Stentless vs. stented aortic valve bioprostheses: a prospective randomized controlled trial.
OBJECTIVE
We sought to assess the haemodynamic profile of the Freedom stentless aortic valve compared with a stented bioprosthesis in a randomized controlled trial using echocardiography.


RESULTS
Sixty patients (mean age 73 years) undergoing bioprosthetic aortic valve replacement (AVR) were randomized to either Sorin Freedom stentless (n=31) or Sorin More stented (n=29) valves. The primary endpoints were left ventricular mass index (LVMI) reduction at 6 and 12-months. We also assessed post-operative effective orifice area index (EOAI), aortic gradient and operative time. There were no significant differences in baseline characteristics. The stentless valve was associated with a lower post-operative gradient [PG 17 (12) vs. 31 (13) mmHg, P<0.0001] and greater EOAI [1.1 (0.3) vs. 0.8 (0.2) cm2/m2, P<0.0001]. A highly significant reduction in LVMI occurred by 6 months in both groups, but LVMI was significantly lower in the stentless group [LVMI 119 (39) vs. 135 (30) g/m2, P=0.05]. However, there was continued regression of left ventricular hypertrophy (LVH) in the stented but not in the stentless group, resulting in no significant difference in LVMI at 12 months [119 (36) vs. 126 (31) g/m2, P=0.42].


CONCLUSIONS
The use of the Sorin Freedom stentless bioprosthesis for AVR results in lower PG and greater EOA when compared with a Sorin More stented valve. This is associated with earlier regression of LVH.
Department of Cardiothoracic Surgery, James Cook University Hospital, Middlesbrough, TS4 3BW, UK. joeldunning@doctors.org.uk
J
J
Dunning
R J
RJ
Graham
J
J
Thambyrajah
M J
MJ
Stewart
S W H
SW
Kendall
S
S
Hunter
D000368:Aged; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery*; D001705:Bioprosthesis; D004452:Echocardiography; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D017379:Hypertrophy, Left Ventricular / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery; D008297:Male; D011446:Prospective Studies; D016037:Single-Blind Method; D015607:Stents; D016896:Treatment Outcome