BACKGROUND It is suggested that a simplified implant model Cryolife-O'Brien (CryoLife International, Kennesaw, GA) offers less satisfactory outcome compared with standard stentless models. This study was conducted to prospectively evaluate the midterm results after aortic valve replacement with the Cryolife-O'Brien stentless bioprosthesis. METHODS In 1996, a prospective clinical trial using different stentless valves was initiated. From September 1996 through September 2002, 156 consecutive patients with a mean age of 74.5 years underwent aortic valve replacement with the Cryolife-O'Brien porcine stentless bioprosthesis. The predominant aortic valve lesion was stenosis in 128 and insufficiency in 28 cases. Patients have been followed from 2 to 72 months (mean, 42 months). Echocardiography was performed by one echocardiographer preoperatively, intraoperatively, postoperatively at discharge, 2 to 6 months later, and annually thereafter. RESULTS Sixty percent of patients received a valve 25 mm in diameter or larger; 39% had concomittant coronary bypass grafting. The 30-day operative mortality rate was 6.4%. Ten late nonvalve-related deaths have occurred. Severe aortic insufficiency caused by oversizing leads to early reoperation in 3 patients. The peak and mean systolic gradients decreased significantly during the first 12 months after implantation, p < 0.001, and the effective valve areas increased significantly during this time interval p < 0.001. At 5 years, ten patients have moderate aortic insufficiency. The actuarial survival at 5 years was 88 +/- 3%. The rate for freedom from endocarditis was 100% and for freedom from thromboembolic events was 94%. CONCLUSIONS Midterm results after aortic valve replacement with the Cryolife-O'Brien stentless bioprosthesis are encouraging. Good hemodynamics have been coupled with low rate of valve-related complications, thus representing a very good alternative to conventional stented bioprostheses.