Transvalvular in Vivo Gradients of the New Generation Bileaflet Heart Valve Prosthesis St. Jude Medical Regent® in Aortic Position

 

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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.

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MD Michael Südkamp

Klinik und Poliklinik für Herz- und Thoraxchirurgie, Universitätsklinikum Köln

Joseph-Stelzmann-Str. 9

50924 Köln

Germany

Phone: +49/221/4786043

Fax: +49/221/4785906

Email: michael.suedkamp@medizin.uni-koeln.de