Evidence map›Paper›PMID 39284292›Full record

ArticleRespiration; international review of thoracic diseases2025

Lung Tensioning Device Coil Treatment in Patients with Severe Emphysema: A Prospective Safety and Feasibility Trial (EFFORT).

Sharyn A Roodenburg, Karin Klooster, Jorine E Hartman, Konstantina Kontogianni, Judith M Brock, A Susanne Dittrich, Marlies van Dijk, T David Koster, Felix J F Herth, Dirk-Jan Slebos

Abstract readMulticenter Study
In one paragraph

Article in Respiration; international review of thoracic diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Sharyn A RoodenburgDepartment of Pulmonary Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Karin KloosterDepartment of Pulmonary Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Jorine E HartmanDepartment of Pulmonary Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Konstantina KontogianniDepartment of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.
Judith M BrockDepartment of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.
A Susanne DittrichDepartment of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.
Marlies van DijkDepartment of Pulmonary Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
T David KosterDepartment of Pulmonary Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Felix J F HerthDepartment of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.
Dirk-Jan SlebosDepartment of Pulmonary Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCurrently, there is a lack of bronchoscopic lung volume reduction options that do not depend on fissure integrity. Endobronchial coils have been extensively studied to address this need but exhibited variable patient response and have been discontinued. Lung tension device (LTD) coils represent the next-generation coil treatment. This study aimed to evaluate safety, feasibility, and efficacy of LTD-coil treatment.

methodsPatients with advanced emphysema and hyperinflation were enrolled at two European sites. LTD-coils (Free Flow Medical, Fremont, CA, USA) were implanted in the two most destructed lobes, as determined by quantitative CT analysis, in two separate procedures. The primary endpoint was 3-month follow-up after the last treatment.

resultsFourteen patients (50% male, median age 64 years, FEV1 23%predicted, RV 249%predicted) received LTD-coil treatment: 12 received bilateral and 2 unilateral treatment. Six serious respiratory adverse events occurred within the initial 3 months posttreatment, including one device-associated death. Treatment significantly reduced in- and expiratory volume of the treated lobes (-410 [-710, -340], p = 0.004 and -650 [-730, -190] mL, p < 0.001, respectively) and improved quality of life (SGRQ total score -4.6 [-21.0, -2.6], p < 0.001). However, at a group level, no significant improvements in pulmonary function or 6-min walk distance were observed. Responder rates ranged from 18% to 54% for the different endpoints.

conclusionThis first-in-human study shows that the new LTD-coil procedure is feasible with a safety profile comparable to the previous coil treatment. While the treatment effectively reduced lobar volume and modestly improved quality of life up to 3 months' follow-up, at a group level it did not significantly enhance pulmonary function or exercise capacity.

Indexed as

PneumonectomyPulmonary EmphysemaAgedBronchoscopyFeasibility StudiesFemaleForced Expiratory VolumeHumansMaleMiddle AgedProspective StudiesQuality of LifeTomography, X-Ray ComputedTreatment OutcomeBronchoscopic lung volume reductionChronic obstructive pulmonary diseaseCoilsEmphysema

Identifiers

PMID39284292
PMCPMC11731836

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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.