Inferior vena CAVA and lung ultraSound-guided therapy in acute heart failure: A randomized pilot study (CAVAL US-AHF study).

BACKGROUND: The optimal assessment of systemic and lung decongestion during acute heart failure is not clearly defined. We evaluated whether inferior vena cava (IVC) and pulmonary ultrasound (CAVAL US) guided therapy is superior to standard care in reducing subclinical congestion at discharge in patients with AHF. METHODS: CAVAL US-AHF was an investigator-initiated, single-center, single-blind, randomized controlled trial. A daily quantitative ultrasound protocol using the 8-zone method was used and treatment was adjusted according to an algorithm. The primary endpoint was the presence of more than 5 B-lines and/or an increase in IVC diameter and collapsibility at discharge. And secondary endpoint exploratory outcome was the composite of readmission for HF, unplanned visit for worsening HF or death at 90 days RESULTS: Sixty patients were randomized to CAVAL US (n = 30) or control (n = 30). The primary endpoint was achieved in 4 patients (13.3%) in the CAVAL US group and 20 patients (66.6%) in the control group (P < .001). A significant reduction in HF readmission, unplanned visit for worsening HF or death at 90 days was seen in the CAVAL US group (13.3% vs 36.7%; log rank P = .038). Other endpoints such as NT-proBNP reduction at discharge showed a nonstatistically significant reduction in the CAVAL US group (48% IQR 27-67 vs 37% -3-59; P = .09). Safety outcomes were similar in both groups. CONCLUSION: IVC and lung ultrasound-guided therapy in AHF patients significantly reduced subclinical congestion at discharge. CAVAL US-AHF provides preliminary evidence for the potential use of a simple technique to guide decongestive therapy during hospitalization for AHF, which may reduce the composite outcome at 90 days.

Impact of a dedicated radial lounge on same-day discharge percutaneous coronary intervention.

BACKGROUND: The same-day discharge (SDD) program after elective percutaneous coronary intervention (PCI) is a safe strategy that allows for the optimization of hospital resources. However, the lack of adequate infrastructure and a specially targeted care model may limit its implementation. Our center developed an outpatient care model based on an area designed for percutaneous procedures called radial lounge (RL). AIMS: Evaluate the efficacy and safety of the RL care model: (1) SDD rate, (2) patient experience, (3) major adverse cardiac events (MACEs) (in-hospital, 30-day, and 1-year mortality and intervention), and (4) vascular access complication. SECONDARY OBJECTIVE:  Impact of RL SDD rate on total elective SDD-PCI volume. METHODS: We conducted a retrospective observational cohort study at a cardiovascular hospital, including consecutive patients undergoing elective PCI between 2015 and 2022 who were admitted to the conventional hospitalization area (CHA) or the RL about the stated objectives. Patient experience was assessed using the Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. RESULTS: A total of 5466 elective PCI procedures were included: 2102 in the RL and 3364 in the CHA. The SDD rate was 85.2% in the RL group and 54% in the CHA. After the implementation of RL, a significant increase in the volume of elective SDD-PCI was observed and patient satisfaction improved significantly (p < 0.005) with CHA. Finally, a greater amount of MACEs were not observed in the RL. CONCLUSIONS: The PCI program in RL proved to be safe and effective. It showed a higher rate of SDD and a significant improvement in patient experience was observed without affecting safety.

Does high sensitivity troponin add prognostic value to validated risk scores to predict in-hospital mortality in patients with acute heart failure?

Troponin elevation correlates with an increased short and long-term mortality in patients with acute decompensated heart failure (AHF). However, it has not been included in the development of multiple validated predictive models of mortality. We aim to  determine whether the addition of high-sensitivity troponin T (hs-TnT) to clinical risk scores improves the prediction of in-hospital mortality in patients with AHF. A retrospective analysis of a prospective and consecutive cohort was performed. Adult patients hospitalized between 2015 and 2019 with a primary diagnosis of AHF were included. Hs-TnT was measured on admission. OPTIMIZE-HF, GWTG-HF, and ADHERE risks score were calculated for each patient. The primary endpoint was all-cause in-hospital mortality. Discrimination of isolated hs-TnT and the risk scores with and without the addition of hs-TnT were evaluated using the area under the ROC curve (AUC-ROC). A subanalysis was performed according to left ventricular ejection fraction (LVEF). Of 712 patients, 562 (79%) had hs-TnT measurement upon admission, and was elevated in 91%. In-hospital mortality was 8.7% (n = 49). The AUC-ROC was 0.70 (95% CI 0.63-0.77) for isolated hs-TnT, and 0.80 (0.74-0.87), 0.79 (0.72 -0.86) and 0.79 (0.71-0.86) for the OPTIMIZE-HF, GWTG-HF and ADHERE scores, respectively. The addition of hs-TnT to the models did not increase the AUC: 0.72 (0.66-0.79) for the OPTIMIZE-HF + hs-TnT score (difference between AUC - 0.08 p = 0.04), 0.74 (0.68-0.80) for GWTG-HF (difference between AUC-0.04, p = 0.2) and 0.7 (0.63-0.77) for ADHERE (difference between AUC - 0.085 p = 0.07). The models presented good calibration (p > 0.05). In the sub-analysis, no differences were found between risk scores with the addition of hs-TnT in the population with LVEF < 40% and ≥ 40%. Elevated hs-TnT on admission was frequent and its incorporation into the validated risk scores did not prove an incremental prognostic benefit in patients hospitalized for AHF, regardless of LVEF. Isolated hs-TnT had a modest ability to predict hospital mortality. Additional prospective studies are needed to validate these findings.

Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial.

BACKGROUND: Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. METHODS: In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. FINDINGS: Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55-0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55-1·53; p=0·76). INTERPRETATION: Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication [corrected]. FUNDING: Boehringer Ingelheim and Canadian Institutes of Health Research.

Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial.

BACKGROUND: The relative contributions of intraoperative and postoperative hypotension to perioperative morbidity remain unclear. We determined the association between hypotension and a composite of 30-day myocardial infarction and death over three periods: (1) intraoperative, (2) remaining day of surgery, and (3) during the initial four postoperative days. METHODS: This was a substudy of POISE-2, a 10,010-patient factorial-randomized trial of aspirin and clonidine for prevention of myocardial infarction. Clinically important hypotension was defined as systolic blood pressure less than 90 mmHg requiring treatment. Minutes of hypotension was the exposure variable intraoperatively and for the remaining day of surgery, whereas hypotension status was treated as binary variable for postoperative days 1 to 4. We estimated the average relative effect of hypotension across components of the composite using a distinct effect generalized estimating model, adjusting for hypotension during earlier periods. RESULTS: Among 9,765 patients, 42% experienced hypotension, 590 (6.0%) had an infarction, and 116 (1.2%) died within 30 days of surgery. Intraoperatively, the estimated average relative effect across myocardial infarction and mortality was 1.08 (98.3% CI, 1.03, 1.12; P < 0.001) per 10-min increase in hypotension duration. For the remaining day of surgery, the odds ratio was 1.03 (98.3% CI, 1.01, 1.05; P < 0.001) per 10-min increase in hypotension duration. The average relative effect odds ratio was 2.83 (98.3% CI, 1.26, 6.35; P = 0.002) in patients with hypotension during the subsequent four days of hospitalization. CONCLUSIONS: Clinically important hypotension-a potentially modifiable exposure-was significantly associated with a composite of myocardial infarction and death during each of three perioperative periods, even after adjustment for previous hypotension.

Clonidine in patients undergoing noncardiac surgery.

BACKGROUND: Marked activation of the sympathetic nervous system occurs during and after noncardiac surgery. Low-dose clonidine, which blunts central sympathetic outflow, may prevent perioperative myocardial infarction and death without inducing hemodynamic instability. METHODS: We performed a blinded, randomized trial with a 2-by-2 factorial design to allow separate evaluation of low-dose clonidine versus placebo and low-dose aspirin versus placebo in patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery. A total of 10,010 patients at 135 centers in 23 countries were enrolled. For the comparison of clonidine with placebo, patients were randomly assigned to receive clonidine (0.2 mg per day) or placebo just before surgery, with the study drug continued until 72 hours after surgery. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: Clonidine, as compared with placebo, did not reduce the number of primary-outcome events (367 and 339, respectively; hazard ratio with clonidine, 1.08; 95% confidence interval [CI], 0.93 to 1.26; P=0.29). Myocardial infarction occurred in 329 patients (6.6%) assigned to clonidine and in 295 patients (5.9%) assigned to placebo (hazard ratio, 1.11; 95% CI, 0.95 to 1.30; P=0.18). Significantly more patients in the clonidine group than in the placebo group had clinically important hypotension (2385 patients [47.6%] vs. 1854 patients [37.1%]; hazard ratio 1.32; 95% CI, 1.24 to 1.40; P<0.001). Clonidine, as compared with placebo, was associated with an increased rate of nonfatal cardiac arrest (0.3% [16 patients] vs. 0.1% [5 patients]; hazard ratio, 3.20; 95% CI, 1.17 to 8.73; P=0.02). CONCLUSIONS: Administration of low-dose clonidine in patients undergoing noncardiac surgery did not reduce the rate of the composite outcome of death or nonfatal myocardial infarction; it did, however, increase the risk of clinically important hypotension and nonfatal cardiac arrest. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.).

Aspirin in patients undergoing noncardiac surgery.

BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P=0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P=0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.).

Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery.

IMPORTANCE: Little is known about the relationship between perioperative high-sensitivity troponin T (hsTnT) measurements and 30-day mortality and myocardial injury after noncardiac surgery (MINS). OBJECTIVE: To determine the association between perioperative hsTnT measurements and 30-day mortality and potential diagnostic criteria for MINS (ie, myocardial injury due to ischemia associated with 30-day mortality). DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort study of patients aged 45 years or older who underwent inpatient noncardiac surgery and had a postoperative hsTnT measurement. Starting in October 2008, participants were recruited at 23 centers in 13 countries; follow-up finished in December 2013. EXPOSURES: Patients had hsTnT measurements 6 to 12 hours after surgery and daily for 3 days; 40.4% had a preoperative hsTnT measurement. MAIN OUTCOMES AND MEASURES: A modified Mazumdar approach (an iterative process) was used to determine if there were hsTnT thresholds associated with risk of death and had an adjusted hazard ratio (HR) of 3.0 or higher and a risk of 30-day mortality of 3% or higher. To determine potential diagnostic criteria for MINS, regression analyses ascertained if postoperative hsTnT elevations required an ischemic feature (eg, ischemic symptom or electrocardiography finding) to be associated with 30-day mortality. RESULTS: Among 21 842 participants, the mean age was 63.1 (SD, 10.7) years and 49.1% were female. Death within 30 days after surgery occurred in 266 patients (1.2%; 95% CI, 1.1%-1.4%). Multivariable analysis demonstrated that compared with the reference group (peak hsTnT <5 ng/L), peak postoperative hsTnT levels of 20 to less than 65 ng/L, 65 to less than 1000 ng/L, and 1000 ng/L or higher had 30-day mortality rates of 3.0% (123/4049; 95% CI, 2.6%-3.6%), 9.1% (102/1118; 95% CI, 7.6%-11.0%), and 29.6% (16/54; 95% CI, 19.1%-42.8%), with corresponding adjusted HRs of 23.63 (95% CI, 10.32-54.09), 70.34 (95% CI, 30.60-161.71), and 227.01 (95% CI, 87.35-589.92), respectively. An absolute hsTnT change of 5 ng/L or higher was associated with an increased risk of 30-day mortality (adjusted HR, 4.69; 95% CI, 3.52-6.25). An elevated postoperative hsTnT (ie, 20 to <65 ng/L with an absolute change ≥5 ng/L or hsTnT ≥65 ng/L) without an ischemic feature was associated with 30-day mortality (adjusted HR, 3.20; 95% CI, 2.37-4.32). Among the 3904 patients (17.9%; 95% CI, 17.4%-18.4%) with MINS, 3633 (93.1%; 95% CI, 92.2%-93.8%) did not experience an ischemic symptom. CONCLUSIONS AND RELEVANCE: Among patients undergoing noncardiac surgery, peak postoperative hsTnT during the first 3 days after surgery was significantly associated with 30-day mortality. Elevated postoperative hsTnT without an ischemic feature was also associated with 30-day mortality.

Myocardial injury after noncardiac surgery: a large, international, prospective cohort study establishing diagnostic criteria, characteristics, predictors, and 30-day outcomes.

BACKGROUND: Myocardial injury after noncardiac surgery (MINS) was defined as prognostically relevant myocardial injury due to ischemia that occurs during or within 30 days after noncardiac surgery. The study's four objectives were to determine the diagnostic criteria, characteristics, predictors, and 30-day outcomes of MINS. METHODS: In this international, prospective cohort study of 15,065 patients aged 45 yr or older who underwent in-patient noncardiac surgery, troponin T was measured during the first 3 postoperative days. Patients with a troponin T level of 0.04 ng/ml or greater (elevated "abnormal" laboratory threshold) were assessed for ischemic features (i.e., ischemic symptoms and electrocardiography findings). Patients adjudicated as having a nonischemic troponin elevation (e.g., sepsis) were excluded. To establish diagnostic criteria for MINS, the authors used Cox regression analyses in which the dependent variable was 30-day mortality (260 deaths) and independent variables included preoperative variables, perioperative complications, and potential MINS diagnostic criteria. RESULTS: An elevated troponin after noncardiac surgery, irrespective of the presence of an ischemic feature, independently predicted 30-day mortality. Therefore, the authors' diagnostic criterion for MINS was a peak troponin T level of 0.03 ng/ml or greater judged due to myocardial ischemia. MINS was an independent predictor of 30-day mortality (adjusted hazard ratio, 3.87; 95% CI, 2.96-5.08) and had the highest population-attributable risk (34.0%, 95% CI, 26.6-41.5) of the perioperative complications. Twelve hundred patients (8.0%) suffered MINS, and 58.2% of these patients would not have fulfilled the universal definition of myocardial infarction. Only 15.8% of patients with MINS experienced an ischemic symptom. CONCLUSION: Among adults undergoing noncardiac surgery, MINS is common and associated with substantial mortality.

Prevalence and Burden of Carotid and Femoral Atherosclerosis in Subjects Without Known Cardiovascular Disease in a Large Community Hospital in South-America.

INTRODUCTION: Clinical guidelines recommend measurement of arterial (carotid and femoral) plaque burden by vascular ultrasound (VUS) as a risk modifier in individuals at low or moderate risk without known atherosclerotic cardiovascular disease (ASCVD). AIM: To evaluate the prevalence of carotid and femoral plaques by age and sex, the burden of subclinical atherosclerosis (SA), and its association with classic CVRF in subjects over 30 years of age without ASCVD. METHODS: We prospectively enrolled 5775 consecutive subjects referred for cardiovascular evaluation and determined the prevalence and burden of SA using 2D-VUS in carotid and femoral arteries. RESULTS: Sixty-one percent were men with a mean age of 51.3 (SD 10.6) years. Overall, plaque prevalence was 51% in carotid arteries, 39.3% in femoral arteries, 62.4% in carotid or femoral arteries, and 37.6% in neither. The prevalence of plaques and SA burden showed an increasing trend with age, being higher in men than in women and starting before the age of 40, both in the carotid and femoral sites. There was also an increasing prevalence of plaques according to the number of CVRF, and interestingly we found a high prevalence of plaques in subjects with 0 or 1 classic CVRF. CONCLUSIONS: We observed an increased prevalence and burden of carotid or femoral SA, higher in men, beginning before the fourth decade of life and increasing with age. Despite a significant association with classic CVRF, a significant number of subjects with low CVRF were diagnosed with SA.

Association between postoperative troponin levels and 30-day mortality among patients undergoing noncardiac surgery.

CONTEXT: Of the 200 million adults worldwide who undergo noncardiac surgery each year, more than 1 million will die within 30 days. OBJECTIVE: To determine the relationship between the peak fourth-generation troponin T (TnT) measurement in the first 3 days after noncardiac surgery and 30-day mortality. DESIGN, SETTING, AND PARTICIPANTS: A prospective, international cohort study that enrolled patients from August 6, 2007, to January 11, 2011. Eligible patients were aged 45 years and older and required at least an overnight hospital admission after having noncardiac surgery. MAIN OUTCOME MEASURES: Patients' TnT levels were measured 6 to 12 hours after surgery and on days 1, 2, and 3 after surgery. We undertook Cox regression analysis in which the dependent variable was mortality until 30 days after surgery, and the independent variables included 24 preoperative variables. We repeated this analysis, adding the peak TnT measurement during the first 3 postoperative days as an independent variable and used a minimum P value approach to determine if there were TnT thresholds that independently altered patients' risk of death. RESULTS: A total of 15,133 patients were included in this study. The 30-day mortality rate was 1.9% (95% CI, 1.7%-2.1%). Multivariable analysis demonstrated that peak TnT values of at least 0.02 ng/mL, occurring in 11.6% of patients, were associated with higher 30-day mortality compared with the reference group (peak TnT ≤ 0.01 ng/mL): peak TnT of 0.02 ng/mL (adjusted hazard ratio [aHR], 2.41; 95% CI, 1.33-3.77); 0.03 to 0.29 ng/mL (aHR, 5.00; 95% CI, 3.72-6.76); and 0.30 ng/mL or greater (aHR, 10.48; 95% CI, 6.25-16.62). Patients with a peak TnT value of 0.01 ng/mL or less, 0.02, 0.03-0.29, and 0.30 or greater had 30-day mortality rates of 1.0%, 4.0%, 9.3%, and 16.9%, respectively. Peak TnT measurement added incremental prognostic value to discriminate those likely to die within 30 days for the model with peak TnT measurement vs without (C index = 0.85 vs 0.81; difference, 0.4; 95% CI, 0.2-0.5; P < .001 for difference between C index values). The net reclassification improvement with TnT was 25.0% (P < .001). CONCLUSION: Among patients undergoing noncardiac surgery, the peak postoperative TnT measurement during the first 3 days after surgery was significantly associated with 30-day mortality.

[Role of polypills in cardiovascular risk reduction in primary prevention]. / Rol de las polipíldoras en la reducción del riesgo cardiovascular en prevención primaria.

Unlike medications that contain fixed-dose combinations, such as those recommended by clinical guidelines for treating high blood pressure, the so-called polypills contain several drugs that simultaneously treat two or more cardiovascular conditions or risk factors. They were proposed 2 decades ago, both for primary and secondary prevention with the hypothesis that they could have wide dissemination and population penetration, improving the use of therapeutics with proven benefits individually, thanks to an increase in patient adherence by reducing the number of daily tablets and also by having an equal or lower cost. In this simple review, we present a look at risk stratification different from that posed by clinical scores and summarize the benefits of polypills in the treatment of risk factors and in the reduction of major cardiovascular events. Additionally, we review the clinical messages of the HOPE-3 trial, which aim to control two of the most prevalent conditions, such as high blood pressure and high cholesterol, through a combination of candesartan, hydrochlorothiazide and rosuvastatin. Finally, we propose its potential indication in a heterogeneous health system such as that of our country, both at the population level based on intermediate or low risk, determined intuitively or using a risk calculator, as well as in the personalized care that is practiced in many health scenarios.

A diferencia de los medicamentos que contienen combinaciones de dosis fijas, como los recomendados por las guías clínicas para tratar la hipertensión arterial, las llamadas polipíldoras contienen varios fármacos que tratan simultáneamente dos o más afecciones cardiovasculares o factores de riesgo. Se propusieron hace 2 décadas, tanto para prevención primaria como secundaria, con la hipótesis de que tengan amplia difusión y penetración poblacional, es decir, que mejoren el uso de terapéuticas con probados beneficios en forma individual, gracias a un incremento en la adherencia de los pacientes al reducir el número de comprimidos diarios y también al tener un costo igual o menor. En esta revisión simple, planteamos una mirada de la estratificación del riesgo distinta a la planteada por los puntajes clínicos y resumimos los beneficios de las polipíldoras en el tratamiento de los factores de riesgo y en la reducción de eventos cardiovasculares mayores. Adicionalmente, repasamos los mensajes clínicos del ensayo HOPE-3, que apuntan a controlar dos de las condiciones más prevalentes, como son la hipertensión arterial y el colesterol elevado, mediante una combinación de candesartán, hidroclorotiazida y rosuvastatina. Finalmente, proponemos su potencial indicación en un sistema sanitario heterogéneo como el de nuestro país, tanto a nivel poblacional basado en el riesgo intermedio o bajo, determinado intuitivamente o usando un calculador de riesgo, así como también en la atención personalizada que se practica en muchos escenarios sanitarios.

SCAI Cardiogenic Shock Classification for Predicting In-Hospital and Long-Term Mortality in Acute Heart Failure.

Background: SCAI classification in cardiogenic shock is simple and suitable for rapid assessment. Its predictive behavior in patients with primary acute heart failure (AHF) is not fully known. We aimed to evaluate the ability of the SCAI classification to predict in-hospital and long-term mortality in AHF. Methods: We conducted a single-center study and performed a retrospective analysis of prospectively collected data of consecutive patients admitted with AHF between 2015 and 2020. The primary end points were in-hospital and long-term mortality from all causes. Results: In total, 856 patients were included. The unadjusted in-hospital mortality was as follows: A, 0.6%; B, 2.7%; C, 21.5%; D 54.3%; and E, 90.6% (log rank, P < .0001), and long-term mortality was as follows: A, 24.9%; B, 24%; C, 49.6%; D, 62.9%; and E, 95.5% (log rank, P < .0001). After multivariable adjustment, each SCAI SHOCK stage remained associated with increased mortality (all P < .001 compared with stage A). With the exception of the long-term end point, there were no differences between stages A and B for adjusted mortality (P = .1). Conclusions: In a cohort of patients with AHF, SCAI cardiogenic shock classification was associated with in-hospital and long-term mortality. This finding supports the rationale of the classification in this setting.

Design and rationale of the inferior vena CAVA and Lung UltraSound-guided therapy in Acute Heart Failure (CAVAL US-AHF Study): a randomised controlled trial.

BACKGROUND: Between 25% and 30% of patients hospitalised for acute heart failure (AHF) are readmitted within 90 days after discharge, mostly due to persistent congestion on discharge. However, as the optimal evaluation of decongestion is not clearly defined, it is necessary to implement new tools to identify subclinical congestion to guide treatment. OBJECTIVE: To evaluate if inferior vena cava (IVC) and lung ultrasound (CAVAL US)-guided therapy for AHF patients reduces subclinical congestion at discharge. METHODS: CAVAL US-AHF is a single-centre, single-blind randomised controlled trial designed to evaluate if an IVC and lung ultrasound-guided healthcare strategy is superior to standard care to reduce subclinical congestion at discharge. Fifty-eight patients with AHF will be randomised using a block randomisation programme that will assign to either lung and IVC ultrasound-guided decongestion therapy ('intervention group') or clinical-guided decongestion therapy ('control group'), using a quantitative protocol and will be classified in three groups according to the level of congestion observed: none or mild, moderate or severe. The treating physicians will know the result of the test and the subsequent adjustment of treatment in response to those findings guided by a customised therapeutic algorithm. The primary endpoint is the presence of more than five B-lines and/or an increase in the diameter of the IVC, with and without collapsibility. The secondary endpoints are the composite of readmission for HF, unplanned visit for worsening HF or death at 90 days, variation of pro-B-type natriuretic peptide at discharge, length of hospital stay and diuretic dose at 90 days. Analyses will be conducted as between-group by intention to treat. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Review Board and registered in the PRIISA.BA platform of the Ministry of Health of the City of Buenos Aires. TRIAL REGISTRATION NUMBER: NCT04549701.

[MANAGEMENT RECOMMENDATIONS FOR DIRECT ORAL ANTICOAGULANTS (DOACs) ANTI Xa AND ANTI IIa]. / RECOMENDACIONES DE MANEJO DE LOS ANTICOAGULANTES ORALES DIRECTOS (DOACS) ANTI Xa Y ANTI IIa.

Direct oral anticoagulants have emerged as the drugs that have changed the management of the antithrombotic treatment in the last 15 years. Their advantages, like a more friendly way of anticoagulation and their lower risk of bleeding, especially in the brain, have positioned these new anticoagulants as the first drug of choice in the two most frequent indications of anticoagulation, atrial fibrillation, and the venous thromboembolic disease. However, not all the patients can receive these agents, not all the direct oral anticoagulants have the same characteristics, and most importantly, not all the diseases with an indication of an anticoagulant drug can be treated with them. Therefore, it is mandatory that all the faculties involved in the management of these drugs must know them in depth, to decide the best treatment for the patient. This position paper, from a group of experts in anticoagulation in Argentina, can help the general practitioner in the daily use of direct oral anticoagulants based on the new evidence and the experience of a wide group of professionals. The way we relate to the anticoagulant treatment has changed in the last years. The doctors who work with them must also do so.

Los anticoagulantes orales directos han surgido como una de las herramientas que ha cambiado el manejo de la enfermedad trombótica en los últimos 15 años. Sus ventajas, desde el punto de vista de la facilidad de uso y menor riesgo de sangrado, especialmente de sangrado cerebral, han posicionado a estos nuevos anticoagulantes como la primera alternativa de tratamiento en las dos indicaciones más frecuentes en que necesitamos estas drogas, la fibrilación auricular y la enfermedad tromboembólica venosa. Sin embargo, no todos los pacientes pueden recibir estos agentes, no todos los anticoagulantes directos tienen las mismas propiedades y fundamentalmente, no todas las enfermedades con indicación de un anticoagulante pueden tratarse con ellos;con lo cual es necesario que todos los profesionales que están involucrados en el manejo de estos medicamentos estén obligados a conocerlos en profundidad, para poder decidir el mejor tratamiento en cada caso particular. Este documento de posición de expertos de diferentes especialidades de Argentina, presenta lineamientos para el uso correcto de los anticoagulantes directos en base a nueva evidencia y a la experiencia de uso de un amplio grupo de profesionales. La forma de relacionarnos con el tratamiento anticoagulante ha cambiado. Los médicos que trabajamos con ellos también debemos hacerlo.

Impact of COVID-19 Pandemic Lockdown in Decompensated Heart Failure Hospitalizations.

Background and Objectives: Coronavirus disease 2019 (COVID-19) pandemic lockdown may have collaterally affected the care of patients with acute decompensated heart failure (ADHF). We aimed to evaluate the impact of lockdown pandemic on hospitalizations for ADHF. Methods: We conducted a single-center study, performing a retrospective analysis of prospectively collected data. We included consecutive adult patients with a primary diagnosis of ADHF admitted to a cardiovascular disease specialized hospital. We compared those patients admitted between March-June of 2019 (before COVID-19 [BC]) and 2020 (after COVID-19 [AC]), during mandatory lockdown. Results: A total 79 corresponding to BC period and 60 to AC period were included, representing a decrease of 25% (interquartile range [IQR], 11-33). During the BC period, 31.6% of patients were referred from other centers compared to 15% during the pandemic (p=0.02). In the AC period patients were older (median age, 81[IQR, 73-87] years vs. 77 [IQR, 64-84] years, p=0.014). The etiology of HF, cause of decompensation, left ventricular function, and laboratory parameters were similar in both periods. The use of mechanical ventilation (13.9% vs. 3.3%, p=0.03) and circulatory support (7.6% vs. 0%, p=0.02) was higher in the BC period. During the BC period, 5 emergency heart transplants were performed, and none in AC, (p=0.004). In-hospital mortality was similar in both periods (3.8% vs. 3.3%; p=0.80). Conclusions: We observed a reduction in the number of hospitalizations and referral of patients for ADHF during COVID-19 pandemic.

Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized With COVID-19: A Randomized Clinical Trial.

Importance: Hospitalized patients with COVID-19 pneumonia have high rates of morbidity and mortality. Objective: To assess the efficacy of colchicine in hospitalized patients with COVID-19 pneumonia. Design, Setting, and Participants: The Estudios Clínicos Latino América (ECLA) Population Health Research Institute (PHRI) COLCOVID trial was a multicenter, open-label, randomized clinical trial performed from April 17, 2020, to March 28, 2021, in adults with confirmed or suspected SARS-CoV-2 infection followed for up to 28 days. Participants received colchicine vs usual care if they were hospitalized with COVID-19 symptoms and had severe acute respiratory syndrome or oxygen desaturation. The main exclusion criteria were clear indications or contraindications for colchicine, chronic kidney disease, and negative results on a reverse transcription-polymerase chain reaction test for SARS-CoV-2 before randomization. Data were analyzed from June 20 to July 25, 2021. Interventions: Patients were assigned in a 1:1 ratio to usual care or usual care plus colchicine. Colchicine was administered orally in a loading dose of 1.5 mg immediately after randomization, followed by 0.5 mg orally within 2 hours of the initial dose and 0.5 mg orally twice a day for 14 days or discharge, whichever occurred first. Main Outcomes and Measures: The first coprimary outcome was the composite of a new requirement for mechanical ventilation or death evaluated at 28 days. The second coprimary outcome was death at 28 days. Results: A total of 1279 hospitalized patients (mean [SD] age, 61.8 [14.6] years; 449 [35.1%] women and 830 [64.9%] men) were randomized, including 639 patients in the usual care group and 640 patients in the colchicine group. Corticosteroids were used in 1171 patients (91.5%). The coprimary outcome of mechanical ventilation or 28-day death occurred in 160 patients (25.0%) in the colchicine group and 184 patients (28.8%) in the usual care group (hazard ratio [HR], 0.83; 95% CI, 0.67-1.02; P = .08). The second coprimary outcome, 28-day death, occurred in 131 patients (20.5%) in the colchicine group and 142 patients (22.2%) in the usual care group (HR, 0.88; 95% CI, 0.70-1.12). Diarrhea was the most frequent adverse effect of colchicine, reported in 68 patients (11.3%). Conclusions and Relevance: This randomized clinical trial found that compared with usual care, colchicine did not significantly reduce mechanical ventilation or 28-day mortality in patients hospitalized with COVID-19 pneumonia. Trial Registration: ClinicalTrials.gov Identifier: NCT04328480.

[Cardiovascular disease in times of COVID-19]. / Enfermedad cardiovascular en tiempos de COVID-19.

There are increasing reports of a drastic drop in consultations and cardiovascular procedures (including urgencies and emergencies) in regions affected by the COVID-19 pandemic, with a consequent marked increase in total mortality that is not fully explained by COVID-19. Cardiovascular disease leads the ranking in deaths in adults in Argentina with 280 deaths per day, and in recent decades we have reduced its mortality by 20-30% through various evidence-based interventions. Herein we conducted predictive analyses to understand what could be the consequences of a worse implementation of those interventions. We estimate that less control of cardiovascular risk factors from April to October 2020 could cause up to 10 500 new preventable cases of cardiovascular disease. In terms of myocardial infarction, a drop from 40% to 60% of the reperfusion treatment could increase mortality by 3% to 5%. A marginal 10% to 15% increase in relative risk of cardiovascular death would be equivalent to an excess of 6000 to 9000 preventable deaths. In conclusion, given the high prevalence and fatality of cardiovascular disease, even a small negative impact on the efficacy of its care will translate into large numbers of people affected in Argentina. It is necessary to inform the authorities and educate the public so cardiovascular diseases and their risk factors remain a health priority, as long as resources exist and minimizing the risk of contagion and spread of the virus.

Existen crecientes informes sobre una drástica caída en consultas y realización de procedimientos cardiovasculares (incluyendo urgencias y emergencias) en regiones afectadas por la pandemia de COVID-19, con el consecuente incremento marcado de la mortalidad total que no se explica totalmente por las defunciones atribuidas a COVID-19. En Argentina, la enfermedad cardiovascular lidera el ranking de muertes en adultos con 280 muertes por día, y en las últimas décadas hemos reducido su mortalidad entre 20 y 30% mediante diversas intervenciones basadas en la evidencia. En el presente trabajo realizamos análisis predictivos para entender cuáles podrían ser las consecuencias de una peor implementación de dichas intervenciones. Estimamos que un menor control de los factores de riesgo cardiovascular de abril a octubre de 2020 podría causar hasta 10 500 nuevos casos prevenibles de enfermedad cardiovascular. En términos de infarto de miocardio, una caída del 40% al 60% del tratamiento de reperfusión podría incrementar la mortalidad del 3% al 5%. Un incremento marginal de riesgo relativo de 10% a 15% de muerte cardiovascular equivaldría a un exceso de 6000 a 9000 muertes evitables. En conclusión, dada la alta prevalencia y fatalidad de la enfermedad cardiovascular, incluso un pequeño impacto negativo en la eficacia de su cuidado se traducirá en grandes cantidades de afectados en Argentina. Es necesario informar a las autoridades y educar al público para que sigan controlando enfermedades cardiovasculares y sus factores de riesgo, siempre que existan recursos y minimizando el riesgo de contagio y propagación del virus.