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Georges-Philippe Pageaux CHU Saint Eloi, Pôle digestif [email protected] The Six month Rule When we still need it and when we don’t Alcoholic Liver Disease: the new challenge Rome, October 6 th , 2017

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Georges-Philippe PageauxCHU Saint Eloi, Pôle [email protected]

The Six month RuleWhen we still need it and when we don’t

Alcoholic Liver Disease: the new challengeRome, October 6 th, 2017

GP Pageaux, MD, PhDCHU Saint Eloi, Montpellier, France

I have financial relationships to disclose within the past 12 months relevant to my presentation

Advisory Board, Speaking, Grants: Astellas, Novartis

AND

My presentation does not include/includes discussion of off-label or investigational use

LT for ALD: increasing indication

Liver Transplantation and ALD in France

Rapport ABM 2015

Patients transplanted during the year

2005 2010 2015

Total 1024 1092 1355

Primary ALD 296(29%) 261(24%) 363(27%)

Secondary ALD 8 174 233HCC, HCV, HBV

29.6% 40% 44%

In 2015, 1756 new inscriptions / 47% alcohol

Outline

The 6-month rule as a determinant of transplant can didacy

The 6-month rule as a predictor of alcohol use afte r LT

Post-LT alcohol use as a predictor of graft/patient survival

From the 6-month rule to a thorough psychosocialand substance abuse assessment

an accepted principle or instruction that states the way things are or should be done, and tells you what you are allowed or are not allowed to do

rule

Julapalli VR, Liver Transpl 2005

The 6-month rule may affect referral patterns for L T evaluation

Prioritize the “deserving” patients

J Hepatol 2012 J Hepatol 2016

Veldt BJ, J Hepatol 2002

The medical management of ALD starts with abstinenc efrom alcohol: first step of liver function recovery

The 6-month ruleto avoid unnecessary transplantation

74 pts CP CImprovement = CP B or A66% at 3 and 6 months

In the MELD era, what is the cut-off?

Male, 56 yrs One month later, abstinentAlcoholic cirrhosis, Ascites controlled ascitesAbsence of HE

INR 1.8 1.2Bilirubin 145 µmol/L 87Creatinine 95 µmol/L 78

MELD 21 15

Male, 59 yrs One month later, abstinentAlcoholic cirrhosis, Ascites non controlled ascitesStage 1HE fluctuant

INR 2.5 1.9Bilirubin 216 µmol/L 195Creatinine 95 µmol/L 89

MELD 27 24

Outline

The 6-month rule as a determinant of transplant can didacy

The 6-month rule as a predictor of alcohol use afte r LT

Post-LT alcohol use as a predictor of graft/patient survival

From the 6-month rule to a thorough psychosocialand substance abuse assessment

an accepted principle or instruction that states the way things are or should be done, and tells you what you are allowed or are not allowed to do

rule

The 6-month ruleas a predictor of relapse

DiMartini A, Liver Transpl 2006

Prediction of relapseusing months soberprior to LT

« Longer pre-LT sobriety predictsless risk of alcohol use after LT »

Perney P, Transplant Int 2005

Tandon P, Am J Gastroenterol 2009

PD: problem drinking / > 20g/d F, > 40g/d M

Outline

The 6-month rule as a determinant of transplant can didacy

The 6-month rule as a predictor of alcohol use afte r LT

Post-LT alcohol use as a predictor of graft/patient survival

From the 6-month rule to a thorough psychosocialand substance abuse assessment

an accepted principle or instruction that states the way things are or should be done, and tells you what you are allowed or are not allowed to do

rule

Is it important to predict alcohol use after LT?Alcohol use after LT

DiMartini A, Am J Transplant 2010

Alcohol relapse after LT

208 patients

80% abstinent or minimal6% early onset moderate use6% early onset heavy use8% late onset moderate to heavy

Faure S, J Hepatol 2012

441 patientsmean FU 82 monthsExcessive alcohol use 13%

Is it important to predict alcohol use after LT?

Dumortier J, Am J Gastroenterol 2015

Is it important to predict alcohol use after LT?

Outline

The 6-month rule as a determinant of transplant can didacy

The 6-month rule as a predictor of alcohol use afte r LT

Post-LT alcohol use as a predictor of graft/patient survival

From the 6-month rule to a thorough psychosocialand substance abuse assessment

an accepted principle or instruction that states the way things are or should be done, and tells you what you are allowed or are not allowed to do

rule

High Risk Alcohol Relapse

High Risk Alcohol Relapse

From a single criterion to a more sophisticated eva luation

Who are the relapsers ?Favorable factors We don’t need

The ackowledgment by the patient of his/her alcoholis mThe presence of strong social supportSubstitute activitiesA source of self-esteem or hopeA rehabilitation relationshipAn awareness of the negative consequences of alcohol re lapse

Negative factors We « need »

Preexisting psychotic disordersUnstable character disordersUnremitting multidrug abuseRepeated unsuccessful attempts of rehabilitationSocial isolationYears of heavy drinkingAlcohol dependency

Vaillant GE, Addiction 2003Perney P, Transpl Int 2005DiMartini A, Liver Transpl 2006Pfitzmann R, Liver Transpl 2007Lucey MR, Liver Transpl 2011

Estimating the prognosis for abstinence after LT

No single measure is a reliable prognostic factor for relaps einto harmful drinking after transplantation

The psychosocial assessment by a trained addiction special istdetermines lower and higher risks of relapsing into harmfuldrinking, but does not determine the absolute risk

The severely ill patient who has been drinking recently but h asother favorable prognostic factors with respect to addicti onposes a difficult question for a transplant program

Lucey MR, Liver Transpl 2011

Who does the job?Transplant team or independent addiction specialist

Addolorato G, Alcohol Clin Exp Res 2013

AAU = alcohol addiction unit

Transplantation 2016