First-in-Human Study of the Novel Transcatheter Mitral Valve Repair System for Mitral Regurgitation

Abstract

Transcatheter mitral valve intervention treatment is a promising alternative therapy for patients with severe mitral regurgitation (MR). This is a multicenter, prospective, first-in-human study of transcatheter edge-to-edge repair (TEER) using a novel device for severe MR. Safety and efficacy were assessed immediately after the procedure and at 30-day follow-up. Twenty-three patients (age 70.0 ± 5.2 years) who were at high/prohibitive surgical risk underwent successful procedures without major periprocedural complications. All patients achieved residual MR ≤2+ at discharge, with 73.9% with 1+ residual MR. The left ventricular end-systolic diameter improved from 4.1 cm at baseline to 3.4 cm at 30-day follow-up. New York Heart Association functional class I/II after TEER was achieved in 87% of patients. This study demonstrated that TEER with the device was feasible and safe for the treatment of patients with severe MR. (Dragonfly-M Transcatheter Mitral Valve Repair System Early Feasibility Study; NCT04528576).

Keywords: DMR, degenerative mitral regurgitation; FMR, functional mitral regurgitation; GDMT, guideline-directed medical therapy; MAE, major adverse event; MR, mitral regurgitation; NYHA, New York Heart Association; TEER, transcatheter edge-to-edge repair; a novel system; degenerated mitral regurgitation; functional mitral regurgitation; transcatheter edge-to-edge repair.

Conflict of interest statement

This work obtained funding support from the Zhejiang Province Science and Technology Department Key R & D Program (2021C03097), China, and Zhejiang Province Science and Technology Department Key R & D Program (2018C03084), China. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

© 2022 The Authors.

Figures

Graphical abstract

Figure 1

Characteristics of the TEER Device (A) Four sizes of clip (SN0409: width 4 mm, length 9 mm; XN0412: width 4 mm, length 12 mm; SW0609: width 6 mm, length 9 mm; XW0612: width 6 mm, length 12 mm) and choice making. (B) The entire delivery system of the device; the handle of the guiding sheath and steering sheath with calibration markers. The stabilizer is used on the sterile field to support and position the entire delivery system during the procedure. MVOA = Mitral Valve Orifice Area; TEER = transcatheter edge-to-edge repair.