Safety verification of carbon-ion radiotherapy for patients with cardiac implantable electronic devices (CIEDs)

Abstract

According to guidelines, carbon-ion beam therapy is considered to carry a high safety risk for patients with cardiac implantable electronic devices (CIEDs), although the actual impacts remain unclear. In this study, we investigated the safety of carbon-ion beam therapy in patients with CIEDs. Patients with CIEDs who underwent carbon-ion therapy at Gunma University Heavy Ion Medical Center between June 2010 and December 2019 were identified and investigated for abnormalities in the operation of their CIEDs, such as oversensing and resetting during irradiation, and abnormalities in operation after treatment. In addition, the risk of irradiation from carbon-ion beam therapy was evaluated by model simulations. Twenty patients (22 sites) with CIEDs were identified, 19 with pacemakers and one with an implantable cardioverter-defibrillator (ICD). Treatments were completed without any problems, except for one case in which the treatment was discontinued because of worsening of the primary disease. Monte Carlo simulation indicated that the carbon beam irradiation produced neutrons at a constant and high level in the irradiation field. Nevertheless, with the distances between the CIEDs and the irradiation fields in the analyzed cases, the quantity of neutrons at the CIEDs was lower than that within the irradiation. Although carbon-ion beam therapy can be safely administered to patients with CIEDs, it is advisable to perform the therapy with sufficient preparation and backup devices because of the risks involved.

A systematic review and meta‐analysis on oncological radiotherapy in patients with a cardiac implantable electronic device: Prevalence and predictors of device malfunction in 3121 patients

“…Relevant citations were assessed following the Patient/Population, Intervention, Comparison, Outcomes (PICO) process. Thirty‐two papers matched the inclusion/ exclusion criteria and were included in the present meta‐analysis 12–43 . Figure 1 summarizes the study selection process.…”

“…Among the 32 studies considered, 13 (41%) were prospective 12,14–19,21,22,24,33,37,40 and 19 (59%) were retrospective 13,20,23,25–32,34–36,38,39,41–43 . With regard to CIED type, PM/CRT‐P were considered in 28 studies, 13,14,16–21,23–26,28–43 ICD in 29 studies 12,13,15,16,19–43 and CRT‐D in 12 studies 22,24,25,28–30,32–34,37,39,43 . Publication years ranged from 2002 to 2021.…”

“…In 25 studies (3018 patients), it was possible to compare PM/CRT‐P versus ICD/CRT‐D 13,16,19–21,23–26,28–43 . The meta‐analysis showed a risk ratio of 2.07 (95% CI: 1.40–3.06) for malfunctions in ICD/CRT‐D patients when compared to PM/CRT‐P patients (Figure 3, Panel B), with low heterogeneity ( I 2 = 1%).…”

“…Thirty‐two papers matched the inclusion/ exclusion criteria and were included in the present meta‐analysis. 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 Figure 1 summarizes the study selection process. The quality assessment performed using the Newcastle‐Ottawa scale showed an overall high quality of the studies included (Table S1 ).…”

“…Among the 32 studies considered, 13 (41%) were prospe ctive 12,[14][15][16][17][18][19]21,22,24,33,37,40 and 19 (59%) were retrospective . 13,20,23,[25][26][27][28][29][30][31][32][34][35][36]38,39,[41][42][43] With regard to CIED type, PM/ CRT-P were considered in 28 studies, 13,14,[16][17][18][19][20][21][23][24][25][26][28][29][30][31][32][33][34][3...…”