1. 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

2. 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.

3. 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.

4. 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

5. Adult Recipients of Deceased Donor Liver Transplants, All Programs in Region 5 July 1, December 31, 2015
Donor Type
Variable N
Min
25th
Pctl
Median
75th
Max
DCD
DRI %Micro fat
%Macro fat
ECD
SCD

6. Adult Recipients of Deceased Donor Liver Transplants, Potential Participants in Region 5 July 1, 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

7. Adult Recipients of Deceased Donor Liver Transplants, Potential Participants in Region 5 July 1, 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

8. 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

9. 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 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.