title: Transvalvular in vivo gradients of the new generation bileaflet heart valve prosthesis St. Jude Medical Regent in aortic position.
abstract: BACKGROUND
  By changing the design of the St. Jude Medical Regent prosthesis in shifting both sewing cuff and retaining ring into a completely supra-annular position, the Regent valve has a greater geometric orifice for a given outer diameter. Accordingly, in vitro studies have shown increased effective orifice areas (EOAs) and lower transvalvular gradients. The aim of our study was to determine in vivo transvalvular gradients and EOAs in patients after aortic valve replacement (AVR).
  
  
  METHODS
  We investigated 75 patients at 12 to 21 months follow-up after AVR using transthoracic echocardiography. We determined left ventricular systolic and diastolic function, EOA, and transvalvular peak gradient parameters at rest. Outcomes were assessed using the NYHA classification and functional status.
  
  
  RESULTS
  No patient experienced cardiac failure. The majority reported good functional status and good quality of life. Five (6.7 %) late deaths were observed within the surveillance period. At follow-up, 92 % of the patients had improved by at least one NYHA class. Transvalvular peak gradients at rest for patients with Regent valves were 25.4 +/- 7.7 mmHg, 19.2 +/- 4.6 mmHg, 15.6 +/- 5.8 mmHg, 14.6 +/- 5.5 mmHg, and 8.5 +/- 2.5 mmHg; EOAs were 1.38 +/- 0.32 cm2, 1.62 +/- 0.49 cm2, 2.24 +/- 0.83 cm2, 2.63 +/- 0.70 cm2, and 3.28 +/- 0.34 cm2 for valve sizes 19 mm, 21 mm, 23 mm, 25 mm, and 27 mm, respectively.
  
  
  CONCLUSIONS
  The SJM Regent valve shows excellent in vivo hemodynamics as confirmed by echocardiography. Clinically, 92 % of the patients improved by at least one NYHA class.
authors.affiliation: Department of Cardiothoracic Surgery, University of Cologne, Germany. michael.sudkamp@medizin.uni-koeln.de
authors.forename: M
authors.initials: M
authors.lastname: Südkamp
authors.forename: A J
authors.initials: AJ
authors.lastname: Lercher
authors.forename: F
authors.initials: F
authors.lastname: Müller-Riemenschneider
authors.forename: K
authors.initials: K
authors.lastname: LaRosee
authors.forename: P
authors.initials: P
authors.lastname: Tossios
authors.forename: U
authors.initials: U
authors.lastname: Mehlhorn
authors.forename: E R
authors.initials: ER
authors.lastname: de Vivie
mesh_terms: D001021:Aortic Valve; D004452:Echocardiography; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D011474:Prosthesis Design; D016277:Ventricular Function, Left