Management of patients with implantable cardioverter-defibrillators and pacemakers who require radiation therapy

doi:10.1016/j.hrthm.2015.06.003

Heart Rhythm

Volume 12, Issue 10, October 2015, Pages 2148-2154

https://doi.org/10.1016/j.hrthm.2015.06.003 Get rights and content

Background

Radiation therapy (RT) may pose acute and long-term risks for patients with cardiac implantable electronic devices (CIEDs), including pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs). However, the frequency of these problems has not been accurately defined.

Objective

The purpose of this study was to determine the prevalence of CIEDs among patients requiring RT and report the common CIED-related problems when patients are managed according to a standard clinical care path.

Methods

In a single tertiary-care center, we prospectively screened all patients requiring RT and identified patients with ICDs or PMs. We collected clinical data about their cancer, RT treatment plan, and CIED. Radiation dose to the device was estimated in all patients, and any device malfunction during RT was documented.

Results

Of the 34,706 consecutive patients receiving RT, 261 patients (0.8%, mean age 77.9 ± 9.4 years) had an implantable cardiac device: 54 (20.7%) ICDs and 207 (79.3%) PMs. The site of RT was head and neck (27.4%), chest (30.0%), and abdomen/pelvis (32.6%). Using our care path, 63.2% of patients required continuous cardiac monitoring, 14.6% required device reprogramming, 18.8% required magnet application during RT, and 3.4% required device repositioning to the contralateral side before RT. Four patients (1.5%) had inappropriate device function during RT: 3 experienced hemodynamically tolerated ventricular pacing at the maximum sensor rate, and 1 experienced a device power-on-reset. No patient died or suffered permanent device failure.

Conclusion

Nearly 1% of patients receiving RT in this series has a PM or ICD. However, with a systematic policy of risk assessment and patient management, significant device-related complications are rare.

Introduction

Use of cardiac implantable electronic devices (CIEDs), including pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs), along with radiation therapy (RT) has increased significantly over the past 2 decades.1, 2 As each of these therapies is increasingly indicated in older patients, it is not surprising that many patients who require RT have some type of CIED. Although it has been demonstrated that RT can cause both transient malfunction of PMs and ICDs as well as permanent damage to device circuitry,3, 4, 5, 6 precise estimates of this risk are not known. As a result, there are no widely accepted guidelines on how to best manage these patients, although individual institutions have developed local guidelines.7, 8, 9, 10

Modern CIEDS incorporate circuitry composed of complementary metal oxide semiconductor (CMOS) transistors, which allows devices to be smaller, reliable, and energy efficient but makes them susceptible to the effects of ionizing radiation.11, 12, 13 This effect may range from mild corruption of their programming to power-on-reset or complete failure of the device. The likelihood of damage increases with cumulative radiation exposure to the device.11, 12, 13, 14, 15 RT may also acutely affect the function of CIEDs through the generation of electromagnetic noise or other phenomena.8, 16

This single-center study sought to determine the prevalence of CIEDs among patients receiving RT, systematically report the common CIED-related problems in this population, and evaluate a management care path, which was modeled on guidelines for perioperative management of PMs and ICDs¹⁷ and refined using the published literature of the effects of RT on CIEDs.11, 12, 13, 14, 15, 16

Section snippets

Methods

At a single tertiary-care center between February 2008 and December 2012, we prospectively screened consecutive patients scheduled to undergo RT and identified those patients with an ICD or PM. Patients treated with only orthovoltage therapy were excluded. Clinical and RT treatment plan information as well as CIED-related data, including device location and PM dependency (defined as no intrinsic rhythm >40 bpm), were collected.

Before RT initiation, cumulative radiation exposure to the device,

Results

Of the 34,706 patients receiving RT between February 2008 and December 2012, 261 (0.8%) had a CIED: 207 (79.3%) PMs and 54 (20.7%) ICDs (Table 2). Of these patients, 67 (25.7%) were PM dependent. Clinical characteristics and RT treatment features of the study population are summarized in Table 2. Treatment regions included head and neck (27.4%), chest ipsilateral to device (9.3%), chest contralateral to device (15.2%), bilateral chest (5.6%), abdomen (3.3%), pelvis (29.3%), and limb (4.4%).

Discussion

This large cohort of patients undergoing RT demonstrates that CIEDs are common in this population, present in nearly 1% of individuals. The enrollment of consecutive patients and systematic monitoring for complications also allow precise estimation of the rate of RT-induced CIED complications in this population. Our results suggest that CIED malfunctions are rare in centers that follow a systematic policy of risk assessment in conjunction with an algorithm for device management. Only 1.5% of

Conclusion

Health care professionals will have to care for a growing population of patients with CIEDs who require RT. Although the potential for RT to cause transient and permanent malfunction in cardiac devices is well established, formal guidelines on how to best manage these patients are lacking. However, RT therapy among patients with CIEDs is safe when a systematic policy of risk assessment and patient management is implemented.

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This article describes a community-based hospital's policy for the management of patients with medical implanted electronic devices other than pacemakers or implanted cardiac defibrillators (ICDs). The policy may be adapted as needed for other radiation oncology groups requiring a practical solution for managing the care of patients with implanted devices, noting the need for changes for departments offering proton, neutron, heavy ion, or magnetic resonance–guided linear accelerator (MR-linac) treatment modalities.
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Radiation therapy (RT) may pose acute and long-term risks for patients with cardiac implantable electronic devices (CIEDs), including pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs).
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The meta-analysis showed that RT was associated with an increased risk of ICD malfunctions (odds ratio [OR] 2.75; 95% confidence interval [CI] 1.74–4.33). Five studies were included in the subgroup analysis regarding photon beam energy, showing that radiation-induced CIED failure was more likely to occur in ICDs when beam energy was ≥10 MV (OR 5.28; 95% CI 2.14–13.03). Neutron-generating RT significantly increased the risk of CIED malfunctions (OR 3.97; 95% CI 1.70–9.26), especially the risk of reset (OR 5.79; 95% CI 2.37–14.12; P = .0001). We did not find significant differences in the risk of CIED failure between chest RT and other RT sites (OR 1.09; 95% CI 0.63–1.88).
Our meta-analysis suggests that ICDs are more likely to be affected by RT than PMs. These adverse events, especially reset, in patients with cancer were associated with neutron-generating RT and beam energy ≥10 MV. Given the increasing requirement for RT in several patients with cancer as well as the increasing implantation rates of CIEDs, a better risk stratification is needed in this setting.
In-vitro investigation of cardiac implantable electronic device malfunction during and after direct photon exposure: A three-centres experience
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Citation Excerpt :
The strategies to manage transient and/or permanent issues depend on the eventually expected malfunctions. In order to prevent inappropriate shock delivery in ICDs or pacing inhibition in PM-dependent patients, a magnet over the ICD site can be placed, as also reported by some authors[24–31]. This disables inappropriate VT/VF detection in ICD patients and inappropriate pacing inhibition resulting in ventricular asystole in PM-dependent patients.
Radiotherapy may cause malfunction of implantable cardioverter-defibrillators (ICDs) and pacemakers (PMs). We carried-out a multicentre randomized in-vitro study on 65 ICDs and 145 PMs to evaluate malfunctions during and after direct irradiation to doses up to 10 Gy.
Three centres equipped with different linear accelerator and treatment-planning systems participated in the study. Computed Tomography (CT) acquisitions were performed to build the treatment plans. All devices were exposed to dose of 2, 5, or 10 Gy (6 MV). All devices underwent a baseline examination and 64 wireless real-time telemetry-transmissions (47 ICDs and 17 PMs) were monitored during photon exposures. All devices were interrogated after exposure and once monthly for six subsequent months.
Fifty-four of the 64 wireless-enabled CIEDs (84.4%) recorded noise-related interferences during exposure. In detail, 40/47 ICDs (85.1%) reported interference, of which 16 ICDs (34%) reported potentially clinically relevant pacing inhibition and inappropriate detections. Following exposure, a soft reset occurred in 1/145 PM (0.7%) while 7/145 PMs (4.8%) reported battery issues. During the six-month follow-up, 1/145 PM (0.7%) reported a soft reset, while 12/145 more PMs (8.3%) and 1/64 ICD (1.5%) showed abnormal battery depletion.
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Radiotherapy in patients with cardiac implantable electronic device such as pacemakers or defibrillators, is a clinical situation that is becoming increasingly common. There is a risk of interaction between the magnetic field induced by accelerators and the cardiac implantable electronic device, but also a risk of device dysfunction due to direct and/or indirect irradiation if the cardiac implantable electronic device is in the field of treatment. The risk can be dose-dependent, but it is most often independent of the total dose and occurs randomly in case of neutron production (stochastic effect). The presence of this type of device is therefore described as a contraindication for radiotherapy by the French national agency for the safety of medicines and health products (Agence nationale de sécurité du médicament et des produits de santé, ANSM). Nevertheless, since radiotherapy is often possible, it is advisable to respect the recommendations of good practice, in particular the eligibility criteria, the monitoring modalities before, during and after irradiation according to the type of treatment, the dose and the characteristics of the cardiac implantable electronic device. It is sometimes necessary to discuss repositioning the device and/or modifying the treatment plan to minimize the risk of cardiac implantable electronic device dysfunction. We present the update of the recommendations of the French society of oncological radiotherapy on in patients with cardiac implantable electronic device.
La radiothérapie chez les patients porteurs de dispositifs rythmologiques implantables, de type stimulateur ou défibrillateur cardiaque, est une situation clinique qui devient de plus en plus fréquente. Il existe un risque d’interaction entre le champ magnétique induit par l’accélérateur et le boîtier du dispositif rythmologique implantable, mais surtout un risque de dysfonction du dispositif du fait de l’irradiation directe et/ou indirecte sur le boîtier. Le risque peut être dose-dépendant, mais il est le plus souvent indépendant de la dose totale et survenant de façon aléatoire en cas de production de neutrons secondaires (effet stochastique). La présence de ce type de dispositifs est donc décrite comme contre-indication relative à la radiothérapie par l’Agence nationale de sécurité du médicament et des produits de santé. Néanmoins, la radiothérapie est le plus souvent possible. Il convient de respecter les recommandations de bonnes pratiques notamment les critères d’éligibilité, les modalités de surveillance avant, pendant et après l’irradiation selon le type de traitement, la dose et les caractéristiques du dispositif rythmologique implantable. Il est parfois nécessaire de discuter un repositionnement du dispositif et/ou une modification du plan de traitement pour minimiser les risques de dysfonction du dispositif rythmologique implantable. Nous présentons la mise à jour des recommandations de la Société française de radiothérapie oncologique sur la mise en œuvre d’une radiothérapie chez un patient porteur d’un dispositif rythmologique implantable.

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: Dr. Connolly has received consulting fees, lecture fees, and grant support from Boehringer Ingelheim. Dr. Healey has received consulting fees, lecture fees and grant support from Boehringer-Ingelheim, Astra-Zeneca, Bayer, St. Jude Medical, and Boston Scientific; and has a personnel award from the Heart and Stroke Foundation, Ontario Provincial office (MC7450). Dr. Capucci receives consulting fees from Merck, Sanofi-Aventis, and Meda Pharmaceuticals; lecture fees from Merck and Sanofi-Aventis; and reimbursement for meeting expenses from Sorin, Boston Scientific, Merck, and Sanofi-Aventis. Dr. Morillo receives consulting fees from St. Jude Medical, Biotronik, Medtronic, Boston Scientific, Sanofi-Aventis, and Boehringer Ingelheim; grant support from St. Jude Medical, Medtronic, and Boston Scientific; and lecture fees from Boston Scientific, St. Jude Medical, Medtronic, Boehringer Ingelheim, Sanofi-Aventis, and Biotronik.

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Management of patients with implantable cardioverter-defibrillators and pacemakers who require radiation therapy

Background

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Methods

Results

Discussion

Conclusion

Int J Radiat Oncol Biol Phys

Clin Oncol (R Coll Radiol)

Int J Radiat Oncol Biol Phys

Int J Radiat Oncol Biol Phys

Int J Radiat Oncol Biol Phys

Int J Radiat Oncol Biol Phys

Heart Rhythm

J Electrocardiol

The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009—A World Society of Arrhythmia’s project

Pacing Clin Electrophysiol

A prospective survey of radiotherapy practice 2001 in Sweden

Acta Oncol

Pacemaker failure resulting from radiation damage

Radiology

Life-threatening pacemaker dysfunction associated with therapeutic radiation: a case report

Angiology