Transcatheter mitral valve edge-to-edge repair in patients with severe mitral regurgitation: data from the MitraClip Russia Trial

Abstract

Aim. To study the immediate and short-term outcomes of transcatheter mitral valve edge-to-edge repair with the MitraClip NT in patients with severe mitral regurgitation as part of the MitraClip Russia prospective single-center study.Material and methods. The study included 16 patients (men, 10; women, 6) with mean age of 70,1±2,1 years (mean Euroscore II, 6,90±5,56%; STS, 6,33±3,94%). Immediate technical success was defined as successful access, delivery, and removal of the device, and adequate placing the clip(s) to reduce the mitral regurgitation to grade 2 or below without the need for device- or procedure-related reintervention.Results. Immediate technical success was achieved in all patients. The average number of implanted clips per 1 patient was 1,7. In 1 patient (6,3%), a clip was attached to one mitral leaflet, which required an non-scheduled implantation of a second clip. In hospital mortality was 6,3%: a 92-year-old patient on the 3rd day after the operation had a sudden cardiac arrest followed by coma, hemispheric ischemic stroke and death on the 6th day. An autopsy revealed an iatrogenic atrial septal defect. Echocardiography performed on the 10th and 30th day after surgery showed a decrease in mitral regurgitation grade in 15 patients, while grade 3 residual mitral regurgitation did not reveal in any patient.Conclusion. Transcatheter mitral valve edge-to-edge repair with the MitraClip is a minimally invasive method for treating severe symptomatic mitral regurgitation (degenerative and functional). The results demonstrate high immediate efficacy and an acceptable safety profile in high surgical risk patients. Based on the analysis of death causes, the authors conclude that it is necessary to include initial pulmonary hypertension above 75 mm Hg as a relative contraindication to this procedure. The study limitations are the small sample size and short follow-up period.