Use of a novel valve stent for transcatheter pulmonary valve replacement: an animal study.

Objective: The goal of this study was to evaluate valvular functionality after transcatheter pulmonary valve replacement in sheep using a novel pulmonary valve stent.

Methods: Fresh porcine pericardium cross-linked with 0.6% glutaraldehyde was treated with L-glutamine to eliminate glutaraldehyde toxicity and sutured onto a valve ring before mounting on a nitinol stent to construct the pulmonary valve stent. Percutaneous femoral vein transcatheter pulmonary valve replacement was performed with the newly constructed valve stent. Pulmonary valve stents were implanted in 10 healthy sheep (6 males and 4 females) weighing an average of 25.7 +/- 4.1 kg. Color Doppler echocardiography, 64-row computed tomography, and direct catheter examination were used to assess valvular function.

Results: Implantation was successful in 8 sheep. Shortly after surgery, all artificial valve stents exhibited normal open and close functionality and no stenosis or insufficiency. Heart rate was slightly elevated at this time, while all other hemodynamic parameters were normal. Six-month follow-up revealed no evidence of valve stent dislocation and normal valvular and cardiac functionality. There was no evidence of stent fracture. Repeated valve stent implantation was well tolerated as indicated by good valvular functionality 2 months postdelivery.

Conclusion: The novel pulmonary valve stent described herein can be delivered via percutaneous femoral vein transcatheter implantation and is highly efficacious at 6 months postdelivery. Furthermore, repeated valve stent replacement was successful.