Acute safety and efficacy of the NeoChord procedure

• Published in: Interactive cardiovascular and thoracic surgery Vol. 20; no. 5; pp. 575 - 581
• Main Authors: Colli, Andrea, Manzan, Erica, Rucinskas, Kestutis, Janusauskas, Vilius, Zucchetta, Fabio, Zakarkaitė, Diana, Aidietis, Audrius, Gerosa, Gino
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01-05-2015
• Subjects: Aged; Cardiac Catheterization - methods; Chordae Tendineae - surgery; Cohort Studies; Echocardiography, Transesophageal - methods; Feasibility Studies; Female; Follow-Up Studies; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - methods; Hospitals, University; Humans; Italy; Length of Stay; Male; Middle Aged; Minimally Invasive Surgical Procedures - methods; Mitral Valve Insufficiency - diagnostic imaging; Mitral Valve Insufficiency - physiopathology; Mitral Valve Insufficiency - surgery; Patient Safety; Postoperative Complications - physiopathology; Prospective Studies; Prosthesis Design; Prosthesis Failure; Treatment Outcome; Mitral valve; NeoChord procedure; Mitral valve repair; Off-pump; Regurgitation
• ISSN: 1569-9293; 1569-9285
• DOI: 10.1093/icvts/ivv014

OBJECTIVES
Transapical off-pump mitral valve repair using the NeoChord device has been proposed to treat degenerative mitral valve regurgitation. This prospective study sought to evaluate acute safety and efficacy of this innovative, minimally invasive, transcatheter mitral valve repair approach.
METHODS
Symptomatic patients with severe mitral regurgitation (MR) were selected if they presented a favourable valve anatomy (the presence of leaflet flail/prolapse with consistent overlap of tissue). Early device success was defined as placement of at least two neochordae with residual mitral regurgitation ≤2+ after the procedure. The primary acute safety and efficacy end points were evaluated at 30 days.
RESULTS
Between February 2013 and June 2014, in Padua and Vilnius University Hospitals, a total of 62 patients were treated, with a median age of 66 years (IQR 52–76) and a median EuroSCORE I of 1.9% (IQR 0.9–6). Fifty-six patients (88.9%) presented with a posterior leaflet prolapse, 4 (6%) with an anterior leaflet prolapse and 3 (5%) with a combined disease. Early procedural success was achieved in all patients. Two neochordae were implanted in 2 patients (3%), 3 in 20 (32%), 4 in 28 (44%), 5 in 10 (16%), 6 in 2 (3%) and 7 in 1 (2%). At 30 days, major adverse events included only 1 acute myocardial infarction (2%) successfully treated percutaneously and 2 cases of sepsis (3%). Mitral regurgitation at 30 days was absent in 29 patients (46%), Grade 1+ in 16 (25%), Grade 2+ in 10 (16%), Grade 3+ in 7 (11%) and Grade 4+ in 1 (2%). All 8 patients with MR >2+ were successfully reoperated with conventional surgery or NeoChord reintervention.
CONCLUSIONS
Initial results with the NeoChord procedure in a small number of patients indicate that transapical off-pump mitral valve repair is feasible and safe. Efficacy is maintained up to the 30-day follow-up with significant clinical benefit for patients.