168ACUTE SAFETY AND EFFICACY OF THE NEOCHORD PROCEDURE

Objectives: Transapical off-pump mitral valve repair using the Neochord device has been proposed to treat degenerative mitral valve regurgitation (MR). This prospective study sought to evaluate the safety and efficacy of this innovative minimal invasive transcatheter mitral valve repair approach. Methods: Symptomatic patients with 3–4+ MR were selected if they presented a favourable anatomy (presence of flail/prolapse with consistent overlap of tissue). Acute device success was defined as residual MR ≤2+ after procedure. The primary safety and efficacy end-point was evaluated at 30 days. Results: A total of 53 patients were treated, median age 66 years (range 31–90), median EuroSCORE-I 1.9% (range 0.9–38.9). Forty-seven patients (88.7%) presented a posterior leaflet disease, 4 (7.5%) an anterior leaflet disease and 2 (3.8%) a combined disease. Acute procedure success was achieved in all patients. Two Neochord devices were implanted in 2 patients (3.8%), 3 in 16 (30.2%), 4 in 24 (45.3%), 5 in 8 (15.1%), 6 in 2 (3.8%) and 7 in 1 (2%). No death, stroke, acute myocardial infarction or bleeding events occurred within 30 days. MR at 30 days was absent in 25 patients (47.2%), grade 1+ in 18 patients (34%), grade 2+ in 6 patients (11.3%) and grade 3+ in 4 patients (7.5%). All 4 patients with MR >2+ were successfully reoperated with conventional surgery. Conclusion: Our initial results with the Neochord procedure in a small number of patients indicate that transapical off-pump mitral valve repair is feasible and may be accomplished with favourable short-term safety, efficacy and clinical benefit.