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To assess the interaction of health literacy and a shared intervention concerning decision quality in patients considering the destination therapy of left ventricular assist device (DT LVAD) implantation.Evidence is limited for the use of decision aids by patients with low health literacy and with life-threatening illnesses.We performed a secondary analysis of the DECIDE-LVAD Trial, a randomized, stepped-wedge trial conducted from 2015-2017 in the United States. The intervention was the integration of a formal shared decision-making intervention. The main outcome was decision quality as measured by LVAD knowledge and values-treatment concordance. Two components of health literacy were measured by the Rapid Estimate of Adult Literacy in Medicine and Subjective Numeracy Scale instruments.Of the 228 patients studied, 44% (n = 101) received the formal shared decision-making intervention, and half had low health literacy. Knowledge of LVAD improved for patients with low literacy in the intervention group compared to the control group: the difference in increased knowledge score was 10.6%; P = 0.04. Values-treatment concordance improved significantly for patients with low literacy in the intervention group compared to the control group: the median improvement in values-treatment correlation coefficient was 0.43; P = 0.03. These benefits were not significant in those with adequate literacy (n = 171). Patients with low numeracy (n = 94) did not show significant improvements in either measure of decision quality, and patients with adequate numeracy (n = 134) showed improvement in LVAD knowledge but not in values-treatment concordance.Patients considering DT LVAD implantation with low literacy showed improvement in decision quality after the integration of a shared decision-making intervention.

Background: Some patients with heart failure (HF) will go on to develop advanced HF, characterized by severe HF symptoms despite attempts to optimize medical therapy. The goals of this study were to examine the risk of developing advanced HF in patients with newly diagnosed HF, identify risk factors for developing advanced HF, and evaluate the impact of advanced HF on outcomes. Methods: This was a population-based, retrospective cohort study of Olmsted County, Minnesota, residents with a new clinical diagnosis of HF between 2007 and 2017. Risk factors for the development of advanced HF (2018 European Society of Cardiology criteria) were examined using cause-specific Cox proportional hazard regression models. The associations of development of advanced HF with risks of hospitalization and mortality were examined using the Andersen-Gill and Cox models, respectively. Results: There were 4597 residents with incident HF from 2007 to 2017. The cumulative incidence of advanced HF was 11.5% (95% CI, 10.5%–12.5%) at 6 years after incident HF diagnosis overall and was 14.4% (95% CI, 12.3%–16.9%), 11.4% (95% CI, 8.9%–14.6%), and 11.7% (95% CI, 10.3%–13.2%) in patients with incident HF with reduced, mildly reduced, and preserved ejection fraction, respectively. Key demographics, comorbidities, and echocardiographic characteristics were independently associated with the development of advanced HF. Development of advanced HF was associated with increased risks of all-cause hospitalization (adjusted hazard ratio, 3.0 [95% CI, 2.7–3.4]; P P Conclusions: In this population-based study, development of advanced HF was common and was associated with markedly increased morbidity and mortality.

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.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.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.

Background Diabetes mellitus is associated with increased rates of mortality in patients with less severe (stage C) heart failure (HF). The prevalence of diabetes and its complications in advanced (stage D) HF and their contributions to mortality risk are unknown. Methods and Results We conducted a retrospective population-based cohort study of all adult residents of Olmsted County, Minnesota, who had advanced HF between 2007 and 2017. Patients with diabetes were identified by using the criteria of the Healthcare Effectiveness Data and Information Set. Diabetes complications were captured by using the Diabetes Complications Severity Index. Of 936 patients with advanced HF, 338 (36.1%) had diabetes. Overall, median survival time after development of advanced HF was 13.1 (3.9–33.1) months; mortality did not vary by diabetes status (aHR 1.06, 95% CI 0.90–1.25; P = 0.45) or by glycated hemoglobin levels in those with diabetes (aHR 1.01 per 1% increase, 95% CI 0.93–1.10; P = 0.82). However, patients with diabetes and 4 (aHR 1.24, 95% CI 0.92–1.67) or 5–7 (aHR 1.49, 95% CI 1.09–2.03) diabetes complications were at increased risk of mortality compared to those with ≤ 3 complications. Conclusions More than one-third of patients with advanced HF have diabetes. In advanced HF, overall prognosis is poor, but we found no evidence that diabetes is associated with a significantly higher mortality risk.

Background Sepsis is associated with an elevated risk of late cardiovascular events among hospital survivors. Methods and Results We included OptumLabs Data Warehouse patients from 2009 to 2019 who survived a medical/nonsurgical hospitalization lasting at least 2 nights. The association between sepsis during hospitalization, based on explicit and implicit discharge International Classification of Diseases, Ninth Revision ( ICD‐9 )/ Tenth Revision ( ICD‐10 ) diagnosis codes, with subsequent death and rehospitalization was analyzed using Kaplan–Meier survival analysis and multivariable Cox proportional‐hazards models. The study population included 2 258 464 survivors of nonsurgical hospitalization (5 396 051 total patient‐years of follow‐up). A total of 808 673 (35.8%) patients had a sepsis hospitalization, including implicit sepsis only in 448 644, explicit sepsis only in 124 841, and both in 235 188. Patients with sepsis during hospitalization had an elevated risk of all‐cause mortality (adjusted hazard ratio [HR], 1.27 [95% CI, 1.25–1.28]; P P P P P Conclusions Survivors of sepsis hospitalization are at elevated risk of early and late post‐discharge death as well as cardiovascular and non‐cardiovascular rehospitalization. This hazard spans the spectrum of cardiovascular events and may suggest that sepsis is an important cardiovascular risk factor.

Objectives The goal of this study was to evaluate the prevalence, characteristics, and outcomes of patients with advanced heart failure (HF) in a geographically defined population. Background Some patients with HF progress to advanced HF, characterized by debilitating HF symptoms refractory to therapy. Limited data are available on the epidemiology and outcomes of patients with advanced HF. Methods This was a population-based cohort study of all Olmsted County, Minnesota, adults with and without HF from 2007 to 2017. The 2018 European Society of Cardiology advanced HF diagnostic criteria were operationalized and applied to all patients with HF. Hospitalization and mortality in advanced HF, overall and according to ejection fraction (EF) type (reduced EF Results Of 6,836 adults with HF, 936 (13.7%) met criteria for advanced HF. The prevalence of advanced HF increased with age and was higher in men. At advanced HF diagnosis, 396 (42.3%) patients had HFrEF, 134 (14.3%) had HFmrEF, and 406 (43.4%) had HFpEF. The median (interquartile range) time from advanced HF diagnosis to death was 12.2 months (3.7-29.9 months). The mean rate of hospitalization was 2.91 (95% CI: 2.78-3.06) per person-year in the first year after advanced HF diagnosis. There were no differences in risks of all-cause mortality or hospitalization by EF. Patients with advanced HFpEF were at lower risk for cardiovascular mortality compared with advanced HFrEF (HR: 0.79; 95% CI: 0.65-0.97). Conclusions In this population-based study, more than one-half of patients with advanced HF had mid-range or preserved EF, and survival was poor regardless of EF.

Aims This study aims to evaluate the impact of the combination of cardiogenic shock (CS) and cardiac arrest (CA) complicating non‐ST‐segment elevation myocardial infarction (NSTEMI). Methods and results Adult (>18 years) NSTEMI admissions using the National Inpatient Sample database (2000 to 2017) were stratified by the presence of CA and/or CS. Outcomes of interest included in‐hospital mortality, early coronary angiography, hospitalization costs, and length of stay. Of the 7 302 447 hospitalizations due to NSTEMI, 147 795 (2.0%) had CS only, 155 522 (2.1%) had CA only, and 41 360 (0.6%) had both CS and CA. Compared with 2000, the adjusted odds ratios (ORs) and 95% confidence interval (CIs) for CS, CA, and both CS and CA in 2017 were 3.75 (3.58–3.92), 1.46 (1.42–1.50), and 4.52 (4.16–4.87), respectively (all P

Aims There are limited contemporary data on the use of initial fibrinolysis in ST‐segment elevation myocardial infarction cardiogenic shock (STEMI‐CS). This study sought to compare the outcomes of STEMI‐CS receiving initial fibrinolysis vs. primary percutaneous coronary intervention (PPCI). Methods Using the National (Nationwide) Inpatient Sample from 2009 to 2017, a comparative effectiveness study of adult (>18 years) STEMI‐CS admissions receiving pre‐hospital/in‐hospital fibrinolysis were compared with those receiving PPCI. Admissions with alternate indications for fibrinolysis and STEMI‐CS managed medically or with surgical revascularization (without fibrinolysis) were excluded. Outcomes of interest included in‐hospital mortality, development of non‐cardiac organ failure, complications, hospital length of stay, hospitalization costs, use of palliative care, and do‐not‐resuscitate status. Results During 2009–2017, 5297 and 110 452 admissions received initial fibrinolysis and PPCI, respectively. Compared with those receiving PPCI, the fibrinolysis group was more often non‐White, with lower co‐morbidity, and admitted on weekends and to small rural hospitals (all P

Heart failure (HF) with an ejection fraction (EF) of 41%-49% is recognized as HF with a mildly reduced EF (HFmrEF). However, existing knowledge of the HFmrEF phenotype is based on HF clinical trial and registry cohorts that may be limited by multiple forms of bias.In a community-based, retrospective cohort study, adult residents of Olmsted County, Minnesota, with validated (Framingham criteria) incident HF from 2007 to 2015 were categorized by echocardiographic EF at first HF diagnosis. Among 2035 adults with incident HF, 12.5% had HFmrEF, 29.9% had HF with reduced EF (HFrEF), and 57.6% had HF with preserved EF (HFpEF). Mean age and sex varied by EF group, with HFmrEF (75.6 years, 45.3% female), HFrEF (70.9 years, 36.5% female), and HFpEF (76.9 years, 59.7% female). Most comorbid conditions were more common in HFmrEF vs HFrEF, but similar in HFmrEF and HFpEF. After a mean follow-up of 4.6 ± 3.5 years, adjusting for age, sex, and comorbidities, the risks of hospitalization and cardiovascular mortality did not differ by EF category. Of patients who began as HFmrEF, 26.9% declined to an EF of 40% or less and 44.8% improved to an EF of 50% or greater.In this community cohort of incident HF, 12.5% have HFmrEF. Clinical characteristics in HFmrEF resemble HFpEF more than HFrEF. Adjusted hospitalization and mortality risks did not vary by EF group. Patients with incident HFmrEF usually transitioned to a different EF category on follow-up.

Guideline-directed medical therapy (GDMT) dramatically improves outcomes in heart failure with reduced ejection fraction (HFrEF). Our goal was to examine GDMT use in community patients with newly diagnosed HFrEF.We performed a population-based, retrospective cohort study of all Olmsted County, Minnesota, residents with newly diagnosed HFrEF (EF ≤ 40%) 2007-2017. We excluded patients with contraindications to medication initiation. We examined the use of beta-blockers, HF beta-blockers (metoprolol succinate, carvedilol, bisoprolol), angiotensin converting enzyme inhibitors (ACEis), angiotensin receptor blockers (ARBs), angiotensin receptor neprilysin inhibitors (ARNIS), and mineralocorticoid receptor antagonists (MRAs) in the first year after HFrEF diagnosis. We used Cox models to evaluate the association of being seen in an HF clinic with the initiation of GDMT. From 2007 to 2017, 1160 patients were diagnosed with HFrEF (mean age 69.7 years, 65.6% men). Most eligible patients received beta-blockers (92.6%) and ACEis/ARBs/ARNIs (87.0%) in the first year. However, only 63.8% of patients were treated with an HF beta-blocker, and few received MRAs (17.6%). In models accounting for the role of an HF clinic in initiation of these medications, being seen in an HF clinic was independently associated with initiation of new GDMT across all medication classes, with a hazard ratio (95% CI) of 1.54 (1.15-2.06) for any beta-blocker, 2.49 (1.95-3.20) for HF beta-blockers, 1.97 (1.46-2.65) for ACEis/ARBs/ARNIs, and 2.14 (1.49-3.08) for MRAs.In this population-based study, most patients with newly diagnosed HFrEF received beta-blockers and ACEis/ARBs/ARNIs. GDMT use was higher in patients seen in an HF clinic, suggesting the potential benefit of referral to an HF clinic for patients with newly diagnosed HFrEF.

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.

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.

Background: There are limited sex-specific data on patients receiving temporary mechanical circulatory support (MCS) for acute myocardial infarction-cardiogenic shock (AMI-CS). Methods: All admissions with AMI-CS with MCS use were identified using the National Inpatient Sample from 2005 to 2016. Outcomes of interest included in-hospital mortality, discharge disposition, use of palliative care and do-not-resuscitate (DNR) status, and receipt of durable left ventricular assist device (LVAD) and cardiac transplantation. Results: In AMI-CS admissions during this 12-year period, MCS was used more frequently in men—50.4% vs 39.5%; P < 0.001. Of the 173,473 who received MCS (32% women), intra-aortic balloon pumps, percutaneous LVAD, extracorporeal membrane oxygenation, and ≥ 2 MCS devices were used in 92%, 4%, 1%, and 3%, respectively. Women were on average older (69 ± 12 vs 64 ± 13 years), of black race (10% vs 6%), and had more comorbidity (mean Charlson comorbidity index 5.0 ± 2.0 vs 4.5 ± 2.1). Women had higher in-hospital mortality than men (34% vs 29%, adjusted odds ratio [OR]: 1.19, 95% confidence interval [CI]: 1.16-1.23; P < 0.001) overall, in intra-aortic balloon pumps users (OR: 1.20 [95% CI: 1.16-1.23]; P < 0.001), and percutaneous LVAD users (OR: 1.75 [95% CI: 1.49-2.06]; P < 0.001), but not in extracorporeal membrane oxygenation or ≥ 2 MCS device users (P > 0.05). Women had higher use of palliative care, DNR status, and discharges to skilled nursing facilities. Conclusions: There are persistent sex disparities in the outcomes of AMI-CS admissions receiving MCS support. Women have higher in-hospital mortality, palliative care consultation, and use of DNR status. Résumé: Contexte: On dispose de peu de données quant à l’influence du sexe sur les résultats pour les patients qui reçoivent une assistance circulatoire mécanique (ACM) temporaire à la suite d’un infarctus aigu du myocarde accompagné d’un choc cardiogénique (IAM-CC). Méthodologie: Nous avons recensé dans l’échantillon national des patients hospitalisés (NIS, National Inpatient Sample) tous les patients admis à l’hôpital pour un IAM-CC qui ont reçu une ACM de 2005 à 2016. Les résultats d’intérêt comprenaient la mortalité hospitalière, l’état à la sortie, le recours aux soins palliatifs et à une ordonnance de non-réanimation (ONR), l’implantation d’un dispositif d’assistance ventriculaire gauche (DAVG) permanent et la transplantation cardiaque. Résultats: Chez les patients admis à l’hôpital pour un IAM-CC durant la période de 12 ans étudiée, l’ACM a été utilisée plus fréquemment chez les hommes que chez les femmes (50,4 % vs 39,5 %; p < 0,001). Sur les 173 473 patients qui ont reçu une ACM (dont 32 % étaient des femmes), les méthodes employées se répartissaient comme suit : ballon de contre-pulsion intra-aortique, 92 %; assistance ventriculaire gauche percutanée, 4 %; oxygénation extracorporelle par membrane, 1 %; et au moins 2 types d’ACM, 3 %. Les femmes étaient plus âgées en moyenne (69 ± 12 ans vs 64 ± 13 ans), étaient plus souvent de race noire (10 % vs 6 %) et présentaient un plus grand nombre d’affections concomitantes (indice de comorbidité de Charlson moyen de 5,0 ± 2,0 vs 4,5 ± 2,1). Le taux de mortalité hospitalière était plus élevé chez les femmes que chez les hommes (34 % vs 29 %, risque relatif approché [RRA] corrigé : 1,19; intervalle de confiance [IC] à 95 % : de 1,16 à 1,23; p < 0,001) dans l’ensemble, ainsi que chez les utilisateurs d’un ballon de contre-pulsion intra-aortique (RRA : 1,20 [IC à 95 % : de 1,16 à 1,23]; p < 0,001), et chez les utilisateurs d’un DAVG percutané (RRA : 1,75 [IC à 95 % : 1,49 à 2,06]; p < 0,001), mais pas chez les utilisateurs de l’oxygénation extracorporelle par membrane ni chez les utilisateurs d’au moins 2 types d’ACM (p > 0,05). Le recours aux soins palliatifs, l’établissement d’une ordonnance de non-réanimation et l’orientation vers un établissement de soins infirmiers spécialisés à la sortie de l’hôpital étaient plus fréquents chez les femmes. Conclusions: Il existe toujours des disparités entre les sexes à l’égard des résultats pour les patients admis à l’hôpital pour IAM-CC recevant une ACM. Le taux de mortalité hospitalière était plus élevé chez les femmes, et celles-ci avaient plus souvent recours à une consultation en soins palliatifs et à une ONR.

This study sought to evaluate long-term mortality and major adverse cardiac and cerebrovascular events (MACCE) in patients with cardiac arrest (CA) and cardiogenic shock (CS) complicating acute myocardial infarction (AMI). This was a retrospective cohort study using an administrative claims database. AMI patients from January 1, 2010 to May 31, 2018 were stratified into CA + CS, CA only, CS only, and AMI alone cohorts. Outcomes of interest were long-term mortality and MACCE (death, AMI, cerebrovascular accident, unplanned revascularization) in AMI survivors. A total 163,071 AMI patients were included with CA + CS, CA only, and CS only in 2.4%, 5.0%, and 4.0%, respectively. The CA + CS cohort had higher rates of multiorgan failure, mechanical circulatory support use and less frequent coronary angiography use. In-hospital mortality was noted in 10,686 (6.6%) patients - CA + CS (48.8%), CA only (35.9%), CS only (24.1%), and AMI alone (2.9%; p0.001). Over 23.5 ± 21.7 months follow-up after hospital discharge, patients with CA + CS (hazard ratio [HR] 1.36 [95% confidence interval {CI} 1.19 to 1.55]), CA only (HR 1.16 [95% CI 1.08 to 1.25]), CS only (HR 1.39 [95% CI 1.29 to 1.50]) had higher all-cause mortality compared with AMI alone (all p0.001). Presence of CS, either alone (HR 1.22 [95% CI 1.16 to 1.29]; p0.001) or with CA (HR 1.18 [95% CI 1.07 to 1.29]; p0.001), was associated with higher MACCE compared with AMI alone. In conclusion, CA + CS, CA, and CS were associated with worse long-term survival. CA and CS continue to influence outcomes beyond the index hospitalization in AMI survivors.

BACKGROUND: In the Catheter Ablation for Atrial Fibrillation with Heart Failure (CASTLE-AF) trial, catheter ablation reduced the risk of death and heart failure (HF) hospitalization in patients with atrial fibrillation and HF by 40%. OBJECTIVES: The study aimed to assess the generalizability of CASTLE-AF to routine clinical practice. METHODS: Using a large US administrative database, we identified 289,831 patients with atrial fibrillation and HF treated with ablation (n = 7465) or medical therapy alone (n = 282,366) from January 1, 2008, through August 31, 2018. Patients were divided into 3 groups on the basis of trial eligibility: (1) eligible for CASTLE-AF, (2) failing to meet the inclusion criteria, and (3) meeting at least 1 of the exclusion criteria. Propensity score overlap weighting was used to balance ablated and drug-treated patients on 90 baseline characteristics. Cox proportional hazards regression was used to compare ablation with medical therapy for the primary outcome of a composite end point of all-cause mortality and HF hospitalization. RESULTS: Only 7.8% of patients would have been eligible for the trial; 91.0% failed to meet the trial inclusion criteria;and 15.5% met the exclusion criteria. Ablation was associated with a lower risk of the primary outcome in the overall cohort (hazard ratio [HR] 0.81; 95% confidence interval [CI] 0.76–0.87; P < .001), in the trial-eligible cohort (HR 0.82; 95% CI 0.70–0.96; P = .01), and in patients who failed to meet inclusion criteria (HR 0.79; 95% CI 0.73–0.86; P < .001) but not in patients who met the exclusion criteria (HR 0.97; 95% CI 0.81–1.17). The relative risk reduction was consistent regardless of whether patients had HF with reduced left ventricular ejection fraction. CONCLUSION: The benefit associated with ablation appears to be more modest in practice than that reported in the CASTLE-AF trial.

Aims The aim of this study is to evaluate the contemporary use of a pulmonary artery catheter (PAC) in acute myocardial infarction‐cardiogenic shock (AMI‐CS). Methods and results A retrospective cohort of AMI‐CS admissions using the National Inpatient Sample (2000–2014) was identified. Admissions with concomitant cardiac surgery or non‐AMI aetiology for cardiogenic shock were excluded. The outcomes of interest were in‐hospital mortality, resource utilization, and temporal trends in cohorts with and without PAC use. In the non‐PAC cohort, the use and outcomes of right heart catheterization was evaluated. Multivariable regression and propensity matching was used to adjust for confounding. During 2000–2014, 364 001 admissions with AMI‐CS were included. PAC was used in 8.1% with a 75% decrease during over the study period (13.9% to 5.4%). Greater proportion of admissions to urban teaching hospitals received PACs (9.5%) compared with urban non‐teaching (7.1%) and rural hospitals (5.4%); P < 0.001. Younger age, male sex, white race, higher comorbidity, noncardiac organ failure, use of mechanical circulatory support, and noncardiac support were independent predictors of PAC use. The PAC cohort had higher in‐hospital mortality (adjusted odds ratio 1.07 [95% confidence interval 1.04–1.10]), longer length of stay (10.9 ± 10.9 vs. 8.2 ± 9.3 days), higher hospitalization costs ($128 247 ± 138 181 vs. $96 509 ± 116 060), and lesser discharges to home (36.3% vs. 46.4%) (all P < 0.001). In 6200 propensity‐matched pairs, in‐hospital mortality was comparable between the two cohorts (odds ratio 1.01 [95% confidence interval 0.94–1.08]). Right heart catheterization was used in 12.5% of non‐PAC admissions and was a marker of greater severity but did not indicate worse outcomes. Conclusions In AMI‐CS, there was a 75% decrease in PAC use between 2000 and 2014. Admissions receiving a PAC were a higher risk cohort with worse clinical outcomes.

Background The epidemiology of ventricular arrhythmias (VAs) in patients with advanced heart failure (HF) is not well defined. Methods and Results Residents of Olmsted County, Minnesota, with advanced HF from 2007 to 2017 were identified using the 2018 European Society of Cardiology criteria. Billing codes were used to capture VAs; severe VAs requiring emergency care were defined as events associated with emergency department visits or hospitalizations. The cumulative incidence of VAs postadvanced HF was estimated with the Kaplan–Meier method. Multivariable Cox analyses were used to determine the following: (1) Predictors of severe VAs postadvanced HF; and (2) Impact of severe VAs on mortality. Of 936 patients with advanced HF, 261 (27.9%) had a history of VA. The 1‐year cumulative incidence of severe VAs postadvanced HF was 5.4%. Prior VAs (hazard ratio [HR] 2.22 [95% CI, 1.26–3.89], P =0.006) and left ventricular ejection fraction P P P =0.77). Severe VAs were associated with increased mortality in patients without implantable cardioverter defibrillators (HR, 4.89 [95% CI, 2.89–8.26]; P P =0.11). Conclusions Patients with left ventricular ejection fraction

Little is known regarding the causes of critical illness and determinants of prognosis of patients with heart failure (HF) admitted to the modern cardiac intensive care unit (CICU). We sought to describe the epidemiology and outcomes of patients with HF admitted to the contemporary CICU.Retrospective cohort analysis of Mayo Clinic CICU patients admitted with HF from 2007 to 2018 who had left ventricular ejection fraction (LVEF) data. HF with reduced LVEF (HFrEF) was defined as a LVEF of less than 50%, and HF with preserved LVEF (HFpEF) as a LVEF of 50% or greater. In-hospital mortality was analyzed using multivariable logistic regression. Survival to 1 year was analyzed using a Kaplan-Meier analysis. We included 4012 patients, including 67.8% with HFrEF and 32.2% with HFpEF. Patients with HFrEF and HFpEF were comparable and had equivalent severity of illness. Critical care therapies were used in 59.4%, with a slight preponderance in patients with HFrEF. In-hospital mortality occurred in 12.5% of patients and was similar in HFrEF vs HFpEF. Shock and cardiac arrest were the strongest predictors of adjusted in-hospital mortality, followed by Braden skin score and serum chloride level; patients with HFrEF and HFpEF had similar adjusted mortality rates. The 1-year survival after hospital discharge was 74.5% and was slightly lower for patients with HFpEF. All-cause rehospitalization occurred in 36.6%, and 52.8% of hospital survivors died or were readmitted within 1 year.CICU patients with HF have a substantial burden of critical illness, high use of critical care therapies, and poor outcomes regardless of LVEF. This finding emphasizes the potential unmet care needs in this cohort.Patients with heart failure who require admission to the cardiac intensive care unit have high severity of illness and are at significant risk of death during and after hospitalization. These patients often require specialized critical care therapies to treat manifestations of critical illness. Patients who are admitted with cardiac arrest or shock, including those who require mechanical ventilation or vasopressors, are at particularly high risk of death. Patients' left ventricular ejection fraction is not strongly associated with the risk of death when accounting for other major predictors including frailty and laboratory abnormalities.

Introduction: Guideline-directed medical therapy (GDMT) dramatically improves outcomes in heart failure with reduced ejection fraction (HFrEF). Our goal was to examine GDMT use in community patients with newly diagnosed HFrEF. Methods: We performed a population-based, retrospective cohort study of all Olmsted County, Minnesota residents with newly diagnosed HFrEF (EF≤40%) 2007-2017. We excluded patients with contraindications to medication initiation (allergy, intolerance, heart rate3 mg/dL ACEi/ARB/ARNI, >2.5 men or >2.0 mg/dL women for mineralocorticoid receptor antagonists, MRAs) or hyperkalemia (potassium >5 meQ/L for ACEi/ARB/ARNI, MRA). We examined use and peak dose achieved for beta blockers, HF beta blockers (metoprolol succinate, carvedilol, bisoprolol), ACEi/ARB/ARNI, and MRA in the first year after HFrEF diagnosis. We used logistic regression to evaluate predictors of GDMT use. Results: From 2007-2017, 1160 patients were diagnosed with HFrEF (mean age 69.7 years, 65.6% men). Most eligible patients received beta blockers (92.1%) and ACEi/ARB/ARNI (86.5%) in the first year after HFrEF. However, only 63.6% of patients were treated with a HF beta blocker, and most did not receive MRAs (82.6%). The percentage of treated patients reaching medication target doses was 20.5% for HF beta blockers, 25.3% for ACEi/ARB/ARNI, and 11.2% for MRA. Compared to patients not seen in an HF clinic, patients seen in an HF clinic (n=380, 32.8%) were at greater odds of receiving beta blockers (OR 3.85, 95% CI 1.79-8.33); HF beta blockers (OR 3.85, 95% CI 2.63-5.26); ACEi/ARB/ARNIs (OR 3.85, 95% CI 2.17-6.67); and MRAs (OR 3.03, 95% CI 2.08-4.35). Other independent predictors of GDMT use included younger age (beta blockers, ACEi/ARB/ARNI), male gender (MRAs), higher SBP (beta blockers, ACEi/ARB/ARNI), lower EF (HF beta blockers), higher BMI (MRAs), and diabetes (ACEi/ARB/ARNI, p Conclusions: In this population-based study, most patients with newly diagnosed HFrEF received beta blockers and ACEi/ARB/ARNIs, but goal doses were usually not achieved. GDMT use was much higher in patients referred to an HF clinic.

Introduction: Advanced or “Stage D” heart failure (Adv HF) patients are at high risk of poor outcomes. However, recognition of Adv HF is limited as diagnostic criteria are complex. Administrative algorithms to identify Adv HF could enable better understanding of who has advanced HF and lead to enhanced therapeutics development, dissemination, and outcomes. Methods: In a population-based cohort of all Olmsted County, Minnesota residents with ≥1 HF billing code 2007-2017 (n=9881), we identified all patients with Adv HF (n=753) by applying the gold standard European Society of Cardiology Adv HF criteria via manual medical review by a HF cardiologist. The Adv HF index date was the date the patient first met all ESC criteria. We then developed candidate algorithms to identify Adv HF using only administrative data (billing codes and HF prescriptions or comorbidities known to affect HF outcomes), applied them to the entire HF cohort and assessed their ability to identify patients with Adv HF on or after their Adv HF index date. Results: A single hospitalization (Hsp) for HF or ventricular arrhythmias (VA, 2007-2017) identified all patients with Adv HF (sensitivity 100%), but the PPV was low (36.4%). Requiring more Hsp, other signs of Adv HF such as hyponatremia, acute kidney injury, hypotension or high-dose diuretic use decreased the sensitivity but improved specificity and PPV. As Adv HF was relatively uncommon, negative predictive values (NPV) were high regardless of algorithm characteristics. Conclusions: Algorithms using administrative data can identify patients with Adv HF with clinically useful accuracy.

Introduction: Some patients with heart failure (HF) will go on to develop advanced HF, characterized by severe HF symptoms despite attempts to optimize medical therapy. Our understanding of advanced HF at a population level remains limited. The goals of this study were to determine the risk of developing advanced HF in patients with newly diagnosed HF, identify risk factors for developing advanced HF, and evaluate the impact of advanced HF on outcomes. Methods: This was a population-based, retrospective cohort study of Olmsted County, Minnesota residents with a new clinical diagnosis of HF between 2007-2017. The primary outcome was development of advanced HF, defined using the 2018 European Society of Cardiology Criteria. Risk factors for development of advanced HF from the time of incident HF diagnosis were examined using cause-specific Cox proportional hazard regression models. The associations of development of advanced HF with risks of hospitalization and mortality were examined using Andersen-Gill and Cox models, respectively, with advanced HF treated as a time dependent covariate. Results: There were 4597 residents with incident HF from 2007 to 2017. The cumulative incidence of advanced HF was 6.0%, 9.1%, and 11.5% at 2, 4, and 6 years after incident HF diagnosis. Characteristics independently associated with development of advanced HF included older age, male sex, diabetes, chronic obstructive pulmonary disease, peripheral vascular disease, lower serum sodium, worse right ventricular function, left atrial enlargement, higher estimated filling pressures, and higher right ventricular systolic pressure (p Conclusions: In this population-based study, clinical, laboratory and echocardiographic characteristics at the time of incident HF diagnosis were associated with future risk of advanced HF. Development of advanced HF was associated with markedly increased morbidity and mortality.

Background: The Kansas City Cardiomyopathy Questionnaire (KCCQ) has been psychometrically evaluated in multiple heart failure (HF) populations, but the comparability of its psychometric properties between men and women is unknown. Methods: Data from 3 clinical trials (1 in stable HF with preserved ejection fraction, 1 each in stable and acute HF with reduced ejection fraction) and 1 prospective cohort study (stable HF with reduced ejection fraction), incorporating 6773 men and 3612 women with HF, were used to compare the construct validity, internal and test-retest reliability, ability to detect change, predict mortality and hospitalizations and minimally important differences between the 2 sexes. Interactions of the KCCQ overall summary and subdomain scores by sex were independently examined. Results: The KCCQ-Overall Summary score correlated well with New York Heart Association functional class in both sexes across patients with stable (correlation coefficient: −0.40 in men versus −0.49 in women) and acute (−0.37 in men versus −0.34 in women) HF. All KCCQ subdomains demonstrated concordant relationships with relevant comparison standards with no significant interactions by sex in 19 of 21 of these construct validity analyses. All KCCQ scores were equally predictive and other psychometric evaluations showed similar results by sex: test-retest reliability (intraclass correlation coefficient 0.94 in men versus 0.92 in women), responsive to change (standardized response mean 1.01 in both sexes), as were the minimally important differences and internal reliability. Conclusions: The psychometric properties of the KCCQ, in terms of validity, prognosis, reliability, and sensitivity to change, are comparable in men and women with HF with preserved ejection fraction and HF with reduced ejection fraction.

IMPORTANCE: Heart failure (HF) with preserved ejection fraction (HFpEF) is common, is frequently associated with ventricular wall thickening, and has no effective therapy. Transthyretin amyloid cardiomyopathy (ATTR-CM) can cause the HFpEF clinical phenotype, has highly effective therapy, and is believed to be underrecognized. OBJECTIVE: To examine the prevalence of ATTR-CM without and with systematic screening in patients with HFpEF and ventricular wall thickening. DESIGN, SETTING, AND PARTICIPANTS: This population-based cohort study assessed ATTR-CM prevalence in 1235 consecutive patients in southeastern Minnesota with HFpEF both without (prospectively identified cohort study) and with (consenting subset of cohort study, n = 286) systematic screening. Key entry criteria included validated HF diagnosis, age of 60 years or older, ejection fraction of 40% or greater, and ventricular wall thickness of 12 mm or greater. In this community cohort of 1235 patients, 884 had no known ATTR-CM, contraindication to technetium Tc 99m pyrophosphate scanning, or other barriers to participation in the screening study. Of these 884 patients, 295 consented and 286 underwent scanning between October 5, 2017, and March 9, 2020 (community screening cohort). EXPOSURES: Medical record review or technetium Tc 99m pyrophosphate scintigraphy and reflex testing for ATTR-CM diagnosis. MAIN OUTCOMES AND MEASURES: The ATTR-CM prevalence by strategy (clinical diagnosis or systematic screening), age, and sex. RESULTS: A total of 1235 patients participated in the study, including a community cohort (median age, 80 years; interquartile range, 72-87 years; 630 [51%] male) and a community screening cohort (n = 286; median age, 78 years; interquartile range, 71-84 years; 149 [52%] male). In the 1235 patients in the community cohort without screening group, 16 patients (1.3%; 95% CI, 0.7%-2.1%) had clinically recognized ATTR-CM. The prevalence was 2.5% (95% CI, 1.4%-4.0%) in men and 0% (95% CI, 0.0%-0.6%) in women. In the 286 patients in the community screening cohort, 18 patients (6.3%; 95% CI, 3.8%-9.8%) had ATTR-CM. Prevalence increased with age from 0% in patients 60 to 69 years of age to 21% in patients 90 years and older (P

Type 2 diabetes mellitus is a risk factor for incident heart failure and increases the risk of morbidity and mortality in patients with established disease. Secular trends in the prevalence of diabetes mellitus and heart failure forecast a growing burden of disease and underscore the need for effective therapeutic strategies. Recent clinical trials have demonstrated the shared pathophysiology between diabetes mellitus and heart failure, the synergistic effect of managing both conditions, and the potential for diabetes mellitus therapies to modulate the risk of heart failure outcomes. This scientific statement on diabetes mellitus and heart failure summarizes the epidemiology, pathophysiology, and impact of diabetes mellitus and its control on outcomes in heart failure; reviews the approach to pharmacological therapy and lifestyle modification in patients with diabetes mellitus and heart failure; highlights the value of multidisciplinary interventions to improve clinical outcomes in this population; and outlines priorities for future research.

Aims To evaluate sex‐specific disparities in acute kidney injury (AKI) complicating acute myocardial infarction‐related cardiogenic shock (AMI‐CS) in the United States. Methods and results This was a retrospective cohort study from 2000 to 2014 from the National Inpatient Sample (20% sample of all hospitals in the United States). Patients >18 years admitted with a primary diagnosis of AMI and concomitant CS that developed AKI were included. The endpoints of interest were the prevalence, trends, and outcomes of men and women with AKI in AMI‐CS. Multivariable hierarchical logistic regression was used to control for confounding, and a two‐sided P

Objectives This study sought to evaluate the clinical characteristics and outcomes of Takotusbo cardiomyopathy cardiogenic shock (TC-CS) in comparison to those of acute myocardial infarction cardiogenic shock (AMI-CS) among patients hospitalized in the United States. We additionally sought to compare the incidence of multiorgan failure and use of supportive therapies as well as the trends over time, given the increasing awareness and diagnosis of TC. Background CS is a major complication of TC; however, there are limited data, especially as to how TC-CS compares to AMI-CS. Methods The National Inpatient Sample Database was used to identify adults hospitalized with CS in the setting of TC and AMI from 2007 to 2014. We required patients admitted with TC to have undergone coronary angiography without intervention. Clinical characteristics and in-hospital outcomes in TC-CS patients were compared with those in AMI-CS patients. Multivariate regression and propensity matching were used to adjust for potential confounding factors. Results Between 2007 and 2014, there were 374,152 admissions for CS due to either TC or AMI, of which 4,614 patients (1.2%) had TC-CS. TC-CS admission patients were more likely to be younger, white females with fewer comorbidities. Rates of respiratory failure and mechanical ventilation were higher in TC-CS, but cardiac arrest and acute kidney injury were lower. There were no differences between cohorts in use of intra-aortic balloon pumps. TC-CS admissions had lower in-hospital mortality (15% vs. 37%, respectively) and hospital costs (U.S. dollars: $135,397 ± $127,617 vs. $154,827 ± $186,035, respectively) and were discharged home more often (45% vs. 36%, respectively) compared to AMI-CS admissions (all: p Conclusions There are key differences between the clinical characteristics and multiorgan failure patterns in TC-CS compared to those in AMI-CS. In-hospital mortality (15%) is lower in TC-CS.

There are limited data on prolonged invasive mechanical ventilation (IMV) and tracheostomy use in intubated acute myocardial infarction with cardiogenic shock (AMI-CS) patients.Using the National Inpatient Sample, all admissions with AMI-CS requiring IMV between January 1, 2000, and December 31, 2014, were included. Prolonged IMV was defined as IMV use96 h. Outcomes of interest included temporal trends in use of prolonged IMV and tracheostomy, in-hospital mortality, and resource utilization.In this 15-year period, 185,589 intubated AMI-CS admissions met the inclusion criteria. Prolonged IMV (96 h) and tracheostomy use were noted in 68,544 (36.9%) and 10,645 (5.7%), respectively. Prolonged IMV and tracheostomy were used more commonly in younger patients. The cohort with prolonged IMV had higher organ failure and greater use of cardiac and non-cardiac organ support. Temporal trends showed a decline in prolonged IMV (adjusted odds ratio {aOR} 0.61 [95% confidence interval {CI} 0.57-0.65]) and tracheostomy use (aOR 0.80 [95% CI 0.70-0.90]) in 2014 compared to 2000. Prolonged IMV (aOR 0.45 [95% CI 0.44-0.47]; p 0.001) and tracheostomy (aOR 0.28 [95% CI 0.27-0.29]; p 0.001) were associated with lower in-hospital mortality with a decreasing trend between 2000 and 2014 in intubated AMI-CS admissions. Patients with prolonged IMV and tracheostomy use had nearly three-fold higher health care costs, and four-fold longer hospital stays.In this cohort of intubated AMI-CS admissions, prolonged IMV and tracheostomy showed a temporal decrease between 2000 and 2014. Prolonged IMV and tracheostomy use was associated with high resource utilization.

Background There are limited data on acute noncardiac multiorgan failure in cardiogenic shock complicating acute myocardial infarction (AMI-CS). Objectives The authors sought to evaluate the 15-year national trends, resource utilization, and outcomes of single and multiple noncardiac organ failures in AMI-CS. Methods This was a retrospective cohort study of AMI-CS using the National Inpatient Sample database from 2000 to 2014. Previously validated codes for respiratory, renal, hepatic, hematologic, and neurological failure were used to identify single or multiorgan (≥2 organ systems) noncardiac organ failure. Outcomes of interest were in-hospital mortality, temporal trends, and resource utilization. The effects of every additional organ failure on in-hospital mortality and resource utilization were assessed. Results In 444,253 AMI-CS admissions, noncardiac single or multiorgan failure was noted in 32.4% and 31.9%, respectively. Multiorgan failure was seen more commonly in admissions with non–ST-segment elevation AMI-CS, nonwhite race, and higher baseline comorbidity. There was a steady increase in the prevalence of single and multiorgan failure. Coronary angiography and revascularization were performed less commonly in multiorgan failure. Single-organ failure (odds ratio: 1.28; 95% confidence interval: 1.26 to 1.30) and multiorgan failure (odds ratio: 2.23; 95% confidence interval: 2.19 to 2.27) were independently associated with higher in-hospital mortality, greater resource utilization, and fewer discharges to home. There was a stepwise increase in in-hospital mortality and resource utilization with each additional organ failure. Conclusions There has been a steady increase in the prevalence of multiorgan failure in AMI-CS. Presence of multiorgan failure was independently associated with higher in-hospital mortality and greater resource utilization.

Background In patients undergoing heart transplantation, significant allosensitization limits access to organs, resulting in longer wait times and high waitlist mortality. Current desensitization strategies are limited in enabling successful transplantation. Objectives The purpose of this study was to describe the cumulative experience of combined heart-liver transplantation using a novel heart-after-liver transplant (HALT) protocol resulting in profound immunologic protection. Methods Reported are the results of a clinical protocol that was instituted to transplant highly sensitized patients requiring combined heart and liver transplantation at a single institution. Patients were dual-organ listed with perceived elevated risk of rejection or markedly prolonged waitlist time due to high levels of allo-antibodies. Detailed immunological data and long-term patient and graft outcomes were obtained. Results A total of 7 patients (age 43 ± 7 years, 86% women) with high allosensitization (median calculated panel reactive antibody = 77%) underwent HALT. All had significant, unacceptable donor specific antibodies (DSA) (>4,000 mean fluorescence antibody). Prospective pre-operative flow cytometric T-cell crossmatch was positive in all, and B-cell crossmatch was positive in 5 of 7. After HALT, retrospective crossmatch (B- and T-cell) became negative in all. DSA fell dramatically; at last follow-up, all pre-formed or de novo DSA levels were insignificant at 1R rejection over a median follow-up of 48 months (interquartile range: 25 to 68 months). There was 1 death due to metastatic cancer and no significant graft dysfunction. Conclusions A heart-after-liver transplantation protocol enables successful transplantation via near-elimination of DSA and is effective in preventing adverse immunological outcomes in highly sensitized patients listed for combined heart-liver transplantation.

Anticoagulation management is challenging in bariatric surgery patients, due to altered gastrointestinal anatomy and potentially reduced absorption. Few studies have evaluated clinical outcomes in this population. The objective of this study was to compare the efficacy and safety of oral anticoagulants in patients with and without a history of bariatric surgery. A retrospective, matched cohort study was conducted, utilizing data from the OptumLabs Data Warehouse. Patients ≥18 years old, with nonvalvular atrial fibrillation (NVAF), and treated with an oral anticoagulant between January 1, 2010 and December 31, 2018 were included. Outcomes were compared between bariatric and nonbariatric surgery patients. Secondary analysis compared warfarin to the direct oral anticoagulants (DOAC) in the bariatric cohort. The primary efficacy outcome was the rate of ischemic stroke and systemic embolism and the primary safety outcome was major bleeding. A total of 1,673 bariatric surgery and 155,619 nonbariatric surgery patients were identified. There was no significant difference in the rate of ischemic stroke or systemic embolism (0.83 vs 1.32 per 100 person years; Hazard ratio [HR] 0.62, 95% confidence interval [CI] 0.31 to 1.22; p = 0.17) or major bleeding (5.30 vs 4.87 per 100 person years; HR 1.05, 95% CI 0.80 to 1.37; p = 0.73) between bariatric and nonbariatric surgery patients. In bariatric surgery patients alone, efficacy and safety were similar with warfarin compared with the DOACs. Results of this study suggest that bariatric surgery patients are not at an increased thrombotic or bleeding risk when using oral anticoagulants for NVAF. DOACs may be a reasonable alternative to warfarin.

There are limited data on the outcomes of cardiogenic shock (CS) and cardiac arrest (CA) complicating ST-segment-elevation myocardial infarction (STEMI).Adult (18 years) STEMI admissions were identified using the National Inpatient Sample (2000-2017) and classified as CS + CA, CS only, CA only and no CS/CA. Outcomes of interest included temporal trends, in-hospital mortality, hospitalization costs, use of do-not-resuscitate (DNR) status and palliative care referrals across the four cohorts.Of the 4,320,117 STEMI admissions, CS, CA and both were noted in 5.8%, 6.2% and 2.7%, respectively. In 2017, compared to 2000, there was an increase in CA (adjusted odds ratio [aOR] 1.83 [95% confidence interval {CI} 1.79-1.86]), CS (aOR 3.92 [95% CI 3.84-4.01]) and both (aOR 4.09 [95% CI 3.94-4.24]) (all p 0.001). The CS+CA (77.2%) cohort had higher rates of multiorgan failure than CS only (59.7%) and CA only (26.3%), p 0.001. The CA only cohort had lower rates (64%) of coronary angiography compared to the other groups (70%), p 0.001. In-hospital mortality was higher in CS+CA compared to CS alone (adjusted OR 1.87 [95% CI 1.83-1.91]), CA alone (adjusted OR 1.99 [95% CI 1.95-2.03]) or neither (aOR 18.37 [95% CI 18.02-18.71]). The CS+CA cohort had higher use of palliative care and DNR status. The presence of CS, either alone or in combination with CA, was associated with higher hospitalization costs.The combination of CS and CA was associated with higher rates of non-cardiac organ failure and in-hospital mortality in STEMI compared to those with either CS or CA alone.

Many individuals living with heart failure (HF) rely on unpaid support from their partners, family members, friends, or neighbors as caregivers to help manage their chronic disease. Given the advancements in treatments and devices for patients with HF, caregiving responsibilities have expanded in recent decades to include more intensive care for increasingly precarious patients with HF—tasks that would previously have been undertaken by healthcare professionals in clinical settings. The specific tasks of caregivers of patients with HF vary widely based on the patient’s symptoms and comorbidities, the relationship between patient and caregiver, and the complexity of the treatment regimen. Effects of caregiving on the caregiver and patient range from physical and psychological to financial. Therefore, it is critically important to understand the needs of caregivers to support the increasingly complex medical care they provide to patients living with HF. This scientific statement synthesizes the evidence pertaining to caregiving of adult individuals with HF in order to (1) characterize the HF caregiving role and how it changes with illness trajectory; (2) describe the financial, health, and well-being implications of caregiving in HF; (3) evaluate HF caregiving interventions to support caregiver and patient outcomes; (4) summarize existing policies and resources that support HF caregivers; and (5) identify knowledge gaps and future directions for providers, investigators, health systems, and policymakers.

Background: There are few studies evaluating regional disparities in the care of acute myocardial infarction-cardiogenic shock (AMI-CS). Methods and Results: Using the National Inpatient Sample from 2000 to 2016, we identified adults with a primary diagnosis of AMI and concomitant CS admitted to the United States census regions of Northeast, Midwest, South, and West. Interhospital transfers were excluded. End points of interest included in-hospital mortality, use of coronary angiography, percutaneous coronary intervention, mechanical circulatory support, hospitalization costs, length of stay, and discharge disposition. Multivariable regression was used to adjust for potential confounding. Of the 402 825 AMI-CS admissions, 16.8%, 22.5%, 39.3%, and 21.4% were admitted to the Northeast, Midwest, South, and West, respectively. Higher rates of ST-elevation AMI-CS were noted in the Midwest and West. Admissions to the Northeast were on average characterized by a higher frequency of whites, Medicare beneficiaries, and lower rates of cardiac arrest. Admissions to the Northeast were less likely to receive coronary angiography, percutaneous coronary intervention, and mechanical circulatory support, despite the highest rates of extracorporeal membrane oxygenation use. Compared with the Northeast, in-hospital mortality was lower in the Midwest (adjusted odds ratio [aOR], 0.96 [95% CI, 0.93–0.98]; P P =0.001) but higher in the South (aOR, 1.04 [95% CI, 1.01–1.06]; P =0.002). The Midwest (aOR, 1.68 [95% CI, 1.62–1.74]; P P P Conclusions: There remain significant regional disparities in the management and outcomes of AMI-CS.

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

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

Device indications have changed for placement of continuous-flow left ventricular assist devices (CF-LVADs). We performed a multicenter analysis evaluating temporal variations in outcomes after CF-LVAD implantation.We retrospectively defined 3 time intervals to reflect changes in CF-LVAD technology (period 1, 2004-2009; period 2, 2010-2012; and period 3, 2012-2014). A total of 1,064 patients (Heartmate II [HMII] = 835; Heartware [HVAD] = 229) underwent CF-LVAD implantation from May 2004 to October 2014. Device utilization was different between periods: period 1: HMII = 134 (100%); period 2: HMII = 480 (88%) and HW = 63 (12%); and period 3: HMII = 221 (57%) and HW = 166 (43%); P .001. Despite few baseline group differences, adjusted survivals were similar among the time periods (P = .96). Adjusted multivariable analysis revealed age (per 10-year increase) and Interagency Registry for Mechanically Assisted Circulatory Support category (1 vs all others) as the only independent predictors of mortality: P .001 and P = .008, respectively. Furthermore, it also showed the later periods to be at an increased risk of adverse events: 1) pump thrombosis (periods 2 and 3); and 2) gastrointestinal bleeding (period 3).Despite significant differences in device types, indications, and patient characteristics, post-implantation survivals were similar across time intervals. The most recent cohort seems to be at an increased risk of gastrointestinal bleeding and pump thrombosis.

Background Although guidelines call on clinicians to conduct regular conversations about advance care planning and end-of-life (EOL) preferences with patients with heart failure (HF), research suggests that physicians often avoid these discussions. Methods and Results From January 20, 2014, to January 18, 2016, Southeastern Minnesota residents hospitalized with acute decompensated HF (ADHF) at Mayo Clinic hospitals were enrolled into an observational cohort study that included the administration of face-to-face questionnaires. Risk of death (prognosis) was estimated using the Meta-analysis Global Group in Chronic Heart Failure score. Among 400 patients (mean age 77.7 years, 46% female, 48% preserved ejection fraction), only 69 (17%) reported previously discussing EOL wishes with their physician. Patients reporting EOL discussions more often had an advance directive (81% vs 66%; P = .009), recognized the term “hospice” (96% vs 87%; P = .027), and had more favorable attitudes of dying and hospice ( P = .030). Resuscitation preferences and rates of completion of advance directives varied with prognosis, although patient-clinician EOL discussions did not. Conclusions The majority of patients hospitalized with ADHF did not recall discussing their preferences for EOL care with their physician. This represents an important modifiable gap in the optimal longitudinal care of HF patients.

Beliefs around deactivation of a left ventricular assist device (LVAD) vary substantially among clinicians, institutions, and patients. Therefore, we sought to understand perspectives regarding LVAD deactivation among cardiology and hospice/palliative medicine (HPM) clinicians.We administered a 41-item survey via electronic mail to members of 3 cardiology and 1 HPM professional societies. A convergent parallel mixed-methods design was used. From October through November 2011, 7168 individuals were sent the survey and 440 responded. Three domains emerged: (1) LVAD as a life-sustaining therapy; (2) complexities of the process of LVAD deactivation; and (3) legal and ethical considerations of LVAD deactivation. Most respondents (cardiology 92%; HPM 81%; P = .15) believed that an LVAD is a life-sustaining treatment for patients with advanced heart failure; however, 60% of cardiology vs 2% of HPM clinicians believed a patient should be imminently dying to deactivate an LVAD (P .001). Additionally, 87% of cardiology vs 100% of HPM clinicians believed the cause of death following LVAD deactivation was from underlying disease (P .001), with 13% of cardiology clinicians considering it to be a form of euthanasia or physician-assisted suicide.Cardiology and HPM clinicians have differing perspectives regarding LVAD deactivation. Bridging the gaps and engaging in dialog between these 2 specialties is a critical first step in creating a more cohesive approach to care for LVAD patients.

Heart failure (HF) with preserved ejection fraction (HFpEF) is a clinical syndrome associated with poor quality of life, substantial health-care resource utilization, and premature mortality. We summarize the current knowledge regarding the epidemiology of HFpEF with a focus on community-based studies relevant to quantifying the population burden of HFpEF. Current data regarding the prevalence and incidence of HFpEF in the community as well as associated conditions and risk factors, risk of morbidity and mortality after diagnosis, and quality of life are presented. In the community, approximately 50% of patients with HF have HFpEF. Although the age-specific incidence of HF is decreasing, this trend is less dramatic for HFpEF than for HF with reduced ejection fraction (HFrEF). The risk of HFpEF increases sharply with age, but hypertension, obesity, and coronary artery disease are additional risk factors. After adjusting for age and other risk factors, the risk of HFpEF is fairly similar in men and women, whereas the risk of HFrEF is much lower in women. Multimorbidity is common in both types of HF, but slightly more severe in HFpEF. A majority of deaths in patients with HFpEF are cardiovascular, but the proportion of noncardiovascular deaths is higher in HFpEF than HFrEF.

Temporary circulatory support (TCS) is used to stabilize patients in critical cardiogenic shock and bridge patients to a durable ventricular assist device (VAD). Whether TCS confers increased risk at the time of VAD implant is unknown.Prospectively collected data from five institutions was retrospectively reviewed. All profile 1 through profile 3 patients implanted with a continuous-flow VAD (n = 804) were categorized into three groups: TCS (n = 68); non-TCS profile 1 (n = 70); and non-TCS profile 2-3 (n = 666).End-organ function and hemodynamics were worse before TCS than in non-TCS profile 1 patients: creatinine (1.7 ± 0.1 mg/dL versus 1.3 ± 0.06 mg/dL, p = 0.003); and right atrial pressure (16 ± 0.8 mm Hg versus 13 ± 1.1 mm Hg, p = 0.048). The TCS restored cardiac output before durable VAD (4.9 ± 0.2 L/min), and was comparable to profile 2-3 patients (4.3 ± 0.05 L/min) and better than profile 1 patients (4.0 ± 0.2 L/min, p = 0.002). Markers of hepatic function such as bilirubin were impaired before VAD in TCS and profile 1 patients (2.0 ± 0.2 mg/dL) compared with profile 2 and 3 patients (1.1 ± 0.03, p0.001). The incidence of postoperative right ventricular failure necessitating a right VAD was 21% for TCS patients and non-TCS profile 1 patients compared with 2% for profile 2-3 patients (p0.001). Profile 1 and TCS patients had similar 1-year survival (70% and 77%, p = 0.57), but inferior survival as compared with profile 2 and 3 patients (82%, p0.001). On multivariable analysis, TCS increased the hazard of death twofold.Temporary circulatory support restores hemodynamics and reverses end-organ dysfunction. Nevertheless, these patients have high residual risk with postoperative morbidity and mortality that parallels profile 1 patients without TCS. Caution is suggested in downgrading risk for TCS patients with improved hemodynamic stability.

Background: Extracorporeal membrane oxygenation (ECMO) is increasingly used in acute myocardial infarction (AMI); however, there are limited large-scale national data. Methods: Using the National Inpatient Sample database from 2000 to 2014, a retrospective cohort of AMI utilizing ECMO was identified. Use of percutaneous coronary intervention, intra-aortic balloon pump, and percutaneous left ventricular assist device (LVAD) was also identified in this population. Outcomes of interest included temporal trends in utilization of ECMO alone and with concomitant procedures (percutaneous coronary intervention, intra-aortic balloon pump, and percutaneous LVAD), in-hospital mortality, and resource utilization. Results: In ≈9 million AMI admissions, ECMO was used in 2962 ( Conclusions: In AMI admissions, a steady increase was noted in the utilization of ECMO alone and with concomitant procedures (percutaneous coronary intervention, intra-aortic balloon pump, and percutaneous LVAD). In-hospital mortality remained high in AMI admissions treated with ECMO.

Background The presence of a durable left ventricular assist device ( LVAD ) is associated with increased risk of vasoplegia in the early postoperative period following heart transplantation ( HT ). However, preoperative predictors of vasoplegia and its impact on survival after HT are unknown. We sought to examine predictors and outcomes of patients who develop vasoplegia after HT following bridging therapy with an LVAD . Methods and Results We identified 94 patients who underwent HT after bridging with continuous‐flow LVAD from 2008 to 2018 at a single institution. Vasoplegia was defined as persistent low vascular resistance requiring ≥2 intravenous vasopressors within 48 hours after HT for >24 hours to maintain mean arterial pressure >70 mm Hg. Overall, 44 patients (46.8%) developed vasoplegia after HT . Patients with and without vasoplegia had similar preoperative LVAD , echocardiographic, and hemodynamic parameters. Patients with vasoplegia were significantly older; had longer LVAD support, higher preoperative creatinine, longer cardiopulmonary bypass time, and higher Charlson comorbidity index; and more often underwent combined organ transplantation. In a multivariate logistic regression model, older age (odds ratio: 1.08 per year; P =0.010), longer LVAD support (odds ratio: 1.06 per month; P =0.007), higher creatinine (odds ratio: 3.9 per 1 mg/dL; P =0.039), and longer cardiopulmonary bypass time (odds ratio: 1.83 per hour; P =0.044) were independent predictors of vasoplegia. After mean follow‐up of 4.0 years after HT , vasoplegia was associated with increased risk of all‐cause mortality (hazard ratio: 5.20; 95% CI, 1.71–19.28; P =0.003). Conclusions Older age, longer LVAD support, impaired renal function, and prolonged intraoperative CPB time are independent predictors of vasoplegia in patients undergoing HT after LVAD bridging. Vasoplegia is associated with worse prognosis; therefore, detailed assessment of these predictors can be clinically important.

Background The American College of Cardiology and American Heart Association periodically revise clinical practice guidelines. We evaluated changes in the evidence underlying guidelines published over a 10‐year period. Methods and Results Thirty‐five American College of Cardiology/American Heart Association guidelines were divided into 2 time periods: 2008 to 2012 and 2013 to 2017. Guidelines were categorized into the following topic areas: arrhythmias, prevention, acute and stable ischemia, heart failure, valvular heart disease, and vascular medicine. Changes in recommendations were assessed for each topic area. American College of Cardiology/American Heart Association designated class of recommendation as level I, II , or III (I represented “strongly recommended”) and levels of evidence ( LOE ) as A, C, or C (A represented “highest quality”). The median number of recommendations per each topic area was 281 (198–536, interquartile range) in 2008 to 2012 versus 247 (190–451.3, interquartile range) in 2013 to 2017. The median proportion of class of recommendation I was 49.3% and 44.4% in the 2 time periods, 38.0% and 44.5% for class of recommendation II , and 12.5% and 11.2% for class of recommendation III . Median proportions for LOE A were 15.7% and 14.1%, 41.0% and 52.8% for LOE B, and 46.9% and 32.5% for LOE C. The decrease in the proportion of LOE C was highest in heart failure (24.8%), valvular heart disease (22.3%), and arrhythmia (19.2%). An increase in the proportion of LOE B was observed for these same areas: 31.8%, 23.8%, and 19.2%, respectively. Conclusions There has been a decrease in American College of Cardiology/American Heart Association guidelines recommendations, driven by removal of recommendations based on lower quality of evidence, although there was no corresponding increase in the highest quality of evidence.

Type 2 diabetes mellitus is a risk factor for incident heart failure and increases the risk of morbidity and mortality in patients with established disease. Secular trends in the prevalence of diabetes mellitus and heart failure forecast a growing burden of disease and underscore the need for effective therapeutic strategies. Recent clinical trials have demonstrated the shared pathophysiology between diabetes mellitus and heart failure, the synergistic effect of managing both conditions, and the potential for diabetes mellitus therapies to modulate the risk of heart failure outcomes. This scientific statement on diabetes mellitus and heart failure summarizes the epidemiology, pathophysiology, and impact of diabetes mellitus and its control on outcomes in heart failure; reviews the approach to pharmacological therapy and lifestyle modification in patients with diabetes mellitus and heart failure; highlights the value of multidisciplinary interventions to improve clinical outcomes in this population; and outlines priorities for future research.

Background This study sought to evaluate the 15‐year national utilization, trends, predictors, disparities, and outcomes of palliative care services ( PCS ) use in cardiogenic shock complicating acute myocardial infarction. Methods and Results A retrospective cohort from January 1, 2000 through December 31, 2014 was analyzed using the National Inpatient Sample database. Administrative codes for acute myocardial infarction–cardiogenic shock and PCS were used to identify eligible admissions. The primary outcomes were the frequency, utilization trends, and predictors of PCS . Secondary outcomes included in‐hospital mortality and resources utilization. Multivariable regression and propensity‐matching analyses were used to control for confounding. In this 15‐year period, there were 444 253 acute myocardial infarction–cardiogenic shock admissions, of which 4.5% received PCS . The cohort receiving PCS was older, of white race, female sex, and with higher comorbidity and acute organ failure. The PCS cohort received fewer cardiac procedures, but more noncardiac organ support therapies. Older age, female sex, white race, higher comorbidity, higher socioeconomic status, admission to a larger hospital, and admission after 2008 were independent predictors of PCS use. Use of PCS was independently associated with higher in‐hospital mortality (odds ratio 6.59 [95% CI 6.37–6.83]; P PCS use had >2‐fold higher in‐hospital mortality, 12‐fold higher use of do‐not‐resuscitate status, lesser in‐hospital resource utilization, and fewer discharges to home. Similar findings were observed in the propensity‐matched cohort. Conclusions PCS use in patients with acute myocardial infarction–cardiogenic shock is low, though there is a trend towards increased adoption. There are significant patient and hospital‐specific disparities in the utilization of PCS .

Aims Patient-reported quality of life (QOL) is a highly prognostic and clinically relevant endpoint in patients with heart failure (HF) with preserved ejection fraction (HFpEF). The relationships between QOL and different markers of HF severity remain unclear, particularly as they relate to functional capacity and directly measured activity levels. We hypothesized that QOL would demonstrate a stronger relationship with measures of exercise capacity and adiposity compared to other disease measures. Methods and results This is a secondary analysis of the National Heart, Lung, and Blood Institute-sponsored RELAX, NEAT-HFpEF and INDIE-HFpEF trials to determine the relationships between QOL (assessed by the Kansas City Cardiomyopathy Questionnaire and Minnesota Living with Heart Failure Questionnaire) and different domains reflecting HF severity, including maximal aerobic capacity (peak oxygen consumption), submaximal exercise capacity (6-min walk distance), volume of daily activity (accelerometry), physician-estimated functional class, resting echocardiography, and plasma natriuretic peptide levels. A total of 408 unique patients with chronic HFpEF were split into tertiles of QOL scores defined as QOLworst, QOLintermediate , QOLbest . The QOLworst HFpEF group was youngest, with a higher body mass index, greater prevalence of class II obesity and diabetes, and the lowest N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. After adjustment for age, sex and body mass index, poorer QOL was associated with worse physical capacity and activity levels, assessed by peak oxygen consumption, 6-min walk distance and actigraphy, but was not associated with NT-proBNP or indices from resting echocardiography. QOL was similarly reduced in patients with and without prior HF hospitalization. Conclusions Quality of life in HFpEF is poorest in patients who are young, obese and have diabetes, and is more robustly tied to measures reflecting functional capacity and daily activity levels rather than elevations in NT-proBNP or prior HF hospitalization. These findings have major implications for the understanding of QOL in HFpEF and for the design of future clinical trials targeting symptom improvement in HFpEF. Clinical trial registration RELAX, NCT00763867; NEAT-HFpEF, NCT02053493; INDIE-HFpEF, NCT02742129.