Myosplint implant and shape-change procedure: intra- and peri-operative safety and feasibility

BACKGROUND: In patients with dilated cardiomyopathy (DCM), the heart enlarges, leading to a corresponding increase in ventricular wall stress. To reduce the stress, transventricular tension members (Myosplint, Myocor, Inc.) were implanted to change the left ventricle (LV) effective radius and to reduce the LV wall stress by 20%. We conducted this study to evaluate the intra- and peri-operative safety and feasibility of LV-shape change therapy.

METHODS: In 7 patients, all diagnosed with DCM, Myosplints were implanted. New York Heart Association class ranged from III-IV, and LV end-diastolic diameter ranged from 70 to 102 mm. Mitral valve regurgitation was classified as mild in 3 and moderate in 4 cases. Four patients underwent mitral valve annuloplasty.

RESULTS: We observed no significant device-related complications, such as thromboembolism, bleeding, device instability, or vascular damage, at 90 days. Early indications in a small patient population demonstrate some improvements in clinical parameters.

CONCLUSIONS: From this initial experience, one may conclude that placement of the Myosplint devices can be safely performed without early, significant adverse events. In patients with significant mitral valve incompetence, concomitant mitral valve repair is indicated to realize the full benefit of the procedure. This study also suggests that Myosplints can be safely implanted in combination with mitral valve repair. The long-term effect of each procedure on cardiac function and survival will require further evaluation.