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Ann Thorac Surg 2002;74:2003-2009
© 2002 The Society of Thoracic Surgeons
a Department of Medicine, Division of Cardiology, University of Michigan, Ann Arbor, Michigan, USA
b Section of Cardiothoracic Surgery, Department of Surgery, William Beaumont Hospital, Royal Oak, Michigan, USA
c Section of Cardiothoracic Surgery, Department of Surgery, London Health Sciences Center, London, Ontario, Canada
d Section of Cardiothoracic Surgery, Department of Surgery, St. Thomas Hospital, Nashville, Tennessee, USA
e Section of Cardiothoracic Surgery, Department of Surgery, Herzzentrum Universitat Leipzig, Leipzig, Germany
* Address reprint requests to Dr Bach, University of Michigan, L3119 Women’s—0273, Ann Arbor, MI 48109, USA.
e-mail: dbach{at}umich.edu
Presented at the Thirty-eighth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 28–30, 2002.
BACKGROUND: The St. Jude Medical Regent valve is the next-generation bileaflet aortic prosthesis, modified from the currently marketed St. Jude Medical mechanical valve to achieve a larger geometric orifice without changing the existing design of the pivot mechanism or blood-contact surface areas. The present study reports the hemodynamic and early clinical results of an ongoing multicenter trial investigating the performance of the Regent valve.
METHODS: Between July 1998 and July 2001, 361 patients at 17 centers in North America and Europe underwent implantation of a Regent mechanical aortic valve prosthesis. Clinical status was prospectively recorded, and echocardiography with Doppler was performed at discharge and at 2 months, 6 months, 1 year, and 2 years after operation.
RESULTS: Follow-up to date is 300 patient-years (average, 0.8 ± 0.7 years per patient; range, 0.0 to 2.7 years). There were low rates of clinical adverse events. Mean gradient at 6 months was 9.7 ± 5.3 mm Hg, 7.6 ± 5.2 mm Hg, 6.3 ± 3.7 mm Hg, 5.8 ± 3.4 mm Hg, and 4.0 ± 2.6 mm Hg, respectively, for 19-mm, 21-mm, 23-mm, 25-mm, and 27-mm valves; effective orifice area was 1.6 ± 0.4 cm2, 2.0 ± 0.7 cm2, 2.2 ± 0.9 cm2, 2.5 ± 0.9 cm2, and 3.6 ± 1.3 cm2, respectively. Indexed effective orifice area was equal to or greater than 1.0 cm2/m2 for all valve sizes. Left ventricular mass index decreased significantly between early postoperative (165.9 ± 57.1 g/m2) and 6-month follow-up (137.9 ± 41.0 g/m2; 
= -28.0 ± 49.1 g/m2; p < 0.0001).
CONCLUSIONS: The St. Jude Medical Regent aortic valve has excellent hemodynamics and early clinical results, with rapid and significant left ventricular mass regression. Long-term clinical assessment is ongoing.
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