1. Supporting the Neonatal and Pediatric Donor Breakout Session A Presenters: Jeffrey Johnson, MD, LAC + USC Medical Center Mudit Mather, MD, Loma Linda University Medical Center Moderator: Marcia Penido, LCSW, MPH, Huntington Hospital

2. Discuss the means by which ICU staff preserve the opportunity for donation Review the ethics of donation and pre-donor management Understand how to identify patients that meet criteria for DCD referral. Discuss the true donation potential for pediatric DCD donors. Objectives:

3. What practices can I implement to improve the pediatric and neonatal donation programs at my hospital? Questions to Run On:

4. Preserving the option for donation: Making sure the means justify the end Jeffrey L. Johnson, MD, MA, FAAP Associate Chief of Pediatrics Director of Pediatric Inpatient and Critical Care Services LAC+USC Medical Center Assistant Professor of Clinical Pediatrics Keck USC I have no financial conflicts of interest to report

5. Ends and Means are essential to ethical analysis A good end is desired, eg. providing for his family before he dies. But the way the end is achieved, the means he chooses to make money, is the basis for all the mayhem the show delivers For example:

6. Does your hospital have a brain death committee? My credentials Goal: In this talk I want to focus on the means by which we in ICUs preserve the opportunity for donation, by focusing on objective actions and intentions

7. I suspect this group already has better than average education about organ donation

8. Wednesday, September 25, 2013 “For me personally, human life requires the ability of the person to intellectually connect to, and interact with, the environment.” Medscape editor

9. ICU nurses’ attitudes: Barriers to donation? 702 ICU nurses responded to a survey in Sweden <50% trusted that the clinical dx of brain death was accurate w/o a confirmatory study 25% indicated that mechanical ventilation was withdrawn in pts to reduce suffering in persons presumed dead without the issue of donation ever being raised Floden et al, J Clinical Nursing, Nov 2011

10. What does this tell us? Some nurses may have doubts as to whether some people being treated as dead are really dead Some nurses may feel that there is a conflict of interest between being a pt advocate and being an organ donation advocate So I am going to tell you how I think this relates to ends and means and barriers to donation

11. Do I have biases? I am an advocate for critically ill and injured children. I am an advocate for the families of my patients I am an advocate for Organ donation Are there potential conflicts of interest in these statements?

12. Some are obvious For example: Why do Hospitals have policies that prohibit the primary care team from being involved in the removal of organs and decisions for donation? “Neither the physician making the determination of brain death nor the physician making the independent confirmation may participate in procedures for the removal or transplanting of organs after death” ASA 106: LAC+USC Policy on determination of death That policy’s fundamental purpose is to minimize conflict of interest

13. Some people are afraid that they will be “used” (ie treated as a means to some other end) Medical history is full of examples in which great abuses were justified by utilitarian calculations. A Google search will uncover dozens of bloggers commenting on this issue It is frequently sited as a major reason why people, even those that may favor donation, do not have “red dots” on their drivers’ license. Therefore, traditional ethics of transplant medicine as it applies to the individual has been much more deontological in emphasis.

14. Utilitarian vs Deontological –Mr. Spock when asked why he sacrificed himself to save his crew “The needs of the many outweighed the needs of the one” (a “logical” calculation of utility) –MAXIMUM pleasure or happiness (J Bentham), monistic –Human flourishing (JS Mill), can also be rule based –Capt Kirk when asked why the crew risked their lives to save Spock “The need of the one outweighed the needs of the many” (an “irrational” expression of duty) –Virtue based ethics (Aristotle, Divine law) we are obligated by rules or “right-making” characteristics –Categorical Imperative (Kant), technical reformulation of the Golden Rule, Do unto others as you would have them do unto you Utilitarian Deontological

15. Kant’s Supreme Moral Law 1.Act only on a maxim that at the same time you would will that it should become a universal law 2.Act as if one were a king creating universal laws for a kingdom of ends-in–themselves 3.No person should be treated as a means to an end Rational agents recognize themselves as “ends-in- themselves” and because they are rational, recognize other rational beings as belonging to the same kingdom and therefore respect them as such Categorical Imperative

16. I think this is essential to the success of organ transplant as a societal enterprise Individuals, families, communities must be certain that they are not viewed as just a means to an end by the medical profession, that is Their loved ones are not going to be treated as just sources of organs for someone else

17. What does that mean in practice? Lets say we have a catastrophically brain injured pt in an ER GCS is 3, pupils are fixed, no resp effort FS Glu 418, pulse 130, pt hypotensive. In the ED resuscitative efforts are started CT shows a non-operable subdural bleed and edema HOW SHOULD CARE CONTINUE? 3 choices –Full court resuscitation –Comfort care only approach –Something in between Diametrically opposed

18. “Full court press”: I pity the fool that makes a decision to withhold care before this pt has a full chance at resuscitation “Full court press”: this patient could be an organ donor But how do we justify one choice or another? “Nothing”: there is no point, this pt will die. Damn it Jim, I am a doctor not a miracle worker

19. How good are we at predicting the future in Medicine? Pretty good but far from perfect We are better when we create self-fulfilling prophesy. (If I don’t resuscitate a critical pt that pt will die)

20. Modified Pascal’s Wager If one doesn’t aggressively resuscitate this pt one will lose everything by not trying, but if one does aggressively resuscitate he may survive and if not the family may still retain the option of donation. If God does not exist, one will lose nothing by believing in him, while if he does exist, one will lose everything by not believing. Blaise Pascal (1623-1662) Pensees 1658

21. Is it ethically possible/appropriate to hold to hold two views about the injured person? He or she is a catastrophically injured, but still living, patient He or she is a potential organ donor. I believe it is because focusing on optimizing the care of the injured person will avoid the temptation to view the injured as only a means to another end while also optimizing the conditions needed to maximize donations should that choice come to pass

22. Let’s go one step further. Consider this nurse’s feelings… “Its hard to explain but I felt like I was doing something dishonest almost. All the hard work the family thought was for their loved one was actually all for someone else, some person who might eventually receive organs. No one had talked to the family yet about outcome or that we were hoping they would donate, they didn’t know why we were doing what we were doing. It was all standard care, but I still felt wrong.” »RN describing feelings in caring for a man with a non-survivable brain injury in the ICU

23. What’s going on? This nurse thought this pt was being used as a means to an end and was not being treated with the respect he deserved There is a major communication problem in this unit

24. How do we best proceed? Clear objectives and communication with everyone The patient’s best interest is first priority »Never treat a living pt like a dead patient I can maximize my ability to help the patient and to prognosticate accurately when I am aggressive in my resuscitation and care of a severely injured pt.

25. Our “modified wager” works in favor of any end Even if the family wishes to withdraw care? –I can agree prognostically because I have done everything and it hasn’t helped ( and this still might permit the best outcome in DCDD) When death is declared it must be done with the utmost care and consistency. –Be empowered to guard that it is done correctly –Policies and best practices should be strictly followed (“almost” doesn’t cut it) In no case should the medical care givers discuss donation, that would be left to the OPO after care decisions had been made No conflict of interest

26. When are OneLegacy reps most succesful? When families are certain that everything possible was done for their loved one When there has been communication between caregivers and families (honest, clear, timely) When families understand death and the process for determining it has been unambiguous When caregivers do not discuss donation with families If we do the right things (means) for the right reasons (ends)

27. Thank you This means the end

28. Potential organ donors among newborns undergoing circulatory determination of death Mudit Mathur, MD Associate Professor, Pediatrics/Critical Care Loma Linda University Children’s Hospital Pediatric Intensivist, Huntington Hospital

29. Why is brain death rare in NICU? Mechanisms-non trauma, focal bleeds-maybe less edema? Open fontanelle, non-fused sutures: lower ICP? Withdrawal before progression? Brain death criteria limitations-not any more – 2011 update (Nakagawa et al, Crit Care Med 2011) – Defines gestational age (>37 weeks) – Defines inter-examination interval (24 hours)-may be shortened if ancillary study consistent with BD – Clarifies ancillary study preferred (CBF)

31. NICU DCDD potential-Heart donors Potential donors can be readily identified among NICU patients undergoing withdrawal of life support (5 infants, 4.3% of all deaths) over 5 years NICU DCDD donor Potential is similar to PICU data (5.5-8.7%) Identifying NICU donors may – Markedly expand the infant donor pool – Reduce short-term wait-list mortality rates for infants waitlisted for heart transplantation

32. The percentage of waitlisted patients needing a kidney is (approximately): A. 20% B. 40% C. 60% D. 80% E. 100%

33. Can’t we just continue dialysis? Over 95,000 wait-listed for kidney transplant 35,000 added to the list annually (about 17,000 cadaveric and living donor transplants per year) 5% mortality for each year on dialysis 5,000 kidney waitlist deaths/year

34. Pediatric En Bloc Kidney Transplantation to Adult Recipients: More Than Suboptimal? Bhayana et al. Transplantation 2010; 90 (3): 248-54

35. How about pediatric recipients? Small en bloc kidneys into 8 pediatric recipients Donors 4-22 kg One kidney lost to intraoperative thrombosis, other remained viable All grafts increased in size Median eGFR was 130 mL/min/1.73 m2 size Butani et al. Outcomes of children receiving en bloc renal transplants from small pediatric donors. Pediatr Transpl 2013; 17: 55-58

36. Our study Discharges from our 84 bed NICU over 10 years (November 2002-October 2012) All deaths categorized into four modes: Brain death, Death despite CPR, Death with DNR order in place, Withdrawal of life support Examined patients undergoing withdrawal for cause of death and criteria for kidney donation

37. Current Literature on Donor Selection Criteria Shore et al. Potential for Liver and Kidney Donation After Circulatory Death in Infants and Children. Pediatrics 2011; 128 (3)

38. Inclusion Criteria > 1.8 kg DCD warm ischemia ≤ 120 mins Cold ischemia < 48 hours No systemic infection, HIV, or tumor Acute kidney injury okay unless donor is anuric

39. Exclusion Criteria Presence of tumor, systemic infection, or HIV Requirement of renal replacement therapy Urine output < 0.5 mL/kg/h Creatinine ≥ 1.5 mg/dL Death greater than 120 minutes after withdrawal

40. Results Total NICU discharges: 11,201 Deaths: 609 Weight ≥ 1.8 kg at the time of death: 359 Mode of Death – Brain deaths: 0 – Death despite CPR: 55 (15.1%) – Withdrawal: 159 (44.3%) – DNR: 145 (40.6%)

41. Mode of Death (n=359)

42. Results 159/359 (44%) patients withdrawn from life support Age: 1 day to 284 days Weight 1800 to 9845 grams at the time of death

43. Potential Newborn DCDD Ventilator withdrawn in all 159, also inotropes in 57, ECMO in 7 patients 97 patients had at least one exclusion criteria, time of withdrawal not recorded in 2 patients leaving 60 eligibles WIT <60 min in 45 babies WIT < 120 min in 60 babies

44. Cause of DeathWarm ischemic time <60 minutes (n= 45) Warm ischemic time <120 minutes (n= 60) Complex Congenital Heart Disease 1116 Neurological Anomaly, Disorder or Injury 1115 Respiratory Failure due to Diaphragmatic Hernia or Lung hypoplasia 89 Genetic Disorder, Multiple Congenital Anomalies 59 Prematurity56 Congenital Anomaly- Omphalocele, Gastroschisis 44 Inborn Error of Metabolism11

45. Warm Ischemic Time <60 minutes (n=45) (median) Warm Ischemic Time <120 minutes (n= 60) (median) Age Range (days)1 to 214 (13.5)1 to 284 (12.5) Weight Range (kilograms)1.8 to 9.8 (3.3)1.8 to 9.8 (3.2) Males2029 Females2531 Urine Output Range (ml/kg/hr)0.6 to 7.4 (2.8)0.6 to 7.4 (3) Serum Creatinine Range (mg/dL) 0.1 to 1.2 (0.3)0.1 to 1.2 (0.4) Warm Ischemic Time Range (minutes) 1 to 57 (29.5)1 to 115 (37.5)

46. Study Summary No brain deaths 28-38% of newborns ≥ 1.8 kg undergoing withdrawal could be potential DCDD kidney donors A NICU DCDD donor program at our center would provide about 3-4 additional paired kidneys per year for transplantation (based on 68% PICU brain death consent rate over the study period)

47. The true potential-DCDD Brain death is rare in NICU-very few donors now, in the future?? In California alone there are 89 Level IIIB and C NICUs with a total of 2726 NICU beds: 97-120 additional paired DCDD kidneys available for transplant each year Nationally: 677 Level III B and C NICUs with 24,043 beds: 859 to 1145 paired donor kidneys

48. Conclusions/Action plan The potential for newborn DCDD donation exists – Solid organs-primarily kidneys, potentially heart – Hepatocytes for research Discuss this on your unit Consider any newborn > 2 kg undergoing withdrawal for evaluation as a potential donor

49. Acknowledgements Loma Linda University Children’s Hospital – Heather Hanley, MD (PICU fellow) – Sunhwa Kim, MD (Neonatologist) – Erin Willey, MD (NICU fellow) OneLegacy – Dana Castleberry, RN, CPTC (In-house coordinator)

50. What practices can I implement to improve the pediatric and neonatal donation programs at my hospital? Questions to Run On: