Work

Five-year outcomes of chordal replacement therapy for primary mitral regurgitation: The CHAGALL (CHordArt System Study for the Treatment of Mitral ReGurgitAtion due to Leaflet ProLapse or fLail) study

Year: 2026

Type: article

Abstract: Objectives: The CHAGALL (CHordArt System Study for the Treatment of Mitral ReGurgitAtion due to Leaflet ProLapse or fLail) study is a prospective, first-in-human early feasibility study evaluating the technical feasibility, the long-term safety, and device durability of a novel chordal replacement system for the treatment of primary degenerative mitral regurgitation. Methods: Five patients with symptomatic severe primary degenerative mitral regurgitation attributable to isolated central posterior leaflet prolapse or flail underwent surgical implantation of the ChordArt chordal replacement system through a left atrial approach under cardiopulmonary bypass combined with ring annuloplasty. Clinical and transthoracic echocardiographic follow-up was prospectively performed at discharge and through 60 months. Results: Technical device success was achieved in all patients. Mitral regurgitation was reduced to none or trace immediately after implantation and remained stable throughout the 5-year follow-up. No device-related major adverse events, structural device failure, implant dislodgement, chordal rupture, reoperation, or rehospitalization occurred. Reverse cardiac remodeling was observed, including reduction in left ventricular end-diastolic diameter and left atrial volume, whereas left ventricular function remained preserved during long-term follow-up. Conclusions: Surgical implantation of the ChordArt chordal replacement system was simple to perform and demonstrated excellent long-term technical durability and sustained clinical performance over 5 years. These findings support further clinical evaluation of this technology and the ongoing development of a fully transcatheter transseptal delivery platform.

Source: JTCVS Open

DOI: 10.1016/j.xjon.2026.102055