HeartCare is a service which includes AlloMap® and AlloSure-Heart® to provide information
to help clinicians to more comprehensively monitor heart transplant recipients for
allograft rejection. An approach to surveillance using HeartCare provides information
from two complementary measures; AlloMap is a gene-expression profile based measure of
host immune activity and risk of acute rejection. AlloSure-Heart monitors graft injury.
AlloMap is the first FDA cleared test and is the only non-invasive, blood test method
recommended in the International Society for Heart and Lung Transplantation (ISHLT)
guidelines for surveillance of heart transplant recipients for rejection. AlloSure-Heart
measures donor-derived cell-free DNA (dd-cfDNA) to help discriminate acute cellular
rejection and antibody-mediated rejection from no rejection. Patients who receive
HeartCare, as part of their post-transplant management, will give informed consent for
information on their outcomes and other relevant clinical information, found in their
medical records, to be entered into a SHORE database for purposes of the study.