Objective Guidelines developed by the American College of Cardiology/American Heart Association (ACC/AHA) recommend lipid-lowering therapies (LLTs) to reduce low-density lipoprotein cholesterol (LDL-C) and atherosclerotic cardiovascular disease (ASCVD) risk. This study described LLT utilization patterns and LDL-C goal achievement (to <70 mg/dL) among patients with ASCVD in the United States.Methods This retrospective study was conducted using Optum's de-identified Clinformatics Data Mart Database (CDM). Patients with their first ASCVD diagnosis (index date) in the CDM database between July 1, 2015, and December 31, 2018, were followed for >= 12 months to assess LLT utilization patterns and change in LDL-C. LLTs included were statins and non-statin LLTs (ezetimibe, fibrates, and proprotein convertase subtilisin/kexin type 9 inhibitors). Adherence was measured as the proportion of days covered (PDC), defined as the number of days with drug on-hand (or number of days exposed to drug) divided by the 12-month follow-up period. Patients with PDC >= 0.8 were considered adherent.Results Among the patients with ASCVD (N = 1,424,893) included in this study, only 621,978 (43.7%) had at least one LDL-C measurement at baseline (6 months prior to and 3 months after the index date). The mean age was 71.5 years, and almost half of the patients were female. Patients were followed for a mean (standard deviation [SD]) duration of 30.6 (11.4) months (median of 29.9 months). During the follow-up, about one-quarter of the patients did not receive any LLT. Among treated patients, 89.5% received statins and 10.5% received non-statin LLT. Less than half (47.6%) of the patients were adherent to the index treatment during the 12-month follow-up. Even in patients receiving combination therapy (statin + non-statin LLT), a sizable proportion (35.8%) showed an increase in LDL-C over the follow-up period.Conclusions This retrospective study highlighted limited LDL-C monitoring in patients with ASCVD, and unmet need in terms of suboptimal utilization of non-stain LLTs, limited adherence to LLTs, and inadequate lipid control after treatment (among those with LDL-C measurements during the follow-up period) need to be addressed to improve outcomes in this patient cohort.

BACKGROUND: Lipoprotein(a) (Lp(a)) is an inherited, independent, and causal risk factor for atherosclerotic cardiovascular disease (ASCVD). OBJECTIVE: To assess the burden of elevated Lp(a) for patients with ASCVD in a real-world setting in the United States. METHODS: This retrospective cohort study assessed US patients with available Lp(a) measurement and established ASCVD using Optum's Clinformatics Data Mart database (2007-2020). Index date was defined as the first diagnosis of an ASCVD event. Patient demographics, medications, health care resource utilization (HCRU), and occurrence of cardiovascular events were assessed for patients with elevated (>= 150 nmol/L) vs normal (< 65 nmol/L) Lp(a) levels, within the first year of index date. HCRU was characterized by inpatient hospitalization, inpatient length of stay (LOS), outpatient visits, and emergency department (ED) visits. All comparative analyses of patients with elevated (>= 150 nmol/L) vs normal (< 65 nmol/L) Lp(a) levels within the first year of index date were adjusted for age, sex, baseline statin use, and diabetes. RESULTS: 8,372 patients with ASCVD and Lp(a) measurement in nmol/L were included in this study. Patient demographics and baseline clinical characteristics were similar among those with normal and elevated Lp(a). However, the proportion of patients receiving statins and beta-blockers at baseline were significantly higher in the elevated vs normal Lp(a) group (54.76% vs 42.91%, P<0.0001, and 30.92% vs 27.32%, P = 0.0183, respectively). At 1 year of follow-up, the rates per 100 person-years for ASCVD-related inpatient hospitalizations, outpatient hospitalizations, and ED visits were higher among patients with elevated Lp(a) compared with normal Lp(a) (13.33 vs 9.46, 89.08 vs 85.10, and 2.89 vs 2.29, respectively). The mean LOS per ASCVD-related hospitalization was 7.21 days in the elevated and 6.26 days in the normal Lp(a) group (P = 0.3462). During the 1-year post-index follow-up period, 15% of patients in the elevated Lp(a) group required revascularization compared with 10% of patients in the normal Lp(a) group (P=0.0002). The odds of composite myocardial infarction, ischemic stroke, and revascularization occurrence of events within the first year of index was significantly higher in the elevated Lp(a) group compared with the normal Lp(a) group (1.46; 95% CI = 1.20-1.77; P<0.05). CONCLUSIONS: HCRU within the first year of ASCVD diagnosis is substantial among patients with ASCVD and elevated Lp(a). Relatively higher rates of inpatient hospitalizations, increased LOS per hospitalization, and requirement of revascularization procedures within the first year of ASCVD index diagnosis were observed in patients with elevated Lp(a) compared with normal Lp(a) levels. Lp(a) testing in routine clinical practice could help in identification of high-risk patients with ASCVD and play an important role in the overall cardiovascular risk management, aiming to reduce the HCRU associated with ASCVD.

Background Elevated lipoprotein(a) [Lp(a)] level is an independent genetic risk factor that increases the risk of atherosclerotic cardiovascular disease (ASCVD) by 2–4 fold. We aimed to report the burden of clinically relevant elevated Lp(a) in secondary prevention ASCVD population as the evaluation of such evidence is lacking. Methods A systematic literature review (SLR) was conducted using Embase ® , MEDLINE ® , and MEDLINE ® In-Process databases to identify studies reporting burden of elevated Lp(a) levels from January 1, 2010, to March 28, 2022. Full-text, English-language studies including ≥500 participants with ≥1 Lp(a) assessment were included. Results Sixty-one studies reported clinical burden of elevated Lp(a). Of these, 25 observational studies and one clinical trial reported clinical burden of clinically relevant elevated Lp(a) levels. Major clinical outcomes included major adverse cardiovascular event (MACE; n = 20), myocardial infarction (MI; n = 11), revascularization (n = 10), stroke (n = 10), cardiovascular (CV) mortality (n = 9), and all-cause mortality (n = 10). Elevated Lp(a) levels significantly increased the risk of MACE (n = 15) and revascularization (n = 8), while they demonstrated a trend for positive association with remaining CV outcomes. Meta-analysis was not feasible for included studies due to heterogeneity in Lp(a) thresholds, outcome definitions, and patient characteristics. Three studies reported humanistic burden. Patients with elevated Lp(a) levels had higher odds of manifesting cognitive impairment (odds ratio [OR] [95% confidence interval; CI]: 1.62 [1.11–2.37]) and disability related to stroke (OR [95% CI]:1.46 [1.23–1.72)]) (n = 2). Elevated Lp(a) levels negatively correlated with health-related quality of life (R = −0.166, p = 0.014) (n = 1). A single study reported no association between elevated Lp(a) levels and economic burden. Conclusions This SLR demonstrated a significant association of elevated Lp(a) levels with major CV outcomes and increased humanistic burden in secondary prevention ASCVD population. These results reinforce the need to quantify and manage Lp(a) for CV risk reduction and to perform further studies to characterize the economic burden.

Abstract Background Heart failure (HF) is a global illness and is a leading cause of hospitalizations. Recurrent HF hospitalization (HFH) is associated with increased risk of cardiovascular (CV) and all-cause mortality, thereby burdening the health system. Type 2 diabetes mellitus (T2DM) and atrial fibrillation (AF) are two important comorbidities in patients living with HF. This study aims to assess the association between recurrent HFHs with CV and all-cause mortality in patients living with HF and having AF and/or T2DM. Methods This study was conducted using primary care data from the Clinical Practice Research Datalink database with linkage to hospital data and mortality data. Adults living with HF and with at least 1 HFH were identified from January 2010 to December 2014. Patients were grouped based on the number of recurrent HFHs. During follow-up, all-cause mortality or CV mortality for the HF population with AF and T2DM was recorded. Results Overall, 32.9% of 2344 T2DM patients and 28.2% of 4585 AF patients had at least 1 recurrent HFH. The patients were relatively elderly and were predominantly male. The mean number of all-cause hospitalizations in HF patients having T2DM and AF, with ≥ 1 recurrent HFH were significantly higher than patients without recurrent HFH. The annualized mortality rates in CV mortality as the primary cause and for all-cause mortality and increased with recurrent HFHs, in T2DM and AF patients. The risk of CV mortality as primary cause and all cause morality were 5.39 and 3.19 times higher in T2DM patients with 3 recurrent HFHs versus no recurrent HFH. Similarly, the risk of CV mortality as primary cause and all cause morality was 5.98 and 4.3 times higher in AF patients with 3 recurrent HFHs versus those with no recurrent HFH. Conclusions Recurrent HFHs are strongly associated with CV mortality and all-cause mortality in HF patients with TD2M or AF. The hospitalization rate highlights the need for treatment and disease management, which will improve the course of the disease and help patients stay out of hospital.

The angiotensin receptor neprilysin inhibitor (ARNI) sacubitril/valsartan (SAC/VAL) has shown benefit in patients with symptomatic heart failure (HF), including those naïve to renin–angiotensin–aldosterone system inhibitor (RAASi) therapy, and is considered the preferred RAASi for chronic HF. Real-world data on ARNI, specifically in RAASi-naïve patients, are limited. This study compared real-world outcomes of ARNI (SAC/VAL) vs. angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) therapy in RAASi-naïve patients with HF and reduced ejection fraction (HFrEF). This retrospective cohort study included de-identified data on RAASi-naïve patients with HFrEF (left ventricular ejection fraction ≤ 40%) who had newly initiated SAC/VAL or ACEi/ARB between July 1, 2015, and March 31, 2019, from the Optum® Electronic Health Records database in the US. New SAC/VAL users were propensity score matched 1:2 with new ACEi/ARB users by pre-selected characteristics. One-year post-index rates of all-cause, HF, and cardiovascular hospitalizations and the composite of HF hospitalization or emergency room (ER) visits were measured using negative binomial regression. Time to first all-cause hospitalization, HF hospitalization, and composite of HF hospitalization or ER visits was measured using a subdistribution hazards model. The matched sample included 3059 new SAC/VAL and 6118 new ACEi/ARB users. Rates of all-cause hospitalization and composite of HF hospitalization or ER visits were significantly lower with SAC/VAL compared with ACEi/ARB (incidence rate ratio [95% confidence interval]: 0.87 [0.81–0.93] and 0.87 [0.81–0.94], respectively), whereas rates of HF hospitalizations and cardiovascular hospitalizations were similar (1.00 [0.91–1.11] and 0.94 [0.87–1.02], respectively). Time-to-event analyses also showed a similar trend. In real-world clinical practice, RAASi-naïve patients with HFrEF initiating SAC/VAL were less likely to be hospitalized than those initiating ACEi/ARB, suggesting a potential for a reduced clinical and economic burden in these patients.

Lead Author's Financial Disclosures Divyagiri Seshagiri is an employee of Novartis Pharma AG, Basel, Switzerland. Study Funding None. Background/Synopsis Despite current lipid-lowering treatments (LLT), patients with atherosclerotic cardiovascular disease (ASCVD) do not reach the current guidelines recommended LDL-C goal. Objective/Purpose To describe the clinical characteristics of patients with atherosclerotic cardiovascular disease with hypercholesterolemia (ASCVD-H) and familial hypercholesterolemia (FH) in the United States (US). Methods This retrospective non-interventional study included patients from Optum's de-identified Clinformatics Data Mart database (2007-2019) in the US. Hypercholesterolemia was defined if patients had a recorded diagnosis, were prescribed LLT or had LDL-C levels of ≥70 mg/dL for ASCVD or ≥100mg/dL for FH, anytime within 6 months before and 3 months after index date. Index date was first ASCVD encounter or FH diagnosis during the identification period (1/07/2015-31/12/2018). Results 1,817,577 patients with ASCVD-H (50% females) and 66,277 patients with FH (53.6% females) with a mean (SD) age of 71 (11) years and 63 (18) years, respectively, were included. Use of statins was reported in 60% (ASCVD-H) and 49% (FH) patients at index, while 38% (ASCVD-H) and 48% (FH) patients received no LLT at index. Only 39% (ASCVD-H) and 43% (FH) patients receiving statins had LDL-C measurements within 6 months before and 3 months after index date. Higher proportion of male patients had controlled LDL-C levels than female patients across both cohorts (Table 1). Conclusions About 60% of ASCVD-H and FH patients did not have LDL-C measurements. More than one third of ASCVD-H patients and almost half of FH patients received no LLT. A substantial proportion of patients remain uncontrolled with LDL-C levels ≥70 mg/dL despite receiving LLT. Divyagiri Seshagiri is an employee of Novartis Pharma AG, Basel, Switzerland. None.

Background: Transparent and robust real-world evidence sources are increasingly important for global health, including cardiovascular (CV) diseases. We aimed to identify global real-world data (RWD) sources for heart failure (HF), acute coronary syndrome (ACS), and atrial fibrillation (AF). Methods: We conducted a systematic review of publications with RWD pertaining to HF, ACS, and AF (2010–2018), generating a list of unique data sources. Metadata were extracted based on the source type (e.g., electronic health records, genomics, and clinical data), study design, population size, clinical characteristics, follow-up duration, outcomes, and assessment of data availability for future studies and linkage. Results: Overall, 11,889 publications were retrieved for HF, 10,729 for ACS, and 6,262 for AF. From these, 322 (HF), 287 (ACS), and 220 (AF) data sources were selected for detailed review. The majority of data sources had near complete data on demographic variables (HF: 94%, ACS: 99%, and AF: 100%) and considerable data on comorbidities (HF: 77%, ACS: 93%, and AF: 97%). The least reported data categories were drug codes (HF, ACS, and AF: 10%) and caregiver involvement (HF: 6%, ACS: 1%, and AF: 1%). Only a minority of data sources provided information on access to data for other researchers (11%) or whether data could be linked to other data sources to maximize clinical impact (20%). The list and metadata for the RWD sources are publicly available at www.escardio.org/bigdata. Conclusions: This review has created a comprehensive resource of CV data sources, providing new avenues to improve future real-world research and to achieve better patient outcomes.

Abstract Background and Aims Immunoglobulin A nephropathy (IgAN) is a chronic glomerular disease that affects approximately 100,000-200,000 people in the US. Approximately 15-40% of IgAN patients will eventually progress to end stage kidney disease (ESKD) within 10-20 years of diagnosis, and there is currently no targeted therapy for this disease. Decreased kidney function, persistent proteinuria and hypertension are some of the clinical manifestations of IgAN, and with demographic aspects (e.g. ethnicity) are considered as predictors of disease progression. The aim of this study is to better understand the demographic and clinical characteristics of IgAN patients in the US identified via physician notes. Method This is a descriptive, retrospective study of adult (≥ 18 years) IgAN patients in Optum® Electronic Health Records (EHRs), between January 2007 and December 2019. Optum® EHRs contain de-identified clinical and medical administrative data from 96 million people in 50 states that come from more than 140,000 providers at 740 hospitals and over 7,000 clinics. Identification of IgAN patients is challenging because there are no specific ICD codes for this disease so we used natural language processing of physician notes and chose patients with at least two IgAN records with the first one considered to be the index date, and no negative mention, as well as a biopsy procedure. Here, we present the baseline demographic and clinical characteristics of the identified patients up to 12 months before and at the index date. Results A total of 1803 patients with a biopsy record (22% of all patients with at least two IgAN records in their EHRs in our study) were included in this analysis; results are presented in Table 1. The mean age was 48 years, and the majority of patients were male (60.9%) and white (75.7%). Proteinuria levels of ≥1 g/day were found in 34% of patients. The mean eGFR was 45 ml/min/1.73m2 and 21.6% of patients had severe deterioration of kidney function (eGFR <15). The mean creatinine level was 3 mg/dL. Pain, edema and fatigue/tiredness were reported in 39.6%, 18.1% and 13.4% of patients, respectively. Hypertension was reported in 73% of patients. Based on the ICD 9 (585.6) and ICD-10 (N18.6) codes for diagnosis, 17.5% of patients had ESKD in our study. Conclusion In our cohort, a significant proportion of patients were found to have high proteinuria levels and severe deterioration of kidney function or ESKD. Moreover, edema and fatigue were recorded for a noticeable proportion of patients. In addition to the commonly reported symptoms, our study also found that pain was reported in a high proportion of patients. These findings highlight the clinical and symptom burden to patients with IgAN, suggesting that future targeted interventions are needed to reduce the burden and delay the progression of this disease.

Purpose: To assess the burden among caregivers of patients with heart failure (HF) with left ventricular ejection fraction (LVEF) <= 60%. The burden by New York Heart Association (NYHA) functional class was also characterized. Patients and Methods: A cross-sectional study was conducted in France, Germany, Italy, Spain, and UK from June to November 2019. Patient record forms were completed by 257 cardiologists and 158 general practitioners for consecutive HF patients. Caregivers who accompanied the patient to their consultation completed a caregiver self-completion survey voluntarily, which included the Family Caregiver Quality of Life Questionnaire (FAMQOL) and 5-level 5-dimension EuroQol questionnaire (EQ-5D-5L). Results: We analyzed 361 caregivers of patients with HF (NYHA class I, n=41; II, n=212; III IV, n=108). Mean age of caregivers was 58.8 years (NYHA I/II/III-IV: 59.1/60.8/54.6 years; p=0.0029), with majority being females (73.1%). Caregivers spent on average 19.8 hours/week caring for a HF patient, which increased with increase in NYHA class (I/II/III-IV: 11.8/18.1/25.9 hours/week; p=0.0094). Caregivers (24.1%) reported providing emotional support/encouragement to patients as the most troublesome/inconvenient caregiving activity (no significant difference across NYHA class). Nearly one-third of caregivers experienced stress (NYHA I/II/III-IV: 17.1%/28.8%/40.7%; p=0.0111) and anxiety (26.8%/24.1%/39.8%; p=0.0127) due to caregiving burden. The overall FAMQOL mean score decreased significantly (poorer QoL) with increase in NYHA class (I/II/III-IV: 58.1/56.3/52.2; p=0.0069). A trend of decreasing scores with increasing NYHA class was observed across physical, emotional, and social domains (each p=0.012). Conclusion: Caregivers of HF patients with LVEF <= 60% experienced a significant burden, which was higher among caregivers of patients with more severe and symptomatic disease.

AbstractAimsHeart failure (HF) is a leading cause of hospitalization and is associated with high morbidity and mortality. We examined the impact of recurrent HF hospitalizations (HFHs) on cardiovascular (CV) mortality among patients with HF in Sweden.Methods and resultsAdults with incident HF were identified from linked national health registers and electronic medical records from 01 January 2005 to 31 December 2013 for Uppsala and until 31 December 2014 for Västerbotten. CV mortality and all‐cause mortality were evaluated. A time‐dependent Cox regression model was used to estimate relative CV mortality rates for recurrent HFHs. Assessment was also done for ejection fraction‐based HF phenotypes and for comorbid atrial fibrillation, diabetes, or chronic renal impairment. Overall, 3878 patients with HF having an index hospitalization were included, providing 9691.9 patient‐years of follow‐up. Patients were relatively old (median age: 80 years) and were more frequently male (55.5%). Compared with patients without recurrent HFHs, the adjusted hazard ratio (HR [95% confidence interval; CI]) for CV mortality and all‐cause mortality were statistically significant for patients with one, two, three, and four or more recurrent HFHs. The risk of CV mortality and all‐cause mortality increased approximately six‐fold in patients with four or more recurrent HFHs vs. those without any HFHs (HR [95% CI]: 6.26 [5.24–7.48] and 5.59 [4.70–6.64], respectively). Similar patterns were observed across the HF phenotypes and patients with comorbidities.ConclusionsThere is a strong association between recurrent HFHs and CV and all‐cause mortality, with the risk increasing progressively with each recurrent HFH.

Background: PARADIGM-HF demonstrated superiority of sacubitril/valsartan (sac/val) over enalapril in patients with heart failure with reduced ejection fraction (HFrEF). However, patients in clinical practice may differ in their characteristics and overall risk compared with patients in clinical trials, and additional outcomes can be observed in real world (RW). Hence, a systematic review was conducted to identify and describe RW data on sac/val. Methods: RW studies evaluating the effects of sac/val in adult patients with HFrEF with a sample size >= 100 were identified via MEDUNE (R) and Embase (R) from 2015 to January 2020. Citations were screened, critically appraised and relevant data were extracted. Results: A total of 68 unique studies were identified. Nearly half of the studies were conducted in Europe (n = 34), followed by the US (n = 15) and Asia (n = 11). Median follow-up period varied from 1 to 19 months. Mean age ranged between 48.7 and 79.0 years; patients were mostly male and in New York Heart Association (NYHA) functional class II/III, and mean left ventricular ejection fraction varied between 23%and 38%. Of studies performing comparisons, most reported superior efficacy of sac/val in reducing the risk of HF hospitalisations, allcause hospitalisations, and all-cause mortality as compared to standard-of-care. Many studies reported significant improvements in NYHA functional class and reduction in biomarker levels post sac/val. Hypotension and hyperkalaemia were the most frequently reported adverse events. Conclusions: This comprehensive overview of currently available RW evidence on sac/val complements the evidence from randomised controlled trials, substantiating its effectiveness in heterogeneous real-world Hr populations. (C) 2021 The Authors. Published by Elsevier B.V.

Lead Author's Financial Disclosures R.L. is an employee of Novartis Pharma AG, Basel, Switzerland. Study Funding None. Background/Synopsis There is currently little real-world research examining lipid-lowering treatments (LLT) treatment patterns in atherosclerotic cardiovascular disease (ASCVD) patients, and the associated change in LDL-C lab results. Objective/Purpose To describe the real-world treatment patterns and LDL-C outcomes in ASCVD patients with hypercholesterolemia (ASCVD-H) and patients with familial hypercholesterolemia (FH) in the United States (US). Methods Patients were identified from Optum's de-identified Clinformatics Data Mart database (2007-2019) in the US. Hypercholesterolemia was defined if patients had a recorded diagnosis, were prescribed LLT or had LDL-C levels of ≥70 mg/dL for ASCVD-H and ≥100mg/dL FH, anytime within 6 months before and 3 months after index date. Patients had to have ≥1 year follow-up after index date for the persistence and adherence analysis. Index date was first ASCVD encounter or FH diagnosis during the identification period (1/07/2015-31/12/2018). Results 1,424,893 patients with ASCVD-H (50% females) and 47,268 patients with FH (54% females) with a mean (SD) age of 72 (11) years and 64 (17) years, respectively, were included. At index date, statins monotherapy was the most commonly prescribed LLTs reported in 64% (ASCVD-H) and 51% (FH) patients. In patients with uncontrolled LDL-C (≥70mg/dL) and ASCVD-H or FH, 52.4% or 41.1% were receiving statins monotherapy while 38.5% or 48.9% respectively were not receiving any LLT. Out of 29,353 ASCVD-H patients receiving statins combinations with any drug, 18,372 (63%) were still uncontrolled despite 78.5% patients being adherent. Conclusions This data suggests low uptake of non-statins LLTs. Still 77% of ASCVD-H and 51% of FH patients remain with uncontrolled LDL-C, regardless of treatment received. Increased adherence only showed a small reduction in the proportion of patients with uncontrolled LDL-C suggesting an unmet need. R.L. is an employee of Novartis Pharma AG, Basel, Switzerland. None.

The aim of this cross-sectional survey was to characterize the role of and burden on caregivers of heart failure (HF) patients in Japan, since such data are limited at present. Data from 126 caregivers whose average age was 63.5 years were analyzed. Helping to prepare meals/cooking was the most frequently reported activity (47% of caregivers); 24% found this the most burdensome. The most frequently reported physical consequence of caregiving was feeling physically tired (44%); emotionally worrying about the patient (62%) was the most frequent psychological consequence. Approximately half of the caregivers reported that caring for patients impacted their lifestyle. Although 40% of caregivers asked questions to physicians regarding diet or lifestyle modifications, 19% did not ask any. Caregivers play a crucial role in the management of HF patients in Japan but experience physical and emotional burden. Solutions are required to reduce the caregiver burden associated with HF.

PURPOSE:To characterize symptoms, clinical burden, and health-related quality of life (HRQoL) among women and men with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≤60% in Europe.PATIENTS AND METHODS:A real-world cross-sectional study was conducted in France, Germany, Italy, Spain, and United Kingdom from June to November 2019. Patient record forms were completed by 257 cardiologists and 158 general practitioners for consecutive patients with HF. The same patients were invited to complete a questionnaire comprising patient-reported outcomes: the Minnesota Living with Heart Failure Questionnaire (MLHFQ), five-level five-dimension EuroQol questionnaire (EQ-5D-5L), Visual Analogue Scale (VAS), and Work Productivity and Activity Impairment questionnaire.RESULTS:The mean age of 804 patients (men, n=517; women, n=287) was 68.6 years (men, 67.8 years; women, 70.2 years; p=0.0022). The mean LVEF was 44.7% (men, 43.6%; women, 46.8%; p<0.0001). Patients reported dyspnoea when active (overall, 55.7%; men, 56.0%; women, 55.3%), fatigue/weakness/faintness (34.5%; men, 32.9%; women, 37.2%), and oedema (20.3%; men, 18.7%; women, 23.1%) as the most troublesome HF symptoms. Overall, 54.1% of patients reported low mood/depression (men, 50.8%; women, 60.1%). The overall MLHFQ mean score was higher (ie, poorer HRQoL) among women vs men (37.9 vs 34.6; p=0.0481). MLHFQ was consistently higher (ie, poorer HRQoL) for women vs men across the physical (18.6 vs 16.6; p=0.0041) and emotional (9.4 vs 7.9; p=0.0021) scoring domains. Mean EQ-5D utility (0.69 vs 0.75; p=0.0046) and VAS scores (55.4 vs 61.3; p<0.0001) were lower among women compared with men. Overall, 23.4% of patients were hospitalized owing to HF in the previous year (men, 22.7%; women, 24.6%). Patients reported 43.2% activity impairment due to HF (men, 41.6%; women, 46.4%; p=0.01).CONCLUSION:HF causes a substantial burden on patients, with a greater burden among women vs men. This gender-related difference is consistent with other HF studies, warranting further research to understand the underlying reasons.

Abstract Aims Heart failure (HF) is a leading cause of hospitalization and is associated with high morbidity and mortality post‐diagnosis. Here, we examined the impact of recurrent HF hospitalization (HFH) on cardiovascular (CV) and all‐cause mortality among HF patients. Methods and Results Adult HF patients identified in the Clinical Practice Research Datalink with a first (index) hospitalization due to HF recorded in the Hospital Episode Statistics data set from January 2010 to December 2014 were included. Patients were followed up until death or end of study (December 2017). CV mortality as primary and as any reported cause and all‐cause mortality were evaluated. An extended Cox regression model was used for reporting adjusted relative CV mortality rates for time‐dependent recurrent HFHs. Overall, 8603 HF patients with an index hospitalization were included, providing 15 964 patient‐years of follow‐up. Patients were relatively old (median age: 80 years) and were mostly male (54.6%), with main co‐morbidities being hypertension and atrial fibrillation. Recurrent HFHs occurred one, two, three, and more than four times in 1561 (18.2%), 518 (6.02%), 206 (2.4%), and 153 (1.8%) patients, respectively. The median time to mortality was 215 (38–664) days for 50.8% of patients who died for any cause during the study period and 139 (27–531) days for 31.3% who died with CV reasons as primary cause. Compared with those of patients without recurrent HFHs, the adjusted hazard ratios (95% CI) for CV mortality as primary cause were 2.65 (2.35–2.99), 3.69 (3.06–4.43), 5.82 (4.48–7.58), and 5.95 (4.40–8.05) for those with one, two, three, and more than four recurrent HFHs. Conclusions There is a strong association between recurrent HFH and CV mortality, with the risk increasing progressively with each recurrent HFH.

Background Administrative claims do not contain ejection fraction information for heart failure patients. We recently developed and validated a claims-based model to predict ejection fraction subtype. Methods Heart failure patients aged 65 years or above from US Medicare fee-for-service claims were identified using diagnoses recorded after a 6-month baseline period of continuous enrollment, which was used to identify predictors and to apply the claims-based model to distinguish heart failure with reduced or preserved ejection fraction (HFrEF or HFpEF). Patients were followed for the composite outcome of time to first worsening heart failure event (heart failure hospitalization or outpatient intravenous diuretic treatment) or all-cause mortality. Results A total of 3,134,414 heart failure patients with an average age of 79 years were identified, of which 200,950 (6.4%) were classified as HFrEF. Among those classified as HFrEF, men comprised a larger proportion (68% vs 41%) and the average age was lower (76 vs 79 years) compared with HFpEF. History of myocardial infarction was more common in HFrEF (32% vs 13%), while hypertension was more common in HFpEF (71% vs 77%). One-year cumulative incidence of the composite endpoint was 42.6% for HFrEF and 36.9% for HFpEF. One-year all-cause mortality incidence was similar between the groups (27.4% for HFrEF and 26.4% for HFpEF), however, cardiovascular mortality was higher for HFrEF (15.6% vs 11.3%), whereas noncardiovascular mortality was higher for HFpEF (11.8% vs 15.1%). Conclusion We replicated well-documented differences in key patient characteristics and cause-specific outcomes between HFrEF and HFpEF in populations identified based on the application of a claims-based model.

Background: Sac/val, an angiotensin receptor neprilysin inhibitor, reduces the risk for cardiovascular (CV) death and hospitalization for HF in HF with reduced ejection fraction (HFrEF). SGLT2i are glucose lowering medications that have shown reduction in CV risk in patients with very high CV risk and diabetes. Recently, the SGLT2i dapagliflozin has shown improvement in outcomes in patients with chronic HFrEF, with or without diabetes, when used in addition to standard of care including sac/val. As the use of SGLT2i in HF evolves, and given the large overlap of HF and type 2 diabetes (T2D) populations, it is of interest to understand the drug utilization of concomitant use of sac/val and SGLT2i. This study describes the time to discontinuation for patients treated concomitantly with sac/val and SGLT2i or with sac/val and dipeptidyl peptidase-4 inhibitors (DPP4i) or glucagon-like peptide-1 receptor agonists (GLP1). Methods: This retrospective non-interventional cohort study describes two mutually exclusive adult patient cohorts diagnosed with HF and T2D concomitantly prescribed sac/val and SGLT2i, or sac/val and DPP4i/GLP1. All patients had a minimum follow-up time of 3 months. All patients were identified any time between 1 st July 2015 and 30 th Sep 2019 in the Optum® de-identified EHR data from providers across the continuum of care. Results: 783 patients were prescribed sac/val and SGLT2i (cohort 1) and 1,855 sac/val and DPP4i-/GLP1 (cohort 2). Treatment continuation was higher for cohort 1 compared to cohort 2 (57.3% and 49.9%). 11.1% and 10.6% of patients discontinued sac/val in cohort 1 and 2, respectively, 20.3% discontinued SGLT2i in cohort 1 and 23.1% discontinued DPP4i/GLP1 in cohort 2. Conclusions: Of the patients with HF and T2D prescribed sac/val and SGLT2i or DPP4i/GLP1 concomitantly, discontinuation rates of at least one product within 3 months are relatively high. Fewer patients discontinued sac/val compared to SGLT2i or DPP4i/GLP1.