The revascular active percutaneous interventional device for coronary total occlusions study.

BACKGROUND: Despite the well-documented benefit of recanalization of an occluded vessel in some symptomatic patients, attempt is only performed in a minority of them. Percutaneous coronary intervention (PCI) of CTO is associated with high incidence of complications and unsuccessful procedure, mainly due to inability to cross the lesion. We sought to evaluate the efficacy and safety of the novel RVT CTO Guidewire Device (RVT-GDW, ReVascular Therapeutics, Sunnyvale, CA) in this complex scenario. METHODS: The RAPID-CTO study is a non-randomized, single center, first-in-man evaluation of a new guidewire system for treatment of CTO. The RVT-GDW is a new device designed to provide enhanced penetration and positioning control for crossing CTO via: (1) an 0.014 "guidewire with a mechanically active distal end; (2) a handle attached proximally to the guidewire, with an adjustable torquer, and interfaced to (3) a non-disposable, battery-operated, control unit, that provides activation control and audio feedback during the CTO crossing procedure. Per protocol, the RVT-GDW device was only used after at least 5 min (fluoroscopy time) of attempt with commercially available conventional guidewires to cross the target lesion. RESULTS: A total of 16 patients (16 lesions) were treated with the RVT-GDW. Mean age was 56.25 years, 56.2% were men, and 25% diabetics. The average duration of occlusion was 4.7 +/- 2.1 months. The mean vessel reference diameter was 2.76 +/- 0.31 mm and the mean lesion length was 16.64 +/- 7.70 mm (range 4.37-35.0 mm). Thirteen patients (81.2%) had "tapered stump" morphology at the proximal end of the occlusion, and a side branch was involved in 12 (75.0%). All lesions had contralateral circulation; bridging collaterals were seen in three (18.7%). Procedural success was achieved in 10 lesions (62.5%), with an average procedural time of 111.43 +/- 35.76 min. There were no major adverse cardiac events at both in-hospital and 30-day clinical follow-up. CONCLUSIONS: The first-in-man RAPID-CTO study suggests that the novel RVT-GDW device is technically feasible, safe and effective in crossing chronically occluded coronary arteries. Larger studies are warranted.

Diabetes and cardiovascular events in high-risk patients: Insights from a multicenter registry in a middle-income country.

AIMS: The aim of this study was to determine the rate of major clinical events and its determinants in patients with previous cardiovascular event or not, and with or without diabetes from a middle-income country. METHODS: REACT study is a multicenter registry conducted between July 2010 and May 2013 in Brazil. Patients were eligible if they were over 45years old and high cardiovascular risk. Patients were followed for 12months; data were collected regarding adherence to evidence-based therapies and occurrence of clinical events (all-cause mortality, non-fatal cardiac arrest, myocardial infarction, or stroke). RESULTS: A total of 5006 subjects was included and analyzed in four groups: No diabetes and no previous cardiovascular event, n=430; diabetes and no previous cardiovascular event, n=1138; no diabetes and previous cardiovascular event, n=1747; and diabetes and previous cardiovascular event, n=1691. Major clinical events in one-year follow-up occurred in 332 patients. A previous cardiovascular event was associated with a higher risk of having another event in the follow-up (HR 2.31 95% CI 1.74-3.05, p<0.001), as did the presence of diabetes (HR 1.28 95% CI 1.10-1.73, p=0.005). In patients with diabetes,failure to reach HbA1c targetswas related topoorer event-free survival compared to patients with good metabolic control (HR 1.70 95% CI 1.01-2.84, p=0.044). CONCLUSIONS: In Brazil, diabetes confers high risk for major clinical events, but this condition is not equivalent to having a previous cardiovascular event. Moreover, not so strict targets for HbA1c in patients with diabetes and previous cardiovascular events might be considered.

Diabetes and cardiovascular events in high-risk patients: Insights from a multicenter registry in a middle-income country

AIMS:The aim of this study was to determine the rate of major clinical events and its determinants in patients with previous cardiovascular event or not, and with or without diabetes from a middle-income country.METHODS:REACT study is a multicenter registry conducted between July 2010 and May 2013 in Brazil. Patients were eligible if they were over 45years old and high cardiovascular risk. Patients were followed for 12months; data were collected regarding adherence to evidence-based therapies and occurrence of clinical events (all-cause mortality, non-fatal cardiac arrest, myocardial infarction, or stroke).

Serial angiographic and intravascular ultrasound evaluation to interrogate the presence of late "catch-up" phenomenon after Cypher® sirolimus-eluting stent implantation.

Despite the expressive reduction in the intimal hyperplasia (IH) formation after DES implantation at the mid-term, late restenosis has been recently noticed. Our objective was to determine, by means of serial angiography (QCA) and intravascular ultrasound (IVUS) at two different time points, whether the occurrence of the "late catch-up" phenomenon occurs after sirolimus-eluting stent (SES) implantation. Thirty-eight non-complex patients treated with a single 18-mm SES who had systematic serial QCA and IVUS analyses at mean 8 and 20 months were enrolled. Primary endpoint is to evaluate the temporal course of IH formation after SES implantation, by comparing QCA in-stent late loss and IVUS percent IH obstruction between the invasive follow-ups. Mean cohort age was 59.3 years and 31.6% were diabetics. Baseline reference vessel diameter was 2.8 ± 0.4 mm and lesion length was 11.5 ± 3.5 mm. Left anterior descending artery was the most frequent target vessel (55.3%). Between 8 and 20 months, a non-significant increase in in-stent late loss from 0.10 ± 0.18 to 0.15 ± 0.30 mm (P = 0.38) was observed. By IVUS, a slight increase in the percent IH obstruction (1.03 ± 2.13 to 1.76 ± 1.87%, P = 0.12) was detected between the two evaluations. Interestingly, all the neoformed tissue accrued from 8 to 20 months accumulated in the distal portion of the stent. In the non-complex scenario, SES implantation was associated with a minimal, non-significant increase in the IH volume between 8 and 20 months.

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.

Stents farmacológicos no mundo real: impacto de sua disponibilidade no perfil de pacientes tratados por meio de intervenção coronária percutânea em um Hospital Público / Drug-eluting stents in the real world scenario: the impact of their availability in the profile of patients treated percutaneously in a public hospital

Introdução: Pacientes submetidos a intervenção percutânea em hospitais públicos brasileiros não têm acesso aos stents farmacológicos. No início de 2006, participamos de um registro multicêntrico internacional que disponibilizava o uso rotineiro dessas próteses, no cenário do mundo real. Neste artigo, procuramos identificar os perfis clínico, angiográfico e do procedimento de pacientes consecutivamente tratados em períodos subseqüentes de dois meses, de acordo com a disponibilidade desses modelos, visando à identificação de eventuais alterações nesses perfis. Método: Estudo observacional de uma série de 471 pacientes, divididos em dois grupos: A, 229 casos dilatados na vigência da disponibilidade de stents farmacológicos; e B, 242 pacientes subseqüentes tratados da forma usual. Não houve critérios de inclusão/exclusão. Resultados: Stents farmacológicos foram mais implantados no grupo A (44% vs. 2%; p < 0,0001). No que se refere às características de base, observou-se predomínio significante de diabéticos dependentes de insulina em A (8% vs. 3%; p = 0,02), o mesmo ocorrendo com lesões-alvo tipos B2 ou C (73% vs. 57%; p < 0,0001), lesões situadas em bifurcações (15% vs. 9%; p = 0,02) e intervenções multiarteriais (15% vs. 6%; p = 0,003). A angiografia quantitativa identificou os casos de A como portadores de estenoses situadas em vasos de menor calibre (2,4 mm vs. 2,6 mm; p = 0,0004), também exibindo lesões mais longas (14,9 mm vs. 12,7 mm; p = 0,0008). Conclusões: A disponibilidade dos stents farmacológicos gerou alterações no perfil dos casos tratados, que passou a abordar situações mais predispostas à reestenose, como os diabéticos dependentes de insulina, os multiarteriais com lesões de alta complexidade e os portadores de lesões mais longas em vasos de fino calibre.

Introduction: Patients submitted to percutaneous intervention in public hospitals in Brazil have no access to DES. At the beginning of 2006, we participated in an international multicenter registry which made available the routine use of these prosthesis, in a “real world” scenario. In this article, we intend to identify the clinical, angiographical and procedural profiles of the patients, consecutively treated in two-month subsequent periods, according to the availability of these models, with the aim of identifying eventual changes in their profiles. Method: Observational series of 471 patients, divided into two groups: A) 229 cases, treated during a period of availability of DES for routine use; and B) 242 patients subsequently treated as usual (no routine avalilability of DES). There were no inclusion/exclusion criteria. Results: More DES were implanted in group A (44% vs. 2%; p<0.0001). Regarding baseline clinical and angiographic characteristics, a significant predominance of insulin-dependent diabetics was observed in group A (8% vs. 3%; p=0.02), as well as B2 or C lesions (73% vs. 57%; p<0.0001); lesions in bifurcations (15% vs. 9%; p=0.02), and multiarterial interventions (15% vs. 6%; p=0.003). Quantitative angiography identified the A group cases as bearers of stenosis placed in smaller vessels (2.4 mm vs. 2.6 mm; p=0.0004), also exhibiting longer lesions (14.9 mm vs. 12.7 mm; p=0.0008). Conclusions: The availability of DES changed the profile of the patients treated, being more likely situations prone to restenosis, such as insulin dependent diabetics, multiarterial disease, patients presenting complex lesions, longer lesions and smaller target vessels.

Angioplastia com implante de stents para o tratamento de dissecção coronária espontânea / Angioplasty with stent implantation for the treatment of spontaneous coronary artery dissection

É relatado o caso de uma mulher de 40 anos, hipertensa e tabagista, que foi admitida com quadro de infarto agudo do miocárdio sem supradesnivelamento do segmento ST. A cinecoronariografia inicial revelava lesão moderada no terço proximal da artéria circunflexa. Proposto tratamento percutâneo da referida lesão e, no momento do procedimento, a angiografia revelou ausência de lesões na circunflexa e aparecimento de extensa dissecção desde o óstio até o terço médio da artéria descendente anterior, com fluxo distal TIMI III, optando-se por tratamento clínico...

Inibição da proliferação neointimal após o implante de stents eluidores de biolimus A9: Análise volumétrica tardia com ultra-som intracoronário / Supressiion of intimal proliferation after implantation of biolimus A9-eluting stents: 6-month single-center intravascular ultrasound follow-up

Introdução: O estudo STEALTH I demonstrou a eficácia e segurança dos stents eluidores de Biolimus A (BA9) em reduzir a perda-tardia angiográfica e apresentar uma baixa incidência de eventos cardíacos maiores, entretanto os achados de ultra-som intracoronário (USIC) ainda não foram descritos. O objetivo deste estudo é descrever os achados de análise volumétrica por USIC nos pacientes recrutados em nossa instituição. Métodos e Resultados: Quarenta e cinco pacientes apresentando lesão coronária de novo, única, foram randomizados 2:1 para receber stents eluidores de BA9 (n igual 30) ou stents controle (n igual 15). A média de idade foi de 58 anos, com 16 por cento diabéticos e 62 por cento do sexo masculino. As características clínicas e angiográficas foram similares entre os grupos. Aos 6 meses de seguimento não houve diferença significativa entre os grupos quanto a desfechos clínicos. O índice de hiperplasia intimal intra-stent foi inferior no grupo dos stents eluidores de BA9 em comparação ao grupo controle 0,19 mais/menos 0,08 vs. 2.71 mais/menos 0.50, ) menor 0.0001), assim como o percentual de obstrução...

Background: Biolimus A9 (BA9) is a novel sirolimus analog with similar antiproliferative properties. BA9-eluting stents reduce angiographic late-loss compared to bare metal stents (BMS), with a low incidence of major adverse cardiac events (MACE), as reported in the randomized, controlled STEALTH I trial. We describe the intravascular ultrasound (IVUS) volumetric findings of patients enrolled at our institution. Methods and Results: Forty-five patients presenting a single, de novo coronary lesion (2.5-4.0 mm vessels; lesion length <24 mm) were randomly assigned in a 2:1 basis to receive either BA9-eluting (n=30) or bare metal stents (n=15). Mean age was 58 years, with 16% diabetics and 62% men. Baseline clinical and angiographic characteristics were similar between groups. At 6 month follow-up, there was no statistical difference in clinical outcomes between groups. In-stent intimal hyperplasia index measured by IVUS was 0.19+/-0.08 mm3/ mm3 for the BA9 group vs. 2.71+/-0.50 mm3/mm3 for BMS controls. The percentage of stent obstruction was also significantly lower for the BA9 group when compared to BMS (2.2+/-0.80% vs. 19.9+/-4.67%, P<0.0001). No stent thrombosis, aneurysm formation or incomplete stent apposition was observed in any group. Conclusions: Using IVUS volumetric analysis, we showed that BA9-eluting stents have a potent inhibitory effect on neointimal proliferation when compared to BMS at 6-month follow-up.

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)...

Intervençoes percutâneas para revascularização do miocárdio no Brasil em 1996 e 1997 comparadas as do biênio 1992 e 1993. Relatório do registro CENIC (Central Nacional de Intervenoes Cardiovasculares) / Percutaneous myocardial revascularization procedures in Brazil in 1996-1997 compared to the 1992-1993 period. A report of the National Registry--National Center for Cardiovascular Interventions (CENIC)

PURPOSE: To report the results of percutaneous coronary interventions, in Brazil, in the years 1996-97, comparing them to those of 1992-93. METHODS: Data were collected in a standard form and the 1996-97 results were compared to those of 1992-93. RESULTS: The current Registry received data from 79effective members of the SBHCI in 127 hospitals, including 22,025 patients, 60.67of whom underwent PTCA, 36.57stent implantation, 2.3PTRA, 0.06DCA and 0.4laser angioplasty. Balloon angioplasty was the most frequent procedure in 1996-97, but its overall rate fell from 6.75to 55.8(p = 0.0001) concomitantly, there was a 35relative increase in the use of stents from 1992-93 to 1996-97. The success rate of the later period was higher (89.7vs 92.8, p = 0.000001), with lower residual stenosis (22vs 19, p = 0.001). Besides, there were lower major complications rates: acute myocardial infarction (2.5vs 1.2, p = 0.002) and death (1.8vs 1.4, p = 0.0003). CONCLUSION: The procedures most often carried out in both periods were balloon angioplasty (60.67) and implantation of stents (36.57); the success rate high, abrupt closure rate was low (1.5). These favorable results corroborate the high standards of the Brazilian Interventional Cardiology.

Estudo prospectivo e randomizado de pacientes tratados com e sem stents revestidos com carbeto de silício amorfo para a prevenção da reestenose coronariana. Avaliação ultra-sonográfica / Randomized intravascular ultrasound comparison between endoprostheses with and without amorphous silicon-carbide

OBJETIVO: A reestenose intra-stent é a maior limitação das intervenções coronárias percutâneas. O carbeto de silício amorfo (SiC-a), substância antitrombótica e antiinflamatória capaz de reduzir a deposição de fibrina, plaquetas e leucócitos sobre o stent, apresenta potencial de prevenir a hiperplasia neo-intimal e a reestenose. MÉTODOS: Estudo prospectivo, randomizado e tipo rótulo aberto comparando pacientes com doença coronariana tratados com e sem stents revestidos com o SiC-a, utilizando a angiografia quantitativa e o ultra-som intracoronário. Foram incluídos 100 pacientes (50 em cada grupo) a fim de mensurar o volume de hiperplasia neo-intimal intra-stent/extremidades. Como os stents comparados apresentavam extensões diferentes, o volume de hiperplasia foi analisado em valores absolutos (por paciente) e relativos (por milímetro de extensão do stent). Avaliaram-se ainda os eventos cardíacos maiores e os resultados da angiografia quantitativa. RESULTADOS: Os grupos apresentaram características de base semelhantes. Todos os pacientes foram tratados com sucesso. No 6° mês de evolução foram reestudados 94 por cento dos casos dos dois grupos, obtendo-se ultra-som em 92 por cento. O volume de hiperplasia neo-intimal absoluto foi significativamente maior nos tratados com os stents revestidos (51.2 DP 18.8 mm³ vs 41.9 DP 16.4 mm³; p=0.014), porém o relativo foi semelhante (2.9 DP 1.0 mm³/mm stent vs 2.5 DP 0.9 mm³/mm stent; p=0.108). A obstrução volumétrica da luz também foi similar (36.4 DP 11.1 por cento vs 37.9 DP 10.9 por cento; p=0.505). O diâmetro mínimo da luz (1.9 DP 0.7 mm vs 1.8 DO 0.6 mm; p=0.552), a reestenose (19.1 por cento vs 17 por cento; p>0.999) e a revascularização do vaso-alvo (16 por cento vs 14 por cento; p>0.999) não diferiram. CONCLUSÃO: Os stents revestidos apresentaram resultados clínicos, angiográficos e ultra-sonográficos similares aos controles.

Angioplastia coronária em longevos na 8ª e 9ª décadas de vida: uma opção eficaz de revascularizaçäo? / Transluminal coronary angioplasty in patients 70 years of age and older: an effective technique for myocardial revascularization?

Objetivo Avaliar a eficácia da angioplastia coronária como procedimento de revascularização miocárdica na doença aterosclerótica coronária sintomática, em pacientes na 8a e 9a décadas de vida. Métodos Quatrocentos e cincoenta e dois pacientes idosos (idade média 74,7 anos) foram submetidos à dilatação coronária, entre abril de 1982 e junho de 1990, no Instituto Dante Pazzanese de Cardiologia. Eram 70,4% do sexo masculino, 34,9% hipertensos, 18,8% fumantes e 10,8% diabéticos. Noventa e quatro pacientes (20,7%) exibiam infarto prévio e em cerca de 14% constataram-se doenças sistêmicas severas associadas (insuficiência renal 5,1%; insuficiência respiratória 3,1%; doenças ósseas e reumáticas 1,1%; neoplasias malignas 4,2% e doenças hematológicas—0,4%). Cento e setenta e três pacientes (38,3%) eram multiarteriais e 84 (18,5%) apresentavam moderado a severo comprometimento da função ventricular esquerda. A dilatação coronária foi realizada segundo a metodologia descrita por Grüntzig, utilizando-se em todos os casos os cateteres-balão dirigíveis over the wire (LPS-USCI, Mini Profile-USCI, ACX-ACS) ou on a wire (ProbeUSCI, AXCEL-ACS...

Purpose—To evaluate the efficacy of percutaneous transluminal angioplasty (PTCA), as a revascularization procedure in patients with symptomatic coronary artery disease in the 8th and 9th decades of life. Methods Four hundred and fifty-two elderly patients (mean age 74.7 years) underwent balloon dilation, between April 1982 and June 1990, at the Institute Dante Pazzanese of Cardiology. There were 70.4% male, 34.9% with high blood pressure, 18.8% smoked and 10.8% with diabetes. Ninety-four patients (20.7%) had previous myocardial infarction and systemic disorders were diagnosed in 14% (renal failure 5.1%, respiratory insufficiency 3.1%, rheumatic and bone disorders 1.1%, malignancy 4.2%, haematologic disorders 0.4%). One hundred and seventy-three (38.3%) had multivessel coronary artery disease whereas 84 (18.5%) had moderate to severe dysfunction of the left ventricle. PTCA was done according to the method described by Grüntzig, with the use of a “over the wire (LPS, USCI, Mini Profile USCI, ACX ACS) balloon or a on the wire (Probe USCI, Axcel ACS) System...

Angioplastia da artéria descendente anterior de origem anômala: aplicaçäo de novo cateter-baläo de baixo perfil; relato de caso / Angioplasty of anterior descending artery from anomalous origin: use of a new low profile catheter baloon: report of a case

Atualmente existe a possibilidade de se realizar angioplastia translumina coronaria em artérias de fino calibre e que apresentem lesöes distais graves. Isto se deve, entre outros fatores, à introduçäo de sistemas dilatadores dotados de inovaçöes tecnológicas que favorecem sua realizaçäo nestas e em outras circunstâncias. Nesta paciente o procedimento foi efetivado em uma artéria coronária com origem anômala e fino calibre, variedade anatômica rara e de acesso problemático à angioplastia, utilizando para tanto, cateter-baläo de baixo perfil do tipo Probe**TM, que apresenta características que diferenciam daqueles convencionalmente utilizados

It is possible to perform transluminal coronary angioplasty (TCA) in thin vessels presenting severe obstructions. One of the achievements that made such procedure possible is the development of a new generation of balloon catheters. In this case report the TCA was performed in a very thin left anterior descending artery with an anomalous origin, a quite rare situation that represents a major problem to the traditional dilator system. The catheter used was a ProbeTM (USCI), which differs of the traditional balloons in a number of characteristics. The authors consider the procedure in detail pointing out the advantages of using of the new generations and discuss the impact that newer technological developments will have in enlarging the indications for TCA and improving the results.

Angioplastia coronária: eficácia dos novos cateteres-baläo de baixo perfil / Coronary angioplasty: efficacy of the new low profile balloon catheter

Os novos cateteres-baläo de baixo perfil têm permitido a realizaçäo da angioplastia coronária (ATC) em lesöes mais complexas. O nosso estudo mostra a experiência inicial com estes novos sistemas em 50 (50%) de 101 pacientes submetidos à ATC entre 15 de março e 15 de maio de 1989 no Instituto Dante Pazzanese de Cardiologia. A idade média foi de 58,6 ñ 10,4 anos, com a maioria (75%) dos pacientes do sexo masculino. Cinqüenta e quatro lesöes foram dilatadas, e a doença uniarterial participou com 84% dos casos. Das lesöes nos vasos, 56% se encontravam nos terços médio ou distal e a média do grau de estenose pré-ATC era de 84 ñ 10,2%. A funçäo ventricular esquerda era normal em 60% dos pacientes. O índice de sucesso primário por paciente foi de 95% e a ultrapassagem das obstruçöes coronárias foi possível em todos os casos. O número médio de insuflaçöes foi de 2,7 ñ 0,6. As médias de pressäo máxima de insuflaçäo e de tempo máximo de insuflaçäo foram de 8 ñ 1,15 atm e 86,1 ñ 29,0 segundos, respectivamente. A lesäo residual média correspondeu a 15,2 ñ 10,6%. Em relaçäo às complicaçöes maiores, ocorreu apenas um episódio de infarto lateral. Cirurgias de emergências näo foram necessárias, assim como näo houve óbitos. Em conclusäo, estes novos cateteres-baläo permitiram ampliar o espectro de indicaçäo da ATC para lesöes mais complexas, com elevada taxa (95%) de sucesso primário, e baixo (2,5%) índice de complicaçöes

Angioplastia coronária de lesöes moderadas (50 a 60%) / Coronary angioplasty of moderate lesions (50 to 60%)

Objetivo - Avaliar a eficácia da angioplastia coronária em pacientes com lesöes moderadas (obstruçäo 50 a 60% da luz arterial). Material e Métodos - Cento e trinta e nove pacientes, sendo 108 (78%) homens, com idades média de 55 anos, submetidos à angioplastia coronária entre agosto de 1983 e janeiro de 1989. O quadro clínico era angina estável em 91 (65%) e angina instável em 48 (35%). Lesäo uniarterial foi observada em 117 pacientes (84%); os restantes 22 (16%) exibiam doença biarterial. Resultados - Obteve-se sucesso primário em 130 (94%) casos. Todos os pacientes biarteriais foram revascularizados de forma completa. Entre os insucessos, houve 2 (1,4%) casos de infarto do miocárdio e 4 (2,8%) de cirurgia de emergência. Näo houve óbitos hospitalares. Cento e dezenove (92%) dos com sucesso foram acompanhados tardiamente (média de 31 meses). Constatamos 85 (71%) assintomáticos e recidiva dos sintomas em 27 (23%). Houve 2 óbitos tardios de causa cardiovascular e 5 por doenças sistêmicas. Em 54 reestudos angiográficos, observamos em 42 (78%) manutençäo do resultado inicíal, e em 12 (22%) reestenose, em grau de obstruçäo médio mais severo que pré-angioplastia. Conclusäo - Angioplastia coronária de lesöes moderadas apresenta elevado percentual de sucesso primário (965); entretanto, os índices de complicaçöes maiores e reestenose assemelham-se aos observados para obstruçöes de grau severo, o que nos leva a reservar sua indicaçäo para os casos de alto risco clínico ou que apresentem evidências objetivas de isquemia miocárdica, apesar de terapêutica medicamentosa

Influência do quadro clínico nos resultados imediatos e tardios após aterectomia rotacional / Influence of the Clinical Presentation in Acute and Long-Term Results After Rotational Atherectomy

PURPOSE: To analyse the influence of unstable coronary syndromes (UCS) in the early and late prognosis after rotational atherectomy (RA). METHODS: We treated 236 patients with RA between Aug/1992 and May/1996. Patients were divided into two groups: A) stable coronary syndromes 120 (51) patients; B) UCS: 116 (49) patients. Definitions: 1) procedure success (PS)--lesion success in all locations were RA use was attempted, without a major complication; 2) late coronary events (LCE)--angina, MI, additional revascularization or death. RESULTS: There was a significant predominance of age > 70 (A = 14x B = 24, p = 0.03) in B and previous MI (A = 32x B = 11, p = 0.0001) in A. Other characteristics were similar in both groups, including complex lesions (type B2/C), which were observed in 77A stenosis and 80B lesions. PS was 95in A and 92in B (p = NS). In-hospital major complications were observed in 2.5A and 4.3B patients, (p = NS). One patient died in each group. A and B patients had similar time of follow-up. LCE occurred in 25A and 39B patients (p = 0.002). Recurrence of angina (36x 23; p = 0.01) and target lesion revascularization (29x 18; p = 0.03) were also more frequently required in B cases. CONCLUSION: This study suggests that UCS (group A) does not implicate in worse acute results after RA. However, UCS patients present greater incidence of late coronary events, particularly recurrence of angina and target-lesion revascularization.

Emprego da angioplastia coronária primária no infarto agudo do miocárdio em pacientes acima de 70 anos / Use of primary coronary angioplasty in acute myocardial infarction in patients over 70 years of age

Objetivo - A análise da experiência com a utilizaçäo da angioplastia coronária primária no infarto agudo do miocárdio em pacientes acima de 70 anos, sem o uso prévio de agentes, trombolíticos. Métodos - Quarenta e dois pacientes com diagnóstico de infarto agudo do miocárdio foram submetidos à angioplastia transluminal coronária nas primeiras 12 horas de evoluçäo do episódio agudo dos quais 47% nas 3 horas iniciais de apresentaçäo. As idades variaram de 70 a 86 (m = 76,4) anos; 54,7% eram do sexo masculino e 43% exibiam infarto da parede anterior do ventrículo esquerdo. A angioplastia coronária foi realizada apenas para a artéria responsável pelo evento agudo; a descendente anterior foi tratada em 43% dos pacientes, a coronária direita em 47% e a circunflexa em 10%. Oitenta e um por cento dos casos encontravam-se nas classes funcionais I e II de Killip e os demais nas classes III e IV. Resultados - Sucesso primário foi de 86%. A mortalidade hospitalar ocorreu em 14,2% dos pacientes, sendo significativamente superior nos pacientes do sexo feminino (26,3%), naqueles na classificaçäo de Killip III e IV (37,5%), nos portadores de doença coronária multiarterial (16,6%) e nos casos com insucesso da angioplastia coronária (33%). Ocorreram 8,3% de reinfartos e nenhuma complicaçäo hemorrágica de maior porte. O reestudo angiográfico foi realizado em 50% dos pacientes revelando 72% de permeabilidade arterial tardia com melhora significativa da fraçäo de ejeçäo global e regional, principalmente nos que mantiveram o resultado inicial do procedimento. Conclusäo - A angioplastia coronária primária, sem o uso prévio de agentes trombolíticos, quando empregada em pacientes idosos e infartados, exibe alto percentual de sucesso, baixa taxa de mortalidade e ausência de fenômenos hemorrágicos graves

Purpose - To evaluate the use of primary coronary angioplasty (PTCA) in patients older than 70 years, evolving with acute myocardial infarction, without the previous administration of thrombolitic agents. Methods - Forty-two patients with acute myocardial infarction (AMI) and more than 70 years of age (m = 76.4y). There were 54.7% men and 43% of them had anterior MI. PTCA was carried out during the first 12 hours of evolution and in the first 3 hours of duration in 47% of them. PTCA was done only to the AMI related artery, which was the left descending artery in 43%, the right coronary artery in 47% and the left circunflex in the remaining patients. Nineteen percent of these patients were in Killip class III e IV. Results - Primary success was achieved in 86%. The in hospital mortality was 14.2%, and it was superior in female gender (26,3%), in Killip class III and IV (37.5%), in those with multivessel coronary disease (16.6%) and in those where primary PTCA failed (33%). There were 9.3% of reinfarction, but no major hemorrhagies happened. Late angiography was done in 50% of patients, showing 72% of patency in the AMI related artery, and a significant improval of global ejection fraction and of the wall motion, particularly, in those who maintained arterial patency. Conclusion - Primary PTCA, without former use of thrombolytic agents, when applied early in elderly patients evolving with AMI, has a high success rate and low mortality rate in this subset of high risk patients. It also shows no major hemorrhagic complications