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

OBJECTIVES: To compare the radial versus femoral approach using Angio-Seal for the incidence of access site complications among non-ST-segment elevation acute coronary syndrome patients undergoing invasive strategy. BACKGROUND: Arterial access is a major site of complications after invasive coronary procedures. Vascular closure devices provide more comfort to patients decreasing time to hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications. METHODS: Single-center non-inferiority trial where 240 patients were randomized to radial or femoral access using Angio-Seal. The primary objective was the occurrence of complications at the arterial puncture site until 30 days after the procedure. RESULTS: There were no baseline clinical differences between groups, except for a greater prevalence of female patients in the radial group (33.3 vs. 20.0%, P = 0.020). Hemostasis was achieved in the entire radial group with the use of TR Band and in 95% of the procedures in the femoral group with Angio-Seal (P = 0.029). Except for a higher incidence of asymptomatic arterial occlusion in the radial group, there were no differences among the other analyzed outcomes. According to the noninferiority test, the use of Angio-Seal was noninferior to the radial approach, considering the margin of 15% (12.5 vs. 13.3%, difference -0.83%, 95% CI -9.31 - 7.65, P for noninferiority <0.001). CONCLUSIONS: Angio-Seal seems noninferior in the incidence of access site complications at 30 days when compared with the radial approach. © 2016 Wiley Periodicals, Inc.

Temporal Trends in Transcatheter Aortic Valve Implantation: 10-Year Analysis of the TAVIDOR Registry. / Tendência Temporal no Implante Percutâneo de Bioprótese Aórtica: Análise de 10 Anos do Registro TAVIDOR.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has established itself as the preferential strategy to approach severe aortic stenosis. Information on procedural improvements and nationwide results obtained with the technique throughout the past decade are unknown. OBJECTIVES: To assess the temporal variation of the demographic profile, procedural characteristics, and in-hospital outcomes of patients undergoing TAVI procedures at the Rede D'Or São Luiz. METHODS: Observational registry comprising 29 national institutions, comparing the characteristics of the TAVI procedures performed from 2012 to 2017 (Group 1) to those performed from 2018 to 2023 (Group 2). The statistical significance level adopted was p < 0.05. RESULTS: This study assessed 661 patients, 95 in Group 1 and 566 in Group 2, with a mean age of 81.1 years. Group 1 patients had a higher prevalence of New York Heart Association functional class III or IV and STS risk score > 8%. In addition, they more often underwent general anesthesia, transesophageal echocardiographic monitoring, and access through femoral dissection. Group 2 patients had a higher success rate of the TAVI procedure (95.4% versus 89.5%; p = 0.018), lower mortality (3.9% versus 11.6%; p = 0.004), and less often needed permanent pacemaker implantation (8.5% versus 17.9%; p = 0.008). CONCLUSIONS: The 10-year temporal trends analysis of the TAVIDOR Registry shows a reduction in patients' clinical complexity over time. Furthermore, the advance to minimalistic implantation techniques, added to the technological evolution of the devices, may have contributed to the favorable outcomes observed among those whose implantation occurred in the last 5 years studied.

FUNDAMENTO: O implante percutâneo de bioprótese valvar aórtica (TAVI) consolidou-se como opção terapêutica da estenose aórtica de grau importante. Dados sobre as características evolutivas dos procedimentos e dos resultados obtidos com a técnica ao longo da última década, em escala nacional, são desconhecidos. OBJETIVOS: Analisar a tendência temporal referente ao perfil demográfico, características dos procedimentos e desfechos hospitalares de pacientes submetidos a TAVI na Rede D'Or São Luiz. MÉTODOS: Registro observacional envolvendo 29 instituições nacionais. Comparou-se características dos procedimentos realizados de 2012 a 2017 (Grupo 1) e de 2018 a 2023 (Grupo 2). Foram considerados significantes os resultados com valor de p < 0,05. RESULTADOS: Foram analisados 661 casos, 95 pertencentes ao Grupo 1 e 566 ao Grupo 2. A média de idade foi 81,1 anos. Observou-se no Grupo 1 maior prevalência de pacientes em classe funcional III ou IV e escore de risco > 8%. Foi mais frequente o emprego de anestesia geral, monitorização ecocardiográfica transesofágica e via de acesso por dissecção. Maior taxa de sucesso do procedimento (95,4% versus 89,5%; p = 0,018) foi aferida em implantes efetivados a partir de 2018, assim como menor mortalidade (3,9% versus 11,6%; p = 0,004) e necessidade de marcapasso definitivo (8,5% versus 17,9%; p = 0,008). CONCLUSÕES: A análise temporal de 10 anos do Registro TAVIDOR demonstra uma queda na complexidade clínica dos pacientes. Além disso, o avanço para técnicas de implante minimalistas, somadas à evolução tecnológica dos dispositivos, podem ter contribuído para desfechos favoráveis dentre aqueles cujo implante ocorreu no último quinquênio.

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.

TIger II vs JUdkins Catheters for Transradial Coronary Angiography (TIJUCA Study): A Randomized Controlled Trial of Radiation Exposure.

BACKGROUND: In high-expertise transradial (TR) centers, the radiation exposure to patients during coronary angiography (CAG) is equivalent to transfemoral use. However, there is no definitive information during TR-CAG regarding the use of a single, dedicated catheter to impart less radiation exposure to patients. OBJECTIVE: We compare the radiation exposure to patients during right TR-CAG with Tiger II catheter (Terumo Interventional Systems) vs Judkins right (JR) 4.0/Judkins left (JL) 3.5 catheters (Cordis Corporation). METHODS: This multicenter, randomized, and prospective trial included 180 patients submitted to right TR-CAG, with the primary objective of observing radiation exposure to patients through the measurement of fluoroscopy time, air kerma (AK), and dose-area product (DAP) using Tiger II (group 1) vs JR 4.0 and JL 3.5 Judkins catheters (group 2). Secondary outcomes included contrast volume usage and the need to use additional catheters to complete the procedure (the crossover technique). RESULTS: Group 1 demonstrated reduced fluoroscopy time (2.47 ± 1.05 minutes in group 1 vs 2.68 ± 1.26 minutes in group 2; P=.01) and non-significant reduction of AK (540.9 ± 225.3 mGy in group 1 vs 577.9 ± 240.1 mGy in group 2; P=.34) and DAP (3786.7 ± 1731.7 µGy•m² in group 1 vs 4058.0 ± 1735.4 µGy•m² in group 2; P=.12). Contrast volume usage (53.46 ± 10.09 mL in group 1 vs 55.98 ± 10.43 mL in group 2; P=.13) and the need for additional catheters (5.56% in group 1 vs 4.44% in group 2; P>.99) were similar between groups. CONCLUSION: The Tiger II catheter was able to reduce radiation exposure to patients submitted to TR-CAG through a significant reduction in fluoroscopy time.

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.

Performance of coronary procedures through the transulnar access without assessment of the integrity of the deep palmar arch.

Occurrence of ischemic complications after transulnar coronary procedures is virtually absent. The presence of a complete deep palmar arch in approximately 95% of the population as well as the great capacity of the collateral circulation of the hand might justify these findings. We report the occurrence of complications in 62 patients submitted to coronary procedures through the transulnar approach, without assessment of the integrity of the deep palmar arch by the inverse Allen's test. The rate of asymptomatic occlusion of the ulnar artery was 3%, without any ischemic complication. We believe the performance of Allen's test is not necessary when using transulnar access.

Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients.

BACKGROUND: Arterial access is a major site of bleeding complications after invasive coronary procedures. Among strategies to decrease vascular complications, the radial approach is an established one. Vascular closure devices provide more comfort to patients and decrease hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications, requiring evidence through adequately designed randomized trials. The aim of this study is to compare the radial versus femoral approach using a vascular closure device for the incidence of arterial puncture site vascular complications among non-ST-segment elevation acute coronary syndrome patients submitted to an early invasive strategy. METHODS: ARISE is a national, multicenter, non-inferiority randomized clinical trial. Two hundred patients with non-ST-segment elevation acute coronary syndrome will be randomized to either radial or femoral access using a vascular closure device. The primary outcome is the occurrence of vascular complications at an arterial puncture site 30 days after the procedure, including major bleeding, retroperitoneal hematoma, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arterio-venous fistula, infection, limb ischemia, arterial occlusion, adjacent nerve injury or the need for vascular surgical repair. RESULTS: Enrollment was initiated in September 2012, and until October 2013 91 patients were included. The inclusion phase is expected to last until the second half of 2014. CONCLUSIONS: The ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01653587.

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

Radial approach in percutaneous coronary interventions: current status in Brazil.

BACKGROUND: Although the radial approach offers an unquestionable result in terms of reduction of vascular complications and occurrence of severe bleeding in comparison to the femoral approach, so far it has only been used in few centers which elected it as the preferential access. OBJECTIVE: To evaluate the current status of percutaneous coronary interventions in Brazil, as regards the use of the radial approach. METHODS: Analysis of data spontaneously recorded in Central Nacional de Intervenções Cardiovasculares - CENIC (National Center for Cardiovascular Interventions) from 2005 to 2008, in a total of 83,376 procedures. RESULTS: The radial approach was used in 12.6% of the procedures performed, and the femoral approach, in 84.3%. The remaining 3.1% corresponded to brachial artery dissection or puncture. With a success rate of 97.5%, the choice of the radial approach was associated with a significant reduction of vascular complications in comparison to the femoral approach (2.5% versus 3.6 %, p < 0.0001). CONCLUSION: The radial approach remains uncommonly used in Brazil, and this is possibly explained by the lack of training programs, uncertainties regarding the learning curve, and the lack of large-scale studies corroborating the benefits demonstrated to date.

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

Implante percutâneo de prótese valvar aórtica ­ experiência com o dispositivo reposicionável LotusTM / Percutaneous aortic valve implantation ­ an experience with the LotusTM repositionable device

Introdução: A válvula aórtica transcateter de segunda geração LotusTM foi desenhada para proporcionar ao intervencionista o controle completo de sua liberação durante o procedimento. O presente estudo apresenta a experiência inicial e os desfechos hospitalares de pacientes tratados com essa prótese no Brasil. Métodos: Registro observacional, retrospectivo, que incluiu pacientes com estenose aórtica grave sintomáticos, considerados de alto risco cirúrgico, tratados em sete centros.Resultados: Receberam o dispositivo 31 pacientes, sendo 61,3% do sexo feminino, com idade de 82,9 ± 6,9 anos e escore STS de 6,5 ± 4,1%. A área valvar aórtica foi de 0,73 ± 0,18 cm2 e o gradiente médio de 51,7 ± 13,9 mmHg. Todos os procedimentos foram realizados pela via transfemoral, e a pré-dilatação foi necessária em 65% dos casos. A taxa de sucesso do procedimento foi de 96,7%. Não houve complicação vascular com necessidade de intervenção cirúrgica e nem casos de acidente vascular cerebral. O gradiente médio após o procedimento foi de 10,5 ± 5,8 mmHg e não foram observadas regurgitações aórticas de graus moderado/importante. A taxa de implante de marca-passo definitivo foi de 38,7%, e a permanência hospitalar de 8,5 ± 4,8 dias. Conclusões: Na experiência inicial com o implante da válvula aórtica LotusTM, os resultados hospitalares demostraram a segurança e a eficácia do dispositivo, além de ausência de regurgitação aórtica relevante

Background: The second-generation LotusTM transcatheter aortic valve was designed to provide the interventional cardiologist with complete control of its release during the procedure. This study presents the initial experience and in-hospital outcomes of patients treated with this prosthesis in Brazil. Methods: This observational and retrospective study included patients with symptomatic severe aortic stenosis considered at high surgical risk, treated in seven centers. Results: The device was used in 31 patients, 61.3% female, aged 82.9 ± 6.9 years, and with STS score of 6.5 ± 4.1%. The aortic valve area was 0.73 ± 0.18 cm2 and the mean gradient was 51.7 ± 13.9 mmHg. All procedures were performed by the transfemoral access route, and pre-dilation was necessary in 65% of cases. The success rate of the procedure was 96.7%. There were no vascular complications requiring surgical intervention nor cases of stroke. The mean gradient after the procedure was 10.5 ± 5.8 mmHg; no cases of moderate to severe aortic regurgitation were observed. The rate of permanent pacemaker implantation was 38.7%, and mean in-hospital length of stay was 8.5 ± 4.8 days. Conclusions: In the initial experience with the use of the LotusTM aortic valve, in-hospital results demonstrated the safety and efficacy of the device; no cases of significant aortic regurgitation were observed

Comparação entre as vias de acesso femoral e radial em procedimentos coronários invasivos após cirurgia de revascularização miocárdica / Comparison between femoral and radial approach in invasive coronary

Procedimentos coronários invasivos são comuns em pacientes com revascularizaçãomiocárdica cirúrgica prévia. Dados acerca do real papel e das possíveis limitações do acesso radial nesse subgrupo de pacientes são infrequentes. O objetivo deste estudo foi avaliar a factibilidade e a segurança do acesso radial em pacientes revascularizados cirurgicamente e que foram submetidos a procedimentos coronários invasivos diagnósticos ou terapêuticos subsequentes, comparando-o ao acesso femoral. Métodos: Entre maio de 2008 e novembro de 2014, foram analisados 959 procedimentos, sendo 539 realizados pelo acesso radial e 420 pelo femoral. Todos os operadores estavam familiarizados com ambos os acessos vasculares, cabendo a eles a decisão final sobre a via a ser utilizada. Resultados: A prevalência de insucesso foi de 6,1% vs. 0,5% (p < 0,0001), favorecendo a técnica femoral. As taxas de eventos cardíacos adversos graves (0,4% vs. 0,7%) e de complicações vasculares (1,5% vs. 1,9%)foram baixas, sem diferença entre os grupos. A opção pela técnica radial implicou em maior tempo de fluoroscopia e necessidade de cruzamento entre vias de acesso, principalmente em procedimentos diagnósticos. Conclusões: O acesso radial representou uma opção segura e eficaz para a realização de procedimentos coronários invasivos em pacientes cirurgicamente revascularizados, notadamente para os procedimentos terapêuticos...

Invasive coronary procedures are common in patients with previous coronary artery by-pass graft surgery. Data on the actual role and possible limitations of the radial approach in this subgroup of patients are sparse. The objective of this study was to evaluate the feasibility and safety of radial accessin patients surgically revascularized and who under went subsequent invasive diagnostic or therapeutic coronary procedures, comparing it to the femoral access. Methods: Between May 2008 and November 2014, 959 procedures were included; 539 performed by radial access and 420 by femoral access. All operators were familiar with both vascular accesses, and the final decision on the route to be used was left to the operators discretion. Results: The failure rate was 6.1% vs. 0.5% (p < 0.0001), favoring the femoral approach. Major adverse cardiac events (0.4% vs. 0.7%) and vascular complications (1.5% vs. 1.9%) rates were low, with no difference between groups. The choice of the radial approach resulted in greater fluoroscopy time and crossover rate between access routes, especially in diagnostic procedures. Conclusions: The radial approach was a safe and effective option for invasive coronary procedures in post coronary artery bypass graft patients, especially for therapeutic procedures...

Perfil clínico e angiográfico de pacientes jovens submetidos à intervençãocoronária percutânea primária / Clinical and angiographic profile of young patients undergoing primarypercutaneous coronary intervention

Introdução: O atual declínio observado na taxa de mortalidade entre pacientes com infarto do miocárdio com supradesnivelamento do segmento ST pode ser atribuído não apenas a maior utilização de estratégias de reperfusão, mas também a uma mudança no perfil demográfico dessa população, notadamente à redução em sua média de idade. Métodos: Foram analisados retrospectivamente todos os pacientes submetidos à intervenção coronáriapercutânea primária no período de abril de 2010 a dezembro de 2014. O objetivo primário foi a caracterização dos fatores de risco mais prevalentes, a natureza angiográfica das lesões, os aspectos técnicos do procedimento e a evolução clínica hospitalar de pacientes jovens, com idade ≤ 45 anos,comparando-os àqueles com idade > 45 anos. Resultados: Dentre 489 pacientes com diagnóstico de infarto agudo do miocárdio, 54 tinham idade ≤ 45 anos e 435, idade > 45 anos. Pacientes jovens exibiram maior prevalência de tabagismo e obesidade, enquanto pacientes > 45 anos eram mais propensos a apresentar hipertensão arterial sistêmica, diabetes melito, dislipidemia e infarto do miocárdio antigo. Intervenção coronária percutânea primária em jovens associou-se ao uso de menor quantidade de cateteres-guia, menor tempo de fluoroscopia e maior porcentual de implante direto de stent. Pacientes jovens exibiram boa evolução hospitalar, com reduzida taxa de eventos cardíacos adversos (3,7% vs. 9,2%; p = 0,30).Conclusões: Pacientes com idade ≤ 45 anos representaram aproximadamente 10% dos casos de infarto do miocárdio com supradesnivelamento do segmento ST e exibiram elevada prevalência de fatores de risco modificáveis.

Background: The current decline observed in mortality rate among patients with ST-segment elevationacute myocardial infarction can be attributed not only to the increased use of reperfusion strategies, but also to a change in the demographic profile of this population, notably the reduction in mean age. Methods: We retrospectively reviewed all patients undergoing primary percutaneous coronary interventionin the period from April 2010 to December 2014. The primary objective was the characterization of the most prevalent risk factors, the angiographic nature of the lesions, the technical aspects of the procedure, and in-hospital clinical outcomes in patients aged ≤ 45 years, comparing them to those aged > 45 years. Results: Among 489 patients with acute myocardial infarction, 54 were ≤ 45 years, and 435 were > 45years. Young patients exhibited a higher prevalence of smoking and obesity, while patients > 45 years were more likely to have hypertension, diabetes mellitus, dyslipidemia, and previous myocardial infarction. Primary percutaneous coronary intervention in young patients was associated with the use of fewer guide catheters, shorter fluoroscopy time, and higher percentage of direct stent implantation. Young patientsexhibited good in-hospital outcomes, with lower rate of adverse cardiac events (3.7% vs. 9.2%; p = 0.30).Conclusions: Patients aged ≤ 45 years accounted for approximately 10% of cases of ST-segment elevation acute myocardial infarction and exhibited high prevalence of modifiable risk factors.

Desfechos hospitalares e tardios de pacientes submetidos à valvoplastia mitral percutânea em centro com volume intermediário de procedimentos estruturais / In-hospital and late outcomes of patients undergoing percutaneous mitral valvuloplasty in a center with intermediate volume of structural procedures

A valvoplastia mitral percutânea é o tratamento de escolha da estenose mitral reumática comanatomia favorável, por sua capacidade de prevenir complicações inerentes ao tratamento cirúrgico e com manutenção da eficácia. Faz-se necessário promover comparações entre os resultados obtidos com o procedimento por centros de referência e alta drenagem de pacientes e por instituições de menor volume e casuística, sendo este o objetivo principal deste estudo. Métodos: Foram analisados 31 pacientes consecutivos submetidos à valvoplastia mitral percutânea no período de setembro de 2006 a janeiro de 2015. Avaliaram-se o sucesso imediato do procedimento e a sobrevida livre de eventos tardios, definidos como morte cardiovascular ou necessidade de novaintervenção valvar mitral. Resultados: A média de idade foi de 40,9 ± 14,2 anos, com predomínio do sexo feminino (96,8%). O escore médio de Wilkins e Block foi de 8,1 ± 1,2. A totalidade dos procedimentos foi efetivada pela técnica de Inoue, com taxa de sucesso imediato de 90,3%. Em acompanhamento médio de 6,8 ± 2,5 anos, foram constatadossete eventos (22,6%), sendo dois óbitos de etiologia cardiovascular, quatro cirurgias de troca valvar mitral e uma comissurotomia mitral. Conclusões: Em um hospital com volume intermediário de procedimentos, os resultados da valvoplastia mitral percutânea no tratamento da estenose mitral reumática com anatomia favorável foram comparáveis àqueles alcançados por centros de alto referenciamento...

Background: Percutaneous mitral valvuloplasty is the treatment of choice for rheumatic mitral stenosis with favorable anatomy, for its ability to prevent complications inherent to a surgical procedure, while maintaining effectiveness. It is necessary to promote comparisons between the results obtained by the procedure performed at referral centers with high patient inflow and at institutions with lower volume and fewer patients, which represents the main objective of this study. Methods: Thirty-one consecutive patients undergoing percutaneous mitral valvuloplasty were analyzed from September 2006 to January 2015. Immediate procedural success and late event-free survival rates were evaluated, defined as cardiovascular death or need for a new mitral valve intervention. Results: The mean age was 40.9 ± 14.2 years, with a predominance of females (96.8%). The mean Wilkinsand Block score was 8.1 ± 1.2. All procedures were performed using the Inoue technique, with na immediate success rate of 90.3%. At mean follow-up of 6.8 ± 2.5 years, seven events (22.6%) were observed: two cardiovascular deaths, four surgeries for mitral valve replacement, and one mitral commissurotomy Conclusions: In a hospital with intermediate procedure volume, the results of percutaneous mitral valvuloplasty in the treatment of rheumatic mitral stenosis with favorable anatomy were comparable to those achieved by high-volume centers...

Fatores de risco para complicações relacionadas ao acesso vascular em pacientes submetidos à estratégia invasiva precoce / Risk factors for vascular access-related complications in patients undergoing early invasive strategy

Introdução: O conhecimento dos fatores de risco relacionados às complicações do acesso vascular em pacientes submetidos à estratégia invasiva precoce permite adotar estratégias capazes de minimizá-las. Métodos: Realizamos subanálise do estudo ARISE, com o objetivo de identificar preditores de complicações vasculares em pacientes randomizados para as técnicas radial ou femoral com emprego de dispositivo de oclusão vascular (DOV). Resultados: Foram incluídos 240 pacientes, com média de idade de 63,0 ± 10,7 anos, sendo 30,8% diabéticos e, exceto pela maior prevalência de mulheres no grupo radial, não foram observadas diferenças clínicas entre os grupos. Intervenção coronária percutânea foi realizada em 86,7% dos casos. A taxa de complicações vasculares aos 30 dias foi de 13,3% no grupo radial, à custa de hematomas > 5 cm (6,7%) e oclusão arterial assintomática (5,8%), e de 12,5% no grupo femoral, à custa de hematomas > 5 cm, sem diferença significativa. Foram identificados como fatores de risco para complicações do acesso vascular o índice de massa corporal (IMC), o acidente vascular encefálico prévio, a maior duração do procedimento e o insucesso do DOV. Pela análise estratificada, o sexo feminino e o escore CRUSADE de alto ou muito alto risco foram variáveis preditoras de complicações apenas para o grupo femoral. No modelo multivariado, os fatores que permaneceram significantes foram o IMC e o insucesso do DOV. Conclusões: As técnicas radial e femoral, com o emprego de DOV, compartilharam variáveis preditoras de complicações. Fatores de risco, como sexo feminino e escore CRUSADE de alto risco, foram atenuados pela utilização da técnica radial

Background: The knowledge of risk factors related to vascular access complications in patients undergoing early invasive strategy allows the adoption of methods to minimize them. Methods: We performed a subanalysis of the ARISE study, aiming to identify predictors of vascular complications in patients randomized to the radial or femoral techniques with the use of vascular closure device (VCD). Results: A total of 240 patients with a mean age of 63.0 ± 10.7 years were included, with 30.8% of diabetics. Except for a higher prevalence of women in the radial group, there were no clinical differences between the groups. Percutaneous coronary intervention was performed in 86.7% of the cases. The rate of vascular complications after 30 days was 13.3% in the radial group, due to hematoma > 5 cm (6.7%) and asymptomatic artery occlusion (5.8%), and 12.5% in femoral group, due to hematoma > 5 cm, without significant difference. The following were identified as risk factors for vascular access complications: body mass index (BMI), previous stroke, longer duration of the procedure, and VCD failure. At the stratified analysis, female gender and high or very high-risk CRUSADE score were predictors of complications only for the femoral group. In the multivariate model, the factors that remained significant were BMI and VCD failure. Conclusions: The radial and femoral techniques, with the use of VCD, shared variables that were predictors of complications. Risk factors, such as female gender and high-risk CRUSADE score, were attenuated by the use of the radial technique

Segurança e Factibilidade do Acesso Ulnar Após Falha do Acesso Radial Ipsilateral / Safety and Feasibility of Ulnar Access After Failure of Ipsilateral Radial Access

Introdução: Publicações pioneiras desencorajam o uso do acesso ulnar após falha na tentativa de obtenção do acesso radial ipsilateral. Métodos: Registro prospectivo de eficácia e segurança comparando a ocorrência de sangramento e complicações vasculares entre casos com intenção inicial de utilizar o acesso ulnar e aqueles cujo emprego desse acesso se deu após falha na canulação da artéria radial ipsilateral. Resultados: Entre maio de 2007 e dezembro de 2013, foram realizados 11.825 procedimentos coronários invasivos em um único centro, 473 (4%) deles pelo acesso ulnar. Em 65 casos, a canulação da artéria ulnar foi precedida por falha na obtenção do acesso radial ipsilateral. A taxa de sucesso da técnica foi superior a 98%, sendo baixo o número de complicações, em sua maioria decorrentes de hematomas superficiais, sem diferença entre os grupos. Não houve casos de sangramento grave relacionado a via de acesso, pseudoaneurisma, fístula arteriovenosa ou lesão do nervo ulnar adjacente. Conclusões: O acesso ulnar representa uma alternativa segura e eficaz para a realização de procedimentos coronários invasivos selecionados, a despeito de tentativa prévia de obtenção do acesso radial ipsilateral.

Background: Pioneering publications discourage the use of ulnar access after failed attempt to obtain ipsilateral radial access. Methods: Prospective efficacy and safety registry comparing the incidence of bleeding and vascular complications in patients with an initial intention to use ulnar access and those who used this access after a failed attempt to cannulate the ipsilateral radial artery. Results: Between May 2007 and December 2013, 11,825 invasive coronary procedures were performed at a single center, 473 (4%) of them by ulnar access. In 65 cases, the ulnar artery cannulation was preceded by a failed attempt to obtain the ipsilateral radial access. The technical success rate was higher than 98%, with low complication rates, mostly due to superficial hematomas, and no differences between groups. There were no cases of major bleeding related to the access site, pseudoaneurysm, arteriovenous fistula or injury to the adjacent ulnar nerve. Conclusions: The ulnar access is a safe and effective alternative to perform selected invasive coronary procedures, despite previous attempts to obtain the ipsilateral radial access.