Changes in mitral annular and left ventricular dimensions and left ventricular pressure-volume relations after off-pump treatment of mitral regurgitation with the Coapsys device.

OBJECTIVE: The objective of this study was to evaluate the changes in mitral annular and left ventricular dimensions and left ventricular pressure-volume relations produced by the Myocor Coapsys device that has been developed to treat functional mitral regurgitation (MR) off-pump. METHODS: The Coapsys device, which consists of anterior and posterior epicardial pads connected by a sub-valvular chord, was implanted in seven dogs with functional MR resulting from pacing induced cardiomyopathy. The Coapsys device was then sized by drawing the posterior leaflet and annulus toward the anterior leaflet. During sizing, MR grade was assessed using color flow Doppler echocardiography. Final device size was selected when MR was eliminated or minimized. Following implantation, heart failure was maintained by continued pacing for a period of 8 weeks. Mitral annular and left ventricular dimensions and left ventricular pressure-volume relations were evaluated by two-dimensional echocardiography and a conductance catheter, respectively, at pre-sizing, post-sizing, and after 8 weeks. RESULTS: All implants were performed on beating hearts without cardiopulmonary bypass. Mean MR grade was reduced from 2.9+/-0.7 at pre-sizing to 0.7+/-0.8 at post-sizing (P<0.001), and was maintained at 0.8+/-0.8 after 8 weeks (P<0.01). The septal-lateral dimensions were significantly reduced at both mitral annular level 2.4+/-0.2 cm at pre-sizing, 1.5+/-0.3 cm at post-sizing (P<0.001) and 1.8+/-0.3 cm after 8 weeks (P<0.05)] and mid-papillary level 4.1+/-0.4 cm at pre-sizing, 2.4+/-0.2 cm at post-sizing (P<0.001) and 3.3+/-0.4 cm after 8 weeks (P<0.001)]. The end-systolic pressure-volume relation shifted leftward at post-sizing with a significantly steeper slope (P=0.03). There was a significant (P=0.03) leftward shift of the end-diastolic pressure-volume relation at post-sizing. After 8 weeks, these changes in pressure-volume relations tended to return to pre-sizing relations. CONCLUSIONS: The Coapsys device significantly reduced MR by treating both the mitral annular dilatation and the papillary muscle displacement. Despite these significant dimensional changes, the Coapsys device did not negatively affect the left ventricular pressure-volume relations.