Expandable Pediatric Pulmonary Heart Valve

EXPANDABLE PEDIATRIC PULMONARY HEART VALVE About 1-2% of people are born with a heart valve defect, with the most common being a bicuspid aortic valve with pulmonary valves following. To treat newborns with severe heart valve defects, surgeons need small diameter valves that can grow larger with the patient and double in size within 20 years. Such devices do not exist in the marketplace. Due to this technology gap, the family and care team is faced with a palliative treatment approach of waiting as long as possible before implanting an oversized valve with several open-heart re- interventions every couple of years, when they outgrow or outlive their initial valve device. In addition to the safety and outcomes issues above, the financial and emotional burden for these patients, their families, and the medical system at large is huge, especially when an infant or child could need 3-4 valve replacement surgeries in their lifetime. A replacement heart valve is needed that can provide a “once and done” solution for these children who are facing multiple valve replacements in their lifetime. We hypothesize that an expandable surgical valve will meet this demand. We designed a novel expandable stent that can be extended as needed, onto which stabilized and anti-calcification treated elastic tissue is attached as a tri-leaflet valve. When tested in a bioreactor, valves expanded by 50% and 100% using balloons while functioning well hemodynamically. In the current project, we propose 1) optimizing the stent design and 2) testing the valve device in a juvenile pig model. The research team is led by Dr. Leslie Sierad, with expertise in bioreactor development and valve design and manufacturing; Dr. Dan Simionescu, with expertise in scaffold generation and tissue analysis; and Dr. Minoo Kavarana, a pediatric cardiac surgeon with expertise in animal studies. We expect this device to exhibit adequate hemodynamics and biocompatibility, thus advancing the field of artificial heart valves for pediatric patients. Project Number: 1R21HL181551-01 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: Leslie Sierad | Institution: APTUS, LLC, CLEMSON, SC | Award Amount: $321,679 | Activity Code: R21 | Study Section: Bioengineering, Technology and Surgical Sciences Study Section[BTSS] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R21HL18155101