Transapical balloon explandable mitral valve development

• Grant number: 10/18983-2
• Support Opportunities: Regular Research Grants
• Start date: December 01, 2011
• End date: November 30, 2012
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Enio Buffolo
• Grantee: Enio Buffolo
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil
• Associated researchers: André Telis de Vilela Araújoq ; Carolina Baeta Neves Duarte Ferreira ; Diego Felipe Gaia dos Santos ; Jose Augusto Marcondes de Souza ; José Cícero Stocco Guilhen ; José Honório de Almeida Palma da Fonseca ; Marcio Rodrigo Martins ; Murilo Teixeira Macedo

Abstract

Mitral valve replacement and repair are procedures are well established.Nevertheless, some patients have a high surgical risk. Alternatives have been proposed in these patients, but limitations persist and surgical results are still disappointing. Traditional repair involves valve replacement or repair undercardiopulmonary bypass (CPB). Reports have demonstrated less invasive repair initiatives without CPB. There is no valve mounted on a catheter with adequate results for mitral valve implant. The purpose of this study is to develop a transcatheter balloon-expandable mitral valve for minimally invasive implant without CPB.Methods: Valved stents will be developed and deployed in sheep thought ventricular apex. Echocardiographic and fluoroscopic control will be used for implant guidance. The use of high frequency pacemaker will help device opening and a purse string suture occlude ventricular apex. Invasive and non invasive hemodynamics measurements will be performed immediately and during follow-up period. Results: An appropriate implant is expected in mitral position with maintenance of adequate hemodynamic profile in 6 month follow-up. Hemodynamic performance and prosthesis-left-atrium-inflow tract analysis will allow the development of prototypes to be used in humans. Conclusion: Development of a balloon-expandable mitral valved stent will allow the advent of a new technique for mitral intervention, using national technology, and possibly applicableto high risk surgical patients reducing morbidity and mortality. (AU)