松原 礼明

<title>Abstract</title> Cardiac implantable electronic devices (CIEDs) were believed to have a tolerance dose and that direct irradiation has to be avoided. Thus, no clinical guidelines have mentioned the feasibility of total body irradiation (TBI) with a CIED directly. The purpose of this work was to study a feasible and safe condition for TBI using a CIED. Eighteen CIEDs were directly irradiated by a 6-MV X-ray beam, where a non-neutron producible beam was employed for the removal of any neutron contribution to CIED malfunction. Irradiation up to 10 Gy in accumulated dose was conducted with a 100-cGy/min dose rate, followed by up to 20 Gy at 200 cGy/min. An irradiation test of whether inappropriate ventricular shock therapy was triggered or not was also performed by using a 6-MV beam of 5, 10, 20 and 40 cGy/min to two CIEDs. No malfunction was observed during irradiation up to 20 Gy at 100 and 200 cGy/min without activation of shock therapy. These results were compared with typical TBI, suggesting that a CIED in TBI will not encounter malfunction because the prescribed dose and the dose rate required for TBI are much safer than those used in this experiment. Several inappropriate shock therapies were, however, observed even at 10 cGy/min if activated. The present result suggested that TBI was feasible and safe if a non-neutron producible beam was employed at low dose-rate without activation of shock therapy, where it was not inconsistent with clinical and non-clinical data in the literature. The feasibility of TBI while using a CIED was discussed for the first time.

<title>ABSTRACT</title> This publication is an English version of the Japanese Society for Radiation Oncology (JASTRO) and The Japanese Circulation Society official guidelines for patients with cardiac implantable electronic devices (CIEDs). Several radiotherapy-associated malfunctions have been reported for CIEDs such as pacemakers and implantable cardioverter-defibrillators. Accordingly, guidelines for radiotherapy in patients with CIEDs have been issued by other countries and societies. In August 2010, JASTRO published the ‘Radiotherapy Guidelines for Patients with Pacemakers and Implantable Defibrillators’ (hereafter referred to as the former guidelines). Given new findings in this decade, a multidisciplinary working group of radiation oncologists, medical physicists, radiation therapists and cardiologists jointly reviewed and revised the former guidelines.

PURPOSE: Cardiac implantable electronic devices (CIEDs) were believed to possess a tolerance dose to malfunction during radiotherapy. Although recent studies have qualitatively suggested neutrons as a cause of malfunction, numerical understanding has not been reached. The purpose of this work is to quantitatively clarify the contribution of secondary neutrons from out-of-field irradiation to the malfunction of CIEDs as well as to deduce the frequency of malfunctions until completion of prostate cancer treatment as a typical case. MATERIALS AND METHODS: Measured data were gathered from the literature and were re-analyzed. Firstly, linear relationship for a number of malfunctions to the neutron dose was suggested by theoretical consideration. Secondly, the accumulated number of malfunctions of CIEDs gathered from the literature was compared with the prescribed dose, scattered photon dose, and secondary neutron dose for analysis of their correlation. Thirdly, the number of malfunctions during a course of prostate treatment with high-energy X-ray, passive proton and passive carbon-ion beams was calculated while assuming the same response to malfunctions, where X-rays consisted of 6-MV, 10-MV, 15-MV, and 18-MV beams. Monte Carlo simulation assuming simple geometry was performed for the distribution of neutron dose from X-ray beams, where normalization factors were applied to the distribution so as to reproduce the empirical values. RESULTS: Linearity between risk and neutron dose was clearly found from the measured data, as suggested by theoretical consideration. The predicted number of malfunctions until treatment completion was 0, 0.02±0.01, 0.30±0.08, 0.65±0.17, 0.88±0.50, and 0.14±0.04 when 6-MV, 10-MV, 15-MV, 18-MV, passive proton, and passive carbon-ion beams, respectively, were employed, where the single model response to a malfunction of 8.6±2.1 Sv-1 was applied. CONCLUSIONS: Numerical understanding of the malfunction of CIEDs has been attained for the first time. It has been clarified that neutron dose is a good scale for the risk of CIEDs in radiotherapy. Prediction of the frequency of malfunction as well as discussion of the risk to CIEDs in radiotherapy among the multiple modalities have become possible. Because the present study quantitatively clarifies the neutron contribution to malfunction, revision of clinical guidelines is suggested.