Eight-year results of Freestyle stentless bioprosthesis in the aortic position: a single-center study of 500 patients.
OBJECTIVE
Stentless bioprostheses may be the future valve of choice for aortic valve replacement (AVR). The study aim was to investigate mid-term clinical outcome after AVR with the Medtronic Freestyle valve.


METHODS
Between April 1997 and November 2004, a total of 500 patients (241 females, 259 males) was implanted with a Freestyle bioprosthesis for AVR, without population selection, by a single surgical team at the authors' institutions. Mean patient age was 74.5 +/- 9.6 years (range: 26-91 years); 34 patients (7%) were aged < 60 years, 121 (24%) were aged > 80 years, and 205 (41%) were in NYHA classes III or IV. The surgical procedure used included a modified subcoronary technique in 482 cases and complete root replacement in 18, conducted with mini-extracorporeal circulation. Concomitant procedures included coronary artery bypass grafting in 123 patients (25%), mitral valve repair/replacement in five, and maze in two. Follow up was 98% complete; the mean follow up was 31.3 months (range: 4-95 months).


RESULTS
The mean cardiopulmonary bypass time was 98 +/- 26 min, and total aortic cross-clamp time 77 +/- 19 min. Operative mortality was 5.2% (n = 26), and no patients aged under 60 years died. At eight years, freedom from structural valve deterioration was 100% (0% in the young population), freedom from endocarditis 97.2%, freedom from reoperation 97%, and overall survival 83%. Most of the late deaths (n = 56) were of non-cardiac origin, and occurred in older patients. After one year, the mean aortic echocardiographic gradient was 11.5 +/- 1.1 mmHg, and was improved compared to that at discharge. No significant aortic insufficiency occurred.


CONCLUSIONS
Use of the Freestyle stentless bioprosthesis for AVR resulted in excellent short-term survival in the octogenarian population, and excellent mid-term results in the younger population. In time, experience will indicate whether the Freestyle should be considered as the bioprosthesis of choice for patients of all ages.
Deleuze
Philippe H
PH
St. Joseph Hospital, Paris, France. phideleuze@free.fr
Fromes
Yves
Y
Khoury
Wassim
W
Maribas
Philippe
P
Lemaire
Sacha
S
Bical
Olivier M
OM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001705:Bioprosthesis; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011474:Prosthesis Design; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome