Abstract 12228: Transfemoral Aortic Implantation of Repositionable and Retrievable Foldavalve: A Proof of Concept in Animals
Introduction: Transcatheter therapies for severe aortic stenosis have progressed rapidly over the past several years. However, as the indications for transcatheter aortic valve replacement (TAVR) expand, technological challenges still exist. One major challenge is to minimize the size of the delivery catheters to reduce vascular trauma, while maintaining features such as repositionability and retrievability. Here we describe the proof of concept study for totally repositionable and retrievable valve with a 14Fr delivery system expandable to 25mm, FOLDAVALVE (Figure 1).
Methods: FOLDAVALVE was successfully implanted in a short term ovine model at Institut Mutualiste Montsouris in Paris.
Results: Successful implantation was achieved in 3 sheep from a femoral approach. Implantation was preceded by repositioning and retrieval into the delivery system. Figure 2 illustrates the smooth transition of the valve over the aortic arch followed by seamless delivery into the native ovine aortic position. After full valve deployment and imaging, the animals were sacrificed and gross inspections revealed good anatomic positioning.
Conclusions: Here we report the successful implantation of FOLDAVALVE in the aortic position of an ovine model. Reducing the size of transcatheter valve delivery sheaths while maintaining optimal features, such as repositionability and retrievability, is critical for the continued development and expansion of indications of TAVR. FOLDAVALVE is a new promising technology that spares the leaflet from being crunched during delivery and has been shown to be feasible in preclinical studies for transfemoral aortic valve implantation.
Author Disclosures: A. Kheradvar: Research Grant; Modest; Wallace H. Coulter Foundation. Ownership Interest; Modest; shareholder Folda LLC. E.M. Groves: None. E. Tseng: None.
- © 2014 by American Heart Association, Inc.