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

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.