Procedural performance and healing response of a novel low-profile transseptal transcatheter mitral valve replacement system

Mitral regurgitation (MR) is the most prevalent valvular heart disease in the United States1. A substantial proportion of MR patients are suboptimal surgical candidates due to their advanced age, comorbidities or frailty, and such patients may be better suited for transcatheter treatments. Transcatheter mitral valve replacement (TMVR) is emerging as an alternative for surgical high-risk MR patients2. However, the TMVR devices that are currently undergoing clinical testing have a high anatomical screen failure rate due to challenges with annulus size or left ventricular outflow tract (LVOT) obstruction34. The Saturn valve (InnovHeart) is a novel, low-profile TMVR bioprosthesis (available in 28 and 31 mm) that has a central valve which is mechanically connected to an annular ring. The aim of this study was to assess the procedural performance and long-term healing profile of this TMVR system in healthy preclinical models.

Procedural performance of the transseptal delivery system was tested using an acute porcine model (N=16), and the healing response was evaluated after transapical implantation in an ovine model (N=4). Moving image 1 shows a transseptal procedural...