Cardiac Implantable Electronic Devices Malfunctions Research Articles

A Systematic Review and Meta-analysis of the Prevalence and Risk Factors in Cardiac Implantable Electronic Device Malfunction.

Cardiac implantable electronic devices (CIED) include permanent pacemakers (PPMs), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. They treat several cardiac issues and are dependent on batteries; however, similar to any medical equipment, they can fail. The prevalence and risk factors for CIED malfunction must be understood for earlier detection and better patient outcomes. A comprehensive search was conducted through electronic bibliographic sources (PubMed and Cochrane) until January 2023 in order to identify reviews, cohort studies and case reports pertaining to CIED. The primary outcome is the probability of CIED malfunction. The secondary outcome concerned significant risk factors. Two authors independently extracted articles by utilizing pre-established data fields. Using a random-effects model, the aggregated prevalence and 95 % confidence intervals (CIs) were computed. The meta-analysis comprised eight review articles, twenty-two retrospective studies, and thirty-seven case reports from the systematic review. The eight review articles contained a CIED malfunction of 4.03 % (random-effects model). The pooled prevalence of CIED malfunction in the meta-analysis of 22 retrospective studies was 0.41 percent (using a fixed-effects model) and 8.01 percent (using a random-effects model). Moreover, age, pre-existing cardiac conditions, CIED type, lead placement, and medical device interactions all contributed to an increase in the heterogeneity (I2 = 98.90 %) of the risk of CIED malfunction. CIED malfunction is common and more likely to occur in elderly individuals and in certain types of CIED. Clinicians should focus on risk factors and closely monitor the patients with higher probability for CIED malfunction with short intervals.

Abstract 11603: Reexamining the Incidence and Predictors of Radiation Induced Cardiac Implantable Electronic Device Malfunction in Cancer Patients and Streamlining Management

Background: Historically, the reported incidence of Cardiac Implantable Electronic Device (CIED) malfunction during Radiotherapy (RT) is estimated to range from 3% to 20%. However, most of these studies had small sample sizes and may have overestimated the clinical impact of this problem. In this retrospective study, we examined the incidence of device reset and transient signal interference due to RT in a large cohort of patients. In addition, we studied the feasibility of a novel method of monitoring CIEDs during RT: pulse check method (PCM). Methods: From 1/2015 to 4/2023, patients with CIEDs requiring RT at a tertiary cancer center were identified. CIEDs were checked prior to RT. Candidate patients were managed with PCM, which involves programming the lower pacing rate at 75 bpm (slightly faster than lower rate of pacing during reset mode). Pulse checks were performed after each fraction of RT. Patients with heart rate less than 75 bpm had immediate device interrogation to assess for reset. After completion of RT, devices were interrogated and CIED programming returned to original settings. Results: Our study reviewed 720 patients with CIEDs undergoing 837 courses (560 pacemakers and 277 defibrillators) of RT, of which the majority (85%) were managed with PCM. Neutron producing RT (proton and photon with >10MV beam energy) was used in 189 (22.6%) cases, and 9 (1.1%) devices experienced reset. All resets were recoverable and occurred in the setting of neutron-producing radiation, especially proton therapy [OR 12.06 (3.37 - 43.10), p-value 0.0001]. Site of radiation, type of device, and number of RT fractions did not predict reset. No transient signal interference or oversensing events occurred during RT. Conclusions: CIED malfunction is a rare complication of RT, occurring in the setting of neutron producing radiation, with no serious clinical consequence. Transient signal interference and oversensing during RT was not observed to be a clinical concern in contemporary devices. Thus, asynchronous pacing in pacer dependent patients and deactivation of defibrillator tachy-therapy during RT is not necessary. PCM is a practical and cost-effective way to monitor CIEDs during RT.

Management of Cardiac Implantable Electronic Devices for Patients Receiving MR-Guided Radiotherapy: 4-Year Single Institution Experience

<h3>Purpose/Objective(s)</h3> Implanted metallic devices are a potential contraindication to MR-guided radiotherapy (MRgRT). The safety and feasibility of treating patients with a cardiac implantable electronic device (CIED), such as a pacemaker/defibrillator/loop recorder, is not well understood. We developed an institutional CIED MRgRT workflow for patient triage/evaluation and treatment on a 0.35 T MR Linac. <h3>Materials/Methods</h3> Patients (including pacemaker dependent) with MR-compatible CIEDs were prospectively evaluated according to an institutional MRgRT CIED workflow. This workflow includes prior to simulation: (1) MR patient screening form at consultation to identify CIED; (2) Medical necessity for MRgRT determined by clinician and approved by MRgRT director. If medical necessity not established, patient is triaged to non-MR RT; (3) Cardiologist to complete CIED programming orders; (4) Medical physicist to verify that MR-compatible CIED matches vendor's records; (5) Chest X-ray to be reviewed to ensure no extenders, adaptors, or abandoned leads and to confirm radiopaque CIED ID; (6) Patient to consent for off-label CIED according to risk assessment. The workflow for MRgRT treatment includes: (1) Crash cart, pulse oximetry, and electrocardiogram availability/use; (2) Cardiology present; (3) CIED pacemaker and defibrillator interrogated for lead impedance, battery voltage, and pacing threshold; (4) CIED programmed according to orders; (5) Vitals monitored during MRgRT using in-vault camera; (6) Post-treatment, CIED returned to normal pacing and interrogated. (7) All patients monitored for cardiac events throughout the course of treatment. <h3>Results</h3> Five different CIED models in 12 patients (9 pacemaker, 2 loop recorder, 1 defibrillator) were encountered in patients with cancers of the pancreas (5), kidney (2), lung (2), adrenal (1), bile duct (1), oligometastases (1). Patients received a median dose of 50 Gy (range 25-60 Gy) in 5 fractions (fx) (range 1-5); 80% of patients were adaptively replanned on-table. Maximum CIED dose was < 2 Gy for all patients. No intra- or interfraction CIED change was noted for lead impedance, pacing threshold voltage, and battery voltage. With median follow up of 5.2 months, no patient experienced a cardiac event or CIED malfunction. <h3>Conclusion</h3> We developed a thorough and efficient workflow for management of CIED in patients receiving MRgRT. Safety of consecutive use of MR imaging up to 6 sessions (i.e., simulation and treatment) was shown. Under controlled conditions and monitoring, low-field MRgRT, with cumulative device dose < 2 Gy, may be used without adverse events in patients with CIEDs, including high-risk patients. Ultra-hypofractionation (1-3 fxns) may be considered to further reduce patient risk and departmental resources.

In-vitro investigation of cardiac implantable electronic device malfunction during and after direct photon exposure: A three-centres experience.

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 10Gy. 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 10Gy (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. All reported issues occurred independently of exposure dose. Finally, irreversible effects on software and battery life occurred in only non-MRI-compatible devices. ICDs mostly featured real-time transient sensing issues, while PMs mostly experienced long-term battery or software issues that were observed immediately following radiation exposure and during follow-up. Irreversible effects on battery life and software occurred in only non-MRI-compatible devices.

Retrospective Review of Patients With Cardiac Implantable Electronic Devices Treated With Spot Scanning Proton Therapy

There is limited data on the effects of intensity modulated proton therapy (IMPT) on cardiac implantable electronic devices (CIEDs) such as pacemakers or defibrillators. Neutron scatter could affect CIED function and great caution needs to be taken when treating patients (pts) with CIEDs with IMPT. The purpose of this retrospective study was to review our experience treating CIED pts with IMPT.We retrospectively reviewed 50 pts age ≥18 years with CIEDs underwent IMPT for esophageal (11), H&N (10), other GI (7), NSCLC (6), prostate (6), brain (3), and breast (2) cancers, 4 pts with sarcomas and 1 pt with metastatic disease to bone between June 2015 and July 2020 at our institution on this IRB approved study. Thirty-seven pts were male and the average age (range) was 74 years (25-91). CIED manufacturers were Medtronic (21), Boston Scientific (15), Abbott (10), Biotronik (3) and Sorin (1). Forty-three pts had pacemakers and 7 had defibrillators. Eight pts were pacemaker dependent. Prior to treating the first CIED pt with IMPT, a multidisciplinary team including radiation oncology, cardiology, anesthesiology and nursing was established to develop guidelines for safe treatment and monitoring before, during and after IMPT. We implemented a risk-based decision tree for monitoring during treatment based on CIED dependence and underlying heart rate. We report with descriptive statistics pt demographics, cancer diagnosis, dose and distance from CIED, and CIED events and outcomes (CIED malfunctions, resets, battery depletion).Thirteen pts had intensive monitoring of their CIED during IMPT and the remaining 37 pts had reduced monitoring. Overall, 619 fractions were analyzed. The median prescribed proton dose (range) of radiation was 50 GyRBE1.1 in 25 fractions (25-75 GyRBE1.1). 46 pts had zero proton dose to the CIED. Those who had dose to the CIED had an average dose of 0.85 GyRBE1.1 (range of 0.03-2.18 GyRBE1.1). The average distance from CIED was 16.4cm (range: 2.4- > 50cm). There were no major CIED events related to the IMPT. There were three pts who had pacemaker programming resets to manufacturer settings, and all three of these pts had Biotronik CIEDs. These three pts had 6, 1 and 3 resets, and their CIED were 4cm, 7cm and 9cm from the 80% isodose line, respectively. No clinical cardiac events were related to these resets, and the CIEDS were reprogrammed to original settings uneventfully. Routine CIED battery depletion occurred in 2 pts, one of whom underwent CIED replacement during treatment. Projected CIED battery longevity decreased by 1-4 yrs in five pts.Treating pts with CIEDs undergoing IMPT seems to be safe as long as pts are carefully monitored. Infrequent CIED resets may occur. Frequent CIED monitoring may be associated with reduced projected CIED battery longevity. Long term outcomes will be reviewed and reported at the meeting.

Radiotherapy in Patients With a Cardiac Implantable Electronic Device

Recently, the Heart Rhythm Society published recommendations on management of patients with cardiac implantable electronic device (CIED) who require radiotherapy (RT). We aimed to report the experience of a teaching hospital, and discuss our practice in the context of recently published guidelines. We identified all consecutive CIED recipients (12,736 patients) who underwent RT between March 2006 and June 2017. Among them, 90 (1%) patients (78.2 ± 10 years, 73% male) had a CIED: 82 pacemakers and 8 implantable cardioverter-defibrillators. Two patients required CIED extraction prior to RT for ipsilateral breast cancer (no device replacement in 1 patient). Four patients (5%) were considered at high-risk, 35 (39%) at intermediate-risk, and the remaining 50 (56%) at low-risk for CIED dysfunction. Overall, only a minority of patients followed recommended local protocol during RT delivery (31%) and during follow-up (56%). CIED malfunction was detected in 5 patients (6%), mainly back-up mode resetting (80%), with 4 (including 3 pelvic cancer location) patients initially classified as being at intermediate-risk and 1 at low-risk. Four out of the 5 patients with CEID malfunction had received neutron producing beams. In conclusion, our findings underline the lack of rigorous monitoring of patients undergoing RT (though CIED malfunction appears to be rare and relatively benign in nature), and emphasize the interest of considering neutron producing beam for risk stratification as recommended in recent guidelines. Optimization of patient's management requires a close collaboration between both CIED clinicians and radiation oncologists, and more systematic remote CIED monitoring may be helpful.

P682Radiotherapy-induced malfunction in cancer patients with cardiac implantable electronic devices

Abstract Background The number of patients with cardiac implantable electronic devices (CIED) requiring a radiation therapy (RT) for cancer treatment is increasing over time. Nevertheless, the rate and predictors of CIED malfunctions are still controversial. Purpose The aim of our study is to estimate the prevalence and possible predictors of RT-related CIED malfunctions and to describe malfunction characteristics. Methods We retrospectively reviewed medical records of all pacemaker (PM)/implantable cardioverter defibrillator (ICD) patients who underwent RT at our centre between January 2004 and July 2018. We included data from the CIED interrogation performed before the RT course to the first interrogation after the end of the RT course. As a safety measure, during RT a magnet was applied to every ICD and, in all PM-dependent patients, the device was temporarily reprogrammed in V00. Device relocation from the RT field was performed in 2/150 (1.3%) RT courses. Results One hundred twenty-seven patients were included, who underwent 150 separate RT courses. Eighty one percent of patients had a PM, while 19% had an ICD. Of note 17.4% of patients were PM-dependent. Neutron producing RT was used in 37/139 (26.6%) patients, whereas marginal neutron producing and non-neutron producing RT was used in 9/139 (6.4%) and 93/139 (67%) patients respectively. The cumulative dose (Dmax) delivered to the CIED exceeded 5Gy only in 2/132 (1.5%) cases. Three device-related malfunctions were found (2%). None of them were life-threatening or lead to a clinical event. All dysfunctions were resolved by reprogramming the device and did not require CIED substitution or leads extraction. Details of dysfunctions included: 1) a partial reset of an ICD, leading to self-reprogramming in safety mode, 2) full reset of a PM, which required the re-initialisation of the device and 3) programming change of the magnetic PM frequency to 30bpm (instead of 90 bpm). In all cases the Dmax delivered to the CIED was &lt;1Gy. A neutron producing RT was used in the first two cases, whereas a non-neutron producing RT was used in the last case. Conclusions In accordance with the current literature, our results show that RT in patients with CIED is substantially safe. Malfunctions are uncommon and do not result in clinical events, but can develop even if the Dmax delivered to the CIED is &lt;1 Gy. Device interrogation on a regular basis is advisable to promptly recognise CIED malfunctions.

P2858Cardiac implantable device malfunctions during radiotherapy courses up to 10 Gy: a double-center, prospective, randomized, in-vitro evaluation

Abstract Background Exposure to radiotherapy in patients with cardiac implantable electronic devices (CIEDs), both pacemakers (PMs) or implantable cardioverter defibrillators (ICDs), seems to be still troubleshooting. Unlike magnetic resonance imaging, high dose photon radiation at even less than 6MV power, notoriously a non-neutron-producing setting, may transiently or permanently affect normal device function. Malfunctions may be harmfull and life-threatening in high risk patients, such as PM-dependent or ICD ones. Purpose To evaluate CIED malfunctions by direct exposure to doses more than 2Gy in oncologic radiotherapy, 162 CIEDs (116 PMs and 46 ICDs) from two different centers, with at least 4 months to Elective Replacement Indicator (E.R.I.) were evaluated. Methods All CIEDs had a baseline telemetry interrogation. Single chamber devices were programmed in the VVI/40 mode and dual or triple chamber devices were programmed in the DDD/40 mode. Rate adaptive function was disabled. In ICDs, antitachycardia therapies were disabled with the ventricular tachycardia/fibrillation monitor still enabled. To build the corresponding treatment plan a centering Computed Tomography was performed and CIEDs were blinded randomized (4:4:4) to either 2, 5 or 10 Gy direct exposure by a low photon-energy LINAC (6MV) in a water phantom. An in-vivo dosimetry assessed the effective dose received by the CIEDs. All CIEDs had a telemetry-interrogation, using manufacturer specific equipment, immediately after exposure and monthly for a four-month follow-up. Results Immediately after exposure, 1 reset to emergency mode was observed in a PM (0.6% overall; 0.9% among PMs)), while 7 PMs reached the E.R.I immediately after exposure (4.3% overall; 6% among PMs). 10 ICDs (6.2% overall; 21.8% among ICDs) reporded multiple ventricular fibrillation detection stored in the device memory. During follow-up, 3 PMs (1.9% overall; 2.6% among PMs) and 1 ICD (0.6% overall; 2.2% among ICDs) reached the E.R.I. and 1 PM (0.6% overall; 0.9% among PMs) switched to emergency mode. All reported events occurred regardless of either 2, 5, or 10 Gy direct exposure. Malfunctions were observed in only older CIEDs. Conclusions Our data suggest recent CIEDs withstanding direct oncologic radiotherapy exposure up to 10 Gy, commonly considered not recommended or even unsafe by manufacturer statements and clinical guidelines. Malfunctions occurred in only older devices. Acknowledgement/Funding None

A review and analysis of stereotactic body radiotherapy and radiosurgery of patients with cardiac implantable electronic devices.

The implementation of stereotactic body radiation therapy (SBRT) and stereotactic radiosurgery (SRS) has greatly increased due to its convenience and advantages from perspectives ranging from radiobiology to radio physics. Because SBRT/SRS delivers high doses in few fractions, precise dose delivery to target volumes and sufficient sparing of adjacent organs at risk (OARs) are required. Achieving these conflicting objectives is challenging for all patients receiving SBRT/SRS and may be particularly challenging when SBRT/SRS is adopted for treating patients with cardiac implantable electronic devices (CIEDs) because cumulative doses in CIEDs must be limited. Published research considering the different aspects of stereotactic treatment in patients with CIEDs was reviewed to summarise their findings in the following sections: (I) conventional linear accelerator (linac)-based SBRT and SRS; (II) CyberKnife, Gamma-Knife, VERO and helical tomotherapy SBRT and SRS; and (III) proton therapy. A total of 65 patients who had CIEDs and underwent SRS, SBRT, or SABR treatments were identified in the reviewed studies. The functionality of the CIEDs was assessed for 58 patients. Of those, CIED malfunctions (such as data loss, mode change, and inappropriate shock) were reported in four patients (6.89%). This review highlights the available sparse information in the literature by posing questions for future research.

CIED malfunction in patients receiving radiation is a rare event that could be detected by remote monitoring.

An increasing number of patients with cardiac devices require radiation therapy for treatment of a variety of cancers. This study aimed to identify the incidence and predictors of cardiac implantable electronic devices (CIED) malfunction in a real-world population that has received radiation therapy. This retrospective cohort study included 109 adult patients who received radiation therapy at the University of Rochester Medical Center, Radiation Oncology Department, between 2000 and 2015. Sixty patients had pacemakers and 49 had automatic implantable cardioverter defibrillators. Subjects received either high energy (16 MV) and/or low energy (6 MV) photon beams with or without electron beams (6-16 MeV). We included interrogations done from first day of radiation and up to 3 months' postradiation therapy. Outcomes analyzed were device-related malfunctions and device-related clinical events. Fisher's exact, Wilcoxon, and Kruskall-Wallis tests were used for bivariate analysis. Logistic regression with robust adjustment was used for multivariate analysis. We identified six device-related malfunctions. All events were minor and included partial settings reset leading to loss of historical data, pacing thresholds changes, lead impedance changes, and LV output increase. Two patients had device-related clinical events, including dyspnea and diaphragmatic-stimulation. In bivariate analysis, CIED malfunction was associated with CIED duration in situ. In multivariate analysis, there was no significant statistical association between adverse events and beam energy type, CIED location, or dose of radiation delivered to the target. CIED malfunctions are uncommon in real-world patients and associated with minor clinical events. In our cohort, remote CIED monitoring would have identified all events.

Radiotherapy in patients with pacemakers and implantable cardioverter defibrillators: What is next?

Introduction Practical recommendations for patients undergoing radiation therapy with Cardiac Implantable Electronic Devices (CIEDs) were published in 2012 from the Dutch Society of Radiotherapy. Purpose Our goal was to validate this guideline and to investigate whether we could advise for or against some specific recommendations. Materials and methods Between 2009 and 2016, 56 patients with CIEDs were treated in our institution. Dose to the CIED was assessed for every patient who was classified according to his risk. Patients were evaluated before, during and after radiotherapy by a cardiologist following guideline recommendations. Results Our patient focus group consisted of 39, 15 and 1 patients categorized into low, medium and high risk groups, respectively. The median age was 75 (range 54–98) years. Most treatments were prostate primaries (20%), brain metastasis (16%), head and neck primaries (9%) lung primaries (7%), and esophagus (5%). The prescribed dose ranged from 8 to 78 Gy with a daily dose ranging from 1.8 to 8 Gy. The maximum doses to the CIEDs were 179.1 cGy, 751 cGy and 1270 cGy, for the low, medium and high risk groups, respectively. Radiation therapy was safely delivered in all patients. Conclusion Our data support the fact that radiation dose seems to play a lesser role in inducing CIEDs malfunctions. Beam energy appears to be the essential factor in inducing these damaging effects according to the literature. Based on our work the following suggestions could be advocated: inactivation of antitachycardia therapies during RT as well as heart rhythm monitoring seems to be redundant and photon beam energy should be limited to ⩽10 MV.