Salvador André Bavaresco Cristóvão

Batimastat-eluting stent implantation for the treatment of coronary artery disease: results of the Brazilian pilot study

OBJECTIVE The excellent results obtained with sirolimus (rapamicin)-eluting stents for preventing restenosis have motivated the evaluation of other substances with that property. Batimastat is a highly effective metalloproteinase enzyme blocker, with the potential to reduce the degradation of extracellular matrix and to inhibit the migration of smooth muscle cells, with the consequent capacity to control coronary restenosis. METHODS From October 2001 to April 2002, 34 patients were prospectively selected with de novo lesions in a native coronary artery > 50% and < 100%, which could be treated with stents of 3 to 4 mm in diameter and 18 mm in length. The primary outcome of the study was to assess the occurrence of major cardiovascular events (death of cardiac origin, acute myocardial infarction, and the need for revascularizing the target vessel) by the 30th day and fourth month; the secondary outcome of the study was to assess the rate of coronary restenosis 4 months after implantation and subacute thrombosis by the 30th day. RESULTS The success rate of the procedure was 97.1%. The primary outcome occurred in 2.9% and 27.2% of the patients by the 30th day and fourth month, respectively. The binary restenosis rate on angiography was 39.3%. No episode of subacute thrombosis occurred. The comparative analysis between groups with and without restenosis showed no significant difference between both, except for late luminal loss, which was greater in G-I. CONCLUSION Batimastat-eluting stents had a good safety profile; however, they were not effective in controlling coronary restenosis.

Incidência, preditores e impacto clínico dos sangramentos maiores associados à intervenção coronária percutânea

BACKGROUND: Bleeding is one of the most frequent complications of percutaneous coronary intervention (PCI). The objective of this study was to evaluate the incidence and predictors of major bleeding and the impact of this complication on adverse events after PCI. METHOD: A retrospective analysis of 8,739 consecutive patients who were submitted to elective PCI from June/1997 to February/ 2008 was carried out. We compared patients with or without major bleeding in relation to pre-procedure clinic and angiographic characteristics and in-hospital and late outcomes. RESULTS: Major bleeding was identified in 1.6% of the patients. A multiple logistic regression model identified as independent predictors of major bleeding: female sex, age, previous coronary bypass surgery and use of glycoprotein IIb/IIIa inhibitors. Major bleeding was an independent predictor of in-hospital acute renal failure, myocardial infarction and death and of myocardial infarction in the late follow-up. CONCLUSION: Our study demonstrates that procedure-related major bleeding is an independent predictor of acute and late adverse events post-PCI.

Angioplastia coronária nas indicações off-label: comparação das vias radial vs. femoral

BACKGROUND: There is increasing interest in the use of the radial approach in diagnostic and therapeutic procedures due to several advantages such as patient comfort in the immediate post-procedure with early return to daily routine activities, decreased hospitalization time and consequent reduction of hospital costs and low puncture site complication rates when compared with the femoral approach, reducing the rate of major bleeding, which is in turn related to increased risk of death and ischemic events METHOD: Retrospective analysis of 1,807 consecutive patients undergoing off-label percutaneous transluminal coronary angioplasty (PTCA) from September 2006 to December 2009. The outcome of patients undergoing PTCA using the radial and femoral approaches during hospitalization and late follow-up were compared RESULTS: The radial approach prevailed in younger, male patients with lower angiographic complexity, which was due to the learning curve. Major adverse cardiac events (MACE), death and target-vessel revascularization rates were lower when the radial approach was used, both during hospitalization and in the late follow-up due to a more favorable clinical-angiographic profile. The femoral approach was an independent predictor of hospital MACE. The adjusted survival curve, however, showed that the access route did not have a significant impact on long-term clinical events CONCLUSION: The transradial approach is safe when used in selected patients with off-label indication, providing good clinical results in the early and late follow-up.

Atriosseptostomia por cateter balão guiada pela ecocardiografia em unidade de terapia intensiva neonatal

BACKGROUND The bedside two-dimensional echocardiography (2-D ECHO) has been successfully used to guide the balloon atrial septostomy, speeding up the procedure and preventing the risks of transportation to the hemodynamics laboratory. OBJECTIVE To assess the results of the bedside balloon atrial septostomy in cyanotic neonates. METHODS Between January/1997 and July/2008, 102 atrioseptostomies by balloon catheter guided by echocardiography were carried out and saturation levels, defect diameter, oxygen saturation, clinical-laboratory response and complications related to the procedure were evaluated. RESULTS Of 102 cases of bedside Rashkind septostomy, 98 met the inclusion criteria, with 90 neonates in Group A (Rashkind procedure in the preoperative phase) and 8 in Group B (procedure at the postoperative phase). There was a predominance of the male sex (75%), mean age was 8.3 ± 9.3 days and the mean weight was 3,100 ± 1,100 g; the transposition of the great arteries was the most frequent congenital heart disease (n = 74). When comparing the levels of saturation pre and post-procedure (65.9 ± 19.5% and 86 ± 9.7%) and the diameter of the interatrial septal defect pre and post-procedure (2.3 ± 1.0 mm and 5.5 ± 1.3 mm) there was a statistically significant difference (p < 0.001). When comparing the levels of saturation and the diameter of the interatrial septal defect between the group of survivors vs non-survivor, there was no statistically significant difference (p > 0.05). CONCLUSION The balloon atrial septostomy guided by the echocardiography reduces the risks by allowing the effective palliative procedure to be carried out promptly in cyanotic neonates, in addition to presenting lower hospital costs.

Experiência inicial utilizando a via radial no tratamento percutâneo de doença coronária

INTRODUCAO: A via radial e objeto de interesse crescente para procedimentos diagnosticos e terapeuticos, por possuir diversas vantagens, como comodidade para o paciente no pos-procedimento imediato, diminuicao do tempo de internacao com consequente reducao dos custos hospitalares e menor indice de complicacoes no sitio de puncao, quando comparada a via femoral. METODO: Realizada analise retrospectiva de 2.027 pacientes consecutivos submetidos a intervencao coronaria percutânea eletiva no periodo de junho de 2006 a janeiro de 2008. Comparamos os pacientes tratados pelas vias radial e femoral (grupos VR e VF, respectivamente) em relacao a caracteristicas clinicas, angiograficas e do procedimento, e evolucao tanto hospitalar como tardia. RESULTADOS: Angioplastia coronaria por via radial foi realizada em 27% dos pacientes. O grupo VR mostrou maior numero de pacientes do sexo masculino (75% vs. 63,8%; P < 0,001) e com lesoes uniarteriais (45,1% vs. 37,3%; P < 0,001). Nao encontramos diferenca em relacao a disfuncao do ventriculo esquerdo, tipo de lesao tratada ou uso de inibidor da glicoproteina IIb/IIIa. O sucesso angiografico foi maior na via radial (99% vs. 97,3%; P = 0,046). Houve menor numero de eventos cardiacos adversos maiores com a via radial nas fases tanto hospitalar (0,7% vs. 2%; P = 0,043) como tardia (11,3% vs. 16,3%; P < 0,005), em virtude da menor complexidade clinica e angiografica dos pacientes. CONCLUSAO: A tecnica radial, na curva inicial de aprendizado dos operadores e em pacientes selecionados, mostrou excelentes resultados clinicos quando comparada a femoral. Sua incorporacao a pratica clinica podera ser uma opcao adicional na abordagem de pacientes com perfil mais complexo.

A importância dos procedimentos operacionais padrão (POPs) para os centros de pesquisa clínica

Rev Assoc Med Bras 2011; 57(2):134-135 Os Procedimentos Operacionais Padrão (POPs) são instruções detalhadas descritas para alcançar a uniformidade na execução de uma função específica1,2. Basicamente, a importância do estabelecimento de POPs em um Centro de Pesquisa Clínica reside em: melhor preparo na condução de estudos clínicos, harmonização dos processos em pesquisa clínica no Centro de Pesquisa, treinamentos, profissionalismo, credibilidade e garantia da qualidade por meio da padronização e da rastreabilidade do processo em auditorias e inspeções3. A Instrução Normativa no 4 da Agência Nacional de Vigilância Sanitária (Anvisa) dispõe sobre o Guia de Inspeção em Boas Práticas Clínicas (BPC) no qual lista alguns POPs que serão exigidos durante a inspeção do estudo clínico no Centro de Pesquisa4. As inspeções têm como principais objetivos verificar o grau de aderência à legislação brasileira vigente e às BPC4,5, proteção dos direitos e bem-estar dos sujeitos de pesquisa2,6. As BPC constituem um padrão para planejamento, condução, realização e monitoramento de estudos clínicos. Para a correta realização de um projeto de pesquisa clínica, devem ser implementados sistemas com procedimentos que assegurem a qualidade de cada aspecto do estudo1,2 com a elaboração de POPs específicos para cada uma das etapas da realização da pesquisa7, sendo fundamental o desenvolvimento de um formato-padrão, ou seja, um POP de como fazer um POP3. Cada uma das etapas de elaboração do POP deverá ter a participação da equipe envolvida, que poderá avaliar e validar seus procedimentos, e, se necessário, contratar pessoal especializado para esta função. Nesses casos, é importante que a equipe detenha o conhecimento do setor e interaja com o grupo do centro, conhecendo cada um dos seus processos e discutindo cada novo POP elaborado. O POP deve ser escrito de forma detalhada para a obtenção da uniformidade, seja na produção ou na prestação Pesquisa Clínica A importância dos procedimentos operacionais padrão (POPs) para os centros de pesquisa clínicaCristiane Moraes Barbosa – Nucleo de Pesquisa da Equipe de Hemodinâmica e Cardiologia Intervencionista Dr. Jose Armando Mangione – Real e Benemerita Associacao Portuguesa de Beneficencia – Rua Maestro Cardim, 769. 1 SS – Bloco 1 - Sala 71 – Sao Paulo – SP – CEP: 01323-900 – pesquisaclinica@bpmangione.com.br

Resultados da intervenção coronária percutânea com o stent biomatrix TM em pacientes não selecionados

BACKGROUND: Drug-eluting stents have reduced the need of target vessel revascularization (TVR), when compared to bare metal stents. However, some studies have shown increased risk of stent thrombosis with the use of these devices. As a consequence, new drug-eluting stents with biodegradable polymers have been developed to improve results. METHODS: The first 100 patients treated with the BiomatrixTM stent from November 2008 to September 2010, were included. Only those with contraindication to dual antiplatelet therapy were excluded. Primary endpoint was the occurrence of major adverse cardiac events in the late follow-up. RESULTS: Mean age was 64 ± 11.7 years, 73% were men, 43% were diabetic and 40% had stable angina. One hundred and sixty-four lesions were treated, 71% of them were complex lesions (B2/C). The vessel reference diameter and the length of lesions were, respectively, 2.79 ± 0.49 mm and 18.3 ± 9.2 mm. Procedure success was 96%. Clinical follow-up data was obtained in 99% of the eligible patients in a mean period of 243 ± 160 days. The primary endpoint rate was 9% (cardiac death 4%, nonfatal myocardial infarction 2%, TVR 3%). Stent thrombosis was observed in 1% of the patients. There was no late or very late thrombosis CONCLUSIONS: In this real world experience, the use of the BiomatrixTM stent showed good results. These findings, together with those available in the literature, provide additional evidences for the use of this stent in the daily clinical practice, including off-label indications.

Stent implantation in surgical cavopulmonary conduit: report of two cases

Apesar dos avancos na cirurgia de Fontan, obstrucoes nos condutos extracardiacos podem ocorrer e causar deterioracao clinica. Relatamos dois casos em que foram realizados implante de stent para correcao de estenose na cirurgia de Fontan. Ascite era o sinal clinico comum; um paciente tinha enteropatia perdedora de proteinas.Todos os procedimentos obtiveram sucesso angiografico e clinico.Despite advances in Fontan surgery, obstruction in extracardiac ducts may occur and cause clinical deterioration. We report two cases of stent implantation for correction of stenosis in the Fontan surgery. Ascites was a common clinical sign; a patient was protein losing enteropathy. All procedures were angiographically and clinically successful.

Impacto do Escore SYNTAX no Prognóstico de Pacientes com Doença Multiarterial Tratados por Intervenção Coronária Percutânea

Introducao: O escore SYNTAX estratifica a complexidade angiografica e estabelece o prognostico de portadores de doenca triarterial e/ou com lesao de tronco, sendo uma importante ferramenta para decidir a melhor estrategia de revascularizacao. Avaliamos o impacto do escore SYNTAX no prognostico de pacientes com doenca arterial coronariana multiarterial da pratica clinica tratados por intervencao coronaria percutânea. Metodos: Identificamos no Registro SAFIRA pacientes com acometimento multiarterial tratados eletivamente com stents farmacologicos. Os pacientes foram agrupados em escore SYNTAX ≤ 8; escore SYNTAX > 8 e ≤ 16; e escore SYNTAX > 16, e comparados quanto aos eventos cardiacos adversos maiores. Resultados: No periodo de 2009 a 2014, identificamos 244 pacientes, que preencheram os criterios de inclusao para o estudo. Foram distribuidos em escore SYNTAX ≤ 8 (n = 61; 25%), > 8 e ≤ 16 (n = 116; 47,5%), e > 16 (n = 67; 27,5%). A media de idade foi de 64,6 ± 11,5 anos e 73% eram do sexo masculino. O escore SYNTAX variou de 1 a 39, com media de 13,4 ± 6,8. No periodo de 3,6 ± 2,1 anos, observaram-se maiores taxas de eventos cardiacos adversos maiores no grupo > 16 (4,9% vs. 6,9% vs. 11,9%; p < 0,01), as custas de maior revascularizacao do vaso-alvo (1,6% vs. 2,6% vs. 7,5%; p = 0,08). Quatro casos de trombose do stent definitiva ou provavel foram detectados (zero vs. 1,7% vs. 3,0%; p = 0,41). Conclusoes: O escore SYNTAX e capaz de estratificar o risco em uma populacao com doenca coronaria multiarterial da pratica clinica submetida a revascularizacao percutânea com implante de stents farmacologicos.

TAVI: the game changer for the future! Are we ready to implant hope into patient's heart?

Amanda Rodrigues de Oliveira Siqueira1, Sara Rodrigues de Oliveira Siqueira1, Jose Armando Mangione2, Salvador Andre Bavaresco Cristovao2, Maria Fernanda Zuliani Mauro2, Fernando Augusto Alves da Costa3 1Universidade Anhembi Morumbi – Curso de Graduacao em Medicina – Sao Paulo, SP – Brazil 2Hospital Beneficencia Portuguesa de Sao Paulo – Setor de Cardiologia Hemodinâmica – Sao Paulo, SP – Brazil 3Hospital Beneficencia Portuguesa de Sao Paulo – Setor de Cardiologia – Sao Paulo, SP – Brazil