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 with a SJMR-19. There were 51 males. Mean age was 67.5 ± 12.72 years and mean body surface area (BSA) was 1.67 ± 0.14 m2. Thirty-six patients required annulus enlargement. The mean follow-up was 34.5 ± 18.8 months (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 ± 9 mmHg. At six months follow-up the mean NYHA FC class was 1.6 ± 0.5 significantly lower than preoperatively 2.4 ± 0.75 (p < 0.0001). The M-TPG was 15.2 ± 6.5 mmHg within one year after surgery. Left ventricular mass (LVM) and indexed left ventricular mass (LVMi ) 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 LVMi reduction in patients with small aortic annulus. This data demonstrate that the modern St Jude small mechanical protheses do not influence the intermediate free-reoperation survival.