Objectives: New generation bileaflet valve prostheses with a silver-coated sewing cuff like the St Jude Medical (SJM((R)) Regent) model are designed to offer a larger valvular orifice as well as a better resistance to postoperative prosthetic endocarditis, at the expense of a smaller sewing cuff.
Methods and results: We report on four cases of aortic valve replacement where during the implantation procedure the fixation cuff disrupted, leading to the exchange of all four valve prostheses. This happened three times with silver- coated sewing cuffs and after withdrawal of the silver- coated cuff prostheses from the market, once with a non silver- coated sewing cuff. This was due to the arbitrary cutting of the cuff fixation suture at the ventricular side of the prosthesis, although the implantation was performed according to the recommendations of the company. This problem didn't occur previously, using other models of the same manufacturer, although the sewing cuff had been fixed in the same technique.
Conclusion: Fixation of smaller sewing cuffs of mechanical valve prostheses with a critically exposed fixation suture at the ventricular side of the prosthesis represents a significant risk for disruption during the implantation process through cut off by chance. We recommend meticulous inspection of the sewing cuff for signs of disruption before seating the valve into position. During follow-up particular attention should be paid to valve dislodgement and leakage. The company was informed and advised by us to modify the fixation of the prosthetic annulus of the SJM((R)) Regent valve, which has led to an alternative cuff design, called the SJM Flex cuff.