Hemodynamics and early performance of the St. Jude Medical Regent (TM) aortic valve prosthesis

Background and aim of the study: The St. Jude Medical (SJM) Regent (TM) hea rt valve is a new bileaflet prosthetic valve modified from the currently ma rketed SJM mechanical valve, with a modified external profile that results in a larger geometric orifice area without changing the existing design of the pivot mechanism or blood contact surface areas. The aim of the present study was to report the early hemodynamic and clinical results of an on-goi ng multicenter trial investigating the clinical performance of the Regent m echanical aortic valve prosthesis. Methods: The early results from 204 patients at 11 centers in North America and Europe who underwent implantation of a Regent mechanical aortic valve prosthesis are described. Clinical status was prospectively recorded, and e chocardiography with Doppler performed at hospital discharge, and at two an d six months and one year postoperatively. Results: Follow up to date is 109.3 patient-years (average follow up 0.5 +/ - 0.4 years per patient; range: 0 to 1.7 years). NYHA class improved for th e group, and there were low rates of clinical adverse effects. Echocardiogr aphic mean pressure gradient at six months was 13.8 +/- 10.3,7.4 +/- 4.1, 5 .4 +/- 3.2, 5.2 +/- 2.8,3.4 +/- 2.3 and 3.6 mmHg, respectively, for 19, 21, 23, 25, 27 and 29 mm valves; effective orifice area was 1.5 +/- 0.6, 2.0 /- 0.7, 2.4 +/- 1.0, 2.5 +/- 0.7, 3.6 +/- 1.4 and 4.8 cm(2), respectively. There was a statistically significant decrease in left ventricular mass ind ex between early postoperative (169.1 +/- 57.7 g/m(2)) and six months follo w up (137.2 +/- 42.7 g/m(2), Delta = -30.1 +/- 42.5 g/m(2), p <0.0001). Conclusion: The SJM Regent aortic valve has excellent associated hemodynami cs with rapid and significant left ventricular mass regression. In all case s of adverse events, rates fell within Objective Performance Criteria guide lines. Long-term clinical assessment is on-going.