Evidence map›Paper›PMID 38553812›Full record

Observational studyPediatric transplantation2024

Evaluating threshold for donor fraction cell-free DNA using clinically available assay for rejection in pediatric and adult heart transplantation.

Shriprasad R Deshpande, Steven D Zangwill, Marc E Richmond, Steven J Kindel, Jacob N Schroder, Nunzio Gaglianello, David P Bichell, Mark A Wigger, Kenneth R Knecht, Phillip T Thrush and 7 more

Abstract readObservational Study
In one paragraph

Observational study in Pediatric transplantation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Shriprasad R DeshpandeDivision of Pediatric Cardiology, Children's National Heart Institute, Children's National Hospital, Washington, DC, USA.ORCID 0000-0002-8358-9783
Steven D ZangwillDivision of Cardiology, Phoenix Children's Hospital, Phoenix, Arizona, USA.ORCID 0000-0002-1838-4714
Marc E RichmondDepartment of Pediatrics, Division of Pediatric Cardiology, College of Physicians and Surgeons, Columbia University, New York, New York, USA.
Steven J KindelDivision of Pediatric Cardiology, Department of Pediatrics, Medical College of Wisconsin, Herma Heart Institute, Children's Wisconsin, Milwaukee, Wisconsin, USA.
Jacob N SchroderDivision of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, North Carolina, USA.
Nunzio GaglianelloDivision of Cardiology, Department of Medicine, Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
David P BichellDivision of Pediatric Cardiac Surgery, Department of Surgery, Vanderbilt University, Nashville, Tennessee, USA.
Mark A WiggerDivision of Cardiovascular Medicine, Department of Medicine, Vanderbilt University, Nashville, Tennessee, USA.
Kenneth R KnechtDepartment of Pediatrics, Arkansas Children's Hospital, Little Rock, Arkansas, USA.
Phillip T ThrushDepartment of Cardiology, Lurie Children's Hospital, Chicago, Illinois, USA.
William T MahleDivision of Cardiology, Department of Pediatrics, Emory University, Children's Healthcare of Atlanta, Atlanta, Georgia, USA.ORCID 0000-0003-1065-3972
Paula E NorthDepartment of Pathology, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee, Wisconsin, USA.
Pippa M SimpsonDepartment of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Liyun ZhangDepartment of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Mahua DasguptaDepartment of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Aoy Tomita-MitchellDivision of Pediatric Cardiothoracic Surgery, Department of Surgery, Medical College of Wisconsin, Herma Heart Institute, Milwaukee, Wisconsin, USA.
Michael E MitchellDivision of Pediatric Cardiothoracic Surgery, Department of Surgery, Medical College of Wisconsin, Herma Heart Institute, Children's Wisconsin, Milwaukee, Wisconsin, USA.

Funding

Targeted, Highly Sensitive, Non-Invasive Cardiac Transplant Rejection MonitoringR01HL119747 · NHLBI · MEDICAL COLLEGE OF WISCONSIN · PI MITCHELL, AOY TOMITA, MITCHELL, MICHAEL EDWARD · 2013 to 2017
$3.3M
Natera Inc.NHLBI NIH HHS R01 HL119747NIH HHS 5R01HL119747TAI Diagnostics Inc.
6 · The paper itself

Abstract

backgroundThe aims of the study were to assess the performance of a clinically available cell-free DNA (cfDNA) assay in a large cohort of pediatric and adult heart transplant recipients and to evaluate performance at specific cut points in detection of rejection.

methodsObservational, non-interventional, prospective study enrolled pediatric and adult heart transplant recipients from seven centers. Biopsy-associated plasma samples were used for cfDNA measurements. Pre-determined cut points were tested for analytic performance.

resultsA total of 487 samples from 160 subjects were used for the analysis. There were significant differences for df-cfDNA values between rejection [0.21% (IQR 0.12-0.69)] and healthy samples [0.05% (IQR 0.01-0.14), p < .0001]. The pediatric rejection group had a median df-cfDNA value of 0.93% (IQR 0.28-2.84) compared to 0.09% (IQR 0.04-0.23) for healthy samples, p = .005. Overall negative predictive value was 0.94 while it was 0.99 for pediatric patients. Cut points of 0.13% and 0.15% were tested for various types of rejection profiles and were appropriate to rule out rejection.

conclusionThe study suggests that pediatric patients with rejection show higher levels of circulating df-cfDNA compared to adults and supports the specific cut points for clinical use in pediatric and adult patients with overall acceptable performance.

Indexed as

Cell-Free Nucleic AcidsHeart TransplantationAdultBiomarkersChildGraft RejectionHumansProspective StudiesTissue DonorsBiomarkersCell-Free Nucleic Acidsacute rejectionantibody mediated rejectioncell‐free DNAheart transplantpediatric heart transplantscreeningsurveillance

Identifiers

PMID38553812
PMCPMC10987078

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.