Precision Rehabilitation After Neurostimulation Implantation for Multifidus Dysfunction in Nociceptive Mechanical Chronic Low Back Pain.

Chronic low back pain (CLBP) is a debilitating, painful, and costly condition. Implantable neuromuscular electrical stimulation targeting the multifidus musculature is growing as a non-pharmacologic option for patients with recalcitrant nociceptive mechanical CLBP who have failed conservative treatments (including medications and physical therapy) and for whom surgery is not indicated. Properly selecting patients who meet specific criteria (based on historical results from randomized controlled trials), who diligently adhere to implant usage and precisely implement neuromuscular rehabilitation, improve success of significant functional recovery, as well as pain medication reductions. Patients with nociceptive mechanical CLBP who underwent implanted multifidus neurostimulation have been treated by physicians and rehabilitation specialists who have honed their experience working with multifidus neurostimulation. They have collaborated on consensus and evidence-driven guidelines to improve quality outcomes and to assist providers when encountering patients with this device. Physicians and physical therapists together provide precision patient-centric medical management with quality neuromuscular rehabilitation to encourage patients to be experts of both their implants and quality spine motion to help override long-standing multifidus dysfunction related to their CLBP.

Stimulation of the Internal Superior Laryngeal Nerve as a Potential Therapy for Obstructive Sleep Apnea in a Porcine Model.

Impaired pharyngeal sensing of negative pressure can lead to a blunted response of the upper airway dilator muscles and contribute to the development of obstructive sleep apnea (OSA). This response is modulated by the nerve fibers in the internal branch of the superior laryngeal nerve (iSLN), mediating negative pressure sensation. Artificial excitation of these fibers could be a potential treatment target for OSA. To evaluate this, electrostimulation of the iSLN was performed in a porcine isolated upper airway model. Artificial obstructions were induced by varying levels of negative pressure and the ability of the animal to resolve these obstructions was evaluated. The pressure at which the animal was still able to resolve the obstruction was quantified as 'Resolvable Pressure'. Thereby, the effects on pharyngeal patency (n=35) and the duration of the therapeutic effect outlasting the stimulation (n=6) were quantified. Electrostimulation prior to the introduction of an artificial obstruction improved the median resolvable pressure from -28.3 cmH2O [IQR: -45.9; -26.1] to -92.6 cmH2O [IQR: -105.1; -78.6]. The median therapeutic effect was found to outlast the last stimulation burst applied by 163 s when five stimulation bursts were applied in short succession [IQR: 58; 231], 58 s when two were applied [IQR: 7; 65], and 6 s when one was applied [IQR: 0; 51]. Stimulation of the iSLN increased EMG in the genioglossus. The proposed treatment concept can improve pharyngeal patency in the model. Transfer of the results to clinical application could enable the development of a new neuromodulation therapy for OSA.

Beyond Hypoglossal Hype: Social Media Perspectives on the Inspire Upper Airway Stimulation System.

In the landscape of sleep surgery, the Inspire® Upper Airway Stimulation (UAS) device has gained prominence as an increasingly popular treatment option for obstructive sleep apnea, prompting significant discourse across social media platforms. This study explores the social media narrative of the UAS device, particularly the nature of multimedia content, author demographics, and audience engagement on Instagram, Facebook, and TikTok. Our analysis encompassed 423 public posts, revealing images (67.4%) and videos (28.1%) as the dominant content types, with over a third of posts authored by physicians. A notable 40% of posts were advertisements, whereas patient experiences comprised 34.5%. TikTok, although presenting a smaller sample size, showed a substantially higher engagement rate, with posts averaging 152.9 likes, compared with Instagram and Facebook at 32.7 and 41.2 likes, respectively. The findings underscore the need for otolaryngologists and healthcare professionals to provide clear, evidence-based information on digital platforms. Given social media's expanding role in healthcare, medical professionals must foster digital literacy and safeguard the accuracy of health information online. In this study, we concluded that maintaining an evidence-based, transparent digital dialogue for medical innovations such as the UAS device necessitates collaborative efforts among physicians, health institutions, and technology companies.

Soft Neural Interfacing based on Implantable Graphene Fiber Microelectrode Arrays.

Microelectrode Arrays (MEAs) neural interfaces are considered implantable devices that interact with the nervous system to monitor and/or modulate brain activity. Graphene-based materials are utilized to address some of the current challenges in neural interface design due to their desirable features, such as high conductance, large surface-to-volume ratio, suitable electrochemical properties, biocompatibility, flexibility, and ease of production. In the current study, we fabricated and characterized a type of flexible, ultrasmall, and implantable neurostimulator based on graphene fibers. In this procedure, wet-spinning was employed to create graphene fibers with diameters of 10 to 50 µm. A 10-channel polyimide Printed Circuit Board (PCB) was then custom-designed and manufactured. The fibers were attached to each channel by conductive glue and also insulated by soaking them in a polyurethane solution. The tips were subsequently exposed using a blowtorch. Microstructural information on the fibers was obtained using Scanning Electron Microscopy (SEM), and the measurements of Electrochemical Impedance Spectroscopy (EIS) were conducted for each electrode. Flexible MEAs were created using graphene fibers with diameters ranging from 10 to 50 microns with a spacing of 150 microns. This method leads to producing electrode arrays with any size of fibers and a variety of channel numbers. The flexible neural prostheses can replace conventional electrodes in both neuroscience and biomedical research.

Intraoperative Neurophysiological Monitoring During Spinal Cord Stimulation Surgery: A Systematic Review.

OBJECTIVES: This study aims to describe the state of literature regarding the use of intraoperative neurophysiological monitoring (IONM) during spinal cord stimulator surgery. MATERIALS AND METHODS: A systematic review of the use of IONM during spinal cord stimulation (SCS) surgery was performed using the following three data bases: PubMed, Ovid MEDLINE, and Embase. Research techniques included systematic research following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol by Cochrane, and backward searching. Qualitative analysis of included articles was performed using the methodologic index for nonrandomized studies assessment tool. Direction of effect, consistency across studies, and cost-effectiveness were narratively synthesized. RESULTS: A total of 15 records were identified through data base searching. All records used IONM methods under general anesthesia for guidance of epidural lead placement. IONM techniques used for determining lateralization in the found articles were compound muscle action potentials (CMAPs) (n = 8), somatosensory evoked potentials (SSEPs) (n = 3) or both (n = 4). Motor evoked potentials were used in three trials for neuroprotection purposes. Two studies were comparative, and 12 were noncomparative. CONCLUSIONS: We found a good body of level II evidence that using IONM during SCS surgery is a valid alternative to awake surgery and may even be superior regarding pain management, cost-effectiveness, and postoperative neurologic deficits. In direct comparison, the found evidence suggested using CMAP provided more consistently favorable results than using SSEP for midline placement of epidural leads under general anesthesia. Selection of IONM modality should be made on the basis of pathophysiology of disease, individual IONM experience, and the individual patient.

Microbial colonization of sacral nerve stimulators pseudo-capsule: A single institution experience.

PURPOSE: To evaluate the incidence and type of microbial colonization of the pseudo-capsule (PC) that forms around sacral nerve stimulators (SNS) and consequently the significance of surgical excision of this PC at time of SNS revision or removal. MATERIALS AND METHODS: A cohort of 31 patients who underwent SNS revision or removal from January 2018 to June 2021 were retrospectively reviewed. The baseline demographics, rate and type of PC microbial colonization and development of SNS insertion site infection were reported. RESULTS: A cohort of 31 patients who underwent "InterStim device (Medtronic)" revision or removal were included. The majority were females (93.5%). The most common indication for SNS insertion was refractory overactive bladder (67.7%). Nine patients (29.0%) underwent SNS revision due to malfunctional device, and 9 patients had SNS removal for the need of MRI procedures. Four patients (12.9%) had positive tissue culture growing Coryneform bacillus (50.0%), Cutibacterium acnes (25.0%) and Pseudomonas aeruginosa (25.0%). CONCLUSIONS: PC colonization was uncommon at the time of SNS explant. However, more research is needed to better understand the role of PC-positive culture in increasing the risk of SNS device infections if strict adherence to sterile techniques is adopted.

Continuing trial responsibilities for implantable neural devices.

Participants of neural implant studies have research-related posttrial care needs (e.g., hardware replacements). Gaps in plans for posttrial care are currently common, which can have major consequences for patients. Professionals and organizations involved should address important unmet posttrial needs.

Structure and establishment of the German Cochlear Implant Registry (DCIR).

Hearing rehabilitation of patients with severe hearing loss or deafness using cochlear implants (CI) is a very successful but also complex and lifelong process that requires high quality standards for structure, process, and results. Medical registries represent an ideal tool for conducting quality control relevant to care while at the same time collecting scientific data. Therefore, at the initiative of the Executive Committee of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), a Germany-wide CI registry (the German Cochlear Implant Register, DCIR) was to be established. The following goals were to be achieved: 1) legal and contractual basis for the register; 2) definition of the register contents; 3) development of evaluation standards (hospital-specific and national annual reports); 4) development of a logo; 5) practical operation of the registry. After defining a catalog of services that defines the content, structure, and operation of the DCIR, a registry operator with audiological expertise was sought. After considering various offers, the registry was technically implemented in cooperation with the provider INNOFORCE (Ruggell, Liechtenstein) as registry operator. This also included the realization of an interface for data transfer from previously existing databases and development of a data protection concept for productive operation of the DCIR under the scientific leadership of the DGHNO-KHC Executive Committee. Since January 2022, it has been possible for participating hospitals to enter pseudonymized data into the DCIR. To date, 75 hospitals in Germany have contractually agreed to participate in the registry. During the first 15 months, data from over 2500 implants in over 2000 patients were registered in the DCIR. The work presented here describes the structuring, development, and successful establishment of the DCIR. Introduction of the DCIR represents an important milestone of future scientifically based quality control in CI care. The registry presented here can therefore be considered as an example for other areas of medical care and thus also sets an international standard.

Conception and implementation of a certification system for quality control of cochlear implant treatment in Germany.

A standardized and structured process is indispensable for optimal hearing rehabilitation with cochlear implants (CI). The Executive Committee of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC), initiated the conception of a certification program and a Whitepaper based on the Association of the Scientific Medical Societies in Germany (AWMF) clinical practice guideline (CPG) describing the current medical standards of CI care in Germany. The goal was to independently confirm implementation of this CPG and make this information publicly available. With the support of an independent certification organization, successful implementation of the CI-CPG by a hospital would then be verified and confirmed by awarding the "Cochlear implant-provision institution" (Cochlea-Implantat-versorgende Einrichtung, CIVE) quality certificate. A structure for implementation of a certification system was developed based on the CI-CPG. The following steps were required: 1) conception of a quality control system for certification of hospitals working in accordance with the CI-CPG; 2) development of required structures for an independent review of quality-relevant structure, process, and result parameters; 3) development of a standard procedure for independent certification of hospitals; 4) development of a certificate and a logo to demonstrate successful certification; 5) practical implementation of the certification. Following design of the certification program and the required organizational structure, the certification system was successfully launched in 2021. Applications for the quality certificate could be formally submitted from September 2021. A total of 51 off-site evaluations were performed by December 2022. In the first 16 months from introduction, 47 hospitals were successfully certified as CIVE. In this period, 20 experts were trained as auditors, who have since then carried out 18 on-site audits in hospitals. In summary, the conceptual design, structure, and practical implementation of a certification program for quality control in CI care was successfully implemented in Germany.

Patterns of utilization and cost of healthcare services and pharmacotherapy among patients with drug-resistant epilepsy during the two-year period before neurostimulation: A descriptive analysis of the journey to implantation based on analyses of a large United States healthcare claims database.

OBJECTIVE: To conduct a descriptive assessment of patterns of utilization and cost of healthcare services and pharmacotherapies among patients with drug-resistant epilepsy (DRE) before neurostimulator implantation. METHODS: Using a large United States healthcare claims database, we identified all patients with DRE who were implanted with neurostimulators between January 1, 2012, and December 31, 2019. Patients without an epilepsy diagnosis on their implantation date were excluded, as were those without (1) anti-seizure medication (ASM) dispenses within 12 months of implantation date, and (2) continuous enrollment for the 24-month period before this date. Demographic and clinical characteristics were assessed over the two-year period before implantation, as were patterns of utilization and cost of healthcare services and pharmacotherapy. Care was assessed as all-cause or epilepsy-related, with the latter defined as all medical (inpatient and outpatient) care resulting in diagnoses of epilepsy and all ASM dispenses. RESULTS: Eight hundred sixty patients met all selection criteria. Among these patients, comorbidities were common, including depression (27%), anxiety (30%), and learning disabilities (25%). Fifty-nine percent of patients had ≥1 all-cause hospitalizations; 57% had ≥1 epilepsy-related admissions. Patients averaged 8.6 epilepsy-related visits to physicians' offices, including 5.1 neurologist visits. Mean all-cause and epilepsy-related healthcare costs during the pre-implantation period were $123,500 and $91,995, respectively; corresponding median values were $74,567 and $53,029. Median monthly all-cause healthcare costs increased by 138% during the 24-month period (from $1,042 to $2,481 in the month prior to implantation); median epilepsy-related costs, by 290% (from $383 to $1,492). CONCLUSIONS: The two-year period before neurostimulator implantation is a long and costly journey. Estimates likely minimize the burden experienced during this period, given that seizure frequency and severity-and corresponding impacts on quality of life-were unavailable in these data. Further research is needed to understand the clinical, economic, and psychological impact of the time between DRE onset and implantation among qualifying patients.

Intraoperative Predictors of Sacral Neuromodulation Implantation and Treatment Response: Results From the ROSETTA Trial.

PURPOSE: We determined the utility of intraoperative data in predicting sacral neuromodulation outcomes in urgency urinary incontinence. MATERIALS AND METHODS: Intraoperative details of sacral neuromodulation stage 1 were recorded during the prospective, randomized, multicenter ROSETTA trial, including responsive electrodes, amplitudes, and response strengths (motor and sensory Likert scales). Stage 2 implant was performed for stage 1 success on 3-day diary with 24-month follow-up. An intraoperative amplitude response score for each electrode was calculated ranging from 0 (no response) to 99.5 (maximum response, 0.5 V). Predictors for stage 1 success and improvement at 24 months were identified by stepwise logistic regression confirmed with least absolute shrinkage and selection operator and stepwise linear regression. RESULTS: Intraoperative data from 161 women showed 139 (86%) had stage 1 success, which was not associated with number of electrodes generating an intraoperative motor and/or sensory response, average amplitude at responsive electrodes, or minimum amplitude-producing responses. However, relative to other electrodes, a best amplitude response score for bellows at electrode 3 was associated with stage 1 failure, a lower reduction in daily urgency urinary incontinence episodes during stage 1, and most strongly predicted stage 1 outcome in logistic modeling. At 24 months, those who had electrode 3 intraoperative sensory response had lower mean reduction in daily urgency urinary incontinence episodes than those who had no response. CONCLUSIONS: Specific parameters routinely assessed intraoperatively during stage 1 sacral neuromodulation for urgency urinary incontinence show limited utility in predicting both acute and long-term outcomes. However, lead position as it relates to the trajectory of the sacral nerve root appears to be important.

[Interaural stimulation timing mismatch in listeners provided with a cochlear implant and a hearing aid : A review focusing on quantification and compensation]. / Unterschiedliche Stimulationszeitpunkte bei bimodaler Versorgung mit Hörgerät und Cochleaimplantat : Übersichtsartikel zu Quantifizierung und Kompensation.

Bimodal provision of patients with asymmetric hearing loss with a hearing aid ipsilaterally and a cochlear implant (CI) contralaterally is probably the most complicated type of CI provision due to a variety of inherent variables. This review article presents all the systematic interaural mismatches between electric and acoustic stimulation that can occur in bimodal listeners. One of these mismatches is the interaural latency offset, i.e., the time difference of activation of the auditory nerve by acoustic and electric stimulation. Methods for quantifying this offset are presented by registering electrically and acoustically evoked potentials and measuring processing delays in the devices. Technical compensation of the interaural latency offset and its positive effect on sound localization ability in bimodal listeners is also described. Finally, most recent findings are discussed which may explain why compensation of the interaural latency offset does not improve speech understanding in noise in bimodal listeners.

[Structure and establishment of the German Cochlear Implant Registry]. / Struktur und Einrichtung des Deutschen Cochlea-Implantat-Registers (DCIR).

Hearing rehabilitation of patients with severe hearing loss or deafness using cochlear implants (CI) is a very successful but also complex and lifelong process that requires high quality standards for structure, process, and results. Medical registries represent an ideal tool for conducting quality control relevant to care while at the same time collecting scientific data. Therefore, at the initiative of the Executive Committee of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), a Germany-wide CI registry (the German Cochlear Implant Register, DCIR) was to be established. The following goals were to be achieved: 1) legal and contractual basis for the register; 2) definition of the register contents; 3) development of evaluation standards (hospital-specific and national annual reports); 4) development of a logo; 5) practical operation of the registry. After defining a catalog of services that defines the content, structure, and operation of the DCIR, a registry operator with audiological expertise was sought. After considering various offers, the registry was technically implemented in cooperation with the provider INNOFORCE (Ruggell, Liechtenstein) as registry operator. This also included the realization of an interface for data transfer from previously existing databases and development of a data protection concept for productive operation of the DCIR under the scientific leadership of the DGHNO-KHC Executive Committee. Since January 2022, it has been possible for participating hospitals to enter pseudonymized data into the DCIR. To date, 75 hospitals in Germany have contractually agreed to participate in the registry. During the first 15 months, data from over 2500 implants in over 2000 patients were registered in the DCIR. The work presented here describes the structuring, development, and successful establishment of the DCIR. Introduction of the DCIR represents an important milestone of future scientifically based quality control in CI care. The registry presented here can therefore be considered as an example for other areas of medical care and thus also sets an international standard.

[Conception and implementation of a certification system for quality control of cochlear implant treatment in Germany. German version]. / Konzeption und Implementierung eines Zertifizierungssystems zur Qualitätssicherung der Cochlea-Implantat-Versorgung in Deutschland.

A standardized and structured process is indispensable for optimal hearing rehabilitation with cochlear implants (CI). The Executive Committee of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC), initiated the conception of a certification system and a Whitepaper based on the Association of the Scientific Medical Societies in Germany (AWMF) clinical practice guideline (CPG) describing the current medical standards of CI care in Germany. The goal was to independently confirm implementation of this CPG and make this information publicly available. With the support of an independent certification organization, successful implementation of the CI-CPG by a hospital would then be verified and confirmed by awarding the "Cochlear implant-provision institution" (Cochlea-Implantat-versorgende Einrichtung, CIVE) quality certificate. A structure for implementation of a certification system was developed based on the CI-CPG. The following steps were required: 1) conception of a quality control system for certification of hospitals working in accordance with the CI-CPG; 2) development of required structures for an independent review of quality-relevant structure, process, and result parameters; 3) development of a standard procedure for independent certification of hospitals; 4) development of a certificate and a logo to demonstrate successful certification; 5) practical implementation of the certification. Following design of the certification system and the required organizational structure, the certification system was successfully launched in 2021. Applications for the quality certificate could be formally submitted from September 2021. A total of 51 off-site evaluations were performed by December 2022. In the first 16 months from introduction, 47 hospitals were successfully certified as CIVE. In this period, 20 experts were trained as auditors, who have since then carried out 18 on-site audits in hospitals. In summary, the conceptual design, structure, and practical implementation of a certification system for quality control in CI care was successfully implemented in Germany.

Upper Airway Stimulation in Patients with Obstructive Sleep Apnea: Long-Term Surgical Success, Respiratory Outcomes, and Patient Experience

Abstract Introduction Upper airway stimulation (UAS) with electric activation of the hypo-glossal nerve has emerged as a promising treatment for patients with moderate-to-severe obstructive sleep apnea. Objective To retrospectively analyze objective and subjective outcome measures after long-term follow-up in obstructive sleep apnea patients receiving upper airway stimulation. Methods An observational retrospective single-center cohort study including a consecutive series of patients diagnosed with obstructive sleep apnea receiving upper airway stimulation. Results Twenty-five patients were included. The total median apnea-hypopnea index (AHI) significantly decreased from 37.4 to 8.7 events per hour at the 12-month follow-up (p < 0.001). The surgical success rate was 96%. Adverse events were reported by 28% of the patients. Conclusion Upper airway stimulation is an effective and safe treatment for obstructive sleep apnea in patients with continuous positive airway pressure (CPAP) failure or intolerance. However, it is possible that the existing in and exclusion criteria for UAS therapy in the Netherlands have positively influenced our results.

Effect of pulse width variations on sacral neuromodulation for overactive bladder symptoms: A prospective randomized crossover feasibility study.

INTRODUCTION/BACKGROUND: The pulse width (PW) parameter in sacral neuromodulation (SNM) is understudied, with no evidence-based guidance available on optimal PW for urinary indications. The aim of this prospective, randomized, single-blinded, 3 × 3 cross over design study was to estimate the effect of two PW settings (60 µs, 420 µs) compared to the industry standard (210 µs) on SNM efficacy, quality of life, and device parameters in patients who were stable and satisfied with their SNM treatment. METHODS/MATERIALS: Eligible patients were previously implanted and had urge incontinence or urgency-frequency with satisfaction on SNM at time of enrollment. Patients completed a 3-day voiding diary, validated questionnaires, and device interrogations with sensory threshold assessment at baseline and after a 4-week period on each of the three PW settings, to which they were randomized. Eighteen participants completed the study, as called for by power analysis. RESULTS: Eighteen patients were enrolled in the study. Mean age was 68 years and implant duration at the time of participation was 4.4 years. While PW variations did not produce significant differences in overall objective outcomes, device parameters, including sensory threshold amplitude and battery life differed significantly. Shortened PW necessitated higher amplitude while conserving battery life. Stimulus sensation location, quality, and intensity did not differ between PW. Standard PW was chosen by 11 patients after the study, 5 chose extended, and 2 chose shortened. Those who chose alternative PW achieved significant reductions in urinary frequency from enrollment -2.23 voids/day (p = 0.015). Upon sub-analysis, patients reporting "much better" or "very much better" on extended PW achieved significant reductions in urinary frequency and nocturia at 5.6 and 0.4, compared to 8.5 and 2.16 at baseline (p = 0.005, p = <0.001). Whereas those reporting "much better" or "very much better" on shortened PW achieved significant reductions in urinary frequency at 5.15 compared to 7.35 (p = 0.026). There were no adverse events or complications. CONCLUSIONS: Overall SNM effectiveness was unchanged with alternative PW; however, 39% of patients preferred alternative to standard PW and achieved significant improvements in urinary symptoms with such. Shorter PW can also provide savings in estimated battery life without sacrificing therapeutic efficacy.

Upper Airway Stimulation in Patients with Obstructive Sleep Apnea: Long-Term Surgical Success, Respiratory Outcomes, and Patient Experience.

Introduction Upper airway stimulation (UAS) with electric activation of the hypoglossal nerve has emerged as a promising treatment for patients with moderate-to-severe obstructive sleep apnea. Objective To retrospectively analyze objective and subjective outcome measures after long-term follow-up in obstructive sleep apnea patients receiving upper airway stimulation. Methods An observational retrospective single-center cohort study including a consecutive series of patients diagnosed with obstructive sleep apnea receiving upper airway stimulation. Results Twenty-five patients were included. The total median apnea-hypopnea index (AHI) significantly decreased from 37.4 to 8.7 events per hour at the 12-month follow-up ( p < 0.001). The surgical success rate was 96%. Adverse events were reported by 28% of the patients. Conclusion Upper airway stimulation is an effective and safe treatment for obstructive sleep apnea in patients with continuous positive airway pressure (CPAP) failure or intolerance. However, it is possible that the existing in and exclusion criteria for UAS therapy in the Netherlands have positively influenced our results.

A case report of sacral neuromodulation tined lead migration into the rectum.

This report describes a 26-year-old woman who underwent sacral neuromodulation explant following lead migration and rectal wall penetration. Her device was implanted due to persistent urinary retention. The tined lead wire was dissected to the fascia and cut. The rectal part of the lead was removed with gentle traction.

Computed tomography scanning of implanted hypoglossal nerve stimulators and approach to device malfunction: case series.

OBJECTIVE: Serious device-related complications for hypoglossal nerve stimulators are rare, but surgeons should implement a prompt and systematic approach to quickly troubleshoot a non-functioning device. METHOD: Records were queried at a single academic tertiary referral centre between January 2019 and June 2021. RESULTS: The authors present four cases of non-functioning hypoglossal nerve stimulator devices: one case in which migration of the stimulation lead required a revision implantation, one in which the implantable pulse generator was found to be non-functional intra-operatively, one case of an intramuscular sensory lead tract causing pain and one case of implantable pulse generator failure that was probably triggered by implantable cardiac device discharge. In this study, computed tomography imaging was critical to the diagnosis for the first and third cases. CONCLUSION: Given the limited complication reporting available for hypoglossal nerve stimulators, these cases highlight management and unique imaging findings. The authors present an algorithm to work-up non-functioning hypoglossal nerve stimulator devices.

Development of an implant technique and early experience using a novel implantable pulse generator with a quadripolar electrode array at the tibial nerve for refractory overactive bladder.

OBJECTIVES: Tibial nerve stimulation is an effective treatment for overactive bladder (OAB) and has been utilized as an in-person recurring session treatment option for many years. The primary objective of this study was to evaluate the safety and efficacy of a long-term implantable device and the method of utilizing a retrograde approach to place the device (a percutaneous implantable pulse generator [pIPG] with integrated quadripolar electrodes) at the tibial nerve (Protect PNS; Uro Medical Corp.). METHODS: A novel retrograde implant technique was developed through multiple cadaveric dissections to percutaneously implant a chronic, wireless, minimally invasive pIPG device with integrated quadripolar electrodes (now licensed to Uro Medical) at the tibial nerve. A proof-of-concept pIPG device approved as part of an FDA IDE was designed to gain early experience in subjects with refractory OAB. The pIPG was implanted in the office under local anesthesia using the novel retrograde approach, and stimulation was activated using an external wireless energy source called a transmitter. Initially, a pilot study was designed to compare outcomes in subjects randomized to either percutaneous tibial nerve stimulation (PTNS) or Protect PNS. However, due to the small sample sizes available at this time, it was not possible to compare the two groups. Thus, the purpose of this manuscript is to describe the outcome of subjects who underwent implantation of the Protect PNS system. Twelve-month safety and efficacy were evaluated. RESULTS: Nine subjects were enrolled in the randomized pilot study; 5 to the pIPG group and 4 to PTNS, and all completed the 13-week primary endpoint. Subsequently, two subjects in the PTNS group chose to cross over and have the pIPG implanted after 13 weeks. Outcomes of the seven subjects who underwent implantation of the pIPG are described. No complications related to the office procedure were noted. Two of the older model pIPG devices became nonresponsive at 1 and 4 weeks and were replaced. Six minor adverse events were reported and resolved. Subjects reported improvement in urge urinary incontinence (UUI) episodes, OAB symptoms, and quality of life. Subjects impanted with a pIPG reported a 50% reduction in UUI as early as 1 week. CONCLUSIONS: Results of this pilot study suggest that retrograde percutaneous implantation of a pIPG is a safe, minimally invasive one-stage office procedure for treatment for urge incontinence related OAB symptoms, without significant complications after 12 months follow-up. Future studies will be required to compare outcomes among treatment modalities.