Renal denervation for the treatment of ventricular arrhythmias: A systematic review and meta-analysis.

INTRODUCTION: Ventricular arrhythmias (VAs) are a major cause of morbidity and mortality in patients with heart disease. Recent studies evaluated the effect of renal denervation (RDN) on the occurrence of VAs. We conducted a systematic review and meta-analysis to determine the efficacy and safety of this procedure. METHODS AND RESULTS: A systematic search of the literature was performed to identify studies that evaluated the use of RDN for the management of VAs. Primary outcomes were reduction in the number of VAs and implantable cardioverter-defibrillator (ICD) therapies. Secondary outcomes were changes in blood pressure and renal function. Ten studies (152 patients) were included in the meta-analysis. RDN was associated with a reduction in the number of VAs, antitachycardia pacing, ICD shocks, and overall ICD therapies of 3.53 events/patient/month (95% confidence interval [CI] = -5.48 to -1.57), 2.86 events/patient/month (95% CI = -4.09 to -1.63), 2.04 events/patient/month (95% CI = -2.12 to -1.97), and 2.68 events/patient/month (95% CI = -3.58 to -1.78), respectively. Periprocedural adverse events occurred in 1.23% of patients and no significant changes were seen in blood pressure or renal function. CONCLUSIONS: In patients with refractory VAs, RDN was associated with a reduction in the number of VAs and ICD therapies, and was shown to be a safe procedure.

Optical Coherence Tomography Versus Intravascular Ultrasound and Angiography to Guide Percutaneous Coronary Interventions: The iSIGHT Randomized Trial.

[Figure: see text].

Denervação renal no tratamento de arritmias ventriculares: revisão sistemática e metanálise / Renal denervation in the treatment of ventricular arrhythmias: systematic review and meta-analysis

FUNDAMENTO: As arritmias ventriculares (AV) constituem importante causa de orbimortalidade em portadores de cardiopatia estrutural. Apesar dos avanços terapêuticos, o tratamento desta condição continua sendo um desafio na prática clínica. Publicações prévias avaliaram o efeito da denervação simpática renal (DR) no manejo das AVs refratárias ao tratamento medicamentoso e por meio da ablação por cateter. Conduzimos uma revisão sistemática e metanálise para avaliar a eficácia e segurança deste tratamento. Métodos: Uma revisão sistemática da literatura foi realizada para identificar estudos que avaliaram o emprego da DR no tratamento de AVs refratárias. Artigos de revisão e estudos em animais foram excluídos. Os desfechos primários foram a redução do número de AVs (taquicardia ventricular e fibrilação ventricular) e redução do número de terapias pelo cardiodesfibrilador implantável (CDI). Alterações da pressão arterial e de função renal constituíram desfechos secundários de segurança. Resultados: Dez estudos (152 pacientes) foram incluídos na metanálise. No grupo de pacientes submetidos à intervenção, observou-se uma redução no número de AV, ATP, choques e terapias apropriadas pelo CDI de 3,53 eventos/paciente/mês (IC95% = -5,48 a -1,57), 2,86 eventos/paciente/mês (IC95% = -4,09 a -1,63), 2,04 eventos/paciente/mês (IC95% = -2,12 a -1,97) e 2,68 eventos/paciente/mês (IC95% = - 3,58 a -1,78), respectivamente. Complicações periprocedimento ocorreram em apenas 1,23% dos pacientes e não houve alterações significativas nas pressões arteriais sistólica e diastólica (redução de 3,3mmHg, IC95% = -7,1 a 0,4, e de 0,2mmHg IC95%= -3,6 a 4,1, respectivamente). Não se observaram variações significativas na função renal (queda de 0,22mg/dL na creatinina sérica, IC95%= -0,48 a 0,05, e aumento de 2,37 mL/min/1.73m2 na taxa de filtração glomerular, IC95%= -9,98 a 14,71). Conclusões: A denervação simpática renal associou-se a uma redução do número de arritmias ventriculares e terapias apropriadas pelo CDI. O procedimento se mostrou seguro, com poucas complicações e eventos adversos.

Adequação das práticas do laboratório de cateterismo durante a pandemia de COVID-19: o protocolo do Instituto Dante Pazzanese de Cardiologia / Adapted Catheterization Laboratory Practices during the COVID-19 Pandemic: The Instituto Dante Pazzanese de Cardiologia Protocol

Introdução A pandemia global da doença de coronavírus 2019 (COVID-19) causada pelo novo vírus de síndrome respiratória aguda grave coronavírus 2 (SARS-CoV-2) começou em Wuhan, China, em dezembro de 2019 e afetou mais de 4,4 milhões de pessoas em todo o mundo, com 302.169 mortes até o dia 16 de maio de 2020.1 Embora os sintomas respiratórios sejam a apresentação mais comum de COVID-19, o envolvimento cardíaco é uma característica proeminente dessa doença, ocorrendo em 20% a 30% dos pacientes hospitalizados e contribuindo para 40% dos óbitos.2-4 O envolvimento cardíaco relacionado à COVID-19 tem sido documentado por elevações em biomarcadores cardíacos e frequentemente apresenta alterações no segmento ST-T no eletrocardiograma (ECG) de 12 derivações, motivo pelo qual a equipe do laboratório de cateterismo é frequentemente ativada. Além disso, as atividades do laboratório de cateterismo devem continuar no atendimento a pacientes não COVID-19 que apresentam síndrome coronariana aguda (SCA) verdadeira, infarto do miocárdio com supradesnivelamento do segmento ST (IAMCSST) e doença cardíaca isquêmica estável muito sintomática. Devido à escalada no número de casos de COVID-19 na cidade de São Paulo, epicentro da doença no Brasil, reformularam-se a logística e as práticas no laboratório de cateterismo cardíaco do Instituto Dante Pazzanese de Cardiologia, que entraram em vigor em abril de 2020 e continuarão durante o período da pandemia. Os objetivos são fornecer atendimento otimizado à população que necessita de procedimentos cardíacos invasivos durante a pandemia, com a proteção adequada aos profissionais de saúde (PS), pacientes e seus familiares. Os protocolos aqui descritos representam os esforços multidisciplinares e dinâmicos do Departamento de Cardiologia Invasiva do Instituto Dante Pazzanese de Cardiologia validados pelo Comitê de Controle de Infecção da instituição. Essas práticas estão sujeitas a alterações em função do estado epidemiológico local, a fase da epidemia e a disponibilidade de equipamento de proteção individual (EPI). Estes protocolos podem não se aplicar a outras localidades sem casos (ou casos esporádicos) de COVID-19 ou a serviços que atendem diferentes perfis populacionais com logísticas e disponibilidade de EPI diversas.

Serial intravascular ultrasound evaluation of the DESolve™ novolimus-eluting bioresorbable coronary scaffold system.

INTRODUCTION: Bioresorbable coronary scaffolds (BRS) have been developed to increase the late safety of coronary angioplasty by providing transitory coronary support and then being fully incorporated to the vessel wall. In the present trial, we sought to evaluate the performance and changes over time in the DESolve™ novolimus-eluting BRS using serial intravascular ultrasound (IVUS) in patients submitted to percutaneous coronary interventions. METHODS: Single-center, prospective, non-randomized study involving 17 consecutive patients submitted to implantation of the DESolve™ scaffold and serial evaluated with IVUS at different time points (post procedure, 6 and 18 months). Primary endpoint included the variation in lumen, scaffold, and vessel diameter and area along the months. RESULTS: Angiographic success was achieved in all cases. Scaffold area and volume on IVUS were significantly greater at 6 months than at baseline (6.41 ± 1.35 mm2 vs. 7.35 ± 1.53 mm2 , P < 0.002; and 101.19 ± 20.9 mm3 vs. 118.51 ± 26.6 mm3 , P = 0.001). Late lumen loss was 0.22 ± 0.30 mm at 6 months and 0.33 ± 0.44 mm at 18 months. No major adverse cardiac events occurred. At late follow-up (18 months) the scaffold was not visualized by IVUS; therefore the evaluation was restricted to lumen and vessel at that time point. CONCLUSIONS: IVUS serial evaluation of the novel DESolve BRS showed an increase in the device dimensions between baseline and 6 months, with concomitant enlargement of lumen dimensions and effective suppression of neointimal proliferation. At 18 months, no footprint of the scaffold was detected and the initial lumen enlargement was sustained.

Terapias anticoagulantes na doença renal crônica / Anticoagulant therapies in chronic renal disease

Os pacientes com doença renal crônica (DRC) têm tendências hemorrágicas e trombóticas e, por isso, a indicação de anticoagulantes é complexa nos indivíduos com fibrilação atrial (FA). A FA é a arritmia mais frequente na DRC, sendo o tromboembolismo e o ictus suas principais complicações. A introdução de novos anticoagulantes orais diretos (DOACs) tem se mostrado superior aos antagonistas da vitamina K, tanto na prevenção de tromboembolismos sistêmicos como no risco de sangramento. Contudo, devem ser prescritos com cautela nesse grupo de pacientes. Para os indivíduos com DRC e clearance renal entre 30 e 50 ml/min, as doses da dabigatrana e da rivaroxabana devem ser reduzidas, no caso de pacientes com elevado risco de sangramento, não havendo necessidade de reduzir as doses de apixabana e edoxabana. Em pacientes com clearance renal entre 15 e 29 ml/min o uso da dabigatrana é contraindicado, a rivaroxabana e a edoxabana não exigem ajuste terapêutico e a dose de apixabana deve ser ajustada. Nenhum dos DOACs é indicado em pacientes com clearance renal < 15 mg/min. Outro problema da terapêutica com os DOACs é o custo do medicamento, muito superior aos dos antagonistas da vitamina K, trazendo algumas implicações clínicas relevantes: suspensão terapêutica por restrições econômicas, que mesmo quando transitória, coloca o paciente em risco de eventos tromboembólicos devido à perda rápida de seus efeitos anticoagulantes e pela possibilidade de hipercoagulabilidade paradoxal. A maior parte da população é tratada em hospitais públicos e recebe os antagonistas de vitamina K. Por isso, enquanto a relação custo-efetividade dos DOACs não for esclarecida, a prevenção e o tratamento de pacientes com DRC e FA com os antagonistas de vitamina K estão consagrados e podem trazer benefícios para esse grupo de pacientes

Patients with chronic renal disease (CRD) have hemorrhagic and thrombotic tendencies, therefore the indication of anticoagulants is complex in individuals with atrial fibrillation (AF). AF is the most frequent arrhythmia in CRD, and thromboembolism and cerebral stroke are its main complications. The introduction of new oral anticoagulants (DOACs) has proven to be superior to vitamin K antagonists in preventing systemic thromboembolisms and bleeding risk. However, they should be prescribed with caution in this group of patients. For individuals with CRD and renal clearance between 30 and 50 ml/min, the doses of dabigatran and rivaroxaban should be reduced, in the case of patients with high risk of bleeding, and it is not necessary to reduce the doses of apixaban and edoxaban. In patients with renal clearance between 15 and 29 ml/min, the use of dabigatran is contraindicated, rivaroxaban and edoxaban do not require therapeutic adjustment, and the dose of apixaban should be adjusted. No DOACs is indicated in patients with renal clearance < 15 mg/min. Another problem with DOACs therapy is the cost of the medication, which is much higher than that of vitamin K antagonists, with some important clinical implications: therapeutic suspension due to economic restrictions, even if temporary, place the patient at risk of thromboembolic events due to the rapid loss of anticoagulant effects and the possibility of paradoxical hypercoagulability. Most of the population is treated in public hospitals, and receives vitamin K antagonists. Therefore, while the cost-effectiveness ratio of DOACs has not been clarified, prevention and treatment of patients with CRD and AF with vitamin K antagonists is consecrated, and can bring benefits for this group of patients

Impact of the Occlusion Duration on the Performance of J-CTO Score in Predicting Failure of Percutaneous Coronary Intervention for Chronic Total Occlusion.

OBJECTIVES: The present study examined the association between Multicenter CTO Registry in Japan (J-CTO) score in predicting failure of percutaneous coronary intervention (PCI) correlating with the estimated duration of chronic total occlusion (CTO). BACKGROUND: The J-CTO score does not incorporate estimated duration of the occlusion. METHODS: This was an observational retrospective study that involved all consecutive procedures performed at a single tertiary-care cardiology center between January 2009 and December 2014. RESULTS: A total of 174 patients, median age 59.5 years (interquartile range [IQR], 53-65 years), undergoing CTO-PCI were included. The median estimated occlusion duration was 7.5 months (IQR, 4.0-12.0 months). The lesions were classified as easy (score = 0), intermediate (score = 1), difficult (score = 2), and very difficult (score ≥3) in 51.1%, 33.9%, 9.2%, and 5.7% of the patients, respectively. Failure rate significantly increased with higher J-CTO score (7.9%, 20.3%, 50.0%, and 70.0% in groups with J-CTO scores of 0, 1, 2, and ≥3, respectively; P<.001). There was no significant difference in success rate according to estimated duration of occlusion (P=.63). Indeed, J-CTO score predicted failure of CTO-PCI independently of the estimated occlusion duration (P=.24). Areas under receiver-operating characteristic curves were computed and it was observed that for each occlusion time period, the discriminatory capacity of the J-CTO score in predicting CTO-PCI failure was good, with a C-statistic >0.70. CONCLUSION: The estimated duration of occlusion had no influence on the J-CTO score performance in predicting failure of PCI in CTO lesions. The probability of failure was mainly determined by grade of lesion complexity.

Randomized Angiographic and Intravascular Ultrasound Comparison of Dual-Antiplatelet Therapy vs Triple-Antiplatelet Therapy to Reduce Neointimal Tissue Proliferation in Diabetic Patients.

BACKGROUND: Previous studies have suggested a benefit of cilostazol in addition to standard dual-antiplatelet therapy (DAPT), reducing in-stent late luminal loss and restenosis after percutaneous coronary intervention (PCI) with bare-metal and drug-eluting stent (DES) implantation. However, there is a paucity of intravascular ultrasound (IVUS) assessment of neointimal tissue hyperplasia (NIH) after triple-antiplatelet therapy (TAPT), especially in diabetic patients treated with DES. METHODS: This prospective, placebo-controlled trial was conducted in diabetic patients randomized (1:1) to receive either standard DAPT (aspirin and clopidogrel) vs TAPT with cilostazol for a minimum of 12 months after PCI with Endeavor zotarolimus-eluting stent (E-ZES). The primary endpoint was the 9-month comparison of percentage of NIH in both groups. Additionally, we compared in-stent late lumen loss, binary restenosis, major adverse cardiac event (MACE; cardiac death, non-fatal myocardial infarction, and restenosis) rates, and the incidence of vascular/bleeding complications. RESULTS: In total, 133 diabetic patients were enrolled (cilostazol cohort = 65 patients) with 56.4% male and mean age of 60.8 years. Overall, the two cohorts were comparable in terms of baseline clinical and angiographic characteristics, except for the reference vessel diameter, which was smaller among patients randomized to cilostazol (2.48 ± 0.46 mm vs 2.69 ± 0.48 mm; P=.01). At 9 months, there was a non-significant trend toward less percentage of NIH obstruction in the TAPT cohort (33.2 ± 8.29% vs 35.1 ± 8.45%; P=.07). However, this finding did not impact angiographic late-lumen loss (0.60 ± 0.46 mm cilostazol group vs 0.64 ± 0.48 mm control group; P=.30) and binary restenosis (9.8% vs 6.8%; P=.99). MACE rate also did not significantly differ between the cohorts (13.8% cilostazol group vs 8.8% control group; P=.81). Of note, the addition of a third antiplatelet agent did not increase vascular and bleeding complications. CONCLUSION: In diabetic patients treated with E-ZES, TAPT with cilostazol did not add any significant benefit in terms of NIH suppression or MACE reduction.

Long-Term Follow-Up of Patients after Percutaneous Coronary Intervention with Everolimus-Eluting Bioresorbable Vascular Scaffold / Seguimento Muito Tardio de Pacientes após Intervenção Coronária Percutânea com Suporte Vascular Bioabsorvível Eluidor de Everolimus

Abstract Background: Bioresorbable vascular scaffolds (BVS) were developed to improve the long-term results of percutaneous coronary intervention, restoring vasomotion. Objectives: To report very late follow-up of everolimus-eluting Absorb BVS (Abbott Vascular, Santa Clara, USA) in our center. Methods: Observational retrospective study, in a single Brazilian center, from August 2011 to October 2013, including 49 patients submitted to Absorb BVS implantation. Safety and efficacy outcomes were analyzed in the in-hospital and very late follow-up phases (> 2 years). Results: All 49 patients underwent a minimum follow-up of 2.5 years and a maximum of 4.6 years. Mean age was 56.8 ± 7.6 years, 71.4% of the patients were men, and 26.5% were diabetic. Regarding clinical presentation, the majority (94%) had stable angina or silent ischemia. Device success was achieved in 100% of cases with 96% overall procedure success rate. Major adverse cardiovascular events rate was 4% at 30 days, 8.2% at 1 year, and 12.2% at 2 years, and there were no more events until 4.6 years. There were 2 cases of thrombosis (1 subacute and 1 late). Conclusions: In this preliminary analysis, Absorb BVS showed to be a safe and effective device in the very late follow-up. Establishing the efficacy and safety profiles of these devices in more complex scenarios is necessary.

Resumo Fundamento: Os suportes vasculares bioabsorvíveis (SVB) foram desenvolvidos com o intuito de melhorar os resultados da intervenção coronária percutânea a longo prazo, restabelecendo-se a vasomotricidade. Objetivos: Reportar o seguimento muito tardio do implante do SVB eluidor de everolimus Absorb® (Abbot Vascular, Santa Clara, EUA) em nosso centro. Métodos: Estudo observacional, retrospectivo, em um único centro brasileiro, que incluiu 49 pacientes submetidos ao implante do SVB Absorb® entre agosto/2011 e outubro/2013. Foram analisados os desfechos de segurança e eficácia na fase hospitalar e bastante tardia (> 2 anos). Resultados: Todos os 49 pacientes completaram um seguimento mínimo de 2,5 anos, sendo o máximo de 4,6 anos. A média de idade foi 56,8 ± 7,6 anos, sendo 71,4% da população estudada do sexo masculino e 26,5% composta por diabéticos. Considerando a apresentação clínica, a grande maioria (94%) tinha angina estável ou isquemia silenciosa. Obteve-se sucesso do dispositivo em 100% dos casos e do procedimento, em 96%. A taxa de eventos cardiovasculares maiores foi de 4% aos 30 dias, de 8,2% em 1 ano, e de 12,2% em 2 anos, sem mais eventos até 4,6 anos. Houve 2 casos de trombose (1 subaguda e 1 tardia) até o último seguimento. Conclusões: Nesta análise preliminar, o uso do SVB Absorb® mostrou-se seguro e eficaz no seguimento bastante tardio. Faz-se necessário estabelecer o perfil de eficácia e segurança destes dispositivos em cenários de maior complexidade.

Long-Term Follow-Up of Patients after Percutaneous Coronary Intervention with Everolimus-Eluting Bioresorbable Vascular Scaffold.

BACKGROUND:: Bioresorbable vascular scaffolds (BVS) were developed to improve the long-term results of percutaneous coronary intervention, restoring vasomotion. OBJECTIVES:: To report very late follow-up of everolimus-eluting Absorb BVS (Abbott Vascular, Santa Clara, USA) in our center. METHODS:: Observational retrospective study, in a single Brazilian center, from August 2011 to October 2013, including 49 patients submitted to Absorb BVS implantation. Safety and efficacy outcomes were analyzed in the in-hospital and very late follow-up phases (> 2 years). RESULTS:: All 49 patients underwent a minimum follow-up of 2.5 years and a maximum of 4.6 years. Mean age was 56.8 ± 7.6 years, 71.4% of the patients were men, and 26.5% were diabetic. Regarding clinical presentation, the majority (94%) had stable angina or silent ischemia. Device success was achieved in 100% of cases with 96% overall procedure success rate. Major adverse cardiovascular events rate was 4% at 30 days, 8.2% at 1 year, and 12.2% at 2 years, and there were no more events until 4.6 years. There were 2 cases of thrombosis (1 subacute and 1 late). CONCLUSIONS:: In this preliminary analysis, Absorb BVS showed to be a safe and effective device in the very late follow-up. Establishing the efficacy and safety profiles of these devices in more complex scenarios is necessary. FUNDAMENTO:: Os suportes vasculares bioabsorvíveis (SVB) foram desenvolvidos com o intuito de melhorar os resultados da intervenção coronária percutânea a longo prazo, restabelecendo-se a vasomotricidade. OBJETIVOS:: Reportar o seguimento muito tardio do implante do SVB eluidor de everolimus Absorb® (Abbot Vascular, Santa Clara, EUA) em nosso centro. MÉTODOS:: Estudo observacional, retrospectivo, em um único centro brasileiro, que incluiu 49 pacientes submetidos ao implante do SVB Absorb® entre agosto/2011 e outubro/2013. Foram analisados os desfechos de segurança e eficácia na fase hospitalar e bastante tardia (> 2 anos). RESULTADOS:: Todos os 49 pacientes completaram um seguimento mínimo de 2,5 anos, sendo o máximo de 4,6 anos. A média de idade foi 56,8 ± 7,6 anos, sendo 71,4% da população estudada do sexo masculino e 26,5% composta por diabéticos. Considerando a apresentação clínica, a grande maioria (94%) tinha angina estável ou isquemia silenciosa. Obteve-se sucesso do dispositivo em 100% dos casos e do procedimento, em 96%. A taxa de eventos cardiovasculares maiores foi de 4% aos 30 dias, de 8,2% em 1 ano, e de 12,2% em 2 anos, sem mais eventos até 4,6 anos. Houve 2 casos de trombose (1 subaguda e 1 tardia) até o último seguimento. CONCLUSÕES:: Nesta análise preliminar, o uso do SVB Absorb® mostrou-se seguro e eficaz no seguimento bastante tardio. Faz-se necessário estabelecer o perfil de eficácia e segurança destes dispositivos em cenários de maior complexidade.

Desfechos clínicos precoces e tardios após tratamento de enxertos de veia safena com stents MGuardTM vs. stents farmacológicos / Early and late clinical outcomes after saphenous vein graft treatment with MGuardTM stents vs. drug-eluting stents

Introdução: O stent MGuard™, revestido por malha polimérica microscópica, tem a finalidade de reduzir a embolização distal de fragmentos durante a intervenção coronária percutânea (ICP) em enxertos de veia safena (EVS). Avaliamos os desfechos clínicos precoces e tardios de pacientes submetidos à ICP de EVS com stents MGuard™ vs. stents farmacológicos (SF). Métodos: Estudo observacional, retrospectivo, realizado em dois centros terciários, envolvendo uma coorte de pacientes com lesões em EVS, tratados de forma eletiva ou de emergência com stents MGuard™ ou SF. Resultados: Foram incluídos 271 pacientes, sendo 220 tratados com SF. O Grupo MGuard™ apresentou maior proporção de mulheres (25,5% vs. 10,5%; p=0,01), com média de idades de 65,0 ± 13,9 anos vs. 69,0 ± 9,6 anos (p = 0,06). O Grupo SF utilizou com maior frequência filtro de proteção distal (5,8% vs. 10,0%; p = 0,001). Sucesso angiográfico foi obtido na maioria dos casos (96,2% vs. 98,0%; p = 0,22). O Grupo MGuard™ teve menores taxas de eventos cardiovasculares adversos maiores (ECAM) na fase hospitalar que o Grupo SF (1,9% vs. 13,6%; p = 0,01) devido exclusivamente à menor incidência de infarto periprocedimento. Entretanto, a taxa de ECAM em 1 ano foi maior no grupo MGuard™ (14,3% vs. 4,4%; p = 0,01) à custa de maior taxa de revascularização da lesão alvo (7,1% vs. 1,3%; p = 0,048). Conclusões: A utilização de stent MGuard™ resultou em redução de eventos na fase hospitalar, porém, no longo prazo, os SF foram superiores em reduzir desfechos maiores, sobretudo a necessidade de revascularização da lesão alvo

Background: The MGuard™ stent, which has a microscopic polymer mesh coating, is intended to reduce the distal embolization of fragments during percutaneous coronary intervention (PCI) in saphenous vein grafts (SVG). This study evaluated the early and late clinical outcomes of patients undergoing PCI in SVG with MGuard™ stents vs. drug­eluting stents (DES). Methods: Observational, retrospective study conducted at two tertiary centers, involving a cohort of patients with SVG lesions submitted to elective or emergency treatment with MGuard™ stents or DES. Results: A total of 271 patients were included, of whom 220 were treated with DES. The MGuard™ group had a higher proportion of women (25.5% vs. 10.5%; p = 0.01), with a mean age of 65.0 ± 13.9 years vs. 69.0 ± 9.6 years (p = 0.06). The DES group more frequently used distal protection filter (5.8% vs. 10.0%; p = 0.001). Angiographic success was attained in most cases (96.2% vs. 98.0%; p = 0.22). The MGuard™ group had lower rates of early major adverse cardiovascular events (MACE) than the DES group (1.9% vs. 13.6%; p = 0.01), due solely to the lower incidence of periprocedural infarction. However, the MACE rate at 1 year was higher in the MGuard™ group (14.3% vs. 4.4%; p = 0.01) at the expense of a higher rate of target lesion revascularization (7.1% vs. 1.3%; p = 0.048). Conclusions: The use of the MGuard™ stent resulted in a reduction of events during hospitalization; however, in the long term the DES were superior in reducing major outcomes, mainly the need for target lesion revascularization

Impacto do tempo de oclusão na taxa de sucesso e nos resultados da intervenção coronária percutânea em obstruções totais crônicas / Impact of occlusion duration on the success rate and outcomes of percutaneous coronary intervention in chronic total occlusions

Estudos iniciais mostram que oclusões antigas ou com tempo indeterminado têm sido associadas a insucesso da intervenção coronária percutânea (ICP) e a pior prognóstico. Nosso objetivo foi determinar o impacto do tempo de oclusão no sucesso e nos resultados da ICP contemporânea na obstrução total crônica (OTC). Métodos: Analisamos uma coorte retrospectiva de pacientes consecutivos que realizaram ICP em OTC, e que foram comparados de acordo com o tempo de oclusão confirmado (TOC) < 12 meses, ≥ 12 meses, ou indeterminado (TOI).Resultados: Foram tratados 168 pacientes, 122 (72,6%) com TOC (80 < 12 meses, 42 ≥ 12 meses) e 46(24,7%) com TOI. A extensão da lesão foi de 17,0 ± 13,6 mm, em vasos de 2,90 ± 0,58 mm, e a abordagemanterógrada foi utilizada em 98,8% dos casos. Sucesso angiográfico foi obtido em 79,2% dos pacientes (80,0% vs. 73,8% vs. 82,6%; p = 0,73). A principal causa de insucesso foi a incapacidade de cruzar a lesão com o fio-guia (68,6%). O tempo de oclusão não teve impacto na taxa de eventos cardiovasculares hospitalares (4,8% vs. 7,1% vs. 6,0%; p = 0,73), explicados em sua quase totalidade pelos infartos do miocárdioperiprocedimento, ou nos eventos tardios (18,8% vs. 7,1% vs. 15,3%; p = 0,23). Na análise multivariada,comprimento da lesão ≥ 20 mm (odds ratio - OR = 7,27; intervalo de confiança de 95% - IC 95% 1,94-29,1; p = 0,003), calcificação (OR = 4,72; IC 95% 1,19-19,1; p = 0,02) e tortuosidade do segmento ocluído (OR = 15,98; IC 95% 2,18-144,7; p = 0,007) foram preditores de insucesso. Conclusões: O tempo de oclusão não está associado ao aumento da taxa de insucesso do procedimento ou a piores resultados da ICP em OTC...

Initial studies have shown that old occlusions or those with indeterminate occlusion durationhave been associated with percutaneous coronary intervention (PCI) failure and a worse prognosis. This study aimed to determine the impact of occlusion duration on the success and outcomes of contemporary PCI on chronic total occlusion (CTO). Methods: The authors analyzed a retrospective cohort of consecutive patients submitted to PCI in CTO, who were compared according to the confirmed occlusion duration (COD) < 12 months, ≥ 12 months, orindeterminate occlusion duration (IOD).Results: A total of 168 patients were treated, 122 (72.6%) with COD (80 < 12 months, 42 ≥ 12 months) and 46(24.7%) with an IOD. Lesion extension was 17.0 ± 13.6 mm, in 2.90 ± 0.58 mm vessels, and the anterogradeapproach was used in 98.8% of cases. Angiographic success was attained in 79.2% of patients (80.0% vs. 73.8%vs. 82.6%; p = 0.73). The main cause of failure was the inability to cross the lesion with the guidewire (68.6%).Occlusion duration had no impact on in-hospital events (4.8% vs. 7.1% vs. 6.0%; p = 0.73), which were almostentirely explained by periprocedural myocardial infarction, or on late outcomes (18.8% vs. 7.1% vs. 15.3%;p = 0.23). At the multivariate analysis, lesion length ≥ 20 mm (odds ratio - OR = 7.27; 95% confidence interval- 95% IC 1.94-29.1; p = 0.003), calcification (OR = 4.72; 95% CI 1.19-19.1; p = 0.02), and tortuosity of theoccluded segment (OR = 15.98; 95% CI 2.18-144.7; p = 0.007) were predictors of failure...

6-Month Outcomes in Patients With Implantable Cardioverter-Defibrillators Undergoing Renal Sympathetic Denervation for the Treatment of Refractory Ventricular Arrhythmias.

OBJECTIVES: This study aimed to assess 6-month outcomes in patients with implantable cardioverter-defibrillators (ICDs) undergoing renal sympathetic denervation (RSD) for refractory ventricular arrhythmias (VAs). BACKGROUND: ICDs are generally indicated for patients at high risk of malignant VAs. Sympathetic hyperactivity plays a critical role in the development, maintenance, and aggravation of VAs. METHODS: A total of 10 patients with refractory VA underwent RSD. Underlying conditions were Chagas disease (n = 6), nonischemic dilated cardiomyopathy (n = 2), and ischemic cardiomyopathy (n = 2). Information on the number of ventricular tachycardia (VT)/ventricular fibrillation (VF) episodes and device therapies (antitachycardia pacing/shocks) in the previous 6 months as well as 1 and 6 months post-treatment was obtained from ICD interrogation. RESULTS: The median number of VT/VF episodes/antitachycardia pacing/shocks 6 months before RSD was 28.5 (range 1 to 106)/20.5 (range 0 to 52)/8 (range 0 to 88), respectively, and was reduced to 1 (range 0 to 17)/0 (range 0 to 7)/0 (range 0 to 3) at 1 month and 0 (range 0 to 9)/0 (range 0 to 7)/0 (range 0 to 3) at 6 months afterward, respectively. There were no major procedure-related complications. Two patients experienced sustained VT within the first week; in both cases, no further episodes occurred during follow-up. Two patients were nonresponders: 1 with persistent idioventricular rhythm and 1 with multiple renal arteries and incomplete ablation. Three patients died during follow-up. None of the deaths was attributed to VA. CONCLUSIONS: In patients with ICDs and refractory VAs, RSD was associated with reduced arrhythmic burden with no procedure-related complications. Randomized controlled trials investigating RSD for treatment of refractory VAs in patients with increased sympathetic activity are needed.

A Randomized Trial of Creatine-kinase Leak After Rosuvastatin in Elective Percutaneous Coronary Intervention (CLEAR-PCI).

OBJECTIVES: To determine the impact of percutaneous coronary intervention (PCI) performed at the same time of the peak concentration of rosuvastatin to reduce periprocedural myocardial infarction (PMI). BACKGROUND: Prior studies suggest that a high dose of statin before PCI reduce periprocedural myocardial infarction. However, there is no information regarding the elective PCI performed at the time of the peak of statin concentration to reduce PMI. METHODS: From 2001 to 2013, at a single center in Brazil we enrolled 544 patients who underwent elective PCI and after exclusions for baseline biases in clinical and angiographic characteristics, yielding 528 patients, we prospectively randomly assigned them to either a high loading dose of Rosuvastatin before PCI (n = 264) or standard treatment (n = 264). After exclusions for biases in procedural characteristics a total of 487 patients underwent to end points analysis. The primary outcome was the incidence of MB fraction of creatine kinase (CK-MB) greater than three times the upper limit of normal. RESULTS: The primary end point occurred in 7.6% in the rosuvastatin and 4.8% in the control group (P = 0.200). There was a higher incidence in elevation of CK-MB than normal baseline in the rosuvastatin (67.1% vs 59.2%, P = 0.701). There was no difference in major adverse event (0% in the rosuvastatin group vs 0.8% in control).