Evidence map›Paper›PMID 34222469›Full record

ArticleBioMed research international2021

Preclinical Assessment of a Novel Conformable Foam-Based Left Atrial Appendage Closure Device.

Robert J Sommer, Ronald Lamport, David Melanson, Carol Devellian, Andy Levine, Christopher M Cain, Aaron V Kaplan, William A Gray

Open access · hybridAbstract read
In one paragraph

Article in BioMed research international, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.3field-weighted citation impact, top 19% 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.

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

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
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  5. Review
  6. Foam-based Left Atrial Appendage Closure (CLAAS) Device: Evaluation in a Chronic Canine Model.Journal of the Society for Cardiovascular Angiography & Interventions
    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

8 authors at 3 institutions in 1 country.

Robert J SommerColumbia University Medical Center, NY, NY, USA.
Ronald LamportConformal Medical, Inc., Nashua, NH, USA.
David MelansonConformal Medical, Inc., Nashua, NH, USA.ORCID https://orcid.org/0000-0003-0023-7000
Carol DevellianConformal Medical, Inc., Nashua, NH, USA.ORCID https://orcid.org/0000-0003-4308-1405
Andy LevineConformal Medical, Inc., Nashua, NH, USA.
Christopher M CainConformal Medical, Inc., Nashua, NH, USA.
Aaron V KaplanConformal Medical, Inc., Nashua, NH, USA.
William A GrayLankenau Heart Institute, Wynnewood, PA, USA.ORCID https://orcid.org/0000-0003-4676-2839
Columbia University Irving Medical Center · USDartmouth–Hitchcock Medical Center · USLankenau Heart Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeft atrial appendage (LAA) occlusion has been established as an alternative to systemic anticoagulation for stroke prevention in patients with atrial fibrillation; however, limitations of current devices have slowed adoption. We present preclinical evaluations of a novel device, the Conformal Left Atrial Appendage Seal (CLAAS).

methodsAn in vitro assessment of conformability was conducted to evaluate the two CLAAS devices (regular 27 mm and large 35 mm) and a Watchman 2.5 (27 mm). Devices were placed within silicone tubes and compressed in a vise submerged in a water bath at 37°C. Changes in device diameter and visual seal were noted. Acute (

resultsConformability bench tests demonstrated that the regular CLAAS implant was able to seal oval orifices from 20 × 30 mm to 15 × 33 mm and the large from 30 × 35 mm to 20 × 40 mm. As the CLAAS implant was compressed in the minor diameter, it increased in the major diameter, thereby filling the oval space, whereas the Watchman 2.5 showed gaps and maintained its round configuration when compressed in one direction. Seven devices were successfully implanted in the canine model with complete seal without thrombus. Histologic examination showed complete neointima covering with minimal inflammation at 60 days.

conclusionsPreclinical testing demonstrated the conformability of the CLAAS implant and its ability to seal the LAA. Clinical studies are ongoing to characterize the utility of the CLAAS implant in the treatment of patients with atrial fibrillation.

Indexed as

Cardiac Surgical ProceduresSeptal Occluder DeviceAnimalsAtrial AppendageAtrial FibrillationCardiac CatheterizationDogsEchocardiographyEquipment DesignInflammationMaleNeointimaProsthesis DesignSiliconesStrokeTreatment OutcomeSilicones

Identifiers

PMID34222469
PMCPMC8213491
OpenAlexW3170001803

What OpenQuestion holds

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LicenceCC BY
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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.