Melody valve-in-ring procedure for mitral valve replacement: feasibility in four annuloplasty types

Abstract

Background: The recurrence of regurgitation after surgical mitral valve (MV) repair remains a significant clinical problem. Mitral annuloplasty rings are commonly used in MV repair procedures. The purpose of this study was to demonstrate the feasibility of transvenous valve-in-ring (VIR) implantation using the Melody valve (Medtronic, Minneapolis, MN), which is a valved-stent designed for percutaneous pulmonary valve replacement, and 4 distinct types of annuloplasty ring (AR) in an ovine model.

Methods: Ten sheep underwent surgical MV annuloplasty ring placement (n=10): CE-Physio, Edwards Lifesciences, Irvine, CA [n=5]; partial ring [n=3]; flexible ring [n=1]; and saddle ring [n=1]). All animals underwent cardiac catheterization, hemodynamic assessment, and Melody VIR implantation through a transfemoral venous, transatrial septal approach 1 week after surgery. Follow-up hemodynamic, angiographic, and echocardiographic data were recorded.

Results: Melody VIR implantation was technically successful in all but 1 animal. In this animal a 26-mm partial AR proved too large for secure anchoring of the Melody valve. In the remaining 9 animals, fluoroscopy showed the Melody devices securely positioned within the annuloplasty rings. Echocardiography revealed no perivalvular leak, and angiography revealed no left ventricular outflow tract obstruction, vigorous left ventricular function, and no aortic valve insufficiency. The median procedure time was 55.5 (range, 45 to 78) minutes.

Conclusions: This study demonstrates the feasibility of a purely percutaneous approach to MV replacement in patients with preexisting annuloplasty rings, regardless of ring type. This approach may be of particular benefit to patients with failed repair of ischemic mitral regurgitation.