Department of Radiation Oncology, "G. D'Annunzio" University, "SS. Annunziata" Hospital, Chieti, Italy.
Medical Physics Unit, ASST "Papa Giovanni XXIII", Bergamo, Italy.
Phys Med. 2022 Feb;94:94-101. doi: 10.1016/j.ejmp.2021.12.015. Epub 2022 Jan 7.
Radiotherapy may cause malfunction of implantable cardioverter-defibrillators (ICDs) and pacemakers (PMs). We carried-out a multicentre randomized in-vitro study on 65 ICDs and 145 PMs to evaluate malfunctions during and after direct irradiation to doses up to 10 Gy.
Three centres equipped with different linear accelerator and treatment-planning systems participated in the study. Computed Tomography (CT) acquisitions were performed to build the treatment plans. All devices were exposed to dose of 2, 5, or 10 Gy (6 MV). All devices underwent a baseline examination and 64 wireless real-time telemetry-transmissions (47 ICDs and 17 PMs) were monitored during photon exposures. All devices were interrogated after exposure and once monthly for six subsequent months.
Fifty-four of the 64 wireless-enabled CIEDs (84.4%) recorded noise-related interferences during exposure. In detail, 40/47 ICDs (85.1%) reported interference, of which 16 ICDs (34%) reported potentially clinically relevant pacing inhibition and inappropriate detections. Following exposure, a soft reset occurred in 1/145 PM (0.7%) while 7/145 PMs (4.8%) reported battery issues. During the six-month follow-up, 1/145 PM (0.7%) reported a soft reset, while 12/145 more PMs (8.3%) and 1/64 ICD (1.5%) showed abnormal battery depletion. All reported issues occurred independently of exposure dose. Finally, irreversible effects on software and battery life occurred in only non-MRI-compatible devices.
ICDs mostly featured real-time transient sensing issues, while PMs mostly experienced long-term battery or software issues that were observed immediately following radiation exposure and during follow-up. Irreversible effects on battery life and software occurred in only non-MRI-compatible devices.
放射治疗可能导致植入式心脏复律除颤器（ICD）和起搏器（PM）出现故障。我们对 65 台 ICD 和 145 台 PM 进行了多中心随机体外研究，以评估直接照射高达 10 Gy 时和照射后的故障情况。
三个配备不同线性加速器和治疗计划系统的中心参与了这项研究。进行计算机断层扫描（CT）采集以建立治疗计划。所有设备均接受 2、5 或 10 Gy（6 MV）的剂量照射。所有设备均进行了基线检查，并在光子照射期间监测了 64 次无线实时遥测传输（47 个 ICD 和 17 个 PM）。所有设备在照射后和随后的六个月内每月进行一次询问。
在照射期间，记录到 64 个可无线启用的 CIED 中有 54 个（84.4%）出现与噪声相关的干扰。具体来说，47 个 ICD 中有 40 个（85.1%）报告了干扰，其中 16 个 ICD（34%）报告了潜在的临床相关起搏抑制和不当检测。照射后，145 个 PM 中有 1 个（0.7%）发生软复位，而 145 个 PM 中有 7 个（4.8%）报告电池问题。在六个月的随访中，145 个 PM 中有 1 个（0.7%）发生软复位，而 145 个 PM 中有 12 个（8.3%）和 64 个 ICD 中有 1 个（1.5%）出现异常电池耗尽。所有报告的问题均与照射剂量无关。最后，仅在非 MRI 兼容设备上出现软件和电池寿命的不可逆影响。
ICD 主要表现为实时瞬态感应问题，而 PM 主要经历长期电池或软件问题，这些问题在辐射暴露后和随访期间立即出现。仅在非 MRI 兼容设备上出现电池寿命和软件的不可逆影响。
