S. Westaby et al., VALVE-REPLACEMENT WITH A STENTLESS BIOPROSTHESIS - VERSATILITY OF THEPORCINE AORTIC ROOT, Journal of thoracic and cardiovascular surgery, 116(3), 1998, pp. 477-484
Objective: Stentless valves convey important hemodynamic benefits but
are used selectively depending on aortic root structure. The Freestyle
valve (Medtronic, Inc, Minneapolis, Minn) is a versatile device that
can be implanted by different methods depending on operating condition
s. We aimed to demonstrate that a stentless valve could be used in eve
ry patient without increased risk of morbidity or mortality. We docume
nted the effects of this valve on clinical outcome and left ventricula
r mechanics. Methods: The Freestyle valve was implanted by the modifie
d subcoronary method into 200 consecutive unselected patients who rece
ived a tissue valve in the aortic position and by root replacement in
2, Forty-three percent were older than 75 years. Forty percent underwe
nt coronary bypass. Detailed clinical and echocardiographic follow-up
(Food and Drug Administration protocol) was used out to 3 years. Resul
ts: Mean ischemic time was 43 +/- 6 minutes for isolated aortic valve
replacement and 63 +/- 14 minutes with concomitant procedures. Thirty-
day mortality was 6%, none of the deaths being valve related. Hemodyna
mic function improved progressively with falling valve gradients and i
ncreased effective orifice areas. Left ventricular mass fell within no
rmal limits over 2 years, but at 3 years there was a non-valve-related
upswing. No instances of valve thrombosis, hemolysis, or paravalvular
leak were noted. Less than 5% had mild to moderate aortic regurgitati
on, Conclusions: The Freestyle valve can be used in virtually every pa
tient with aortic valve disease and provides superlative hemodynamic o
utcome. Hospital mortality and morbidity are similar to those reported
for stented valves in an elderly population.