Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia.

BACKGROUND: A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS: In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS: A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS: In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).

Predictors of bleeding and thrombotic events among patients admitted to the hospital with COVID-19 and elevated D-dimer: insights from the ACTION randomized clinical trial.

Therapeutic anticoagulation showed inconsistent results in hospitalized patients with COVID-19 and selection of the best patients to use this strategy still a challenge balancing the risk of thrombotic and hemorrhagic outcomes. The present post-hoc analysis of the ACTION trial evaluated the variables independently associated with both bleeding events (major bleeding or clinically relevant non-major bleeding) and the composite outcomes thrombotic events (venous thromboembolism, myocardial infarction, stroke, systemic embolism, or major adverse limb events). Variables were assessed one by one with independent logistic regressions and final models were chosen based on Akaike information criteria. The model for bleeding events showed an area under the curve of 0.63 (95% confidence interval [CI] 0.53 to 0.73), while the model for thrombotic events had an area under the curve of 0.72 (95% CI 0.65 to 0.79). Non-invasive respiratory support was associated with thrombotic but not bleeding events, while invasive ventilation was associated with both outcomes (Odds Ratio of 7.03 [95 CI% 1.95 to 25.18] for thrombotic and 3.14 [95% CI 1.11 to 8.84] for bleeding events). Beyond respiratory support, creatinine level (Odds Ratio [OR] 1.01 95% CI 1.00 to 1.02 for every 1.0 mg/dL) and history of coronary disease (OR 3.67; 95% CI 1.32 to 10.29) were also independently associated to the risk of thrombotic events. Non-invasive respiratory support, history of coronary disease, and creatinine level may help to identify hospitalized COVID-19 patients at higher risk of thrombotic complications.ClinicalTrials.gov: NCT04394377.

In-Hospital Management and Long-term Clinical Outcomes and Adherence in Patients With Acute Decompensated Heart Failure: Primary Results of the First Brazilian Registry of Heart Failure (BREATHE).

BACKGROUND: Heart failure (HF), a common cause of hospitalization, is associated with poor short-term clinical outcomes. Little is known about the long-term prognoses of patients with HF in Latin America. METHODS: BREATHE was the first nationwide prospective observational study in Brazil that included patients hospitalized due to acute heart failure (HF). Patients were included during 2 time periods: February 2011-December 2012 and June 2016-July 2018 SUGGESTION FOR REPHRASING: In-hospital management, 12-month clinical outcomes and adherence to evidence-based therapies were evaluated. RESULTS: A total of 3013 patients were enrolled at 71 centers in Brazil. At hospital admission, 83.8% had clear signs of pulmonary congestion. The main cause of decompensation was poor adherence to HF medications (27.8%). Among patients with reduced ejection fraction, concomitant use of beta-blockers, renin-angiotensin-aldosterone inhibitors and spironolactone decreased from 44.5% at hospital discharge to 35.2% at 3 months. The cumulative incidence of mortality at 12 months was 27.7%, with 24.3% readmission at 90 days and 44.4% at 12 months. CONCLUSIONS: In this large national prospective registry of patients hospitalized with acute HF, rates of mortality and readmission were higher than those reported globally. Poor adherence to evidence-based therapies was common at hospital discharge and at 12 months of follow-up.

Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial.

BACKGROUND: COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population. METHODS: We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged ≥18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation. Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg/kg twice per day) or intravenous unfractionated heparin (to achieve a 0·3-0·7 IU/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin. The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. This study is registered with ClinicalTrials.gov (NCT04394377) and is completed. FINDINGS: From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated (311 [50%] to the therapeutic anticoagulation group and 304 [50%] to the prophylactic anticoagulation group). 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis. The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28 899 (34·8%) wins in the therapeutic group and 34 288 (41·3%) in the prophylactic group (win ratio 0·86 [95% CI 0·59-1·22], p=0·40). Consistent results were seen in clinically stable and clinically unstable patients. The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation (relative risk 3·64 [95% CI 1·61-8·27], p=0·0010). Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group. INTERPRETATION: In patients hospitalised with COVID-19 and elevated D-dimer concentration, in-hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation. Therefore, use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation. FUNDING: Coalition COVID-19 Brazil, Bayer SA.

Discontinuing vs continuing ACEIs and ARBs in hospitalized patients with COVID-19 according to disease severity: Insights from the BRACE CORONA trial.

BACKGROUND: We explored the effect of discontinuing versus continuing angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) on clinical outcomes in patients with COVID-19 according to baseline disease severity. METHODS: We randomized 659 patients with a confirmed diagnosis of COVID-19 and classified them as having mild or moderate COVID-19 disease severity at hospital presentation using blood oxygen saturation and lung imaging. The primary outcome was the mean ratio of number of days alive and out of the hospital at 30 days according to disease severity. RESULTS: At presentation, 376 patients (57.1%) had mild and 283 (42.9%) had moderate COVID-19. In patients with mild disease, there was no significant difference in the number of days alive and out of the hospital between ACEI/ARB discontinuation (mean 23.5 [SD 6.3] days) and continuation (mean 23.8 [SD 6.5] days), with a mean ratio of 0.98 (95% CI 0.92-1.04). However, in patients with moderate disease, there were fewer days alive and out of the hospital with ACEI/ARB discontinuation (mean 19.6 [SD 9.5] days) than continuation (mean 21.6 [SD 7.6] days), with a mean ratio of 0.90 (95% CI 0.81-1.00; P-interaction = .01). The impact of discontinuing versus continuing ACEIs/ARBs on days alive and out of hospital through 30 days differed according to baseline COVID-19 disease severity. CONCLUSIONS: Unlike patients with mild disease, patients with moderate disease who continued ACEIs/ARBs had more days alive and out of hospital through 30 days than those who discontinued ACEIs/ARBs. This suggests that ACEIs/ARBs should be continued for patients with moderate COVID-19 disease severity. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT04364893).

Randomized clinical trial to evaluate a routine full anticoagulation Strategy in Patients with Coronavirus Infection (SARS-CoV2) admitted to hospital: Rationale and design of the ACTION (AntiCoagulaTlon cOroNavirus)-Coalition IV trial.

BACKGROUND: Observational studies have suggested a higher risk of thrombotic events in patients with coronavirus disease 2019 (COVID-19). Moreover, elevated D-dimer levels have been identified as an important prognostic marker in COVID-19 directly associated with disease severity and progression. Prophylactic anticoagulation for hospitalized COVID-19 patients might not be enough to prevent thrombotic events; therefore, therapeutic anticoagulation regimens deserve clinical investigation. DESIGN: ACTION is an academic-led, pragmatic, multicenter, open-label, randomized, phase IV clinical trial that aims to enroll around 600 patients at 40 sites participating in the Coalition COVID-19 Brazil initiative. Eligible patients with a confirmed diagnosis of COVID-19 with symptoms up to 14 days and elevated D-dimer levels will be randomized to a strategy of full-dose anticoagulation for 30 days with rivaroxaban 20 mg once daily (or full-dose heparin if oral administration is not feasible) vs standard of care with any approved venous thromboembolism prophylaxis regimen during hospitalization. A confirmation of COVID-19 was mandatory for study entry, based on specific tests used in clinical practice (RT-PCR, antigen test, IgM test) collected before randomization, regardless of in the outpatient setting or not. Randomization will be stratified by clinical stability at presentation. The primary outcome is a hierarchical analysis of mortality, length of hospital stay, or duration of oxygen therapy at the end of 30 days. Secondary outcomes include the World Health Organization's 8-point ordinal scale at 30 days and the following efficacy outcomes: incidence of venous thromboembolism , acute myocardial infarction, stroke, systemic embolism, major adverse limb events, duration of oxygen therapy, disease progression, and biomarkers. The primary safety outcomes are major or clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria. SUMMARY: The ACTION trial will evaluate whether in-hospital therapeutic anticoagulation with rivaroxaban for stable patients, or enoxaparin for unstable patients, followed by rivaroxaban through 30 days compared with standard prophylactic anticoagulation improves clinical outcomes in hospitalized patients with COVID-19 and elevated D-dimer levels.

Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial.

Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN: BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 34 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels. SUMMARY: BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.

Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial.

Importance: The effects of loading doses of statins on clinical outcomes in patients with acute coronary syndrome (ACS) and planned invasive management remain uncertain. Objective: To determine if periprocedural loading doses of atorvastatin decrease 30-day major adverse cardiovascular events (MACE) in patients with ACS and planned invasive management. Design, Setting, and Participants: Multicenter, double-blind, placebo-controlled, randomized clinical trial conducted at 53 sites in Brazil among 4191 patients with ACS evaluated with coronary angiography to proceed with a percutaneous coronary intervention (PCI) if anatomically feasible. Enrollment occurred between April 18, 2012, and October 6, 2017. Final follow-up for 30-day outcomes was on November 6, 2017. Interventions: Patients were randomized to receive 2 loading doses of 80 mg of atorvastatin (n = 2087) or matching placebo (n = 2104) before and 24 hours after a planned PCI. All patients received 40 mg of atorvastatin for 30 days starting 24 hours after the second dose of study medication. Main Outcomes and Measures: The primary outcome was MACE, defined as a composite of all-cause mortality, myocardial infarction, stroke, and unplanned coronary revascularization through 30 days. Results: Among the 4191 patients (mean age, 61.8 [SD, 11.5] years; 1085 women [25.9%]) enrolled, 4163 (99.3%) completed 30-day follow-up. A total of 2710 (64.7%) underwent PCI, 333 (8%) underwent coronary artery bypass graft surgery, and 1144 (27.3%) had exclusively medical management. At 30 days, 130 patients in the atorvastatin group (6.2%) and 149 in the placebo group (7.1%) had a MACE (absolute difference, 0.85% [95% CI, -0.70% to 2.41%]; hazard ratio, 0.88; 95% CI, 0.69-1.11; P = .27). No cases of hepatic failure were reported; 3 cases of rhabdomyolysis were reported in the placebo group (0.1%) and 0 in the atorvastatin group. Conclusions and Relevance: Among patients with ACS and planned invasive management with PCI, periprocedural loading doses of atorvastatin did not reduce the rate of MACE at 30 days. These findings do not support the routine use of loading doses of atorvastatin among unselected patients with ACS and intended invasive management. Trial Registration: clinicaltrials.gov Identifier: NCT01448642.

Impact of Chest Pain Protocol with Access to Telemedicine on Implementation of Pharmacoinvasive Strategy in a Private Hospital Network.

BACKGROUND: Brazilian registries have shown a gap between evidence-based therapies and real treatments. We aim to compare the use of the pharmacoinvasive strategy and mortality in patients with ST elevation myocardial infarction (STEMI) transferred pre- and post-chest pain protocol with access to telemedicine (CPPT) in a private hospital network. MATERIALS AND METHODS: A CPPT was implemented in 22 private emergency departments in 2012. Emergency physicians and nurses of all facilities were trained to disseminate the information to comply with a chest pain protocol focusing on reperfusion therapy (pharmacoinvasive strategy) for STEMI. To conduct clinical discussions using telemedicine, a cardiologist from a reference hospital in cardiology (RHC) was available 24 h/day, 7 days/week. Using the database of all consecutive admissions, we compared the data of patients with STEMI transferred to the RHC in 2011 (pre-CPPT) and 2013-2014 (post-CPPT). RESULTS: We included 376 patients (113 pre-CPPT and 263 post-CPPT) with STEMI. All patients admitted in the RHC were transferred from the 22 emergency departments. Comparing pre-CPPT and post-CPPT, we did not find differences regarding age, gender, hypertension, dyslipidemia, diabetes, smoking, previous myocardial infarction, or Killip classification. However, the use of CPPT was associated with a greater use of pharmacoinvasive strategy (55.8% versus 38%; p = 0.002) and a trend toward lower in-hospital mortality (3% versus 8%; p = 0.06). CONCLUSIONS: The implementation of a CPPT was associated with a significant increase in the use of pharmacoinvasive strategy in patients with STEMI and a trend toward reduced in-hospital mortality in a private hospital network.

Lipid Control and Medical Costs Among Patients With and Without Established Atherosclerotic Cardiovascular Disease Followed in a Brazilian Private Healthcare System.

Background: There is limited real-world data of lipid control and healthcare costs among patients with and without Atherosclerotic Cardiovascular Disease (ASCVD) in Latin America. Methods: A retrospective cohort study including patients with LDL-cholesterol (LDL-C) assessment from 2015 to 2017 was performed in a health insurance database. Patient characteristics, comorbidities and laboratory data were collected, and International Classification of Diseases (ICD) codes were used to identify a subcohort of patients with ASCVD (secondary prevention) and assess the proportion of these patients with LDL-C controlled. Lipid control among patients without ASCVD (primary prevention) and healthcare costs in one year in the overall population were also assessed. Results: From the 17,434 patients selected, 5,208 (29.8%) had ASCVD. The mean age of these patients in secondary prevention was 68.9 (±12.3) years and 47.8% were male patients. LDL-C < 70 mg/dL was identified in 19.1% of the ASCVD population and only 4.1% had an LDL-C < 50 mg/dL. LDL control was worse in women compared to men (13.1% vs. 25.7%; P < 0.01). The average cost in one year was 3,591 American dollars (USD) per patient in primary prevention compared to 8,210 dollars per year for patients in secondary prevention (P < 0.01). While outpatient costs accounted for 59.8% of the total cost in the primary prevention group, the main cost of the secondary prevention population was related to hospital costs (54.1%). Conclusion: Despite the favorable evidence for intensive cholesterol reduction, the evaluation of large real-world database with more than 17,000 individuals showed that the targets of guideline recommendations have not yet been adequately incorporated into clinical practice. Average annual cost per patient in secondary prevention is more than twice compared to primary prevention. Hospital expenses account for most of the cost in the secondary prevention group, while outpatient costs predominate in primary prevention.

More Hospital Complications in Women after Cabg Even for Reduced Surgical Times: Call to Action for Equity in Quality Improvement. / Mais Complicações em Mulheres após Revascularização do Miocárdio Mesmo com Tempos Cirúrgicos Reduzidos: Atenção por Equidade e Melhoria da Qualidade.

BACKGROUND: Analyses of extensive registries indicate adverse outcomes for women undergoing coronary artery bypass grafting (CABG) surgery, while randomized studies often lack representativeness. OBJECTIVE: To compare adjusted hospital outcomes between men and women undergoing CABG. METHODS: From July 2017 to June 2019, 3991 patients underwent primary isolated CABG, both electively and urgently, in 5 hospitals in the state of São Paulo, Brazil. To mitigate demographic differences between men and women, populations were adjusted using propensity score matching (PSM). The outcomes considered for analysis were those used by the STS Adult Database. The analyses were performed using R software, with a significance set at p<0.05. RESULTS: After PSM (1:1), each group included 1089 patients. Regarding intraoperative variables, men exhibited longer cardiopulmonary bypass (CPB) time (p<0.001), surgical time (p<0.001), a higher number of distal anastomoses (p<0.001), and increased use of arterial grafts. Regarding outcomes, women had a higher incidence of deep sternal wound infection (p=0.006), prolonged Intensive Care Unit stay (p=0.002), increased need for an intra-aortic balloon pump (p=0.04), higher blood transfusion rates (p<0.001), higher 30-day hospital readmission rates after surgery (p=0.002) and higher mortality rate (p=0.03). CONCLUSIONS: Although men had longer CPB times, a greater number of arterial grafts, and a greater number of distal anastomoses, immediate results after CABG were poorer in women.

FUNDAMENTO: Análises em grandes registros apontam desfechos desfavoráveis para mulheres submetidas à cirurgia de revascularização do miocárdio (CRM), enquanto estudos randomizados sofrem com a falta de representatividade. OBJETIVO: Comparar os resultados hospitalares ajustados entre homens e mulheres submetidos à CRM. MÉTODOS: Entre julho de 2017 e junho de 2019, 3991 pacientes foram submetidos à CRM primária isolada, tanto de forma eletiva como de urgência, em 5 hospitais de estado de São Paulo, Brasil. Para equilibrar as diferenças entre homens e mulheres, as populações foram ajustadas utilizando o Propensity Score Matching. Os desfechos considerados para análise foram os utilizados pelo STS Adult Database. As análises foram conduzidas no software R, considerando significância valores de p < 0,05. RESULTADOS: Após o Propensity Score Matching (1:1), cada grupo incluiu 1089 pacientes. Em relação às variáveis intraoperatórias os homens apresentaram maior tempo de CEC (p<0,001), tempo cirúrgico (p<0,001), número de anastomoses distais (p<0,001) e uso de enxertos arteriais. Em relação aos desfechos as mulheres apresentaram maior incidência de infecção de ferida profunda (p=0,006), tempo prolongado na Unidade de Terapia Intensiva (p=0,002), maior necessidade do uso de balão intraórtico (p=0,04), maior taxa de transfusão sanguínea (p<0,001), maior readmissão hospitalar em até 30 dias após a cirurgia (p=0,002) e maior taxa de óbitos (p=0,03). CONCLUSÕES: Apesar dos homens terem apresentado um maior tempo de CEC, maior número de enxertos arteriais e maior número de anastomoses distais, os resultados imediatos após CRM foram piores em mulheres.

Sacubitril/Valsartan Versus Enalapril in Chronic Chagas Cardiomyopathy: Rationale and Design of the PARACHUTE-HF Trial.

Chronic Chagas cardiomyopathy (CCC) has unique pathogenic and clinical features with worse prognosis than other causes of heart failure (HF), despite the fact that patients with CCC are often younger and have fewer comorbidities. Patients with CCC were not adequately represented in any of the landmark HF studies that support current treatment guidelines. PARACHUTE-HF (Prevention And Reduction of Adverse outcomes in Chagasic Heart failUre Trial Evaluation) is an active-controlled, randomized, phase IV trial designed to evaluate the effect of sacubitril/valsartan 200 mg twice daily vs enalapril 10 mg twice daily added to standard of care treatment for HF. The study aims to enroll approximately 900 patients with CCC and reduced ejection fraction at around 100 sites in Latin America. The primary outcome is a hierarchical composite of time from randomization to cardiovascular death, first HF hospitalization, or relative change from baseline to week 12 in NT-proBNP levels. PARACHUTE-HF will provide new data on the treatment of this high-risk population. (Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC [PARACHUTE-HF]; NCT04023227).

Data-driven coaching to improve statewide outcomes in CABG: before and after interventional study.

BACKGROUND: The impact of quality improvement initiatives program (QIP) on coronary artery bypass grafting surgery (CABG) remains scarce, despite improved outcomes in other surgical areas. This study aims to evaluate the impact of a package of QIP on mortality rates among patients undergoing CABG. MATERIALS AND METHODS: This prospective cohort study utilized data from the multicenter database Registro Paulista de Cirurgia Cardiovascular II (REPLICCAR II), spanning from July 2017 to June 2019. Data from 4018 isolated CABG adult patients were collected and analyzed in three phases: before-implementation, implementation, and after-implementation of the intervention (which comprised QIP training for the hospital team). Propensity Score Matching was used to balance the groups of 2170 patients each for a comparative analysis of the following outcomes: reoperation, deep sternal wound infection/mediastinitis ≤30 days, cerebrovascular accident, acute kidney injury, ventilation time >24 h, length of stay <6 days, length of stay >14 days, morbidity and mortality, and operative mortality. A multiple regression model was constructed to predict mortality outcomes. RESULTS: Following implementation, there was a significant reduction of operative mortality (61.7%, P =0.046), as well as deep sternal wound infection/mediastinitis ( P <0.001), sepsis ( P =0.002), ventilation time in hours ( P <0.001), prolonged ventilation time ( P =0.009), postoperative peak blood glucose ( P <0.001), total length of hospital stay ( P <0.001). Additionally, there was a greater use of arterial grafts, including internal thoracic ( P <0.001) and radial ( P =0.038), along with a higher rate of skeletonized dissection of the internal thoracic artery. CONCLUSIONS: QIP was associated with a 61.7% reduction in operative mortality following CABG. Although not all complications exhibited a decline, the reduction in mortality suggests a possible decrease in failure to rescue during the after-implementation period.

Age, Renal Failure and Transfusion are Risk Predictors of Prolonged Hospital Stay after Coronary Artery Bypass Grafting Surgery. / Idade, Insuficiência Renal e Transfusão são Preditores de Risco de Longa Permanência Hospitalar após Cirurgia de Revascularização do Miocárdio.

BACKGROUND: Identifying risk factors in cardiovascular surgery assists in predictability, resulting in optimization of outcomes and cost reduction. OBJECTIVE: This study aimed to identify preoperative and intraoperative risk predictors for prolonged hospitalization after coronary artery bypass grafting (CABG) surgery in the state of São Paulo, Brazil. METHODS: A cross-sectional analysis using data from the REPLICCAR II database, a prospective, consecutive, multicenter registry that included CABG surgeries performed between August 2017 and July 2019. The primary outcome was a prolonged hospital stay (PHS), defined as a postoperative period exceeding 14 days. Univariate and multivariate logistic regression analyses were performed to identify the predictors with significance set at p <0.05. RESULTS: The median age was 63 (57-70) years and 26.55% of patients were female. Among the 3703 patients analyzed, 228 (6.16%) had a PHS after CABG, with a median hospital stay of 17 (16-20) days. Predictors of PHS after CABG included age >60 years (OR 2.05; 95% CI 1.43-2.87; p<0.001); renal failure (OR 1.73; 95% CI 1.29-2.32; p <0.001) and intraoperative red blood cell transfusion (OR 1.32; 95% CI 1.07-2.06; p=0.01). CONCLUSION: Age >60 years, renal failure, and intraoperative red blood cell transfusion were independent predictors of PHS after CABG. The identification of these variables can help in multiprofessional strategic planning aimed to enhance results and resource utilization in the state of São Paulo.

FUNDAMENTO: A identificação de fatores de riscos na cirurgia cardiovascular auxilia na previsibilidade resultando na otimização de desfechos e redução de custos. OBJETIVO: Identificação dos preditores de risco pré e intraoperatórios para internação prolongada após cirurgia de revascularização do miocárdio (CRM) no Estado de São Paulo. MÉTODOS: Análise transversal no banco de dados REPLICCAR II, registro prospectivo, consecutivo, multicêntrico que incluiu cirurgias de revascularização miocárdica realizadas entre agosto de 2017 e julho de 2019. O desfecho principal foi o tempo de internação prolongado, definida como período de pós-operatório superior a 14 (quatorze) dias. Para a identificação dos preditores foram realizadas análises de regressão logística uni- e multivariada. Os valores de p menores de 0,05 foram considerados significativos. RESULTADOS: A mediana de idade foi de 63 (57-70) anos e 26,55% eram do sexo feminino. Dos 3703 pacientes analisados, 228 (6,16%) apresentaram longa permanência hospitalar (LPH) após a CRM e a mediana da internação foi de 17 (16-20) dias. Foram preditores da LPH após a CRM: idade >60 anos (OR 2,05; IC95% 1,43 - 2,87; p<0,001); insuficiência renal (OR 1,73; IC95% 1,29 - 2,32; p<0,001) e transfusão de hemácias no intraoperatório (OR 1,32; IC 1,07 - 2,06; p=0,01). CONCLUSÃO: Nesta análise, a idade > 60 anos, insuficiência renal e a transfusão de hemácias no intraoperatório foram preditores independentes de LPH após a CRM. A identificação destas variáveis pode ajudar no planejamento estratégico multiprofissional visando melhoria de resultados e otimização de recursos no estado de São Paulo.

Effect of psychotherapy on recurrence of events and quality of life in patients with vasovagal syncope.

Emotional distress is related to recurrence of syncope compromising patient's quality of life (QoL). The aim of this study was to determine if weekly sessions of psychotherapy reduce recurrence of events and improve QoL by SF-36 among patients with refractory vasovagal syncope. A randomised controlled pilot trial including 10 patients with recurrent vasovagal syncope and positive tilt table test was conducted. Known cardiac disease and ongoing psychotherapeutic interventions were the main exclusion criteria. All patients received standard of care treatment. Additionally, after randomisation, half of the patients underwent weekly sessions of psychotherapy for 12 months. Analysis of recurrence of events and QoL showed no significant change in the control group but, in the intervention group, there was a significant reduction in the rate of near-syncope episodes per month (5.7 ± 1.4 × 1.7 ± 1.0; P < 0.01), syncope in 1 year (4.6 ± 0.9 × 1.0 ± 0.7; P < 0.01) and a significant improvement in the overall assessment of QoL (44.1 ± 10.0 vs. 70.3 ± 10.3, P < 0.01). In conclusion, patients with refractory vasovagal syncope undergoing regular psychotherapeutic intervention had less recurrence of events and improved their quality of life in 1 year.Trial Registration: ClinicalTrials.gov number, NCT04252729.

Rivaroxaban Versus Enoxaparin for Thromboprophylaxis After major Gynecological Cancer Surgery: The VALERIA Trial : Venous thromboembolism prophylAxis after gynecoLogical pElvic cancer surgery with RIvaroxaban versus enoxAparin (VALERIA trial).

Direct oral anticoagulants (DOACs) for venous thromboembolism (VTE) prevention after major gynecological cancer surgery might be an alternative to parenteral low-molecular-weight heparin (LMWH). Patients undergoing major gynecological cancer surgery were randomized at hospital discharge to receive rivaroxaban 10 mg once daily or enoxaparin 40 mg once daily for 30 days. The primary efficacy outcome was a combination of symptomatic VTE and VTE-related death or asymptomatic VTE at day 30. The primary safety outcome was the incidence of major or clinically relevant nonmajor bleeding. Two hundred and twenty-eight patients were enrolled and randomly assigned to receive rivaroxaban (n = 114)or enoxaparin (n = 114). The trial was stopped due to a lower-than-expected event rate. The primary efficacy outcome occurred in 3.51% of patients assigned to rivaroxaban and in 4.39% of patients assigned to enoxaparin (relative risk 0.80, 95% CI 0.22 to 2.90; p = 0.7344). Patients assigned to rivaroxaban had no primary bleeding event, and 3 patients (2.63%) in the enoxaparin group had a major or CRNM bleeding event (hazard ratio, 0.14; 95% CI, 0.007 to 2.73; P = 0.1963). In patients undergoing major gynecological cancer surgery, thromboprophylaxis with rivaroxaban 10 mg daily for 30 days had similar rates of thrombotic and bleeding events compared to parenteral enoxaparin 40 mg daily. While the power is limited due to not reaching the intended sample size, our results support the hypothesis that DOACs might be an attractive alternative strategy to LMWH to prevent VTE in this high-risk population.

Chest Pain Network with Support of Telemedicine: Impact on Reperfusion Therapy and Clinical Outcomes After 8 Years of Experience.

Background: Different approaches of evaluation by cardiologists using telemedicine have the potential of improving care of patients with ST elevation myocardial infarction (STEMI). Objective: To compare the use of pharmacoinvasive strategy and associated clinical outcomes (heart failure [HF] and mortality) among patients with STEMI before and after a program of telemedicine and also according to the level of support by telemedicine. Methods: A chest pain network with the support of a cardiologist through telemedicine was implemented in 2012 in 22 emergency departments without a local cardiac catheterization laboratory. Initially (phase 1 of telemedicine), the decision to discuss the case with the cardiologist was based on the judgment of the emergency physician. At the end of 2018, the use of telemedicine was modified and a dedicated cardiologist was available continuously to discuss systematically all suspected cases (phase 2 of telemedicine). The use of fibrinolytics and the rates of HF and in-hospital mortality were compared among three different periods: pretelemedicine (2011), and phase 1 and phase 2 of the telemedicine program. Results: We evaluated 1034 STEMI patients and after comparing the three phases, we did not find significant differences regarding age, gender, and comorbidities. The use of fibrinolytics before transferring STEMI patients to a percutaneous coronary intervention center (pharmacoinvasive strategy) increased after telemedicine implementation (38% vs. 65.2%; p < 0.01), which was associated with a lower rate of HF (23.9% vs. 14.4%; p = 0.01) and death (7.9% vs. 4.0%; p = 0.05). The in-hospital mortality was lower in phase 2 with systematic evaluation by telemedicine compared with pretelemedicine (7.9% vs. 3.3%; p = 0.04). Conclusion: The implementation of a systematic and organized chest pain protocol, including telemedicine support, was associated with a significant increase in the use of pharmacoinvasive strategy and better clinical patient outcomes in patients with STEMI. Our findings provide important insights on how to improve the management of this high-risk population, reducing the gap between evidence and clinical practice.

Atypical chest pain due to multiple coronary arteries fistulas occluded with percutaneous interlock coils: A case report.

Coronary artery fistulas, although rare, should be included in the differential diagnosis of atypical chest pain, generally unveiled by cardiac catheterization or multidetector computed tomography. Such anatomical findings in conjunction with detectable ischemia and severe symptoms should prompt their closure. Transcatheter closure of fistulas is an attractive alternative to surgery, especially with the novel devices such as the interlock fibered detachable coils, which can be safely and effectively performed in a variety of circumstances, including the coronary arteries with tortuous anatomies. We present a case of atypical chest pain and large burden of ischemia in the stress scintigraphy, due to multiple coronary fistulas to the bronchial arteries successfully occluded with percutaneous interlock coils. .