Early and Mid-term Outcome of the St. Jude Medical Regent 19-mm Aortic Valve Mechanical Prosthesis. Functional and Haemodynamic Evaluation

Background and Objectives The aim of the present study is to report the early and mid-term clinical and haemodynamic results of the St Jude Medical Regent 19-mm aortic mechanical prothesis (SJMR-19). Materials and Methods Between January 2002 and January 2012, 265 patients with aortic valve disease underwent AVR (Aortic Valve Replacement) with a SJMR-19 (St Jude Medical Regent Nr.19). There were 51 males. Mean age was 67.5±12.72years and mean body surface area (BSA) was 1.67±0.14m2. Thirty-six patients required annulus enlargement. The mean follow-up was 34.5±18.8months (range 6–60 months). All patients underwent echocardiographic examination at discharge and within one year after surgery. Results There were 14 (5.3%) hospital deaths. Six of the hospital deaths were identified in patients undergoing reoperation, significantly higher than patients undergoing first time operation (p=0.0001). Also the postoperative mortality was significantly higher in patients undergoing annulus enlargement versus patients not requiring annulus enlargement (p=0.02). The mean transprosthesis gradient at discharge was 19±9mmHg. At six months follow-up the mean NYHA FC class was 1.6±0.5 significantly lower than preoperatively 2.4±0.75 (p i ) were significantly lower than preoperatively The actuarial survival and cumulative freedom from reoperation at one, two and three years follow-up were 99.5%, 97.5%, 96.7% and 99.2%, 96.5%, 94.5% respectively. The cumulative actuarial free-events survival at four years was 92%. The Cox model identified age (p=0.015), LVEF≤35% (p=0.043), reoperation (p=0.031), combined surgery (p=0.00002), and annulus enlargement (p=0.015) as strong predictors for poor actuarial free-major events survival. Conclusions The SJMR-19 offers excellent postoperative clinical, haemodynamic outcome and LVM i reduction in patients with small aortic annulus. These data demonstrate that the modern St Jude small mechanical protheses do not influence the intermediate free-reoperation survival.