Eight-Year Results
of Freestyle Stentless Bioprosthesis in the Aortic Position: A Single-Center
Study of 500 Patients
Philippe H. Deleuze1,2, Yves Fromes1,3,
Wassim Khoury1,2, Philippe Maribas1,2, Sacha Lemaire1, Olivier M. Bical1,2
1St. Joseph Hospital, Paris, 2CMC Parly
2, Le Chesnay, 3Inserm U 582, Paris, France |
Background and aim of the study: 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).
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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.
Conclusion: 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.
The Journal of Heart Valve Disease 2006;15:247-252 |