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Expérimentation innovante en
Transplantation Hépatique: ERAS
Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique
Raffaele BRUSTIA
Olivier SCATTON
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INTRODUCTION
ERAS EN TRANSPLANTATION
HEPATIQUE
INDICATEURS/OUTCOMES
CONCLUSION
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INTRODUCTION
ERAS EN TRANSPLANTATION
HEPATIQUE
INDICATEURS/OUTCOMES
CONCLUSION
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L’innovation en santé c’est aussi…
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Ljungqvist JAMA Surgery, 2017
INNOVATION ORGANISATIONNELLE EN CHIRURGIE?
ERAS AND COLORECTAL (656 publications)
ERAS AND LIVER SURGERY (179 publications)
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Evidence-Based Guidelines
• patient education
• goal-directed fluid
management
• decreased use of
unnecessary NG tubes and
drains
• minimal use of opioid
analgesia
• early mobilization
• resumption of oral intake
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WHICH OUTCOMEs IN ERAS?
CRITERE DE JUGEMENT IMPACT EFFET
Durée Hospitalisation ✔ 20-50 %
Taux de complications ✔ 30-60 %
Impact économique ✔ 0-70%
Brustia et al. J Visc Surg 2018
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• ERAS nouveau mode de prise en charge
• Critères de jugement
– Récupération
– Morbidité
– Médico-Eco
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INTRODUCTION
ERAS EN TRANSPLANTATION
HEPATIQUE
INDICATEURS/OUTCOMES
CONCLUSION
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MORBIDIT
E
DUREE
SEJOUR
TRANSPLANTATION HEPATIQUE?
COUTS DE
SANTE
STANDARD
S
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INNOVATION ORGANISATIONNELLE EN TH?
ERAS AND COLORECTAL (656 publications)
ERAS AND LIVER SURGERY (179 publications)
ERAS AND LIVER TRANSPLANTATION (2 publications) - 47%
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Guidelines for Perioperative
Care
for Liver Transplantation 1_preoperative_counselling
2_prehabilitation
3_perioperative_fasting_and_carbohydrate_loading
4_antimicrobial_prophylaxis
5_antithrombotic_anticoagulation_prophylaxis 6_anesthetic_premedication
7_incision
8_portocaval_shunt 9_short_acting_anesth
10_perioperative_analgesia
11_early_extubation
12_abdominal_drainage
13_fluid_blood_managment 14_perioperative_normothermia
15_nasogastric_intubation
16_PONV
17_early_nutrition_supplementation
18_early_mobilisation
19_glycemic_control 20_postoperative_ileus 21_postoperative_education
22_AUDIT
Literature screening n°2271 references => n° 43 full text included
Raffaele Brustia, Olivier Scatton. Systematic review for perioperative care in liver transplantation - Enhanced Recovery After Surgery (ERAS). PROSPERO 2019 CRD42019132798
Dr Monsel – Dr Skurzak
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Expert panel
Mean (SD) 15.7 (7.86)
N=21
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0
10
20
30
40
50
60
70
80
90
100
Round 1
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0 10 20 30 40 50 60 70 80 90
100
ROUND1 ROUND2
Round 2
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A systematic review and meta-analysis64 reported a significant increase in the absolute risk of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients with cirrhosis, compared to those without. Retrospective data found veno-venous bypass, antifibrinolytic medication and pulmonary artery hypertension as risk factors for PE during or early after LT 65,66. To date there is no direct evidence in favour or against thrombotic prophylaxis early after LT. Evidence derived from liver surgery37,67,68 suggest that the use of compressive stockings and intermittent pneumatic compression devices may be effective and safe against DVT. Early ambulation and optimal hydration can be safely recommended as general measures against DVT69, being therefore part of ERAS recommendations. Recommendations There is no evidence in favour or against thrombotic prophylaxis, but compressive stockings and intermittent pneumatic compression devices during LT may be recommended. Evidence level Very Low Recommendation grade Weak
An example = Antithrombotic prophylaxis
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ERAS EN TRANSPLANTATION HEPATIQUE
• Nouveau mode de prise en charge/parcours de soins coordonné
• Quelques études pilotes
• Recommandations en cours
• Méthode d’évaluation?
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INTRODUCTION
ERAS EN TRANSPLANTATION
HEPATIQUE
INDICATEURS/OUTCOMES
CONCLUSION
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WHICH OUTCOMES IN LT? Patient reported outcomes
Recovery Graft dysfunction
Mortality
Brustia R, Dechartres A, Scatton O, HPB 2020
Morbidity CRITERE DE
JUGEMENT
IMPAC
T
Durée
Hospitalisation ✔
Taux de
complications ✔
Impact économique ✔
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DMS après TH: QUEL STANDARD?
4 13 26 33 60
Lee, Korea
Laiz, Spain
Parik, US Uemoto,
JP Muller,
Benchmark*
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RECUPERATION FONCTIONNELLE
HOSPITALISATION
DELAI DE RECUPERATION FONCTIONNELLE
DUREE D’HOSPITALISATION
IMS*
*Indication Médicale de Sortie
Step 1 Exploring functional recovery Discussion with experts
Step 2 Exploratory e-Delphi study Restricted panel
Summary of functional recovery in LT
Step 3 Pilot, field study
Proposal: 10 points - Functional recovery checklist criteria
Consensus based 10 points - Functional recovery checklist criteria
Prospective assessment of the 10 points - functional recovery checklist: strengths and weaknesses
Step 4 Validation e-Delphi study Extended panel
Extended Panel identification via official networks
Restricted Panel identification via networks and snowballing
Proposal: 10 points - Functional recovery checklist criteria
Pragmatic, Consensus based 10 points - Functional recovery checklist criteria
Aim To develop a pragmatic, consensus-based checklist to assess functional recovery after liver transplantation
Design Mixed-method study: (1) literature review and expert discussion to draft first checklist criteria; (2) an exploratory online e-Delphi study with a restricted interdisciplinary panel of experts; (3) a small-scale field study to test the feasibility ; and (4) a validation e-Delphi study with an extended interdisciplinary panel of experts.
Figure 1, Study Design
Literature review of functional recovery
in Liver Surgery
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STEP 1 = Exploring functional recovery
Author Year Study Comparaison N°pt Lap/Open LoS (days) F. recovery
(days) Pain
control Solid food
Mobility Biology No
perfusion
No fever
Wong1 2014 Cohort
ERAS high compliance vs
low compliance
165 L-O 7 5 X x x x x
Jones2 2013 RCT ERAS vs control
91 L * 4 vs 7 * 3 vs 6 x x x x
Dasari3 2015 Cohort ERAS vs control
184 L-O 6 vs 6 5 vs 5 x x x x x
Liang4 2016 RCT ERAS vs
control (Lap.) 187 L * 6 vs 10 * 5 vs 8 x x x x
Ratti5 2016 Cohort ERAS open
vs ERAS lap. vs control (HCC)
207 L-O * 4 vs 6 * 3 vs 5 x x x x x
Wong6 2017 RCT ERAS Open vs
Lap (LLS) 24 L-O
* 4 lap vs 4.5 open
3 vs 3 x x x x x
Pt=patients, RCT=randomized clinical trial, Lap= laparoscopy, LLS=Left Lateral Sectionectomy, y=years, *= significative statistical difference, LoS=length of stay
TABLE 2 Results of the preliminary e-Delphi, n= 9 participants.
Round 1 Round 2
DISCHARGE CRITERIA % agreement % agreement
1 Adequate pain control with oral analgesics 89% 100%
2 Independently mobile 89% 100%
3 Tolerance to solid food 89% 100%
4 Absence of uncontrolled surgical complications 78% 100%
5 No IV perfusion 89% 100%
6 Normal/declining TB, ALT, AST, and a PT > 80% 89% 100%
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Residual Tacrolimus 5<ng/ml<10 on two consecutive controls 78% 100%
8 Compliance with therapeutic education 89% 100%
9 No immunosuppressive-induced adverse effect 67% 100%
10 Normal postoperative imaging 67% 100%
IV=intra venous, TB=total bilirubin, ALT= alanine aminotransferase, AST= aspartate aminotransferase, PT=prothrombin time, IQR=inter quartile range
STEP 2 = Exploring functional recovery
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TABLE 3 General characteristics of the cohort.
Patients N=45 % (n)
RECEIVER
MELD score, median (IQR) 11.5 (8.0-16.5)
Postoperative complications, Clavien-Dindo
I 20% ( 9) II 22% (10) III 9% ( 4) IV 2% ( 1) ICU stay, days, median (IQR) 5.0 (4.0-8.0) PRIMARY OUTCOME Functional recovery, days, median (IQR) 14.0 (11.0-20.0) Hospital stay, days, median (IQR) 18.0 (14.0-21.0) Gap, days, median (IQR) 3.00 (1.00-4.00) Gap, % 14.3 (5.9-23.5) Y=years, BMI=body mass index, MELD=model for end stage liver disease, RBC=red blood cells, LT=liver transplantation, ICU=intensive care unit, IQR=inter quartile range
STEP 3 = Pilot Field study
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STEP 3 = Pilot Field study
TABLE 4 Discharge criteria.
Patients N=45 Fulfilled at discharge % (n)
Completion days, median (IQR)
1 Adequate pain control with oral analgesics 100% (45) 6.0 (3.0-9.0) 2 Independently mobile 100% (45) 7.0 (5.0-10.0) 3 Tolerance to solid food 100% (45) 4.0 (3.0-7.0) 4 Absence of uncontrolled surgical complications 100% (45) 9.0 (5.0-15.0) 5 No IV perfusion 100% (45) 9.0 (6.0-15.0) 6 Normal/declining TB, ALT, AST, and a PT > 80% 100% (45) 5.0 (4.0-8.0) 7 Residual Tacrolimus 5<ng/ml<10 on two consecutive controls 47% (21) 13.0 (9.0-15.0) 8 Compliance with therapeutic education 100% (45) 11.0 (7.0-15.0) 9 No immunosuppressive-induced adverse effect 96% (43) 9.0 (6.0-12.0) 10 Normal postoperative imaging 98% (44) 10.0 (7.0-17.0) IV=intra venous, TB=total bilirubin, ALT= alanine aminotransferase, AST= aspartate aminotransferase, PT=prothrombin time, IQR=inter quartile range
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STEP 4 = Validation e-Delphi study - Extended panel
60
56
66
6
10
128
0 50 100 150 200
Round 3
Round 2
Round 1
Number of panelists
Responders Non responders
14.49.1
GREF2 - ACHBT
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CRITÈRES “PATIENT” 1. Contrôle de la douleur satisfaisant par analgésie orale (EVA < 4/10) 2. Mobilisation indépendante (marche seul sans aide, ou capable de s’habiller seul ou avec assistance minime) et capable de rejoindre le Service de Transplantation en cas de symptômes d’alarme (fièvre, douleur, ictère). 3. Tolérance à l’alimentation per os (autrement dit, le malade est capable de manger une quantité minimale et suffisante pour éviter de devoir le perfuser. Exemple=yaourt, compote, repas léger). 4. Absence de complications chirurgicales majeures ou complications infectieuses non contrôlées. 5. Absence de perfusion.
CRITÈRES “GREFFON”. 6. Diminution de bilirubinémie totale, ASAT, ALAT et Temps de Prothrombine > 80% par rapport aux valeurs avant TH 7. Dosage résiduel du Tacrolimus plasmatique (T0) 5<ug/L<10, sur au moins deux prélèvements consécutifs avant la sortie. 8. Education thérapeutique adaptée au patient, concernant tous les traitements inhérents à la TH (par exemple traitement immunosuppresseur, contrôle de la glycémie, ou traitement par insuline si nécessaire.) 9. Absence d’effets indésirables majeurs du traitement immunosuppresseur. (e.g., insuffisance rénale, surdosage en Tacrolimus, cytopénie). 10. Imagerie de contrôle normale (Echo-Doppler ou Scanner) avant la sortie.
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STEP 4 = Validation e-Delphi study - Extended panel
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
round_1 round_2 round_3
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3 Tolérance à l’alimentation
per os
• autrement dit, le malade est capable de manger
une quantité minimale et suffisante pour éviter de
devoir le perfuser.
• Exemple=yaourt, compote, repas léger.
Tolérance digestive à
l’alimentation
• Une alimentation par voie orale ou entérale est possible
sans entraîner de nausées, reflux, régurgitations ou
vomissements nécessitant de limiter les apports.
• les apports liquidiens par voie orale ou entérale sont
suffisants pour assurer l'équilibre hydro-électrolytique,
sans nécessité de perfusion intraveineuse.
• en cas d'alimentation exclusivement par voie orale, le
patient est capable d'ingérer au moins un repas-type par
jour (comprenant au moins un plat de résistance, ex:
"purée-jambon"); il prend ses repas seul ou, en cas
d'autonomie limitée, une aide à la prise des repas est
possible.
• lorsqu'une nutrition artificielle par voie entérale, nocturne
et/ou diurne, est nécessaire, sa mise en œuvre à domicile
est possible sans délai.
STEP 4 = à propos d’un critère…
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INTRODUCTION
ERAS EN TRANSPLANTATION
HEPATIQUE
INDICATEURS/OUTCOMES
CONCLUSION
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ERAS = nouveau mode de prise en charge
ERAS en TH = recommandations en cours
RECUPERATION FONCTIONNELLE = Critère de
jugement validé
raffaele . brustia @ aphp . fr
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