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


Journal

Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]
ISSN: 1439-099X
Titre abrégé: Strahlenther Onkol
Pays: Germany
ID NLM: 8603469

Informations de publication

Date de publication:
Mar 2021
Historique:
received: 28 01 2020
accepted: 01 06 2020
pubmed: 21 6 2020
medline: 5 5 2021
entrez: 21 6 2020
Statut: ppublish

Résumé

High-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. CIEDs 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. During 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%). Apart 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.

Sections du résumé

BACKGROUND AND PURPOSE OBJECTIVE
High-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 METHODS METHODS
CIEDs 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.
RESULTS RESULTS
During 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%).
CONCLUSION CONCLUSIONS
Apart 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.

Identifiants

pubmed: 32561941
doi: 10.1007/s00066-020-01651-7
pii: 10.1007/s00066-020-01651-7
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

198-208

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Auteurs

Maria Daniela Falco (MD)

Department of Radiation Oncology, "SS. Annunziata" Hospital, "G. D'Annunzio" University, Via De' Vestini, 66100, Chieti, Italy. mdanielafalco@hotmail.com.

Domenico Genovesi (D)

Department of Radiation Oncology, "SS. Annunziata" Hospital, "G. D'Annunzio" University, Via De' Vestini, 66100, Chieti, Italy.

Luciana Caravatta (L)

Department of Radiation Oncology, "SS. Annunziata" Hospital, "G. D'Annunzio" University, Via De' Vestini, 66100, Chieti, Italy.

Clelia Di Carlo (C)

Department of Radiation Oncology, "SS. Annunziata" Hospital, "G. D'Annunzio" University, Via De' Vestini, 66100, Chieti, Italy.

Ekaterina Bliakharskaia (E)

Department of Clinical Medicine, Public Health, Life and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.

Marianna Appignani (M)

Intensive Cardiac Care Unit, "SS. Annunziata" Hospital, Chieti, Italy.

Massimiliano Faustino (M)

Arrhythmology Unit, "SS. Annunziata" Hospital, Chieti, Italy.

Nanda Furia (N)

Arrhythmology Unit, "SS. Annunziata" Hospital, Chieti, Italy.

Enrico Di Girolamo (E)

Arrhythmology Unit, "SS. Annunziata" Hospital, Chieti, Italy.

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