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Master's Dissertation
DOI
https://doi.org/10.11606/D.98.2021.tde-08022022-142326
Document
Author
Full name
Pedro Campelo Neto
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2020
Supervisor
Committee
Siqueira, Dimytri Alexandre de Alvim (President)
Cantarelli, Marcelo José de Carvalho
Costa Junior, José de Ribamar
Tarasoutchi, Flavio
Title in Portuguese
Durabilidade após implante de bioprótese aórtica transcateter: incidência e preditores de deterioração estrutural
Keywords in Portuguese
Implante de Prótese de Valva Cardíaca
Substituição da Valva Aórtica Transcateter.
Valva aórtica
Abstract in Portuguese
Introdução: O implante valvar aórtico percutâneo (TAVI - transcatheter aortic valve implantation) se estabeleceu como o tratamento mais indicado para pacientes com estenose aórtica (EA) severa sintomática de alto ou proibitivo risco cirúrgico. Estudos recentes demonstraram não-inferioridade ou superioridade para TAVI em relação à cirurgia tradicional em pacientes de risco intermediário e baixo. Em razão da alta mortalidade de pacientes idosos e de alto risco, associada ao fato de que a deterioração raramente ocorre nos primeiros anos, pouco ainda se sabe sobre a durabilidade do TAVI. Com a expansão de suas indicações a pacientes mais jovens e com menor risco cirúrgico, faz-se necessário conhecer melhor a incidência de deterioração protética e prognóstico ao longo dos anos. Os objetivos deste estudo são descrever a evolução do perfil hemodinâmico e a durabilidade da bioprótese nos pacientes submetidos ao TAVI. Além disso, identificar fatores de risco independentes para deterioração valvar relacionados a características clínicas e do procedimento. Metodologia: Pesquisa observacional, longitudinal, com análise retrospectiva de banco de dados de pacientes com diagnóstico de EA sintomática submetidos ao TAVI no período de dezembro de 2009 até outubro de 2017, em dois centros nacionais. Foram selecionados pacientes sobreviventes e sem insucesso do procedimento em até 30 dias do TAVI, e acompanhados através de seguimento clínico e ecocardiográfico sistemático. Utilizamos as definições para deterioração estrutural (SVD structural valve deterioration) e falência de prótese (BVF bioprosthetic valve failure) publicadas pelo consenso da European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Society of Cardiology (ESC) e European Association for Cardio-Thoracic Surgery (EACTS). Resultados: Obtivemos dados iniciais de 318 pacientes, com média de idade de 81,9 ± 7,1 anos, sendo 54,7% (n=174) mulheres. A média do Euroscore II foi de 7,4±5,9% e o STS (Society of Thoracic Surgeons) de 6,4 ± 5,8%. Após seguimento médio de 25,4 meses, e 28 (8,89%) pacientes apresentaram SVD, e 2 (0,63%) pacientes com BVF. O gradiente pressórico médio reduziu de 52,9 ± 15 mmHg (pré-TAVI) para 10,4 ± 4,8 mmHg (pós-TAVI) (p<0,001), e manteve-se estável ao longo do tempo. Área valvar aórtica aumentou de 0,7 ± 18 para 1,9 ± 0,3 cm² após TAVI (p<0,001), e em nossa amostra teve leve redução ao longo do tempo. Em análise univariada, o uso de bioprótese balão expansível (p < 0,001), gradiente aórtico médio prévio (p = 0,026) e ausência de pós dilatação (p = 0,013) se associaram com SVD. O uso de prótese balão expansível (p = 0,001) foi preditor de SVD em análise multivariada. Conclusões: O seguimento após TAVI mostrou favorável performance hemodinâmica, com baixas taxas de deterioração valvar e falência de prótese em nossa população selecionada. Fatores clínicos e de procedimento estão relacionados à deterioração estrutural.
Title in English
Durability after transcatheter aortic bioprosthesis implantation: incidence and predictors of structural deterioration
Keywords in English
Aortic Stenosis
Heart Valve Prosthesis Implantation
Transcatheter Aortic Valve Replacement
Abstract in English
Introduction: Transcatheter aortic valve implantation (TAVI) is an established treatment for patients with severe symptomatic aortic stenosis who are considered at high or prohibitive surgical risk. Recent studies have demonstrated non-inferiority or superiority for TAVI over traditional surgery in patients at intermediate and low risk. Due to the high mortality of elderly and high-risk patients, associated with the fact that deterioration rarely occurs in the first years, little is known about the durability of TAVI. With the expansion of its indications to younger patients and with less surgical risk, it is necessary to better understand the incidence of prosthetic deterioration and prognosis over the years. The objectives of this study are to describe the evolution of the hemodynamic profile and the durability of the bioprosthesis in patients undergoing TAVI. In addition, to identify independent risk factors for valve deterioration related to clinical and procedure characteristics. Methodology: Observational, longitudinal research, with retrospective analysis of the database of patients diagnosed with symptomatic aortic stenosis submitted to TAVI from December 2009 to October 2017, in two national centers. Surviving patients with no bioprosthesis failure within 30 days of TAVI were selected. Systematic clinical and echocardiographic follow-up was perfomed. We used the definitions for structural deterioration (SVD - structural valve deterioration) and prosthesis failure (BVF - bioprosthetic valve failure) published by the consensus of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), European Society of Cardiology (ESC) and European Association for Cardio -Thoracic Surgery (EACTS). Results: We obtained initial data from 318 patients; mean age was 81.9 ± 7.1 years, with 54.7% (n = 174) women. Euroscore II was 7.4 ± 5.9% and the STS score was 6.4 ± 5.8%. After a mean follow-up of 25.4 months, 28 (8.89%) patients had SVD, and 2 (0.63%) patients had BVF. The mean gradient decreased from 52.9 ± 15 mmHg (pre TAVI) to 10.4 ± 4.8 mmHg (post TAVI) (p <0.001), and remained stable over time. Aortic valve area increased from 0.7 ± 18 to 1.9 ± 0.3 cm² after TAVI (p <0.001), and in our sample it had a slight reduction over time. In univariate analysis, the use of an expandable balloon bioprosthesis (p <0.001), previous mean aortic gradient (p = 0.026) and absence of post-dilation (p = 0.013) were associated with SVD. The use of an expandable balloon prosthesis (p = 0.001) was a predictor of SVD in multivariate analysis. Conclusions: Follow-up after TAVI showed favorable hemodynamic performance, with low rates of valve deterioration and prosthesis failure in our selected population. Clinical and procedural factors are related to structural deterioration.
 
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Publishing Date
2022-05-23
 
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