Abstract
Orthotopic heart transplantation is the gold standard treatment for end-stage heart failure. However, the persistent shortage of available donor organs has resulted in an ever-increasing waitlist and longer waiting periods for transplantation. On the contrary, increasing the number of heart transplants by preserving extended criteria donors and donation after circulatory death hearts with the Organ Care System™ (OCS) Heart System has the potential to provide the gold standard, life-saving treatment to patients with end-stage heart failure. The objective of the Donation After Circulatory Death Heart Trial is to evaluate the effectiveness of the OCS Heart System to preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation, which can potentially provide patients with end-stage heart failure with the life-saving treatment.
Clinical Trial Registration: NCT03831048 (ClinicalTrials.gov)
Papers of special note have been highlighted as: • of interest
References
- 1. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). Circulation 112, e154–e235 (2005).
- 2. . Heart and lung transplantation in the United States, 1997–2006. Am J. Transplant. 8, 977–987 (2008). • Highlights the trends in heart and lung transplantation between 1997 and 2006.
- 3. US Department of Health and Human Services. Organ procurement and transplantation network. https://optn.transplant.hrsa.gov/
- 4. Ex-vivo perfusion of donor hearts for human transplantation (PROCEED II): a prospective, open-label, multicenter, randomised non-inferiority trial. Lancet 385(9987), 2577–2584 (2015). • Indicates that heart transplantation using donor hearts adequately preserved with the Organ Care System™ or with standard cold storage yield similar short-term clinical outcomes.
- 5. Outcome after heart transplantation from donation after circulatory-determined death donors. J. Heart Lung Transplant. 36(12), 1311–1312 (2017). • Demonstrates that heart transplantation from donation after circulatory death heart donation provides comparable short-term outcomes to traditional donation after brain death heart transplants.
- 6. TransMedics. www.transmedics.com
- 7. Adult heart transplantation with distant procurement and ex-vivo preservation of donor hearts after circulatory death: a case series. Lancet 385(9987), 2585–2591 (2015).
- 8. Outcomes of donation after circulatory death heart transplantation in Australia. J. Am. Coll. Cardiol. 73(12), 1447–1459 (2019).
- 9. Heart transplantation after donor circulatory death in patients bridged to transplant with implantable left ventricular assist devices. J. Heart Lung Transplant. 35(10), 1255–1260 (2016).
- 10. Physiologic changes in the heart following cessation of mechanical ventilation in a porcine model of donation after circulatory death: implications for cardiac transplantation. Am. J. Transplant 16(3), 783–793 (2016).
- 11. Pathophysiological trends during withdrawal of life support: implications for organ donation after circulatory death. Transplantation 100(12), 2621–2629 (2016).
- 12. Report from a consensus conference on primary graft dysfunction after cardiac transplantation. J. Heart Lung Transplant. 33, 327–340 (2014).
- 13. Donors After Circulatory Death Heart Trial (2019). https://clinicaltrials.gov/ct2/show/NCT03831048