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Comparison and Selection of Current Implantable Anti-Epileptic Devices.

ABSTRACT: Implantable neural stimulators represent an advanced treatment adjunct to medication for pharmacoresistant epilepsy and alternative for patients that are not good candidates for resective surgery. Three treatment modalities are currently FDA-approved: vagus nerve stimulation, responsive neurostimulation, and deep brain stimulation. These devices were originally trialed in very similar patient populations with focal epilepsy, but head-to-head comparison trials have not been performed. As such, device selection may be challenging due to large overlaps in clinical indications and efficacy. Here we will review the data reported in the original pivotal clinical trials as well as long-term experience with these technologies. We will highlight differences in their features and mechanisms of action which may help optimize device selection on a case-by-case basis.

SUBMITTER: Wong S

PROVIDER: S-EPMC6554379 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Comparison and Selection of Current Implantable Anti-Epileptic Devices.

Wong Stephen S Mani Ram R Danish Shabbar S

Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics 20190401 2

Implantable neural stimulators represent an advanced treatment adjunct to medication for pharmacoresistant epilepsy and alternative for patients that are not good candidates for resective surgery. Three treatment modalities are currently FDA-approved: vagus nerve stimulation, responsive neurostimulation, and deep brain stimulation. These devices were originally trialed in very similar patient populations with focal epilepsy, but head-to-head comparison trials have not been performed. As such, de ...[more]

PMID: 31062294

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Current status of reimbursement practices for remote monitoring of cardiac implantable electrical devices across Europe.

Project description:Remote monitoring (RM) of cardiac implantable electrical devices (CIEDs) is currently proposed as a standard of care for CIEDs follow-up, as recommended by major cardiology societies worldwide. By detecting a series of relevant device and patient-related parameters, RM is a valuable option for early detection of CIEDs' technical issues, as well as changes in parameters related to cardio-respiratory functions. Moreover, RM may allow longer spacing between in-office follow-ups and better organization of in-hospital resources. Despite these potential advantages, resulting in improved patient safety, we are still far from a widespread diffusion of RM across Europe. Reimbursement policies across Europe still show an important heterogeneity and have been considered as an important barrier to full implementation of RM as a standard for the follow-up of all the patients with pacemakers, defibrillators, devices for cardiac resynchronization, or implantable loop recorders. Indeed, in many countries, there are still inertia and unresponsiveness to the request for widespread implementation of RM for CIEDs, although an improvement was found in some countries as compared to years ago, related to the provision of some form of reimbursement. As a matter of fact, the COVID-19 pandemic has promoted an increased use of digital health for connecting physicians to patients, even if digital literacy may be a limit for the widespread implementation of telemedicine. CIEDs have the advantage of making possible RM with an already defined organization and reliable systems for data transmissions that can be easily implemented as a standard of care for present and future cardiology practice.

| S-EPMC9384581 | biostudies-literature

Candidemia in Patients With Cardiovascular Implantable Electronic Devices: Uncertainty in Management Based on Current International Guidelines.

Project description:BackgroundIn contrast to bloodstream infection due to a variety of bacteria in patients with cardiovascular implantable electronic devices (CIED), there are limited data regarding candidemia and risk of CIED infection.MethodsAll patients with candidemia and a CIED at Mayo Clinic Rochester between 2012 and 2019 were reviewed. Cardiovascular implantable electronic device infection was defined by (1) clinical signs of pocket site infection or (2) echocardiographic evidence of lead vegetations.ResultsA total of 23 patients with candidemia had underlying CIED; 9 (39.1%) cases were community onset. None of the patients had pocket site infection. The duration between CIED placement and candidemia was prolonged (median 3.5 years; interquartile range, 2.0-6.5). Only 7 (30.4%) patients underwent transesophageal echocardiography and 2 of 7 (28.6%) had lead masses. Only the 2 patients with lead masses underwent CIED extraction, but device cultures were negative for Candida species. Two (33.3%) of 6 other patients who were managed as candidemia without device infection subsequently developed relapsing candidemia. Cardiovascular implantable electronic device removal was done in both patients and device cultures grew Candida species. Although 17.4% of patients were ultimately confirmed to have CIED infection, CIED infection status was undefined in 52.2%. Overall, 17 (73.9%) patients died within 90 days of diagnosis of candidemia.ConclusionsAlthough current international guidelines recommend CIED removal in patients with candidemia, the optimal management strategy remains undefined. This is problematic because candidemia alone is associated with increased morbidity and mortality as seen in this cohort. Moreover, inappropriate device removal or retention can both result in increased patient morbidity and mortality.

| S-EPMC10326679 | biostudies-literature

Endoscopy and implantable electronic devices.

Project description:The increasing use of implantable electronic devices such as cardiac pacemakers and neurostimulators means that they are being increasingly encountered in endoscopy departments. The electromagnetic fields generated during electrosurgery and with magnetic imaging systems have the potential to interfere with such devices. The authors present a case that highlights some of the steps necessary for minimising risk, review the evidence and summarise the currently available guidance.

| S-EPMC5517255 | biostudies-other

Mechanically transformative electronics, sensors, and implantable devices.

Project description:Traditionally, electronics have been designed with static form factors to serve designated purposes. This approach has been an optimal direction for maintaining the overall device performance and reliability for targeted applications. However, electronics capable of changing their shape, flexibility, and stretchability will enable versatile and accommodating systems for more diverse applications. Here, we report design concepts, materials, physics, and manufacturing strategies that enable these reconfigurable electronic systems based on temperature-triggered tuning of mechanical characteristics of device platforms. We applied this technology to create personal electronics with variable stiffness and stretchability, a pressure sensor with tunable bandwidth and sensitivity, and a neural probe that softens upon integration with brain tissue. Together, these types of transformative electronics will substantially broaden the use of electronics for wearable and implantable applications.

| S-EPMC6824851 | biostudies-literature

MRI for patients with cardiac implantable electrical devices.

Project description:MRI has become an invaluable tool in the evaluation of soft tissue and bony abnormalities. The presence of a cardiac implantable electrical device (CIED) may complicate matters, however, because these devices are considered a contraindication to MRI scanning. When MRI is performed in patients with a CIED, risks include reed switch activation in older devices, lead heating, system malfunction, and significant radiofrequency noise resulting in inappropriate inhibition of demand pacing, tachycardia therapies, or programming changes. This report reviews indications and risk-benefit evaluation of MRI in patients with CIED and provides a clinical algorithm for performing MRI in patients with implanted devices.

| S-EPMC4010944 | biostudies-literature

Tricuspid valve disease and cardiac implantable electronic devices.

Project description:The role of cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is increasingly recognized as an independent clinical entity. Hence, interventional TR treatment options continuously evolve, surgical risk assessment and peri-operative care improve the management of CIED-related TR, and the role of lead extraction is of high interest. Furthermore, novel surgical and interventional tricuspid valve treatment options are increasingly applied to patients suffering from TR associated with or related to CIEDs. This multidisciplinary review article developed with electrophysiologists, interventional cardiologists, imaging specialists, and cardiac surgeons aims to give an overview of the mechanisms of disease, diagnostics, and proposes treatment algorithms of patients suffering from TR associated with CIED lead(s) or leadless pacemakers.

| S-EPMC10834167 | biostudies-literature

Subclinical Atrial Tachyarrhythmias:Implantable Devices and Remote Monitoring.

Project description:Atrial fibrillation (AF) and Atrial Tachyarrhythmias (AT) are the most common clinical arrhythmias and their worst issue is a well-recognized correlation with ischemic stroke. High incidence of "subclinical" AF/ATs has been demonstrated in several trials (TRENDS, ASSERT, CRYSTAL AF, EMBRACE) in patients with both cardiac implantable electronic devices (CIEDS) and external loop recorders. Moreover, a relationship between device-detected AF/ATs and stroke risk has been observed in the same studies. However, while the net clinical benefit of the antithrombotic treatment is well established in patients with "clinical" atrial fibrillation, there may be a lower benefit in patients with device-detected arrhythmias. Subclinical AF/ATs may be considered as a marker of stroke risk rather than the proximate cause and their burden may be used in combination with CHA2DS2-VASC and HAS-BLED scores to identify high-risk population who deserves anticoagulation. Today the remote monitoring associated with the CIEDs is effective in the early detecting of AF/ATs by avoiding delays in the therapy evaluation, as demonstrated by several trials (TRUST, CONNECT, COMPAS). However clinical evidence for stroke risk reduction by remote monitoring is still awaited; the recent trial IMPACT failed to demonstrate that the handling of the anticoagulation therapy guided by device-detected ATs and remote monitoring improves the patients' outcome. The challenges for clinicians are to deal with the huge data entry, to define new organizational models, to improve device patient management and to continuously update AF guidelines in according to the great amount of data offered by the new technology.

| S-EPMC5135181 | biostudies-other

Outcomes of infected cardiovascular implantable devices in dialysis patients.

Project description:Dialysis patients are at a higher risk for cardiovascular implantable electronic device (CIED) infection-related hospitalizations. We compared the outcomes and cost for dialysis and non-dialysis patients hospitalized with CIED infections.We conducted a retrospective analysis of the Nationwide Inpatient Sample (NIS) discharge records from 2005 to 2010. Patients with CIED infections were identified using ICD-9 codes for device-related infections or device procedure along with bacteremia, endocarditis or systemic infection. Dialysis patients were identified using ICD-9 codes. Multivariable logistic and linear regressions were performed to examine in-hospital mortality, length of stay and cost.Of the 87,798 estimated hospitalizations with CIED infections, 6,665 (7.6%) were dialysis patients. CIED-infection-related hospitalization has increased over time among dialysis patients. In-hospital mortality was higher among dialysis patients (13.6% vs. 5.9%, p < 0.001). In the multivariable model, dialysis patients had higher odds of in-hospital mortality (odds ratio 1.98; 95% CI: 1.6, 2.4) compared to the non-dialysis group. Dialysis patients had a longer median length of stay (12 days vs. 7 days, p < 0.001) and majority required extended care facility upon discharge (51.2% vs. 35.0%, p < 0.001) compared to the non-dialysis group. Dialysis status was associated with 50.3% increased cost of hospitalization (p < 0.001).CIED-infection related hospitalization is increasing among patients undergoing dialysis and is associated with higher in-hospital mortality, longer hospital stay and higher costs of hospitalization. Future studies should examine the reasons for such a high risk and find means to improve outcomes in dialysis population.

| S-EPMC4216629 | biostudies-literature

Monitoring implantable immunoisolation devices with intrinsic fluorescence of genipin.

Project description:Imaging of implanted hydrogel-based biosystems usually requires indirect labeling of the vehicle or cargo, adding complexity and potential risk of altering functionality. Here, for the first time, it is reported that incorporation of genipin into the design of immunoisolation devices can be harnessed for in vivo imaging. Using cell-compatible in situ cross-linking reactions, a fast, efficient and noncytotoxic procedure is shown to maximize fluorescence of microcapsules. Moreover, genipin is validated as a quantitative imaging probe by injecting increasing doses of microcapsules in the subcutaneous space of mice, obtaining strong, stable fluorescence with good linearity of signal to microcapsule dose over several weeks. This allows immediate assessment of the actual injected dose and monitoring of its position over time, thereby significantly enhancing the efficacy and biosafety of the therapy. These outcomes may facilitate clinical translation and optimize medical applications of multiple hydrogel-based biotechnologies.

| S-EPMC6351221 | biostudies-literature

Remote management of heart failure using implantable electronic devices.

Project description:AimsRemote management of heart failure using implantable electronic devices (REM-HF) aimed to assess the clinical and cost-effectiveness of remote monitoring (RM) of heart failure in patients with cardiac implanted electronic devices (CIEDs).Methods and resultsBetween 29 September 2011 and 31 March 2014, we randomly assigned 1650 patients with heart failure and a CIED to active RM or usual care (UC). The active RM pathway included formalized remote follow-up protocols, and UC was standard practice in nine recruiting centres in England. The primary endpoint in the time to event analysis was the 1st event of death from any cause or unplanned hospitalization for cardiovascular reasons. Secondary endpoints included death from any cause, death from cardiovascular reasons, death from cardiovascular reasons and unplanned cardiovascular hospitalization, unplanned cardiovascular hospitalization, and unplanned hospitalization. REM-HF is registered with ISRCTN (96536028). The mean age of the population was 70 years (range 23-98); 86% were male. Patients were followed for a median of 2.8 years (range 0-4.3 years) completing on 31 January 2016. Patient adherence was high with a drop out of 4.3% over the course of the study. The incidence of the primary endpoint did not differ significantly between active RM and UC groups, which occurred in 42.4 and 40.8% of patients, respectively [hazard ratio 1.01; 95% confidence interval (CI) 0.87-1.18; P = 0.87]. There were no significant differences between the two groups with respect to any of the secondary endpoints or the time to the primary endpoint components.ConclusionAmong patients with heart failure and a CIED, RM using weekly downloads and a formalized follow up approach does not improve outcomes.

| S-EPMC5837548 | biostudies-literature

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