Development of a balloon-expandable valved stent for implant in mitral position

• Grant number: 13/07343-0
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: July 01, 2013
• End date: June 30, 2014
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Diego Felipe Gaia dos Santos
• Grantee: Luís Augusto Furlan Financi
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

Objectives: Mitral valve replacement and repair are procedures are well established. Nevertheless, some patients have a high surgical risk. Several alternatives have been proposed in these patients, but many restrictions remain and the surgical results are still disappointing. The traditional repair involves valve replacement or repair under cardiopulmonary bypass. Several reports have demonstrated efforts to correct mitral insufficiency using less invasive techniques without the use of cardiopulmonary bypass. Until now there is no adequate transcatheter mitral valve. The objective of this study is to develop a transcatheter balloon-expandable mitral valve for minimally invase implant without cardiopulmonary bypass. Methods: Biological transcatheter mitral valves will be developed and implanted in 10 pigs thought the left ventricle apex. Echocardiographic and fluoroscopic control will 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 moth 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 applicable to high risk surgical patients reducing morbidity and mortality. (AU)