Evidence map›Paper›PMID 35496450›Full record

ArticleHeart rhythm O22022

New-generation miniaturized insertable cardiac monitor with a long sensing vector: Insertion procedure, sensing performance, and home monitoring transmission success in a real-world population.

Thomas Deneke, Pilar Cabanas, Daniel Hofer, Thomas Gaspar, Bertrand Pierre, Giovanni Bisignani, Rajeev Kumar Pathak, Victor Manuel Sanfins, Eimo Martens, Jacques Mansourati and 7 more

Open access · goldAbstract read
In one paragraph

Article in Heart rhythm O2, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.1field-weighted citation impact, top 9% 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

12 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Implantation of a novel insertable cardiac monitor: preliminary multicenter experience in Europe.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Review
  4. Feasibility, safety, and comfort of the '2BB' (2 cm below the bra) position of insertable cardiac monitors in women: the IN-WOMEN-ICM pilot study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
    Article
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  12. Accuracy of atrial fibrillation detection by an insertable cardiac monitor in patients undergoing catheter ablation: Results of the BioVAD study.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2022
    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

17 authors at 16 institutions in 8 countries.

Thomas DenekeRhön Clinic Campus Bad Neustadt, Bad Neustadt a. d. Saale, Germany.
Pilar CabanasHospital Álvaro Cunqueiro, Vigo, Spain.
Daniel HoferUniversity Hospital Zurich, Zurich, Switzerland.
Thomas GasparHeart Center, University of Dresden, Dresden, Germany.
Bertrand PierreTours University Hospital, Tours, France.
Giovanni BisignaniOspedale Civile Ferrari, Castrovillari, Italy.
Rajeev Kumar PathakCanberra Heart Rhythm Clinic, Canberra, Australia.
Victor Manuel SanfinsHospital Senhora da Oliveira - Guimarães, Guimarães, Portugal.
Eimo MartensKlinikum rechts der Isar, Technical University Munich, Munich, Germany.
Jacques MansouratiUniversity Hospital of Brest, Brest, France.
Antonio Berruezo-SanchezTeknon Heart Institute, Barcelona, Spain.
Marcus WiemerJohannes Wesling Klinikum Minden, Minden, Germany.
Andreas HainKerckhoff-Klinik GmbH, Bad Nauheim, Germany.
Thomas PezawasMedical University of Vienna, Vienna, Austria.
Beate WenzelBiotronik SE & CO. KG, Berlin, Germany.
Dennis LauRoyal Adelaide Hospital, Adelaide, Australia.
BIO|MASTER.BIOMONITOR III study and BIO|STREAM.ICM registry investigators
Biotronik (Germany) · DECanberra Hospital · AUCentre Hospitalier Régional Universitaire de Brest · FRFerrari (Italy) · ITFundación Teknon · ESHospital da Senhora da Oliveira Guimarães · PTJohannes Wesling Klinikum Minden · DEKerckhoff Klinik · DEMedical University of Vienna · ATRhön-Klinikum · DERoyal Adelaide Hospital · AUTechnische Universität Dresden · DETUM Klinikum · DEUniversité de Tours · FRUniversity Hospital Complex Of Vigo · ESUniversity Hospital of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Insertable cardiac monitors (ICMs) require an invasive procedure and are used for purely diagnostic purposes. Therefore, simplicity of the insertion procedure, low complication rate, long-term patient acceptance, sensing quality, and reliable remote monitoring are of great importance. Objective: To evaluate a novel ICM (BIOMONITOR III) regarding all these aspects. Methods: BIOMONITOR III has a miniaturized profile, long sensing vector (≈70 mm), a fast insertion tool for pocket formation and ICM placement in 1 step, and daily automatic Home Monitoring (HM) function. We evaluated the insertion procedure, complication rate, patient acceptance, sensing quality, and HM performance in 653 patients with BIOMONITOR III inserted for any ICM indication within 2 ongoing studies involving 51 sites in 11 countries. Results: The median time from skin incision to wound closure was 4.0 minutes (interquartile range, 2.3-6.2 minutes). Median follow-up period was 274 days (interquartile range, 175-342 days). Serious adverse device-related events occurred in 6 patients (0.9%). No deep infections were reported in 334 patients without antibiotic prophylaxis. The wearing comfort was good or excellent in ≈95%. The mean R-wave amplitude (0.73 mV) and HM transmission rate (≈94% of days) were stable over 1.5 years. R-wave amplitudes were larger (mean 0.80 vs 0.62 mV, Conclusion: The study demonstrated fast insertion times, low complication rate, high patient acceptance, and favorable long-term sensing and HM performance of the ICM.

Indexed as

Cardiac arrhythmiaHome MonitoringImplantable loop recorderInsertable cardiac monitorRemote monitoring

Identifiers

PMID35496450
PMCPMC9043386
OpenAlexW4210684740

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.