Influence of high-energy photon beam irradiation on pacemaker operation.

In this paper, we determine the influence of high-energy photon beam irradiation used for external radiotherapy on pacemakers, at different doses and dose rates. Ninety-six pacemakers of various origins and ages underwent in vitro high-energy photon irradiation under technical conditions close to external radiotherapy, using a linear accelerator delivering photons of high energy (18 MV). Various dose levels (up to 200 Gy for certain particularly resistant pacemakers) were delivered to pacemakers located in a water-equivalent phantom with several dose rates (from 0.05 to 8 Gy min(-1)). Observed failures were sorted into eight classes of progressive harmfulness, some of them possibly lethal. One irradiated pacemaker exhibited an important defect at a dose rate of 0.2 Gy min(-1), for a cumulative dose of 0.15 Gy. Two pacemakers showed an important defect at a cumulative dose of 1 Gy, while nine pacemakers failed at a cumulative dose lower than or equal to 2 Gy and 13 failed at a cumulative dose lower than or equal to 5 Gy. The most important failure probability (70% of irradiated pacemakers) is observed for 8 Gy min(-1), whereas no pacemakers failed at a dose rate lower than or equal to 0.2 Gy min(-1). In conclusion, warnings given by manufacturers about the maximum tolerable cumulative radiation doses for safe operation of irradiated pacemakers (5 Gy), even reduced to 2 Gy, are not reliable. The spread of cumulative doses inducing failures is very large since our observations show an important failure at 0.15 Gy, while ten pacemakers withstood more than 140 Gy of cumulative dose. The safe operation of pacemakers under irradiation depends mainly on type and model. It depends also on dose rate. From our observations, for the safe operation of pacemakers, a recommendation of a maximum dose rate of 0.2 Gy min(-1) rejecting direct irradiation of the pacemaker at a standard dose rate for tumour treatment (2 Gy min(-1)) is made.