Publications by authors named "Marcelo Franken"

33 Publications

The Finnish Diabetes Risk Score (FINDRISC), incident diabetes and low-grade inflammation.

Diabetes Res Clin Pract 2021 Jan 23;171:108558. Epub 2020 Nov 23.

Hospital Israelita Albert Einstein, São Paulo, SP, Brazil; Heart Institute (InCor) University of Sao Paulo Medical School Hospital, Sao Paulo, Brazil.

Aims: The FINDRISC was created to predict the development of type 2 diabetes mellitus (T2DM). Since T2DM associates with inflammation we evaluated if the FINDRISC could predict either current or incident T2DM, and elevated high sensitivity C-reactive protein (hs-CRP).

Methods: 41,880 people (age 41.9 ± 9.7 years; 31% female) evaluated between 2008 and 2016 were included. First, the cross-sectional association between the FINDRISC with presence of either T2DM or hs-CRP ≥ 2.0 mg/L was tested. After a 5 ± 3 years follow-up we tested the score predictive value for incident T2DM and inflammation in respectively 10,559 individuals without diabetes and in a subset of 2,816 individuals having no elevated hs-CRP at baseline.

Results: In the cross sectional analysis the FINDRISC was associated with both T2DM (OR 1.24, 95% CI: 1.23-1.26, P < 0.001) and inflammation (OR 1.10, 95% CI: 1.09-1.11, P < 0.001) per FINDRISC unit, as well as in longitudinal analyses (OR 1.17, 95% CI: 1.14-1.20, P < 0.001; and OR 1.04, 95% CI: 1.02-1.07, P < 0.001; respectively, per FINDRISC unit). The C-statistic for incident T2DM and inflammation was 0.79 (95% CI 0.77-0.82) and 0.55 (95% CI 0.53-0.58), respectively.

Conclusion: The FINDRISC shows good discrimination for incident T2DM but less for inflammation.
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http://dx.doi.org/10.1016/j.diabres.2020.108558DOI Listing
January 2021

Cluster of climatic and pollutant characteristics increases admissions for acute myocardial infarction: Analysis of 30,423 patients in the metropolitan area of Sao Paulo.

Heart Lung 2020 Nov 20;50(2):161-165. Epub 2020 Nov 20.

Heart Institute (InCor) - University of São Paulo Medical School, São Paulo, Brazil; Insituto Prevent Senior, São Paulo, Brazil. Electronic address:

Background: The impact of simultaneous adverse climate conditions in the risk of myocardial infarction (MI) was not tested before. The aim of the present study was to investigate the impact of the combination of climate and air pollution features in the number of admissions and mortality due to acute myocardial infarction in 39 municipalities of São Paulo from 2012 to 2015.

Methods: Data about MI admissions were obtained from the Brazilian public health system (DataSUS). Daily information on weather were accessed from the Meteorological Database for Teaching and Research. Additionally, daily information on air pollution were obtained from the Environmental Company of the State of São Paulo. A hierarchical cluster analysis was applied for temperature, rainfall patterns, relative air humidity, nitrogen dioxide, particulate matter 2.5 and particulate matter 10. MI admissions and in-hospital mortality were compared among the clusters.

Results: Data analysis produced 3 clusters: High temperature variation-Low humidity-high pollution (n=218 days); Intermediate temperature variation/high humidity/intermediate pollution (n=751 days) and low temperature variation/intermediate humidity-low pollution (n=123 days). All environmental variables were significantly different among clusters. The combination of high temperature variation, dry weather and high pollution resulted in a significant 9% increase in hospital admissions for MI [30.5 (IQR 25.0-36.0)]; patients/day; P<0.01). The differences in weather and pollution did not have impact on in-hospital mortality (P=0.88).

Conclusion: The combination of atmospheric conditions with high temperature variation, lower temperature, dryer weather and increased inhalable particles was associated with a marked increase of hospital admissions due to MI.
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http://dx.doi.org/10.1016/j.hrtlng.2020.04.018DOI Listing
November 2020

Robotic-assisted intervention strategy to minimize air exposure during the procedure: a case report of myocardial infarction and COVID-19.

Cardiovasc Diagn Ther 2020 Oct;10(5):1345-1351

Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil.

Percutaneous coronary interventions (PCI) is traditionally a manual procedure executed by one or more operators positioned at a close distance from the patient. The ongoing pandemic of coronavirus disease 2019 (COVID-19) has imposed severe restrictions to such an interventional environment. The novel SARS-CoV-2 virus that causes COVID-19 is transmitted mainly through expelled respiratory particles, which are known to travel approximately 3-6 feet away from infected persons. During PCI, that contamination range obligatorily poses the team and the patient to direct air exposure. We herein present a case report with the description of a minimum-contact strategy to reduce interpersonal air exposure during PCI. The approach designed to minimize proximity between the patient and the healthcare team included the performance of robotic-assisted PCI, operated by unscrubbed cardiac interventionalists from a control cockpit located outside the catheterization suite. Also included, was the delineation of the potential zone of respiratory particle spread; a circle measuring 4 meters (13.1 feet) in diameter was traced on the floor of the cath lab with red tape, centered on the patient's mouth and nose. The team was rigorously trained and advised to minimize time spent within the 4-meter perimeter as much as possible during the procedure. Following this strategy, a 60-year-old male with non-ST-elevation myocardial infarction and COVID-19 was treated with successful coronary implantation of two stents in the obtuse marginal branch and one stent in the circumflex artery. The total duration of the procedure was 103 minutes and 22 seconds. During most of the procedure, the 4-meter spread zone was not entered by any personnel. For each individual team member, the proposed strategy was effective in ensuring that they stayed outside of the 4-meter area for the majority of their work time, ranging from 96.9% to 59.7% of their respective participation. This case report illustrates the potential of robotic-assisted percutaneous coronary intervention in reducing physical proximity between the team and the patient during the procedure.
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http://dx.doi.org/10.21037/cdt-20-521DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7666926PMC
October 2020

Comparison of contractility patterns on left ventriculogram versus longitudinal strain by echocardiography in patients with Takotsubo Cardiomyopathy.

Cardiovasc Revasc Med 2020 Jul 25. Epub 2020 Jul 25.

Hospital Israelita Albert Einstein, São Paulo, Brazil; Instituto do Coração (InCor), Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil.

Background: Takotsubo Cardiomyopathy (TTC) is characterized by transient left ventricular (LV) dysfunction, electrocardiographic changes that can mimic acute myocardial infarction (MI), and release of myocardial enzymes in the absence of obstructive coronary artery disease (CAD). Conventionally, gross visual assessment of LV angiogram has been used to classify TTC. We aim to compare quantitative assessment of different regions of LV on angiogram and segmental strain on transthoracic echo to determine a better way to classify TTC rather than conventional qualitative visual assessment.

Methods: We conducted a retrospective observational study of 20 patients diagnosed with TTC who had LV angiogram and transthoracic echocardiograms performed on presentation that were suitable for analysis. 20 LV angiograms were analyzed using Rubo DICOM viewer software. Area of different LV regions were measured in diastole and systole, and percentage change in area of these regions were calculated. Percentage change in area of less than 10% was considered "akinetic". On the other hand, using echocardiograms of these patients, LV regional longitudinal strain (LS) was derived from speckle tracking analysis. These findings were compared to determine concordance between both modalities.

Results: On quantitative analysis of 20 LV angiograms, the area of all the three LV regional (apex, mid ventricle and base) shortening (>10%) was observed in 16 patients (80%) during systole as compared to diastole. However, only 4 out of 20 patients (20%) were noted to have apical region area change of <10% between diastole and systole. Analysis of LV regional LS patterns of 20 patients showed that 14 patients had abnormal values (> -18%) in all three LV regions- apex, mid ventricle and base. The apical region has the most severely affected region (mean LS -13.9%), followed by the basal region (mean -14.7%) and the mid ventricular region (mean -15.1%). Comparing the results of both modalities showed that there was 35% (n = 7) concordance in the results noted for base and apical regions of the LV, whereas, only 20% (n = 4) concordance was noted in mid ventricular region.

Conclusion: Contractility (shortening) on LV angiogram is present in majority of patients in the three LV regions, but contractility assessed by LS is impaired in most of them. The concordance in both quantitative assessment modalities was low. LV angiogram may not be an accurate imaging modality to assess contractility patterns in Takotsubo patients and echocardiographic LS analysis should be taken as the preferred imaging modality.
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http://dx.doi.org/10.1016/j.carrev.2020.07.021DOI Listing
July 2020

Intensive support recommendations for critically-ill patients with suspected or confirmed COVID-19 infection.

Einstein (Sao Paulo) 2020 3;18:eAE5793. Epub 2020 Jun 3.

Hospital Israelita Albert Einstein , São Paulo , SP , Brazil .

In December 2019, a series of patients with severe pneumonia were identified in Wuhan, Hubei province, China, who progressed to severe acute respiratory syndrome and acute respiratory distress syndrome. Subsequently, COVID-19 was attributed to a new betacoronavirus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Approximately 20% of patients diagnosed as COVID-19 develop severe forms of the disease, including acute hypoxemic respiratory failure, severe acute respiratory syndrome, acute respiratory distress syndrome and acute renal failure and require intensive care. There is no randomized controlled clinical trial addressing potential therapies for patients with confirmed COVID-19 infection at the time of publishing these treatment recommendations. Therefore, these recommendations are based predominantly on the opinion of experts (level C of recommendation).
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http://dx.doi.org/10.31744/einstein_journal/2020AE5793DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7259830PMC
June 2020

Short- and Midterm Adherence to Platelet P2Y12 Receptor Inhibitors After Percutaneous Coronary Intervention With Drug-Eluting Stents.

J Cardiovasc Pharmacol Ther 2020 09 18;25(5):466-471. Epub 2020 May 18.

Department of Cardiology, Hospital Israelita Albert Einstein, São Paulo, Brazil.

Introduction/objectives: In patients who have undergone recent percutaneous coronary intervention (PCI), poor adhesion to antiplatelet agents may increase the risk of stent thrombosis and death. We aimed to investigate the adherence to different P2Y12 receptor inhibitors after PCI with drug-eluting stent in stable and unstable patients and to evaluate the factors associated with low adherence.

Method: In a prospective study conducted between 2014 and 2018, the 8-item Morisky scale was applied at 30 days and 6 months post-PCI to measure P2Y12 receptor inhibitors adherence. Also, we describe the characteristics of patients using different platelet receptor P2Y12 inhibitors. Regression models were used to identify predictors of poor adherence.

Results: A total of 214 patients were included (65 ± 12 years, 81% man, 61% acute coronary syndromes). Patients in the clopidogrel group were older than those in the prasugrel (68 ± 12 vs 59 ± 11 years, < .01, respectively) or ticagrelor group (68 ± 12 vs 62 ± 12 years, < .01). Patients with low/moderate adherence at 30 days and 6 months represented, respectively, 19.8% and 27.5% of our sample. Current smokers and preexisting cardiovascular disease at presentation were associated with lower adherence at 30 days.

Conclusions: We found substantial rates of moderate and low adherence to P2Y12 receptor inhibitors early after PCI. Current smokers and preexisting cardiovascular disease at presentation were associated with a lower likelihood of adherence. These results highlight the need of monitoring adherence to medical treatment after PCI.
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http://dx.doi.org/10.1177/1074248420926667DOI Listing
September 2020

Paraganglioma: An Uncommon Cause of Mediastinal Mass.

Circ Cardiovasc Imaging 2020 02 31;13(2):e009693. Epub 2020 Jan 31.

Department of Radiology (M.C., H.S., L.M.N., M.B.G.F., G.S.), Hospital Israelita Albert Einstein, Sao Paulo, Brazil.

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http://dx.doi.org/10.1161/CIRCIMAGING.119.009693DOI Listing
February 2020

Benchmarking as a quality of care improvement tool for patients with ST-elevation myocardial infarction: an NCDR ACTION Registry experience in Latin America.

Int J Qual Health Care 2020 Apr;32(1):A1-A8

Hospital Israelita Albert Einstein, São Paulo, Brazil.

Objective: We aim to examine the effect of benchmarking on quality-of-care metrics in patients presenting with ST-elevation myocardial infarction (STEMI) through the implementation of the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) ACTION Registry.

Design: From January 2005 to December 2017, 712 patients underwent primary percutaneous coronary intervention PCI-499 before NCDR ACTION Registry implementation (prior to 2013) and 213 after implementation.

Setting: STEMI.

Participants: 712 patients.

Intervention(s): Primary PCI.

Main Outcome Measure(s): We examined hospital performance for the quality indicators in processes and outcomes of the management of patients presenting with STEMI. Outcome measures include door-to-balloon time (DBT), antiplatelet therapy and anti-ischemic drugs prescribed at discharge from pre-NCDR ACTION Registry to post-implementation.

Results: There was improvement in DBT, decreasing from 94 min in 2012 (before NCDR adoption) to reach a median of 47 min in 2017 (Ptrend < 0.001). The percentage of cases with the optimal DBT of < 90 min increased from 55.8% before to 90.1% after the implementation of the NCDR ACTION Registry (Ptrend < 0.001). The rate of aspirin (90.3-100%, P < 0.001), P2Y12 inhibitor (70.1-78.4%, P = 0.02), beta-blocker (76.8-100%, P < 0.001) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (60.1-99.5%, P < 0.001) prescribed at discharge increased from pre-NCDR ACTION Registry to post-implementation. Adjusted mortality before and after NCDR ACTION Registry implementation showed significant change (from 9.04 to 5.92%; P = 0.027).

Conclusions: The introduction of the ACC NCDR ACTION Registry led to incremental gains in the quality in STEMI management through the benchmarking of process of care and clinical outcomes, achieving reduced DBT, improving guideline-directed medication adherence and increasing patient safety, treatment efficacy and survival.
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http://dx.doi.org/10.1093/intqhc/mzz115DOI Listing
April 2020

Performance of acute coronary syndrome approaches in Brazil: a report from the BRACE (Brazilian Registry in Acute Coronary SyndromEs).

Eur Heart J Qual Care Clin Outcomes 2020 10;6(4):284-292

Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Enéas de Carvalho Aguiar, 44, Sao Paulo 05403900, Brazil.

Aims: Diagnostic and therapeutic tools have a significant impact on morbidity and mortality associated with acute coronary syndromes (ACS). Data about ACS performance measures are scarce in Brazil, and improving its collection is an objective of the Brazilian Registry in Acute Coronary syndromEs (BRACE).

Methods And Results: The BRACE is a cross-sectional, observational epidemiological registry of ACS patients. Stratified 'cluster sampling' methodology was adopted to obtain a representative picture of ACS. A performance score (PS) varying from 0 to 100 was developed to compare studied parameters. Performance measures alone and the PS were compared between institutions, and the relationship between the PS and outcomes was evaluated. A total of 1150 patients, median age 63 years, 64% male, from 72 hospitals were included in the registry. The mean PS for the overall population was 65.9% ± 20.1%. Teaching institutions had a significantly higher PS (71.4% ± 16.9%) compared with non-teaching hospitals (63.4% ± 21%; P < 0.001). Overall in-hospital mortality was 5.2%, and the variables that correlated independently with in-hospital mortality included: PS-per point increase (OR = 0.97, 95% CI 0.95-0.98, P < 0.001), age-per year (OR = 1.06, 95% CI 1.03-1.09, P < 0.001), chronic kidney disease (OR = 3.12, 95% CI 1.08-9.00, P = 0.036), and prior angioplasty (OR = 0.25, 95% CI 0.07-0.84, P = 0.025).

Conclusions: In BRACE, the adoption of evidence-based therapies for ACS, as measured by the performance score, was independently associated with lower in-hospital mortality. The use of diagnostic tools and therapeutic approaches for the management of ACS is less than ideal in Brazil, with high variability especially among different regions of the country.
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http://dx.doi.org/10.1093/ehjqcco/qcz045DOI Listing
October 2020

Coronary fractional flow reserve derived from intravascular ultrasound imaging: Validation of a new computational method of fusion between anatomy and physiology.

Catheter Cardiovasc Interv 2019 02 12;93(2):266-274. Epub 2018 Sep 12.

Division of Interventional Cardiology, Heart Institute (InCor), University of Sao Paulo Medical School, Sao Paulo, Brazil.

Objectives: To evaluate the diagnostic performance of a novel computational algorithm based on three-dimensional intravascular ultrasound (IVUS) imaging in estimating fractional flow reserve (IVUS ), compared to gold-standard invasive measurements (FFR ).

Background: IVUS provides accurate anatomical evaluation of the lumen and vessel wall and has been validated as a useful tool to guide percutaneous coronary intervention. However, IVUS poorly represents the functional status (i.e., flow-related information) of the imaged vessel.

Methods: Patients with known or suspected stable coronary disease scheduled for elective cardiac catheterization underwent FFR measurement and IVUS imaging in the same procedure to evaluate intermediate lesions. A processing methodology was applied on IVUS to generate a computational mesh condensing the geometric characteristics of the vessel. Computation of IVUS was obtained from patient-level morphological definition of arterial districts and from territory-specific boundary conditions. FFR measurements were dichotomized at the 0.80 threshold to define hemodynamically significant lesions.

Results: A total of 24 patients with 34 vessels were analyzed. IVUS significantly correlated (r = 0.79; P < 0.001) and showed good agreement with FFR , with a mean difference of -0.008 ± 0.067 (P = 0.47). IVUS presented an overall accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of 91%, 89%, 92%, 80%, and 96%, respectively, to detect significant stenosis.

Conclusion: The computational processing of IVUS is a new method that allows the evaluation of the functional significance of coronary stenosis in an accurate way, enriching the anatomical information of grayscale IVUS.
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http://dx.doi.org/10.1002/ccd.27822DOI Listing
February 2019

Circulating osteogenic proteins are associated with coronary artery calcification and increase after myocardial infarction.

PLoS One 2018 23;13(8):e0202738. Epub 2018 Aug 23.

Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.

Background: Coronary artery calcification (CAC) and atherosclerotic inflammation associate with increased risk of myocardial infarction (MI). Vascular calcification is regulated by osteogenic proteins (OPs). It is unknown whether an association exists between CAC and plasma OPs and if they are affected by atherothrombotic inflammation. We tested the association of osteogenic and inflammatory proteins with CAC and assessed these biomarkers after MI.

Methods: Circulating OPs (osteoprotegerin, RANKL, fetuin-A, Matrix Gla protein [MGP]) and inflammatory proteins (C-reactive protein, oxidized-LDL, tumoral necrosis factor-α, transforming growth factor [TGF]-β1) were compared between stable patients with CAC (CAC ≥ 100 AU, n = 100) and controls (CAC = 0 AU, n = 30). The association between biomarkers and CAC was tested by multivariate analysis. In patients with MI (n = 40), biomarkers were compared between acute phase and 1-2 months post-MI, using controls as a baseline.

Results: MGP and fetuin-A levels were higher within individuals with CAC. Higher levels of MGP and RANKL were associated with CAC (OR 3.12 [95% CI 1.20-8.11], p = 0.02; and OR 1.75 [95% CI 1.04-2.94] respectively, p = 0.035). After MI, C-reactive protein, OPG and oxidized-LDL levels increased in the acute phase, whereas MGP and TGF-β1 increased 1-2 months post-MI.

Conclusions: Higher MGP and RANKL levels associate with CAC. These findings highlight the potential role of these proteins as modulators and markers of CAC. In addition, the post-MI increase in OPG and MGP, as well as of inflammatory proteins suggest that the regulation of these OPs is affected by atherothrombotic inflammation.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0202738PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6107213PMC
February 2019

Percutaneous Transhepatic Mitral Valve Repair With the MitraClip System.

JACC Cardiovasc Interv 2018 07 27;11(14):e109-e111. Epub 2018 Jun 27.

Interventional Cardiology Department, Hospital Israelita Albert Einstein, São Paulo, Brazil.

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http://dx.doi.org/10.1016/j.jcin.2018.02.013DOI Listing
July 2018

Increased hospitalizations for decompensated heart failure and acute myocardial infarction during mild winters: A seven-year experience in the public health system of the largest city in Latin America.

PLoS One 2018 4;13(1):e0190733. Epub 2018 Jan 4.

Hospital Israelita Albert Einstein, Sao Paulo, Sao Paulo, Brazil.

Background: In high-income temperate countries, the number of hospitalizations for heart failure (HF) and acute myocardial infarction (AMI) increases during the winter. This finding has not been fully investigated in low- and middle-income countries with tropical and subtropical climates. We investigated the seasonality of hospitalizations for HF and AMI in Sao Paulo (Brazil), the largest city in Latin America.

Methods: This was a retrospective study using data for 76,474 hospitalizations for HF and 54,561 hospitalizations for AMI obtained from public hospitals, from January 2008 to April 2015. The average number of hospitalizations for HF and AMI per month during winter was compared to each of the other seasons. The autoregressive integrated moving average (ARIMA) model was used to test the association between temperature and hospitalization rates.

Findings: The highest average number of hospital admissions for HF and AMI per month occurred during winter, with an increase of up to 30% for HF and 16% for AMI when compared to summer, the season with lowest figures for both diseases (respectively, HF: 996 vs. 767 per month, p<0.001; and AMI: 678 vs. 586 per month, p<0.001). Monthly average temperatures were moderately lower during winter than other seasons and they were not associated with hospitalizations for HF and AMI.

Interpretation: The winter season was associated with a greater number of hospitalizations for both HF and AMI. This increase was not associated with seasonal oscillations in temperature, which were modest. Our study suggests that the prevention of cardiovascular disease decompensation should be emphasized during winter even in low to middle-income countries with tropical and subtropical climates.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0190733PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5754126PMC
February 2018

Treating of aortic valve stenosis in real-life: A multifaceted decision-making challenge.

Catheter Cardiovasc Interv 2017 10;90(4):671-672

Hospital Israelita Albert Einstein - Department of Cardiology, Sao Paulo, Brazil.

In this issue of CCI, Vejpongsa and coworkers showed that TAVR represented 20.4% of all aortic valve replacements performed in elderly patients from 21 US states in the year 2013. Patients treated with SAVR or TAVR largely overlapped in their baseline characteristics, indicating that both modalities concur in everyday life. One out of six patients was readmitted within 30 days, with no significant differences between the TAVR and SAVR in propensity score analysis. One may ask: since the indications of transcatheter and surgical treatments are interchanged for many cases, and the global results look similar, how to finally select the best therapeutic option for an individual case? Would the results be the same if patient-reported outcomes and experiences, such as pain and analgesic use, time to return to routine activities, or quality of life scores were measured? Combining traditional and patient-reported outcomes, in relation to costs, is the optimal approach to assess value in healthcare. Time has come for investigators to adopt value-based healthcare measures as endpoints in registries and clinical trials.
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http://dx.doi.org/10.1002/ccd.27337DOI Listing
October 2017

Value-Based Health Care in Latin America: An Urgent Discussion.

J Am Coll Cardiol 2017 08;70(7):904-906

Hospital Israelita Albert Einstein, Sao Paulo, Brazil.

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http://dx.doi.org/10.1016/j.jacc.2017.06.050DOI Listing
August 2017

Risk and timing of clinical events according to diabetic status of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting stent: 2-year results from a propensity score matched comparison of ABSORB EXTEND and SPIRIT trials.

Catheter Cardiovasc Interv 2018 02 4;91(3):387-395. Epub 2017 May 4.

Department of Interventional Cardiology, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.

Objectives: to compare the occurrence of clinical events in diabetics treated with the Absorb bioresorbable vascular scaffold (Absorb BVS; Abbott Vascular, Santa Clara, CA) versus everolimus-eluting metal stents (EES; XIENCE V; Abbott Vascular, Santa Clara, CA) BACKGROUND: There are limited data dedicated to clinical outcomes of diabetic patients treated with bioresorbable scaffolds (BRS) at 2-year horizon.

Methods: The present study included 812 patients in the ABSORB EXTEND study in which a total of 215 diabetic patients were treated with Absorb BVS. In addition, 882 diabetic patients treated with EES in pooled data from the SPIRIT clinical program (SPIRIT II, SPIRIT III and SPIRIT IV trials) were used for comparison by applying propensity score matching using 29 different variables. The primary endpoint was ischemia driven major adverse cardiac events (ID-MACE), including cardiac death, myocardial infarction (MI), and ischemia driven target lesion revascularization (ID-TLR).

Results: After 2 years, the ID-MACE rate was 6.5% in the Absorb BVS vs. 8.9% in the Xience group (P = 0.40). There was no difference for MACE components or definite/probable device thrombosis (HR: 1.43 [0.24,8.58]; P = 0.69). The occurrence of MACE was not different for both diabetic status (insulin- and non-insulin-requiring diabetes) in all time points up to the 2-year follow-up for the Absorb and Xience groups.

Conclusion: In this largest ever patient-level pooled comparison on the treatment of diabetic patients with BRS out to two years, individuals with diabetes treated with the Absorb BVS had a similar rate of MACE as compared with diabetics treated with the Xience EES. © 2017 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/ccd.27109DOI Listing
February 2018

Mechanical Ventilation and Clinical Outcomes in Patients with Acute Myocardial Infarction: A Retrospective Observational Study.

PLoS One 2016 15;11(3):e0151302. Epub 2016 Mar 15.

Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina, United States of America.

Purpose: Patients with acute myocardial infarction (AMI) and respiratory impairment may be treated with either invasive or non-invasive mechanical ventilation (MV). However, there has been little testing of non-invasive MV in the setting of AMI. Our objective was to evaluate the incidence and associated clinical outcomes of patients with AMI who were treated with non-invasive or invasive MV.

Methods: This was a retrospective observational study in which consecutive patients with AMI (n = 1610) were enrolled. The association between exclusively non-invasive MV, invasive MV and outcomes was assessed by multivariable models.

Results: Mechanical ventilation was used in 293 patients (54% invasive and 46% exclusively non-invasive). In-hospital mortality rates for patients without MV, with exclusively non-invasive MV, and with invasive MV were 4.0%, 8.8%, and 39.5%, respectively (P<0.001). The median lengths of hospital stay were 6 (5.8-6.2), 13 (11.2-4.7), and 28 (18.0-37.9) days, respectively (P<0.001). Exclusively non-invasive MV was not associated with in-hospital death (adjusted HR = 0.90, 95% CI 0.40-1.99, P = 0.79). Invasive MV was strongly associated with a higher risk of in-hospital death (adjusted HR = 3.07, 95% CI 1.79-5.26, P<0.001).

Conclusions: In AMI setting, 18% of the patients required MV. Almost half of these patients were treated with exclusively non-invasive strategies with a favorable prognosis, while patients who needed to be treated invasively had a three-fold increase in the risk of death. Future prospective randomized trials are needed to compare the effectiveness of invasive and non-invasive MV for the initial approach of respiratory failure in AMI patients.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0151302PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4792462PMC
August 2016

Acute management of unstable angina and non-ST segment elevation myocardial infarction.

Einstein (Sao Paulo) 2015 Jul-Sep;13(3):454-61

Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brazil.

Non-ST segment elevation coronary syndrome usually results from instability of an atherosclerotic plaque, with subsequent activation of platelets and several coagulation factors. Its treatment aims to reduce the ischemic pain, limiting myocardial damage and decreasing mortality. Several antiplatelet and anticoagulation agents have been proven useful, and new drugs have been added to the therapeutic armamentarium in the search for higher anti-ischemic efficacy and lower bleeding rates. Despite the advances, the mortality, infarction and readmission rates remain high.
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http://dx.doi.org/10.1590/S1679-45082015RW3172DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4943796PMC
March 2016

Heart failure with preserved left ventricular ejection fraction in patients with acute myocardial infarction.

Arq Bras Cardiol 2015 Aug 29;105(2):145-50. Epub 2015 May 29.

Hospital Israelita Albert Einstein, São Paulo, SP, BR.

Background: The prevalence and clinical outcomes of heart failure with preserved left ventricular ejection fraction after acute myocardial infarction have not been well elucidated.

Objective: To analyze the prevalence of heart failure with preserved left ventricular ejection fraction in acute myocardial infarction and its association with mortality.

Methods: Patients with acute myocardial infarction (n = 1,474) were prospectively included. Patients without heart failure (Killip score = 1), with heart failure with preserved left ventricular ejection fraction (Killip score > 1 and left ventricle ejection fraction ≥ 50%), and with systolic dysfunction (Killip score > 1 and left ventricle ejection fraction < 50%) on admission were compared. The association between systolic dysfunction with preserved left ventricular ejection fraction and in-hospital mortality was tested in adjusted models.

Results: Among the patients included, 1,256 (85.2%) were admitted without heart failure (72% men, 67 ± 15 years), 78 (5.3%) with heart failure with preserved left ventricular ejection fraction (59% men, 76 ± 14 years), and 140 (9.5%) with systolic dysfunction (69% men, 76 ± 14 years), with mortality rates of 4.3%, 17.9%, and 27.1%, respectively (p < 0.001). Logistic regression (adjusted for sex, age, troponin, diabetes, and body mass index) demonstrated that heart failure with preserved left ventricular ejection fraction (OR 2.91; 95% CI 1.35-6.27; p = 0.006) and systolic dysfunction (OR 5.38; 95% CI 3.10 to 9.32; p < 0.001) were associated with in-hospital mortality.

Conclusion: One-third of patients with acute myocardial infarction admitted with heart failure had preserved left ventricular ejection fraction. Although this subgroup exhibited more favorable outcomes than those with systolic dysfunction, this condition presented a three-fold higher risk of death than the group without heart failure. Patients with acute myocardial infarction and heart failure with preserved left ventricular ejection fraction encounter elevated short-term risk and require special attention and monitoring during hospitalization.
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http://dx.doi.org/10.5935/abc.20150055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4559123PMC
August 2015

Prognostic value of serial brain natriuretic Peptide measurements in patients with acute myocardial infarction.

Cardiology 2015 21;131(2):116-21. Epub 2015 Apr 21.

Hospital Israelita Albert Einstein, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

Objectives: Elevated B-type natriuretic peptide (BNP) levels following acute myocardial infarction (AMI) are associated with adverse outcomes. The role of serial BNP monitoring after AMI has been poorly investigated. We aimed to evaluate the prognostic value of in-hospital serial BNP measurements in AMI patients.

Methods: Patients with AMI (n=1,924) were retrospectively evaluated. We selected patients with at least 2 in-hospital BNP measurements. The association between in-hospital mortality and BNP measurements (earliest, highest follow-up and the variation between measurements) were tested in multivariate models.

Results: Serial BNP levels were determined in 176 patients. Compared to the rest of the population, these patients were older and had higher mortality rates. In the adjusted models, only the highest follow-up BNP remained associated with in-hospital death (odds ratio 1.06; 95% confidence interval, CI, 1.01-1.15; p=0.014). Receiver-operating characteristic curve analysis demonstrated that the highest follow-up BNP was the best predictor of in-hospital death (area under the curve=0.75; 95% CI 0.64-0.86).

Conclusions: Serial BNP monitoring was performed in a high-risk subgroup of AMI patients. The highest follow-up BNP was a better predictor of short-term death than the baseline and in-hospital variation values. In AMI patients, a later in-hospital BNP assessment may be more useful than an early measurement.
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http://dx.doi.org/10.1159/000375398DOI Listing
February 2016

Do diabetic patients with acute coronary syndromes have a higher threshold for ischemic pain?

Arq Bras Cardiol 2014 Sep 29;103(3):183-91. Epub 2014 Jul 29.

Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Background: Data from over 4 decades have reported a higher incidence of silent infarction among patients with diabetes mellitus (DM), but recent publications have shown conflicting results regarding the correlation between DM and presence of pain in patients with acute coronary syndromes (ACS).

Objective: Our primary objective was to analyze the association between DM and precordial pain at hospital arrival. Secondary analyses evaluated the association between hyperglycemia and precordial pain at presentation, and the subgroup of patients presenting within 6 hours of symptom onset.

Methods: We analyzed a prospectively designed registry of 3,544 patients with ACS admitted to a Coronary Care Unit of a tertiary hospital. We developed multivariable models to adjust for potential confounders.

Results: Patients with precordial pain were less likely to have DM (30.3%) than those without pain (34.0%; unadjusted p = 0.029), but this difference was not significant after multivariable adjustment, for the global population (p = 0.84), and for subset of patients that presented within 6 hours from symptom onset (p = 0.51). In contrast, precordial pain was more likely among patients with hyperglycemia (41.2% vs 37.0% without hyperglycemia, p = 0.035) in the overall population and also among those who presented within 6 hours (41.6% vs. 32.3%, p = 0.001). Adjusted models showed an independent association between hyperglycemia and pain at presentation, especially among patients who presented within 6 hours (OR = 1.41, p = 0.008).

Conclusion: In this non-selected ACS population, there was no correlation between DM and hospital presentation without precordial pain. Moreover, hyperglycemia correlated significantly with pain at presentation, especially in the population that arrived within 6 hours from symptom onset.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4193065PMC
http://dx.doi.org/10.5935/abc.20140106DOI Listing
September 2014

The bleeding risk score as a mortality predictor in patients with acute coronary syndrome.

Arq Bras Cardiol 2013 Dec 12;101(6):511-8. Epub 2013 Nov 12.

Background: It is well known that the occurrence of bleeding increases in-hospital mortality in patients with acute coronary syndromes (ACS), and there is a good correlation between bleeding risk scores and bleeding incidence. However, the role of bleeding risk score as mortality predictor is poorly studied.

Objective: The main purpose of this paper was to analyze the role of bleeding risk score as in-hospital mortality predictor in a cohort of patients with ACS treated in a single cardiology tertiary center.

Methods: Out of 1655 patients with ACS (547 with ST-elevation ACS and 1118 with non-ST-elevation ACS), we calculated the ACUITY/HORIZONS bleeding score prospectively in 249 patients and retrospectively in the remaining 1416. Mortality information and hemorrhagic complications were also obtained.

Results: Among the mean age of 64.3 ± 12.6 years, the mean bleeding score was 18 ± 7.7. The correlation between bleeding and mortality was highly significant (p < 0.001, OR = 5.296), as well as the correlation between bleeding score and in-hospital bleeding (p < 0.001, OR = 1.058), and between bleeding score and in-hospital mortality (adjusted OR = 1.121, p < 0.001, area under the ROC curve 0.753, p < 0.001). The adjusted OR and area under the ROC curve for the population with ST-elevation ACS were, respectively, 1.046 (p = 0.046) and 0.686 ± 0.040 (p < 0.001); for non-ST-elevation ACS the figures were, respectively, 1.150 (p < 0.001) and 0.769 ± 0.036 (p < 0.001).

Conclusions: Bleeding risk score is a very useful and highly reliable predictor of in-hospital mortality in a wide range of patients with acute coronary syndromes, especially in those with unstable angina or non-ST-elevation acute myocardial infarction.
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http://dx.doi.org/10.5935/abc.20130223DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4106809PMC
December 2013

Effect of implementing an acute myocardial infarction guideline on quality indicators.

Einstein (Sao Paulo) 2013 Jul-Sep;11(3):357-63

Objective: To evaluate the compliance rates to quality of care indicators along the implementation of an acute myocardial infarction clinical practice guideline.

Methods: A clinical guideline for acute myocardial infarction was introduced on March 1st, 2005. Patients admitted for acute myocardial infarction from March 1st, 2005 to December 31st, 2012 (n=1,431) were compared to patients admitted for acute myocardial infarction before the implementation of the protocol (n=306). Compliance rates to quality of care indicators (ASA prescription on hospital admission and discharge, betablockers on discharge and door-to-balloon time) as well as the length of hospital stay and in-hospital mortality were compared before and after the implementation of the clinical guideline.

Results: The rates of ASA prescription on admission, on discharge and of betablockers were higher after guideline implementation: 99.6% versus 95.8% (p<0.001); 99.1% versus 95.8% (p<0.001); and 95.9% versus 81.7% (p<0.001), respectively. ASA prescription rate increased over time, reaching 100% from 2009 to 2012. Door-to-balloon time after versus before implementation was of 86(32) minutes versus 93(51) (p=0.20). The length of hospital stay after the implementation versus before was of 6(6) days versus 6(4) days (p=0.34). In-hospital mortality was 7.6% (before the implementation), 8.7% between 2005 and 2008, and 5.3% between 2009 and 2012, (p=0.04).

Conclusion: The implementation of an acute myocardial infarction clinical practice guideline was associated with an increase in compliance to quality of care indicators.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878596PMC
http://dx.doi.org/10.1590/s1679-45082013000300016DOI Listing
January 2014

Clinical characteristics and long-term outcome of patients with acute coronary syndromes and Takayasu arteritis.

Rev Port Cardiol 2013 Apr 20;32(4):297-302. Epub 2013 Mar 20.

Unidade Clínica de Emergência, Instituto do Coração, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.

Introduction: Monitoring of disease activity and the best therapeutic approach are a challenge in Takayasu arteritis (TA). When associated with acute coronary syndromes (ACS), the best interventional treatment has not been established. The objective of this study was to describe the baseline characteristics, clinical manifestations, treatment and long-term outcome of patients with TA and ACS.

Methods: We retrospectively analyzed eight patients between 2004 and 2010. The following data were obtained: age, gender, clinical and electrocardiographic manifestations, Killip class, risk factors for ACS, markers of myocardial necrosis (CK-MB and troponin), creatinine clearance, left ventricular ejection fraction, inflammatory markers (C-reactive protein and erythrocyte sedimentation rate [ESR]), medication during hospital stay, angiographic findings, treatment (medical, percutaneous or surgical) and long-term outcome. Statistical data were expressed as percentages and absolute values.

Results: All eight patients were women, median age 49 years. Typical chest pain was present in 37.5%. Elevated ESR was observed in 85.7%. Three patients underwent coronary artery bypass grafting, three underwent percutaneous coronary angioplasty (two with bare-metal stents and one with a drug-eluting stent) and two were treated medically. In-hospital mortality was 25%. There were no deaths during a mean follow-up of 30 months.

Conclusions: In our study, patients who were discharged home had good outcomes in long-term follow-up with medical, percutaneous or surgical treatment. ESR appears to be associated with ACS in TA.
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http://dx.doi.org/10.1016/j.repc.2012.06.020DOI Listing
April 2013

Hands as diagnostic tools in medicine: should physicians touch their patients?

Arq Bras Cardiol 2013 Jan;100(1):e12-3

Faculdade de Ciências Médicas, Santa Casa de São Paulo, Brasil.

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http://dx.doi.org/10.1590/s0066-782x2013000100020DOI Listing
January 2013

ST Elevation Myocardial Infarction in the elderly.

J Geriatr Cardiol 2012 Jun;9(2):108-14

INCOR Heart Institute, University of Sao Paulo Medical School, Av. Dr. Enéas Carvalho de Aguiar, 44-05403-000, São Paulo, Brasil.

Acute coronary syndromes (ACS) are the leading causes of death in the elderly. The suspicion and diagnosis of ACS in this age group is more difficult, since typical angina is less frequent. The morbidity and mortality is greater in older age patients presenting ACS. Despite the higher prevalence and greater risk, elderly patients are underrepresented in major clinical trials from which evidence based recommendations are formulated. The authors describe, in this article, the challenges in the diagnosis and management of ST elevation myocardial infarction in the elderly, and discuss the available evidence.
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http://dx.doi.org/10.3724/SP.J.1263.2011.12297DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3418898PMC
June 2012

Use of demonstrably effective therapies in the treatment of acute coronary syndromes: comparison between different Brazilian regions. Analysis of the Brazilian Registry on Acute Coronary Syndromes (BRACE).

Arq Bras Cardiol 2012 Apr;98(4):282-9

Instituto do Coração (InCOr) - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil.

Background: Little is known in our country about regional differences in the treatment of acute coronary disease.

Objective: To analyze the behavior regarding the use of demonstrably effective regional therapies in acute coronary disease.

Methods: A total of 71 hospitals were randomly selected, respecting the proportionality of the country in relation to geographic location, among other criteria. In the overall population was regionally analyzed the use of aspirin, clopidogrel, ACE inhibitors / AT1 blocker, beta-blockers and statins, separately and grouped by individual score ranging from 0 (no drug used) to 100 (all drugs used). In myocardial infarction with ST elevation (STEMI) regional differences were analyzed regarding the use of therapeutic recanalization (fibrinolytics and primary angioplasty).

Results: In the overall population, within the first 24 hours of hospitalization, the mean score in the North-Northeast (70.5 ± 22.1) was lower (p <0.05) than in the Southeast (77.7 ± 29.5), Midwest (82 ± 22.1) and South (82.4 ± 21) regions. At hospital discharge, the score of the North-Northeast region (61.4 ± 32.9) was lower (p <0.05) than in the Southeast (69.2 ± 31.6), Midwest (65.3 ± 33.6) and South (73.7 ± 28.1) regions; additionally, the score of the Midwest was lower (p <0.05) than the South region. In STEMI, the use of recanalization therapies was highest in the Southeast (75.4%, p = 0.001 compared to the rest of the country), and lowest in the North-Northeast (52.5%, p <0.001 compared to the rest of the country).

Conclusion: The use of demonstrably effective therapies in the treatment of acute coronary disease is much to be desired in the country, with important regional differences.
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http://dx.doi.org/10.1590/s0066-782x2012000400001DOI Listing
April 2012

In patients with acute myocardial infarction, the impact of hyperglycemia as a risk factor for mortality is not homogeneous across age-groups.

Diabetes Care 2012 Jan 25;35(1):150-2. Epub 2011 Oct 25.

Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil.

Objective: To assess the impact of hyperglycemia in different age-groups of patients with acute myocardial infarction (AMI).

Research Design And Methods: A total of 2,027 patients with AMI were categorized into one of five age-groups: <50 years (n = 301), ≥50 and <60 (n = 477), ≥60 and <70 (n = 545), ≥70 and <80 (n = 495), and ≥80 years (n = 209). Hyperglycemia was defined as initial glucose ≥115 mg/dL.

Results: The adjusted odds ratios for hyperglycemia predicting hospital mortality in groups 1-5 were, respectively, 7.57 (P = 0.004), 3.21 (P = 0.046), 3.50 (P = 0.003), 3.20 (P < 0.001), and 2.16 (P = 0.021). The adjusted P values for correlation between glucose level (as a continuous variable) and mortality were 0.007, <0.001, 0.043, <0.001, and 0.064. The areas under the ROC curves (AUCs) were 0.785, 0.709, 0.657, 0.648, and 0.613. The AUC in group 1 was significantly higher than those in groups 3-5.

Conclusions: The impact of hyperglycemia as a risk factor for hospital mortality in AMI is more pronounced in younger patients.
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http://dx.doi.org/10.2337/dc11-1170DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3241319PMC
January 2012