Safety and performance of a novel transventricular beating heart mitral valve repair system: 1-year outcomes

Abstract

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 1 year 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. Clinical registration numbers NCT02432196 and NCT02768870.

Transcatheter mitral valve repair: an overview of current and future devices

“…The Early Feasibility Study and CE Mark TRACER trial investigated the early feasibility and safety of treatment with the HARPOON system in 13 and 52 patients, respectively. [31][32][33] Of 65 patients enrolled in the two studies, 62 (95%) achieved technical success, 2 patients required conversion to open surgery and one procedure was terminated. The primary endpoint was met in 91% of patients.…”

“…32 At 1 year of follow-up, 98% of patients were in NYHA Class ≤II; MR was ≤mild in 75% and ≤moderate in 98% of patients. 33 In Europe, Post-Market Clinical Follow-Up trials are currently underway and will collect additional safety and device performance data on the HARPOON MVRS in patients with severe degenerative MR. The RESTORE IDE pivotal trial (ClinTrials.Gov: NCT04375332) is being initiated in North-America to evaluate the safety and effectiveness of the HARPOON MVRS in patients with severe degenerative MR presenting with mid-segment posterior mitral leaflet prolapse.…”

“… 32 At 1 year of follow-up, 98% of patients were in NYHA Class ≤II; MR was ≤mild in 75% and ≤moderate in 98% of patients. 33 …”

Actual perspective on off‐pump transapical artificial chord implantation

“…Published results of transapical chordal implantation show significant percentages of more than mild residual mitral regurgitation 5,6,8,11,38,39 . Gammie et al 23 introducing Harpoon results in their series of more than 60 patients show at 30 days 13% of moderate MR and 2% of severe MR. At 1 year, these percentages increase up to 23% and 2% for moderate and severe MR, respectively; 13% of the patients required reoperations. Lozos et al, 10 publishing the results of the first experience in Greece with Neochord DS1000, presented a 16% and 7% of moderate and severe residual MR, respectively.…”

“…Neochord and Harpoon procedures have been used in both high‐ and low‐risk patients; overall results are encouraging but still distant from surgery. Citing Ilir Hysi and Olivier Fabre 37 in their commentary to the 1‐year results of Harpoon published by Gammie et al, 23 “Where do we set the limit” for mitral valve repair? Published results of transapical chordal implantation show significant percentages of more than mild residual mitral regurgitation 5,6,8,11,38,39 .…”