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

Background and purpose: 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: 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: 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: 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.