Novel Direct Annuloplasty Fastener System for Minimally Invasive Mitral Valve Repair.

ABSTRACT

The development of less invasive approaches for mitral valve repair remains an important objective, particularly in patients with multiple comorbidities. We describe a novel method to affix a mitral valve annuloplasty ring in a minimally invasive manner. A delivery apparatus for an annuloplasty fastener system was designed. Two channels were created, one for advancing the annuloplasty ring, and another to accommodate the fastener applicator. Custom designed fasteners, either with a helical-shaped screw or a strap-shaped tack structure, were tested. Fasteners were primed within an application device and automatic alignment of fasteners was achieved to allow accurate firing of the fixators securing the ring. The delivery apparatus was constructed to be deployed within a 10 mm trocar through a left atrial approach. Using a cadaveric swine heart model, access to the mitral valve from the left atrium was obtained with insertion of a trocar. The delivery apparatus was accurately directed to the mitral annulus under echocardiographic guidance. Fasteners were placed along the annular plane to secure the annuloplasty ring. Both fastener designs achieved considerable fixation force; the helical-shaped screw was found to have significantly greater fixation force compared to the strap-shaped tack design. The annuloplasty ring remained intact and did not experience any structural deformity during the fixation process. The use of a novel fastener system was successful in deploying and securing a mitral valve annuloplasty ring. These promising results may have further application for minimally invasive mitral valve repairs. Additional evaluation of this procedure with pre-clinical in vivo animal studies is necessary.