HeartCare is a multi-modality approach that utilizes two complementary technologies.
New ISHLT Guidelines Support Use of CareDx’s HeartCare Solutions, AlloMap and AlloSure, in Routine Monitoring of Heart Transplant Patients – Read More
HeartCare is a non-invasive leading indicator of graft injury and immune activation/quiescence.
HeartCare is a multi-modality approach that utilizes two complementary technologies.
AlloSure Heart provides peace-of-mind that injury is unlikely with dd-cfDNA levels below 0.15%.
*Clinical correlation is required.
As defined by their institutional protocol.
Interpretation of AlloSure in Heart Transplantation graph is based on data from the D-OAR study.
AlloMap Heart is an established standard in heart transplant.
This study1 compares paired use of AlloSure dd-cfDNA and AlloMap GEP testing as compared to GEP testing alone – this resulted in similar post-transplant survival, rejection free survival and graft function at 1 year, while requiring significantly fewer endomyocardial biopsies.
AlloSure Heart was clinically validated in the multi-center prospective D-OAR study.2
Clinical validation:
ACR = Grade 2R and Grade 3R
Grades 0R and 1R are in the No Rejection group
AMR = pAMR1 and pAMR2
Kaplan–Meier Estimates of the Time to the Composite Primary Outcome: This image shows the time to the first occurrence of any of the following primary events: rejection with hemodynamic compromise, graft dysfunction due to other causes, death, or retransplantation. Only the first event that was part of the composite primary outcome was considered.
Kaplan–Meier curve demonstrating probability of event-free progression for GEP and EMB groups in the first 18 months post transplant.
Watch the HeartCare specimen collection and shipping video and download step by step instructions.
Watch the AlloMap specimen collection and shipping video and download step by step instructions.
1Henricksen EJ, Moayedi Y, Purewal S, et al. Combining donor derived cell free DNA and gene expression profiling for non-invasive surveillance after heart transplantation [published online ahead of print, 2022 May 12]. Clin Transplant. 2022;e14699. doi:10.1111/ctr.14699
2 Khush KK, Patel J, Pinney S, et al. Noninvasive detection of graft injury after heart transplant using donor-derived cell-free DNA: A prospective multicenter study. Am J Transplant. 2019;19(10):2889-2899. doi:10.1111/ajt.15339. D-OAR is a sub-study of the Outcomes AlloMap Registry (OAR).
3 Pham MX, Teuteberg JJ, Kfoury AG, et al. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010;362(20):1890-1900. doi:10.1056/NEJMoa0912965.
4 Kobashigawa J, Patel J, Azarbal B, et al. Randomized pilot trial of gene expression profiling versus heart biopsy in the first year after heart transplant: early invasive monitoring attenuation through gene expression trial. Circ Heart Fail. 2015;8(3):557-564. doi:10.1161/CIRCHEARTFAILURE.114.001658.
5 Teuteberg, J., Kobashigawa, J., Shah, P., Ghosh, S., Ross, D., DePasquale, E., & Khush, K. (2021). Donor-Derived Cell-Free DNA Predicts De Novo DSA after Heart Transplantation. J Heart Lung Transplant, 40(4), S30.
6[ABSTRACT] DePasquale E, Kobashigawa J, Pinney S, Khush K. dd-cfDNA as a Risk Factor for Initiating De-Novo Donor Specific Antibodies in Heart Transplantation [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/dd-cfdna-as-a-risk-factor-for-initiating-de-novo-donor-specific-antibodies-in-heart-transplantation/. Accessed August 3, 2022.
7 Holzhauser L, Clerkin KJ, Fujino T, et al. Donor-derived cell-free DNA is associated with cardiac allograft vasculopathy. Clin Transplant. 2021;35(3):e14206. doi:10.1111/ctr.14206.
8[ABSTRACT] Franzwa, J., Laxson, C., Chawla, R., Nabeel, Y., & Johnson, F. (2018). Low Allomap Ordinal and Variability Scores Are Associated with Increased Malignancy Post Heart Transplant. The J Heart Lung Transplant, 37(4), S335-S336.
9 Kanwar, M. K., Khush, K. K., Pinney, S., Sherman, C., Hall, S., Teuteberg, J., … &Kobashigawa, J. (2021). Impact of cytomegalovirus infection on gene expression profile in heart transplant recipients. J Heart Lung Transplant, 40(2), 101-107.
