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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: A growing population of patients with end-stage heart failure (HF) with reduced ejection fraction has limited treatment options to improve their quality and quantity of life. Although positive inotropes have failed to show survival benefit, these agents may enhance patient-reported health status, that is, symptoms, functional status, and health-related quality of life. We sought to review the available clinical trial data on positive inotrope use in patients with end-stage HF and to summarize evidence supporting the use of these agents to improve health status of patients with end-stage HF., Methods: A literature review of randomized controlled trials examining the use of positive inotropy in HF with reduced ejection fraction was conducted. We searched MEDLINE, SCOPUS, and Web of Science between January 1980 to December 2018 for randomized controlled trials that used as their main outcome measures the effects of inotrope therapy on (1) morbidity/mortality, (2) symptoms, (3) functional status, or (4) health-related quality of life. Inotropes of interest included adrenergic agents, phosphodiesterase inhibitors, calcium sensitizers, myosin activators, and SERCA2a (sarcoplasmic reticulum Ca 2+ -ATPase) modulators., Results: Twenty-two out of 26 inotrope randomized controlled trials measured the effect of inotropes on at least one patient-reported health status domain. Among the 22 studies with patient-related health status outcomes, 11 (50%) gauged symptom response, 15 (68%) reported functional capacity changes, and 12 (54%) reported health-related quality of life measures. Fourteen (64%) of these trials noted positive outcomes in at least one health status domain measured; 11 (79%) of these positive studies used agents that worked through phosphodiesterase inhibition., Conclusions: There has been a lack of standardization surrounding measurement of patient-centered outcomes in studies of inotropes for end-stage HF with reduced ejection fraction. The degree to which positive inotropes can improve patient-reported health status and the adverse risk they pose remains unknown.

Background: Atrial fibrillation (AF) adversely impacts health-related quality of life (hrQoL). While some patients demonstrate improvements in hrQoL, the factors associated with large improvements in hrQoL are not well described., Methods: We assessed factors associated with a 1-year increase in the Atrial Fibrillation Effect on Quality-of-Life score of 1 SD (≥18 points; 3× clinically important difference), among outpatients in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation I registry., Results: Overall, 28% (181/636) of patients had such a hrQoL improvement. Compared with patients not showing large hrQoL improvement, they were of similar age (median 73 versus 74, P =0.3), equally likely to be female (44% versus 48%, P =0.3), but more likely to have newly diagnosed AF at baseline (18% versus 8%; P =0.0004), prior antiarrhythmic drug use (52% versus 40%, P =0.005), baseline antiarrhythmic drug use (34.8% versus 26.8%, P =0.045), and more likely to undergo AF-related procedures during follow-up (AF ablation: 6.6% versus 2.0%, P =0.003; cardioversion: 12.2% versus 5.9%, P =0.008). In multivariable analysis, a history of alcohol abuse (adjusted OR, 2.41; P =0.01) and increased baseline diastolic blood pressure (adjusted OR, 1.23 per 10-point increase and >65 mm Hg; P =0.04) were associated with large improvements in hrQoL at 1 year, whereas patients with prior stroke/transient ischemic attack, chronic obstructive pulmonary disease, and peripheral arterial disease were less likely to improve ( P <0.05 for each)., Conclusions: In this national registry of patients with AF, potentially treatable AF risk factors are associated with large hrQoL improvement, whereas less reversible conditions appeared negatively associated with hrQoL improvement. Understanding which patients are most likely to have large hrQoL improvement may facilitate targeting interventions for high-value care that optimizes patient-reported outcomes in AF. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01165710.

Background Patient-reported outcomes (PROs) objectively measure health-related quality of life and provide prognostic information. Advances in technology now allow for rapid, patient-friendly PRO assessment and scoring, yet the adoption of PROs in clinic has been slow. We conducted a multicenter qualitative study of diverse providers to describe the barriers and facilitators of routine PRO use in heart failure clinics. Methods and Results Sixty heart failure providers from 5 institutions participated in 8 focus groups to explore provider perspectives on the use of heart failure-specific and generic PROs in clinical practice. A qualitative editing approach was used to analyze the data, whereby a coding dictionary was iteratively developed and applied using the qualitative software program Altas.ti. Three main themes, supporting and impeding PRO use, emerged: (1) data collection; (2) presentation and interpretation; and (3) utility and value. For each construct, we identified perspectives that highlighted both barriers and facilitators. Providers identified burden, survey fatigue, and language/health literacy barriers as potentially impeding data collection. Optimal workflow, PRO frequency and length, use of PRO translations, and assistance of a patient's proxy were suggested as facilitators. Focus group discussions provided insight on how to display PROs to support its interpretability and sharing. Furthermore, the need to educate providers on the utility and value PROs over and above current clinical approaches emerged. Conclusions Overcoming the barriers and supporting facilitators of PRO adoption could potentially lead to more successful adoption of PROs in heart failure clinics.

Background The Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire has recently been validated to measure the impact of atrial fibrillation on quality of life, but a clinically important difference in AFEQT score has not been well defined. Methods and Results To determine the clinically important difference in overall AFEQT (score range= 0 [worst] to 100 [best]) and selected subscales, we analyzed data in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry, a United States-based outpatient atrial fibrillation registry. AFEQT was assessed at baseline and 1 year in a subset of 1347 ORBIT-AF patients from 80 US sites participating in ORBIT-AF from June 2010 to August 2011. The mean change method was used to relate changes in 1-year AFEQT scores to clinically important changes in the physician assessment of European Heart Rhythm Association functional status (1 class improvement and separately 1 class deterioration). Clinically important differences and 95% CI corresponding to either a 1 European Heart Rhythm Association class improvement or deterioration were 5.4 (3.6-7.2) and -4.2 (-6.9 to -1.5) AFEQT points, respectively. Similarly, clinically important difference values were seen for a 1 European Heart Rhythm Association class improvement for the AFEQT subscales Activities of Daily Living and Symptoms: 5.1 (2.5-7.6) and 7.1 (5.3-9.0) AFEQT points, respectively. Conclusions Based on the anchor of 1 European Heart Rhythm Association class change, changes in AFEQT score of + or -5 points are clinically important changes in patients' health. Clinical Trial Registration URL: https://clinicaltrials.gov . Unique identifier: NCT01165710.

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.)

The degree to which clinical outcomes are worsened in patients with atrial fibrillation (AF) with heart failure (HF) compared with those without HF is not well described. This study aimed to determine the impact of HF on clinical outcomes in patients with AF. We analyzed data from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation, a national registry of 10,135 patients with AF to determine associations between HF and left ventricular ejection fraction (LVEF) and outcomes, including stroke, mortality, and hospitalization using Cox multivariable modeling. Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) scores between groups were also compared. Overall, 33% (n = 3,203) of patients had HF; of these 33% (n = 985) had LVEF ≤40%. Oral anticoagulation was prescribed more commonly in patients with HF (81% vs 74%). Compared with patients without HF, those with HF had similar rate of stroke (1.28 vs 0.88 per 100-patient years, hazard ratio [HR] 1.11, confidence interval [CI] 0.83 to 1.48, p = 0.47) but higher mortality (HR 1.69, CI 1.49 to 1.92, p <0.001) and hospitalization (HR 1.31, CI 1.23 to 1.39, p <0.0001). Patients with LVEF ≤40% had similar stroke risk (HR 1.06, CI 0.67 to 1.67) but higher mortality (HR 2.06, CI 1.74 to 2.44) and hospitalization (HR 1.38, CI 1.25 to 1.51). AFEQT overall score was significantly lower (76.9 vs 83.3, p <0.0001) in patients with HF. In conclusion, HF was associated with increased risk of death and hospitalization and worse quality of life, but similar rates of thromboembolism regardless of LVEF among patients with AF. These findings highlight the need to develop therapeutic strategies targeting functional status and survival for patients with HF and AF., (Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: The prognostic value of heart failure specific and global health status before and after left ventricular assist device (LVAD) implantation in the usual care setting is not well studied., Methods: We included 3,836 continuous-flow LVAD patients in the INTERMACS registry. Health status was measured pre-operatively and 3 months post-LVAD using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQol visual analog scale (VAS). Primary outcomes were mortality/rehospitalization. Inverse propensity weighting was used to minimize bias from missing data., Results: Pre-operative global and heart failure-specific health status were very poor: KCCQ median 34.6 (IQR 21.4-50.5); VAS median 43 (interquartile range (IQR) 25-65). Health status measures improved 3 months after LVAD placement: KCCQ median 69.3 (IQR 54.2-82.3); VAS median 75 (IQR 60-85). Pre-operative health status was not associated with death (unadjusted HR for lowest vs. highest score quartiles: 1.09 (0.85-1.41) KCCQ; 1.12 (0.85-1.49) VAS) or rehospitalization (unadjusted HR 0.83 (0.72-0.96) KCCQ; 0.99 (0.85-1.16) VAS). Three-month KCCQ was associated with mortality (unadjusted HR 2.17 (1.47-3.21); VAS was not (1.43 (0.94-2.17). Three-month KCCQ added incremental discriminatory value to the HeartMate II Risk Score for death (c-stat 0.60 to 0.66); VAS did not (c-stat 0.59 to 0.60). Three-month health status was associated with rehospitalization (unadjusted HR 1.31 (1.15-1.57) KCCQ; 1.24 (1.05-1.46) VAS), but did not add incremental discriminatory value (c-stat 0.52 to 0.55 and 0.54, respectively)., Conclusions: These real-world data suggest that pre-operative health status has limited association with outcomes after LVAD. However, persistently low health status after surgery may independently signal higher risk for subsequent death. Further study is needed to determine the clinical utility of routinely collected health status data after LVAD implantation.

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.)

Background: As treatment options for atrial fibrillation (AF) increase, more attention is focused on patients' experiences and quality of life (QoL). However, little is known about the factors associated with these outcomes., Methods: The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) is a disease-specific QoL tool for AF, with domain and summary scores ranging from 0 (the worst QoL) to 100. Using multivariable linear regression, we evaluated factors associated with baseline AFEQT Summary and Subscale Scores in ORBIT AF, a large, community-based AF registry. Independent associations were reported as coefficient estimates in scores and 95% confidence intervals (CI)., Results: Overall, AFEQT was assessed in 2007 AF outpatients from 99 sites. Median age (IQR) was 76 years (67-82) and 43% were female. The median AFEQT summary score was 82 (67-94). Female sex, younger age, new onset AF, higher heart rate, obstructive sleep apnea, symptomatic heart failure (HF), chronic obstructive pulmonary disease and coronary artery disease were all independently associated with reduced QoL. Female sex [Estimate -7.03, 95% CI (-9.31, -4.75)] and new onset versus permanent AF [Estimate -7.44, 95% CI (-11.03, -3.84)] were independently associated with increased symptoms. NYHA Class III or IV HF [Estimate -14.44, 95% CI (-19.46, -8.76)] and female sex [Estimate -7.91, 95% CI (-9.95, -5.88)] were most independently associated with impaired daily activities., Conclusions: QoL in patients with AF varies widely and is associated with several patient factors. Understanding patient factors independently associated with worse QoL can be a foundation for tailoring treatment., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Despite advances in cardiac therapy, heart failure (HF) remains a progressive, highly symptomatic, and deadly disease that places great demands on patients, caregivers, and healthcare systems. Palliative care is a multidisciplinary approach to care that focuses on communication, shared decision making, and advance care planning; provides relief from pain and other distressing symptoms; integrates psychological and spiritual aspects of care; and offers a support system to help families cope during illness and bereavement. Palliative care has applications across the stages of heart failure, including early in the course of illness, often in conjunction with other therapies that are intended to prolong life. However, the incorporation of palliative care into the management of heart failure has been suboptimal for several reasons: uncertainty in the disease trajectory, failure to reward communication between healthcare providers and patients, siloed care, lack of knowledge, overlay of comorbidity and frailty, life saving devices with complex trade-offs, and a limited evidence base. This review will summarize the current literature on the emerging role of palliative care in patients with heart failure and the challenges and opportunities for its integration into routine care. It will discuss current initiatives and future directions of the collaborative relationship between the palliative care and heart failure disciplines., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

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.)

We propose that stage D advanced heart failure be defined as the presence of progressive and/or persistent severe signs and symptoms of heart failure despite optimized medical, surgical, and device therapy. Importantly, the progressive decline should be primarily driven by the heart failure syndrome. Formally defining advanced heart failure and specifying when medical and device therapies have failed is challenging, but signs and symptoms, hemodynamics, exercise testing, biomarkers, and risk prediction models are useful in this process. Identification of patients in stage D is a clinically important task because treatments are inherently limited, morbidity is typically progressive, and survival is often short. Age, frailty, and psychosocial issues affect both outcomes and selection of therapy for stage D patients. Heart transplant and mechanical circulatory support devices are potential treatment options in select patients. In addition to considering indications, contraindications, clinical status, and comorbidities, treatment selection for stage D patients involves incorporating the patient's wishes for survival versus quality of life, and palliative and hospice care should be integrated into care plans. More research is needed to determine optimal strategies for patient selection and medical decision making, with the ultimate goal of improving clinical and patient centered outcomes in patients with stage D heart failure., (Copyright © 2015 Elsevier Inc. All rights reserved.)

BackgroundA better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients' physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care.MethodsAdults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes.ResultsParticipants' (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p

Current pharmacological therapies for heart failure with reduced ejection fraction are largely either repurposed anti-hypertensives that blunt overactivation of the neurohormonal system or diuretics that decrease congestion. However, they do not address the symptoms of heart failure that result from reductions in cardiac output and reserve. Over the last few decades, numerous attempts have been made to develop and test positive cardiac inotropes that improve cardiac haemodynamics. However, definitive clinical trials have failed to show a survival benefit. As a result, no positive inotrope is currently approved for long-term use in heart failure. The focus of this state-of-the-art review is to revisit prior clinical trials and to understand the causes for their findings. Using the learnings from those experiences, we propose a framework for future trials of such agents that maximizes their potential for success. This includes enriching the trials with patients who are most likely to derive benefit, using biomarkers and imaging in trial design and execution, evaluating efficacy based on a wider range of intermediate phenotypes, and collecting detailed data on functional status and quality of life. With a rapidly growing population of patients with advanced heart failure, the epidemiologic insignificance of heart transplantation as a therapeutic intervention, and both the cost and morbidity associated with ventricular assist devices, there is an enormous potential for positive inotropic therapies to impact the outcomes that matter most to patients.

BackgroundAs treatment options for atrial fibrillation (AF) increase, more attention is focused on patients' experiences and quality of life (QoL). However, little is known about the factors associated with these outcomes.MethodsThe Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) is a disease-specific QoL tool for AF, with domain and summary scores ranging from 0 (the worst QoL) to 100. Using multivariable linear regression, we evaluated factors associated with baseline AFEQT Summary and Subscale Scores in ORBIT AF, a large, community-based AF registry. Independent associations were reported as coefficient estimates in scores and 95% confidence intervals (CI).ResultsOverall, AFEQT was assessed in 2007 AF outpatients from 99 sites. Median age (IQR) was 76 years (67-82) and 43% were female. The median AFEQT summary score was 82 (67-94). Female sex, younger age, new onset AF, higher heart rate, obstructive sleep apnea, symptomatic heart failure (HF), chronic obstructive pulmonary disease and coronary artery disease were all independently associated with reduced QoL. Female sex [Estimate -7.03, 95% CI (-9.31, -4.75)] and new onset versus permanent AF [Estimate -7.44, 95% CI (-11.03, -3.84)] were independently associated with increased symptoms. NYHA Class III or IV HF [Estimate -14.44, 95% CI (-19.46, -8.76)] and female sex [Estimate -7.91, 95% CI (-9.95, -5.88)] were most independently associated with impaired daily activities.ConclusionsQoL in patients with AF varies widely and is associated with several patient factors. Understanding patient factors independently associated with worse QoL can be a foundation for tailoring treatment.

BackgroundAlthough digoxin has long been used to treat atrial fibrillation (AF) and heart failure (HF), its safety remains controversial.ObjectivesThis study sought to describe digoxin use over time in patients with AF who were stratified by the presence or absence of HF, to characterize the predictors of digoxin use and initiation, and to correlate digoxin use with outcomes.MethodsLongitudinal patterns of digoxin use and its association with a variety of outcomes were assessed in a prospective outpatient registry conducted at 174 U.S. sites with enrollment from June 2010 to August 2011.ResultsAmong 9,619 patients with AF and serial follow-up every 6 months for up to 3 years, 2,267 (23.6%) received digoxin at study enrollment, 681 (7.1%) were initiated on digoxin during follow-up, and 6,671 (69.4%) were never prescribed digoxin. After adjusting for other medications, heart rate was 72.9 beats/min among digoxin users and 71.5 beats/min among nonusers (p < 0.0001). Prevalent digoxin use at registry enrollment was not associated with subsequent onset of symptoms, hospitalization, or mortality (in patients with HF, adjusted hazard ratio [HR] for death: 1.04; without HF, HR: 1.22). Incident digoxin use during follow-up was not associated with subsequent death in patients with HF (propensity adjusted HR: 1.05), but was associated with subsequent death in those without HF (propensity adjusted HR: 1.99).ConclusionsAfter adjustment for detailed clinical factors, digoxin use in registry patients with AF had a neutral association with outcomes under most circumstances. Because of the multiple conflicting observational reports about digoxin's safety and possible concerns in specific clinical situations, a large pragmatic trial of digoxin therapy in AF is needed.

Background: Women are less likely to receive left ventricular assist devices and are more likely to experience poor outcomes. However, how gender impacts LVAD decision-making regarding LVAD implantation and the effects of that decision remains unknown. Methods: We performed a sub-group analysis from the stepped-wedge DECIDE-LVAD trial, which tested a decision-support intervention for patients considering LVAD therapy. Results: Excluding 9 patients who withdrew from assessments, of the 239 patients analyzed, 203 (85%) were men and 36 (15%) were women. More men received LVADs (70%) than women (61%) and more men were alive at 6 months compared to women, both among those who received LVADs (87% vs 82%) and those who did not (74% vs 50%) (p = 0.002). Compared to men, women were more likely to have decision regret, depressive symptoms and perceived stress at baseline but not at follow-up. At 6-month follow-up, men experience improvements in decisional conflict, acceptance of illness, struggle with illness, and perceived stress–none of those improvements were noted amongst women. Compared to men who received LVADs, women receiving LVADs had worse decision regret and depressive symptoms at baseline and worse acceptance of illness and perceived stress at six months. Men who received LVADs experienced improvement in decisional conflict and perceived stress, while women did not experience these improvements. Both men and women who received LVADs experienced improvement in depressive symptoms. Quality of life as assessed by EuroQol visual analog scale improved for both men and women who received LVADs but not for those who did not receive LVADs; no gender differences in quality of life were noted. Conclusion: Women require greater decisional support at time of decision to undergo LVAD implantation and subsequently might benefit from more intensive psychosocial support. [ABSTRACT FROM AUTHOR]

Objective: Chronic obstructive pulmonary disease (COPD) is associated with the development of atrial fibrillation (AF), and may complicate treatment of AF. We examined the association between COPD and symptoms, quality of life (QoL), treatment and outcomes among patients with AF.Methods: We compared patients with and without a diagnosis of COPD in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation, a prospective registry that enrolled outpatients with AF not secondary to reversible causes, from both academic and community settings.Results: Among 9749 patients with AF, 1605 (16%) had COPD. Relative to patients without COPD, those with COPD were more likely to be older, current/former smokers (73% vs 43%), have heart failure (54% vs 29%) and coronary artery disease (49% vs 34%). Oral anticoagulant and beta blocker use were similar, whereas digoxin use was more common among patients with COPD. Symptom burden was generally higher, and QoL worse, among patients with COPD (median Atrial Fibrillation Effect on QualiTy-of-Life score 76 vs 83). Patients with COPD had higher risk of all-cause mortality (adjusted HR 1.52 (95% CI 1.32 to 1.74)), cardiovascular mortality (adjusted HR 1.51 (95% CI 1.24 to 1.84)) and cardiovascular hospitalisation (adjusted HR 1.15 (95% CI 1.05 to 1.26)). Patients with COPD also had higher risk of major bleeding events (adjusted HR 1.25 (95% CI 1.05 to 1.50)). There did not appear to be associations between COPD and AF progression, ischaemic events or new-onset heart failure.Conclusions: Among patients with AF, COPD is associated with higher symptom burden, worse QoL, and worse cardiovascular and bleeding outcomes. These associations were not fully explained by cardiovascular risk factors, AF treatment or smoking history.Clinical Registration Number: NCT01165710. [ABSTRACT FROM AUTHOR]

Background. Unrestrained use of expensive, high-risk interventions runs counter to the idea of a limited medical commons. Objective. To examine the effect of displaying the total first-year cost of implanting a left ventricular assist device (LVAD) on a hypothetical treatment decision and whether this effect differs when choosing for oneself versus for another person. Design. We conducted an online survey in February 2016. The survey described the clinical course of end-stage heart failure and the risks and benefits of an LVAD. Participants were randomized to 1 of 4 scenarios, which varied by patient identity (oneself versus another person) and description of total cost. Measurements. This study measured acceptance of LVAD implantation. Reasoning and attitudes were secondarily explored. Results. We received 1211 valid responses. The mean age was 38.3 y (±12.8); 53.5% were female and 84.4% were white. Participants were more likely to accept an LVAD when shown the total cost (66.2% v. 58.0%, P = 0.003) or when choosing for another (68.0 % v. 56.4%, P < 0.001). Open-ended responses indicated that acceptors wanted to extend survival while decliners feared poor quality of life with LVAD therapy. Acceptors and decliners agreed that consumers can help lower the cost of health care, but decliners were more likely to consider cost when making health care decisions (P < 0.001). Limitations. Limitations include the use of a hypothetical scenario, the use of paid participants, and differences between the respondents and the typical patient facing an LVAD decision. Conclusions. In this sample, being shown the total cost increased the likelihood of accepting an expensive, high-risk treatment. The results question how well consumers understand the relationship between expensive treatments and the commons. [ABSTRACT FROM AUTHOR]

Background: Increased spiritual well-being is related to quality of life (QOL) in patients with heart failure (HF). However, consistent and deliberate integration of spirituality into HF patient care has received limited attention. Objective: The aim of this study was to evaluate the feasibility, acceptability, and preliminary evidence regarding the efficacy of a resource-sparing psychospiritual intervention to improve QOL in HF patients. Methods: A12-week mail-based intervention addressing spirituality, stress, coping, and adjusting to illness was developed and tested using a mixed-methods, 1-group pretest-posttest pilot study design. A convenience sample of patients with HF completed prestudy and poststudy questionnaires, including the Kansas City Cardiomyopathy Questionnaire, Patient Health Questionnaire, Meaning in Life Questionnaire, and Functional Assessment of Chronic Illness Therapy-Spiritual. Research staff conducted semistructured interviews with program completers. Interviews were coded and analyzed using conventional content analysis. Results: Participants (N = 33; 82% male; mean age, 61 years) completed 87% of baseline data collection, an average of 9 intervention modules, and 55% of poststudy questionnaires. Participants rated all the modules as at least moderately helpful, and qualitative themes suggested that patients found the intervention acceptable and beneficial. Most participants believed spirituality should continue to be included, although they disagreed on the extent to which religion should remain. Participants who completed the intervention reported evidence suggesting increased QOL (Kansas City Cardiomyopathy Questionnaire; effect size [ES], 0.53), decreased depressive symptoms (Patient Health Questionnaire-9; ES, 0.62), and less searching for meaning (Meaning in Life Questionnaire; ES, 0.52). Conclusions: Results indicate that a module-based program integrating spirituality and psychosocial coping strategies was feasible and acceptable and may improve QOL. This preliminary study suggests that clinicians be open to issues of spirituality as they may relate to QOL in patients with HF. Future research will test a revised intervention. [ABSTRACT FROM AUTHOR]

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 6 months 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. [ABSTRACT FROM AUTHOR]

Background-A left ventricular assist device (LVAD) improves survival and quality of life for many, but not all, patients with end-stage heart failure who are ineligible for transplantation. We sought to evaluate the frequency of poor outcomes using a novel composite measure that integrates quality of life with mortality. Methods and Results-Within the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) national registry, poor outcome was defined as death or an average Kansas City Cardiomyopathy Questionnaire <45 during the year after LVAD (persistently limiting heart failure symptoms and poor quality of life). Among 1638 patients with LVAD, 29.7% had a poor outcome, with death in 22.4% and persistently poor quality of life in 7.3%. Patients who had a poor outcome were more likely to have higher body mass indices (29.3 versus 28.2 kg/m2; P=0.007), lower hemoglobin levels (11.1 versus 11.4 g/dL; P=0.005), previous cardiac surgery (47.8% versus 39.8%; P=0.004), history of cancer (13.8% versus 9.7%; P=0.025), severe diabetes mellitus (15.6% versus 11.5%; P=0.038), and poorer quality of life preimplant (Kansas City Cardiomyopathy Questionnaire scores: 29.8 versus 35.3; P<0.001). Conclusions-Nearly one third of patients die or have a persistently poor quality of life during the year after LVAD. We identified several factors associated with a poor outcome, which may inform discussions before LVAD implantation to enable more realistic expectations of recovery. [ABSTRACT FROM AUTHOR]

Heart failure (HF) is a major cause of mortality and morbidity, representing a leading cause of death and hospitalization among U.S. Medicare beneficiaries. Advances in science have generated effective interventions to reduce adverse outcomes in HF, particularly in patients with reduced left ventricular ejection fraction. Unfortunately, effective therapies for heart failure are often not utilized in an effective, safe, timely, equitable, patient-centered, and efficient manner. Further, the risk of adverse outcomes for HF remains high. The last decades have witnessed the growth of efforts to measure and improve the care and outcomes of patients with HF. This paper will review the evolution of quality measurement for HF, including a brief history of quality measurement in medicine; the measures that have been employed to characterize quality in heart failure; how the measures are obtained; how measures are employed; and present and future challenges surrounding quality measurement in heart failure. [ABSTRACT FROM AUTHOR]

The article highlights the unfavorable future quality of life assessment for patients with heart failure. Data from the Kansas City Cardiomyopathy Questionnaire was used by the authors to identify the factors associated with 6-month mortality and additional data was derived from the Efficacy of Vasopressin Antagonism in HF Outcome Study with Tolvaptan (EVEREST). The authors say patients who were found to be at high risk for unfavorable QoL should be educated about his options before discharge.

Supplemental Digital Content is available in the text. Background: Family caregivers of patients with a destination therapy left ventricular assist device play a central and formalized role in postimplant care. We aimed to characterize longitudinal stress, predictors and correlates of stress, and coping processes among left ventricular assist device caregivers. Methods: We performed a sequential, exploratory, mixed-methods study from 6 diverse left ventricular assist device programs. The primary outcome for the quantitative analysis was the Perceived Stress Scale-10 at 6 months (0–40). Based on the quantitative findings and guided by the Transactional Model of Stress and Coping, semistructured interviews explored causes of stress and coping processes. Integration was performed during the qualitative and interpretation phase. Results: A total of 96 caregivers met inclusion criteria for quantitative analysis. Mean (SD) Perceived Stress Scale score was 14.3 (5.5) preimplant and 11.8 (6.9) at 6 months. Preimplant, only decreased preparedness for caregiving was associated with higher Perceived Stress Scale score at 6 months. At 6 months, increased caregiver depressive symptoms, decreased caregiver preparedness for caregiving, and lower patient quality of life were associated with higher Perceived Stress Scale score. Qualitative analysis of 25 caregivers revealed the causes of stress coalesced around 3 themes: (1) lack of preparedness to be a caregiver, (2) uniqueness of stress for the caregiver and patient situation, and (3) caregiving responsibilities physically and emotionally impacting caregivers. To cope with stress, most caregivers employed emotion-focused coping. Conclusions: In family caregivers of patients with a left ventricular assist device, higher perceived stress was associated with lower caregiver preparedness, higher caregiver depressive symptoms, and lower patient quality of life. Emotion-focused coping strategies were common for caregivers. Future work should better prepare caregivers for this role and support them through the caregiving experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02344576. [ABSTRACT FROM AUTHOR]

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). 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. 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. 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. [ABSTRACT FROM AUTHOR]

The authors discuss a study which investigated the prediction of the outcome of transcatheter aortic valve replacement (TAVR), by Arnold and colleagues, published within the issue. They offer clinical information on TAVR, as well as the possible outcomes of TAVR, the risk factors that can lead to poor TAVR outcome, and the clinical significance of the study findings.

Background: Many patients with severe aortic stenosis (AS) have the option of transcatheter aortic valve replacement (TAVR). Individual treatment considerations hinge on the likelihood of improvements to quality of life (QOL), especially when uncertainty is amplified by the presence of comorbidities or the necessity of non-transfemoral approaches. Methods: Using PRISMA guidelines, we conducted an ongoing multi-database search for all trials of TAVR including QOL assessment at 1 and 12 mos post-procedure. Trials were included if they were published in English since 2013 and used either the KCCQ or SF-12 as outcome measures. We performed a mixed-effects meta-regression of extant trial data to determine whether short and long-term quality of life (QOL) improvements attributable to TAVR differed according to patient surgical risk (inoperable, high, or intermediate) or access approach (transfemoral or alternate). Results: We identified 29 total trial-cohorts meeting criteria. After removing duplicate analyses, we were left with 15 cohorts including 4383 total patients who received TAVR. Due to heterogeneity of variance, random effects models were fit, illustrating a consistent positive effect on QOL across trials, both at 1mo (log relative mean difference=-0.6, 95% CI: -0.91 to -0.37), and 12mos (lrmd=-0.99, 95% CI: -1.25 to --0.73). At 1mo, QOL impact was moderated according to whether trans-femoral or alternate approaches were used (p<.02) but not by surgical risk. At 12 mos, neither factor moderated improvements to QOL. Conclusion: TAVR is consistently associated with improved QOL at 1 and 12mos post-procedure. Pooled analyses suggest that short-term QOL improvement is moderated by procedural approach, but not surgical risk, and longitudinal QOL is independent of both. These data support the adoption of TAVR among patients with varied surgical risk, even in need for alternative access approaches. [ABSTRACT FROM AUTHOR]

Our understanding of the risk factors and complications of atrial fibrillation (AF) is based mostly on studies that have evaluated AF in a binary fashion (present or absent) and have not investigated AF burden. This scientific statement discusses the published literature and knowledge gaps related to methods of defining and measuring AF burden, the relationship of AF burden to cardiovascular and neurological outcomes, and the effect of lifestyle and risk factor modification on AF burden. Many studies examine outcomes by AF burden classified by AF type (paroxysmal versus nonparoxysmal); however, quantitatively, AF burden can be defined by longest duration, number of AF episodes during a monitoring period, and the proportion of time an individual is in AF during a monitoring period (expressed as a percentage). Current guidelines make identical recommendations for anticoagulation regardless of AF pattern or burden; however, a review of recent evidence suggests that higher AF burden is associated with higher risk of stroke. It is unclear whether the risk increases continuously or whether a threshold exists; if a threshold exists, it has not been defined. Higher burden of AF is also associated with higher prevalence and incidence of heart failure and higher risk of mortality, but not necessarily lower quality of life. A structured and comprehensive risk factor management program targeting risk factors, weight loss, and maintenance of a healthy weight appears to be effective in reducing AF burden. Despite this growing understanding of AF burden, research is needed into validation of definitions and measures of AF burden, determination of the threshold of AF burden that results in an increased risk of stroke that warrants anticoagulation, and discovery of the mechanisms underlying the weak temporal correlations of AF and stroke. Moreover, developments in monitoring technologies will likely change the landscape of long-term AF monitoring and could allow better definition of the significance of changes in AF burden over time. [ABSTRACT FROM AUTHOR]

Introduction: Mental health in patients (pts) with advanced heart failure (HF) who undergo implantation of mechanical circulatory support (MCS) is poorly described. Further research is needed to identify areas of risk and guide mental health-related therapies. The purpose of this report is to describe and compare mental health sub-domains at early, mid, and later time periods after durable MCS implantation with a left ventricular assist device. Methods: Using a cross-sectional design, we enrolled 238 MCS pts who were at least 3 months post implantation from 9 US sites between 10/26/16 - 11/21/17. Mental health sub-domains, assessed via self-report, were perception of anxiety and depression (PROMIS, v1.0), perception of cognitive function (PROMIS, v2.0), stigma (Neuro-QoL, modified), and spirituality (FACIT-Sp-12, v4). Pt characteristics and mental health sub-domains were compared across time periods with Chi-Square tests and ANOVAs. Results: The majority of pts were male, White, and well educated; age differed by time period post implant. Etiology of HF and implant strategy were similar among time periods. For all three time periods, anxiety and depression scores approximated the US general population mean (50). Cognitive function scores across the three time periods were also similar to the US general population mean (50). Pts at all time periods reported never to rarely experiencing stigma; pts >6mos-24mos post implant reported more stigma than pts earlier or later post implant. Pts at all time periods reported very good spiritual well-being; scores trended lower (worse) among pts >6-24 mos. post implant (Table). Conclusions: MCS pts at all three times post implant reported anxiety, depression, and cognitive function similar to that of the US general population. Spiritual well-being was high, and stigma was low, although it varied by time period. These findings may provide direction for mental health focused therapies after MCS implantation. [ABSTRACT FROM AUTHOR]