A comparison of the in vivo performance of the 19-mm St. Jude Medical Hemodynamic Plus and 21-mm standard valve.

Background: In the present study we analyzed the in vivo performance of the 19-mm St. Jude Medical Hemodynamic Plus aortic prosthesis (19HP), evaluated the midterm performance of 19HP in the aortic position, and compared the implantability and hemodynamic characteristics of this valve with those of the 21-mm standard St. Jude Medical valve (21SD) in adult patients with aortic stenosis and a narrowed aortic annulus.
Methods: From February 1994 to December 1999, 60 patients who underwent isolated aortic valve replacement with either the 19HP (n = 31) or the 21SD (n = 29) were studied. Comparison between the two models included analysis of early and late mortality and morbidity. Pre- and postoperative echocardiography was performed in all patients to evaluate and compare the hemodynamic performance of both prosthetic valves. The postoperative serum lactic dehydrogenase activity was measured in both groups of patients as an indicator of hemolysis.
Results: The mean body surface area was 1.46 +/- 0.16 m2 in the 19HP group and 1.49 +/- 0.13 m2 in the 21SD group (p = 0.1577). Other than female dominance in the 19HP group, there was no statistically significant difference between the two groups in terms of preoperative variables (age, preoperative pressure gradients, and New York Heart Association functional class). The average postoperative peak pressure gradient was 23.3 +/- 10.5 mm Hg in the 19HP group and 27.9 +/- 9.9 mm Hg in the 21SD group (p = 0.0666). There was no hospital death in either group. Six-year follow-up was completed in both groups of patients. Late death occurred in 1 patient in the 19HP group (1.09% per patient-year). Actuarial survival at 6 years was 92.3% +/- 7.4% in the 19HP group, and 100% in the 21SD group (p = 0.33). The linearized complication rate was 1.09% per patient-year and 1.02% per patient-year for thromboembolism, and 1.09% per patient-year and 1.02% per patient-year for anticoagulant-related hemorrhage in the 19HP group and the 21SD group, respectively. Freedom from all complications at 6 years did not show any significant difference between the two groups (p = 0.54). Although left ventricular mass indices decreased significantly after aortic valve replacement in both groups (19HP group, p = 0.0002; 21SD group, p = 0.0006), there were no significant differences in the two indices between the groups after aortic valve replacement (p = 0.999). There was no significant difference in the lactic dehydrogenase level between the two groups (p = 0.4915).
Conclusions: In vivo hemodynamic performance of the 19HP valve as well as the early and intermediate clinical outcome up to 6 years was satisfactory and corresponded closely to that of the 21SD valve in adult patients. The 19-mm Hemodynamic Plus model can be recommended in patients with a measured 19-mm annulus and this valve will minimize the need for the aortic annular enlargement procedure.