Clinical and hemodynamic performance of the freestyle aortic root bioprosthesis

Background. The objective of this study is to assess the clinical and hemod ynamic performance of a stentless porcine bioprosthesis, the Freestyle aort ic root bioprosthesis. Methods. Consenting patients requiring isolated aortic valve or aortic root replacement received the Freestyle bio-prosthesis. Clinical follow-up and echocardiographic data were obtained at discharge, 3 to 6 months, 1 year, a nd annually thereafter. Results. Two hundred seventy-six patients received a Freestyle aortic root bioprosthesis between January 1993 and July 1997. The mean age was 67.7 yea rs. Preoperatively, 86.3% were either New York Heart Association class III or IV. Two hundred thirty-eight patients underwent valve (subcoronary) repl acement, 36 underwent aortic root replacement, and 2 underwent valve replac ement using the root-inclusion technique. The early mortality was 5.4%, wit h 3.3% mortality for the subcoronary technique and 19.4% mortality for aort ic root replacement. The mean gradient decreased significantly between disc harge and the 3- to 6-month follow-up and stabilized thereafter. The effect ive orifice area increased significantly from discharge to 3 to 6 months' f ollow-up. At 3 years, 84.4% of the patients had either no or trivial regurg itation. Conclusions. The Freestyle bioprosthesis has good clinical performance and good short-term hemodynamic performance. The majority of the regurgitation identified is not clinically significant. (C) 1999 by The Society of Thorac ic Surgeons.