Evidence map›Paper›PMID 32083653›Full record

ArticleEuropean journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery2020

Intraoperative localization of cardiac conduction tissue regions using real-time fibre-optic confocal microscopy: first in human trial.

Aditya K Kaza, Abhijit Mondal, Breanna Piekarski, Frank B Sachse, Robert Hitchcock

Registry-linked trialOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03189134 (Utilization of Confocal Microscopy During Cardiac Surgery), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 23% 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.

NCT03189134 phase1completednot on this map

Utilization of Confocal Microscopy During Cardiac Surgery

TypeinterventionalSponsorAditya KazaRan2018 to 2019Enrolled6ConditionsAtrial Septal DefectArmsFluorescite, Cellvizio 100 Series System with Confocal Miniprobes
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. 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

5 authors at 2 institutions in 1 country.

Aditya K KazaDepartment of Cardiac Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
Abhijit MondalDepartment of Cardiac Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
Breanna PiekarskiDepartment of Cardiac Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
Frank B SachseDepartment of Biomedical Engineering, University of Utah, Salt Lake City, UT, USA.
Robert HitchcockDepartment of Biomedical Engineering, University of Utah, Salt Lake City, UT, USA.
Boston Children's Hospital · USUniversity of Utah · US

Funding

Evaluation of Fiberoptic Confocal Microscopy for Pediatric Cardiac SurgeryR01HL135077 · NHLBI · BOSTON CHILDREN'S HOSPITAL · PI HITCHCOCK, ROBERT, KAZA, ADITYA K · 2017 to 2020
$2.0M
Evaluation of Fiberoptic Confocal Microscopy for Pediatric Cardiac SurgeryR56HL128813 · NHLBI · BOSTON CHILDREN'S HOSPITAL · PI HITCHCOCK, ROBERT, KAZA, ADITYA K · 2016 to 2016
$620k
NHLBI NIH HHS R01 HL135077NHLBI NIH HHS R56 HL128813
6 · The paper itself

Abstract

objectivesThe aim of this study was to evaluate the feasibility and safety of fibre-optic confocal microscopy (FCM) using fluorescein sodium dye for the intraoperative location of conduction tissue regions during paediatric heart surgery.

methodsThe pilot study included 6 patients undergoing elective surgery for the closure of isolated secundum atrial septal defect aged 30 days to 21 years. FCM imaging was integrated within the normal intraoperative protocol for atrial septal defect repair. Fluorescein sodium dye was applied on the arrested heart. FCM images were acquired at the atrioventricular node region, sinus node region and right ventricle (RV). Total imaging time was limited to 3 min. Any adverse events related to the study were recorded and analysed. Subjects received standard postoperative care. Trained reviewers (n = 9) classified, de-identified and randomized FCM images (n = 60) recorded from the patients as presenting striated, reticulated or indistinguishable microstructures. The reliability of reviewer agreement was assessed using Fleiss' kappa.

resultsThe FCM imaging instruments were integrated effectively into the cardiac surgery operating room. All adverse events found in the study were deemed expected and not related to FCM imaging. Reticulated myocardial microstructures were found during FCM imaging at atrioventricular node and sinus node regions, while striated microstructures were observed in RV. Reliability of agreement of reviewers classifying the FCM images was high (Fleiss' kappa: 0.822).

conclusionsFCM using fluorescein sodium dye was found to be safe for use during paediatric heart surgery. The study demonstrates the potential for FCM to be effective in identifying conduction tissue regions during congenital heart surgery. CLINICAL TRIAL REGISTRATION NUMBER: NCT03189134.

Indexed as

Cardiac Surgical ProceduresHeart Septal Defects, AtrialChildHeartHumansMicroscopy, ConfocalPilot ProjectsReproducibility of ResultsConduction tissueCongenital heart surgeryIntraoperative confocal imagingPilot studyTissue microstructure

Identifiers

PMID32083653
PMCPMC7594189
OpenAlexW3006694377

What OpenQuestion holds

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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.