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Background: U.S. nationwide estimates of the proportion of patients newly diagnosed with heart failure with reduced ejection fraction (HFrEF) eligible for quadruple medical therapy, and the associated benefits of rapid implementation, are not well characterized., Objectives: This study sought to characterize the degree to which patients newly diagnosed with HFrEF are eligible for quadruple medical therapy, and the projected benefits of in-hospital initiation., Methods: Among patients hospitalized for newly diagnosed HFrEF in the Get With The Guidelines-Heart Failure registry from 2016 to 2023, eligibility criteria based on regulatory labeling, guidelines, and expert consensus documents were applied for angiotensin receptor-neprilysin inhibitor, beta-blocker, mineralocorticoid receptor antagonist, and sodium-glucose cotransporter 2 inhibitor therapies. Of those eligible, the projected effect of quadruple therapy on 12-month mortality was modeled using treatment effects from pivotal clinical trials utilized by the AHA/ACC/HFSA Guideline for the Management of Heart Failure, and compared with observed outcomes among patients treated with angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and beta-blockers., Results: Of 33,036 patients newly diagnosed with HFrEF, 27,158 (82%) were eligible for quadruple therapy, and 30,613 (93%) were eligible for ≥3 components. From 2021 to 2023, of patients eligible for quadruple therapy, 15.3% were prescribed quadruple therapy and 41.5% were prescribed triple therapy. Among Medicare beneficiaries eligible for quadruple therapy, 12-month incidence of mortality was 24.7% and HF hospitalization was 22.2%. Applying the relative risk reductions in clinical trials, complete implementation of quadruple therapy by time of discharge was projected to yield absolute risk reductions in 12-month mortality of 10.4% (number needed to treat = 10) compared with angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and beta-blocker, and 24.8% (number needed to treat = 4) compared with no GDMT., Conclusions: In this nationwide U.S. cohort of patients hospitalized for newly diagnosed HFrEF, >4 of 5 patients were projected as eligible for quadruple therapy at discharge; yet, <1 in 6 were prescribed it. If clinical trial benefits can be fully realized, in-hospital initiation of quadruple medical therapy for newly diagnosed HFrEF would yield large absolute reductions in mortality., Competing Interests: Funding Support and Author Disclosures The Get With The Guidelines–Heart Failure (GWTG-HF) program is provided by the American Heart Association and sponsored, in part, by Novartis, Boehringer Ingelheim, and Eli Lilly Diabetes Alliance, Novo Nordisk, Sanofi, AstraZeneca, and Bayer. Dr Greene has received research support from the Duke University Department of Medicine Chair’s Research Award, American Heart Association, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cytokinetics, Merck, Novartis, Pfizer, and Sanofi; has served on advisory boards or as consultant for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Corteria Pharmaceuticals, CSL Vifor, Cytokinetics, Eli Lilly, Lexicon, Merck, Roche Diagnostics, Sanofi, scPharmaceuticals, Tricog Health, and Urovant Pharmaceuticals; and has received speaker fees from Bayer, Boehringer Ingelheim, Cytokinetics, Lexicon, and Roche Diagnostics. Dr Fonarow has consulted for Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Eli Lilly, Johnson and Johnson, Medtronic, Merck, Novartis, and Pfizer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Patient-reported outcome (PRO) measures of distinct concepts are often put together into patient profile assessments. When brief, profile assessments can decrease respondent burden and increase measure completion rates. In this report, we describe the creation of 5 self-reported 4-item short forms and the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) 20-item profile to assess PROs specific to adjustment and health-related quality of life (HRQOL) among patients who undergo left ventricular assist device (LVAD) implantation., Methods: Using a cross-sectional sample of patients (n = 620) who underwent LVAD implantation at 12 U.S. sites or participated in the MyLVAD.com support group, we created 5 4-item short forms: Satisfaction with Treatment, ventricular assist device (VAD) Team Communication, Being Bothered by VAD Self-care and Limitations, Self-efficacy Regarding VAD self-care, and Stigma, which we combined into a 20-item profile. Analyses included intercorrelations among measures, Cronbach's alpha (i.e., internal consistency reliability)/score-level-specific reliability, and construct validity., Results: The 620 patients were mean age = 57 years, 78% male, 70% White, and 56% on destination therapy LVADs. Intercorrelations among the 5 4-item measures were low to moderate (≤0.50), indicating they are associated yet largely distinct, and correlations with calibrated measures and 6-item short forms were ≥0.76, indicating their ability to reflect full-item bank scores. Internal consistency reliability for the 5 4-item short forms ranged from acceptable (≥0.70) to good (≥0.80). Construct validity was demonstrated for these measures., Conclusions: Our 5 4-item short forms are reliable and valid and may be used individually or together as a 20-item profile to assess adjustment and HRQOL in patients who undergo LVAD implantation., Competing Interests: Disclosure statement Kathleen L. Grady, PhD, RN – NIH Grants (NIA and NHLBI) and payment of room reservation by NIH as faculty at the Ten-day Seminar; lecturer (registration fees paid for meeting: Heart Failure Society of America, American Heart Association, International Society for Heart and Lung Transplantation, and American College of Cardiology); leadership or fiduciary role (ISHLT Board of Directors, Foundation Board, Research Oversight Committee, Governance Committee, Leadership Advisory Forum, and chair, Grants and Awards Committee). Michael Kallen, PhD – Deceased; ICMJE Disclosure Form not completed. Larry A. Allen, MD, MHS – Grant from PCORI and NIH; Consultant for ACI Clinical, Boston Scientific, Cytokinetics, Novartis, UpToDate, and Quidel. JoAnn Lindenfeld, MD –Consulting fees from Abbott, Alleviant, Axon, Astra Zenaca, Boston Scientific, CVRx, Merck, Medtronic, VWave, Edwards Lifesciences, Whiteswell, and Vascular Dynamicx. Colleen K. McIlvennan, PhD, DNP, ANP – Grant from PCORI and Cambia Health Foundation; HFSA Board of Directors. Christopher S. Lee, PhD, RN – DSMB chair: COMBAT-DS; US Department of Health and Human Services: National Advisory Council (member). Josef Stehlik, MD – Grants from Natera and Merck and consulting for Medtronic, Natera, and TransMedics. James K. Kirklin, MD – Intellectual properties for IT software development in registry database design developed at and licensed from the University of Alabama at Birmingham; chair of DSMB for Xeltis cardiac conduit clinical trial, chair of DSMB for Carmat TAH clinical trial, chair XVIVO Clinical Safety Monitoring Board; President World Society for Pediatric and Congenital Heart Surgery; common stock in Kirklin Solutions Co. Database development and analytics (20% ownership; $3.75 per share; current market value $700,000); partial salary support as Director of the Data Center for STS Intermacs/Pedimacs (no payments for any of these roles related to this publication). Jeffrey Teuteberg, MD – Consultant for Abbott, CareDx, Medtronic and Takeda; Lecturer for CareDx, Cytokinetics, Medtronic, and Paragonix. Eric Adler, MD – Grants from Lexeo Therapeutics, Rocket Pharmaceuticals, and California Institute for Regenerative Medicines; Royalties or licenses from Lexeo Therapeutics, Rocket Pharmaceuticals, and Papillion Therapeutics; consulting fees from Abiomed, Norvartis, Abbott, Ionis, Kiniska, Sana, Medtronic, and Cytokinetics; payment for expert testimony on behalf of Astro Zeneca; patents planned, issued or pending: Method for treating Danon disease and other disorders of autophagy and ex vivo genetic modification of hematopoietic cells for the treatment of Danon Disease; participation on DSMB: Edwards Lifesciences, Ancora Heart, and Corstasis Therapeutics; leadership or fiduciary role: Chief Science Officer for Lexeo Therapeutics, Scientific Advisory Board for Sarnoff Foundation, and Board of Directors for Papillion Therapeutics; stock or stock options: Rocket Pharmaceuticals, Lexeo Therapeutics, Corstasis Therapeutics, and Papillion Therapeutics. Michael Kiernan, MD – Steering Committee: Medtronic and Endotronix. The other authors have no conflicts of interest to disclose. Michael Kallen, PhD, MPH, coauthor and statistician/psychometrician for MCS A-QOL and this paper, passed away on July 27, 2023. His contributions to this manuscript were substantial and his passion for the development of patient-reported outcome measures was inspiring. He was a kind and gentle person who is genuinely missed by Beth Hahn, my co-PI on MCS A-QOL, and me. Words cannot adequately express our deep sense of gratitude and loss. This work was sponsored by the National Institutes of Health, National Heart Lung and Blood Institute (NHLBI), Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL, [R01HL130502], Grady K.L. and Hahn E.A. [co-PIs])., (Copyright © 2024. Published by Elsevier Inc.)

Background: People with heart failure (HF) and cancer experience impaired physical and mental health status. However, health-related quality of life (HRQOL) has not been directly compared between these conditions in a contemporary population of older people., Objectives: The authors sought to compare HRQOL in people with HF vs those with lung, colorectal, breast, and prostate cancers., Methods: The authors performed a pooled analysis of Medicare Health Outcomes Survey data from 2016 to 2020 in participants ≥65 years of age with a self-reported history of HF or active treatment for lung, colon, breast, or prostate cancer. They used the Veterans RAND-12 physical component score (PCS) and mental component score (MCS), which range from 0-100 with a mean score of 50 (based on the U.S. general population) and an SD of 10. The authors used pairwise Student's t-tests to evaluate for differences in PCS and MCS between groups., Results: Among participants with HF (n = 71,025; 54% female, 16% Black), mean PCS was 29.5 and mean MCS 47.9. Mean PCS was lower in people with HF compared with lung (31.2; n = 4,165), colorectal (35.6; n = 4,270), breast (37.7; n = 14,542), and prostate (39.6; n = 17,670) cancer (all P < 0.001). Participants with HF had a significantly lower mean MCS than those with lung (31.2), colon (50.0), breast (52.0), and prostate (53.0) cancer (all P < 0.001)., Conclusions: People with HF experience worse HRQOL than those with cancer actively receiving treatment. The pervasiveness of low HRQOL in HF underscores the need to implement evidence-based interventions that target physical and mental health status and scale multidisciplinary clinics., Competing Interests: Funding Support and Author Disclosures Dr Ahmad was supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute (K23HL155970) and the American Heart Association (856917). 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.)

Persons with heart failure (HF) often suffer from poor symptom control, decreased quality of life, and poor communication with their health care providers. These needs are particularly acute in advanced HF, a leading cause of death in the United States. Palliative care, when offered alongside HF disease management, offers improved symptom control, quality of life, communication, and caregiver satisfaction as well as reduced caregiver anxiety. The dynamic nature of the clinical trajectory of HF presents distinct symptom patterns, changing functional status, and uncertainty, which requires an adaptive, dynamic model of palliative care delivery. Due to a limited specialty-trained palliative care workforce, patients and their caregivers often cannot access these benefits, especially in the community. To meet these needs, new models are required that are better informed by high-quality data, engage a range of health care providers in primary palliative care principles, and have clear triggers for specialty palliative care engagement, with specific palliative interventions tailored to patient's illness trajectory and changing needs., Competing Interests: Funding Support and Author Disclosures Dr Gelfman has received support from the Claude D. Pepper Older Americans Independence Center at the Icahn School of Medicine at Mount Sinai (5P30AG028741) and the Sojourns Scholars Leadership Award from the Cambia Health Foundation. Dr Ogunniyi has received institutional research support grants from AstraZeneca, Boehringer Ingelheim, Cardurion Pharmaceuticals, and Pfizer, outside of the submitted work. Dr Kavalieratos has served as a member of the Board of Directors of the American Academy of Hospice and Palliative Medicine. Dr Allen has received research funding from the National Institutes of Health and Patient-Centered Outcomes Research Institute; and has received consulting fees from ACI Clinical, American Heart Association, Boston Scientific, Cytokinetics, Medscape, Novartis, Quidel, and UpToDate. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background: Individuals with acute decompensated heart failure (ADHF) have a varying response to diuretic therapy. Strategies for the early identification of low diuretic efficiency to inform decongestion therapies are lacking., Objectives: The authors sought to develop and externally validate a machine learning-based phenomapping approach and integer-based diuresis score to identify patients with low diuretic efficiency., Methods: Participants with ADHF from ROSE-AHF, CARRESS-HF, and ATHENA-HF were pooled in the derivation cohort (n = 794). Multivariable finite-mixture model-based phenomapping was performed to identify phenogroups based on diuretic efficiency (urine output over the first 72 hours per total intravenous furosemide equivalent loop diuretic dose). Phenogroups were externally validated in other pooled ADHF trials (DOSE/ESCAPE). An integer-based diuresis score (BAN-ADHF score: blood urea nitrogen, creatinine, natriuretic peptide levels, atrial fibrillation, diastolic blood pressure, hypertension and home diuretic, and heart failure hospitalization) was developed and validated based on predictors of the diuretic efficiency phenogroups to estimate the probability of low diuretic efficiency using the pooled ADHF trials described earlier. The associations of the BAN-ADHF score with markers and symptoms of congestion, length of stay, in-hospital mortality, and global well-being were assessed using adjusted regression models., Results: Clustering identified 3 phenogroups based on diuretic efficiency: phenogroup 1 (n = 370; 47%) had lower diuretic efficiency (median: 13.1 mL/mg; Q1-Q3: 7.7-19.4 mL/mg) than phenogroups 2 (n = 290; 37%) and 3 (n = 134; 17%) (median: 17.8 mL/mg; Q1-Q3: 10.8-26.1 mL/mg and median: 35.3 mL/mg; Q1-Q3: 17.5-49.0 mL/mg, respectively) (P < 0.001). The median urine output difference in response to 80 mg intravenous twice-daily furosemide between the lowest and highest diuretic efficiency group (phenogroup 1 vs 3) was 3,520 mL/d. The BAN-ADHF score demonstrated good model performance for predicting the lowest diuretic efficiency phenogroup membership (C-index: 0.92 in DOSE/ESCAPE validation cohort) that was superior to measures of kidney function (creatinine or blood urea nitrogen), natriuretic peptide levels, or home diuretic dose (DeLong P < 0.001 for all). Net urine output in response to 80 mg intravenous twice-daily furosemide among patients with a low vs high (5 vs 20) BAN-ADHF score was 2,650 vs 660 mL per 24 hours, respectively. Participants with higher BAN-ADHF scores had significantly lower global well-being, higher natriuretic peptide levels on discharge, a longer in-hospital stay, and a higher risk of in-hospital mortality in both derivation and validation cohorts., Conclusions: The authors developed and validated a phenomapping strategy and diuresis score for individuals with ADHF and differential response to diuretic therapy, which was associated with length of stay and mortality., Competing Interests: Funding Support and Author Disclosures Dr Pandey has received research support from the National Institute of Health (5R01MD017529, R21HL169708) and grant funding from Applied Therapeutics and Gilead Sciences; has received honoraria outside of the present study as an advisor/consultant for Tricog Health Inc, Lilly USA, Rivus, Cytokinetics, Roche Diagnostics, Axon Therapies, Medtronic, Edward Lifesciences, Science37, Novo Nordisk, Bayer, Merck, Sarfez Pharmaceuticals, and Emmi Solutions; has received nonfinancial support from Pfizer and Merck; and is also a consultant for Palomarin Inc with stock compensation. Dr Segar has received honoraria from Merck. Dr Patel has served as a consultant to Novo Nordisk. Dr Fonarow has done consulting for Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Janssen, Medtronic, Merck, and Novartis. Dr Mentz has 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, Windtree Therapeutics, and Zoll. Dr Allen reports grant funding from American Heart Association, National Institutes of Health, and PCORI; and consulting fees from Amgen, Boston Scientific, Cytokinetics, Novartis, and WCG ACI Clinical. Dr Pandey has received grant funding from Applied Therapeutics and Gilead Sciences; has received honoraria outside of the present study as an advisor/consultant for Tricog Health Inc, Lilly USA, Rivus, Cytokinetics, Bayer, Edwards Lifesciences, Medtronic, Sarfez Pharmacuticals, Novo Nordisk, and Roche Diagnostics; has received support from Pfizer and Merck; and is a consultant for Palomarin Inc with stock compensation. Dr Khan serves as an advisory board member for Bayer. 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: Patients with heart failure with reduced ejection fraction (HFrEF) have persistent impairments in functional capacity after continuous-flow left ventricular assist device (CF-LVAD) implantation., Objectives: This study aims to characterize longitudinal changes in exercise hemodynamics and functional capacity among patients with HFrEF before and after CF-LVAD implantation., Methods: Ten patients underwent 3 invasive cardiopulmonary exercise tests on upright cycle ergometry with pulmonary artery catheterization: 1) Visit 1 before CF-LVAD implantation; 2) Visit 2 after device implantation with CF-LVAD pump speed held constant at baseline speed; and 3) Visit 3 with increases in pump speed during exercise (median: 1,050 rpm [IQR: 750-1,150 rpm] and 220 rpm [IQR: 120-220 rpm] for HeartMate 3 and HeartWare VAD, respectively). Hemodynamics and direct Fick cardiac output were monitored using pulmonary artery catheterization. Gas exchange metrics were determined using indirect calorimetry., Results: Maximal oxygen uptake (Visits 1, 2, and 3: 10.8 ± 2.5 mL/kg/min, 10.7 ± 2.2 mL/kg/min, and 11.5 ± 1.7 mL/kg/min; P = 0.92) did not improve after device implantation. Mean pulmonary arterial and pulmonary capillary wedge pressures increased significantly during submaximal and peak exercise on preimplantation testing (P < 0.01 for rest vs peak exercise) and remained elevated, with minimal change on Visits 2 and 3 regardless of whether pump speed was fixed or increased., Conclusions: Among patients with HFrEF, cardiovascular hemodynamics and exercise capacity were similar after CF-LVAD implantation, regardless of whether patients exercised at fixed or adjusted pump speeds during exercise. Further research is needed to determine methods by which LVADs may alleviate the HFrEF syndrome after device implantation. (Effect of mechanIcal circulatoRy support ON exercise capacity aMong pAtieNts with heart failure [IRONMAN]; NCT03078972)., Competing Interests: Funding Support and Author Disclosures Dr Cornwell has received funding by an National Institutes of Health/National Heart, Lung and Blood Institute Mentored Patient-Oriented Research Career Development Award (#1K23HLI32048-01), as well as the National Institutes of Health/National Center for Advancing Translational Sciences (#UL1TR002535), the Clinical Translational Science Institute at the University of Colorado Anschutz Medical Campus, and Medtronic Inc. Dr Allen has received consulting fees from Boston Scientific, Medtronic, Abbott, ACI Clinical, Amgen, Cytokinetics, and Novartis. Dr Cornwell has received research funding from Merck Corp and Medtronic Inc; and is a consultant for Merck Corp, Medtronic Inc, and Bioventrix Inc. All other author 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: Generic and heart failure-specific measures do not capture unique aspects of living with a ventricular assist device (VAD). Using state-of-the-science psychometric measurement methods, we developed a measurement system to assess post-ventricular assist device adjustment and health-related quality of life (HRQOL)., Methods: Patients were recruited from 10/26/16-2/29/20 from 12 U.S. VAD programs. We created a dataset of participants (n = 620) enrolled before left (L)VAD implantation, with data at 3- or 6- months post-implantation (group1 [n = 154]), and participants enrolled after LVAD implantation, with data at one timepoint (group 2 [n = 466]). We constructed 5 item banks: 3 modified from existing measures and 2 new measures. Analyses included item response theory (IRT) modeling, differential item functioning tests for systematic measurement bias, and indicators of reliability and validity., Results: Of 620 participants, 56% (n = 345) were implanted as destination therapy, 51% (n = 316) were <12 months post-implantation, mean age = 57.3 years, 78% (n = 485) male, 70% (n = 433) White, 58% (n = 353) married/partnered, and 58% (n = 357) with >high school education. We developed 5 new VAD item banks/measures: 6-item VAD Team Communication; 12-item Self-efficacy Regarding VAD Self-care; 11-item Being Bothered by VAD Self-care and Limitations; 7-item Satisfaction with Treatment; and 11-item Stigma. Cronbach's alpha reliability ranged from good (≥0.80) to excellent (≥0.90) for item banks/measures. All measures, except VAD Team Communication, demonstrated at least moderate correlations (≥0.30) with construct validity indicators., Conclusions: These measures meet IRT modeling assumptions and requirements; scores demonstrate reliability and validity. Use of these measures may assist VAD clinicians to inform patients about VADs as a treatment option and guide post-VAD interventions., (Copyright © 2023 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Treatment of heart failure with reduced ejection fraction (HFrEF) has benefitted from a proliferation of new medications and devices. These treatments carry important clinical benefits, but also come with costs relevant to payers, providers, and patients. Patient out-of-pocket costs have been implicated in the avoidance of medical care, nonadherence to medications, and the exacerbation of health care disparities. In the absence of major health care policy and payment redesign, high-quality HFrEF care delivery requires transparent integration of cost considerations into system design, patient-clinician interactions, and medical decision making., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The contribution of clinical inertia to suboptimal guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) remains unclear., Objectives: This study examined reasons for GDMT nonintensification and characterized clinical inertia., Methods: In this secondary analysis of EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction), a randomized clinical trial evaluating a patient-activation tool on GDMT utilization, we performed a sequential, explanatory mixed-methods study. Reasons for nonintensification among 4 medication classes were assigned according to an expanded published taxonomy using structured chart reviews. Audio transcripts of clinic encounters were analyzed to further characterize nonintensification reasons. Integration occurred during the interpretation phase., Results: Among 292 HFrEF patients who completed a cardiology visit, 185 (63.4%) experienced no treatment intensification, of whom 90 (48.6%) had at least 1 opportunity for intensification of a medication class with no documented contraindication or barriers (ie, clinical inertia). Nonintensification reasons varied by medication class, and included heightened risk of adverse effects (range 18.2%-31.6%), patient nonadherence (range 0.8%-1.1%), patient preferences and beliefs (range 0.6%-0.9%), comanagement with other providers (range 4.6%-5.6%), prioritization of other issues (range 15.6%-31.8%), multiple categories (range 16.5%-22.7%), and clinical inertia (range 22.7%-31.6%). A qualitative analysis of 32 clinic audio recordings demonstrated common characteristics of clinical inertia: 1) clinician review of medication regimens without education or intensification discussions; 2) patient stability as justification for nonintensification; and 3) shorter encounters for nonintensification vs intensification., Conclusions: In this comprehensive study exploring HFrEF prescribing, clinical inertia is a main contributor to nonintensification within an updated taxonomy classification for suboptimal GDMT prescribing. This approach should help target strategies overcoming GDMT underuse., Competing Interests: Funding Support and Author Disclosures This project/publication is supported in part by National Institutes of Health/NCATS Colorado CTSA Grant Number UL1 TR002535. Contents are the authors’ sole responsibility and do not necessarily represent official National Institutes of Health views. Dr Swat has received funding from the National Institutes of Health T32 Training Grant 5T32-HL-007822-22. Dr Allen has received grant funding from the American Heart Association, National Institutes of Health, and Patient-Centered Outcomes Research Institute; and has received consulting fees from Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, Novartis, Quidel, and UpToDate. 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: Initiation of evidence-based medications for patients with heart failure with reduced ejection fraction (HFrEF) during hospitalization in contemporary practice is unknown., Objectives: This study characterized opportunities for and achievement of heart failure (HF) medication initiation., Methods: Using the GWTG-HF (Get With The Guidelines-Heart Failure) Registry 2017-2020, which collected data on contraindications and prescribing for 7 evidence-based HF-related medications, we assessed the number of medications for which each patient with HFrEF was eligible, use before admission, and prescribed at discharge. Multivariable logistic regression identified factors associated with medication initiation., Results: Among 50,170 patients from 160 sites, patients were eligible for mean number of 3.9 ± 1.1 evidence-based medications with 2.1 ± 1.3 used before admission and 3.0 ± 1.0 prescribed on discharge. The number of patients receiving all indicated medications increased from admission (14.9%) to discharge (32.8%), a mean net gain of 0.9 ± 1.3 medications over a mean of 5.6 ± 5.3 days. In multivariable analysis, factors associated with lower odds of HF medication initiation included older age, female sex, medical pre-existing conditions (stroke, peripheral arterial disease, pulmonary disease, and renal insufficiency), and rural location. Odds of medication initiation increased during the study period (adjusted OR: 1.08; 95% CI: 1.06-1.10)., Conclusions: Nearly 1 in 6 patients received all indicated HF-related medications on admission, increasing to 1 in 3 on discharge with an average of 1 new medication initiation. Opportunities to initiate evidence-based medications persist, particularly among women, those with comorbidities, and those receiving care at rural hospitals., Competing Interests: Funding Support and Author Disclosures Dr Swat has received funding from the National Institutes of Health (NIH) T32 Training Grant 5T32-HL-007822-22. The GWTG-HF (Get With The Guidelines–Heart Failure) program is provided by the American Heart Association. GWTG-HF is sponsored, in part, by Novartis, Boehringer Ingelheim, Novo Nordisk, AstraZeneca, Bayer, Tylenol, and Alnylam Pharmaceuticals. Dr Allen has received grant funding from American Heart Association (AHA), NIH, and Patient-Centered Outcomes Research Institute (PCORI); and has received consulting fees from Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis. Dr Greene has received research support from the Duke University Department of Medicine Chair’s Research Award, American Heart Association, Amgen, AstraZeneca, Bristol Myers Squibb, Cytokinetics, Merck, Novartis, Pfizer, and Sanofi; has served on advisory boards for Amgen, AstraZeneca, Bristol Myers Squibb, Cytokinetics, Roche Diagnostics, and Sanofi; has received speaker fees from Boehringer Ingelheim; and has served as a consultant for Amgen, Bayer, Bristol Myers Squibb, Merck, PharmaIN, Roche Diagnostics, Sanofi, Urovant Pharmaceuticals, and Vifor. Dr DeVore has received research funding through his institution from the American Heart Association, Amgen, Biofourmis, Bodyport, Cytokinetics, American Regent Inc, the National Heart, Lung, and Blood Institute (NHLBI), and Novartis; he has also provided consulting services for and/or received honoraria from Abiomed, Amgen, AstraZeneca, Cardionomic, InnaMed, LivaNova, Natera, Novartis, Procyrion, Story Health, Vifor, and Zoll; he has also received nonfinancial support from Abbott for educational and research activities. Dr Peterson is supported by the NHLBI of the NIH under Award Number R33HL143324. Dr Fonarow has consulted for Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Edwards, Janssen, Medtronic, Merck, and Novartis. Dr Hess is supported by VA Career Development Award HX002621 and American Heart Association Career Development Award 19CDA34760126. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background: Guidelines recommend incorporation of caregiver burden assessment and list significant caregiver burden as a relative contraindication when considering left-ventricular assist device (LVAD) implantation., Methods: To assess national practices regarding caregiver burden assessment, in 2019 we administered a 47-item survey to LVAD clinicians using 4 convenience samples., Results: Responses were obtained from 191 registered nurses, 109 advance practice providers, 71 physicians, 59 social workers, and 40 others representing 132 LVAD programs; 125 of 173 total United States programs were included in the final analysis. While most programs (83.2%) assessed caregiver burden, assessment was most frequently conducted informally during social work evaluation (83.2%), with only 8.8% incorporating validated measures of caregiver burden. Larger programs were more likely to use a validated assessment measure (OR 6.68 [1.33-33.52])., Conclusions: Future research should focus on how programs can standardize caregiver burden assessment and how the level of burden may impact patient and caregiver outcomes., Competing Interests: Disclosure statement Dr. Allen reports grant funding from AHA, NIH, PCORI; and consulting fees from Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis The remaining authors report no significant conflicts., (Copyright © 2023 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: In January 2021, vericiguat, a soluble guanylate cyclase stimulator, was approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of cardiovascular death and heart failure (HF) hospitalization among patients with a recent worsening HF event based on the VICTORIA (VerICiguaT Global Study in Subjects with Heart Failure with Reduced Ejection Fraction) trial., Objectives: This study sought to leverage a contemporary U.S. registry of patients hospitalized for heart failure (HF) to characterize patients who may be candidates for vericiguat based on FDA label and the VICTORIA trial eligibility criteria., Methods: The authors studied patients hospitalized for HF with ejection fraction (EF) <45% across 525 sites in the GWTG-HF (Get With The Guidelines-Heart Failure) registry between January 2014 and December 2020. Approximate FDA label criteria (excluding estimated glomerular filtration rate [eGFR] <15 mL/min/1.73 m 2 , dialysis, or patients with heart transplantation or durable mechanical circulatory support) and eligibility criteria for the VICTORIA trial were applied to the GWTG-HF cohort., Results: Among 241,057 patients with EF <45% in the GWTG-HF registry, 221,730 (92%) could be candidates for vericiguat under the FDA label and 92,249 (38%) would have been eligible for the VICTORIA trial. The most frequent reasons for ineligibility for the FDA label were eGFR <15 mL/min/1.73 m 2 (5.7%) and dialysis (1.6%). Although there were greater proportions of women and Black patients in the GWTG-HF registry, most clinical characteristics were qualitatively similar with patients enrolled in the VICTORIA trial. Among Medicare beneficiaries in the GWTG-HF registry eligible for vericiguat by either FDA label or VICTORIA trial criteria, 12-month postdischarge rates of mortality (36%-37%), HF hospitalization (33%-35%), all-cause hospitalization (64%-66%), and mean health care expenditure (U.S. $25,106-$25,428) were high., Conclusions: Data from a large, contemporary U.S. registry of patients actively hospitalized for HF with EF <45% suggest that approximately 4 in 10 patients meet the criteria of the VICTORIA trial and that more than 9 in 10 patients are potential candidates for vericiguat based on the FDA label. Contemporary Medicare beneficiaries hospitalized for HF with EF <45% and eligible for vericiguat face high rates of postdischarge mortality and readmission and accrue substantial health care costs., Competing Interests: Funding Support and Author Disclosures This study was supported by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc (Rahway, New Jersey, USA). The Get With The Guidelines–Heart Failure program is provided by the American Heart Association and sponsored, in part, by Novartis, Boehringer Ingelheim and Eli Lilly Diabetes Alliance, Novo Nordisk, Sanofi, AstraZeneca, and Bayer. Dr Fonarow has served as a consultant for Abbott, Amgen, AstraZeneca, Bayer, Cytokinetics, Janssen, Medtronic, Merck Sharp & Dohme LLC (a subsidiary of Merck & Co, Inc), and Novartis. Drs Lautsch and Hilkert are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc. Dr Allen has received grant support from the National Institutes of Health and Patient-Centered Outcomes Research Institute; and has received consulting fees from ACI Clinical, American Heart Association, Boston Scientific, Cytokinetics, Novartis, and UpToDate. Dr Albert has received grant support from Novartis and AstraZeneca; and consulting fees from Boston Scientific, Boehringer Ingelheim/Lilly, Cytokinetics, and Merck Sharp & Dohme LLC (a subsidiary of Merck & Co, Inc). Dr Butler has served as a consultant for Abbott, Adrenomed, Arena Pharma, Array, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Cardior, CVRx, Eli Lilly, G3 Pharma, Imbria, Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck Sharp & Dohme LLC (a subsidiary of Merck & Co, Inc), Novartis, Novo Nordisk, Sequana Medical, V-Wave Limited, and Vifor. Dr Greene has received research support from the Duke University Department of Medicine Chair’s Research Award, American Heart Association (#929502), National Heart, Lung, and Blood Institute, Amgen, AstraZeneca, Bristol Myers Squibb, Cytokinetics, Merck Sharp & Dohme LLC (a subsidiary of Merck & Co, Inc), Novartis, Pfizer, and Sanofi; served on the advisory board for Amgen, AstraZeneca, Boehringer Ingelheim/Lilly, Bristol Myers Squibb, Cytokinetics, Roche Diagnostics, scPharmaceuticals, and Sanofi; and served as a consultant for Amgen, Bayer, Boehringer Ingelheim/Lilly, Bristol Myers Squibb, CSL Vifor, Corteria Therapeutics, Merck Sharp & Dohme LLC (a subsidiary of Merck & Co, Inc), PharmaIN, Roche Diagnostics, Sanofi, Tricog Health, and Urovant Pharmaceuticals; and has received speaker fees from Boehringer Ingelheim and Cytokinetics. 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.)

Understanding patients' preferred roles in medical decision making (i.e., passive, collaborative, active) is important to personalized care and patient engagement. Patient control preferences have been described for many treatment decisions, but their stability over time has not been characterized, particularly for major medical events with long-term implications. We prospectively surveyed 233 patients at the initiation of evaluation for a left ventricular assist device, and 1 and 6 months later, including collection of the Control Preferences Scale. Collaborative and active preferences were most common initially, followed by a shift towards more active. Approximately half of patients reported a different control preference in follow up. Patients with higher income and education levels were more likely to prefer an active role. These findings suggest that most patients want to be engaged in shared decision making, but to what degree is varied, can change over time, and is influenced by social determinants of health., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Allen reports grant funding from AHA, NIH, and PCORI, and reports consulting fees from ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis. All other authors declare that they have no conflicts of interest., (© 2023 The Authors.)

Objective: Patient-clinician relationship quality and patient activation can both improve patient health outcomes, but prior work has primarily examined these factors independently. We examine how these two factors shape patient behavior in the setting of ambulatory heart failure care, where serial intensification of multiple medications is central to chronic care delivery., Methods: We used content analysis to analyze 22 in-depth patient interviews and 32 audio-recorded clinic visits collected for the EPIC-HF Trial. This was a secondary analysis providing qualitative depth to the parent RCT., Results: We identified a typology of patient activation and patient-clinician relationship quality, with four types: Supported, Skeptical, Deferential, and Unempowered. Types were sensitive to time and context; a given patient might occupy multiple types throughout the course of a single clinic visit. The effects of patient-activation and the patient-clinician relationship appeared to be bidirectional, with each influencing the other., Conclusion: Patient-clinician relationship quality and patient activation are dominant in shaping clinical interactions and disease management. This interaction is dynamic, and patients may change types depending on time, place, or context., Practice Implications: These findings suggest that both patient activation and high relationship quality work together to create a supportive environment for chronic care, where intermittent skepticism, deference or empowerment may be useful at particular times or in certain situations., Competing Interests: Declaration of Competing Interest Dr. Allen reports grant funding from AHA, NIH, and PCORI; and consulting fees from Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis. Remaining authors report no significant conflicts., (Copyright © 2022. Published by Elsevier B.V.)

Objectives: This study aims to examine a novel patient-centered metric of time spent engaging in left ventricular assist device (LVAD)-related clinical care outside the home., Background: Although LVAD implantation can improve survival and functional capacity in patients with advanced heart failure, this may occur at the expense of significant time spent engaging in LVAD-related health care activities., Methods: The authors retrospectively assessed consecutive patients at a single center who received a continuous-flow LVAD between May 9, 2008, and December 31, 2019, and queried health care encounters after implantation, including all inpatient encounters and LVAD-related ambulatory encounters. Patient-level time metrics were determined, including the total number of days with any health care encounter, and the total estimated time spent receiving care. The primary outcome was the proportion (%) of days alive with an LVAD spent engaged in at least 1 health care encounter. The secondary outcome was the proportion (%) of total time alive with an LVAD spent receiving care., Results: Among 373 patients, the median number of days alive with LVAD was 390 (IQR: 158-840 days). Patients had a median number of 88 (IQR: 45-161) days with ≥1 health care encounter, accounting for 23.2% (IQR: 16.3%-32.4%) of their days alive with an LVAD. A median 6.0% (IQR: 2.1%-14.1%) and 15.0% (IQR: 10.7%-20.0%) of total days alive were spent in inpatient and ambulatory encounters, respectively. Patients spent a median of 592 (IQR: 197-1,257) hours receiving care, accounting for 5.6% (IQR: 2.2%-12.7%) of their total time alive with an LVAD., Conclusions: LVAD patients spent more than 1 of every 5 days engaging in health care. Our findings may inform strategies to improve efficiency of postdischarge care delivery and expectations for post-treatment care., Competing Interests: Funding Support and Author Disclosures Research reported in this publication was supported, in part, by Northwestern University Clinical and Translational Sciences Institute’s Enterprise Data Warehouse. Dr Ahmad has received consulting fees from Amgen, Teladoc Linvongo, and Pfizer unrelated to this manuscript. Dr Allen has received grant funding from the AHA, NIH, and PCORI; and has received consultative fees from Abbott, ACI Clinical, Boston Scientific, Cytokinetics, and Novartis. Dr Grady has received consulting fees from Amgen, and has received grant funding from the NHLBI and NIH. Dr Rich has received consulting fees from Abbott. Dr Pham serves as a consultant for MedTronic, Abbott, and Abiomed. Dr Wilcox has received grant funding from the AHA and NIH; has received consulting fees from Amgen, Abbott, Abiomed, and Novartis; and serves on the scientific advisory boards for Abiomed and Cytokinetics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The authors sought to investigate associations between sacubitril/valsartan adherence and clinical outcomes after hospitalization for heart failure with reduced ejection fraction (HFrEF)., Background: Sacubitril/valsartan improves outcomes in HFrEF, though the extent to which medication adherence is associated with outcomes in routine care is less well characterized., Methods: The authors analyzed patients aged ≥65 years hospitalized for HFrEF within the Get With the Guidelines-Heart Failure registry linked with Medicare claims between October 2015 and September 2018 who were discharged with sacubitril/valsartan. Sacubitril/valsartan adherence was assessed using medication fills to calculate proportion of days covered (PDC) through 90 days postdischarge. Associations between postdischarge adherence (PDC < or ≥80%) and risk of readmission and death within 1 year were examined by comparing cumulative incidences and adjusted event rates., Results: Among 897 patients prescribed sacubitril/valsartan at discharge, 295 (32.9%) had PDC ≥80% and 602 (67.1%) had PDC <80%. Baseline characteristics were balanced between groups. Compared with patients with PDC <80%, patients with PDC ≥80% had a significantly lower adjusted hazard of all-cause rehospitalization (HR: 0.66 [95% CI: 0.48-0.89]) and death (HR: 0.42 [95% CI: 0.22-0.79]) at 90 days and at 1 year (HR: 0.69 [95% CI: 0.56-0.86] and HR: 0.53 [95% CI: 0.38-0.74], respectively). For every 5 percentage point increase in PDC, patients experienced a significant reduction in rehospitalization (HR: 0.98 [95% CI: 0.97-0.99]) and death (HR: 0.96 [95% CI: 0.94-0.97]) at 1 year., Conclusions: In patients hospitalized for HFrEF and discharged on sacubitril/valsartan, high adherence to sacubitril/valsartan within 90 days after discharge was associated with substantially lower rates of readmission and death. Additional efforts to improve adherence with sacubitril/valsartan and other guideline-directed medical therapies in HFrEF are warranted., Competing Interests: Funding Support and Author Disclosures This work was sponsored by Novartis Pharmaceuticals. The GWTG-HF (Get With the Guideline–Heart Failure) program is provided by the American Heart Association. The GWTG-HF registry is sponsored, in part, by Novartis, Boehringer Ingelheim, Eli Lilly Diabetes Alliance, Novo Nordisk, Sanofi, AstraZeneca, and Bayer. Dr Carnicelli has received research grant funding from the National Institutes of Health (NIH). Dr Lippmann has received research grant funding from Novartis. Dr Greene has received a Heart Failure Society of America/Emergency Medicine Foundation Acute Heart Failure Young Investigator Award funded by Novartis; receives research support from the American Heart Association, Amgen, AstraZeneca, Bristol Myers Squibb, Merck, and Novartis; has served on advisory boards for Amgen and Cytokinetics; and serves as a consultant for Amgen and Merck. Dr Mentz has 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. Dr Shen is employed by and has received stock from Novartis. Dr Peterson has received grant funding from National Institutes of Health (NIH). Dr Allen has received grant funding from the American Heart Association, NIH, and the Patient-Centered Outcomes Research Institute; and consulting fees from Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis. Dr Fonarow has received consulting fees from Abbott, Amgen, AstraZeneca, Bayer, Edwards, Janssen, Medtronic, Merck, and Novartis. Dr O’Brien has received grant funding from Bristol Myers Squibb, Novartis, GlaxoSmithKline, and Novo Nordisk., (Copyright © 2021. Published by Elsevier Inc.)

Medications with proven benefit in patients with heart failure with reduced ejection fraction are recommended, according to prospective large clinical trials, in the stable patient after careful up-titration in a strict sequential order. Although the relevance of careful clinical up-titration is unproven, there is evidence that after recompensation and shortly after hospital discharge, the rate of cardiovascular death and hospitalization is high. Clinical studies provided evidence that the onset of treatment effects is rapid, occurring within 28 days with most of these drugs used, and in some trials, early treatment after discharge or already started in the hospital has provided benefits. Therefore, early treatment without deferring it to the stable outpatient may be useful to reduce cardiac-related events further. This expert opinion proposes treatment layering according to individual patient phenotypes involving heart rate, blood pressure, impaired renal function, and electrolyte disturbances, as well as dedicated subgroups of patients with specific requirements for treatment initiation. This complements other approaches that suggest starting sequential treatment according to the size of treatment effects of drugs, specific cardiac diseases, and patient wishes. Patient phenotyping may guide personalized drug layering in heart failure with reduced ejection fraction that provides the best outcomes, whereas pragmatic clinical trials are warranted to scrutinize the effectiveness of these approaches., Competing Interests: Funding Support and Author Disclosures Dr Allen has received grants from the American Heart Association, the National Institutes of Health, and the Patient-Centered Outcomes Research Institute; and consulting fees from Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis. Dr Abdin has received speaker honoraria from Novartis; and travel grants from Biotronik, Medtronic, and Novartis. Dr Lindenfeld has received grant funding from AstraZeneca, Sensible Medical, Volumetrix; and personal fees from Abbott, AstraZeneca, Boehringer Ingelheim, Boston Scientific, CVRx, Edwards Lifesciences, Impulse Dynamics, and VWave. Dr Lam has received research support from AstraZeneca, Bayer, Boston Scientific, and Roche Diagnostics; consultancy fees from service on the advisory board, steering committee, or executive committee of Actelion, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Cytokinetics, Darma Inc, Us2.ai, Janssen Research & Development LLC, Medscape, Merck, Novartis, Novo Nordisk, Radcliffe Group Ltd, Roche Diagnostics, Sanofi, and WebMD Global LLC; and holds a position as cofounder and nonexecutive director of Us2.ai. Dr Savarese has received grants from Boston Scientific (outside the submitted work), Vifor, Boehringer Ingelheim, AstraZeneca, and Novartis; nonfinancial support from Boehringer Ingelheim; and personal fees from Vifor and the Societá Prodotti Antibiotici, AstraZeneca, Roche, Servier, GENESIS, Cytokinetics, and Medtronic. Dr Gottlieb has received grants from Pfizer, Cytokinetics, and Amgen; and consulting for Cytokinetics. Dr Böhm has received support from the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project number 322900939); and has fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Servier, Medtronic, Vifor, and Novartis. 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 sought to better understand the discrepant results of 2 trials of serelaxin on acute heart failure (AHF) and short-term mortality after AHF by analyzing causes of death of patients in the RELAX-AHF-2 (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF-2) trial., Background: Patients with AHF continue to suffer significant short-term mortality, but limited systematic analyses of causes of death in this patient population are available., Methods: Adjudicated cause of death of patients in RELAX-AHF-2, a randomized, double-blind, placebo-controlled trial of serelaxin in patients with AHF across the spectrum of ejection fraction (EF), was analyzed., Results: By 180 days of follow-up, 11.5% of patients in RELAX-AHF-2 died, primarily due to heart failure (HF) (38% of all deaths). Unlike RELAX-AHF, there was no apparent effect of treatment with serelaxin on any category of cause of death. Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and noncardiovascular (CV) death (27% vs. 19%) compared to younger patients. Patients with preserved EF (≥50%) had lower rates of HF-related mortality (30% vs. 40%) but higher non-CV mortality (36% vs. 20%) compared to patients with reduced EF., Conclusions: Despite previous data suggesting benefit of serelaxin in AHF, treatment with serelaxin was not found to improve overall mortality or have an effect on any category of cause of death in RELAX-AHF-2. Careful adjudication of events in the serelaxin trials showed that older patients and those with preserved EF had fewer deaths from HF or sudden death and more deaths from other CV causes and from noncardiac causes. (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF [RELAX-AHF-2]; NCT01870778)., Competing Interests: Author Disclosures The RELAX-AHF-2 trial was funded by Novartis. Dr. Loungani receives research support from Pfizer and Boston Scientific. Dr. Teerlink has received research grants and/or consulting fees from Abbott, AbbVie, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Cytokinetics, EBR Systems, Medtronic, Merck, and Novartis. Dr. Metra has received consulting honoraria as a member of trials’ committees or advisory boards from Abbott Vascular, Amgen, Bayer, Edwards Therapeutics, and Vifor Pharma. Dr. Allen has received research grants from National Heart, Lung, and Blood Institute (NHLBI), PCORI, and American Heart Association; and has acted as a consultant to Abbott, ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis. Dr. Butler serves as a consultant for Abbott, Adrenomed, Amgen, Array, AstraZeneca, Bayer, Boehringer Ingelheim, CVRx, InnoLife, Janssen, LivaNova, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, V-Wave Limited, and Vifor. Dr. Carson has received honoraria as a CEC member from Novartis. Drs. Chen, Gimpelewicz, and Holbro are all employees and shareholders of Novartis Pharma AG. Drs. Cotter and Davison received research grants and personal fees from Novartis during the trials’ conduct; and grants from Abbott Laboratories, Amgen, Celyad, Cirius Therapeutics, Roche Diagnostics, Sanofi, and Windtree Therapeutics. Dr. Filippatos has participated in committees of trials and registries sponsored by Novartis, Servier, Medtronic, Vifor, BI, and Bayer. Dr. Greenberg has received research support from the AHA, NIH, and Rocket Pharma; and serves as a consultant for ACI, Actelion, Akcea, Amgen, EBR Systems, Ionis, Janssen, Merck, MyoKardia, Novartis, Sanofi, Viking, Zensun, and Zoll. Dr. Januzzi is a Trustee of the American College of Cardiology; has received grant support from Novartis Pharmaceuticals and Abbott Diagnostics, and consulting income from Abbott, Janssen, Novartis, MyoKardia, and Roche Diagnostics; and participates in clinical endpoint committees/data safety monitoring boards for Abbott, AbbVie, Amgen, CVRx, Janssen, and Takeda. Dr. Lanfear has received research grants from NHLBI, Amgen, Bayer, and Janssen; and has acted as a consultant for Amgen, Janssen, Ortho Diagnostics, and Novartis. Dr. Pang has served as a consultant for Baxter, Bristol Myers Squibb, and Merck; and has received research or other support from Bristol Myers Squibb, Roche, Novartis, PCORI, AHA, NHLBI, AHRQ, OrthoDiagnostics, and Abbott. Dr. Piña is an Advisory Board member of Relypsa and Vifor. Dr. Ponikowski receives consulting fees and speaker honoraria from Vifor Pharma, Amgen, Servier, Novartis, Berlin Chemie, Bayer, Pfizer, Cibiem, Impulse Dynamics, Renal Guard Solutions, Boehringer Ingelheim, and AstraZeneca, and research grants from Vifor Pharma. Dr. Miller serves as a consultant for Abbott, Boehringer, CVRx, Pfizer, Novartis, and Respicardia; and receives research support from Merck. Dr. Voors has received consultancy fees and/or grant support from Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim, Cytokinetics, MyoKardia, Novo Nordisk, Novartis, Roche Diagnostics, Servier, and Vifor Pharma. Dr. Felker has received research grants from NHLBI, American Heart Association, Amgen, Bayer Merck, Cytokinetics, and Roche Diagnostics; and has acted as a consultant to Novartis, Amgen, Bristol Myers Squibb, Cytokinetics, Medtronic, Cardionomic, V-Wave, MyoKardia, InnoLife, EBR Systems, Arena, Abbott, Roche Diagnostics, Alnylam, LivaNova, Rocket Pharma, Reprieve, and SC Pharma. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study compared the characteristics of Medicare beneficiaries who were hospitalized for heart failure (HF) and then discharged home who received home health care (HHC) to the characteristics of those who did not, and examined associations among HHC and readmission and mortality rates., Background: After hospitalization for HF, some patients receive HHC. However, the use of HHC over time, the factors associated with its use, and the post-discharge outcomes after receiving it are not well studied., Methods: This study used Get With The Guidelines-HF data, merged with Medicare fee-for-service claims. Propensity score matching and Cox proportional hazards models were used to evaluate the associations between HHC and post-discharge outcomes., Results: From 2005 to 2015, 95,531 patients were admitted for HF, and 32,697 (34.2%) received HHC after discharge. The rate of HHC increased over time from 31.4% to 36.1% (p < 0.001). HHC recipients were older, more likely to be female, and had more comorbidities. HHC was associated with a higher risk of all-cause 30-day readmission (hazard ratio [HR]: 1.25; 95% confidence interval [CI]: 1.20 to 1.30), HF-specific 30-day readmission (HR: 1.20; 95% CI: 1.13 to 1.28), all-cause 90-day readmission (HR: 1.23; 95% CI: 1.19 to 1.26), HF-specific 90-day readmission (HR: 1.16; 95% CI: 1.11 to 1.22), and all-cause 30-and 90-day mortality, respectively (HR: 1.70; 95% CI: 1.56 to 1.86) and HR: 1.49; 95% CI: 1.41 to 1.57) compared to those who did not receive HHC., Conclusions: Use of HHC after HF hospitalization increased among Medicare beneficiaries. HHC recipients were older and sicker than non-HHC recipients. Although HHC was associated with a higher risk of readmissions and mortality, this finding should be interpreted cautiously, given the presence of unmeasured variables that could affect receipt of HHC. Research is needed to determine whether the results reflect appropriate health care use., Competing Interests: Author DISCLOSURES This study was funded by an American Heart Association-Get with The Guidelines (GWTG-HF) Young Investigator Database Seed Grant Award (to Dr. Sterling). The GWTG-HF program is provided by the American Heart Association. GWTG-HF has been funded in the past through support from Medtronic, GlaxoSmithKline, Ortho-McNeil, and the American Heart Association Pharmaceutical Roundtable. Dr. Sterling is supported by K23HL150160 from the National Institutes of Health/National Heart Lung and Blood Institute (NHLBI). Dr. DeVore has received research funding from the American Heart Association, Amgen, AstraZeneca, Bayer, Intra-Cellular Therapies, Luitpold Pharmaceuticals, Medtronic, the NHLBI, Novartis and PCORI; and has consulted for AstraZeneca, Bayer, LivaNova, Mardil Medical, Novartis and Procyrion. Dr. Fonarow has consulted for Abbott, Amgen, Bayer, CHF Solutions, Janssen, Medtronic, and Novartis. Dr. Allen has received research funding from the American Heart Association, the National Institutes of Health, and the Patient Centered Outcomes Research Institute; and has received consulting fees from ACI Clinical, Amgen/Cytokinetics, Boston Scientific, and Janssen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The mandatory federal pay-for-performance Hospital Readmissions Reduction Program (HRRP) was created to decrease 30-day hospital readmissions by instituting accountability and stimulating quality care and coordination, particularly during care transitions. The HRRP has changed the landscape of hospital readmissions and reimbursement within the United States by imposing substantial Medicare payment penalties on hospitals with higher-than-expected readmission rates. However, the HRRP has been controversial since its inception, particularly in the field of heart failure. Proponents argue that it has reduced national readmission rates, in part by raising awareness and investment in mechanisms to better assist patients during discharge and transitions; opponents contend that it unfairly penalizes hospitals for issues beyond their control, has unintended negative consequences due to incentivizing readmission over survival, that it encourages "gaming" the system, was not tested before implementation, and that it does not specify how hospitals can improve their performance. This paper incorporates the diverse, nuanced, and sometimes divergent interpretations presented during a multifaceted expert clinician discussion regarding the HRRP and heart failure; in cases in which consensus opinions were achieved, they are presented, including regarding potential new iterations of the HRRP for the future. Potential improvements include more comprehensive incorporation of outcomes into the HRRP measure and better risk adjustment to improve equality and fairness., (Copyright © 2020 American College of Cardiology Foundation. All rights reserved.)

Background: Trial and registry data have reported mortality rates and causes of death in patients with left ventricular assist devices (LVADs); however, a more granular description is needed of end of life, including location of death and quality of life (QOL), to better guide expectations and care., Methods: To identify where patients with an LVAD died, characterize QOL before death, and cause of death over time, we evaluated patients in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) implanted with a continuous-flow LVAD., Results: From 18,733 patients implanted with an LVAD during the period 2008 to 2016, 4,916 patients were known to have died, of whom 98% had a recorded location of death. Overall, 76.9% died in the hospital, with progressively more patients dying outside of the hospital further post-LVAD implant: <1 month, 2.3%; 1 to 12 months, and 16.8%; and >12 months, 37.4%. In a multivariable analysis, increased age (RR (risk ratio) 1.06, 95% confidence interval [CI] 1.02 to 1.12, p = 0.01) and destination therapy indication (RR 1.15, 95% CI 1.03 to 1.28, p = 0.01) increased the likelihood of dying outside the hospital. Comparing 3 months post-implant with 6 months before death in a subset of patients, QOL remained clinically stable (EQ-5D Visual Analog Scale [mean ± SD]: 68.3 ± 22.2 to 66.7 ± 21.7, p = 0.11; KCCQ: 61.0 ± 22.2 to 57.8 ± 23.2, p = 0.003). The most common cause of death <1 month post-implant was multiple-organ failure (20.4%) and at >1 month post-implant it was neurologic dysfunction (28.2%)., Conclusions: Most patients with an LVAD died in the hospital. QOL remained stable months before death and causes of death were varied, but increasingly dominated by stroke. By understanding death with an LVAD in place, clinicians are in a better position to educate patients and caregivers about what to expect and provide to support tailored to patient and caregiver needs., (Copyright © 2018 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aims to characterize caregivers of patients considering destination therapy left ventricular assist device (DT-LVAD) and evaluate the effectiveness of a shared decision-making (SDM) intervention., Background: Caregivers play an integral role in the care of patients with chronic illness. At the extreme, pursuing a DT-LVAD is a major preference-sensitive decision that requires high-level caregiver engagement. Yet, little is known about caregivers of patients considering DT-LVAD, and there is a paucity of research on the involvement of caregivers in medical decision-making., Methods: A 6-center, stepped-wedge trial was conducted. After varying time in usual care (control), sites were transitioned to an SDM intervention consisting of staff education and pamphlet and video decision aids (DAs). The primary outcome was decision quality, measured by knowledge and values-choice concordance., Results: From 2015 to 2017, 182 caregivers of patients considering DT-LVAD were enrolled (control group, n = 111; intervention group, n = 71). The median age was 61 years, 86.5% were female, and 75.8% were spouses. Caregiver knowledge (0% to 100%) improved from baseline to post-education in both groups: in the control group it improved from 64.2% to 73.3%; in the intervention group it improved from 62.6% to 76.4% (adjusted difference of difference: 4.8%; p = 0.08). At 1 month, correlation between stated values and caregiver-reported treatment choice was stronger in the intervention group (difference in Kendall's tau: 0.36, 95% confidence interval: 0.04 to 0.71; p = 0.03). Caregivers reported decisional conflict (0 to 100) at baseline (control group: 19.0 ± 2.1; intervention group: 21.4 ± 2.6), which decreased post-education more in the control group (control group: 9.0 ± 1.9, intervention group: 18.8 ± 2.4; p = 0.009). Caregivers in the control group were more likely to "definitely recommend" the educational materials than those in the intervention group (93.5% vs. 74.5%, respectively; p = 0.004)., Conclusions: An SDM intervention improved concordance between caregiver values and treatment choice for their loved ones but did not significantly impact knowledge. Caregivers found the DAs less acceptable than more biased educational materials and exposure to DAs led to higher conflict initially. These findings highlight the complexity of SDM involving caregivers of patients with chronic illness. (PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device [DECIDE-LVAD]; NCT02344576)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to systematically review the available evidence of risks and benefits of ambulatory intravenous inotrope therapy in advanced heart failure (HF)., Background: Ambulatory inotrope infusions are sometimes offered to patients with advanced Stage D HF; however, an understanding of the relative risks and benefits is lacking., Methods: On August 7, 2016, we searched SCOPUS, Web of Science, Ovid EMBASE, and Ovid MEDLINE for studies of long-term use of intravenous inotropes in outpatients with advanced HF. Meta-analysis was performed using random effects models., Results: A total of 66 studies (13 randomized controlled trials and 53 observational studies) met inclusion criteria. Most studies were small and at high risk for bias. Pooled rates of death (41 studies), all-cause hospitalization (15 studies), central line infection (13 studies), and implantable cardioverter-defibrillator shocks (3 studies) of inotropes were 4.2, 22.2, 3.6, and 2.4 per 100 person-months follow-up, respectively. Improvement in New York Heart Association (NYHA) functional class was greater in patients taking inotropes than in controls (mean difference of 0.60 NYHA functional classes; 95% confidence interval [CI]: 0.22 to 0.98; p = 0.001; 5 trials). There was no significant difference in mortality risk in those taking inotropes compared with controls (pooled risk ratio: 0.68; 95% CI: 0.40 to 1.17; p = 0.16; 9 trials). Data were too limited to pool for other outcomes or to stratify by indication (i.e., bridge-to-transplant or palliative)., Conclusions: High-quality evidence for the risks and benefits of ambulatory inotrope infusions in advanced HF is limited, particularly when used for palliation. Available data suggest that inotrope therapy improves NYHA functional class and does not impact survival., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to determine whether the likelihood of receiving primary intensive care unit (ICU) care by a cardiologist versus a noncardiologist was greater for Caucasians than for African Americans admitted to an ICU for heart failure (HF). The authors further evaluated whether primary ICU care by a cardiologist is associated with higher in-hospital survival, irrespective of race., Background: Increasing data demonstrate an association between better HF outcomes and care by a cardiologist. It is unclear if previously noted racial differences in cardiology care persist in an ICU setting., Methods: Using the Premier database, adult patients admitted to an ICU with a primary discharge diagnosis of HF from 2010 to 2014 were included. Hierarchical logistic regression models were used to determine the association between race and primary ICU care by a cardiologist, adjusting for patient and hospital variables. Cox regression with inverse probability weighting was used to assess the association between cardiology care and in-hospital mortality., Results: Among 104,835 patients (80.3% Caucasians, 19.7% African Americans), Caucasians had higher odds of care by a cardiologist than African Americans (adjusted odds ratio: 1.42; 95% confidence interval: 1.34 to 1.51). Compared with a noncardiologist, primary ICU care by a cardiologist was associated with higher in-hospital survival (adjusted hazard ratio: 1.20, 95% confidence interval: 1.11 to 1.28). The higher likelihood of survival did not differ by patient race (interaction p = 0.32)., Conclusions: Among patients admitted to an ICU for HF, African Americans were less likely than Caucasians to receive primary care by a cardiologist. Primary care by a cardiologist was associated with higher survival for both Caucasians and African Americans., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Context: Whether to engage hospice is one of the most difficult medical decisions patients and families make. Meanwhile, misperceptions about hospice persist. Within this context, the breadth and depth of patient decision support materials for hospice are unknown., Objectives: The objective of this study was to identify available patient decision aids (PtDAs) relating information about hospice care and compare that information with the informational needs expressed by real-world health care consumers., Methods: First, the research team conducted an environmental scan of available PtDAs that included hospice as a treatment option and met six basic criteria defined by the International Patient Decision Aid Standards. Second, laypersons conducted an organic Web search for information regarding hospice, followed by a semi-structured interview eliciting perceptions of the available information. The setting was the University of Colorado Health Care System. Participants included 20 laypersons aged 18 years or older., Results: The environmental scan identified 7PtDAs that included hospice. No PtDAs were designed primarily around hospice; rather, hospice was referenced under the umbrella of another treatment option. The layperson search identified information distinct from the scan; no participant accessed any of the above 7PtDAs. Many participants found the available online material confusing and biased, while failing to provide clear information on cost and lacking desired patient and caregiver testimonials., Conclusion: We found no formal PtDA designed primarily to help patients/families contemplating hospice. Furthermore, accessible online information about hospice does not appear to meet patient and caregiver decisional needs. These findings support the development and dissemination of high-quality decision support materials for hospice., (Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Quantifying quality of life (QoL) after left ventricular assist device (LVAD) remains challenging. Heart failure (HF)-specific health status measures are ideal for assessing symptoms of HF; however, if patients' QoL is limited by other factors, they may experience improved HF-specific QoL but no concurrent improvement in generic QoL. We sought to examine and predict discrepancies between disease-specific and generic QoL measures after LVAD., Methods: We examined HF-specific and generic QoL with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQol-5D Visual Analog Scale (VAS), respectively, among 1,888 patients with advanced heart failure who underwent LVAD implantation from 2012 to 2014 as part of the INTERMACS registry., Results: Both measures showed substantial improvement, on average, at 6 months after LVAD, with mean changes of 32.7 ± 25.0 and 27.6 ± 27.4, respectively. Among the 1,539 patients (81.5%) with moderate/large improvement in KCCQ, 334 (21.7%) had discordant changes in generic QoL (i.e., VAS did not substantially increase despite improvement in KCCQ). In a multivariable logistic regression model, baseline VAS score was the strongest predictor of KCCQ-VAS discordance, whereas post-LVAD complications were not significant predictors of discordance., Conclusions: Most patients have major improvements in both HF-specific and generic QoL after LVAD implantation, and discordance in these measures after LVAD is uncommon. When it did occur, discordance was primarily observed in patients who reported good generic QoL on the VAS before LVAD (despite substantial impairment due to congestive HF). These results support the continued use of HF-specific health status measures to monitor QoL before and after LVAD implantation., (Copyright © 2017 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Context: Health status (i.e., symptoms, function, and quality of life) is an important palliative care outcome in patients with heart failure; however, patterns of health status over time (i.e., trajectories) are not well described., Objectives: The objective of this study was to identify health status trajectories in outpatients with heart failure and assess whether depression, symptom burden, or sense of peace predict health status trajectory., Methods: This is an observational study utilizing data from the Patient-Centered Disease Management for Heart Failure trial. Participants completed Kansas City Cardiomyopathy Questionnaires at baseline, three, six, and 12 months. Latent class growth analysis identified health status trajectories; multinomial logistic regression models identified predictors of trajectory membership., Results: Patients (n = 384) were primarily men (97%) and older (mean age 67.6 ± 10.1). Three health status trajectories were identified. All three trajectories improved at three months; however, the marked improvement health status trajectory (n = 19) showed progressive improvement over one year, whereas the poor (n = 119) and moderate (n = 246) health status trajectories had little change after three months. In adjusted analyses, worse baseline depression (odds ratio 1.10; 95% confidence interval 1.01-1.20), symptom burden (1.45; 1.15-1.83), and sense of peace (0.41; 0.22-0.75) predicted membership in the poor vs. moderate health status trajectory., Conclusion: We identified three one-year health status trajectories in patients with heart failure, with the two most common trajectories characterized by early improvement followed by limited change. Future research should assess these findings in nonveterans and women and explore whether treatment of depression, high symptom burden, and low sense of peace leads to improved long-term heart failure health status trajectory., (Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine if the Affordable Care Act (ACA) Medicaid Expansion was associated with increased census-adjusted heart transplant listing rates for racial/ethnic minorities., Background: Underinsurance limits access to transplants, especially among racial/ethnic minorities. Changes in racial/ethnic listing rates post-ACA Medicaid Expansion are unknown., Methods: Using the Scientific Registry of Transplant Recipients, we analyzed 5,651 patients from early adopter states (implemented the ACA Medicaid Expansion by January 2014) and 4,769 patients from non-adopter states (no implementation during the study period) from 2012 to 2015. Piecewise linear models, stratified according to race/ethnicity, were fit to monthly census-adjusted rates of heart transplant listings before and after January 2014., Results: A significant 30% increase in the rate of heart transplant listings for African-American patients in early adopter states occurred immediately after the ACA Medicaid Expansion on January 1, 2014 (before 0.15 to after 0.20/100,000; increase 0.05/100,000; 95% confidence interval [CI]: 0.01 to 0.08); in contrast, the rates for African-American patients in non-adopter states remained constant (before and after 0.15/100,000; increase 0.006/100,000; 95% CI: -0.03 to 0.04). Hispanic patients experienced an opposite trend, with no significant change in early adopter states (before 0.03 to after 0.04/100,000; increase 0.01/100,000; 95% CI: -0.004 to 0.02) and a significant increase in non-adopter states (before 0.03 to after 0.05/100,000; increase 0.02/100,000; 95% CI: 0.002 to 0.03). There were no significant changes in listing rates among Caucasian patients in either early adopter states or non-adopter states., Conclusions: Implementation of the ACA Medicaid Expansion was associated with increased heart transplant listings in African-American patients but not in Hispanic or Caucasian patients. Broadening of the ACA in states with large African-American populations may reduce disparities in heart transplant listings., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to determine the significant clinical predictors of incident heart failure (HF) and its prognostic effect on long-term outcomes among community-based patients with established atrial fibrillation (AF)., Background: AF is associated with an increased risk of HF. However, in this population, little focus is placed on risk stratification for and the prevention of HF., Methods: Patients with AF but without HF at baseline enrolled in the ORBIT-AF (Outcomes Registry for Informed Treatment of Atrial Fibrillation) registry were included. Separate multivariable-adjusted Cox frailty regression models were used to identify significant predictors of HF incidence and determine the associated risk of adverse clinical events., Results: The study included 6,545 participants with AF from 173 participating sites. Incident HF developed in 236 participants (3.6%) over the 2-year follow-up period; ejection fraction was preserved (>40%) in 64%, reduced (≤40%) in 13.5%, and missing in 22.5%. In multivariable analysis, traditional HF risk factors (age, coronary artery disease, renal dysfunction, and valvular disease), presence of permanent AF (hazard ratio [HR]: 1.60 [95% confidence interval (CI): 1.18 to 2.16]; reference group: paroxysmal AF), and elevated baseline heart rate (HR: 1.07 [95% CI: 1.02 to 1.13] per 5 beats/min higher heart rate) were independently associated with incident HF risk. Incident HF among patients with AF was independently associated with higher risk of mortality, all-cause hospitalization, and bleeding events., Conclusions: Incident HF among patients with AF is common, is more likely to be HF with preserved ejection fraction, and is associated with poor long-term outcomes. Traditional HF risk factors, AF type, and baseline heart rate are independent clinical predictors of incident HF., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

While contemporary heart failure management has led to some improvements in morbidity and mortality, patients continue to report poor health status (i.e., burdensome symptoms, impaired function, and poor quality of life). The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial is a NIH-funded, three-site, randomized clinical trial that examines the effect of the CASA intervention compared to usual care on the primary outcome of patient-reported health status at 6months in patients with heart failure and poor health status. The CASA intervention involves a nurse who works with patients to treat symptoms (e.g., shortness of breath, fatigue, pain) using disease-specific and palliative approaches, and a social worker who provides psychosocial care targeting depression and adjustment to illness. The intervention uses a collaborative care team model of health care delivery and is structured and primarily phone-based to enhance reproducibility and scalability. This article describes the rationale and design of the CASA trial, including several decision points: (1) how to design a patient-centered intervention to improve health status; (2) how to structure the intervention so that it is reproducible and scalable; and (3) how to systematically identify outpatients with heart failure most likely to need and benefit from the intervention. The results should provide valuable information to providers and health systems about the use of team care to manage symptoms and provide psychosocial care in chronic illness., (Published by Elsevier Inc.)

Objectives: This study aimed to create decision aids (DAs) for patients considering a destination therapy left ventricular assist device (DT LVAD)., Background: Insertion of a DT LVAD is a major decision for patients with end-stage heart failure. Patients facing decisions with complex trade-offs may benefit from high-quality decision support resources., Methods: In accordance with the International Patient Decision Aid Standards guidelines and based on a needs assessment with stakeholders, we developed drafts of paper and video DAs. With input from patients, caregivers, and clinicians through alpha testing, we iteratively modified the DAs to ensure acceptability., Results: We conducted semistructured interviews with 24 patients, 20 caregivers, and 24 clinicians to assess readability, bias, and usability of the DAs. Stakeholder feedback allowed us to integrate aspects critical to decision making around highly invasive therapies for life-threatening diseases, including addressing emotion and fear of death, using gain frames for all options that focus on living, highlighting palliative and hospice care, integrating the caregiver role, and using a range of balanced testimonials. After 19 iterative versions of the paper DA and 4 versions of the video DA, final materials were made available for wider use., Conclusions: We developed the first International Patient Decision Aid Standards-level DAs for DT LVAD. Given the extreme nature of this medical decision, we augmented traditional DA characteristics with nontraditional DA features to address a spectrum of cognitive, automatic, and emotional aspects of end-of-life decision making. Not only are the DAs important tools for those confronting end-stage heart failure, but the lessons learned will likely inform decision support for other invasive therapies., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Health status predicts adverse outcomes in heart failure and cardiac surgery patients, but its prognostic value in left ventricular assist device (LVAD) placement is unknown., Methods: We examined the association of pre-operative health status, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), with survival and hospitalization after LVAD using the KCCQ score as a continuous variable and stratified by KCCQ score quartile plus missing KCCQ in 1,125 clinical trial participants who received the HeartMate II (Thoratec Corp, Pleasanton, CA) as destination therapy (n = 635) or bridge to transplantation (n = 490)., Results: The mean pre-operative KCCQ score was 29.4 ± 18.7 among survivors (n = 719), and 27.1 ± 18.3 (n = 406) in those who died. In time-to-event analysis for all available follow-up using health status as a continuous variable, the pre-operative KCCQ score did not correlate with overall mortality after LVAD implantation (p = 0.178). Small absolute differences were seen between the pre-operative KCCQ quartile and 30-day survival (Q4 95% vs. Q1 89% vs. missing 87%; p = 0.0009 for trend), 180-day survival (Q4 83% vs. Q1 76% vs missing 79%; p = 0.060 for trend), and days hospitalized at 180 days (Q4 29.8 ± 25.6 vs. Q1 34.1 ± 27.1 vs. missing 36.5 ± 29.9 days; p = 0.009 for trend)., Conclusion: Our findings suggest that pre-operative health status has limited association with outcomes after LVAD implantation. Although these data require further study in a diverse population, mechanical circulatory support may represent a relatively unique clinical situation, distinct from heart failure and other cardiac surgeries, in which heart failure-specific health status measures may be largely reversed., (© 2013 International Society for Heart and Lung Transplantation Published by International Society for the Heart and Lung Transplantation All rights reserved.)