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AASLD/ILTS Transplant CourseThe Critically Ill Patient and Challenges in Liver Transplantation
Program Chairs:
Sanjiv Saigal, MD Catherine Paugam-Burtz, MD, PhD Roberto Hernandez-Alejandro, MD
Friday, November 8 | 8 am – 3:30 pm
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The CME/CE/MOC evaluations can be completed in the following ways:
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The Use of AASLD Scientific Program Content Information presented during the AASLD/ILTS Transplant Course is the property of AASLD and the presenter. Information may not be recorded, photographed, copied, photocopied, transferred to electronic format, reproduced or distributed without the written permission of AASLD and the presenter. Any use of the program content, which includes, but is not limited to, oral presentations, audiovisual materials used by speakers and program handouts without the written consent of AASLD, is prohibited.
Table of Contents 2019 AASLD/ILTS Transplant Course Continuing Education Information ..................................................... 1
Program Agenda ........................................................................................................................................... 3 Session I Presentations: Assessing Frailty and Malnutrition Jennifer C. Lai, MD ........................................................................................................................................ 5 Gender Disparities in Access to LT in the Very Sick Patient Monika Sarkar, MD, MAS ............................................................................................................................ 27 Assessment of Volume Status in the Fluid Overload Critically Ill Patient François Durand, MD .................................................................................................................................. 66 Neurocognitive Assessment of the Sick Intubated Patient Ram M. Subramanian, MD, FAASLD ........................................................................................................... 77 Session II Presentations: Hepatopulmonary Syndrome and Portopulmonary Syndrome James Findlay, MB ChB, BSc ........................................................................................................................ 90 Coronary Artery Disease Before Transplantation (Stent or Not Stent) Lisa Van Wagner, MD, MSc....................................................................................................................... 114 Window Opportunities in the Very Sick Patients with Sepsis in the ICU? Catherine Paugam-Burtz, MD, PhD ........................................................................................................... 145 Selection Issues in Critical ACLF Patient (the optimal timing for LT, diagnostic criteria for ACLF) Constantine Karvellas, MD, SM, FRCPC ..................................................................................................... 146 Early Liver Transplantation for Severe Alcoholic Hepatitis Debate Disscusants: Ramon Bataller, MD, PhD and Carmen Vinaixa, MD ........................................................... 180 Session III Presentations: Morbid Obesity in the Transplant Recipient Julie Heimbach, MD, FAASLD .................................................................................................................... 218 The Need of LDLT in the US, Initiating a Program Roberto Hernandez-Alejandro, MD ......................................................................................................... 249 Altruistic LDLT, is it Feasible? Elizabeth Pomfret, MD, PhD ..................................................................................................................... 276
The Use of AASLD Scientific Program Content Information presented during the AASLD/ILTS Transplant Course is the property of AASLD and the presenter. Information may not be recorded, photographed, copied, photocopied, transferred to electronic format, reproduced or distributed without the written permission of AASLD and the presenter. Any use of the program content, which includes, but is not limited to, oral presentations, audiovisual materials used by speakers and program handouts without the written consent of AASLD, is prohibited.
Challenges in Pediatric Liver Transplantation Yuri Genyk, MD ......................................................................................................................................... 311 Debate on Simultaneous Kidney/Liver Transplantation UNOS Policy Disscusants: Vatche Agopian, MD and Mitra Nadim, MD ........................................................................ 347 Faculty, Planner and AASLD Staff Disclosures .......................................................................................... 381
2019 AASLD/ILTS Transplant Course The Critically Ill Patient and Challenges in Liver Transplantation
Friday, November 8, 2019 8 am – 3:30 pm
Program Chairs: Sanjiv Saigal; Catherine Paugam-Burtz and Roberto Hernandez-Alejandro
Session Description/Needs Statement This course will review the perioperative challenges faced in very sick liver transplant candidates, and is useful for intensivists, hepatologists, anesthesiologists and surgeons. Liver transplantation outcomes in sick patients significantly depend on perioperative management. Faculty will address the special challenges faced in liver transplantation, including those of living donor organs.
Learning Objectives Upon completion of this activity, participants will be able to:
• Review the various perioperative challenges faced in the management of very sick livertransplant candidates
• Describe the special challenges faced in liver transplantation such as morbid obesity,simultaneous liver & kidney transplantation and living donor liver transplantation
• Appraise recent advances & innovations in the field of liver transplantation
CONTINUING MEDICAL EDUCATION (CME) Accreditation Statement The American Association for the Study of Liver Diseases (AASLD) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Credit Designation Statement AASLD designates this live activity for a maximum of 6.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
The CME/CE* evaluations are available online and can be completed in the following ways: • During the session:
Download The Liver Meeting® app and evaluate the sessions in real time – refer to the CME iconto access the evaluation.
• In your hotel room or at home:Access the evaluation website using your personal device of choice. Go directly to the CMEevaluation and/or CE* evaluation.
• At any Continuing Education/Certificate Stations:Visit the Continuing Education/Certificate Stations in Hall A to access the evaluation from anyavailable kiosk.
Certificates of Attendance Certificates of Attendance are available to attendees completing The Liver Meeting® evaluation and may be printed on-site in Tech Connect or after the meeting at aasld.org/livermeeting by March 15, 2020.
1
CONTINUING EDUCATION (CE) STATEMENT Satisfactory Completion Learners must complete an evaluation form to receive a certificate of completion. Your chosen sessions must be attended in their entirety. Partial credit of individual sessions is not available. If you are seeking continuing education credit for a specialty not listed below, it is your responsibility to contact your licensing/certification board to determine course eligibility for your licensing/certification requirement.
Nurses In support of improving patient care, this activity has been planned and implemented by Amedco LLC and the American Association for the Study of Liver Diseases. Amedco LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Credit Designation Statement— Amedco LLC designates this live activity for a maximum of 6.0 contact hours for nurses. Learners should claim only the credit commensurate with the extent of their participation in the activity.
Nurse Pharmacology Credits Please note onsite agenda for identification of sessions eligible for pharmacotherapeutic hours and self-submit those to your board. Keep the agenda as a reference in case they have questions.
DEADLINE: Be sure to complete the CME and/or CE evaluation for credit at aasld.org/livermeeting before the following dates:
• CME evaluation – March 15, 2020• CE* evaluation – December 31, 2019
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2019 AASLD/ILTS Transplant Course Program Agenda
Session I: Perioperative Challenges in the Very Sick Liver Transplant Candidate – Part I Moderators: Catherine Paugam-Burtz and Kymberly Watt
8:00 – 8:05 AM Welcome and Introductions
8:05 – 8:25 AM Assessing Frailty and Malnutrition Jennifer C. Lai, MD
8:25 – 8:45 AM Gender Disparities in Access to LT in the Very Sick Patient Monika Sarkar, MD, MAS
8:45 – 9:05 AM Assessment of Volume Status in the Fluid Overload Critically Ill Patient François Durand, MD
9:05 – 9:25 AM Neurocognitive Assessment of the Sick Intubated Patient Ram M. Subramanian, MD, FAASLD
9:25 – 9:40 AM Panel Discussion
9:40 – 9:55 AM Break
Session II: Perioperative Challenges in the Very Sick Liver Transplant Candidate – Part II Moderators: Catherine Paugam-Burtz and Sanjiv Saigal
9:55 – 10:15 AM Hepatopulmonary Syndrome and Portopulmonary Syndrome James Findlay, MB ChB, BSc
10:15 – 10:35 AM Coronary Artery Disease Before Transplantation (Stent or Not Stent) Lisa Van Wagner, MD, MSc
10:35 – 10:55 AM Window Opportunities in the Very Sick Patients with Sepsis in the ICU? Catherine Paugam-Burtz, MD, PhD
10:55 – 11:15 AM Selection Issues in Critical ACLF Patient (the Optimal Timing for LT, Diagnostic Criteria for ACLF) Constantine Karvellas, MD, SM, FRCPC
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11:15 – 11:45 AM Debate: LT for Severe Acute Alcoholic Hepatitis Pro: Carmen Vinaixa, MD Cons: Ramón Bataller, MD, PhD 11:45 AM – Noon Panel Discussion Noon – 1:20 PM Intermission Session III: Special Challenges in Liver Transplantation Moderators: Sanjiv Saigal and Roberto Hernandez-Alejandro 1:20 – 1:40 PM Morbid Obesity in the Transplant Recipient Julie Heimbach, MD, FAASLD 1:40 – 2:00 PM The Need of LDLT in the US, Initiating a Program Roberto Hernandez-Alejandro, MD 2:00 – 2:20 PM Altruistic LDLT, is it Feasible? Elizabeth Pomfret, MD, PhD 2:20 – 2:40 PM Challenges in Pediatric LT Yuri Genyk, MD 2:40 – 3:10 PM Debate on Simultaneous Kidney/Liver Transplantation
UNOS Policy Pro: Vatche Agopian, MD Con: Mitra Nadim, MD 3:10 – 3:25 PM Panel Discussion
3:25 – 3:30 PM Closing Remarks
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Morbid Obesity in the Transplant Recipient
Julie Heimbach Professor of Surgery and Chair Division of Transplantation Surgery Mayo Clinic, Rochester MN The worldwide obesity epidemic has significantly impacted the liver transplant landscape. Obesity can be the cause of liver disease due to metabolic syndrome resulting in NAFLD and NASH. Outcomes after liver transplant for NASH and NASH-related HCC are comparable to other indications. However, this requires a careful selection of candidates with special attention to their cardiovascular health, physical debility, sarcopenia, and glycemic control. To ensure positive long-term outcomes, it requires an enhanced multi-disciplinary team that includes specialized dieticians, psychologists, social workers and for selected patients, a bariatric team. It is imperative to carefully manage their nutrition, medication intake, and ambulatory status during the peri-operative phase, and follow-up on their metabolic targets post-operatively as the risk of recurrent obesity and NAFLD is high. Weight loss strategies can be non-invasive or surgical, and may be integrated into the course of treatment before, during, or after liver transplant, with the major limiting factor being the patient’s severity of liver disease. Combining liver transplantation and bariatric surgery at the same setting is an option, and a sleeve gastrectomy appears to be the bariatric procedure of choice in this setting.
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Morbid Obesity in the Transplant Recipient
Julie Heimbach Professor of Surgery and Chair
Division of Transplantation SurgeryMayo Clinic, Rochester MN
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• Outline current scope of the obesity epidemic
• Implications of obesity pre and post LT
• Discuss the role of bariatric surgery
Objectives
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- World wide, obesity has doubled since 1980- Currently, 600 million obese adults in the world
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The systemic impact of obesity
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Impact of obesity on incidence of NASH• 1/3 US population is obese
• 2/3 of obese people have steatosis (108 million US).
• Of these, 2/3 remain with bland steatosis, 1/3 progress to steatohepatitis (30 million)
• 5-15% progress to cirrhosis (3 million US)
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NASH as an indication for listing for liver transplantation in US
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Impact of obesity on pre-transplant patient selection
Ekstadt et al Hepatology 2006:4;865-73. Vanwagner et al Hepatology. 2012 Nov;56(5):1741-50Choudary et al Clin Transplant 2015: 29: 211–215.
• Most common cause of death for patients with NAFLD is a cardiovascular event.
• Patients who undergo LT for NASH may be at an increased risk for perioperative/post-op cardiac events
• Sarcopenia is associated with worse outcomes, including patients with sarcopenic obesity
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Slides are the property of the author and AASLD. Permission is required from both AASLD and the author for reuse.Liver Transplantation 2009
Impact of obesity on outcome:
• SRTR data 1987-2007• 68,172 BMI 18.5-40, 1827
<18.5, and 1,447>40.• Outcome worse high and low
BMI patients (similar to previous report Nair et al 2002)
• No correction for ascites, small number of patients in each of the “extreme” groups
Dick, Liver Transpl. 2009:15;968-77.
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• SRTR 2004-2011
• N=38,194• Compared <18.5, 18.5-45, >45.
• BMI<18.5 associated worse survival
• No difference in outcomes for obese patients
Orci Transpnt Int. 2012: 26;170-6.
female
male
Impact of obesity on outcome
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Impact of obesity on long term outcome
• Multi-center Australian LT cohort N=617 2002-2009
• Obese plus Diabetes associated with worse outcomes at 5 years post LT.
• Obese non-DM and non-obese DM were both similar to non-obese, non-DM.
Watt. AJT 2010
Adams et al:Journal of Gastroenterology and Hepatology 31 (2016) 1016–1024
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Impact of weight loss on liver fibrosis:• 45 patients, followed for mean of 4.6
years with serial biopsies every 5 years
• 12 patients with bariatric surgery, 6 more who lost weight with medical management
• On multivariate analysis, only weight loss of >10 % TBW predicted fibrosis regression, OR 8.14
Glass et al. ( Dig Dis 2015 60:1024–1030)
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*Sjostrom et al NEJM 2007;357:741-752
Bariatric surgery provides effective long-term weight loss
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12 year outcomes post Roux-Y Gastric bypass:
• 95% reduction in new-onset DM at 12 years
• 51% resolution of DM type II at 12 years
• Effective long-term weight loss
Adams et al NEJM 2017: 377; 1143-55.
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Bariatric surgery proceduresRestrictive• Lap band: reversible, low rate of
serious complications. Less effective weight loss, and >50% failure rate at 10 years. ? Access to distal varices
• Gastric sleeve: slower weight loss, low rate of complications, appears durable (early). Not reversible. Preserves access to biliary tree and varices.
Restrictive +Malabsorptive• Roux-en-Y Gastric bypass: gold
standard. Effective, long-term weight loss. Serious complication rate 0.5-2%. No access to distal varices. ? Rapid weight loss
• Duodenal switch: rarely used, reserved for very severe obesity. Not appropriate for patients with liver disease.
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Bariatric Surgery in patients with cirrhosis
• 5 studies (13-23 patients)• Lap sleeve gastrectomy or RYGB• Longer OR time and higher
complications • Conclude: bariatric surgery safe,
effective in selected patients with compensated cirrhosis (child’s A.)
Lin et al Obes Relat Dis. 2013;9(5):653–8. Woodford et al Obesity Surg (2015) 1623-9. Shimizu et al Obesity Rel Dis (2013)9;1–6. Rebibo et al Obesity Rel Dis (2014)405-10. Pestana et al Mayo Clin. Proc. (2015)209-15
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• UCSF N= 32
• MELD=12 (11-13)
• BMI=45
• No deaths
• 1 leak
• 21 listed and 14 transplanted
Sharpton Liver Trans 2019
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Bariatric surgery in cirrhosis • Nationwide Inpatient Sample (NIS) between 1998 and 2007
• Patients identified as having bariatric surgery and decompensated cirrhosis (n=62), compensated (n=3888) or or no cirrhosis (n=670,950).
• Diagnosis code of ascites or varices required to be classified as decompensated.
• In-hospital mortality 16.3 % vs 0.9% and 0.3%,( P <.0002).
• LOS higher in cirrhosis: 6.7 and 4.4 d vs 3.2 d, respectively; P<.0001.
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Post LT bariatric surgery• Lin et al: Lap gastric sleeve post
LT n=9 patients• Mean time from transplant 5.9
years, age=56, BMI=41, OR time 165 minutes (lysis of adhesions), hospital stay 5.6 days
• Mean f/u 6 months• 3 patients required re-op in first
30 days
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Post LT bariatric surgery• open RYGB post LT n=7 patients• Mean time from transplant 2.6 years, age=56, BMI=44• Mean f/u 5 years• 2 patients died in first 1 year, and 1 reversal
Al-Nowaliti et al (LT 2013;19(12):1324-9): 237
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Post LT bariatric surgery• N=6 post LT SG. (3 open, 3 lap).
Performed at average of 43 months post LT.
• Mean follow up 37 months• Median LOS =9 days, 1 leak with
subsequent prolonged stay/multiple reoperations/death. One complication > 30 days (infected mesh requiring re-op).
• Mean BMI 28 post procedure.
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2017 Aug 3. 7:
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Perioperative bariatric surgery: MCR Approach
• Enroll all pre-transplant patients with BMI>35 in an obesity management protocol: 4 step approach, goal is BMI<35
• Calorie restricted diet • Food record • Weigh and record.• Activity: determine restrictions, pedometer, etc.
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• Option for selected patients who have not attained goal weight and have high MELD
• Gastric sleeve resection combined with liver transplant
• No malabsorption, slower weight loss, technically easier
Heimbach et al AJT 2013240
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Long-term outcomes of patients undergoing simultaneous Liver Transplantation and Sleeve Gastrectomy
• N=29 LT+SG, with 17 >3 years of follow-up, 36 LT alone
• 29.4% of patients in LT cohort maintained >10% loss in TBW, while 100% of the LT+SG patients did (p<0.001)
• %TBWL= LT cohort 3.9±13.3% vs. LT+SG cohort 34.8±17.3%; p<0.001)
Zamora-Valdez et al, Hepatology Feb 2018
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Long-term outcomes of patients undergoing simultaneous Liver Transplantation and Sleeve Gastrectomy
Zamora-Valdez et al, Hepatology Feb 2018
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Long-term outcomes of patients undergoing simultaneous Liver Transplantation and Sleeve Gastrectomy
Less DM, less hypertension, lower triglyceridesZamora-Valdez et al, Hepatology Feb 2018
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Treatment:Compensated cirrhosis
Goal attain >10% body weight loss to improve liver fibrosis, metabolic
complications
Non-invasive weight loss
Consider lap sleeve gastrectomy (or LRYGB)
Decompensated cirrhosis
Transplant candidate?
Non-invasive attempt at weight loss (selected)
Sleeve gastrectomy (during or after LT)
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Summary for liver transplant:• Post LT outcomes for selected obese patients appear acceptable• Complications may be higher• Long term outcomes post LT impacted by obesity
• Lifestyle modification• Pre-transplant obesity surgery: highly selected patients• Post-transplant obesity surgery: favor Lap sleeve• Combined approach may be an option for selected patients who have
not attained goal weight
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Key Take Home Points:
• Post LT outcomes for selected obese patients appear acceptable
• Complications may be higher
• Long term outcomes post LT impacted by obesity• Lifestyle modification• Pre-transplant obesity surgery: highly selected patients• Post-transplant obesity surgery: favor Lap sleeve• Combined approach may be an option for selected patients who have not
attained goal weight
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Questions? Heimbach.julie@mayo.edu
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The Need of LDLT in the US, Initiating a Program Roberto Hernandez-Alejandro Professor of Surgery University of Rochester Medical Center Living liver donation has waxed and waned in popularity in the United States since its debut in 1989. In an era where the waitlist continues to outpace available deceased donor organs and thousands die waiting yearly, expanding and LDLT is one viable option to increase transplantation. Live donor hepatectomy has proven to be a safe procedure that offers recipients equivalent- or better graft survival than deceased donation; but starting a program is not a task that should be taken lightly. The proper environment, resources, and team (technically experienced surgeons, independent donor advocate, supportive administration, etc.) are foundational. The potential impact of a well-formed program, such as reducing waitlist mortality and expanding your recipient population are boundless.
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The Need of LDLT in the US, Initiating a Program
Roberto Hernandez- Alejandro, MD, FACSProfessor of Surgery
Chief, Division of Abdominal Transplant Hepatobiliary Surgery
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In the United States• 38,050 liver Tx in the last 5 years (7,610/yr)
• 89% DBD
• 6% DCD
• 5% LDLT
GODT 2018 data
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France UK Canada Brazil Japan US SouthKorea
Turkey India
International Comparison of LDLT/yr
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The Critical Need of Organ Donation
010,00020,00030,00040,00050,00060,00070,00080,00090,000
100,000110,000120,000130,000
1993
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Transplants Deceased DonorsSize of Waiting Lists Living Donors
OPTN Data updated 9/19/19 (all donors, all organs, all ages)
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DCD/ECD Increase over the Past Decade in the US
OPTN Data updated 9/30/19
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Older and DCD Liver Donors 2009-2018
65+ DCD
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US Living Donor Liver Transplant Numbers
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Living Donor Hepatectomy-Donor Mortality
• 26 “perioperative” (related or possibly related)
• 7 late (> 1 year)
• Poorly documented: probably + at least 4
• 18 RL, 7 LL or LLL, others unknown
• Estimated 14,000 LD hepatectomies
• Mortality = ~0.2%
• USA: 5 / 4,534 = 0.1%
• Since 2008 - At least 3 more
• USA – 2 (2010)
• India – 1 (2010)
33 Deaths after Living Liver DonationRinge and Strong, Transpl 2008: 85:790-2
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Requiem for a Champion?
Clavien PA, Dutkowski P, Trotter JF. Requiem for a champion? Living donor liver transplantation. J Hepatol. 2009 Oct;51(4):635-7.
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Donor Risk
National Data
• Overall complications 30%• Major complications 10%
6826 LDLT(Jan 2019)
6 donor deaths(0.10%)
3 donors received a LTX
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Regional Variation
• > 4-fold differential in DBD liver availability according to UNOS region
Jay CL, et al. J Hepatol. 2011 Oct;55(4):808-13.
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Does Every Center Need a LDLT Program
Median MELD at Transplant
Transplant Rate
Waitlist Mortality Rate
Regional Organ Acceptance Rate Ratio0.8
0.9
1.0
1.1
1.2
1.5
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Who Should Have a LDLT program?
1) A team dedicated and a similar vision and support for LDLT
• Hepatologist
• LDLT Coordinators
• Outreach/marketing
2) Surgeons with skills and knowledge
• LT and HPB
• Experience in LDLT (overseas)
• At least 2
3) Be prepare for a bad outcome or a fatality
• Need to have a disaster plan
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Outcomes: Living vs. Deceased Donor Graft Survivalby Era and Age (UNOS Data)Adult
Pediatric
Gruessner. Transplantation proceedings. Vol. 50. No. 10. Elsevier, 2018.
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LDLT in Rochester - PhilosophyLDLT may be the best choice for most recipients. This procedure provides a healthy
organ
1. Maximizing recipient benefits
2. Offering the opportunity to help a “loved one”
3. Increasing the number of DD organs for others
Our focus is on
1. Donor safety
2. Ensuring an autonomous, well-informed donor choice
3. Advancing knowledge.
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Liver Transplant Volume URMC since LDLT Restart
05
1015202530354045
Living DonorsDCD DonorsBrain Dead Donors
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Liver Catchment Area- New Allocation
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From Liver Resection to Live Donor Liver Tx
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Living Liver Donation Safety
• Full disclosure of donor and recipient results.
• HPB “field strength”
• A well-resourced, cohesive team focused on patient safety:• Checklists• Weekly planning mtgs• Continuous quality review• Ethics support• Disaster plan
• A shared commitment to quality improvement & generating new knowledge.
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Tumor Board Consensus
• Start Systemic Chemotherapy
• FOLFOX 12 treatments
• Bevacizumab
• Re-assess in 6 months
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#chemo treatment and CEA
607
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28 8.7 3.4 2.1 3.40
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Baseline Cycle 2 Cycle 4 Cycle 6 Cycle 8 Cycle 10 Cycle 12
CEA and Chemo Treatment
CEA and Chemo Treatment
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Is he a candidate for Liver TX?
• Unresectable
• > 1 year responding to chemo
• K Ras Wild type
• CEA below 80
• Max tumor diameter< 5.5 cm
• ECOG 0
• Potential LD
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Road to transplant
Primary to be removed
Review Pathology of primary
No progression for 3 months
Complete LD work up
Transplant
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Outcomes SECA-II: No evidence of disease
5y = 67,0%
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THANK YOU !!!
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Altruistic Living Donor Liver Transplantation: Is It Feasible?
Elizabeth A. Pomfret, MD, PhD, FACSProfessor of Surgery and Igal Kam MD Endowed Chair of Transplant Surgery
Chief of Transplantation, University of Colorado Anschutz Medical Campus
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Living Donor Liver Transplantation: AdvantagesShorter waiting time for the recipients with lower wait-list mortality and similar posttransplant survival
Berg et. al. (Hepatol 2011; 54:1313-21)reported a 56% lower risk of death for patients who choose LDLT vs. those waiting for a DDLT.
Despite this only about 5% of liver transplants in the US are LDLT
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Why is live donation necessary at all and is it different depending on donor relationship to the recipient?
Even in countries with adequate access to DDLT, live liver donation is appropriate due to organ shortages
Donor safety is of paramount importance in living donor liver transplantation and yet living donor complications and deaths occur even in the most experienced hands (0.1–0.5% mortality, 10–38% morbidity)
278
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Right Lobe
Risk of Death 1 in 200
Risk of Complication 30-40%
Left Lobe
Risk of Death 1 in 1000
Risk of Complication 10%
Barr ML et al. Transplantation. 2006Cheah YL and Pomfret EA. Liver Transpl. 2013.
1 in 500
Living Liver Donor Morbidity & Mortality
Program Experience
Selection of Donors
Extent of the Donor Hepatectomy
279
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A Report of the Vancouver Forum on the Care of the Live Organ Donor: Lung, Liver, Pancreas, Intestine Data and Medical Guidelines
Barr ML, Belghiti J, Villamil FG, Pomfret EA, Sutherland DS, Gruessner RW, LangnasAN, Delmonico FL. Transplantation. 2006; 81(10): 1373-85
280
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Donor Safety is of Paramount Importance
The “Vancouver Forum” held in 2006 established practice principles for LDLT:
Live liver donation should only be performed if the risk to the donor is justified by the expectation of an acceptable outcome in the recipient.
Indications for LDLT should be the same as those established for DDLT with the exception of institutionally-approved protocol studies that consider LDLT preferential to DDLT.
LDLT should offer an overall advantage to the recipient when compared to waiting for an acceptable DD organ to become available for transplantation. The decision to proceed with a LDLT should be made after a careful analysis of the recipient risk to benefit ratio as it relates to severity of liver failure, quality of life and expected wait list time for a deceased donor.
Barr ML et al., Transplantation 2006;81:1373–85. 281
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What is Double Equipoise?
As long as there is a disparity between supply and demand of DD livers, organ allocation and the system of distribution must be based on the ethical principles of utility, justice and equity.
Utility represents the beneficial outcome of the transplant (i.e. patients likely to have the best survival). Justice implies that all candidates have equal access to transplant.Equity often interchanged with justice, ensures that the organ allocation policy is applied equally and that similar recipients have equal priority.
In living donation, the ethical principles of justice and equity used for deceased donation do not applysince the recipient is not competing with other listed candidates for organs. In fact, live donor liver transplant recipients may benefit all candidates awaiting deceased donor liver transplantation by eliminating themselves from the waiting list.
282
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Miller CM. Transplantation Rev. 2008.Barr ML et al. Transplantation. 2006.
Pruett el at. Transplantation. 2006.
Beneficence: “Do good”Expected Recipient Outcome
Non-Maleficence: “Do no harm”Donor Safety
Utility: “Promote Net Good”Need
Autonomy
Principals Unique to DDLT:Justice - all candidates have equal access to transplant
Equity - applying organ allocation equally
283
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Concept of Double Equipoise
Describes the balance between the recipient’s survival benefit with or without a live donor transplant and the probability of donor mortality risk.
Risk/benefit analyses for LDLT are not confined to those of the individual donor and recipient, but include balancing the donor risk against the recipient benefit.
The concept of double equipoise suggests that there clearly exists an area of excessive donor risk and unacceptably low recipient benefit.
Ethically unacceptable for LD to undergo an operation that had a mortality risk > 0.5%-1%, nor would it be acceptable for the donor to undertake any risk if the recipient benefit were very low.
284
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Concept of Double Equipoise
Conversely, there are situations of donor/recipient balance that appear to be ethically acceptable. Adult donor providing a liver segment for the pediatric recipient.
Here the donor risk is well defined and small, and recipient benefit is almost always a highly successful and durable transplant.
The two extremes appear easily definable and defensible, the zone of “ethical uncertainty” is the most complex area.
What are the minimal benefits to recipients that warrant the use of a live donor and how is use of a live donor for extended indications and marginal recipient benefit justified?
285
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The concept of double equipoise describes the balance between the recipient’s survival benefit with or without a LDLT and the probability of donor mortality risk
Pomfret et al. 2011 Liver Transplant. Suppl 2: S128-132286
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AltruismThe word was coined by the French philosopher Auguste Comte from
the Latin word alteri, meaning “other people” or “somebody else”
“The belief in or practice of disinterested and selfless concern for the well-being of others.”
“Principle and moral practice of concern for the happiness of other human beings, resulting in a quality of life both material and spiritual.”
Synonyms: selflessness, benevolence, humanitarianism, kindness, charity, social conscience, philanthropy
287
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Is There a Hierarchy of Altruism? • Perhaps the most unique form of altruism is an act undertaken which
has risk to the benefactor in an effort to help an unknown or anonymous beneficiary.
Zwick and Fletcher’s Levels of Altruism
Description Type of Living Organ Donor and Example
Human Species Altruism Universal ethics calls for other species to be regarded as oneself
Anonymous non-directed donation
Group Altruism Solidarity with members of one’s community or ethnic group. The key is the extension of self to encompass others
Anonymous non-related directed donationEx: donation to an anonymous church member
Interaction Based Altruism
Altruism towards agents in direct interaction with the individual. Information available to be assured or reciprocal altruism. The Golden Rule: “Do onto others as you would want them to do onto you”
Non-related directed donation Ex: donation to a friend
Kin Altruism This bond is not free of self-interest Related directed donation Ex: donation from a parent to child
Self Interest The foundation of action for others is action for oneself To seek medical attentionEx: to be listed for transplant
Adapted from Zwick and Fletcher’s Levels of Altruism 288
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289
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29 Consecutive anonymous potential liver donors12 accepted (6 male and 6 female) and 17 rejected4 directed towards recipients who undertook media appeal5 LLS and 7 RLDonor morbidity: 40% (1 Clavien 3: PTX)All doing wellNone regret donation
All donors were strongly motivated by a desire and sense of responsibility to help others.
290
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Assessment: used standard live liver donor assessment process, augmented with the following additional acceptance criteria: a logical rationale for donation, a history of social altruism, strong social supports and a willingness to maintain the confidentiality of patient information
291
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292
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293
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294
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295
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296
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Probability trade-off technique
297
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Donors inclination to undergo hepatectomy in relation to:
298
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299
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Conclusions:1. Today: mortality is between 0.1%-0.5% and recipient 5-year survival exceeds 70%2. Participants in this study were willing to accept 70% risk for morbidity and 30% risk for mortality and recipient life gained of 6 months3. Donors are willing to accept a greater level of risk then the clinicians
300
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Living donation and cosmetic surgery: a double standard in medical ethics?
Testa, G., et al. J Clin Ethics. 2012; 23(2):110
•Commitment of the transplant MD to protect the physical and psychological health of the donor
•Appropriate that strict regulations to govern an individual’s decision to donate have been developed
•One argument: adherence to these regulations creates a doctor-patient relationship that is rooted in paternalism
•This is in direct contrast to doctor-patient relationship rooted in patient’s autonomy(e.g. cosmetic surgery)
301
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Living donation and cosmetic surgery: a double standard in medical ethics?
Testa, G., et al. J Clin Ethics. 2012; 23(2):110
•Argue that both operative interventions should be guided by the same ethical principle: a respect for the patient’s autonomy
•Conclude that if living organ donation valued donor autonomy as much as cosmetic surgery does, we might see a wider acceptance and more living donation
302
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303
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Case: R.L.• Donor: In 2017, a 28 year old female
approached us asking to donate to someone in need. She had no recipient in mind. Would donate to an adult or child.
• She was a prior non-directed kidney donor
• Her mother was a prior kidney donor• She was raised in a religious household• She came for a 2 day evaluation including
psychological evaluation• 5 ft 9 in; 70 kg• LLSeg 249g (17.8% TLV)
• Recipient: a child with biliary atresia
LLS
RL
304
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Case of M.R.41 year old former Navy SEAL learns of a young mother of 3 in need of a liver transplant. He would be suitable as a left lobe donor.
305
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36 year old mother of 3 (ages 12, 10, 7) learned of a 58 year old woman in her church with PSC in need of a liver transplant. The donor feels a moral obligation to help if she can and hopes that someone would do the same for her. She would require a right hepatectomy to be sufficient for the donor
306
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A selfless behavior undertaken to benefit someone other than oneself Some have questioned if altruism truly exist
https://www.donoralliance.org/newsroom/donation-essentials/colorado-earns-top-spot-in-the-nation-for-highest-donor-designation-rate-wyoming-sixth-in-the-nation/
Altruism in Colorado
307
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The Colorado ExperienceAltruistic Non-Directed Liver Donors
Donor Characteristics n=13
Median Age at Donation 39 (22-53)
Female 77% (10/13)
Median BMI 25 (21-32)
History of altruism * 100%
Prior kidney donation 62% (8/3)
0
1
2
3
4
5
6
7
8
9
2017 2018 2019
Altruistic Live Liver Donor Surgeries
LLS LL RL
*employment in a field characterized by sacrifice: military, peacecorp, teacher; history of volunteer work or blood donation
Donor Complications n=13
Readmission 23% (3/13)
wound infection 8% (1/13)
duodenal ulcer due to excess NSAID use 8% (1/13)
pain requiring nerve block 8% (1/13)
Center data 9/2019308
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Donor Outcomes and Motivations All donors are back to their normal level of activity All of our donors say if given the chance they would donate again
”Because I value life; there are people in need“ "I just wanted to help someone and I felt like I was healthy and able to do this“ ”No one deserves to die“ ”After having donated the kidney I had participated in a fundraiser and we
stayed and listened to the testimonials and I decided I wanted to pursue it in the future" ”We're a community and have to take care of each other"
Center data 9/2019309
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Conclusions1. Altruistic donation (directed and non-directed) is ethically appropriate and is an example of pushing the limits in living donors.
2. Unlike DDLT, LDLT is governed by utility concerns that we describe as “double equipoise,” and NOT by equity and justice considerations.
3. Altruistic non-directed donors increase the total organ pool and benefit all potential recipients on the list.
4. Altruistic non-directed donors are motivated by their values and are very satisfied with their experience (essentially all would do it again).
310
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Challenges in Pediatric Liver Transplantation
Yuri Genyk, MD Program Director
Children’s Hospital Los Angeles
University of Southern California
311
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Barriers to ideal outcomes after pediatric liver transplantationNg, VL, et.al Pediatr Transplant 2019
312
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Challenge:To Eliminate Pediatric Liver Waitlist Mortality
Each year, approximately 60 children, representing 12% of waitlist candidates, die awaiting liver transplantation
• Is PELD accurate in predicting pre-transplant mortality
• Is there a shortage of liver donors?/Liver allocation in pediatric recipients
• Transplant options - CAD vs. SLT vs. LDLT
313
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Selection of Pediatric Candidates Under the PELD System
McDiarmid, SV et.al. Liver Transplant 2004
314
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Predicted probability of waiting survival at 3 months by severity scores
315
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Reasons for removal from the liver waiting list before and after implementation of MELD/PELD
316
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Death adjusted per 1,000 patient years on theliver waiting list before and after implementation ofMELD/PELD
317
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Conclusions
• The PELD score accurately predicts the 3 month probability of waiting list death for children with chronic liver disease
• Comparing pre and post PELD and MELD implementation, the percent of children receiving deceased donor livers increased and the percent of children dying on the list decreased after PELD/MELD implementation.
• Excluding children transplanted at status 1, the largest percentage of children are transplanted at a PELD score<10.
• Before MELD/PELD 48% of all children receiving deceased donor organs were transplanted at status 1, compared to 41% in the PELD/MELD era
318
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Impact of the Pediatric End‐Stage Liver Disease (PELD) growth failure thresholds on mortality among pediatric liver transplant candidatesSwenson, SM et.al. AJT 2019
319
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(PELD calculator simulation): Impact of PELD's growth failure thresholds on PELD score
320
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Prevalence of growth failure, by age and growth failure definition
321
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Mortality on the pediatric liver transplant waitlist within 6 months of listing
322
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Conclusions
• Current methods for determining growth failure in PELD disadvantage candidates arbitrarily and increase their waitlist mortality risk.
• PELD should be revised to correct this disparity.
323
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Accuracy of the Pediatric End-stage Liver Disease Scorein Estimating Pretransplant Mortality Among Pediatric Liver Transplant CandidatesChang, CCH, et.al. JAMA Pediatrics
324
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Actual and Estimated 90-Day Pretransplant Mortalityby Pediatric End-stage Liver Disease (PELD) Score
325
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Actual and Estimated 90-Day Pretransplant Mortality by Pediatric End-stage Liver Disease (PELD) Score in Each Disease Diagnosis Category at Listing
326
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Conclusions
• Despite good concordance, the current PELD system significantly underestimated the true risk of death
• The precision of the PELD score to be poor, especially for children who are more sick (PELD score >20). For children with PELD scores greater than 30, the 95%CI for the likelihood of dying in 90days spanned from 23% to 43%
• Children may be disadvantaged in the current organ allocation system compared with adults, the transplant community should develop a risk estimation tool for children that allows for the direct comparison of risk of death with that among adults
327
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Deceased Pediatric Donor Livers: How Current Policy Drives Allocation and TransplantationGe, L, et.al. Hepatology 2019
• 45% of pediatric donor livers were transplanted into adults: 390 adults were transplanted with pediatric organs never offered to children, while 278 children died or were delisted due to illness, which was more apparent in DSAs with low pediatric transplant volumes
• We advocate for a change to allocation policies to allow pediatric organs to be offered to national children with status 1B or Model for End-Stage Liver Disease/Pediatric End-Stage Liver Disease >15 before being offered to local/regional + circle non–status 1A adults
• Pediatric livers would be prioritized to children who have a “time-limited opportunity for growth and development and may suffer lifelong consequences if not expeditiously transplanted,” a principle that has been articulated by the OPTN/UNOS Pediatric Transplantation and Ethics Committees
328
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Frequency of whole-organ in lieu of split-liver transplantation over the last decade: Children experienced increased wait time and death. Valentino, P et.al. AJT 2019
• 420 children next on the list suitable for SLT
• 333 children (79%) underwent LT, but had longer wait-times compared to 591 actual pediatric SLT recipients (median 147 days vs 44 days, P < 0.001)
• 33 of 420 children died on waitlist
• Sharing organs suitable for splitting increases the number of LT, saving more lives with careful patient selection, SLT will not be a disadvantage to the adult recipients
• With a children-first allocation scheme, SLT will naturally increase the number of allografts
329
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A national mandatory-split liver policy: A report from the Italian experience. Angelico, R et.al. AJT 2019
• Since August 2015
• Children undergoing SLT increased from 49.3% to 65.8% (P = .009)
• Pediatric LT‐waiting list time dropped (229 [10‐2121] vs
80 [12‐2503] days [P = .045])
• The pediatric (4.5% vs 2.5% [P = .398]) and adult (9.7% to 5.2% [P < .001]) LT‐waiting list mortality reduced
• A national mandatory‐split policy maximizes the SLT donor resources
330
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331
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Patient (A) and graft (B) survival of left‐lateral segment transplantation
332
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Patient (A) and graft (B) survival of extended right graft transplantation
333
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Similarities and Differences in Allocation Policies for Pediatric Liver Transplantation Across the WorldFischler, B et.al. JPGN 2019
• Replies were obtained from 15 countries from 5 of the world continents.
• In children younger than 2 years mortality on the waiting list (WL)varied between 0 and 20%
• In the same age group, there were large differences in the ratio of living donor LT to deceased donor LT and in the ratio of split liver segments to whole liver
• These differences were associated with possible discrepancies in WL mortality
• Our survey suggests that although the rate of pediatric liver transplantations is quite similar between these 15 countries, there are important differences regarding organ donation rates, mortality on the waiting list for the youngest children, and the type of liver graft most commonly used
334
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Donation rate per million inhabitants
335
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Pediatric liver transplantations per million inhabitants younger than 18 years
336
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Waiting list mortality (%), children younger than 2 years
337
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Percentage of deceased donor liver transplantation (DDLT) and living donor liver transplantation in recipients younger than 2 years
338
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Type of organ in DDLT recipient younger than 2 years
339
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Waiting list mortality for children younger than 2 years of age in relation to pattern of allocation
a) Countries with >2/3 of LDLT and <1/3 SLT or DD
b) Countries with >2/3 SLT or DD and <1/3 LDLT
c) Countries with SLT or DD = LDLT
d) USA, where only small numbers of patients received SLT or LDLT and a majority of the transplantations are performed with whole DD livers
340
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Fifteen-Year Trends in Pediatric Liver Transplants: Split, Whole Deceased, and Living Donor GraftsMogul, DB et,al. J Pediatr 2018
341
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Kaplan-Meier curve of graft survival by allograft type in the first year after transplant
342
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Kaplan-Meier curve of patient survival by allograft type in the first year after transplant
343
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Split, Whole Deceased, and Living Donor Grafts
2002-2009
WLT SLT Size-reduced LDLT
2010-2015
WLT SLT Size-reduced LDLT
344
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Conclusions
In recent years, outcomes after the use of technical variant grafts are comparable with whole grafts, and may be superior for LDLT. Greater use of technical variant grafts might provide an opportunity to increase organ supply without compromising post-transplant outcomes.
345
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Key Take-Away Slide
• The pediatric pre-transplant mortality is preventable
• PELD and pediatric liver allocation needs to be adjusted
• LDLT and graft variants should be increased
346
Debate on Simultaneous Liver/Kidney Transplantation UNOS Policy: PRO POSITION
Vatche G. Agopian Associate Professor of Surgery David Geffen School of Medicine at UCLA
Since the adoption of the model for end-stage liver disease (MELD) score as the standard for donor liver allocation in the United States in 2002, there has been a significant prioritization of liver candidates with pre-existing renal dysfunction for life-saving liver transplantation (LT). Due to poor post-LT outcomes in LT recipients who remain on renal replacement therapy, and the lack of both accurate predictors of renal recovery as well as standardized OPTN policy for simultaneous liver/kidney (SLK) listing, there has been a dramatic increase in the number of SLK. In 2017, UNOS enacted policies that defined strict medical criteria to allow for SLK listing (9.7) as well as a “safety net” to allow for expedited kidney after liver transplantation for LT recipients who have sustained renal dysfunction following LT. This new policy aligns SLK listing practices with the OPTN final rule which requires standardized medical criteria in allocation policies, and aims to reduce inappropriate and futile SLK, thereby saving high-quality kidneys for select kidney transplant alone candidates while simultaneously providing a mechanism for LT recipients to receive a kidney transplant in an expeditious manner. As with any policy change, ongoing critical evaluation of the data is necessary and may inform necessary refinements of the policy.
347
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AASLD/ILTS Transplant CourseThe Critically Ill Patient and Challenges in Liver Transplantation
Debate on Simultaneous Kidney/Liver Transplantation UNOS Policy: PRO
Vatche G. Agopian, MD
Associate Professor of Surgery
David Geffen School of Medicine at UCLA
348
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OVERVIEW• Background
• Kidneys in the MELD Era
• Significant increase in SLK
• “The Problem”• No standardization
• “The Solution”• Policy 9.7 – Medical Criteria for SLK Listing
• Policy 8.5G – “Safety Net”
• “The Arguments”
349
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BACKGROUND: SLK in the MELD EraMELD allocates livers to sickest recipients
Pre-MELD (’84-’02)
Post-MELD (’02-present)
P
Recipients, n 2678 1896
OLT, n 3218 2129
MELD 19 28 <.001
MELD ≥ 35 13% 37% <.001
National UCLA
MELD in 2011 22 38 Agopian, Ann Surg 2013
350
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BACKGROUND: SLK in the MELD EraPrioritization of liver candidates with renal dysfunction
Pre-MELD (’84-’02)
Post-MELD (’02-present)
P
Recipients, n 2678 1896
Pre-LT dialysis, % 12 34 <.001
Liver/Kidney, % 2.1 6.8 <.001
Agopian, Ann Surg 2013
351
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BACKGROUND: SLK in the MELD EraDramatic Increase in Number of SLK
Formica, AJT 2016
MELD introduced
* 450% increase
*
352
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BACKGROUND: SLK in the MELD EraDramatic Increase in Number of SLK
Hussain, JCTH 2018
MELD introduced
* 450% increase
*
557
731
353
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“The Problem”Why is this Happening???
354
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“The Problem”: Increase in SLKRecognition that pre-LT Renal Dysfunction is BAD
Gonwa, AJT 2006
355
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2003
“The Problem”: Increase in SLKPost-LT Renal Dysfunction Common
356
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“The Problem”: Increase in SLKPost-LT Renal Dysfunction/ESRD results in poor LT Survival
Gonwa, Transplantation 2001
357
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“The Problem”: Increase in SLKPost-LT ESRD Receiving KTX do much better than staying on HD!!
Gonwa, Transplantation 2001
358
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“The Problem”: Increase in SLKInability to Predict Renal Recovery
Formica, AJT 2016
359
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“The Problem”: Increase in SLKNo Standardization for Listing: Transplant Center Variation
Nadim, AJT 2012
360
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“The Problem”: Increase in SLKNo Standardization for Listing: SLK Recipient Variation
Formica, AJT 2016
361
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“The Solution”
On August 10th, 2017 UNOS enacted policies 9.7 and 8.5G to address several critical deficiencies in
simultaneous liver kidney transplantation
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“The Solution”: UNOS SLK PolicyPolicy 9.7 – Medical Criteria for SLK Listing
Lum E, LT 2019
363
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System to allow for expedite KT following LT in 2 scenarios:
• LT recipients unexpectedly developingkidney disease/need for RRT
• LT recipients listed for SLKT but notreceiving a kidney
• To qualify, LT recipients must have GFR < 20ml/min or maintenance HD
• Register between 60 and 365 days post-LT
“The Solution”: UNOS SLK PolicyPolicy 8.5G – “Safety Net”
Lum E, LT 2019
364
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“The Arguments”
365
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“The Arguments”Argument # 1 – Standardizes Criteria
• Prior to the policy, there was significant variation in transplant center practices, as well as recipient characteristics.
• Clear violation of OPTN’s “Final Rule”…allocation policies must be based on sound medical judgment and standardized criteria, must seek to achieve the best use of organs and must avoid futile transplants”
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“The Arguments”Argument # 2 – Reduces Inappropriate SLK
Adapted from Gonwa, AJT 2016
65
70
75
80
85
90
no dialysis creat>2,no dialysis on dialysis
80.6
69.868.3
73.1
69.9
74.8
LTA SLK
Survival benefit of SLK occurs only in pre-LT HD patients
3-yr
Pat
ient
Sur
viva
l (%
)n=24,173 liver
recipients
P=0.0003
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“The Arguments”Argument # 2 – Reduces Inappropriate SLK
~60 % of patients with < 2 month dialysis!
Formica, AJT 2016
368
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“The Arguments”Argument # 3 – Saves high quality kidneys
• Kidneys used in SLK allocation tend tocome from donors with lower kidneydonor profile index (KDPI) and thus havelonger expected longevity
• Of total number of SLK transplants, 49% ofdonor kidneys had a KDPI < 35% whichwould otherwise be offered to otherprioritized groups, including pediatric,young adult, or highly sensitized
Lum E, LT 2019
369
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“The Arguments”Argument # 4 – Avoids Futility
+
3- working kidneys post-LT
+
0- working kidneys post-LT
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“The Arguments”Argument # 4 – Avoiding Futility in SLK
“The highest reported median
MELD score was 39, in Los Angeles,
California (CAOP), and the lowest 20
In Indianapolis, Indiana (INOP)”
Median MELD at LT by DSARegion 5 among the highest in
the country
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“The Arguments”Argument # 4 – Avoiding Futility in SLK
50%
60%
70%
80%
90%
100%
15-20 20-21 21-22 22-23 >23 KTA
90.70%88.50%
87%
79.50%76%
89.60%
On
e Y
ear
Kid
ney
Gra
ft S
urv
ival
(%
)
SLKT by MELD score
• Kidney allograft survival
significantly worse than
expected at higher MELD
• A failed kidney allograft
after SLKT represents loss
of 7.2 years of life if kidney
were allocated to a patient
on the kidney list
Adapted from Locke 2008 Transplantation
P=0.02
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“The Arguments”Argument # 4 – Avoiding Futility in SLK
Lunsford, Agopian Ann Surg 2017
373
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Argument # 4 –Avoiding Futility in SLK
All Patients Listed for Liver Transplants at UCLA1/1/2004 – 8/30/2014
N=3892
Study CohortN=331
Received Liver TransplantN=160 (48%)
Excluded (N=51)Actively Listed (30), Pediatric Patients (19),Multivisceral (1), Intraoperative Death (1)
SLKTN=145 (90.6%)
LTAN=15 (9.4%)
Expired Awaiting TransplantN=171 (52%)
Patients simultaneously listed for liver and kidney transplantN=382
Non-Futile SLKTN=116 (80%)
Futile SLKT(death or HD at 3mo postTx)
N=29 (20%) Lunsford, Agopian Ann Surg 2017
374
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“The Arguments”Argument # 4 – Avoiding Futility in SLK
• 39% of SLKT experienced delayed graft function (DGF)
• DGF = RRT > 7 days postTx
• 20% of SLKT experienced renal allograft futility (RAF)
• RAF = Death or need for RRT at 3 mo postTx
• Futile liver transplants accounted for 72% of RAF
0 365 730 1095 1460 18250
10
20
30
40
50
60
70
80
90
100
Time Post-Transplant (Days)
Cu
mu
lati
ve
Pa
tie
nt
Su
rviv
al (%
)
Comparative Survival for SLKT Recipients Based on Renal Allograft Futility
All SLKT Recipients (n=145)Renal Allograft Futility (n=29)Non-Renal Allograft Futility (n=116)
p<0.0001
Lunsford, Agopian Ann Surg 2017
375
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“The Arguments”Argument # 4 – Avoiding Futility in SLK
• 40% of SLK listed patients who underwent LTA actually recovered native renal function
Lunsford, Agopian Ann Surg 2017
376
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Argument # 4 – Avoiding Futility in SLKPeri-LT factors and Association with RAF
Non RAF(N=116)
RAF(N=29) P-value
Mean STD Mean STD
Lab MELD 33.3 7.7 36.2 5.0 0.02
Days of PreTx HD 267.7 428.6 535.8 909.7 0.051
PreTx LOS (days) 18.6 19.0 30.7 19.7 0.015
Kidney Cold Ischemia Time (min) 827 329 1089 579 <0.0001
Worst IntraOp Base Deficit -8.7 5.1 -10.5 4.4 0.036
% N % N
Female Donor Gender 66.4 77 44.8 13 0.03
Instability at Transplant Completion 15.5 18 37.9 11 0.007 Lunsford, Agopian Ann Surg
2017
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Argument # 4 – Avoiding Futility in SLKPost-LT factors and Association with RAF
Non RAF(N=116)
RAF(N=29) P-value
Mean STD Mean STD
PostTx ICU LOS (days) 15.9 17.4 38.4 42.4 <0.0001
PostTx Total LOS (days) 36 26.2 71 75.5 <0.0001
PostTx HD (days) 8.1 13.8 88.4 110.0 <0.0001
% N % N
In-Hospital Mortality 0.8 1 65.5 19 <0.0001
One Year Mortality 6.9 8 79.3 23 <0.0001
Liver Allograft Futility 2.6 3 72.4 21 <0.0001Lunsford, Agopian Ann Surg
2017
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Argument # 4 – Avoiding Futility in SLK
Lunsford, Agopian Ann Surg 2017
• 20% of kidneys transplanted at SLKT never function (RAF).• Occurs in patients with higher medical acuity at transplant
• Occurs most commonly due to futile liver outcomes (72% oftime)
• Overall, these data suggest that renal transplant shouldbe deferred at liver transplant in patients with highmedical acuity to avoid RAF
• “Safety net” allows for deferral of KT at time of LT• Allows observation of native kidney function
• Allows prioritization of KT in LT recipients remaining on HD
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Take-away/Key Points
1. MELD prioritization has dramatically increased the number of SLKs, but with significant variation in practices and no standardized listing criteria
2. New UNOS SLK Policy standardizes strict medical listing criteria, and defines a “safety net” provision which allows for expedited kidney after liver transplant in recipients who remain in renal failure following LT
3. Policy is essential for compliance with OPTN final rule, and aims to minimize inappropriate SLK, saves high-quality kidneys for KT recipients, and will help to minimize futile LT
4. Ongoing assessment and refinement will certainly be necessary to assure intentof the policy actually results in improved outcomes
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Faculty, Planner and AASLD Staff Disclosures This live educational activity has been planned in accordance with AASLD and ACCME Standards of Commercial Support by members of the AASLD/ILTS Transplant Course faculty and the following planning committees: Surgery and Liver Transplantation Committee, ILTS Transplant Committee, Scientific Program Committee, and the Governing Board. As an accredited provider, AASLD requires individuals involved in the planning of continuing medical education (CME) activities to disclose all financial relationships, including those of their spouse or partner, with a commercial interest within the past 12 months. A commercial interest is defined as any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. All conflicts of interest are resolved prior to participation. Statement on off-label and investigational use: Speakers are asked to make a reasonable effort to identify during their presentation any discussion of off-label or investigative use or application of a product or device. Financial disclosures will appear at the beginning of each session and are provided below:
AASLD/ILTS Transplant Course Faculty Disclosures Vatche Agopian Nothing to Disclose Ramon Bataller Nothing to Disclose Francois Durand Consulting: Gilead James Findlay Nothing to Disclose Yuri Genyk Consulting: Baxter Julie Heimbach Nothing to Disclose Roberto Hernandez-Alejandro Nothing to Disclose Constantine Karvellas Consulting: Mallinckrodt Pharmaceuticals Jennifer C. Lai Consulting: Axcella Health, Inc
381
Mitra Nadim Nothing to Disclose Catherine Paugam-Burtz Disclosures were not provided Elizabeth Pomfret Nothing to Disclose Sanjiv Saigal Disclosures were not provided Monika Sarkar Grant/Research Support: Zydus Pharmaceuticals Ram Subramanian Nothing to Disclose Lisa VanWagner Grant/Research Support: AMRA Medical, Gore Medical Speaking and Teaching: Salix Pharmaceuticals, Gore Medical Carmen Vinaixa Nothing to Disclose Kymberly Watt Stock Shareholder: Madrigal, Arbutus, BMS, Viking
Planner Disclosures Deniz Balci (ILTS Education Committee) Stock Shareholder: Livervision LTD, UK Meena Bansal (Governing Board and Scientific Program Committee) Data Safety Monitoring Board for Industry or Commercial Enterprise: TREAT Consortium (NIH; not commercial entity) Research Grants: Paid to institution: NIH R01 Scientific Consultant/Advisor to Industry or Commercial Enterprise, including Development of Educational Presentations: Kinetix Group; Boehringer-Ingelheim Alex Befeler (Scientific Program Committee) Stock/Stock Options with Relevant Pharmaceutical or Biotechnology Companies: Amgen long term stockholder (independently managed by CPA), Gilead long term stockholder (independently managed by CPA) Research Grants: mallinckrodt, Salix, Sillajen
382
Marina Berenguer (ILTS Education Committee) Advisory Committee or Review Panel: Gilead, Intercept, Abbvie Grant/Research Support: Gilead Speaking and Teaching: Astellas
Jorge Bezerra (Governing Board and Scientific Program Committee) Research Grants: Gilead; Shyer
Raymond Chung (Governing Board and Scientific Program Committee) Data Safety Monitoring Board for Industry or Commercial Enterprise: DSMB Alnylam Research Grants: Gilead Sciences. Abbvie, Boehringer Ingelheim, BMS, Roche, Janssen, Merck, Kaleido, Synlogic
Laurie DeLeve (Governing Board) Scientific Consultant/Advisor to Industry or Commercial Enterprise, including Development of Educational Presentations: Abbvie, Pfizer, Daiichi Sankyo, Boehringer-Ingelheim Intellectual Property Rights (Patents, Royalties, Licensing fees): 2017-230-01 US no. 62/544,589 End-organ selective MMP inhibition enhances bone marrow progenitor cell recruitment, COMPOSITIONS AND METHODS FOR AMELIORATING TISSUE INJURY, ENHANCING LIVER REGENERATION AND STEM CELL THERAPIES -(sole inventor) - Applicant: University of Southern California, GBC ref.: 6177.132445PCT
Lorna Dove (Surgery and Liver Transplantation Committee) Company: Independent Contractor: Projects in Knowledge
Bijan Eghtesad (Surgery and Liver Transplantation Committee) Research Grants: Sanofi
Michael Fried (Governing Board and Scientific Program Committee) Research Grants: AbbVie, BMS, Gilead, Merck, National Institutes of Health Scientific Consultant/Advisor to Industry or Commercial Enterprise, including Development of Educational Presentations: AbbVie, BMS, Merck, TARGET PharmaSolutions (All uncompensated) Stock/Stock Options with Relevant Pharmaceutical or Biotechnology Companies: TARGET PharmaSolutions (Maintained in independent blind trust)
Katryn Furuya (Surgery and Liver Transplantation Committee) Nothing to Disclose
David Gerber (Surgery and Liver Transplantation Committee) Scientific Consultant/Advisor to Industry or Commercial Enterprise, including Development of Educational Presentations: Organova, Inc, Medtronic, Inc.
Roberto Hernandez-Alejandro (ILTS Education Committee) Nothing to Disclose
Moira Hilscher (Surgery and Liver Transplantation Committee) Disclosures were not provided
383
Patrick Horne (Scientific Program Committee) Scientific Consultant/Advisor to Industry or Commercial Enterprise, including Development of Educational Presentations: Abbvie, Gilead, Intercept
Simon Horslen (Surgery and Liver Transplantation Committee) Research Grants: Shire
Manhal Izzy (ILTS Education Committee) Nothing to Disclose
Dong Jiahong (ILTS Education Committee) Disclosures were not provided
John Lake (Governing Board) Research Grants: CymbaBay, Data Safety Monitoring Board for Industry or Commercial Enterprise: Intercept DSMB Scientific Consultant/Advisor to Industry or Commercial Enterprise, including Development of Educational Presentations: SRTR
Josh Levitsky (Surgery and Liver Transplantation Committee) Commercial Speaker's Bureau: Gilead Scientific Consultant/Advisor to Industry or Commercial Enterprise, including Development of Educational Presentations: Novartis, Transplant Genomics Incorporated Research Grants: Novartis
Bruce Luxon (Governing Board) Data Safety Monitoring Board for Industry or Commercial Enterprise: DSMB for Baxalta; DSMB for Sparks (for treatment of Hemophilia) Leadership in related society: Board, Committee, Journal: Research Committee member for the ACG
John Magee (Surgery and Liver Transplantation Committee and Scientific Program Committee) Nothing to Disclose
Harmeet Malhi (Scientific Program Committee) Research Grants: NIH R01 NIH U01
Nancy Man (ILTS Education Committee) Nothing to Disclose
Lopa Mishra (Governing Board) Research Grants: NIH
David Mulligan (Surgery and Liver Transplantation Committee and Governing Board) Nothing to Disclose
Lauren Myers (Surgery and Liver Transplantation Committee) Disclosures were not provided
384
Mitra Nadim (ILTS Education Committee) Nothing to Disclose
Catherine Paugam-Burtz (ILTS Education Committee) Disclosures were not provided
Henrik Petrowsky (ILTS Education Committee) Nothing to Disclose
K. Gautham Reddy (Scientific Program Committee)Research Grants: CymaBay; Genfit; Intercept; Target PharmaSolutions; Arrowhead; Gilead; Durect;Commercial Speaker's Bureau: Intercept, DovaLeadership in related society: Board, Committee, Journal: Member, Training Committee: AmericanCollege of GastoneterologyScientific Consultant/Advisor to Industry or Commercial Enterprise, including Development of EducationalPresentations: Intercept
John Renz (Surgery and Liver Transplantation Committee) Disclosures were not provided
Sanjiv Saigal (ILTS Education Committee) Disclosures were not provided
Nazia Selzner (ILTS Education Committee) Nothing to Disclose
Ronald Sokol (Governing Board) Research Grants: Paid to institution: Lumena/Shire; Albireo Scientific Consultant/Advisor to Industry or Commercial Enterprise, including Development of Educational Presentations: Alexion; Albireo; Retrophin; Shire; Mirum
Grace Su (Scientific Program Committee) Intellectual Property Rights (Patents, Royalties, Licensing fees): Patent on Image analysis and Morphomics Leadership in related society: Board, Committee, Journal: Member, Clinical Guidelines Committee, AGA; Company Employee, Officer, Director : My husband and son have equity interest in Applied Morphomics and Prenovo.
Timucin Taner (Surgery and Liver Transplantation Committee) Nothing to Disclose
Norah Terrault (Governing Board) Scientific Consultant/Advisor to Industry or Commercial Enterprise, including Development of Educational Presentations: Advisory Committees or Review Panels: Dova Pharmaceuticals Research Grants: Grant/Research Support: AbbVie, Gilead, BMS, Merck
Jason Vanatta (ILTS Education Committee) Nothing to Disclose
385
Kymberly Watt (Scientific Program Committee) Expert testimony: Intercept - site- PI Gilead - site PI, co-I Conatus - site co-I Novartis - previous site PI, co author study subanalysis Pfizer- site co-I (all multicenter study related) Stock/Stock Options with Relevant Pharmaceutical or Biotechnology Companies: BMS; Arbutus; Madrigal; Viking
AASLD Staff Disclosures
Amy D'Amato Nothing to Disclose
Greg Bologna Nothing to Disclose
Katie Duggan Nothing to Disclose
Julie Deal Nothing to Disclose
Stephanie Graham Nothing to Disclose
Stephanie Grimsby Nothing to Disclose
Jessica Jessop Nothing to Disclose
Janeil C. Klett Nothing to Disclose
John Lingerfelt Nothing to Disclose
Julia Merrill Nothing to Disclose
Bette Anne Preston Nothing to Disclose
Denise Seise Nothing to Disclose
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