Transcatheter native pulmonary valve and tricuspid valve replacement with the sapien XT: Initial experience and development of a new delivery platform.

Abstract

While the Melody valve is unable to be used for replacement of large pulmonary outflow tracts, the 29mm Sapien XT transcatheter valve, designed specifically for aortic valve replacement, can potentially be used in these large native outflow tracts. Techniques to enable off-label use of the Sapien XT valve for large-diameter pulmonary and tricuspid valve replacement are described. Use of the Sapien valve for transcatheter pulmonary and tricuspid valve replacement using both the commercially available Novaflex+ system and using a novel flexible delivery system was reviewed. This customized flexible delivery platform was constructed using the Ensemble sheath and a 30 mm Nucleus balloon. This system was bench tested prior to its clinical use. Ten patients had successful implantation of Sapien valves into native right ventricular outflow tracts (RVOTs) (n=7) or tricuspid valves (n=3). There was no stenosis or regurgitation after Sapien valve implantation. Several of the pulmonary valve replacement cases were extremely challenging due to the limited flexibility of the Novaflex system. The Sapien valve was crimped onto a 30mm Nucleus balloon preloaded through an Ensemble sheath. This system was able to consistently deliver the Sapien valve safely in a bench model as well as in native RVOTs in two patients. The 29 mm Sapien XT valve allows for large-diameter transcatheter valve replacement in both the pulmonary and tricuspid positions. Initial results of new techniques to utilize a more flexible delivery platform are described that could obviate the need for the Novaflex system. © 2016 Wiley Periodicals, Inc.