M. R. Helder1, N. T. Kouchoukos4, K. Zehr2, J. A. Dearani1, C. N. Heins3, H. V. Schaff1 1Mayo Clinic,Cardiovascular Surgery,Rochester, MN, USA 2Johns Hopkins University School Of Medicine,The John Hopkins Heart & Vascular Institute,Baltimore, MD, USA 3Mayo Clinic,Biomedical Statistics And Informatics,Rochester, MN, USA 4Missouri Baptist Medical Center,St. Louis, MO, USA
Introduction: Decellularized bioprostheses utilized for aortic valve replacement (AVR) have the theoretical advantage of reduced antigenicity and increased durability. Prior studies demonstrated satisfactory early outcome and negative panel reactive antibody in >90% of pt with DAVA 1 year postoperatively. However, long-term durability of DAVA is unknown.
Methods: We reviewed 42 consecutive pt who underwent AVR with a decellularized allograft from March 12, 2002 to October 6, 2004 at 2 institutions. We compared this cohort to 29 consecutive control pt who underwent AVR with a standard cryopreserved allograft during the same interval. The primary outcome was aortic valve reoperation, and secondary outcome was overall mortality.
Results:In pt undergoing AVR with DAVA, aortic reoperation was required in 37% (15/41) of survivors, and the most common indication was allograft regurgitation (7/15, 47%). In the 29 control pt receiving standard cryopreserved allografts, aortic valve reoperation was required in 17% (4/24), and aortic regurgitation was the indication in 2 (50%). Freedom from reoperation 5 yr postoperatively was 92% (95% CI, 84%-100%) in the DAVA group compared to 100% in the control group. Freedom from reoperation at 10 yr postoperatively was 51% (95% CI, 34%-76%) in pt receiving DAVA compared to 80% (95% CI, 60%-100%) in the control group (p=0.06). Overall 5 and 10-yr survival were 90% (95% CI, 80%-100%) and 76% (95% CI, 61%-93%) in the decellularized group compared the 72% (95% CI, 57%-90%) and 57% (95% CI, 38%-79%) in the control group (p=0.09).
Conclusion: Late survival of pt receiving DAVA was similar to that of pt with standard cryopreserved allografts. This study identified a strong trend for late allograft deterioration and reoperation beyond 5 yr postoperatively in the DAVA group. These findings should be considered when designing clinical trials of tissue-engineered bioprostheses.