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Novel Composite Endpoint for Assessing Outcomes in Liver Transplantation: Arterial and Biliary Complication–Free Survival

Authors :
Joan Fabregat
Josefina Lopez-Dominguez
Olivier Scatton
Emilio Ramos
Alba Cachero
Pierre Rufat
Daniel Azoulay
Claire Goumard
Fabiano Perdigao
Yann De Rycke
Chetana Lim
Eric Savier
Laura Lladó
Geraldine Rousseau
Chady Salloum
Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière]
CHU Pitié-Salpêtrière [AP-HP]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Centre de Recherche Saint-Antoine (CR Saint-Antoine)
Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP]
Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Institute of cardiometabolism and nutrition (ICAN)
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)
Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP)
Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi)
Service de Département de santé publique
Service de Chirurgie Digestive, Hépato-Bilio-pancréatique et Transplantation Hépatique [CHU Pitié-Salpétrière]
Service de Département d'Information Médicale [CHU Pitié-Salpêtrière] (DIM)
Hôpital Paul Brousse
Institut d'Investigació Biomèdica de Bellvitge [Barcelone] (IDIBELL)
Centre de Recherche Saint-Antoine (CRSA)
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)
Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases (ICAN)
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière] (IHU ICAN)
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)
Service de Département de santé publique [CHU Pitié-Salpêtrière]
HAL-SU, Gestionnaire
Source :
Liver Transplantation, Liver Transplantation, Wiley, In press, ⟨10.1002/lt.26269⟩, Liver Transplantation, In press, ⟨10.1002/lt.26269⟩
Publication Year :
2021
Publisher :
HAL CCSD, 2021.

Abstract

International audience; Transplant and patient survival are the validated endpoints to assess the success of liver transplantation (LT). This study evaluates arterial and biliary complication-free survival (ABCFS) as a new metric. ABC, considered as an event, was an arterial or biliary complication of Dindo-Clavien grade ≥III complication dated at the interventional, endoscopic, or surgical treatment required to correct it. ABCFS was defined as the time from the date of LT to the dates of first ABC, death, relisting, or last follow-up (transplant survival is time from LT to repeat LT or death). Following primary whole LT (n = 532), 106 ABCs occurred and 99 (93%) occurred during the first year after LT. An ABC occurring during the first year after LT (overall rate 19%) was an independent factor associated with transplant survival (hazard ratio [HR], 3.17; P < 0.001) and patient survival (HR, 2.7; P = 0.002) in univariate and multivariate analyses. This result was confirmed after extension of the cohort to splitliver graft, donation after circulatory death, or re-LT (n = 658). Data from 2 external cohorts of primary whole LTs (n = 249 and 229, respectively) confirmed that the first-year ABC was an independent prognostic factor for transplant survival but not for patient survival. ABCFS was correlated with transplant and patient survival (ρ = 0.85 [95% CI, 0.78-0.90] and 0.81 [95% CI, 0.71-0.88], respectively). Preoperative factors known to influence 5-year transplant survival influenced ABCFS after 1 year of follow-up. The 1-year ABCFS was indicative of 5-year transplant survival. ABCFS is a reproducible metric to evaluate the results of LT after 1 year of follow-up and could serve as a new endpoint in clinical trials.

Details

Language :
English
ISSN :
15276465 and 15276473
Database :
OpenAIRE
Journal :
Liver Transplantation, Liver Transplantation, Wiley, In press, ⟨10.1002/lt.26269⟩, Liver Transplantation, In press, ⟨10.1002/lt.26269⟩
Accession number :
edsair.doi.dedup.....45cda812afd10c95d062aa4c866eb1d4
Full Text :
https://doi.org/10.1002/lt.26269⟩