CORTICOSTEROID AVOIDANCE AMELIORATES LYMPHOCELE FORMATION AND WOUND HEALING COMPLICATIONS ASSOCIATED WITH SIROLIMUS THERAPY: 2 YEAR FOLLOW-UP IN 109 PATIENTS

Abstract

O10 Aims: Both sirolimus (RAPA) and corticosteroids (CS) have been shown to adversely impact wound healing. Moreover, since RAPA and CS may have additive effects on wound healing; we sought to determine if corticosteroid avoidance (CSAV) would ameliorate the wound healing complications associated with RAPA. Methods: 109 patients (pts) treated with a CSAV regimen (no pre or post transplant CS) were compared to a historical control group (n=72) that received cyclosporine (CsA), mycophenolate mofetil (MMF) and CS. The CSAV regimen included thymoglobulin (mean 2.6 doses), RAPA (8-12 ng/ml), MMF (2 grams/day), low-dose CsA, (trough 100 ng/ml, discontinued at 4-6 months. Complications were classified as: wound healing complications (WHC) or infectious wound complications (IWC). WHC include lymphocele, hernia, dehiscence, and skin edge separation. IWC include wound abscess and empiric antibiotic therapy for wound erythema. Results: The CSAV group was largely CS free: 11% of pts received CS for rejection, 12% received CS for recurrent disease and 85% of pts are currently off CS. 5% of patients who received CS developed wound complications however, CS were started after the development of all wound complications.FigureIn a subgroup analysis the reduction in lymphocele formation was seen primarily in patients with a BMI > 30 (3.5% vs. 31.8%, p=0.006). A multivariate analysis showed that African American race appears to be a strong risk factor for the development of any wound complication and wound healing complications. African Americans were 3.5 times more likely (CI 1.63-7.63, p=0.001) to develop any complication and 3.8 times more likely (CI 1.64-8.91, p=0.0002) to develop a wound healing complication. Those patients who received early CSWD were 18% less likely (CI 0.41-1.64, p=0.57) to develop any type of complication, 41% less likely (CI 0.26-1.33, p=0.20) to develop a wound healing complication, 71% less likely (CI 0.103-0.808, 0.018) to develop a lymphocele and 1.5 times more likely (CI 0.53-4.04, p=0.46) to develop and infectious complication. Conclusions: CSAV in a RAPA based regimen results in: 1) marked reduction in lymphoceles and WHC and 2) a reduction in lymphoceles primarily in obese patients. African American race appears to be a strong risk factor for the development of wound healing complications whereas CSWD offers protection against the development of lymphoceles and wound healing complications. CSAV provides a promising approach for addressing WHC associated with RAPA therapy. Transplantation, Volume 78, Number 2, July 27, 2004