Security millimetre wave body scanner safe for patients with leadless pacemakers or subcutaneous implantable cardioverte

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Security millimetre wave body scanner safe for patients with leadless pacemakers or subcutaneous implantable cardioverter-defibrillators Patrick Blažek 1 & Matthew J. O’Connor 2 & Severin Weigand 1,3 & Christian Grebmer 1 & Sebastian Reif 4 & Stephanie Fichtner 5 & Lena Friedrich 1 & Tilko Reents 1 & Marc Kottmaier 1 & Verena Semmler 1 & Felix Bourier 1 & Heribert Schunkert 1,3 & Isabel Deisenhofer 1 & Christof Kolb 1 & Carsten Lennerz 1,3 Received: 16 May 2020 / Accepted: 17 July 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020

Abstract Purpose This study was designed to evaluate the electromagnetic interference (EMI) effects and safety of the new security screening millimetre wave body scanners (MWBSs) for patients with rare cardiac implantable electronic devices (CIEDs). Methods We identified 73 patients with either entirely subcutaneous implantable cardioverter-defibrillators (S-ICD) or leadless pacemakers (LPM) attending routine device follow-up. CIED programming was optimised for the detection of EMI occurrence, and high-voltage therapy was disabled. Patients then underwent millimetre wave body scans under continuous ECG monitoring. Scanning was performed at the recommended distance as well as in close proximity to the scanner emulating accidental exposure. CIED function was observed for EMI effects. Results There were no episodes of inhibition of pacing in the leadless pacemaker subgroup, no oversensing in the S-ICD subgroup and no spontaneous device reprogramming in any group. There was no change in pacing or sensing thresholds, and S-ICD vector eligibility remained unchanged after scanning with the MWBS. No CIEDs were identified by the MWBS during the study. Conclusion No EMI events were detected during the use of MWBSs by patients with either S-ICDs or LPMs. This data should be reassuring for patients suggesting that they can undergo security body scans without worries or disclosure of their CIED status. Keywords Electromagnetic interference . Subcutaneous ICD . Leadless pacemaker . Micra . Security screening

1 Introduction Rarer cardiac implantable electronic devices (CIEDs) such as leadless pacemakers (LPMs) and entirely subcutaneous implantable cardioverter-defibrillators (S-ICDs) are being

* Carsten Lennerz [email protected] 1

Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Klinik an der Technischen Universität München, Munich, Germany

2

Department of Cardiology, Wellington Hospital, Wellington, New Zealand

3

DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany

4

Klinik für Kardiologie und Internistische Intensivmedizin, Klinikum Bogenhausen, Munich, Germany

5

Klinikum Großhadern, Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany

implanted with increasing frequency since receiving their CE (Conformité Européene) mark in 2015 and 2009 respectively [1]. S-ICD implantation is a class IIa indication as an alternative to a transvenous ICD in patients witho