Assessment of the addition of bristles to the transcatheter prosthesis Braile Inovare in the reduction of perivalvular leakage

• Grant number: 15/15293-9
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: December 01, 2015
• End date: November 30, 2016
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Diego Felipe Gaia dos Santos
• Grantee: Matheus Simonato dos Santos
• Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

Objectives: Transcatheter valve replacement is a well-established procedure for patients with high risk for conventional surgery. Initial results are satisfactory and safe. However, the onset of post-procedural perivalvular leakage remains a disadvantage when compared to the conventional procedure and patients with significant leakage show a worse long-term prognosis. Therefore, reducing perivalvular leak is fundamental in the improvement of results. Methods: Bristles used in embolization coils were added to the external surface of the Braile Inovare prosthesis with the objective of reducing perivalvular leakage. 60 patients with severe aortic stenosis will be selected and then randomized for the procedure with bristled Inovare or regular Inovare. Perivalvular leakage will be assessed with tridimensional transesophageal echocardiography and the groups will be compared regarding the presence and degree of the issue.Expected results: It is expected that the addition of bristles to the external part of the Braile Inovare should be able to reduce perivalvular leakage associated to transcatheter aortic valve replacement. Thus, we would be able to see a reduction in procedural morbimortality.