Expandable polyurethane stent valve implantation, by catheter, in patients with pulmonary valve dysfunction

• Grant number: 21/05201-0
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: June 01, 2021
• End date: May 31, 2022
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Miguel Angel Maluf
• Grantee: Fernanda Yoshinaga
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

Synthetic prosthesis model: stent Polyurethane Expandable Valve, developed with new concepts, experimentally tested and approved in the tests required by ANVISA / FDA: ISO 5840, 2015, showed advantages when compared with the current biological prostheses that are in the current market. Goals: This is a Prospective, Single-Arm study to assess the safety and efficacy of the expandable polyurethane valve stent, approach technique and its implantation in the pulmonary position. Research protocol approved by the Research Ethics Committee of Hospital Alemão Oswaldo Cruz, CONEP and authorized by ANVISA. Material and Method Initially, a Pilot Study will be carried out, with 5 adult patients, over 18 years of age, with tetrade of Fallot, already operated and evolving with Pulmonary Insufficiency and Right Ventricular Dysfunction. (Evaluation by the Nuclear Magnetic Resonance Examination)The technique of surgical approach, will be through mini-thoracotomy, and aid of Extracorporeal Circulation. The prosthesis will be implanted in a pulmonary position and expanded with a balloon catheter under direct view. Results The evaluation of the results of the pulmonary valve implantation and the performance of the pulmonary prosthesis will be carried out by the transesophageal eco-Doppler cardiographic study. Conclusion Results of imaging tests and functional tests will be compared with tests performed preoperatively, in order to classify the functional class of patients.