Evidence map›Paper›PMID 40008508›Full record

Observational studyJournal of the American Heart Association2025

OPTILOW: A Low-Profile Approach for Implanting Optimus-L Stents in Infants and Children.

Katarzyna Gendera, James R Bentham, Stanimir Georgiev, Mohamed Kasem, Peter Ewert, Jörg Michel, Raymond N Haddad

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of the American Heart Association, 2025. 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

7 authors.

Katarzyna GenderaDepartment of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich Technical University of Munich Munich Germany.ORCID 0000-0001-6228-3550
James R BenthamDepartment of Congenital Cardiology Leeds Teaching Hospitals NHS Trust Leeds UK.ORCID 0000-0003-0559-1316
Stanimir GeorgievDepartment of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich Technical University of Munich Munich Germany.ORCID 0000-0002-6239-8160
Mohamed KasemDepartment of Pediatric Cardiology, Heart Centre of Excellence Al Jalila Children's Speciality Hospital Dubai United Arab Emirates.
Peter EwertDepartment of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich Technical University of Munich Munich Germany.ORCID 0000-0003-0253-1190
Jörg MichelDepartment of Pediatric Cardiology University Children's Hospital Tuebingen Tuebingen Germany.ORCID 0000-0001-8376-4724
Raymond N HaddadM3C-Necker, Necker-Enfants Malades University Hospital, Assistance Publique - Hôpitaux de Paris (AP-HP) Paris France.ORCID 0000-0001-7605-4708

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStent implantation poses challenges in small children due to their limited vessel size and rapid growth. This multicenter study evaluates in vivo efficacy of implanting Optimus-L stents in small patients using a low-profile approach.

methodsWe retrospectively reviewed data from children weighing ≤20 kg with congenital heart stenotic lesions who received Optimus-L stents manually mounted on small-sized balloon catheters (diameter ≤12 mm) using a hand-actuated compression tool and implanted through small-sized sheaths (≤8 Fr) at our institutions between May 2022 and January 2024. Stent performance was assessed.

resultsWe identified 28 patients (67.8% male) with median age and weight of 3.4 years (interquartile range [IQR], 1.5-5.5) and 12.9 kg (IQR, 9.1-16.4). Six (21.4%) were infants, 11 (39.3%) ≤10 kg. Stenotic lesions included 16 branch pulmonary arteries, 9 aortic isthmus, 2 right ventricular outflow tracts, and 1 Glenn anastomosis. Percentage of stenosis was 50% (IQR, 36%-58%). All implantations were successful without complications. The procedures mostly used 7 Fr sheaths for stents on 6, 7, and 8 mm balloons and 8 Fr sheaths for 9, 10, 12 mm balloons. Median stent expansion percentage was 95% (IQR, 90%-96%). Median vessel diameters increased from 4.6 mm (IQR, 3.8-5.1) to 8.8 mm (IQR, 7.5-9.5) (

conclusionsOptimus-L stents can safely treat arterial and venous stenosis in infants and small children via a low-profile approach with good outcomes.

Indexed as

Heart Defects, CongenitalStentsChildChild, PreschoolFemaleHumansInfantMaleProsthesis DesignRetrospective StudiesTreatment Outcomechildrencongenital heart diseaseinfantsinnovationstenttranscatheter interventions

Identifiers

PMID40008508
PMCPMC12132698

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.