Objective: To estimate the prevalence, incidence, and describe the characteristics and management of patients with heart failure with preserved (HFpEF), mildly reduced (HFmrEF), and reduced ejection fraction (HFrEF) in Spain. Methods: Adults with ≥1 inpatient or outpatient HF diagnosis between 1 January 2013 and 30 September 2019 were identified through the BIG-PAC database. Annual incidence and prevalence by EF phenotype were estimated. Characteristics by EF phenotype were described in the 2016 and 2019 HF prevalent cohorts and outcomes in the 2016 HF prevalent cohort. Results: Overall, HF incidence and prevalence were 0.32/100 person-years and 2.34%, respectively, but increased every year. In 2019, 49.3% had HFrEF, 38.1% had HFpEF, and 4.3% had HFmrEF (in 8.3%, EF was not available). Compared with HFrEF, patients with HFpEF were largely female, older, and had more atrial fibrillation but less atherosclerotic cardiovascular disease. Among patients with HFrEF, 76.3% were taking renin-angiotensin system inhibitors, 69.5% beta-blockers, 36.8% aldosterone antagonists, 12.5% sacubitril/valsartan and 6.7% SGLT2 inhibitors. Patients with HFpEF and HFmrEF took fewer HF drugs compared to HFrEF. Overall, the event rates of HF hospitalization were 231.6/1000 person-years, which is more common in HFrEF patients. No clinically relevant differences were found in patients with HFpEF, regardless EF (50- < 60% vs. ≥60%). Conclusions: >2% of patients have HF, of which around 50% have HFrEF and 40% have HFpEF. The prevalence of HF is increasing over time. Clinical characteristics by EF phenotype are consistent with previous studies. The risk of outcomes, particularly HF hospitalization, remains high, likely related to insufficient HF treatment.

Objective: The objective of this study was to describe the rates of adverse clinical outcomes, including all-cause mortality, heart failure (HF) hospitalization, myocardial infarction, and stroke, in patients newly diagnosed with HF to provide a comprehensive picture of HF burden. Methods: This was a retrospective and observational study, using the BIG-PAC database in Spain. Adults, newly diagnosed with HF between January 2013 and September 2019 with ≥1 HF-free year of enrolment prior to HF diagnosis, were included. Results: A total of 19,961 patients were newly diagnosed with HF (43.5% with reduced ejection fraction (EF), 26.3% with preserved EF, 5.1% with mildly reduced EF, and 25.1% with unknown EF). The mean age was 69.7 ± 19.0 years; 53.8% were men; and 41.0% and 41.5% of patients were in the New York Heart Association functional classes II and III, respectively. The baseline HF treatments included beta-blockers (70.1%), renin–angiotensin system inhibitors (56.3%), mineralocorticoid receptor antagonists (11.8%), and SGLT2 inhibitors (8.9%). The post-index incidence rates of all-cause mortality, HF hospitalization, and both combined were 102.2 (95% CI 99.9–104.5), 123.1 (95% CI 120.5–125.7), and 182 (95% CI 178.9–185.1) per 1000 person-years, respectively. The rates of myocardial infarction and stroke were lower (26.2 [95% CI 25.1–27.4] and 19.8 [95% CI 18.8–20.8] per 1000 person-years, respectively). Conclusions: In Spain, patients newly diagnosed with HF have a high risk of clinical outcomes. Specifically, the rates of all-cause mortality and HF hospitalization are high and substantially greater than the rates of myocardial infarction and stroke. Given the burden of adverse outcomes, these should be considered targets in the comprehensive management of HF. There is much room for improving the proportion of patients receiving disease-modifying therapies.

Objective. To analyze the clinical characteristics of patients taking Factor Xa inhibitors (FXai), either direct FXai or enoxaparin (only in active cancer patients), and to estimate the incidence of and risk factors for major bleeding during FXai use. Methods. A retrospective cohort study, which included secondary data from computerized health records of primary care centers and hospitals in seven Spanish Autonomous Communities. Results. 9374 patients were analyzed, with 8972 taking direct FXai and 402 enoxaparin. At baseline, the mean age (SD) was 71.8 (9.4) years, 56.0% were women, 76.3% had hypertension, 33.6% had type 2 diabetes, and 25.5% had heart failure. The most common indication for FXai use was atrial fibrillation (72.3%), followed by venous thromboembolism (22.2%) and non-mechanical cardiac–valve replacement (5.6%). At the end of the follow-up period, the incidence rates of major bleeding overall, gastrointestinal, and intracranial were 10.2, 9.0, and 0.8 per 100 person-years, respectively. The total incidence of fatal major bleeding was 0.5 per 100 person-years. Incidence rates of all bleedings progressively decreased over time, with 62.5% of the first events occurring in the initial three months and reaching 76.8% within six months following initiation of treatment. Only 4.8% of the 1st major bleedings led to death, 2.3% in the case of major gastrointestinal bleeding, and 30.8% after an intracranial bleeding. 65.9% of patients discontinued anticoagulation after experiencing major bleeding. Conclusions. In Spain, patients taking FXai were old and had many comorbidities. Despite incidence rates of major bleeding were high, incidence rates of intracranial and fatal bleedings were low, but more efforts are required due to their relevant clinical impact.

Background/Objectives: Evidence of patient experiences with heart failure with preserved ejection fraction (HFpEF) and disease impact on quality of life (QoL) is scarce. This study explored perceived impacts on QoL and healthcare experiences of HFpEF patients and their caregivers. Methods: This was a mixed-methods study with HFpEF patients, ≥40 years, New York Heart Association functional classes I-IV in Spain. Qualitative data were collected through semi-structured interviews with patients (n = 19) and caregivers (n = 17). The EuroQoL 5D-5L, Patient Global Impression of Severity, and Kansas City Cardiomyopathy Questionnaire were used to collect QoL measures. Results: The themes were as follows. (1) Impact of HFpEF on QoL; (2) new roles of informal caregiving; and (3) the increasing value of multidisciplinary care. Qualitative data were supported by a trend of worsening QoL on quantitative measures as HF progressed, despite quantitative measures not fully capturing the burden. Qualitative data further captured discrepancies of QoL perceptions. Conclusions: The impact of HFpEF on patients and their caregivers was similar to the HFrEF population’s. Insights from discrepancies between PROMs data and interviews could help with tailoring QoL questionnaires to capture the broader impact of HFpEF, identify unmet needs, and customize care.

Aims: Our aims were to describe the clinical characteristics, adverse clinical events, healthcare resource utilization (HCRU) and costs of patients with major bleeding during direct Factor Xa inhibitor (FXai) use. Methods: This is a retrospective cohort study that included secondary data from computerized health records of seven Spanish Autonomous Communities. Patients with a first major bleeding during treatment with a direct FXai were analyzed during a 3-year period. Results: Of 8972 patients taking a direct FXai, 470 (5.24%) had major bleeding (mean age (SD) 77.93 (9.71) years, 61.06% women). The most frequent indications for using FXais were atrial fibrillation (78.09%) and venous thromboembolism (17.66%). Among those with major bleeding, 88.94% presented with gastrointestinal bleeding, 6.81% intracranial bleeding, 2.13% trauma-related bleeding and 4.26% other major bleeding. Prothrombin complex concentrates were used in 63.19%, followed by transfusion of blood products (20.21%) and Factor VIIa (7.66%). In total, 4.26% of patients died in the hospital due to the first major bleeding. At the study end (after 3-year follow-up), 28.94% of the patients had died, 12.34% had a myocardial infarction and 9.15% an ischemic stroke. At year 3, overall bleeding cost was EUR 5,816,930.5, of which 79.74% accounted for in-hospital costs to treat the bleeding episode. Conclusions: Despite the use of replacement agents being high, major events were common, with a 29% mortality at the end of the follow up, and HCRU and costs were high, evidencing the need for new reversal treatment strategies.

Objective: To analyze clinical characteristics of non-anticoagulated subjects with major bleeding, and to determine the incidence of adverse events, healthcare resource utilization (HCRU) and associated costs following a major bleeding event. Methods: Retrospective observational cohort study that analyzed secondary data from electronic health records in Spain. Non-anticoagulated patients with a first major bleeding during the study period (between January 2013 and December 2022) were analyzed for 3 years. Results: A total of 4089 patients (mean age 57.26 (12.87) years, 58.47% female) were included. A proportion of 27.63% presented with genitourinary bleeding, 22.43% with gastrointestinal bleeding, 5.16% with respiratory bleeding and 3.11% with intracranial hemorrhage. At the end of the first major bleeding event, 0.56% of patients died (5.51% after intracranial hemorrhage, 3.23% in case of trauma-related bleeding). The incidence rates of clinical outcomes per 100 person-years within the first 3 months of the major bleeding were death from any cause 7.51 (95% CI 6.70–8.32), cardiovascular death 1.80 (95% CI 1.39–2.21), acute myocardial infarction 4.53 (95% CI 3.89–5.17), and ischemic stroke 3.52 (95% CI 2.96–4.08), and decreased over time. At year 3, mean overall major bleeding cost per patient was EUR 13,310.00 (5153.05), of which EUR 7648.20 (2674.46) (57.46%) accounted for in-hospital costs to treat the major bleeding event. Conclusions: Among non-anticoagulated patients presenting with a first major bleeding, <1% of patients died during index hospitalization. However, these patients had a substantial risk of adverse clinical events during the follow-up, as well as high associated HCRU and costs.