Does the St. Jude Regent 17-mm Offer Better Outcomes Than the Hemodynamic Plus 17-mm Aortic Valve Mechanical Prothesis?

Objective: The aim of the present study is to report the early and mid-term clinical and hemodynamic results of a prospective trial investigating the clinical performance of the St. Jude Medical Regent 17 mm (SJMR-17) versus St. Jude Medical Hemodynamic Plus 17 mm (SJMHP-17).

Materials And Methods: Between January 2000 and August 2013, 20 patients (Group I) with aortic valve (AV) stenosis underwent first time AV replacement with a SJMR-17 and nine patients (Group II) underwent AV replacement with a SJMHP-17. The mean follow-up was 58 ± 31 months.

Results: There was one death in Group I. The end-diastolic IVS thickness and end-systolic posterior left ventricle (LV) wall thickness was reduced significantly in boths groups (p = 0.001 and p = 0.006 in Group I and p = 0.007 and p = 0.011 in Group II). The peak and mean transprosthesis gradients (P-TPG and M-TPG) were 29 ± 6.8 mmHg and 17.5 ± 4.5 mmHg in Group I, significantly lower than in Group II (55.2 ± 19.7 mmHg and 28.8 ± 7.7 mmHg). The postoperative left ventricular mass (LVM) and indexed left ventricular mass (LVMi) were reduced significantly in both groups versus the preoperative values. The postoperative LVMi was 114.5 ± 10.6 g/m(2) in Group I versus 127 ± 8 g/m(2) in Group II (p = 0.01). With dobutamine, heart rate, left ventricular ejection fraction, cardiac output, transprosthesis peak, and mean gradients increased significantly in both groups, however, the P-TPG and M-TPG were significantly higher in Group II (p = 0.026 and p = 0.022) despite a non-significant increase of the indexed effective orifice area.

Conclusions: The SJMR-17 can be employed with satisfactory postoperative clinical and hemodynamic outcomes in patients with small aortic annulus, especially in elderly patients offering better outcome than SJMHP-17.