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BACKGROUND: Prevalence of bioprosthetic valve degeneration (BVD) is rising as the use of bioprosthetic aortic valves increases. Detecting early signs of BVD remains a challenge, with conventional imaging methods often failing to identify early deterioration stages. 18F-fuoride positron emission tomography (PET-CT) is an emerging technique that offers promising prospects to detect subclinical BVD. This study aimed to compare early PET parameters of fluoride uptake with echocardiographic hemodynamic parameters and compare outcomes according to anticoagulation in patients who received bioprosthetic valves. METHODS: This is a sub-study of the ANTIPRO clinical trial, which involved patients undergoing surgical aortic valve replacement (SAVR) with a porcine bioprosthesis and randomized them into anticoagulated and non-anticoagulated groups. Hemodynamic changes were assessed by transthoracic echocardiography (TTE), while 18F-fluoride PET-CT quantified fluoride uptake and divided the patients in two groups: high-uptake and low-uptake. Mean and maximum gradients by TTE at three years were compared between the two uptake groups. Fluoride uptake was also compared between the anticoagulated and control groups. RESULTS: We found no significant differences in transprosthetic gradients between high-uptake(21.4 ± 8.6 mmHg) and low-uptake(17.3 ± 11.2 mmHg.p = 0.244) PET-defined groups in this specific timeframe. Notably, anticoagulated patients exhibited significantly risk of higher fluoride uptake(OR = 4.34;95%CI:1.04-18.21.p = 0.045). CONCLUSIONS: No association was found between fluoride uptake and hemodynamic evaluation. Anticoagulation was associated with higher fluoride uptake. These findings highlight the emerging role of PET-CT in studying bioprosthetic aortic valves and emphasize the need for extended follow-up to evaluate the impact of anticoagulation on valve degeneration.
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Composite end points are common primary outcomes in clinical trials. Their main benefit of utilizing a composite outcome is increasing the number of primary outcome events, meaning fewer participants are required to deliver an adequately powered trial. By combining multiple important end points in the primary outcome rather than having to select only 1, composite end points potentially make clinically meaningful benefits easier to detect and avoid ranking outcomes hierarchically. However, there are a number of important considerations when designing and interpreting clinical trials that utilize composite end points. In this Statistical Primer, issues with composite end points such as competing events, halo effect, risk of bias, time-to-event limitations and the win ratio are discussed in the context of real world clinical trials.
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BACKGROUND: Most evidence for anticoagulation in aortic bioprosthesis is centered on embolic events, bleeding and re-intervention risk. The effect of anticoagulation on hemodynamics has not been previously assessed. Our hypothesis was that patients with anticoagulation (AC) early after aortic valve replacement (AVR) with porcine bioprosthesis have better hemodynamics at 3 years of follow-up. METHODS: This is a follow-up evaluation of the ANTIPRO trial. All patients undergoing AVR with porcine bioprosthesis were consecutively recruited. The AC group received warfarin+aspirin and the non-AC(control) only aspirin. The primary outcome was mean gradient after 3 years of AVR and change in New York Heart Association (NYHA) class. Secondary outcomes were major and minor bleeding and embolic events. RESULTS: Of 140 participants in the study, 71 were assigned to the AC group and 69 to the control group. Mean age of the overall population was 72.4(SD: 7.1) years. Global euroSCORE was 7.65(SD: 5.73). At 3 years the mean gradient was similar between both groups (19.4(SD: 9.6 mmHg) and 18.6(SD: 8.2 mmHg) in the control and AC group respectively, p = 0.7). No differences in functional class at 3 years were found among groups. No differences were found among groups in the secondary outcomes. CONCLUSIONS: The addition of 3 months of oral anticoagulation to anti-aggregation treatment did not affect bioprosthetic hemodynamics nor functional class at years after AVR.
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ABSTRACT Introduction: There is a lack of information about cardiac surgery training and professional practice in Latin American (LATAM) countries. This study is the first comparative analysis of cardiac surgical training and professional practice across LATAM and provides the fundamentals for future academic projects of the Latin American Association of Cardiac and Endovascular Surgery (LACES). Methods: International survey-based comparative analysis of the training and professional practice of cardiac surgeons across LATAM. Trainees (residents/fellows) and staf (graduated) surgeons from LATAM countries were included. Results: A total of 289 respondents (staf surgeons N=221 [76.5%]; residents/fellows N=68 [23.5%]) from 18 different countries participated in the survey. Most surgeons (N=92 [45.3%]) reported being unsatisfied with their salaries. Most respondents (N=181 [62.6%]) stated that it was difficult to obtain a leadership position, and 149 (73.8%) stated that it was difficult to find a job after completing training. Only half of the trainee respondents (N=32 [47.1%]) reported that their program had all resident spots occupied. Only 22.1% (N=15) of residents/fellows were satisfied with their training programs. The majority (N=205 [70.9%]) of respondents would choose cardiac surgery as their specialty again. Most surgeons (N=129 [63.9%]) and residents/fellows (N=52 [76.5%]) indicated that the establishment of a LATAM cardiac surgery board examination would be beneficial. Conclusion: Modernization and standardization of training, as well as greater access to opportunities, may be required in LATAM to increase professional satisfaction of cardiac surgeons and to reduce disparities in the specialty. Such changes may enhance the regional response to the dynamic challenges in the feld.
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ABSTRACT Introduction: Since the coronavirus disease 2019 (COVID-19) pandemic, cardiac surgeries in patients with previous infection by COVID-19 were suspended or postponed, which led to surgeries performed in patients with an advanced stage of their disease and an increase in the waiting list. There is a heterogeneous attitude in Latin America on the optimal timing to cardiac surgery in patients with previous COVID-19 infection due to scarce data on its outcome. Two Latin American associations joined to establish common suggestions on the optimal timing of surgery in patients with previous COVID-19 infection. Methods: Data collection was performed using a pre-established form, which included year of publication, objective, type of study (prospective/retrospective, descriptive/analytical), number of patients, year of study, waiting time between infection and surgery, type of surgery, morbidity, mortality, and conclusions regarding the association between mortality and morbidity. Final recommendations were approved by the board of directors of Latin American Association of Cardiac and Endovascular Surgery (LACES) and Latin American Confederation of Anesthesia Societies (CLASA). Results: Of the initial 1,016 articles, 11 comprised the final selection. Only six of them included patients who underwent cardiac surgery. According to the analyzed literature, optimal timing for cardiac surgery needs to consider the following aspects: deferable surgery, symptomatic COVID-19 infection, completeness of COVID-19 vaccination. Conclusion: These recommendations derive from the analysis of the scarce literature published at present on outcomes after cardiac surgery in patients with previous COVID-19 infection. These are to be taken as a dynamic recommendation in which Latin American reality was taken into consideration.
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Resumen Se han publicado ya las nuevas guías 2020 de recomendación clínica de la AHA/ACC para el tratamiento de pacientes con valvulopatía. Luego de un análisis profundo, con base en los más grandes estudios clínicos y en la situación en los países de Latinoamérica, la Latinoamerican Association of Cardiac & Endovascular Surgery (LACES) redactó una declaración en relación con algunas de las nuevas recomendaciones.
Abstract The new clinical guidelines of the AHA/ACC for the treatment of patients with Valvulopathy 2020 have been published. After an in-depth analysis, based on the largest clinical trials and taking into account the situation in our countries in Latin America, the Latinoamerican Association of Cardiac & Endovascular Surgery (LACES) drafting a statement on some of the new recommendations.
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Abstract Introduction: Acute aortic dissection (AAD) is a devastating surgical emergency, with high operative mortality. Several scoring algorithms have been used to establish the expected mortality in these patients. Our objective was to define the predictive factors for mortality in our center and to validate the EuroSCORE and Penn classification system. Methods: Patients who underwent surgery for AAD from 2006 to 2016 were retrieved from the institution's database. Preoperative, operative and postoperative variables were collected. Observed and expected mortality was calculated by EuroSCORE. Logistic regression analysis and Cox regression analysis were performed to find predictors of operative mortality and survival, respectively. The receiver operating characteristic (ROC) curves were plotted for logistic EuroSCORE, and the area under the ROC curve (AUC) was calculated. Results: 87 patients (27.6% female) underwent surgery for AAD. The mean age was 58.6±9.7 years. Expected and observed operative mortality was 25.8±15.1% and 20.7%, respectively. Penn Aa, Ab and Abc shared similar observed/expected (O/E) mortality ratio. The only independent predictor of operative mortality (OR: 3.63; 95% CI: 1.19-11.09) and survival (HR: 2.6; 95% CI: 1.5-4.8) was female gender. EuroSCORE showed a very poor prediction capacity, with an AUC=0.566. Conclusion: Female gender was the only independent predictor of operative mortality and survival in our institution. EuroSCORE is a poor scoring algorithm to predict mortality in AAD, but with consistent results for Penn Aa, Ab and Abc.
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Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Algoritmos , Procedimentos Cirúrgicos Cardíacos/estatística & dados numéricos , Dissecção Aórtica/cirurgia , Modelos Logísticos , Fatores de Risco , Curva ROC , Mortalidade Hospitalar/tendências , Medição de RiscoRESUMO
Abstract Objective: To evaluate the clinical and echocardiographic outcomes in aortic valve replacement (AVR) patients with aortic bioprosthesis under oral anticoagulation (OA). Methods: Patients who underwent AVR with bioprosthesiswere prospectively enrolled. They were classified based on postoperative use of OA. Clinical and operative variables were collected. Echocardiographic and clinical follow-ups were performed two years after surgery. The primary outcome evaluated was change in transprosthetic gradient. Secondary outcomes analyzed were change in New York Heart Association (NYHA) class, major bleeding episodes, hospitalization, stroke, and transient ischemic attack. Results: We included 103 patients (61 without OA and 42 with OA). Clinical characteristics were similar among groups, except for younger age (76±6.3 vs. 72.4±8.1 years, P=0.016) and higher prevalence of atrial fibrillation (0% vs. 23.8%, P<0.001) in the OA group. Mean (21.4±10 mmHg vs. 16.8±7.7 mmHg, P=0.037) and maximum (33.4±13.7 mmHg vs. 28.4±10.2 mmHg, P=0.05) transprosthetic gradients were higher in patients without OA. Improvement in NYHA class was more frequent in patients with OA (73% vs. 45.3%, P=0.032). Major bleeding, stroke, and hospitalization were similar among groups. OA was the only independent predictor for improvement of NYHA class after multivariate logistic regression analysis (odds ratio [OR]: 5.9, 95% confidence interval [CI]: 1.2-29.4; P=0.028). Stratification by prosthesis size showed that patients with ≤ 21 mm prosthesis benefited from OA. Conclusion: Early anticoagulation after AVR with bioprosthesis was associated with significant decrease of transprosthesis gradient and improvement in NYHA class. These associations were seen mainly in patients with ≤ 21 mm prosthesis.
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Humanos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/tratamento farmacológico , Estenose da Valva Aórtica/diagnóstico por imagem , Bioprótese/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Desenho de Prótese , Resultado do Tratamento , Hemodinâmica , Anticoagulantes/uso terapêuticoRESUMO
Resumen: Introducción: la pandemia COVID-19 ha determinado la aplicación de medidas sanitarias de emergencia, tendientes a evitar la progresión a nivel nacional. Reportes internacionales han sugerido que dichas medidas determinaron secundariamente una desatención en otras patologías, principalmente cardiovasculares, y eventual aumento de paros cardíacos extrahospitalarios (PCEH). Objetivo: determinar la frecuencia de consultas en emergencia por dolor precordial a nivel nacional y de PCEH asistidos por los principales servicios de emergencia prehospitalaria (SEP) de Montevideo, durante la pandemia. Método: se solicitó información del número de consultas por dolor precordial y de consultas totales, a las instituciones médicas de Montevideo y del interior del país, realizadas en el período comprendido entre el 13 de marzo y el 30 de abril de los años 2018, 2019 y 2020. Se solicitó a los SEP información sobre la frecuencia de PCEH en Montevideo durante los mismos períodos. Los datos se expresan como frecuencia absoluta y tasa de incidencia (por 100.000 afiliados) con su intervalo de confianza estimado mediante Fisher. Resultados: el número de consultas por dolor precordial fue estable durante el período 2018-2019. Durante 2020, dichas consultas disminuyeron, representando entre 11,3% y 21,7% del total de consultas. Se evidenció un aumento no significativo en la tasa de PCEH en el 2020 (9,05, IC95%: 7,15-11,30) comparado con el 2019 (7,94, IC95%: 6,19-10,04) y 2018 (7,43, IC95%: 5,75-9,45). Conclusiones: los datos crudos presentados muestran que desde el 13 de marzo hasta el 30 de abril de 2020 hubo una disminución en las consultas en emergencia por dolor precordial, aumentando de forma no significativa el número de PCEH durante el mes de abril, respecto al mismo período de los dos años anteriores.
Summary: Introduction: the COVID-19 pandemic has determined the application of emergency health measures aimed at preventing progression at national level. International reports have suggested that these measures lead to a lack of care in other pathologies, mainly cardiovascular, and eventually increase out-of-hospital cardiac arrests. Objective: to determine the frequency of emergency consultation for chest pain and out-of-hospital cardiac arrests, assisted by the main pre-hospital emergency services of Montevideo, during the COVID-19 pandemic. Methods: information was requested to the medical institutions of Montevideo and all over the country, on the number of consultations for chest pain and total consultations, in the period March 13- April 30 of 2018, 2019 and 2020. The frequency of out-of-hospital cardiac arrests in Montevideo was requested to the pre-hospital emergency services during the same period. The data is expressed as absolute frequency and incidence rates (x 100,000) with its 95% CI calculated by Fisher. Results: the number of consultations for precordial pain was stable during the 2018-2019 period. During 2020, these consultations decreased and represented between 11.3% and 21.7% of the total number of consultations. Out-of-hospital cardiac arrests showed a non significant increase in its incidence rate in 2020 (9.05, 95%IC: 7.15-11.30) compared with 2019 (7.94, 95%IC: 6.19-10.04) and 2018 (7.43, 95%IC: 5.75-9.45). Conclusions: the raw data presented shows that from March 13 to April 30 of 2020, there was a decrease in emergency visits for precordial pain and a non-significant increase in the incidence rate of out-of-hospital cardiac arrests.
Resumo: Introdução: a pandemia do COVID-19 determinou a aplicação de medidas emergenciais de saúde destinadas a impedir a progressão em nível nacional. Relatórios internacionais sugerem que essas medidas levam à falta de atendimento em outras patologias, principalmente cardiovasculares, e eventualmente aumentam as paradas cardíacas fora do hospital. Objetivo: determinar a frequência da consulta de emergência para dor no peito e paradas cardíacas fora do hospital, assistidas pelos principais serviços de emergência pré-hospitalar de Montevidéu, durante a pandemia do COVID-19. Métodos: foram solicitadas informações às instituições médicas de Montevidéu e de todo o país sobre o número de consultas para dor no peito e total de consultas, no período de 13 de março a 30 de abril de 2018, 2019 e 2020. A frequência de -as paradas cardíacas no hospital foram solicitadas aos serviços de emergência pré-hospitalares durante o mesmo período. Os dados são expressos como frequência absoluta e taxa de incidência (x 100.000) com seu intervalo de confiança estimado por Fisher. Resultados: o número de consultas para dor precordial permaneceu estável no período 2018-2019. Durante 2020, essas consultas representaram entre 11,3% e 21,7% do número total de consultas. Um aumento não significativo da taxa de paradas cardíacas fora do hospital foi evidente em 2020 (9,05, IC 95%: 7,15-11,30) em comparação com 2019 (7,94, IC 95%: 6,19-10,04) e 2018 (7,43, 95%IC: 5,75-9,45), o que não é significativo. Conclusões: os dados brutos apresentados mostram que de 13 de março a 30 de abril de 2020 houve uma diminuição nas visitas de emergência por dor precordial, não aumentando significativamente o número de paradas cardíacas fora do hospital em comparação aos dois anos anteriores.
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Resumen: Antecedentes: la endocarditis infecciosa es una enfermedad con elevada morbimortalidad, la cual se encuentra en torno al 25%. Aproximadamente el 50% de los casos requiere tratamiento quirúrgico. En nuestro medio se desconocen las características clínicas y evolutivas de pacientes operados por endocarditis infecciosa activa. Objetivos: primario, determinar mortalidad operatoria (MO) y sobrevida a largo plazo; secundario, definir predictores de embolias, complicaciones locales (CL), MO y endocarditis protésica (EP) en la evolución. Métodos: trabajo retrospectivo y analítico. Se identificaron pacientes que recibieron cirugía cardíaca por endocarditis activa entre enero de 2006 y diciembre de 2017. Mediante regresión logística multivariada se identificaron predictores para los objetivos enunciados. Resultados: se incluyeron 101 pacientes. El microorganismo más frecuentemente encontrado fue Staphylococcus aureus (SA) (15,8%). La topografía fue protésica en 20,8%, aórtica en 46,5%, mitral en 23,8% y mitro-aórtica en 13,9%. La MO fue 11,3% y 29,5% (p=0,025), según ausencia o presencia de CL, único predictor independiente de mortalidad (OR=3,38). El 47,5% presentó CL, siendo la más frecuente el absceso (25,7%). Fueron predictores independientes: EP (OR=5,8), endocarditis valvular aórtica (OR=2,9) y sexo masculino (OR=3,5). La incidencia de EP precoz fue 3% y tardía 4%. El 30% de los pacientes adquirió la EI como consecuencia de un procedimiento médico invasivo en los 6 meses previos. De los siete pacientes con EP en la evolución, seis tenían CL (p<0,05). El 31,7% presentaba embolias, resultando predictores independientes: Staphylococcus aureus (OR=4,6), vegetación en el velo mitral posterior (OR=3,2) y antecedente de hipertensión arterial (OR=3,32). La sobrevida a cinco y diez años fue de 88,20%±0,04 y 81,50%±0,05 respectivamente. Conclusiones: la MO de la endocarditis activa en nuestro medio es similar a la reportada internacionalmente. La presencia de CL se asocia a EP en la evolución y resultó ser un predictor independiente de sobrevida a largo plazo, y de MO. La sobrevida a largo plazo es similar a la reportada internacionalmente. Se observó una alta incidencia de agentes intrahospitalarios y procedimientos invasivos como causas probables.
Summary: Introduction: infective endocarditis is a high morbidity and mortality disease, which is about 25%. About fifty percent of patients require heart surgery. In our environment, clinical and evolutionary characteristics of patients operated with active endocarditis are unknown. Objective: primary, determine operative mortality and long-term survival; secondary, define predictors of embolisms, local complications, operative mortality and prosthetic endocarditis in evolution. Methods: retrospective, analytical study. Patients who received cardiac surgery for active endocarditis between January 2006 and December 2017 were identified. Through multivariate logistic regression, predictors were identified for the stated objectives. Results: one hundred and one patients were included. The most frequently found microorganism was Staphylococcus aureus (15.8%). The topography was prosthetic in 20.8%, aortic 46.5%, mitral 23.8% and mitro-aortic 13.9%. The operative mortality was 11.3% and 29.5% (p = 0.025) according to the absence or presence of local complications , the only independent predictor of mortality (OR = 3.32). Local complications were present in 47.5%, the most frequent were abscess (25.7%), independent predictors were: prosthetic endocarditis (OR=5.8), aortic endocarditis (OR=2.9) and male sex (OR=3.5). The incidence of early prosthetic endocarditis was 3% and late 4%. Thirty percent of patients acquired infective endocarditis as a result of an invasive medical procedure in the previous 6 months. Of the seven patients with prosthetic endocarditis in evolution, six had local complications (p <0.05). Embolic events were present in 31.7% of patients, were independent predictors: Staphylococcus aureus (OR=4.6), presence of vegetation in the posterior mitral leaflet (OR=3.2) and history of hypertension (OR=3.32). Survival at 5 and 10 years was 88.20% ± 0.04 and 81.50% ± 0.05 respectively. Conclusions: operative mortality of active endocarditis in our environment is high and similar to that reported internationally. The presence of local complications is associated with prosthetic endocarditis in evolution and proved to be an independent predictor of long-term survival, and operative mortality. Long-term survival is similar to that reported internationally. A high incidence of in-hospital agents was observed and invasive procedures as probable causes.
Resumo: Antecedentes: a endocardite infecciosa é uma doença com alta morbimortalidade. Requerem tratamento cirúrgico o 50%. Em nosso meio, as características clínicas e evolutivas dos pacientes operados com endocardite ativa são desconhecidas. Objetivos: primário, determinar a mortalidade operatória e a sobrevida a longo prazo; secundário: Definir preditores de embolias, complicações locais, mortalidade operatória e endocardite protética na evolução. Métodos: trabalho retrospectivo, analítico. Foram identificados no banco de dados pacientes submetidos à cirurgia de endocardite ativa entre janeiro de 2006 e dezembro de 2017. Através de regressão logística multivariada, os preditores foram identificados para os objetivos estabelecidos. Resultados: cento e um pacientes foram incluídos. Staphylococcus aureus foi o microrganismo mais frequente (15,8%). A topografia foi protética em 20,8%, aórtica 46,5%, mitral 23,8% e mitroaórtica 13,9%. A mortalidade operatória foi de 11,3% e 29,5% (p = 0,025), de acordo com a ausência ou presença de complicações locais, o único preditor independente de mortalidade (OR). Um 47,5% apresentaram complicações locais, sendo o mais frequente o abscesso (25,7%). Os preditores independentes foram: endocardite protética (OR = 5,8), endocardite valvar aórtica (OR=2,9)) e sexo masculino (OR = 3,5). A incidência de endocardite protética precoce foi de 3% e tardia de 4%. Trinta por cento dos pacientes adquiriram endocardite infecciosa como resultado de um procedimento médico invasivo nos 6 meses anteriores. Dos pacientes com endocardite protética na evolução, 85,7% apresentava complicações locais (p <0,05). O 31,7% apresentava embolia, resultando em preditores independentes: Staphylococcus aureus (OR = 4,6), vegetação no véu mitral posterior (OR = 3,2) e história de hipertensão arterial (OR = 3,32). A sobrevida em 5 e 10 anos foi de 88,20% ± 0,04 e 81,50% ± 0,05, respectivamente. Conclusões: a mortalidade operatória da endocardite ativa em nosso ambiente é alto e semelhante ao relatado internacionalmente. A presença de complicações locais está associada à endocardite protética na evolução e provou ser um preditor independente de sobrevida a longo prazo e mortalidade operatória. A sobrevivência a longo prazo é semelhante à relatada internacionalmente. Foi observada alta incidência de agentes hospitalares e procedimentos invasivos como causas prováveis.