Safety and efficacy of the automated suture system in valvular heart surgery: a multicenter, prospective registry.

Abstract

Background: In the last years, the Cor-Knot^® device has been increasingly used in heart valve surgery. Our aim was to investigate the incidence of valvular complications in patients who underwent valvular surgery using the Cor-Knot^® device in multicentric cohorts at one-year follow-up.

Methods: Three hundred and sixty-eight patient underwent heart valve repair or replacement surgery using automated titanium suture fasteners in four cardiothoracic surgery departments between September 2018 and January 2020.

Results: The mean age was 66.3±10.2 years. The mean Euroscore II was 3.14±5.65. Procedures were performed by right anterior mini-thoracotomy for 264 patients (71.7%) and by conventional sternotomy for 76 (20.7%). Isolated single valve surgery was most common (285 patients, 77.4%), 31 patients (8.4%) underwent isolated double valve surgery and 6 patients isolated triple valve surgery (1.6%). An associated procedure was performed in 46 patients (12.5%). Sixteen patients (4.3%) required permanent pacemaker implantation in the postoperative period. Eighteen patients died postoperatively (4.9%). Two patients had paravalvular leak ≥2 (0.5%). Mean follow-up was 14.7±7.1 months. Eight patients died during the follow-up (2.2%). Four patients had infectious endocarditis. The rate of valvular leak ≥2 was 1.5% and four patients underwent valve-related reoperation (1.2%), no reoperation was related to a valve lesion due to Cor-Knot^®. There were three pacemaker implantation (0.9%) and 12 patients had NYHA>2 (3.7%). No case of metallic embolization, prosthesis thrombosis or leaflet perforation was reported during follow-up.

Conclusions: The use of the Cor-Knot^® automated knotting system in valve surgery is not associated with an increase in the rate of paravalvular leakage, permanent pacemaker implantation or mortality postoperatively or during follow-up.