Key result
St. Jude Regent aortic valve demonstrates excellent hemodynamics with ~92% of patients improving NYHA class.
Why the study?
Does the St. Jude Medical Regent bileaflet mechanical heart valve prosthesis improve hemodynamics and functional status in patients after aortic valve replacement?
Observational (n=75)
Does the St. Jude Medical Regent bileaflet mechanical heart valve prosthesis improve hemodynamics and functional status in patients after aortic valve replacement?
The St. Jude Medical Regent aortic valve prosthesis demonstrates favorable in vivo hemodynamics and is associated with clinical improvement at 12 to 21 months follow-up.
Adds observational support for Regent valve use in AVR; leaves open need for randomized comparisons before practice change.
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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Südkamp et al. (2003) conducted an observational in Aortic valve replacement (n=75). St. Jude Medical Regent prosthesis was evaluated on In vivo transvalvular gradients and effective orifice areas (EOAs). The St. Jude Medical Regent valve demonstrated excellent in vivo hemodynamics across sizes 19-27 mm, with 92% of patients improving by at least one NYHA class at 12 to 21 months follow-up.
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