Yasbanoo Moayedi1, Farid Foroutan2, Robert J H Miller3, ChunPo S Fan2, Juan G Duero Posada2, Mosaad Alhussein2, Maxime Tremblay-Gravel3, Gabriela Oro3, Helen I Luikart3, James Yee4, Michael A Shullo5, Kiran K Khush3, Heather J Ross2, Jeffrey J Teuteberg6. 1. Section of Heart Failure, Cardiac Transplant, and Mechanical Circulatory Support, and Department of Medicine, Stanford University, Stanford, California; Ted Rogers Centre of Excellence in Heart Function, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada. 2. Ted Rogers Centre of Excellence in Heart Function, Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada. 3. Section of Heart Failure, Cardiac Transplant, and Mechanical Circulatory Support, and Department of Medicine, Stanford University, Stanford, California. 4. CareDx, Brisbane, California. 5. West Virginia University, Transplant Services, Morgantown, West Virginia. 6. Section of Heart Failure, Cardiac Transplant, and Mechanical Circulatory Support, and Department of Medicine, Stanford University, Stanford, California. Electronic address: jeff.teuteberg@stanford.edu.
Abstract
BACKGROUND: Gene expression profiling (GEP) was developed for non-invasive surveillance of acute cellular rejection. Despite its widespread use, there has been a paucity in outcome data for patients managed with GEP outside of clinical trials. METHODS: The Outcomes AlloMap Registry (OAR) is an observational, prospective, multicenter study including patients aged ≥ 15 years and ≥ 55 days post-cardiac transplant. Primary outcome was death and a composite outcome of hemodynamically significant rejection, graft dysfunction, retransplantation, or death. Secondary outcomes included readmission rates and development of coronary allograft vasculopathy and malignancies. RESULTS: The study included 1,504 patients, who were predominantly Caucasian (69%), male (74%), and aged 54.1 ± 12.9 years. The prevalence of moderate to severe acute cellular rejection (≥2R) was 2.0% from 2 to 6 months and 2.2% after 6 months. In the OAR there was no association between higher GEP scores and coronary allograft vasculopathy (p = 0.25), cancer (p = 0.16), or non-cytomegalovirus infection (p = 0.10). Survival at 1, 2, and 5 years post-transplant was 99%, 98%, and 94%, respectively. The composite outcome occurred in 103 patients during the follow-up period. GEP scores in dual-organ recipients (heart-kidney and heart-liver) were comparable to heart-alone recipients. CONCLUSIONS: This registry comprises the largest contemporary cohort of patients undergoing GEP for surveillance. Among patients selected for GEP surveillance, survival is excellent, and rates of acute rejection, graft dysfunction, readmission, and death are low.
BACKGROUND: Gene expression profiling (GEP) was developed for non-invasive surveillance of acute cellular rejection. Despite its widespread use, there has been a paucity in outcome data for patients managed with GEP outside of clinical trials. METHODS: The Outcomes AlloMap Registry (OAR) is an observational, prospective, multicenter study including patients aged ≥ 15 years and ≥ 55 days post-cardiac transplant. Primary outcome was death and a composite outcome of hemodynamically significant rejection, graft dysfunction, retransplantation, or death. Secondary outcomes included readmission rates and development of coronary allograft vasculopathy and malignancies. RESULTS: The study included 1,504 patients, who were predominantly Caucasian (69%), male (74%), and aged 54.1 ± 12.9 years. The prevalence of moderate to severe acute cellular rejection (≥2R) was 2.0% from 2 to 6 months and 2.2% after 6 months. In the OAR there was no association between higher GEP scores and coronary allograft vasculopathy (p = 0.25), cancer (p = 0.16), or non-cytomegalovirus infection (p = 0.10). Survival at 1, 2, and 5 years post-transplant was 99%, 98%, and 94%, respectively. The composite outcome occurred in 103 patients during the follow-up period. GEP scores in dual-organ recipients (heart-kidney and heart-liver) were comparable to heart-alone recipients. CONCLUSIONS: This registry comprises the largest contemporary cohort of patients undergoing GEP for surveillance. Among patients selected for GEP surveillance, survival is excellent, and rates of acute rejection, graft dysfunction, readmission, and death are low.
Authors: Kiran K Khush; Jignesh Patel; Sean Pinney; Andrew Kao; Rami Alharethi; Eugene DePasquale; Gregory Ewald; Peter Berman; Manreet Kanwar; David Hiller; James P Yee; Robert N Woodward; Shelley Hall; Jon Kobashigawa Journal: Am J Transplant Date: 2019-04-08 Impact factor: 8.086