Safety and Management of Implanted Epilepsy Devices for Imaging and Surgery.
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ABSTRACT:
SUBMITTER: Lundstrom BN
PROVIDER: S-EPMC9888397 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
Publications
Safety and Management of Implanted Epilepsy Devices for Imaging and Surgery.
Lundstrom Brian N BN Lin Chen C Starnes D Keith DK Middlebrooks Erik H EH Tatum William W Grewal Sanjeet S SS Crepeau Amy Z AZ Gregg Nicholas M NM Miller Kai J KJ Van Gompel Jamie J JJ Watson Robert E RE
Mayo Clinic proceedings 20221007 11
Permanently implanted devices that deliver electrical stimulation are increasingly used to treat patients with drug-resistant epilepsy. Primary care physicians, neurologists, and epilepsy clinicians may encounter patients with a variety of implanted neuromodulation devices in the course of clinical care. Due to the rapidly changing landscape of available epilepsy-related neurostimulators, there may be uncertainty related to how these devices should be handled during imaging procedures and periop ...[more]
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Project description:PurposeTo propose and test a modified wideband late gadolinium enhancement (LGE) magnetic resonance (MR) imaging technique to overcome hyperintensity image artifacts caused by implanted cardiac devices.Materials and methodsWritten informed consent was obtained from all participants, and the HIPAA-compliant study protocol was approved by the institutional review board. Studies in phantoms and in a healthy volunteer were performed to test the hypothesis that the hyperintensity artifacts that are typically observed on LGE images in patients with implanted cardiac devices are caused by insufficient inversion of the affected myocardial signal. The conventional LGE MR imaging pulse sequence was modified by replacing the nonselective inversion pulse with a wideband inversion pulse. The modified LGE sequence, along with the conventional LGE sequence, was evaluated in 12 patients with implantable cardioverter defibrillators (ICDs) who were referred for cardiac MR imaging.ResultsThe ICD causes 2-6 kHz in frequency shift at locations 5-10 cm away from the device. This off-resonance falls outside the typical spectral bandwidth of the nonselective inversion pulse used in conventional LGE, which results in the hyperintensity artifact. In 10 of the 12 patients, the conventional LGE technique produced severe, uninterpretable hyperintensity artifacts in the anterior and lateral portions of the left ventricular wall. These artifacts were eliminated with use of the wideband LGE sequence, thereby enabling confident evaluation of myocardial viability.ConclusionThe modified wideband LGE MR imaging technique eliminates the hyperintensity artifacts seen in patients with cardiac devices. The technique may enable LGE MR imaging in patients with cardiac devices, in whom LGE MR imaging otherwise could not be used for diagnosis.
| S-EPMC4228714 | biostudies-literature
Project description:The number of patients supported with left ventricular assist devices (LVADs) is rising rapidly, and noncardiac surgery (NCS) in these patients presents unique challenges. Given the controversy regarding the safety and timing of elective NCS, we performed a systematic review examining the perioperative morbidity and mortality of NCS in stable patients with LVADs. The published literature was searched using strategies created by a medical librarian. All reports involving five or more patients with implanted LVAD undergoing NCS were eligible for inclusion. One hundred and sixty one patients who underwent 252 surgeries were included from seven studies. Cohort size ranged from 8 to 47 patients undergoing 12 to 67 NCS. Median age ranged from 50.1 to 68 years and 75 to 100% were male. Thirty day postoperative mortality ranged from 6.4 to 16.7%, although four studies reported no deaths. Due to the small number of included studies with relative few patients and widely heterogeneous reporting of outcomes a formal quantitative meta-analysis was not performed. Noncardiac surgery in patients with LVADs appears to be safe and feasible in select patients. Future studies should use standard study design and reporting parameters to facilitate the systematic examination of safety and outcomes for elective NCS in LVAD patients.
| S-EPMC7380324 | biostudies-literature
Project description:BackgroundDeep brain stimulation (DBS) is an established treatment for patients with movement disorders. Patients receiving chronic DBS provide a unique opportunity to explore the underlying mechanisms of DBS using functional MRI. It has been shown that the main safety concern with MRI in these patients is heating at the electrode tips - which can be minimised with strict adherence to a supervised acquisition protocol using a head-transmit/receive coil at 1.5T. MRI using the body-transmit coil with a multi-channel receive head coil has a number of potential advantages including an improved signal-to-noise ratio.Study outlineWe compared the safety of cranial MRI in an in vitro model of bilateral DBS using both head-transmit and body-transmit coils. We performed fibre-optic thermometry at a Medtronic ActivaPC device and Medtronic 3389 electrodes during turbo-spin echo (TSE) MRI using both coil arrangements at 1.5T and 3T, in addition to gradient-echo echo-planar fMRI exposure at 1.5T. Finally, we investigated the effect of transmit-coil choice on DBS stimulus delivery during MRI.ResultsTemperature increases were consistently largest at the electrode tips. Changing from head- to body-transmit coil significantly increased the electrode temperature elevation during TSE scans with scanner-reported head SAR 0.2W/kg from 0.45°C to 0.79°C (p<0.001) at 1.5T, and from 1.25°C to 1.44°C (p<0.001) at 3T. The position of the phantom relative to the body coil significantly impacted on electrode heating at 1.5T; however, the greatest heating observed in any position tested remained <1°C at this field strength.ConclusionsWe conclude that (1) with our specific hardware and SAR-limited protocol, body-transmit cranial MRI at 1.5T does not produce heating exceeding international guidelines, even in cases of poorly positioned patients, (2) cranial MRI at 3T can readily produce heating exceeding international guidelines, (3) patients with ActivaPC Medtronic systems are safe to be recruited to future fMRI experiments performed under the specific conditions defined by our protocol, with no likelihood of confound by inappropriate stimulus delivery.
| S-EPMC4465697 | biostudies-literature
Project description:Implantable neural micro-electrode arrays have the potential to restore lost sensory or motor function to many different areas of the body. However, the invasiveness of these implants often results in scar tissue formation, which can have detrimental effects on recorded signal quality and longevity. Traditional histological techniques can be employed to study the tissue reaction to implanted micro-electrode arrays, but these techniques require removal of the brain from the skull, often causing damage to the meninges and cortical surface. This is especially unfavorable when studying the tissue response to electrode arrays such as the micro-electrocorticography (micro-ECoG) device, which sits on the surface of the cerebral cortex. In order to better understand the biological changes occurring around these types of devices, a cranial window implantation scheme has been developed, through which the tissue response can be studied in vivo over the entire implantation period. Rats were implanted with epidural micro-ECoG arrays, over which glass coverslips were placed and sealed to the skull, creating cranial windows. Vascular growth around the devices was monitored for one month after implantation. It was found that blood vessels grew through holes in the micro-ECoG substrate, spreading over the top of the device. Micro-hematomas were observed at varying time points after device implantation in every animal, and tissue growth between the micro-ECoG array and the window occurred in several cases. Use of the cranial window imaging technique with these devices enabled the observation of tissue changes that would normally go unnoticed with a standard device implantation scheme.
| S-EPMC3819462 | biostudies-literature
Project description:BackgroundMagnetic resonance imaging (MRI) has been performed safely in patients without MRI-conditional cardiac implantable electronic devices (CIEDs), but experience specifically with cardiac magnetic resonance imaging (CMR) is limited in this patient population.ObjectiveEvaluate the safety of CMR in non-MRI-conditional CIEDs and the interpretability of images using wideband sequences.MethodsWe performed 114 consecutive CMR studies in 111 patients (mean age 59 ± 14 years, with 12 pacemakers, 73 implantable cardioverter defibrillators, 29 biventricular defibrillators) using a wideband pulse sequence for late gadolinium enhancement (LGE) imaging. A standardized protocol for device management and patient monitoring was followed. Patients were evaluated for major clinical adverse events and device parameter changes immediately after CMR and at clinical follow-up.ResultsIn total, 111 CMR studies were completed successfully. There were no patient deaths, new arrhythmias, immediate generator or lead failures, electrical resets, or pacing capture failures in dependent patients. Right atrial, right ventricular, and left ventricular lead impedances were significantly lower post CMR, with median differences -7 Ω (interquartile range [IQR] -20 to 0 Ω; P < .0001), 0 Ω (IQR -19 to 0 Ω; P = .0001), and -10 Ω (IQR -30 to 0 Ω; P = .023), respectively. These changes persisted through the follow-up period, with median differences -18.5 Ω (IQR -41 to -66 Ω; P = .007), -19 Ω (IQR -44 to -7 Ω; P = .006), and -30 Ω (IQR -130 to 0 Ω; P = .003), respectively. Ninety-seven studies (87%) had no artifact limiting interpretation.ConclusionsCMR can be performed safely in non-MRI-conditional CIEDs using a standardized protocol. Use of a wideband pulse sequence for LGE imaging yields a high rate of studies unaffected by artifact.
| S-EPMC5823604 | biostudies-literature
Project description:ObjectiveMagnetic resonance imaging (MRI) is a crucial tool for identifying brain abnormalities in a wide range of neurological disorders. In focal epilepsy, MRI is used to identify structural cerebral abnormalities. For covert lesions, machine learning and artificial intelligence (AI) algorithms may improve lesion detection if abnormalities are not evident on visual inspection. The success of this approach depends on the volume and quality of training data.MethodsHerein, we release an open-source data set of pre-processed MRI scans from 442 individuals with drug-refractory focal epilepsy who had neurosurgical resections and detailed demographic information. We also share scans from 100 healthy controls acquired on the same scanners. The MRI scan data include the preoperative three-dimensional (3D) T1 and, where available, 3D fluid-attenuated inversion recovery (FLAIR), as well as a manually inspected complete surface reconstruction and volumetric parcellations. Demographic information includes age, sex, age a onset of epilepsy, location of surgery, histopathology of resected specimen, occurrence and frequency of focal seizures with and without impairment of awareness, focal to bilateral tonic-clonic seizures, number of anti-seizure medications (ASMs) at time of surgery, and a total of 1764 patient years of post-surgical followup. Crucially, we also include resection masks delineated from post-surgical imaging.ResultsTo demonstrate the veracity of our data, we successfully replicated previous studies showing long-term outcomes of seizure freedom in the range of ~50%. Our imaging data replicate findings of group-level atrophy in patients compared to controls. Resection locations in the cohort were predominantly in the temporal and frontal lobes.SignificanceWe envisage that our data set, shared openly with the community, will catalyze the development and application of computational methods in clinical neurology.
| S-EPMC11827737 | biostudies-literature
Project description:BackgroundMagnetic resonance imaging (MRI) is avoided in most patients with implanted cardiac devices because of safety concerns.ObjectiveTo define the safety of a protocol for MRI at the commonly used magnetic strength of 1.5 T in patients with implanted cardiac devices.DesignProspective nonrandomized trial. (ClinicalTrials.gov registration number: NCT01130896) SETTING: One center in the United States (94% of examinations) and one in Israel.Patients438 patients with devices (54% with pacemakers and 46% with defibrillators) who underwent 555 MRI studies.InterventionPacing mode was changed to asynchronous for pacemaker-dependent patients and to demand for others. Tachyarrhythmia functions were disabled. Blood pressure, electrocardiography, oximetry, and symptoms were monitored by a nurse with experience in cardiac life support and device programming who had immediate backup from an electrophysiologist.MeasurementsActivation or inhibition of pacing, symptoms, and device variables.ResultsIn 3 patients (0.7% [95% CI, 0% to 1.5%]), the device reverted to a transient back-up programming mode without long-term effects. Right ventricular (RV) sensing (median change, 0 mV [interquartile range {IQR}, -0.7 to 0 V]) and atrial and right and left ventricular lead impedances (median change, -2 Ω [IQR, -13 to 0 Ω], -4 Ω [IQR, -16 to 0 Ω], and -11 Ω [IQR, -40 to 0 Ω], respectively) were reduced immediately after MRI. At long-term follow-up (61% of patients), decreased RV sensing (median, 0 mV, [IQR, -1.1 to 0.3 mV]), decreased RV lead impedance (median, -3 Ω, [IQR, -29 to 15 Ω]), increased RV capture threshold (median, 0 V, IQR, [0 to 0.2 Ω]), and decreased battery voltage (median, -0.01 V, IQR, -0.04 to 0 V) were noted. The observed changes did not require device revision or reprogramming.LimitationsNot all available cardiac devices have been tested. Long-term in-person or telephone follow-up was unavailable in 43 patients (10%), and some data were missing. Those with missing long-term capture threshold data had higher baseline right atrial and right ventricular capture thresholds and were more likely to have undergone thoracic imaging. Defibrillation threshold testing and random assignment to a control group were not performed.ConclusionWith appropriate precautions, MRI can be done safely in patients with selected cardiac devices. Because changes in device variables and programming may occur, electrophysiologic monitoring during MRI is essential.
| S-EPMC4337840 | biostudies-literature
Project description:Background and aimsCongestion is a key driver of morbidity and mortality in heart failure. Implanted haemodynamic monitoring devices might allow early identification and management of congestion. Here, we provide a state-of-the-art review of implanted haemodynamic monitoring devices for patients with heart failure, including a meta-analysis of randomised trials.Methods and resultsWe did a systematic search for pre-print and published trials in Medline, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) on the 22nd of September 2021. We included randomised trials that compared management with or without information from implanted haemodynamic monitoring devices for patients with heart failure. Outcomes selected were hospitalisation for heart failure and all-cause mortality. Changes in treatment associated with haemodynamic monitoring resulted in only a small reduction in mean pulmonary artery pressure (typically < 1 mmHg as a daily average), which generally remained much greater than 20 mmHg. Haemodynamic monitoring reduced hospitalisations for heart failure (HR 0.75; 95% CI 0.58-0.96; p = 0.03) but not mortality (RR 0.92; 95% CI 0.68-1.26; p = 0.48).ConclusionsHaemodynamic monitoring for patients with heart failure may reduce the risk of hospitalization for heart failure but this has not yet translated into a reduction in mortality, perhaps because the duration of trials was too short or the reduction in pulmonary artery pressure was not sufficiently large. The efficacy and safety of aiming for larger reductions in pulmonary artery pressure should be explored. After selecting key words, a systematic review for implanted haemodynamic telemonitoring devices was performed in different dataset and 4 randomised clinical trials were identified and included in this meta-analysis. Three different devices (Chronicle, Chronicle/ICD and CardioMEMS) were tested. All-cause mortality and total heart failure hospitalisations were selected as outcomes. No reduction in all-cause mortality rate was reported but a potential benefit on total heart failure hospitalisation was identified.
| S-EPMC9568893 | biostudies-literature
Project description:BackgroundPatients who have pacemakers or defibrillators are often denied the opportunity to undergo magnetic resonance imaging (MRI) because of safety concerns, unless the devices meet certain criteria specified by the Food and Drug Administration (termed "MRI-conditional" devices).MethodsWe performed a prospective, nonrandomized study to assess the safety of MRI at a magnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%) or an implantable cardioverter-defibrillator (42%) that was not considered to be MRI-conditional (termed a "legacy" device). Overall, the patients underwent 2103 thoracic and nonthoracic MRI examinations that were deemed to be clinically necessary. The pacing mode was changed to asynchronous mode for pacing-dependent patients and to demand mode for other patients. Tachyarrhythmia functions were disabled. Outcome assessments included adverse events and changes in the variables that indicate lead and generator function and interaction with surrounding tissue (device parameters).ResultsNo long-term clinically significant adverse events were reported. In nine MRI examinations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient's device reset to a backup mode. The reset was transient in eight of the nine examinations. In one case, a pacemaker with less than 1 month left of battery life reset to ventricular inhibited pacing and could not be reprogrammed; the device was subsequently replaced. The most common notable change in device parameters (>50% change from baseline) immediately after MRI was a decrease in P-wave amplitude, which occurred in 1% of the patients. At long-term follow-up (results of which were available for 63% of the patients), the most common notable changes from baseline were decreases in P-wave amplitude (in 4% of the patients), increases in atrial capture threshold (4%), increases in right ventricular capture threshold (4%), and increases in left ventricular capture threshold (3%). The observed changes in lead parameters were not clinically significant and did not require device revision or reprogramming.ConclusionsWe evaluated the safety of MRI, performed with the use of a prespecified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter-defibrillator system. No long-term clinically significant adverse events were reported. (Funded by Johns Hopkins University and the National Institutes of Health; ClinicalTrials.gov number, NCT01130896 .).
| S-EPMC5894885 | biostudies-literature
Project description:Therapeutic devices provide new options for treating drug-resistant epilepsy. These devices act by a variety of mechanisms to modulate neuronal activity. Only vagus nerve stimulation (VNS), which continues to develop new technology, is approved for use in the United States. Deep brain stimulation of anterior thalamus for partial epilepsy recently was approved in Europe and several other countries. Responsive neurostimulation, which delivers stimuli to 1 or 2 seizure foci in response to a detected seizure, recently completed a successful multicenter trial. Several other trials of brain stimulation are in planning or underway. Transcutaneous magnetic stimulation (TMS) may provide a noninvasive method to stimulate cortex. Controlled studies of TMS are split on efficacy, which may depend on whether a seizure focus is near a possible region for stimulation. Seizure detection devices in the form of shake detectors via portable accelerometers can provide notification of an ongoing tonic-clonic seizure, or peace of mind in the absence of notification. Prediction of seizures from various aspects of electroencephalography (EEG) is in early stages. Prediction appears to be possible in a subpopulation of people with refractory seizures, and a clinical trial of an implantable prediction device is underway. Cooling of neocortex or hippocampus reversibly can attenuate epileptiform EEG activity and seizures, but engineering problems remain in its implementation. Optogenetics is a new technique that can control excitability of specific populations of neurons with light. Inhibition of epileptiform activity has been demonstrated in hippocampal slices, but use in humans will require more work. In general, devices provide useful palliation for otherwise uncontrollable seizures, but with a different risk profile than with most drugs. Optimizing the place of devices in therapy for epilepsy will require further development and clinical experience.
| S-EPMC3296971 | biostudies-literature