Radiotherapy of patients with cardiac implantable electronic devices according to the DEGRO/DGK guideline—is the risk of relevant errors overestimated?

Steger, Felix; Hautmann, Matthias G.; Süß, Christoph; Hubauer, Ute; Ücer, Ekrem; Maier, Lars S.; Kölbl, Oliver; Jungbauer, Carsten

doi:10.1007/s00066-019-01502-0

Cited by 7 publications

(16 citation statements)

References 31 publications

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“…This may result in the exclusion of patients from the trial after treatment planning (e.g., if the PTV is close or overlapping with coronary arteries or the stomach). All SBRT techniques/platforms available at the meantime are well capable to generate highly conformal treatment plans anywhere in the body [42,66,67], though we are restricting the use of higher energies (maximum 6 mega electronvolt) for cardiac radiosurgery due to the presence of an ICD in these patients [72,73]. Plan optimization will be performed using the best-practice guidelines for each system according to the ALARA (as low as reasonably achievable) principle for critical structures inside and outside of the heart.…”

Section: Study Treatmentmentioning

confidence: 99%

Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)

et al. 2020

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Background Single-session high-dose stereotactic radiotherapy (radiosurgery) is a new treatment option for otherwise untreatable patients suffering from refractory ventricular tachycardia (VT). In the initial single-center case studies and feasibility trials, cardiac radiosurgery has led to significant reductions of VT burden with limited toxicities. However, the full safety profile remains largely unknown. Methods/design In this multi-center, multi-platform clinical feasibility trial which we plan is to assess the initial safety profile of radiosurgery for ventricular tachycardia (RAVENTA). High-precision image-guided single-session radiosurgery with 25 Gy will be delivered to the VT substrate determined by high-definition endocardial electrophysiological mapping. The primary endpoint is safety in terms of successful dose delivery without severe treatment-related side effects in the first Jürgen Dunst and Hendrik Bonnemeier have equally contributed to this work. This is the first publication for the RAVENTA study.

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Section: Study Treatmentmentioning

confidence: 99%

Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)

et al. 2020

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“…The data from Aslian et al. serve well for the explanation of several case reports of high cumulative absorbed radiation doses to CIEDs [ 17 , 18 ]. The authors show that even high dose-rates of 1200 MU/min can be withstood by an ICD for a short time.…”

Section: Discussionmentioning

confidence: 91%

“…Hurkmans et al have suggested for FFF beams, that at the location of a CIED outside of the target volume, the LDR would be lower than 100 cGy/min and therefore dose-rate effects are rare [16]. The data from Aslian et al serve well for the explanation of several case reports of high cumulative absorbed radiation doses to CIEDs [17,18]. The authors show that even high dose-rates of 1200 MU/min can be withstood by an ICD for a short time.…”

Section: Discussionmentioning

confidence: 96%

Local dose rate effects in implantable cardioverter–defibrillators with flattening filter free and flattened photon radiation

et al. 2022

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Purpose In the beam penumbra of stereotactic body radiotherapy volumes, dose rate effects in implantable cardioverter–defibrillators (ICDs) may be the predominant cause for failures in the absence of neutron-generating photon energies. We investigate such dose rate effects in ICDs and provide evidence for safe use of lung tumor stereotactic radioablation with flattening filter free (FFF) and flattened 6 Megavolt (MV) beams in ICD-bearing patients. Methods Sixty-two ICDs were subjected to scatter radiation in 1.0, 2.5, and 7.0 cm distance to 100 Gy within a 5 × 5 cm2 radiation field. Radiation was applied with 6 MV FFF beams (constant dose rate of 1400 cGy/min) and flattened (FLAT) 6 MV beams (430 cGy/min). Local dose rates (LDR) at the position of all ICDs were measured. All ICDs were monitored continuously. Results With 6 MV FFF beams, ICD errors occurred at distances of 1.0 cm (LDR 46.8 cGy/min; maximum ICD dose 3.4 Gy) and 2.5 cm (LDR 15.6 cGy/min; 1.1 Gy). With 6 MV FLAT beams, ICD errors occurred only at 1 cm distance (LDR 16.8 cGy/min; 3.9 Gy). No errors occurred at an LDR below 7 cGy/min, translating to a safe distance of 2.5 cm (1.5 Gy) in flattened and 7 cm (0.4 Gy) in 6 MV FFF beams. Conclusion A LDR in ICDs larger than 7 cGy/min may cause ICD malfunction. At identical LDR, differences between 6 MV FFF and 6 MV FLAT beams do not yield different rates of malfunction. The dominant reason for ICD failures could be the LDR and not the total dose to the ICD. For most stereotactic treatments, it is recommended to generate a planning risk volume around the ICD in which LDR larger than 7 cGy/min are avoided.

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“…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.…”

Section: Resultsmentioning

confidence: 99%

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

Malavasi

Imberti

Tosetti

et al. 2022

Eur J Clin Investigation

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Background The number of patients with cardiac implantable electronic devices (CIEDs) undergoing radiotherapy (RT) for cancer treatment is growing. At present, prevalence and predictors of RT‐induced CIEDs malfunctions are not defined. Methods Systematic review and meta‐analysis conducted following the PRISMA recommendations. PubMed, Scopus and Google Scholar were searched from inception to 31/01/2022 for studies reporting RT‐induced malfunctions in CIEDs patients. Aim was to assess the prevalence of RT‐induced CIEDs malfunctions and identify potential predictors. Results Thirty‐two out of 3962 records matched the inclusion criteria and were included in the meta‐analysis. A total of 135 CIEDs malfunctions were detected among 3121 patients (6.6%, 95% confidence interval [CI]: 5.1%–8.4%). The pooled prevalence increased moving from pacemaker (PM) to implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy and defibrillator (CRT‐D) groups (4.1%, 95% CI: 2.9–5.8; 8.2% 95% CI: 5.9–11.3; and 19.8%, 95% CI: 11.4–32.2 respectively). A higher risk ratio (RR) of malfunctions was found when neutron‐producing energies were used as compared to non‐neutron‐producing energies (RR 9.98, 95% CI: 5.09–19.60) and in patients with ICD/CRT‐D as compared to patients with PM/CRT‐P (RR 2.07, 95% CI: 1.40–3.06). On the contrary, no association was found between maximal radiation dose at CIED >2 Gy and CIEDs malfunctions (RR 0.93; 95% CI: 0.31–2.76). Conclusions Radiotherapy related CIEDs malfunction had a prevalence ranging from 4% to 20%. The use of neutron‐producing energies and more complex devices (ICD/CRT‐D) were associated with higher risk of device malfunction, while the radiation dose at CIED did not significantly impact on the risk unless higher doses (>10 Gy) were used.

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Radiotherapy of patients with cardiac implantable electronic devices according to the DEGRO/DGK guideline—is the risk of relevant errors overestimated?

Cited by 7 publications

References 31 publications

Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)

Radiosurgery for ventricular tachycardia: preclinical and clinical evidence and study design for a German multi-center multi-platform feasibility trial (RAVENTA)

Local dose rate effects in implantable cardioverter–defibrillators with flattening filter free and flattened photon radiation

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

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