Development of Novel Sutureless Balloon Expandable Fetal Heart Valve Device Using Absorbable Polycaprolactone...

Area of Science:

• Biomedical Engineering
• Cardiovascular Surgery
• Pediatric Cardiology

Background:

• Congenital heart disease (CHD) is a leading cause of congenital defects, often necessitating multiple valve replacements due to implant failure.
• Current treatments for severe CHD like pulmonary atresia with intact ventricular septum (PA/IVS) face challenges with bioprosthetic valve durability and surgical repair limitations.

Purpose of the Study:

• To develop and evaluate a sutureless fetal transcatheter pulmonary valve replacement (FTPVR) for in utero correction of congenital heart defects.
• To assess the feasibility and hemodynamic performance of a novel balloon-expandable FTPVR design using computational simulations and in vitro testing.

Main Methods:

• Computational simulations were employed to analyze a balloon-expandable FTPVR design and identify potential failure points.
• Five sutureless FTPVR devices were manufactured and tested in a fetal right heart simulator (FRHS) to assess hemodynamic function.
• Key hemodynamic parameters including effective orifice area, pressure gradient, and regurgitation fraction were measured.

Main Results:

• Computational analysis indicated that sutureless attachment techniques significantly reduced leaflet commissural loads.
• In vitro testing demonstrated favorable hemodynamic characteristics: effective orifice area of 0.08 cm², mean transvalvular pressure gradient of 7.52 mmHg, and regurgitation fraction of 8.42%.
• The FTPVR system performed effectively over 100 cardiac cycles in the simulated fetal heart environment.

Conclusions:

• The developed fetal transcatheter pulmonary valve replacement (FTPVR) exhibits promising hemodynamic performance for in utero treatment of congenital heart defects.
• Sutureless leaflet attachment proved effective in reducing stress on valve components.
• Further research involving biodegradable stent materials is ongoing to advance this innovative therapeutic approach.