Evaluation of the efficacy and safety of a stent covered with biosynthetic cellulose in a rabbit iliac artery model.

OBJECTIVES: We sought to test the efficacy and safety of the implantation of a stent covered with biosynthetic cellulose compared to a conventional bare-metal stent (BMS) in a rabbit iliac artery model. BACKGROUND: Biosynthetic cellulose is a biocompatible film used in several fields of medicine. Stents covered with biosynthetic cellulose are devices with the potential of achieving total lesion coverage, acting as a physical barrier to the migration of smooth muscle cells from the artery wall to the arterial lumen, and capturing circulating endothelial progenitor cells that may form a functional endothelial layer. METHODS AND RESULTS: Seven BMS and 7 stents covered with biosynthetic cellulose were implanted in the iliac arteries of 7 rabbits. Angiographic restudy and morphometric analysis of the specimens were performed after 4 weeks. No intrastent angiographic restenosis was observed, either with BMS or with stents covered with biosynthetic cellulose. There was also no acute or late vessel occlusion caused by stent thrombosis in either group. In the BMS and biosynthetic cellulose stented groups, respectively, mean neointimal thicknesses were 0.18 +/- 0.02 mm and 0.35 +/- 0.02 mm*; lumen area, 4.6 +/- 0.43 mm2 and 4.04 +/- 0.42 mm2; neointimal area, 0.58 +/- 0.09 mm2 and 2.13 +/- 0.11 mm(2)*; % lumen, 79.09 +/- 1.6% and 58.44 +/- 3.26%*; % stenosis, 10.97 +/- 1.23% and 35.55 +/- 3.39%* (*p < 0.05 vs. bare-metal). CONCLUSIONS: Implantation of stents covered with biosynthetic cellulose was safe, with no acute or late vessel occlusion caused by stent thrombosis, although it resulted in a more pronounced absolute neointimal thickness when compared to BMS.

Expert consensus (SBC/SBHCI) on the use of drug-eluting stents: recommendations of the Brazilian society of interventional cardiology/ Brazilian society of cardiology for the Brazilian public single healthcare system.

The authors review percutaneous coronary intervention (PCI) evolution and its growing application in myocardial revascularization for patients with coronary heart disease in Brazil and worldwide. PCI was introduced in 1977 using only the catheter balloon. Limitations of this method (acute occlusion and coronary restenosis) led to the adoption of coronary stents and more recently the advent of drug-eluting stents2, which were developed to drastically reduce restenosis rates. These developments allowed the exponential growth of percutaneous coronary intervention (PCI) procedures in Brazil which have replaced many bypass surgery procedures and have become the gold standard for the majority of symptomatic patients suffering from coronary artery disease. The preference for this procedure gained new dimensions in 2000 when the Brazilian Public Healthcare System (SUS) began reimbursing for stent procedures. This measure exemplified the importance of the Public Healthcare System's participation in incorporating medical advances and offering a high standard of cardiovascular treatment to a large portion of the Brazilian population. It is emphasized that prevention of in-stent restenosis is complex due to its unpredictable and ubiquitous occurrence. Control of this condition improves quality of life and reduces the recurrence of angina pectoris, the need to perform new revascularization procedures and hospital readmissions. The overall success of the drug-eluting stents has proven to be reliable and consistent in overcoming restenosis and has some beneficial impact for all clinical and angiographic conditions. This paper discusses the adoption and criteria for the use of drug-eluting stents in other countries as well as the recommendations established by the Brazilian Society of Interventional Cardiology for their reimbursement by SUS. The incorporation of new healthcare technology involves two distinct stages. During the first stage, the product is registered with the National Health Surveillance Agency (ANVISA). During this stage the interested company submits to the regulatory agency, results from clinical studies that demonstrate the efficacy and safety of the new device or pharmaceutical product. Frequently, in addition to clinical studies, approval records for clinical use from the regulatory agencies of other countries, mainly the United States of America and the European Community are also submitted. The successful completion of this stage means that the medication or device may be prescribed or used by the physicians in Brazil. The second stage in the incorporation of new healthcare technology involves the reimbursement or financing of the treatment that was approved in the previous stage based on its efficacy and safety. This stage can be more complex than the first one since the new technology, whether a substitution for established treatment methods or the introduction of a new treatment concept, are usually more expensive. The incorporation of new technology requires a cost-effectiveness analysis so that fund administrators can make decisions based on the universal scenario of limited resources to finance healthcare with treatments that are more and more burdensome. The difficulties of funding management are aggravated by medical and social ethical implications that arise when a treatment is approved based on its efficacy and safety but is not made available to patients who could benefit greatly from it. In Brazil, assessment methods for the incorporation of new technology based on reimbursement or financing have not been fully developed for either the private healthcare plans or the Brazilian Public Healthcare System (SUS). The implementation of new technology in both healthcare systems is a slow process and frequently the implementation is a result of the requirements of patients or the organizations that represent them and at times is the result of legal proceedings or political pressure imposed by physicians and their respective scientific societies. Our objective is to review the evolution of percutaneous coronary intervention (PCI) in Brazil and its current status in view of the advent of drug-eluting stents, the growing participation of drug-eluting stents in myocardial revascularization to treat patients with coronary heart disease, as well as, to compare the regulatory standards from Brazil and other countries regarding the incorporation and recommendations for the use of this new technology.

Consenso de especialistas (SBC/SBHCI) sobre o uso de stents farmacológicos: recomendações da sociedade brasileira de cardiologia/sociedade brasileira de hemodinâmica e cardiologia intervencionista ao sistema único de saúde / Expert consensus (SBC/SBHCI) on the use of drug-eluting stents: recommendations of the Brazilian society of interventional cardiology/ Brazilian society of cardiology for the Brazilian public single healthcare system / Expert consensus (SBC/SBHCI) on the use of drug-eluting stents: recommendations of the Brazilian society of interventional cardiology/ Brazilian society of cardiology for the Brazilian public single healthcare system

Os autores revisam a evolução da intervenção coronariana percutânea, a sua crescente aplicação na revascularização miocárdica de pacientes portadores de doença arterial coronariana, seja no Brasil, seja no âmbito mundial. Desde a introdução do método, em 1977, com a utilização isolada do cateter-balão, a constatação de que o mesmo tinha limitações (oclusão aguda e reestenose), a adoção dos stents coronarianos e, mais recentemente, o advento dos stents farmacológicos, idealizados para reduzir ainda mais as taxas de reestenose, possibilitaram o crescimento exponencial da aplicação da intervenção coronariana percutânea (ICP) no Brasil, superando a cirurgia de revascularização e tornando-se o tratamento majoritário para enfermos sintomáticos, acometidos de aterosclerose obstrutiva coronariana. Esta preferência se salienta, a partir do ano 2000, após o início do reembolso dos stents pelo Sistema de Unico de Saúde Brasileiro. Este fato demonstra a importância do Sistema Público de Saúde, quando este incorpora os avanços médicos, e passa a oferecer bons padrões de tratamento cardiovascular a grande número de brasileiros. Destaca-se a complexidade da profilaxia da reestenose intra-stent, por sua ocorrência imprevisível e ubíqua. O controle deste fenômeno melhora a qualidade de vida, reduzindo o retorno da angina do peito, a realização de novos procedimentos de revascularização e a re-internação hospitalar. Os stents farmacológicos lograram êxito sólido e consistente na conquista deste objetivo de forma abrangente, beneficiando todas as apresentações clínicas e angiográficas, em maior ou menor grau. Sua adoção e critérios para sua utilização em outros países são discutidos, assim como a formalização das indicações preconizadas pela Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista, para o seu reembolso pelo SUS. A incorporação de novas tecnologias em saúde é um processo que compreende duas etapas distintas: na primeira, o registro do produto é efetivado na Agência Nacional de Vigilância Sanitária (ANVISA)...

The authors review percutaneous coronary intervention (PCI) evolution and its growing application in myocardial revascularization for patients with coronary heart disease in Brazil and worldwide. PCI was introduced in 1977 using only the catheter balloon. Limitations of this method (acute occlusion and coronary restenosis) led to the adoption of coronary stents and more recently the advent of drug-eluting stents², which were developed to drastically reduce restenosis rates. These developments allowed the exponential growth of percutaneous coronary intervention (PCI) procedures in Brazil which have replaced many bypass surgery procedures and have become the gold standard for the majority of symptomatic patients suffering from coronary artery disease. The preference for this procedure gained new dimensions in 2000 when the Brazilian Public Healthcare System (SUS) began reimbursing for stent procedures. This measure exemplified the importance of the Public Healthcare System's participation in incorporating medical advances and offering a high standard of cardiovascular treatment to a large portion of the Brazilian population. It is emphasized that prevention of in-stent restenosis is complex due to its unpredictable and ubiquitous occurrence. Control of this condition improves quality of life and reduces the recurrence of angina pectoris, the need to perform new revascularization procedures and hospital readmissions. The overall success of the drug-eluting stents has proven to be reliable and consistent in overcoming restenosis and has some beneficial impact for all clinical and angiographic conditions. This paper discusses the adoption and criteria for the use of drug-eluting stents in other countries as well as the recommendations established by the Brazilian Society of Interventional Cardiology for their reimbursement by SUS. The incorporation of new healthcare technology involves two distinct stages. During the first stage, the product is registered with the National Health Surveillance Agency (ANVISA)...

Randomized comparison between Inoue balloon and metallic commissurotome in the treatment of rheumatic mitral stenosis: immediate results and 6-month and 3-year follow-up.

The metallic commissurotome (MC) technique is a cheaper alternative to the Inoue balloon (IB) technique for percutaneous mitral valvuloplasty (PMV). There are no randomized trials comparing these techniques with longer follow-up of the patients. The objective of this study was to compare the immediate results and short- and medium-term follow-up of PMV using either the IB or the MC technique. Fifty patients with rheumatic mitral stenosis were randomly assigned to PMV using the IB (n = 27) or the MC (n = 23) technique. There were no significant differences between the groups regarding baseline clinical, echocardiographic, and hemodynamic data. Clinical and echocardiographic follow-up were done 6 months and 3 years after the procedure. The success rate was 100% in the IB group and 91.3% in the MC group (P = 0.15); two patients in the latter group developed mitral regurgitation grade 3/4, requiring elective surgery. The mean final mitral valve area was bigger in the MC group (2.17 +/- 0.13 vs. 2.00 +/- 0.36 cm2; P = 0.04), but after 6-month and 3-year follow-up, this difference was no longer significant (2.06 +/- 0.27 vs. 1.98 +/- 0.38 cm2, P = 0.22, and 1.86 +/- 0.32 vs. 1.87 +/- 0.34 cm2, P = 0.89, respectively). This finding suggests valve stretching as an important mechanism of valve dilation with the MC. Three patients in the MC group and two patients in the IB group (P = 0.65) developed mitral valve restenosis; one of them underwent repeat PMV and the other four, all asymptomatic, were clinically followed. PMV performed either with the IB or the MC technique is effective and provides excellent short- and medium-term outcomes regardless of the technique employed.

Dual anterior descending coronary artery associated with coronary artery disease.

The patient is a male with risk factors for coronary artery disease, who was referred for cardiac catheterization after acute myocardial infarction in the inferior wall. The patient underwent transluminal coronary angioplasty in the right coronary artery with successful stent implantation.

Dupla origem do ramo descendente anterior associado à doença arterial coronariana / Dual anterior descending coronary artery associated with coronary artery disease

The patient is a male with risk factors for coronary artery disease, who was referred for cardiac catheterization after acute myocardial infarction in the inferior wall. The patient underwent transluminal coronary angioplasty in the right coronary artery with successful stent implantation

Aneurisma de tronco de coronária esquerda / Aneurysm of the left main coronary artery

Aneurysm of the left main coronary artery is a rare angiographic finding, with few cases described in the international literature. We report the case of a 42-year-old male with a previous history of acute myocardial infarction, whose coronariography indicated triple vessel coronary disease and an aneurysm of the left main coronary artery. A review of the etiology, clinical aspects, and surgical management of coronary arterial aneurysm is presented

Angioplastia cirúrgica de óstio e tronco coronariano: experiência de oito casos / a

No período de abril de 1980 a março de 1990, foram realizadas oito cirurgias de angioplastias de óstio e/ou tronco de coronária esquerda ou direita. Nao houve mortalidade imediata e esses pacientes foram acompanhados por um período de 1-109 meses (43,2 meses). Houve melhora clínica de classe funcional. Seis pacientes fizeram estudo cineangigráfico das coronárias e do ventrículo esquerdo, revelando uma anatomia de óstio e tronco adequada na área operada, e melhora da contratilidade do ventrículo esquerdo. Na evoluçao tardia houve dois óbios. Um paciente morreu a 39 meses do pós-operatório, com insuficiência cardíaca congestiva e dor anginosa; o outro faleceu em acidente rodoviário, após 109 meses da cirurgia. Estes resultados permitem concluir que a angioplastia por lesoes obstrutivas em óstio ou tronco coronário direito ou esquerdo, isoladas ou associadas a outros defeitos, é um procedimento cirurgico com baixo risco imediato, com evoluçao favorável a longo prazo e que pode ser considerado com o tratamento opcional para revascularizaçao coronária.

Valvoplastia com cateter baläo na estenose pulmonar / Valvoplasty with catheter balloon in pulmonary stenosis

O presente trabalho relata os resultados obtidos com a realizaçäo de valvoplastia pulmonar em 13 pacientes. A média do gradiente pressórico VD - TP (ventrículo direito - tronco pulmonar) prévio à valvoplastia foi 74,6 mmHg e após procedimento diminui para 20,2 mmHg. A pressäo sistólica média em VD prévia era 90,93 mmHg e após 39,5 mmHg. O seguimento realizado e 8 pacientes, entre 6 e 12 meses, demonstrou: 4 pacientes com manutençäo do padräo pós-imediato, 1 paciente com reestenose atribuída à valva pulmonar displásica (redilatada), 1 paciente com reestenose redilatada com cateter de maior diâmetro e 2 pacientes com seguimento clínico de boa evoluçäo. Demonstrou-se que em todos os procedimentos houve alívio da estenose pulmonar valvar (EPV) com queda do gradiente pressórico VD - TP e melhora do fluxo central através da valvoplastia pulmonar. Concluiu-se, entäo, que o método é eficaz no tratamento dsa EPV