription (50.6% vs 53.8%; OR, 0.63; 95% CI, 0.42-0.95), or an aldosterone antagonist (50.4% vs 53.5%; OR, 0.69; 95% CI, 0.50-0.97). Overall defect-free HF care was similar between both groups of hospitals (82.6% vs 83.4%; OR, 0.89; 95% CI, 0.67-1.19) and there were no significant within-hospital differences in quality for Black patients vs White patients. Among Medicare beneficiaries, the risk-adjusted hazard ratio (HR) for 30-day readmissions was higher at high-proportion Black vs other hospitals (HR, 1.14; 95% CI, 1.02-1.26), but similar for 30-day mortality (HR 0.92; 95% CI,0.84-1.02). Conclusions and Relevance: Quality of care for HF was similar across 11 of 14 measures at hospitals caring for high proportions of Black patients compared with other hospitals, as was overall defect-free HF care. There were no significant within-hospital differences in quality for Black patients vs White patients.

Achieving Equity in Hospital Performance Assessments Using Composite Race-Specific Measures of Risk-Standardized Readmission and Mortality Rates for Heart Failure.

BACKGROUND: The contemporary measures of hospital performance for heart failure hospitalization and 30-day risk-standardized readmission rate (RSRR) and risk-standardized mortality rate (RSMR) are estimated using the same risk adjustment model and overall event rate for all patients. Thus, these measures are mainly driven by the care quality and outcomes for the majority racial and ethnic group, and may not adequately represent the hospital performance for patients of Black and other races. METHODS: Fee-for-service Medicare beneficiaries from January 2014 to December 2019 hospitalized with heart failure were identified. Hospital-level 30-day RSRR and RSMR were estimated using the traditional race-agnostic models and the race-specific approach. The composite race-specific performance metric was calculated as the average of the RSRR/RMSR measures derived separately for each race and ethnicity group. Correlation and concordance in hospital performance for all patients and patients of Black and other races were assessed using the composite race-specific and race-agnostic metrics. RESULTS: The study included 1 903 232 patients (75.7% White [n=1 439 958]; 14.5% Black [n=276 684]; and 9.8% other races [n=186 590]) with heart failure from 1860 hospitals. There was a modest correlation between hospital-level 30-day performance metrics for patients of White versus Black race (Pearson correlation coefficient: RSRR=0.42; RSMR=0.26). Compared with the race-agnostic RSRR and RSMR, composite race-specific metrics for all patients demonstrated stronger correlation with RSRR (correlation coefficient: 0.60 versus 0.74) and RSMR (correlation coefficient: 0.44 versus 0.51) for Black patients. Concordance in hospital performance for all patients and patients of Black race was also higher with race-specific (versus race-agnostic) metrics (RSRR=64% versus 53% concordantly high-performing; 61% versus 51% concordantly low-performing). Race-specific RSRR and RSMR metrics (versus race-agnostic) led to reclassification in performance ranking of 35.8% and 39.2% of hospitals, respectively, with better 30-day and 1-year outcomes for patients of all race groups at hospitals reclassified as high-performing. CONCLUSIONS: Among patients hospitalized with heart failure, race-specific 30-day RSMR and RSRR are more equitable in representing hospital performance for patients of Black and other races.

Assessment of caregiver burden prior to implantation of left ventricular assist device: A national survey.

BACKGROUND: Guidelines recommend incorporation of caregiver burden assessment and list significant caregiver burden as a relative contraindication when considering left-ventricular assist device (LVAD) implantation. METHODS: To assess national practices regarding caregiver burden assessment, in 2019 we administered a 47-item survey to LVAD clinicians using 4 convenience samples. RESULTS: Responses were obtained from 191 registered nurses, 109 advance practice providers, 71 physicians, 59 social workers, and 40 others representing 132 LVAD programs; 125 of 173 total United States programs were included in the final analysis. While most programs (83.2%) assessed caregiver burden, assessment was most frequently conducted informally during social work evaluation (83.2%), with only 8.8% incorporating validated measures of caregiver burden. Larger programs were more likely to use a validated assessment measure (OR 6.68 [1.33-33.52]). CONCLUSIONS: Future research should focus on how programs can standardize caregiver burden assessment and how the level of burden may impact patient and caregiver outcomes.

Quality of Care and Outcomes Among Patients Hospitalized for Heart Failure in Rural vs Urban US Hospitals: The Get With The Guidelines-Heart Failure Registry.

Importance: Prior studies have suggested patients with heart failure (HF) from rural areas have worse clinical outcomes. Contemporary differences between rural and urban hospitals in quality of care and clinical outcomes for patients hospitalized for HF remain poorly understood. Objective: To assess quality of care and clinical outcomes for US patients hospitalized for HF at rural vs urban hospitals. Design, Setting, and Participants: This retrospective cohort study analyzed 774 419 patients hospitalized for HF across 569 sites in the Get With The Guidelines-Heart Failure (GWTG-HF) registry between January 1, 2014, and September 30, 2021. Postdischarge outcomes were assessed in a subset of 161 996 patients linked to Medicare claims. Data were analyzed from August 2022 to January 2023. Main Outcomes and Measures: GWTG-HF quality measures, in-hospital mortality, length of stay, and 30-day mortality and readmission outcomes. Results: This study included 19 832 patients (2.6%) and 754 587 patients (97.4%) hospitalized at 49 rural hospitals (8.6%) and 520 urban hospitals (91.4%), respectively. Of 774 419 included patients, 366 161 (47.3%) were female, and the median (IQR) age was 73 (62-83) years. Compared with patients at urban hospitals, patients at rural hospitals were older (median [IQR] age, 74 [64-84] years vs 73 [61-83] years; standardized difference, 10.63) and more likely to be non-Hispanic White (14 572 [73.5%] vs 498 950 [66.1%]; standardized difference, 34.47). In adjusted models, patients at rural hospitals were less likely to be prescribed cardiac resynchronization therapy (adjusted risk difference [aRD], -13.5%; adjusted odds ratio [aOR], 0.44; 95% CI, 0.22-0.92), angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (aRD, -3.7%; aOR, 0.71; 95% CI, 0.53-0.96), and an angiotensin receptor-neprilysin inhibitor (aRD, -5.0%; aOR, 0.68; 95% CI, 0.47-0.98) at discharge. In-hospital mortality was similar between rural and urban hospitals (460 of 19 832 [2.3%] vs 20 529 of 754 587 [2.7%]; aOR, 0.86; 95% CI, 0.70-1.07). Patients at rural hospitals were less likely to have a length of stay of 4 or more days (aOR, 0.75; 95% CI, 0.67-0.85). Among Medicare beneficiaries, there were no significant differences between rural and urban hospitals in 30-day HF readmission (adjusted hazard ratio [aHR], 1.03; 95% CI, 0.90-1.19), all-cause readmission (aHR, 0.97; 95% CI, 0.91-1.04), and all-cause mortality (aHR, 1.05; 95% CI, 0.91-1.21). Conclusions and Relevance: In this large contemporary cohort of US patients hospitalized for HF, care at rural hospitals was independently associated with lower use of some guideline-recommended therapies at discharge and shorter length of stay. In-hospital mortality and 30-day postdischarge outcomes were similar at rural and urban hospitals.

Applicability of Vericiguat to Patients Hospitalized for Heart Failure in the United States.

BACKGROUND: In January 2021, vericiguat, a soluble guanylate cyclase stimulator, was approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of cardiovascular death and heart failure (HF) hospitalization among patients with a recent worsening HF event based on the VICTORIA (VerICiguaT Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial. OBJECTIVES: This study sought to leverage a contemporary U.S. registry of patients hospitalized for heart failure (HF) to characterize patients who may be candidates for vericiguat based on FDA label and the VICTORIA trial eligibility criteria. METHODS: The authors studied patients hospitalized for HF with ejection fraction (EF) <45% across 525 sites in the GWTG-HF (Get With The Guidelines-Heart Failure) registry between January 2014 and December 2020. Approximate FDA label criteria (excluding estimated glomerular filtration rate [eGFR] <15 mL/min/1.73 m2, dialysis, or patients with heart transplantation or durable mechanical circulatory support) and eligibility criteria for the VICTORIA trial were applied to the GWTG-HF cohort. RESULTS: Among 241,057 patients with EF <45% in the GWTG-HF registry, 221,730 (92%) could be candidates for vericiguat under the FDA label and 92,249 (38%) would have been eligible for the VICTORIA trial. The most frequent reasons for ineligibility for the FDA label were eGFR <15 mL/min/1.73 m2 (5.7%) and dialysis (1.6%). Although there were greater proportions of women and Black patients in the GWTG-HF registry, most clinical characteristics were qualitatively similar with patients enrolled in the VICTORIA trial. Among Medicare beneficiaries in the GWTG-HF registry eligible for vericiguat by either FDA label or VICTORIA trial criteria, 12-month postdischarge rates of mortality (36%-37%), HF hospitalization (33%-35%), all-cause hospitalization (64%-66%), and mean health care expenditure (U.S. $25,106-$25,428) were high. CONCLUSIONS: Data from a large, contemporary U.S. registry of patients actively hospitalized for HF with EF <45% suggest that approximately 4 in 10 patients meet the criteria of the VICTORIA trial and that more than 9 in 10 patients are potential candidates for vericiguat based on the FDA label. Contemporary Medicare beneficiaries hospitalized for HF with EF <45% and eligible for vericiguat face high rates of postdischarge mortality and readmission and accrue substantial health care costs.

Real-world safety of neurohormonal antagonist initiation among older adults following a heart failure hospitalization.

AIMS: To optimize guideline-directed medical therapy for heart failure, patients may require the initiation of multiple neurohormonal antagonists (NHAs) during and following hospitalization. The safety of this approach for older adults is not well established. METHODS AND RESULTS: We conducted an observational cohort study of 207 223 Medicare beneficiaries discharged home following a hospitalization for heart failure with reduced ejection fraction (HFrEF) (2008-2015). We performed Cox proportional hazards regression to examine the association between the count of NHAs initiated within 90 days of hospital discharge (as a time-varying exposure) and all-cause mortality, all-cause rehospitalization, and fall-related adverse events over the 90 day period following hospitalization. We calculated inverse probability-weighted hazard ratios (IPW-HRs) with 95% confidence intervals (CIs) comparing initiation of 1, 2, or 3 NHAs vs. 0. The IPW-HRs for mortality were 0.80 [95% CI (0.78-0.83)] for 1 NHA, 0.70 [95% CI (0.66-0.75)] for 2, and 0.94 [95% CI (0.83-1.06)] for 3. The IPW-HRs for readmission were 0.95 [95% CI (0.93-0.96)] for 1 NHA, 0.89 [95% CI (0.86-0.91)] for 2, and 0.96 [95% CI (0.90-1.02)] for 3. The IPW-HRs for fall-related adverse events were 1.13 [95% CI (1.10-1.15)] for 1 NHA, 1.25 [95% CI (1.21-1.30)] for 2, and 1.64 [95% CI (1.54-1.76)] for 3. CONCLUSIONS: Initiating 1-2 NHAs among older adults within 90 days of HFrEF hospitalization was associated with lower mortality and lower readmission. However, initiating 3 NHAs was not associated with reduced mortality or readmission and was associated with a significant risk for fall-related adverse events.

Assessing Heuristic Bias During Care for Patients Hospitalized for Heart Failure: Get With The Guidelines-Heart Failure.

BACKGROUND: Heuristic biases are increasingly recognized, and potentially modifiable, contributors to patient care and outcomes. Left digit bias is a cognitive bias where continuous variables are categorized by their left-most digit. The impact of this heuristic bias applied to patient age on quality of care in heart failure has not been explored. METHODS: We examined participants admitted from 2005 to 2021 in the Get With The Guidelines-Heart Failure registry. To create 2 naturally randomized groups, isolating the effect of left digit bias, we dichotomized patients into those discharged within 60 days prior to their 80th birthday (N=4238) and those discharged within 60 days after their 80th birthday (N=4329). We performed multivariable logistic regression to assess the association between discharge date relative to 80th birthday and several in-hospital quality metrics and in-hospital outcomes. Among Medicare participants (N=2759), we performed adjusted Cox regression to analyze the relationship between discharge date and risk of 1-year mortality or readmission. RESULTS: Among 8567 patients, 50.4% were female, 73% were non-Hispanic White, and 42.9% had an ejection fraction ≤40%. Discharge date relative to 80th birthday was not associated with numerous in-hospital quality metrics or in-hospital outcomes on unadjusted or adjusted logistic regression. Among Medicare beneficiaries, there was no association between discharge date and risk of mortality or readmission at 1-year postdischarge (hazard ratio, 1.03 [95% CI, 0.95-1.12]; P=0.52). CONCLUSIONS: In a large registry of patients hospitalized for heart failure, we did not detect a left digit bias' with respect to age at discharge, which resulted in differential quality of care or outcomes.

Patient control preferences for medical decision making before and after evaluation for left ventricular assist device.

Understanding patients' preferred roles in medical decision making (i.e., passive, collaborative, active) is important to personalized care and patient engagement. Patient control preferences have been described for many treatment decisions, but their stability over time has not been characterized, particularly for major medical events with long-term implications. We prospectively surveyed 233 patients at the initiation of evaluation for a left ventricular assist device, and 1 and 6 months later, including collection of the Control Preferences Scale. Collaborative and active preferences were most common initially, followed by a shift towards more active. Approximately half of patients reported a different control preference in follow up. Patients with higher income and education levels were more likely to prefer an active role. These findings suggest that most patients want to be engaged in shared decision making, but to what degree is varied, can change over time, and is influenced by social determinants of health.

Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial.

BACKGROUND: Shared decision making (SDM) is gaining importance in cardiology, including Centers for Medicare & Medicaid Services (CMS) reimbursement policies requiring documented SDM for patients considering primary prevention implantable cardioverter defibrillators. The DECIDE-ICD Trial (Decision Support Intervention for Patients offered implantable Cardioverter-Defibrillators) assessed the implementation and effectiveness of patient decision aids (DAs) using a stepped-wedge design at 7 sites. The purpose of this subanalysis was to qualitatively describe electrophysiology clinicians' experience implementing and using the DAs. METHODS: This included semi-structured individual interviews with electrophysiology clinicians at participating sites across the US, at least 6 months following conversion into the implementation phase of the trial (from June 2020 through February 2022). The interview guide was structured according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance [implementation evaluation model]) framework, assessing clinician experiences, which can impact implementation domains, and was qualitatively assessed using a mixed inductive/deductive method. RESULTS: We completed 22 interviews post-implementation across all 7 sites. Participants included both physicians (n=16) and other clinicians who counsel patients regarding treatment options (n=6). While perception of SDM and the DA were positive, participants highlighted reasons for uneven delivery of DAs to appropriate patients. The CMS mandate for SDM was not universally viewed as associating with patients receiving DA's, but rather (1) logistics of DA delivery, (2) perceived effectiveness in improving patient decision-making, and (3) match of DA content to current patient populations. Remaining tensions include the specific trial data used in DAs and reconciling timing of delivery with when patients are actively making decisions. CONCLUSIONS: Clinicians charged with delivering DAs to patients considering primary prevention implantable cardioverter defibrillators were generally supportive of the tenets of SDM, and of the DA tools themselves, but noted several opportunities to improve the reach and continued use of them in routine care. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique Identifier: NCT03374891.

Left Atrial Appendage Occlusion Versus Oral Anticoagulation in Atrial Fibrillation : A Decision Analysis.

BACKGROUND: Left atrial appendage occlusion (LAAO) is a potential alternative to oral anticoagulants in selected patients with atrial fibrillation (AF). Compared with anticoagulants, LAAO decreases major bleeding risk, but there is uncertainty regarding the risk for ischemic stroke compared with anticoagulation. OBJECTIVE: To determine the optimal strategy for stroke prevention conditional on a patient's individual risks for ischemic stroke and bleeding. DESIGN: Decision analysis with a Markov model. DATA SOURCES: Evidence from the published literature informed model inputs. TARGET POPULATION: Women and men with nonvalvular AF and without prior stroke. TIME HORIZON: Lifetime. PERSPECTIVE: Clinical. INTERVENTION: LAAO versus warfarin or direct oral anticoagulants (DOACs). OUTCOME MEASURES: The primary end point was clinical benefit measured in quality-adjusted life-years. RESULTS OF BASE-CASE ANALYSIS: The baseline risks for stroke and bleeding determined whether LAAO was preferred over anticoagulants in patients with AF. The combined risks favored LAAO for higher bleeding risk, but that benefit became less certain at higher stroke risks. For example, at a HAS-BLED score of 5, LAAO was favored in more than 80% of model simulations for CHA2DS2-VASc scores between 2 and 5. The probability of LAAO benefit in QALYs (>80%) at lower bleeding risks (HAS-BLED score of 0 to 1) was limited to patients with lower stroke risks (CHA2DS2-VASc score of 2). Because DOACs carry lower bleeding risks than warfarin, the net benefit of LAAO is less certain than that of DOACs. RESULTS OF SENSITIVITY ANALYSIS: Results were consistent using the ORBIT bleeding score instead of the HAS-BLED score, as well as alternative sources for LAAO clinical effectiveness data. LIMITATION: Clinical effectiveness data were drawn primarily from studies on the Watchman device. CONCLUSION: Although LAAO could be an alternative to anticoagulants for stroke prevention in patients with AF and high bleeding risk, the overall benefit from LAAO depends on the combination of stroke and bleeding risks in individual patients. These results suggest the need for a sufficiently low stroke risk for LAAO to be beneficial. The authors believe that these results could improve shared decision making when selecting patients for LAAO. PRIMARY FUNDING SOURCE: None.

Variation in Left Ventricular Assist Device Postdischarge Caregiver Requirements: Results From a Mixed-Methods Study With Equity Implications.

BACKGROUND: Left ventricular assist device (LVAD) evaluation includes a psychosocial assessment, conducted by social workers (SWs) on the advanced heart failure multidisciplinary team. Postdischarge caregiving plans are central to psychosocial evaluation. Caregiving's relationship with LVAD outcomes is mixed, and testing patients' social resources may disadvantage those from historically undertreated groups. We describe variation in policies defining adequate caregiving plans post-LVAD implant and possible impacts on patients from marginalized groups. METHODS: This was a 2-phase sequential mixed-methods study: (1) phase 1, survey of US-based LVAD SWs, describing assessment structure and policies guiding candidacy outcomes; and (2) phase 2, individual interviews with SWs to further describe how caregiving plan adequacy impacts LVAD candidacy. RESULTS: Sixty-seven SWs returned surveys (rr=47%) from unique programs. Caregiving plan inadequacy (n=30) was the most common psychosocial dealbreaker. When asked what duration of caregiving is required, 23% indicated ≥3 months, 27% 4 to 12 weeks, and 30% <4 weeks. Two reported no duration requirement, 6 stated an indefinite 24/7 commitment was necessary. Across 22 interviews, SWs mirrored that caregiving plans were the most common psychosocial contraindication. How caregiving is operationalized varied. Participants voiced a tension between extended caregiving improving outcomes and the sense that some people of color, women, or low socioeconomic status patients struggle to meet stringent requirements. CONCLUSIONS: Policies regarding adequate duration of 24/7 caregiving vary, but inadequate caregiving plans are the most common psychosocial contraindication. Participants worry about patients' ability to meet restrictive requirements, particularly from historically undertreated groups. This highlights a need to operationalize quality caregiving, standardize assessment, and support medically appropriate patients with strained social resources.

Impact of Financial Considerations on Willingness to Take Sacubitril/Valsartan for Heart Failure.

Background Sacubitril/valsartan improves health outcomes for heart failure with reduced ejection fraction relative to angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, but it carries higher out-of-pocket costs. Neither the impact of cost nor how to integrate cost into medical decisions is well studied. Methods and Results To evaluate the impact of out-of-pocket costs and a novel cost-priming intervention on willingness to take sacubitril/valsartan for heart failure with reduced ejection fraction, participants with self-reported heart disease were surveyed using the online Ipsos Knowledge Panel. Participants were presented with a modified decision aid for sacubitril/valsartan and then, in a 3×2 factorial design, randomly assigned to 1 of 3 cost conditions ($10, $50, or $100/month) and to a control group or cost-priming intervention, defined by being asked questions about their financial situation before learning about the benefits of sacubitril/valsartan. Of the 1013 participants included in the analysis, 85% of respondents were willing to take sacubitril/valsartan at $10, 62% at $50, and 33% at $100 (P<0.0001). In a multivariable logistic regression model, participants were more likely to take sacubitril/valsartan at $10 versus $100 (odds ratio [OR], 14.3 [95% CI, 9.4-21.8]) and $50 compared with $100 (OR, 3.6 [95% CI, 2.5-5.1]). Overall, participants in the cost-primed group were more willing to take sacubitril/valsartan than those not primed to consider their financial situation (63% versus 56%, P=0.04). There was no statistically significant interaction between cost conditions and cost priming. Perceived benefit of sacubitril/valsartan over angiotensin-converting enzyme inhibitors or angiotensin receptor blockers decreased as cost increased but did not vary by cost priming. Conclusions Commonly encountered out-of-pocket costs of sacubitril/valsartan may impact individuals' willingness to take the medication even when recommended by their physicians. Priming individuals to consider personal finances before learning about the drug increased willingness to take sacubitril/valsartan.

Association of readmission penalty amount with subsequent 30-day risk standardized readmission and mortality rates among patients hospitalized with heart failure: An analysis of get with the guidelines - heart failure participating centers.

BACKGROUND: The Hospital Readmissions Reduction Program penalizes hospitals with excess 30-day risk-standardized readmission rates (RSRR) for heart failure (HF). The association of financial penalty amount with subsequent short-term clinical outcomes is unknown. METHODS: Patients admitted to American Heart Association Get With The Guidelines-HF registry participating centers from October 1, 2012 through December 1, 2015 who had Medicare-linked data were included. October 2012 hospital-specific penalty amounts were calculated based on diagnosis-related group payments and excess readmission ratios. Adjusted Cox models were created to evaluate the association of penalty amount categories (non-penalized: 0%; low-penalized: >0%-<0.50%; mid-penalized ≥0.50%-<0.99%; high-penalized ≥0.99%) with subsequent 30-day RSRR and risk-standardized mortality rates (RSMR). Trends in post-discharge 30-day RSRR and RSMR from 2012 to 2015 were analyzed across hospitals stratified by penalty amount categories. RESULTS: The present study included 61,329 patients who were admitted across 262 hospitals. Compared with patients admitted to non-penalized hospitals (36.3%), those admitted to increasingly penalized hospitals were more likely to have higher 30-day RSRR (low-penalized [43.9%]: HR, 1.10 [95% CI, 1.04-1.16]; mid-penalized [12.0%]: HR, 1.07 [95% CI, 0.99-1.16]; high-penalized [7.9%]: HR, 1.23 [95% CI, 1.12-1.35]) but not 30-day RSMR. Over time, 30-day RSRR and RSMR did not meaningfully change across penalized versus non-penalized hospitals. CONCLUSIONS: Financial penalties based on 30-day RSRR are not associated with declines in 30-day RSRR or RSMR from 2012 to 2015 among patients hospitalized with HF. Financially penalizing hospitals based on current Hospital Readmissions Reduction Program metrics may not incentivize improvements in short-term clinical outcomes for HF.