Evidence map›Paper›PMID 38755520›Full record

ReviewJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2024

Implantation of a novel insertable cardiac monitor: preliminary multicenter experience in Europe.

S Fareh, S Nardi, L Argenziano, A Diamante, F Scala, C Mandurino, M Magnocavallo, L Poggio, M Scarano, D Gianfrancesco and 9 more

Abstract readMulticenter StudyReview
In one paragraph

Review in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. 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

19 authors.

S FarehDepartment of Cardiology, Hôpital de La Croix Rousse Et Hôpital Lyon Sud, Hospices Civils de Lyon, 103 Gd Rue de La Croix-Rousse, 69004, Lyon, France. samirfareh@yahoo.com.ORCID http://orcid.org/0009-0009-3539-4680
S NardiPineta Grande" Hospital, Castel Volturno, CE, Italy.
L ArgenzianoClinica Sanatrix, Naples, Italy.
A DiamanteCasa Di Cura "Villa Azzurra", Siracusa, Italy.
F ScalaFatebenefratelli Hospital, Naples, Italy.
C MandurinoSantissima Annunziata" Hospital, Taranto, Italy.
M MagnocavalloOspedale Isola Tiberina - Gemelli Isola, Rome, Italy.
L PoggioOspedale Maggiore Di Lodi, Lodi, Italy.
M ScaranoMadonna del Soccorso" Hospital, San Benedetto del Tronto (AP), Italy.
D Gianfrancesco"L. Bonomo" Hospital, Andria, Italy.
F PalmaMons. Dimiccoli" Hospital, Barletta, Italy.
M S SilvettiBambin Gesù" Pediatric Hospital, Rome, Italy.
D PorcelliSan Pietro-Fatebenefratelli Hospital, Rome, Italy.
M RacheliSan Pellegrino Hospital, Castiglione Delle Stiviere (MN), Italy.
M MontoyDepartment of Cardiology, Hôpital de La Croix Rousse Et Hôpital Lyon Sud, Hospices Civils de Lyon, 103 Gd Rue de La Croix-Rousse, 69004, Lyon, France.
P CharlesDepartment of Cardiology, Hôpital de La Croix Rousse Et Hôpital Lyon Sud, Hospices Civils de Lyon, 103 Gd Rue de La Croix-Rousse, 69004, Lyon, France.
M CampariBoston Scientific Italia, Milan, Italy.
S ValsecchiBoston Scientific Italia, Milan, Italy.
C LavalleDepartment of Cardiovascular, Respiratory, NephrologicalAnesthesiological and Geriatric Sciences, "Sapienza" University of Rome, Policlinico Umberto I, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe LUX-Dx™ is a novel insertable cardiac monitor (ICM) introduced into the European market since October 2022. PURPOSE: The aim of this investigation was to provide a comprehensive description of the ICM implantation experience in Europe during its initial year of commercial use.

methodsThe system comprises an incision tool and a single-piece insertion tool pre-loaded with the small ICM. The implantation procedure involves incision, creation of a device pocket, insertion of the ICM, verification of sensing, and incision closure. Patients receive a mobile device with a preloaded App, connecting to their ICM and transmitting data to the management system. Data collected at European centers were analyzed at the time of implantation and before patient discharge.

resultsA total of 368 implantation procedures were conducted across 23 centers. Syncope (235, 64%) and cryptogenic stroke (34, 9%) were the most frequent indications for ICM. Most procedures (338, 92%) were performed in electrophysiology laboratories. All ICMs were successfully implanted in the left parasternal region, oriented at 45° in 323 (88%) patients. Repositioning was necessary after sensing verification in 9 (2%) patients. No procedural complications were reported, with a median time from skin incision to suture of 4 min (25th-75th percentiles 2-7). At implantation, the mean R-wave amplitude was 0.39 ± 0.30 mV and the P-wave visibility was 91 ± 20%. Sensing parameters remained stable until pre-discharge and were not influenced by patient characteristics or indications. Procedural times were fast, exhibited consistency across patient groups, and improved after an initial experience with the system. Operator Operator feedback on the system was positive. Patients reported very good ease of use of the App and low levels of discomfort after implantation.

conclusionsLUX-Dx™ implantation appears efficient and straightforward, with favorable post-implantation sensing values and associated with positive feedback from operators and patients.

Indexed as

Electrocardiography, AmbulatoryEquipment DesignAgedEuropeFemaleHumansMaleMiddle AgedArrhythmiasAtrial fibrillationCryptogenic strokeImplantationInsertable cardiac monitorLoop recorderSyncope

Identifiers

PMID38755520
PMCPMC11711855

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.