Safety And Performance Of A Novel Transventricular Beating Heart Mitral Valve Repair System: 1-Year Outcomes

OBJECTIVES: The objective of this study was to evaluate the safety and performance of a novel, beating heart procedure that enables echocardiographic-guided beating heart implantation of expanded polytetrafluoroethylene (ePTFE) artificial cords on the posterior mitral leaflet of patients with degenerative mitral regurgitation.METHODS: Two prospective multicentre studies enrolled 13 (first-in-human) and 52 subjects, respectively. Patients were treated with the HARPOON beating heart mitral valve repair system. The primary (30-day) end point was successful implantation of cord(s) with mitral regurgitation reduction to <= moderate. An independent core laboratory analysed echocardiograms.RESULTS: Of 65 patients enrolled, 62 (95%) achieved technical success, 2 patients required conversion to open surgery and 1 procedure was terminated. The primary end point was met in 59/65 (91%) patients. Among the 62 treated patients, the mean procedural time was 2.1 +/- 0.5 h. Through discharge, there were no deaths, strokes or renal failure events. At 1 year, 2 of the 62 patients died (3%) and 8 (13%) others required reoperations. At 1 year, 98% of the patients with HARPOON cords were in New York Heart Association class I or II, and mitral regurgitation was none/trace in 52% (n = 27), mild in 23% (n = 12), moderate in 23% (n = 12) and severe in 2% (n = 1). Favourable cardiac remodelling outcomes at 1year included decreased end-diastolic left ventricular volume (153 +/- 41 to 119 +/- 28 ml) and diameter (53 +/- 5 to 47 +/- 6 mm), and the mean transmitral gradient was 1.4 +/- 0.7 mmHg.CONCLUSIONS: This initial clinical experience with the HARPOON beating heart mitral valve repair system demonstrates encouraging early safety and performance.