DCD Heart Donation Understanding the Regulatory, Ethical and Clinical Issues. Valluvan Jeevanandam MD University of Chicago Medicine

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1 DCD Heart Donation Understanding the Regulatory, Ethical and Clinical Issues Valluvan Jeevanandam MD University of Chicago Medicine

2 Disclosure Txn None MCS Scientific Advisor Thoratec/Abbott: Chairman CEC for MOMENTUM 3

3 Heart DCD Outline What is a DCD allograft? Clinical relevance Regulatory and Ethical considerations How is DCD performed Clinical considerations Russell SD, Miller LW, Pagani FD. Advanced heart failure: a call to action. Congest Heart Fail. 2008;14:

4 DCD transplantation Severe irreversible devastating neurological injury Not brain death Donation after cardiac death Donation after circulatory death Controlled Better for kidney, lung, liver Better handle hypoxia Filters Heart challenging mechanical function mandatory Acute support (ECMO, IABP, VADs) make more plausible 4

5 Heart DCD clinical relevance Need to increase heart donors ever present goal SRTR data : ~40% of hearts (including extended criteria) not utilized DCD : estimates of 5-15% increase ( donors per year)* Younger, non-extended criteria organs Potentially better long term survival *Noterdaeme T, Detry O, Hans MF, et al. What is the potential increase in heart graft donor pool by cardiac DCD? Transplant 2013;26:61 5

6 Heart DCD regulatory & ethical considerations (1) JACHO all hospitals doing organ harvesting must have DCD protocols in place UNOS Model Elements For Controlled DCD Recovery Protocols Dead Donor Rule Organ recovery cannot cause donor death Prevents killing of innocents Donor must be dead prior to recovery Prevents mistreatment of donors Maintains public trust Miller & Troug- withdrawal of life-sustaining measures allows premortem recovery Not accepted Death cessation of functioning of the organism as a whole Neurological Circulatory *Ethical Controversies in Organ donation After Circulatory Death. Pediatrics V131,N 5,

7 Heart DCD regulatory & ethical considerations (2) Circulatory death Permanent Cannot autoresuscitate Since donors are DNR, CPR not used Time to wait : 2-5 min Invasive monitoring (arterial line, echo) vs auscultation Irreversible Would preclude donation Is permanence enough for death? Ultimately neurological death takes too long External assessment needed to declare death Lack of equipoise Individuals and surgeons cannot be compelled to participate 7

8 Heart DCD regulatory & ethical considerations (2) Conflict of Interest : donor vs recipient Need to decrease warm and cold ischemia Pre-mortem preparation of donor Central lines Anti-coagulation Drugs Must obtain informed consent Withdrawal of life support and donation need to be de-coupled Palliative care teams: any alteration in withdrawal of life support (location, method, medication) done to decrease ischemic time needs consent Donor team should not be present or participate during withdrawal of life support Donor team cannot participate in declaration of death 8

9 Heart DCD technique (1) Ventilation stopped Ideally in the OR Allow to progress to hypoxic circulatory collapse Wait 5 minutes form loss of pulse Facilitated by Arterial line Pulse oximeter Independent declaration of pulseless death Donor family time Sternotomy Heparinize Aorta or RA PA Dhital KK, Chew HC, et al. Donation after circulatory death heart transplantation. Current Opinion Organ Transplant 2017 Apr 4 9

10 Heart DCD technique (2) Normothermic Regional Perfusion (NRP) Aortic / RA cannulae for CPB Clamp off cerebral blood vessels Allow heart to recover Wean off CPB Continue with Beating heart procurement Ethical dilemma : Are you creating brain death by clamping off vessels?? Direct Procurement and Perfusion Withdraw 1.5-2L blood and prime ex-vivo circuit (Transmedics OCS) Clamp and retrieve heart Place on OCS Ethically cleaner Evaluating heart function on OCS retrograde aortic perfusion vs working heart 10

11 Heart DCD technique (2) Direct Procurement and Preservation Clamp and retrieve heart using cold preservation Co-locate donor and recipient Proceed with transplant Recover heart in recipient after transplant Works with children Investigational OCS limited by need for fresh, whole, human blood?? Substitutes Cross-circulation with recipient Allows long time on a OCS type device for recovery and assessment 11

12 Heart DCD conclusion DCD could increase donor pool but SRTR and the dreaded Red Flag How do you address risk Exceptions frowned upon Expected mortality risk adjustment DCD role in face of Extended criteria hearts not being utilized LVADs Back to the Future 12

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