Fast sutureless implantation of mechanical aortic valve prostheses using Nitinol attachment rings: Feasibility in acute pig experiments

Objective There is a need for fast sutureless implantation of valve prostheses with a better outcome than that of current valved stents. Methods The suture ring of a St Jude mechanical valve prosthesis (St Jude Medical, Minneapolis, Minn) was replaced by a proprietary non–stent-based attachment ring made of Nitinol memory metal (Endosmart, Stutensee, Germany) and covered with textile. In acute pig experiments, the aortic valve was removed and the device was introduced in a temporary stretched shape and activated by removing constrainers and heating to reach its final attachment shape. Results The devices could be actuated within seconds. Echocardiography showed normal prosthetic valve and heart function. No paradevice leakage was demonstrated by supravalvular angiography. At autopsy, no abnormalities were found in the surrounding structures or valve prostheses. Pulling tests showed the strong adhesive power of Nitinol attachment rings withstanding up to 5 kg of pulling force. Conclusion Nitinol memory metal attachment rings, covered with textile, around suture ring-denuded St Jude mechanical aortic valve prostheses enabled fast and strong sutureless implantation in acute pig experiments. Further studies in chronic animal models and humans are needed to determine long-term safety.