Rationale and design of the First Brazilian Cardiovascular Registry of Atrial Fibrillation: The RECALL study.

BACKGROUND: Atrial fibrillation (AF) is an important and growing public health problem worldwide, but data about its actual prevalence, therapeutic management, and clinical outcomes in middle- to low-income countries are scarce. DESIGN: The First Brazilian Cardiovascular Registry of Atrial Fibrillation (the RECALL study) will assess demographic characteristics and evidence-based practice of a representative sample of patients with AF in Brazil. The prospective, multicenter registry has a planned sample size of around 5,000 patients at approximately 80 sites. Eligibility criteria include age >18 years and permanent, paroxysmal, or persistent AF documented by electrocardiogram, 24-hour Holter monitoring, or device interrogation. Patients will be followed up through 1 year after enrollment. Information on laboratory tests, echocardiographic data, medication use, and clinical outcomes will be obtained. Various aspects of the population will be described, including demographic characteristics; antithrombotic therapies; antiarrhythmic agents; level of control of international normalized ratio (by average time within the therapeutic range) among patients using vitamin K antagonists; rates of warfarin discontinuation; outcomes such as death, stroke, systemic embolism, and major bleeding within 1 year after enrollment in the study; and rates of electrical cardioversion, percutaneous ablation of AF, ablation of the atrioventricular junction, and pacemaker/cardioverter-defibrillator implantation. SUMMARY: RECALL is the first prospective, multicenter registry of AF in Brazil. This study will provide important information about demographics, practice patterns, treatments, and associated outcomes in patients with AF. The results of this registry will also allow Brazilian data to be put in perspective with other AF registries across the world and provide opportunities to improve care of patients with AF in Brazil.

Transulnar approach as an alternative access site for coronary invasive procedures after transradial approach failure.

BACKGROUND: Unsuccessful radial artery puncture, inability to advance the guide catheter to the ascending aorta, and inadequate guide catheter support represent mechanisms of transradial approach failure. With the rationale of sharing the same efficacy and safety promoted by radial access, the transulnar approach represents an alternative access site for percutaneous coronary procedures. METHODS: Between May 2007 and May 2012, 11,059 coronary invasive procedures were performed in a single institution: 10,108 by transradial approach (91.4%), 541 by transfemoral approach (4.9%), and 410 by transulnar approach (3.7%). Patients who underwent coronary procedures through transulnar access were included in a prospective registry of effectiveness and safety. RESULTS: Diagnostic procedures accounted for 71.8% of cases, and the right ulnar access was the most common route (88.9%). Procedure success was high (98.5%), with a crossover rate of 1.5% (6 cases), of which 5 were achieved through the contralateral radial access and 1 through femoral approach. Complications related to access site were low (3.9%), consisting mostly of minor bleeding due to subcutaneous hematomas. There were no cases of major bleeding, nerve injury, pseudoaneurysm, arteriovenous fistula, or necessity of vascular surgical repair. CONCLUSIONS: The transulnar approach represents an alternative to the transradial approach in selected cases when performed by radial-trained operators, sharing a high success rate and extremely low incidence of access-site complications.

Drug-eluting stents during ST-segment elevation acute myocardial infarction: a critical analysis.

Primary percutaneous coronary intervention is the preferred reperfusion therapy for ST-segment elevation acute myocardial infarction patients within 12 hours of symptom-onset. Routine stent implantation during the procedure significantly reduces the rate of target vessel revascularization, although restenosis still represents a current limitation of the technique. Drug-eluting stents were developed to treat and prevent coronary restenosis. Randomized trials, meta-analysis, and registries proved their efficacy and safety in different clinical situations, including acute myocardial infarction. However, the increased risk of late stent thrombosis associated with drug-eluting stents during primary percutaneous coronary interventions encourages a careful analysis to identify which patients most benefit from them, as well as those where a prolonged dual antiplatelet therapy does not represent a limiting factor.

Transulnar approach: the rationale from the radialist's view.

BACKGROUND: Radial access, besides providing greater comfort to the patient and reduction of hospital costs, promotes unequivocal reduction of vascular complications, with possible prognosis implication. A series of cases has shown that when its use is not suitable, ulnar access presents itself as a viable and effective alternative. OBJECTIVE: To evaluate the safety and effectiveness of ulnar approach in the performance of coronary procedures after failed attempt in obtaining radial access. METHODS AND RESULTS: From May 2007 to February 2009, 115 patients underwent 122 coronary procedures via ulnar access and were included in a prospective registry. The average age was 61.3 +/- 11.1 years, 67 (58%) were female and 36 (31%) were diabetic. Procedure success was achieved in 116 (95%) cases. There were no cases of major bleeding, transfusions or vascular repair surgery among the complications. There were hematomas in 4.9% of the cases, though mostly superficial, light to moderate spasms in 4% and asymptomatic ulnar artery occlusion, with no evidence of ischemia in 1.6%. CONCLUSIONS: The ulnar artery is a feasible and effective alternative approach to perform coronary procedures. When radial access is not available, it presents a similar safety profile with virtually no occurrence of hemorrhagic complications.

Vascular Closure Devices Attenuate Femoral Access Complications of Primary Percutaneous Coronary Intervention.

OBJECTIVES: To compare severe complications related to radial access and those related to femoral access using vascular closure devices for patients undergoing primary percutaneous coronary intervention (PCI). BACKGROUND: Femoral artery access is still used for acute myocardial infarction management; studies comparing state-of-the-art radial and femoral techniques are required to minimize bias regarding the outcomes associated with operator preferences. METHODS: We performed a randomized study comparing radial access with a compression device and anatomic landmark-guided femoral access with a hemostatic vascular closure device. The severe complication rates related to the access site were assessed until hospital discharge. A meta- analysis including studies with comparable populations reporting severe bleeding and major adverse cardiovascular event rates was performed. RESULTS: A total of 250 patients were included who underwent PCI between January 2016 and February 2019. Mean age was 61.5 ± 12.2 years, 73.2% were men, and 28.4% had diabetes. There were no differences between groups or in vascular access-related severe complication rates (8.0% for femoral group vs 5.6% for radial group; P=.45). Although radial access was associated with decreased vascular complications related to the access site when compared with the femoral approach (relative risk [RR], 0.64; 95% confidence interval [CI], 0.43-0.95), the meta-analysis did not show an impact on severe bleeding (RR, 0.74; 95% CI, 0.37-1.46) or severe cardiovascular adverse events (RR, 0.69; 95% CI, 0.30-1.58). CONCLUSIONS: Compliance with femoral artery puncture techniques and routine use of a vascular closure device promoted low severe complication rates.

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.

Femoral versus radial access in primary angioplasty. Analysis of the ACCEPT registry.

BACKGROUND: The radial access provides a lower risk of bleeding and vascular complications related to the puncture site in comparison to the femoral access. Recent studies have suggested a reduction in mortality associated with the radial access in patients with acute myocardial infarction undergoing percutaneous coronary intervention. OBJECTIVE: To compare the occurrence of adverse cardiovascular ischemic and hemorrhagic events in patients undergoing primary angioplasty according to the type of arterial access route. METHODS: From August 2010 to December 2011, 588 patients undergoing primary percutaneous coronary intervention during acute ST-segment elevation myocardial infarction were assessed; they were recruited from 47 centers participating in the ACCEPT registry. Patients were grouped and compared according to the arterial access used for the procedure. RESULTS: The mean age was 61.8 years; 75% were males and 24% had diabetes mellitus. There was no difference between groups as regards the procedure success rate, as well as regards the occurrence of death, reinfarction, or stroke at six months of follow-up. Severe bleeding was reported in 1.1% of the sample analyzed, with no statistical difference related to the access used. CONCLUSIONS: The femoral and radial accesses are equally safe and effective for the performance of primary percutaneous coronary intervention. The low rate of cardiovascular events and of hemorrhagic complications reflects the quality of the participating centers and the operators expertise with the use of both techniques.

Evidence-based therapy prescription in high-cardiovascular risk patients: the REACT study.

BACKGROUND: Data on outpatient care provided to patients at high cardiovascular risk in Brazil are insufficient. OBJECTIVE: To describe the profile and document the clinical practice of outpatient care in patients at high cardiovascular risk in Brazil, regarding the prescription of evidence-based therapies. METHODS: Prospective registry that documented the ambulatory clinical practice in individuals at high cardiovascular risk, which was defined as the presence of the following factors: coronary artery disease, cerebrovascular and peripheral vascular diseases, diabetes, or those with at least three of the following factors: hypertension, smoking, dyslipidemia, age > 70 years, family history of coronary artery disease, chronic kidney disease or asymptomatic carotid artery disease. Basal characteristics were assessed and the rate of prescription of pharmacological and non-pharmacological interventions was analyzed. RESULTS: A total of 2364 consecutive patients were included, of which 52.2% were males, with a mean age of 66.0 years (± 10.1). Of these, 78.3% used antiplatelet agents, 77.0% used statins and of patients with a history of myocardial infarction, 58.0% received beta-blockers. Concomitant use of these three classes of drugs was 34%; 50.9% of hypertensive, 67% of diabetic and 25.7% of dyslipidemic patients did not achieve the goals recommended by guidelines. The main predictors of prescription therapies with proven benefit were centers with a cardiologist and history of coronary artery disease. CONCLUSION: This national and representative registry identified important gaps in the incorporation of therapies with proven benefit, offering a realistic outlook of patients at high cardiovascular risk.

Seguimento de 12 Meses de Pacientes Submetidos à Estratégia Intervencionista Precoce pelo Acesso Radial ou Femoral com Dispositivo de Oclusão Vascular / 12-Month Clinical Follow-Up of Patients Undergoing Early Invasive Strategy by the Transradial or Transfemoral Approach with Vascular Closure Device

Fundamento: A técnica radial reduz a prevalência de complicações vasculares, sangramento grave e mortalidade quando cotejada à técnica femoral. Entretanto, esta ainda predomina como via de acesso preferencial para a efetivação de procedimentos coronários invasivos, requerendo a adoção de estratégias capazes de minimizar intercorrências. Objetivos: Comparar a sobrevida livre de eventos cardiovasculares adversos graves aos 12 meses de pacientes submetidos à estratégia intervencionista precoce pelo acesso radial ou femoral com dispositivo de oclusão vascular. Métodos: Estudo randomizado de não inferioridade envolvendo 240 pacientes com síndrome coronariana aguda sem supradesnível do segmento ST. A função de sobrevivência livre de morte, infarto agudo do miocárdio ou acidente vascular encefálico foi estimada pelo modelo de Kaplan-Meier e comparada utilizando-se o teste de log rank. Resultados: A taxa de complicações vasculares no sítio de punção arterial aos 30 dias foi de 12,5% no grupo Angio-Seal e de 13,3% no grupo radial (p = 1,000). A incidência de sangramento grave ou transfusão sanguínea aos 12 meses também não diferiu entre os grupos (2,5% versus 1,7%, p = 1,000). Não se observou diferença quanto à curva de sobrevida livre de eventos cardiovasculares adversos graves (90,8% versus 94,2%, p = 0,328). Conclusões: Não houve distinção entre as técnicas na sobrevida livre de eventos cardiovasculares adversos graves aos 12 meses de seguimento. Ensaios clínicos com maior poder estatístico são necessários para a validação desses achados

Background: The radial approach reduces the prevalence of vascular complications, major bleeding and mortality when compared to the femoral approach. However, the last still prevails as the preferred approach for the performance of invasive coronary procedures, requiring the adoption of strategies to minimize complications. Objectives: To compare the survival free of major adverse cardiovascular events at 12 months in patients undergoing early intervention strategy by the radial or femoral access with vascular closure device. Methods: Randomized non inferiority trial involving 240 non-ST-segment elevation acute coronary syndrome patients. The survival free of death, myocardial infarction or stroke was estimated by the Kaplan-Meier method and compared using the log rank test. Results: The 30-day rate of vascular complications in the arterial puncture site was 12.5% in the Angio-Seal group and 13.3% in the radial group (p = 1.000). The 12-month incidence of major bleeding or blood transfusion did not differ between groups (2.5% vs. 1.7%, p = 1.000). There was no difference in survival free of major adverse cardiovascular events (90.8% versus 94.2%, p = 0.328). Conclusions: There was no distinction between the techniques in survival free of major adverse cardiovascular events at 12 months of followup. Clinical trials with greater statistical power are needed to validate these findings

Major bleeding in acute coronary syndromes.

Treatment of acute coronary syndrome has been based on the prevention of ischemic complications by means of antithrombotic therapy and invasive strategies. The desired reduction reached in the recurrence of ischemic events reveals its price, an increase in the occurrence of major bleeding. Initially tolerated as a benign complication, it is now shown to be an important predictor of mortality. Greater attention dedicated to the prognostic impact of bleeding is recent, motivated by the development of new antithrombotic agents. Detailed analysis of the risk factors for myocardial infarction or bleeding is an important issue and allows institution of individualized approach.

Transição entre ticagrelor e duas diferentes doses de clopidogrel na alta hospitalar de pacientes submetidos à intervenção coronária percutânea na vigência de síndrome coronariana aguda / Transition between ticagrelor and two different doses of clopidogrel at hospital discharge in patients with acute coronary syndrome submitted to percutaneous coronary intervention

Introdução: A transição do ticagrelor para o clopidogrel não está fundamentada em estudos farmacodinâmicos ou clínicos, mas é uma prática comum. O objetivo do presente estudo foi testar, de forma exploratória, em pacientes com diagnóstico de síndrome coronariana aguda submetidos à intervenção coronariana percutânea, inicialmente tratados com ticagrelor, a transição para duas diferentes doses de clopidogrel no momento da alta hospitalar. Métodos: Pacientes previamente tratados com ticagrelor foram randomizados para receber uma dose de ataque de 300 mg de clopidogrel no momento da alta hospitalar, ou 75 mg, omitindo-se a dose de ataque. O objetivo primário foi a incidência de eventos adversos cardiovasculares ou sangramento aos 30 dias. Resultados: Dentre 348 pacientes selecionados, 132 foram incluídos e completaram o estudo. A incidência de eventos isquêmicos e hemorrágicos aos 30 dias foi similar entre os grupos, traduzindo-se em uma taxa de eventos cardíacos e cerebrovasculares de 6,1% vs. 9,1% (RR: 0,787; IC 95%: 0,361-1,715; p = 0,74). Conclusões: A transição para clopidogrel com a dose de 75 mg no momento da alta, omitindo-se uma dose de ataque, aparenta ser uma estratégia possível. Estudos com maior poder estatístico são necessários para confirmar estes achados

Background: The transition from ticagrelor to clopidogrel is not based on pharmacodynamic or clinical studies, but it is a common practice. The aim of the present study was to test, in an exploratory way, the transition to two different doses of clopidogrel at the time of hospital discharge in patients diagnosed with acute coronary syndrome submitted to percutaneous coronary intervention who were initially treated with ticagrelor. Methods: Patients previously treated with ticagrelor were randomized to receive a loading dose of 300 mg clopidogrel at hospital discharge, or 75 mg without the loading dose. The primary endpoint was the incidence of cardiovascular adverse events or bleeding at 30 days. Results: Of 348 selected patients, 132 were enrolled and completed the study. The incidence of ischemic and hemorrhagic events at 30 days was similar between the groups, resulting in a rate of cardiac and cerebrovascular events of 6.1% vs. 9.1% (RR: 0.787; 95% CI: 0.361-1.715; p = 0.74). Conclusions: The transition to clopidogrel with a dose of 75 mg at discharge, without a loading dose, appears to be a possible strategy. Studies with greater statistical power are needed to confirm these findings

Estratégia minimamente invasiva para o implante percutâneo de bioprótese aórtica de segunda geração Lotus™ / Minimally-invasive strategy for transcatheter implantation of second-generation Lotus™ aortic valve system

O implante percutâneo de bioprótese aórtica é a terapia estabelecida em pacientes com estenose aórtica grave. Houve um progressivo aperfeiçoamento na tecnologia dos dispositivos que, associada a maior experiência dos operadores, resultou em procedimentos mais seguros e com melhores resultados. O primeiro dispositivo de segunda geração aprovado no Brasil, o sistema de válvula Lotus™ (Boston Scientific Corporation, Natick, EUA), incorpora várias dessas novas características. Descrevemos aqui os dois primeiros casos realizados no país, conduzidos sob anestesia local e sedação consciente, ambos com sucesso

Transcatheter aortic valve implantation is a well-established therapy in patients with severe aortic stenosis. There has been a progressive improvement in device technology associated with increased experience of the interventionists, resulting in safer procedures with better outcomes. The first secondgeneration device approved in Brazil, Lotus™ Valve System (Boston Scientific Corporation, Natick, USA), incorporates several of these new characteristics. This report describes the first two cases, both successfully performed in the country, carried out under local anesthesia and conscious sedation

Unstable angina patients treated with percutaneous coronary intervention in the new millennium: what characterizes them?

OBJECTIVE: To identify clinical and angiographic profiles of patients with unstable angina seen at a tertiary hospital and treated with percutaneous coronary intervention (PCI). METHODS: Study of a consecutive series of 1413 patients, selected from a computerized database, who underwent percutaneous revascularization in the three-year period of 2002-2004. There were no inclusion/exclusion criteria. RESULTS: Systemic arterial hypertension (74%) and hypercholesterolemia (65%) were the classical risk factors for coronary disease most frequently observed. Coronary artery bypass grafting and history of myocardial infarction were found in 24% and 28% of the cases, respectively. The subgroups most commonly treated were the IIB (48%) and IIIB (28%). Clopidogrel was prescribed for 51% of the patients and glycoprotein IIb/IIIa inhibitors, for 7%. Multivessel disease evidenced by coronary angiography was detected in 42% of the cases. Type B2 or C lesions were treated in 64%, 94% of which in native vessels. Restenotic lesions were dilated in 5% of the patients. All interventions were performed using coronary stents, the majority of which (67%) were standard bare-metal stents. CONCLUSIONS: 1) Subgroups IIB and IIIB were the most frequently treated (76%); 2) Clopidogrel was the most prescribed antithrombotic agent (51%); 3) Multivessel coronary artery disease was found in 42% of the cases, most of which were complex target lesions located in native vessels; 4) Coronary stent implantation was the chief dilation technique used.

Evolução clínica tardia dos stents farmacológicos: segurança e eficácia até cinco anos do registro DESIRE / Long-term clinical outcomes of drug eluting stents: safety and efficacy up to five years of the DESIRE registry

Fundamentos: A expansão das indicações para o uso dos stents farmacológicos liberadores de sirolimus e de paclitaxel lesões de complexidade crescente e populações com perfil clínico muito diferente daquele dos estudos randomizados fundamentais. O registro DESIRE foi idealizado para monitorar a efetividade e a segurança institucional dos stents farmacológicos disponíveis pra uso clínico desde 2002, em nosso meio. Método e Resultados: Entre maio/2002 e março/2007, foram incluídos 2.043 pacientes (P) tratados com maior ou menor Cypher ou Taxus, no Hospital do Coração da Associação do Sanatório Sírio, em São Paulo - SP. A média das idades foi de 63,8 mais ou menos 11,3 anos, 76,6 por cento eram do sexo masculino e 28,49 por cento eram diabéticos. Um total de 2.415 lesõs foram tratadas, sendo implantados 2.983 stents: 2.608 Cypher e 375 Taxus. as tromboses agudas/subagudas (menor ou igual 30 dias),...

Background: Indications for the implantation of sirolimusand paclitaxel-eluting stents are expanding and include complex lesions and subsets of patients with clinical and demographic characteristics very different from those of early pivotal randomized trials. The DESIRE Registry was planned to monitor the safety of both Cypher® and Taxus® stent available in Brazil since 2002. Methods and Results: From May 2002 through March 2007, 2043 patients treated with one or more than one stent (either Cypher® or Taxus®) at Hospital do Coração da Associação do Sanatório Sírio were included in this Registry. Mean age was 63.8 (11.3) years; 76.6% were male and 28.4% had diabetes. A total of 2,415 lesions were treated and 2,983 stents were implanted: 2,608 Cypher® and 375 Taxus®. Acute and subacute (≤30 days); late thrombosis (31 days - 360 days) and very late thrombosis (>360 days) occurred in 0.34%, 0.73% and 0.34% of the patients, adding up to a 1.42% overall rate. Likewise, the major adverse cardiac event rate was low and added up to 8.6% (154 patients), including: 45 (2.51%) cardiac deaths; 50 (2.8%) myocardial infarctions and 59 (3.3%) of additional revascularizations...