Abstract

BackgroundIn this study, we sought to evaluate the feasibility of improved transcatheter aortic valve implantation (TAVI) in noncalcified aortic valve by using the novel concept of double-layer ChenValve prosthesis. TAVI was initially considered as an alternative treatment for high-risk patients with aortic stenosis. However, non noncalcified aortic valve disease was considered as a contraindication to TAVI.MethodsChenValve prosthesis, which consisted of a self-expanding Nitinol ring, a balloon-expandable cobalt-chromium alloy stent and a biological valve, was implanted at the desired position under fluoroscopic guidance in a transapical approach through a 20F sheath in 10 goats. Aortic angiography was performed to measure the diameter of the aotic annulus and assess the performance of the artificial valve. The ultrasound was used to evaluate the regurgitation or paravalvular leakage and trans-prosthetic vascular flow velocity postoperatively. The aortogram and transthoracic echocardiography were applied to observe whether the valve stent was implanted at the desired position.ResultsChenValve prosthesis was successfully transppical implanted in all animals. The aortogram and transthoracic echocardiography performed immediately after implantation revealed that the valve stent was implanted at the desired position. There was no significant paravalvular leakage, obstruction of coronary artery ostia, stent malpositioning or dislodgement occurred.ConclusionsThis preliminary trial with the novel double-layer ChenValve prosthesis demonstrated the feasibility of improved TAVI in noncalcified aortic valve. The mechanism of Nitinol ring-guided locating the aortic sinus enables us to anatomically correct position the artifact valve. This improved strategy seems to make the TAVI process more safe and repeatable in noncalcified aortic valve.

Highlights

  • In this study, we sought to evaluate the feasibility of improved transcatheter aortic valve implantation (TAVI) in noncalcified aortic valve by using the novel concept of double-layer ChenValve prosthesis

  • The main reason is that the noncalcified aortic valve lacks fluoroscopic landmarks and anchor site for prosthesis, which tends to increase the risk of prosthesis dislocation in TAVI [6, 7]

  • We developed the ChenValve with a novel double-layer stent and featured with a nitinol outer-ring

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Summary

Introduction

We sought to evaluate the feasibility of improved transcatheter aortic valve implantation (TAVI) in noncalcified aortic valve by using the novel concept of double-layer ChenValve prosthesis. Non noncalcified aortic valve disease was considered as a contraindication to TAVI. Transcatheter aortic valve implantation (TAVI) is developed as the standard of care for inoperable patients with severe symptomatic calcific aortic stenosis and is recommended by clinical practice guidelines [2, 3]. The main reason is that the noncalcified aortic valve lacks fluoroscopic landmarks and anchor site for prosthesis, which tends to increase the risk of prosthesis dislocation in TAVI [6, 7]. Absent or minimal calcification of aortic valve induced insufficient anchoring results in prosthesis dislodgement, which can lead to poor prognosis. For these reasons, improving the TAVI is critical for the therapy of AR

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