Background: Rejection continues to be one of the leading causes of death during the first year after cardiac transplantation. With the advent of more potent immunosuppressive therapies, the incidence of graft rejection has been reported to be decreasing. Yet, this trend has not been well established due to differences in the interpretation of and the protocols for endomyocardial biopsy specimens. Additionally, the incidence of humoral (noncellular) rejection has not been adequately addressed.
Methods: Six thousand one hundred thirty endomyocardial biopsy specimens in 487 cardiac transplant recipients during the first year posttransplantation from 1990 to 2000 were reviewed to assess the incidences of acute cellular and treated noncellular rejection episodes. Cellular rejection was defined as ISHLT grades 3-4; noncellular rejection as a 20% decrease in echo LVEF, cardiac index <2.0, and/or inotropic support associated with ISHLT grades 0-2 necessitating treatment.
Results: The incidence of noncellular rejection has remained relatively unchanged at approximately 20% (P=nonsignificant for all years); in contrast, there has been a significant decrease (P <.001) in the incidence of cellular rejection from 54% to 5%.
Conclusion: The incidence of noncellular rejection in cardiac transplant recipients has remained unchanged through the 1990s despite improved immunosuppressive therapies, which have significantly decreased the incidence of acute cellular rejection. There appears to be a need for newer immunosuppressive agents to effectively treat noncellular rejection. Clinical trials using allograft rejection as a major endpoint will need to increase the enrollment of patients to achieve adequate power to demonstrate differences between study groups.