Objective: Our objective was to access the clinical and hemodynamic performance of a stentless porcine bioprosthesis: The Freestyle aortic root bioprosthesis.

Methods: Patients requiring isolated aortic valve or aortic root replacement are implanted with the bioprosthesis. Clinical follow-up and echocardiographic data are obtained at discharge, 3-6 months, one year and annually thereafter.

There were 281 patients (150 men and 131 women) who received a Freestyle bioprosthesis between January 1993 and July 1997. Of these, 247 patients underwent valve replacement, 33 underwent aortic root replacement, and one underwent root inclusion. Mean age was 68 years (range 45 years to 85 years), and 86.6% of the patients were in either NYHA Class III or IV, preoperatively.

Results: Overall mortality was 4.9% with 3.6% mortality for valve replacement and 15% mortality for aortic root replacement. There were four valve-related reoperations (two for endocarditis and two for valve-related insufficiency). At the most recent follow-up, 95.5% of patients were in Class I or II. At follow-up the mean gradient decreased significantly between discharge and 3 to 6 months follow-up (p < 0.001) this trend continued at one and two years follow-up. The effective orifice area also increased significantly from discharge to 3-6 months follow-up and up to the third year. Cardiac output, however, did not vary during this period. Of all patients, 84.4% have either trivial or no regurgitation at three years. Freedom from the following valve-related complications at 3 years was: for valve-related death, 99.1%; for permanent neurologic deficit, 97.7%; for endocarditis, 98.3%; and for reoperation, 98.7%.

Conclusions: The Freestyle bioprosthesis has exceptional clinical performance and good short term hemodynamic performance. Presence of regurgitation is, for the majority of patients, not significant.