RESUMO

OBJECTIVE: To assess actual data on the safety, effectiveness, and hemodynamic performance of Bovine Pericardium Organic Valvular Bioprosthesis (BVP). METHODS: The BIOPRO Trial is an observational, retrospective, non-comparative, non-randomized, and multicenter study. We collected data from 903 patients with symptomatic, moderate, or severe valve disease who underwent BVP implants in the timeframe from 2013 to 2020 at three Brazilian institutions. Death, valve-related adverse events (AEs), functional recovery, and hemodynamic performance were evaluated at the hospital, at discharge, and six months and one year later. Primary analysis compared late (> 30 days after implant) linearized rates of valve-related AEs, such as thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, and endocarditis, following objective performance criteria (OPC). Analysis was performed to include at least 400 valve-years for each valve position (aortic and mitral) for complete comparisons to OPC. Kaplan-Meier survival and major adverse cardiovascular and cerebrovascular event analyses were also performed. RESULTS: This retrospective study analyzed follow-up data collected from 903 patients (834.2 late patient-years) who have undergone surgery for 455 isolated aortic valve replacement (50.4%), 382 isolated mitral valve replacement (42.3%), and 66 combined valve replacement or other intervention (7.3%). The linearized rates of valve-related AEs were < 2 × OPC. One-year survival rates were 95.1% and 92.7% for aortic and mitral valve replacement, respectively. This study demonstrated an improvement in the New York Heart Association classification from baseline and hemodynamic performance within an expected range. CONCLUSION: According to this analysis, BVP meets world standards for safety and clinical efficacy.

Assuntos

RESUMO

Background An aspect not so clear in the scenario of aortic surgery is how patients fare after composite aortic valve graft replacement (CAVGR) depending on the type of valve (bioprosthetic versus mechanical). We performed a study to evaluate the long-term outcomes of both strategies comparatively. Methods and Results Pooled meta-analysis of Kaplan-Meier-derived time-to-event data from studies with follow-up for overall survival (all-cause death), event-free survival (composite end point of cardiac death, valve-related complications, stroke, bleeding, embolic events, and/or endocarditis), and freedom from reintervention. Twenty-three studies met our eligibility criteria, including 11 428 patients (3786 patients with mechanical valves and 7642 patients with bioprosthetic valve). The overall population was mostly composed of men (mean age, 45.5-75.6 years). In comparison with patients who underwent CAVGR with bioprosthetic valves, patients undergoing CAVGR with mechanical valves presented no statistically significant difference in the risk of all-cause death in the first 30 days after the procedure (hazard ratio [HR], 1.24 [95% CI, 0.95-1.60]; P=0.109), but they had a significantly lower risk of all-cause mortality after the 30-day time point (HR, 0.89 [95% CI, 0.81-0.99]; P=0.039) and lower risk of reintervention (HR, 0.33 [95% CI, 0.24-0.45]; P<0.001). Despite its increased risk for the composite end point in the first 6 years of follow-up (HR, 1.41 [95% CI, 1.09-1.82]; P=0.009), CAVGR with mechanical valves is associated with a lower risk for the composite end point after the 6-year time point (HR, 0.46 [95% CI, 0.31-0.67]; P<0.001). Conclusions CAVGR with mechanical valves is associated with better long-term outcomes in comparison with CAVGR with bioprosthetic valves.

Assuntos

RESUMO

RESUMEN Introducción : El reemplazo de la raíz aórtica con conservación valvular (valve-sparing aortic root replacement, VSAR) se ha consolidado como un procedimiento eficaz para el tratamiento del aneurisma de la raíz aórtica, el síndrome de Marfan, la válvula bicúspide y la disección aórtica. Sin embargo, es necesario llegar a una opinión unánime sobre los aspectos clave del VSAR. Material y métodos : Se realizó una revisión bibliográfica de los debates y controversias más frecuentes del VSAR. A partir de esta información se elaboró una encuesta en línea que se envió a cirujanos con experiencia comprobada en VSAR para conocer su opinión sobre los factores relacionados con los pacientes, los aspectos técnicos, la ecocardiografía, la investigación, la formación y el futuro del VSAR. Resultados : Veinte cirujanos completaron la encuesta. Según 14 de cada 20 encuestados, la fracción de eyección grave se consideró una contraindicación para el llevar a cabo este procedimiento. El límite del diámetro del anillo aórtico para la remodelación fue heterogéneo entre los participantes. Todos ellos consideraron que el VSAR es un procedimiento seguro para los pacientes con síndrome de Marfan y válvula bicúspide. En el caso de disección de tipo A, 11 de cada 20 prefirieron este procedimiento solo para los pacientes jóvenes. En lo que respecta al tamaño del injerto, la altura del triángulo intervalvar (8/20) y el diámetro sinotubular (7/20) fueron los más frecuentes. Los cirujanos informaron una tasa de fracaso del 7% en la conversión al procedimiento de Bentall, y un cambio de estrategia intraoperatoria del 26%. No se consideró que un abordaje mínimamente invasivo mejorara los resultados. La mayoría de los cirujanos coincidieron en que el VSAR lo deben realizar cirujanos con mucha experiencia. Conclusiones : El VSAR ha sido aceptado como una opción terapéutica para el aneurisma de la raíz aórtica, y, aunque todavía no es posible llegar a un consenso definitivo, se presenta la valiosa experiencia de los cirujanos más destacados en este campo.

ABSTRACT Background : The valve-sparing aortic root replacement (VSAR) has been established as a successful procedure for aortic root aneurysms, Marfan's syndrome, bicuspid valves, and aortic dissections. However, there is a need for a consensus opinion regarding key aspects of VSAR. Methods : A literature review was performed regarding the most frequent debates and controversies in VSAR. An online survey was developed based on this information, and sent to surgeons with known expertise in VSAR regarding their opinion on patient-related factors, technical aspects, echocardiography, research, training, and the future of VSAR. Results : Twenty surgeons completed the survey. The reduction of left ventricular ejection fraction was considered a contra indication to VSAR when severe by 14/20 surveyed. The aortic annulus diameter cutoff point for the remodeling was heterogenous among participants. All of them felt that VSAR is safe for the Marfan´s syndrome population and bicuspid valves. For type A dissections, 11/20 preferred this procedure only in young patients. Regarding to graft sizing, the height of the interleaflet triangle (8/20) and the sino-tubular diameter (7/20) were the more frequent considered parameters. Surgeons reported a 7% of failure rate, leading to conversion to Bentall surgery, and a 26% change of strategy intraoperatively. A minimally invasive approach was not considered to improve results. Most of the surgeons agreed that VSAR should be performed by high-experienced surgeons. Conclusions : The VSAR has been accepted as a treatment option for the aortic root´s aneurysms, and even though there is still not possible to reach a final consensus, a valuable experience from the most relevant surgeons in the field is presented.

RESUMO

INTRODUCTION: The measurement of the health-related quality of life construct can reveal the positive repercussions on the lives of patients undergoing corrective valve procedures, as well as revealing points that prevent new surgical approaches. OBJECTIVE: To identify the health-related quality of life of valvular heart disease in the perioperative period of conventional valve surgery. METHODS: This is an integrative literature review. Searches were performed independently in four databases using controlled and uncontrolled descriptors. Eligibility criteria were: original articles that addressed the assessment of the health-related quality of life of valvular patients undergoing valve repair and/or valve prosthesis implantation; in Portuguese, English, and Spanish; with a time frame for convenience between 2015 and 2019. RESULTS: 14 studies comprised the final review sample, despite being studies conducted in different countries and with different designs, it was possible to verify the improvement in health-related quality of life when evaluated through generic instruments in valvular patients after valve surgery. However, in studies in which the assessment of the construct occurred through specific instruments, the existence of factors that can interfere with the quality of life of patients undergoing valve implantation was revealed. CONCLUSION: It was noticed that there was generally an improvement in health-related quality of life after the surgical intervention.

INTRODUÇÃO: A mensuração do constructo qualidade de vida relacionada à saúde pode revelar as repercussões positivas na vida dos pacientes submetidos a procedimentos valvares corretivos, bem como revelar pontos que para prevenção de novas abordagens cirúrgica. OBJETIVO: Identificar a qualidade de vida relacionada à saúde de valvopatas no perioperatório de intervenção cirúrgica valvar convencional. MÉTODO: Trata-se de uma revisão integrativa da literatura. As buscas foram realizadas de forma independente, em quatro bases de dados por meio de descritores controlados e não controlados. Os critérios de elegibilidade foram: artigos originais que abordassem a avaliação da qualidade de vida relacionada à saúde de valvopatas submetidos à plastia valvar e/ou implante de prótese valvar; nos idiomas português, inglês e espanhol; com recorte temporal por conveniência entre 2015 e 2019. RESULTADOS: 14 estudos compuseram a amostra final da revisão, apesar de serem estudos realizados em distintos países e com diferentes delineamentos foi possível verificar a melhora da qualidade de vida relacionada à saúde quando avaliada por meio de instrumentos genéricos em valvopatas após a intervenção cirúrgica valvar. Todavia, nos estudos em que a avaliação do constructo ocorreu por meio de instrumentos específicos, foi revelada a existência de fatores que podem interferir na qualidade de vida dos pacientes submetidos aos implantes valvares. CONCLUSÃO: Percebeu-se que geralmente houve melhora da qualidade de vida relacionada à saúde após a intervenção cirúrgica.

Assuntos

RESUMO

Resumo A doença valvar cardíaca é um problema de saúde crescente no mundo. Os pacientes com valvopatia podem apresentar diversas emergências cardiovasculares. O manejo desses pacientes é um desafio no departamento de emergência, principalmente quando a condição cardíaca prévia é desconhecida. Atualmente, recomendações específicas para o manejo inicial são limitadas. A presente revisão integrativa propõe uma abordagem baseada em evidência, de três etapas, desde a suspeita de valvopatia à beira do leito até o tratamento inicial das emergências. A primeira etapa é a suspeita de uma condição valvar subjacente com base nos sinais e sintomas. A segunda etapa consiste na tentativa de confirmação diagnóstica e avaliação da gravidade da valvopatia com exames complementares. Finalmente, a terceira etapa aborda as opções diagnósticas e terapêuticas para insuficiência cardíaca, fibrilação atrial, trombose valvar, febre reumática aguda, e endocardite infecciosa. Além disso, apresentamos imagens de exames complementares e tabelas para apoio aos médicos.

Abstract Valvular heart disease (VHD) is an increasing health problem worldwide. Patients with VHD may experience several cardiovascular-related emergencies. The management of these patients is a challenge in the emergency department, especially when the previous heart condition is unknown. Specific recommendations for the initial management are currently poor. This integrative review proposes an evidence-based three-step approach from bedside VHD suspicion to the initial treatment of the emergencies. The first step is the suspicion of underlying valvular condition based on signs and symptoms. The second step comprises the attempt to confirm the diagnosis and assessment of VHD severity with complementary tests. Finally, the third step addresses the diagnosis and treatment options for heart failure, atrial fibrillation, valvular thrombosis, acute rheumatic fever, and infective endocarditis. In addition, several images of complementary tests and summary tables are provided for physician support.

RESUMO

A substituição transcateter valve-in-valve da valva mitral surgiu recentemente como uma alternativa cada vez mais utilizada nos pacientes de alto risco cirúrgico. O presente caso relata uma substituição de valva mitral transcateter valve-in-valve, por via transeptal, como tratamento da degeneração de uma bioprótese mitral cirúrgica e regurgitação grave, em paciente de 86 anos já submetido a uma substituição transcateter valve-in-valve aórtica, há 6 anos. Este caso enfatiza o papel crucial de uma avaliação pré-operatória cuidadosa, com uso de diferentes modalidades de exames de imagem, para planejamento do procedimento, em paciente com maior risco de obstrução da via de saída do ventrículo esquerdo, devido a um procedimento valve-in-valve aórtico prévio.

Transcatheter mitral valve-in-valve replacement has recently emerged as an increasingly common alternative for high surgical risk patients. We report a case of a successful transseptal transcatheter mitral valve-in-valve replacement for the treatment of a bioprosthetic mitral valve degeneration and severe regurgitation, in an 86-year-old patient who had undergone transcatheter aortic valve-in-valve procedure 6 years ago. This case emphasizes the crucial role of a careful preoperative assessment using multimodality imaging to plan the procedure, in a patient with higher risk of left ventricular outflow obstruction due to the previous transcatheter aortic valve-in- valve procedure.

RESUMO

ABSTRACT Objective: To assess actual data on the safety, effectiveness, and hemodynamic performance of Bovine Pericardium Organic Valvular Bioprosthesis (BVP). Methods: The BIOPRO Trial is an observational, retrospective, non-comparative, non-randomized, and multicenter study. We collected data from 903 patients with symptomatic, moderate, or severe valve disease who underwent BVP implants in the timeframe from 2013 to 2020 at three Brazilian institutions. Death, valve-related adverse events (AEs), functional recovery, and hemodynamic performance were evaluated at the hospital, at discharge, and six months and one year later. Primary analysis compared late (> 30 days after implant) linearized rates of valve-related AEs, such as thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, and endocarditis, following objective performance criteria (OPC). Analysis was performed to include at least 400 valve-years for each valve position (aortic and mitral) for complete comparisons to OPC. Kaplan-Meier survival and major adverse cardiovascular and cerebrovascular event analyses were also performed. Results: This retrospective study analyzed follow-up data collected from 903 patients (834.2 late patient-years) who have undergone surgery for 455 isolated aortic valve replacement (50.4%), 382 isolated mitral valve replacement (42.3%), and 66 combined valve replacement or other intervention (7.3%). The linearized rates of valve-related AEs were < 2 × OPC. One-year survival rates were 95.1% and 92.7% for aortic and mitral valve replacement, respectively. This study demonstrated an improvement in the New York Heart Association classification from baseline and hemodynamic performance within an expected range. Conclusion: According to this analysis, BVP meets world standards for safety and clinical efficacy.

RESUMO

A insuficiência mitral moderada a grave é observada em 17 a 35% dos pacientes submetidos a implante transcateter de válvula aórtica. Estudo que reporta a insuficiência mitral pós- realização de implante transcateter de válvula aórtica por estenose aórtica demonstra que 50% dos pacientes com refluxo moderado a grave apresentaram melhora da regurgitação, e 8,7% evidenciam piora do quadro. Nesses pacientes com piora, houve aumento da mortalidade. Essa progressão sugere que condutas convencionais, baseadas em otimização medicamentosa, podem não ser capazes de prevenir quadros negativos. Relatamos um caso sobre a evolução da insuficiência mitral após implante transcateter de válvula aórtica e o uso do MitraClip® como alternativa de tratamento e benefícios.

Moderate to severe mitral regurgitation is observed in 17 to 35% of patients undergoing transcatheter aortic valve implantation. A study reporting mitral regurgitation after transcatheter aortic valve implantation due to aortic stenosis demontrated 50% of patients with moderate to severe reflux showed improvement in regurgitation, and 8.7% showed worsening of the condition, which led to increased mortality. This progression suggested conventional management, based on medication optimization, may not be able to prevent poor outcomes. We report a case on the clinical course of a patient with mitral regurgitation after transcatheter aortic valve implantation, and the use of MitraClip® as an alternative treatment and its benefits.