RESUMEN
BACKGROUND: Robust data on the learning curve (LC) of transcatheter aortic valve replacement (TAVR) are lacking in developing countries. OBJECTIVE: To assess TAVR's LC in Brazil over time. METHODS: We analyzed data from the Brazilian TAVR registry from 2008 to 2023. Patients from each center were numbered chronologically in case sequence numbers (CSNs). LC was performed using restricted cubic splines adjusted for EuroSCORE-II and the use of new-generation prostheses. Also, in-hospital outcomes were compared between groups defined according to the level of experience based on the CSN: 1st to 40th (initial-experience), 41st to 80th (early-experience), 81st to 120th (intermediate-experience), and over 121st (high-experience). Additional analysis was performed grouping hospitals according to the number of cases treated before 2014 (>40 and ≤40 procedures). The level of significance adopted was <0.05. RESULTS: A total of 3,194 patients from 25 centers were included. Mean age and EuroSCORE II were 80.7±8.1 years and 7±7.1, respectively. LC analysis demonstrated a drop in adjusted in-hospital mortality after treating 40 patients. A leveling off of the curve was observed after case #118. In-hospital mortality across the groups was 8.6%, 7.7%, 5.9%, and 3.7% for initial-, early-, intermediate-, and high-experience, respectively (p<0.001). High experience independently predicted lower mortality (OR 0.57, p=0.013 vs. initial experience). Low-volume centers before 2014 showed no significant decrease in the likelihood of death with gained experience, whereas high-volume centers had a continuous improvement after case #10. CONCLUSION: A TAVR LC phenomenon was observed for in-hospital mortality in Brazil. This effect was more pronounced in centers that treated their first 40 cases before 2014 than those that reached this milestone after 2014.
Asunto(s)
Mortalidad Hospitalaria , Curva de Aprendizaje , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Reemplazo de la Válvula Aórtica Transcatéter/estadística & datos numéricos , Brasil/epidemiología , Femenino , Masculino , Anciano de 80 o más Años , Anciano , Factores de Tiempo , Factores de Riesgo , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/mortalidad , Resultado del Tratamiento , Medición de RiesgoRESUMEN
Resumo Fundamento Dados robustos sobre a curva de aprendizagem (LC) da substituição da válvula aórtica transcateter (TAVR) são escassos nos países em desenvolvimento. Objetivo Avaliar a LC da TAVR no Brasil ao longo do tempo. Métodos Analisamos dados do registro brasileiro de TAVR de 2008 a 2023. Pacientes de cada centro foram numerados cronologicamente em número sequencial de caso (NSC). A LC foi realizada usando um spline cúbico restrito ajustado para o EuroSCORE-II e o uso de próteses de nova geração. Ainda, os desfechos hospitalares foram comparados entre grupos definidos de acordo com o nível de experiência, com base no NSC: 1º ao 40º caso (experiência inicial), 41º ao 80º caso (experiência básica), 81º ao 120º caso (experiência intermediária) e 121º caso em diante (experiência alta). Análises adicionais foram conduzidas de acordo com o número de casos tratados antes de 2014 (>40 e ≤40 procedimentos). O nível de significância adotado foi p <0,05. Resultados Foram incluídos 3194 pacientes de 25 centros. A idade média foi 80,7±8,1 anos e o EuroSCORE II médio foi 7±7,1. A análise da LC demonstrou uma queda na mortalidade hospitalar ajustada após o tratamento de 40 pacientes. Um patamar de nivelamento na curva foi observado após o caso 118. A mortalidade hospitalar entre os grupos foi 8,6%, 7,7%, 5,9%, e 3,7% para experiência inicial, básica, intermediária e alta, respectivamente (p<0,001). A experiência alta foi preditora independente de mortalidade mais baixa (OR 0,57, p=0,013 vs. experiência inicial). Centros com baixo volume de casos antes de 2014 não mostraram uma redução significativa na probabilidade de morte com o ganho de experiência, enquanto centros com alto volume de casos antes de 2014 apresentaram uma melhora contínua após o caso de número 10. Conclusão Observou-se um fenômeno de LC para a mortalidade hospitalar do TAVR no Brasil. Esse efeito foi mais pronunciado em centros que trataram seus 40 primeiros casos antes de 2014 que naqueles que o fizeram após 2014.
Abstract Background Robust data on the learning curve (LC) of transcatheter aortic valve replacement (TAVR) are lacking in developing countries. Objective To assess TAVR's LC in Brazil over time. Methods We analyzed data from the Brazilian TAVR registry from 2008 to 2023. Patients from each center were numbered chronologically in case sequence numbers (CSNs). LC was performed using restricted cubic splines adjusted for EuroSCORE-II and the use of new-generation prostheses. Also, in-hospital outcomes were compared between groups defined according to the level of experience based on the CSN: 1st to 40th (initial-experience), 41st to 80th (early-experience), 81st to 120th (intermediate-experience), and over 121st (high-experience). Additional analysis was performed grouping hospitals according to the number of cases treated before 2014 (>40 and ≤40 procedures). The level of significance adopted was <0.05. Results A total of 3,194 patients from 25 centers were included. Mean age and EuroSCORE II were 80.7±8.1 years and 7±7.1, respectively. LC analysis demonstrated a drop in adjusted in-hospital mortality after treating 40 patients. A leveling off of the curve was observed after case #118. In-hospital mortality across the groups was 8.6%, 7.7%, 5.9%, and 3.7% for initial-, early-, intermediate-, and high-experience, respectively (p<0.001). High experience independently predicted lower mortality (OR 0.57, p=0.013 vs. initial experience). Low-volume centers before 2014 showed no significant decrease in the likelihood of death with gained experience, whereas high-volume centers had a continuous improvement after case #10. Conclusion A TAVR LC phenomenon was observed for in-hospital mortality in Brazil. This effect was more pronounced in centers that treated their first 40 cases before 2014 than those that reached this milestone after 2014.
RESUMEN
Coronary artery lesions related to pacemaker implantation are rare complications. With the increasing adoption of the technique of permanent transseptal pacing of the left bundle branch area pacing (LBBAP), an increase in the incidence of these complications may be expected. We report two cases of coronary lesions after permanent transeptal pacing of the LBBAP: the first with a small coronary artery fistula, and the second with an extrinsic coronary compression. Both complications occurred with stylet-driven pacing leads with extendable helix. In the first case, since the shunt volume was small and no major complications were reported, the patient was treated conservatively with good outcome. The second case required lead repositioning due to acute decompensated heart failure.
Asunto(s)
Insuficiencia Cardíaca , Tabique Interventricular , Humanos , Estimulación Cardíaca Artificial/efectos adversos , Estimulación Cardíaca Artificial/métodos , Vasos Coronarios , Electrocardiografía/métodos , Sistema de Conducción Cardíaco , Insuficiencia Cardíaca/etiología , Insuficiencia Cardíaca/prevención & control , Fascículo Atrioventricular , Resultado del TratamientoRESUMEN
BACKGROUND: Influenza vaccination prevents major cardiovascular events in individuals presenting a recent acute coronary syndrome (ACS), however the early effect of an in-hospital double-dose vaccination strategy remains uncertain. METHODS: The VIP-ACS was a randomized, pragmatic, multicenter, open-label trial with a blinded-adjudication endpoint. Patients with ACS ≤ 7 days of hospitalization were randomized to an in-hospital double-dose quadrivalent inactivated influenza vaccine (double-dose) or a standard-dose influenza vaccine at 30 days post-randomization. The primary endpoint was a hierarchical composite of death, myocardial infarction, stroke, hospitalization for unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory infections, analyzed with the win ratio (WR) method in short-term follow-up (45-days after randomization). RESULTS: The trial enrolled 1,801 patients (≥18 years old). Median participant age was 57 years, 70 % were male. There were no significant differences between groups on the primary hierarchical endpoint: there were 5.7 % wins in the double-dose in-hospital group and 5.5 % wins in the standard-dose delayed vaccination group (WR: 1.03; 95 % CI: 0.70---1.53; P = 0.85). In a sensitivity analysis including COVID-19 infection in the hospitalizations for respiratory infections endpoint, overall results were maintained (WR: 1.03; 95 % CI 0.71---1.51; P = 0.87). Results were consistent for major cardiovascular events only (WR: 0.82; 95 % CI: 0.48---1.39; P = 0.46). No serious adverse events were observed. CONCLUSION: In patients with recent ACS, in-hospital double-dose influenza vaccination did not significantly reduce cardiorespiratory events at 45 days compared with standard-dose vaccination at 30 days post-randomization.
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Síndrome Coronario Agudo , Vacunas contra la Influenza , Gripe Humana , Adolescente , Femenino , Humanos , Masculino , Persona de Mediana Edad , Síndrome Coronario Agudo/terapia , Hospitales , Vacunas contra la Influenza/uso terapéutico , Gripe Humana/prevención & control , Factores de Riesgo , Resultado del Tratamiento , Vacunación , Adulto , Ensayos Clínicos Controlados Aleatorios como Asunto , Ensayos Clínicos Pragmáticos como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: There are limited real-world data on the clinical course of untreated coronary lesions according to their functional severity. OBJECTIVE: To evaluate the 5-year clinical outcomes of patients with revascularized lesions with fractional flow reserve (FFR) ≤ 0.8 and patients with non-revascularized lesions with FFR > 0.8. METHODS: The FFR assessment was performed in 218 patients followed for up to 5 years. Participants were classified based on FFR into ischemia group (≤ 0.8, intervention group, n = 55), low-normal FFR group (> 0.8-0.9, n = 91), and high-normal FFR group (> 0.9, n = 72). The primary endpoint was major adverse cardiac events (MACEs), a composite of death, myocardial infarction, and need for repeat revascularization. The significance level was set at 0.05; therefore, results with a p-value < 0.05 were considered statistically significant. RESULTS: Most patients were male (62.8%) with a mean age of 64.1 years. Diabetes was present in 27%. On coronary angiography, the severity of stenosis was 62% in the ischemia group, 56.4% in the low-normal FFR group, and 54.3% in the high-normal FFR group (p<0.05). Mean follow-up was 3.5 years. The incidence of MACEs was 25.5%, 13.2%, and 11.1%, respectively (p=0.037). MACE incidence did not differ significantly between the low-normal and high-normal FFR groups. CONCLUSION: Patients with FFR indicative of ischemia had poorer outcomes than those in non-ischemia groups. There was no difference in the incidence of events between the low-normal and high-normal FFR groups. Long-term studies with a large sample size are needed to better assess cardiovascular outcomes in patients with moderate coronary stenosis with FFR values between 0.8 and 1.0.
FUNDAMENTO: Existem dados limitados sobre a evolução clínica de lesões coronarianas não tratadas de acordo com sua gravidade funcional no mundo real. OBJETIVO: Este estudo teve como objetivo avaliar os resultados clínicos de até 5 anos em pacientes com lesões revascularizadas com reserva de fluxo fracionada (FFR) ≤ 0,8 e em pacientes com lesões não revascularizadas com FFR > 0,8. MÉTODOS: A avaliação pelo FFR foi realizada em 218 pacientes seguidos por até 5 anos. Os participantes foram classificados com base na FFR no grupo isquêmico (≤ 0,8, grupo intervenção, n = 55), no grupo FFR normal-baixa (> 0,8-0,9, n = 91) e no grupo FFR normal-alta (> 0,9, n = 72). O desfecho primário foram eventos cardíacos adversos maiores (ECAMs), um composto de morte, infarto do miocárdio e necessidade de nova revascularização. O nível de significância adotado neste estudo foi alfa = 0,05; deste modo, resultados com valores de p < 0,05 foram considerados estatisticamente significativos. RESULTADOS: A maioria dos participantes era do sexo masculino (62,8%) com média de idade de 64,1 anos. Diabetes estava presente em 27%. À angiografia coronariana, a gravidade da estenose avaliada foi de 62%, 56,4% e 54,3% nos grupos isquêmico, FFR normal-baixa e FFR normal-alta, respectivamente (p < 0,05). O período médio de acompanhamento foi de 3,5 anos. A incidência ECAM foi de 25,5%, 13,2% e 11,1%, respectivamente (p = 0,037). Não houve diferença na incidência de ECAM entre os grupos FFR normal-baixa e FFR normal-alta (p = NS). CONCLUSÃO: Pacientes com FFR indicativa de isquemia apresentaram piores desfechos quando comparados aos dos grupos não isquêmicos. Entre os grupos que apresentaram valores de FFR considerados normal-baixo e normal-alto, não houve diferença na incidência de eventos. Há necessidade de estudos de longo prazo e com grande número de pacientes para melhor avaliar os desfechos cardiovasculares em pacientes portadores de estenose coronariana moderada com valores de FFR entre 0,8 e 1,0.
Asunto(s)
Enfermedad de la Arteria Coronaria , Reserva del Flujo Fraccional Miocárdico , Infarto del Miocardio , Humanos , Masculino , Persona de Mediana Edad , Femenino , Enfermedad de la Arteria Coronaria/diagnóstico , Pronóstico , CorazónRESUMEN
Resumo Fundamento Existem dados limitados sobre a evolução clínica de lesões coronarianas não tratadas de acordo com sua gravidade funcional no mundo real. Objetivo Este estudo teve como objetivo avaliar os resultados clínicos de até 5 anos em pacientes com lesões revascularizadas com reserva de fluxo fracionada (FFR) ≤ 0,8 e em pacientes com lesões não revascularizadas com FFR > 0,8. Métodos A avaliação pelo FFR foi realizada em 218 pacientes seguidos por até 5 anos. Os participantes foram classificados com base na FFR no grupo isquêmico (≤ 0,8, grupo intervenção, n = 55), no grupo FFR normal-baixa (> 0,8-0,9, n = 91) e no grupo FFR normal-alta (> 0,9, n = 72). O desfecho primário foram eventos cardíacos adversos maiores (ECAMs), um composto de morte, infarto do miocárdio e necessidade de nova revascularização. O nível de significância adotado neste estudo foi alfa = 0,05; deste modo, resultados com valores de p < 0,05 foram considerados estatisticamente significativos. Resultados A maioria dos participantes era do sexo masculino (62,8%) com média de idade de 64,1 anos. Diabetes estava presente em 27%. À angiografia coronariana, a gravidade da estenose avaliada foi de 62%, 56,4% e 54,3% nos grupos isquêmico, FFR normal-baixa e FFR normal-alta, respectivamente (p < 0,05). O período médio de acompanhamento foi de 3,5 anos. A incidência ECAM foi de 25,5%, 13,2% e 11,1%, respectivamente (p = 0,037). Não houve diferença na incidência de ECAM entre os grupos FFR normal-baixa e FFR normal-alta (p = NS). Conclusão Pacientes com FFR indicativa de isquemia apresentaram piores desfechos quando comparados aos dos grupos não isquêmicos. Entre os grupos que apresentaram valores de FFR considerados normal-baixo e normal-alto, não houve diferença na incidência de eventos. Há necessidade de estudos de longo prazo e com grande número de pacientes para melhor avaliar os desfechos cardiovasculares em pacientes portadores de estenose coronariana moderada com valores de FFR entre 0,8 e 1,0.
Abstract Background There are limited real-world data on the clinical course of untreated coronary lesions according to their functional severity. Objective To evaluate the 5-year clinical outcomes of patients with revascularized lesions with fractional flow reserve (FFR) ≤ 0.8 and patients with non-revascularized lesions with FFR > 0.8. Methods The FFR assessment was performed in 218 patients followed for up to 5 years. Participants were classified based on FFR into ischemia group (≤ 0.8, intervention group, n = 55), low-normal FFR group (> 0.8-0.9, n = 91), and high-normal FFR group (> 0.9, n = 72). The primary endpoint was major adverse cardiac events (MACEs), a composite of death, myocardial infarction, and need for repeat revascularization. The significance level was set at 0.05; therefore, results with a p-value < 0.05 were considered statistically significant. Results Most patients were male (62.8%) with a mean age of 64.1 years. Diabetes was present in 27%. On coronary angiography, the severity of stenosis was 62% in the ischemia group, 56.4% in the low-normal FFR group, and 54.3% in the high-normal FFR group (p<0.05). Mean follow-up was 3.5 years. The incidence of MACEs was 25.5%, 13.2%, and 11.1%, respectively (p=0.037). MACE incidence did not differ significantly between the low-normal and high-normal FFR groups. Conclusion Patients with FFR indicative of ischemia had poorer outcomes than those in non-ischemia groups. There was no difference in the incidence of events between the low-normal and high-normal FFR groups. Long-term studies with a large sample size are needed to better assess cardiovascular outcomes in patients with moderate coronary stenosis with FFR values between 0.8 and 1.0.
RESUMEN
AIMS: To evaluate whether a strategy of double-dose influenza vaccination during hospitalization for an acute coronary syndrome (ACS) compared with standard-dose outpatient vaccination (as recommended by current guidelines) would further reduce the risk of major cardiopulmonary events. METHODS AND RESULTS: Vaccination against Influenza to Prevent cardiovascular events after Acute Coronary Syndromes (VIP-ACS) was a pragmatic, randomized, multicentre, active-comparator, open-label trial with blinded outcome adjudication comparing two strategies of influenza vaccination following an ACS: double-dose quadrivalent inactivated vaccine before hospital discharge vs. standard-dose quadrivalent inactivated vaccine administered in the outpatient setting 30 days after randomization. The primary outcome was a hierarchical composite of all-cause death, myocardial infarction, stroke, unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory causes, analysed by the win ratio method. Patients were followed for 12 months. During two influenza seasons, 1801 participants were included at 25 centres in Brazil. The primary outcome was not different between groups, with 12.7% wins in-hospital double-dose vaccine group and 12.3% wins in the standard-dose vaccine group {win ratio: 1.02 [95% confidence interval (CI): 0.79-1.32], P = 0.84}. Results were consistent for the key secondary outcome, a hierarchical composite of cardiovascular death, myocardial infarction and stroke [win ratio: 0.94 (95% CI: 0.66-1.33), P = 0.72]. Time-to-first event analysis for the primary outcome showed results similar to those of the main analysis [hazard ratio 0.97 (95% CI: 0.75-1.24), P = 0.79]. Adverse events were infrequent and did not differ between groups. CONCLUSION: Among patients hospitalized with an ACS, double-dose influenza vaccination before discharge did not reduce cardiopulmonary outcomes compared with standard-dose vaccination in the outpatient setting. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: NCT04001504.
Asunto(s)
Síndrome Coronario Agudo , Gripe Humana , Infarto del Miocardio , Accidente Cerebrovascular , Humanos , Síndrome Coronario Agudo/terapia , Gripe Humana/prevención & control , Infarto del Miocardio/prevención & control , Vacunación , Accidente Cerebrovascular/prevención & control , Vacunas de Productos Inactivados , Resultado del TratamientoRESUMEN
BACKGROUND: Acute kidney injury (AKI) has shown to adversely affect outcomes in patients undergoing transcutaneous aortic valve replacement (TAVR), and its correct risk estimation may interfere in procedural planning and strategies. The aim of the study was to test and compare 6 scores in predicting AKI after TAVR. METHODS: We tested 6 scores (the contrast material limit score, volume-to-creatinine clearance ratio, ACEF, CR4EATME3AD3, Mehran model A, and Mehran model B) in a total of 559 consecutive patients included in the Brazilian TAVR registry. RESULTS: All scores had a poor accuracy and calibration to predict the occurrence of AKI grade 1 or 2. All scores improved the accuracy of AKI risk prediction when stratified for AKI grade 2/3 and AKI grade 3 for all scores. The CR4EATME3AD3 was the best predictor of AKI stage 2/3 (AUC: 0.62; OR: 1.12; 95% CI 1.01-1.26; p = 0.04) and AKI stage 3 (AUC: 0.64; OR: 1.16; 95% CI 1.02-1.32; p = 0.02). Mehran models A and B were both good models for AKI stage 3 (AUC: 0.63; OR: 1.10; 95% CI 1.01-1.22; p = 0.05; and AUC: 0.62; OR: 1.10; 95% CI 1.00-1.21; p = 0.05, respectively). CONCLUSIONS: None of the current models demonstrated validity in detecting AKI when its lower grades were evaluated. CR4EATME3AD3 was the best score in predicting moderate to severe AKI after TAVR. These findings suggest that contrast-induced AKI may not be the only factor related to kidney injury after TAVR.
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Lesión Renal Aguda , Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Lesión Renal Aguda/inducido químicamente , Lesión Renal Aguda/diagnóstico , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Humanos , Factores de RiesgoRESUMEN
BACKGROUND: Chronic kidney disease is commonly found in patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) and has marked impact in their prognosis. It has been shown however that TAVR may improve renal function by alleviating the hemodynamic barrier imposed by AS. Nevertheless, the predictors of and clinical consequences of renal function improvement are not well established. Our aim was to assess the predictors of improvement of renal function after TAVR. METHODS: The present work is an analysis of the Brazilian Registry of TAVR, a national non-randomized prospective study with 22 Brazilian centers. Patients with baseline renal dysfunction (estimated glomerular filtration rate [eGFR] < 60mL/min/1.73m2) were stratified according to renal function after TAVR: increase >10% in eGFR were classified as TAVR induced renal function improvement (TIRFI); decrease > 10% in eGFR were classified as acute kidney injury (AKI) and stable renal function (neither criteria). RESULTS: A total of 819 consecutive patients with symptomatic severe AS were included. Of these, baseline renal dysfunction (estimated glomerular filtration rate [eGFR] < 60mL/min/1.73m2) was present in 577 (70%) patients. Considering variance in renal function between baseline and at discharge after TAVR procedure, TIRFI was seen in 197 (34.1%) patients, AKI in 203 (35.2%), and stable renal function in 177 (30.7%). The independent predictors of TIRFI were: absence of coronary artery disease (OR: 0.69; 95% CI 0.48-0.98; P = 0.039) and lower baseline eGFR (OR: 0.98; 95% CI 0.97-1.00; P = 0.039). There was no significant difference in 30-day and 1-year all-cause mortality between patients with stable renal function or TIRFI. Nonetheless, individuals that had AKI after TAVR presented higher mortality compared with TIRFI and stable renal function groups (29.3% vs. 15.4% vs. 9.5%, respectively; p < 0.001). CONCLUSIONS: TIRFI was frequently found among baseline impaired renal function individuals but was not associated with improved 1-year outcomes.
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Riñón/fisiología , Insuficiencia Renal Crónica/fisiopatología , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Femenino , Tasa de Filtración Glomerular/fisiología , Implantación de Prótesis de Válvulas Cardíacas/métodos , Hemodinámica/fisiología , Humanos , Pruebas de Función Renal/métodos , Modelos Logísticos , Masculino , Oportunidad Relativa , Pronóstico , Estudios Prospectivos , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/cirugía , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Immediately post coronary artery bypass graft surgery, a 58-year-old woman developed excessive bleeding through the chest drains and hemodynamic instability, followed by total atrioventricular block requiring use of temporary pacemaker, which precluded electrocardiographic interpretation. She was referred for urgent diagnostic coronary angiography, which demonstrated important contrast leakage from the distal body of the saphenous vein graft to the first marginal branch. Acute saphenous vein graft perforation following coronary artery bypass graft surgery is rare. To the best of our knowledge, this is the first case report of acute saphenous vein graft perforation after coronary artery bypass graft surgery treated with a stent-graft.
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Puente de Arteria Coronaria , Vena Safena , Angiografía Coronaria , Puente de Arteria Coronaria/efectos adversos , Femenino , Hemorragia , Humanos , Persona de Mediana Edad , Vena Safena/diagnóstico por imagen , Vena Safena/cirugía , StentsRESUMEN
Abstract Background: Transcatheter aortic valve implantation (TAVI) is a well-established procedure; however, atrioventricular block requiring permanent pacemaker implantation (PPI) is a common complication. Objectives: To determine the incidence, predictors and clinical outcomes of PPI after TAVI, focusing on how PPI affects left ventricular ejection fraction (LVEF) after TAVI. Methods: The Brazilian Multicenter TAVI Registry included 819 patients submitted to TAVI due to severe aortic stenosis from 22 centers from January/2008 to January/2015. After exclusions, the predictors of PPI were assessed in 670 patients by use of multivariate regression. Analysis of the ROC curve was used to measure the ability of the predictors; p < 0.05 was the significance level adopted. Results: Within 30 days from TAVI, 135 patients (20.1%) required PPI. Those patients were older (82.5 vs. 81.1 years; p = 0.047) and mainly of the male sex (59.3% vs 45%; p = 0.003). Hospital length of stay was longer in patients submitted to PPI (mean = 15.7 ± 25.7 vs. 11.8 ± 22.9 days; p < 0.001), but PPI affected neither all-cause death (26.7% vs. 25.6%; p = 0.80) nor cardiovascular death (14.1% vs. 14.8%; p = 0.84). By use of multivariate analysis, the previous presence of right bundle-branch block (RBBB) (OR, 6.19; 3.56-10.75; p ≤ 0.001), the use of CoreValve® prosthesis (OR, 3.16; 1.74-5.72; p ≤ 0.001) and baseline transaortic gradient > 50 mm Hg (OR, 1.86; 1.08-3.2; p = 0.025) were predictors of PPI. The estimated risk of PPI ranged from 4%, when none of those predictors was present, to 63%, in the presence of all of them. The model showed good ability to predict the need for PPI: 0.69 (95%CI: 0.64 - 0.74) in the ROC curve. The substudy of 287 echocardiograms during the 1-year follow-up showed worse LVEF course in patients submitted to PPI (p = 0.01). Conclusion: BRD prévio, gradiente aórtico médio > 50 mmHg e CoreValve® são preditores independentes de implante de MPD pós-TAVI. Ocorreu implante de MPD em aproximadamente 20% dos casos de TAVI, o que prolongou a internação hospitalar, mas não afetou a mortalidade. O implante de MPD afetou negativamente a FEVE pós-TAVI.
Resumo Fundamento: O implante valvar aórtico transcateter (TAVI) está bem estabelecido, porém, o bloqueio atrioventricular, com necessidade de marca-passo definitivo (MPD), é complicação frequente. Objetivo: Determinar a incidência, preditores e desfechos clínicos de implante de MPD após TAVI, focando em como a evolução da fração de ejeção do ventrículo esquerdo (FEVE), após o TAVI, é afetada pelo MPD. Métodos: No registro brasileiro foram incluídos 819 pacientes submetidos a TAVI por estenose aórtica severa em 22 centros entre janeiro/2008 e janeiro/2015. Após exclusões, os preditores de implante de MPD foram avaliados em 670 pacientes por regressão multivariada. Análise da curva ROC foi utilizada para medir a habilidade dos preditores; p < 0,05 foi considerado significativo. Resultados: Aos 30 dias, 135 pacientes (20,1%) necessitaram de MPD. Tais pacientes eram mais velhos (82,5 vs. 81,1 anos; p = 0,047) e predominantemente homens (59,3% vs 45%; p = 0,003). A permanência hospitalar foi maior no Grupo MPD (média= 15,7 ± 25,7 vs. 11,8 ± 22,9 dias; p < 0,001), mas o implante não afetou morte por qualquer causa (26,7% vs. 25,6%; p = 0,80) nem morte cardiovascular (14,1% vs. 14,8%; p = 0,84). Por análise multivariada, a presença prévia de bloqueio de ramo direito (BRD) (OR, 6,19; 3,56-10,75; p ≤ 0,001), o uso da prótese CoreValve® (OR, 3,16; 1,74-5,72; p ≤ 0,001) e gradiente transaórtico basal > 50 mmHg (OR, 1,86; 1,08-3,2; p= 0,025) foram preditores de implante de MPD. O risco estimado de implante de MPD foi 4%, quando nenhum dos fatores de risco estava presente, e 63% na presença de todos. O modelo mostrou boa habilidade de prever a necessidade de MPD: 0,69 (IC95%: 0,64 - 0,74) na curva ROC. Subestudo de 287 ecocardiogramas durante o seguimento de 1 ano mostrou pior evolução da FEVE no Grupo MPD (p = 0,01). Conclusão: Em crianças de 6 a 11 anos, circunferência da cintura aumentada está associada à PA elevada, mesmo quando o IMC é normal. (Arq Bras Cardiol. 2017; [online].ahead print, PP.0-0)
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Humanos , Masculino , Femenino , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Marcapaso Artificial/efectos adversos , Bloqueo de Rama/cirugía , Prótesis Valvulares Cardíacas/efectos adversos , Estimulación Cardíaca Artificial/métodos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Bloqueo Atrioventricular/cirugía , Estenosis de la Válvula Aórtica/cirugía , Complicaciones Posoperatorias , Brasil , Factores de Riesgo , Electrocardiografía , Bloqueo Atrioventricular/fisiopatologíaRESUMEN
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a well-established procedure; however, atrioventricular block requiring permanent pacemaker implantation (PPI) is a common complication. OBJECTIVES: To determine the incidence, predictors and clinical outcomes of PPI after TAVI, focusing on how PPI affects left ventricular ejection fraction (LVEF) after TAVI. METHODS: The Brazilian Multicenter TAVI Registry included 819 patients submitted to TAVI due to severe aortic stenosis from 22 centers from January/2008 to January/2015. After exclusions, the predictors of PPI were assessed in 670 patients by use of multivariate regression. Analysis of the ROC curve was used to measure the ability of the predictors; p < 0.05 was the significance level adopted. RESULTS: Within 30 days from TAVI, 135 patients (20.1%) required PPI. Those patients were older (82.5 vs. 81.1 years; p = 0.047) and mainly of the male sex (59.3% vs 45%; p = 0.003). Hospital length of stay was longer in patients submitted to PPI (mean = 15.7 ± 25.7 vs. 11.8 ± 22.9 days; p < 0.001), but PPI affected neither all-cause death (26.7% vs. 25.6%; p = 0.80) nor cardiovascular death (14.1% vs. 14.8%; p = 0.84). By use of multivariate analysis, the previous presence of right bundle-branch block (RBBB) (OR, 6.19; 3.56-10.75; p ≤ 0.001), the use of CoreValve® prosthesis (OR, 3.16; 1.74-5.72; p ≤ 0.001) and baseline transaortic gradient > 50 mm Hg (OR, 1.86; 1.08-3.2; p = 0.025) were predictors of PPI. The estimated risk of PPI ranged from 4%, when none of those predictors was present, to 63%, in the presence of all of them. The model showed good ability to predict the need for PPI: 0.69 (95%CI: 0.64 - 0.74) in the ROC curve. The substudy of 287 echocardiograms during the 1-year follow-up showed worse LVEF course in patients submitted to PPI (p = 0.01). CONCLUSION: BRD prévio, gradiente aórtico médio > 50 mmHg e CoreValve® são preditores independentes de implante de MPD pós-TAVI. Ocorreu implante de MPD em aproximadamente 20% dos casos de TAVI, o que prolongou a internação hospitalar, mas não afetou a mortalidade. O implante de MPD afetou negativamente a FEVE pós-TAVI.
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Válvula Aórtica/cirugía , Bloqueo Atrioventricular/cirugía , Bloqueo de Rama/cirugía , Estimulación Cardíaca Artificial/métodos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Prótesis Valvulares Cardíacas/efectos adversos , Marcapaso Artificial/efectos adversos , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Bloqueo Atrioventricular/fisiopatología , Brasil , Electrocardiografía , Femenino , Humanos , Masculino , Complicaciones Posoperatorias , Factores de RiesgoRESUMEN
Abstract Background: Left atrial appendage closure (LAAC) is an effective alternative to oral anticoagulation (OA) for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). Objective: To present the immediate results and late outcomes of patients submitted to LAAC and included in the Brazilian Registry of Percutaneous Left Atrial Appendage Closure. Methods: 91 patients with NVAF, high stroke risk (CHA2DS2VASc score = 4.5 ± 1.5) and restrictions to OAC (HAS-BLED score = 3.6 ± 1.0) underwent 92 LAAC procedures using either the Amplatzer cardiac plug or the Watchman device in 11 centers in Brazil, between late 2010 and mid 2016. Results: Ninety-six devices were used (1.04 device/procedure, including an additional non-dedicated device), with a procedural success rate of 97.8%. Associated procedures were performed in 8.7% of the patients. Complete LAAC was obtained in 93.3% of the successful cases. In cases of incomplete closure, no residual leak was larger than 2.5 mm. One patient needed simultaneous implantation of 2 devices. There were 7 periprocedural major (5 pericardial effusions requiring pericardiocentesis, 1 non-dedicated device embolization and 1 coronary air embolism without sequelae) and 4 minor complications. After 128.6 patient-years of follow-up there were 3 deaths unrelated to the procedure, 2 major bleedings (one of them in a patient with an unsuccessful LAAC), thrombus formation over the device in 2 cases (both resolved after resuming OAC for 3 months) and 2 strokes (2.2%). Conclusions: In this multicenter, real world registry, that included patients with NVAF and high thromboembolic and bleeding risks, LAAC effectively prevented stroke and bleeding when compared to the expected rates based on CHA2DS2VASc and HASBLED scores for this population. Complications rate of the procedure was acceptable considering the beginning of the learning curve of most of the involved operators.
Resumo Fundamento: A oclusão percutânea do apêndice atrial esquerdo (OAAE) é uma alternativa eficaz à anticoagulação oral (ACO) para a prevenção de acidente vascular cerebral (AVC) em pacientes com fibrilação atrial não-valvular (FANV). Objetivo: Apresentar os resultados imediatos e o seguimento tardio de pacientes submetidos a OAAE e incluídos no Registro Brasileiro de Oclusão Percutânea do Apêndice Atrial Esquerdo. Métodos: 91 pacientes com FANV, alto risco de AVC (escore CHA2DS2VASc = 4,5 ± 1,5) e restrição à AO (escore HAS-BLED = 3,6 ± 1,0) foram submetidos a 92 procedimentos de OAAE com as próteses Amplatzer Cardiac Plug e Watchman em 11 centros do Brasil, entre o final de 2010 e a metade de 2016. Resultados: Utilizaram-se 96 próteses no total (1,04 próteses/procedimento, incluindo-se o uso de 1 prótese não-dedicada adicional em um dos casos), obtendo-se sucesso em 97,8% dos procedimentos. Realizaram-se procedimentos associados à OAAE em 8,7% dos pacientes. Observou-se oclusão total do AAE em 93,3% dos casos com sucesso, e nos casos de oclusão incompleta, nenhum leak foi > 2,5 mm. Um paciente necessitou do implante simultâneo de 2 próteses. Houve 7 complicações maiores periprocedimento (5 derrames pericárdicos necessitando pericardiocentese, 1 embolização da prótese não-dedicada e 1 embolia aérea coronariana sem sequelas) e 4 menores. No seguimento de 128,6 pacientes-ano, houve 3 óbitos não relacionados ao procedimento, 2 sangramentos maiores (um deles em um dos casos de insucesso da OAAE), formação de trombo sobre a prótese em 2 casos (tratados com sucesso com reinstituição da ACO por 3 meses), e 2 AVCs (2,2%). Conclusões: Neste registro multicêntrico de mundo real, que incluiu pacientes com FANV e alto risco de sangramento e de eventos tromboembólicos, a OAAE foi eficaz na prevenção de AVC e sangramento quando comparada às taxas de AVC previstas pelos escores CHA2DS2VASc e HASBLED para esta população. O índice de complicações do procedimento foi aceitável, considerando se tratar do início da curva de aprendizado da maioria dos operadores envolvidos.
Asunto(s)
Humanos , Masculino , Femenino , Anciano , Fibrilación Atrial/cirugía , Apéndice Atrial/cirugía , Accidente Cerebrovascular/prevención & control , Dispositivo Oclusor Septal , Fibrilación Atrial/diagnóstico por imagen , Estudios de Seguimiento , Resultado del Tratamiento , Ecocardiografía Transesofágica , Apéndice Atrial/diagnóstico por imagen , Accidente Cerebrovascular/etiologíaRESUMEN
BACKGROUND: Left atrial appendage closure (LAAC) is an effective alternative to oral anticoagulation (OA) for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). OBJECTIVE: To present the immediate results and late outcomes of patients submitted to LAAC and included in the Brazilian Registry of Percutaneous Left Atrial Appendage Closure. METHODS: 91 patients with NVAF, high stroke risk (CHA2DS2VASc score = 4.5 ± 1.5) and restrictions to OAC (HAS-BLED score = 3.6 ± 1.0) underwent 92 LAAC procedures using either the Amplatzer cardiac plug or the Watchman device in 11 centers in Brazil, between late 2010 and mid 2016. RESULTS: Ninety-six devices were used (1.04 device/procedure, including an additional non-dedicated device), with a procedural success rate of 97.8%. Associated procedures were performed in 8.7% of the patients. Complete LAAC was obtained in 93.3% of the successful cases. In cases of incomplete closure, no residual leak was larger than 2.5 mm. One patient needed simultaneous implantation of 2 devices. There were 7 periprocedural major (5 pericardial effusions requiring pericardiocentesis, 1 non-dedicated device embolization and 1 coronary air embolism without sequelae) and 4 minor complications. After 128.6 patient-years of follow-up there were 3 deaths unrelated to the procedure, 2 major bleedings (one of them in a patient with an unsuccessful LAAC), thrombus formation over the device in 2 cases (both resolved after resuming OAC for 3 months) and 2 strokes (2.2%). CONCLUSIONS: In this multicenter, real world registry, that included patients with NVAF and high thromboembolic and bleeding risks, LAAC effectively prevented stroke and bleeding when compared to the expected rates based on CHA2DS2VASc and HASBLED scores for this population. Complications rate of the procedure was acceptable considering the beginning of the learning curve of most of the involved operators.
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Apéndice Atrial/cirugía , Fibrilación Atrial/cirugía , Dispositivo Oclusor Septal , Accidente Cerebrovascular/prevención & control , Anciano , Apéndice Atrial/diagnóstico por imagen , Fibrilación Atrial/diagnóstico por imagen , Ecocardiografía Transesofágica , Femenino , Estudios de Seguimiento , Humanos , Masculino , Accidente Cerebrovascular/etiología , Resultado del TratamientoRESUMEN
BACKGROUND & AIMS: The ingestion of small to moderate alcohol consumption amounts has been associated to cardiovascular protection. This study aimed to evaluate the association between alcohol consumption and coronary artery disease severity. MATERIAL AND METHODS: Cross-sectional Study with patients undergoing coronary angiography. Age, cardiovascular risk factors (smoking, systemic arterial hypertension, dyslipidemia and diabetes) and alcohol drinking habit were investigated. Alcohol consumption was divided in three categories: nondrinker, moderate alcohol consumption (less than 15 g ethanol/day for women or 30 g ethanol/day for men) and heavy alcohol consumption. Coronary artery disease severity was assessed through the Friesinger Score (FS) in the coronary angiography, by interventional cardiologists blinded to alcohol consumption. RESULTS: The final sample included 363 adults; of those, 228 were men (62.81%). Mean age was 60.5 ± 10.9 y. Unadjusted analyses identified sex, age, hypertension, diabetes, dyslipidemia and alcohol consumption as the main covariates associated with the Friesinger score. Lower Friesinger scores were also observed in moderate alcohol consumption when comparing to those who do not drink (RR 0.86; 95% CI 0.79-0.95). CONCLUSION: Among patients with suspected coronary artery disease undergoing coronary angiography, moderate alcohol consumption is associated to a lower coronary artery disease severity than heavy drinking.
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Abstinencia de Alcohol , Consumo de Bebidas Alcohólicas/efectos adversos , Alcoholismo/fisiopatología , Enfermedad de la Arteria Coronaria/etiología , Vasos Coronarios/diagnóstico por imagen , Adulto , Anciano , Anciano de 80 o más Años , Brasil/epidemiología , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/fisiopatología , Estudios Transversales , Femenino , Hospitales Urbanos , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Autoinforme , Índice de Severidad de la Enfermedad , Adulto JovenRESUMEN
AbstractBackground:Predicting mortality in patients undergoing transcatheter aortic valve implantation (TAVI) remains a challenge.Objectives:To evaluate the performance of 5 risk scores for cardiac surgery in predicting the 30-day mortality among patients of the Brazilian Registry of TAVI.Methods:The Brazilian Multicenter Registry prospectively enrolled 418 patients undergoing TAVI in 18 centers between 2008 and 2013. The 30-day mortality risk was calculated using the following surgical scores: the logistic EuroSCORE I (ESI), EuroSCORE II (ESII), Society of Thoracic Surgeons (STS) score, Ambler score (AS) and Guaragna score (GS). The performance of the risk scores was evaluated in terms of their calibration (Hosmer–Lemeshow test) and discrimination [area under the receiver–operating characteristic curve (AUC)].Results:The mean age was 81.5 ± 7.7 years. The CoreValve (Medtronic) was used in 86.1% of the cohort, and the transfemoral approach was used in 96.2%. The observed 30-day mortality was 9.1%. The 30-day mortality predicted by the scores was as follows: ESI, 20.2 ± 13.8%; ESII, 6.5 ± 13.8%; STS score, 14.7 ± 4.4%; AS, 7.0 ± 3.8%; GS, 17.3 ± 10.8%. Using AUC, none of the tested scores could accurately predict the 30-day mortality. AUC for the scores was as follows: 0.58 [95% confidence interval (CI): 0.49 to 0.68, p = 0.09] for ESI; 0.54 (95% CI: 0.44 to 0.64, p = 0.42) for ESII; 0.57 (95% CI: 0.47 to 0.67, p = 0.16) for AS; 0.48 (95% IC: 0.38 to 0.57, p = 0.68) for STS score; and 0.52 (95% CI: 0.42 to 0.62, p = 0.64) for GS. The Hosmer–Lemeshow test indicated acceptable calibration for all scores (p > 0.05).Conclusions:In this real world Brazilian registry, the surgical risk scores were inaccurate in predicting mortality after TAVI. Risk models specifically developed for TAVI are required.
ResumoFundamento:Ainda é desafiador prever a mortalidade de pacientes que se submetem ao TAVI (sigla do inglês Transcatheter Aortic Valve Implantation).Objetivos:Avaliar o desempenho de cinco escores de risco para cirurgia cardíaca em prever mortalidade em 30 dias de pacientes inscritos no Registro Brasileiro de TAVI.Métodos:O Registro Multicêntrico Brasileiro inscreveu prospectivamente 418 pacientes submetidos ao TAVI em 18 centros entre 2008 e 2013. Os seguintes escores cirúrgicos foram usados para calcular o risco de mortalidade no período de 30 dias: EuroSCORE I (ESI) logístico, EuroSCORE II (ESII), STS Score (STS), Ambler Score (AS) e Guaragna Score (GS). O desempenho dos escores de risco foram avaliados através de sua calibração (teste Hosmer-Lemeshow) e discriminação [área sob a curva (AUC) do inglês receiver-operating characteristic curve)].Resultados:A idade média foi de 81,5 ± 7,7 anos. A prótese aórtica CoreValve (Medtronic) foi usada em 86,1% da coorte e a abordagem transfemural usada em 96,2%. A mortalidade observada no período de 30 dias foi de 9,1%. A mortalidade no período de 30 dias prevista pelos escores foi: ESI, 20,2 ± 13,8%; ESII, 6,5 ± 13,8%; STS, 14,7 ± 4,4%; AS, 7,0 ± 3,8%; GS, 17,3 ± 10,8%. Nenhum dos escores testados com a AUC foi capaz de prever a mortalidade no período de 30 dias de forma precisa. As AUC para os escores foram: 0,58 [95% de intervalo de confiança (IC): 0,49 a 0,68, p = 0,09] para ESI; 0,54 (IC de 95%: 0,44 a 0,64, p = 0,42) para ESII; 0,57 (IC de 95%: 0,47 a 0,67, p = 0,16) para AS; 0,48 (IC de 95%: 0,38 a 0,57, p = 0,68) para STS e 0,52 (IC de 95%: 0,42 a 0,62, p = 0,64) para GS. O teste Hosmer-Lemeshow indicou uma calibração aceitável para todos os escores (p > 0,05).Conclusões:Neste registro brasileiro de mundo real, os escores de risco cirúrgico foram imprecisos para prever a mortalidade após o TAVI. São necessários modelos de risco desenvolvidos especificamente para o TAVI.
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Humanos , Masculino , Femenino , Anciano , Anciano de 80 o más Años , Medición de Riesgo/métodos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , Brasil , Calibración , Métodos Epidemiológicos , Valores de Referencia , Reproducibilidad de los Resultados , Factores de TiempoRESUMEN
BACKGROUND: Predicting mortality in patients undergoing transcatheter aortic valve implantation (TAVI) remains a challenge. OBJECTIVES: To evaluate the performance of 5 risk scores for cardiac surgery in predicting the 30-day mortality among patients of the Brazilian Registry of TAVI. METHODS: The Brazilian Multicenter Registry prospectively enrolled 418 patients undergoing TAVI in 18 centers between 2008 and 2013. The 30-day mortality risk was calculated using the following surgical scores: the logistic EuroSCORE I (ESI), EuroSCORE II (ESII), Society of Thoracic Surgeons (STS) score, Ambler score (AS) and Guaragna score (GS). The performance of the risk scores was evaluated in terms of their calibration (Hosmer-Lemeshow test) and discrimination [area under the receiver-operating characteristic curve (AUC)]. RESULTS: The mean age was 81.5 ± 7.7 years. The CoreValve (Medtronic) was used in 86.1% of the cohort, and the transfemoral approach was used in 96.2%. The observed 30-day mortality was 9.1%. The 30-day mortality predicted by the scores was as follows: ESI, 20.2 ± 13.8%; ESII, 6.5 ± 13.8%; STS score, 14.7 ± 4.4%; AS, 7.0 ± 3.8%; GS, 17.3 ± 10.8%. Using AUC, none of the tested scores could accurately predict the 30-day mortality. AUC for the scores was as follows: 0.58 [95% confidence interval (CI): 0.49 to 0.68, p = 0.09] for ESI; 0.54 (95% CI: 0.44 to 0.64, p = 0.42) for ESII; 0.57 (95% CI: 0.47 to 0.67, p = 0.16) for AS; 0.48 (95% IC: 0.38 to 0.57, p = 0.68) for STS score; and 0.52 (95% CI: 0.42 to 0.62, p = 0.64) for GS. The Hosmer-Lemeshow test indicated acceptable calibration for all scores (p > 0.05). CONCLUSIONS: In this real world Brazilian registry, the surgical risk scores were inaccurate in predicting mortality after TAVI. Risk models specifically developed for TAVI are required.
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Medición de Riesgo/métodos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , Brasil , Calibración , Métodos Epidemiológicos , Femenino , Humanos , Masculino , Valores de Referencia , Reproducibilidad de los Resultados , Factores de TiempoRESUMEN
O stent liberador de everolimus XIENCE V® é um stent farmacológico de nova geração que incorpora uma plataforma de cromo-cobalto de baixo perfil (81 m) e um polímero de elevada biocompatibilidade (fluoropolímero), o qual carreia e controla a liberação do fármaco everolimus. Estudos recentes demonstram segurança e eficácia sustentadas do dispositivo XIENCE V® no tratamento de populações da prática clínica. Nosso objetivo foi reportar resultados clínicos de 12 meses do protocolo brasileiro BRAVO. Métodos: O registro BRAVO foi um estudo prospectivo, não randomizado, de braço único, multicêntrico (25centros), que avaliou os resultados clínicos tardios de 535 pacientes minimamente selecionados, tratados com o stent farmacológico XIENCE V®.Resultados: Cerca de 40% dos pacientes tinham diabetes, 25% infarto agudo do miocárdio prévio e 42% apresentaram-se com síndrome coronária aguda. A maioria das lesões (69%) era de elevada complexidade(ACC/AHA tipo B2/C). As médias da extensão e do diâmetro nominais dos stents foram, respectivamente, 19,9 ± 5,3 mm e 3,0 ± 0,4 mm. Os sucessos angiográfico e de procedimento foram de 99,7 e 98%, respectivamente. Aos 12 meses, a taxa cumulativa de eventos cardíacos adversos maiores, disponível em 100% dos pacientes, foi de 5,6% (morte cardíaca: 1,3%; infarto agudo do miocárdio: 3,0%; revascularização da lesão-alvo: 2,2%). Já a trombose de stent ocorreu em cinco pacientes (0,9%), sendo reportada apenas uma ocorrência entre 6 e 12 meses. Conclusões: O stent farmacológico XIENCE V® demonstrou segurança e eficácia sustentadas ao final de 12meses no tratamento de lesões coronárias complexas em pacientes da prática diária...
The Xience VTM everolimus-eluting stents is a new generation drug-eluting stent (DES)that incorporates a low profile cobalt-chromium platform (81 m) and a highly biocompatible polymer(fluoropolymer), which carries and controls the release of everolimus. Recent studies have demonstrated sustained safety and efficacy of the Xience VTM in the treatment of real-world populations. Our aim was to report the clinical results of 12 months of the BRAVO Brazilian protocol. Methods: The BRAVO Registry was a prospective, non-randomized, single-arm, multicenter (25 centers) study that evaluated the late clinical results of 535 minimally selected patients treated with the drug eluting stent Xience VTM in Brazilian daily practice. Results: Overall, 40% of patients had diabetes, 25% prior myocardial infarction, and 42% presented with acute coronary artery syndrome. The majority of lesions (69%) was highly complex (ACC/AHA type B2 or C).The mean length and the nominal stent diameter were 19.9 ± 5.3 mm and 3.0 ± 0.4 mm, respectively.The angiographic and procedural successes were 99.7 and 98%, respectively. At 12 months, the cumulative rate of major adverse cardiac events, available in 100% of patients, was 5.6% (cardiac death: 1.3%; acute myocardial infarction: 3.0%; revascularization of the target lesion: 2.2%). Stent thrombosis occurred in 5 patients (0,9%), and only 1 case was reported between 6 and 12 months. Conclusions: The drug-eluting stent Xience V demonstrated sustained safety and efficacy up to 12 months in the treatment of complex coronary lesions in patients from daily practice...