The Need to Define Treatment Goals for Protein-Losing Enteropathy in Fontan Care and Research

(1) would have been overestimated because the effect on the surrogate, although statistically significant, was not of sufficient size and duration (mean change in albumin level 1.50 ± 1.03 g/dl, need for several procedures, duration of 4 months) in those patients with a treatment effect to predict a...

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Published inJournal of the American College of Cardiology Vol. 70; no. 20; pp. 2602 - 2603
Main Authors ten Dam, Kim, Germund, Ingo, Khalil, Markus, Helbing, Willem A., Sreeram, Narayanswami, Udink ten Cate, Floris E.A.
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 14.11.2017
Elsevier Limited
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Summary:(1) would have been overestimated because the effect on the surrogate, although statistically significant, was not of sufficient size and duration (mean change in albumin level 1.50 ± 1.03 g/dl, need for several procedures, duration of 4 months) in those patients with a treatment effect to predict a meaningful alteration in clinical outcome (1,3). [...]the results of liver lymphatic embolization should be interpreted with caution, because this surrogate endpoint can yield misleading conclusions. [...]the Central Illustration and Table 3 (1) are somewhat confusing. [...]the duodenum as the site of lymph leakage in Fontan patients with PLE has not been reported previously (1).
Bibliography:SourceType-Other Sources-1
content type line 63
ObjectType-Correspondence-1
ObjectType-Commentary-2
ISSN:0735-1097
1558-3597
DOI:10.1016/j.jacc.2017.07.800