Seventy-three patients with a CarboMedics aortic bileaflet valve prosthesis were examined by Doppler ultrasonography, and 27 of them were also assessed by transseptal catheterization. The ultrasonic mean systolic gradient was 17.1 +/- 5.6 mm Hg for valve size 19 mm, falling gradually with increasing valve size to 6.8 +/- 2.5 mm Hg for size 27 mm. The catheter mean systolic gradient was consistently smaller than the ultrasonic gradient (4.3 +/- 4.8 mm Hg), but Tobit regression analysis showed a significant association between the two methods. In all patients both methods revealed negligible to small amounts of retrograde leakage, which is assumed to be a normal finding for this valve. The effective flow areas of the valves calculated from the ultrasonic data were similar to the in vitro calculated flow areas. The hemodynamic potential of this valve is therefore completely utilized in vivo. The effective orifice area corrected for body surface area increased with increasing valve size, which demonstrates a moderate valve-patient mismatch.