Novel suture device for beating-heart mitral leaflet approximation.

Abstract

BACKGROUND: This investigation evaluates the potential of using a novel suturing device to achieve mitral valve repair (Alfieri type) on a beating heart without cardiopulmonary bypass. METHODS: Eight healthy adult sheep were anesthetized and the chest was opened via a left thoracotomy. The suture device was directly inserted into the appendage of the left atrium. Suction ports on the distal tip of the device grasped and approximated the mitral leaflets while the heart was beating. Two-dimensional echocardiography and intracardiac pressure monitoring at the tip of the device were utilized to guide the procedure. The device was used to place two single sutures across the two leaflets at the center of the mitral valve. A knot pusher with integrated cutter was used to tie the sutures and cut the suture ends. RESULTS: In all animals, the free margins of the mitral leaflets were successfully grasped and approximated by this device. Echocardiography confirmed successful deployment of the sutures in all cases, with a figure-of-eight appearance of the valve and normal valve hemodynamic function after placement of the sutures. Mid-leaflet approximation was verified at autopsy immediately after the procedure. No tissue damage was observed. CONCLUSIONS: This study demonstrates that mitral valve repair (Alfieri type) can be performed safely and consistently on a beating heart without cardiopulmonary bypass using this new tissue approximation suture device. This technique may be applicable to the treatment of ischemic mitral regurgitation in conjunction with revascularization procedures or to mitral regurgitation in heart failure patients.