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Novel Direct Annuloplasty Fixation System for Minimally Invasive Mitral Valve Repair
Joshua L. Chan, Ming Li, Dumitru Mazilu, Justin G. Miller, Keith A. Horvath.
National Institutes of Health, Bethesda, MD, USA.

OBJECTIVE: Mitral valve repair is an effective therapeutic option for mitral regurgitation. The development of less invasive approaches that additionally avoid the need for cardiopulmonary bypass and cardioplegia remains an important objective, particularly in patients with multiple comorbidities. Here we describe a novel method and system to deploy strap fixators to affix a commercially available mitral valve annuloplasty ring in a minimally invasive manner.
METHODS: A delivery apparatus for an annuloplasty fixator system was designed. Two channels were created, one for advancing the mitral annuloplasty ring, with the second channel designed to hold the fixator device. U-shaped strap fixators were primed within the fixator device and automatic alignment of these fixators was achieved to allow accurate firing of the fasteners securing the ring. The delivery apparatus was constructed to be deployed within a trocar through a left atrial approach.
RESULTS: Using swine heart as an ex vivo model, access to the mitral valve from the left atrium was obtained. The delivery apparatus was advanced and placement of 6 strap fixators equidistant along the annular plane was performed for each annuloplasty ring. Subsequent post-procedural testing revealed that the use of the strap fixator system achieved significant fixation force; a considerable magnitude of force was required to detach the ring (mean force: 420.83 gm; 95% confidence interval: 319.29 gm, 522.37 gm). The annuloplasty ring remained intact and did not experience any structural deformity during fixation process.
CONCLUSIONS: The use of a novel strap fixator 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. Further evaluation of this procedure with in vivo animal studies is necessary.

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