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1.
JACC Heart Fail ; 9(1): 65-73, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33384064

RESUMO

OBJECTIVES: The purpose of this study was to evaluate in-hospital outcomes among patients with a history of heart failure (HF) hospitalized with coronavirus disease-2019 (COVID-19). BACKGROUND: Cardiometabolic comorbidities are common in patients with severe COVID-19. Patients with HF may be particularly susceptible to COVID-19 complications. METHODS: The Premier Healthcare Database was used to identify patients with at least 1 HF hospitalization or 2 HF outpatient visits between January 1, 2019, and March 31, 2020, who were subsequently hospitalized between April and September 2020. Baseline characteristics, health care resource utilization, and mortality rates were compared between those hospitalized with COVID-19 and those hospitalized with other causes. Predictors of in-hospital mortality were identified in HF patients hospitalized with COVID-19 by using multivariate logistic regression. RESULTS: Among 1,212,153 patients with history of HF, 132,312 patients were hospitalized from April 1, 2020, to September 30, 2020. A total of 23,843 patients (18.0%) were hospitalized with acute HF, 8,383 patients (6.4%) were hospitalized with COVID-19, and 100,068 patients (75.6%) were hospitalized with alternative reasons. Hospitalization with COVID-19 was associated with greater odds of in-hospital mortality as compared with hospitalization with acute HF; 24.2% of patients hospitalized with COVID-19 died in-hospital compared to 2.6% of those hospitalized with acute HF. This association was strongest in April (adjusted odds ratio [OR]: 14.48; 95% confidence interval [CI]:12.25 to 17.12) than in subsequent months (adjusted OR: 10.11; 95% CI: 8.95 to 11.42; pinteraction <0.001). Among patients with HF hospitalized with COVID-19, male sex (adjusted OR: 1.26; 95% CI: 1.13 to 1.40) and morbid obesity (adjusted OR: 1.25; 95% CI: 1.07 to 1.46) were associated with greater odds of in-hospital mortality, along with age (adjusted OR: 1.35; 95% CI: 1.29 to 1.42 per 10 years) and admission earlier in the pandemic. CONCLUSIONS: Patients with HF hospitalized with COVID-19 are at high risk for complications, with nearly 1 in 4 dying during hospitalization.


Assuntos
/epidemiologia , Insuficiência Cardíaca/epidemiologia , Hospitalização/estatística & dados numéricos , Pandemias , Idoso , Comorbidade , Feminino , Insuficiência Cardíaca/terapia , Mortalidade Hospitalar/tendências , Humanos , Masculino , Fatores de Risco , Estados Unidos/epidemiologia
2.
JACC Heart Fail ; 9(1): 1-12, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33309582

RESUMO

The treatment of heart failure with reduced ejection fraction (HFrEF) has changed considerably over time, particularly with the sequential development of therapies aimed at antagonism of maladaptive biologic pathways, including inhibition of the sympathetic nervous system and the renin-angiotensin aldosterone system. The sequential nature of earlier HFrEF trials allowed the integration of new therapies tested against the background therapy of the time. More recently, multiple heart failure therapies are being evaluated simultaneously, and the number of therapeutic choices for treating HFrEF has grown considerably. In addition, implementation science has lagged behind discovery science in heart failure. Furthermore, given there are currently >200 ongoing clinical trials in heart failure, further complexities are anticipated. In an effort to provide a decision-making framework in the current era of expanding therapeutic options in HFrEF, the Heart Failure Collaboratory convened a multi-stakeholder group, including patients, clinicians, clinical investigators, the U.S. Food and Drug Administration, industry, and payers who met at the U.S. Food and Drug Administration campus on March 6, 2020. This paper summarizes the discussions and expert consensus recommendations.

3.
J Am Coll Cardiol ; 76(20): 2368-2378, 2020 11 17.
Artigo em Inglês | MEDLINE | ID: mdl-33183511

RESUMO

The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment. The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory and the Academic Research Consortium, composed of academic investigators from the United States and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of Health, and industry members. A series of meetings were convened to address the challenges caused by the COVID-19 pandemic, review options for maintaining or altering best practices, and establish key recommendations for the conduct and analysis of clinical trials for cardiovascular disease and heart failure. This paper summarizes the discussions and expert consensus recommendations.


Assuntos
Ensaios Clínicos como Assunto , Infecções por Coronavirus , Pandemias , Pneumonia Viral , Determinação de Ponto Final , Humanos , Fatores Socioeconômicos , Estatística como Assunto
7.
Clin Cardiol ; 43(12): 1573-1578, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33089909

RESUMO

BACKGROUND: High-sensitivity troponin assays (hs-Tn) detect lower serum concentrations than prior-generation assays and help guide acute coronary syndrome (ACS) evaluation in emergency departments. Outpatient hs-Tn utilization is not well described. HYPOTHESIS: Outpatient providers use hs-TnT to triage patients with suspected ACS. METHODS: We compared the volume of outpatient prior-generation troponin tests in the pre-hsTn implementation period (January 2015-March 2018) with outpatient hs-TnT volume in the post-implementation period (April 2018-January 2020). Triage patterns were compared between patients with hs-TnT≥99th vs <99th percentile, using two-sample t tests. In patients triaged home, adverse events were compared between patients with hs-TnT≥99th vs <99th percentile, using log-rank tests. RESULTS: Across a large tertiary healthcare system, a mean of 80 prior-generation tests/month were ordered during the pre-hsTn implementation period compared with 12 hs-TnT tests/month in the post-implementation period. Prior-generation orders rose by 1.72 tests/month during pre-implementation, vs a decline of 2.74 hs-TnT tests/month during post-implementation (P < .001). Among 129 hs-TnT orders, most were placed by cardiologists (54%) and primary care providers (32%). Patient symptoms at the time of troponin ordering included dyspnea (34%) and chest pain (33%), although 25% were asymptomatic. Among symptomatic patients (n = 74), those with hs-TnT > 99th percentile were more likely to be sent to the ED (RR, 3.36; 95% CI, 1.22-9.25; P = .002). Among patients sent home (n = 66), those with hs-TnT > 99th percentile had more adverse events by 6 months (3.3% vs 22.2% RR, 6.67; 95% CI, 1.04-42.9; P = .026). CONCLUSIONS: In this healthcare system, outpatient troponin utilization significantly declined since hs-TnT implementation. Some providers use hs-TnT to triage patients with suspected ACS to the ED; others test asymptomatic patients and some send patients home despite high hs-TnT values.

8.
Am Heart J ; 232: 105-115, 2020 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-33121978

RESUMO

Morbidity and mortality associated with COVID-19 has increased exponentially, and patients with cardiovascular (CV) disease are at risk for poor outcomes. Several lines of evidence suggest a potential role for CV therapies in COVID-19 treatment. Characteristics of clinical trials of CV therapies related to COVID-19 registered on ClinicalTrials.gov have not been described. METHODS: ClinicalTrials.gov was queried on August 7, 2020 for COVID-19 related trials. Studies evaluating established CV drugs, other fibrinolytics (defibrotide), and extracorporeal membrane oxygenation were included. Studies evaluating anti-microbial, convalescent plasma, non-colchicine anti-inflammatory, and other therapies were excluded. Trial characteristics were tabulated from study-specific entries. RESULTS: A total of 2,935 studies related to COVID-19 were registered as of August 7, 2020. Of these, 1,645 were interventional studies, and the final analytic cohort consisted of 114 studies evaluating 10 CV therapeutic categories. Antithrombotics (32.5%; n = 37) were most commonly evaluated, followed by pulmonary vasodilators (14.0%; n = 16), renin-angiotensin-aldosterone system-related therapies (12.3%; n = 14), and colchicine (8.8%; n = 10). Trials evaluating multiple CV therapy categories and CV therapies in combination with non-CV therapies encompassed 4.4% (n = 5) and 9.6% (n = 11) of studies, respectively. Most studies were designed for randomized allocation (87.7%; n = 100), enrollment of less than 1000 participants (86.8%; n = 99), single site implementation (55.3%; n = 63), and had a primary outcome of mortality or a composite including mortality (56.1%; n = 64). Most study populations consisted of patients hospitalized with COVID-19 (81.6%; n = 93). At the time of database query, 28.9% (n = 33) of studies were not yet recruiting and the majority were estimated to be completed after December 2020 (67.8%; n = 78). Most lead sponsors were located in North America (43.9%; n = 50) or Europe (36.0%; n = 41). CONCLUSIONS: A minority (7%) of clinical trials related to COVID-19 registered on ClinicalTrials.gov plan to evaluate CV therapies. Of CV therapy studies, most were planned to be single center, enroll less than 1000 inpatients, sponsored by European or North American academic institutions, and estimated to complete after December 2020. Collectively, these findings underscore the need for a network of sites with a platform protocol for rapid evaluation of multiple therapies and generalizability to inform clinical care and health policy for COVID-19 moving forward.

9.
Heart Fail Clin ; 16(4): 433-440, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32888638

RESUMO

Despite steady progress over the past 3 decades in advancing drug and device therapies to reduce morbidity and mortality in heart failure with reduced ejection fraction, large registries of usual care demonstrate incomplete use of these evidence-based therapies in clinical practice. Potential strategies to improve guideline-directed medical therapy include leveraging non-physician clinicians, solidifying transitions of care, incorporating telehealth solutions, and engaging in comprehensive comorbid disease management via multidisciplinary team structures. These approaches may be particularly relevant in an era of Coronavirus Disease 2019 and associated need for social distancing, further limiting contact with traditional ambulatory clinic settings.


Assuntos
Assistência Ambulatorial , Infecções por Coronavirus , Insuficiência Cardíaca/terapia , Pandemias , Pneumonia Viral , Assistência Ambulatorial/métodos , Assistência Ambulatorial/organização & administração , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Insuficiência Cardíaca/epidemiologia , Humanos , Inovação Organizacional , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle
11.
JAMA Cardiol ; 5(8): e203255, 2020 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-32822461
12.
J Am Coll Cardiol ; 76(3): 280-288, 2020 Jul 21.
Artigo em Inglês | MEDLINE | ID: mdl-32470516

RESUMO

BACKGROUND: Although patients with cardiovascular disease face excess risks of severe illness with coronavirus disease-2019 (COVID-19), there may be indirect consequences of the pandemic on this high-risk patient segment. OBJECTIVES: This study sought to examine longitudinal trends in hospitalizations for acute cardiovascular conditions across a tertiary care health system. METHODS: Acute cardiovascular hospitalizations were tracked between January 1, 2019, and March 31, 2020. Daily hospitalization rates were estimated using negative binomial models. Temporal trends in hospitalization rates were compared across the first 3 months of 2020, with the first 3 months of 2019 as a reference. RESULTS: From January 1, 2019, to March 31, 2020, 6,083 patients experienced 7,187 hospitalizations for primary acute cardiovascular reasons. There were 43.4% (95% confidence interval [CI]: 27.4% to 56.0%) fewer estimated daily hospitalizations in March 2020 compared with March 2019 (p < 0.001). The daily rate of hospitalizations did not change throughout 2019 (-0.01% per day [95% CI: -0.04% to +0.02%]; p = 0.50), January 2020 (-0.5% per day [95% CI: -1.6% to +0.5%]; p = 0.31), or February 2020 (+0.7% per day [95% CI: -0.6% to +2.0%]; p = 0.27). There was significant daily decline in hospitalizations in March 2020 (-5.9% per day [95% CI: -7.6% to -4.3%]; p < 0.001). Length of stay was shorter (4.8 days [25th to 75th percentiles: 2.4 to 8.3 days] vs. 6.0 days [25th to 75th percentiles: 3.1 to 9.6 days]; p = 0.003) and in-hospital mortality was not significantly different (6.2% vs. 4.4%; p = 0.30) in March 2020 compared with March 2019. CONCLUSIONS: During the first phase of the COVID-19 pandemic, there was a marked decline in acute cardiovascular hospitalizations, and patients who were admitted had shorter lengths of stay. These data substantiate concerns that acute care of cardiovascular conditions may be delayed, deferred, or abbreviated during the COVID-19 pandemic.


Assuntos
Doenças Cardiovasculares , Infecções por Coronavirus , Hospitalização/estatística & dados numéricos , Pandemias , Pneumonia Viral , Idoso , Idoso de 80 Anos ou mais , Betacoronavirus , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Centros de Atenção Terciária/estatística & dados numéricos
13.
Eur J Heart Fail ; 22(6): 1022-1031, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32212297

RESUMO

AIMS: Non-cardiac comorbidities are highly prevalent in patients with heart failure (HF). Our objective was to define the association between non-cardiac comorbidity burden and clinical outcomes, costs of care, and length of stay within a large randomized trial of acute HF patients. METHODS AND RESULTS: Patients with complete medical history for the following comorbidities were included: diabetes mellitus, chronic obstructive pulmonary disease, chronic liver disease, history of cancer within the last 5 years, chronic renal disease (baseline serum creatinine >3.0 mg/mL), current smoking, alcohol abuse, depression, anaemia, peripheral arterial disease, and cerebrovascular disease. Patients were classified by overall burden of non-cardiac comorbidities (0, 1, 2, 3, and 4+). Hierarchical generalized linear models were used to assess associations between comorbidity burden and 30-day all-cause death or HF hospitalization and 180-day all-cause death in addition to costs of care and length of stay. A total of 6945 patients were included in the final analysis. Mean comorbidity number was 2.2 (± 1.34). Patients with 4+ comorbidities had higher rates of 30-day all-cause death/HF hospitalization as compared with patients with no comorbidities [odds ratio (OR) 3.32, 95% confidence interval (CI) 1.61-6.84; P < 0.01]. Similar results were seen with respect to 180-day death (OR 2.13, 95% CI 1.33-3.43; P < 0.01). Higher comorbidity burden was associated with higher 180-day costs of care and length of stay. CONCLUSIONS: Higher comorbidity burden is associated with poor clinical outcomes, higher costs of care, and extended length of stay. Further studies are needed to define the impact of comorbidity management programmes on outcomes for HF patients.

17.
Am Heart J ; 218: 57-65, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31707329

RESUMO

International differences in management/outcomes among patients with type 2 diabetes and heart failure (HF) are not well characterized. We sought to evaluate geographic variation in treatment and outcomes among these patients. METHODS AND RESULTS: Among 14,671 participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), those with HF at baseline and a documented ejection fraction (EF) (N = 1591; 10.8%) were categorized by enrollment region (North America, Latin America, Western Europe, Eastern Europe, and Asia Pacific). Cox models were used to examine the association between geographic region and the primary outcome of all-cause mortality (ACM) or hospitalization for HF (hHF) in addition to ACM alone. Analyses were stratified by those with EF <40% or EF ≥40%. The majority of participants with HF were enrolled in Eastern Europe (53%). Overall, 1,267 (79.6%) had EF ≥40%. ß-Blocker (83%) and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (86%) use was high across all regions in patients with EF <40%. During a median follow-up of 2.9 years, Eastern European participants had lower rates of ACM/hHF compared with North Americans (adjusted hazard ratio: 0.45; 95% CI: 0.32-0.64). These differences were seen only in the EF ≥40% subgroup and not the EF <40% subgroup. ACM was similar among Eastern European and North American participants (adjusted hazard ratio: 0.79; 95% CI: 0.44-1.45). CONCLUSIONS: Significant variation exists in the clinical features and outcomes of HF patients across regions in TECOS. Patients from Eastern Europe had lower risk-adjusted ACM/hHF than those in North America, driven by those with EF ≥40%. These data may inform the design of future international trials.


Assuntos
Diabetes Mellitus Tipo 2/mortalidade , Insuficiência Cardíaca/mortalidade , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Ásia , Causas de Morte , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diuréticos/uso terapêutico , Método Duplo-Cego , Europa (Continente) , Feminino , Seguimentos , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/tratamento farmacológico , Hospitalização , Humanos , Hipoglicemiantes/uso terapêutico , Estimativa de Kaplan-Meier , América Latina , Masculino , Pessoa de Meia-Idade , América do Norte , Modelos de Riscos Proporcionais , Fosfato de Sitagliptina/uso terapêutico , Volume Sistólico , Resultado do Tratamento
20.
JACC Heart Fail ; 6(10): 844-855, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30098960

RESUMO

OBJECTIVES: This study sought to evaluate and contribute to the limited data on U.S. hospital practice patterns with respect to respiratory vaccination in patients hospitalized with heart failure (HF). BACKGROUND: Respiratory infection is a major driver of morbidity in patients with HF, and many influenza and pneumococcal infections may be prevented by vaccination. METHODS: This study evaluated patients hospitalized at centers participating in the Get With The Guidelines-HF (GWTG-HF) registry from October 2012 to March 2017. The proportion of patients receiving vaccination was described for influenza and pneumococcal vaccination, respectively. The association of hospital-level vaccination rates with individual GWTG-HF performance measures and defect-free care was evaluated using multivariable modeling. RESULTS: This study evaluated 313,761 patients discharged from 392 hospitals during the study period. The proportion of patients receiving influenza vaccination was 68% overall and declined from 70% in 2012 to 2013 to 66% in 2016 to 2017 (p < 0.001), although this was not statistically significant after adjustment (odds ratio: 1.05 per flu season; 95% confidence interval [CI]: 0.94 to 1.18). The proportion of patients receiving pneumococcal vaccination was 66% overall and decreased over the study period from 71% in 2013 to 60% in 2016 (p < 0.001), remaining significant after adjustment (odds ratio: 0.75 per calendar year; 95% CI: 0.67 to 0.84). Hospitals with higher vaccination rates were more likely to discharge patients with higher performance on defect-free care and individual GWTG-HF performance measures (p < 0.001). In a subset of patients with linked Medicare claims, vaccinated patients had similar rates of 1-year all-cause mortality (adjusted hazard ratio: 0.96 [95% CI: 0.89 to 1.03] for influenza vaccination; adjusted hazard ratio: 0.95 [95% CI: 0.89 to 1.01] for pneumococcal vaccination) compared with those not vaccinated. CONCLUSIONS: Nearly 1 in 3 patients hospitalized with HF at participating hospitals were not vaccinated for influenza or pneumococcal pneumonia, and vaccination rates did not improve from 2012 to 2017. Hospitals that exhibited higher vaccination rates performed well with respect to other HF quality of care measures. Vaccination status was not associated with differences in clinical outcomes. Further randomized controlled data are needed to assess the relationship between vaccination and outcomes.


Assuntos
Insuficiência Cardíaca/complicações , Vacinas contra Influenza/uso terapêutico , Vacinas Pneumocócicas/uso terapêutico , Vacinação/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Feminino , Fidelidade a Diretrizes/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Humanos , Influenza Humana/prevenção & controle , Masculino , Pessoa de Meia-Idade , Pneumonia Pneumocócica/prevenção & controle , Sistema de Registros , Estados Unidos
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