Fit of biokinetic data in molecular radiotherapy: a machine learning approach.

BACKGROUND: In literature are reported different analytical methods (AM) to choose the proper fit model and to fit data of the time-activity curve (TAC). On the other hand, Machine Learning algorithms (ML) are increasingly used for both classification and regression tasks. The aim of this work was to investigate the possibility of employing ML both to classify the most appropriate fit model and to predict the area under the curve (τ). METHODS: Two different ML systems have been developed for classifying the fit model and to predict the biokinetic parameters. The two systems were trained and tested with synthetic TACs simulating a whole-body Fraction Injected Activity for patients affected by metastatic Differentiated Thyroid Carcinoma, administered with [131I]I-NaI. Test performances, defined as classification accuracy (CA) and percentage difference between the actual and the estimated area under the curve (Δτ), were compared with those obtained using AM varying the number of points (N) of the TACs. A comparison between AM and ML were performed using data of 20 real patients. RESULTS: As N varies, CA remains constant for ML (about 98%), while it improves for F-test (from 62 to 92%) and AICc (from 50 to 92%), as N increases. With AM, [Formula: see text] can reach down to - 67%, while using ML [Formula: see text] ranges within ± 25%. Using real TACs, there is a good agreement between τ obtained with ML system and AM. CONCLUSIONS: The employing of ML systems may be feasible, having both a better classification and a better estimation of biokinetic parameters.

Dose-Related Analysis in Percutaneous Central Venous Catheters Insertion: Experience of a Pediatric Interventional Radiology Center.

BACKGROUND: There are many techniques for long-term central venous catheter (CVC) placement, but none of them are specific for pediatric patients or focused on the delivered dose of ionizing radiation. MATERIALS AND METHODS: This retrospective study examined a sample of pediatric patients who received percutaneous long-term CVC positioning in a tertiary care pediatric hospital. Effective dose, dose-area product (DAP) and length of time of exposition during the procedure were determined, using an appropriate technical procedure, exam and program set of the angiograph, and compared with an unpaired t-test analysis. RESULTS: The study included 1410 enrolled patients, with a median age of 10 years (range 0.2-18 years), between 2016 and 2019. In 2016 (318 pts), the mean effective dose was 0.13 mSv and the mean DAP dose was 18.95 µGy/m2 In 2017 (353 pts), the mean effective dose was 0.11 mSv and the mean DAP dose was 17.26 µGy/m2. In 2018 (351 pts), the mean effective dose was 0.05 mSv and the mean DAP dose was 7.23 µGy/m2. In 2019 (388 pts), the mean effective dose was 0.02 mSv and the mean DAP dose was 3.10 µGy/m2. CONCLUSIONS: Medical and technical expertise led to a remarkable reduction in the radiation dose. Therefore, the authors' hypothesis is that US- and fluoroscopy-guided percutaneous long-term CVC insertion technique is safer, more cost-effective and lower in terms of radiation exposure if correctly applied, compared to surgical or percutaneous by direct puncture techniques.

Personalized dosimetry for a deeper understanding of metastatic response to high activity 131I-mIBG therapy in high risk relapsed refractory neuroblastoma.

BACKGROUND: Dosimetry in molecular radiotherapy for personalized treatment is assuming a central role in clinical management of aggressive/relapsed tumors. Relapsed/refractory metastatic high-risk neuroblastoma (rrmHR-NBL) has a poor prognosis and high-activity 131I-mIBG therapy could represent a promising strategy. The primary aim of this case series study was to report the absorbed doses to whole-body (DWB ), red marrow (DRM ) and lesions (DLesion ). A secondary aim was to correlate DLesion values to clinical outcome. METHODS: Fourteen patients affected by rrmHR-NBL were treated with high-activity 131I-mIBG therapy (two administrations separated by 15 days). The first administration was weight-based whereas the second one was dosimetry-based (achieving DWB equals to 4 Gy). In all patients DWB and DRM was assessed; 9/14 patients were selected for DLesion evaluation using planar dosimetric approach (13 lesions evaluated). Treatment response was classified as progressive and stable disease (PD and SD), partial and complete response (PR and CR) according to the International Neuroblastoma Response Criteria. Patients were divided into two groups: Responder (CR, PR, SD) and Non-Responder (PD), correlating treatment response to DLesion value. RESULTS: The cumulative DWB , DRM and DLesion ranged from (1.5; 4.5), (1.0; 2.6) and (44.2; 585.8) Gy. A linear correlation between DWB and DRM and a power law correlation between the absorbed dose to WB normalized for administered activity and the mass of the patient were observed. After treatment 3, 2, 4 and 5 patients showed CR, PR, SD and PD respectively, showing a correlation between DLesion and the two response group. CONCLUSIONS: Our experience demonstrated feasibility of high activity therapy of 131I-mIBG in rrmHR-NBL children as two administration intensive strategy. Dosimetric approach allowed a tailored high dose treatment maximizing the benefits of radionuclide therapy for pediatric patients while maintaining a safety profile. The assesment of DLesion contributed to have a deeper understaning of metabolic treatment effects.

Tandem high-dose 131I-MIBG therapy supported by dosimetry in pediatric patients with relapsed-refractory high-risk neuroblastoma: the Bambino Gesu' Children's Hospital experience.

OBJECTIVE: 131I-meta-iodobenzylguanidine (131I-MIBG) combined with myeloablative chemotherapy represents an effective treatment in children affected by relapsed/refractory neuroblastoma (NBL) for disease palliation and in improving progression-free survival. The aim of our study is to evaluate the feasibility, safety and efficacy of tandem 131I-MIBG followed by high-dose chemotherapy with Melphalan. METHODS: Thirteen patients (age range: 3-17 years) affected by relapsed/refractory NB, previously treated according to standard procedures, were included in the study. Each treatment cycle included two administrations of 131I-MIBG (with a dosimetric approach) followed by a single dose of Melphalan with peripheral blood stem cell rescue. RESULTS: At the end of the treatment, ten patients experienced grade 4 neutropenia, two grade 3 and one patient grade 2, three patients presented febrile neutropenia and all needed RBC and platelets transfusions; one patient presented grade 4 mucositis, four grade 3 and one patient grade 2 mucositis. One patient showed progressive disease, eight patients showed stable disease and four patients showed partial response. CONCLUSION: High-dose 131I-MIBG therapy combined with chemotherapy represent a well-tolerated and effective modality of treatment in heavily pretreated patients affected by relapsed/refractory NBL. However, further studies, including a wider cohort of patients, are needed.

Dosimetric optimization of nuclear medicine therapy based on the Council Directive 2013/59/EURATOM and the Italian law N. 101/2020. Position paper and recommendations by the Italian National Associations of Medical Physics (AIFM) and Nuclear Medicine (AIMN).

This recommendation by the Italian Associations of Nuclear Medicine (AIMN) and Medical Physics (AIFM) focuses on the dosimetric optimization of Nuclear Medicine Therapy (NMT) as clearly requested by the article 56 of the EURATOM Directive 2013/59 and its consequent implementation in article 158 in the Italian Law n. 101/2020. However, this statement must deal with scientific and methodological limits that still exist and, above all, with the currently available limited resources. This paper addresses these specific issues. It distinguishes among many possible kinds of NMT. For each type, dosimetric optimization is recommended or considered optional, according to the general criteria adopted in any human choice, i.e. a check of technical feasibility first, followed by a cost/benefit argument. The classification of therapies as standardized or non-standardized is presented. This is based on the complexity of the type of pathology, on the variability of the treatment outcome, and on the risks involved. According to the present document, which was officially delivered to Italian Health Ministry as necessary interpretation of the law, a therapeutic team can, in science and consciousness, overcome the indications of posology, to optimize and tailoring a treatment with dosimetry, on the basis of published national or international data or guidelines, without need of an Ethics Committee approval. Data collected in this way will provide additional evidence about optimal dosimetric reference values. As conclusion, a formal appeal is made to the European and National regulatory agencies for pharmaceuticals to obtain the official acknowledgment of this principle.

Italian inter-society expert panel position on radiological exposure in Neonatal Intensive Care Units.

BACKGROUND: In the recent years, clinical progress and better medical assistance for pregnant women, together with the introduction of new complex technologies, has improved the survival of preterm infants. However, this result requires frequent radiological investigations mostly represented by thoracic and abdominal radiographs in incubators. This document was elaborated by an expert panel Italian inter-society working group (Radiologists, Paediatricians, Medical Physicists) with the aim to assist healthcare practitioners in taking choices involving radiation exposures of new-born infants and to provide practical recommendations about justification and optimization in Neonatal Intensive Care Units. The adherence to these practice recommendations could ensure a high quality and patient safety. More complex and less common radiological practice, such as CT scan or fluoroscopy have been excluded. METHODS: The consensus was reached starting from current good practice evidence shared by four scientific societies panel: AIFM (Italian Association of Physics in Medicine), SIN (Italian Neonatology Society), SIP (Italian Paediatric Society), SIRM (Italian Medical Radiology Society) in order to guarantee good standard practices for every professional involved in Neonatal Intensive Care Units (NICU). The report is divided into clinical and physical-dosimetric sections: clinical Indications, good practice in radiological exposures, devices, exposure parameters and modalities, patient positioning and immobilization, Reference Diagnostic Levels, operators and patient's radiation protection. Another important topic was the evaluation of the different incubators in order to understand if the consequences of the technological evolution have had an impact on the increase of the dose to the small patients, and how to choose the best device in terms of radiation protection. At the end the working group faced the problem of setting up the correct communication between clinicians and parents following the most recent indications of the international paediatric societies. RESULTS: Taking into account the experience and expertise of 10 Italian Centres, the guideline sets out the criteria to ensure a high standard of neonatal care in NICU about procedures, facilities, recommended equipment, quality assurance, radiation protection measures for children and staff members and communication on radiation risk. CONCLUSIONS: This document will allow a standardization of the approach to the exposures in NICU, although oriented to a flexible methodology.

Protecting sensitive patient groups from imaging using ionizing radiation: effects during pregnancy, in fetal life and childhood.

The frequency of imaging examinations requiring radiation exposure in children (especially CT) is rapidly increasing. This paper reviews the current evidence in radiation protection in pediatric imaging, focusing on the recent knowledge of the biological risk related to low doses exposure. Even if there are no strictly defined limits for patient radiation exposure, it is recommended to try to keep doses as low as reasonably achievable (the ALARA principle). To achieve ALARA, several techniques to reduce the radiation dose in radiation-sensitive patients groups are reviewed. The most recent recommendations that provide guidance regarding imaging of pregnant women are also summarized, and the risk depending on dose and phase of pregnancy is reported. Finally, the risk-benefit analysis of each examination, and careful communication of this risk to the patient, is emphasized.

Pre and post operative radiation protection in Ru-106 brachytherapy ophthalmic plaque surgery and related material shielding properties.

Pre and post-operative exposure levels of medical staff and people from public in intra-operative Ru-106 ophthalmic brachytherapy are reported, together with attenuation properties of selected shielding materials. In particular radiation exposure of workers during plaque transportation and during medical assistance of implanted plaque patient was measured. Taking into account dose rates and considering standard assistance procedure of hospitalized patients, the exposure of medical staff and people of the public were evaluated for a given workload. In order to provide tools to optimize radiation protection, considering social and economic aspects due to possible hospital discharge or hospital stay, the attenuation properties of common shielding materials (lead, concrete, red brick, PMMA and gypsum) were measured, considering both narrow and broad beam setups. The eye was simulated using a water equivalent phantom and plaque was fixed on it. All measurements were performed with calibrated survey meters. Results were compared with numerical simulation of bremsstrahlung X-ray radiation spectra emitted from patient eye. Exposure levels measured at 1 m distance in front of the implanted eye are 0.05 µSv/h/MBq, at 10 cm from patient head, 0.44 µSv/h/MBq (plaque side), 0.4 µSv/h/MBq (front), 0.25 µSv/h/MBq (lateral, opposed to plaque), 0.2 µSv/h/MBq (back). Average exposure levels, under conservative assumptions, for medical staff is 17 µSv/patient and less than 23 µSv/patient for careers and comforters. TVLs in lead and concrete are about 1.6 cm and 11.5 cm respectively.

Is MRI imaging in pediatric age totally safe? A critical reprisal.

Current radiological literature is strongly focussed on radiation imaging risks. Indeed, given there is a small but actual augment in cancer risk from exposure to ionizing radiation in children, it is important to understand what the risk of alternative techniques could be. We retrospectively review literature data concerning possible MR imaging risks, focussing on the biological effects of MR, sedation and gadolinium compound risks when dealing with infant patients. The main concerns can be summarized in: (1) Biological effects of non-ionizing electromagnetic fields (EMF) employed-whose mechanisms of interaction with human tissues are polarization, induced current, and thermal heating, respectively. (2) Risks associated with noises produced during MRI examinations. (3) Hazards from ferromagnetic external and/or implanted devices-whose risk of being unintentionally brought inside MR room is higher in children than in adults. (4) Risks associated with sedation or general anaesthesia, essential problem in performing MR in very young patients, due to the exam long-lasting. (5) Risks related to gadolinium-based contrast agents, especially considering the newly reported brain deposition.

Quantification of scatter radiation from radiographic procedures in a neonatal intensive care unit.

BACKGROUND: In a neonatal intensive care unit (NICU), preterm infants are often exposed to a large number of radiographic examinations, which could cause adjacent neonates, family caregivers and staff members to be exposed to a dose amount due to scatter radiation. OBJECTIVE: To provide information on scatter radiation exposure levels in a NICU, to compare these values with the effective dose limits established by the European Union and to evaluate the effectiveness of radiation protection devices in this setting. MATERIALS AND METHODS: Radiation exposure levels due to scatter radiation were estimated by passive detectors (thermoluminescent dosimeters) and direct dosimetric measurements (with a dose rate meter); in the latter case, an angular map of the scatter dose distribution was achieved. RESULTS: The dose due to scatter radiation to staff in our setting is approximately 160 µSv/year, which is markedly lower than the effective dose limit for workers established by the European Union (20 mSv/year). The doses range between 0.012 and 0.095 µSv/radiograph. Considering a mean hospitalization period of 3 months and our NICU workload, the corresponding scatter radiation dose to an adjacent patient and/or his/her caregiver is at most 40 µSv. CONCLUSION: For distances greater than 1 m from the irradiation field, both scatter dose absorbed by a staff member during a year and that by an adjacent patient and/or his/her caregiver during hospitalization is less than 1 mSv, which is the exposure limit for public members in a year.

Occupational exposure in MR facilities due to movements in the static magnetic field.

PURPOSE: The exposure of operators moving in the static field of magnetic resonance (MR) facilities was assessed through measurements of the magnetic flux density, which is experienced as variable in time because of the movement. Collected data were processed to allow the comparison with most recent and authoritative safety standards. METHODS: Measurements of the experienced magnetic flux density B were performed using a probe worn by volunteers moving in MR environments. A total of 55 datasets were acquired nearby a 1.5 T, 3 T, and 7 T whole body scanners. Three different metrics were applied: the maximum intensity of B, to be compared with 2013/35/EU Directive exposure limit values for static fields; the maximum variation of the vector B on every 3s-interval, for comparison with the ICNIRP-2014 basic restriction aimed at preventing vertigo effects; two weighted-peak indices (for "sensory" and "health" effects: SENS-WP, HLTH-WP), assessing compliance with ICNIRP-2014 and EU Directive recommendations intended to prevent stimulation effects. RESULTS: Peak values of |B| were greater than 2 T in nine of the 55 datasets. All the datasets at 1.5 T and 3 T were compliant with the limit for vertigo effects, whereas six datasets at 7 T turned out to be noncompliant. At 7 T, all 36 datasets were noncompliant for the SENS-WP index and 26 datasets even for the HLTH-WP one. CONCLUSIONS: Results demonstrate that compliance with EU Directive limits for static fields does not guarantee compliance with ICNIRP-2014 reference levels and clearly show that movements in the static field could be the key component of the occupational exposure to EMF in MR facilities.

A novel method for CT dosimetry with a suspended phantom setup.

PURPOSE: This work presents a method for estimating CT dosimetric indices with a prototype designed for suspending the phantom/ion chamber system fixed at the CT isocenter. The purpose of this study was to validate the proposed methodology, which can be used to provide a direct assessment of dosimetric indices in helical scans. METHODS: The method is based on a reference setup in which the measuring system for CT dosimetry is in a stationary configuration, i.e. not bound to the CT table, and on a mathematical formalism developed for the proposed reference system. The reliability of the method was demonstrated through a set of experimental measurements. Firstly, dosimetric indices were measured with the new method and compared with the indices obtained with the procedure currently used for CT dosimetry (measuring system bound to the CT table). Secondly, dosimetric indices measured with the new method were compared with those displayed on the CT console. RESULTS: There is good agreement between the dosimetric indices obtained with the standard setup and those obtained with the suspended phantom setup, within the expected range of errors. The difference between dosimetric indices estimated with the proposed method and those displayed on the CT console is below 2%. CONCLUSIONS: The method enables CT dosimetry to be performed with the dose detector in a stationary longitudinal position thanks to the newly introduced suspended phantom setup. Using this approach, CT dose can be assessed for high pitch helical scans, acquisitions without complete tube rotation and for cases where dynamic collimation is used.

Radiation exposure in diagnostic imaging: wisdom and prudence, but still a lot to understand.

Since 2000, a series of scientific articles on CT have been raising increasing concern about the risk of radiation induced cancer in children. The alarming conclusions of some of these articles had international echo through global media, provoking widespread public concern. Actually, many of these alarming scientific publications appeared to be flawed by poor study design, but their conclusions were not openly contradicted. In US and Europe pediatric radiologists had to face a huge challenge, which brought to the Image Gently campaign and the Eurosafe initiative with the aim to rebut misinformation and to support medical radiation protection. The Linear No Threshold model-which is the base of contemporary radioprotection-is increasingly questioned by new recent studies suggesting that low dose radiation would decrease cancer risk thanks to the enhancement of immune system response. Actually, pediatric radiologists have to cope with many important issues and contradictory messages. Good medical practice includes good communication about the benefits and risks of health procedures, thus the communication of radiation risk is a key component for radiologists. When considering benefits and risks, an important risk is too often ignored: the risk that skipping a diagnostic exam may cause a misdiagnosis, and therefore, a poor outcome. We should emphasize that a risk from a radiological investigation is very small, if a risk at all, and we are not sure that there is a risk at very low doses, like those doses in the majority of X-ray procedures including CT.

[Exposure to hand-arm vibrations in orthopaedic plaster room: risk management]. / Esposizione a vibrazioni mano-braccio nel personale di sala gessi: risk management.

BACKGROUND: In hospitals, the use of vibrating tools, such as oscillating saws to cut plaster, can expose the staff to hand-arm vibrations. OBJECTIVES: The aim of the study was to assess the exposure of workers to vibrations in the plaster room and then  identify the most appropriate  intervention for  prevention and protection to be implemented in order to minimize  exposure and  protect  workers' health, considering different individual hyper-susceptibility conditions. METHODS: Four different models of plaster saws were examined for the evaluation.  Various measurements were made in normal working conditions of the operators. RESULTS AND CONCLUSIONS: The values of acceleration and noise detected on the instruments  were  in line with those reported in the literature. The preventive measure adopted (replacing plaster saws currently used in the hospital with similar ones with lower vibration emission) was an adequate means of protection. Health surveillance activities  recorded a higher level of wellbeing, both environmentally and individually and, specifically, an increased protection level for the hyper-susceptibility conditions observed during health checks of exposed personnel  which will be monitored regularly by the Occupational Health Service.

Comparison of cryoablation with 3D mapping versus conventional mapping for the treatment of atrioventricular re-entrant tachycardia and right-sided paraseptal accessory pathways.

UNLABELLED: Aim Transcatheter cryoablation is a well-established technique for the treatment of atrioventricular nodal re-entry tachycardia and atrioventricular re-entry tachycardia in children. Fluoroscopy or three-dimensional mapping systems can be used to perform the ablation procedure. The aim of this study was to compare the success rate of cryoablation procedures for the treatment of right septal accessory pathways and atrioventricular nodal re-entry circuits in children using conventional or three-dimensional mapping and to evaluate whether three-dimensional mapping was associated with reduced patient radiation dose compared with traditional mapping. METHODS: In 2013, 81 children underwent transcatheter cryoablation at our institution, using conventional mapping in 41 children - 32 atrioventricular nodal re-entry tachycardia and nine atrioventricular re-entry tachycardia - and three-dimensional mapping in 40 children - 24 atrioventricular nodal re-entry tachycardia and 16 atrioventricular re-entry tachycardia. RESULTS: Using conventional mapping, the overall success rate was 78.1 and 66.7% in patients with atrioventricular nodal re-entry tachycardia or atrioventricular re-entry tachycardia, respectively. Using three-dimensional mapping, the overall success rate was 91.6 and 75%, respectively (p=ns). The use of three-dimensional mapping was associated with a reduction in cumulative air kerma and cumulative air kerma-area product of 76.4 and 67.3%, respectively (p<0.05). CONCLUSIONS: The use of three-dimensional mapping compared with the conventional fluoroscopy-guided method for cryoablation of right septal accessory pathways and atrioventricular nodal re-entry circuits in children was associated with a significant reduction in patient radiation dose without an increase in success rate.

Test-retest reliability of graph metrics of resting state MRI functional brain networks: A review.

The employment of graph theory to analyze spontaneous fluctuations in resting state BOLD fMRI data has become a dominant theme in brain imaging studies and neuroscience. Analysis of resting state functional brain networks based on graph theory has proven to be a powerful tool to quantitatively characterize functional architecture of the brain and it has provided a new platform to explore the overall structure of local and global functional connectivity in the brain. Due to its increased use and possible expansion to clinical use, it is essential that the reliability of such a technique is very strongly assessed. In this review, we explore the outcome of recent studies in network reliability which apply graph theory to analyze connectome resting state networks. Therefore, we investigate which preprocessing steps may affect reproducibility the most. In order to investigate network reliability, we compared the test-retest (TRT) reliability of functional data of published neuroimaging studies with different preprocessing steps. In particular we tested influence of global signal regression, correlation metric choice, binary versus weighted link definition, frequency band selection and length of time-series. Statistical analysis shows that only frequency band selection and length of time-series seem to affect TRT reliability. Our results highlight the importance of the choice of the preprocessing steps to achieve more reproducible measurements.

Wrong detection of ventricular fibrillation in an implantable cardioverter defibrillator caused by the movement near the MRI scanner bore.

The static magnetic field generated by MRI systems is highly non-homogenous and rapidly decreases when moving away from the bore of the scanner. Consequently, the movement around the MRI scanner is equivalent to an exposure to a time-varying magnetic field at very low frequency (few Hz). For patients with an implanted cardiac stimulators, such as an implantable cardioverter/defibrillator (ICD), the movements inside the MRI environment may thus induce voltages on the loop formed by the leads of the device, with the potential to affect the behavior of the stimulator. In particular, the ICD's detection algorithms may be affected by the induced voltage and may cause inappropriate sensing, arrhythmia detections, and eventually inappropriate ICD therapy.We performed in-vitro measurements on a saline-filled humanshaped phantom (male, 170 cm height), equipped with an MRconditional ICD able to transmit in real-time the detected cardiac activity (electrograms). A biventricular implant was reproduced and the ICD was programmed in standard operating conditions, but with the shock delivery disabled. The electrograms recorded in the atrial, left and right ventricle channels were monitored during rotational movements along the vertical axis, in close proximity of the bore. The phantom was also equipped with an accelerometer and a magnetic field probe to measure the angular velocity and the magnetic field variation during the experiment. Pacing inhibition, inappropriate detection of tachyarrhythmias and of ventricular fibrillation were observed. Pacing inhibition began at an angular velocity of about 7 rad/s, (dB/dt of about 2 T/s). Inappropriate detection of ventricular fibrillation occurred at about 8 rad/s (dB/dt of about 3 T/s). These findings highlight the need for a specific risk assessment of workers with MR-conditional ICDs, which takes into account also effects that are generally not considered relevant for patients, such as the movement around the scanner bore.

An optically coupled sensor for the measurement of currents induced by MRI gradient fields into endocardial leads.

OBJECT: The gradient fields generated during magnetic resonance imaging (MRI) procedures have the potential to induce electrical current on implanted endocardial leads. Whether this current can result in undesired cardiac stimulation is unknown. MATERIALS AND METHODS: This paper provides a detailed description of how to construct an optically coupled sensor for the measurement of gradient-field-induced currents into endocardial leads. The system is based on a microcontroller that works as analog-to-digital converter and sends the current signal acquired from the lead to an optical high-speed, light-emitting diode transmitter. A plastic fiber guides the light outside the MRI chamber to a photodiode receiver and then to an acquisition board connected to a PC laptop. RESULTS: The performance of the system has been characterized in terms of power consumption (8 mA on average), sampling frequency (20.5 kHz), measurement range (-12.8 to 10.3 mA) and resolution (22.6 µA). Results inside a 3 T MRI scanner are also presented. CONCLUSIONS: The detailed description of the current sensor could permit more standardized study of MRI gradient current induction in pacemaker systems. Results show the potential of gradient currents to affect the pacemaker capability of triggering a heartbeat, by modifying the overall energy delivered by the stimulator.

Currents induced by fast movements inside the MRI room may cause inhibition in an implanted pacemaker.

The static magnetic field generated by MRI systems is highly non-homogenous and rapidly decreases when moving away from the bore of the scanner. Consequently, the movement around the MRI scanner is equivalent to an exposure to a time-varying magnetic field at very low frequency (few Hz). If people with an implanted pacemaker (PM) enter the MRI room, fast movements may thus induce voltages on the loop formed by the PM lead, with the potential to modify the correct behavior of the stimulator. In this study, we performed in-vitro measurements on a human-shaped phantom, equipped with an implantable PM and with a current sensor, able to monitor the activity of the PM while moving the phantom in the MRI room. Fast rotational movements in close proximity of the bore of the scanner caused the inappropriate inhibition of the PM, programmed in VVI modality, maximum sensitivity, unipolar sensing and pacing. The inhibition occurred for a variation of the magnetic field of about 3 T/s. These findings demonstrate that great care must be paid when extending PM MRI compatibility from patients to healthcare personnel, since the safety procedures and the MRI-conditional PM programming (e.g. asynchronous stimulation or bipolar sensing) used for patients cannot be applied.