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The 3f Bioprosthetic Aortic Valve - Early Experience with a Novel Stentless Valve Design

Jonathan A. Yang, Michael S. Koeckert, Brittney P. Shulman, Alex Kossar, Hiroo Takayama, Yoshifumi Naka, Craig R. Smith, Allan S. Stewart.
Columbia University Medical Center, New York, NY, USA.


OBJECTIVE:
Degenerative aortic valve disease is increasing in incidence. Due to the risks of long-term anticoagulation and the promise of transcatheter rescue, biologic valves are implanted with growing frequency. Stentless valves are hemodynamically superior but technically more complex to implant. The 3f aortic bioprosthesis (Medtronic) offers design advantages to assist reproducible implantation with excellent hemodynamics. We also developed a novel composite biologic graft (CBG) utilizing the 3f valve. We assessed our single-institution experience with the 3f prosthesis both in traditional aortic valve replacement (AVR) and as a CBG for aortic valve and root replacement.
METHODS:
This retrospective analysis included patients from 11/1/2008-12/1/2010 who underwent 3f AVR or CBG implantation. CBG construction was performed in the operating room prior to cardiopulmonary bypass (CPB). A 3f valve was sewn into the sinus portion of a Valsalva graft.
RESULTS:
We identified 221 cases (111 AVRs, 110 CBGs). Overall age was 66±14.5 with 71.5% males. All CBGs except one were constructed with a 29mm 3f valve in a 30mm Valsalva graft (serving annular sizes 19-46mm), while the mean and median AVR valve size was 23mm. Median aortic cross-clamp (AXC) and CPB times were 87 (interquartile range 70-115) and 112 (89-147) minutes, respectively, with no significant difference between groups. Eighty-eight (40%) patients had concomitant procedures. Mean post-operative aortic valve gradient (AVG) following AVR was 11.9±7.5mmHg vs 6.9±3.7mmHg in the CBG group (p<0.0001). Stroke rate was 2.3% and in-hospital mortality was 1.8%. There were only 2 (0.9%) early valve-related complications requiring reoperation (endocarditis, paravalvular leak).
CONCLUSIONS:
Patients implanted with the 3f valve had relatively low operative times, AV gradients, and rates of reoperation and infection, with acceptable morbidity and mortality. The 3f valve has technical advantages over other stentless valves, with increased reproducibility and decreased cross-clamp times due to the presence of three tabs that eliminate the need of a second suture line. Post-operative mean AVGs were lower in the CBG group, likely due to the standard use of a 29mm prosthesis, and may allow for improved durability and functionality. Additional studies are needed to assess these potential hemodynamic advantages and long term outcomes.
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