Mitral valve repair with a device for artificial chordal implantation at 2 years

Abstract

Objectives: This study examines the early and midterm safety, efficacy, and durability of mitral valve repair for primary mitral regurgitation (MR) using the ChordArt device (CoreMedic) for chordal replacement.

Methods: Five patients with symptomatic severe primary degenerative MR due to isolated central posterior leaflet prolapse/flail were treated with the ChordArt device in a transseptal surgical approach and followed prospectively with periodical clinical and echocardiographic assessments for 2 years.

Results: Reduction of MR immediately after the implantation of artificial chords was achieved in all patients showing no or trace MR (<1+/4+). In all patients, MR <1+ was maintained during 24 months of follow-up. No dehiscence, detachment, or dislocation of the implanted ChordArt devices was observed. Transthoracic echocardiography showed that left ventricle end diastolic diameter significantly decreased during the whole follow-up period in comparison to baseline condition, especially at discharge and 1-month follow-up. Left ventricle end systolic diameter also significantly decreased during the whole follow-up period in comparison to baseline condition. Left atrial volume significantly decreased during the follow-up period in comparison to discharge. No major adverse events, as defined per protocol, were observed during the intervention or during the follow-up period.

Conclusions: The ChordArt device allows successful treatment of primary degenerative MR due to posterior mitral leaflet prolapse or flail, with a good safety profile and promising immediate clinical and echocardiographic benefits that are confirmed up to 24 months.

Keywords: EDD, end diastolic diameter; ESD, end systolic diameter; GLS, global longitudinal strain; LVEDD, left ventricular end diastolic diameter; LVEF, left ventricular ejection fraction; LVESD, left ventricular end systolic diameter; MAE, major adverse event; MR, mitral regurgitation; MV, mitral valve; NYHA, New York Heart Association; TEE, transesophageal echocardiograph; TTE, transthoracic echocardiograph; chordal repair; mitral regurgitation; mitral valve repair.

Graphical abstract

ChordArt implant (CoreMedic).

Figure 1

Mitral regurgitation (MR) severity at baseline, discharge, 1-, 12-, and 24-months' follow-up. The curves show excellent valve function following the procedure with no or trivial MR with persistent good results up to 2 years' follow-up.

Figure 2

Mitral valve repair with the ChordArt device (CoreMedic) and results up to 24 months postoperatively. Left, The picture shows a ruptured chord on the posterior leaflet as the reason for severe mitral regurgitation (MR) (top). An artificial chord has been implanted using the automatic ChordArt device (bottom) with a proximal anchor in the tip of the papillary muscle and the distal anchor into the posterior leaflet (both leave a minimal footprint in the native mitral valve). Right, the implantation of ChordArt device was successful in all patients and allowed very stable results in term of the excellent function of the reconstructed mitral valve and the absence of any detachment or dislocation of the new device. CHAGALL, The ChordArt System Study for the Treatment of Mitral Regurgitation due to Leaflet Prolapse or Flail.

Figure 3

Ultrasound parameters (multigraph) at baseline, discharge, 1 month, 12 months, and 24 months: A, Left ventricle ejection fraction obtained with transthoracic echocardiography (LVEF-TTE). B, Global longitudinal strain (GLS). C, Left ventricle end-systolic (LVESD). D, End-diastolic diameter (LVEDD). E, Left atrial volume (LAV). Lines represent mean (95% CI).

Figure E1

Consolidated standards of reporting trials diagram.

Figure E2

Ultrasound parameters at baseline, discharge, 1 month, 12 months and 24 months per patient: A, Left ventricle ejection fraction obtained with transthoracic echocardiography (LVEF-TTE). B, Global longitudinal strain (GLS). C, Left ventricle end-diastolic (LVEDD). D, End-systolic diameter (LVESD). E, Mitral regurgitation (MR) severity. F, Left atrial volume (LAV). Lines represent the values of examined ultrasound parameter in each time point per patient.