Initial Safety and Feasibility Clinical Trial of the Myosplint Device

BACKGROUND: The Myocor Myosplint device is a passive implantable device for the treatment of heart failure by changing the geometry of the left ventricle (LV). AIM: The purpose of this evaluation was to describe the first human experience with the Myosplint device to demonstrate safety and feasibility. METHODS: Of the first consecutive 21 patients, 9 patients received a Myosplint device alone while 12 patients underwent a mitral valve repair as well. Safety and efficacy data were gathered at enrollment and during follow-up. RESULTS: No serious device-related adverse events or device failures were observed. Three patients died during the follow-up period, and 2 patients underwent heart transplantation. There was a significant improvement in the New York Heart Association (NYHA) functional class from 3.0 +/- 0.3 at baseline to 2.1 +/- 0.7 at 6 months (p = 0.001). Both LV end-diastolic and end-systolic volumes had decreased at follow-up. The LV ejection fraction significantly increased in the Myosplint alone group (from 17.1 +/- 4.0% at baseline to 21.8 +/- 4.1% at 3 months and 23.1 +/- 7.2% at 6 months) but not in the Myosplint and mitral valve repair group. The mitral regurgitation (MR) grade had a significant (p = 0.002) linear relationship with the NYHA functional class. CONCLUSIONS: The initial clinical experience of the Myosplint device demonstrated both safety and feasibility, validating the LV shape change concept in humans. A remodeling solution must, however, include MR resolution, to illustrate the need for a device that can simultaneously reduce or eliminate functional MR off-pump.