Percutaneous aortic valve replacement using a W-model valved stent: a preliminary feasibility study in sheep.

ABSTRACT

BACKGROUND: Percutaneous aortic valve replacement is a promising strategy in the treatment of patients with aortic valve stenosis. And many kinds of valved stents have been implanted in selected patients worldwide. However, the clinical experience is still limited. We developed a W-model valved stent and evaluated the feasibility and safety of percutaneous implantation of the device in the native aortic valve position. METHODS: A self expanding nitinol stent with W-model, containing porcine pericardium valves in its proximal part, was implanted in six sheep by means of a 14 French catheter through the right common iliac artery under guidance of fluoroscopy. During stent deployment the original aortic valve was pushed against the aortic wall by the self expanding force of the stent while the new valve was expanded. These sheep were followed up shortly after procedure with supra-aortic angiogram and left ventriculography. Additionally, one sheep was sacrificed after the procedure for anatomic evaluation. RESULTS: It was possible to replace the aortic valve in the beating heart in four sheep. The procedure failed in two sheep due to coronary orifice occlusion in one case and severe aortic valve regurgitation in the other case. One sheep was killed one hour after percutaneous aortic valve replacement for anatomic evaluation. There were no signs of damage of the aortic intima, or of obstruction of the coronary orifice. CONCLUSIONS: Percutaneous aortic valve replacement with a W-model valved stent in the beating heart is possible. Further studies are mandatory to assess safety and efficacy of this kind of valved stent in larger sample size and by longer follow-up period.