Evidence map›Paper›PMID 32561941›Full record

ArticleStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]2021

A randomized in vitro evaluation of transient and permanent cardiac implantable electronic device malfunctions following direct exposure up to 10 Gy.

Maria Daniela Falco, Domenico Genovesi, Luciana Caravatta, Clelia Di Carlo, Ekaterina Bliakharskaia, Marianna Appignani, Massimiliano Faustino, Nanda Furia, Enrico Di Girolamo

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In one paragraph

Article in Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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 synthesis or guideline pooled it.

  1. Pooled it
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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

9 authors.

Maria Daniela FalcoDepartment of Radiation Oncology, "SS. Annunziata" Hospital, "G. D'Annunzio" University, Via De' Vestini, 66100, Chieti, Italy. mdanielafalco@hotmail.com.
Domenico GenovesiDepartment of Radiation Oncology, "SS. Annunziata" Hospital, "G. D'Annunzio" University, Via De' Vestini, 66100, Chieti, Italy.
Luciana CaravattaDepartment of Radiation Oncology, "SS. Annunziata" Hospital, "G. D'Annunzio" University, Via De' Vestini, 66100, Chieti, Italy.
Clelia Di CarloDepartment of Radiation Oncology, "SS. Annunziata" Hospital, "G. D'Annunzio" University, Via De' Vestini, 66100, Chieti, Italy.
Ekaterina BliakharskaiaDepartment of Clinical Medicine, Public Health, Life and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
Marianna AppignaniIntensive Cardiac Care Unit, "SS. Annunziata" Hospital, Chieti, Italy.
Massimiliano FaustinoArrhythmology Unit, "SS. Annunziata" Hospital, Chieti, Italy.
Nanda FuriaArrhythmology Unit, "SS. Annunziata" Hospital, Chieti, Italy.
Enrico Di GirolamoArrhythmology Unit, "SS. Annunziata" Hospital, Chieti, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeHigh-dose 6‑MV radiotherapy may cause cardiac implantable electronic devices (CIEDs) to malfunction. To assess CIED malfunctions resulting from direct exposure up to 10 Gy, 100 pacemakers (PMs) and 40 implantable cardioverter-defibrillators (ICDs) were evaluated. MATERIALS AND

methodsCIEDs underwent baseline interrogation. In ICDs, antitachycardia therapies were disabled via the programmer while the detection windows were left enabled. A computed tomography (CT) scan was performed to build the corresponding treatment plan. CIEDs were "blinded" and randomized to receive single doses of either 2, 5, or, 10 Gy via a 6-MV linear accelerator (linac) in a water phantom. Twenty-two wireless telemetry-enabled CIEDs underwent a real-time session, and their function was recorded by the video camera in the bunker. The CIEDs were interrogated after exposure and once monthly for 6 months.

resultsDuring exposure, regardless of dose, 90.9% of the CIEDs recorded electromagnetic interference, with 6 ICDs (27.3%) reporting pacing inhibition and inappropriate arrhythmia detections. After exposure, a backup reset was observed in 1 PM (0.7% overall, 1% among PMs), while 7 PMs (5% overall, 7% among PMs) reported battery issues (overall immediate malfunction rate was 5.7%). During follow-up, 4 PMs (2.9% overall; 4% among PMs) and 1 ICD (0.7% overall; 2.5% among ICDs) reported abnormal battery depletion, and 1 PM (0.7% overall; 1% among PMs) reported a backup reset (overall late malfunction rate was 4.3%).

conclusionApart from transient electromagnetic interference, last-generation CIEDs withstood direct 6‑MV exposure up to 10 Gy. Permanent battery or software errors occurred immediately or later only in less recent CIEDs.

Indexed as

Equipment FailureRadiotherapy DosageDefibrillators, ImplantableEquipment Failure AnalysisHumansPacemaker, ArtificialRadiotherapyArrhythmiasElectromagnetic interferenceImplantable cardioverter-defibrillatorPacemakerRadiotherapy

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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.