Shared Decision-Making and Cardiovascular Health: A Scientific Statement From the American Heart Association.

Shared decision-making is increasingly embraced in health care and recommended in cardiovascular guidelines. Patient involvement in health care decisions, patient-clinician communication, and models of patient-centered care are critical to improve health outcomes and to promote equity, but formal models and evaluation in cardiovascular care are nascent. Shared decision-making promotes equity by involving clinicians and patients, sharing the best available evidence, and recognizing the needs, values, and experiences of individuals and their families when faced with the task of making decisions. Broad endorsement of shared decision-making as a critical component of high-quality, value-based care has raised our awareness, although uptake in clinical practice remains suboptimal for a range of patient, clinician, and system issues. Strategies effective in promoting shared decision-making include educating clinicians on communication techniques, engaging multidisciplinary medical teams, incorporating trained decision coaches, and using tools (ie, patient decision aids) at appropriate literacy and numeracy levels to support patients in their cardiovascular decisions. This scientific statement shines a light on the limited but growing body of evidence of the impact of shared decision-making on cardiovascular outcomes and the potential of shared decision-making as a driver of health equity so that everyone has just opportunities. Multilevel solutions must align to address challenges in policies and reimbursement, system-level leadership and infrastructure, clinician training, access to decision aids, and patient engagement to fully support patients and clinicians to engage in the shared decision-making process and to drive equity and improvement in cardiovascular outcomes.

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

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

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

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

Clinician Insights into Effective Components, Delivery Characteristics, and Implementation Strategies of Ambulatory Palliative Care for People with Heart Failure: A Qualitative Analysis.

OBJECTIVES: To elicit perspectives from specialist palliative care (SPC) and cardiology clinicians on the necessary components, delivery characteristics, and implementation strategies of successful ambulatory SPC for people with heart failure (HF). BACKGROUND: Palliative care is a recommended component of guideline-directed care for people with HF. However, optimal strategies to implement SPC within ambulatory settings are unknown. METHODS: We conducted a qualitative descriptive study comprised of semi-structured interviews with SPC and cardiology clinicians at Veterans Affairs Medical Centers (VAMCs) with the highest number of ambulatory SPC consultations within the VA system among people with HF from 2021-2022. Clinicians were asked how they provided ambulatory SPC and what they felt were the necessary components, delivery characteristics, and implementation strategies of care delivery. Interviews were analyzed using directed content analysis. RESULTS: We interviewed 14 SPC clinicians and 9 cardiology clinicians at seven national VAMCs; 43% were physicians and 48% were advanced practice registered nurses/physician associates. Essential components of ambulatory SPC encompassed discussion of goals of care (e.g., prognosis, advance directives) and connecting patients/caregivers to resources (e.g., homecare). Preferred delivery characteristics included integrated (i.e., embedded) approaches to SPC delivery, standardized patient selection and referral procedures, and formalized procedures for handoffs to and from SPC. Strategies that addressed SPC implementation included deploying palliative champions, educating non-SPC clinicians on the value of ambulatory SPC for people with HF, and developing ambulatory models through leadership support. CONCLUSIONS/IMPLICATIONS: Facilitating the broader adoption of ambulatory SPC among people with HF may be achieved by prioritizing these mutually valued and necessary features of SPC delivery.

Cognitive Impairment in Heart Failure: A Heart Failure Society of America Scientific Statement.

Cognitive impairment is common among adults with heart failure (HF), as both diseases are strongly related to advancing age and multimorbidity (including both cardiovascular and noncardiovascular conditions). Moreover, HF itself can contribute to alterations in the brain. Cognition is critical for a myriad of self-care activities that are necessary to manage HF, and it also has a major impact on prognosis; consequently, cognitive impairment has important implications for self-care, medication management, function and independence, and life expectancy. Attuned clinicians caring for patients with HF can identify clinical clues present at medical encounters that suggest cognitive impairment. When present, screening tests such as the Mini-Cog, and consideration of referral for comprehensive neurocognitive testing may be indicated. Management of cognitive impairment should focus on treatment of underlying causes of and contributors to cognitive impairment, medication management/optimization, and accommodation of deficiencies in self-care. Given its implications on care, it is important to integrate cognitive impairment into clinical decision making. Although gaps in knowledge and challenges to implementation exist, this scientific statement is intended to guide clinicians in caring for and meeting the needs of an increasingly complex and growing subpopulation of patients with HF.

Remote Follow-up in a Heart Failure Pragmatic Trial: Insights From the CONNECT-HF.

BACKGROUND: Randomized controlled trials typically require study-specific visits, which can burden participants and sites. Remote follow-up, such as centralized call centers for participant-reported or site-reported, holds promise for reducing costs and enhancing the pragmatism of trials. In this secondary analysis of the CONNECT-HF (Care Optimization Through Patient and Hospital Engagement For HF) trial, we aimed to evaluate the completeness and validity of the remote follow-up process. METHODS AND RESULTS: The CONNECT-HF trial evaluated the effect of a post-discharge quality-improvement intervention for heart failure compared to usual care for up to 1 year. Suspected events were reported either by participants or by health care proxies through a centralized call center or by sites through medical-record queries. When potential hospitalization events were suspected, additional medical records were collected and adjudicated. Among 5942 potential hospitalizations, 18% were only participant-reported, 28% were reported by both participants and sites, and 50% were only site-reported. Concordance rates between the participant/site reports and adjudication for hospitalization were high: 87% participant-reported, 86% both, and 86% site-reported. Rates of adjudicated heart failure hospitalization events among adjudicated all-cause hospitalization were lower but also consistent: 45% participant-reported, 50% both, and 50% site-reported. CONCLUSIONS: Participant-only and site-only reports missed a substantial number of hospitalization events. We observed similar concordance between participant/site reports and adjudication for hospitalizations. Combining participant-reported and site-reported outcomes data is important to capture and validate hospitalizations effectively in pragmatic heart failure trials.

Bias in team decision-making for advanced heart failure therapies: model application.

Bias in advanced heart failure therapy allocation results in inequitable outcomes for minoritized populations. The purpose of this study was to examine how bias is introduced during group decision-making with an interprofessional team using Breathett's Model of Heart Failure Decision-Making. This was a secondary qualitative descriptive analysis from a study focused on bias in advanced heart failure therapy allocation. Team meetings were recorded and transcribed from four heart failure centers. Breathett's Model was applied both deductively and inductively to transcripts (n = 12). Bias was identified during discussions about patient characteristics, clinical fragility, and prior clinical decision-making. Some patients were labeled as "good citizens" or as adherent/non-adherent while others benefited from strong advocacy from interprofessional team members. Social determinants of health also impacted therapy allocation. Interprofessional collaboration with advanced heart failure therapy allocation may be enhanced with the inclusion of patient advocates and limit of clinical decision-making using subjective data.

2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure" replaces the "2013 ACCF/AHA Guideline for the Management of Heart Failure" and the "2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure." The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose, and manage patients with heart failure. METHODS: A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies, published through September 2021, were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021. Structure: Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients' interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments with high-quality published economic analyses.

2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure" replaces the "2013 ACCF/AHA Guideline for the Management of Heart Failure" and the "2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure." The 2022 guideline is intended to provide patient-centric recommendations for clinicians to prevent, diagnose, and manage patients with heart failure. METHODS: A comprehensive literature search was conducted from May 2020 to December 2020, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from MEDLINE (PubMed), EMBASE, the Cochrane Collaboration, the Agency for Healthcare Research and Quality, and other relevant databases. Additional relevant clinical trials and research studies, published through September 2021, were also considered. This guideline was harmonized with other American Heart Association/American College of Cardiology guidelines published through December 2021. Structure: Heart failure remains a leading cause of morbidity and mortality globally. The 2022 heart failure guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with heart failure, with the intent to improve quality of care and align with patients' interests. Many recommendations from the earlier heart failure guidelines have been updated with new evidence, and new recommendations have been created when supported by published data. Value statements are provided for certain treatments with high-quality published economic analyses.

Secondary analysis of electronic opt-out consent in pragmatic research: A study design method to diversify clinical trials?

We conducted a multi-center pragmatic trial of a low-risk intervention focused on medication adherence using an opt-out consent approach, where patients could opt out by letter and then electronically. We focus on the cohort after opt-out by mail. Here, we describe that 8% of patients opted out electronically, resulting in a 92% participation rate. Patients who self-identify as Black or Hispanic were less likely to opt out in the study, and half the study cohort was female. This demographic data is useful for planning future trials employing this approach.

Transthyretin amyloid cardiomyopathy among patients hospitalized for heart failure and performance of an adapted wild-type ATTR-CM machine learning model: Findings from GWTG-HF.

BACKGROUND: An 11-factor random forest model has been developed among ambulatory heart failure (HF) patients for identifying potential wild-type amyloidogenic TTR cardiomyopathy (wtATTR-CM). The model has not been evaluated in a large sample of patients hospitalized for HF. METHODS: This study included Medicare beneficiaries aged ≥65 years hospitalized for HF in the Get With The Guidelines-HF® Registry from 2008-2019. Patients with and without a diagnosis of ATTR-CM were compared, as defined by inpatient and outpatient claims data within 6 months pre- or post-index hospitalization. Within a cohort matched 1:1 by age and sex, univariable logistic regression was used to evaluate relationships between ATTR-CM and each of the 11 factors of the established model. Discrimination and calibration of the 11-factor model were assessed. RESULTS: Among 205,545 patients (median age 81 years) hospitalized for HF across 608 hospitals, 627 patients (0.31%) had a diagnosis code for ATTR-CM. Univariable analysis within the 1:1 matched cohort of each of the 11-factors in the ATTR-CM model found pericardial effusion, carpal tunnel syndrome, lumbar spinal stenosis, and elevated serum enzymes (e.g., troponin elevation) to be strongly associated with ATTR-CM. The 11-factor model showed modest discrimination (c-statistic 0.65) and good calibration within the matched cohort. CONCLUSIONS: Among US patients hospitalized for HF, the number of patients with ATTR-CM defined by diagnosis codes on an inpatient/outpatient claim within 6 months of admission was low. Most factors within the prior 11-factor model were associated with greater odds of ATTR-CM diagnosis. In this population, the ATTR-CM model demonstrated modest discrimination.

Palliative Care for Patients With Heart Failure: Results From a Heart Failure Society of America Survey.

BACKGROUND: Multiple guidelines recommend specialty palliative care (PC) for patients with heart failure (HF), including patients with left ventricular assist devices (LVADs). However, the degree of integration and clinicians' perceptions of PC in HF care remain incompletely characterized. METHODS AND RESULTS: A 36-item survey was sent to 2109 members of the Heart Failure Society of America. Eighty respondents (53% physicians), including 51 respondents from at least 42 medical centers, completed the survey, with the majority practicing in urban (76%) academic medical centers (62%) that implanted LVADs (81%). Among the 42 unique medical centers identified, respondents reported both independent (40%) and integrated (40%) outpatient PC clinic models, whereas 12% reported not having outpatient PC at their institutions. A minority (12%) reported that their institution used triggered PC referrals based on objective clinical data. Of respondents from LVAD sites, the majority reported that a clinician from the PC team was required to see all patients prior to implantation, but there was variability in practices. Among all respondents, the most common reasons for PC referral in HF were poor prognosis, consideration of advanced cardiac therapies or other high-risk procedures and advance-care planning or goals-of-care discussions. The most frequent perceived barriers to PC consultation included lack of PC clinicians, unpredictable HF clinical trajectories and limited understanding of how PC can complement traditional HF care. CONCLUSION: PC integration and clinician perceptions of services vary in HF care. More research and guidance regarding evidence-based models of PC delivery in HF are needed.

The Promise and Risks of mHealth in Heart Failure Care.

Mobile health (mHealth) is an emerging approach to health care. It involves wearable, connected technologies that facilitate patient-symptom or physiological monitoring, support clinical feedback to patients and physicians, and promote patients' education and self-care. Evolving algorithms may involve artificial intelligence and can assist in data aggregation and health care teams' interpretations. Ultimately, the goal is not merely to collect data; rather, it is to increase actionability. mHealth technology holds particular promise for patients with heart failure, especially those with frequently changing clinical status. mHealth, ideally, can identify care opportunities, anticipate clinical courses and augment providers' capacity to implement, titrate and monitor interventions safely, including evidence-based therapies. Although there have been marked advancements in the past decade, uncertainties remain for mHealth, including questions regarding optimal indications and acceptable payment models. In regard to mHealth capability, a better understanding is needed of the incremental benefit of mHealth data over usual care, the accuracy of specific mHealth data points in making clinical care decisions, and the efficiency and precision of algorithms used to dictate actions. Importantly, emerging regulations in the wake of COVID-19, and now the end of the federal public health emergency, offer both opportunity and risks to the broader adoption of mHealth-enabled services. In this review, we explore the current state of mHealth in heart failure, with particular attention to the opportunities and challenges this technology creates for patients, health care providers and other stakeholders.

PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study.

Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life.

Sex-disparities in chest pain workup: a retrospective cohort review of a university based clinical decision pathway.

BACKGROUND: Females have historically lower rates of cardiovascular testing when compared to males. Clinical decision pathways (CDP) that utilize standardized risk-stratification methods may balance this disparity. We sought to determine whether clinical decision pathways could minimize sex-based differences in the non-invasive workup of chest pain in the emergency department (ED). Moreover, we evaluated whether the HEART score would minimize sex-based differences in risk-stratification. METHODS: We conducted a retrospective cohort review of adult ED encounters for chest pain where CDP was employed. Primary outcome was any occurrence of non-invasive imaging (coronary CTA, stress imaging), invasive testing, intervention (PCI or CABG), or death. Secondary outcomes were 30-day major adverse cardiac events (MACE). We stratified HEART scores and primary/secondary outcomes by sex. RESULTS: A total of 1078 charts met criteria for review. Mean age at presentation was 59 years. Females represented 47% of the population. Low, intermediate, and high-risk patients as determined by the HEART score were 17%, 65%, and 18% of the population, respectively, without any significant differences between males and females. Non-invasive testing was similar between males and females when stratified by risk. Males categorized as high risk underwent more coronary angiogram (33% vs. 16%, p = 0.01) and PCI (18% vs. 8%, p = 0.04) than high risk females, but this was not seen in patients categorized as low or intermediate risk. Males experienced more MACE than females (8% vs. 3%, p = 0.001). CONCLUSIONS: We identified no sex-based differences in risk-stratification or non-invasive testing when the CDP was used. High risk males, however, underwent more coronary angiogram and PCI than high risk females, and consequently males experienced more overall MACE than females. This disparity may be explained by sex-based differences in the pathophysiology driving each patient's presentation.

Magnitude of troponin elevation in patients with biomarker evidence of myocardial injury: relative frequency and outcomes in a cohort study across a large healthcare system.

BACKGROUND: Serum troponin levels correlate with the extent of myocyte necrosis in acute myocardial infarction (AMI) and predict adverse outcomes. However, thresholds of cardiac troponin elevation that could portend to poor outcomes have not been established. METHODS: In this cohort study, we characterized all cardiac troponin elevations > 0.04 ng/mL (upper limit of normal [ULN]) from patients hospitalized with an ICD-9/10 diagnosis of AMI across our health system from 2012-2019. We grouped events into exponential categories of peak cardiac troponin and evaluated the association of these troponin categories with all-cause mortality, heart transplants, or durable left ventricular assist devices (LVAD). Patients with cardiac troponin > 10,000 × ULN were manually chart reviewed and described. RESULTS: There were 18,194 AMI hospitalizations with elevated cardiac troponin. Peak troponin was 1-10 × ULN in 21.1%, 10-100 × ULN in 34.8%, 100-1,000 × ULN in 30.1%, 1,000-10,000 × ULN in 13.1%, and > 10,000 × ULN in 0.9% of patients. One-year mortality was 17-21% across groups, except in > 10,000 × ULN group where it was 33% (adjusted hazard ratio (99%CI) for > 10,000 × ULN group compared to all others: 1.86 (1.21, 2.86)). Hazards of one-year transplant and MCS were also significantly elevated in the > 10,000 × ULN group. CONCLUSIONS: Elevation in cardiac troponin levels post AMI that are > 10,000 × ULN was rare but identified patients at particularly high risk of adverse events. These patients may benefit from clarification of goals of care and early referral for advanced heart failure therapies. These data have implications for conversion to newer high-sensitivity cardiac troponin assays whose maximum assay limit is often lower than traditional assays.

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

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

Applying terror management theory to patients with life-threatening illness: a systematic review.

BACKGROUND: Terror management theory (TMT) posits that people manage death-related anxiety through the meaning provided by their cultural world-views and the sense of personal value provided by self-esteem. While a large body of research has supported the core propositions of TMT, little research has focused on its application to individuals with terminal illness. If TMT can help healthcare providers better understand how belief systems adapt and change in life-threatening illness, and the role they play in managing death-related anxiety, it may provide guidance on how to improve communication around treatments near the end of life. As such, we set out to review the available research articles that focus on describing the relationship between TMT and life-threatening illness. METHODS: We reviewed PubMed, PsycINFO, Google Scholar, and EMBASE through May 2022 for original research articles focused on TMT and life-threatening illness. Articles were only deemed appropriate for inclusion if direct incorporation of the principles of TMT were made in reference to a population of interest whom had life-threatening illness Results were screened by title and abstract, followed by full review of candidate articles. References were also scanned. Articles were assessed qualitatively. RESULTS: Six relevant and original research articles were published which provide varied levels of support for TMT's application in critical illness, each article detailed evidence of ideological changes consistent with what TMT would predict. Building self-esteem, enhancing the experience of life as meaningful, incorporating spirituality, engaging family members, and caring for patients at home where meaning and self-esteem can be better maintained are strategies supported by the studies and serve as starting points for further research. CONCLUSION: These articles suggest that applying TMT to life-threatening illness can help identify psychological changes that may effectively minimize the distress from dying. Limitations of this study include a heterogenous group of relevant studies and qualitative assessment.

ENABLE-LVAD: Development and Implementation of a Novel Training Program for Clinicians Supporting Family Caregivers of Patients With a Left Ventricular Assist Device.

BACKGROUND: Despite significant family caregiver (FCG) burnout, there are currently no tested interventions to support the FCG role after left ventricular assist device (LVAD) implantation or formalized training for clinicians to support FCGs. OBJECTIVE: We adapted the existing ENABLE (Educate, Nurture, Advise Before Life Ends) intervention to LVAD clinicians and FCGs and assessed clinical implementation and dissemination. METHODS: ENABLE-LVAD is an interactive, self-paced clinician training coupled with FCG-facing guidebooks and resources. Implementation and dissemination were evaluated by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. RESULTS: As of May 2023, 187 clinicians registered for the training, and 41 completed all modules (22.0% completion rate). Of those who completed the training and responded to a 6-month survey, one-third (n = 10, 33.3%) used ENABLE-LVAD with FCGs, and 100% of those planned to continue using it. The primary barrier to completing the training was time. CONCLUSIONS: The ENABLE-LVAD clinician training was successfully disseminated and implemented as a useful resource to support LVAD FCGs.

An Electronically Delivered Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure With Reduced Ejection Fraction: The EPIC-HF Trial.

BACKGROUND: Major gaps exist in the routine initiation and dose up-titration of guideline-directed medical therapies (GDMT) for patients with heart failure with reduced ejection fraction. Without novel approaches to improve prescribing, the cumulative benefits of heart failure with reduced ejection fraction treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. METHODS: The EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction) trial randomized patients with heart failure with reduced ejection fraction from a diverse health system to usual care versus patient activation tools-a 3-minute video and 1-page checklist-delivered electronically 1 week before, 3 days before, and 24 hours before a cardiology clinic visit. The tools encouraged patients to work collaboratively with their clinicians to "make one positive change" in heart failure with reduced ejection fraction prescribing. The primary endpoint was the percentage of patients with GDMT medication initiations and dose intensifications from immediately preceding the cardiology clinic visit to 30 days after, compared with usual care during the same period. RESULTS: EPIC-HF enrolled 306 patients, 290 of whom attended a clinic visit during the study period: 145 were sent the patient activation tools and 145 were controls. The median age of patients was 65 years; 29% were female, 11% were Black, 7% were Hispanic, and the median ejection fraction was 32%. Preclinic data revealed significant GDMT opportunities, with no patients on target doses of ß-blocker, sacubitril/valsartan, and mineralocorticoid receptor antagonists. From immediately preceding the cardiology clinic visit to 30 days after, 49.0% in the intervention and 29.7% in the control experienced an initiation or intensification of their GDMT (P=0.001). The majority of these changes were made at the clinician encounter itself and involved dose uptitrations. There were no deaths and no significant differences in hospitalization or emergency department visits at 30 days between groups. CONCLUSIONS: A patient activation tool delivered electronically before a cardiology clinic visit improved clinician intensification of GDMT. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03334188.