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Neurostimulation provides a new dimension in the treatment of neurologic disorders. For patients with drug-resistant epilepsy, the Responsive Neurostimulation (RNS) System (NeuroPace, Inc.) provides treatment of seizures with a closed-loop device that continuously records brain activity and provides stimulation designed to reduce seizure frequency over time. The presence of a chronic implanted device that can provide an electrographic record of neural activity provides great opportunities for treatment of seizure disorders and neuroscience research. However, our experience with this device indicates that a number of ethical and clinical challenges arise, and these issues may be applicable to neurotechnology developed for other disease states in the future. We present clinical scenarios based on cases from our center that present clinical or ethical dilemmas. The dilemmas revolve around 4 core themes: (1) electroclinical correlation and dissociation; (2) patient concerns about device capabilities; (3) clinician opportunities and burdens; and (4) data ownership and access. Developing a framework for understanding these issues will be critical as closed-loop neuromodulation is applied to a growing range of neuropsychiatric disorders.

Background: Procedural success of transcatheter left atrial appendage closure (LAAC) is dependent on correct device selection. Three-dimensional transesophageal echocardiography (3DTEE) is more accurate than the two-dimensional (2D) modality for evaluation of the complex anatomy of LAA. However, 3D-TEE analysis of LAA is challenging and highly expertise dependent. In this study, we sought to evaluate the feasibility and accuracy of a novel software tool for automated 3D analysis of the LAA using 3D-TEE data. Methods: The intra-procedural 3D TEE data of 158 patients who underwent LAAC were retrospectively analyzed with a novel automated LAA analysis software tool. Based on the 3D TEE data, the software semi-automatically segmented the 3D LAA structure, determined the device landing zone (LZ), and generated measurements of the LZ dimensions and the LAA length, allowing manual editing if necessary. The accuracy of LAA pre-implantation anatomic measurement reproducibility, and time for analysis of the automated software were compared against expert manual 3D analysis. The software feasibility to predict the optimal device size was directly compared to implanted models. Results: Automated 3D analysis of the LAA on 3D-TEE was feasible in all patients. There were excellent agreements between automated and manual measurements of LZ maximal diameter (bias:-0.32, LOA:-3.56; 2.92), area-derived mean diameter (bias:-0.24, LOA:-3.12, 2.64), and LAA depth (bias:0.02, LOA:-3.14; 3.18). Automated 3D analysis, with manual editing if necessary, accurately identified the implanted device size in 90.5% of patients, outperforming 2DTEE (68.9%, p, This work was funded by the projects “NORTE-01-0145-FEDER-000045” and “NORTE-01-0145-FEDER-000059”, supported by Northern Portugal Regional Operational Programme (Norte2020), under the Portugal 2020 Partnership Agreement, through the European Regional Development Fund (FEDER). It was also funded by national funds, through the FCT – Fundação para a Ciência e Tecnologia and FCT/MCTES in the scope of the project UIDB/05549/2020 and UIDP/05549/2020 and the grant CEECIND/03064/2018. This work was also funded by the Hong Kong Special Administrative Region Government Health and Medical Research Fund (05160976)

With advancement in the technology of cardiovascular implantable electronic devices (CIEDs), including the development of transvenous leads and compact pulse generators, sports participation is now possible for athletes and patients with these devices. The safety of competitive sports for patients with CIEDs has been questioned and studied over many years. Historically, expert-consensus guideline recommendations have discouraged patients with implantable cardioverter-defibrillators (ICDs) from engaging in competitive sports and advised sport participation restricted to low-intensity class IA sports. In the presence of these guidelines, however, some athletes have continued participation in sports. Growing data, including an ICD Sports Safety Registry of athletes, have demonstrated a low incidence of adverse sequelae associated with competitive sports participation in patients with ICDs. The most recent 2015 American Heart Association/American College of Cardiology guidelines regarding sports participation for athletes with cardiovascular disease incorporated these data and left open the possibility for athletes to engage in more intensive sports through a shared decision making construct whereby the athlete assumes a portion of the potential risk for adverse events. Athletes with ICDs, and physicians, must weigh the benefits of sport participation with risks that are related to the underlying heart condition and inherent risks associated with the implanted device. This chapter will review the current recommendations for athletic participation in athletes with CIEDs, present data demonstrating the safety of CIEDs while highlighting potential adverse outcomes associated with competitive sports participation, and review quality of life factors for athletes with CIEDs.

Introduction: Transesophageal echocardiography (TEE) fails to display optimal views to guide left atrial appendage closure (LAAC) procedure in some patients due to atrio-esophageal anatomical limitation. We aimed to investigate if intracardiac echocardiography (ICE) conducted from left atrium (LA) achieves comparable multi-planar views and clinical outcomes as TEE during LAAC. Methods and Results: This study prospectively enrolled 102 consecutive patients with non-valvular atrial fibrillation receiving LAmbre implants under local anesthesia at the First Affiliated Hospital of Wenzhou Medical University from August 2018 to July 2019. The procedures were guided by either ICE (n=40), TEE (n=50) or combined ICE-TEE (n=12). A novel multi-angled “FLAVOR” approach was used in ICE group for assessment. ICE allowed visualization of implanted device in all patients at all proposed angles with long-axis views, while TEE failed to do so in at least one of the angles in 36% of cases. In the combined ICE-TEE cohort, TEE failed peri-device leak assessment in 2 patients. Rates of procedural success, recapture, resizing and complications were similar between ICE and TEE groups. Fluoroscopy time, radiation dose and volume of contrast use in ICE group were significantly lower than the TEE cohort. At 45-day TEE follow-up, rate and degree of peri-device leaks were similar between the ICE and TEE groups. Conclusions: A systematic approach using ICE to guide LAmbre LAA occlusion was safe and feasible. This method was more reliable in comprehensive, multi-angled imaging assessment, and achieving shorter fluoroscopy time, lower radiation dose and less contrast use than TEE.

This study investigates the radio frequency (RF)-induced heating for a common medical implanted device, the trauma screw, in different human models under 1.5 T and 3 T magnetic resonance imaging (MRI) systems. Three different human models, Duke, Ella, and Fats from the virtual family project, are used in the simulations. The human models and the device are loaded in a generic 32 ports RF coil. The screws with suitable sizes are implanted in four regions (hip, knee, shoulder, and wrist) for each human model. From the simulation results, the RF-induced heating near the device shows significantly difference within the models. Consequently, the clinically relevant RF induced heating can be patient specific and needs to be investigated individually.

Introduction: DBS is a widely used therapy for PD. There is now a choice between fixed-life implantable pulse generators (IPGs) and rechargeable IPGs, each having advantages and disadvantages. This study aimed to evaluate the preference and satisfaction of Chinese patients with Parkinson's disease (PD) who were treated with deep brain stimulation (DBS).Materials and Methods: Two hundred and twenty PD patients were treated with DBS and completed a self-reported questionnaire to assess their long-term satisfaction and experience with the type of battery they had chosen and the key factors affecting these choices. The survey was performed online and double-checked for completeness and accuracy.Results: The median value of the postoperative duration was 18 months. The most popular way for patients to learn about DBS surgery was through media (79/220, 35.9%) including the Internet and television programs. In total, 87.3% of the DBS used rechargeable IPGs (r-IPG). The choice between rechargeable and non-rechargeable IPGs was significantly associated with affordability (χ(1)2 = 19.13, p < 0.001). Interestingly, the feature of remote programming significantly affected patients' choices between domestic and imported brands (χ(1)2 = 16.81, p < 0.001). 87.7% of the patients were satisfied with the stimulating effects as well as the implanted device itself. 40.6% of the patients with r-IPGs felt confident handling devices within 1 week after discharge. More than half of the patients checked their batteries every week. The mean interval for battery recharge was 4.3 days. 57.8% of the patients spent around 1 h recharging, and 71.4% of them recharged the battery independently.Conclusions: Most patients were satisfied with their choice of IPGs. The patients' economic status and the remote programming function of the device were the two most critical factors in their decision. The skill of recharging the IPG was easy to master for most patients.

Objectives To assess the long-term compliance and usability of the non-implantable, adhesive bone conduction hearing aid system in children. Review of patient demographics, compliance and continued use. Identification of factors that impact on future patient selection. Methods Retrospective case series review of all children aged 5 and above fitted with the adhesive bone conduction hearing aid at a paediatric tertiary centre in the UK between 2015 and 2019. Data collected from medical and audiological records. Patient demographics, skin complications, patient feedback and changes in hearing aid provision were recorded. Results 82 children (40 female, 42 male) were provided with 89 adhesive hearing devices. To date 72 (87.8%) of the fitted patients, continue to use the device daily with minimal reported skin complications. Of the 10 patients that no longer use the adhesive aid, 5 no longer use any hearing device at all and the remaining 5 patients use an alternative hearing system. These include spectacle aids (n = 2) and bone anchored hearing implant (n = 3). Conclusion Adhesive aid products are reported to provide comparable audiological results to the commercial softband hearing aids. They provide an excellent alternative in the treatment of conductive hearing loss without the costs and possible complications of a surgical intervention. A compliance rate of 87.8% of all patients fitted with the adhesive system demonstrates a high level of patient satisfaction. The device may also provide an appropriate stepping stone to implanted device once a child reaches the age in which an autonomous decision can be made. Limitations of the device have been the variability in the longevity of the adhesive adaptor and interference with headscarves, hats and glasses with a low frequency of transient minor skin reactions reported.

We discuss the perspectives of designing implantable medical devices that have the criterion of being symbiotic. Our starting point was whether the implanted device is intended to have any two-way (“duplex”) communication of energy or materials with the body. Such duplex communication extends the existing concepts of a biomaterial and biocompatibility to include the notion that it is important to consider the intended functional use of the implanted medical device. This demands a biomimetic approach to design functional symbiotic implantable medical devices that can be more efficient in mimicking what is happening at the molecular and cellular levels to create stable interfaces that allow for the unfettered exchanges of molecules between an implanted device and a body. Such a duplex level of communication is considered to be a necessary characteristic of symbiotic implanted medical devices that are designed to function for long periods of time inside the body to restore and assist the function of the body. We illustrate these perspectives with experience gained from implanting functional enzymatic biofuel cells.

In this paper, a 3D printed geometry for optimal ex-vivo in-lab microwave monitoring applications is presented. This geometry is meant to be of use for mimicking the shape and dielectric properties of certain parts of the human body, and to recreate the conditions present during in-field measurements. This geometry is validated through analytic and experimental tests by monitoring an implanted device at different depths inside the set up, and the results are presented.

Introduction: Compared to Staphylococcus aureus, coagulase-negative staphylococci (CoNS) are characterized by a lower capacity to cause acute, live-threatened infections. CoNS are, however, of ever increasing importance as pathogens causing infections in immunocompromised patients and after foreign-material implantation. Typically, antibiotics fail to cure foreign body-related infections and removal of the implanted device is inevitable.Areas covered: This review focuses on the emergence of CoNS species, their pathogenic potential in particular due to their ability to form therapy-refractory biofilms on biotic and abiotic surfaces and evasion strategies to resist host response and antibiotic treatment. Their medical significance and proven and novel therapy strategies are discussed.Expert opinion: CoNS contribute significantly to morbidity and socio-economic costs. The anticipated developments in modern medicine, in particular the increasing use of foreign materials and the rising numbers of immunocompromised patients, as well as the changing demographic and hospital-related factors will inevitably contribute to further emergence of CoNS infections. Increasing rates of (multi-)resistant CoNS strains will limit the therapeutic armamentarium and aggravate treatment strategies. Increased research is necessary to understand their role as resistance and virulence gene reservoir and to reduce CoNS infections by the development of innovative colonization-preventing materials and other CoNS-tailored treatment strategies.

The aim of this study was to investigate the adequacy of the reporting of cochlear implant device failures. Data from a parallel study involving over 6300 children [1] was used to calculate the instantaneous failure rate for explantations. We found that this is comparable to what manufacturers term ‘Cumulative Failure Percentage’ (CFP). This finding raises concerns about the information provided by manufacturers on the reliability of their implants.

The ever-expanding use of modern medical implants demands continual development to improve implant performance and extend their useful lifespan. Systematic implant retrieval and evaluation describes a method of scientific analysis for determining the efficacy and safety or biocompatibility of medical implants in vivo. Its clinical value is rooted in patient safety through detailed analysis of clinical complications associated with an implanted device and biocompatibility at the implant–tissue interface. It is complimentary to global regulatory pathways and helps meet the recognized need for scientific evidence to support claims of substantial equivalence across various medical implant categories. Implant retrieval and evaluation generates long-term data on implant performance and provides an evidence-based approach for driving change in implant biomaterials, designs, and related technology. Ultimately, it benefits patients through improvements in implant safety and effectiveness. This chapter focuses on the human biological response and performance of implant biomaterials and designs after they have functioned in people during general clinical use. Case studies covering a broad spectrum of implants (i.e. intrauterine devices, hip joint replacements, heart valves, surgical mesh) are instructive for linking implant retrieval, evaluation, and failure analysis to biomaterials performance, clinical outcomes, and subsequent regulatory actions.

Radio-frequency identification (RFID) is a technology that allows to store and retrieve a huge amount of data through electromagnetic transmission using radio-frequency (RF) devices and a strategically installed technological structure ( Seol et al., 2017 ). RFID technology uses radio waves and has the capacity to identify thousands of tagged items per second via wireless transmission ( Yazici, 2014 ). More recently, the healthcare sector is taking advantage of information technologies to improve the health delivery, the patient safety, and to save costs. The use of bar codes has spread very much among hospitals, but the limitations of this technology are causing many concerns. For this reason the healthcare industry and most hospitals are searching for other new alternatives ( Coustasse et al., 2013 ). Currently bar codes and associated technology are being replaced with RFID tags and readers in hospitals, to manage healthcare products and to improve operations’ efficiency, reduce the inventory level, and achieve substantial saving ( Chan et al., 2012 ). Nowadays, the RFID technology is applied to real-time traceability, communication, identification, location of assets, medical devices and people, preventing counterfeiting of drugs, saving nurse time in locating medical equipment or tools, identifying under- or overutilization of medical equipment, reducing medical errors in laboratory tests, managing blood distribution, improving security of a hospital or treatment center, and scanning information from implanted device ( Yazici, 2014 ; Fosso Wamba et al., 2013 ).

IntroductionFatigue is a debilitating symptom of subjective nature which lacks effective therapy. The aim of the study was to assess levels of fatigue and the associated factors among patients with permanent cardiac pacemaker (PCM).Material and methodsThis was a cross-sectional study carried out in Athens. The study sample consisted of 250 patients with a PCM.ResultsData indicated moderate to low levels of fatigue. Furthermore, women (median: 24, p = 0.001), those with primary school education (median: 21, p = 0.001), those who were “a little-not at all” informed about PCM (median: 31, p = 0.001), those who had someone to help them in daily activities (median: 23, p = 0.001), those who did not believe that PCM solved their cardiac problem (median: 36, p = 0.001), and those who did not believe that their quality of life was improved (median: 35, p = 0.001) had high levels of fatigue. Moreover, high levels of fatigue were felt by those who characterized themselves as anxious and those who reported to be very anxious about their heart rate and the proper function of PCM (medians: 21.5, 25 and 25 respectively). Additionally, more fatigue was felt by participants who did not smoke after implantation and did not exercise at all (medians: 20 and 24 respectively). Finally, older patients felt more fatigue (rho = 0.248) while the later the implantation device was inserted the more fatigue the patients felt (rho = 0.274).ConclusionsThe present results will help clinicians to acquire an in-depth knowledge of factors associated with fatigue after implantation.

In the past two decades, significant advances have been made on automated electroencephalogram (EEG)-based diagnosis of epilepsy and seizure detection. A number of innovative algorithms have been introduced that can aid in epilepsy diagnosis with a high degree of accuracy. In recent years, the frontiers of computational epilepsy research have moved to seizure prediction, a more challenging problem. While antiepileptic medication can result in complete seizure freedom in many patients with epilepsy, up to one-third of patients living with epilepsy will have medically intractable epilepsy, where medications reduce seizure frequency but do not completely control seizures. If a seizure can be predicted prior to its clinical manifestation, then there is potential for abortive treatment to be given, either self-administered or via an implanted device administering medication or electrical stimulation. This will have a far-reaching impact on the treatment of epilepsy and patient's quality of life. This paper presents a state-of-the-art review of recent efforts and journal articles on seizure prediction. The technologies developed for epilepsy diagnosis and seizure detection are being adapted and extended for seizure prediction. The paper ends with some novel ideas for seizure prediction using the increasingly ubiquitous machine learning technology, particularly deep neural network machine learning.

Aim. To assess clinical and hemodynamic outcomes of aortic valve replacement with xenoaortic biological prosthesis “Aspire Vascutek” and xenopericardial biological prosthesis “UniLine”. Methods. 130 patients who underwent aortic valve replacement with bioprostheses in the period from October 2012 to March 2016 were included in the study. All patients were enrolled into two groups according to the model of the implanted device. 65 recipients of xenoaortic bioprostheses “Aspire Vascutek” were included in Group 1, whereas patients (n = 65) xenopericardial bioprostheses “UniLine” were assigned in Group 2. Males prevailed in Group 1 (63%, the mean age - 66.4±5.5 years). 85% of Group 1 patients had heart failure Strazhesko-Vasilenko IIA grade and 94% of patients had chronic heart failure NYHA III. Similarly, male patients (58%) prevailed in Group 2. The mean age of Group 2 patients was 66.5±3.65 years. All patients in Group 2 II had heart failure Strazhesko-Vasilenko IIA grade and chronic heart failure NYHA III. Results Two patients in Group 1 died in the early postoperative period (the overall mortality was 1.5%). All patients had chronic heart failure NYHA I-II at discharge. Peak transvalvular pressure gradient significantly decreased in the in-hospital period, particularly in Group 2 patients (82,3±22,7 mm Hg vs. 28.8±7.6 mm Hg). 88% of Group 1 patients underwent the 60-month follow-up, and 96% of Group 2 patients - the 48-month follow-up. Transvalvular pressure gradients decreased progressively in both study groups within 60 months follow-up. This decrease was more pronounced in recipients of xenopericardial biological prostheses. Conclusion. Aortic valve replacement with xenopericardial bioprostheses “UniLine” and xenoaortic bioprostheses “Aspire Vascutek” for aortic valvular disease allows treating intracardiac hemodynamic derangements and achieving good clinical and hemodynamic outcomes.

Despite the increasing use of percutaenous valves, little is known about valve performance after external chest compression. We report a case of a compressed pulmonary Edwards Sapien® XT valve after resuscitation. With the patient on ECMO, successful redilatation was performed with unimpaired postprocedural valve function. We aim to increase the awareness for valve distortion after external chest compression with increasing numbers of transcatheter valvulations. We suggest that immediate re-evaluation of the implanted device via biplane fluoroscopy is mandatory after resuscitation in such cases.

This clinical report describes and evaluates a novel periosteal flap design. This technique was applied in 26 patients who underwent cochlear implantation surgery at two tertiary referral centers. No complications were observed during or after the surgery. Additionally, there was no evidence of device migration, wound infection, wound hematoma, or delayed wound healing. Notably, the mastoid emissary vein was intact in all cases. In conclusion, this modified anterior-based periosteal flap is a safe procedure and is aimed at avoiding mastoid emissary vein bleeding and allowing complete repositioning of the periosteum over the implanted device.

Using in vitro models, the mechanics as well as surgical techniques for mitral valves (MV) and MV devices can be studied in a more controlled environment with minimal monetary investment and risk. However, these current models rely on certain simplifications, one being that the MV has a static, rigid annulus. In order to study more complex issues of imaging diagnostics and implanted device function, it would be more advantageous to verify their use for a dynamic environment in a dynamic simulator. This study provides the novel design and development of a dynamically contracting annulus (DCA) within an in vitro simulator, and its subsequent use to study MV biomechanics. Experiments were performed to study the ability of the DCA to reproduce the MV leaflet mechanics in vitro, as seen in vivo, as well as investigate how rigid annuloplasties affect MV leaflet mechanics. Experiments used healthy, excised MVs and normal hemodynamics; contractile waveforms were derived from human in vivo data. Stereophotogrammetry and echocardiography were used to measure anterior leaflet strain and the change in MV geometry. In pursuit of the first in vitro MV simulator that more completely represents the dynamic motion of the full valvular apparatus, this study demonstrated the successful operation of a dynamically contracting mitral annulus. It was seen that the diseased contractile state increased anterior leaflet strain compared to the healthy contractile state. In addition, it was also shown in vitro that simulated rigid annuloplasty increased mitral anterior leaflet strain compared to a healthy contraction.

Implants that electrically stimulate nerves continuously to treat disease can cause off-target effects and pain. An implant that uses light to modulate the activity of genetically modified nerve cells might offer a solution. Rat organ function can be regulated by an engineered closed-loop system.

Purpose Continuous-flow left ventricular assist devices (CF-LVADs) have been extensively used in a strategy of bridge to orthotopic heart transplant due to increasing number of patients with end-stage heart failure and worldwide shortage of heart donors. However, usage of CF-LVADs is not free from limitations such as device-related adverse events, including pump thrombosis (PT). The purpose of this study was to develop an early PT detection algorithm based on the basic parameters monitored by the implanted device. Methods We analyzed the power consumption recorded by pump controller, normalized with respect to impeller speed. The signal was transformed to Open-High-Low-Close form with the averaging window of 4 hours, which enabled calculation of Typical Price (TP) technical indicator. We then developed an algorithm that learns patient's usual TP values over two consecutive days. Later such an algorithm was able to analyze each subsequent data point and indicate whether the probability of thrombotic event meets predetermined threshold. Results We retrospectively reviewed log files of 101 patients implanted with HeartWare pump (HVAD). Seventeen had suspected or confirmed PT (21 events) according to INTERMACS definitions. Our algorithm classified correctly all cases with 100% sensitivity and 100% specificity. Based on abnormally high power consumption (Fig 1A) and TP evaluation, the algorithm alerted at least 40% probability of pump thrombosis (Fig 1B) preceding the onset of PT by 5.4 days on average. In the worst-case scenario, the threshold was reached 16 hours prior to the event. Conclusion Our study shows that it is possible to predict PT events with use of a dedicated, custom-made algorithm. Automatic event detection and alarming could enable earlier medical management of PT and improve prognosis in patients implanted with HVAD.

Importance US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation. Objective To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020. Evidence Review Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry. Findings Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are “substantially equivalent” to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products. Conclusions and Relevance Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients.

International audience; Parylene C has rapidly gained attention as a exible biomaterial for a new generation of chronic neural probes. However, polymeric material failure in the form of delamination, swelling or tearing, often compromises device biostability in the long term. This work constitutes a rst step towards lifetime assessment of Parylene C implanted devices. We have conceived a Parylene C-based neural probe with PEDOT-nanostructured gold electrodes for the recording of brain activity. The material response to its biological environment was studied through in vitro soaking tests and in vivo wireless recordings in mice brain, both carried out for up to 6 months. Impedance monitoring and SEM images indicate that over the length of this trial, none of the implants presented with apparent signs of material degradation. Packaging reliability was a predominant factor in device failure, with a certain number of faulty connection appearing over time. This parameter aside, all soaked devices were stable in Articial Cerebro-Spinal Fluid, with impedances within 10% of their initial value after 6 months at 37°C. Besides, at least 70% of the implanted device were able to accurately record wirelessly high amplitude hippocampal Local Field Potentials from freely-moving mice, with steady Signal-to-Noise Ratio. In other terms, Parylene C implantable sensors responded minimally to articial and actual physiological conditions during a period of 6 months, which makes them promising candidates for reliable, chronically implanted sensors in the biomedical eld.

Artificial anal sphincter (AAS) is an in situ implanted device that acts as a treatment for fecal incontinence regardless of etiology by augmenting the incompetent sphincteric structures. However, AAS is impeded from becoming a valid therapy by its high rate of ischemic complication and malfunction. This article presents an original puborectalis-like artificial anal sphincter (PAAS) that features a low risk of ischemia necrosis and rectal perception remodeling. The device retains continence by reproducing the action, including the pulling and angulating the rectum, of the puborectalis muscle, which forms the anorectal angle and reduces the required clamping pressure. Three rectal pressure sensors were embedded to maintain the pressure exerted on the rectal wall in a safe range and to monitor the distention of the rectum. A series of in vitro studies were conducted with a porcine rectum, and this PAAS prototype manifested the ability of maintaining continence with a clamping pressure considerably lower than that required by other AAS devices. The pressure sensors exhibit good linearity, and the function of rectal perception remodeling has also revealed high reliability with a success rate of 93.3%.

Objective/Hypothesis Upper airway stimulation (UAS) of the hypoglossal nerve has been implemented in the routine clinical practice for patients with moderate-to-severe obstructive sleep apnea (OSA) who could not adhere to continuous positive airway pressure. This study reports objective and patient-reported outcome after 12 months of implantation. Study Design Multicenter prospective single-arm study. Methods Consecutive patients who received the UAS system (Inspire Medical Systems, Inc., Minneapolis, Minnesota, Maple Grove, MN, U.S.A.) were enrolled in three German centers. Key study exclusion criteria included body mass index > 35 kg/m2, apnea–hypopnea index (AHI) 65, or complete concentric collapse at the soft palate during sedated endoscopy. Data collection at 6- and 12-month visit include home sleep test and patient-reported outcome measures. Results Among the total of 60 participants, the median AHI reduced from 28.6 to 9.5 from baseline to 12 months. Patient-reported outcome measured in Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire both improved significantly from baseline to 12 months. The average usage time was 39.1 ± 14.9 hours per week among all participants based on recordings by the implanted device. One patient requested a removal of the device for cosmetic and other personal reasons and was completed without sequelae. Conclusion This study supported that UAS is a safe and effective treatment option for patients with OSA in routine clinical practice. Level of Evidence 4. Laryngoscope, 2017

Background This study sought to evaluate the feasibility, safety, and efficacy of perventricular device closure of a doubly committed sub-arterial ventricular septal defect (dcVSD) through a left infra-axillary approach. Method Forty-five patients, with a dcVSD of less than 8 mm in diameter, were enrolled in this study. The pericardium was exposed and opened through a left infra-axillary mini-incision. Two parallel purse-string sutures were placed on the right ventricle outflow tract and under transesophageal echocardiography guidance, a delivery sheath loaded with the device was inserted into the right ventricle and advanced through the defect into the left ventricle. The device, connected to a delivery cable, was then deployed. Results Forty-one patients achieved successful device closure. In four patients, the device failed to occlude the VSD due to device dislodgement, device-related aortic regurgitation, and residual shunts, and open surgical repair was required. The mean dcVSD diameter was 4.5 ± 1.0 mm (range, 3.0-8.0 mm). The implanted device size was 6.0 ± 1.5 mm (range, 4-10 mm). All patients were implanted with an eccentric device. The mean intracardiac manipulation time was 20.9 ± 7.1 min (range, 9-45 min). The procedure time was 62.5 ± 19.5 min (range 34-105 min). There were no severe adverse events. Conclusions Perventricular device closure of a dcVSD through a left infra-axillary approach is feasible, safe, and efficacious in selected patients with dcVSD.

The increased demand for minimally invasive placement of intravascular medical devices has led to increased procedure-related complications, including retention of all or part of the implanted device. A number of risk factors can predispose to unintentionally retained vascular devices (uRVD); most are technical in etiology. Despite best efforts to insert and remove vascular devices properly, uRVD still occur. Prevention or early identification of uRVD is ideal; however, procedural complications are not always recognized at the time of device insertion or removal. In these cases, early radiologic diagnosis is important to enable expeditious removal and reduction of morbidity, mortality, and medicolegal consequences. The diagnostic radiologist's role is to identify suspected uRVD and ensure proper communication of the findings to the referring clinician. The diagnostic radiologist can implement various strategies to increase detection of uRVD and advise the referring clinician regarding the use of minimally invasive percutaneous techniques for safe removal of uRVD.

BACKGROUND Infections are major complications in patients with ventricular assist devices (VAD). Positron emission tomography with deoxyglucose marked by fluorine-18 ( 18 F-FDG PET/CT) is a diagnostic tool to scan for tissue with high metabolism as present in infections. The specificity of 18 F-FDG PET/CT to discriminate between infection and an aseptic reaction of the implanted device is not defined and its evaluation is the aim of this retrospective analysis. METHODS Until September 2015 a total of 100 patients underwent VAD implantations in our institution. Twenty-one patients (mean age 53.7 ± 14.3 years) had 29 PET-CT examinations for a suspected infection. All radiology reports were compared to clinical and intraoperative parameters. Infections were reported according to the guidelines of the International Society of Heart and Lung Transplantation. Follow-up was 222 days (range 107-484 days) after PET-CT scans and was complete in all patients. RESULTS In 7 patients PET-CT scan ruled out any VAD associated infection. Sixteen patients had a VAD specific infection. Two patients had false negative PET-CT scan results. The sensitivity of VAD-specific infections was 87.5%, the specificity 100%, the positive predictive value was 100% and the negative predictive value 86.7%. Seven patients had more than one PET-CT scans at different time points. CONCLUSIONS PET-CT scan findings showed a high specificity and positive predictive value for VAD-specific infections. Therefore, it may have the potential to guide the clinician in handling patients with infectious complications after VAD implantation.

Over the past 20 years, the field of antimicrobial medical device coatings has expanded nearly 30-fold with technologies shifting their focus from diffusion-only based (short-term antimicrobial eluting) coatings to long-term antimicrobial eluting and intrinsically antimicrobial functioning materials. A variety of emergent coatings have been developed with the goal of achieving long-term antimicrobial activity in order to mitigate the risk of implanted device failure. Specifically, the coatings can be grouped into two categories: those that use antibiotics in conjunction with a polymer coating and those that rely on the intrinsic properties of the material to kill or repel bacteria that come into contact with the surface. This review covers both long-term drug-eluting and non-eluting coatings and evaluates the inherent advantages and disadvantages of each type while providing an overview of variety applications that the coatings have been utilized in. Impact statement This work provides an overview, with advantages and limitations of the most recently developed antibacterial coating technologies, enabling other researchers in the field to more easily determine which technology is most advantageous for them to further develop and pursue.

Background Skin erosion is a dire complication of implantable cardiac pacemakers and defibrillators. Classical treatments involve removal of the entire generator and lead systems, however, these may result in fatal complications. In this study, we present our experience with a simplified salvage technique for exposed implantable cardiac electronic devices (ICEDs) without removing the implanted device, in an attempt to reduce the risks and complication rates associated with this condition. Methods The records of 10 patients who experienced direct ICED exposure between January 2012 and December 2015 were retrospectively reviewed. The following surgical procedure was performed in all patients: removal of skin erosion and capsule, creation of a new pocket at least 1.0–1.5 cm inferior to its original position, migration of the ICED to the new pocket, and insertion of closed-suction drainage. Patients with gross local sepsis or septicemia were excluded from this study. Results Seven patients had cardiac pacemakers and the other 3 had implantable cardiac defibrillators. The time from primary ICED placement to exposure ranged from 0.3 to 151 months (mean, 29 months. Postoperative follow-up in this series ranged from 8 to 31 months (mean follow-up, 22 months). Among the 10 patients, none presented with any signs of overt infection or cutaneous lesions, except 1 patient with hematoma on postoperative day 5. The hematoma was successfully treated by surgical removal and repositioning of the closed-suction drainage. Conclusions Based on our experience, salvage of exposed ICEDs is possible without removing the device in selected patients.

As the number of implantable cardioverter defibrillators (ICDs) implanted continues to rise, there is a growing challenge to ensure patients and family members are adequately equipped for involvement in future end-of-life decisions concerning their device.ObjectiveTo explore patients’, family members’ and professionals’ attitudes and understanding towards discussing ICD deactivation.MethodsCase study approach using qualitative interviews and framework analysis. A total of 29 qualitative interviews were undertaken, involving patients with a device, family members and healthcare professionals. Interviews were audio-recorded, transcribed verbatim and analysed using framework analysis. Data were triangulated with information obtained from the patients’ medical records (n=10).ResultsThree main themes: (1) Professionals were reluctant to engage in conversations concerning deactivation, particularly prior to implantation, believing this was in the patient’s best interest. (2) Patients and family members had limited understanding of the implanted device and its functions. It was frequently perceived as ‘life-saving’ with any negativity of the shock experience seen as acceptable. (3) All patients wanted the opportunity to discuss deactivation when death was imminent, but were indecisive whether family members should be involved. Similarly, some patients felt the decision to deactivate rested solely with the medical profession while others felt it should be a joint decision between patient, family and clinical team.ConclusionsPatients and family members require improved communication and information concerning their future treatment plan and functionality of an ICD. A proactive approach to discuss deactivation would enable shared clinical decision-making in the advanced stages of illness.

Introduction The risk of neurovascular and cardiovascular morbidity is substantially increased by undetected atrial fibrillation (AF). Therefore, early detection of AF is crucial to initiate appropriate therapy in persons at risk and may improve outcome. An implantable loop recorder (ILR) can monitor the heart rhythm for up to three years, modern devices provide dedicated algorithms to detect AF. Hypothesis We aimed to investigate the AF detection rate by the use of an ILR in patients after a recent cerebrovascular event (TIA n=137 or stroke n=363) presenting in sinus rhythm and no history of AF in the ambulatory setting by office based cardiologists. Purpose Observational study in patients with no prior diagnosis of AF, who had (presumably thromboembolic) transient ischemic attack (TIA) or stroke within 12 months and were implanted an ILR in the last 6 months. Follow-up visits every 3 months for 1 year overall. Results In 34 outpatient cardiology centers in Germany, a total of 500 patients were documented (mean age 63.1±12.7 years, 35.4% >70 years; 60.8% males). The qualifying event - diagnosed by neurologists - was a TIA in 137 (27.4%) and a stroke in 363 (72.6%) with typical thromboembolic pattern in NMR imaging (29.2% TIA/45.2% stroke, p During follow-up, AF was newly detected by the device in TIA patients in 29.9% and in stroke patients in 25.6% (n.s.). The mean screening period until detection of AF with the Reveal LinQ device was 170±134 days in TIA, 145±128 in stroke respectively (n.s.). 95.7% had paroxysmal and 4.3% persistent AF in stroke, TIA patients had 100% paroxysmal AF (n.s.), median duration was 5.0 min in TIA and 5.2 min in stroke, respectively (n.s.). Most AF patients were asymptomatic (68.3% TIA/ 83.9% stroke, p The mean CHA2DS2Vasc score in patients with AF was 4.0 and 4.1 in those with TIA and stroke (n.s.), for patients in sinus rhythm 3.7 and 3.9, respectively (n.s.). Arterial hypertension was present in 71.5% with TIA/76.0% with stroke (n.s.), diabetes mellitus in 15.3% with TIA/25.1% with stroke (p Conclusions In patients in sinus rhythm and no history of AF after a TIA or stroke, during 1-year follow-up AF could be newly detected in a quarter of patients by means of systematic continuous screening with an implantable ECG device. As AF diagnosis usually leads to immediate secondary prevention with long-term anticoagulation, such screening is useful not only in stroke but also in TIA patients and may substantially reduce the risk of recurrent stroke and cardiovascular morbidity. Acknowledgement/Funding SPIDER-AF registry was performed by BNK Service GmbH, Munich (Germany) and supported by Bayer Vital GmbH and Medtronic GmbH in equal parts