Management of radiotherapy patients with implanted cardiac pacemakers and defibrillators: A Report of the AAPM TG-203†.

Managing radiotherapy patients with implanted cardiac devices (implantable cardiac pacemakers and implantable cardioverter-defibrillators) has been a great practical and procedural challenge in radiation oncology practice. Since the publication of the AAPM TG-34 in 1994, large bodies of literature and case reports have been published about different kinds of radiation effects on modern technology implantable cardiac devices and patient management before, during, and after radiotherapy. This task group report provides the framework that analyzes the potential failure modes of these devices and lays out the methodology for patient management in a comprehensive and concise way, in every step of the entire radiotherapy process.

Image guidance doses delivered during radiotherapy: Quantification, management, and reduction: Report of the AAPM Therapy Physics Committee Task Group 180.

BACKGROUND: With radiotherapy having entered the era of image guidance, or image-guided radiation therapy (IGRT), imaging procedures are routinely performed for patient positioning and target localization. The imaging dose delivered may result in excessive dose to sensitive organs and potentially increase the chance of secondary cancers and, therefore, needs to be managed. AIMS: This task group was charged with: a) providing an overview on imaging dose, including megavoltage electronic portal imaging (MV EPI), kilovoltage digital radiography (kV DR), Tomotherapy MV-CT, megavoltage cone-beam CT (MV-CBCT) and kilovoltage cone-beam CT (kV-CBCT), and b) providing general guidelines for commissioning dose calculation methods and managing imaging dose to patients. MATERIALS & METHODS: We briefly review the dose to radiotherapy (RT) patients resulting from different image guidance procedures and list typical organ doses resulting from MV and kV image acquisition procedures. RESULTS: We provide recommendations for managing the imaging dose, including different methods for its calculation, and techniques for reducing it. The recommended threshold beyond which imaging dose should be considered in the treatment planning process is 5% of the therapeutic target dose. DISCUSSION: Although the imaging dose resulting from current kV acquisition procedures is generally below this threshold, the ALARA principle should always be applied in practice. Medical physicists should make radiation oncologists aware of the imaging doses delivered to patients under their care. CONCLUSION: Balancing ALARA with the requirement for effective target localization requires that imaging dose be managed based on the consideration of weighing risks and benefits to the patient.

Assessment of radiopharmaceutical retention for vascular access ports using positron emission tomography imaging.

PURPOSE: The purpose of this study was to resolve the issue of whether various generations of CR Bard peripheral vascular access ports and catheters are prone to retain PET radiopharmaceuticals. The study evaluates the residual radioactivity remaining following injection for two PET radiopharmaceuticals currently used extensively in the clinic, FDG and Na18 F. METHODS: FDG was purchased from a local cyclotron facility and Na18 F was prepared in-house. Three generations of currently marketed vascular access ports were tested. A total of five (n = 5) of each model was tested. Radiopharmaceutical of 2-3 mCi of each was injected into each port and flushed with 10, 30, 60, and 120 ml of saline. MicroPET scans were performed after each flush to detect the residual radioactivity on each port. A dose calibrator was used to detect the retention of radioactivity after each flush. RESULTS: Radioactivity retention for all vascular port models measured by microPET imaging was similar for both FDG and Na18 F, with less than 1% residual activity following a 10 ml saline flush. Based on the microPET images, all the subsequent flushes of 30, 60, and 120 ml were also considered. Dose calibrator activity measurements validated microPET measurements as negligible for all the ports, even with the first 10 ml flush. CONCLUSIONS: MicroPET imaging was more sensitive than the dose calibrator in determining the radioactivity retention of the vascular access ports from CR Bard. These ports may be used for the injection of FDG and Na18 F to track glucose metabolism and bone uptake with PET imaging. It is recommended to apply at least a 10 ml flush after radiopharmaceutical administration, to reduce residual activity to baseline levels.

In Vitro PET Imaging of a Miniature Ventricular Assist Device.

UNLABELLED: Interactions between the life-sustaining ventricular assist devices and diagnostic therapies must be carefully considered to decrease the risk of inaccurate diagnostic imaging or pump failure. METHODS: The MVAD(®) pump, currently under investigational use, was tested for interaction with radiotracers in an in vitro flow-loop study. The radiotracers (18)F-sodium fluoride and (18)F-FDG were injected into a closed loop to determine the feasibility of direct imaging of the MVAD(®) pump in a PET scanner. RESULTS: No real-time changes were observed in pump operation, and there were no statistical differences in pump parameters (power consumption, speed, and estimated flow rate) between the baseline and circulation conditions. In addition, no effect was observed on any external components, including the permissive-action-link controller and the batteries powering the device. Imaging of the internal pump components was possible, with obscuration observed only in the portion of the pump where the spinning impeller is located. Retention of radiotracer in the pump components after circulation was minimal (<1%). CONCLUSION: PET imaging is an attractive diagnostic tool for patients with a ventricular assist device and may have additional utility outside its current use, detection of infection.

Addendum to brachytherapy dose-volume histogram commissioning with multiple planning systems.

The process for validating dose-volume histogram data in brachytherapy software is presented as a supplement to a previously published article. Included is the DVH accuracy evaluation of the Best NOMOS treatment planning system called "Best TPS VolumePlan." As done previously in other software, a rectangular cuboid was contoured in the treatment planning system. A single radioactive 125I source was positioned coplanar and concentric with one end. Calculations were performed to estimate dose deposition in partial volumes of the cuboid structure, using the brachytherapy dosimetry formalism defined in AAPM Task Group 43. Hand-calculated, dose-volume results were compared to TPS-generated, point-source-approximated dose-volume histogram data to establish acceptance. The required QA for commissioning was satisfied for the DVH as conducted previously for other software, using the criterion that the DVH %VolTPS "actual variance" calculations should differ by no more than 5% at any specific radial distance with respect to %VolTG-43, and the "average variance" DVH %VolTPS calculations should differ by no more than 2% over all radial distances with respect to %VolTG-43. The average disagreement observed between hand calculations and treatment planning system DVH was less than 0.5% on average for this treatment planning system and less than 1.1% maximally for 1 ≤ r ≤ 5 cm.

Radiation Testing of the GERD Stimulation Therapy System Using a Particle Accelerator.

OBJECTIVE: This testing was conducted to determine if exposure from a particle accelerator used to treat cancer patients would alter the performance of the EndoStim® neurostimulator when programmed either passively or actively and while being irradiated. METHODS: A total of 12 EndoStim Lower Esophageal Sphincter (LES) Stimulation System implantable neurostimulators were investigated in this research. Included were six each of the EndoStim I and EndoStim II. Half were used for passive testing, with the remaining half for active testing. Bremsstrahlung x-rays were delivered having a nominal energy of 18 MV at a rate of 6 Gy/min. A total dose of 80 Gy was achieved in testing minimally. RESULTS: Monitoring of stimulation frequency, amplitude, pulse width, stimulation time, and voltage was conducted using software developed by EndoStim along with an oscilloscope. No observed changes to the intended stimulation were noted and all scheduled parameter magnitudes were achieved with device operation. All functional parameter changes were within ±10% from baseline. CONCLUSIONS: EndoStim I and EndoStim II implant pulse generators appear to be immune to x-ray radiation from the particle accelerator at energies up to 18 MV, at dose rates of up to 6 Gy/min, and up to cumulative doses of minimally 80 Gy. As there were no observable effects on neurostimulation requirements, the EndoStim LES Stimulation System implantable neurostimulators are capable of withstanding direct radiation. The recommendations of the manufacturer should be followed further regarding the labeling requirements for insured safety to patients.

Treatment approach, delivery, and follow-up evaluation for cardiac rhythm disease management patients receiving radiation therapy: retrospective physician surveys including chart reviews at numerous centers.

In a 2-part study, we first examined the results of 71 surveyed physicians who provided responses on how they address the management of patients who maintained either a pacemaker or a defibrillator during radiation treatment. Second, a case review study is presented involving 112 medical records reviewed at 18 institutions to determine whether there was a change in the radiation prescription for the treatment of the target cancer, the method of radiation delivery, or the method of radiation image acquisition. Statistics are provided to illustrate the level of administrative policy; the level of communication between radiation oncologists and heart specialists; American Joint Committee on Cancer (AJCC) staging and classification; National Comprehensive Cancer Network (NCCN) guidelines; tumor site; patient׳s sex; patient׳s age; device type; manufacturer; live monitoring; and the reported decisions for planning, delivery, and imaging. This survey revealed that 37% of patient treatments were considered for some sort of change in this regard, whereas 59% of patients were treated without regard to these alternatives when available. Only 3% of all patients were identified with an observable change in the functionality of the device or patient status in comparison with 96% of patients with normal behavior and operating devices. Documented changes in the patient׳s medical record included 1 device exhibiting failure at 0.3-Gy dose, 1 device exhibiting increased sensor rate during dose delivery, 1 patient having an irregular heartbeat leading to device reprogramming, and 1 patient complained of twinging in the chest wall that resulted in a respiratory arrest. Although policies and procedures should directly involve the qualified medical physicist for technical supervision, their sufficient involvement was typically not requested by most respondents. No treatment options were denied to any patient based on AJCC staging, classification, or NCCN practice standards.

Detector system dose verification comparisons for arc therapy: couch vs. gantry mount.

The aim of this study was to assess the performance of a gantry-mounted detector system and a couch set detector system using a systematic multileaf collimator positional error manually introduced for volumetric-modulated arc therapy. Four head and neck and esophagus VMAT plans were evaluated by measurement using an electronic portal imaging device and an ion chamber array. Each plan was copied and duplicated with a 1 mm systematic MLC positional error in the left leaf bank. Direct comparison of measurements for plans with and without the error permitted observational characteristics for quality assurance performance between detectors. A total of 48 different plans were evaluated for this testing. The mean percentage planar dose differences required to satisfy a 95% match between plans with and without the MLCPE were 5.2% ± 0.5% for the chamber array with gantry motion, 8.12% ± 1.04% for the chamber array with a static gantry at 0°, and 10.9%± 1.4% for the EPID with gantry motion. It was observed that the EPID was less accurate due to overresponse of the MLCPE in the left leaf bank. The EPID always images bank-A on the ipsilateral side of the detector, whereas for a chamber array or for a patient, that bank changes as it crosses the -90° or +90° position. A couch set detector system can reproduce the TPS calculated values most consistently. We recommend it as the most reliable patient specific QA system for MLC position error testing. This research is highlighted by the finding of up to 12.7% dose variation for H/N and esophagus cases for VMAT delivery, where the mere source of error was the stated clinically acceptability of 1 mm MLC position deviation of TG-142.

Brachytherapy dose-volume histogram commissioning with multiple planning systems.

The first quality assurance process for validating dose-volume histogram data involving brachytherapy procedures in radiation therapy is presented. The process is demonstrated using both low dose-rate and high dose-rate radionuclide sources. A rectangular cuboid was contoured in five commercially available brachytherapy treatment planning systems. A single radioactive source commissioned for QA testing was positioned coplanar and concentric with one end. Using the brachytherapy dosimetry formalism defined in the AAPM Task Group 43 report series, calculations were performed to estimate dose deposition in partial volumes of the cuboid structure. The point-source approximation was used for a 125I source and the line-source approximation was used for a 192Ir source in simulated permanent and temporary implants, respectively. Hand-calculated, dose-volume results were compared to TPS-generated, dose-volume histogram (DVH) data to ascertain acceptance. The average disagreement observed between hand calculations and the treatment planning system DVH was less than 1% for the five treatment planning systems and less than 5% for 1 cm ≤ r ≤ 5 cm. A reproducible method for verifying the accuracy of volumetric statistics from a radiation therapy TPS can be employed. The process satisfies QA requirements for TPS commissioning, upgrading, and annual testing. We suggest that investigations be performed if the DVH %Vol(TPS) "actual variance" calculations differ by more than 5% at any specific radial distance with respect to %Vol(TG-43), or if the "average variance" DVH %Vol(TPS) calculations differ by more than 2% over all radial distances with respect to %Vol(TG-43).

Microbubble-assisted p53, RB, and p130 gene transfer in combination with radiation therapy in prostate cancer.

Combining radiation therapy and direct intratumoral (IT) injection of adenoviral vectors has been explored as a means to enhance the therapeutic potential of gene transfer. A major challenge for gene transfer is systemic delivery of nucleic acids directly into an affected tissue. Ultrasound (US) contrast agents (microbubbles) are viable candidates to enhance targeted delivery of systemically administered genes. Here we show that p53, pRB, and p130 gene transfer mediated by US cavitation of microbubbles at the tumor site resulted in targeted gene transduction and increased reduction in tumor growth compared to DU-145 prostate cancer cell xenografts treated intratumorally with adenovirus (Ad) or radiation alone. Microbubble-assisted/US-mediated Ad.p53 and Ad.RB treated tumors showed significant reduction in tumor volume compared to Ad.p130 treated tumors (p<0.05). Additionally, US mediated microbubble delivery of p53 and RB combined with external beam radiation resulted in the most profound tumor reduction in DU-145 xenografted nude mice (p<0.05) compared to radiation alone. These findings highlight the potential therapeutic applications of this novel image-guided gene transfer technology in combination with external beam radiation for prostate cancer patients with therapy resistant disease.

Vagus nerve stimulator stability and interference on radiation oncology x-ray beams.

Five different models of Cyberonics, Inc. vagus nerve stimulation (VNS) therapy pulse generators were investigated for their stability under radiation and their ability to change the absorbed dose from incident radiation. X-ray beams of 6 MV and 18 MV were used to quantify these results up to clinical doses of 68-78 Gy delivered in a single fraction. In the first part, the effect on electronic stimulation signaling of each pulse generator was monitored during and immediately afterwards with computer interrogation. In the second part, the effects of having the pulse generators scatter or attenuate the x-ray beam was also characterized from dose calculations on a treatment planning system as well as from actual radiation measurements. Some device models were found to be susceptible to radiation interference when placed directly in the beam of high energy therapeutic x-ray radiation. While some models exhibited no effect at all, others showed an apparent loss of stimulation output immediately after radiation was experienced. Still, other models were observed to have a cumulative dose effect with a reduced output signal, followed by battery depletion above 49 Gy. Absorbed dose changes on computer underestimated attenuation by nearly half for both energies amongst all pulse generators, although the computer did depict the proper shape of the changed distribution of dose around the device. Measured attenuation ranged from 7.0% to 11.0% at 6 MV and 4.2% to 5.2% at 18 MV for x-rays. Processes of back-scatter and side-scatter were deemed negligible although recorded. Identical results from 6 MV and 18 MV x-ray beams conclude no neutron effect was induced for the 18 MV beam. As there were documented effects identified in this research regarding pulse generation, it emphasizes the importance of caution when considering radiation therapy on patients with implanted VNS devices with observed malfunctions consequential.

Evaluation of a ventricular assist device system: stability in a proton beam therapy.

Inadequate research exists regarding testing of a ventricular assist device (VAD) for susceptibility to radiation damage. Specifically, minimal data are available to radiation oncologists prescribing treatment plans for patients with an implanted VAD. As the number of implanted devices increases, patients requiring radiation at tissue sites near or at the device will increase. The purpose of this study is to provide the first analysis of radiation effects of proton beams on VADs. Five left VAD (LVAD) pumps (HeartWare Inc., Miami Lakes, FL) were exposed to proton beam radiation at a calibrated dose rate of 5 Gy/min up to a cumulative dose of 70 Gy. The Heartware LVAD pump recorded parameters including power (W), speed (revolutions/min), and estimated flow (L/min). Analysis of collected data after each irradiation found no deviation in pump parameters from baseline values. The Heartware LVAD pump exhibited no change in device function when directly irradiated by a high energy proton beam. Secondary neutron fluence created in the proton beam during irradiation had no effect on external components including the system controller and batteries powering the Heartware LVAD.

Evaluation of a ventricular assist device: stability under x-rays and therapeutic beam attenuation.

Improved outcomes and quality of life of heart failure patients have been reported with the use of left ventricular assist devices (LVADs). However, little information exists regarding devices in patients undergoing radiation cancer treatment. Two HeartWare Ventricular Assist Device (HVAD) pumps were repeatedly irradiated with high intensity 18 MV x-rays to a dosage range of 64-75 Gy at a rate of 6 Gy/min from a radiation oncology particle accelerator to determine operational stability. Pump parameter data was collected through a data acquisition system. Second, a computerized tomography (CT) scan was taken of the device, and a treatment planning computer estimated characteristics of dose scattering and attenuation. Results were then compared with actual radiation measurements. The devices exhibited no changes in pump operation during the procedure, though the titanium components of the HVAD markedly attenuate the therapy beam. Computer modeling indicated an 11.8% dose change in the absorbed dosage that was distinctly less than the 84% dose change measured with detectors. Simulated and measured scattering processes were negligible. Computer modeling underestimates pretreatment dose to patients when the device is in the field of radiation. Future x-ray radiation dosimetry and treatment planning in HVAD patients should be carefully managed by radiation oncology specialists.

A novel phantom model for mouse tumor dose assessment under MV beams.

In order to determine a mouse's dose accurately and prior to engaging in live mouse radiobiological research, a tissue-equivalent tumor-bearing phantom mouse was constructed and bored to accommodate detectors. Comparisons were made among four different types of radiation detectors, each inserted into the mouse phantom for radiation measurement under a 6 MV linear accelerator beam. Dose detection response from a diode, thermoluminescent dosimeters, and metal-oxide semiconductor field-effect transistors were used and compared to that of a reference pinpoint ionization chamber. A computerized treatment planning system was also directly compared to the chamber. Each detector system demonstrated results similar to the dose computed by the treatment planning system, although some differences were noted. The average disagreement from an accelerator calibrated output dose prescription in the range of 200-400 cGy was -0.4% ± 0.5 σ for the diode, -2.4% ± 2.6 σ for the TLD, -2.9% ± 5.0 σ for the MOSFET, and +1.3% ± 1.4 σ for the treatment planning system. This phantom mouse design is unique, simple, reproducible, and therefore recommended as a standard approach to dosimetry for radiobiological mouse studies by means of any of the detectors used in this study. The authors fully advocate for treatment planning modeling when possible prior to linac-based dose delivery.

Design of site-specific prognostic morbidity-mortality studies and internal outcome focus studies in radiation oncology.

This research focuses on morbidity-mortality reviews and internal outcome focus studies. Definitions are provided as well as a complete discussion of the ideal parameters to consider when constructing each of these. The implementation of the design characteristics used may be of assistance to a center pursuing achievement of these requirements toward accreditation to exemplify continuous quality improvement in external-beam radiation therapy. The article further provides the educational tools necessary for readers to mature expanded studies from it for advanced site-specific clinical analyses.

Beam profile disturbances from implantable pacemakers or implantable cardioverter-defibrillator interactions.

The medical community is advocating for progressive improvement in the design of implantable cardioverter-defibrillators and implantable pacemakers to accommodate elevations in dose limitation criteria. With advancement already made for magnetic resonance imaging compatibility in some, a greater need is present to inform the radiation oncologist and medical physicist regarding treatment planning beam profile changes when such devices are in the field of a therapeutic radiation beam. Treatment plan modeling was conducted to simulate effects induced by Medtronic, Inc.-manufactured devices on therapeutic radiation beams. As a continuation of grant-supported research, we show that radial and transverse open beam profiles of a medical accelerator were altered when compared with profiles resulting when implantable pacemakers and cardioverter-defibrillators are placed directly in the beam. Results are markedly different between the 2 devices in the axial plane and the sagittal planes. Vast differences are also presented for the therapeutic beams at 6-MV and 18-MV x-ray energies. Maximum changes in percentage depth dose are observed for the implantable cardioverter-defibrillator as 9.3% at 6 MV and 10.1% at 18 MV, with worst distance to agreement of isodose lines at 2.3 cm and 1.3 cm, respectively. For the implantable pacemaker, the maximum changes in percentage depth dose were observed as 10.7% at 6 MV and 6.9% at 18 MV, with worst distance to agreement of isodose lines at 2.5 cm and 1.9 cm, respectively. No differences were discernible for the defibrillation leads and the pacing lead.

Radiation therapy in cochlear implant recipients.

HYPOTHESIS: Processes of scattering and attenuation were investigated to determine the consequence on dose distributions by having a cochlear implant in the field of therapeutic radiation. BACKGROUND: Radiation oncology medical accelerator beams of 6- and 18-MV x-ray energy were used. Five cochlear implants were investigated. METHODS: Each implant model was individually studied using computer dose modeling and through exercises in radiation measurement during live delivery. RESULTS: No side scatter was detected, and negligible backscattering was observed for the primary device housing and electrodes. Attenuation consequences were found to be dependent on the model of cochlear implant studied and specifically dependent on the material composition of each device. CONCLUSION: The maximum attenuated dose change for the study was found to be -8.8% for 6 MV and -6.6% for 18 MV. This study presents the first comparison of therapeutic radiation delivery versus computerized treatment simulation involving cochlear implants.

Effects on radiation oncology treatments involving various neuromodulation devices.

OBJECT: Where no society-based or manufacturer guidance on radiation limits to neuromodulation devices is available, this research provides the groundwork for neurosurgeons and radiation oncologists who rely on the computerized treatment plan clinically for cancer patients. The focus of the article is to characterize radiation parameters of attenuation and scatter when an incident therapeutic x-ray beam is directed upon them. At the time of this writing, manufacturers of Neuromodulation products do not recommend direct exposure of the device in the beam nor provide guidance for the maximum dose for these devices. METHODS: Ten neuromodulation models were chosen to represent the finite class of devices marketed by Medtronic before 2011. CT simulations permitted computer treatment modeling for dose distribution analysis as used routinely in radiation oncology for patients. Phantom case results were directly compared to actual clinical patient cases. Radiation detection measurements were then correlated to computational results. Where the x-ray beam passes through the device and is attenuated, dose reduction was identified with Varian Eclipse computer modeling for these posterior locations. RESULTS: Although the computer algorithm did not identify physical processes of side-scatter and back-scatter, these phenomena were proven by radiation measurement to occur. In general, the computer results underestimated the level of change seen by measurement. CONCLUSIONS: For these implantable neurostimulators, the spread in dose changes were found to be -6.2% to -12.5% by attenuation, +1.7% to +3.8% by side-scatter, and +1.1% to +3.1% by back-scatter at 6 MV. At 18 MV, these findings were observed to be -1.4% to -7.0% by attenuation, +1.8% to 5.7% by side-scatter, and 0.8% to 2.7% by back-scatter. No pattern for the behavior of these phenomena was deduced to be a direct consequence of device size.