Association of Abnormal Cardiac Biomarkers and Cardiovascular Complications, with Mortality in Patients with SARS-CoV-2 Infection in Latin America.

BACKGROUND: The COVID-19 pandemic has highlighted a correlation between cardiac complications and elevated cardiac biomarkers, which are linked to poorer clinical outcomes. OBJECTIVE: This study aims to determine the clinical impact of cardiac biomarkers in COVID-19 patients in Latin America. SUBJECTS AND METHODS: The CARDIO COVID 19-20 Registry is a multicenter observational study across 44 hospitals in Latin America and the Caribbean. It included hospitalized COVID-19 patients (n = 476) who underwent troponin, natriuretic peptide, and D-dimer tests. Patients were grouped based on the number of positive biomarkers. RESULTS: Among the 476 patients tested, 139 had one positive biomarker (Group C), 190 had two (Group B), 118 had three (Group A), and 29 had none (Group D). A directly proportional relationship was observed between the number of positive biomarkers and the incidence of decompensated heart failure. Similarly, there was a proportional relationship between the number of positive biomarkers and increased mortality. In Group B, patients with elevated troponin and natriuretic peptide and those with elevated troponin and D-dimer had 1.4 and 1.5 times higher mortality, respectively, than those with elevated natriuretic peptide and D-dimer. CONCLUSIONS: In Latin American COVID-19 patients, a higher number of positive cardiac biomarkers is associated with increased cardiovascular complications and mortality. These findings suggest that cardiac biomarkers should be utilized to guide acute-phase treatment strategies.

American registry of ambulatory and acute decompensated heart failure (AMERICCAASS registry): Rationale and design.

AIMS: Heart failure (HF) is a highly prevalent and progressive condition associated with significant morbidity and mortality rates. Acute decompensated HF precipitates millions of hospitalizations each year. Despite therapeutic advances, the overall prognosis of HF is poor. The varying clinical courses and outcomes of patients with this disease may be due to region-specific gaps and since most HF studies are conducted in developed countries, the participation of Latin American and Caribbean countries is low. Considering this, the American Registry of Ambulatory and Acute Decompensated Heart Failure (AMERICCAASS) aims to characterize the population with ambulatory and acute decompensated HF in the American continent and to determine rehospitalization and survival outcomes during the 12 months of follow-up. METHODS AND RESULTS: AMERICCAASS Registry is an observational, prospective, and hospital-based registry recruiting patients with ambulatory or acute decompensated HF. The registry plans to include between two and four institutions per country from at least 20 countries in the Americas, and at least 60 patients recruited from each participant institution regardless of their ambulatory or acutely decompensated condition. Ambulatory patients with confirmed HF diagnosis or inpatients presenting with acute decompensated HF will be included. Follow-up will be performed at 12 months in ambulatory patients or 1, 6, and 12 months after hospital discharge in acutely decompensated HF patients. This ongoing study began on 1 April 2022, with recruitment scheduled to end on 30 November 2023, and follow-up on 31 January 2025. Ethics approval was obtained from the Biomedical Research Ethics Committee of Fundación Valle del Lili. Data collected in the AMERICCAASS registry is being stored on the electronic platform REDCap (Research Electronic Data Capture), which allows different forms for patient groups to enable unbiased analyses. For quantitative variables comparison, we will use the Student's t-test or non-parametric tests accordingly. Categorical variables will be presented as proportions, and groups will be compared with Fisher's exact test. The significance level will be <0.05 for comparisons. Readmissions and post-discharge mortality will be calculated as proportions at 1, 6, and 12 months, with a survival analysis by conditional probability and the Kaplan-Meier method. CONCLUSIONS: AMERICCAASS Registry is intended to be the most important registry of the continent for obtaining important information about demographics, aetiology, co-morbidities, and treatment received, either ambulatory or hospitalized. This registry may contribute to the optimization of national and regional evidence and public policies for the diagnosis and treatment of HF disease.

Semaglutide and NT-proBNP in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program.

BACKGROUND: The glucagon-like peptide-1 receptor agonist, semaglutide, improved health status and reduced body weight in patients with obesity-related heart failure (HF) with preserved ejection fraction (HFpEF) in the STEP-HFpEF (Semaglutide Treatment Effect in People with Obesity and HFpEF) program. Whether benefits were due to mechanical unloading or effects on HF pathobiology is uncertain. OBJECTIVES: This study sought to determine if semaglutide 2.4 mg reduced N-terminal pro-B-type natriuretic peptide (NT-proBNP) in patients with obesity-related HFpEF and compare treatment responses by baseline NT-proBNP. METHODS: This was a prespecified secondary analysis of pooled data from 2 double-blind, placebo-controlled, randomized trials (STEP-HFpEF [Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity] and STEP-HFpEF DM [Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes]) testing effects of semaglutide in patients with obesity-related HFpEF. The main outcomes were change in NT-proBNP at 52 weeks and change in the dual primary endpoints of Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and body weight by baseline NT-proBNP. RESULTS: In total, 1,145 patients were randomized. Semaglutide compared with placebo reduced NT-proBNP at 52 weeks (estimated treatment ratio: 0.82; 95% CI: 0.74-0.91; P = 0.0002). Improvements in health status were more pronounced in those with higher vs lower baseline NT-proBNP (estimated difference: tertile 1: 4.5 points, 95% CI: 0.8-8.2; tertile 2: 6.2 points, 95% CI: 2.4-10.0; tertile 3: 11.9 points, 95% CI: 8.1-15.7; P interaction = 0.02; baseline NT-proBNP as a continuous variable: P interaction = 0.004). Reductions in body weight were consistent across baseline NT-proBNP levels (P interaction = 0.21). CONCLUSIONS: In patients with obesity-related HFpEF, semaglutide reduced NT-proBNP. Participants with higher baseline NT-proBNP had a similar degree of weight loss but experienced larger reductions in HF-related symptoms and physical limitations with semaglutide than those with lower NT-proBNP.

Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials.

BACKGROUND: In the STEP-HFpEF (NCT04788511) and STEP-HFpEF DM (NCT04916470) trials, the GLP-1 receptor agonist semaglutide improved symptoms, physical limitations, bodyweight, and exercise function in people with obesity-related heart failure with preserved ejection fraction. In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, we aimed to provide a more definitive assessment of the effects of semaglutide across a range of outcomes and to test whether these effects were consistent across key patient subgroups. METHODS: We conducted a prespecified pooled analysis of individual patient data from STEP-HFpEF and STEP-HFpEF DM, randomised, double-blind, placebo-controlled trials at 129 clinical research sites in 18 countries. In both trials, eligible participants were aged 18 years or older, had heart failure with a left ventricular ejection fraction of at least 45%, a BMI of at least 30 kg/m2, New York Heart Association class II-IV symptoms, and a Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS; a measure of heart failure-related symptoms and physical limitations) of less than 90 points. In STEP-HFpEF, people with diabetes or glycated haemoglobin A1c concentrations of at least 6·5% were excluded, whereas for inclusion in STEP-HFpEF DM participants had to have been diagnosed with type 2 diabetes at least 90 days before screening and to have an HbA1c of 10% or lower. In both trials, participants were randomly assigned to either 2·4 mg semaglutide once weekly or matched placebo for 52 weeks. The dual primary endpoints were change from baseline to week 52 in KCCQ-CSS and bodyweight in all randomly assigned participants. Confirmatory secondary endpoints included change from baseline to week 52 in 6-min walk distance, a hierarchical composite endpoint (all-cause death, heart failure events, and differences in changes in KCCQ-CSS and 6-min walk distance); and C-reactive protein (CRP) concentrations. Heterogeneity in treatment effects was assessed across subgroups of interest. We assessed safety in all participants who received at least one dose of study drug. FINDINGS: Between March 19, 2021 and March 9, 2022, 529 people were randomly assigned in STEP-HFpEF, and between June 27, 2021 and Sept 2, 2022, 616 were randomly assigned in STEP-HFpEF DM. Overall, 1145 were included in our pooled analysis, 573 in the semaglutide group and 572 in the placebo group. Improvements in KCCQ-CSS and reductions in bodyweight between baseline and week 52 were significantly greater in the semaglutide group than in the placebo group (mean between-group difference for the change from baseline to week 52 in KCCQ-CSS 7·5 points [95% CI 5·3 to 9·8]; p<0·0001; mean between-group difference in bodyweight at week 52 -8·4% [-9·2 to -7·5]; p<0·0001). For the confirmatory secondary endpoints, 6-min walk distance (mean between-group difference at week 52 17·1 metres [9·2 to 25·0]) and the hierarchical composite endpoint (win ratio 1·65 [1·42 to 1·91]) were significantly improved, and CRP concentrations (treatment ratio 0·64 [0·56 to 0·72]) were significantly reduced, in the semaglutide group compared with the placebo group (p<0·0001 for all comparisons). For the dual primary endpoints, the efficacy of semaglutide was largely consistent across multiple subgroups, including those defined by age, race, sex, BMI, systolic blood pressure, baseline CRP, and left ventricular ejection fraction. 161 serious adverse events were reported in the semaglutide group compared with 301 in the placebo group. INTERPRETATION: In this prespecified pooled analysis of the STEP-HFpEF and STEP-HFpEF DM trials, semaglutide was superior to placebo in improving heart failure-related symptoms and physical limitations, and reducing bodyweight in participants with obesity-related heart failure with preserved ejection fraction. These effects were largely consistent across patient demographic and clinical characteristics. Semaglutide was well tolerated. FUNDING: Novo Nordisk.

Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes.

BACKGROUND: Obesity and type 2 diabetes are prevalent in patients with heart failure with preserved ejection fraction and are characterized by a high symptom burden. No approved therapies specifically target obesity-related heart failure with preserved ejection fraction in persons with type 2 diabetes. METHODS: We randomly assigned patients who had heart failure with preserved ejection fraction, a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or more, and type 2 diabetes to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The primary end points were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary end points included the change in 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level. RESULTS: A total of 616 participants underwent randomization. The mean change in the KCCQ-CSS was 13.7 points with semaglutide and 6.4 points with placebo (estimated difference, 7.3 points; 95% confidence interval [CI], 4.1 to 10.4; P<0.001), and the mean percentage change in body weight was -9.8% with semaglutide and -3.4% with placebo (estimated difference, -6.4 percentage points; 95% CI, -7.6 to -5.2; P<0.001). The results for the confirmatory secondary end points favored semaglutide over placebo (estimated between-group difference in change in 6-minute walk distance, 14.3 m [95% CI, 3.7 to 24.9; P = 0.008]; win ratio for hierarchical composite end point, 1.58 [95% CI, 1.29 to 1.94; P<0.001]; and estimated treatment ratio for change in CRP level, 0.67 [95% CI, 0.55 to 0.80; P<0.001]). Serious adverse events were reported in 55 participants (17.7%) in the semaglutide group and 88 (28.8%) in the placebo group. CONCLUSIONS: Among patients with obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide led to larger reductions in heart failure-related symptoms and physical limitations and greater weight loss than placebo at 1 year. (Funded by Novo Nordisk; STEP-HFpEF DM ClinicalTrials.gov number, NCT04916470.).

Relationship between donor ejection fraction, left ventricular wall thickness and mortality in heart transplants recipients.

This study explored the impact of donor left ventricular ejection fraction (EF) and left ventricular wall thickness (LVWT) on mortality among heart transplant (HTx) recipients. Utilizing data from the United Network for Organ Sharing (UNOS) registry, adult HTx recipients between 2006-2022 were analyzed. Patients were categorized into four groups based on donor EF(>50 % or ≤50 %) and LVWT(<1.4 cm or ≥1.4 cm). 21,012 patients were included. There were significant differences in baseline characteristics among the groups. Unadjusted mortality was 6.3 %, 6.0 %, 6.0 %, and 2.4 %(p=0.86) at 30-days; 16.2 %, 13.5 %, 16.8 %, and 7.3 %(p=0.08) at 1-year; and 32.2 %, 29.2 %, 35.4 %, and 29.0 %(p=0.18) at 5-years, respectively. In addition, adjusted mortality did not differ across the groups. There were no significant differences in recipient mortality in groups based on donor EF and LVWT. Expanding the donor selection criteria would allow for increase in the donor pool and assist in decreasing the mortality, while on the waitlist for HTx.

Cardiovascular Complications in Patients with Heart Failure and COVID-19: CARDIO COVID 19-20 Registry.

Since early 2020, different studies have shown an increased prevalence of COVID-19 and poorer prognosis in older adults with cardiovascular comorbidities. This study aimed to assess the impact of heart failure (HF) on cardiovascular complications, intensive care unit (ICU) admissions, and in-hospital mortality in patients hospitalized with COVID-19. The CARDIO COVID 19-20 registry includes 3260 hospitalized patients with a COVID-19 serological diagnosis between May 2020 and June 2021 from Latin American countries. A history of HF was identified in 182 patients (5.6%). In patients with and without previous HF, the incidence of supraventricular arrhythmia was 16.5% vs. 6.3%, respectively (p = 0.001), and that of acute coronary syndrome was 7.1% vs. 2.7%, respectively (p = 0.001). Patients with a history of HF had higher rates of ICU admission (61.5% vs. 53.1%, respectively; p = 0.031) and in-hospital mortality (41.8% vs. 24.5%, respectively; p = 0.001) than patients without HF. Cardiovascular mortality at discharge (42.1% vs. 18.5%, respectively; p < 0.001) and at 30 days post-discharge (66.7% vs. 18.0%, respectively) was higher for patients with a history of HF than for patients without HF. In patients hospitalized with COVID-19, previous history of HF was associated with a more severe cardiovascular profile, with increased risk of cardiovascular complications, and poor in-hospital and 30-day outcomes.

American Registry of Ambulatory or acutely decompensated heart failure (AMERICCAASS Registry): First 1000 patients.

BACKGROUND: About 80% of cardiovascular diseases (including heart failure [HF]) occur in low-income and developing countries. However, most clinical trials are conducted in developed countries. HYPOTHESIS: The American Registry of Ambulatory or Acutely Decompensated Heart Failure (AMERICCAASS) aims to describe the sociodemographic characteristics of HF, comorbidities, clinical presentation, and pharmacological management of patients with ambulatory or acutely decompensated HF in America. METHODOLOGY: Descriptive, observational, prospective, and multicenter registry, which includes patients >18 years with HF in an outpatient or hospital setting. Collected information is stored in the REDCap electronic platform. Quantitative variables are defined according to the normality of the variable using the Shapiro-Wilk test. RESULTS: This analysis includes data from the first 1000 patients recruited. 63.5% were men, the median age of 66 years (interquartile range 56.7-75.4), and 77.6% of the patients were older than 55 years old. The percentage of use of the four pharmacological pillars at the time of recruitment was 70.7% for beta-blockers (BB), 77.4% for angiotensin-converting enzyme inhibitor (ACEI)/angiotensin II receptor blocker (ARB II)/angiotensin receptor-neprilysin inhibitor (ARNI), 56.8% for mineralocorticoid receptor antagonists (MRA), and 30.7% for sodium-glucose cotransporter type-2 inhibitors (SGLT2i). The main cause of decompensation in hospitalized patients was HF progression (64.4%), and the predominant hemodynamic profile was wet-warm (68.3%). CONCLUSIONS: AMERICCAASS is the first continental registry to include hospitalized or outpatient patients with HF. Regarding optimal medical therapy, approximately a quarter of the patients still need to receive BB and ACEI/ARB/ARNI, less than half do not receive MRA, and more than two-thirds do not receive SGLT2i.

Heart Failure at Admission Complicating ST-Elevation Myocardial Infarction in a Middle-Income Country. Experience of the ARGEN-IAM-ST Registry.

Despite advances in the management of ST-elevation myocardial infarction (STEMI), when associated with heart failure (HF) its prognosis remains ominous. This study assessed the differences in admission and mortality of HF complicating STEMI at admission (HFad) in a middle-income country. Data from the National Registry of STEMI of Argentina (ARGEN-IAM-ST) from January 1, 2016, to September 30, 2020, were analyzed. HFad was defined by the identification of Killip/Kimball ≥2 at admission. About 3174 patients were analyzed (22.3% had HFad). Patients with HFad were older, more often women, hypertensive, and diabetic. Received less reperfusion (87.6% vs 92.6%, P < 0.001) and had increased in-hospital mortality (28.4% vs 3.0%, P < 0.001). In multivariate analysis HFad was an independent predictor of death (OR: 4.88 [95%CI: 3.33-7.18], P < 0.001) and reperfusion adjusted to HFad was associated with lower mortality (OR: 0.57 [95%CI: 0.34-0.95], P = 0.03). HFad in STEMI is associated with a worse clinical profile, receives fewer reperfusion strategies, and carries a higher risk of in-hospital mortality while reperfusion reduces mortality.

Latin-American Registry of Cardiovascular Disease and COVID-19: Final Results.

Background: Socioeconomic factors contribute to a more severe impact of COVID-19 in Latin American and Caribbean (LA&C) countries than in developed countries. Patients with a severe or critical illness can develop respiratory and cardiovascular complications. Objective: To describe a LA&C population with COVID-19 to provide information related to this disease, in-hospital cardiovascular complications, and in-hospital mortality. Methods: The CARDIO COVID-19-20 Registry is an observational, multicenter, prospective, and hospital-based registry of patients with confirmed COVID-19 infection that required in-hospital treatment in LA&C. Enrollment of patients started on May 01, 2020, and ended on June 30, 2021. Results: The CARDIO COVID-19-20 Registry included 3260 patients from 44 institutions of 14 LA&C countries. 63.2% patients were male and median age was 61.0 years old. Most common comorbidities were overweight/obesity (49.7%), hypertension (49.0%), and diabetes mellitus (26.7%). Most frequent cardiovascular complications during hospitalization or reported at discharge were cardiac arrhythmia (9.1%), decompensated heart failure (8.5%), and pulmonary embolism (3.9%). The number of patients admitted to the Intensive Care Unit (ICU) was 1745 (53.5%), and median length of their stay at the ICU was 10.0 days. Support required in ICU included invasive mechanical ventilation (34.2%), vasopressors (27.6%), inotropics (10.3%), and vasodilators (3.7%). Rehospitalization after 30-day post discharge was 7.3%. In-hospital mortality and 30-day post discharge were 25.5% and 2.6%, respectively. Conclusions: According to our findings, more than half of the LA&C population with COVID-19 assessed required management in ICU, with higher requirement of invasive mechanical ventilation and vasoactive support, resulting in a high in-hospital mortality and a considerable high 30-day post discharge rehospitalization and mortality.

Semaglutide in Patients With Obesity and Heart Failure Across Mildly Reduced or Preserved Ejection Fraction.

BACKGROUND: Many therapies for heart failure (HF) have shown differential impact across the spectrum of left ventricular ejection fraction (LVEF). OBJECTIVES: In this prespecified analysis, the authors assessed the effects of semaglutide across the baseline LVEF strata in patients with the obesity phenotype of HF with preserved ejection fraction (HFpEF) in the STEP-HFpEF (Semaglutide Treatment Effect in People with obesity and HFpEF) trial. METHODS: STEP-HFpEF randomized 529 patients (263 semaglutide; 266 placebo). For this prespecified analysis, patients were categorized into 3 groups based on LVEF: 45% to 49% (n = 85), 50% to 59% (n = 215), and ≥60% (n = 229). RESULTS: At 52 weeks, semaglutide improved the dual primary endpoints of Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (estimated treatment difference: EF [ejection fraction] 45%-49%: 5.0 points [95% CI: -2.7 to 12.8 points], EF 50%-59%: 9.8 points [95% CI: 5.0 to 14.6 points], and EF ≥60%: 7.4 points [95% CI: 2.8 to 12.0 points]; P interaction = 0.56) and body weight (EF: 45%-49%: -7.6 [95% CI: -10.7 to -4.4], EF 50%-59%: -10.6 [95% CI: -12.6 to -8.6] and EF ≥60%: -11.9 [95% CI: -13.8 to -9.9]; P interaction = 0.08), to a similar extent across LVEF categories. Likewise, LVEF did not influence the benefit of semaglutide on confirmatory secondary endpoints: 6-minute walk distance (P interaction = 0.19), hierarchal composite endpoint (P interaction = 0.43), and high-sensitivity C-reactive protein (P interaction = 0.26); or exploratory endpoint of N-terminal pro-brain natriuretic peptide (P interaction = 0.96). Semaglutide was well-tolerated across LVEF categories. CONCLUSIONS: In patients with HFpEF and obesity, semaglutide 2.4 mg improved symptoms, physical limitations, and exercise function, and reduced inflammation and body weight to a similar extent across LVEF categories. These data support treatment with semaglutide in patients with the obesity phenotype of HFpEF regardless of LVEF. (Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity [STEP-HFpEF]; NCT04788511).

Semaglutide in HFpEF across obesity class and by body weight reduction: a prespecified analysis of the STEP-HFpEF trial.

In the STEP-HFpEF trial, semaglutide improved symptoms, physical limitations and exercise function and reduced body weight in patients with obesity phenotype of heart failure and preserved ejection fraction (HFpEF). This prespecified analysis examined the effects of semaglutide on dual primary endpoints (change in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) and body weight) and confirmatory secondary endpoints (change in 6-minute walk distance (6MWD), hierarchical composite (death, HF events, change in KCCQ-CSS and 6MWD) and change in C-reactive protein (CRP)) across obesity classes I-III (body mass index (BMI) 30.0-34.9 kg m-2, 35.0-39.9 kg m-2 and ≥40 kg m-2) and according to body weight reduction with semaglutide after 52 weeks. Semaglutide consistently improved all outcomes across obesity categories (P value for treatment effects × BMI interactions = not significant for all). In semaglutide-treated patients, improvements in KCCQ-CSS, 6MWD and CRP were greater with larger body weight reduction (for example, 6.4-point (95% confidence interval (CI): 4.1, 8.8) and 14.4-m (95% CI: 5.5, 23.3) improvements in KCCQ-CSS and 6MWD for each 10% body weight reduction). In participants with obesity phenotype of HFpEF, semaglutide improved symptoms, physical limitations and exercise function and reduced inflammation and body weight across obesity categories. In semaglutide-treated patients, the magnitude of benefit was directly related to the extent of weight loss. Collectively, these data support semaglutide-mediated weight loss as a key treatment strategy in patients with obesity phenotype of HFpEF. ClinicalTrials.gov identifier: NCT04788511 .

Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity.

BACKGROUND: Heart failure with preserved ejection fraction is increasing in prevalence and is associated with a high symptom burden and functional impairment, especially in persons with obesity. No therapies have been approved to target obesity-related heart failure with preserved ejection fraction. METHODS: We randomly assigned 529 patients who had heart failure with preserved ejection fraction and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or higher to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. The dual primary end points were the change from baseline in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS; scores range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations) and the change in body weight. Confirmatory secondary end points included the change in the 6-minute walk distance; a hierarchical composite end point that included death, heart failure events, and differences in the change in the KCCQ-CSS and 6-minute walk distance; and the change in the C-reactive protein (CRP) level. RESULTS: The mean change in the KCCQ-CSS was 16.6 points with semaglutide and 8.7 points with placebo (estimated difference, 7.8 points; 95% confidence interval [CI], 4.8 to 10.9; P<0.001), and the mean percentage change in body weight was -13.3% with semaglutide and -2.6% with placebo (estimated difference, -10.7 percentage points; 95% CI, -11.9 to -9.4; P<0.001). The mean change in the 6-minute walk distance was 21.5 m with semaglutide and 1.2 m with placebo (estimated difference, 20.3 m; 95% CI, 8.6 to 32.1; P<0.001). In the analysis of the hierarchical composite end point, semaglutide produced more wins than placebo (win ratio, 1.72; 95% CI, 1.37 to 2.15; P<0.001). The mean percentage change in the CRP level was -43.5% with semaglutide and -7.3% with placebo (estimated treatment ratio, 0.61; 95% CI, 0.51 to 0.72; P<0.001). Serious adverse events were reported in 35 participants (13.3%) in the semaglutide group and 71 (26.7%) in the placebo group. CONCLUSIONS: In patients with heart failure with preserved ejection fraction and obesity, treatment with semaglutide (2.4 mg) led to larger reductions in symptoms and physical limitations, greater improvements in exercise function, and greater weight loss than placebo. (Funded by Novo Nordisk; STEP-HFpEF ClinicalTrials.gov number, NCT04788511.).

Risk stratification, prognosis, and survival in a pulmonary arterial hypertension cohort in Latin America. A multicenter study.

BACKGROUND: Pulmonary arterial hypertension (PAH) guidelines suggest that achieving a low-risk profile should be the treatment goal. Our aim was to assess a risk assessment strategy based on three non-invasive variables from the ESC/ERS 2015 guidelines in a Latin American cohort. METHODS: 92 incident patients (mean [SD] age 47, 77% female, 53% idiopathic PAH) were included in this retrospective, multicenter study. Patients were stratified at baseline and at early follow-up, within the first year, using three non-invasive variables (WHO functional class, 6-minute walking distance, BNP/NT-proBNP) from the ESC/ERS 2015 risk assessment instrument. Median (IQR) follow-up was 3.11 years (3.01 years). RESULTS: At baseline assessment, 25% of patients were at low risk, 61.9% at intermediate-risk, and 13% at high-risk. At early follow-up (median 9.5 months), 56.5% of patients were at low-risk, 40.2% at intermediate-risk, and 3.2% at high-risk (p<0.001 vs. baseline). According to risk stratification at early follow-up, one, three and five-year overall survival was 100% in the low-risk group (no deaths at five-year follow-up), and 100%, 84% (95% CI: 72-98%), and 66% (95% CI: 48-90%) respectively in the intermediate-risk group, p = 0.0003. Mortality in the high-risk patients at early follow-up was 1/3 (33.3%). One, three, and five-year event-free survival (death or transplant or first hospitalization due to worsening PAH) based on early follow-up risk assessment was higher in the low-risk group, p = 0.0003. CONCLUSION: Our study validates a risk assessment strategy based on three non-invasive variables and confirms that early achievement of a low-risk profile should be the treatment goal.

Clinical characteristics and evolution of patients with cardiogenic shock in Argentina in the context of an acute myocardial infarction with ST segment elevation. Data from the nationwide ARGEN-IAM-ST Registry.

Cardiogenic Shock is one of the main causes of death in ST segment Elevation Myocardial Infarction. To know the clinical characteristics, in-hospital evolution and mortality of patients with Cardiogenic Shock. Patients enrolled in the ARGEN-IAM-ST Registry were analyzed. Predictors of Cardiogenic Shock and death during hospital stay were established. A total of 6122 patients were admitted between 2015 and 2022. Cardiogenic Shock was present in 10.75% of cases. Patients with CS were older (64.5 vs 60 years), more females (41% vs 36%), with more antecedents of infarction and a higher prevalence of anterior location of infarction and multivessel disease. They were also less revascularized (88.5% vs 91.5%) and had a higher incidence of failed angioplasty (15.7% vs 2.7%). They also evidenced a higher occurrence of mechanical complications (6.8% vs 0.4%), ischemic recurrence (7.4% vs 3.4%) and cardiac arrest on admission (44.8% vs 2.6%). All the differences described showed statistical significance with P < 0.05. Overall mortality was 58% in contrast to 2.77% in patients without Cardiogenic Shock (P < 0.001). Only age, DBT, and early cardiac arrest were independent predictors of shock on admission whereas age, female gender, cardiac arrest on admission and failed angioplasty were independent predictors of death. One out of 10 patients with ST Elevation Myocardial Infarction presented cardiogenic shock. Its clinical characteristics were similar to those described more than 20 years ago. Despite a high use of reperfusion strategy cardiogenic shock continues to have a very high mortality Argentina.

Insuficiencia cardíaca crónica en Argentina. OFFICE IC AR, un registro conjunto de la Sociedad Argentina de Cardiología y de la Federación Argentina de Cardiología / Chronic Heart Failure in Argentina. OFFICE IC AR, a joint registry of the Argentine Society of Cardiology and the Argentine Federation of Cardiology

RESUMEN Introducción: Diferentes registros argentinos de insuficiencia cardíaca crónica (ICC) fueron generados en los últimos 25 años, en forma individual por la Sociedad Argentina de Cardiología (SAC) y la Federación Argentina de Cardiología (FAC), con diversa representatividad. Los últimos datos conocidos datan de 2013. El Registro OFFICE IC AR fue encarado en forma conjunta por la SAC y la FAC para conocer la realidad de la ICC en Argentina. Objetivos: Describir en forma amplia y comprensiva las características salientes de la ICC en Argentina, incluyendo las características de los pacientes, el uso de recursos diagnósticos y terapéuticos, la adherencia a las guías de práctica y el pronóstico a mediano y largo plazo. Material y Métodos: Estudio prospectivo de cohorte, de pacientes con ICC de al menos 6 meses de evolución, alejados de una internación por al menos 3 meses. Se recabaron datos clínicos y paraclínicos. Los pacientes fueron categorizados, de acuerdo a la fracción de eyección ventricular izquierda (FEVI), en IC con FE reducida, ICFER (≤40%); IC con FE en el rango medio, ICFErm, ahora denominada IC con FE levemente reducida, ICFElr (41%-49%), e IC con FE preservada, ICFEP (≥50%). En seguimiento de al menos 1 año se registró la incidencia de hospitalización por insuficiencia cardíaca (HIC), muerte cardiovascular (MCV) y muerte de todas las causas (MTC) Resultados: Entre noviembre de 2017 y enero de 2020, 100 cardiólogos de todo el país incluyeron 1004 pacientes con ICC; edad media 65,8 ± 12,4 años, 74,6% hombres, FEVI conocida en el 93,8%. El 68,4% tenía ICFER, el 16% ICFElr y el 15,6% ICFEP. Hubo alta prevalencia de comorbilidades, incluyendo diabetes y anemia en el 30%, e insuficiencia renal crónica en el 22%. Fue elevada la utilización de antagonistas neurohormonales (ANH): 89,5% betabloqueantes; 57,3% inhibidores o antagonistas del sistema renina angiotensina, 28,9% sacubitril valsartán y 78,6% antialdosterónicos. En 69% se utilizó triple terapia. Su empleo fue mayor en la ICFER, pero elevado incluso en la ICFEP. En una mediana de seguimiento de 1,7 años la incidencia anual de MCV/HIC fue 12,8%, la de MCV 6,6% y la de MTC 8,4%, sin diferencia entre las distintas categorías de FEVI. Conclusiones: En el primer registro conjunto de ICC SAC-FAC se verificó elevada prevalencia de ICFER, alta prevalencia de comorbilidades, uso frecuente de ANH y pronóstico acorde a los registros internacionales.

ABSTRACT Background: Several Argentine registries on chronic heart failure (CHF) have been generated over the past 25 years, either individually by the Argentine Society of Cardiology (SAC) or the Argentine Federation of Cardiology (FAC), with different representativeness. The last known data are from 2013. The OFFICE IC AR registry was jointly undertaken by the SAC and FAC to know the reality of CHF in Argentina. Objective: The aim of this registry was to extensively and comprehensively describe the outstanding characteristics of CHF in Argentina, including patient characteristics, use of diagnostic and therapeutic resources, adherence to practice guidelines and mid-and long-term prognosis. Methods: This was a prospective cohort study of patients with at least 6-month evolution CHF and not hospitalized for at least the past 3 months. Clinical and paraclinical data were collected. Patients were categorized according to left ventricular ejection fraction (LVEF), into HF with reduced EF, HFrEF (≤40 %), HF with midrange EF, now termed HF with mildly reduced EF, HFmrEF (41%-49%), and HF with preserved EF, HFpEF (≥50%). The incidence of hospitalization for HF (HHF), cardiovascular mortality (CVM) and all-cause mortality (ACM) was recorded for at least 1-year follow-up. Results: Between November 2017 and January 2020, 100 cardiologists from all over the country included 1004 patients with CHF. Mean age was 65.8 ± 12.4 years, 74.6% were men, and 93.8% had known LVEF. In 68.4% of cases, patients had HFrEF, 16% HFmrEF and 15.6% HFpEF. A high prevalence of comorbidities was found, including diabetes and anemia in 30% of cases, and chronic renal failure in 22%. There was high use of neurohormonal antagonists (NHA): 89.5% betablockers, 57.3% renin-angiotensin system inhibitors or antagonists, 28.9% sacubitril-valsartan and 78.6% aldosterone antagonists. Triple therapy was used in 69% of patients, with higher prescription in HFrEF, but elevated even on HFpEF. At a median follow-up of 1.7 years, the annual incidence of CVM/HHF was 12.8%, CVM 6.6% and ACM 8.4%, without statistical differences between the different LVEF categories. Conclusions: This first SAC-FAC joint CHF registry verified a high prevalence of HFrEF, a high prevalence of comorbidities, frequent use of NHA and prognosis according to international registries.

Valor pronóstico del índice de shock en el infarto de miocardio. Datos del Registro Argentino de infarto con elevación del segmento ST (ARGEN IAM-ST) / Prognostic value of the shock index in myocardial infarction. Data from Argentine Registry of ST-segment elevation infarct (ARGEN IAM-ST)

Resumen El índice de shock (IS) se obtiene mediante un cálculo simple del cociente entre la frecuencia cardíaca (FC) y la tensión arterial sistólica (PAS) (IS: FC/TAS) y el índice de shock ajustado por edad (ISA) multiplicando el IS x edad. Evaluamos su valor predictivo para el evento combinado intrahospitalario (EC) muerte y/o shock cardiogénico (SC) y de los eventos individuales en los pacientes incluidos en el registro argentino de infarto con elevación del segmento ST (ARGEN-IAM-ST). Se excluyeron 248 con SC de ingreso. Se realizaron curvas ROC para ambos índices utilizando el mejor punto de corte para dicotomizar la población. Se incluyeron 2928 pacientes. Edad (mediana) 60 años (RIC 25-75% 53-68), varones 80%, EC: 6.4%. Un 30.5% tuvo IS ≥ 0.67 y éstos presentaron mayor incidencia de EC: 11% vs. 4% (p < 0.001), shock cardiogénico (8% vs. 2.6%, p <0.0001) y muerte (7.3% vs. 3%, p < 0.0001) que los pacientes con IS < 0.67. Un 28% tuvo ISA ≥ 41.5. Estos presentaron más EC: 14% vs. 3%, p < 0.001, SC: 10% vs. 2%, (p < 0.001) y muerte: 9.5% vs. 2.3%, (p < 0.001) comparados con los pacientes con valores ISA < 41.5. El área bajo la curva ROC del ISA para EC fue significativamente mejor que la del IS (0.72 vs. 0.62, p < 0.001).En los modelos de análisis multivariados reali zados, el IS tuvo un OR de 2.56 (IC95% 1.56-4.02; p < 0.001) y el ISA de 3.43 (IC95% 2.08-5.65; p<0.001) para EC. El IS y el ISA predicen muerte y/o el desarrollo de shock cardiogénico intrahospitalario en una población no seleccionada de infartos con elevación del ST.

Abstract The shock index (IS) is the quotient between the heart rate (HR) and the systolic blood pressure (SBP) (IS: HR / SBT), and the age-adjusted shock index (ISA) multiplying the IS by age. We evaluated its predictive value for the combined in-hospital event (EC), death and / or cardiogenic shock (CS) and for individual events in the patients included in the Argentine registry of ST-segment elevation infarction (ARGEN-ST-AMI); 248 with CS on admission were excluded. ROC curves were made for both indices using the best cut-off point to dichotomize the population. The analysis included 2928 subjects. Age (median) 60 years (IQR 25-75% 53-68), men 80%, EC: 6.4%; 30.5% had IS ≥ 0.67, and they had a higher incidence of EC: 11% vs. 4% (p < 0.001), cardiogenic shock (8% vs. 2.6%, p <0.0001) and death (7.3% vs. 3%), p <0.0001) than patients with IS < 0.67. A 28% had ISA ≥ 41.5. These presented plus EC: 14% vs. 3%, p < 0.001, SC: 10% vs. 2%, (p < 0.001) and death: 9.5% vs. 2.3%, (p < 0.001) compared with patients with values < 41.5. The area under the ROC curve of the ISA for EC was significantly better than that of the IS (0.72 vs. 0.62, p < 0.001). In the multivariate analysis models performed, the IS had an OR: 2.56 (95% CI 1.56-4.02; p < 0.001) and the ISA: 3.43 (95% CI 2.08-5.65; p < 0.001) for EC. The IS and ISA predict death and / or the development of in-hospital cardiogenic shock in an unselected population of ST elevation infarcts.

[Prognostic value of the shock index in myocardial infarction. Data from Argentine Registry of ST-segment elevation infarct (ARGEN IAM-ST)]. / Valor pronóstico del índice de shock en el infarto de miocardio. Datos del Registro Argentino de infarto con elevación del segmento ST (ARGEN IAM-ST).

The shock index (IS) is the quotient between the heart rate (HR) and the systolic blood pressure (SBP) (IS: HR / SBT), and the age-adjusted shock index (ISA) multiplying the IS by age. We evaluated its predictive value for the combined in-hospital event (EC), death and / or cardiogenic shock (CS) and for individual events in the patients included in the Argentine registry of ST-segment elevation infarction (ARGEN-ST-AMI); 248 with CS on admission were excluded. ROC curves were made for both indices using the best cut-off point to dichotomize the population. The analysis included 2928 subjects. Age (median) 60 years (IQR 25-75% 53-68), men 80%, EC: 6.4%; 30.5% had IS = 0.67, and they had a higher incidence of EC: 11% vs. 4% (p < 0.001), cardiogenic shock (8% vs. 2.6%, p <0.0001) and death (7.3% vs. 3%), p <0.0001) than patients with IS < 0.67. A 28% had ISA = 41.5. These presented plus EC: 14% vs. 3%, p < 0.001, SC: 10% vs. 2%, (p < 0.001) and death: 9.5% vs. 2.3%, (p < 0.001) compared with patients with values < 41.5. The area under the ROC curve of the ISA for EC was significantly better than that of the IS (0.72 vs. 0.62, p < 0.001). In the multivariate analysis models performed, the IS had an OR: 2.56 (95% CI 1.56-4.02; p < 0.001) and the ISA: 3.43 (95% CI 2.08-5.65; p < 0.001) for EC. The IS and ISA predict death and / or the development of in-hospital cardiogenic shock in an unselected population of ST elevation infarcts.

El índice de shock (IS) se obtiene mediante un cálculo simple del cociente entre la frecuencia cardíaca (FC) y la tensión arterial sistólica (PAS) (IS: FC/TAS) y el índice de shock ajustado por edad (ISA) multiplicando el IS x edad. Evaluamos su valor predictivo para el evento combinado intrahospitalario (EC) muerte y/o shock cardiogénico (SC) y de los eventos individuales en los pacientes incluidos en el registro argentino de infarto con elevación del segmento ST (ARGEN-IAM-ST). Se excluyeron 248 con SC de ingreso. Se realizaron curvas ROC para ambos índices utilizando el mejor punto de corte para dicotomizar la población. Se incluyeron 2928 pacientes. Edad (mediana) 60 años (RIC 25-75% 53-68), varones 80%, EC: 6.4%. Un 30.5% tuvo IS = 0.67 y éstos presentaron mayor incidencia de EC: 11% vs. 4% (p < 0.001), shock cardiogénico (8% vs. 2.6%, p <0.0001) y muerte (7.3% vs. 3%, p < 0.0001) que los pacientes con IS < 0.67. Un 28% tuvo ISA = 41.5. Estos presentaron más EC: 14% vs. 3%, p < 0.001, SC: 10% vs. 2%, (p < 0.001) y muerte: 9.5% vs. 2.3%, (p < 0.001) comparados con los pacientes con valores ISA < 41.5. El área bajo la curva ROC del ISA para EC fue significativamente mejor que la del IS (0.72 vs. 0.62, p < 0.001).En los modelos de análisis multivariados realizados, el IS tuvo un OR de 2.56 (IC95% 1.56-4.02; p < 0.001) y el ISA de 3.43 (IC95% 2.08-5.65; p <0.001) para EC. El IS y el ISA predicen muerte y/o el desarrollo de shock cardiogénico intrahospitalario en una población no seleccionada de infartos con elevación del ST.

PULSE-HF: A Simple Clinical and Geriatric Score to Predict Systolic Dysfunction in the Elderly Without Heart Failure.

To develop a clinical score to determine preclinical predictors of systolic dysfunction in an outpatient elderly population without a diagnosis of heart failure (HF). PULSE-HF is a cross-sectional study in elderly at-risk (coronary artery disease, diabetes or hypertension) outpatients without a diagnosis of heart failure (HF). The objective in this population was to develop a clinical score to determine preclinical predictors of systolic dysfunction. Clinical and geriatric variables were analyzed; independent predictive factors in the logistic regression analysis were included for the score calculation. Of the 722 subjects enrolled, 47 (6.5%) had a left ventricular ejection fraction (LVEF) < 50%, and 15 (2.1%) a LVEF < 40%. Mean age was 76.5 years (5.18) and 445 (61.6%) were female. Multiple logistic regression analysis identified abnormal Q waves (odds ratio [OR]: 4.36; P = 0.003), cardiomegaly (OR: 3.32; P < 0.001), right bundle branch block (OR: 2.84; P = 0.011), cognitive dysfunction (OR: 2.14; P = 0.027) and NT-proBNP (OR 5.43; P < 0.001) as independent predictors of LVEF < 50%. Two prediction scores were built, without and with NT-proBNP inclusion; the area under ROC curves were 0.70 and 0.76, respectively. As the score increased, the sensitivity decreases but increases specificity, and accuracy (97.17% and 91.64% respectively in ≥6 points). NT-proBNP was associated with an increment in the performance (accuracy of 93.18% for score ≥10). We conclude that a simple score using clinical information might be useful to predicting asymptomatic systolic dysfunction in the elderly.

[Relevance of right ventricle in the clinical management of pulmonary arterial hypertension]. / Manejo clínico de la hipertensión arterial pulmonar. Relevancia del ventrículo derecho.

Pulmonary arterial hypertension (PAH) requires structured processes of diagnosis and risk stratification, being the function of the right ventricle (RV) a hallmark prognosis determinant. The main therapeutic goals in PAH are to improve and try to revert RV dysfunction and maintaining a low risk. Currently, there are multiple treatments with different mechanisms of action, the combination of which in double or triple therapy has shown improved results compared to monotherapy. Recent clinical evidence shows the importance of early incorporation of parenteral prostanoids to the scheme, improving RV function and survival. In this review, we discuss the role of the RV function in the diagnosis, prognosis, and follow-up of PAH. We recommend the systematic and standardised evaluation of the RV as well as the early initiation of combined treatment in cases of intermediatehigh risk to try to reach and keep the patient with PAH at a low risk and / or avoid the progression of PAH.

La hipertensión arterial pulmonar (HAP) requiere procesos estructurados de diagnóstico y estratificación de riesgo, siendo la función del ventrículo derecho (VD) un marcador pronóstico central. Los principales objetivos terapéuticos en la HAP son mejorar y/o intentar revertir la disfunción del VD y mantener condición de bajo riesgo. Actualmente existen múltiples fármacos con diferentes mecanismos de acción cuya combinación en doble o triple terapia ha mostrado mejores resultados que la monoterapia. Evidencia actual demuestra la importancia de incorporar tempranamente prostanoides parenterales al esquema, mejorando la funcionalidad del VD y la supervivencia. En esta revisión se refleja el papel de la función del VD en el diagnóstico, pronóstico y seguimiento de la HAP. Se recomienda la evaluación sistemática y estandarizada del VD, así como el inicio temprano de tratamiento combinado en riesgo intermedio-alto para obtener las metas de alcanzar y mantener un riesgo bajo y/o evitar la progresión de la HAP.