Innovative, Replaceable Heart Valve: Concept, In Vitro Study, and Acute In Vivo Study

Abstract

The purpose of this study was to evaluate the feasibility of our innovative, replaceable heart valves that can be easily detached from the sewing ring at the time of repeat replacement. The prototype devices consist of the base magnet ring assembly and the valve magnet ring assembly that utilize magnetic coupling force for the locking mechanism. Magnetic coupling strength was evaluated in vitro. Prototype bioprosthetic valves were implanted acutely in three sheep to confirm the feasibility of the replaceable mitral valve. The static separation force of prototype size #25 was 12.5 lb, meeting the design goal. In situ attachment and detachment of the valve magnet ring assembly from the base magnet ring assembly were very easily accomplished in all animals. The magnetic coupling did not decouple even under extremely high left ventricular pressures. We have demonstrated the feasibility of this innovative concept of a replaceable mitral valve.

Preclinical Large Animal In-Vivo Experiments for Surgically Implanted Atrioventricular Valve: Reappraisal and Systematic Review

“…Sheep have been associated with most of the studies, but the use of different sheep species was variable and largely dependent on the availability and geographical distribution. Use of Juvenile sheep was found in most cases [ 10 , 11 , 17 , 20 ], while Collatusso et al . used Texel juvenile sheep [ 8 ] and Navia et al .…”

Artificial Organs 2008: A Year in Review

“…Kiyotaka Fukamachi et al. (129) of the Cleveland Clinic, Cleveland, OH, USA evaluated the feasibility of replacement heart valves that can be easily detached from the sewing ring at the time of repeat replacement. The prototype devices consist of the base magnet ring assembly and the valve magnet ring assembly that utilize magnetic coupling force for the locking mechanism.…”

Possible Magnetic Field Effects From an Innovative, Replaceable Magnetic Heart Valve

“…We appreciate Drs. Kanwal, Malik, and Cheema's comments in their Letter to the Editor regarding our work (1) and thank them for their insightful and knowledgeable questions. With regard to magnetic field effects on electrocardiograms (EKGs), when we compared EKGs recorded pre‐ and postmagnetic valve implantation in our experiments, we found no sign of artifacts induced by the neodymium‐iron‐boron (NdFeB) magnets.…”