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Risk of Cardiac Implantable Electronic Device Malfunctioning During Pencil Beam Proton Scanning in an in Vitro Setting

International Journal of Radiation Oncology Biology Physics(2021)SCI 2区

Aarhus Univ Hosp | Aalborg Univ Hosp | Scand Clin

Cited 7|Views25
Abstract
PurposeCardiac implantable electronic devices (CIED) are sensitive to scattered secondary neutrons from proton beam irradiation. This experimental in vitro study investigated risk of CIED errors during pencil beam proton therapy.Methods and MaterialsWe used 62 explanted CIEDs from 4 manufacturers; 49 CIEDs were subjected to a simulated clinical protocol with daily 2 Gy relative biological effectiveness fractions prescribed to the phantom. Devices were located at 3 different lateral distances from the spread-out Bragg peak to investigate the risk of permanent or temporary device errors. Additionally, 13 devices with leads connected were monitored live during consecutive irradiations to investigate the risk of noise, over- or undersense, pace inhibition, and inappropriate shock therapy.ResultsWe detected 61 reset errors in 1728 fractions, and all except 1 CIED were reprogrammed to normal function. All, except 1 reset, occurred in devices from the same manufacturer. These were successfully reprogrammed to normal function. The 1 remaining CIED was locked in permanent safety mode. Secondary neutron dose, as estimated by Monte Carlo simulations, was found to significantly increase the odds of CIED resets by 55% per mSv. Clinically significant battery depletion was observed in 5 devices. We observed no noise, over- or undersense, pace inhibition, or inappropriate shock therapy during 362 fractions of live monitoring.ConclusionsReprogrammable CIED reset was the most commonly observed malfunction during proton therapy, and reset risk depended on secondary neutron exposure. The benefits of proton therapy are expected to outweigh the risk of CIED malfunctioning for most patients.
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要点】:该实验性体外研究调查了心脏植入式电子设备(CIED)在质子束治疗过程中出现故障的风险,并发现可重编程CIED重置是质子治疗中最常见的故障,且重置风险取决于次级中子暴露。

方法】:研究使用了来自4家制造商的62个移除的CIED,对49个CIED进行了模拟临床协议处理,每天向模拟人体 phantom 施以2Gy的相对生物效应分数的质子束辐射。设备被放置在距离散布的布拉格峰3个不同的横向距离处,以调查永久或临时设备错误的风险。此外,在连续辐照过程中对13个带有导线的设备进行了实时监控,以调查噪声、过感或欠感、节律抑制和不当电击治疗的风险。

实验】:通过蒙特卡洛模拟估计次级中子剂量,发现次级中子暴露显著增加了CIED重置的风险,每毫希沃特增加55%的几率。在362次实时监控中未观察到临床显著的电池耗尽,也未观察到噪声、过感或欠感、节律抑制或不当电击治疗。