The Cardioband transcatheter annular reduction system.

Abstract

Surgical implantation of a complete or incomplete ring to reduce the mitral valve annulus and improve leaflet coaptation is the foundation of valve repair for degenerative and functional mitral and tricuspid regurgitation. The Cardioband system (Edwards Lifesciences, Irvine, CA, USA) is a catheter-delivered annular reduction system that mimics the surgical approach. Sequential anchors are used to secure the Cardioband implant from trigone to trigone. The Cardioband implant is contracted under transesophageal guidance until valvular regurgitation is reduced. In the initial clinical experience, the Cardioband system was safely deployed in patients with clinically significant functional mitral regurgitation (MR) and yielded durable MR reduction, improved quality of life, and improved exercise capacity. The early and still-evolving Cardioband experience for tricuspid regurgitation is also promising. The ongoing pivotal ACTIVE Trial is designed to demonstrate the superiority of the Cardioband system to guideline-directed medical therapy in patients with clinically significant functional MR (FMR) using a composite endpoint of mortality, heart failure (HF) hospitalization, quality of life, and exercise capacity.