Liver Transplantation and Hepatitis C A Clinical Update Joseph S. Galati, M.D Medical Director St. Luke’s Texas Liver Institute

Liver Transplant Evaluation Goals Systematic team approach Fairness among patients Protect a scarce resource Establish a relationship Assure patient understanding Meet the patient’s support system Improve outcome of liver transplantation!

Systematic team approach

Fairness among patients

Protect a scarce resource

Establish a relationship

Assure patient understanding

Meet the patient’s support system

Improve outcome of liver transplantation!

Liver Transplant Evaluation RISK BENEFIT

Components of the Evaluation Liver Transplant Surgery Medical evaluation Psycho-social Evaluation Financial Evaluation Nutritional Evaluation Radiology Pharmacy

Liver Transplant Evaluation Transplant Nurse Coordinator Medical Evaluation Financial evaluation Psychosocial evaluation

Evaluation for Liver Transplantation What is the cause of the patient’s liver disease? Does the patient need a liver transplant evaluation at this time? Is the patient a good candidate for liver transplantation?

What is the cause of the patient’s liver disease?

Does the patient need a liver transplant evaluation at this time?

Is the patient a good candidate for liver transplantation?

Medical Evaluation for Liver Transplantation Severity of Liver Disease Absolute indications: Hepatic synthetic dysfunction Peritonitis Hepatorenal syndrome Fulminant hepatic failure Relative indications : Refractory encephalopathy Refractory variceal bleeding Refractory ascites Refractory pruritus Disabling fatigue HCC

Absolute indications:

Hepatic synthetic dysfunction

Peritonitis

Hepatorenal syndrome

Fulminant hepatic failure

Relative indications :

Refractory encephalopathy

Refractory variceal bleeding

Refractory ascites

Refractory pruritus

Disabling fatigue

HCC

Medical Evaluation Assessment of Extrahepatic Diseases Cardiac evaluation: age, risk factors, symptoms Pulmonary evaluation: risk factors, symptoms Gastrointestinal evaluation: age, risk factors, symptoms Renal evaluation: abnormal renal function Neuro-psychiatric evaluation: ? encephalopathy Cancer assessment: extent of current disease, screening

Cardiac evaluation: age, risk factors, symptoms

Pulmonary evaluation: risk factors, symptoms

Gastrointestinal evaluation: age, risk factors, symptoms

Renal evaluation: abnormal renal function

Neuro-psychiatric evaluation: ? encephalopathy

Cancer assessment: extent of current disease, screening

Evaluation for Liver Transplantation Surgical Assessment Portal vein thrombosis Prior surgeries Obesity Surgical risk Assess suitable size of donor liver

Portal vein thrombosis

Prior surgeries

Obesity

Surgical risk

Assess suitable size of donor liver

Psycho-Social Evaluation Social Worker Social support Medical compliance Sobriety Psychiatrist Psychiatric disorders Personality disorders

Social Worker

Social support

Medical compliance

Sobriety

Psychiatrist

Psychiatric disorders

Personality disorders

Evaluation for Liver Transplantation Assessment of Compliance Clinic visits Instructions Medications Sobriety contract Diet

Clinic visits

Instructions

Medications

Sobriety contract

Diet

Patients with History of Substance Abuse Abstinence for at least 6 months Assess need for sobriety contract Random alcohol and drug screens Watch for narcotics abuse potential Appropriate medical work up based on nature of substance abuse history

Abstinence for at least 6 months

Assess need for sobriety contract

Random alcohol and drug screens

Watch for narcotics abuse potential

Appropriate medical work up based on nature of substance abuse history

Psychosocial Assessment Sobriety contract: AA attendance x 6 mo Random blood alcohol levels Random urine drug screens Continued sobriety I will not drink I will not smoke pot I will take my pills X___________

Sobriety contract:

AA attendance x 6 mo

Random blood alcohol levels

Random urine drug screens

Continued sobriety

Survival After Liver Transplantation By Pre-Transplant Length of Abstinence

Evaluation for Liver Transplantation Financial Assessment Pre-approval by patients’ health insurance company for the evaluation and the transplant. Assess patients’ support system resources for the expenses of travel and stay during the peri-operative period Assess patients’ financial responsibility towards all hospital bills and post transplant medications

Pre-approval by patients’ health insurance company for the evaluation and the transplant.

Assess patients’ support system resources for the expenses of travel and stay during the peri-operative period

Assess patients’ financial responsibility towards all hospital bills and post transplant medications

Primary Biliary Cirrhosis When to refer to OLT ? Bilirubin rising or approaching 6 mg/dl Child-Pugh class B or C cirrhosis First variceal bleed Refractory pruritus (with good function) Disabling fatigue

Bilirubin rising or approaching 6 mg/dl

Child-Pugh class B or C cirrhosis

First variceal bleed

Refractory pruritus (with good function)

Disabling fatigue

Primary Sclerosing Cholangitis: When to refer to transplant ? Predictor models not as reliable Child-Pugh class B or C cirrhosis Recurrent cholangitis Refractory pruritus Cholangiocarcinoma?

Predictor models not as reliable

Child-Pugh class B or C cirrhosis

Recurrent cholangitis

Refractory pruritus

Cholangiocarcinoma?

Viral Hepatitis and Liver Transplant Hepatitis C: 100% serologic recurrence 60-70% histologic recurrence 10-15% severe recurrence Hepatitis B: With no HBIG = 90 % histologic recurrence With HBIG 30 % histologic recurrence With lamivudine + HBIG = ?

Hepatitis C:

100% serologic recurrence

60-70% histologic recurrence

10-15% severe recurrence

Hepatitis B:

With no HBIG = 90 % histologic recurrence

With HBIG 30 % histologic recurrence

With lamivudine + HBIG = ?

Liver Transplant Evaluation Acceptable candidate P lace on waiting list Unacceptable candidate Able to modify negative factors Unable to modify negative factors Reject for liver transplant

On the “List” Status 3: minimum 7 C-P points Status 2b: minimum 10 C-P points Status 1: FHF, children, non-function, HA-T Status 2a: 10 C-P points, plus be in the ICU with the following Variceal hemorrhage (after TIPSS/shunt) Hepatorenal Encephalopathy (despite therapy) Refractory ascites Status 1: FHF, children, non-function, HA-T

Status 3: minimum 7 C-P points

Status 2b: minimum 10 C-P points

Status 1: FHF, children, non-function, HA-T

Status 2a: 10 C-P points, plus be in the ICU with the following

Variceal hemorrhage (after TIPSS/shunt)

Hepatorenal

Encephalopathy (despite therapy)

Refractory ascites

Status 1: FHF, children, non-function, HA-T

Deaths on the Waiting List 1990/1995/2000 This accounts for a 25% death rate on the liver list

Cadaveric Donors, Cadaveric Transplants, and Number on Waiting List Source: Donors from OPTN data as of 9/5/00; transplants from Scientific Registry data as of 9/5/00; snapshot of OPTN waiting list on the last day of each year. Donors Transplants Waiting List at Year’s End

Waiting List Characteristics Liver Registrants in 1999 35% Ages 35-49, 44% Ages 50-64 78% White, 7% Black, 10% Hispanic 51% Blood type O 95% Waiting for first transplant 56% On waiting list for 1 year or more 66% Medical urgency status 3

35% Ages 35-49, 44% Ages 50-64

78% White, 7% Black, 10% Hispanic

51% Blood type O

95% Waiting for first transplant

56% On waiting list for 1 year or more

66% Medical urgency status 3

Liver Graft Survival Rates by Waiting List Status at Transplant Note: Waiting list status for 1-year survival reported for codes 1, 2A, 2B, and 3; 5-year survival reported for codes 1, 2, 3, and 4. Source: Scientific Registry data as of 9/5/00. 1 Year (1998 Cohort) 5 Years (1992-97 Cohort)

So…when is the proper time to refer for transplant?

Never too early