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BACKGROUND: Functional health status is increasingly being recognized as a viable endpoint in heart failure (HF) trials. We sought to assess its prognostic impact and relationship with traditional clinical outcomes in patients with HF. METHODS: MEDLINE and Cochrane central were searched up to January 2021 for post hoc analyses of trials or observational studies that assessed independent association between baseline health/functional status, and mortality and hospitalization in patients with HF across the range of left ventricular ejection fractions to evaluate the prognostic ability of NYHA class [II, III, IV], KCCQ, MLHFQ, and 6MWD. Hazard ratios (HR) with 95% confidence intervals were pooled. RESULTS: Twenty-two studies were included. Relative to NYHA I, NYHA class II (HR 1.54 [1.16-2.04]; p < 0.01), NYHA class III (HR 2.08 [1.57-2.77]; p < 0.01), and NYHA class IV (HR 2.53 [1.25-5.12]; p = 0.01) were independently associated with increased risk of mortality. 6MWD (per 10 m) was associated with decreased mortality (HR 0.98 [0.98-0.99]; p < 0.01). A 5-point increase in KCCQ-OSS (HR 0.94 [0.91-0.96]; p < 0.01) was associated with decreased mortality. A high MLHFQ score (> 45) was significantly associated with increased mortality (HR 1.30 [1.14-1.47]; p < 0.01). NHYA class, 6MWD (per 10 m), KCCQ-OSS, and MLHFQ all significantly associated with all-cause mortality in patients with HF. CONCLUSION: Identifying such patients with poor health status using functional health assessment can offer a complementary assessment of disease burden and trajectory which carries a strong prognostic value.
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This document describes performance measures for heart failure that are appropriate for public reporting or pay-for-performance programs and is meant to serve as a focused update of the "2020 ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures." The new performance measures are taken from the "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines" and are selected from the strongest recommendations (Class 1 or Class 3). In contrast, quality measures may not have as much evidence base and generally comprise metrics that might be useful for clinicians and health care organizations for quality improvement but are not yet appropriate for public reporting or pay-for-performance programs. New performance measures include optimal blood pressure control in patients with heart failure with preserved ejection fraction, the use of sodium-glucose cotransporter-2 inhibitors for patients with heart failure with reduced ejection fraction, and the use of guideline-directed medical therapy in hospitalized patients. New quality measures include the use of sodium-glucose cotransporter-2 inhibitors in patients with heart failure with mildly reduced and preserved ejection fraction, the optimization of guideline-directed medical therapy prior to intervention for chronic secondary severe mitral regurgitation, continuation of guideline-directed medical therapy for patients with heart failure with improved ejection fraction, identifying both known risks for cardiovascular disease and social determinants of health, patient-centered counseling regarding contraception and pregnancy risks for individuals with cardiomyopathy, and the need for a monoclonal protein screen to exclude light chain amyloidosis when interpreting a bone scintigraphy scan assessing for transthyretin cardiac amyloidosis.
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Phase 3 randomized controlled trials (RCTs), while the gold standard for treatment efficacy and safety, are not always feasible, are expensive, can be prolonged and can be limited in generalizability. Other under-recognized sources of evidence can also help advance drug development. Basic science, proof-of-concept studies and early-phase RCTs can provide evidence regarding the potential for clinical benefit. Real-world evidence generated from registries or observational datasets can provide insights into the treatment of rare diseases that often pose a challenge for trial recruitment. Pragmatic trials embedded in healthcare systems can assess the treatment effects in clinical settings among patient populations sometimes excluded from trials. This Perspective discusses potential sources of evidence that may be used to complement explanatory phase 3 RCTs and to speed the development of new cardiovascular medications. Content is derived from the 19th Global Cardiovascular Clinical Trialists meeting (December 2022), involving clinical trialists, patients, clinicians, regulators, funders and industry representatives.
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Desenvolvimento de Medicamentos , Humanos , Desenvolvimento de Medicamentos/métodos , Fármacos Cardiovasculares/uso terapêutico , Fármacos Cardiovasculares/efeitos adversos , Ensaios Clínicos Fase III como Assunto , Ensaios Clínicos Pragmáticos como Assunto/métodos , Projetos de Pesquisa/normas , Doenças Cardiovasculares/tratamento farmacológico , Medicina Baseada em Evidências/métodos , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Estudos Observacionais como Assunto/métodosRESUMO
This document describes performance measures for heart failure that are appropriate for public reporting or pay-for-performance programs and is meant to serve as a focused update of the "2020 ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures." The new performance measures are taken from the "2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines" and are selected from the strongest recommendations (Class 1 or Class 3). In contrast, quality measures may not have as much evidence base and generally comprise metrics that might be useful for clinicians and health care organizations for quality improvement but are not yet appropriate for public reporting or pay-for-performance programs. New performance measures include optimal blood pressure control in patients with heart failure with preserved ejection fraction, the use of sodium-glucose cotransporter-2 inhibitors for patients with heart failure with reduced ejection fraction, and the use of guideline-directed medical therapy in hospitalized patients. New quality measures include the use of sodium-glucose cotransporter-2 inhibitors in patients with heart failure with mildly reduced and preserved ejection fraction, the optimization of guideline-directed medical therapy prior to intervention for chronic secondary severe mitral regurgitation, continuation of guideline-directed medical therapy for patients with heart failure with improved ejection fraction, identifying both known risks for cardiovascular disease and social determinants of health, patient-centered counseling regarding contraception and pregnancy risks for individuals with cardiomyopathy, and the need for a monoclonal protein screen to exclude light chain amyloidosis when interpreting a bone scintigraphy scan assessing for transthyretin cardiac amyloidosis.
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Cardiovascular diseases (CVDs) are responsible for approximately 35% of all deaths in women. In 2019, the global age-standardized CVD prevalence and mortality of women were 6,403 per 100,000 and 204 per 100,000, respectively. Although the age- and population-adjusted prevalence has decreased globally, opposite trends are evident in regions of socioeconomic deprivation. Cardiovascular health and outcomes are influenced by regional socioeconomic, environmental, and community factors, in addition to health care system and individual factors. Cardiovascular care in women is commonly plagued by delayed diagnoses, undertreatment, and knowledge gaps, particularly in women-specific or women-predominant conditions. In this paper, we describe the global epidemiology of CVD and highlight multilevel determinants of cardiometabolic health. We review knowledge and health care gaps that serve as barriers to improving CVD outcomes in women. Finally, we present national, community, health care system, and research strategies to comprehensively address cardiometabolic risk and improve outcomes in women.
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Doenças Cardiovasculares , Saúde Global , Humanos , Doenças Cardiovasculares/epidemiologia , Feminino , Saúde da Mulher , PrevalênciaRESUMO
OBJECTIVES: Data sharing statements are considered routine in clinical trial reporting and represent a step toward data transparency. The International Committee of Medical Journal Editors (ICMJE) required clinical trials to publish data sharing statements. We aimed to assess the requirement for data sharing statements of individual participant data by biomedical journals and explore associations between journal characteristics and journal requirements for data sharing statements. STUDY DESIGN AND SETTING: In this cross-sectional study, we included all biomedical journals that published clinical trials from January 1, 2019, to December 31, 2022, and that were indexed by the Journal Citation Reports. The study outcome was the journal requirement for data sharing statements. Multivariable logistic regression analysis was used to assess the relationship between journal characteristics and requirement for data sharing statements. RESULTS: Of the 3229 biomedical journals included in the analysis, 2345 (72.6%) required authors to include data sharing statements. Journals published in the UK (OR, 3.19 [95% CI, 2.43-4.22]) and endorsing the Consolidated Standards of Reporting Trials (OR, 3.30 [95% CI, 2.78-3.92]) had greater odds of requiring data sharing statements. Journals that were open access, non-English language, in the Journal Citation Reports group of clinical medicine, and on the ICMJE list had lower odds of requiring data sharing statements, with ORs ranging from 0.18 to 0.81. CONCLUSION: Despite ICMJE recommendations, more than 27% of the biomedical journals that published clinical trials did not require clinical trials to include data sharing statements, highlighting room for improved transparency.
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Ensaios Clínicos como Assunto , Políticas Editoriais , Disseminação de Informação , Publicações Periódicas como Assunto , Disseminação de Informação/métodos , Estudos Transversais , Humanos , Ensaios Clínicos como Assunto/normas , Publicações Periódicas como Assunto/normas , Publicações Periódicas como Assunto/estatística & dados numéricosRESUMO
BACKGROUND: Evidence for the relationship between remnant cholesterol (RC) and incident atrial fibrillation (AF) risk remains sparse and limited. METHODS AND RESULTS: Participants were enrolled between 2006 and 2010 and followed up to 2021. The multivariable Cox proportional hazards model was used to examine the relationship between RC quartiles and risk of incident AF. Subgroup analyses and sensitivity analyses were performed to explore the potential modification of the association and the robustness of the main findings. A total of 422 316 participants (mean age, 56 years; 54% women) were included for analyses. During a median follow-up of 11.9 years (first quartile-third quartile, 11.6-13.2 years), there were 24 774 AF events documented with an incidence of 4.92 events per 1000 person-years (95% CI, 4.86-4.98). Participants in higher RC quartiles had a lower risk of incident AF than those in the lowest quartile (first quartile): hazard ratio (HR)=0.96 (95% CI, 0.91-1.00) for second quartile; HR=0.92 (95% CI, 0.88-0.96) for third quartile; and HR=0.85 (95% CI, 0.81-0.89) for fourth quartile (P for trend <0.001). The association between RC quartiles and risk of incident AF was stronger in participants aged ≥65 years, in men, and in participants without history of diabetes when compared with control groups (P<0.001 for interaction). CONCLUSIONS: On the basis of data from this large-scale prospective cohort study, elevated RC was associated with a lower risk of incident AF.
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Fibrilação Atrial , Colesterol , Humanos , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/sangue , Fibrilação Atrial/diagnóstico , Masculino , Feminino , Pessoa de Meia-Idade , Incidência , Estudos Prospectivos , Colesterol/sangue , Fatores de Risco , Idoso , Medição de Risco , Biomarcadores/sangueRESUMO
Introduction: Women are underrepresented in the leadership of and participation in randomized controlled trials (RCTs). We conducted a bibliometric review of nephrology RCTs to examine trial leadership by women and participation of women in nephrology RCTs. Methods: A bibliometric review of RCTs published in top medical, surgical, or nephrology journals was conducted using MEDLINE and EMBASE from January 2011 to December 2021. Leadership by women as corresponding authors, women trial participation, and trial characteristics were examined with duplicate independent data extraction. Logistic regression was used to examine associations between trial characteristics and women leadership and trial participation. Results: A total of 1770 studies were screened and 395 RCTs met eligibility criteria. The number (%) of women in corresponding, first, and last authorship positions were as follows: 89 (22%), 109 (28%), and 74 (19%), respectively, without change over time (P = 0.94). The median percentage (interquartile range [IQR]) of women trial participants was 39.0% (13.5%) with no difference between women or men lead authors (P = 0.15). Men lead authors were statistically less likely to enroll women in RCTs. Women lead authors were less likely to be funded by industry (odds ratio [OR]: 0.30; 95% confidence interval [CI]: 0.14-0.63; P = 0.002) or lead international trials (OR: 0.11; 95% CI: 0.01-0.83; P = 0.03). Trials with sex-specific eligibility criteria were more likely to have women leaders (OR: 2.56; 95% CI: 1.19-5.49; P = 0.02) than those without. Discussion: Gender inequalities in RCT leadership and RCT participation exist in nephrology and did not improve over time. Strategies to improve inequalities need to be implemented and evaluated.
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BACKGROUND: U.S. nationwide estimates of the proportion of patients newly diagnosed with heart failure with reduced ejection fraction (HFrEF) eligible for quadruple medical therapy, and the associated benefits of rapid implementation, are not well characterized. OBJECTIVES: This study sought to characterize the degree to which patients newly diagnosed with HFrEF are eligible for quadruple medical therapy, and the projected benefits of in-hospital initiation. METHODS: Among patients hospitalized for newly diagnosed HFrEF in the Get With The Guidelines-Heart Failure registry from 2016 to 2023, eligibility criteria based on regulatory labeling, guidelines, and expert consensus documents were applied for angiotensin receptor-neprilysin inhibitor, beta-blocker, mineralocorticoid receptor antagonist, and sodium-glucose cotransporter 2 inhibitor therapies. Of those eligible, the projected effect of quadruple therapy on 12-month mortality was modeled using treatment effects from pivotal clinical trials utilized by the AHA/ACC/HFSA Guideline for the Management of Heart Failure, and compared with observed outcomes among patients treated with angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and beta-blockers. RESULTS: Of 33,036 patients newly diagnosed with HFrEF, 27,158 (82%) were eligible for quadruple therapy, and 30,613 (93%) were eligible for ≥3 components. From 2021 to 2023, of patients eligible for quadruple therapy, 15.3% were prescribed quadruple therapy and 41.5% were prescribed triple therapy. Among Medicare beneficiaries eligible for quadruple therapy, 12-month incidence of mortality was 24.7% and HF hospitalization was 22.2%. Applying the relative risk reductions in clinical trials, complete implementation of quadruple therapy by time of discharge was projected to yield absolute risk reductions in 12-month mortality of 10.4% (number needed to treat = 10) compared with angiotensin-converting enzyme inhibitor/angiotensin receptor blocker and beta-blocker, and 24.8% (number needed to treat = 4) compared with no GDMT. CONCLUSIONS: In this nationwide U.S. cohort of patients hospitalized for newly diagnosed HFrEF, >4 of 5 patients were projected as eligible for quadruple therapy at discharge; yet, <1 in 6 were prescribed it. If clinical trial benefits can be fully realized, in-hospital initiation of quadruple medical therapy for newly diagnosed HFrEF would yield large absolute reductions in mortality.
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Antagonistas Adrenérgicos beta , Antagonistas de Receptores de Angiotensina , Inibidores da Enzima Conversora de Angiotensina , Quimioterapia Combinada , Insuficiência Cardíaca , Antagonistas de Receptores de Mineralocorticoides , Volume Sistólico , Humanos , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/mortalidade , Masculino , Antagonistas Adrenérgicos beta/uso terapêutico , Feminino , Idoso , Antagonistas de Receptores de Mineralocorticoides/uso terapêutico , Antagonistas de Receptores de Angiotensina/uso terapêutico , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Volume Sistólico/fisiologia , Estados Unidos/epidemiologia , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Inibidores do Transportador 2 de Sódio-Glicose/administração & dosagem , Sistema de Registros , Neprilisina/antagonistas & inibidores , Pessoa de Meia-Idade , Hospitalização/estatística & dados numéricos , Idoso de 80 Anos ou mais , Definição da ElegibilidadeRESUMO
AIM: Heart failure (HF) is a major cause of morbidity and mortality in older adults. Randomized controlled trials (RCTs) inform HF policy and practice, but the accurate interpretation of results is contingent on clear and transparent reporting. The CONsolidated Standards Of Reporting Trials (CONSORT) statement serves as a guide to RCT reporting. We evaluated the quality of reporting in HF RCTs in high-impact journals by assessing their adherence to CONSORT. METHODS AND RESULTS: We searched MEDLINE, EMBASE and CINAHL for HF RCTs published in high-impact journals 2000-2020. We assessed the proportion of CONSORT criteria that individual HF RCTs adhered to, and used the Jonckheere-Terpstra test to examine temporal trends in adherence. Multivariable linear regression explored the association between trial characteristics and adherence to CONSORT. Primary analysis assessed adherence to CONSORT 2010 update. A sensitivity analysis assessed adherence to the original (1996) CONSORT criteria. Among 221 RCTs analysed, the mean (standard deviation [SD]) adherence was suboptimal overall (mean [SD] adherence 69.7 [11.5]%) (5513/7913 criteria), with a temporal increase in adherence over the 20-year period (p < 0.001). Factors associated with adherence included publication after versus during/before 2010 (ß = 10.17, 95% confidence interval [CI] 7.64-12.70; p < 0.001); two-group parallel individual-level randomization versus other (including multi-group or cluster randomization) (ß = 5.81, 95% CI 2.88-8.73; p < 0.001); and multicentre versus single-centre trials (ß = 7.26, 95% CI 3.25-11.27; p < 0.001). There was no difference in trial adherence to the updated CONSORT (2010) versus the original (1996) CONSORT criteria, and temporal trends in adherence to both sets of criteria were similar, likely due to overlap between the two sets of criteria. Trials with greater adherence to CONSORT were published in higher impact factor journals, with a positive correlation (r = 0.312; p < 0.001). CONCLUSION: The quality of reporting in HF RCTs, as measured by CONSORT adherence, has improved over time but remains suboptimal.
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Fidelidade a Diretrizes , Insuficiência Cardíaca , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Insuficiência Cardíaca/terapia , Projetos de Pesquisa/normasRESUMO
Guideline-directed medical therapies and guideline-directed nonpharmacological therapies improve quality of life and survival in patients with heart failure (HF), but eligible patients, particularly women and individuals from underrepresented racial and ethnic groups, are often not treated with these therapies. Implementation science uses evidence-based theories and frameworks to identify strategies that facilitate uptake of evidence to improve health. In this scientific statement, we provide an overview of implementation trials in HF, assess their use of conceptual frameworks and health equity principles, and provide pragmatic guidance for equity in HF. Overall, behavioral nudges, multidisciplinary care, and digital health strategies increased uptake of therapies in HF effectively but did not include equity goals. Few HF studies focused on achieving equity in HF by engaging stakeholders, quantifying barriers and facilitators to HF therapies, developing strategies for equity informed by theory or frameworks, evaluating implementation measures for equity, and titrating strategies for equity. Among these HF equity studies, feasibility was established in using various educational strategies to promote organizational change and equitable care. A couple include ongoing randomized controlled pragmatic trials for HF equity. There is great need for additional HF implementation trials designed to promote delivery of equitable guideline-directed therapy.
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American Heart Association , Equidade em Saúde , Insuficiência Cardíaca , Ciência da Implementação , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/diagnóstico , Humanos , Estados Unidos , Disparidades em Assistência à SaúdeRESUMO
PURPOSE OF REVIEW: To review ongoing and planned clinical trials of weight loss among individuals with or at high risk of heart failure. RECENT FINDINGS: Intentional weight loss via semaglutide among persons with heart failure and preserved ejection fraction and obesity significantly improves weight loss and health status as assessed by the KCCQ-CSS score and is associated with improvements in 6-min walk test. Ongoing and planned trials will explore the role of intentional weight loss with treatments such as semaglutide or tirzepatide for individuals with heart failure across the entire ejection fraction spectrum.
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Insuficiência Cardíaca , Obesidade , Redução de Peso , Humanos , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/fisiopatologia , Obesidade/complicações , Obesidade/tratamento farmacológico , Ensaios Clínicos como Assunto , Volume Sistólico/fisiologiaRESUMO
Despite significant progress in medical research and public health efforts, gaps in knowledge of women's heart health remain across epidemiology, presentation, management, outcomes, education, research, and publications. Historically, heart disease was viewed primarily as a condition in men and male individuals, leading to limited understanding of the unique risks and symptoms that women experience. These knowledge gaps are particularly problematic because globally heart disease is the leading cause of death for women. Until recently, sex and gender have not been addressed in cardiovascular research, including in preclinical and clinical research. Recruitment was often limited to male participants and individuals identifying as men, and data analysis according to sex or gender was not conducted, leading to a lack of data on how treatments and interventions might affect female patients and individuals who identify as women differently. This lack of data has led to suboptimal treatment and limitations in our understanding of the underlying mechanisms of heart disease in women, and is directly related to limited awareness and knowledge gaps in professional training and public education. Women are often unaware of their risk factors for heart disease or symptoms they might experience, leading to delays in diagnosis and treatments. Additionally, health care providers might not receive adequate training to diagnose and treat heart disease in women, leading to misdiagnosis or undertreatment. Addressing these knowledge gaps requires a multipronged approach, including education and policy change, built on evidence-based research. In this chapter we review the current state of existing cardiovascular research in Canada with a specific focus on women.
En dépit des avancées importantes de la recherche médicale et des efforts en santé publique, il reste des lacunes dans les connaissances sur la santé cardiaque des femmes sur les plans de l'épidémiologie, du tableau clinique, de la prise en charge, des résultats, de l'éducation, de la recherche et des publications. Du point de vue historique, la cardiopathie a d'abord été perçue comme une maladie qui touchait les hommes et les individus de sexe masculin. De ce fait, la compréhension des risques particuliers et des symptômes qu'éprouvent les femmes est limitée. Ces lacunes dans les connaissances posent particulièrement problème puisqu'à l'échelle mondiale la cardiopathie est la cause principale de décès chez les femmes. Jusqu'à récemment, la recherche en cardiologie, notamment la recherche préclinique et clinique, ne portait pas sur le sexe et le genre. Le recrutement souvent limité aux participants masculins et aux individus dont l'identité de genre correspond au sexe masculin et l'absence d'analyses de données en fonction du sexe ou du genre ont eu pour conséquence un manque de données sur la façon dont les traitements et les interventions nuisent aux patientes féminines et aux individus dont l'identité de genre correspond au sexe féminin, et ce, de façon différente. Cette absence de données a mené à un traitement sous-optimal et à des limites de notre compréhension des mécanismes sous-jacents de la cardiopathie chez les femmes, et est directement reliée à nos connaissances limitées, et à nos lacunes en formation professionnelle et en éducation du public. Le fait que les femmes ne connaissent souvent pas leurs facteurs de risque de maladies du cÅur ou les symptômes qu'elles peuvent éprouver entraîne des retards de diagnostic et de traitements. De plus, le fait que les prestataires de soins de santé ne reçoivent pas la formation adéquate pour poser le diagnostic et traiter la cardiopathie chez les femmes les mène à poser un mauvais diagnostic ou à ne pas traiter suffisamment. Pour pallier ces lacunes de connaissances, il faut une approche à plusieurs volets, qui porte notamment sur l'éducation et les changements dans les politiques, et qui repose sur la recherche fondée sur des données probantes. Dans ce chapitre, nous passons en revue l'état actuel de la recherche existante sur les maladies cardiovasculaires au Canada, plus particulièrement chez les femmes.
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This final chapter of the Canadian Women's Heart Health Alliance "ATLAS on the Epidemiology, Diagnosis, and Management of Cardiovascular Disease in Women" presents ATLAS highlights from the perspective of current status, challenges, and opportunities in cardiovascular care for women. We conclude with 12 specific recommendations for actionable next steps to further the existing progress that has been made in addressing these knowledge gaps by tackling the remaining outstanding disparities in women's cardiovascular care, with the goal to improve outcomes for women in Canada.
Dans ce chapitre final de l'ATLAS sur l'épidémiologie, le diagnostic et la prise en charge de la maladie cardiovasculaire chez les femmes de l'Alliance canadienne de santé cardiaque pour les femmes, nous présentons les points saillants de l'ATLAS au sujet de l'état actuel des soins cardiovasculaires offerts aux femmes, ainsi que des défis et des occasions dans ce domaine. Nous concluons par 12 recommandations concrètes sur les prochaines étapes à entreprendre pour donner suite aux progrès déjà réalisés afin de combler les lacunes dans les connaissances, en s'attaquant aux disparités qui subsistent dans les soins cardiovasculaires prodigués aux femmes, dans le but d'améliorer les résultats de santé des femmes au Canada.
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PURPOSE OF REVIEW: Obesity is associated with cardiovascular (CV) conditions, including but not limited to atherosclerotic disease, heart failure, and atrial fibrillation. Despite this, the impact of intentional weight loss on CV outcomes for persons with obesity and established CV conditions remains poorly studied. New and emerging pharmacologic therapies for weight loss primarily targeting the incretin/nutrient sensing axes induce substantial and sustained weight loss. The glucagon-like-peptide 1 receptor agonists (GLP-1 RA) liraglutide and semaglutide have US FDA approval for the treatment of obesity, and the application for an obesity indication for the dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist tirzepatide is presently under FDA review. Extensive phase II and IIIa randomized controlled trials are underway evaluating permutations of combined GLP-1 RA, GIP receptor agonist, GIP receptor antagonist, and glucagon receptor agonists. Clinical outcome trials of these therapies in persons with obesity at high risk of established CV conditions should make it possible to estimate the role of intentional weight loss in managing CV risk via these medications. RECENT FINDINGS: High-dose once weekly injectable semaglutide (2.4 mg/week) use among persons with obesity and heart failure with preserved ejection fraction was effective at both reducing weight and improving health status; exercise capacity was also improved. Ongoing CV outcome trials of oral semaglutide and once weekly injectable tirzepatide will help to establish the role of these therapies among persons with other CV conditions. In addition to these two therapies targeting a CV claim or indication, many other new therapeutics for weight loss, as reviewed, are currently in development. The impact of pharmacologic-induced weight loss on CV conditions for persons with obesity and established CV conditions is currently under investigation for multiple agents. These therapies may offer new avenues to manage CV risk in persons with obesity and with established or at high risk for CV disease.
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Fibrilação Atrial , Diabetes Mellitus Tipo 2 , Cardiopatias , Insuficiência Cardíaca , Humanos , Peptídeo 1 Semelhante ao Glucagon , Obesidade/complicações , Obesidade/tratamento farmacológico , Redução de Peso , HipoglicemiantesRESUMO
Background: Although numerous studies have examined readmission with heart failure (HF) after acute myocardial infarction (AMI), limited data are available on HF readmission in cancer patients post-AMI. Objectives: This study aimed to assess the rates and factors associated with HF readmission in cancer patients presenting with ST-segment elevation myocardial infarction (STEMI). Methods: A nationally linked cohort of STEMI patients between January 2005 and March 2019 were obtained from the UK Myocardial Infarction National Audit Project registry and the UK national Hospital Episode Statistics Admitted Patient Care registry. Multivariable Fine-Gray competing risk models were used to evaluate HF readmission at 30 days and 1 year. Results: A total of 326,551 STEMI indexed admissions were included, with 7,090 (2.2%) patients having active cancer. The cancer group was less likely to be admitted under the care of a cardiologist (74.5% vs 81.9%) and had lower rates of invasive coronary angiography (62.2% vs 72.7%; P < 0.001) and percutaneous coronary intervention (58.4% vs. 69.5%). There was a significant prescription gap in the administration of post-AMI medications upon discharge such as an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (49.5% vs 71.1%) and beta-blockers (58.4% vs 68.0%) in cancer patients. The cancer group had a higher rate of HF readmission at 30 days (3.2% vs 2.3%) and 1 year (9.4% vs 7.3%). However, after adjustment, cancer was not independently associated with HF readmission at 30 days (subdistribution HR: 1.05; 95% CI: 0.86-1.28) or 1 year (subdistribution HR: 1.03; 95% CI: 0.92-1.16). The opportunity-based quality indicator was associated with higher rates of HF readmission independent of cancer diagnosis. Conclusions: Cancer patients receive care that differs in important ways from patients without cancer. Greater implementation of evidence-based care may reduce HF readmissions, including in cancer patients.
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SOURCE CITATION: Maurer MS, Kale P, Fontana M, et al; APOLLO-B Trial Investigators. Patisiran treatment in patients with transthyretin cardiac amyloidosis. N Engl J Med. 2023;389:1553-1565. 37888916.
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Neuropatias Amiloides Familiares , Adulto , Humanos , Neuropatias Amiloides Familiares/complicações , Neuropatias Amiloides Familiares/tratamento farmacológico , Pré-Albumina , RNA Interferente Pequeno/efeitos adversosRESUMO
AIMS: Patients are at high risk of death or readmission following hospitalization for heart failure (HF). We tested the effect of a transitional care model that included month-long nurse-led home visits and long-term heart function clinic visits - with services titrated to estimated risk of clinical events - on 3-year outcomes following hospitalization. METHODS AND RESULTS: In a pragmatic, stepped-wedge cluster randomized trial, 10 hospitals were randomized to the intervention versus usual care. The primary outcome was a composite of all-cause death, readmission, or emergency department (ED) visit. Secondary outcomes included components of the primary composite outcomes, HF readmissions and healthcare resource utilization. There were 2494 patients (50.4% female) with mean age of 77.7 years. The primary outcome was reached in 1040 (94.2%) patients in the intervention and 1314 (94.5%) in the usual care group at 3 years. The intervention did not reduce the risk of the primary composite outcome (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.81-1.05) nor the component outcomes overall, although numerically reduced the risk of ED visits in women but not men (HR 0.79, 95% CI 0.63-1.00 vs. HR 0.98, 95% CI 0.80-1.19; sex-treatment interaction p = 0.23). The uptake of guideline-directed medical therapy was no different with the intervention than with usual care, with the exception of sacubitril/valsartan, which increased with the intervention (3.3% vs 1.5%; relative risk 6.2, 95% CI 1.92-20.06). CONCLUSIONS: More than 9 of 10 patients hospitalized for HF experienced all-cause death, readmission, or ED visit at 3 years. A transitional care model with services titrated to risk did not improve the composite of these endpoints, likely because there were no major differences in uptake of medical therapies between the groups. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02112227.
Assuntos
Insuficiência Cardíaca , Hospitalização , Readmissão do Paciente , Assistência Centrada no Paciente , Cuidado Transicional , Humanos , Insuficiência Cardíaca/terapia , Feminino , Masculino , Idoso , Hospitalização/estatística & dados numéricos , Assistência Centrada no Paciente/métodos , Readmissão do Paciente/estatística & dados numéricos , Idoso de 80 Anos ou mais , Serviço Hospitalar de EmergênciaRESUMO
BACKGROUND: The American Heart Association (AHA), in conjunction with the National Institutes of Health, annually reports the most up-to-date statistics related to heart disease, stroke, and cardiovascular risk factors, including core health behaviors (smoking, physical activity, nutrition, sleep, and obesity) and health factors (cholesterol, blood pressure, glucose control, and metabolic syndrome) that contribute to cardiovascular health. The AHA Heart Disease and Stroke Statistical Update presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, brain health, complications of pregnancy, kidney disease, congenital heart disease, rhythm disorders, sudden cardiac arrest, subclinical atherosclerosis, coronary heart disease, cardiomyopathy, heart failure, valvular disease, venous thromboembolism, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs). METHODS: The AHA, through its Epidemiology and Prevention Statistics Committee, continuously monitors and evaluates sources of data on heart disease and stroke in the United States and globally to provide the most current information available in the annual Statistical Update with review of published literature through the year before writing. The 2024 AHA Statistical Update is the product of a full year's worth of effort in 2023 by dedicated volunteer clinicians and scientists, committed government professionals, and AHA staff members. The AHA strives to further understand and help heal health problems inflicted by structural racism, a public health crisis that can significantly damage physical and mental health and perpetuate disparities in access to health care, education, income, housing, and several other factors vital to healthy lives. This year's edition includes additional global data, as well as data on the monitoring and benefits of cardiovascular health in the population, with an enhanced focus on health equity across several key domains. RESULTS: Each of the chapters in the Statistical Update focuses on a different topic related to heart disease and stroke statistics. CONCLUSIONS: The Statistical Update represents a critical resource for the lay public, policymakers, media professionals, clinicians, health care administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions.