Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial.

INTRODUCTION AND OBJECTIVES: The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. METHODS: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. RESULTS: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. CONCLUSIONS: The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.

Diagnostic Accuracy of 320-Row Computed Tomography for Characterizing Coronary Atherosclerotic Plaques: Comparison with Intravascular Optical Coherence Tomography.

BACKGROUND/PURPOSE: This study sought to determine the diagnostic accuracy of 320-row computed tomography (320CT) for characterizing coronary atherosclerotic plaques in comparison with optical coherence tomography (OCT). METHODS/MATERIALS: From 32 patients, 42 coronary segments were evaluated and co-registered by both 320CT and OCT. 320CT vulnerable plaque characteristics included low attenuation plaque (LAP) (<30HU), napkin-ring sign (NRS), positive remodeling (PR) and spotty calcification (SC). The presence of macrophage, neovascularization and cholesterol crystals was also determined by OCT. RESULTS: Minimal lumen area was 2.78 ±â€¯1.23 mm by OCT and 3.29 ±â€¯1.49 mm by 320CT (p < 0.001). Noncalcified plaques were classified accordingly by both methods in 88.2% of the cases (p = 0.005). There was no association between any 320CT plaque type and OCT fibroatheroma (p = 0.62). The combination of 2 or more of the 320CT vulnerable plaque characteristics was associated with the presence of macrophage (74.2 vs. 25.8%; p = 0.034) and cholesterol crystals (85.7 vs. 14.3%; p = 0.04), but not with neovascularization (p = 0.65). The presence of all four characteristics demonstrated an accuracy of 75.1% for detecting OCT fibroatheroma. CONCLUSIONS: 320CT is useful for non-invasive evaluation of calcified and noncalcified tissue characteristics of coronary atheroma. The combination of all four 320CT vulnerable plaque characteristics provided the highest accuracy for detecting fibroatheromas. SUMMARY: 320CT is useful for non-invasive evaluation of calcified and noncalcified tissue characteristics of coronary atheroma. The combination of all 320CT vulnerable plaque characteristics (low attenuation plaque (<30HU), napkin-ring sign, positive remodeling and spotty calcification) provided the highest accuracy for detecting fibroatheromas compared to optical coherence tomography.

Impact of acute kidney Injury on short-and long-term outcomes after transcatheter aortic valve implantation

Acute kidney injury (AKI) is frequently observed after transcatheter aortic valve implantation (TAVI) and is associated with higher mortality. However, the impact of AKI on long-term outcomes remains controversial. Therefore, we sought to evaluate the impact of AKI on short- and long-term outcomes following TAVI using the Valve Academic Research Consortium 2 criteria. METHODS: Consecutive patients (n = 794) with severe aortic stenosis who underwent TAVI were included in a multicenter Brazilian registry. Logistic regression analysis was used to identify predictors of AKI. Four-year outcomes were determined as Kaplan-Meier survival curves, and an adjusted landmark analysis was used to test the impact of AKI on mortality among survivors at 12 months. RESULTS: The incidence of AKI after TAVI was 18%. Independent predictors of AKI were age, diabetes mellitus, major or life-threatening bleeding and valve malpositioning. Acute kidney injury was independently associated with higher risk of all-cause death (adjusted HR, 2.8; 95%CI, 2.0-3.9; P < .001) and cardiovascular mortality (adjusted HR, 2.9; 95%CI, 1.9-4.4; P < .001) over the entire follow-up period. However, when considering only survivors at 12 months, there was no difference in both clinical endpoints (adjusted HR, 1.2; 95%CI, 0.5-2.4; P = .71, and HR, 0.7; 95%CI, 0.2-2.1; P = .57, respectively). CONCLUSIONS: Acute kidney injury is a frequent complication after TAVI. Older age, diabetes, major or life-threatening bleeding, and valve malpositioning were independent predictors of AKI. Acute kidney injury is associated with worse short- and long-term outcomes. However, the major impact of AKI on mortality is limited to the first year after TAVI. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved. KEYWORDS: Acute kidney injury; Aortic stenosis; Daño renal agudo; Edad avanzada; Elderly; Estenosis aórtica; Implante percutáneo de válvula aórtica; Mortalidad; Mortality; Transcatheter aortic valve implantation; Valve Academic Research Consortium.

Impacto del daño renal agudo en el seguimiento a corto y a largo plazo tras el implante percutáneo de válvula aórtica / Impact of acute kidney injury on short- and long-term outcomes after transcatheter aortic valve implantation

Introducción y objetivos: El daño renal agudo (DRA) ocurre con frecuencia tras el implante percutáneo de válvula aórtica (TAVI) y se asocia con una mayor mortalidad. Sin embargo, el impacto del DRA en la evolución a largo plazo continúa siendo controvertida. Por dicho motivo se evalúa el impacto del DRA el resultado a corto y largo plazo tras el TAVI usando los criterios Valve Academic Research Consortium 2. Métodos: Se incluyeron 794 pacientes consecutivos con estenosis aórtica grave en un registro multicéntrico brasileño. Para la identificación de los predictores de DRA se utilizó el análisis de regresión logística. La supervivencia a 4 años se determinó mediante las curvas de Kaplan-Meier y para determinar el impacto del DRA en la mortalidad entre los supervivientes a 12 meses se usó un análisis de punto de referencia ajustado. Resultados: La incidencia de DRA tras el TAVI fue del 18%. Los predictores independientes de DRA fueron: edad, diabetes mellitus, hemorragia mayor o amenazante para la vida y la malaposición valvular. El DRA se asoció independientemente con un riesgo mayor de muerte total (HR ajustada = 2,8; IC95%, 2,0-3,9; p < 0,001) y cardiovascular (HR ajustada = 2,9; IC95%, 1,9-4,4; p < 0,001) durante el periodo de seguimiento completo. Sin embargo, cuando se consideró solo los supervivientes a 12 meses, no hubo diferencias en ambos objetivos clínicos (HR ajustada = 1,2; IC95%, 0,5-2,4; p = 0,71, y HR = 0,7; IC95%, 0,2-2,1; p = 0,57, respectivamente). Conclusiones: El DRA es una complicación frecuente tras el TAVI. La edad avanzada, la diabetes, la hemorragia mayor o amenazante para la vida y la malaposición valvular eran factores predictivos de DRA. El DRA se asoció con el pronóstico a corto y largo plazo, sin embargo, el impacto del DRA sobre la mortalidad se limitó al primer año tras el TAVI

Introduction and objectives: Acute kidney injury (AKI) is frequently observed after transcatheter aortic valve implantation (TAVI) and is associated with higher mortality. However, the impact of AKI on long-term outcomes remains controversial. Therefore, we sought to evaluate the impact of AKI on short- and long-term outcomes following TAVI using the Valve Academic Research Consortium 2 criteria. Methods: Consecutive patients (n = 794) with severe aortic stenosis who underwent TAVI were included in a multicenter Brazilian registry. Logistic regression analysis was used to identify predictors of AKI. Four-year outcomes were determined as Kaplan-Meier survival curves, and an adjusted landmark analysis was used to test the impact of AKI on mortality among survivors at 12 months. Results: The incidence of AKI after TAVI was 18%. Independent predictors of AKI were age, diabetes mellitus, major or life-threatening bleeding and valve malpositioning. Acute kidney injury was independently associated with higher risk of all-cause death (adjusted HR, 2.8; 95%CI, 2.0-3.9; P < .001) and cardiovascular mortality (adjusted HR, 2.9; 95%CI, 1.9-4.4; P < .001) over the entire follow-up period. However, when considering only survivors at 12 months, there was no difference in both clinical endpoints (adjusted HR, 1.2; 95%CI, 0.5-2.4; P = .71, and HR, 0.7; 95%CI, 0.2-2.1; P = .57, respectively). Conclusions: Acute kidney injury is a frequent complication after TAVI. Older age, diabetes, major or life-threatening bleeding, and valve malpositioning were independent predictors of AKI. Acute kidney injury is associated with worse short- and long-term outcomes. However, the major impact of AKI on mortality is limited to the first year after TAVI

Safety and Effectiveness of Suture-mediated Arterial Closure Device in Hepatocellular Carcinoma Patients Who Underwent Drug-Eluting Beads Transarterial Chemoembolization.

BACKGROUND: The number of transarterial percutaneous procedures has risen over the years, consequently reducing puncture site related complications has become a necessity. To this end, the use of arterial closure devices has been growing progressively and their benefits have become a focus of research. The purpose of this study is to assess the safety and effectiveness of a suture-mediated closure device, Perclose ProGlide® (Abbott Vascular, Redwood City, CA), in patients with liver disease and hepatocellular carcinoma who underwent transarterial liver chemoembolization with drug-eluting beads. MATERIALS AND METHODS: A cohort of 253 hepatocellular carcinoma patients who underwent 449 procedures of transarterial liver chemoembolization with drug-eluting beads using the Perclose Proglide device was prospectively studied. The main endpoints evaluated were the technical success of the device, defined as complete hemostasis achieved within 3 min after the closure, and the incidence of puncture-site complications. The secondary endpoints evaluated were the correlation between epidemiological factors, coagulation profile and degree of liver disease, and the occurrence of complications. RESULTS: Technical success was achieved in 96% of the cases. Among patients who underwent repeated procedures using the same vascular access, this rate was 95.3%. Puncture-site complications were observed in 7 procedures (1.56%); 4 (0.89%) were due to hemorrhage, 2 (0.44%) hematomas and 2 (0.44%) pseudoaneurysms; 2 (0.44%) due to limb ischemia; and 1 (0.22%) due to arterial dissection. Among them, 3 cases required intervention. The statistical analysis of demographic characteristics, Child-Pugh classification, and coagulation status did not show a significant correlation with the occurrence of complications. Of the 449 procedures, only 4 (0.89%) needed hospitalization due to puncture-site complications. CONCLUSIONS: The use of Perclose Proglide is safe and effective in patients with liver disease and hepatocellular carcinoma who underwent transarterial liver chemoembolization with drug-eluting beads.

Impact of Acute Kidney Injury on Short- and Long-term Outcomes After Transcatheter Aortic Valve Implantation.

INTRODUCTION AND OBJECTIVES: Acute kidney injury (AKI) is frequently observed after transcatheter aortic valve implantation (TAVI) and is associated with higher mortality. However, the impact of AKI on long-term outcomes remains controversial. Therefore, we sought to evaluate the impact of AKI on short- and long-term outcomes following TAVI using the Valve Academic Research Consortium 2 criteria. METHODS: Consecutive patients (n = 794) with severe aortic stenosis who underwent TAVI were included in a multicenter Brazilian registry. Logistic regression analysis was used to identify predictors of AKI. Four-year outcomes were determined as Kaplan-Meier survival curves, and an adjusted landmark analysis was used to test the impact of AKI on mortality among survivors at 12 months. RESULTS: The incidence of AKI after TAVI was 18%. Independent predictors of AKI were age, diabetes mellitus, major or life-threatening bleeding and valve malpositioning. Acute kidney injury was independently associated with higher risk of all-cause death (adjusted HR, 2.8; 95%CI, 2.0-3.9; P < .001) and cardiovascular mortality (adjusted HR, 2.9; 95%CI, 1.9-4.4; P < .001) over the entire follow-up period. However, when considering only survivors at 12 months, there was no difference in both clinical endpoints (adjusted HR, 1.2; 95%CI, 0.5-2.4; P = .71, and HR, 0.7; 95%CI, 0.2-2.1; P = .57, respectively). CONCLUSIONS: Acute kidney injury is a frequent complication after TAVI. Older age, diabetes, major or life-threatening bleeding, and valve malpositioning were independent predictors of AKI. Acute kidney injury is associated with worse short- and long-term outcomes. However, the major impact of AKI on mortality is limited to the first year after TAVI.

Assessment of long-term mortality in patients with complex coronary artery disease undergoing percutaneous intervention: comparison of multiple anatomical and clinical prognostic risk scores.

AIMS: Three-vessel and left main coronary artery disease (CAD) have important prognostic implications. Consequently, numerous risk scores have been developed to stratify patients with complex CAD. The aim of the present study was to compare the predictive performance of six risk scores for occurrence of fouryear all-cause mortality. METHODS AND RESULTS: From March 2008 to December 2012, 348 consecutive patients with complex CAD undergoing percutaneous coronary intervention (PCI) in a tertiary centre in São Paulo, Brazil, were analysed. Four-year mortality was assessed. The scores compared were: baseline SYNTAX score (SS), residual SYNTAX score (rSS), ACEF score, clinical SYNTAX score (cSS), SYNTAX revascularisation index (SRI) and SYNTAX score II (SSII). SSII had the best predictive performance, AUC 0.82, Brier score 0.10, surpassing all the other scores for long-term mortality prediction. Moreover, SSII discriminated well PCI patients in risk groups with p<0.01 for four-year all-cause mortality. The ACEF score (AUC 0.77) and the cSS (AUC 0.78) were significantly better than the SS (AUC 0.65), SRI (AUC 0.60) or the rSS (AUC 0.55). CONCLUSIONS: For patients with complex CAD treated by PCI, the combination of baseline clinical and angiographic factors provided better risk assessment. The SSII demonstrated the most precise predictive performance for long-term mortality.

Pregnancy-associated spontaneous coronary artery dissection: insights from a case series of 13 patients.

AIMS: We sought to present a series of 13 pregnancy-associated spontaneous coronary artery dissection (P-SCAD), their angiographic and multimodal imaging findings, acute phase treatment, and outcomes. METHODS AND RESULTS: Between 2005 and 2015, 13 cases of P-SCAD were collected from a database of 11 tertiary hospitals. The mean age was 33.8 ± 3.7 years; most patients had no risk factors for coronary artery disease, and the majority were multiparous. P-SCAD occurred during the puerperium in 12 patients with a median time of 10 days. Only one patient presented with P-SCAD in the 37th week of pregnancy, and she was the only patient who died in this series. Six patients (46%) presented with ST-segment elevation acute myocardial infarction (STEMI), six (46%) presented with non-STEMI, and one presented with unstable angina; one-third of women had cardiogenic shock. In 12 patients, the dissection involved the left anterior descending or circumflex artery, and it extended to the left main coronary artery in 6 patients. Intravascular ultrasound or optical coherence tomography helped to confirm diagnosis and guide treatment in 46% of cases. Seven women were managed clinically; percutaneous coronary intervention was performed in five cases, and coronary artery bypass grafting was performed in one patient. CONCLUSION: In these 13 cases of P-SCAD, clinical presentation commonly included acute myocardial infarction and cardiogenic shock. Multivessel dissections and involvement of the left coronary artery and left main coronary artery were highly prevalent. Clinicians must be aware of angiographic appearances of P-SCAD for prompt diagnosis and management in these high-risk patients.

Pregnancy-associated spontaneous coronary artery dissection: insights from a case series of 13 patients

AIMS: We sought to present a series of 13 pregnancy-associated spontaneous coronary artery dissection (P-SCAD), their angiographic and multimodal imaging findings, acute phase treatment, and outcomes. METHODS AND RESULTS: Between 2005 and 2015, 13 cases of P-SCAD were collected from a database of 11 tertiary hospitals. The mean age was 33.8 ± 3.7 years; most patients had no risk factors for coronary artery disease, and the majority were multiparous. P-SCAD occurred during the puerperium in 12 patients with a median time of 10 days. Only one patient presented with P-SCAD in the 37th week of pregnancy, and she was the only patient who died in this series. Six patients (46%) presented with ST-segment elevation acute myocardial infarction (STEMI), six (46%) presented with non-STEMI, and one presented with unstable angina; one-third of women had cardiogenic shock. In 12 patients, the dissection involved the left anterior descending or circumflex artery, and it extended to the left main coronary artery in 6 patients. Intravascular ultrasound or optical coherence tomography helped to confirm diagnosis and guide treatment in 46% of cases. Seven women were managed clinically; percutaneous coronary intervention was performed in five cases, and coronary artery bypass grafting was performed in one patient...

Video densitometric assessment of aortic regurgitation after transcatheter aortic valve implantation: results from the Brazilian TAVI registry.

AIMS: We sought to examine the feasibility and reproducibility of a new video densitometric (VD) quantification of aortic regurgitation (AR) on aortography, and its long-term clinical impact. METHODS AND RESULTS: Using dedicated video densitometry software, AR after TAVI was quantified, and inter- and intra-observer reproducibility was investigated in 182 aortograms of the Brazilian TAVI registry. The aortograms were analysed using two software algorithms: 1) the quantitative regurgitation analysis (qRA) index interrogating the entire left ventricle (LV), and 2) a new method with the left ventricle outflow tract (LVOT) as a region of interest (ROI) (LVOT-AR). LVOT-AR was feasible in 64.8% vs. 29.7% of aortograms, compared with qRA index. Using the LVOT-AR, inter-observer variability was low (mean difference±standard deviation [SD]: 0.01±0.05, p=0.53), and the two observers' measurements were highly correlated (r=0.95, p<0.001). Patients with LVOT-AR >0.17 had a significantly higher one-year all-cause mortality risk compared with patients with LVOT-AR ≤0.17 (37.1% vs. 11.2%, p=0.0008). CONCLUSIONS: This study proposes an alternative methodology for AR assessment after TAVI by using the LVOT method (LVOT-AR) of VD angiography. The assessment of LVOT-AR is feasible, reproducible and potentially predictive of one-year mortality.

Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

AIMS: To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. METHODS: This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. RESULTS: After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. CONCLUSIONS: The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.

Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial.

BACKGROUND: The Inspiron™ sirolimus-eluting stent (SES) is a low-dose, ultra-thin-strut cobalt-chromium stent abluminally coated with biodegradable polymers (BP). Previous results from the INSPIRON-I trial, a first-in-man study, have proven the efficacy of the novel stent in reducing neointimal proliferation. The present report aims at evaluating the long-term clinical outcomes of patients enrolled into the INSPIRON-I trial (Clinical Trials Gov. identifier: NCT01093391). METHODS: A total of 57 patients (60 lesions) were randomly allocated in a 2:1 ratio to treatment with the Inspiron™ SES vs. its equivalent Cronus™ bare metal stent (BMS, both by Scitech Medical™, Aparecida de Goiânia, Goiás, Brazil), in four tertiary centers. The primary endpoint of the present analysis was the occurrence of major adverse cardiac events (MACE) [death, myocardial infarction (MI), target vessel revascularization (TVR) and/or target lesion revascularization (TLR)] at 4 years. RESULTS: Baseline clinical and angiographic characteristics of both groups were similar. After 4 years, the primary endpoint occurred in 7.9% vs. 23.5% of patients in Inspiron and control groups respectively (P=0.11). The rate of death/MI was similar between the groups, but there was a significant decrease in the risk of repeat revascularization in the Inspiron group compared to the control arm TLR (0.0% vs. 23.5% respectively, P=0.02). There were no stent thromboses in the study population. CONCLUSIONS: The novel Inspiron™ SES showed a sustained safe and effective clinical profile after 4-year of follow-up, with very low adverse events and null stent thrombosis (ST) occurrence.

Tratamento percutâneo da insuficiência mitral por MitraClip®: relato dos dois primeiros procedimentos no Brasil / Percutaneous treatment of mitral regurgitation by MitraClipTM: report on the first two procedures in Brazil

O sistema MitraClip® foi recentemente aprovado para uso clínico no Brasil para o tratamento percutâneo da insuficiência valvar mitral. Esse dispositivo se baseia na cirurgia de Alfieri, criando um orifício duplo pela união central das duas cúspides da valva mitral. Descrevemos aqui os dois primeiros procedimentos realizados em nosso meio utilizando esse dispositivo. Tratam-se de duas pacientes do sexo feminino, consideradas de alto risco cirúrgico pela idade avançada e pela presença de comorbidades, portadoras de insuficiência mitral degenerativa por prolapso/flail associado à rotura de cordoalhas. Nos dois casos, obteve-se redução expressiva da intensidade da regurgitação mitral com a utilização do MitraClip®, demonstrando o grande potencial dessa tecnologia inovadora para o tratamento percutâneo da insuficiência valvar mitral.

The MitraClipTM system has been recently approved for clinical use in Brazil for percutaneous treatment of mitral valve regurgitation. This device is based on the Alfieri surgical procedure, creating a double orifice by bringing together the central segments of the two mitral valve cusps. This report describes the first two procedures performed in Brazil using this device. Two female patients considered to be at high surgical risk due to advanced age and presence of comorbidities were treated, with degenerative mitral regurgitation due to prolapse/flail, associated with chordae tendineae rupture. In both cases, significant mitral regurgitation intensity reduction was obtained using the MitraClipTM, demonstrating the great potential of this innovative technology for the percutaneous treatment of mitral valve regurgitation.

Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial

Background: The Inspiron™ sirolimus-eluting stent (SES) is a low-dose, ultra-thin-strut cobalt-chromium stent abluminally coated with biodegradable polymers (BP). Previous results from the INSPIRON-I trial, a first-in-man study, have proven the efficacy of the novel stent in reducing neointimal proliferation. The present report aims at evaluating the long-term clinical outcomes of patients enrolled into the INSPIRON-I trial (Clinical Trials Gov. identifier: NCT01093391).Methods: A total of 57 patients (60 lesions) were randomly allocated in a 2:1 ratio to treatment with the Inspiron™ SES vs. its equivalent Cronus™ bare metal stent (BMS, both by Scitech Medical™, Aparecida de Goiânia, Goiás, Brazil), in four tertiary centers. The primary endpoint of the present analysis was the occurrence of major adverse cardiac events (MACE) [death, myocardial infarction (MI), target vessel revascularization (TVR) and/or target lesion revascularization (TLR)] at 4 years.Results: Baseline clinical and angiographic characteristics of both groups were similar. After 4 years, the primary endpoint occurred in 7.9% vs. 23.5% of patients in Inspiron and control groups respectively (P=0.11)...

Crioablação em atleta com via acessóriaanterosseptal parahissiana. Uma nova esperança para pacientes com WPW e vias acessórias de alto risco / Cryoablation in athlete with accessory pathway anteroseptal to His bundle. New hope for patients with WPW and roads Ancillary high risk

A eliminação do feixe anômalo em atletas portadores de síndrome de Wolff-Parkinson-White deve sempreser o objetivo do tratamento. O comportamento dofeixe durante exercício máximo pode ser avaliado como preditor de risco de morte súbita...

Resultados angiográficos e do seguimento clínico de 5 Anos após implante de stents farmacológicos com revestimento biodegradável em pacientes com alto risco de reestenose: análise de subgrupo do estudo randomizado PAINT / Angiographic and 5-year clinical follow-up after implantation of drug-eluting stents with biodegradable coating in patients at high risk of restenosis: the PAINT randomized trial

Introdução: Polímeros biodegradáveis foram desenvolvidos para reduzir a reação de hipersensibilidade associada aos polímeros duráveis dos stents farmacológicos de primeira geração, mantendo sua eficácia antiproliferativa e aumentado sua segurança. Avaliamos os resultados angiográficos de 9 meses e os resultados clínicos de longo prazo dos stents farmacológicos com polímeros biodegradáveis em pacientes com alto risco de reestenose. Métodos: Pacientes com diâmetro de referência ≤ 2,5 mm, extensão da lesão ≥ 15 mm, diabetes, ou uma combinação dessas características foram selecionados da população do estudo PAINT. Esses pacientes foram previamente randomizados e alocados para intervenção coronária percutânea recebendo os stents farmacológicos com polímeros biodegradáveis com sirolimus ou com paclitaxel ou stents metálicos, na razão 2:2:1. Resultados: Cento e setenta e oito pacientes foram tratados com stents farmacológicos com polímeros biodegradáveis (n = 142) ou stents metálicos (n = 36). No acompanhamento angiográfico de 9 meses, os primeiros mostraram menor perda tardia (0,40 ± 0,42 mm vs. 0,90 ± 0,47 mm; p < 0,01) e reestenose binária (7,4% vs. 25%; p < 0,01). No acompanhamento clínico de 5 anos, o grupo com stents farmacológicos com polímeros biodegradáveis mostrou menores taxas do desfecho combinado de morte cardíaca, infarto do miocárdio e revascularização do vaso-alvo (16,2% vs. 38,0%; p = 0,03), principalmente devido à redução da revascularização do vaso-alvo (9,9% vs. 36,1%; p < 0,01). Morte total, morte cardíaca e infarto do miocárdio não foram diferentes entre os grupos. A trombose do stent, provável ou definitiva, ocorreu em 2,8% vs. 0% (p = 0,30). Conclusões: Os stents farmacológicos com polímeros biodegradáveis eluidores de paclitaxel ou sirolimus foram eficazes na redução de reestenose angiográfica aos 9 meses e na necessidade de reintervenção por reestenose clínica em 5 anos, sem aumentar o risco de...

Background: Biodegradable polymers were developed to reduce the hypersensitivity reaction associated to durable polymers found with the first generation drug-eluting stents, while maintaining antiproliferative efficacy and increasing safety. This study evaluated the 9-month angiographic follow-up and long-term clinical outcomes of biodegradable polymer-coated drug-eluting stents compared with identical platform metallic stents in patients with high-risk for restenosis. Methods: Patients with a reference diameter ≤ 2.5 mm, lesion length ≥ 15 mm, diabetes, or a combination of these characteristics were selected from the population of the PAINT trial. These patients were previously randomized and allocated for percutaneous coronary intervention with either a sirolimus-eluting biodegradable polymer-coated stent, a paclitaxel-eluting biodegradable polymer-coated stent, or an identical metallic platform stent, at a ratio of 2:2:1. Results: One hundred and seventy-eight patients were treated with biodegradable polymer-coated drug-eluting stents (n = 142) or bare metal stents (n = 36). At the 9-month angiographic follow-up, biodegradable polymercoated drug-eluting stents had lower rates of late loss (0.40 ± 0.42 mm vs. 0.90 ± 0.47 mm; p < 0.01) and binary restenosis (7.4% vs. 25%; p <0.01). In the 5-year clinical follow-up, the group with biodegradable polymer-coated drug-eluting stents had lower rates of the composite endpoint of cardiac death, myocardial infarction, and target vessel revascularization (16.2% vs. 38.0%; p = 0.03), especially due to the reduction of target vessel revascularization (9.9% vs. 36.1%; (p 0.01). Total death, cardiac death and myocardial infarction were not different among groups. 0% (p = 0.30). Conclusions: Paclitaxel or sirolimus-eluting biodegradable polymer-coated stents were effective in reducing angiographic restenosis at 9 months and the need of reintervention for clinical restenosis in 5...

Intravascular ultrasound guidance to minimize the use of iodine contrast in percutaneous coronary intervention: the MOZART (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy) randomized controlled trial.

OBJECTIVES: The aim of this study was to evaluate the impact of intravascular ultrasound (IVUS) guidance on the final volume of contrast agent used in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: To date, few approaches have been described to reduce the final dose of contrast agent in PCIs. We hypothesized that IVUS might serve as an alternative imaging tool to angiography in many steps during PCI, thereby reducing the use of iodine contrast. METHODS: A total of 83 patients were randomized to angiography-guided PCI or IVUS-guided PCI; both groups were treated according to a pre-defined meticulous procedural strategy. The primary endpoint was the total volume contrast agent used during PCI. Patients were followed clinically for an average of 4 months. RESULTS: The median total volume of contrast was 64.5 ml (interquartile range [IQR]: 42.8 to 97.0 ml; minimum, 19 ml; maximum, 170 ml) in the angiography-guided group versus 20.0 ml (IQR: 12.5 to 30.0 ml; minimum, 3 ml; maximum, 54 ml) in the IVUS-guided group (p < 0.001). Similarly, the median volume of contrast/creatinine clearance ratio was significantly lower among patients treated with IVUS-guided PCI (1.0 [IQR: 0.6 to 1.9] vs. 0.4 [IQR: 0.2 to 0.6, respectively; p < 0.001). In-hospital and 4-month outcomes were not different between patients randomized to angiography-guided and IVUS-guided PCI. CONCLUSIONS: Thoughtful and extensive use of IVUS as the primary imaging tool to guide PCI is safe and markedly reduces the volume of iodine contrast compared with angiography-alone guidance. The use of IVUS should be considered for patients at high risk of contrast-induced acute kidney injury or volume overload undergoing coronary angioplasty. (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy [MOZART]; NCT01947335).

First-in-man randomised comparison of a novel sirolimus-eluting stent with abluminal biodegradable polymer and thin-strut cobalt-chromium alloy: INSPIRON-I trial.

AIMS: The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy. METHODS AND RESULTS: This is a randomised, multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution (Cronus). The primary objective was to evaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE). Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographic characteristics of both groups were similar. At six months, the in-segment LLL was reduced in the Inspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), as well as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidence of MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesion revascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis. CONCLUSIONS: Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months.

Coronary obstruction following transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) was established as an important alternative for high-risk patients with severe aortic stenosis. However, there are few data in the literature regarding coronary obstruction, that although rare, is a potentially fatal complication. OBJECTIVE: Evaluate this complication in Brazil. METHODS: We evaluated all patients presenting coronary obstruction from the Brazilian Registry of TAVI. Main baseline and procedural characteristics, management of the complication, and clinical outcomes were collected from all patients. RESULTS: From 418 consecutive TAVI procedures, coronary obstruction occurred in 3 cases (incidence of 0.72%). All patients were women, without prior coronary artery bypass grafting (CABG), and with mean age of 85 ± 3 years, logistic EuroSCORE of 15 ± 6% and STS-PROM score of 9 ± 4%. All of the cases were performed with balloon-expandable Sapien XT prosthesis. In one patient, with pre-procedural computed tomography data, coronary arteries presented a low height and a narrow sinus of Valsalva. All patients presented with clinically significant severe maintained hypotension, immediately after valve implantation, and even though coronary angioplasty with stent implantation was successfully performed in all cases, patients died during hospitalization, being two periprocedurally. CONCLUSION: Coronary obstruction following TAVI is a rare but potentially fatal complication, being more frequent in women and with the balloon-expandable prosthesis. Anatomical factors might be related with its increased occurrence, highlighting the importance of a good pre-procedural evaluation of the patients in order to avoid this severe complication.