Use of a covered stent modification to produce a transcatheter valve: laboratory and animal testing

Stent-based transcatheter valves continue to require large sheaths inappropriate for deployment in children. Low-profile covered stent valves (CSVs) were constructed by removing triangular sections from two sides of partially expanded Palmaz P308 stents before covering the stents with 0.1 mm polytetrafluoroethylene. Valves were carefully crimped onto balloon catheters and deployed in a pulsatile flow loop. With fixed afterload and pump output, flow, degree of stenosis, effect on pulse pressure, and ease of deployment were determined for each valve. In vivo transcatheter feasibility studies were then performed by disabling the aortic valve of two 25-kg pigs, and deploying transcatheter CSVs into their descending aorta. All transcatheter valves deployed consistently via sheaths three French sizes larger than the recommended sheath for their balloon and none created significant obstruction. With the bicuspid and supravalvar CSVs, the flow was 64% and 79% (respectively) of a commercially available valve. Angiograms revealed excellent acute CSV function after deployment with only mild regurgitation and without significant obstruction to systolic flow. Although long-term testing is required, a modified CSV design may have utility in low-profile pediatric transcatheter valve replacement.