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.

Reoperaçäo em pacientes revascularizados / Reoperation in patients for myocardial revascularization

Um grupo de pacientes submetidos a cirurgia de revascularizaçäo do miocárdio pode vir a necessitar uma reoperaçäo tardia. Neste trabalho, discute-se quais os possíveis fatores determinantes deste evento, bem como o prognóstico imediato destes indivíduos. Foram analisados 261 (10,5%) pacientes, submetidos a reoperaçäo para revascularizaçäo isolada do miocárdio entre janeiro de 1984 e junho de 1986. Havia 109 (41%) hipertensos e 145 (55%) portdores de infarto do miocárdio prévio. A reoperaçäo foi indicada pela presença de lesöes no leito nativo das artérias em 66 (25%), por lesöes nos enxertos em 88 (33%) e por lesöes nos leitos nativos e nos enxertos em 107 (42%). O tempo de reoperaçäo foi de 7,1 ñ 3,3 anos, sendo 75% dos pacientes reoperados num intervalo superior a 6 anos. O número global de artérias mamárias obstruídas foi de 5 (20%) enquanto que 171 (75%) das pontes de veia safena apresentavam lesöes. A mortalidade hospitalar foi de 23 (9%). Os autores discutem as relaçöes destes achados com a incidência da reoperaçäo bem como as possíveis causas da mortalidade elevada

Valvoplastia mitral com duplo cateter-baläo: análise de 200 casos / Percutaneous mitral balloon valvotomy: analysis of 200 cases

Objetivo - Avaliar a valvoplastia mitral por duplo cateter-baläo como técnica alternativa näo cirúrgica para tratamento da estenose mitral reumática. Método - Duzentos pacientes foram submetidos ao procedimento, sendo 86,5% do sexo feminino, com idade média de 35,2 anos. Oitenta e um por cento estavam em classes funcionais III e IV (NYHA), e 4% exibiam ritmo de fibrilaçäo atrial. Quatro por cento foram submetidos à comissurotomia cirurgica prévia e 7% eram gestantes. Utilizou-se a técnica de dilataçäo com duplo cateter-baläo, após punçäo septal esquerda. Resultados - O procedimento foi realizado com sucesso em 89% dos pacientes. A área valvar mitral aumentou de 0,91 ñ 0,27 para 2,10 ñ 0,47 cm*, p < 0,001; ocorreu reduçäo do gradiente transvalvar mitral de 20,86 ñ 6,16 para 4,26 ñ 3,13 mmHg, p < 0,001; as pressöes do átrio esquerdo e do tronco da artéria pulmonar reduziram de 25,90 ñ 7,10 para 12,10 ñ 9,0 mmHg e de 36,47 ñ 12,93 para 24,56 ñ 9,98 mmHg, p < 0,001, respectivamente. Dos 21 casos com insucesso, em 19 ocorreram dificuldades com a técnica transeptal. Em 12, constataram-se graus distintos de derrame pericárdico, dos quais 6 exibiram sinais de tamponamento cardíaco. Os 21 casos foram operados, ocorrendo 1 óbito. O refluxo mitral aparece em 50 casos e aumentou em 8. Quinze destes casos, exibiram descompensaçäo clínica, dos quais 10 foram operados, 3 estäo sob controle clínico e 2 faleceram tardiamente. Conclusäo - A valvoplastia mitral pelo duplo cateter-baläo é técnica segura, com bons resultados, constituindo-se me procedimento terapêutico alternativo näo cirúrgico da estenose mitral

Purpose - To study the immediate clinical, echocardiographic and hemodynamic results Of 200 patients who underwent percutaneous mitral balloon valvotomy (PMV) with double balloon technique. Methods - Two hundred patients were submitted to PVM for treatment of congestive heart failure secondary to severe mitral stenosis, between August 1987 to July 1991. Their mean age was 35.2 years, and 86.5% were female patients: 81% of them was in functional class, New York Heart Association (NYHAJ III or IV; 4% was in atrial fibrilation and 4% had previous surgical commissurotomy. Results - PMV was successfully performed in 89% of the patients. The mitral valve area, by pressure half time method, increased from 0.91 ± 0.27 to 2.10 ± 0.47 cm2, p < 0.001; the mean mitral gradient decreased from 20,86 ± 6.16 to 4.26 ± 3.13 mmHg, p < 0.001; the left atrium and mean pulmonary artery pressure decreased from 22.3 ± 7.1 to 11.9 ± 8.3 and 36.47 ± 12.93 to 24.56 ± 9.98 mmHg, p < 0.001, respectively. Complications related to transeptal technique occurred in 12 patients, which resulted in cardiac tamponade in 5 and death in 1. In 19 patients the punction of the atrial septum could not be performed. Mitral regurgitation (MR) immediately after PMV appeared 1 + or more grade in 50 patients, increased in 8 patients and remained unchanged in 11 patients. Ten patients needed mitral valve replacement in the first 48h after PMV, for treatment of severe MR. Conclusion - PMV prod uces excellent immediate results and can be considered an alternative to surgery for the relief of mitral stenosis

Utilidade da angiografia digital na realizaçäo da angioplastia coronária: análise de 100 casos / Utility of Digital Angiography in the Coronary Angioplasty. Analysis of 100 Cases

Objetivo - Analisar a real contribuição da angiografia digital para a realização da angioplastia coronária e como ela ajudaria na otimização dos resultados da dilatação. Métodos - Cem pacientes uniarteriais, sem angioplastia ou cirurgia de revascularização prévias, submetidos à dilatação de estenoses coronárias entre janeiro e dezembro de 1990. Além do registro cinecoronariográfico convencional foram feitas aquisições digitais antes do procedimento, para medir o diâmetro da artéria, escolhendo-se, dessa forma, o cateter balão mais adequado para cada caso, e também para quantificar a importância da estenose coronária a ser tratada. Novas aquisições eram feitas durante o procedimento para medir o diâmetro no local dilatado e, logo após a retirada do sistema dilatador, um novo registro digital permitia a quantificação da lesão residual e o diâmetro final do segmento tratado. Resultados - A estenose média pré-angioplastia era de 78,2%. O diâmetro de referência médio era de 2,8mm e no local estenosado 0,8mm. A relação balão/artéria era 0,9:1. A lesão residual pós-angioplastia foi de 13,6% e o diâmetro no local dilatado aumentou para 2,6mm. Não houve complicações em qualquer paciente. Conclusão - A angiografia digital é um método útil para os laboratórios que se dedicam a intervenções coronárias pois permite a confirmação da severidade anatômica da estenose, otimizar a escolha do cateter-balão a ser utilizado e monitorar os resultados obtidos, quantificando a lesão residual e medindo o diâmetro final atingido

Purpose - To analyse the actual contribution of digital angiography in the angioplasty setting and to assess its utility to optimize angioplasty results. Methods - One hundred patients with single vessel coronary artery disease, without previous angioplasty or coronary artery bypass graft surgery, who underwent angioplasty from January to December 1990. Views were obtained in standard films and also in digitized angiograms. The latter was acquired before angioplasty in order to precisely quantify the stenosis and also to measure the reference diameter of the artery that was used and to choose the balloon catheterfor each case. New acquisitions were done during and after the end of the procedure to confirm the residual stenosis and to measure the final diameter. Results - The mean stenosis pre angioplasty was 78.2%, the mean reference diameter 2.8 mm and the mean diameter at the stenotic site 0.8mm. The balloon artery relation was 0.9:1. After angioplasty the residual stenosis was 13.6% and the dilated segment had a final diameter of 2. 6mm. There were no complications in any patient. Conclusion - Digital angiography is a useful methodfor laboratories devoted to coronary interventions forit allows confirmation of the severity of the stenosis, optimizes the balloon/artery relation, monitors partial results and measures the residual stenosis as well as the final diameter.

Cateterismo cardíaco ambulatorial: análise da experiência acumulada em 10 meses / Outpatient Cardiac Catheterization. Analysis of a 10 Month Experience

Objetivo - Identificar pacientes que se prestem à estratégia do cateterismo cardíaco ambulatorial, com base nos aspectos sociais, riscos e complicações, por um período de 24 h. Métodos - Dos 2.126 casos submetidos a ca-teterismo cardíaco, no Instituto Dante Pazzanese de Cardiologia, no período de setembro de 1990 a junho de 1991, excluíramse: a) aqueles com idade superior a 75 anos; b) os com síndromes isquêmicas agudas; c) os com descompensação cardíaca classe IV (NYHA); d) os estudados pela técnica femoral com sistemas introdutores de alto perfil; e) os submetidos à anestesia geral, estudos eletrofisiológicos ou biópsias endomiocárdicas. Após a realização do exame, seguia-se período de observação de 3 h e, na ausência de complicacões, os pacientes re-cebiam alta com orientação de retorno obrigatório no dia seguinte, para reavaliação clínica. As eventuais complicacões deste período foram anotadas. Resultados - Dos 719pacientes elegíveis, 68% eram do sexo masculino, e a idade média era de 55,3 anos. Sessenta e um por cento estavam em classefuncional I da NYHA e a maioria (80,8%) foi estudada pela via braquial. Em 83% dos casos realizou-se a coronariografia, dos quais, 52%exibiam aterosclerose coronária. Quatrocentos e quatorze casos não receberam alta, pela seguintes razões: 217 por término do exame após as 18 h, 111 por razões sócio-econômicas, 23 por recusa do médico assistente, 8 devido à lesão do tronco da coronária esquerda e 55 por complicacões diversas. Todos os 305 pacientes que receberam alta ambulatorial não mostraram qualquer complicação na avaliação clínica do dia seguinte. Conclusão - O cateterismo ambulatorial demonstrou ser seguro em pacientes selecionados, viabilizando grande número de exames, com relativa economia de leitos e outros recursos hospitalares

Purpose - To identify patients suitable for out-patient cardiac catheterization strategy, based on social aspects, risks and complications, for a 24 hour period. Methods - In a series of 2.126 cases submitted to cardiac catheterization at the Instituto Dante Pazzanese de Cardiologia, between September 1990 and June 1991, were excluded: a) those over 75 years of age; b) the acute ischemic syndroms; c) those in NYHA functional class IV; d) patients who used 7 or 8 French femoral angiographtc catheters; e) patients who had undergone general anesthesia, electrophysiological study or endomyocardial biopsy. After the procedure, the patients were observed for a 3 hour period and in the absence of any complication, they were discharged from the hospital, returning the next day for clinical evaluation. If any complication occurred it was registered. Results - In a cohort of 719 eligible patients, 68% were male, with a mean age of 55,3 years. Sixty one per cent were in NYHA functional class I and most of them (80,8%) were studied by the brachial approach. Eigthy-three per cent of the patients were submitted to coronary angiography, with 52% of them having coronary artery disease. Four hundred and fourteen patients were not discharged on the same day: 217 did not have their procedures finish after 6p.m., 111forsocial-economical reasons, 23 because of theirphysician's refuse, 8 because of left main coronary disease, 55 because of any kind of complication. All the 305 patients who were discharged on the same day, did not have shown any complication in the next day evaluation. Conclusion - Outpatient cardiac catheterization is a safe technique in selected patients, making possible the accomplishment of a greater number of procedures improving bed utilization and decreasing hospitalar costs

Heparina na angioplastia coronária: estudo randomizado em casos com baixo risco para oclusäo aguda / Use of heparin in coronary angioplasty: randomizad trial in low risk patients for abrupt closure

Objetivo - Avaliar prospectivamente a eficácia da heparina em prevenir a oclusäo aguda pós-angioplastia coronária em situaçöes de baixo risco para a ocorrência deste fenômeno. Métodos - Nos últimos 4 anos, 525 pacientes submetidos a dilataçäo coronária com sucesso, foram randomizados para receber (n=264) ou näo (n=261) heparina, após procedimento. Os critérios de oclusäo foram contra-indicaçäo ao uso da droga e risco elevado para oclusäo aguda (angina instável refratária angioplastia direta no infarto do miocárdio, dissecçäo coronária, presença de trombos intracoronários e dilataçäo de oclusöes crônicas). Comparando os que receberam heparina com os que näo receberam, näo se observou qualquer diferença significativa, quanto ao sexo (15% x 17% do sexo feminino, NS), idade acima de 70 anos (7% x 9% NS), infarto prévio (26% x 24% NS), dilataçäo de múltiplos vasos (4% x 7% NS), angina estável (40% x 46X NS), angina instável (52% x 48%NS) e trombólise preliminar (8% x 6% NS). Resultados - No total dos casos, ocorreram 2/525 (0,4%, oclusöes agudas, sendo uma (0,4%) em cada grupo. Houve 1/525 (0,2%) óbito hospitalar, causado por infarto do miocárdio (grupo com heparina. A incidência de infarto foi 0,4% nos dois grupos: ocorreu 1 (0,4%) operaçäo de emergência no grupo sem heparina. Foram observadas complicaçöes hemorrágicas em 7% dos pacientes com heparina e em 2% dos que näo receberam a droga (p=0,02),todas nos locais de punçäo e dissecçäo utilizados para o cateterismo cardíaco. Näo houve hemorragias sistêmicas ou necessidade de transfusäo sanguínea. Conclusäo - Nos pacientes considerados de baixo risco para oclusäo aguda pós-angioplastia coronária, a ocorrência deste fenômeno foi realmente reduzida (0,4%). O emprego da heparina, em dose plena e com ajustes adequados aparentemente, näo influenciou este resultado

Purpose - To assess the efficacy of heparin in preventing the abrupt closure after coronary angioplasty in low risk patients for this phenomenon. Methods - In the last 4 years, 525 patients sucessfully dilated wore randomized to receive intravenous heparin (n=264) or not (n=261) after the angioplasty. The excluding criteria were contraindications for heparin and risifor abrupt closure (reiractory unstable angina, primary coronary angioplasty in acute myocardial inforction, evidence of intracoronary thrombos, intimal tear after the procedure and cases of chronic total oclusions). Both heparin and non heparin groups were similar in respect to female sex (15% x 17%; p=NS), age over 70 years old (7% x 9%; p=NS), previous myocardial infarction (26% x 24%; p=NS), multi-vessel procedures (4%x 7%; p=NS, stable angina (40% x 46%; p=NS), unstable angina (52% x 48%; p=NS) and angioplasty after thrombolitic therapy (8% x 6%; p=NS). Results - The overall incidence of abrupt closure was 2/525 (0.4%), with one case (0.4%) in each group. The in-hospital mortality was 1/525 (0.2%), which occured in a non-heparin patient, due to a anterior myocardial inforction. Major complications occured similary in heparin and non-heparin groups (0.4%). Bleeding complications were observed more frequently in the heparin group (7% x 2%,p=0.002). All of them were in the catheterization site and none required blood transfusion. Severe sistemic bleeding were not observed. Conclusion - In patients regarded as low risk for abrupt closure, the incidence of this complication was really low (0.4%) and heparin probably do not prevent it

Tratamento näo-cirúrgico de fístula artério-venosa coronária pulmonar / Nonsurgical treatment of Arterio-venous coronary - pulmonary fístula

Paciente de 58 anos de idade, do sexo masculino, portador de dispnéia, fadiga e angina do peito progressiva aos esforços. Grande fístula artério-venosa coronária pulmonar foi demonstrada através da cinecoronariografia que se originava da artéria circunflexa. A oclusäo da fístula, por técnica percutânea, foi realizada com sucesso. A evoluçäo clínica foi excelente e o resultado angiográfico, 6 meses após, evidenciou manutençäo do resultado

Fifty eight year old man, with dispneia, fatigue and progressive angina underwent cinecoronariography, which showed an arterio-venous coronary-pulmonary fistula originating from the circumflex artery to the pulmonary circulation. We decided to oclude it percutaneously, using a detachable balloon technic. The occlusion was accomplished successfully. Clinical evolution was excellent and the follow-up cinecoronariography 6 months later showed the maintainance of the initial results

Oclusão aguda pós-angioplastia coronária. Manuseio precoce e evolução tardia / Acute Closure After Coronary Angioplasty. Management and Follow-Up

PURPOSE--Assess the efficacy of the different strategies employed in the management of acute closure and verify the late prognosis of patients who develop this complication. METHODS--From january 1987, through December 1990, 2315 consecutive patients underwent percutaneous transluminal coronary angioplasty (PTCA) in our Institution. We analyzed 100 patients who had had acute closure of the dilated vessel determining the total incidence of myocardial infarction and death, the effectiveness of the different treatment strategies and clinical and angiographic predictors of poor in-hospital outcome. Late follow-up was obtained in the hospital survivors. RESULTS--The incidence of acute myocardial infarction in the group of 100 patients was 57; death occurred in 12of the patients. Forty-one individuals were referred to emergency bypass surgery, 35 received clinical treatment and 24 underwent redilatation of the vessel. Those managed clinically had a higher incidence of myocardial infarction compared to the ones who underwent either redilatation or surgery (74.3versus 50and 48.8). The in-hospital mortality rate was significantly higher in patients with left ventricular ejection fraction < 45(44.4, p < 0.001) and in procedures involving the left anterior descending artery (20, p < 0.05); patients undergoing repeat dilatation had the lower death rate (4.2versus 8.6in the clinical group and 17.1in the surgical group). Late follow-up was obtained in 65 of 88 hospital survivors (mean follow-up = 17 months). Patients who underwent repeat dilatation were significantly less symptomatic in the follow-up than those who received medical therapy during the acute phase (89versus 60.9of patients without symptoms respectively, p < 0.05). Patients who were referred to surgery had also a tendency towards having less symptoms (87.5of asymptomatic patients in the late follow-up) although the difference was not statistically significant (0.01 > p > 0.05). CONCLUSION--Acute coronary occlusion is a serious complication of angioplasty and is associated with high rates of major complications (myocardial infarction, death). Low left ventricular ejection fraction and PTCA involving the left anterior descending are predictors of higher in-hospital mortality in patients with acute closure. Late outcome is less favourable in patients submitted to clinical treatment in the acute phase.