Preclinical analysis: flexible cardiac valve bioprosthesis of Instituto Nacional de Cardiología

To evaluate the safety, functionality, and adaptability of the Flexible Cardiac Valve Bioprosthesis developed at the National Institute of Cardiology (BVC-F INC) as a viable and accessible alternative for the treatment of valvular heart disease, with particular emphasis on its applicability in valve-in-valve (ViV) procedures. This initiative aims to strengthen the national development of cardiovascular devices.

Computational analyses, mechanical tests, and hydrodynamic tests (normocardic and accelerated fatigue) were performed. The BVC-F was evaluated in a range of 20 to 200 beats per minute for 30 min. The accelerated fatigue tests were carried out at a frequency of 1050-1080 beats/min for a period of 1 month, followed by implantation in five Yorkshire porcine models using extracorporeal circulation.

Finite element analysis indicated a low risk of fracture (stresses 73% below yield strength) and radial expansion (15.95%). Tests validated an effective orifice area of 2.25 cm², transvalvular gradients < 10 mmHg, and a regurgitant flow lower than 5%. Accelerated fatigue tests confirmed structural integrity equivalent to 2.2 years. In vivo porcine implantation (n = 5) was successful, maintaining a mean gradient of 10 ± 2 mmHg with no paravalvular leakage. Furthermore, the viability of a ViV procedure was validated, resulting in sufficient annulus expansion and stable hemodynamics.

The BVC-F INC achieved compliance with preliminary safety and efficacy standards. Nonetheless, extended and complex simulations are requisite to assess long-term mechanical behavior, wear resistance, and functional stability before human clinical trials.