Vinícius Cardozo Esteves

Preliminary results of the INSPIRE trial with the novel MGuard™ stent system containing a protection net to prevent distal embolization

Objective: To assess the efficacy of the MGuardTM stent combining a polymer‐mesh sleeve attached to the external surface of a bare‐metal stent in preventing distal embolization during percutaneous coronary intervention (PCI). Background: Distal embolization of thrombus/platelet agreggates is associated with worse immediate and long‐term prognosis after PCI. Treatment of saphenous vein graft (SVG) and PCI in the setting of acute coronary syndromes (ACS) is often related to this complication. Although protection and aspiration devices have been shown to reduce distal embolization, they add time and cost to PCI. Methods: A total of 30 patients were included. Inclusion criteria were de novo lesions in SVG or native vessels with angiographic evidence of instability with potential to provoke flow disturbances and/or distal embolization. Primary endpoint included the incidence of major adverse cardiac events (MACE) (composite of cardiac death, non‐fatal myocardial infarction and TLR) up to 30 days of the procedure and TIMI flow right after the PCI. Results: Mean population age was 60.8 years with 36.7% of diabetes. Overall, 53.3% presented with ACS, and most lesions were located in SVG (16 of 30). The majority of lesions had complex morphology including the presence of thrombus (30%) and ulcer (33.3%). The MGuard stent was successfully deployed in all cases with no angiographic/clinical complications including distal embolization. Final TIMI‐3/blush‐3 were achieved in all cases with no MACE up to 30 days of the procedure. Conclusions: In this preliminary evaluation, the MGuard device demonstrated excellent performance in a highly complex lesion subset, including absence of angiograhpic/procedural complications, and no adverse events up to 30‐day FU.

Preditores e impacto clínico intra-hospitalar do sangramento associado à intervenção coronária percutânea

ABSTRACT Predictors and In-hospital Clinical Impactof Post-PCI Bleeding Background: Percutaneous coronary intervention (PCI)-related bleeding is a frequent complication whose prognosisis often neglected. Several studies have shown the adverseclinical impact of bleeding, especially increased short andlong-term mortality rates. The purpose of this study was toevaluate predictors and clinical impact of this complicationin a large cohort of patients undergoing PCI. Method: Weperformed a prospective analysis of 2,892 consecutive pa-tients undergoing elective or urgent PCI from January/2008to June/2009. Patients with and without bleeding werecompared for clinical, angiographic and procedure-relatedvariables as well as in-hospital clinical outcomes. Multiplelogistic regression analysis was performed to determine theinfluence and independence of bleeding predictors. Results: Procedure-related bleeding was identified in 1.7% of thepatients. Taking in account only patients with acute coronarysyndrome (ACS) the incidence increased to 3.4%. Multi-variate analysis identified ACS [odds ratio (OR) 3.96, 95%confidence interval (95% CI) 1.45-11.42], use of glycoproteinIIb/IIa inhibitors (OR 2.55, 95% CI 1.68-3.87), chronic renalfailure (OR 2.34, 95% CI 1.11-3.49), Killip IV (OR 2.32,95% CI 1.54-3.5) and femoral access (OR 1.72, 95% CI1.19-3.14) as independent predictors of bleeding. Procedure-related bleeding was associated with in-hospital acute renalfailure (16.7% vs. 1.6%; P < 0.001) and in-hospital mortality(10.4% vs. 0.7%; P < 0.001).

Occlusion of the perimembranous ventricular septal defect using CERA® devices†

High incidence of atrioventricular (AV) block has been the major limitation of percutaneous closure of perimembranous ventricular septal defect (PMVSD).

Comparison of a vascular closure device versus the radial approach to reduce access site complications in non-ST-segment elevation acute coronary syndrome patients: The angio-seal versus the radial approach in acute coronary syndrome trial

To compare the radial versus femoral approach using Angio‐Seal for the incidence of access site complications among non‐ST‐segment elevation acute coronary syndrome patients undergoing invasive strategy.

Impacto da transferência inter-hospitalar nos resultados da intervenção coronária percutânea primária

BACKGROUND: Delays resulting from the transfer to perform primary percutaneous coronary intervention (PCI) have a negative impact on the benefits of the procedure. METHODS: Prospective registry aimed at comparing the results of primary PCI in patients with ST-segment elevation myocardial infarction (STEMI) admitted or transferred to an interventional cath lab equipped hospital. RESULTS: Between February 2009 and December 2011, 319 patients were included in the study with mean age of 59.8 ± 12 years, 28.5% were female and 22.3% were diabetics. Patients transferred for primary PCI (n = 201) had longer door-to-balloon time (86.4 ± 26.6 min vs 69 ± 22.6 min; P < 0.0001), a non-significant decrease in ST-segment elevation resolution (83.5% vs 90.4%; P = 0.18), final TIMI 3 flow (90.1% vs 94.1%; P = 0.30), myocardial blush grade 3 (74.3% vs 78.8%; P = 0.22) and angiographic success (90.1% vs 94.1%; P = 0.30), and a non-significant increase in major bleeding (2% vs 0.9%; P = 0.20) and hospital mortality (6.5% vs 4%; P = 0.29). CONCLUSIONS: The referral of patients with STEMI directly to an interventional cath lab equipped hospital is associated with shorter door-to-balloon time and non-significant improvement of reperfusion markers and mortality.

Valvotomia Mitral Percutânea: da Primeira à Terceira Dilatação

INTRODUCAO: As causas de reestenose pos-valvotomia mitral percutânea dependem principalmente das caracteristicas da populacao submetida a tecnica. O objetivo deste trabalho foi comparar os resultados imediatos e tardios dos pacientes submetidos a dois ou mais procedimentos de valvotomia mitral percutânea (VMP) a um grupo de pacientes submetidos apenas a uma dilatacao para o tratamento da estenose mitral grave. METODO: Os pacientes foram divididos em dois grupos: o grupo A incluiu 90 pacientes submetidos a uma primeira VMP e que, em decorrencia de reestenose ecocardiografica e clinica, foram encaminhados a uma segunda intervencao, e 9 pacientes que, pelo mesmo motivo, foram submetidos a um terceiro procedimento; e grupo B, composto de 90 pacientes selecionados por amostra aleatoria simples submetidos a apenas uma dilatacao, todas com sucesso. As variaveis ecocardiograficas analisadas para comparacao dos resultados dentro do mesmo grupo e entre os grupos A e B foram a area valvar mitral (AVM), os gradientes diastolicos maximo (GDM) e medio (GDm), o diâmetro do atrio esquerdo e a incidencia de reestenose. RESULTADOS: Nos pacientes do grupo A, a primeira dilatacao foi realizada com sucesso em 87 (96,7%) pacientes. Comparativamente, a media das areas valvares apos a primeira dilatacao dos pacientes que compoem o grupo A foi menor que a dos pacientes do grupo B (1,97 ± 0,17 cm2 vs. 2,10 ± 0,33 cm2; P = 0,011). Em ambos os grupos, nao se observou diferenca estatisticamente significante, pre e imediatamente apos o primeiro procedimento, na reducao da media do GDM e do GDm e na media dos diâmetros do atrio esquerdo. Nos pacientes do grupo A, apos a segunda valvotomia, os criterios de sucesso foram alcancados em 77 (85,5%) pacientes. A media das areas valvares, nessa oportunidade, foi menor que apos a primeira intervencao (1,83 ± 0,28 cm2 vs. 1,97 ± 0,17 cm2; P < 0,005). Ainda dentro desse mesmo grupo, observou-se queda significativa do GDM e do GDm quando comparados os valores apos o primeiro e o segundo procedimentos. Uma terceira dilatacao foi realizada com 100% de sucesso nos 9 pacientes do grupo A. Resultados semelhantes aos anteriores foram obtidos na comparacao das mesmas variaveis apos a segunda e a terceira dilatacoes. O tempo medio para o aparecimento da reestenose ecocardiografica entre a primeira, a segunda e a terceira dilatacoes foi de 54,12 meses, 25,23 meses e 29,30 meses, respectivamente. CONCLUSAO: A obtencao de areas valvares e o tempo para o aparecimento da reestenose significativamente menores imediatamente apos uma segunda ou terceira valvotomias mitrais percutâneas, quando comparadas a primeira, nao devem ser fatores para contraindicacao do procedimento. Apesar de menores, as AVMs obtidas apos uma segunda ou terceira intervencao enquadram-se, na maioria dos casos, dentro dos parâmetros de sucesso do procedimento, justificando assim sua indicacao em casos selecionados.

Resolução do segmento ST após intervenção coronária percutânea primária: características, preditores de insucesso e impacto na mortalidade

BACKGROUND: ST-segment resolution is an important predictor of infarct-related artery patency and effective microcirculatory perfusion. The aim of this study was to compare patients with and without ST-segment elevation resolution and identify variables that are associated with failure of ST-segment resolution. METHODS: Between March 2012 and July 2013, 61 patients with ST-segment elevation acute myocardial infarction underwent primary percutaneous coronary intervention (PCI) and were included in a prospective registry. To compare the groups with and without ST-segment resolution, the chi-square test or Fishers exact test were used for qualitative variables and Students t test or Mann-Whitneys test for quantitative variables. Simple and multiple logistic regression models were used to identify variables associated with failure of ST-segment resolution. RESULTS: The group of patients without ST-segment resolution had higher heart rate, higher prevalence of diabetes mellitus, chronic renal failure and a trend towards longer ischemia time. There was a higher mortality rate in patients who did not achieve ST-segment elevation resolution. In the univariate analysis, heart rate, diabetes mellitus, chronic renal failure and ischemia time were associated with increased odds of not obtaining ST-segment resolution, losing significance in the multivariate model. CONCLUSIONS: Failure of ST-segment resolution is observed in up to one-third of patients undergoing primary PCI and requires new pharmacologic strategies or interventions to minimize it.

Análise Comparativa entre Sistema de Proteção Distal e Novo Stent MGuard TM para o Tratamento de Lesões Complexas em Pontes de Safena

ABSTRACT Comparative Analysis of a Distal Protection Systemand the New Stent MGuard TM for the Treatmentof Complex Lesions in Saphenous Vein Grafts Background: Percutaneous coronary intervention in saphe-nous vein grafts remain a major challenge due to the highcomplication rates associated to the procedure. The newballoon-expandable MGuard™ stent was developed with anultra-thin mesh sleeve attached to its outer surface, designedto reduce distal embolization during the procedure. Ourobjective was to evaluate the efficacy of the new deviceto prevent periprocedural embolic complications. Method: A consecutive cohort of patients with complex saphenousvein graft lesions treated with the MGuard TM stent werecompared to patients treated with bare metal stents anddistal filter protection. The primary objective included theoccurrence of major adverse cardiovascular events (com-posite of death, non-fatal myocardial infarction and targetlesion revascularization) up to 30 days of the procedure. Results:

Insucesso da Técnica Radial em Centro com Alto Volume de Procedimentos

Failure of the Transradial Approach in a High-Volume Center background: The mechanisms and predictors of failed transradial approach in centers dedicated to this technique are not well characterized and were the main objective of this analysis. methods: 6,808 consecutive patients undergoing transradial coronary procedures by operators with utilization rate greater than 90% were included. Simple and multiple logistic regression models were used to identify the predictors of failed transradial approach. Results: Transradial failure rate was 1.7%. Vascular complications were observed in 5%, with a prevalence of asymptomatic arterial occlusion and subcutaneous hematomas. Predictors of failure were female gender (OR = 1.87; 95% CI 1.29-2.71; p = 0.01), age > 70 years (OR = 1.78; 95% CI 1.06-2.98; p = 0.03) and presence of chronic peripheral arterial disease (OR = 5.71; 95% CI 2.40-13.54; p < 0.01). Conclusions: In a high-volume radial center, failure rate was < 2% and variables associated with technical failure were female gender, advanced age and peripheral arterial disease. DesCRIPToRs: Radial artery. Percutaneous coronary intervention. Hemorrhage. Ischemia.

In-Hospital Outcomes of Percutaneous Coronary Interventions in Type C Lesions: CENIC Registry

Background: Type C coronary lesions represent a complex angiographic scenario, although they are rather common in the daily clinical practice of percutaneous coronary intervention (PCI). This article aimed to report the Brazilian clinical practice outcomes of PCIs performed in patients with type C lesions. Methods: This was a retrospective study with information obtained from the electronic database of the Central Nacional de Intervencoes Cardiovasculares (National Cardiovascular Intervention Centre – CENIC) of the Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista (Brazilian Society of Haemodynamics and Interventional Cardiology – SBHCI), which gathers information on PCI procedures in a dedicated database, entered by volunteer physicians who are members of several Brazilian institutions. Results: Between January, 2010 and December, 2011, 1,693 patients with type C lesions were registered in CENIC. Most patients were males (68%), with a mean age of 63 ± 26.3 years, 40.9% were diabetic, and 45.4% had acute coronary syndromes. Procedural success was achieved in 95.6% of the cases, mortality was 2.1%, acute myocardial infarction was observed in 5%, and repeat target-lesion revascularisation was 0.5% in patients during the hospitalisation. Conclusions: PCIs in type C lesions presented high success and low complication rates in a selected population from the CENIC registry. The former morphological classification of the lesions, still used in the registry, does not properly stratify the outcomes of PCIs. It is urgently necessary to update the data collection form and related measures in order to improve the quality control of the registry.