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- ItemSomente MetadadadosAnálise Do Comportamento Hidrodinâmico In Vitro Dos Implantes De Próteses Valvares Transcateter Dentro De Biopróteses Aórticas Convencionais: Uma Nova Alternativa À Reoperações(Universidade Federal de São Paulo (UNIFESP), 2017-12-21) Cardoso, Caio Cesar [UNIFESP]; Fonseca, Jose Honorio De Almeida Palma Da [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)OBJECTIVE: Hydrodynamic evaluation of the transcatheter valve implantation in aortic bioprosthesis (valve-in-valve) and in sets of bioprosthesis with a transcatheter valve previously implanted (valve-in-valve-in-valve or sequential valve-in-valve), in order to guide therapeutic limits and the optimal transcatheter valve size. METHODS: With the Pulse Duplicator, and accordingly to FDA and ISO 5840 determinations for cardiac output (5L/min), mean arterial blood preesure (100mmHg) and cardiac frequency variation (70-120), the hydrodynamics tests were procedded to measure efective orificial area (EOA-cm²) and transvalvar gradient (ΔP-mmHg) for each set of valve-in-valve and valve-in-valve-in-valve. The valve-in-valve tests: for each bioprosthesis (Braile Biomédica), between 19mm and 25mm, a transcatheter valve (Braile Inovare, with nominal sizes between 20 and 26mm), either 1mm larger or 1mm smaller, was implanted. The valve-in-valve-in-valve tests: for each optimal set of valve-in-valve (determined in the valve-in-valve tests), a transcatheter valve 2mm smaller than the previous was implanted. Each set described of valve-in-valve or valve-in-valve-in-valve was replicated ten times, and the tests in the Pulse Duplicator were performed for each set three times. RESULTS: The set aortic bioprosthesis 19mm and transcatheter valve 20mm, the EOA was 0,5 and the ΔP was 43,7. Moreover, the sets 21-20 and 21-22 resulted in EOA 0,8 and 0,73, and ΔP 19,4 and 23,4. For the sets 23-22 and 23-24, the tests showed EOA 1,06 and 0,8, and ΔP 12,5 and 19,5. And finally, for the sets 25-24 and 25-26, the EOA was 1,085 and 1,0, and the ΔP was 11,76 and 13,56. The valve-in-valve-in-valve tests has shown that the implantation of a transcatheter valve 22mm in a valve-in-valve set of a 25mm bioprosthesis with the 24mm valve transcathter resulted in EOA 0,99 and ΔP 13,59; when for this set was proceeded the implantation of a third transcatheter valve (20mm), was observed an EOA 10 0,84 and a ΔP 15,31. In a valve-in-valve set with a 23mm bioprosthesis and a 22mm transcatheter valve, the EOA was 0,86 and the ΔP was 15,62 when a 20mm transcatheter valve was implanted. CONCLUSION: The aortic valve-in-valve is fasible, with better hydrodynamic results when the transcatheter valve has the nominal size 1mm smaller than the bioprosthesis; this fact can be explained considering the appropriate oversizing between the bioprosthesis true internal diameter and the transcatheter external diameter (between 10 and 20%). The valve-in-valve in 21mm bioprosthesis should be individualized, and in 19mm prohibited. The transcatheter valve-in-valve-in-valve is feasible as well, with great performance with a sequential implantation of a smaller transcatheter valve up to the 22mm, the 20mm should be cautiously implanted; the oversizing between the immediate smaller transcatheter valve was between 4 and 5%.
- ItemAcesso aberto (Open Access)Avaliação do implante valvar aórtico transcateter com a prótese Inovare Proseal® pela tomografia computadorizada de múltiplos detectores(Universidade Federal de São Paulo (UNIFESP), 2019-03-28) Flori, Apoana Gomes [UNIFESP]; Santos, Diego Felipe Gaia Dos [UNIFESP]; Fonseca, José Honório de Almeida Palma da [UNIFESP]; http://lattes.cnpq.br/9343172569048429; http://lattes.cnpq.br/6986305020681547; http://lattes.cnpq.br/2019403372103010; Universidade Federal de São Paulo (UNIFESP)OBJECTIVES: Transcatheter aortic valve replacement (TAVR) is an established procedure for high-risk patients. The Braile Inovare Proseal was developed to reduce the incidence of paravalvular leakage (PVL). Our aim was to evaluate device performance and additionally preand post-operative aortic annulus and the transcatheter prosthesis using multislice computed tomography (MSCT). METHODS: Patients were selected by a multidisciplinary heart team and referred for TAVR. MSCT was performed before and after surgery. Measurements of the aortic valve and prosthesis were conducted and correlated with the valve gradient and residual paravalvular leakage. RESULTS: 21 patients were selected for the protocol. Patients had a mean age of 79 years old and 38% were of female sex. Mean EuroSCORE II was 12.5% ± 10.8. Mean gradient was also reduced from 45.8 ± 11.04 mmHg to 5.59 ± 2.61 mmHg and there were no instances of PVL worse than mild. There were no cases of coronary obstruction or procedural death. Circularity was present in all prostheses evaluated. Circularity indexes for the prostheses were: inflow 0.05 ± 0,03, middle third 0.03 ± 0,02 and outflow 0.03 ± 0,02. The mean distance between the prosthesis and the left and right coronary ostia were 14,8 mm ± 3,3 and 17,3 mm ± 3, respectively. The degree of oversizing was appropriate with a mean of 22.14%. CONCLUSION: Braile Inovare ProSeal transcatheter device has demonstrated good clinical results with low rates of PVL. MSCT was an adequate technique to evaluate device sizing and has demonstrated preserved expansibility and circularity in the evaluated cases.
- ItemAcesso aberto (Open Access)Experiência inicial da Universidade Federal de São Paulo no desenvolvimento e aplicação do implante valvar aórtico transcateter(Universidade Federal de São Paulo (UNIFESP), 2009-11-25) Santos, Diego Felipe Gaia dos [UNIFESP]; Fonseca, José Honório de Almeida Palma da [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)OBJECTIVE: The aortic valve replacement is a routine procedure, and involves replacement of the native valve/prosthesis. In most of the patients who undergo such procedure the risk is acceptable, but in some cases, such risk can justify contraindication. The minimally invasive transcatheter aortic valve implantation has been viable, with lower morbidity and mortality. The aim of this study was to develop a national catheter-mounted aortic bioprosthesis for aortic position implant. METHOD: After animal studies, 14 patients with high EuroSCORE underwent transcatheter aortic valve implantation. Median age was 75,5 years. Median Logistic EuroSCORE was 43,7%. Four patients presented with disfunctional bioprosthesis, remainig ones presented calcified aortic stenosis (peak transvalvular gradient 79,7 mmHg). After minithoracotomy and under echocardiograph and fluoroscopic control, a balloon catheter was placed on aortic position and inflated. After, a second balloon with valved endoprosthesis was positioned and released under high ventricular rate. Echocardiograph and angiograph controls were performed and the patients were referred to ICU. RESULTS: Implant was feasible in 13 cases. There were no intra-operative deaths. Mortality was 42%. Median peak transvalvular aortic gradient reduced to 25,0 mmHg, and left ventricular function improved in the first 7 post operative days. Paravalvular aortic regurgitation was mild and present in most cases. Platelet count significantly decreased after procedure, but returned to normal values after 30 days. CONCLUSION: The transapical implantation of catheter-mounted bioprosthesis was a feasible procedure. Technical details and learning curve require further discussion.