TRACER: Transcatheter MV Neochordal Repair in Severe Primary MR Patients
The Harpoon Mitral Valve Repair System (H-MVRS) "has the potential to simplify and increase the quality and rates of mitral valve (MV) repair and decrease the morbidity associated with conventional open cardiac surgical MV operations," based on findings from the TRACER trial presented at TCT 2017 and published in the Journal of the American College of Cardiology.
H-MVRS is a transesophageal echocardiographic-guided device designed to implant artificial expanded polytetrafluoroethylene (ePTFE) cords on mitral leaflets in the beating heart. Researchers evaluated its safety and performance in 30 consecutive patients with severe degenerative MR. The primary endpoint was successful implantation of cords with MR reduction to moderate or less at 30 days.
Overall, the primary endpoint was met in 90 percent of patients (27/30), with only three patients requiring conversion to open mitral survey. No deaths, strokes or permanent pacemaker implantations occurred. At one month, researchers observed MR was mild or less in 89 percent of patients (24/27), and moderate in 11 percent (3/27). At six months, MR was mild or less in 85 percent of patients (22/26), moderate in 8 percent (2/26) and severe in 8 percent (2/26). Additionally, favorable cardiac remodeling at six months included decreases in end-diastolic and left atrial volumes, as well as anterior-posterior mitral annular dimension and mitral annular area.
"While it remains early in the clinical experience with this device and further investigation with longer term follow-up and direct comparison to conventional mitral valve surgery is necessary, the initial results are promising," said study investigators. They note that H-MVRS has the potential to simplify MV repair operations and increase the rate and quality of repair.
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