Evidence map›Paper›PMID 32532991›Full record

Trial reportNature communications2020

A nonrandomized open-label phase 2 trial of nonischemic heart preservation for human heart transplantation.

Johan Nilsson, Victoria Jernryd, Guangqi Qin, Audrius Paskevicius, Carsten Metzsch, Trygve Sjöberg, Stig Steen

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Nature communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 57 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 2 pooled it
12.1field-weighted citation impact, top 1% of its field
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.

NCT03150147 nacompletednot on this map

A Randomized Controlled Trial Comparing Non-ischemic Hypothermic Cardioplegic Perfusion to Ischemic Cold Static Preservation of Donor Hearts in Adult Cardiac Transplantation

TypeinterventionalSponsorRegion SkaneRan2017 to 2020Enrolled47ConditionsTransplant, Failure, HeartArmsNon-ischemic preservation, Ischemic cold static storage
NCT04066127 naenrolling by invitationnot on this map

A Randomized Controlled Trial Comparing a New State-of-the-art Non Ischemic Heart Preservation Method With the Standard Ischemic Cold Static Storage Method of Donor Hearts in Adult Heart Transplantation

TypeinterventionalSponsorRegion SkaneRan2020 to 2026Enrolled66ConditionsTransplant, Failure, HeartArmsNon-ischemic heart preservation (NIHP), Standard ischemic cold static storage (SCS)
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 2 syntheses or guidelines pooled it, 121 citations in OpenAlex.

  1. Pooled it
  2. Machine Perfusion for Human Heart Preservation: A Systematic Review.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Pooled it
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Technical challenges and prospects for ex vivo heart perfusion: a republication of the review published in Japanese journal of artificial organs.Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs · 2026
    Review
  10. Review
  11. Review
  12. Effects of cooling on pig heart excitation and contraction.Frontiers in cardiovascular medicine · 2026
    Article
  13. New Perfusion and Preservation Strategies for Donor Hearts.European surgical research. Europaische chirurgische Forschung. Recherches chirurgicales europeennes · 2026
    Review
  14. Improved Rat Heart Preservation Using High-Pressure Gaseous Perfusion with Oxygen-Xenon Mixture.Pathophysiology : the official journal of the International Society for Pathophysiology · 2025
    Article
  15. Anti-Icing Organogel Enables Quasi-Homogeneous Supercooling Preservation of Mouse Hearts.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
    Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review
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

7 authors at 1 institution in 1 country.

Johan NilssonDepartment of Clinical Sciences Lund, Cardiothoracic Surgery, Lund University and Skane University Hospital, Lund, Sweden. johan.nilsson@med.lu.se.ORCID http://orcid.org/0000-0001-6860-6090
Victoria JernrydDepartment of Clinical Sciences Lund, Cardiothoracic Surgery, Lund University and Skane University Hospital, Lund, Sweden.
Guangqi QinDepartment of Clinical Sciences Lund, Cardiothoracic Surgery, Lund University and Skane University Hospital, Lund, Sweden.ORCID http://orcid.org/0000-0002-3524-2013
Audrius PaskeviciusDepartment of Clinical Sciences Lund, Cardiothoracic Surgery, Lund University and Skane University Hospital, Lund, Sweden.
Carsten MetzschDepartment of Clinical Sciences Lund, Cardiothoracic Surgery, Lund University and Skane University Hospital, Lund, Sweden.
Trygve SjöbergDepartment of Clinical Sciences Lund, Cardiothoracic Surgery, Lund University and Skane University Hospital, Lund, Sweden.
Stig SteenDepartment of Clinical Sciences Lund, Cardiothoracic Surgery, Lund University and Skane University Hospital, Lund, Sweden.
Lund University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pre-clinical heart transplantation studies have shown that ex vivo non-ischemic heart preservation (NIHP) can be safely used for 24 h. Here we perform a prospective, open-label, non-randomized phase II study comparing NIHP to static cold preservation (SCS), the current standard for adult heart transplantation. All adult recipients on waiting lists for heart transplantation were included in the study, unless they met any exclusion criteria. The same standard acceptance criteria for donor hearts were used in both study arms. NIHP was scheduled in advance based on availability of device and trained team members. The primary endpoint was a composite of survival free of severe primary graft dysfunction, free of ECMO use within 7 days, and free of acute cellular rejection ≥2R within 180 days. Secondary endpoints were I/R-tissue injury, immediate graft function, and adverse events. Of the 31 eligible patients, six were assigned to NIHP and 25 to SCS. The median preservation time was 223 min (IQR, 202-263) for NIHP and 194 min (IQR, 164-223) for SCS. Over the first six months, all of the patients assigned to NIHP achieved event-free survival, compared with 18 of those assigned to SCS (Kaplan-Meier estimate of event free survival 72.0% [95% CI 50.0-86.0%]). CK-MB assessed 6 ± 2 h after ending perfusion was 76 (IQR, 50-101) ng/mL for NIHP compared with 138 (IQR, 72-198) ng/mL for SCS. Four deaths within six months after transplantation and three cardiac-related adverse events were reported in the SCS group compared with no deaths or cardiac-related adverse events in the NIHP group. This first-in-human study shows the feasibility and safety of NIHP for clinical use in heart transplantation. ClinicalTrial.gov, number NCT03150147.

Indexed as

Non-Randomized Controlled Trials as TopicAdultAgedCryopreservationFemaleGraft RejectionHeart TransplantationHumansKaplan-Meier EstimateMaleMiddle AgedOrgan PreservationOutcome Assessment, Health CarePerfusionProspective StudiesTime Factors

Identifiers

PMID32532991
PMCPMC7293246
OpenAlexW3035606256

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.