Evidence map›Paper›PMID 39133179›Full record

ArticleEuropean journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery2024

First-in-men experience with a novel frozen elephant trunk prosthesis featuring an endovascular side branch for left subclavian artery connection.

Sandra Folkmann, Zsuzsanna Arnold, Daniela Geisler, Verena Lenz, David Miosga, Marieluise Harrer, Hubert Trnka, Rene Eller, Thomas Aschacher, Bernhard Winkler and 3 more

Abstract read
In one paragraph

Article in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. RapidlinkAnnals of cardiothoracic surgery · 2025
    Review
  6. Review
  7. Article
  8. Management of Non-A Non-B Aortic Dissection: A Narrative Review.Journal of cardiovascular development and disease · 2024
    Review
  9. 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

13 authors.

Sandra FolkmannDepartment of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria.
Zsuzsanna ArnoldDepartment of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria.
Daniela GeislerDepartment of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria.
Verena LenzDepartment of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria.
David MiosgaDepartment of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria.
Marieluise HarrerDepartment of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria.
Hubert TrnkaDepartment of Radiology and Interventional Radiology, Clinic Floridsdorf, Vienna, Austria.
Rene EllerDepartment of Radiology and Interventional Radiology, Clinic Floridsdorf, Vienna, Austria.
Thomas AschacherDepartment of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria.
Bernhard WinklerDepartment of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria.
Martin CzernyDepartment of Cardiac and Vascular Surgery, University of Freiburg, Freiburg, Germany.ORCID 0000-0003-4766-9775
Gabriel WeissDepartment of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria.
Martin GrabenwögerDepartment of Cardiovascular Surgery, Clinic Floridsdorf, Vienna, Austria.ORCID 0000-0003-0938-0268

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe objective of this study was to enhance the efficiency of aortic arch replacement through the development of a novel frozen elephant trunk (FET) prosthesis with an endovascular side branch for left subclavian artery (LSA) connection. After successful pre-clinical testing, the feasibility and safety of implementing this innovative prosthesis in human subjects were investigated.

methodsBetween September 2020 and September 2021, 4 patients (mean age 67) with conditions such as penetrating ulcer, non A-non B aortic dissection and chronic arch aneurysm underwent surgery utilizing the customized device. Surgeries were performed under high moderate hypothermia (27°C), employing bilateral selective antegrade cerebral perfusion (SACP) and distal aortic perfusion. Anastomosis of the FET prosthesis with the aortic arch occurred in zone 1, followed by separate reimplantation of the left common carotid artery and the brachiocephalic artery.

resultsAll patients were discharged in good clinical condition. The mean aortic cross-clamp, antegrade selective cerebral perfusion and distal aortic perfusion times were 111, 71 and 31 min, respectively. Endovascular extension of the side branch for the LSA was required in all cases to prevent endoleak formation. One patient received a stent graft extension at the end of the operation, while 2 others underwent the procedure during their hospital stay. One patient was diagnosed with an endoleak at the first follow-up after 3 months, and endoleak sealing was achieved via the brachial artery with an extension stent graft.

conclusionsPreliminary clinical outcomes suggest that the newly designed FET prosthesis shows promise in simplifying total arch replacement. These initial findings provide a foundation for planned clinical studies to further assess the effectiveness of this modified surgical hybrid graft, with particular attention to the length and diameter of the LSA sidearm.

Indexed as

Blood Vessel ProsthesisBlood Vessel Prosthesis ImplantationEndovascular ProceduresSubclavian ArteryAgedAorta, ThoracicAortic Aneurysm, ThoracicAortic DissectionFemaleHumansMaleMiddle AgedProsthesis DesignAortic diseaseCerebral perfusion techniqueDistal aortic perfusionFrozen elephant trunkLeft subclavian artery side branch

Identifiers

PMID39133179
PMCPMC11341124

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Registered trials

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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.