An adapted cardioprotective diet with or without phytosterol and/or krill oil supplement in familial hypercholesterolemia: A pilot study protocol

BACKGROUND AND AIMS: A healthy diet is one of the pillars of familial hypercholesterolemia (FH) treatment. However, the best dietary pattern and indication for specific supplementation have not been established. Our aim is to conduct a pilot study to assess the effect of an adapted cardioprotective diet with or without phytosterol and/or krill oil supplement in participants with a probable or definitive diagnosis of FH, treated with moderate/high potency statins. METHODS: A national, multicenter, factorial, and parallel placebocontrolled randomized clinical trial with a superiority design and 1:1:1:1 allocation rate will be conducted. The participants will undergo whole exome sequencing and be allocated into four treatment groups: 1) a cardioprotective diet adapted for FH (DICAFH) þ phytosterol placebo þ krill oil placebo; 2) DICA-FH þ phytosterol 2 g/day þ krill oil placebo; 3) DICA-FH þ phytosterol placebo þ krill oil 2 g/day; or 4) DICA-FH þ phytosterol 2 g/day þ krill oil 2 g/day. The primary outcomes will be low-density lipoprotein (LDL)-cholesterol and lipoprotein (a) levels and adherence to treatment after a 120-day follow-up. LDL- and high-density lipoprotein (HDL)-cholesterol subclasses, untargeted lipidomics analysis, adverse events, and protocol implementation components will also be assessed. RESULTS: A total of 58 participants were enrolled between May e August 2023. After the end of the follow-up period, the efficacy and feasibility results of this pilot study will form the basis of the design of a large-scale randomized clinical trial. CONCLUSIONS: This study's overall goal is to recommend dietary treatment strategies in the context of FH.

Association between obstructive coronary disease and diabetic retinopathy: Cross-sectional study of coronary angiotomography and multimodal retinal imaging.

AIMS: To investigate the association between diabetic retinopathy (DR) and coronary artery disease (CAD) using coronary angiotomography (CCTA) and multimodal retinal imaging (MMRI) with ultra-widefield retinography and optical coherence tomography angiography and structural domain. METHODS: Single-center, cross-sectional, single-blind. Patients with diabetes who had undergone CCTA underwent MMRI. Uni and multivariate analysis were used to assess the association between CAD and DR and to identify variables independently associated with DR. RESULTS: We included 171 patients, 87 CAD and 84 non-CAD. Most CAD patients were males (74 % vs 38 %, P < 0.01), insulin users (52 % vs 38 %, p < 0.01) and revascularized (64 %). They had a higher prevalence of DR (48 % vs 22 %, p = 0.01), microaneurysms (25 % vs 13 %, p = 0.04), intraretinal cysts (22 % vs 8 %, p = 0.01) and areas of reduced capillary density (46 % vs 20 %, p < 0.01). CAD patients also had lower mean vascular density (MVD) (15.7 % vs 16.5,%, p = 0.049) and foveal avascular zone (FAZ) circularity (0.64 ± 0.1 vs 0.69 ± 0.1, p = 0.04). There were significant and negative correlations between Duke coronary score and MVD (r = -0.189; p = 0.03) and FAZ circularity (r = -0,206; p = 0.02). CAD, DM duration and insulin use independently associated with DR. CONCLUSIONS: CAD patients had higher prevalence of DR and lower MVD. CAD, DM duration and insulin use were independently associated with DR.

Primary results of the brazilian registry of atherothrombotic disease (NEAT).

There is limited contemporary prospective real-world evidence of patients with chronic arterial disease in Latin America. The Network to control atherothrombosis (NEAT) registry is a national prospective observational study of patients with known coronary (CAD) and/or peripheral arterial disease (PAD) in Brazil. A total of 2,005 patients were enrolled among 25 sites from September 2020 to March 2022. Patient characteristics, medications and laboratorial data were collected. Primary objective was to assess the proportion of patients who, at the initial visit, were in accordance with good medical practices (domains) for reducing cardiovascular risk in atherothrombotic disease. From the total of patients enrolled, 2 were excluded since they did not meet eligibility criteria. Among the 2,003 subjects included in the analysis, 55.6% had isolated CAD, 28.7% exclusive PAD and 15.7% had both diagnoses. Overall mean age was 66.3 (± 10.5) years and 65.7% were male patients. Regarding evidence-based therapies (EBTs), 4% were not using any antithrombotic drug and only 1.5% were using vascular dose of rivaroxaban (2.5 mg bid). Only 0.3% of the patients satisfied all the domains of secondary prevention, including prescription of EBTs and targets of body-mass index, blood pressure, LDL-cholesterol, and adherence of lifestyle recommendations. The main barrier for prescription of EBTs was medical judgement. Our findings highlight that the contemporary practice does not reflect a comprehensive approach for secondary prevention and had very low incorporation of new therapies in Brazil. Large-scale populational interventions addressing these gaps are warranted to improve the use of evidence-based therapies and reduce the burden of atherothrombotic disease.ClinicalTrials.gov NCT04677725.

Two-Year Follow-Up of Chronic Ischemic Heart Disease Patients in a Specialized Center in Brazil. / Acompanhamento de Dois Anos de Pacientes com Cardiopatia Isquêmica Crônica em um Centro Especializado no Brasil.

The incidence of cardiovascular events in patients with chronic ischemic heart disease (CIHD) may vary significantly among countries. Although populous, Brazil is often underrepresented in international records. This study aimed to describe the quality of care and the two-year incidence of cardiovascular events and associated prognostic factors in CIHD patients in a tertiary public health care center in Brazil. Patients with CIHD who reported for clinical evaluation at Instituto do Coração (São Paulo, Brazil) were registered and followed for two years. The primary endpoint was a composite of myocardial infarction (MI), stroke, or death. A significance level of 0.05 was adopted. From January 2016 to December 2018, 625 participants were included in the study. Baseline characteristics show that 33.1% were women, median age 66.1 [59.6 - 71.9], 48.6% had diabetes, 83.1% had hypertension, 62.6% had previous MI, and 70.4% went through some revascularization procedure. At a median follow-up (FU) of 881 days, we noted 37 (7.05%) primary endpoints. After adjustments, age, previous stroke, and LDL-cholesterol were independently associated with the primary endpoint. Comparing baseline versus FU, participants experienced relief of angina based on the Canadian Cardiovascular Society (CCS) scale according to the following percentages: 65.7% vs. 81.7% were asymptomatic and 4.2% vs. 2.9% CCS 3 or 4 (p < 0.001). They also experienced better quality of medication prescription: 65.8% vs. 73.6% (p < 0.001). However, there was no improvement in LDL-cholesterol or blood pressure control. This study shows that CIHD patients had a two-year incidence of the primary composite endpoint of 7.05%, and the reduction of LDL-cholesterol was the only modifiable risk factor associated with prognosis.

A incidência de eventos cardiovasculares em pacientes com doença cardíaca isquêmica crônica (DCIC) pode variar significativamente entre os países. Embora populoso, o Brasil é frequentemente sub-representado nos registros internacionais. Este estudo teve como objetivo descrever a qualidade do atendimento e a incidência de eventos cardiovasculares em dois anos, além de fatores prognósticos associados em pacientes com DCIC em um centro terciário de saúde pública no Brasil. Pacientes com DCIC que compareceram para avaliação clínica no Instituto do Coração (São Paulo, Brasil) foram cadastrados e acompanhados por dois anos. O desfecho primário foi um composto de infarto do miocárdio (IM), acidente vascular encefálico ou morte. Um nível de significância de 0,05 foi adotado. De janeiro de 2016 a dezembro de 2018, 625 participantes foram incluídos no estudo. As características basais mostram que 33,1% eram mulheres, a idade mediana era de 66,1 [59,6 ­ 71,9], 48,6% tinham diabetes, 83,1% tinham hipertensão, 62,6% tinham IM prévio e 70,4% passaram por algum procedimento de revascularização. Em um acompanhamento mediano de 881 dias, 37 (7,05%) desfechos primários foram observados. Após ajustes, idade, acidente vascular encefálico prévio e colesterol LDL foram independentemente associados ao desfecho primário. Comparando a linha de base com o acompanhamento, os participantes relataram alívio da angina com base na escala da Sociedade Cardiovascular Canadense (SCC) de acordo com as seguintes porcentagens: 65,7% vs. 81,7% eram assintomáticos e 4,2% vs. 2,9% eram SCC 3 ou 4 (p < 0,001). Eles também relataram melhor qualidade na prescrição de medicamentos: 65,8% vs. 73,6% (p < 0,001). No entanto, não houve melhora no colesterol LDL ou no controle da pressão arterial. O presente estudo mostra que pacientes com DCIC apresentaram uma incidência de 7,05% do desfecho primário composto em um período de dois anos, sendo a diminuição do colesterol LDL o único fator de risco modificável associado ao prognóstico.

Rivaroxaban versus warfarin in postoperative atrial fibrillation: Cost-effectiveness analysis in a single-center, randomized, and prospective trial.

Objectives: Postoperative atrial fibrillation is the most common clinical complication after coronary artery bypass graft surgery. It is associated with a high risk of both stroke and death and increases the length of hospital stay and costs. This study aimed to evaluate anticoagulants in postoperative atrial fibrillation. Methods: A single-center, randomized, prospective, and open-label study. The trial was conducted in Heart Institute at University of São Paulo, Brazil. Patients who developed postoperative atrial fibrillation were randomized to anticoagulation with rivaroxaban or warfarin plus enoxaparin bridging. The primary objective was the cost-effectiveness evaluated by quality-adjusted life years, using the SF-6D questionnaire. The secondary end point was the combination of death, stroke, myocardial infarction, thromboembolic events, infections, bleeding, readmissions, and surgical reinterventions. The safety end point was any bleeding using the International Society on Thrombosis and Haemostasis score. Follow-up period was 30 days after hospital discharge. Results: We analyzed 324 patients and 53 patients were randomized. The median cost-effectiveness was $1423.20 in the warfarin group versus $586.80 in the rivaroxaban group (P = .002). The median cost was lower in the rivaroxaban group, $450.20 versus $947.30 (P < .001). The secondary outcome was similar in both groups, 44.4% in warfarin group versus 38.5% in the rivaroxaban group (P = .65). Bleeding occured in 25.9% in the warfarin group versus 11.5% in the rivaroxaban group (P = .18). Conclusions: Rivaroxaban was more cost-effective when compared with warfarin associated with enoxaparin bridging in postoperative atrial fibrillation after isolated coronary artery bypass grafting.

Coronavirus disease-2019 and heart: assessment of troponin and cardiovascular comorbidities as prognostic markers in patients hospitalized with coronavirus disease-2019 in a tertiary center in Brazil.

OBJECTIVE: Our study aimed to evaluate the correlation of cardiac troponin T levels with comorbidities and in-hospital outcomes in patients with coronavirus disease-2019 in Brazil. METHODS: Data from a cohort of 3,596 patients who were admitted with suspected coronavirus disease-2019 in a Brazilian tertiary center, between March and August 2020, were reviewed. A total of 2,441 (68%) patients had cardiac troponin T determined in the first 72 h of admission and were stratified into two groups: elevated cardiac troponin T (cardiac troponin T >0.014 ng/mL) and normal cardiac troponin T. Associations between troponin, comorbidities, biomarkers, and outcomes were assessed. Regression models were built to assess the association of several variables with in-hospital mortality. RESULTS: A total of 2,441 patients were embraced, of which 924 (38%) had normal cardiac troponin T and 1,517 (62%) had elevated cardiac troponin T. Patients with elevated cardiac troponin T were older and had more comorbidities, such as cardiovascular disease, hypertension, diabetes, arrhythmia, renal dysfunction, liver disease, stroke, cancer, and dementia. Patients with abnormal cardiac troponin T also had more altered laboratory parameters on admission (i.e., leukocytes, C-reactive protein, D-dimer, and B-type natriuretic peptide), as well as more need for intensive care unit, vasoactive drugs, mechanical ventilation, dialysis, and blood transfusion. All-cause mortality was markedly higher among patients with increased cardiac troponin T (42 vs. 16%, P<0.001). Multiple regression analysis demonstrated that in-hospital mortality was not independently associated with troponin elevation. CONCLUSION: This study showed that cardiac troponin T elevation at admission was common and associated with several comorbidities, biomarkers, and clinical outcomes in patients hospitalized with coronavirus disease-2019, but it was not an independent marker of in-hospital mortality.

Abnormal release of cardiac biomarkers in the presence of myocardial oedema evaluated by cardiac magnetic resonance after uncomplicated revascularization procedures.

AIMS: To analyse the association of myocardial oedema (ME), observed as high T2 signal intensity (HT2) in cardiac magnetic resonance imaging, with the release of cardiac biomarkers, ventricular ejection, and clinical outcomes after revascularization. METHODS AND RESULTS: Patients with stable coronary artery disease with the indication for revascularization were included. Biomarker levels [troponin I (cTnI) and creatine kinase MB (CK-MB)] and T2-weighted and late gadolinium enhancement (LGE) images were obtained before and after the percutaneous or surgical revascularization procedures. The association of HT2 with the levels of biomarkers, with and without LGE, evolution of left ventricular ejection fraction (LVEF), and 5-year clinical outcomes were assessed. A total of 196 patients were divided into 2 groups: Group 1 (HT2, 40) and Group 2 (no HT2, 156). Both peak cTnI (8.9 and 1.6 ng/mL) and peak CK-MB values (44.7 and 12.1 ng/mL) were significantly higher in Group 1. Based on the presence of new LGE, patients were stratified into Groups A (no HT2/LGE, 149), B (HT2, 9), C (LGE, 7), and D (both HT2/LGE, 31). The peak cTnI and CK-MB values were 1.5 and 12.0, 5.4 and 44.7, 5.0 and 18.3, and 9.8 and 42.8 ng/mL in Groups A, B, C, and D, respectively, and were significantly different. The average LVEF decreased by 4.4% in Group 1 and increased by 2.2% in Group 2 (P = 0.057). CONCLUSION: ME after revascularization procedures was associated with increased release of cardiac necrosis biomarkers, and a trend towards a difference in LVEF, indicating a role of ME in cardiac injury after interventions.

Myocardial tissue microstructure with and without stress-induced ischemia assessed by T1 mapping in patients with stable coronary artery disease.

BACKGROUND: Stress-induced myocardial ischemia seems not to be associated with cardiovascular events. However, its effects on myocardial tissue characteristics remain under debate. Thus, we sought to assess whether documented stress-induced ischemia is associated with changes in myocardial microstructure evaluated by magnetic resonance native T1 map and extracellular volume fraction (ECV). METHODS: This is a single-center, analysis of the previously published MASS V Trial. Multivessel patients with a formal indication for myocardial revascularization and with documented stress-induced ischemia were included in this study. Native T1 and ECV values evaluated by cardiac magnetic resonance imaging of ischemic and nonischemic myocardial segments at rest and after stress were compared. Myocardial ischemia was detected by either nuclear scintigraphy or stress magnetic cardiac resonance protocol. RESULTS: Between May 2012 and March 2014, 326 prospective patients were eligible for isolated CABG or PCI and 219 were included in the MASS V trial. All patients underwent resting cardiac magnetic resonance imaging. Of a total of 840 myocardial segments, 654 were nonischemic segments and 186 were ischemic segments. Native T1 and ECV values of ischemic segments were not significantly different from nonischemic segments, both at rest and after stress induction. In addition, native T1 and ECV values of myocardial segments supplied by vessels with obstructive lesions were similar to those supplied by nonobstructive ones. CONCLUSION AND RELEVANCE: In this study, cardiac magnetic resonance identified similar T1 mapping values between ischemic and nonischemic myocardial segments. This finding suggests integrity and stability of myocardial tissue in the presence of stress-induced ischemia.

The safety of SGLT-2 inhibitors in diabetic patients submitted to elective percutaneous coronary intervention regarding kidney function: SAFE-PCI pilot study.

BACKGROUND: Percutaneous coronary intervention (PCI) is one of the most performed well-succeeded therapeutic procedures worldwide, reducing symptoms and improving quality of life. Neutrophil Gelatinase-associated Lipocalin (NGAL) is a biomarker of acute kidney injury (AKI) produced early after an ischemic renal insult. Osmotic diuresis and the vasoconstriction of the afferent arteriole promoted by Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) generate a concern regarding the possibility of dehydration and consequent AKI. There is no consensus on the maintenance or discontinuation of SGTL2i in patients who will undergo PCI. This study aimed to evaluate the safety of empagliflozin in diabetic patients submitted to elective PCI regarding kidney function. METHODS: SAFE-PCI trial is a prospective, open-label, randomized (1:1), single-center pilot study and a follow-up of 30 days. The SGLT2i empagliflozin 25 mg daily was initiated at least 15 days before PCI in the intervention group and maintained until the end of the follow-up period. Serum NGAL was collected 6 h after PCI and creatinine before PCI, 24 h, and 48 h after the procedure. As per protocol, both groups received optimal medical treatment and standard protocol of nephroprotection. RESULTS: A total of 42 patients were randomized (22 patients in the iSGLT-2 group and 20 patients in the control group). There was no difference between-group baseline data. The primary outcome (NGAL and creatinine values post PCI) did not differ in both groups: the mean NGAL value was 199 ng/dL in the empagliflozin group and 150 ng/dL in the control group (p = 0.249). Although there was an initial increase in creatinine in the SGLT-2i group compared to the control group between baseline creatinine and pre-PCI and 24 h post-PCI creatinine, no difference was detected in creatinine 48 h post-PCI (p = 0.065). The incidence of CI-AKI, determined by KDIGO criteria, in the iSGLT2-group was 13.6% and 10.0% in the control group without statistical difference. CONCLUSION: The present study showed that the use of empagliflozin is safe regarding kidney function during elective PCI in patients with T2D when compared with no use of SGLT2i. Trial registration Our clinical study is registered on ClinicalTrials.gov with the following number: NCT05037695.

Cardiovascular events in patients with coronary artery disease with and without myocardial ischemia: Long-term follow-up.

BACKGROUND: After the results of the ISCHEMIA Trial, the role of myocardial ischemia in the prognosis of coronary artery disease (CAD) was under debate. We sought to comparatively evaluate the long-term prognosis of patients with multivessel CAD with or without documented myocardial ischemia. METHODS: This is a single-center, retrospective, observational cohort study that included patients with CAD obtained from the research protocols database of "The Medicine, Angioplasty or Surgery Study," the MASS Study Group. Patients were stratified according to the presence or absence of myocardial ischemia. Cardiovascular events (overall mortality and myocardial infarction) were tracked from the registry entry up to a median follow-up of 8.7 years. Myocardial ischemia was assessed at baseline by a functional test with or without imaging. RESULTS: From 1995 to 2018, 2015 patients with multivessel CAD were included. Of these, 1001 presented with conclusive tests at registry entry, 790 (79%) presenting with ischemia and 211 (21%) without ischemia. The median follow-up was 8.7 years (IQR 4.04 to 10.07). The primary outcome occurred in 228 (28.9%) patients with ischemia and in 64 (30.3%) patients without ischemia (plog-rank=0.60). No significant interaction was observed with the presence of myocardial ischemia and treatment strategies in the occurrence of the combined primary outcome (pinteration=0.14). CONCLUSIONS: In this sample, myocardial ischemia was not associated with a worse prognosis compared with no ischemia in patients with multivessel CAD. These results refer to debates about the role of myocardial ischemia in the occurrence of cardiovascular events.

Acompanhamento de Dois Anos de Pacientes com Cardiopatia Isquêmica Crônica em um Centro Especializado no Brasil / Two-Year Follow-Up of Chronic Ischemic Heart Disease Patients in a Specialized Center in Brazil

Resumo Fundamento A incidência de eventos cardiovasculares em pacientes com doença cardíaca isquêmica crônica (DCIC) pode variar significativamente entre os países. Embora populoso, o Brasil é frequentemente sub-representado nos registros internacionais. Objetivos Este estudo teve como objetivo descrever a qualidade do atendimento e a incidência de eventos cardiovasculares em dois anos, além de fatores prognósticos associados em pacientes com DCIC em um centro terciário de saúde pública no Brasil. Métodos Pacientes com DCIC que compareceram para avaliação clínica no Instituto do Coração (São Paulo, Brasil) foram cadastrados e acompanhados por dois anos. O desfecho primário foi um composto de infarto do miocárdio (IM), acidente vascular encefálico ou morte. Um nível de significância de 0,05 foi adotado. Resultados De janeiro de 2016 a dezembro de 2018, 625 participantes foram incluídos no estudo. As características basais mostram que 33,1% eram mulheres, a idade mediana era de 66,1 [59,6 - 71,9], 48,6% tinham diabetes, 83,1% tinham hipertensão, 62,6% tinham IM prévio e 70,4% passaram por algum procedimento de revascularização. Em um acompanhamento mediano de 881 dias, 37 (7,05%) desfechos primários foram observados. Após ajustes, idade, acidente vascular encefálico prévio e colesterol LDL foram independentemente associados ao desfecho primário. Comparando a linha de base com o acompanhamento, os participantes relataram alívio da angina com base na escala da Sociedade Cardiovascular Canadense (SCC) de acordo com as seguintes porcentagens: 65,7% vs. 81,7% eram assintomáticos e 4,2% vs. 2,9% eram SCC 3 ou 4 (p < 0,001). Eles também relataram melhor qualidade na prescrição de medicamentos: 65,8% vs. 73,6% (p < 0,001). No entanto, não houve melhora no colesterol LDL ou no controle da pressão arterial. Conclusão O presente estudo mostra que pacientes com DCIC apresentaram uma incidência de 7,05% do desfecho primário composto em um período de dois anos, sendo a diminuição do colesterol LDL o único fator de risco modificável associado ao prognóstico.

Abstract Background The incidence of cardiovascular events in patients with chronic ischemic heart disease (CIHD) may vary significantly among countries. Although populous, Brazil is often underrepresented in international records. Objectives This study aimed to describe the quality of care and the two-year incidence of cardiovascular events and associated prognostic factors in CIHD patients in a tertiary public health care center in Brazil. Methods Patients with CIHD who reported for clinical evaluation at Instituto do Coração (São Paulo, Brazil) were registered and followed for two years. The primary endpoint was a composite of myocardial infarction (MI), stroke, or death. A significance level of 0.05 was adopted. Results From January 2016 to December 2018, 625 participants were included in the study. Baseline characteristics show that 33.1% were women, median age 66.1 [59.6 - 71.9], 48.6% had diabetes, 83.1% had hypertension, 62.6% had previous MI, and 70.4% went through some revascularization procedure. At a median follow-up (FU) of 881 days, we noted 37 (7.05%) primary endpoints. After adjustments, age, previous stroke, and LDL-cholesterol were independently associated with the primary endpoint. Comparing baseline versus FU, participants experienced relief of angina based on the Canadian Cardiovascular Society (CCS) scale according to the following percentages: 65.7% vs. 81.7% were asymptomatic and 4.2% vs. 2.9% CCS 3 or 4 (p < 0.001). They also experienced better quality of medication prescription: 65.8% vs. 73.6% (p < 0.001). However, there was no improvement in LDL-cholesterol or blood pressure control. Conclusion This study shows that CIHD patients had a two-year incidence of the primary composite endpoint of 7.05%, and the reduction of LDL-cholesterol was the only modifiable risk factor associated with prognosis.

Coronavirus disease-2019 and heart: assessment of troponin and cardiovascular comorbidities as prognostic markers in patients hospitalized with coronavirus disease-2019 in a tertiary center in Brazil

SUMMARY OBJECTIVE: Our study aimed to evaluate the correlation of cardiac troponin T levels with comorbidities and in-hospital outcomes in patients with coronavirus disease-2019 in Brazil. METHODS: Data from a cohort of 3,596 patients who were admitted with suspected coronavirus disease-2019 in a Brazilian tertiary center, between March and August 2020, were reviewed. A total of 2,441 (68%) patients had cardiac troponin T determined in the first 72 h of admission and were stratified into two groups: elevated cardiac troponin T (cardiac troponin T >0.014 ng/mL) and normal cardiac troponin T. Associations between troponin, comorbidities, biomarkers, and outcomes were assessed. Regression models were built to assess the association of several variables with in-hospital mortality. RESULTS: A total of 2,441 patients were embraced, of which 924 (38%) had normal cardiac troponin T and 1,517 (62%) had elevated cardiac troponin T. Patients with elevated cardiac troponin T were older and had more comorbidities, such as cardiovascular disease, hypertension, diabetes, arrhythmia, renal dysfunction, liver disease, stroke, cancer, and dementia. Patients with abnormal cardiac troponin T also had more altered laboratory parameters on admission (i.e., leukocytes, C-reactive protein, D-dimer, and B-type natriuretic peptide), as well as more need for intensive care unit, vasoactive drugs, mechanical ventilation, dialysis, and blood transfusion. All-cause mortality was markedly higher among patients with increased cardiac troponin T (42 vs. 16%, P<0.001). Multiple regression analysis demonstrated that in-hospital mortality was not independently associated with troponin elevation. CONCLUSION: This study showed that cardiac troponin T elevation at admission was common and associated with several comorbidities, biomarkers, and clinical outcomes in patients hospitalized with coronavirus disease-2019, but it was not an independent marker of in-hospital mortality.

Long-term analysis of ventricular function in patients with symptomatic coronary disease who underwent on-pump or off-pump coronary artery bypass grafting.

BACKGROUND: Systemic deleterious effects of cardiopulmonary bypass have been observed in the postprocedural period. Long-term assessment, including ventricular function (VF), is unclear. The objective of this study was to compare the change of left ventricular ejection fractions (LVEFs) during a long-term follow-up of coronary artery disease (CAD) patients who underwent off-pump (OPCAB) or on-pump coronary artery bypass grafting (ONCAB). METHODS: This study is a prespecified analysis of the MASS III trial, which was a single-center and prospective study that enrolled stable CAD patients with preserved VF. The CAD patients in our study were randomized to OPCAB or ONCAB. A transthoracic echocardiogram was performed during follow-up and a LVEF value was obtained. The primary endpoint was the difference between the final LVEF and the baseline LVEF. RESULTS: Of the 308 randomized patients, ventricular function were observed in 225 over a mean of 5.9 years of follow-up: 113 in the ONCAB group and 112 in the OPCAB group. Baseline characteristics were similar between the two groups, but there was a larger proportion of subjects with 3-vessel disease in the ONCAB group. There was no difference in the LVEF at the beginning (P = 0.08), but there was a slight decrease in the LVEF in the ONCAB and OPCAB groups (P < 0.001 in both groups) at 5.9 years. The decline was not significantly different between the two groups (delta of -6% for ONCAB and -5% for OPCAB; P = 0.78). In a multivariate analysis, myocardial infarction in the follow-up was a predictor of an LVEF < 40%. CONCLUSIONS: There was no difference in the long-term development of ventricular function between the surgical techniques, despite a decline in the LVEF in both groups. Trial registration Clinical Trial Registration Information-URL: http://www.controlled-trials.com . REGISTRATION NUMBER: ISRCTN59539154. Date of first registration: 10/03/2008.

Evaluation of cardiovascular risk biomarkers after moderate consumption of red wine and cachaça in a randomized crossover trial: The Wine and Cachaça Study (WICAS).

INTRODUCTION: Moderate daily consumption of alcohol (MDCA) is associated with cardiovascular risk (CVR) reduction in observational studies. Some researches have suggested that this benefit may be associated not only with red wine consumption but also with other beverages. However, there are no clinical trials evaluating the possible CVR benefit of Brazilian spirit (cachaça) in humans. METHODS: This is a prospective, randomized, crossover study including healthy individuals initially assigned to a MDCA of cachaça or red wine for a period of 4 weeks. After a one-week abstinence period, the type of drink was changed for another 4 weeks of intervention. The MDCA for both beverages was determined as a dose equivalent to 28 g of ethanol per day for men and 14 g for women. CVR biomarkers analyses were performed before and after each intervention to assess the serologic status of C-reactive protein, lipid profile, platelet aggregation and glycemic profile. This study is registered on the ISRCTN platform under number 15978506. RESULTS: Of the 42 subjects initially randomized, 2 refused to continue in the study. The median age was 44.3 ± 10.3 years and 19 were male (47.5%). Adherence to the protocol was considered ideal with 100% regular use in both interventions and only 3 individuals in each intervention group reported alcohol abuse. There was no significant variation in anthropometric measurements during the study, except for weight gain (0.7 kg) in the red wine group (p = 0.005). The median of the delta of platelet aggregation for MDCA of cachaça was 1.2% (-1.1 to 5.3) and the median of the delta to the MDCA of wine was -1.6% (-4.5 to 2) (p = 0.02). The other biomarkers didn't show any statistically significant variation. CONCLUSION: Moderate consumption of wine and cachaça was related to variation in laboratory biomarkers of CVR related to atherosclerosis. There was significant weight gain during the period of wine consumption and there was observed a difference between platelet aggregation values after both interventions.

Quality improvement program in Latin America decreases mortality after cardiac surgery: a before-after intervention study.

BACKGROUND: The current challenge of cardiac surgery (CS) is to improve outcomes in adverse scenarios. The aim of this study was to assess the impact of a quality improvement program (QIP) on hospital mortality in the largest CS center in Latin America. METHODS: Patients were divided into two groups: before (Jan 2013-Dec 2015, n = 3534) and after establishment of the QIP (Jan 2017-Dec 2019, n = 3544). The QIP consisted of the implementation of 10 central initiatives during 2016. The procedures evaluated were isolated coronary artery bypass grafting surgery (CABG), mitral valve surgery, aortic valve surgery, combined mitral and aortic valve surgery, and CABG associated with heart valve surgery. Propensity Score Matching (PSM) was used to adjust for inequality in patients' preoperative characteristics before and after the implementation of QIP. A multivariate logistic regression model was built to predict hospital mortality and validated using discrimination and calibration metrics. RESULTS: The PMS paired two groups using 5 variables, obtaining 858 patients operated before (non-QIP) and 858 patients operated after the implementation of the QIP. When comparing the QIP versus Non-QIP group, there was a shorter length of stay in all phases of hospitalization. In addition, the patients evolved with less anemia (P = 0.001), use of intra-aortic balloon pump (P = 0.003), atrial fibrillation (P = 0.001), acute kidney injury (P < 0.001), cardiogenic shock (P = 0.011), sepsis (P = 0.046), and hospital mortality (P = 0.001). In the multiple model, among the predictors of hospital mortality, the lack of QIP increased the chances of mortality by 2.09 times. CONCLUSION: The implementation of a first CS QIP in Latin America was associated with a reduction in length of hospital stay, complications and mortality after the cardiac surgeries analyzed.

Surgical and percutaneous revascularization outcomes based on SYNTAX I, II, and residual scores: a long-term follow-up study.

BACKGROUND: The objective of this study was to evaluate the association of SYNTAX scores I, II, and residual with cardiovascular outcomes of patients undergoing coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) and compare both procedures in a long-term follow-up. METHODS: This is a retrospective single-center study from the MASS registry at the Heart Institute of the University of São Paulo, Brazil in which 969 patients with stable coronary artery disease undergoing CABG (559) or PCI (410) were included. We assessed the SYNTAX scores I, II and residual in both interventions. Clinical endpoints were the first occurrence of a composite of overall death, myocardial infarction, stroke, or repeat revascularization (MACCE) and the total occurrence of each component of MACCE. RESULTS: In the CABG sample, SSI had a median of 23 (IQR 17-29.5), median SSII of 25.4 (IQR 19.2-32.8), and median rSS of 2 (IQR 0-6.5); in PCI SSI had a median of 14 (IQR 10-19.1), median SSII of 28.7 (IQR 23-34.2), and median rSS of 4.7 (IQR 0-9). Total of 174 events were documented and CABG patients had a lower rate of MACCE (15.6% vs. 21.2%; adjusted HR 1.98; 95% CI 1.13-3.47; P = 0.016) and repeat revascularization (3.8% vs. 11.5%; adjusted HR 4.35; CI 95% 1.74-10.85; P = 0.002) compared with PCI. No SYNTAX score tertile found a difference in death rate between procedures. In a multivariate analysis, the rSS was an independent predictor for MACCE (HR 1.04; 95% CI 1.01-1.06; P = 0.001). Regarding death, the only independent predictors were ejection fraction and renal function. CONCLUSION: Surgical revascularization resulted in a more complete revascularization and lower rates of major cardiac or cerebrovascular events in a long-term follow-up. Also, grading the incompleteness of revascularization through the residual SYNTAX score identified a higher event rate, suggesting that complete revascularization is associated with a better prognosis.

Effect of diabetic kidney disease on therapeutic strategies for coronary artery disease: ten year follow-up.

BACKGROUND: The best treatment for coronary artery disease (CAD) in patients with type 2 diabetes (DM2) and chronic kidney disease is unknown. METHODS: This retrospective study included MASS registry patients with DM2 and multivessel CAD, stratified by kidney function. Primary endpoint was combined of mortality, myocardial infarction, or additional revascularization. RESULTS: Median follow-up was 9.5 years. Primary endpoint occurrences among strata 1 and 2 were 53.4% and 40.7%, respectively (P=.020). Mortality rates were 37.4% and 24.6% in strata 1 and 2, respectively (P<.001). We observed a lower rate of major adverse cardiovascular events (MACE) (P=.027 for stratum 1 and P<.001 for stratum 2) and additional revascularization (P=.001 for stratum 1 and P<.001 for stratum 2) for those in the surgical group. In a multivariate analysis, eGFR was an independent predictor of MACE (P=.034) and mortality (P=.020). CONCLUSIONS: Among subjects with DM2 and CAD the presence of lower eGFR rate was associated with higher rates of MACE and mortality, irrespective of treatment choice. CABG was associated with lower rates of MACE in both renal function strata. eGFR was an independent predictor of MACE and mortality in a 10-year follow-up.

Most deaths in low-risk cardiac surgery could be avoidable.

It is observed that death rates in cardiac surgery has decreased, however, root causes that behave like triggers of potentially avoidable deaths (AD), especially in low-risk patients (less bias) are often unknown and underexplored, Phase of Care Mortality Analysis (POCMA) can be a valuable tool to identify seminal events (SE), providing valuable information where it is possible to make improvements in the quality and safety of future procedures. Our results show that in São Paul State, only one third of AD in low-risk cardiac surgery was related to specific surgical problems. After a revisited analysis, 75% of deaths could have been avoided, which in the pre-operative phase, the SE was related judgment, patient evaluation and preparation. In the intra-operative phase, most occurrences could have been avoided if other surgical technique had been used. Sepsis was responsible for 75% of AD in the intensive care unit. In the ward phase, the recognition/management of clinical decompensations and sepsis were the contributing factors. Logistic regression model identified age, previous coronary stent implantation, coronary artery bypass grafting + heart valve surgery, ≥ 2 combined heart valve surgery and hospital-acquired infection as independent predictors of AD.

COVID-19-associated euglycemic diabetic ketoacidosis in a patient with type 2 diabetes on SGLT2 inhibitor: a case report.

Type 2 diabetes mellitus (DM) patients are at high risk for the development of severe COVID-19. Euglycemic diabetic ketoacidosis (eu-DKA) is a rare life-threatening complication associated with the use of SGLT2 inhibitor that may be unnoticed, particularly in a pandemic setting, due to the absence of significant hyperglycemia, delaying its treatment. In this report, we describe a case of a 56-year-old patient who presented an elevated anion gap metabolic acidosis during a SARS-CoV-2 infection and was diagnosed with SGLT2-associated euglycemic diabetic ketoacidosis. COVID-19 may increase patients' insulin demand, present gastrointestinal symptoms, and increase the production of ketone bodies. This situation can be worsened in susceptible diabetic patients on SLGT2 inhibitors, due to the persistent glycosuria, which can cause volume depletion. Recently some authors recommended that insulin-deficient patients or those using SGLT2 inhibitors should monitor for ketosis using available home testing kits in case of infections and should discontinue the medication in case of COVID-19. Given the increased use of this drug class in the management of type 2 DM patients due to its reduction of cardiovascular risk, we set out to emphasize the importance for the medical community to consider the possibility of eu-DKA on SARS-CoV-2-infected patients using SLGT2 inhibitors, so physicians can provide these patients with appropriate therapy promptly.

Occurrence of recently diagnosed atrial fibrillation in the immediate postoperative period of myocardial revascularization surgery. Although common, a devalued complication.

Atrial fibrillation (AF) is the most common arrhythmia in the postoperative period of cardiac surgery, with a prevalence between 15-40% after coronary artery bypass surgery (CABG). Several strategies have been tested for the prevention and management of AF postoperatively. Previous studies and analysis of records have shown higher rates of hospitalization and clinical outcomes associated with this entity, including increased mortality in the short- and long-term. This perspective reviews the topic, and offers recommendations for the management of this arrhythmia in the postoperative period of CABG, with a special focus on anticoagulation strategies.