Outcomes Monitoring of Expanded Criteria Donor (ECD)/Donor after Cardiac Death (DCD) Organs in Liver Transplantation: A Region V Transplant Program Collaborative Dr Christopher L. Marsh Scripps Center for Organ Transplantation Scripps Green Hospital La Jolla, CA

Region V Participation Email Sent January 27th, 2016 General support for the concept of a Liver Outcomes Monitoring Registry (LOMR) Portal. A multi-program collaborative project involving 4-5 centers. Incorporates only liver candidate data and is voluntary. Data would be collected on post-transplant outcomes in ECD (including steatotic) and DCD candidates, but will need some SCDs. Defined data elements to be entered are detailed on slides 4 & 5. Post-transplant outcomes will be analyzed for outcomes, and those centers/sub-investigators participating would be authors on any report or manuscript generated from the use of the LOMR dataset. The only aspect of the study that will not be funded at this time is your centers time in entering these additional data elements into the LOMR Portal. Every effort will be made to use data already entered into UNet to minimize the date entry requirement.

Region V Participation Email January 27th, 2016 Cont’d Still several framework decisions to be decided and this will be part of the initial discussions for the LOMR Advisory Group. These include but are not limited to:- The optimal number of candidates to include, The duration of the study, If additional sites can be rolled in over time.

Region V Liver Outcome Monitoring Registry (LOMR) Portal Overview •Identify defined data elements •Develop LOMR Operational Guidelines •Encourage site participation Region V LOMR Advisory Group OPTN Site Data Data •System hosting & support (i.e. LOMR Portal) Data collection System Administrator (UNOS) •LOMR participants to get a dataset of their own patient-identifiable data •LOMR participants have access to the complete (all participants) de-identified dataset Data distribution Data Sharing

Adult Recipients of Deceased Donor Liver Transplants, All Programs in Region 5 July 1, 2015 - December 31, 2015 Donor Type Variable N Min 25th Pctl Median 75th Max DCD DRI %Micro fat %Macro fat 23 2 4 1.5 5.0 0.0 1.8 5.0 0.0 1.9 7.5 2.5 2.3 10.0 5.0 2.4 10.0 5.0 ECD 104 50 54 1.3 0.0 0.0 1.7 0.0 0.0 1.8 5.0 5.0 2.0 10.0 10.0 2.4 70.0 40.0 SCD 302 74 79 0.8 0.0 0.0 1.1 0.0 0.0 1.3 5.0 5.0 1.5 10.0 20.0 2.2 90.0 80.0

Adult Recipients of Deceased Donor Liver Transplants, Potential Participants in Region 5 July 1, 2015 - December 31, 2015 Tx Center ECD/DCD/SDC Total DCD ECD SCD N % AZMC: Mayo Clinic Hospital 7 19.4 10 27.8 19 52.8 36 CAGH: Scripps Green Hospital 4 33.3 8 66.7 12 CAPM: California Pacific Medical Ctr 1 2.6 16 41.0 22 56.4 39 CASF: Univ of California San Francisco Medical Ctr 6 9.7 18 29.0 38 61.3 62 CAUC: Univ of California at Los Angeles Medical Ctr 1.5 14 21.5 50 76.9 65 15 7.0 137 64.0 214

Adult Recipients of Deceased Donor Liver Transplants, Potential Participants in Region 5 July 1, 2015 - December 31, 2015 Tx Center Macro Fat > 20% Micro Fat > 20% DRI > 1.8 N % AZMC: Mayo Clinic Hospital 3 8.3 1 2.8 15 41.7 CAGH: Scripps Green Hospital 2 16.7 25.0 CAPM: California Pacific Medical Ctr 7.7 4 10.3 9 23.1 CASF: Univ of California San Francisco Medical Ctr 1.6 21 33.9 CAUC: Univ of California at Los Angeles Medical Ctr 1.5 12 18.5 Total 10 4.7 5 2.3 60 28.0

LOMR Portal Data Elements OPTN? Form Field/Description/Notes Demographics Recipient Identification Number Yes TRR TRR_ID UNOS Donor ID #* DON_ID Date of Birth* TCR DOB Gender* GENDER Ethnicity/ Race TCR/Calculated ETHCAT Highest Education Level* EDUCATION Employment status* WORK_INCOME Surgical Profile Recipient had a Prior Transplant Procedure Calculated Based on OPTN Data Recipient Height* HGT_CM Recipient Weight* WGT_KG Recipient BMI (calculated) Calculated from height and weight Recipient Diabetes Mellitus DIAB Recipient Hypertension No N/ Current Smoker within One Year Functional Health Status* FUNC_STAT Recipient Recent Infection Patient on Dialysis at Time of Transplant Yes/No WL Collect on waiting list creatinine or yes/no dialysis twice within prior week for MELD calculation Pre-Operative Labs Recipient Blood Type* ABO Recipient Preoperative Lab Value Information (WBC, Cr. AST, ALT, Bili, INR) Yes and No Collect Creatinine, Bilirubin, and INR for MELD calculation Recipient Medical Condition* MED_COND Primary Diagnosis* TCR and TRR Primary and Secondary on TCR, TRR pre-transplant and pathology confirmed Listing Status: Status 1, exception Waiting list information Match Meld UNOS_CAND_STAT_CD Recipient Portal Vein Thrombosis describe Yes/No Field Only Recipient intubated at time of transplant Recipient Cancer * Previous Malignancy at Listing, if yes collect type Recipient Hepatocellular Carcinoma (HCC) Ever diagnosed with HCC on TRR, new field Recipient Transjugular Intrahepatic Portosystemic Shunt (TIPS)? Recipient Prior Abdominal Surgery- verify with living At listing and at transplant History of Spontaneous Bacterial Peritonitis (SBP) ?? Not any history, yes/no at time of listing, not at transplant Recipient MELD Labs Lab values used to calculate MELD Operative Information Date of Procedure* TX_DATE

LOMR Portal Data Elements Cont’d Cold Ischemia Time- calculated Yes TRR Cold Ischemic Time Multi-organ Transplant Calculated Use other OPTN data to calculated Graft Type: split, whole, Living donor Procedure type Biliary Stent Present at Transplant Biliary Anastomosis Portal Vein Reconstruction/Graft Type Hepatic Artery Reconstruction/Bypass Recipient Post-operative Outcomes (collected at 30 days) PRBC Units (0 to 72 hours post-op) No Length of Initial Hospital Stay Discharge Date and Admission Date on TRR Total number of Post-Procedural ICU days N/ On Ventilator > 48 Hours N/ Intraoperative or Postoperative Cardiac Arrest Requiring CPR Portal Vein Thrombosis/Stenosis requiring Therapy Hepatic Artery Stenosis/Thrombosis requiring Therapy Biliary Stricture requiring Intervention Biliary Leak requiring Intervention Graft Loss TRR/TRF Calculated from most recent follow-up information with date Discharge Tab Hospital Readmission Return to the OR Death Patient Follow-up at 90 Days Biliary Stricture requiring intervention Initiation of postoperative dialysis (within POD 31-90 days) need intent, definition/ criteria Reoperation First Follow-up at Six Months Re Intervention-performed IR, procedural room Patient Follow-up at 1 Year Primary Reason for Graft Loss Yes/No Collect all contributing causes of graft failure. Don't collect a primary cause of failure. Re Intervention-performed IR, procedural room Include CPT code No Hospital Readmission Yes/No TRF Collect readmission at six months and one year, if yes on either then yes readmission within one year.