Severe aortic regurgitation after implantation of a sutureless valve prosthesis using an automatic knot fastener device

Abstract

We report the case of severe aortic regurgitation 8 months after implantation of a 25-mm sutureless pericardial aortic valve prosthesis. On echocardiography, the regurgitation was suspected to be paravalvular. The sutureless prosthesis had been implanted using an automatic knot fastener device, which renders the suture tails less pliable because of the metal clip that is crimped around the suture. The patient was reoperated, a paravalvular leak was not observed. The sutureless prosthesis was explanted and a conventional biologic valve prosthesis was implanted instead. On examination of the explanted valve prosthesis, a perforation was observed in one of the leaflets. The leaflet perforation was in alignment with one of the knots produced by the automatic knot fastener. Obviously, the leaflet had hit the knot repeatedly which had caused the perforation. We conclude that knots produced by an automatic fastener device have the potential to cause leaflet perforation.

Use of an Automated Suture Fastening Device in Minimally Invasive Aortic Valve Replacement

“…Although there is a dearth of clinical data on the use of the CK in cardiac surgery, significant complications have been reported. Severe aortic insufficiency necessitating re-operation has been described by two separate centers [19,20]. In both cases, the valvular insufficiency was related to leaflet perforation from improper orientation of the steel crimpers of the fastening device.…”

Delayed Metallic Embolization of a Cor-Knot Fastener

“…There have been reports of erosion of prosthetic valve leaflets which came into contact with the titanium fasteners that required subsequent redo valve replacement. 1 2 According to the company, there have been no previous reports of embolization of the titanium fasteners.…”

The role of Cor‐Knot in the future of cardiac surgery: A systematic review

“…Multiple case reports illustrate that valve leaflet perforation may result from failing to orientate the device in this way. [15][16][17][18] Once the lever has been squeezed for 1 second, it should be released, the device rotated to disengage from the fastener, and withdrawn. It is advised that the fastener is subsequently inspected in situ so as to ensure its correct positioning away from contact with any sensitive tissues or the prosthesis.…”

“…Cor-Knot is the potential for complications, with multiple cases of metallic emboli 28,29 and leaflet perforation being reported. [15][16][17][18] LSI Solutions acknowledge an overall incidence of 0.00015% for adverse events whilst using Cor-Knot for any given procedure. 7 Many authors of the aforementioned case reports state that leaflet perforation may be mitigated by appropriately orientating the fastener so as to prevent prosthesis leaflet damage.…”

“…A number of case reports describe Cor-Knot-inflicted perforation of valves which led to valvular regurgitation after AVR. [15][16][17][18] It is thought that these problems arose as a result of the surgeon's inexperience with the device 6 and, according to LSI Solutions, appropriate fastener orientation will prevent such complications. 7 Additionally, Sagheer et al reported a case of a metallic brain embolus originating either from a mechanical heart valve or a titanium clip in a patient who underwent aortic valve and MV replacement 7 months beforehand.…”