Evidence map›Paper›PMID 41660404›Full record

ArticleStructural heart : the journal of the Heart Team2026

Efficacy and Safety of Electrosurgical Balloon-Assisted Leaflet Modification to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement.

Mostafa Naguib, Chantal Y Asselin, Robert Kipperman, Leo Marcoff, Kostantinos P Koulogiannis, Linda Gillam, Benjamin van Boxtel, John Brown, Philippe Généreux, Gennaro Giustino

Abstract read
In one paragraph

Article in Structural heart : the journal of the Heart Team, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

10 authors.

Mostafa NaguibGagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, USA.
Chantal Y AsselinGagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, USA.
Robert KippermanGagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, USA.
Leo MarcoffGagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, USA.
Kostantinos P KoulogiannisGagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, USA.
Linda GillamGagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, USA.
Benjamin van BoxtelGagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, USA.
John BrownGagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, USA.
Philippe GénéreuxGagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, USA.
Gennaro GiustinoGagnon Cardiovascular Institute, Atlantic Health System, Morristown, New Jersey, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Coronary obstruction (CO) during transcatheter aortic valve replacement (TAVR) is associated with significant morbidity and mortality. UNICORN (Undermining Iatrogenic Coronary Obstruction with Radiofrequency Needle) is a novel technique designed to prevent CO by performing electrosurgical leaflet traversal followed by intraleaflet valve implantation or complete leaflet laceration accomplished using noncompliant balloons. However, its efficacy and safety are not well established. Methods: We retrospectively reviewed all patients who underwent UNICORN-assisted TAVR for both valve-in-valve and native valve procedures at a single high-volume center between September 2024 and September 2025. Patients were selected based on preprocedural cardiac computed tomography demonstrating high anatomic risk for CO. In all cases, the target leaflet was traversed using an electrified 0.014″ wire, followed by serial noncompliant balloon dilatations of the leaflet to either achieve complete leaflet laceration or to accommodate for intra-leaflet valve implantation. Balloon-expandable valves were used in all procedures. Results: Fifteen patients underwent UNICORN-assisted TAVR. Twelve were valve-in-valve cases, and 3 involved native valves. The right coronary cusp was targeted in 11 procedures and the left in 6, including 2 requiring bileaflet modification. Technical success was achieved in all cases (100%). Procedural success was achieved in 93.3%. One patient developed acute CO due to skirt-related occlusion after a high implant in a degenerated self-expanding valve, requiring single-vessel coronary artery bypass surgery. No bailout coronary stenting was required. There were no in-hospital deaths or disabling strokes. All patients were alive at 30-day follow-up. Conclusions: In this single-center experience, UNICORN appears technically reproducible, effective in preventing CO, and safe in TAVR patients at high-risk for CO.

Indexed as

Coronary obstructionElectrosurgical traversalLeaflet modificationMultidetector computed tomographyProcedural safetyTranscatheter aortic valve replacement (TAVR)UNICORN techniqueValve-in-valve

Identifiers

PMID41660404
PMCPMC12878699

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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.