Serial Assessment of Coronary Artery Healing of a Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months by Optical Coherence Tomography (OCT)-The REPAIR Trial.

BACKGROUND: Although first-generation drug-eluting stent (DES) devices have effectively achieved their main goal of reducing restenosis, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization, and local drug toxicity, which ultimately prompted the development of new-generation DES options carrying biocompatible or even biodegradable polymers. AIMS: We sought to assess the vessel-healing pattern of the novel sirolimus-eluting Inspiron DES (Scitech Medical) using serial optical coherence tomography (OCT) and assuming the hypothesis that this thin-strut (75-µm), biodegradable-polymer DES promotes a faster healing, with very early strut coverage. METHODS: This is a prospective, multicenter, open-label, single-arm study enrolling 68 patients who underwent percutaneous coronary intervention guided by OCT. These patients were consecutively assigned into 3 groups. The first group had its OCT imaging follow-up performed at 3 months, the second group at 2 months, and the third group at 1 month. RESULTS: Mean age was 59.5 years, 70.6% were male, 41.2% had type 2 diabetes, and 29.4% presented with acute coronary syndrome. A total of 72 lesions were treated and 1.06 stents were implanted per patient. OCT assessment of the stents at 1, 2, and 3 months showed a strut coverage of 90.41%, 93.96%, and 97.21%, respectively (P=.04). CONCLUSION: The Inspiron DES showed an early strut healing pattern, with >90% of the struts covered by neointima within the first month and with almost all struts covered by the third month.

Health-related quality of life in patients with venous leg ulcer treated in primary care in Brazil and Portugal.

BACKGROUND: Venous ulcers constitute an important public health problem as they can cause disability with consequences for multiple dimensions of quality of life. OBJECTIVE: To describe the quality of life in patients with venous leg ulcer treated in primary care in two cities from Brazil and Portugal. METHODS: This was a cross-sectional comparative study with a non-probabilistic sample of 171 patients with venous leg ulcers who were treated in primary care in two cities from Brazil and Portugal, namely, Natal and Évora. A form covering sociodemographic and health data and the Medical Outcomes Study 36-Item Short-Form Health Survey were used, and descriptive and inferential analyses were performed. RESULTS: Significant differences in age and income were observed between the two samples. Patients with venous leg ulcer from Brazil had lower income and were younger than those from Portugal. Quality of life scores were significantly higher in Portugal for the physical aspects, pain, and social functioning, among domains, and for the physical health dimension and total score of QOL. CONCLUSION: The quality of life was better in Portugal than in Brazil and the differences between the countries need further investigation.

First-in-man assessment of the InSeal VCD, a novel closure device for large puncture accesses.

AIMS: To demonstrate the feasibility and efficacy of the novel InSeal VCD for the closure of large puncture holes following percutaneous structural interventions. METHODS AND RESULTS: Prospective, non-randomised, single-arm, single-centre study with a series of patients submitted to endovascular treatment of abdominal and thoracic aortic aneurysm as well as transcatheter aortic valve implantation in whom the InSeal VCD was used to close the access site. These patients were followed up for one year with clinical examination, ankle-brachial index and Doppler ultrasound. The primary endpoint was the occurrence of major vascular complications at the puncture site. From a total of nine patients screened, seven were selected to receive the InSeal VCD. Technical and therapeutic successes were achieved in all cases. The sheath profiles used in these procedures ranged from 18 Fr to 25 Fr. No major vascular complications were observed during the follow-up period. Average ankle-brachial index pre-intervention and at one-month follow-up were 0.85 and 0.82, respectively. CONCLUSIONS: The InSeal VCD was shown to be effective in achieving acute and chronic haemostasis after usage of higher profile endovascular devices in this study. These results translated into no clinical complications up to one-year clinical follow-up.

Serial greyscale and radiofrequency intravascular ultrasound assessment of plaque modification and vessel geometry at proximal and distal edges of bare metal and first-generation drug-eluting stents.

BACKGROUND: Little is known about the correlation between modifications in plaque composition at stent edges and the changes in vessel geometry. This study sought to evaluate, by serial greyscale intravascular ultrasound (IVUS) and Virtual Histology intravascular ultrasound (VH-IVUS), the modifications in plaque composition at the edges of drug-eluting and bare metal stents and the correlation of these findings with changes in the measurements of vessel, lumen and plaque area at those segments. METHODS AND RESULTS: Single-centre, prospective and randomised (1:1) evaluation of 40 patients with acute coronary syndrome treated with bare metal (Driver; Medtronic, Santa Clara, CA, USA; n=20 patients) or drug-eluting stents (Cypher; Cordis, Miami Lakes, FL, USA; n=20 patients). IVUS and VH-IVUS assessments were done post-procedure and at nine months. Primary endpoint included the modification in vessel, lumen and plaque area and in the composition of the plaque in the mean time between the baseline and follow-up procedure. At the proximal edge of the vessel treated with the Cypher stent, a trend toward positive vessel remodelling (D=+0.6 mm², p=0.06) was observed while at the distal edge, less plaque growth (D=+0.2 mm² vs. D=+1.1 mm², p<0.001), resulted in a larger lumen area at follow-up. By VH, there was a marked reduction in the percentage of fibrotic tissue and necrotic core at the edges of both stents and a positive correlation was seen between increase in percentage of fibro-fatty component and increase in plaque area (r=0.78, p=0.01). CONCLUSION: Patients treated with drug-eluting stents (DES) experienced less plaque growth, especially at the distal edge of the stents. Modifications in plaque composition, with increase in fibrofatty tissue component, may partially explain these findings.

Intravascular ultrasound assessment of the novel AngioSculpt scoring balloon catheter for the treatment of complex coronary lesions.

BACKGROUND: Despite the advances in interventional cardiology, stent expansion remains an important predictor of success, impacting restenosis and thrombosis rates after either bare-metal (BMS) or drug-eluting stent implantation. Especially for the treatment of complex lesions (e.g., calcified lesions, in-stent restenosis, etc.), adequate lesion preparation might help improve procedural results as well as clinical outcomes. We sought to investigate the safety, feasibility and mechanism of action of a new scoring-balloon catheter, the AngioSculpt, comprised of a semicompliant balloon and a nitinol spiral cage designed to address complex lesions. METHODS: A total of 60 consecutive patients at two centers were prospectively enrolled in this first-in-man coronary study and divided into two groups according to the type of lesion treated: Group I: patients with de novo coronary lesions (n = 47) as a pretreatment strategy before BMS implantation, and Group II: patients with BMS restenosis (n = 17) as a standalone therapy. A subgroup of patients in each cohort was assigned to intravascular (IVUS) analysis. Patients in Group II were submitted to routine 6-month follow-up angiography. In Group I, angiographic restudy was contingent upon the presence of ischemia. Lesions longer than 20 mm in very tortuous vessels, in arterial or vein grafts, in the setting of acute myocardial infarction or with visible thrombus were excluded from this study. RESULTS: Success was achieved in all cases. The mean age of the study populations was 62 +/- 11.6 years (Group I) and 53 +/- 9.4 years (Group II), with 26% and 18% diabetics, respectively. In Group I, 73% of lesions were diffuse and fibrocalcified, while in Group II, 72% were classified as diffuse. No serious complications were observed in either group. Balloon slippage (or the "watermelon seed" phenomenon) was not observed. Significant acute gain was achieved in both groups (0.7 mm in Group I and 1.64 mm in Group II). A minimum final area (in-stent) 6.5 mm2 was achieved in 85% of the cases in Group I and in 82% of the cases in Group II. CONCLUSIONS: In this preliminary in vivo study, the use AngioSculpt(R) proved to be feasible and safe for the treatment of complex coronary lesions. Six-month results suggest the use of this novel device as an attractive option for the percutaneous approach of restenotic coronary lesions and should be assessed in a larger, more complex cohort of patients.

Avaliação comparativa do valor prognóstico de quatro marcadores bioquímicos de lesão miocárdica pós intervenções percutâneas utilizando stents coronarianos / Comparative assessment of the prognostic value of four biochemical markers of myocardial damage after percutaneous coronary stenting

OBJETIVO: Verificar o efeito prognóstico das alterações de quatro marcadores de lesão miocárdica (CKMB atividade/massa e troponinas T e I) pós- stent em relação à ocorrência de morte, infarto e novos procedimentos de revascularização em um ano e determinar a incidência e as variáveis preditoras de suas elevações. MÉTODOS: Em 199 pacientes tratados por stents em artérias naturais foram mensurados os quatro marcadores em três períodos: pré-procedimento, 6-8h e 14-18h pós-stent. Curvas de sobrevivência e a regressão logística de Cox determinaram o impacto prognóstico das alterações na ocorrência de eventos cardíacos em um ano. RESULTADOS: A incidência das alterações dos 4 marcadores pós-stent é relativamente freqüente (6,1 por cento a 32,8 por cento), associa-se à maior complexidade das lesões tratadas (longas e angulações >45º) e ao desenvolvimento de intercorrências durante o procedimento (oclusão de ramos secundários, presença de angina e alterações eletrocardiográficas). A sobrevivência livre de infarto e nova revascularização foi significativamente menor somente nos pacientes com elevação da CKMB atividade pós-procedimento em comparação àqueles sem esta alteração (60 por cento x 85,08 por cento, p=0,025). Influenciaram a sobrevivência livre de eventos o diabetes mellitus (OR: 2,27, p=0,0256), pré-dilatação com balão (OR: 3,16, p=0,0082) e elevação da CKMB atividade pós-procedimento (OR: 3,64, p=0,0162). CONCLUSÃO: A recomendação da monitoração sistemática da CKMB atividade pós-stent coronário baseia-se na compreensão do seu comportamento clínico e laboratorial, nos resultados dos estudos que relacionam a elevação de seus níveis pós-procedimento à pior evolução tardia e ao baixo custo do exame.

Papel da avaliação fisiológica nas intervençõespercutâneas / Role of the coronary physiological assessment for guiding percutaneous interventions

Em decorrência dos recentes avanços nos dispositivos percutâneos, a avaliação tanto da pressão como do fluxo coronário tem se tornado acessível e segura. Muitas vezes, no laboratório de cateterismo, o intervencionista defronta-se com a difícil tarefa de definir a gravidade de uma lesão coronária sem a necessidade de exame diagnóstico não-invasivo. Por essa razão, métodos vêm sendo desenvolvidos para avaliar a gravidade hemodinâmica dessas lesões coronárias durante a angiogrâfia. O uso do cateter Doppler intracoronário possibilitou o cálculo de um índice de reserva de velocidade de fluxo coronário (média da velocidade de pico em hiperemia/repouso), que, quando mostra valores acima de 2,0, sugere fortemente a presença de perfusão miocárdica normal, descartando a necessidade de revascularização da lesão coronária em estudo. No entanto, a reserva de velocidade de fluxocoronário é dependente da integridade da microcirculação e pode ser reduzida por fatores sistêmicos,especialmente o diabetes. Em contraste com esse método, a reserva de fluxo fracionada (pressões distal/proximal em hiperemia máxima) é independente da microcirculação e das mudanças no estado hemodinâmico do paciente. Quando acima de 0,75, sugere ausência de obstrução significativa ao fluxo. Após intervenções, a observação de reserva de velocidade de fluxo coronário maior 2,5, especialmente se combinada com um diâmetro de estenose menor 35 por cento, é um preditor de bom prognóstico a longo prazo. Já a reserva de fluxo fracionada após o implante de stent deve ser maior ou menor 0,96, no intuito de evitar a liberação subótima do stent. Os dados que sustentam a reserva de fluxo fracionada para a avaliação prévia de um procedimento e para guiar intervenções percutâneas parecem mais consistentes que os dados sobre reserva de velocidade de fluxo coronário. Por essa razão, e pela relativa facilidade de seu uso, a utilização da reserva de fluxo fracionada é mais recomendada sempre que haja necessidade de avaliação funcional...

Papel do endotélio na regulaçäo celular e no remodelamento vascular: implicaçöes na reestenose pós-angioplastia coronária / Role of the endothelium in the regulation of cell proliferation and vascular remodeling: implications for restenosis after coronary angioplasty

A reestenose representa a maior limitaçäo a longo prazo da angioplastia coronária. O endotélio vascular, além de desempenhar importante papel na regulaçäo do tônus vasomotor arterial, também é o principal mediador de dois processo biológicos extremamente importantes na gênese da reestenose coronária: a proliferaçäo das células musculares lisas e o remodelamento vascular. Além de sintetizar fatores estimuladores e inibidores do crescimento celular, o endolélio ainda é o responsável pela manuntençäo da trombo-resistência, impedindo a ativaçäo das plaquetas, outra importante fonte de mitogenos. O remodelamento vascular e um processo biológico atuante na aterosclerose e evidências recentes indicam que ele é um fator na determinaçäo di surgimento ou näo da reestenose. O endotélio também parece ser o mediador primário do desenvolvimento de alteraçöes estruturais da parede do vaso em resposta a fatores hemodinâmicos. Esses achado säo extremamente úteis para o melhor entendimento da patogenes da reestenose e , além disso, podem ter importantes implicaçöes no desenvolvimento de estratégias que visem o controle dessa complicaçäo da angioplastia coronária.

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