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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.

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.

Predictive models have played a critical role in local, national, and international response to the COVID-19 pandemic. In the United States, health care systems and governmental agencies have relied on several models, such as the Institute for Health Metrics and Evaluation, Youyang Gu (YYG), Massachusetts Institute of Technology, and Centers for Disease Control and Prevention ensemble, to predict short- and long-term trends in disease activity. The Mayo Clinic Bayesian SIR model, recently made publicly available, has informed Mayo Clinic practice leadership at all sites across the United States and has been shared with Minnesota governmental leadership to help inform critical decisions during the past year. One key to the accuracy of the Mayo Clinic model is its ability to adapt to the constantly changing dynamics of the pandemic and uncertainties of human behavior, such as changes in the rate of contact among the population over time and by geographic location and now new virus variants. The Mayo Clinic model can also be used to forecast COVID-19 trends in different hypothetical worlds in which no vaccine is available, vaccinations are no longer being accepted from this point forward, and 75% of the population is already vaccinated. Surveys indicate that half of American adults are hesitant to receive a COVID-19 vaccine, and lack of understanding of the benefits of vaccination is an important barrier to use. The focus of this paper is to illustrate the stark contrast between these 3 scenarios and to demonstrate, mathematically, the benefit of high vaccine uptake on the future course of the pandemic.

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

Objective: To assess 4 adverse renal outcomes in a heterogeneous cohort of patients with systolic heart failure (HF) who were prescribed sacubitril-valsartan vs angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARB). Patients and Methods: The OptumLabs Database Warehouse, which contains linked administrative claims and laboratory results, was used to identify patients with systolic HF who were prescribed sacubitril-valsartan or ACEi/ARB between July 1, 2015, and September 30, 2019. One-to-one propensity score matching and inverse probability of treatment weighting was used to balance baseline variables. Cox proportional hazards modeling was performed to compare renal outcomes in both medication groups, including 30% or more decline in estimated glomerular filtration rate (eGFR), doubling of serum creatinine, acute kidney injury (AKI), and kidney failure (eGFR < 15 mL/min per 1.73 m2, kidney transplant, or dialysis initiation). Results: A total of 4667 matched pairs receiving sacubitril-valsartan or ACEi/ARB were included; the mean follow-up period was 7.8±7.8 months. The mean age was 69.4±11 years; 35% were female, 19% black, and 15% Hispanic. The cumulative risk at 1 year was 6% for 30% or more decline in eGFR, 2% for doubling of serum creatinine, 3% for AKI, and 2% to 3% for kidney failure. Furthermore, no significant differences in risk were observed with sacubitril-valsartan compared with ACEi/ARB for a 30% or more decline in eGFR (hazard ratio [HR], 0.96; 95% CI, 0.79 to 1.10), doubling of serum creatinine (HR, 0.94; 95% CI, 0.69 to 1.27); AKI (HR, 0.80; 95% CI, 0.63 to 1.03), and kidney failure (HR 0.80; 95% CI, 0.59 to 1.08). Conclusion: Among patients with systolic HF, the risk of adverse renal outcomes was similar between patients prescribed sacubitril-valsartan and those prescribed ACEi/ARB.

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

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.

OBJECTIVE: To evaluate outcomes by sex in older adults with cardiogenic shock complicating acute myocardial infarction (AMI-CS). MATERIALS AND METHODS: A retrospective cohort of older (≥75 years) AMI-CS admissions during January 1, 2000, to December 31, 2014, was identified using the National Inpatient Sample. Interhospital transfers were excluded. Use of angiography, percutaneous coronary intervention (PCI), mechanical circulatory support (MCS), and noncardiac interventions was identified. The primary outcome was in-hospital mortality stratified by sex, and secondary outcomes included temporal trends of prevalence, in-hospital mortality, use of cardiac and noncardiac interventions, hospitalization costs, and length of stay. RESULTS: In this 15-year period, there were 134,501 AMI-CS admissions 75 years or older, of whom 51.5% (n=69,220) were women. Women were on average older, were more often Hispanic or nonwhite race, and had lower comorbidity, acute organ failure, and concomitant cardiac arrest. Compared with older men (n=65,281), older women (n=69,220) had lower use of coronary angiography (55.4% [n=35,905] vs 49.2% [n=33,918]), PCI (36.3% [n=23,501] vs 34.4% [n=23,535]), MCS (34.3% [n=22,391] vs 27.2% [n=18,689]), mechanical ventilation, and hemodialysis (all P

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.

There are contrasting data on concomitant Impella device in cardiogenic shock patients treated with venoarterial extracorporeal membrane oxygenation (VA ECMO) (ECPELLA). This study sought to compare early mortality in patients with cardiogenic shock treated with ECPELLA in comparison to VA ECMO alone. We reviewed the published literature from 2000 to 2018 for randomized, cohort, case-control, and case series studies evaluating adult patients requiring VA ECMO for cardiogenic shock. Five retrospective observational studies, representing 425 patients, were included. Venoarterial extracorporeal membrane oxygenation with concomitant Impella strategy was used in 27% of the patients. Median age across studies varied between 51 and 63 years with 59-88% patients being male. Use of ECPELLA was associated with higher weaning from VA ECMO and bridging to permanent ventricular assist device or cardiac transplant in three and four studies, respectively. The studies showed moderate heterogeneity with possible publication bias. The two studies that accounted for differences in baseline characteristics between treatment groups reported lower 30 day mortality with ECPELLA versus VA ECMO. The remaining three studies did not adjust for potential confounding and were at high risk for selection bias. In conclusion, ECPELLA is being increasingly used as a strategy in patients with cardiogenic shock. Additional large, high-quality studies are needed to evaluate clinical outcomes with ECPELLA.

Objective We examined characteristics of depressive symptoms in patients who received left ventricular assist devices (LVAD) to assess their effects on negative outcomes post-implantation. Methods We retrospectively identified 203 adults with pre-operative PHQ-9 scores who underwent LVAD placement as bridge to transplant (BTT) or destination therapy (DT). We analyzed effects of PHQ-9 total, somatic, and cognitive/affective scores and proportion of patients with clinical depression on all-cause mortality, rehospitalization, major bleeding, and neurologic events post-implantation, controlling for demographics and other medical comorbidities. Results Mean total PHQ-9 scores did not differ between 81 BTT and 122 DT patients (BTT 6.4 vs. DT 7.5, p = 0.12). A higher proportion of DT patients had clinical depression (BTT 22% vs. DT 39%, p = 0.015). Somatic symptoms accounted for three-quarters of total scores in both groups. PHQ-9 domains were not associated with negative outcomes post-implantation. Conclusion Depression severity did not differ based on implant strategy, but more DT patients had clinical depression. Somatic symptoms were the biggest contributor to depressive symptoms. Pre-implantation PHQ-9 scores were not associated with outcomes, possibly because depression was mild in both groups. Additional work is needed in LVAD patients to better characterize depressive symptoms and their unique effects on clinical course and well-being.

Background. Despite demonstrated efficacy, patient decision aids (DAs) are rarely used in clinical practice in the absence of coverage mandates. Deciding whether to pursue a left ventricular assist device (LVAD) is a major, preference-sensitive decision—ideal for exploring implementation of a DA. Methods. We conducted a type II effectiveness-implementation hybrid trial at 6 LVAD programs using a stepped-wedge cluster-randomized design. Using the RE-AIM framework, we collected both quantitative and qualitative outcomes, including a checklist collected by study staff for each enrolled patient regarding DA use and interviews with LVAD program clinicians preintervention, 6 months postintervention, and at the conclusion of the study. Results. From June 2015 to January 2017, 248 patients and their caregivers were enrolled. A total of 69 interviews were conducted with 48 clinicians at 3 time points. The DA reached 95% of eligible patients. Adoption was 100%, as all sites approached agreed to participate in the trial. Interviews revealed several themes related to the implementation of the DA: clinicians had a strong desire to ensure patients were informed and embraced the DA. Despite this, they reported communication challenges among their team that impeded implementation. Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation. Conclusions. In this hybrid trial, a DA for patients considering LVADs and their caregivers demonstrated high reach. Adoption and implementation were facilitated by a strong desire to ensure that patients were well informed. Future dissemination research and practice should attend to concerns about procedure volume and coverage mandates and facilitate ongoing communication at sites using the DA.

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 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.

Various risk models with differing discriminatory power and predictive accuracy have been used to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) placement. There remains an unmet need for a contemporary risk score for continuous flow (CF)-LVADs. We sought to independently validate and compare existing risk models in a large cohort of patients and develop a simple, yet highly predictive risk score for acute, severe RVF. Data from the Mechanical Circulatory Support Research Network (MCSRN) registry, consisting of patients who underwent CF-LVAD implantation, were randomly divided into equal-sized derivation and validation samples. RVF scores were calculated for the entire sample, and the need for a right ventricular assist device (RVAD) was the primary endpoint. Candidate predictors from the derivation sample were subjected to backward stepwise logistic regression until the model with lowest Akaike information criterion value was identified. A risk score was developed based on the identified variables and their respective regression coefficients. Between May 2004 and September 2014, 734 patients underwent implantation of CF-LVADs [HeartMate II LVAD, 76% (n = 560), HeartWare HVAD, 24% (n = 174)]. A RVAD was required in 4.5% (n = 33) of the patients [Derivation cohort, n = 15 (4.3%); Validation cohort, n = 18 (5.2%); P = 0.68)]. 19.5% of the patients (n = 143) were female, median age at implant was 59 years (IQR, 49.4-65.3), and median INTERMACS profile was 3 (IQR, 2-3). RVAD was required in 4.5% (n = 33) of the patients. Correlates of acute, severe RVF in the final model included heart rate, albumin, BUN, WBC, cardiac index, and TR severity. Areas under the curves (AUC) for most commonly used risk predictors ranged from 0.61 to 0.78. The AUC for the new model was 0.89 in the derivation and 0.92 in the validation cohort. Proposed risk model provides very high discriminatory power predicting acute severe right ventricular failure and can be reliably applied to patients undergoing placement of contemporary continuous flow left ventricular assist devices.

Objective: To evaluate post–acute care utilization and readmissions after cardiac arrest (CA) and cardiogenic shock (CS) complicating acute myocardial infarction (AMI). Methods: With use of 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. Outcomes included 90-day post–acute care (inpatient rehabilitation or skilled nursing facility) utilization and 1-year emergency department visits and readmissions. Results: Of 163,071 AMI patients, CA+CS, CA only, and CS only were noted in 3965 (2.4%), 8221 (5.0%), and 6559 (4.0%), respectively. In-hospital mortality was noted in 10,686 (6.6%) patients: CA+CS, 1935 (48.8%); CA only, 2948 (35.9%); CS only, 1578 (24.1%); and AMI alone, 4225 (2.9%) (P

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.

Background: There are limited data on the epidemiology and timing of in-hospital death (IHD) in patients with acute myocardial infarction-cardiogenic shock (AMI-CS). Methods: Adult admissions with AMI-CS with IHDs were identified using the National Inpatient Sample (2000–2016) and were classified as early (≤2 days), mid-term (3–7 days), and late (>7 days). Inter-hospital transfers and those with do-not-resuscitate statuses were excluded. The outcomes of interest included the epidemiology, temporal trends and predictors for IHD timing. Results: IHD was noted in 113,349 AMI-CS admissions (median time to IHD 3 (interquartile range 1–7) days), with early, mid-term and late IHD in 44%, 32% and 24%, respectively. Compared to the mid-term and late groups, the early IHD group had higher rates of ST-segment-elevation AMI-CS (74%, 63%, 60%) and cardiac arrest (37%, 33%, 29%), but lower rates of acute organ failure (68%, 79%, 89%), use of coronary angiography (45%, 56%, 67%), percutaneous coronary intervention (33%, 36%, 42%), and mechanical circulatory support (31%, 39%, 50%) (all p < 0.001). There was a temporal increase in the early (adjusted odds ratio (aOR) for 2016 vs. 2000 2.50 (95% confidence interval (CI) 2.22–2.78)) and a decrease in mid-term (aOR 0.75 (95% CI 0.71–0.79)) and late (aOR 0.34 (95% CI 0.31–0.37)) IHD. ST-segment-elevation AMI-CS and cardiac arrest were associated with the increased risk of early IHD, whereas advanced comorbidity and acute organ failure were associated with late IHD. Conclusions: Early IHD after AMI-CS has increased between 2000 and 2016. The populations with early vs. late IHD were systematically different.

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.

Three new classes of glucose-lowering drugs were introduced into practice over the past 15 years. DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors have low hypoglycemia risk, do not cause weight gain, and GLP-1RA and SGLT2i have additional cardiovascular and renal benefits. We previously found low rates of early SGLT2i use by women and black patients, but more recent data and data for other drugs were lacking. Using OptumLabs Data Warehouse, a de-identified dataset of commercially-insured and Medicare Advantage beneficiaries, we identified adults with type 2 diabetes who first started a DPP-4i (n=140,933), GLP-1RA (n=107,331), SGLT2i (n=112,892), or any other diabetes drug (n=1,743,484) between 2013-2018. Odds of starting each medication class were examined in separate logistic regression models for white women (WW), non-white men (NM), and non-white women (NW) compared to white men, adjusting for other factors affecting drug choice (Figure). Results were mixed, as depicted by the Figure. Our study design cannot identify the causes of preferential use of DPP-4i among non-white patients, or the preferential avoidance of SGLT2i among women and NM and of GLP-1RA among NW. Because these drugs have important safety and efficacy benefits, our findings call for closer examination of potential implicit biases surrounding medication prescribing and diabetes management. Disclosure R.G. McCoy: None. H. Van Houten: None. S.M. Dunlay: None. X. Yao: None. T. Dempsey: None. P. Noseworthy: None. L.R. Sangaralingham: None. A.H. Limper: None. N. Shah: None. Funding National Institutes of Health (K23DK114497)

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.

Highly specialized left ventricular assist device care is not readily available in many areas, potentially limiting access to therapy. This retrospective analysis examines the relationship of outcomes by patient distance from implanting left ventricular assist device center within the Mechanical Circulatory Support Research Network. Zip codes were used to calculate patient distance, with the primary outcome of interest being 3-year survival by distance from the surgical center. Secondary outcomes included 90-day survival and incident event rates for the following: gastrointestinal bleeding, infection, cerebral event, and pump thrombosis. Across the four centers, there were 1184 patients supported for a median of 486 days. Overall survival was 91 ± 0.8% at 90 days and 61 ± 1.9% at 3 years, with worse 3-year survival in those living >90 vs. ≤90 miles from the ventricular assist device implant center (55 ± 3.0% vs. 64 ± 2.5, p = 0.019). Patients living >90 miles from an implant center were older, more likely to be implanted for destination therapy support, had a prior sternotomy, and had worse renal function than those living closer (p

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.

Objectives To characterize the individual and combined effects of multimorbidity and functional limitation on healthcare use and mortality in a large, community cohort of individuals with heart failure (HF). Design Prospective cohort study. Setting Eleven southeastern Minnesota counties. Participants Individuals (mean age 74, 54% male) with a first‐ever HF code (International Classification of Diseases, Ninth Revision code 428 or Tenth Revision code I50) between January 1, 2013 and March 31, 2016 (N=2,692). Measurements Eight activities of daily living measured using a survey on a Likert scale (1=without any difficulty, 5=unable to do; median=8). Participants with a score greater than 8 were categorized as having functional limitation. Multimorbidity was defined as having 2 or more noncardiac comorbidities. Results Twenty‐five percent of participants had neither multimorbidity nor functional limitation, 35% had multimorbidity, 9% had functional limitation, and 31% had both. After adjustment, participants with multimorbidity and functional limitation had greater risks of all outcomes (death: hazard ratio (HR)=4.92, 95% confidence interval (CI)=3.03–8.00; emergency department (ED) visit: HR=3.67, 95% CI=2.94–4.59; hospitalization: HR=3.66, 95% CI=2.85–4.70; outpatient visit: HR=1.73, 95% CI=1.52–1.96) than those with neither. Participants with functional limitation alone had greater risks of death (HR=4.84, 95% CI=2.78–8.43), ED visits (HR=2.35, 95% CI=1.75–3.16), and hospitalizations (HR=2.10, 95% CI=1.52–2.88) but not outpatient visits. Those with multimorbidity alone had similar risks of ED visits and hospitalizations as those with functional limitation alone but were more likely to have outpatient visits (HR=1.50, 95% CI=1.34–1.67). Conclusion Individuals with both multimorbidity and functional limitation have the highest risk of death and healthcare use. Individuals with only functional limitation have similar rates of hospitalizations and ED visits as those with only multimorbidity, underscoring the need to consider both when managing individuals with HF.

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.

Objective To assess the associations of perceived discrimination and cardiovascular (CV) outcomes in African Americans (AAs) in the Jackson Heart Study. Patients and Methods In 5085 AAs free of clinical CV disease at baseline enrolled in the Jackson Heart Study from September 26, 2000, through March 31, 2004, and followed through 2012, associations of everyday discrimination (frequency of occurrences of perceived unfair treatment) and lifetime discrimination (perceived unfair treatment in 9 life domains) with CV outcomes (all-cause mortality, incident coronary heart disease [CHD], incident stroke, and heart failure [HF] hospitalization) were examined using Cox proportional hazards regression models. Results Higher levels of everyday and lifetime discrimination were more common in participants who were younger and male and had higher education and income, lower perceived standing in the community, worse perceived health care access, and fewer comorbidities. Before adjustment, higher levels of everyday and lifetime discrimination were associated with a lower risk of all-cause mortality, incident CHD, stroke, and HF hospitalization. After adjustment for potential confounders, we found no association of everyday and lifetime discrimination with incident CHD, incident stroke, or HF hospitalization; however, a decrease in all-cause mortality with progressively higher levels of everyday discrimination persisted (hazard ratio per point increase in discrimination measure, 0.90; 95% CI, 0.82-0.99; P =.02). The unexpected association of everyday discrimination and all-cause mortality was partially mediated by perceived stress. Conclusion We found no independent association of perceived discrimination with risk of incident CV disease or HF hospitalization in this AA population. An observed paradoxical negative association of everyday discrimination and all-cause mortality was partially mediated by perceived stress.

Objectives To examine the effect of skilled nursing facility (SNF) use on hospitalizations in patients with heart failure (HF) and to examine predictors of hospitalization in patients with HF admitted to a SNF. Patients and Methods Olmsted County, Minnesota, residents with first-ever HF from January 1, 2000, through December 31, 2010, were identified, and clinical data were linked to SNF utilization data from the Centers for Medicare and Medicaid Services. Andersen-Gill models were used to determine the association between SNF use and hospitalizations and to determine predictors of hospitalization. Results Of 1498 patients with incident HF (mean ± SD age, 75±14 years; 45% male), 605 (40.4%) were admitted to a SNF after HF diagnosis (median follow-up, 3.6 years; range, 0-13.0 years). Of those with a SNF admission, 225 (37%) had 2 or more admissions. After adjustment for age, sex, ejection fraction, and comorbidities, SNF use was associated with a 50% increased risk of hospitalization compared with no SNF use (adjusted hazard ratio, 1.52; 95% CI, 1.31-1.76). In SNF users, arrhythmia, asthma, chronic kidney disease, and the number of activities of daily living requiring assistance were independently associated with an increased risk of hospitalization. Conclusion Approximately 40% of patients with HF were admitted to a SNF at some point after diagnosis. Compared with SNF nonusers, SNF users were more likely to be hospitalized. Characteristics associated with hospitalization in SNF users were mostly noncardiovascular, including reduced ability to perform activities of daily living. These findings underscore the effect of physical functioning on hospitalizations in patients with HF in SNFs and the importance of strategies to improve physical functioning.

Objective To study the temporal distribution and causes of hospitalizations after heart failure (HF) diagnosis. Patients and Methods Hospitalizations were studied in 1972 Olmsted County, Minnesota, residents with incident HF from January 1, 2000, to December 31, 2011. All hospitalizations were examined for the 2 years following incident HF, and each was categorized as due to HF, other cardiovascular causes, or noncardiovascular causes. Negative binomial regression examined associations between time periods (0-30, 31-182, 183-365, and 366-730 days after diagnosis) and hospitalizations. Results During the 2 years after diagnosis, 3495 hospitalizations were observed among 1336 of the 1972 patients with HF. The age- and sex-adjusted rates of hospitalizations were highest in the first 30 days after diagnosis (3.33 per person-year vs 1.33, 1.07, and 1.00 per person-year for 31-182 days, 183-365 days, and 366-730 days, respectively). The rates of hospitalizations were similar across sex, presentation of HF (inpatient or outpatient), and type of HF (preserved or reduced ejection fraction). Patients diagnosed as inpatients who had long hospital stays (>5 days) experienced more than a 30% increased risk of rehospitalization within 30 days of dismissal. Importantly, most hospitalizations (2222 of 3495 [63.6%]) were due to noncardiovascular causes, and a minority (440 of 3495 [12.6%]) were due to HF. The rates of noncardiovascular hospitalizations were higher than those for HF or other cardiovascular hospitalizations across all follow-up for all time periods after HF. Conclusion Patients with HF experience high rates of hospitalizations, particularly within the first 30 days, and mostly for noncardiovascular causes. To reduce hospitalizations in patients with HF, an integrated approach focusing on comorbidities is required.

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.

Frailty is a syndrome of decreased physiological reserve in response to stressors, which increases the vulnerability to adverse health outcomes. Although there is no standard reference test for detecting frailty before left ventricular assist device (LVAD) implantation, several screening tools can be helpful. Numerous studies have found that frailty is often present in patients scheduled to receive LVADs and is associated with longer and more complicated post-implant hospitalizations and worse long-term mortality. Contemporary data suggest that frailty is at least partially reversible with LVAD therapy in some individuals. New therapeutic strategies to improve or reverse frailty in patients receiving LVADs are needed.

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 Differences in comorbid conditions in patients with heart failure compared with population controls, and whether differences exist by type of heart failure or age, have not been well documented. Methods The prevalence of 17 chronic conditions were obtained in 2643 patients with incident heart failure from 2000 to 2013 and controls matched 1:1 on sex and age from Olmsted County, Minnesota. Logistic regression determined associations of each condition with heart failure. Results Among 2643 matched pairs (mean age 76.2 years, 45.6% men), the comorbidities with the largest attributable risk of heart failure were arrhythmia (48.7%), hypertension (28.4%), and coronary artery disease (33.9%); together these explained 73.0% of heart failure. Similar associations were observed for patients with reduced and preserved ejection fraction, with the exception of hypertension. The risk of heart failure attributable to hypertension was 2-fold higher in patients with heart failure with preserved ejection fraction (38.7%) than in patients with heart failure with reduced ejection fraction (17.8%). Hypertension, coronary artery disease, arrhythmia, and diabetes were more strongly associated with heart failure in younger (≤75 years) compared to older (>75 years) persons. Conclusions Patients with heart failure have a higher prevalence of many chronic conditions than controls. Similar associations were observed in patients with reduced and preserved ejection fraction, with the exception of hypertension, which was more strongly associated with heart failure with preserved ejection fraction. Finally, some cardiometabolic risk factors were more strongly associated with heart failure in younger persons, highlighting the importance of optimizing prevention and treatment of risk factors and, in particular, cardiometabolic risk factors.

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.