Key result
Aortic valve replacement with the St Jude Medical Regent mechanical valve significantly reduced left ventricular mass index from 221 to 161 g/cm2 at two months (p<0.001).
Why the study?
Does aortic valve replacement with the St Jude Medical Regent mechanical heart valve improve hemodynamic performance in patients with pure aortic stenosis?
Cohort (n=32)
Does aortic valve replacement with the St Jude Medical Regent mechanical heart valve improve hemodynamic performance in patients with pure aortic stenosis?
p-value: p=<0.001
The St Jude Medical Regent mechanical heart valve demonstrates satisfactory early hemodynamic performance, significantly reducing transaortic gradients and left ventricular hypertrophy in patients with pure aortic stenosis.
Early LV mass regression after Regent AVR in aortic stenosis; leaves open long-term outcomes versus other prostheses.
BACKGROUND: The St Jude Medical Regent is a new-generation mechanical heart valve that represents a design evolution of the St Jude Hemodynamic Plus Series (HP). The purpose of this study was to evaluate early "in vivo" hemodynamic performance of the Regent valve in patients with aortic stenosis. METHODS: Between March 2000 and December 2001, 32 patients (mean age 59.9 +/- 5.9,56.3% male) with pure aortic stenosis received a Regent mechanical prosthesis in the aortic position. Hemodynamic performance was assessed by Doppler echocardiography at discharge, two months, six months, and one year by calculating peak transprosthetic velocity (Vmax), mean (MG) and peak (PG) transprosthetic gradients, effective orifice area index (EOAI), left ventricular mass index (LVMI), and degree of aortic regurgitation. RESULTS: A significant reduction in mean and peak transaortic gradients (p < 0.001) and a significant increase in EOAI (p < 0.001) over time followed valve replacement, and a bivariate analysis of variance (ANOVA) failed to demonstrate statistical differences by valve size over time (p = ns). A significant reduction in left ventricular hypertrophy occurred over time (p < 0.001) in all valve sizes (p = ns between groups): baseline LVMI was 221 +/- 57 g/cm2; it decreased by 30 g/cm2 (p < 0.001) at discharge. LVMI decreased from 191 +/- 54 g/cm2 to 161 +/- 41 g/cm2 (p < 0.001) from discharge to two months. Further reductions were not significant. At the six-month follow-up no patient in our cohort exhibited moderate or severe aortic regurgitation at Doppler echocardiography. CONCLUSIONS: Early results with the St Jude Medical Regent valve have been satisfactory. Further assessments are necessary to confirm these results.
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Gelsomino et al. (2003) conducted a cohort in Pure aortic stenosis (n=32). St Jude Medical Regent mechanical heart valve was evaluated on Hemodynamic performance (mean and peak transaortic gradients, EOAI, and LVMI) (p=<0.001). Aortic valve replacement with the St Jude Medical Regent mechanical valve significantly reduced left ventricular mass index from 221 to 161 g/cm2 at two months (p<0.001).
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