Experiência Inicial com o Implante Percutâneo da Válvula Melody® no Brasil

Abstract

Background: Transcatheter pulmonary valve implantation is an alternative for dysfunctional conduits. We report the first experience with the Melody™ valve implantation in Brazil. Methods: Patients with significant pulmonary stenosis or significant pulmonary insufficiency in conduits measuring 16 to 22 mm were enrolled. Standardized techniques were employed. The feasibility, safety and efficacy of this procedure were assessed. Results: From December 2013, ten patients (mean age and weight of 16.5 years and 49 kg, respectively) have undergone the procedure with a mean interval of 11.9 ± 8.6 years since the last surgery. Pulmonary insufficiency was an indication for treatment in three patients, pulmonary stenosis in two, and mixed lesion in five. The Melody™ valve was successfully implanted in all cases. Mean right ventricular systolic pressure and right ventricle/left ventricle ratio decreased from 49.2 ± 15.9 to 35.8 ± 5.7 mmHg and from 0.55 ± 0.18 to 0.39 ± 0.08 mmHg (p < 0.01 for both). Significant residual pulmonary stenosis or pulmonary insufficiency was not observed. One patient had a contained conduit tear requiring a covered stent and a second valve implantation. All patients were discharged within 72 hours. The valves were properly functioning in a mean follow-up of 4.1 ± 2.2 months with no complications. Conclusions: Transcatheter Melody™ valve implantation was feasible, safe and effective in our environment and in line with previously published data. Although more patients and a longer follow-up are required, cost-effectiveness studies should be performed for possible incorporation in the Brazilian public health system. DESCRIPTORS:Pulmonary valve stenosis. Pulmonary valve insufficiency. Tetralogy of Fallot. Prostheses and implants. Experiência Inicial com o Implante Percutâneo da Válvula Melody ® no Brasil Introdução: O implante percutâneo da válvula pulmonar é uma alternativa para condutos com disfunção. Descrevemos aqui a primeira experiência com o implante da válvula Melody ® no Brasil. Métodos: Foram selecionados pacientes com estenose ou insuficiência pulmonar significativa em condutos de 16 a 22 mm. Foram empregadas técnicas padronizadas. Factibilidade, segurança e eficácia desse procedimento foram avaliadas. Resultados: Desde dezembro de 2013, dez pacientes (média de idade e peso de 16,5 anos e 49 kg, respectivamente) foram submetidos ao procedimento com intervalo médio de 11,9 ± 8,6 anos desde a última cirurgia. Insuficiência pulmonar foi indicação para o tratamento em três pacientes, estenose em dois e lesão mista em cinco. A válvula Melody ® foi implantada com sucesso em todos os casos. A média da pressão sistólica do ventrículo direito e a relação ventrículo direito/ventrículo esquerdo diminuíram de 49,2 ± 15,9 para 35,8 ± 5,7 mmHg e de 0,55 ± 0,18 para 0,39 ± 0,08 mmHg (p < 0,01 para ambos). Não observamos estenose e nem insuficiência pulmonar residual significativa. Um paciente teve extravasamento contido requerendo um stent coberto e um segundo implante valvular. Todos os pacientes receber...

Melodias do Brasil

“…A significant step in the right direction is the work by Ribeiro et al 6 , which describes the initial experien ce with percutaneous implantation of the Melody ® valve in Brazil. The authors evaluated patients in a multicenter study, and their results were in line with the international experience.…”

Initial experience with the percutaneous implant of the Melody® valve in a hospital center in Mexico City

“…Surgical correction of congenital heart diseases (CHDs) that involve the right ventricle outflow tract (RVOT) favors anatomical and functional alterations of the pulmonary artery valve and trunk in the late post-operative period. For the correction of these alterations, the patient must undergo new surgical events that require implantation of biological devices such as allografts and bioprostheses, among others, which usually deteriorate as a consequence of an adaptive patient response that modifies their geometry, favors caliber reduction and blood flow reduction, which clinically is observed as functional class deterioration, with significantly high morbidity and mortality rate being associated with these reoperations [1][2][3][4] .…”

“…Since most patients with CHD that involves RVOT will require reoperation during their lifetime, the need for options to improve approaching strategies and decrease primary correction reoperation complications was a reason for the development of new technologies aiming to restore the blood flow to the pulmonary circulation, with percutaneous technology appearing for the implantation of pulmonary bioprostheses [1][2][3][4][5][6][7][8][9] .…”

“…The Melody ® valve consists of a 34-mm platinum-iridium bare stent (CP stent, NuMED Inc.; Hopkinton, New York, USA), with one valve made with a bovine jugular vein segment. The device is attached to a balloon catheter and released on a 22-Fr sleeve [1][2][3][4][5][6][7][8][9][10] . Despite its size, the use of the Melody ® valve was intended for those patients with RVOT diameters of < 24 mm, which limited the benefit to a specific group of patients.…”

“…These percutaneous-implantation devices have shown in the USA and in European countries very low morbidity and practically no mortality and have become a real tool for patients with these complications, who also have elevated surgical risk 1,[10][11][12][13][14][15][16][17][18][19][20][21] .…”