Background and aim of the study: The study aim was to evaluate the hemodynamic function after aortic valve replacement (AVR) using the On-X valve, in comparison with St. Jude Medical (SJM) HP bileaflet valves.
Methods: Patients received either the On-X (n = 20) or SJM HP prosthesis (n = 20) for AVR. The control (SJM HP) group was computer-matched with the On-X group for age, gender, aortic stenosis as underlying disease, body surface area, NYHA functional class, left ventricular size, mass and function, transvalvular pressure gradients and cardiac index. Mean implanted valve size was 23.5 mm (three 21 mm, ten 23 mm, six 25 mm, one 27 mm) in both groups. All patients underwent postoperative, and six- and 12-month follow up echocardiography.
Results: The intra- and postoperative course was uneventful in all patients. There were no significant differences in cross-clamp and cardiopulmonary bypass times, intensive care unit stay, in-hospital stay and postoperative NYHA functional class. Two patients (both On-X) had paravalvular leakage postoperatively and at follow up. Five patients in the control group had additional myocardial revascularization. Transvalvular flow velocities were 2.38 +/- 0.3 versus 2.38 +/- 0.4 m/s (p = NS) postoperatively, and 2.08 +/- 0.2 versus 2.22 +/- 0.3 m/s (p = NS) at one year follow up for On-X and SJM HP valves, respectively. Maximum pressure gradients were 16.9 +/- 6.0 versus 18.5 +/- 8.0 mmHg (p = NS) postoperatively and 14.0 +/- 3.7 versus 16.5 +/- 5.7 mmHg (p = NS) at one year for the two valve types, respectively. A relatively pronounced transvalvular reflux was diagnosed for On-X valves.
Conclusion: At one year after implantation, the On-X bileaflet prosthesis is equally suited for AVR in comparison with the 'standard' therapy (SJM HP). Exact sizing requires some experience. There were no significant differences between the two prostheses with regard to hemodynamic parameters either postoperatively or at one-year follow up. Long-term prospective randomized studies yet have to be carried out.