A Priority Approach to Maximizing the Gift from Donation After Cardiac Death Martin D. Jendrisak, MD, FACS Medical Director Gift of Hope Organ and Tissue Donor Network

SRTR Data

Donation Stats as of July 15, 2011 National Organ Waiting List 111,827 Illinois Organ Waiting List 4,912 Indiana Organ Waiting List 1,513 Illinois Organ Waiting List By Organ Kidney 4,111 Liver 495 Heart 141 Kidney/Pancreas 110 Pancreas 100 Lung 69 Intestine 10 Heart/Lung 1

DSA of 12 Million 9 Transplant Centers 180 Donor Hospitals Referral Transplant Allocation Consent Management Recovery Transplant Partners

Catastrophic Neurologic Injury Evaluation and Treatment in the Critical Care Setting Clinical Trigger to donation Referral Donation option is part of end of life care planning Ensures this option is not denied to families Timely notification of OPO is critical to process Futility of Continuation of Care Establish by health care providers Family understanding and acceptance Death Determination

By Neurologic Criteria (DBD) –Cessation of all brain activity (brain death) –Clinically established –Confirmatory testing when indicated By Circulatory – Respiratory Criteria (DCD) –Permanent absence of circulation and respiration –Hospital DCD policy followed

IOM Committee Recommendation: 2006 DNDD – Donation after a neurological determination of death DCDD – Donation after a circulatory determination of death

No Brain Death Determination Yes ME/Coroner Notification - Hospital Consent for Donation ME/Coroner Release - GOH YesNo 1.Implement donor management protocols 2.Donor Testing 3.Organ Evaluation 4.Organ Allocation 5.Coordinate Surgical Recovery OR Access 1.Implement donor management protocols 2.Donor Testing 3.Organ Evaluation 4.Organ Allocation 5.Coordinate Surgical Recovery OR Access Decision & Planning for Withdrawal of Care Consent for Donation YesNo Withdrawal of Care Death Pronouncement ME/Coroner Notification - Hospital Implement DCD Protocol: Time Critical ME/Coroner Release - GOH

Protein S-100 Brain Injury Biomarker Study DonorNs-100bp ValueInjury-> SampleBD-> Sample SCD / / /- 2.5 ECD / / /-3.0 DCD / /- 66.5N/A DCD-A / / N/A

Donor Management Requires a Collaborative Approach between OPO and Donor Hospital Staff Phases: Identification Referral & Initial Evaluation Management of the Potential Donor Brain Death and Consent Donor Management Special Interventions Organ Specific Testing and Assessment

De-escalation of Care Definition: Strategic reduction in the level of care in the setting of patient non-recovery Examples: Withhold or reduce vasopressor support, transfusions, fluid and electrolyte resuscitation, pulmonary care, laboratory monitoring, etc. Consequence on Donation: Renders organs not transplantable Per CMS and Contractual Obligation: Hospitals and providers must provide adequate medical support to give families the option for organ donation. Best Practice: (1) Early contact with GOH and (2) Provide full medical care until GOH determines non-donor status.

Donor Management - Goals Optimize Organ Viability Proper Assessment of Organ Quality Maximize Organ Utilization Optimize Outcomes of Transplantation

Consequences of the Pathophysiology of Brain Death Myocardial Dysfunction Hemodynamic Instability Neurogenic Pulmonary Edema Diabetes Insipidus Organ Dysfunction

Detrimental Physiological Effects of Brain Death Hemodynamic: “Catecholamine storm” Cardiac dysfunction Increase SVR Capillary alveolar membrane damage Hormonal Endocrinopathy Pituitary – ADH, TSH, ACTH Immunologic Activation of inflammatory mediators IL-6, IL-10, ??? Upregulated HLA Class II Expression Upregulated Expression of Adhesion Molecules

GIK Study Cardiac OutputStroke VolumeSVR CaseAgeSexWeightPre-GIKPre-GIKPre-GIK Organs Transplanted 119M70kg lu/li/k/p 245M78kg li/k/p 333F139kg lu/li/k/p 417M64kg li/k/p 547M72kg li/k 634M68kg h/lu/li/k/p SVR = Systemic Vascular Resistance; lu= lungs; li= liver, k= kidneys; p = pancreas; h = heart

Plexmark Study IP - 10MIGOPG SCD125.3+/ / /985.5 ECD275.9+/ / / DCD8.7+/ / /431.6

Cytokine Response to Steroids in DBD TimeIP - 10MIGOPG / / / / / / / / / / /-243.6

DCD PROCESS OPO evaluates donation candidacy OPO coordinates organ procurement/allocation Patient care team withdraws support, provides comfort measures and pronounces death Organ recovery initiated after death – time critical Adherence to “Dead Donor Rule” –Organ can be recovered only after death –Organ recovery process does not hasten death

DCD 90 minute time limit Warm ischemia limits transplant opportunity –Kidneys – generally transplanted –Liver, lungs, pancreas maybe transplanted if organ flush within 20 minutes and donor age<40 DCD evaluation tool

Donation After Cardiac Death Tool

Final Score% Probability of Expiration In <60 minutes % Probability of Expiration in <120 minutes

DCD TOOL LIMITATIONS 80% positive predictive value 20% donors missed Focused on uncertainty of the DCD process Clinician input may add complexity to the decision process

DCD PRACTICE CHANGE Started 3/1/2010 Omit DCD tool Omit reliance on clinician prediction ability Pursue all opportunities –Potential for transplantable organs –Maximize the gift –Family driven Monitor practice through data analysis

Impact of the DCD Evaluation Tool on Organ Procurement With ToolWithout Tool∆ Potential Cases21474 Exclusions82 (38%)16 (22%)16% Pursued Cases132 (62%)58 (78%) Expired117 (89%)38 (66%) DNE15 (11%)20 (34%)23% Missed Donors15 (18%)018%

Donation Patterns of DCD Expired Cases With ToolWithout Tool Time to CPA <90 min11738 <60 min111 (95%)38 (100%) <30 min98 (84%)32 (84%) <20 min85(73%)28(74%) Positive Donors Total118 (89%)29 (89%) Extra-renal39 (40%)11 (40%)

Conclusions New DCD Practice Paradigm Maximizes The Gift –No missed donor opportunity –20% increase in donation with transplantable organs –Meet donor/family wishes 100% of time Demand On Donation Resources Acceptable –Identifies/excludes futile efforts (age>60)

Conclusions (Cont’d) Adds Clarity About DCD Process/Manages Expectations –2 out of 3 attempts (on average), transplantable organs are recovered –3 out of 4 actual donors expire under 20 minutes to permit extra-renal organ recover/transplantation –Clarity of message benefits family/staff