Clinical and hemodynamic performance of the Freestyle aortic root bioprosthesis.
BACKGROUND
The objective of this study is to assess the clinical and hemodynamic performance of a stentless porcine bioprosthesis, the Freestyle aortic root bioprosthesis.


METHODS
Consenting patients requiring isolated aortic valve or aortic root replacement received the Freestyle bioprosthesis. Clinical follow-up and echocardiographic data were obtained at discharge, 3 to 6 months, 1 year, and 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 years. Preoperatively, 86.3% were either New York Heart Association class III or IV. Two hundred thirty-eight patients underwent valve (subcoronary) replacement, 36 underwent aortic root replacement, and 2 underwent valve replacement using the root-inclusion technique. The early mortality was 5.4%, with 3.3% mortality for the subcoronary technique and 19.4% mortality for aortic root replacement. The mean gradient decreased significantly between discharge and the 3- to 6-month follow-up and stabilized thereafter. The effective orifice area increased significantly from discharge to 3 to 6 months' follow-up. At 3 years, 84.4% of the patients had either no or trivial regurgitation.


CONCLUSIONS
The Freestyle bioprosthesis has good clinical performance and good short-term hemodynamic performance. The majority of the regurgitation identified is not clinically significant.
Cartier
P C
PC
Department of Cardiac Surgery, Laval Hospital, Ste-Foy, Quebec, Canada.
Dumesnil
J G
JG
Métras
J
J
Desaulniers
D
D
Doyle
D P
DP
Lemieux
M D
MD
Raymond
G
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001011:Aorta / Q000503:physiopathology / Q000601:surgery; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D004452:Echocardiography; D005260:Female; D006349:Heart Valve Diseases / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000000981:diagnostic imaging* / Q000401:mortality / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation