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Background: Caregivers of patients with advanced heart failure may experience burden in providing care, but whether changes in patient health status are associated with caregiver burden is unknown., Methods: This observational study included older patients (60-80 years old) receiving advanced surgical heart failure therapies and their caregivers at 13 US sites. Patient health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire (range, 0-100; higher scores are better). Caregiver burden was assessed using the Oberst Caregiving Burden Scale, which measures time on task (OCBS-time) and task difficulty (OCBS-difficulty; range, 1-5; lower scores are better). Measurements occurred before surgery and 12 months after in 3 advanced heart failure cohorts: patients receiving long-term left ventricular assist device support; heart transplantation with pretransplant left ventricular assist device support; and heart transplantation without pretransplant left ventricular assist device support. Multivariable linear regression was used to identify predictors of change in OCBS-time and OCBS-difficulty at 12 months., Results: Of 162 caregivers, the mean age was 61.0±9.4 years, 139 (86%) were female, and 140 (86%) were the patient's spouse. At 12 months, 99 (61.1%) caregivers experienced improved OCBS-time, and 61 (37.7%) experienced improved OCBS-difficulty (versus no change or worse OCBS). A 10-point higher baseline 12-item Kansas City Cardiomyopathy Questionnaire predicted lower 12-month OCBS-time (β=-0.09 [95% CI, -0.14 to -0.03]; P <0.001) and OCBS-difficulty (β=-0.08 [95% CI, -0.12 to -0.05]; P <0.001). Each 10-point improvement in the 12-item Kansas City Cardiomyopathy Questionnaire predicted lower 12-month OCBS-time (β=-0.07 [95% CI, -0.12 to -0.03]; P =0.002) and OCBS-difficulty (β=-0.09 [95% CI, -0.12 to -0.06]; P <0.001)., Conclusions: Among survivors at 12 months, baseline and change in patient health status were associated with subsequent caregiver time on task and task difficulty in dyads receiving advanced heart failure surgical therapies, highlighting the potential for serial 12-item Kansas City Cardiomyopathy Questionnaire assessments to identify caregivers at risk of increased burden., Registration: URL: https://www.clinicaltrials.gov; unique identifier: NCT02568930., Competing Interests: Dr Grady is the principal investigator of grants from the National Heart, Lung, and Blood Institute; receives speaker fees from the American Heart Association; and served on the Board of Directors for the International Society for Heart and Lung Transplantation. Dr Spertus is the principal investigator of grants from Myokardia and Janssen; is a consultant to Myokardia, Bristol Meyers Squibb, Merck, Novartis, Pfizer, and Janssen; serves on the Scientific Advisory Board of United Healthcare and the Board of Directors for Blue Cross Blue Shield of Kansas City; and owns the copyright to the Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and Peripheral Artery Questionnaire. The other authors report no conflicts.

Background: The impact of routine clinic use of patient-reported outcome (PRO) measures on clinical outcomes in patients with heart failure (HF) has not been well-characterized. We tested if clinic-based use of a disease-specific PRO improves patient-reported quality of life at 1 year., Methods: The PRO-HF trial (Patient-Reported Outcome Measurement in Heart Failure Clinic) was an open-label, parallel, patient-level randomized clinical trial of routine PRO assessment or usual care at an academic HF clinic between August 30, 2021, and June 30, 2022, with 1 year of follow-up. In the PRO assessment arm, participants completed the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at each HF clinic visit, and results were shared with their treating clinician. The usual care arm completed the KCCQ-12 at randomization and 1 year later, which was not shared with the treating clinician. The primary outcome was the KCCQ-12 overall summary score (OSS) between 12 and 15 months after randomization. Secondary outcomes included domains of the KCCQ-12, hospitalization and emergency department visit rates, HF medication therapy, clinic visit frequency, and testing rates., Results: Across 17 clinicians, 1248 participants were enrolled and randomized to PRO assessment (n=624) or usual care (n=624). The median age was 63.9 years (interquartile range [IQR], 51.8-72.8), 38.9% were women, and the median baseline KCCQ-12 OSS was 82.3 (IQR, 58.3-94.8). Final KCCQ-12 (available in 87.9% of the PRO arm and 85.1% in usual care; P =0.16) median OSS were 87.5 (IQR, 68.8-96.9) in the PRO arm and 87.6 (IQR, 69.7-96.9) in the usual care arm with a baseline-adjusted mean difference of 0.2 ([95% CI, -1.7 to 2.0]; P =0.85). The results were consistent across prespecified subgroups. A post hoc analysis demonstrated a significant interaction with greater benefit among participants with a baseline KCCQ-12 OSS of 60 to 80 but not in less or more symptomatic participants. No significant differences were found in 1-year mortality, hospitalizations, emergency department visits, medication therapy, clinic follow-up, or testing rates between arms., Conclusions: Routine PRO assessment in HF clinic visits did not impact patient-reported quality of life or other clinical outcomes. Alternate strategies and settings for embedding PROs into routine clinical care should be tested., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04164004., Competing Interests: Disclosures Dr Sandhu has consulted for Lexicon Pharmaceuticals and has research funding from Novartis and Reprieve Cardiovascular unrelated to this work. Dr Spertus owns the copyright to the Kansas City Cardiomyopathy Questionnaire. The interpretation and conclusions contained herein are those of the authors and do not necessarily represent the views of the National Institutes of Health.

Background: Quantifying guideline-directed medical therapy (GDMT) intensity is foundational for improving heart failure (HF) care. Existing measures discount dose intensity or use inconsistent weighting., Methods: The Kansas City Medical Optimization (KCMO) score is the average of total daily to target dose percentages for eligible GDMT, reflecting the percentage of optimal GDMT prescribed (range, 0-100). In Change the Management of Patients With HF, we computed KCMO, HF collaboratory (0-7), and modified HF Collaboratory (0-100) scores for each patient at baseline and for 1-year change in established GDMT at the time (mineralocorticoid receptor antagonist, β-blocker, ACE [angiotensin-converting enzyme] inhibitor/angiotensin receptor blocker/angiotensin receptor neprilysin inhibitor). We compared baseline and 1-year change distributions and the coefficient of variation (SD/mean) across scores., Results: Among 4532 patients at baseline, mean KCMO, HF collaboratory, and modified HF Collaboratory scores were 38.8 (SD, 25.7), 3.4 (1.7), and 42.2 (22.2), respectively. The mean 1-year change (n=4061) for KCMO was -1.94 (17.8); HF collaborator, -0.11 (1.32); and modified HF Collaboratory, -1.35 (19.8). KCMO had the highest coefficient of variation (0.66), indicating greater variability around the mean than the HF collaboratory (0.49) and modified HF Collaboratory (0.53) scores, reflecting higher resolution of the variability in GDMT intensity across patients., Conclusions: KCMO measures GDMT intensity by incorporating dosing and treatment eligibility, provides more granularity than existing methods, is easily interpretable (percentage of ideal GDMT), and can be adapted as performance measures evolve. Further study of its association with outcomes and its usefulness for quality assessment and improvement is needed., Competing Interests: Disclosures Drs Khan and Sherrod are supported by the National Heart, Lung, and Blood Institute under award T32H110837. Dr Ikemura received an unrestricted research grant for the Department of Cardiology, Keio University School of Medicine from Bristol Myer Squibb. Dr Sauer reports industry relationships with Abbott, Boston Scientific, Biotronik, Bayer, Amgen, CSL Vifor, Acorai, Story Health, General Prognostics, Impulse Dynamics, and Edwards Lifesciences. He also serves as advisory board member and owns stock in ISHI digital health company. Dr Fonarow reports consulting for Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Eli Lilly Johnson & Johnson, Medtronic, Merck, Novartis, and Pfizer. Dr Butler reports consulting for Abbott, American Regent, Amgen, Applied Therapeutic, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardiac Dimension, Cardior, CVRx, Cytokinetics, Edwards, Element Science, Innolife, Impulse Dynamics, Imbria, Inventiva, Lexicon, Lilly, LivaNova, Janssen, Medtronics, Merck, Occlutech, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Pharmain, Roche, Sequana, SQ Innovation, and Vifor. Dr DeVore reports research funding through his institution from Biofourmis, Bodyport, Cytokinetics, American Regent Inc, the National Institutes of Health and the National Heart, Lung, and Blood Institute, Novartis, and Story Health. He also provides consulting services for and/or receives honoraria from Abiomed, Cardionomic, LivaNova, Natera, NovoNordisk, Story Health, and Zoll. Dr Lund is supported by Karolinska Institutet, the Swedish Research Council (grant 523-2014-2336), the Swedish Heart Lung Foundation (grants 20150557 and 20190310), and the Stockholm County Council (grants 20170112 and 20190525). Dr Lund reports the following relationships with industry: grants, consulting, honoraria: Abbot, Alleviant, AstraZeneca, Bayer, Biopeutics, Boehringer Ingelheim, Edwards, Merck/MSD, Novartis, Novo Nordisk, OrionPharma, Owkin, Pharmacosmos, Vifor Pharma; stock ownership: AnaCardio. Dr Chan is supported by the National Heart, Lung, and Blood Institute under award R01HL160734 and is a consultant for Optum Rx. Dr Spertus has provided consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Myers Squibb, Edwards, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare; holds research grants from Bristol Myers Squibb, Abbott Vascular, and Janssen; owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. The other authors report no conflicts.

Background: The appropriate use criteria (AUCs) are a diverse group of indications aimed to better evaluate the benefits of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy., Objective: The purpose of this study was to quantify the proportion of ICD and cardiac resynchronization therapy with defibrillator (CRT-D) implants as appropriate, may be appropriate (MA), or rarely appropriate (RA) on the basis of the AUC guidelines., Methods: This is a multicenter retrospective study of patients within the National Cardiovascular Data Registry undergoing ICD implantation between April 2018 and March 2019 at >1500 US hospitals. The appropriateness of ICD implants was adjudicated using the AUC., Results: Of 309,318 ICDs, 241,438 were primary prevention implants (78.1%) and 67,880 secondary prevention implants (21.9%); 243,532 (79%) were mappable to the AUC. For primary prevention, 185,431 ICDs (96.4%) were appropriate, 5660 (2.9%) MA, and 1205 (0.6%) RA. For secondary prevention, 47,498 ICDs (92.7%) were appropriate, 2581 (5%) MA, and 1157 (2.3%) RA. A significant number of RA devices were implanted in patients with New York Heart Association class IV heart failure who were ineligible for advanced therapies (53.9%) and those with myocardial infarction within 40 days (18.1%). The appropriateness of the pacing lead was more variable, with 48,470 dual-chamber ICD implants (62%) being classified as appropriate, 29,209 (37.4%) MA, and 448 (0.6%) RA. Among CRT-D implants, 63,848 (82.2%) were appropriate, 9900 (12.7%) MA, and 3940 (5.1%) RA for left ventricular pacing. A total of 99,754 implants were deemed appropriate but excluded from Centers for Medicare & Medicaid Services National Coverage Determination. More than 92% of hospitals had an RA implant rate of <4%., Conclusion: In this large national registry, 95% of mappable ICD and CRT-D implants were considered appropriate, with <2% of RA implants. Nearly 100,000 appropriate implants are excluded by Centers for Medicare & Medicaid Services National Coverage Determination., Competing Interests: Disclosures Dr Yousuf serves as a consultant for Medtronic, Boston Scientific, and Zoll and is a member of the American College of Cardiology NCDR Reporting and Methodologies Committee, Electrophysiology NCDR Registry Suite Steering Committee, Heart Rhythm Society's Digital Health Committee. Dr Atwater serves as a consultant for Medtronic, Abbott, Biotronik, Biosense Webster, and Bristol Myers Squibb. Dr Steinberg has received research support from National Insitutes of Health (#K23HL143156), American Heart Association/Patient-Centered Outcomes Research Institute (PCORI), Boston Scientific, Sanofi, and AltaThera and is consulting to Sanofi, InCarda, Milestone, Pfizer, and AltaThera. He also serves as Chair of the Steering Committee for the NCDR EP registries. Dr Calkins serves as a consultant for Biosense Webster, Medtronic, Abbott Medical, and AtriCure. The rest of the authors report no conflicts of interest., (Copyright © 2024. Published by Elsevier Inc.)

Background: Sodium glucose co-transporter 2 inhibitor (SGLT2i) therapy improves health status in heart failure (HF). There is insufficient description regarding the timing, rate, and extent of the health status changes in heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) after initiation of SGLT2is., Objectives: The authors sought to model the association of canagliflozin treatment with rates of change in HF symptom status in HFpEF and HFrEF., Methods: Study participants with HFrEF and HFpEF were treated with either canagliflozin 100 mg or placebo for 12 weeks. The Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) was assessed at baseline and at 2, 4, 6, and 12 weeks. Longitudinal modeling assessed slope of KCCQ change across the study., Results: Among 448 individuals with HF (181 with HFrEF and 267 with HFpEF), participants with HFpEF had lower baseline KCCQ-TSS scores than those with HFrEF (54 ± 21 vs 64 ± 20). Modeling demonstrated initial rapid improvement in KCCQ-TSS in both HF groups, with deceleration over the next 4 to 6 weeks. The rate of change was greater among HFpEF participants (0.7 points/day; 95% CI: 0.3-1.1 points/day) than HFrEF participants (ΔKCCQ-TSS/day = 0.5; 95% CI: 0.1-1.0 points/day) randomized to canagliflozin, but these differences were not statistically significant (0.2 points/day; 95% CI: -0.4 to 0.7 points/day; P = 056)., Conclusions: After canagliflozin therapy, regardless of EF, modeling shows the KCCQ-TSS improves rapidly with the greatest improvements occurring within the first weeks of treatment. These results have implications for clinical use of SGLT2is and may be useful in the design of trials examining impact of these agents on health status in HF. (A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure [CHIEF-HF]; NCT04252287)., Competing Interests: Funding Support and Author Disclosures Dr Mohebi is supported by the Barry fellowship, and Dr Januzzi is supported in part by the Hutter Family Professorship. The CHIEF-HF study was supported by Janssen Scientific Affairs, LLC. Dr Januzzi is a Trustee of the American College of Cardiology; is a board member of Imbria Pharmaceuticals; has received grant support from Abbott, Applied Therapeutics, HeartFlow, Innolife, and Roche Diagnostics; has received consulting income from Abbott, Beckman, Boehringer Ingelheim, Bristol Myers Squibb, Jana Care, Janssen, Merck, Novartis, Pfizer, Roche Diagnostics, and Siemens; and has participated in clinical endpoint committees/data safety monitoring boards for Abbott, AbbVie, CVRx, Intercept, and Takeda. Dr Spertus has provided consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Meyers Squibb, Edwards, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare; holds research grants from Bristol Meyers Squibb, Abbott Vascular and Janssen; owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. Dr Lingvay has received research funding (paid to institution) from NovoNordisk, Sanofi, Merck, Pfizer, Mylan, and Boehringer-Ingelheim. Dr Lingvay has received advisory/consulting fees and/or other support from Novo Nordisk, Eli Lilly, Sanofi, AstraZeneca, Boehringer-Ingelheim, Johnson and Johnson, Intercept, TARGETPharma, Merck, Pfizer, Valeritas, Zealand Pharma, Shionogi, Carmot Therapeutics, Structure Therapeutics, Bayer, Translational Medical Academy, Mediflix, and WebMD. Dr Lanfear is supported in part by National Institutes of Health grants (P50MD017351 and R01HL132154); he is a consultant for Amgen, Janssen, Ortho Diagnostics, Cytokinetics, AstraZeneca, Otsuka, Abbot Laboratories, Illumina, and DCRI (Novartis); and he has participated in research from Akros, Novartis, Amgen, Lilly, AstraZeneca, Pfizer, Bayer, Illumina, Somalogic, and Janssen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Hypertension (HTN) is common in patients with hypertrophic cardiomyopathy (HCM), but its effect on the treatment of left ventricular outflow tract (LVOT) obstruction is undefined. Although elevated systolic blood pressure (SBP) may impact dynamic LVOT gradients, its response to cardiac myosin inhibition is unknown., Objectives: In a post hoc exploratory analysis of the EXPLORER-HCM trial (Clinical Study to Evaluate Mavacamten [MYK-461] in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy), the authors examined the characteristics of patients with obstructive HCM and HTN and the associations between HTN, SBP, and the response to mavacamten treatment of LVOT obstruction., Methods: Patients were stratified by baseline history of HTN and mean SBP during 30-week treatment with mavacamten or placebo. The study estimated treatment differences and evaluated HTN and SBP groups by treatment interaction. Analysis of covariance was used to model changes in continuous endpoints, and a generalized linear model was used for binary endpoints., Results: HTN was present in 119 of 251 patients (47.4%), including 60 receiving mavacamten and 59 receiving placebo. Patients with HTN vs no HTN were older (63.4 vs 54.0 years; P < 0.001), had higher SBP (134 ± 15.1 mm Hg vs 123 ± 13.8 mm Hg; P < 0.001), more comorbidities, and lower peak oxygen consumption (19 ± 3 vs 20 ± 4 mL/kg/min; P = 0.021). Patients with HTN had similar NYHA functional class (NYHA functional class II, 72% vs 73%), Valsalva LVOT gradients (72 ± 34 mm Hg vs 74 ± 30 mm Hg), Kansas City Cardiomyopathy Questionnaire-Clinical Summary Scores (70.6 ± 18.8 vs 68.9 ± 23.1), and NT pro-B-type natriuretic peptide levels (geometric mean 632 ± 129 pg/mL vs 745 ± 130 pg/mL). Mavacamten-treated patients had improvement in all primary, secondary, and exploratory endpoints regardless of HTN status or mean SBP., Conclusions: The clinical benefits of mavacamten in symptomatic, obstructive HCM were similar in patients with and without HTN, despite differences in baseline characteristics. (Clinical Study to Evaluate Mavacamten [MYK-461] in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy [EXPLORER-HCM]; NCT03470545)., Competing Interests: Funding Support and Author Disclosures MyoKardia, Inc, a wholly owned subsidiary of Bristol Myers Squibb, provided funding for statistical analyses. Dr Wang has been a consultant and/or served on advisory boards for BMS, Cytokinetics, and Biomarin; has served on the Speakers Bureau for BMS; and has received research grants from BMS and Cytokinetics. Dr Spertus has been a consultant for Alnylam, AstraZeneca, Bayer, Merck, Janssen, BMS, Edwards, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare; has received research grants from BMS, Abbott Vascular, and Janssen; holds the copyrights to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and has served on the board of directors for Blue Cross Blue Shield of Kansas City. Dr Owens has been a consultant and/or served on advisory boards for BMS, Cytokinetics, Pfizer, Renovacor, Edgewise, Tenaya, and Lexicon. Dr Saberi has been the site principal investigator for trials for BMS, Cytokinetics, and Novartis; has served on steering committees for trials for BMS and Cytokinetics; and has received consulting/honoraria from BMS and Cytokinetics. Dr Sehnert is an employee of Bristol Myers Squibb. Dr Lakdawala has been a consultant for BMS, Pfizer, Cytokinetics, and Tenaya; and has received research support from Pfizer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Heart failure is a common complication after myocardial infarction (MI) and is associated with increased mortality. Whether remote heart failure symptoms assessment after MI can improve risk stratification is unknown. The authors evaluated the association of the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ) with all-cause mortality after MI., Methods and Results: Prospectively collected data from consecutive patients hospitalized for MI at a large tertiary heart center between June 2017 and September 2022 were used. Patients remotely completed the KCCQ 1 month after discharge. A total of 1135 (aged 64±12 years, 26.7% women) of 1721 eligible patients completed the KCCQ. Ranges of KCCQ scores revealed that 30 (2.6%), 114 (10.0%), 274 (24.1%), and 717 (63.2%) had scores <25, 25 to 49, 50 to 74, and ≥75, respectively. During a mean follow-up of 46 months (interquartile range, 29-61), 146 (12.9%) died. In a fully adjusted analysis, KCCQ scores <50 were independently associated with mortality (hazard ratio [HR], 6.05 for KCCQ <25, HR, 2.66 for KCCQ 25-49 versus KCCQ ≥50; both P <0.001). Adding the 30-day KCCQ to clinical risk factors improved risk stratification: change in area under the curve of 2.6 (95% CI, 0.3-5.0), Brier score of -0.6 (95% CI, -1.0 to -0.2), and net reclassification improvement of 0.71 (95% CI, 0.45-1.04). KCCQ items most strongly associated with mortality were walking impairment, leg swelling, and change in symptoms., Conclusions: Remote evaluation of heart failure symptoms using the KCCQ among patients recently discharged for MI identifies patients at risk for mortality. Whether closer follow-up and targeted therapy can reduce mortality in high-risk patients warrants further study.

Aims: To explore the associations between social determinants of health and patient-centred outcomes among adults with chronic heart failure with reduced ejection fraction., Design: Cross-sectional online self-report survey., Methods: A survey assessing social determinants of health (demographics, socio-economic position, affordability of care and social support) and patient-centred outcomes, including the Kansas City Cardiomyopathy Questionnaire-12 and validated measures of medication adherence, treatment satisfaction, treatment burden and mental health, was completed by 512 adults with chronic heart failure with a reduced ejection fraction between 06 March and 29 June 2020. Multivariable analyses included linear and logistic regression., Results: Female gender, having a care partner, and being offered financial assistance with medications were associated with worse health status, while perceiving medication as affordable and being married were associated with better health status. Females and having Medicaid, dual Medicaid/Medicare or no medical insurance were associated with a higher likelihood of depression, and non-white race/ethnicity was associated with less depression. Medication adherence was lower in patients having a care partner and offered financial assistance. Patients being offered financial and medication management assistance were more likely to be overwhelmed by the treatment burden, whereas those having some college education were less so., Conclusions: Social determinants of health are associated with patients' disease-specific health status, mental health and treatment satisfaction and burden. These findings underscore the importance of assessing social determinants of health in clinical practice and the need for developing and testing novel strategies to determine whether they improve patients' health., Impact: The relationship between social determinants of health- and patient-centred outcomes was assessed; affordability of care and social support factors were most strongly associated with outcomes for patients with chronic heart failure and reduced ejection fraction, underscoring the importance of assessing social determinants of health in routine clinical care., Implications for the Profession And/or Patient Care: Social determinants of health data could potentially inform care delivery for patients with heart failure and reduced ejection fraction by helping to identify those who require additional support to manage their symptoms, access care and adhere to treatment. Social support and affordability of treatment were associated with most patient-centred outcomes, suggesting these factors may provide clinicians with an indicator of a patient's level of general well-being that could be assessed during routine follow-up care., Reporting Method: This research followed the STROBE checklist for cross-sectional studies., Patient or Public Contribution: Adults who have heart failure with reduced ejection fraction that consented to participate in the study provided the data used for all analyses reported on in the manuscript. Service users, caregivers or members of the public had no involvement in the study., (© 2023 John Wiley & Sons Ltd.)

Background: Caregiving for heart failure (HF) patients is burdensome. We examined differences in caregiver burden for 3 groups of older advanced HF patients: (1) supported with mechanical circulatory support (MCS) before heart transplantation (HT MCS), (2) awaiting transplant without MCS (HT non-MCS), and (3) prior to long-term MCS and factors associated with burden., Method: From October 1, 2015 to December 31, 2018, we enrolled 276 caregivers for HF patients from 13 U.S. sites: 85 HT MCS, 96 HT non-MCS, and 95 prior to long-term MCS. At enrollment, caregivers completed the Oberst Caregiving Burden Scale (15 items, 2 subscales: time (range = 1-5; higher score = more time spent on task) and difficulty (range = 1-5; higher score = higher difficulty of task) and other measures. Statistical analyses included descriptive statistics, ANOVA, chi-square tests, and linear regression., Result: Overall, caregivers were aged 60.8 ± 9.8 years and predominantly white, female, spouses, well educated, and reported ≥1 comorbidities. Caregivers overall reported a moderate amount of time spent on tasks and slight task difficulty. Caregivers for HT non-MCS candidates reported significantly less perceived time spent on tasks than caregivers for HT MCS candidates and caregivers for patients prior to long-term MCS (2.2 ± 0.74 vs 2.4 ± 0.74 vs 2.5 ± 0.71, respectively, p = 0.02) and less perceived difficulty of tasks (1.2 ± 0.33 vs 1.4 ± 0.53 vs 1.4 ± 0.54, respectively, p = 0.01). Caregiver and patient factors were associated with caregiver burden., Conclusions: Prior to HT and long-term MCS, caregiver burden was low to moderate. Caregiver factors were predominantly associated with caregiver burden. Understanding caregiver burden and factors affecting caregiver burden may enhance preoperative advanced therapies discussions and guide caregiver support., (Copyright © 2023. Published by Elsevier Inc.)

Aims: Health-related quality of life (HRQoL) is highly relevant in cancer and often assessed with the EORTC QLQ-C30. Cardiovascular HRQoL in cancer can be measured with the ESC HeartQoL questionnaire. We compared these instruments and examined their prognostic value., Methods and Results: Summary scores for EORTC QLQ-C30 (0-100 points) and ESC HeartQoL (0-3 points) questionnaires were prospectively assessed in 290 patients with mostly advanced cancer (stage 3/4: 81%, 1-year mortality: 36%) and 50 healthy controls (similar age and sex). Additionally, physical function and activity assessments were performed. Both questionnaires demonstrated reduced HRQoL in patients with cancer versus controls (EORTC QLQ-C30: 67 ± 20 vs. 91 ± 11, p < 0.001; ESC HeartQoL: 1.8 ± 0.8 vs. 2.7 ± 0.4, p < 0.001). The instruments were strongly correlated with each other (summary scores [r = 0.76], physical [r = 0.81], and emotional subscales [r = 0.75, all p < 0.001]) and independently associated with all-cause mortality (best cut-offs: EORTC QLQ-C30 <82.69: hazard ratio [HR] 2.33, p = 0.004; ESC HeartQoL <1.50: HR 1.85, p = 0.004 - adjusted for sex, age, left ventricular ejection fraction, N-terminal pro-B-type natriuretic peptide [NT-proBNP], high-sensitivity troponin T, cancer stage/type), with no differences in the strength of the association by sex (p-interaction > 0.9). Combining both questionnaires identified three risk groups with highest mortality in patients below both cut-offs (vs. patients above both cut-offs: HR 3.60, p < 0.001). Patients with results below both cut-offs, showed higher NT-proBNP and reduced physical function and activity., Conclusions: The EORTC QLQ-C30 and ESC HeartQoL - assessing cancer and cardiovascular HRQoL - are both associated with increased mortality in cancer patients, with even greater stratification by combing both. Reduced HRQoL scores were associated with elevated cardiovascular biomarkers and decreased functional status., (© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Clinical practice guidelines recommend optimizing the health status of patients with atrial fibrillation (AF) as a primary treatment goal. Whether disease-specific health status is associated with subsequent clinical events is unknown., Objectives: The aim of this study was to investigate the association between health status and subsequent clinical events among patients with AF., Methods: Using a prospective cohort study of patients with new-onset AF referred to 11 hospitals (n = 3,313, 68.4% men, mean age 67.8 ± 11.6 years), data were extracted from 3,296 patients (99.4%) who completed the disease-specific Atrial Fibrillation Effects on Quality-of-Life (AFEQT) questionnaire between 2012 and 2018. Factors associated with baseline AFEQT overall summary (OS) score and associations between major adverse cardiovascular or neurologic events (MACNE; a composite of all-cause death, stroke, or new-onset heart failure hospitalization) over 2 years were investigated., Results: Overall, 517 participants (15.6%) had poor to fair health status (AFEQT OS <60), and 1,035 (31.2%) had fair to good health status (AFEQT OS 60 to <80) at baseline. Female sex, younger age, family history of AF, higher baseline heart rate, paroxysmal AF, initial visit to the emergency department, and history of heart failure were associated with lower AFEQT OS scores. Of those, 226 participants (6.8%) experienced MACNE; restricted cubic spline analysis with adjustment for factors associated with baseline AFEQT score showed a nonlinear increase in the risk for MACNE with AFEQT OS score <80. The strongest associations were observed for baseline AFEQT daily activity scores (for AFEQT daily activity score of <80 vs ≥80, HR: 1.65; 95% CI: 1.21-2.25)., Conclusions: Diminished health status in patients with AF is common and is independently associated with subsequent adverse cardiovascular events., Competing Interests: Funding Support and Author Disclosures This study was funded by a Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (grants 20H03915, 20J01755, and 21K16069) and by an unrestricted research grant from Bayer Yakuhin. Dr Ikemura has received an unrestricted research grant for the Department of Cardiology, Keio University School of Medicine, from Bristol Myers Squibb. Dr Kohsaka has received an unrestricted research grant to the Department of Cardiology at Keio University School of Medicine from Bayer, Novartis, and Daiichi Sankyo; and has received personal fees from Bristol Myers Squibb. Dr Kimura has received grants from Bayer Yakuhin. Dr Takatsuki has received grants and personal fees from Bayer; and has received personal fees from Daiichi Sankyo and Bristol Myers Squibb. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Remote monitoring of pulmonary artery (PA) pressures and serial N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurements guide heart failure (HF) treatment, but their association has yet to be described., Methods and Results: In the Empagliflozin Evaluation by Measuring the Impact on Hemodynamics in Patients with Heart Failure (EMBRACE-HF) trial, patients with HF and a remote PA pressure monitoring device were randomized to empagliflozin vs placebo. PA diastolic pressures (PADP) and NT-proBNP levels were obtained at baseline and 6 and 12 weeks. We used linear mixed models to examine the association between change in PADP and change in NT-proBNP, adjusting for baseline covariates. Of 62 patients, the mean patient age was 66.2 years, and 63% were male. The mean baseline PADP was 21.8 ± 6.4 mm Hg, and the mean NT-proBNP was 1844.6 ± 2767.7 pg/mL. The mean change between baseline and averaged 6- and 12-week PADP was -0.4 ± 3.1 mm Hg, and the mean change between baseline and averaged 6- and 12-week NT-proBNP was -81.5 ± 878.6 pg/mL. In adjusted analyses, every 2-mm Hg decrease in PADP was associated with an NT-proBNP reduction of 108.9 pg/mL (95% confidence interval -4.3 to 222.0, P = .06)., Conclusions: We observed that short-term decreases in ambulatory PADP seem to be associated with decreases in NT-proBNP. This finding may provide additional clinical context when tailoring treatment for patients with HF., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Heart failure (HF) readmission rates are low in some jurisdictions. However, international comparisons are lacking and could serve as a foundation for identifying regional patient management strategies that could be shared to improve outcomes., Objectives: This study sought to summarize 30-day and 1-year all-cause readmission and mortality rates of hospitalized HF patients across countries and to explore potential differences in rates globally., Methods: We performed a systematic review and meta-analysis using MEDLINE, Embase, and CENTRAL for observational reports on hospitalized adult HF patients at risk for readmission or mortality published between January 2010 and March 2021. We conducted a meta-analysis of proportions using a random-effects model, and sources of heterogeneity were evaluated with meta-regression., Results: In total, 24 papers reporting on 30-day and 23 papers on 1-year readmission were included. Of the 1.5 million individuals at risk, 13.2% (95% CI: 10.5%-16.1%) were readmitted within 30 days and 35.7% (95% CI: 27.1%-44.9%) within 1 year. A total of 33 papers reported on 30-day and 45 papers on 1-year mortality. Of the 1.5 million individuals hospitalized for HF, 7.6% (95% CI: 6.1%-9.3%) died within 30 days and 23.3% (95% CI: 20.8%-25.9%) died within 1 year. Substantial variation in risk across countries was unexplained by countries' gross domestic product, proportion of gross domestic product spent on health care, and Gini coefficient., Conclusions: Globally, hospitalized HF patients exhibit high rates of readmission and mortality, and the variability in readmission rates was not explained by health care expenditure, risk of mortality, or comorbidities., Competing Interests: Funding Support and Author Disclosures Dr Lee is the Ted Rogers Chair in Heart Function Outcomes, University Health Network, University of Toronto. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Information about health-related quality of life (HRQOL) among caregivers of older patients with heart failure who receive heart transplantation (HT) and mechanical circulatory support (MCS) is sparse. We describe differences and factors associated with change in HRQOL before and early post-surgery among caregivers of older heart failure patients who underwent 3 surgical therapies: HT with pretransplant MCS (HT MCS), HT without pretransplant MCS (HT non-MCS), and long-term MCS., Methods: Caregivers of older patients (60-80 years) from 13 US sites completed the EQ-5D-3 L visual analog scale (0 [worst]-100 [best] imaginable health state) and dimensions before and 3 and 6 months post-surgery. Analyses included linear regression, t tests, and nonparametric tests., Results: Among 227 caregivers (HT MCS=54, HT non-MCS=76, long-term MCS=97; median age 62.7 years, 30% male, 84% White, 83% spouse/partner), EQ-5D visual analog scale scores were high before (84.8±14.1) and at 3 (84.7±13.0) and 6 (83.9±14.7) months post-surgery, without significant differences among groups or changes over time. Patient pulmonary hypertension presurgery (β=-13.72 [95% CI, -21.07 to -6.36]; P <0.001) and arrhythmia from 3 to 6 months post-operatively (β=-14.22 [95% CI, -27.41 to -1.02]; P =0.035) were associated with the largest decrements in caregiver HRQOL; patient marital/partner status (β=6.21 [95% CI, 1.34-11.08]; P =0.013) and presurgery coronary disease (β=8.98 [95% CI, 4.07-13.89]; P <0.001) were associated with the largest improvements., Conclusions: Caregivers of older patients undergoing heart failure surgeries reported overall high HRQOL before and early post-surgery. Understanding factors associated with caregiver HRQOL may inform decision-making and support needs., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT02568930., Competing Interests: Disclosures Dr Jane received grant support from the American Heart Association and the National Institutes of Health; is a consultant for Amgen, Abbott, Abiomed, and Novartis; and is on the advisory board of Abiomed and Cytokinetics. Dr Kao participated in the advisory board for CareDx and Bioventrix. Dr Spertus is a consultant at Amgen, Novartis, Bayer, Myokardia, and Janssen; on the scientific advisory board of United HealthCare; on the board of directors of BlueCross BlueShield, Kansas City; and is the copyright holder to the Kansas City Cardiomyopathy Questionnaire. Dr Yancy received spousal employment from Abbott Labs Inc. Dr Petty received speaking honorarium from Abbott Inc. M. Murray is a consultant on a research project at GE Healthcare. Dr Silvestry is a consultant at Abiomed, Medtronic, Syncardia, and Abbott. Dr Kirklin is a director of the DCC for STS INTERMACS; and received grant support from the National Institutes of Health/National Institute on Aging. Dr Grady is a consultant at Amgen Inc; is a paid lecturer for the American Heart Association; and received grant support from the National Institutes of Health (National Institute on Aging and National Heart, Lung, and Blood Institute).

Background: Health status outcomes, including symptoms, function, and quality of life, are worse for Black compared with White patients with heart failure. Sodium-glucose cotransporter 2 inhibitors (SGLT2is) reduce cardiovascular mortality and improve health status in patients with heart failure, but whether the health status benefit of SGLT2is is similar across races is not established. The objective of this study was to compare the treatment effect of SGLT2is (versus placebo) on health status for Black compared with White patients with heart failure., Methods: We combined patient-level data from 3 randomized clinical trials of SGLT2is: DEFINE-HF (Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure; n=263), PRESERVED-HF (Dapagliflozin in Preserved Ejection Fraction Heart Failure; n=324), and CHIEF-HF (A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure; n=448). These 3 United States-based trials enrolled a substantial proportion of Black patients, and each used the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure health status at baseline and after 12 weeks of treatment. Among 1035 total participants, selecting self-identified Black and White patients with complete information yielded a final analytic cohort of 935 patients. The primary endpoint was KCCQ Clinical Summary score. Twelve-week change in KCCQ with SGLT2is versus placebo was compared between Black and White patients by testing the interaction between race and treatment using multivariable linear regression models adjusted for trial, baseline KCCQ (as a restricted cubic spline), race, and treatment. The data that support the findings of this study are available from the corresponding author upon reasonable request., Results: Among 935 participants, 236 (25%) self-identified as Black, and 469 (50.2%) were treated with an SGLT2i. Treatment with an SGLT2i, compared with placebo, resulted in KCCQ Clinical Summary score improvements at 12 weeks of +4.0 points (95% CI, 1.7-6.3; P =0.0007) in White patients and +4.7 points (95% CI, 0.7-8.7; P =0.02) in Black patients, with no significant interaction by race and treatment ( P =0.76). Other KCCQ scales showed similar results., Conclusions: Treatment with an SGLT2i resulted in consistent and significant improvements in health status for both Black and White patients with heart failure., Competing Interests: Disclosures Dr Spertus is a principal investigator on grants from the National Institutes of Health (NIH), Abbott Vascular, and the American College of Cardiology Foundation; is a consultant to Janssen, Novartis, Amgen, MyoKardia, AstraZeneca, Bayer, and Merck; serves on the scientific advisory board of United Healthcare and the board of directors for Blue Cross Blue Shield of Kansas City; owns the copyright to the Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and Peripheral Artery Questionnaire; and has an equity interest in Health Outcomes Sciences. Dr Birmingham is an employee of Janssen Scientific Affairs, LLC. Dr Husain has received research grants from AstraZeneca, Merck, and Novo Nordisk and advisory/consultancy fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, and Roche. Dr Kitzman has served as a consultant for Pfizer, Rivus, Corvia Medical, Boehringer-Ingelheim, Novo Nordisk, AstraZeneca, and Novartis; received grant funding from NIH, Pfizer, Novartis, Bayer, Novo Nordisk, and AstraZeneca; and has stock ownership in Gilead Sciences. Dr Pitt consults with AstraZeneca, Bayer, Sanofi Aventis, Vifor, Sarfez, KBP Pharmaceuticals, scPharmaceuticals, and Cereno; has a company relationship with Vifor, Sarfez, KBP Pharmaceuticals, scPharmaceuticals, and Cereno; and holds US patent 9931412 (site-specific delivery of eplerenone to the myocardium). Dr Shah consults with Actelion Clinical Research Inc, Amgen, Aria CV Inc, AstraZeneca, Axon Therapies, Bayer HealthCare Pharmaceuticals Inc, Boehringer Ingelheim, Boston Scientific Corporation, Bristol Myers Squibb, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, GlaxoSmithKline, Intellia Therapeutics, Ionis, Merck Sharp & Dohme Corp, Novartis, Novo Nordisk, Pfizer, Prothena Biosciences Limited, Regeneron Pharmaceuticals, Shifamed LLC/Adona, Tenax Therapeutics, Third Rock Ventures, RIVUS, and Gordian Biotechnology; and has a grant and contract with AstraZeneca, Corvia, Novartis, and Pfizer. Dr Januzzi is a trustee of the American College of Cardiology; is a board member of Imbria Pharmaceuticals; has received research support from Abbott, Applied Therapeutics, Innolife, Novartis Pharmaceuticals, and Roche Diagnostics; has received consulting income from Abbott, Beckman, Bristol Myers, Boehringer Ingelheim, Janssen, Novartis, Pfizer, Merck, Roche Diagnostics, and Siemens; and participates in clinical end point committees/data safety monitoring boards for Abbott, AbbVie, Bayer, CVRx, Intercept, Janssen, and Takeda. Dr Lingvay received research funding (paid to the institution) from Novo Nordisk, Sanofi, Merck, Pfizer, Mylan, and Boehringer-Ingelheim; and advisory/consulting fees or other support from Novo Nordisk, Eli Lilly, Sanofi, AstraZeneca, Boehringer-Ingelheim, Janssen, Intercept, Intarcia, TARGETPharma, Merck, Pfizer, Novartis, GI Dynamics, Mylan, Mannkind, Valeritas, Zealand Pharma, Shionogi, and Bayer. Dr Butler consults with Abbott, Adrenomed, Amgen, Array, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CVRx, G3 Pharmaceutical, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Roche, and Vifor. Dr Kosiborod has received research grants from AstraZeneca and Boehringer Ingelheim; consults for and is on the advisory board of Alnylam, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Eli Lilly, Esperion Therapeutics, Janssen, Lexicon, Merck (Diabetes and Cardiovascular), Novo Nordisk, Pharmacosmos, Sanofi, and Vifor Pharma; and has received other research support from AstraZeneca. Dr Lanfear is supported in part by grants from NIH (P50MD017351 and R01HL132154); has received research funding or support from Amgen, AstraZeneca, Eli Lilly, and SomaLogic; and has acted as consultant to ACI Clinical (Abbott Laboratories), AstraZeneca, Cytokinetics, Duke Clinical Research Institute (CONNECT-HF [Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure]), Illumina, Janssen, Martin Pharmaceuticals, Ortho Clinical Diagnostics, Otsuka, and Vicardia. The other authors report no conflicts.

Background: There has been growing Interest in patient-centered clinical trials using mobile technologies to reduce the need for in-person visits. The CHIEF-HF (Canagliflozin Impact on Health Status, Quality of Life and Functional Status in Heart Failure) trial was designed as a double-blind, randomized, fully decentralized clinical trial (DCT) that identified, consented, treated, and followed participants without any in-person visits. Patient-reported questionnaires were the primary outcome, which were collected by a mobile application. To inform future DCTs, we sought to describe the strategies used in successful trial recruitment., Methods: This article describes the operational structure and novel strategies employed in a completely DCT by summarizing the recruitment, enrollment, engagement, retention, and follow-up processes used in the execution of the trial at 18 centers., Results: A total of 18 sites contacted 130,832 potential participants, of which 2572 (2.0%) opened a hyperlink to the study website, completed a brief survey, and agreed to be contacted for potential inclusion. Of these, 1333 were eligible, and 658 consented; there were 182 screen failures, due primarily to baseline Kansas City Cardiomyopathy Questionnaire scores' not meeting inclusion criteria, resulting in 476 participants' being enrolled (18.5%). There was significant site-level variation in the number of patients invited (median = 2976; range 73-46,920) and in those agreeing to be contacted (median = 2.4%; range 0.05%-16.4%). At the site with the highest enrollment, patients contacted by electronic medical record portal messaging were more likely to opt into the study successfully than those contacted by e-mail alone (7.8% vs 4.4%)., Conclusions: CHIEF-HF used a novel design and operational structure to test the efficacy of a therapeutic treatment, but marked variability across sites and strategies for recruiting participants was observed. This approach may be advantageous for clinical research across a broader range of therapeutic areas, but further optimization of recruitment efforts is warranted., Registration: NCT04252287 https://clinicaltrials.gov/ct2/show/NCT04252287., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Introduction: After left ventricular assist device (LVAD) implantation, caregivers may experience increasing burden because of new roles and responsibilities. We examined the association between caregiver burden at baseline and patient recovery after long-term LVAD implantation in patients ineligible for heart transplantation., Methods: Between October 1, 2015, and December 31, 2018, data from 60 patients with a long-term LVAD (age, 60-80 years) and caregivers through 1 postoperative year were analyzed. Caregiver burden was measured using the Oberst Caregiving Burden Scale, a validated instrument used for measuring caregiver burden. Patient recovery post-LVAD implantation was defined by change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) overall summary score and rehospitalizations over 1 year. Multivariable regression models (least-squares for change in KCCQ-12 and Fine-Gray cumulative incidence for rehospitalizations) were used to assess for association with caregiver burden., Results: Patients were 69.4 ± 5.5 years old, 85% men, and 90% White. Over the first year post-LVAD implantation, there was a 32% cumulative probability of rehospitalization; 72% (43/60) of patients had an improvement of ≥5 points in KCCQ-12 scores. Caregivers were 61.2 ± 11.5 years old, 93% women, 81% White, and 85% married. Median Oberst Caregiving Burden Scale Difficulty and Time scores at baseline were 1.13 and 2.27, respectively. Higher caregiver burden was not significantly associated with hospitalizations or change in patient health-related quality of life during the first year post-LVAD implantation., Conclusions: Higher caregiver burden at baseline was not associated with patient recovery in the first year after LVAD implantation. Understanding the associations between caregiver burden and patient outcomes after LVAD implantation is important as excessive caregiver burden is a relative contraindication for LVAD implantation., Competing Interests: Dr Spertus reports that, relevant to this work, he serves as a consultant for Novartis and owns the copyright to the Kansas City Cardiomyopathy Questionnaire. He also serves as a consultant for Bayer, AstraZeneca, Myokardia, Merck, Amgen, United Healthcare, and Janssen. He has equity in Health Outcomes Sciences and serves on the Board of Directors for Blue Cross-Blue Shield of Kansas City. Dr Grady serves as a consultant to Amgen. The other authors have no conflicts of interest to disclose., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

There are many consequences of heart failure (HF), including symptoms, impaired health-related quality of life (HRQoL), and physical and social limitations (functional status). These have a substantial impact on patients' lives, yet are not routinely captured in clinical trials. Patient-reported outcomes (PROs) can quantify patients' experiences of their disease and its treatment. Steps can be taken to improve the use of PROs in HF trials, in regulatory and payer decisions, and in patient care. Importantly, PRO measures (PROMs) must be developed with involvement of patients, family members, and caregivers from diverse demographic groups and communities. PRO data collection should become more routine not only in clinical trials but also in clinical practice. This may be facilitated by the use of digital tools and interdisciplinary patient advocacy efforts. There is a need for standardization, not only of the PROM instruments, but also in procedures for analysis, interpretation and reporting PRO data. More work needs to be done to determine the degree of change that is important to patients and that is associated with increased risks of clinical events. This 'minimal clinically important difference' requires further research to determine thresholds for different PROMs, to assess consistency across trial populations, and to define standards for improvement that warrant regulatory and reimbursement approvals. PROs are a vital part of patient care and drug development, and more work should be done to ensure that these measures are both reflective of the patient experience and that they are more widely employed., (© 2023 European Society of Cardiology.)

Background: The association between frailty and health status in patients with heart failure with preserved ejection fraction (HFpEF) is not well known., Objectives: The authors examined the association between: 1) patient-reported frailty, measured by the Fried frailty phenotype, Kansas City Cardiomyopathy Questionnaire Physical Limitation Score (KCCQ-PLS), 6-minute walking distance (6MWD), and other baseline characteristics; 2) baseline frailty compared with KCCQ-PLS and 24-week 6MWD; 3) frailty and changes in KCCQ-PLS and 6MWD; and 4) vericiguat and frailty at 24 weeks., Methods: In a post hoc analysis, patients in the VITALITY-HFpEF (Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF) trial were categorized as not frail (0 symptoms), prefrail (1-2 symptoms), and frail (≥3 symptoms) according to patient-reported number of frailty symptoms. Correlations and linear regression models were used to examine the association between frailty and other measures, and between frailty and KCCQ-PLS at baseline with 24-week 6MWD., Results: Among 739 patients, 27.3% were not frail, 37.6% were prefrail, and 35.0% were frail at baseline. Frail patients were older, more likely to be women, and less likely to be from Asia. Baseline KCCQ-PLS and 6MWD (mean ± SD) among not frail, prefrail, and frail patients was 68.2 ± 23.2, 61.7 ± 22.6, and 48.4 ± 23.8 and 328.5 ± 117.1 m, 310.8 ± 98.9 m, and 250.7 ± 104.3 m (P < 0.01 for both). After accounting for baseline 6MWD, frailty status at baseline, but not KCCQ-PLS, was significantly associated with 6MWD at 24 weeks. By 24 weeks, 47.5% of patients had no change in frailty, 45.5% had become less frail, and 7.0% had become more frail. Treatment with vericiguat did not alter frailty status at 24 weeks., Conclusions: Patient-reported frailty is modestly correlated with both the KCCQ-PLS and 6MWD but offers prognostic insight into 6MWD at 24 weeks. (Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF [VITALITY-HFpEF]; NCT03547583)., Competing Interests: Funding Support and Author Disclosures The VITALITY-HFpEF trial was funded by Bayer and Merck Sharp and Dohme Corp, a subsidiary of Merck and Co, Inc. Dr Lam has received research grant support from Bayer, the National Medical Research Council of Singapore, Boston Scientific, Roche Diagnostics, Medtronic, Vifor Pharma, and AstraZeneca; has received consulting fees from Merck, Bayer, Boston Scientific, Roche Diagnostics, Vifor Pharma, AstraZeneca, Novartis, Amgen, Janssen Research and Development LLC, Menarini, Boehringer Ingelheim, Abbott Diagnostics, Corvia, Stealth BioTherapeutics, Novo Nordisk, JanaCare, Biofourmis, Darma, Applied Therapeutics, MyoKardia, Cytokinetics, WebMD Global LLC, Radcliffe Group Ltd, and Corpus; has patent PCT/SG2016/050217 pending and patent 16/216929 pending; and is co-founder and nonexecutive director of eKo.ai. Dr Westerhout has received consulting fees from Bayer Canada. Dr Spertus has received research grant support from the National Institutes of Health, Abbott Vascular, and American College of Cardiology Foundation; has received consulting fees from Janssen, Novartis, Amgen, Myokardia/Bristol Myers Squibb, AstraZeneca, Bayer, and Merck and Co, Inc; has served on the scientific advisory board for United Healthcare; has served on the board of directors for Blue Cross Blue Shield of Kansas City; and owns the copyright to the Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and Peripheral Artery Questionnaire. Dr Anstrom has received research grant support from Merck and Co, Inc, and the National Institutes of Health. Dr Blaustein is an employee of Merck and Co, Inc. Dr Ezekowitz has received research grant support and consulting fees from Bayer, Merck, Servier, Amgen, Sanofi, Novartis, Cytokinetics, American Regent, Otsuka, and Applied Therapeutics. Dr Pieske has received research grant support from Merck Sharp & Dohme, Bayer, and Servier; consulting fees from Merck Sharp & Dohme, Bayer, Servier, Bristol-Myers Squibb, MedScape, Daiichi Sankyo, and Novartis; and nonfinancial support from Merck Sharp & Dohme, Bayer, and Novartis. Dr Roessig is an employee of Bayer AG. Dr Butler has received consulting fees from Abbott, Adrenomed, Amgen, Array, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CVRx, G3 Pharmaceutical, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Roche, and Vifor. Dr Armstrong has received research grant support from Merck, Bayer, Boehringer Ingelheim, Boehringer Ingelheim/Eli Lilly, and CSL Limited; and consulting fees from Merck, Bayer, and Novo Nordisk. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: The purpose of this study is to evaluate potential gender-based differences in interpreting the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and to explore if there are aspects of health-related quality of life (HRQOL) not captured by the KCCQ-23 that are important to assess in men and/or women with heart failure (HF)., Methods: Patients ≥ 22 years of age with clinician-diagnosed HF and left ventricular ejection fraction ≤ 40% were recruited from two academic medical centers to participate in semi-structured concept elicitation and cognitive debriefing interviews. Enrollment was stratified by patient-identified gender (half women/half men). All interviews were conducted over the phone/web and audio recorded. Interviews were transcribed and descriptive qualitative content analysis was used to summarize findings overall and by gender., Results: Twenty-five adults (56% women) diagnosed with HF participated. The average age was 67 years (range: 25-88). Women attributed a wider variety of symptoms to HF than men. Some participants had difficulty differentiating whether their experiences were due to HF, side effects of their medications, or age. We found very little evidence that participants interpreted KCCQ-23 items differently based on gender., Conclusions: Overall, our findings indicate that interpretation of the KCCQ-23 items were similar in men and women. However, some modifications to items may improve clarity of interpretation for a wide range of patients., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

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.

Women diagnosed with heart failure report worse quality of life than men on patient-reported outcome (PRO) measures. An inherent assumption of PRO measures in heart failure is that women and men interpret questions about quality of life the same way. If this is not the case, the risk then becomes that the PRO scores cannot be used for valid comparison or to combine outcomes by subgroups of the population. Inability to compare subgroups validly is a broad issue and has implications for clinical trials, and it also has specific and important implications for identifying and beginning to address health inequities. We describe this threat to validity (the psychometric term is differential item functioning), why it is so important in heart-failure outcomes, the research that has been conducted thus far in this area, the gaps that remain, and what we can do to avoid this threat to validity. PROs bring unique information to clinical decision making, and the validity of PRO measures is key to interpreting differences in heart failure outcomes., Competing Interests: Disclosures JS owns the copyright to the KCCQ and receives license fees for the KCCQ. JS receives consulting fees from Bayer, Merck, Novartis, BMS, Janssen, and United Healthcare. JS is supported in grants from Abbott Vascular, Janssen and Myokardia and is on the Board of Directors for Blue Cross Blue Shield of Kansas City. RM received research support and honoraria from Abbott, American Regent, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim/Eli Lilly, Boston Scientific, Cytokinetics, Fast BioMedical, Gilead, Innolife, Medtronic, Merck, Novartis, Relypsa, Respicardia, Roche, Sanofi, Vifor, and Windtree Therapeutics. TC received research support from Merck and has a consulting agreement with Regenxbio. LL, KW, BR, IP, FB, MT, AS, DH, and BC have no competing interests to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Importance: In the Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction (EMPEROR-Preserved), empagliflozin significantly reduced hospitalizations for heart failure while improving patient-reported health status compared with placebo. The long-term cost-effectiveness of empagliflozin among patients who have heart failure with preserved ejection fraction (HFpEF) remains unclear., Objective: To estimate the cost-effectiveness of empagliflozin in patients with HFpEF., Design, Setting, and Participants: This cost-effectiveness analysis performed from October 2021 to April 2022 included a Markov model using estimates of treatment efficacy, event probabilities, and utilities from EMPEROR-Preserved and published literature. Costs were derived from national surveys and pricing data sets. Quality of life was imputed from a heart failure-specific quality-of-life measure. Two analyses were performed, with and without a treatment effect on cardiovascular mortality. Subgroup analyses were based on diabetes status, ejection fraction, and health status impairment due to heart failure. The model reproduced the event rates and risk reduction with empagliflozin observed in EMPEROR-Preserved over 26 months of follow-up; future projections extended across the lifetime of patients., Exposures: Empagliflozin or standard of care., Main Outcomes and Measures: Hospitalizations for heart failure, life-years, quality-adjusted life-years (QALYs), lifetime costs, and lifetime incremental cost-effectiveness ratio., Results: A total of 5988 patients were included in the analysis, with a mean age of 72 years, New York Heart Association class II to IV heart failure, and left ventricular ejection fraction greater than 40%. At the Federal Supply Schedule price of $327 per month, empagliflozin yielded 0.06 additional QALYs and $26 257 incremental costs compared with standard of care, producing a cost per QALY gained of $437 442. Incremental costs consisted of total drug costs of $29 586 and savings of $3329 from reduced hospitalizations for heart failure. Cost-effectiveness was similar across subgroups. The results were most sensitive to the monthly cost, quality-of-life benefit, and mortality effect of empagliflozin. A price reduction to $153 per month, incremental utility of 0.02, or 8% reduction in cardiovascular mortality would bring empagliflozin to $180 000 per QALY gained, the threshold for intermediate value. Using Medicare Part D monthly pricing of $375 after rebates and $511 before rebates, empagliflozin would remain low value at $509 636 and $710 825 per QALY gained, respectively. Cost-effectiveness estimates were robust to variation in the frequency and disutility of heart failure hospitalizations., Conclusions and Relevance: In this economic evaluation, based on current cost-effectiveness benchmarks, empagliflozin provides low economic value compared with standard of care for HFpEF, largely due to its lack of efficacy on mortality and small benefit on quality of life.

Objective: To determine if health-related quality of life (HRQoL) improvement after cardiac resynchronization therapy (CRT) correlates with improved left-ventricular ejection fraction (EF)., Background: CRT was reported to improve EF and HRQoL in clinical trials of heart failure with reduced EF (HFrEF). It is unknown if improvements in HRQoL reflect EF response to CRT., Methods: We included HFrEF patients who underwent CRT and had both pre- and post-CRT HRQoL assessment. EF response was categorized as absent (0% change or decrease), modest (0%-19% increase), or significant ( > 20% increase). We examined the associations between EF response and generic (PROMIS) and HF-specific (KCCQ-12) HRQoL., Results: The group included 115 patients with mean age of 65 years and baseline EF of 31%; 39% were female (n = 45). Nineteen percent (n = 22) had significant, 57% (n = 66) modest, and 23% (n = 27) absent EF responses. AF burden across significant (8.9%), modest (4.8%), and absent EF responders (1.4%) was similar ( P = 0.20). Significant improvements in KCCQ-12 (43.4-57.5, P = 0.003), current health visual analog scale (49.1-55.9, P = 0.042), PROMIS fatigue (58.9-55.1, P = 0.026), and PROMIS satisfaction (42.7-46.4, P = 0.020) resulted following CRT across all groups. There was no association between significant EF improvement and HRQoL by KCCQ-12 (nonresponse, 44.4%; modest response, 33.3%; and significant response, 22.2%) at 1 year ( P = 0.52 across all groups)., Conclusion: CRT was associated with a modest to significant EF response in a majority of patients. However, EF response did not significantly correlate with generic or HF-specific HRQoL measures. Further investigations are warranted into determinants of improved HRQoL following CRT., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background Although aldosterone antagonists improve outcomes in select individuals with heart failure and reduced ejection fraction, studies in the United States have raised concerns about underuse and overuse. Variations in the prescription of aldosterone antagonist in China are unknown. Methods and Results In the multicenter, hospital-based, retrospective China PEACE (China Patient-Centered Evaluative Assessment of Cardiac Events) study, we identified a nationally representative cohort of admissions for heart failure in a nationally representative sample of Chinese hospitals in 2015. Patients were classified into 1 of 3 groups according to their eligibility for spironolactone-"ideal" (left ventricular ejection fraction <40% and without contraindications), "contraindicated" (a documented contraindication, irrespective of left ventricular ejection fraction), and "uncertain-benefit" (all others). We measured hospital variation of spironolactone prescriptions at discharge in the "ideal" and "contraindicated" group and calculated the median odds ratio (MOR), a measure of institution-level variation for 2 individuals with similar characteristics discharged at 2 randomly selected hospitals. Hospital characteristics associated with spironolactone use were identified using multivariable linear regression model. Among 1222 ideal patients from 97 hospitals, the median rate of spironolactone prescription was 78.6% (interquartile range [IQR], 42.8%-89.6% [range, 0%-100%], MOR, 3.4 [95% CI, 2.7-4.0]) at discharge. Among 900 contraindicated patients from 83 hospitals, the median rate of spironolactone prescription was 30.0% (IQR, 9.1%-50.0% [range, 0%-100%], MOR, 3.1 [95% CI, 2.4-3.9]) at discharge. Hospitals with independent departments of cardiology and located in Eastern China were associated with a 38.0% (95% CI, 18.7-57.3; P <0.001) and a 14.6% (95% CI, 2.3%-26.9%; P =0.020) higher rate of spironolactone use for ideal patients. Conclusions In this national study of hospitals in China, the use of spironolactone among ideal patients and the inappropriate use of spironolactone among patients with contraindications was substantial, with rates that varied markedly by institution. Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT02877914.

Background: Restoring health-related quality of life (HRQOL) is a therapeutic goal for older patients with advanced heart failure. We aimed to describe change in HRQOL in older patients (60-80 years) awaiting heart transplantation (HT) with or without pretransplant mechanical circulatory support (MCS) or scheduled for long-term MCS, if ineligible for HT, from before to 6 months after these surgeries and identify factors associated with change., Methods: Patients from 13 US sites completed the EuroQol 5-dimension 3L questionnaire and Kansas City Cardiomyopathy Questionnaire-12 at baseline and 3 and 6 months after HT or long-term MCS. Analyses included univariate comparisons and multivariable linear regression., Results: Among 305 participants (cohort mean age=66.2±4.7 years, 78% male, 84% White, 55% New York Heart Association class IV), 161 underwent HT (n=68 with and n=93 without pretransplant MCS), and 144 received long-term MCS. From baseline to 3 months, EuroQol 5-dimension visual analog scale scores improved in HT patients without pretransplant MCS (54.5±24.3 versus 75.9±16.0, P <0.001) and long-term MCS patients (45.7±22.9 versus 66.2± 20.9, P <0.001); while Kansas City Cardiomyopathy Questionnaire-12 overall summary scores improved in all 3 groups (HT without pretransplant MCS: 47.2±20.9 versus 77.4±20.1, P <0.001; long-term MCS: 35.3±20.2 versus 58.6±22.0, P <0.001; and HT with pretransplant MCS: 58.3±23.6 versus 72.1±23.5, P =0.002). No further HRQOL improvement was found from 3 to 6 months. Factors most significantly associated with change in HRQOL, baseline 3 months, were right heart failure and 3-month New York Heart Association class, and 3 to 6 months, were 6-month New York Heart Association class and major bleeding., Conclusions: In older heart failure patients, HRQOL improved from before to early after HT and long-term MCS. At 6 postoperative months, HRQOL of long-term MCS patients was lower than one or both HT groups. Understanding change in HRQOL from before to early after these surgeries may enhance decision-making and guide patient care., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT02568930.

Background: The primary goal for treating patients with obstructive hypertrophic cardiomyopathy (oHCM) is to improve their symptoms, function, and quality of life. Although the Kansas City Cardiomyopathy Questionnaire (KCCQ) is a valid, reliable, and sensitive measure for other etiologies of heart failure, its appropriateness for patients with oHCM is unknown., Objectives: The purpose of this study was to establish the interpretability, validity, reliability, and responsiveness of the KCCQ in patients with oHCM., Methods: Cognitive debriefing of the KCCQ was performed in 26 patients with oHCM. The validity, reliability, responsiveness, and interpretability of the KCCQ were tested in 196 participants from the EXPLORER-HCM trial by comparing each scale with relevant comparators, describing the internal reliability and the mean change in stable patients, and comparing the mean change in patients who reported different degrees of clinical change using a patient-reported global impression of change (PGIC)., Results: All KCCQ domains demonstrated strong correlations with external standards of symptoms, function, social limitation, and quality of life, including a recently designed instrument measuring symptoms not captured by the KCCQ (P < 0.0001 for all). Mean changes in stable patients were nonsignificant, ranging from 0.21 to 2.3 points (P > 0.30 for all), with high intraclass correlation coefficients. The mean changes in patients with small, moderate, and large clinical changes were consistent with the 5-, 10-, and 20-point mean differences observed in other etiologies of heart failure., Conclusions: The KCCQ is well understood by patients with oHCM and has strong evidence of good psychometric performance. It can not only serve as a relevant endpoint in clinical trials of oHCM therapy, but may also prove useful in the clinical care of patients with oHCM. (Clinical Study to Evaluate Mavacamten [MYK-461] in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy [EXPLORER-HCM]; NCT03470545)., Competing Interests: Funding Support and Author Disclosures This study was funded by MyoKardia, Inc, a wholly owned subsidiary of Bristol Myers Squibb. Dr Nassif has served as consultant to Amgen, Roche, and Vifor. Drs Fine and Sehnert are employees of and have stock and stock options in MyoKardia, Inc. Dr Dolan has served as a consultant to MyoKardia, Inc, Genentech, Gilead Sciences, Puma Biotechnologies, Regenexbio, Elekta, Global Blood Therapeutics, Lyell Immunopharma, and Coagulant Therapeutics. Drs Reaney, Addepalli, and Allen are employees of IQVIAIqvia. Dr Spertus has served as a consultant to MyoKardia, Inc, Bristol Myers Squibb, Bayer, Amgen, Merck, Pfizer, Novartis, Janssen, and United Healthcare; owns the copyright to the KCCQ, SAQ, and PAQ; and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. Ms Gosch has reported that she has no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Aims: Recovery of well-being after hospitalisation for acute heart failure (AHF) is a measure of the success of interventions and the quality of care but has rarely been quantified. Accordingly, we measured health status after discharge in an international registry (REPORT-HF) of AHF., Methods and Results: The analysis included 4606 patients with AHF who survived to hospital discharge, had known vital status at 6 months, and were enrolled in the United States of America, Russian Federation, or Western Europe, where the Kansas City Cardiomyopathy Questionnaire (KCCQ) was administered. Median age was 69 years (quartiles 59-78), 40% were women, and 34% had a left ventricular ejection fraction (LVEF) <40%, and 12% patients died by 6 months. Of 2475 patients with a follow-up KCCQ, 28% were 'alive and well' (KCCQ >75), while 43% had poor health status (KCCQ ≤50). Being 'alive and well' was associated with new-onset AHF, LVEF <40%, younger age, higher baseline KCCQ, country, and race. Associations were similar for increasing health status, with the exception of country and addition of comorbidities., Conclusion: In this international global registry, health status recovery after AHF hospitalisation was highly variable. Those with the best health status at 6 months were younger, had new-onset heart failure, and higher baseline KCCQ; nearly one-third of survivors were 'alive and well'. Investigating reasons for changes in KCCQ after hospitalisation might identify new therapeutic targets to improve patient-centred outcomes., (© 2022 European Society of Cardiology.)

Background: We examined the effects of vericiguat compared with placebo in patients with heart failure with reduced ejection fraction enrolled in VICTORIA (Vericiguat Global Study in Patients With Heart Failure With Reduced Ejection Fraction) on health status outcomes measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and evaluated whether clinical outcomes varied by baseline KCCQ score., Methods: KCCQ was completed at baseline and 4, 16, and 32 weeks. We assessed treatment effect on KCCQ using a mixed-effects model adjusting for baseline KCCQ and stratification variables. Cox proportional-hazards modeling was performed to evaluate the effect of vericiguat on clinical outcomes by tertiles of baseline KCCQ clinical summary score (CSS), total symptom score (TSS), and overall summary score (OSS)., Results: Of 5050 patients, 4664, 4741, and 4470 had KCCQ CSS (median [25th to 75th], 65.6 [45.8-81.8]), TSS (68.8 [47.9-85.4]), and OSS (59.9 [42.0-77.1]) at baseline; 94%, 88%, and 82% had data at 4, 16, and 32 weeks. At 16 weeks, CSS improved by a median of 6.3 in both arms; no significant differences in improvement were seen for TSS and OSS between the 2 groups ( P =0.69, 0.97, and 0.13 for CSS, TSS, and OSS). Trends were similar at 4 and 32 weeks. Vericiguat versus placebo reduced cardiovascular death or heart failure hospitalization risk similarly across tertiles of baseline KCCQ CSS, TSS, and OSS (interaction P =0.13, 0.21, and 0.65)., Conclusions: Vericiguat did not significantly improve KCCQ scores compared with placebo. Vericiguat reduced the risk of cardiovascular death or heart failure hospitalization across the range of baseline health status., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT02861534.

Aims: Clinically important thresholds in patient-reported outcomes measures like the Kansas City Cardiomyopathy Questionnaire (KCCQ) have not been defined for patients with heart failure and preserved ejection fraction (HFpEF). The aim of this study was to estimate meaningful thresholds for improvement or worsening in the KCCQ physical limitation score (PLS) in patients with HFpEF., Methods and Results: In this pre-specified analysis from VITALITY-HFpEF, anchor- and distribution-based approaches were used to estimate thresholds for improvement or worsening in the KCCQ-PLS using Patient Global Impression of Change (PGIC) as an anchor. The KCCQ-PLS contains six elements, with each increment in response resulting in a change of 4.17 points when converted to a 0-100 scale. The mean change in KCCQ-PLS from baseline to week 12 was calculated for each PGIC group to estimate a meaningful within-patient change. Of 789 patients enrolled, 698 had complete KCCQ-PLS and PGIC data at week 12. The mean (± standard deviation) changes in KCCQ-PLS corresponding to PGIC changes of 'a little better', 'better', and 'much better' were 5.7 ± 18.6, 11.6 ± 19.3, and 18.4 ± 25.3 points, respectively. The scores of patients who responded 'a little better' (n = 177) overlapped substantially with those who reported 'no change' (n = 193; mean change 2.8 ± 18.9). The mean change in KCCQ-PLS for patients responding 'a little worse' (n = 32) was -2.6 ± 18.0 points. The threshold for meaningful within-patient change in KCCQ-PLS based on distribution-based analyses was 12.3 points. Using area under the curve (AUC) analyses of KCCQ-PLS, the sensitivity and specificity of a 4.17-point change were 0.61 and 0.57, for an 8.33-point change they were 0.49 and 0.64, and for a 12.5-point change they were 0.44 and 0.72 for being at least a little better on the PGIC (AUC = 0.54)., Conclusion: In the VITALITY-HFpEF trial, a change in KCCQ-PLS of ≥8.33 points (corresponding to an improvement in ≥2 response categories of KCCQ-PLS) may represent the minimal clinically important difference for improvement and a change of ≤ -4.17 points (corresponding to a worsening in ≥1 response category of KCCQ-PLS) may suggest deterioration in patients with HFpEF., (© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Aims: We assessed for an association between improvements in left ventricular ejection fraction (LVEF) and future outcomes, including health status, in routine clinical practice., Methods and Results: CHAMP-HF was a registry of outpatients with heart failure (HF) and LVEF ≤40%. Enrolled participants completed the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at regular intervals and were followed as part of routine care. We assessed for associations between improvements in LVEF (≥10%) over time and concurrent changes in KCCQ-12, as well as the subsequent risk of poor outcomes. We included 2092 participants in the study. They had the following characteristics: median age 67 years (25th-75th percentile 58-75), 29% female, median duration of HF 2.7 years (0.6-6.8), and median baseline LVEF 30% (23-35). Of the study participants, 689 (33%) had a ≥10% absolute improvement in LVEF. Participants with an LVEF improvement also had an improvement in KCCQ-12 overall summary score compared with participants without an LVEF improvement (+7.6 vs. +3.5, adjusted effect estimate +4.01 [95% confidence interval CI 2.3-5.7]). Similarly, subsequent all-cause death or HF hospitalization occurred in 12% in the LVEF improvement group versus 25% in the group without an LVEF improvement (adjusted hazard ratio 0.50, 95% confidence interval 0.41-0.61)., Conclusion: In a large cohort of outpatients with chronic HF, improvements in LVEF were associated with improved health status and a reduced risk for future clinical events. These data underscore the importance of improvement in LVEF as a treatment target for medical interventions for patients with chronic HF., (© 2022 European Society of Cardiology.)

Large traditional clinical trials suggest that sodium-glucose co-transporter 2 inhibitors improve symptoms in patients with heart failure and reduced ejection fraction (HFrEF) and in patients with heart failure and preserved ejection fraction (HFpEF). In the midst of the Coronavirus Disease 2019 pandemic, we sought to confirm these benefits in a new type of trial that was patient centered and conducted in a completely remote fashion. In the CHIEF-HF trial ( NCT04252287 ), 476 participants with HF, regardless of EF or diabetes status, were randomized to 100 mg of canagliflozin or placebo. Enrollment was stopped early due to shifting sponsor priorities, without unblinding. The primary outcome was change in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at 12 weeks. The 12-week change in KCCQ TSS was 4.3 points (95% confidence interval, 0.8-7.8; P = 0.016) higher with canagliflozin than with placebo, meeting the primary endpoint. Similar effects were observed in participants with HFpEF and in those with HFrEF and in participants with and without diabetes, demonstrating that canagliflozin significantly improves symptom burden in HF, regardless of EF or diabetes status. This randomized, double-blind trial, conducted without in-person interactions between doctor and patient, can serve as a model for future all-virtual clinical trials., (© 2022. The Author(s).)

Background: The comparative effectiveness of differing dosages of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) on clinical and patient-reported outcomes in clinical practice in the United States is unknown. This study sought to characterize associations between the dosing of GDMT and outcomes for patients with HFrEF in U.S. clinical practice., Methods: This analysis included 4832 outpatients who had chronic HFrEF across 150 practices in the U.S. in the Change the Management of Patients with Heart Failure (CHAMP-HF) registry with no contraindication and available dosing data for at least 1 GDMT at baseline. Baseline dosing of angiotensin-converting enzyme (ACEI)/angiotensin II receptor blocker (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), beta-blocker, and mineralocorticoid receptor antagonist (MRA) therapies were examined. For each medication class, multivariable models assessed associations between medication dosing and clinical outcomes over 24 months (all-cause mortality, HF hospitalization) and patient-reported outcomes at 12 months (change in the Kansas City Cardiomyopathy Questionnaire Overall Summary score [KCCQ-OS])., Results: After adjustment, compared with target dosing, lower dosing was associated with higher all-cause mortality for ACEIs/ARBs/ARNIs (50% to < 100% target dosage, HR 1.16 [95% CI 0.87-1.55]; < 50% target dosage, HR 1.37 [95% CI 1.05-1.79]; none, HR 1.75 [95% CI 1.32-2.34; overall P< 0.001) and beta-blockers (50% to < 100% target dosage, HR 1.30 [95% CI 1.00-1.69]; < 50% target dosage, HR 1.41 [95% CI 1.11-1.79; none, HR 1.24 [95% CI 0.92-1.67]; overall P= 0.042). Lower dosing of ACEIs/ARBs/ARNIs was independently associated with higher risk of HF hospitalization (50% to < 100% target dosage, HR 1.08 [95% CI 0.90-1.30]; < 50% target dosage, HR 1.23 [1.04-1.47]; none, HR 1.29 [1.04-1.60]; overall P= 0.046), but beta-blocker dosing was not (overall P= 0.085). Target dosing of MRAs was not associated with risk of mortality or HF hospitalization. For each GDMT, compared with target dosing, lower dosing was not associated with change in the KCCQ-OS at 12 months, with the potential exception of worsening KCCQ-OS scores with lower dosing of ACEIs/ARBs/ARNIs., Conclusions: In this contemporary U.S. outpatient HFrEF registry, target dosing of ACEI/ARB/ARNI and beta-blocker therapy was associated with reduced mortality and was variably associated with HF hospitalization and patient-reported outcomes. MRA dosing was not associated with outcomes. The totality of these findings support the benefits of target dosing of GDMT in routine practice, as tolerated, with unmeasured differences among patients receiving differing dosages potentially explaining the differing results seen here compared with randomized clinical trials., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background There is a paucity of research describing health-related quality of life (HRQOL) in older adults considered for advanced heart failure surgical therapies. Using data from our SUSTAIN-IT (Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support) study, we aimed to compare HRQOL among 3 groups of older (60-80 years) patients with heart failure before heart transplantation (HT) or long-term mechanical circulatory support (MCS) and identify factors associated with HRQOL: (1) HT candidates with MCS, (2) HT candidates without MCS, or (3) candidates ineligible for HT and scheduled for long-term MCS. Methods and Results Patients from 13 US sites completed assessments, including self-reported measures of HRQOL (EuroQol-5 Dimension Questionnaire, Kansas City Cardiomyopathy Questionnaire-12), depressive symptoms (Personal Health Questionnaire-8), anxiety (State-Trait Anxiety Inventory-state form), cognitive status (Montreal Cognitive Assessment), and performance-based measures (6-minute walk test and 5-m gait speed). Analyses included ANOVA, χ 2 tests, Fisher's exact tests, and linear regression. The sample included 393 patients; the majority of patients were White men and married. Long-term MCS candidates (n=154) were significantly older and had more comorbidities and a higher New York Heart Association class than HT candidates with MCS (n=118) and HT candidates without MCS (n=121). Long-term MCS candidates had worse HRQOL than HT candidates with and without MCS (EQ-5D visual analog scale scores, 46±23 versus 68±18 versus 54±23 [ P <0.001] and Kansas City Cardiomyopathy Questionnaire-12 overall summary scores, 35±21 versus 60±21 versus 49±22 [ P <0.001], respectively). In multivariable analyses, lower 6-minute walk distance, higher New York Heart Association class, depressive symptoms, and not being an HT candidate with MCS were significantly associated with worse overall HRQOL. Conclusions Our findings demonstrate important differences in overall and domain-specific HRQOL of older patients with heart failure before HT or long-term MCS. Understanding HRQOL differences may guide decisions toward more appropriate and personalized advanced heart failure therapies.

Background: Clinical practice guidelines support sustained use of renin-angiotensin-aldosterone-system (RAAS) inhibitors over time in heart failure with reduced ejection fraction, yet few data are available regarding the frequency, timing or predictors of early treatment discontinuation in clinical practice., Methods: Among prevalent or new users of angiotensin-converting enzyme inhibitors (ACEis)/angiotensin receptor blockers (ARBs), angiotensin receptor-neprilysin inhibitors (ARNIs), and mineralocorticoid receptor antagonists (MRAs) in the CHAMP-HF (Change the Management of Patients with Heart Failure) registry, we estimated the frequency and independent predictors of treatment discontinuation during follow-up. Among sites with > 5 users of a given RAAS inhibitor, we evaluated practice variation in the proportion of patients with treatment discontinuation., Results: Over median follow-up of 18 months, frequency of drug discontinuation of ACEis/ARBs, ARNIs and MRAs was 12.7% (444 of 3509 users), 10.4% (140 of 1352 users), and 20.4% (435 of 2129 users), respectively. An additional, 149 (11.0%) of ARNI users were switched to ACEis/ARBs, and 447 (12.7%) of ACEi/ARB users were switched to ARNIs during follow-up. Across sites, the median proportion of discontinuation of ACEis/ARBs, ARNIs and MRAs was 12.5% (25th-75th percentiles 6.9%-18.9%), 18.8% (25th-75th percentiles 12.5%-28.6%), and 19.6% (25th-75th percentiles 10.7%-27.0%), respectively. Chronic kidney disease was the only independent predictor of increased risk of discontinuation of each of the RAAS inhibitor classes (P < 0.02 for all). Higher Kansas City Cardiomyopathy Questionnaire overall summary scores independently predicted lower risk of discontinuation of ACEis/ARBs and ARNIs (both P < 0.001) but not of MRAs. Investigator clinical experience was predictive of lower risks of discontinuation of ACEis/ARBs and MRAs (P < 0.02) but not of ARNIs. All other independent predictors of discontinuation were unique to individual therapeutic classes., Conclusions: One in 10 patients discontinue ACEis/ARBs or ARNIs, and 1 in 5 discontinue MRAs in routine clinical practice of heart failure with reduced ejection fraction. Unique patient-level and clinician/practice-level factors are associated with premature discontinuation of individual RAAS inhibitors, which may help to guide structured efforts to promote treatment persistence in clinical care., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Aims: We aimed to develop a risk prediction tool that incorporated both clinical events and worsening health status for patients with heart failure (HF) with reduced ejection fraction (HFrEF). Identifying patients with HFrEF at increased risk of a poor outcome may enable proactive interventions that improve outcomes., Methods and Results: We used data from a longitudinal HF registry, CHAMP-HF, to develop a risk prediction tool for poor outcomes over the next 6 months. A poor outcome was defined as death, an HF hospitalization, or a ≥20-point decrease (or decrease below 25) in 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) overall summary score. Among 4546 patients in CHAMP-HF, 1066 (23%) experienced a poor outcome within 6 months (1.3% death, 11% HF hospitalization, and 11% change in KCCQ-12). The model demonstrated moderate discrimination (c-index = 0.65) and excellent calibration with observed data. The following variables were associated with a poor outcome: age, race, education, New York Heart Association class, baseline KCCQ-12, atrial fibrillation, coronary disease, diabetes, chronic kidney disease, smoking, prior HF hospitalization, and systolic blood pressure. We also created a simplified model with a 0-10 score using six variables (New York Heart Association class, KCCQ-12, coronary disease, chronic kidney disease, prior HF hospitalization, and systolic blood pressure) with similar discrimination (c-index = 0.63). Patients scoring 0-3 were considered low risk (event rate <20%), 4-6 were considered intermediate risk (event rate 20-40%), and 7-10 were considered high risk (event rate >40%)., Conclusions: The PROMPT-HF risk model can identify outpatients with HFrEF at increased risk of poor outcomes, including clinical events and health status deterioration. With further validation, this model may help inform therapeutic decision making., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Atrial fibrillation (AF) frequently complicates heart failure (HF), and each is associated with lower overall health-related quality of life. We aimed to quantify the incremental burden of AF on the health-related quality of life of patients with HF in clinical practice., Methods and Results: We used data from the Utah mEVAL program to analyze patient-reported outcomes (PROs) among patients with HF with and without AF. The primary outcome was the HF-specific Kansas City Cardiomyopathy Questionnaire, with generic PROs as secondary outcomes. Among 1707 patients with HF, 36% had AF (n = 616). Those with HF and AF were older (mean age 69 years vs 58 years, P < .001), more likely to have prior stroke (29% vs 17%, P < .001) and ischemic cardiomyopathy (28% vs 23%, P = .01), but had similar ejection fractions (mean 44% each, P = .6). After adjustment, and compared with HF alone, HF with AF was associated with worse Kansas City Cardiomyopathy Questionnaire scores (adjusted mean difference -3.45, 95% confidence interval [CI] -6.24 to -0.65), and worse Patient-Reported Outcomes Measurement Information System physical function scores (adjusted mean difference -1.63, 95% CI -2.59 to -0.67). The difference in visual analog scale general health was borderline (adjusted mean difference -2.01, 95% CI -4.51 to 0.49), and Patient-Reported Outcomes Measurement Information System depression scores were similar (adjusted mean difference 0.54, 95% CI -0.48 to 1.57)., Conclusions: AF complicates nearly one-third of HF cases, and patients with HF and AF are substantially older and sicker. After adjustment, AF was independently associated with worse disease-specific and overall health-related quality of life than HF alone. Whether maintaining sinus rhythm can improve the HF-related health status of patients with HF in clinical practice should be explored further., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine whether the increased use of telehealth was associated with a difference in outcomes for outpatients with heart failure., Background: The COVID-19 pandemic led to dramatic changes in the delivery of outpatient care. It is unclear whether increased use of telehealth affected outcomes for outpatients with heart failure., Methods: In March 2020, a large Midwestern health care system, encompassing 16 cardiology clinics, 16 emergency departments, and 12 hospitals, initiated a telehealth-based model for outpatient care in the setting of the COVID-19 pandemic. A propensity-matched analysis was performed to compare outcomes between outpatients seen in-person in 2018 and 2019 and via telemedicine in 2020., Results: Among 8,263 unique patients with heart failure with 15,421 clinic visits seen from March 15 to June 15, telehealth was employed in 88.5% of 2020 visits but in none in 2018 or 2019. Despite the pandemic, more outpatients were seen in 2020 (n = 5,224) versus 2018 and 2019 (n = 5,099 per year). Using propensity matching, 4,541 telehealth visits in 2020 were compared with 4,541 in-person visits in 2018 and 2019, and groups were well matched. Mortality was similar for telehealth and in-person visits at both 30 days (0.8% vs 0.7%) and 90 days (2.9% vs 2.4%). Likewise, there was no excess in hospital encounters or need for intensive care with telehealth visits., Conclusions: A telehealth model for outpatients with heart failure allowed for distanced encounters without increases in subsequent acute care or mortality. As the pressures of the COVID-19 pandemic abate, these data suggest that telehealth outpatient visits in patients with heart failure can be safely incorporated into clinical practice., Competing Interests: Funding Support and Author Disclosures Dr Spertus is the principal investigator of grants from National Institutes of Health, Abbott Vascular, and the American College of Cardiology Foundation; is a consultant to Janssen, Novartis, Amgen, Myokardia, AstraZeneca, Bayer, and Merck; serves on the Scientific Advisory Board of United Healthcare and the Board of Directors for Blue Cross Blue Shield of Kansas City; owns the copyright to the Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and Peripheral Artery Questionnaire; and has an equity interest in Health Outcomes Sciences. Dr Sperry is a consultant to Pfizer and Alnylam. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study investigated an enriched cohort of patients with heart failure and preserved ejection fraction (HFpEF) in TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) with an echocardiographic phenotype of cardiac amyloidosis., Background: There is a high prevalence of increased interventricular septal (IVS) thickness and decreased mitral annular systolic (s') velocity in cardiac amyloidosis. In addition, clinical trials of neurohormonal blockade are missing in this population., Methods: TOPCAT randomized patients with HFpEF to spironolactone or placebo therapy with a primary endpoint of cardiovascular death, HF hospitalization, or aborted cardiac arrest. Patients with IVS and s' velocity measurements were included, and adjusted Cox models assessed the effect of echocardiographic variables and spironolactone on the primary endpoint., Results: Among 590 patients, mean s' velocity was 6.4 ± 2.1 cm/s and IVS thickness was 1.2 ± 0.2 cm. The enriched cohort with characteristics of cardiac amyloidosis (s' velocity ≤6 cm/s and IVS thickness ≥1.2 cm) included 135 patients (23% of the cohort). After a median follow-up of 2.6 years (1.5-3.9 years), these patients had the worst prognosis (adjusted HR: 2.10; 95% CI: 1.26-3.50; P = 0.004). Both s' velocity and IVS thickness were individually associated with the primary endpoint, and abnormalities in these parameters were additive as lower s' velocity was particularly prognostic in those with greater IVS thickness (interaction: P = 0.013). Spironolactone was associated with improved outcomes in the overall cohort (P = 0.024), and patients in the enriched cohort had a benefit similar to that in other groups (interaction: P = 0.382)., Conclusions: An enriched subset of patients with structural and functional echocardiographic features of cardiac amyloidosis had the worst prognosis in the TOPCAT study, but they benefitted similarly from spironolactone therapy. Future studies of mineralocorticoid receptor antagonists in patients with cardiac amyloidosis are warranted., Competing Interests: Funding Support and Author Disclosures Dr Shah is supported by U.S. National Institutes of Health research grants R01 HL107577, R01 HL127028, R01 HL140731, and R01 HL149423; has received research grants from Actelion, AstraZeneca, Corvia, Novartis, and Pfizer; and is a consultant for Abbott, Actelion, AstraZeneca, Amgen, Axon Therapies, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardiora, CVRx, Cytokinetics, Eidos, Eisai, GlaxoSmithKline, Ionis, Ironwood, Lilly, Merck, MyoKardia, Novartis, Novo Nordisk, Pfizer, Prothena, Sanofi, Shifamed, Tenax, and United Therapeutics. Dr Sperry is a consultant for Alnylam and Pfizer; and has received research funding from Pfizer. Dr Hanna has served on advisory boards for Alnylam, Eidos, AKCEA, and Pfizer. Dr Spertus is a consultant for Janssen, Bayer, Myokardia, Novartis, Merck Amgen, and United Healthcare and he is a member of the Board of Directors of Blue Cross Blue Shield of Kansas City; and owns the copyrights to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Diuretics are a mainstay therapy for the symptomatic treatment of heart failure. However, in contemporary US outpatient practice, the degree to which diuretic dosing changes over time and the associations with clinical outcomes and health care resource utilization are unknown., Methods: Among 3426 US outpatients with chronic heart failure with reduced ejection fraction in the Change the Management of Patients with Heart Failure registry with complete medication data and who were prescribed a loop diuretic, diuretic dose increase was defined as: (1) change to a total daily dose higher than their previous total daily dose, (2) addition of metolazone to the regimen, (3) change from furosemide to either bumetanide or torsemide, and the change persists for at least 7 days. Adjusted hazard ratios or rate ratios along with 95% CIs were reported for clinical outcomes among patients with an increase in oral diuretic dose versus no increase in diuretic dose., Results: Overall, 796 (23%) had a diuretic dose increase (18 episodes per 100 patient-years). The proportion of patients with dyspnea at rest (38% versus 26%), dyspnea at exertion (79% versus 67%), orthopnea (32% versus 21%), edema (60% versus 43%), and weight gain (40% versus 23%) were significantly (all P <0.001) higher in the diuretic increase group. Baseline angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (hazard ratio, 0.75 [95% CI, 0.65-0.87]) use were associated with lower likelihood of diuretic increase over time. Patients with a diuretic dose increase had a significantly higher number of heart failure hospitalizations (rate ratio, 2.53 [95% CI, 2.10-3.05]), emergency department visits (rate ratio, 1.84 [95% CI, 1.56-2.17]), and home health visits (rate ratio, 1.88 [95% CI, 1.39-2.54]), but not all-cause mortality (hazard ratio, 1.10 [95% CI, 0.89-1.36]). Similarly, greater furosemide dose equivalent increases were associated with greater resource utilization but not with mortality, compared with smaller increases., Conclusions: In this contemporary US registry, 1 in 4 patients with heart failure with reduced ejection fraction had outpatient escalation of diuretic therapy over longitudinal follow-up, and these patients were more likely to have sign/symptoms of congestion. Outpatient diuretic dose escalation of any magnitude was associated with heart failure hospitalizations and resource utilization, but not all-cause mortality.

Background: We conducted a secondary analysis of changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 over 30 days in a randomized trial of self-care coaching versus structured usual care in patients with acute heart failure who were discharged from the emergency department., Methods: Patients in 15 emergency departments completed the KCCQ-12 at emergency department discharge and at 30 days. We compared change in KCCQ-12 scores between the intervention and usual care arms, adjusted for enrollment KCCQ-12 and demographic characteristics. We used linear regression to describe changes in KCCQ-12 summary scores and logistic regression to characterize clinically meaningful KCCQ-12 subdomain changes at 30 days., Results: There were 350 patients with both enrollment and 30-day KCCQ summary scores available; 166 allocated to usual care and 184 to the intervention arm. Median age was 64 years (interquartile range, 55-70), 37% were female participants, 63% were Black, median KCCQ-12 summary score at enrollment was 47 (interquartile range, 33-64). Self-care coaching resulted in significantly greater improvement in health status compared with structured usual care (5.4-point greater improvement, 95% CI, 1.12-9.68; P =0.01). Improvements in health status in the intervention arm were driven by improvements within the symptom frequency (adjusted odds ratio, 1.62 [95% CI, 1.01-2.59]) and quality of life (adjusted odds ratio, 2.39 [95% CI, 1.46-3.90]) subdomains., Conclusions: In this secondary analysis, patients with acute heart failure who received a tailored, self-care intervention after emergency department discharge had clinically significant improvements in health status at 30 days compared with structured usual care largely due to improvements within the symptom frequency and quality of life subdomains of the KCCQ-12. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02519283.

Background: Health status outcomes are increasingly being promoted as measures of health care quality, given their importance to patients. In heart failure (HF), an American College of Cardiology/American Heart Association Task Force proposed using the proportion of patients with preserved health status as a quality measure but not as a performance measure because risk adjustment methods were not available., Methods: We built risk adjustment models for alive with preserved health status and for preserved health status alone in a prospective registry of outpatients with HF with reduced ejection fraction across 146 US centers between December 2015 and October 2017. Preserved health status was defined as not having a ≥5-point decrease in the Kansas City Cardiomyopathy Questionnaire Overall Summary score at 1 year. Using only patient-level characteristics, hierarchical multivariable logistic regression models were developed for 1-year outcomes and validated using data from 1 to 2 years. We examined model calibration, discrimination, and variability in sites' unadjusted and adjusted rates., Results: Among 3932 participants (median age [interquartile range] 68 years [59-75], 29.7% female, 75.4% White), 2703 (68.7%) were alive with preserved health status, 902 (22.9%) were alive without preserved health status, and 327 (8.3%) had died by 1 year. The final risk adjustment model for alive with preserved health status included baseline Kansas City Cardiomyopathy Questionnaire Overall Summary, age, race, employment status, annual income, body mass index, depression, atrial fibrillation, renal function, number of hospitalizations in the past 1 year, and duration of HF (optimism-corrected C statistic=0.62 with excellent calibration). Similar results were observed when deaths were ignored. The risk standardized proportion of patients alive with preserved health status across the 146 sites ranged from 62% at the 10th percentile to 75% at the 90th percentile. Variability across sites was modest and changed minimally with risk adjustment., Conclusions: Through leveraging data from a large, outpatient, observational registry, we identified key factors to risk adjust sites' proportions of patients with preserved health status. These data lay the foundation for building quality measures that quantify treatment outcomes from patients' perspectives.

Aims: While myocardial ischaemia plays a major role in the pathogenesis of heart failure (HF), the indications for coronary angiography during acute HF are not established. We determined the association of early coronary angiography during acute HF hospitalization with 2-year mortality, cardiovascular death, HF readmissions, and coronary revascularization., Methods and Results: In a two-stage sampling process, we identified acute HF patients who presented to 70 emergency departments in Ontario (April 2010 to March 2013) and determined whether they underwent early coronary angiography within 14 days after presentation using administrative databases. After clinical record review, we defined a cohort with acute ischaemic HF as patients with at least one factor suggesting underlying ischaemic heart disease, including previous myocardial infarction, troponin elevation, or angina on presentation. We oversampled patients undergoing angiography. We used inverse-probability-of-treatment weighting (IPTW) to adjust for baseline differences. Of 7239 patients with acute HF, 2994 met inclusion criteria [median age 75 (interquartile range 65-83) years; 40.9% women]. Early angiography was performed in 1567 patients (52.3%) and was associated with lower all-cause mortality [hazard ratio (HR) 0.74, 95% confidence interval (CI) 0.61-0.90, P = 0.002], cardiovascular death (HR 0.72, 95% CI 0.56-0.93, P = 0.012), and HF readmissions (HR 0.84, 95% CI 0.71-0.99, P = 0.042) after IPTW. Those undergoing early angiography experienced higher rates of percutaneous coronary intervention (HR 2.58, 95% CI 1.73-3.86, P < 0.001) and coronary artery bypass grafting (HR 2.94, 95% CI 1.75-4.93, P < 0.001) within 2 years., Conclusions: Early coronary angiography was associated with lower all-cause mortality, cardiovascular death, HF readmissions, and higher rates of coronary revascularization in acute HF patients with possible ischaemia., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)