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

Background and aims: The Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity (SELECT) trial demonstrated significant reductions in cardiovascular outcomes in people with cardiovascular disease (CVD) and overweight or obesity (but without diabetes). However, the cost of the medication has raised concerns about its financial viability and accessibility within healthcare systems. This study explored whether the use of semaglutide for the secondary prevention of CVD in overweight or obesity is cost-effective from the Australian healthcare perspective.

Methods and results: A Markov model was developed based on the SELECT trial to model the clinical outcomes and costs of a hypothetical population treated with semaglutide vs. placebo, in addition to standard care, and followed up over 20 years. With each annual cycle, subjects were at risk of having non-fatal CVD events or dying. Model inputs were derived from SELECT and published literature. Costs were obtained from Australian sources. All outcomes were discounted by 5% annually. The main outcome of interest was the incremental cost-effectiveness ratio (ICER) in terms of cost per year of life saved (YoLS) and cost per quality-adjusted life year (QALY) gained. With an annual estimated cost of semaglutide of A$4175, the model resulted in ICERs of A$99 853 (US$143 504; £40 873) per YoLS and A$96 055 (US$138 046; £39 318) per QALY gained.

Conclusion: Assuming a willingness-to-pay threshold of A$50 000, semaglutide is not considered cost-effective at the current price. A price of ≤A$2000 per year or more targeted use in high-risk patients would be needed for it to be considered cost-effective in the Australian setting.

Aims: Bariatric surgery (BS) is a potential treatment option for patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and obesity. These patients are also at substantial risk of developing cardiovascular events and associated mortality. We aimed to assess whether BS could reduce major adverse cardiovascular events (MACE) and mortality and improve long-term survival.

Methods and results: Using the TriNetX data, adult patients (>18 years) with a diagnosis of MASLD, obesity (i.e. body mass index ≥35 kg/m2), and pre-existing coronary artery disease (CAD) between 1 January 2005 and 31 December 2022 were included. Patients with a BS were compared with those with no history of BS. Primary outcomes were the incidence of MACE, heart failure, cerebrovascular events, and coronary artery procedures or surgeries at years 1, 3, 5, 7, and 10. The secondary outcome was all-cause mortality at years 1, 3, 5, 7, and 10. We performed 1:1 propensity score matching (PSM), sensitivity analysis, and survival analysis. After PSM, both groups had a total of 1038 patients. At year 1, BS patients had a significantly lower incidence of MACE [hazard ratio (HR) = 0.56; 95% confidence interval (CI), 0.39-0.80], cerebrovascular disease (HR = 0.62; 95% CI, 0.46-0.82), and coronary artery procedures and surgeries (HR = 0.65; 95% CI, 0.42-0.98). Similarly, at years 3, 5, 7, and 10, BS patients had a significantly lower incidence of MACE, heart failure, cerebrovascular disease, and coronary artery procedures and surgeries. BS patients had significantly lower 3-, 5-, 7-, and 10-year all-cause mortality. Sensitivity analysis confirmed these findings.

Conclusions: BS in patients with MASLD, obesity, and pre-existing CAD can considerably reduce the risk of recurring cardiovascular events and markedly improve survival immediately within the first year of BS and can persist long-term, even a decade after BS.

Sudden cardiac death is an important cause of death after myocardial infarction. Most of these episodes are considered the result of ventricular arrhythmia, with occurrence higher where myocardial infarction has been complicated by left ventricular systolic dysfunction. The landmark Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) and sudden cardiac death in heart failure (SCD-HeFT) trials, conducted around the turn of the millennium, established that treatment with implantable cardioverter defibrillators was superior to medical therapy for prevention of mortality in this context. Successive European Society of Cardiology guidelines provide a class I recommendation for the use of implantable cardioverter defibrillators for patients with persistent severe left ventricular systolic dysfunction after myocardial infarction and medicine optimization. This narrative review considers the historical randomized clinical trial evidence, the temporal trends in rate and cause of death in this patient population, as well as improvements in medical therapy, and why this necessitates a reappraisal of the benefit of implantable cardioverter defibrillators in the post-myocardial infarction population in contemporary clinical practice. Finally, details of the PROFID-EHRA trial are reported, which seeks to address this critical evidence gap.

Background: Existing data on female sex and excess cardiovascular mortality after myocardial infarction (MI) mostly come from high-income countries (HICs). This study aimed to investigate how sex disparities in treatments and outcomes vary across countries with different income levels.

Methods: Data from the ISACS Archives registry included 22 087 MI patients from 6 HICs and 6 middle-income countries (MICs). MI data were disaggregated by clinical presentation: ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI). The primary outcome was 30-day mortality.

Results: Among STEMI patients, women in MICs had nearly double the 30-day mortality rate of men [12.4% vs. 5.8%; adjusted risk ratio (RR) 2.30, 95% CI 1.98-2.68]. This difference was less pronounced in HICs (6.8% vs. 5.1%; RR 1.36, 95% CI 1.05-1.75). Despite more frequent treatments and timely revascularization in MICs, sex-based mortality differences persisted even after revascularization (8.0% vs. 4.1%; RR 2.05, 95% CI, 1.68-2.50 in MICs and 5.6% vs. 2.6%; RR 2.17, 95% CI, 1.48-3.18) in HICs. Additionally, women from MICs had higher diabetes rates compared to HICs (31.8% vs. 25.1%, standardized difference = 0.15). NSTEMI outcomes were relatively similar between sexes and income groups.

Conclusions: Sex disparities in mortality rates following STEMI are more pronounced in MICs compared to HICs. These disparities cannot be solely attributed to sex-related inequities in revascularization. Variations in mortality may also be influenced by sex differences in socioeconomic factors and baseline comorbidities.

Aims: Metabolic disorders are established risk factors for coronary artery disease (CAD) and major adverse cardiovascular events (MACEs). Although obesity is closely associated with metabolic disease, data on its role as a separate cardiovascular risk modifier in metabolically healthy (MH) individuals are limited, particularly in patients with CAD. Thus, this study aims to investigate risk profiles of metabolic phenotypes on outcomes in patients undergoing invasive coronary angiography.

Methods and results: A total of 12 760 patients evaluated for chronic coronary syndrome (CCS) were distinguished into four metabolic phenotypes: MH/metabolically unhealthy (MU) non-obese/obese (MHN, MHO, MUN, and MUO). The association of metabolic phenotypes with outcome was assessed using Cox regression models, adjusted for age, sex, and renal dysfunction. Within the total study cohort (median age 68 years, 57.3% male), 56.5% presented MH (43.3% MHN; 13.1% MHO) and 43.5% MU (28.3% MUN; 15.2% MUO). Irrespective of CCS, metabolic phenotypes showed different risks for MACE, all-cause mortality, and revascularization. While metabolic disease emerged as a robust predictor of events, obesity alone did not [e.g. in patients with obstructive CCS: MHO vs. MHN: adj. hazard ratio (HR) 0.947, 95% confidence interval (CI) 0.728-1.231, P = 0.683; MUO vs. MUN: adj. HR 0.974 (95% CI 0.809-1.172), P = 0.780]. However, MH individuals experienced lower event rates with increasing body mass index (BMI).

Conclusion: This study indicates metabolic health, rather than obesity, is a key predictor of adverse events in CCS prevention, revealing an obesity paradox in MH individuals. Thus, cardiovascular risk assessment should prioritize metabolic health over BMI. Integrating metabolic profiling into routine evaluations may help optimize prevention and personalized treatment strategies.

Background: Individuals recovering from COVID-19 infection have reported experiencing symptoms of postural orthostatic tachycardia syndrome (POTS). These observations have raised concerns about COVID-19 as a significant precipitating factor in the development of post-viral POTS. Given the increasing number of POTS cases reported after COVID-19, we sought to examine the baseline characteristics of POTS patients before and after COVID-19.

Methods: We conducted an interrupted time series analysis on data obtained from the TriNetX database, which included a cohort of 65 141 065 patients aged 18 and older across 64 healthcare organizations. Monthly data on incidence rates (IR), incidence cases (IC), and prevalence cases (PC) of POTS were collected from January 2018 to June 2024, with 1 March 2020 defined as the cutoff date for pre- and post-COVID analysis.

Results: There was a significant increase in the IR of POTS post-COVID (P < 0.0001), with the IR increasing from 1.42/1000 000 to 20.3/1000 000 cases per person-year. Similarly, the monthly IC trend showed a significant rise from 4.21 to 22.66 cases (P < 0.001). The month-to-month prevalence showed an initial decline after COVID with a robust increase starting January 2023. Additionally, the prevalence of autonomic nervous system disorders and related comorbidities significantly decreased in the post-COVID cohort.

Conclusion: Our findings demonstrate a significant increase in the incidence of POTS following the COVID-19 pandemic, suggesting a potential association between COVID-19 infection and the development of post-viral POTS. Future research should explore the underlying mechanisms and treatment strategies for POTS in the context of post-COVID recovery.

Background: Globally significant variation in treatment and course of heart valve disease (HVD) exists, and outcome measurement is procedure focused instead of patient focused. This article describes the development of a patient-related (International Consortium for Health Outcomes Measurement) standard set of outcomes and case mix to be measured in patients with HVD.

Methods: A multisociety working group was formed that included patient representatives and representatives from scientific cardiology and cardiothoracic surgery societies that publish current guidelines for HVD. The standard set was developed to monitor the patient's journey from diagnosis to treatment with either a surgical or transcatheter procedure. Candidate clinical and patient-reported outcome measures (PROMs) and case mix were identified through benchmark analyses and systematic reviews. Using an online modified Delphi process, the working group voted on final outcomes/case mix and corresponding definition.

Results: Patients with aortic/mitral/tricuspid valve disease or root/ascending aorta >40 mm were included in the standard set. Patients entered the dataset when the diagnosis of HVD was established, allowing outcome measurement in the preprocedural, periprocedural, and postprocedural phases of patients' lives. The working group defined 5 outcome domains: vital status, patient-reported outcomes, progression of disease, cardiac function and durability, and complications of treatment. Subsequently, 16 outcome measures, including 2 patient-reported outcomes, were selected to be tracked in patients with HVD. Case-mix variables included demographic factors, demographic variables, echocardiographic variables, heart catheterization variables, and specific details on aortic/mitral/tricuspid valves and their specific interventions.

Conclusions: Through a unique collaborative effort between patients and cardiology and cardiothoracic surgery societies, a standard set of measures for HVD was developed. This dataset focuses on outcome measurement regardless of treatment, moving from procedure- to patient-centered outcomes. Implementation of this dataset will facilitate global standardization of outcome measurement, allow meaningful comparison between health care systems and evaluation of clinical practice guidelines, and eventually improve patient care for those experiencing HVD worldwide.

Background: Mitral regurgitation (MR) is a prevalent valvular abnormality categorized as primary or secondary based on aetiology. Surgical intervention, particularly mitral valve repair, is often preferred over replacement due to its association with better outcomes. However, the benefits of repair vs. replacement, especially in secondary MR, remain debated.

Objectives: This study aims to evaluate the long-term survival and reoperation rates in patients undergoing mitral valve repair compared to mitral valve replacement for MR in a cardiothoracic surgery unit in North-West England and in subgroups with degenerative and secondary aetiology.

Methods and results: We analysed 1724 eligible patients undergoing first-time mitral valve surgery (repair: n = 1243; replacement: n = 481) between 2000 and 2021. The primary outcome was all-cause mortality. Genetic matching and overlap weighting were used to balance baseline characteristics. Median follow-up was 7.1 years. In the matched cohort, mitral valve replacement was associated with higher rates of blood transfusion (29% vs. 22%), longer Intensive Care Unit (ICU) stays, and more strokes (3.7% vs. 0.4%). While 90-day mortality did not differ significantly between groups, long-term follow-up showed a survival advantage for repair [Hazard ratio: 1.32, 95% confidence interval: 1.08-1.63]. Although repair had higher reoperation rates (4.3% vs. 2.1%), the composite of death or reoperation did not differ significantly. In the degenerative MR subgroup, repair showed superior long-term survival, whereas in secondary MR, no significant survival difference was observed between strategies.

Conclusion: Among patients suitable for either surgical strategy, mitral valve repair showed better long-term survival compared to replacement, particularly in degenerative MR. However, this advantage was not observed in secondary MR.

Background and aims: Direct (medical and non-medical) and indirect (production losses and informal care) costs of cardiovascular disease (CVD) have been captured in two previous United Kingdom (UK) cost-of-illness studies, but the areas of long-term care and medical device costs were neglected. We aimed to quantify the economic burden of CVD in the UK from a societal perspective between the fiscal years 2019/20 and 2021/22.

Methods and results: Mixed-methods study in a prevalence-based retrospective review of economic costs focused on the public sector. Top-down costing was applied to the following areas: inpatient hospital care, outpatient specialist care, emergency care, primary care, medications, medical devices, long-term care, production losses to morbidity, and production losses to mortality. Bottom-up costing was used by applying the marginal effects of having a CVD on several parameters using survey data from the Survey on Health, Aging, and Retirement in Europe to estimate informal care costs. The modelling performed shows that the total costs of CVD in the UK in 2021/22 were £29.021 billion (bn), with direct costs of £16.620 bn and indirect costs of £12.402 bn. The breakdown of direct costs for the UK were inpatient care (£6.732 bn), long-term care (£4.649 bn), medications (£1.940 bn), primary care (£1.556 bn), outpatient care (£1.011 bn), emergency care [£327.6 million (mn)], and medical devices (£404.4 mn). The breakdown of indirect costs for the UK were informal care costs (£6.377 bn), production losses to mortality (£4.544 bn), and production losses to morbidity (£1.481 bn).

Conclusion: There is a significant economic burden of CVD in the UK, with the highest direct cost resulting from inpatient care and the highest indirect cost resulting from informal care.

Background: There is substantial hospital-level variation in 30-day risk-standardized mortality rate (RSMR) and risk-standardized readmission rate (RSRR) after transcatheter aortic valve replacement (TAVR). However, the relationship between hospital RSMRs and RSRRs has not been well characterized.

Methods and results: We analysed data on 141 905 Medicare fee-for-service beneficiaries who underwent TAVR across 512 hospitals between 1 October 2015 and 31 December 2020. The primary and secondary outcomes of interest were 30-day all-cause mortality and 30-day all-cause readmissions, respectively. Hierarchical logistic regression models with random hospital-level intercepts were used to estimate RSMRs and RSRRs for each hospital. We used Pearson correlation coefficient (r) and restricted cubic spline regression to determine the relationship between RSMR and RSRR in the overall cohort and within subgroups based on hospital characteristics. The median [interquartile range (IQR)] hospital-level 30-day RSMR was 2.2% (2.1-2.4%), ranging from 1.3 to 3.5%. Similarly, the median (IQR) hospital-level 30-day RSRR was 13.2% (12.7-13.8%), ranging from 10.6 to 16.8%. In the overall cohort, there was weak correlation between 30-day RSMR and RSRR after TAVR (r = 0.25, 95% CI 0.17-0.33, P < 0.001). Subgroup analyses by hospital characteristics demonstrated the weakest correlation between RSMR and RSRR for non-JCAHO accredited hospitals (r = 0.07), hospitals in the Midwest (r = 0.12), and West (r = 0.14), and hospitals with low TAVR volume (r = 0.15).

Conclusion: Risk-standardized mortality and readmission rates after TAVR are weakly correlated, suggesting that hospital practices and processes of care influencing mortality are likely different from those influencing readmissions after TAVR, thereby necessitating measurement of both outcomes and developing specific interventions to decrease mortality and readmissions.