A NiTi alloy-based cuff for external banding valvuloplasty: a six-week follow-up study in pigs

Abstract

Objective The study aimed to test a Nitinol®-based vein cuff model for external banding valvuloplasty. Method In 12 adult minipigs, the vena jugularis externa was covered for 42 days by a cuff with an inner diameter adapted to the outer vein diameter in supine position. By changing from supine into prone position hypostatically vein dilation was induced to simulate varicose vein dilation. Cuff position and the inner diameter of the vein lumen under the cuff were examined by computer tomography scanning. Also, histological analysis of the vein wall within the cuff was performed. Results The preset tubular shape of the cuff and the cuff position did not change in both prone and supine position, but due to fibrosis the luminal vein diameter within the cuff was decreased (P < 0.01) already after 21 days. Conclusion A foreign body response resulted in a fibrous capsule covering the cuff which might limit cuff functionality.