Ballon-expandable and self-expandable valve development with minimally invasive deployment in aortic and pulmonary positions

• Grant number: 08/04462-0
• Support Opportunities: Regular Research Grants
• Start date: October 01, 2008
• End date: September 30, 2009
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Enio Buffolo
• Grantee: Enio Buffolo
• Host Institution: Departamento de Cirurgia. Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

The aortic valve repair and replacement are well established. In spite of this, some patients presents a high surgical risk. Diverse alternative approaches were proposed, but many limitations exists and surgical results are quite inferior. Pulmonary insufficiency is a comon problem after surcical correction of Fallot disease. Non surgical and clinical follow-up can lead to permanent ventricular disfunction. There is no consensus about design, landing system or access. The aim of this study was the development of a self-expandable aortic valved stent and an off pump minimally invasive implant method. Methods: Ballon and self-expandable valved stents will be implanted in 24 adult pigs (12 aortic and 12 pulmonary)trough direct-access transapical approach or right ventricle outfloe tract using a minimally invasive technique. Echocardiography and fluoroscopy guidance will be used in order to guide the correct deployment. Rapid ventricular pacing will an easier deployment. A purse string suture will occlude the cardiac apex or right ventricle outflow tract. Non invasive and invasive haemodynamics performance measures and histological analisys will be performed imediatly after the procedure and in the follow-up period. RESULTS A correct deployment and a favorable hemodinamic profile are expected in the immediate post-operative period and in tree moth follow-up. Hemodinamic profile and prosthesis-aortic root-coronary ostia and prosthesis-pulmonary trunk analysis will provide a basis to develop a prototype to be used in humans. Conclusions: Ballon-expandable and self-expandable valved stent development will possible allow an emerging new aortic valve and pulmanary intervention techniques. Possible applications will be high risk individuals, offering lower morbity and mortality risks. (AU)