Micheli Zanotti Galon

Avaliação pela tomografia de coerência óptica de stent nacional recoberto com polímero biodegradável eluidor de sirolimus vs. stent eluidor de biolimus A9 em artérias coronárias porcinas

BACKGROUND: InspironTM, a chrome-cobalt sirolimus-eluting stent covered by a mixture of bioabsorbable polymers on its abluminal side is being developed in Brazil. Our objective was to compare in an experimental study the findings of optical coherence tomography for the InspironTM and BioMatrix™ stents. METHODS: Stents were implanted in porcine coronary arteries. Each individual received two types of stents, one in each artery (left anterior descending and left circumflex artery). After 28 days, a new angiography was performed and optical coherence tomography was used to assess neointimal hyperplasia. RESULTS: Seven Inspiron™ stents and 7 BioMatrixTM stents were implanted in 7 domestic pigs. The reference diameter of the treated vessels was 2.16 ± 0.37 mm and the balloon to artery ratio was 1.17 ± 0.16 atm, with no statistical difference between groups. In-stent late loss was 0.53 ± 0.56 mm and 0.32 ± 0.37 mm (P = 0.43) for the InspironTM and BioMatrixTM stents, respectively. There was one case of angiographic restenosis in the InspironTM group (14% vs 0; P = 0.2). Optical coherence tomography showed an instent neointimal area of 1.61 ± 0.57 mm2 for the InspironTM stent and 1.36 ± 0.66 mm2 for the BioMatrixTM stent (P = 0.47). The percentage of neointimal area was 31% for the InspironTM stent vs 23% for the BiomatrixTM stent (P = 0.21). CONCLUSIONS: Twenty-eight days after implantation in porcine coronary arteries the InspironTM stent showed a similar degree of neointimal hyperplasia as the BiomatrixTM stent.

Differences Determined by Optical Coherence Tomography Volumetric Analysis in Non-Culprit Lesion Morphology and Inflammation in ST-Segment Elevation Myocardial Infarction and Stable Angina Pectoris Patients

While the current methodology for determining fibrous cap (FC) thickness of lipid plaques is based on manual measurements of arbitrary points, which could lead to high variability and decreased accuracy, it ignores the three‐dimensional (3‐D) morphology of coronary artery disease.

Estudo da dose excipiente: fármaco com avaliação da hiperplasia neointimal por tomografia de coerência óptica e histopatologia em artérias coronárias porcinas após o emprego do balão eluidor de sirolimus

BACKGROUND: Magic TouchTM is a sirolimus based nano carrier balloon. We aimed at finding the excipient:drug ratio with the highest capacity to inhibit neointimal proliferation 28 days after the use of this balloon after bare metal stenting in porcine coronary arteries. METHODS: Fourteen domestic pigs with coronary bare metal stenting followed by dilation (60 seconds) using balloons with an excipient:sirolimus ratio of 1:1, 0.5:1, 0.25:1, 1:0 or a control balloon were evaluated. After 28 days neointimal hyperplasia was assessed by optical coherence tomography and histopathology. RESULTS: Percent neointimal hyperplasia (%) assessed by optical coherence tomography and histomorphometry was 32.2 and 35.1, 28.1 and 33.4, 17.3 and 20.9, 28.6 and 30.2, and 37.9 and 42.3 in the groups with 0.25:1, 0.5:1, 1:1, 1:0 excipient:sirolimus ratios and control balloon, respectively (P = 0.03 for excipient:sirolimus 1:1 versus control balloon). The neointimal interstrut thickness (mm) was 0.23, 0.30, 0.16, 0.24 and 0.30 in the groups with 0.25:1, 0.5:1, 1:1, 1:0 excipient:sirolimus ratios and control balloon, respectively (P < 0.01 for excipient:sirolimus 1:1 versus control balloon). The scores of inflammation, injury and fibrin deposition were low and there was no significant difference among groups. CONCLUSIONS: There was a stepwise increase in inhibitory efficacy of neointimal proliferation as the excipient concentration increased; the lowest efficacy was observed with the 0.25:1 excipient:sirolimus formulation and the most intensive inhibition was observed with the 1:1 excipient:sirolimus formulation. The 1:1 excipient:sirolimus formulation significantly reduced neointimal proliferation when compared to the control group, with low inflammation and injury scores.

A bifurcation identifier for IV-OCT using orthogonal least squares and supervised machine learning

Intravascular optical coherence tomography (IV-OCT) is an in-vivo imaging modality based on the intravascular introduction of a catheter which provides a view of the inner wall of blood vessels with a spatial resolution of 10-20 μm. Recent studies in IV-OCT have demonstrated the importance of the bifurcation regions. Therefore, the development of an automated tool to classify hundreds of coronary OCT frames as bifurcation or nonbifurcation can be an important step to improve automated methods for atherosclerotic plaques quantification, stent analysis and co-registration between different modalities. This paper describes a fully automated method to identify IV-OCT frames in bifurcation regions. The method is divided into lumen detection; feature extraction; and classification, providing a lumen area quantification, geometrical features of the cross-sectional lumen and labeled slices. This classification method is a combination of supervised machine learning algorithms and feature selection using orthogonal least squares methods. Training and tests were performed in sets with a maximum of 1460 human coronary OCT frames. The lumen segmentation achieved a mean difference of lumen area of 0.11 mm(2) compared with manual segmentation, and the AdaBoost classifier presented the best result reaching a F-measure score of 97.5% using 104 features.

Evolução temporal da proliferação neointimal após implante de dois tipos de stent farmacológico com polímeros biodegradáveis em modelo porcino: avaliação qualitativa por tomografia de coerência óptica sequencial

BACKGROUND: Based on the hypothesis that the neointima found in drug-eluting stents (DES) with biodegradable polymers at 28 days is not a definitive neointima and that optical coherence tomography (OCT) is an effective method for sequential neointimal evaluation, we aim, in this experimental study, to compare OCT findings at 28 and 90 days, in two different DES with biodegradable polymers: the sirolimus-eluting stent (Inspiron®, Scitech) and the biolimus A9-eluting stent (Biomatrix®, Biosensors International). METHODS: Overall, 6 non-atherosclerotic pigs were submitted to the implantation of 6 Inspiron® stents and 6 Biomatrix® stents. Each pig received both stent types, one in each coronary artery (left anterior descending artery and circumflex artery) and after 28 and 90 days qualitative in-stent OCT analyses were performed at 1-millimeter intervals. RESULTS: Qualitative assessment was performed in-stent pairing millimeter by millimeter. Heterogeneous neointimal tissue was evidenced in 39% at 28 days and in 0% at 90 days, the presence of intraluminal tissue in 18% at 28 days and in 0% at 90 days, luminal irregularity in 62% at 28 days and in 2% at 90 days (P 0.05). CONCLUSIONS: The OCT findings corroborate the hypothesis that the neointima found in DES with biodegradable polymers at 28 days is not a definitive neointima. The most significant experimental evidence is the change in the neointimal characteristics observed at sequential OCT.

Optimized computer-aided segmentation and 3D reconstruction using intracoronary optical coherence tomography

We present a novel and time-efficient method for intracoronary lumen detection, which produces three-dimensional (3-D) coronary arteries using optical coherence tomographic (OCT) images. OCT images are acquired for multiple patients and longitudinal cross-section (LOCS) images are reconstructed using different acquisition angles. The lumen contours for each LOCS image are extracted and translated to 2-D cross-sectional images. Using two angiographic projections, the centerline of the coronary vessel is reconstructed in 3-D, and the detected 2-D contours are transformed to 3-D and placed perpendicular to the centerline. To validate the proposed method, 613 manual annotations from medical experts were used as gold standard. The 2-D detected contours were compared with the annotated contours, and the 3-D reconstructed models produced using the detected contours were compared to the models produced by the annotated contours. Wall shear stress (WSS), as dominant hemodynamics factor, was calculated using computational fluid dynamics and 844 consecutive 2-mm segments of the 3-D models were extracted and compared with each other. High Pearsons correlation coefficients were obtained for the lumen area (r = 0.98) and local WSS (r = 0.97) measurements, while no significant bias with good limits of agreement was shown in the Bland–Altman analysis. The overlapping and nonoverlapping areas ratio between experts’ annotations and presented method was 0.92 and 0.14, respectively. The proposed computer-aided lumen extraction and 3-D vessel reconstruction method is fast, accurate, and likely to assist in a number of research and clinical applications.

Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry

Objectives To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 µm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis. Setting Multicentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. Participants 995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months’ follow-up. Interventions Percutaneous coronary intervention with Supraflex SES, Primary and secondary outcome measures The primary endpoint—the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))—was analysed during 12 months. Results At 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 (1.8%) cardiac deaths, 16 (1.6%) MI, 7 (0.7%) TLR and 2 (0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1%), with a mean neointimal thickness of 0.13±0.06 µm. Conclusions The FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up.

Perfil clínico-angiográfico na doença arterial coronariana: desfecho hospitalar com ênfase nos muito idosos

FUNDAMENTO: Conhecer fatores de risco e manifestacoes clinicas da doenca arterial coronariana (DAC) permite-nos intervir de maneira mais eficaz junto a uma determinada populacao. OBJETIVO: Identificar perfis clinicos e angiograficos dos pacientes submetidos a cateterismo cardiaco, atendidos em um hospital terciario e tratados por meio de intervencoes coronarianas percutâneas (ICP). METODOS: Casuistica de 1.282 pacientes submetidos a 1.410 cateterismos cardiacos, selecionados de mar/2007-mai/2008 em um banco de dados de um hospital geral para diagnostico de doenca arterial coronariana (DAC). Fatores de risco, indicacao do exame, detalhes tecnicos da ICP e desfechos intra-hospitalares foram prospectivamente coletados. RESULTADOS: Foram 688 (54,0%) pacientes do sexo masculino, com media de idade de 65,4 ± 10,9 anos, sendo 20,0% acima dos 75 anos. O quadro clinico confirmado com mais frequencia foi o de sindrome coronariana aguda (SCA) sem supradesnivelamento do segmento ST (SST) (38,7%). A DAC multiarterial ocorreu em 46,4%, foi indicada ICP em 464 pacientes, sendo tratadas 547 lesoes-alvo (tipo B2 ou C, em 86,0%), sendo destas, 14,0% tratadas com stent farmacologico. Dentre os IAM com SST, ICP primaria foi realizada em 19,0% dos pacientes, sendo que, destes, 77,0% foram transferidos dos hospitais de origem tardiamente (ICP tardia) e nao receberam trombolitico previo, e 4,0% realizaram ICP de resgate. Foi obtido sucesso angiografico em 94,2% das ICPs. Aconteceu obito em 5,6% dos pacientes, tendo estes uma media de idade de 75,2 ± 10,2 anos. CONCLUSAO: Observamos predominio de idosos (estando 20,1% > 75 anos) e do sexo masculino. Dos fatores de risco para DAC, os mais frequentes foram hipertensao arterial sistemica e dislipidemia. Ocorreu predominio da SCA. A idade > 75 anos, DAC multiarterial e a insuficiencia renal cronica foram os preditores de obito intra-hospitalar.BACKGROUND knowing the risk factors and clinical manifestations of coronary artery disease (CAD) allows us to intervene more effectively with a particular population. OBJECTIVE to identify clinical and angiographic profiles of patients undergoing cardiac catheterization, treated at a tertiary hospital and treated by percutaneous coronary interventions (PCI). METHODS the study of 1,282 patients who underwent 1,410 cardiac catheterizations, selected from March/2007 to May/2008 from a database in a general hospital for diagnosis of coronary artery disease (CAD). Risk factors, indication for examination, technical details of PCI and in-hospital outcomes were prospectively collected. RESULTS there were 688 (54.0%) males, mean age 65.4 ± 10.9 years and 20.0% above 75 years age. The most frequent clinical condition was acute coronary syndrome (ACS) without ST-segment elevation (STS) (38.7%). The multi artery CAD occurred in 46.4%, PCI was indicated in 464 patients, 547 target lesions were treated (type B2 or C, 86.0%), and of these, 14.0% treated with drug eluting stents. Among those with AMI with STS, primary PCI was performed in 19.0% of the patients, from these, 77.0% were transferred from the origin hospitals late (late PCI) and had not received prior thrombolytic, and 4.0% had PCI rescue. Angiographic success was achieved in 94.2% of PCIs. Death occurred in 5.6% of patients, with average age of 75.2 ± 10.2 years. CONCLUSION the prevalence of elderly (20.1% being > 75 years) and male was observed. From the risk factors for CAD, the most common were systemic hypertension and dyslipidemia. There was a predominance of ACS. Age > 75 years old, multiarterial CAD and chronic renal failure were predictors of in-hospital deaths.

Clinical and angiographic profile in coronary artery disease: hospital outcome with emphasis on the very elderly

FUNDAMENTO: Conhecer fatores de risco e manifestacoes clinicas da doenca arterial coronariana (DAC) permite-nos intervir de maneira mais eficaz junto a uma determinada populacao. OBJETIVO: Identificar perfis clinicos e angiograficos dos pacientes submetidos a cateterismo cardiaco, atendidos em um hospital terciario e tratados por meio de intervencoes coronarianas percutâneas (ICP). METODOS: Casuistica de 1.282 pacientes submetidos a 1.410 cateterismos cardiacos, selecionados de mar/2007-mai/2008 em um banco de dados de um hospital geral para diagnostico de doenca arterial coronariana (DAC). Fatores de risco, indicacao do exame, detalhes tecnicos da ICP e desfechos intra-hospitalares foram prospectivamente coletados. RESULTADOS: Foram 688 (54,0%) pacientes do sexo masculino, com media de idade de 65,4 ± 10,9 anos, sendo 20,0% acima dos 75 anos. O quadro clinico confirmado com mais frequencia foi o de sindrome coronariana aguda (SCA) sem supradesnivelamento do segmento ST (SST) (38,7%). A DAC multiarterial ocorreu em 46,4%, foi indicada ICP em 464 pacientes, sendo tratadas 547 lesoes-alvo (tipo B2 ou C, em 86,0%), sendo destas, 14,0% tratadas com stent farmacologico. Dentre os IAM com SST, ICP primaria foi realizada em 19,0% dos pacientes, sendo que, destes, 77,0% foram transferidos dos hospitais de origem tardiamente (ICP tardia) e nao receberam trombolitico previo, e 4,0% realizaram ICP de resgate. Foi obtido sucesso angiografico em 94,2% das ICPs. Aconteceu obito em 5,6% dos pacientes, tendo estes uma media de idade de 75,2 ± 10,2 anos. CONCLUSAO: Observamos predominio de idosos (estando 20,1% > 75 anos) e do sexo masculino. Dos fatores de risco para DAC, os mais frequentes foram hipertensao arterial sistemica e dislipidemia. Ocorreu predominio da SCA. A idade > 75 anos, DAC multiarterial e a insuficiencia renal cronica foram os preditores de obito intra-hospitalar.BACKGROUND knowing the risk factors and clinical manifestations of coronary artery disease (CAD) allows us to intervene more effectively with a particular population. OBJECTIVE to identify clinical and angiographic profiles of patients undergoing cardiac catheterization, treated at a tertiary hospital and treated by percutaneous coronary interventions (PCI). METHODS the study of 1,282 patients who underwent 1,410 cardiac catheterizations, selected from March/2007 to May/2008 from a database in a general hospital for diagnosis of coronary artery disease (CAD). Risk factors, indication for examination, technical details of PCI and in-hospital outcomes were prospectively collected. RESULTS there were 688 (54.0%) males, mean age 65.4 ± 10.9 years and 20.0% above 75 years age. The most frequent clinical condition was acute coronary syndrome (ACS) without ST-segment elevation (STS) (38.7%). The multi artery CAD occurred in 46.4%, PCI was indicated in 464 patients, 547 target lesions were treated (type B2 or C, 86.0%), and of these, 14.0% treated with drug eluting stents. Among those with AMI with STS, primary PCI was performed in 19.0% of the patients, from these, 77.0% were transferred from the origin hospitals late (late PCI) and had not received prior thrombolytic, and 4.0% had PCI rescue. Angiographic success was achieved in 94.2% of PCIs. Death occurred in 5.6% of patients, with average age of 75.2 ± 10.2 years. CONCLUSION the prevalence of elderly (20.1% being > 75 years) and male was observed. From the risk factors for CAD, the most common were systemic hypertension and dyslipidemia. There was a predominance of ACS. Age > 75 years old, multiarterial CAD and chronic renal failure were predictors of in-hospital deaths.

Left Main Compression by a Giant Aneurysm of the Left Sinus of Valsalva: An Extremely Rare Reason for Myocardial Infarction and Cardiogenic Shock

Aneurysms of the sinus of Valsalva are very rare and mostly located in the right coronary sinus. They might course with dyspnea, fatigue, and acute coronary syndromes. We present herein an extremely rare case report of a 61-year-old woman diagnosed with external left main coronary compression by a giant aneurysm of the left sinus of Valsalva, which was successfully managed with percutaneous coronary intervention.