Creation and Implementation of a Prospective and Multicentric Database of Patients with Acute Myocardial Infarction: RIAM. / Criação e Implementação de um Banco de Dados Prospectivo e Multicêntrico de Pacientes com Infarto Agudo do Miocárdio: RIAM.

BACKGROUND: Multicenter registries representing the real world can be a significant source of information, but few studies exist describing the methodology to implement these tools. OBJECTIVE: To describe the process of implementing a database of ST-segment elevation acute myocardial infarction (STEMI) at a reference hospital, and the application of this process to other centers by means of an online platform. METHODS: In 2009, our institution implemented an Registry of Acute Myocardial Infarction (RIAM), with the prospective and consecutive inclusion of every patient admitted to the institution who received a diagnosis of STEMI. From March 2014 to April 2016, the registries were uploaded to a web-based system using the REDCap software and the registry was expanded to other centers. Upon subscription, the REDCap platform is a noncommercial software made available by Vanderbilt University to institutions interested in research. RESULTS: The following steps were taken to improve and expand the registry: 1. Standardization of variables; 2. Implementation of institutional REDCap (Research Electronic Data Capture); 3. Development of data collection forms (Case Report Form - CRF); 4. Expansion of registry to other reference centers using the REDCap software; 5. Training of teams and participating centers following an SOP (Standard Operating Procedure). CONCLUSION: The description of the methodology used to implement and expand the RIAM may help other centers and researchers to conduct similar studies, share information between institutions, develop new health technologies, and assist public policies regarding cardiovascular diseases. (Arq Bras Cardiol. 2020; 114(3):446-455).

FUNDAMENTO: Registros multicêntricos representativos do mundo real podem fornecer informações importantes, mas existem poucos estudos descrevendo como implementar estas ferramentas. OBJETIVO: Descrever o processo de implementação de um banco de dados em infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAMCST) em um hospital de referência e sua aplicação para outros centros com uma plataforma online . MÉTODOS: Nossa instituição implementou em 2009 um Registro de Infarto Agudo do Miocárdio (RIAM), com a inclusão prospectiva e consecutiva de todos os pacientes com diagnóstico de IAMCST que internaram na instituição. No período de março de 2014 a abril de 2016 foi realizada a migração para o sistema online com o software REDCap e expansão do registro para outros centros. A plataforma REDCap é um software de uso gratuito disponibilizado pela Universidade Vanderbilt a instituições interessadas em pesquisa, mediante cadastramento prévio. RESULTADOS: Foram realizadas as seguintes etapas do aprimoramento e expansão do registro: 1. Padronização das variáveis; 2. Implementação do software REDCap ( Research Electronic Data Capture ) institucional; 3. Desenvolvimento de formulários de coleta de dados ( Case Report Form - CRF); 4. Expansão do registro para outros centros de referência utilizando o software REDCap; 5. Treinamento da equipe e dos centros participantes pelo POP (Procedimento Operacional Padrão). CONCLUSÕES: A descrição da metodologia utilizada para implementar e expandir o RIAM pode auxiliar outros centros e pesquisadores a realizar estudos semelhantes, compartilhar informações entre instituições, o desenvolvimento de novas tecnologias em saúde e auxiliar nas políticas públicas em doenças cardiovasculares. (Arq Bras Cardiol. 2020; 114(3):446-455).

Criação e Implementação de um Banco de Dados Prospectivo e Multicêntrico de Pacientes com Infarto Agudo do Miocárdio: RIAM / Creation and Implementation of a Prospective and Multicentric Database of Patients with Acute Myocardial Infarction: RIAM

Resumo Fundamento Registros multicêntricos representativos do mundo real podem fornecer informações importantes, mas existem poucos estudos descrevendo como implementar estas ferramentas. Objetivo Descrever o processo de implementação de um banco de dados em infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAMCST) em um hospital de referência e sua aplicação para outros centros com uma plataforma online . Métodos Nossa instituição implementou em 2009 um Registro de Infarto Agudo do Miocárdio (RIAM), com a inclusão prospectiva e consecutiva de todos os pacientes com diagnóstico de IAMCST que internaram na instituição. No período de março de 2014 a abril de 2016 foi realizada a migração para o sistema online com o software REDCap e expansão do registro para outros centros. A plataforma REDCap é um software de uso gratuito disponibilizado pela Universidade Vanderbilt a instituições interessadas em pesquisa, mediante cadastramento prévio. Resultados Foram realizadas as seguintes etapas do aprimoramento e expansão do registro: 1. Padronização das variáveis; 2. Implementação do software REDCap ( Research Electronic Data Capture ) institucional; 3. Desenvolvimento de formulários de coleta de dados ( Case Report Form - CRF); 4. Expansão do registro para outros centros de referência utilizando o software REDCap; 5. Treinamento da equipe e dos centros participantes pelo POP (Procedimento Operacional Padrão). Conclusões A descrição da metodologia utilizada para implementar e expandir o RIAM pode auxiliar outros centros e pesquisadores a realizar estudos semelhantes, compartilhar informações entre instituições, o desenvolvimento de novas tecnologias em saúde e auxiliar nas políticas públicas em doenças cardiovasculares. (Arq Bras Cardiol. 2020; 114(3):446-455)

Abstract Background Multicenter registries representing the real world can be a significant source of information, but few studies exist describing the methodology to implement these tools. Objective To describe the process of implementing a database of ST-segment elevation acute myocardial infarction (STEMI) at a reference hospital, and the application of this process to other centers by means of an online platform. Methods In 2009, our institution implemented an Registry of Acute Myocardial Infarction (RIAM), with the prospective and consecutive inclusion of every patient admitted to the institution who received a diagnosis of STEMI. From March 2014 to April 2016, the registries were uploaded to a web-based system using the REDCap software and the registry was expanded to other centers. Upon subscription, the REDCap platform is a noncommercial software made available by Vanderbilt University to institutions interested in research. Results The following steps were taken to improve and expand the registry: 1. Standardization of variables; 2. Implementation of institutional REDCap (Research Electronic Data Capture); 3. Development of data collection forms (Case Report Form - CRF); 4. Expansion of registry to other reference centers using the REDCap software; 5. Training of teams and participating centers following an SOP (Standard Operating Procedure). Conclusion The description of the methodology used to implement and expand the RIAM may help other centers and researchers to conduct similar studies, share information between institutions, develop new health technologies, and assist public policies regarding cardiovascular diseases. (Arq Bras Cardiol. 2020; 114(3):446-455)

Chronic total occlusion percutaneous coronary intervention in Latin America.

OBJECTIVES: To report clinical, angiographic characteristics, outcomes, and predictors of unsuccessful procedures in patients who underwent chronic total occlusion (CTO) percutaneous coronary interventions (PCI) in Latin America. BACKGROUND: CTO PCI has been increasingly performed worldwide, but there is a lack of information in this region. METHODS: An international multicenter registry was developed to collect data on CTO PCI performed in centers in Latin America. Patient, angiographic, procedural and outcome data were evaluated. Predictors of unsuccessful procedures were assessed by multivariable analysis. RESULTS: We have included data related to 1,040 CTO PCIs performed in seven countries in Latin America (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, and Puerto Rico). The mean age was 64 ± 10 years, and CTO PCI was performed mainly for angina control (81%) or treatment of a large ischemic area (30%). Overall technical success rate was 82.5%, and it was achieved with antegrade wire escalation in 81%, antegrade dissection/re-entry in 8% and with retrograde techniques in 11% of the successful procedures. Multivariable analysis identified moderate/severe calcification, a blunt proximal cap and a previous attempt as independent predictors of unsuccessful procedures. In-hospital major adverse cardiovascular events (MACE) occurred in 3.1% of the cases, death in 1% and cardiac tamponade in 0.9% CONCLUSIONS: CTO PCI in Latin America has been performed mainly for ischemia relief. Procedures were associated with a success rate above 80% and low incidence of MACE. Predictors of unsuccessful procedures were similar to those previously reported in the literature.

Treating periodontal disease in patients with myocardial infarction: A randomized clinical trial.

BACKGROUND: Periodontitis has been associated with coronary artery disease, but the impact of a periodontal treatment on the endothelial function of patients with a recent ST-segment elevation myocardial infarction (STEMI) was not investigated. METHODS: Randomized controlled trial (NCT02543502). Patients admitted between August 2012 and January 2015 were included. Patients were screened during the index hospitalization for STEMI, and those with severe periodontal disease were randomized 2 weeks later to periodontal treatment or to control. The primary endpoint of this trial was the between group difference in the variation of flow-mediated vasodilation (FMD) in the brachial artery assessed by ultrasound from baseline to the 6-month follow-up. Secondary outcomes were cardiovascular events, adverse effects of periodontal treatment and inflammatory markers. RESULTS: Baseline characteristics were balanced between patients in the intervention (n = 24) and control groups (n = 24). There was a significant FMD improvement in the intervention group (3.05%; p = .01), but not in the control group (-0.29%; p = .79) (p = .03 for the intergroup comparison). Periodontal treatment was not associated with any adverse events and the inflammatory profile and cardiovascular events were not significantly different between both groups. CONCLUSIONS: Treatment of periodontal disease improves the endothelial function of patients with a recent myocardial infarction, without adverse clinical events. Larger trials are needed to assess the benefit of periodontal treatment on clinical outcomes. CLINICAL TRIAL REGISTRATION: NCT02543502 (https://clinicaltrials.gov/ct2/show/NCT02543502?term=NCT02543502&rank=1).

The role of diabetes mellitus in the composition of coronary thrombi in patients presenting with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

BACKGROUND: Although diabetes mellitus (DM) is a predictor of poor outcomes in patients with ST-segment elevation myocardial infarction (STEMI), few studies have analyzed the impact of DM on the constituency of coronary thrombi. OBJECTIVES: Comparing morphologic and histopathologic aspects of coronary thrombi in STEMI patients with and without DM who underwent primary percutaneous coronary intervention. METHODS: All consecutive patients with STEMI admitted to our institution between April 2010 and December 2012 (n = 1,548) were considered for inclusion. Thrombus material was obtained by aspiration thrombectomy; morphologic and histopathologic aspects were assessed by 3 independent pathologists blinded to clinical characteristics and outcomes. Patients with DM were compared with those without DM. A sensitivity analysis was performed using a propensity score. RESULTS: During the study period, coronary thrombi material from 259 patients was obtained, of whom 19% (n = 49) had diabetes. Diabetic patients were older (P = .10), had a higher frequency of hypertension (P < .01) and dyslipidemia (P = .03), and had a trend to a longer time from the onset of chest pain to hospital arrival (P = .08). The number of retrieved fragments, the size of the thrombi and its composition (leukocytes, fibrin, and erythrocytes percent), and thrombus age and color were similar between patients with or without DM. There were also no statistically significant differences in thrombus constituency of the propensity score-matched patients (n = 92). CONCLUSIONS: In this study, morphologic and histopathologic constituency of coronary thrombi in the setting of a ST-elevation myocardial infarction was not significantly different between patients with or without DM. This finding was intriguing and deserves further investigation.

Accuracy of dedicated risk scores in patients undergoing primary percutaneous coronary intervention in daily clinical practice.

BACKGROUND: Comparisons between dedicated risk scores in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) in real-world clinical practice are scarce. The aim of this study was to assess the diagnostic performance of the Global Registry of Acute Coronary Events (GRACE), Primary Angioplasty in Myocardial Infarction (PAMI), Thrombolysis in Myocardial Infarction (TIMI), and Zwolle scores in STEMI patients undergoing pPCI in contemporary clinical practice. METHODS: This was a prospective cohort study of consecutive patients with STEMI undergoing pPCI between December 2009 and November 2010 in a high-volume tertiary referral centre. The outcomes assessed were major cardiovascular events (MACEs) and death within 30 days. The diagnostic accuracy of the scores was assessed using receiver operating characteristic curves, and scores were compared using the DeLong method. RESULTS: During the study period, 501 patients were included. Within 30 days, 62 patients (12.4%) presented a MACE and 39 individuals (7.8%) died. All scores were statistically associated with death and MACE within 30 days (P < 0.01). The c-statistic and 95% confidence intervals for 30-day mortality were: GRACE, 0.84 (0.78-0.90); TIMI, 0.81 (0.74-0.87); Zwolle, 0.80 (0.73-0.87); and PAMI, 0.75 (0.68-0.82) (P < 0.01). There was no statistically significant difference regarding the accuracy of the TIMI, GRACE, and Zwolle scores for 30-day mortality, but the GRACE score was superior to the PAMI score (P < 0.01). CONCLUSIONS: The TIMI, GRACE, and Zwolle scores performed equally well as predictors of mortality in patients who underwent pPCI in current practice. These results suggest that these scores are suitable options for risk assessment in a real-world setting.

Preditores de insucesso de tromboaspiração em pacientes submetidos à intervenção coronária percutânea primária / Predictors of failed thrombus aspiration in patients undergoing primary percutaneous coronary intervention

INTRODUÇÃO: A tromboaspiração é recomendada como método adjunto à intervenção coronária percutânea (ICP) primária, mas o insucesso em recuperar trombos é relativamente frequente. O objetivo deste estudo foi avaliar as taxas de insucesso de tromboaspiração e identificar seus preditores, em uma série contemporânea de pacientes. MÉTODOS: Estudo de coorte prospectivo que incluiu pacientes consecutivos atendidos com infarto agudo do miocárdio com elevação do segmento ST e submetidos à ICP primária com tromboaspiração no período de dezembro de 2009 a dezembro de 2011. Os procedimentos de tromboaspiração foram realizados por decisão do operador, e o sucesso foi definido como aspiração efetiva de trombo pelo cateter dedicado, com recuperação do fluxo coronário (fluxo TIMI > 0). RESULTADOS: Foram realizadas 1.055 ICPs primárias, sendo que a tromboaspiração foi utilizada em 37% dos casos, com taxa de sucesso de 70%. Foram identificados 254 pacientes com sucesso e 107 com insucesso da tromboaspiração. Insucesso de tromboaspiração foi associado a: idade, hipertensão, diabetes mellitus, dislipidemia, ICP prévia, escore de risco TIMI, Killip IV, contagem de leucócitos, fibrinogênio sérico, diâmetro de referência do vaso-alvo e TIMI 3 pré-procedimento. Pacientes com insucesso da tromboaspiração apresentaram tendência a maior mortalidade (11,6% vs. 5,9%; P = 0,09). CONCLUSÕES: Insucesso de tromboaspiração durante ICP primária ocorreu em 30% dos casos e esteve associado a tendência de maior mortalidade. A identificação de preditores clínicos, laboratoriais e angiográficos pode auxiliar no aprimoramento desses dispositivos e em sua técnica, além da escolha de pacientes mais adequados para seu emprego.

BACKGROUND: Aspiration thrombectomy is recommended as an adjunctive method in patients undergoing primary percutaneous coronary intervention (PCI), however, thrombus aspiration failure is relatively frequent. The objective of this study was to evaluate the rate and identify predictors of failed thrombus aspiration in a contemporaneous series of patients. METHODS: Prospective cohort study including consecutive patients with acute ST-segment elevation myocardial infarction undergoing primary PCI with thrombus aspiration from December 2009 to December 2011. Aspiration thrombectomy was performed at the operator's discretion and success was defined as effective thrombus aspiration by a dedicated catheter with the achievement of a final TIMI flow > 0. RESULTS: 1,055 primary PCIs were performed and aspiration thrombectomy was used in 37% of cases with a success rate of 70%. Aspiration thrombectomy success was observed in 254 patients whereas failure was observed in 107 patients. Aspiration thrombectomy failure was associated with age, hypertension, diabetes mellitus, dyslipidemia, previous PCI, TIMI risk score, Killip IV, leukocyte count, serum fibrinogen, target vessel reference diameter and preprocedural TIMI 3 flow. Patients with failed thrombus aspiration had a trend towards higher mortality (11.6% vs. 5.9%; P = 0.09). CONCLUSIONS: Aspiration thrombectomy failure during primary PCI was observed in 30% of the cases and was associated with a trend towards higher mortality. The identification of clinical, laboratory and angiographic predictors may help improve these devices and the technique and enable better patient selection.

Red versus white thrombi in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: clinical and angiographic outcomes.

BACKGROUND: Aspiration thrombectomy is used in primary percutaneous coronary interventions, but the importance of thrombus constituency has been scarcely investigated. The objective of this study was to evaluate thrombus constituency and its association with clinical, laboratory, and angiographic findings in patients with ST-segment elevation myocardial infarction. METHODS: From April 2010 to May 2011, 562 patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary interventions were considered for inclusion, and information on thrombi characteristics was available for 113 patients. Thrombus material were obtained and classified as white or red based on its constituency. Samples were analyzed by 3 independent pathologists blinded to clinical characteristics. RESULTS: The mean age of patients was 58.6 ± 12.7 years, and 69% were men. White thrombi were present in 31% of cases, and red thrombi, in 69%. Patients with white thrombi had smaller vessels and lower ischemic times. All other clinical, angiographic, and laboratory characteristics did not differ. White thrombi were smaller and associated with fibrin infiltration, whereas red thrombi were associated with red blood cell infiltration. Thirty-day death rates were lower in patients with white thrombi than red (0% vs 10.1%, respectively; P = .05), as were 30-day major adverse cardiac event rates (4.2% vs 13.9%; P = .10). Total ischemic time was well correlated with fibrin infiltration (R = -0.30; P < .01), red blood cell infiltration (R = 0.27; P < .01), and thrombus volume (R = 0.22; P = .02). CONCLUSIONS: White thrombi were present in one-third of cases and were associated with lower ischemic times, higher fibrin infiltration, smaller thrombus volume, and lower mortality. These findings suggest that thrombus constituency may be a useful prognostic tool in this setting.

Implante valvular aórtico percutâneo (IVAP): análise de uma série de casos realizados com o dispositivo autoexpansível CoreValveTM sem uso de pré-dilatação / Percutaneous aortic valve implantation )PAVI): analysis of a series of cases usinf the CoreValveTM self-expandable device without pre-dilation

Introdução: O implante valvular aórtico percutâneo (IVAP) vem se desenvolvendo rapidamente nos últimos anos. A manipulação da valva aórtica degenerada pode acarretar complicações. O IVAP direto, sem pré-dilatação com balão e com menor manipulação, seria uma alternativa. O objetivo deste estudo é apresentar uma série de 8 casos de IVAP direto com seguimento a médio prazo realizado no Instituto de Cardiologia do Rio Grande do Sul. Métodos: Série de 8 casos com descrição da técnica e resultados imediatos e a médio prazo do implante do dispositivo CoreValveTM sem valvuloplastia com balão. Resultados: No total, 7 pacientes do sexo masculino e 1 do sexo feminino, com média de idade de 76 anos e EuroSCORE logístico variando de 6 a 62, foram submetidos ao implante do dispositivo CoreValveTM. Houve significativa queda dos gradientes entre o ventrículo esquerdo e a aorta. Foram registrados três casos de insucesso do implante, um óbito no período pós-implante imediato e um óbito aos 6 meses, sem relação com o procedimento. No seguimento de um ano, não houve novos casos de implante de marca-passo e eventos embólicos. Conclusões: O IVAP direto sem pré-dilatação com balão mostrou-se uma alternativa potencialmente eficaz. Quando realizado com sucesso, determina melhora dos sintomas, diminuição sustentável do gradiente transvalvar aórtico e aumento da área valvar aórtica. Não está claro, contudo, qual o paciente e qual a condição anatômica ideal para essa abordagem. Estudos adicionais e seguimento mais prolongado ainda são necessários para definir o exato papel e as precisas indicações dessa variação da técnica.

Psychological characteristics of patients undergoing percutaneous coronary interventions.

BACKGROUND: There is few data evaluating the prevalence and influence of adverse psychological characteristics on the prognosis of individuals submitted to percutaneous coronary interventions. No study has addressed this issue in Brazil. OBJECTIVE: To investigate the prevalence of depression, anxiety, psychological stress, and Type D personality and its association with cardiovascular events in patients undergoing percutaneous coronary interventions. METHODS: Psychological characteristics were evaluated by scales: Beck Depression Inventory, Beck Anxiety Inventory, Lipp Inventory for Stress Symptoms for Adults and Type D Personality Scale. The end-point of this study was the occurrence of major cardiovascular events in one-year follow-up. RESULTS: During March and May 2006, 137 patients were included. Type D personality was identified in 34% of the cases, 29% presented anxiety, 25% presented depression and 70% of the patients presented stress. In relation to the frequency of psychological characteristics according to the occurrence of major adverse cardiovascular events, there was no statistical difference between both groups of patients regarding depression (29% vs. 26% p = 0.8), anxiety (33% vs. 23% p = 0.3), stress (76% vs. 65% p = 0.3), and Type D personality (33% vs. 32% p = 0.9). However, the negative affectivity score was significantly higher in the group of patients presenting events (13.9 vs. 9.8 p = 0.01). CONCLUSION: In patients submitted to percutaneous coronary interventions, the prevalence of adverse psychological characteristics was high. One-year major cardiovascular adverse events were associated with baseline negative affectivity, but not with the other psychological characteristics studied.

Características psicológicas dos pacientes submetidos à intervenção coronária percutânea / Psychological characteristics of patients undergoing percutaneous coronary interventions

FUNDAMENTO: Há poucos dados sobre análises da prevalência e da influência de características psicológicas adversas no prognóstico dos indivíduos submetidos a intervenções coronárias percutâneas. Nenhum estudo abordou essa questão no Brasil. OBJETIVO: Investigar a prevalência de depressão, ansiedade, estresse psicológico e personalidade tipo D, bem como sua associação com eventos cardiovasculares em pacientes submetidos à intervenção coronária percutânea (ICP). MÉTODOS: As características psicológicas foram avaliadas por escalas: inventário de depressão de Beck (IDB), inventário de ansiedade de Beck (IAB), inventário de sintomas de estresse de Lipp para adultos (ISSL) e escala de personalidade tipo D. A meta do estudo foi a ocorrência de eventos cardiovasculares maiores em um seguimento de um ano. RESULTADOS: Durante março e maio de 2006, 137 pacientes foram incluídos. A personalidade tipo D foi identificada em 34 por cento dos casos; 29 por cento apresentaram ansiedade, 25 por cento apresentaram depressão, e 70 por cento dos pacientes apresentaram estresse. Em relação à frequência de características psicológicas de acordo com a ocorrência de eventos cardiovasculares adversos maiores, não houve diferença estatística entre os dois grupos de pacientes no que se refere à depressão (29 por cento vs. 26 por cento p = 0,8), ansiedade (33 por cento vs. 23 por cento p = 0,3), estresse (76 por cento vs. 65 por cento p = 0,3) e personalidade tipo D (33 por cento vs. 32 por cento p = 0,9). No entanto, encontrou-se um escore de afetividade negativa significativamente maior no grupo de pacientes que apresentaram eventos (13,9 vs. 9,8 p = 0,01). CONCLUSÃO: Em pacientes submetidos à intervenção coronária percutânea, a prevalência de efeitos adversos psicológicos característicos foi alta. Eventos adversos cardiovasculares maiores em um ano foram associados à afetividade negativa basal, mas não a outras características psicológicas estudadas.

BACKGROUND: There is few data evaluating the prevalence and influence of adverse psychological characteristics on the prognosis of individuals submitted to percutaneous coronary interventions. No study has addressed this issue in Brazil. OBJECTIVE: To investigate the prevalence of depression, anxiety, psychological stress, and Type D personality and its association with cardiovascular events in patients undergoing percutaneous coronary interventions. METHODS: Psychological characteristics were evaluated by scales: Beck Depression Inventory, Beck Anxiety Inventory, Lipp Inventory for Stress Symptoms for Adults and Type D Personality Scale. The end-point of this study was the occurrence of major cardiovascular events in one-year follow-up. RESULTS: During March and May 2006, 137 patients were included. Type D personality was identified in 34 percent of the cases, 29 percent presented anxiety, 25 percent presented depression and 70 percent of the patients presented stress. In relation to the frequency of psychological characteristics according to the occurrence of major adverse cardiovascular events, there was no statistical difference between both groups of patients regarding depression (29 percent vs. 26 percent p = 0.8), anxiety (33 percent vs. 23 percent p = 0.3), stress (76 percent vs. 65 percent p = 0.3), and Type D personality (33 percent vs. 32 percent p = 0.9). However, the negative affectivity score was significantly higher in the group of patients presenting events (13.9 vs. 9.8 p = 0.01). CONCLUSION: In patients submitted to percutaneous coronary interventions, the prevalence of adverse psychological characteristics was high. One-year major cardiovascular adverse events were associated with baseline negative affectivity, but not with the other psychological characteristics studied.

Intervenção coronária pelas vias radial ou femoral no infarto agudo do miocárdio com supradesnivelamento do segmento ST: um, a visão da prática clínica contemporânea / Coronary intevention by radial or femoral access in acute St-Segment elevation myocardial infarction: the real-world clinical practice

Introdução: A via radial é um acesso seguro para procedimentos percutâneos e reduz as complicações vasculares locais. Neste estudo comparou-se a evolução hospitalar de pacientes com infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAMCSST) submetidos a intervenção coronária percutânea primária (ICPp) por via radial vs. via femoral. Métodos: Estudo de coorte prospectivo com pacientes consecutivamente atendidos entre dezembro de 2009 e maio de 2011. Resultados: Foram incluídos 794 pacientes, 82 (10,3%) tratados por via radial e 712 (89,7%), por via femoral. Pacientes do grupo radial eram mais jovens (56,2 ± 10,7 anos vs. 61,2 ± 11,9 anos; P < 0,01), mais frequentemente do sexo masculino (78% vs. 68%; P = 0,06), com menor prevalência de diabetes (9,8% vs. 20%; P = 0,02) e maior fração de ejeção do ventrículo esquerdo (61,2 ± 11,8% vs. 55,5 ± 12,1%; P = 0,05). Não houve diferença em relação à maior parte das características angiográficas. Tromboaspiração (44% vs. 31%; P = 0,01) e administração de glicoproteína IIb/IIIa (41% vs. 26%; P = 0,004) foram mais utilizadas no grupo radial. O fluxo TIMI 3 final (93% vs. 88%; P = 0,47) e o blush miocárdico 3 (70% vs. 66%; P = 0,87) foram semelhantes entre os grupos. Não foram observadas diferenças em relação a óbito (7,5% vs. 8,4%; P = 0,78), reinfarto (4,9% vs. 4,4%; P = 0,77), revascularização de urgência (3,7% vs. 4,1%; P > 0,99), trombose do stent (2,4% vs. 3%; P > 0,99), sangramento maior (0 vs. 1,6%; P = 0,61) ou sangramento menor (5,3% vs. 7,3%; P = 0,81). Conclusões: A abordagem transradial mostrou-se segura e efetiva, com resultados semelhantes aos da abordagem transfemoral em pacientes com IAMCSST.

BACKGROUND: Radial access is a safe approach for percutaneous procedures and reduces local vascular complications. This study compared the hospital outcomes of patients with ST-elevation acute myocardial infarction (STEMI) submitted to primary percutaneous coronary intervention (pPCI) using the radial vs. femoral approaches. METHODS: Prospective cohort study with consecutive patients treated between December 2009 and May 2011. RESULTS: Seven hundred and ninety-four patients were included, 82 (10.3%) treated by radial access and 712 (89.7%) treated by femoral access. Radial access patients were younger (56.2 ± 10,7 years vs. 61,2 ± 11,9 years; P < 0.01), more often male (78% vs. 68%; P = 0.06), had a lower prevalence of diabetes (9.8% vs. 20%; P = 0.02) and higher left ventricle ejection fraction (61.2 ± 11.8% vs. 55.5 ± 12.1%; P = 0.05). There was no difference for most angiographic characteristics. Thromboaspiration (44% vs. 31%; P = 0.01) and glycoprotein IIb/IIIa administration (41% vs. 26%; P = 0.004) were used more often in the radial group. The final TIMI 3 flow (93% vs. 88%; P = 0.47) and myocardial blush grade 3 (70% vs. 66%; P = 0.87) were similar between groups. There were no differences for death (7.5% vs. 8.4%; P = 0.78), reinfarction (4.9% vs. 4.4%; P = 0.77), emergency revascularization (3.7% vs. 4.1%; P > 0.99), stent thrombosis (2.4% vs. 3%; P > 0.99), major bleeding (0 vs. 1.6%; P = 0.61) or minor bleeding (5.3% vs. 7.3%; P = 0.81) rates. CONCLUSIONS: The transradial approach has proven to be safe and effective with similar results to transfemoral approach in patients with STEMI.

Avaliação do estado de saúde pelo questionário de angina de seattle em pacientes com síndrome coronária aguda / Health status assessment by the seattle angina questionnaire in acute coronary syndromes

Introdução: Estudos que analisaram o estado de saúde não avaliaram diferenças entre pacientes com angina instável e infarto agudo do miocárdio com (IAMCST) e sem (IAMSST) elevação do segmento ST. Este estudo teve como objetivo comparar índices do estado de saúde, de acordo com o Questionário de Angina de Seattle (QAS), em pacientes com síndrome coronária aguda (SCA). Métodos: O QAS foi aplicado na admissão hospitalar e aos seis meses de acompanhamento em 391 pacientes com SCA. Foram analisados três domínios: limitação física (D1), frequência da angina (D3) e qualidade de vida (D5). Índices maiores em D1, D3 e D5 significam menor limitação física, menor frequência da angina e melhor qualidade de vida, respectivamente. Resultados: Na internação hospitalar, pacientes com angina instável apresentaram piores índices de frequência da angina e de qualidade de vida que os portadores de IAMSST, e piores índices de atividade física, frequência da angina e qualidade de vida que aqueles com IAMCST. Aos seis meses de seguimento, os pacientes com angina instável ainda apresentaram piores índices de atividade física, frequência da angina e qualidade de vida que os portadores de IAMCST, mas sem diferença significativa em relação aos pacientes com IAMSST. Pacientes com angina instável foram aqueles que apresentaram maior ganho em todos os domínios do QAS. Conclusões: No espectro da SCA, os pacientes com angina instável demonstraram pior estado de saúde, tanto na internação hospitalar como aos seis meses de acompanhamento, mas, por outro lado, foram os que apresentaram o maior ganho em cada um dos domínios avaliados pelo QAS.

Background: Studies assessing health status have not addressed differences among patients with unstable angina, non- ST elevation myocardial infarction (NSTEMI) and ST-elevation myocardial infarction (STEMI). This study was aimed at comparing health status scores according to the Seattle Angina Questionnaire (SAQ) in patients with acute coronary syndromes (ACS). Methods: SAQ was applied at hospitaladmission and at 6-month follow-up in 391 patients with ACS. Three domains were analyzed: physical limitation (D1),anginal frequency (D3) and disease perception (D5). Higher D1, D3 and D5 scores indicated less physical limitation,lower frequency of angina and better quality of life, respectively. Results: At hospital admission, patients with unstable angina presented significantly lower scores of anginal frequencyand disease perception than those with NSTEMI, and significantly lower scores of physical activity, anginal frequency and disease perception than those with STEMI. At the 6-month follow-up, patients with unstable angina still presented lower scores of physical activity, anginal frequency and disease perception than those with STEMI,but there were no significant differences when compared to those with NSTEMI. The SAQ domains increased to a greater extent in patients with unstable angina. Conclusions:Patients with unstable angina had worse health status at hospital admission and at the 6-month follow-up but, on the other hand, showed the largest improvements for each one of the SAQ domains analyzed.

Quality of life and health status after percutaneous coronary intervention in stable angina patients: results from the real-world practice.

BACKGROUND: Percutaneous coronary interventions (PCI) are associated with quality of life (QoL) and health status improvements in stable angina patients. There are few studies assessing the magnitude of this effect and its predictors in contemporary daily practice. METHODS: Prospective cohort study with stable angina patients submitted to PCI in a tertiary interventional cardiology center. The clinical characteristics and the Seattle Angina Questionnaire (SAQ) were assessed before PCI, and patients were followed-up for 1 year. Mixed linear regression and ANOVA were used to compare SAQ indices, and multivariate analysis to identify predictors of QoL improvement. RESULTS: Between September 2006 and May 2007, 110 patients were included. The mean age of the study population was 62.8 ± 8.7 years, and 62% of the patients were of the male gender. Diabetes mellitus was present in 29%, arterial hypertension in 82%, previous myocardial infarction in 32%, and previous PCI in 29%. Before PCI, only 5% of the patients were free of angina, and this rate improved to 68% in the one-year followup (P < 0.001). There was improvement in all SAQ scales in the one-year followup, which was already shown in the 6-month assessment (P < 0.0001). Quality of life before the procedure was the main predictor of QoL improvement by multivariate analysis (P < 0.001). CONCLUSIONS: Patients with stable angina submitted to PCI in the real-world practice present significant improvement in one-year health status, as assessed by the SAQ. Quality of life before the procedure is the main determinant of improvement in QoL.

Identifying patients at risk for premature discontinuation of thienopyridine after coronary stent implantation.

We sought to identify patients at risk for premature discontinuation of thienopyridines and to develop a risk score for thienopyridine adherence after coronary stent implantation. Patients were prospectively included from December 2007 to March 2008. At 1-month follow-up, all patients were given the Morisky questionnaire and asked if they had stopped taking thienopyridines. Multivariate analysis identified predictors of thienopyridine discontinuation; points were assigned to each variable according to the odds ratios and the c-statistic of the score was calculated. Mean age of the 400 patients included was 61.0 ± 10.4 years; 66 patients (16.5%) stopped thienopyridines after 1 month. Reasons for discontinuation were cost (62%), lack of information (17%), and recommendation by another doctor to stop treatment (15%). Factors associated with discontinuation included unmarried status (odds ratio 2.48, p = 0.046), lack of private health insurance (odds ratio 4.68, p = 0.041), acute coronary syndrome (odds ratio 2.31, p = 0.004), nondiabetics (odds ratio 2.20, p = 0.041), and patients who earned <2 times (odds ratio 8.23, p <0.001) and 2 to 3 times (odds ratio 4.46, p = 0.021) the minimum wage. Total risk score was 0 to 14 points and was strongly associated with thienopyridine discontinuation. For total scores of 0 to 4, 5 to 8, 9 to 12, and ≥13, 0%, 7%, 20%, and 37% of patients, respectively, stopped thienopyridines (c-statistic 0.76, p <0.0001). Risk score was also significantly associated with complete adherence as assessed by the Morisky questionnaire (c-statistic 0.74, p <0.001). In conclusion, we have identified patients at risk for premature discontinuation of thienopyridines using variables obtained before stent implantation and developed a risk score that accurately predicts premature thienopyridine discontinuation.

Angioplastia primária no infarto agudo do miocárdio: existe diferença de resultados entre as angioplastias realizadas dentro e fora do horário de rotina? / Primary percutaneous coronary intervention in acute myocardial infarction: is there a difference in the outcomes of normal and off-hours procedures?

INTRODUÇÃO: Estudos demonstram que as angioplastias primárias realizadas fora do horário de rotina estão relacionadas a pior prognóstico. É objetivo deste estudo avaliar os desfechos das angioplastias primárias realizadas dentro e fora do horário de rotina de serviço de hemodinâmiva. Método: Estudo de coorte prospectivo, incluindo 112 pacientes consecutivamente atendidos por infarto agudo do miocárdio com supradesnivelamento do segmento ST (IAM) entre dezembro de 2009 e janeiro de 2010. Características clínicas e angiográficas e evolução hospitalar foram registradas em banco de dados específicos. Houve dois grupos para comparação: grupo A, IAM tratado entre as 20 horas e as 8 horas e B, IAM tratado entre as 8 horas e as 20 horas. Resultados: A amostra inclui 44 pacientes no grupo A e 68 no grupo B. As características basais foram semelhantes em ambos os grupos. O tempo porta-balão foi significativamente maior no grupo A (133 minutos vs. 90 minutos; P < 0,001). No entanto, não houve diferença significante entre os grupos A e B...

BACKGROUND: Previous studies have reported that off-hours primary percutaneous coronary intervention is related to worse prognosis. The objective of this study is to evaluate the outcomes of normal and off-hours primary percutaneous coronary interventions. METHODS: A prospective observational study including 112 consecutive patients with ST elevation myocardial infarction (MI) was conducted from December 2009 to January 2010. Clinical and angiographic characteristics and in-hospital follow up were registered in a specific database. There were two groups for comparison: group A, MI treated between 8 pm and 8 am and group B, MI treated between 8 am and 8 pm. RESULTS: The sample included 44 patients in group A and 68 in group B. Baseline characteristics were similar in both groups. Door-to-balloon time was significantly longer in group A (133 minutes vs. 90 minutes; P < 0.001). However, there was no significant difference between groups A and B regarding mortality (13.7% vs. 5.9%; P = 0.28), reinfarction (6.8% vs. 4.4%; P = 0.90), progression to cardiogenic shock (11.4% vs. 4.4%; P = 0.30), stent thrombosis (6.8% vs. 1.5%; P = 0.33), or major bleeding (2.3% vs. 1.5%; P > 0.99). The only predictor of combined in-hospital outcome was heart rate at admission (odds ratio 1.02; P < 0.001). CONCLUSIONS: Patients with MI have similar in-hospital clinical outcomes during normal and off-hours primary percutaneous coronary intervention. However, door-to-balloon time is significantly longer during off-hours procedures.

Exposição à radiação ionizante na sala de hemodinâmica / Exposure to ionizing radiation in the cardiac catheterization lab

INTRODUÇÃO: Com a evolução tecnológica e o crescimento da cardiologia intervencionista, os níveis de exposição aos raios X dos pacientes e da equipe técnica assim como o número de procedimentos de cateterismo têm aumentado consideravelmente. Isso tem impacto no inerente risco de exposição à radiação ionizante, ainda subestimado por muitos. Os níveis dessa exposição necessitam de mensuração e correção periódicas. Nosso objetivo foi investigar e aferir os níveis de radiação ionizante emitida por equipamentos de cinefluoroscopia. Método: Foram realizados ensaios técnicos para avaliar a taxa de kerma no ar de 8 equipamentos de hemodinâmica. Resultados: Apenas 2 (25 por cento) dos 8 equipamentos apresentavam dosimetria dentro dos limites máximos de segurança. A média das doses foi 65 por cento maior nos equipamentos com tecnologia flat detector. Após aplicação da manutenção supervisionada, verificou-se diminuição média de 42 por cento nos valores dosimétricos. Todos os equipamentos foram aprovados nos ensaios de resolução espacial de alto e baixo contrastes, e a qualidade da imagem foi corroborada pela equipe médica. Conclusão: A maioria dos equipamentos analisados apresentava dosimetria acima dos limites máximos de segurança, particularmente com a tecnologia flat detector. Essas distorções foram corrigidas com medidas de supervisão simples, sem prejuízo à qualidade da imagem. Nossos resultados ressaltam a necessidade de criação de programas institucionais de auqlidade visando à manutenção regular dos equipamentos e à incorporação criteriosa de novas tecnologias no intuito de minimizar os potenciais efeitos deletérios da radiação ionizante, promovendo maior segurança e economia.

BACKGROUND: With the technological evolution and expansion of interventional cardiology, the levels of X-ray exposure of patients and technical staff as well as the number of catheterization procedures have increased considerably. This has an impact on the inherent risk of exposure to ionizing radiation which is still underestimated by many. The levels of exposure must be routinely measured and adjusted. Our objective was to investigate and measure ionizing radiation levels emitted by cath lab X-ray equipments. METHODS: Technical tests were conducted to evaluate the air kerma of 8 X-ray equipments. RESULTS: Only 2 (25%) of the 8 equipments had dosimetry within maximum safety levels. The mean dose was 65% higher in devices with the flat detector technology. After supervised maintenance, there was a mean decrease of 42% in dosimetry values. All equipments were approved by the high and low contrast spatial resolution tests, and the image quality was approved by the medical team. CONCLUSIONS: Most of the equipments evaluated had dosimetry levels exceeding the maximum safety levels, especially those with the flat detector technology. These distortions were corrected by simple monitoring measures, without losses in image quality. Our results emphasizes the need to create institutional quality programs, to keep regular equipment maintenance and to exercise discretion in the incorporation of new technologies to minimize the potential effects of the deleterious effects of ionizing radiation, promoting greater safety and economy.

Serum bilirubin concentration in patients with an established coronary artery disease.

Bilirubin has been considered an antioxidant, with capacity to remove reactive species of oxygen. Studies have suggested that an increased bilirubin level promotes protection against atherosclerosis. The case group was composed of 100 patients with coronary artery disease and the control group 100 patients with normal coronaries. Blood samples were collected to determine bilirubin concentrations. Bivariate analysis, multiple logistic regression models, and Spearman's correlation index were performed. A P value < 0.05 was considered to be significant. The case group was predominantly composed of men and the control group of women, with a mean age of 60 +/- 8.8 versus 56 +/- 10.9 (P = 0.015). The total bilirubin average was significantly higher in the control group than in the case group (0.76 mg/dL versus 0.39 mg/dL, P < 0.001). The level of ultrasensitive C reactive protein (us-CRP) was increased in the case group (3.63 mg/L versus 0.93 mg/L, P < 0.001). Although the correlation index for this inverse association has been weak, both are independently associated with a higher prevalence of coronary artery disease, total bilirubin 3 mg/L (OR: 1.17; IC: 1.04-1.33; P = 0.009). Reduced serum levels of bilirubin were shown to be associated with a higher prevalence of coronary artery disease emerging as a new potential risk factor marker. Additional studies are still necessary to confirm and demonstrate the association of these findings with clinical outcomes.

Validation of a risk score for target vessel revascularization after coronary stent implantation.

OBJECTIVE: Our aim was to validate a risk score for new target vessel revascularization (TVR) after bare-metal stent (BMS) implantation. METHODS: The risk score was developed in a cohort of patients previously treated with BMS at our institution. This risk score ranges from 0 to 5 points, according to the presence of diabetes mellitus (1 point), reference vessel diameter (> 3.5 mm = 0 points; 3-3.5 mm = 1; < 3 mm = 2) and lesion length (< or = 10 mm = 0 points; 10-20 mm = 1; > 20 mm = 2). Patients included in the validation cohort were treated between January and December 2005. Patient characteristics and 1-year clinical follow up were prospectively recorded into a dedicated database. A new coronary angiography was performed only when recurrent ischemia was suspected. RESULTS: The mean age of the 491 patients included was 61 +/- 10.5 years, and 35% were women. Diabetes mellitus was present in 22%, a previous percutaneous coronary intervention in 12% and previous myocardial infarction in 35%. The mean reference vessel diameter was 2.80 +/- 0.56 mm and the mean lesion length was 12.45 +/- 6.3 mm. The overall 1-year TVR rate was 13.9%. TVR rates increased with each score level: Score = 0, TVR = 0% (n = 16); Score 1 = 5.3% (n = 48); Score 2 = 12% (n = 170); Score 3 = 14% (n = 146); and Score 4/5 = 25% (n = 54); (p = 0.008). CONCLUSIONS: The risk score was significantly associated with TVR rates and can be used as a simple clinical tool to identify those patients at a low risk for a new revascularization procedure.