European Heart Journal - Quality of Care and Clinical Outcomes最新文献

Introduction: Adequate inclusion and representation of patients in clinical studies is critical for the generalizability of research findings. The aim of this analysis was to determine inclusion and reporting by age, sex and ethnicity in clinical studies of high-risk medical devices (orthopaedic, diabetes and cardiovascular) approved in the European Union (EU).

Methods: This is an analysis of data from three co-ordinated systematic reviews of clinical evidence for high-risk medical devices. This analysis includes 641 studies, reporting on more than 1.9 million patients treated with high risk orthopaedic, diabetes and cardiovascular medical devices. The main outcomes were the proportions of studies providing data on the age, sex and ethnicity of participants, and the performance of stratified analyses based on these factors.

Results: The majority (>90%) of studies in all three device categories (orthopaedics, diabetes and cardiovascular) provided data on the age and sex of participants, but only a minority (<10%) provided information on ethnicity. Female patients comprised over half of patients in the included orthopaedic and diabetes device studies, but less than 40% of patients in the included cardiovascular device studies (p < 0.001). A minority of studies performed analyses stratified by age (14.6%) or sex (10.4%), although those were more frequently reported in randomized studies.

Conclusions: Almost all studies in this analysis provided demographic data on age and sex, but only a small minority had analysed if these factors had any impact on device performance. Very few studies provided information on the ethnicity of study participants. Cardiovascular device studies enrolled a lower proportion of female patients in comparison to orthopaedic and diabetes device studies. Study registration Cardiovascular device systematic review: PROSPERO (CRD42022308593, Diabetes device systematic review: PROSPERO (CRD42022366871). Orthopaedic device systematic review: open science framework (https://osf.io/6gmyx).

Background: Ischaemic heart disease (IHD) is a major cause of heart failure (HF), a condition expected to increasingly affect global health and economics. This study evaluates the global burden, trends, and disparities of HF linked to IHD, aiming to inform health policy development.

Methods and results: Data from the Global Burden of Disease Study 2021 (GBD2021) are analysed using joinpoint regression, decomposition analysis, and Bayesian age-period-cohort analysis (BAPC). Health disparities are assessed through the Socio-demographic Index (SDI) via the Slope Index of Inequality and the Concentration Index, with future trends projected from 2022 to 2045. In 2021, global HF cases due to IHD were over 19.16 million, with an age-standardized prevalence rate (ASPR) of 228.31 per 100 000 [95% Uncertainty Interval (UI), 188.18-279.55] and age-standardized years lived with disability (ASYLDs) rate of 20.43 per 100 000 [95% UI, 13.55-28.7]. In 2021, there was a 2.87% increase in ASPR and ASYLDs compared with 1990, primarily driven by population growth and aging. Significant reductions in global ASPR and ASYLDs disparities are observed, though the disease burden has intensified in countries with lower SDI levels. Projections indicate that by 2045, while the prevalence and years lived with disability for HF caused by IHD will increase, the ASPR and ASYLDs are expected to decrease.

Conclusion: The global burden of HF due to IHD remains a significant concern. Urgent improvements in the allocation of medical resources and the implementation of effective prevention and management strategies are necessary to address this issue.

Background: A virtual ward (VW) supports patients who would otherwise need hospitalization by providing acute care, remote monitoring, investigations, and treatment at home. By March 2024, the VW programme had treated 10 950 patients across six speciality VWs, including heart failure (HF). This evaluation presents the economic assessment of the Liverpool HF VW.

Method and results: A comprehensive economic cost comparison model was developed by the York Health Economics Consortium (University of York) to compare the costs of the VW to standard hospital inpatient care [standard care (SC)]. The model included direct VW costs and additional costs across the care pathway. Costs and resource use for 648 patients admitted to the HF VW were calculated for 30 days post-discharge and total cohort costs were extrapolated to a full year. Primary outcomes included costs related to length of stay, readmissions, and NHS 111 contact. The total cost for the HF VW pathway, including set-up costs, was £467 524. This results in an incremental net cost benefit of £735 512 compared with the total SC cost of £1 203 036, indicating a substantial net cost benefit of £1135 per patient per episode (PPPE). This advantage remains despite initial setup expenses and ongoing costs such as home visits, virtual consultations, point-of-care testing, and home monitoring equipment.

Conclusion: Our HF VW model offers a substantial net cost benefit, driven by reduced hospital stays, fewer emergency department visits, and lower readmission rates. The study highlights the importance of considering system-wide impacts and continuous monitoring of VWs as they develop.

Aims: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in selected patients with heart failure (HF) and electrical dyssynchrony. This treatment receives class IA recommendations in European Society of Cardiology (ESC) guidelines. However, despite these strong recommendations, CRT implantation practice varies greatly in Europe. The purpose of the sub-analysis of CRT Survey II data was to describe how countries' health per capita expenditure affects CRT implantation practice.

Methods and results: Between 2015 and 2016, two ESC associations, European Heart Rhythm Association and Heart Failure Association, conducted the CRT Survey II, a survey of CRT implantations in 11 088 patients in 42 ESC member states. We analysed CRT patient selection and guideline adherence in those countries according to high or low health expenditure per capita. There were 21 high health expenditure countries (n = 6844 patients) and 21 (n = 3852) with low health expenditure. The countries with the lowest health expenditure were more likely to implant CRT in patients who had strong guideline recommendations for implantation, younger patients and those recently hospitalized for HF or with symptomatic HF (67% vs. 58%, P < 0.001). The ratio of CRT-Pacemaker (CRT-P) to CRT-Defibrillator (CRT-D) was similar in both spending groups, as was the percentage of CRT implantation in women.

Conclusion: CRT Survey II has demonstrated a non-uniform delivery of healthcare. Countries with low health expenditure per capita appear to be reserving CRT therapy for younger patients, those with class IA indication and patients with more severe symptoms of heart failure.

Background: Significant knowledge gaps remain regarding the heterogeneity of heart failure (HF) phenotypes, particularly among patients with preserved or mildly reduced left ventricular ejection fraction (HFp/mrEF). Our aim was to identify HF subtypes within the HFp/mrEF population.

Methods: K-prototypes clustering algorithm was used to identify different HF phenotypes in a cohort of 2570 patients diagnosed with heart failure with mildly reduced ejection fraction or heart failure with preserved left ventricular ejection fraction. This algorithm employs the k-means algorithm for quantitative variables and k-modes for qualitative variables.

Results: We identified three distinct phenotypic clusters: Cluster A (n = 850, 33.1%), characterized by a predominance of women with low comorbidity burden; Cluster B (n = 830, 32.3%), mainly women with diabetes mellitus and high comorbidity; and Cluster C (n = 890, 34.5%), primarily men with a history of active smoking and respiratory comorbidities. Significant differences were observed in baseline characteristics and 1-year mortality rates across the clusters: 18% for Cluster A, 33% for Cluster B, and 26.4% for Cluster C (P < 0.001). Cluster B had the shortest median time to death (90 days), followed by Clusters C (99 days) and A (144 days) (P < 0.001). Stratified Cox regression analysis identified age, cancer, respiratory failure, and laboratory parameters as predictors of mortality.

Conclusion: Cluster analysis identified three distinct phenotypes within the HFp/mrEF population, highlighting significant heterogeneity in clinical profiles and prognostic implications. Women were classified into two distinct phenotypes: low-risk women and diabetic women with high mortality rates, while men had a more uniform profile with a higher prevalence of respiratory disease.

Background: An estimated two-thirds of heart failure (HF) patients with reduced ejection fraction (HFrEF) hospitalized in the United States have a severely reduced left ventricular ejection fraction (LVEF <30%). Few studies have categorized patients according to their severity of left ventricular dysfunction beyond an LVEF of <30%.

Methods and results: Intermountain Health patients (≥18 years) with a primary HF diagnosis, more than or equal to 1 inpatient hospitalization with a primary discharge diagnosis of HF, a documented LVEF of <30%, and a B-type natriuretic peptide >100 pg/mL within 1 year of hospitalization were studied. Patients were stratified by LVEF levels (≤15%, 16-25%, and 26-29%) and evaluated for death, HF hospitalization, healthcare resource utilization, and medical costs. Overall, 2184 patients (mean age 64.2 ± 15.5 years, 72.5% male) were stratified by LVEF [≤15%, n = 468 (21.4%); 16-25%, n = 1399 (64.1%); and 26-29%, n = 317 (14.5%)]. Lower LVEF was associated with younger age, male sex, and fewer comorbidities. Although 1-year mortality differed significantly between LVEF stratifications, which remained after adjustment by risk factors [vs. LVEF 26-29% (referent): ≤15%, hazard ratio (HR) = 1.92, P < 0.0001; and 16-25%, HR = 1.42, P = 0.01], mortality was similar by 3 years. HF hospitalizations at 1 and 3 years were similar among LVEF groups. Total HF costs-driven by increased HF outpatient costs-were significantly higher among LVEF of ≤15%.

Conclusion: Patients with an LVEF of ≤15% had a modestly increased risk of 1-year mortality, as well as significantly higher total HF costs. Patients with HFrEF and a severely reduced LVEF continue to face an increased clinicoeconomic burden, and novel therapies to treat this unmet medical need are warranted.

Introduction: Hypertrophic cardiomyopathy (HCM) is the most prevalent inherited cardiac disease. The impact of HCM on quality of life (QoL) and societal costs remains poorly understood. This prospective multi-centre burden of disease study estimated QoL and societal costs of genotyped HCM patients and genotype-positive phenotype-negative (G+/P-) subjects.

Methods and results: Participants were categorized into three groups based on genotype and phenotype: (i) G+/P- [left ventricular (LV) wall thickness <13 mm], (ii) non-obstructive HCM [nHCM, LV outflow tract (LVOT) gradient <30 mmHg], and (iii) obstructive HCM (oHCM, LVOT gradient ≥30 mmHg). We assessed QoL with EQ-5D-5L and Kansas City Cardiomyopathy Questionnaires (KCCQ). Societal costs were measured using medical consumption (Medical Consumption Questionnaire) and productivity cost (iMTA Productivity Cost Questionnaire) questionnaires. We performed subanalyses within three age groups: <40, 40-59, and ≥60 years. From three Dutch hospitals, 506 subjects were enrolled (84 G+/P-, 313 nHCM, 109 oHCM; median age 59 years, 39% female). HCM (both nHCM and oHCM) patients reported reduced QoL vs. G+/P- subjects (KCCQ: 88 vs. 98, EQ-5D-5L: 0.88 vs. 0.96; both P < 0.001). oHCM patients reported lower KCCQ scores than nHCM patients (83 vs. 89, P = 0.036). Societal costs were significantly higher in HCM patients (€19,035/year vs. €7385/year) compared with G+/P- controls, mainly explained by higher healthcare costs and productivity losses. Being symptomatic and of younger age (<60 years) particularly led to decreased QoL and increased costs.

Conclusion: HCM is associated with decreased QoL and increased societal costs, especially in younger and symptomatic patients. oHCM patients were more frequently symptomatic than nHCM patients. This study highlights the substantial disease burden of HCM and can aid in assessing new therapy cost-effectiveness for HCM in the future.

Background: Mortality after heart transplantation can be influenced by multiple factors. This study analysed its variation across four regions of the USA.

Objective: Analyse the differences in mortality among patients receiving a heart transplant across four regions of the USA.

Methods and results: Organ Procurement and Transplantation Network/United Network for Organ Sharing registry was analysed for adult heart transplant recipients from 1987 to 2023. They were divided into four regions according to heart transplant recipients' residence: the Northeast, Midwest, South, and West. The endpoint was all-cause mortality. A total of 33 482 heart transplant recipients were included in the analysis. Baseline characteristics differed by region. The median survival (years) was lower in the South [Northeast 12.9 (6.1-17.9), Midwest 13.1 (6.5-18.1), South 11.6 (5.3-16.8), and West 13.6 (7.0-18.6); P < 0.0001]. Mortality incidence rate was greater in the South. When compared to the Northeast, in the unadjusted analysis, mortality was higher in the South {hazard ratio (HR) 1.13 [95% confidence interval (CI) 1.07-1.19], P < 0.001} and lower in the West [HR 0.89 (95% CI 0.83-0.94), P < 0.001]. After adjusting for demographic and clinical variables, only the South retained significant differences [HR 1.17 (95% CI 1.10-1.24), P < 0.001]. Mortality significantly increased in all regions after 2018.

Conclusion: Mortality of heart transplant recipients varies across region of residence in the USA. A significant increase in adjusted mortality was observed in the South. These findings suggest that there are regional disparities in the mortality rates of heart transplant recipients.

Background: Evidence on the longitudinal association of serum uric acid (SUA) with the risk of heart failure (HF) was limited and controversial. This study aimed to investigate the associations of cumulative SUA (cumSUA), incorporating its time course of accumulation, with the risk of HF.

Methods and results: This prospective study enrolled 54 606 participants from the Kailuan study. The magnitude of SUA accumulation was expressed as cumSUA, exposure duration, and cumulative burden from baseline to the third survey, with cumSUA, calculated by multiplying mean values between consecutive examinations by time intervals between visits, as the primary exposure.During a median follow-up of 10 years, 1260 cases of incident HF occurred. A higher risk of HF was observed in participants with the highest vs. the lowest quartile of cumSUA [adjusted hazard ratio (aHR), 1.54; 95% confidence interval (CI), 1.29-1.84], 6-year vs. 0-year exposure duration (aHR, 1.87; 95% CI, 1.43-2.45), cumulative burden >0 vs. = 0 (aHR, 1.55; 95 CI, 1.29-1.86), and those with a negative vs. positive SUA slope (aHR, 1.12; 95% CI, 1.02-1.25). When cumSUA was incorporated with its time course, those with cumSUA ≥median and a negative SUA slope had the highest risk of HF (aHR, 1.55; 95% CI, 1.29-1.86).

Conclusions: Incident HF risk was associated with the magnitude and time course of cumSUA accumulation. Early accumulation resulted in a greater risk of HF compared with later accumulation, indicating the importance of optimal SUA control earlier in life.