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

ABSTRACT: 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 split-liver 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.

SUBMITTER: Savier E

PROVIDER: S-EPMC9293155 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:AimTo review results of endoscopic treatment for anastomotic biliary strictures after orthotopic liver transplantation (OLT) during an 8-year period.MethodsThis is a retrospective review of all endoscopic retrograde cholangiopancreatographys (ERCPs) performed between May 2006 and June 2014 in deceased OLT recipients with anastomotic stricture at a tertiary care hospital. Patients were divided into 2 groups, according to the type of stent used (multiple plastic or covered self-expandable metal stents), which was chose on a case-by-case basis and their characteristics. The primary outcome was anastomotic stricture resolution rate determined if there was no more than a minimum waist at cholangiography and a 10 mm balloon could easily pass through the anastomosis with no need for further intervention after final stent removal. Secondary outcomes were technical success rate, number or ERCPs required per patient, number of stents placed, stent indwelling, stricture recurrence rate and therapy for recurrent anastomotic biliary stricture (AS). Stricture recurrence was defined as clinical laboratorial and/or imaging evidence of obstruction at the anastomosis level, after it was considered completely treated, requiring subsequent interventional procedure.ResultsA total of 195 post-OLT patients were assessed for eligibility. One hundred and sixty-four (164) patients were diagnosed with anastomotic biliary stricture. ERCP was successfully performed in 157/164 (95.7%) patients with AS, that were treated with either multiple plastic (n = 109) or metallic billiary stents (n = 48). Mean treatment duration, number of procedures and stents required were lower in the metal stent group. Acute pancreatitis was the most common procedure related complication, occurring in 17.1% in the covered self-expandable metal stents (cSEMS) and 4.1% in the multiple plastic stent (MPS) group. Migration was the most frequent stent related complication, observed in 4.3% and 5.5% (cSEMS and MPS respectively). Stricture resolution was achieved in 86.8% in the cSEMS group and in 91% in MPS group. Stricture recurrence after a median follow up of 20 mo was observed in 10 (30.3%) patients in the cSEMS and 7 (7.7%) in the plastic stent group, a statistically significant difference (P = 0.0017). Successful stricture resolution after secondary treatment was achieved in 66.6% and 62.5% of patients respectively in the cSEMS and plastic stents groups.ConclusionMultiple plastic stents are currently the first treatment option for AS in patients with duct-to-duct anastomosis. cSEMS was associated with increased pancreatitis risk and higher recurrence rate.

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

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