Novel device to change left ventricular shape for heart failure treatment:Device design and implantation procedure

The Myocor Myosplint is designed to decrease left ventricular (LV) wall str ess by changing LV shape, thus improving contractile function in dilated he arts. This shape change is accomplished by surgically placing three Myospli nts perpendicular to the LV long axis, drawing the LV walls inward, and cre ating a symmetric, bilobular LV. Specialty designed instruments aid in the precise delivery of these devices. The purpose of this study was to test th e safety and feasibility of the procedure in dogs. Dilated cardiomyopathy w as induced in 40 healthy dogs (26.3 +/- 1.7 kg) by ventricular pacing at 23 0 beats per minute for an average of 25 +/- 4 days. Using epicardial echoca rdiography, we placed the Myosplints across the LV chamber, avoiding the ma jor coronary arteries, papillary muscles, and mitral valve. Once placed, th e Myosplints were used to draw the LV walls inward to a prescribed distance . In all cases, we successfully implanted three Myosplints without using ca rdiopulmonary bypass. There were no complications related to the device or procedure. Myosplint implantation to change LV shape is safe and repeatable on a beating cardiomyopathic canine heart. Further study of the procedure will be needed in humans.