Neurostimulator Research Articles

Sacral neuromodulation in patients with detrusor underactivity: Is biological sex an indicator?

This study aimed to report sacral neuromodulation (SNM) outcomes in detrusor underactivity (DU). A multicentric, multinational, retrospective case series was conducted between March 2017 and June 2021 in three different referral centers. Initial test phase stimulation included either a percutaneous nerve evaluation (PNE) or an advanced lead evaluation test phase (ALTP) before permanent SNM implantation. The test phases were performed under local anesthesia, either in the outpatient (PNE) or operating room (ALTP), in the prone position, which was implanted in the third or fourth sacral foramina under fluoroscopic guidance. Patients with favorable response to the initial test phase during the first 2 weeks underwent the implantable pulse generator (IPG) implantation (Medtronic neurostimulation generator device InterStim™). Favorable response was defined as ≥ 50% improvement in symptoms, frequency of clean intermittent catheterization (CIC) and/or decrease in postvoid residual (PVR), increase in voided volume, or improvement in bladder voiding efficiency (BVE) based on the bladder diary. Fifty-eight patients were recruited with a mean age of 39.95 ± 15.28 years. Among the 58 cases, 36 (62.1%) patients responded to the initial stage. Of these, 12 patients (30.8%) with non-neurogenic etiology and nine patients (52.9%) with neurologic etiology did not respond to the initial test phase; thus, they did not undergo full implantation (p = 0.141). Voided volume, PVR, and the median maximum flow rate (Qmax) improved significantly (p < 0.001) in both sexes; however, there was no statistical difference between both genders. Most female cases (78.3%), and nearly half of the men (51.4%), responded to the test phase and were candidates for the IPG phase. Among the 35 cases who underwent IPG, 27 patients (72.2% of males, and 77.8% of females; p = 0.700) had a favorable response to IPG. 46.6% of patients had a successful outcome at the end of the study. This multicentric study showed that SNM effectively and safely provided symptom improvement in refractory DU in males similar to females which is an important finding as previously it has been suggested that SNM works better in nonobstructive urinary retention in women and not in women.

Surgical and Hardware Complications of Deep Brain Stimulation—A Single Surgeon Experience of 519 Cases Over 20 Years

ObjectiveDeep brain stimulation (DBS) surgery has its own set of risks and complications. This study from a single center and a single surgeon analyzes various risk factors for complications and tries to establish if there is a learning curve effect in minimizing the complications. Materials and MethodsA retrospective analysis of 519 patients (1024 leads) who underwent DBS surgery and 232 patients who underwent implantable pulse generator replacement (IPG), by a single surgeon, between the years 1999 and 2019 was performed. Perioperative and hardware related complications were evaluated. ResultsThe follow-up period ranged from six months to 20 years. Surgery-related complications occurred in 46 (8.9%) cases which included confusion in 31 (5.98%), intracerebral hemorrhage in 7 (1.3%), vasovagal attack in 3 (0.58%), respiratory distress in 2 (0.38%), postoperative aggressiveness in 1 (0.19%), and blepharospasm in 2 (0.38%) patients. Complications related to the DBS hardware were found in 35 cases, including erosion and infection in 22 (2.95%), inaccurate lead placement or migration in 6 (0.6%) lead fracture/extension wire failure in 2 (0.26%), IPG malfunction in 2 (0.26%), and hardware discomfort in 3 (0.4%) cases. In three patients, one lead was repositioned. In cases of infection, 87% of patients had either partial or complete removal of hardware. There was no mortality. The complications were analyzed for every 100 DBS procedures. There was a significant drop in the percentage of complications in from 23% in the first 100 cases to 7% in the last 100 cases (p < 0.0001). ConclusionConfusion remains the most frequent operative and perioperative complication. Erosion and infection of the surgical site represents the most frequent hardware complication. DBS surgery is safe and the complication rates are acceptably low. The complication rate also decreases with cumulative years of experience, demonstrating a learning curve effect.

Local Field Potential-Based Programming: A Proof-of-Concept Pilot Study

ObjectivesProgramming deep brain stimulation (DBS) is still based on a trial-and-error approach, often becoming a time-consuming process for both treating physicians and patients. Several strategies have been proposed to streamline DBS programming, most of which are preliminary and mainly address Parkinson's disease, a condition readily responsive to DBS adjustments. In the present proof-of-principle pilot study, we successfully demonstrate that local field potential (LFP)-based programming can be an effective approach when used for DBS indications that have a delayed temporal onset of benefit. Materials and MethodsA recently commercialized implantable pulse generator (IPG) with the capability to non-invasively and chronically stream live and/or record LFPs from a DBS electrode after implantation was used to program one pediatric patient with generalized dystonia and an adult with seizures refractory to multiple medications and vagal nerve stimulation. ResultsThe IPG survey function detected a peak in the delta range (1.95 Hz) in the left globus pallidus of the first patient. This LFP was detected when recording in the brain area adjacent to contacts 9 and 10 and absent when recording from other areas. The chronic recording of the 1.95 Hz LFP with two sets of stimulation showed a greater power increase with the settings associated with a worsening of dystonia. Broadband LFP home recording of “absence seizure” and “focal/partial seizure” was used in the second patient and reviewer with the IPG “timeline” and “event” functions. The chronic recording of the 2.93 Hz and 8.79 Hz (spit sensing) showed a reduced power with the stimulation setting associated with seizure control. ConclusionsThe approach presented in this pilot proof-of-concept study may inform and streamline the DBS programming for conditions requiring clinicians and patients to wait weeks before appreciating any clinical benefit. Prospective studies on larger samples of patients are warranted.

Sacral neuromodulation for the treatment of overactive bladder: systematic review and future prospects

ABSTRACT Introduction Sacral Neuromodulation (SNM) is a minimally invasive treatment for OAB patients following failure of conventional interventions. Patient selection, lead placement, and testing technique are important pillars in optimizing success rates. Areas covered A comprehensive literature search was conducted on ‘sacral neuromodulation’ and ‘overactive bladder.’ There was no date restriction, with the last search dated 31 May 2021. Patient selection, lead placement, test phases, safety, efficacy, and available devices are thoroughly discussedLastly, future perspectives will be presented with the anticipated trajectory of sacral neuromodulation over the next five years. Expert opinion/commentary SNM has proved to be a safe and effective therapy on the short-, medium- and long-term without precluding any other treatment options. In all studies reviewed, no life threatening or major irreversible complications were presented. However, surgical re-intervention rates were high with a median of 33.2% (range: 8–34%) in studies with at least 24 months follow-up. No true consensus could be made regarding prognostic factors. However, optimized lead placement, consequent ideal motor thresholds, and the use of a curved stylet theoretically facilitates reaching maximal success with SNM. Test phase success rates increased to such a level that from a cost-effective point of view, single-stage implants could be considered. Abbreviations: OAB: overactive bladder; SNM: sacral neuromodulation; BoNT-A: Botulinum toxin A; PFM EMG: pelvic floor muscle electromyography; IPG: implantable pulse generator; PNE: percutaneous nerve evaluation; FSTLP: first-stage tined lead procedure; NLUTD: neurogenic lower urinary tract dysfunction; ITT: intention to threat; PPMC: per protocol modified completers; PPC: per protocol completers; AE: adverse event; MRI: magnetic resonance imaging; RCT: randomized controlled trial

Surgical and Hardware-Related Adverse Events of Deep Brain Stimulation: A Ten-Year Single-Center Experience

IntroductionAlthough deep brain stimulation (DBS) is effective for treating a number of neurological and psychiatric indications, surgical and hardware-related adverse events (AEs) can occur that affect quality of life. This study aimed to give an overview of the nature and frequency of those AEs in our center and to describe the way they were managed. Furthermore, an attempt was made at identifying possible risk factors for AEs to inform possible future preventive measures. Materials and MethodsPatients undergoing DBS-related procedures between January 2011 and July 2020 were retrospectively analyzed to inventory AEs. The mean follow-up time was 43 ± 31 months. Univariate logistic regression analysis was used to assess the predictive value of selected demographic and clinical variables. ResultsFrom January 2011 to July 2020, 508 DBS-related procedures were performed including 201 implantations of brain electrodes in 200 patients and 307 implantable pulse generator (IPG) replacements in 142 patients. Surgical or hardware-related AEs following initial implantation affected 40 of 200 patients (20%) and resolved without permanent sequelae in all instances. The most frequent AEs were surgical site infections (SSIs) (9.95%, 20/201) and wire tethering (2.49%, 5/201), followed by hardware failure (1.99%, 4/201), skin erosion (1.0%, 2/201), pain (0.5%, 1/201), lead migration (0.52%, 2/386 electrode sites), and hematoma (0.52%, 2/386 electrode sites). The overall rate of AEs for IPG replacement was 5.6% (17/305). No surgical, ie, staged or nonstaged, electrode fixation, or patient-related risk factors were identified for SSI or wire tethering. ConclusionsMajor AEs including intracranial surgery–related AEs or AEs requiring surgical removal or revision of hardware are rare. In particular, aggressive treatment is required in SSIs involving multiple sites or when Staphylococcus aureus is identified. For future benchmarking, the development of a uniform reporting system for surgical and hardware-related AEs in DBS surgery would be useful.

A Fully Implantable Miniaturized Liquid Crystal Polymer (LCP)-Based Spinal Cord Stimulator for Pain Control.

Spinal cord stimulation is a therapy to treat the severe neuropathic pain by suppressing the pain signal via electrical stimulation of the spinal cord. The conventional metal packaged and battery-operated implantable pulse generator (IPG) produces electrical pulses to stimulate the spinal cord. Despite its stable operation after implantation, the implantation site is limited due to its bulky size and heavy weight. Wireless communications including wireless power charging is also restricted, which is mainly attributed to the electromagnetic shielding of the metal package. To overcome these limitations, here, we developed a fully implantable miniaturized spinal cord stimulator based on a biocompatible liquid crystal polymer (LCP). The fabrication of electrode arrays in the LCP substrate and monolithically encapsulating the circuitries using LCP packaging reduces the weight (0.4 g) and the size (the width, length, and thickness are 25.3, 9.3, and 1.9 mm, respectively). An inductive link was utilized to wirelessly transfer the power and the data to implanted circuitries to generate the stimulus pulse. Prior to implantation of the device, operation of the pulse generator was evaluated, and characteristics of stimulation electrode such as an electrochemical impedance spectroscopy (EIS) were measured. The LCP-based spinal cord stimulator was implanted into the spared nerve injury rat model. The degree of pain suppression upon spinal cord stimulation was assessed via the Von Frey test where the mechanical stimulation threshold was evaluated by monitoring the paw withdrawal responses. With no spinal cord stimulation, the mechanical stimulation threshold was observed as 1.47 ± 0.623 g, whereas the stimulation threshold was increased to 12.7 ± 4.00 g after spinal cord stimulation, confirming the efficacy of pain suppression via electrical stimulation of the spinal cord. This LCP-based spinal cord stimulator opens new avenues for the development of a miniaturized but still effective spinal cord stimulator.

The Challenge of Converting "Failed Spinal Cord Stimulation Syndrome" Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment: A Real Life Retrospective Study.

While paresthesia-based Spinal Cord Stimulation (SCS) has been proven effective as treatment for chronic neuropathic pain, its initial benefits may lead to the development of “Failed SCS Syndrome’ (FSCSS) defined as decrease over time related to Loss of Efficacy (LoE) with or without Loss of Coverage (LoC). Development of technologies associating new paresthesia-free stimulation waveforms and implanted pulse generator adapters provide opportunities to manage patients with LoE. The main goal of our study was to investigate salvage procedures, through neurostimulation adapters, in patients already implanted with SCS and experiencing LoE. We retrospectively analyzed a cohort of patients who were offered new SCS programs/waveforms through an implanted adapter between 2018 and 2021. Patients were evaluated before and at 1-, 3-, 6- and 12-month follow-ups. Outcomes included pain intensity rating with a Visual Analog Scale (VAS), pain/coverage mappings and stimulation preferences. Last follow-up evaluations (N = 27) showed significant improvement in VAS (p = 0.0001), ODI (p = 0.021) and quality of life (p = 0.023). In the 11/27 patients with LoC, SCS efficacy on pain intensity (36.89%) was accompanied via paresthesia coverage recovery (55.57%) and pain surface decrease (47.01%). At 12-month follow-up, 81.3% preferred to keep tonic stimulation in their waveform portfolio. SCS conversion using adapters appears promising as a salvage solution, with an emphasis on paresthesia recapturing enabled via spatial retargeting. In light of these results, adapters could be integrated in SCS rescue algorithms or should be considered in SCS rescue.

Ageing with sacral nerve modulation for fecal incontinence: how many patients get benefit after more than 10years?

Sacral nerve modulation (SNM) has represented a major advancement in the minimally invasive management of patients with fecal incontinence (FI). Although the success rate in the short–medium term has widely been demonstrated, the very long-term outcomes are poorly investigated. This study aims to assess the effectiveness of SNM in a cohort of patients with a follow-up longer than 10 years. Clinical records of patients submitted to SNM for FI in our tertiary referral colorectal Unit between 1998 and 2010 were retrospectively reviewed looking for status of the implantable pulse generator (IPG), follow-up duration, severity of FI by the St Marks’ score and quality of life. 58 patients fulfilled the entry criteria and 36 (58%, median follow-up, 12 years) accepted to take part to the telephone interview, while 22 (38%) were lost to the follow-up. Nineteen patients had their IPG removed (Group A) while 17 (27%) had the SNM still active after a median follow-up of 13 years (Group B). In the group A, the median baseline St Marks’ score was 13 and did not change after the IPG removal. In group B, the median baseline St Marks’ score was 14, at last IPG substitution, it was of 7 and at the last follow-up dropped to 4. In the group A, the median SF-12 physical and mental scores did not change significantly while they improved significantly in group B. A progressive deterioration of the success rate of SNM with the time has been documented after a very long-term follow-up.

The Influence of Electrode Configuration Changes on the Sensory and Motor Response During (Re)Programming in Sacral Neuromodulation

ObjectivesThis study aimed to assess the neurophysiological basis behind troubleshooting in sacral neuromodulation (SNM). Close follow-up of SNM patients with program parameter optimization has proven to be paramount by restoring clinical efficacy and avoiding surgical revision. Materials and MethodsA total of 34 successful SNM patients (28 overactive bladder wet, six nonobstructive urinary retention) with an implantable pulse generator were included. All possible bipolar and monopolar electrode settings were tested at sensory threshold (ST) to evaluate sensory (mapped on a perineal grid with 1 cm2 coordinates) and motor (peak-to-peak amplitude and latency of muscle action potential) responses of the pelvic floor. Pelvic floor muscle electromyography was recorded using a multiple array probe, placed intravaginally. Parametric tests were used for paired data: repeated-measures ANOVA or t-test. A nonparametric test was used for paired data: Friedman ANOVA or Wilcoxon signed rank (WSR) test; p < 0.05 was considered statistically significant. If significant, ANOVA was followed by Dunn-Bonferroni post hoc analysis. ResultsMonopolar configurations showed significantly lower STs—1.38 ± 0.73 V vs 1.76 ± 0.89 V (paired t-test: p < 0.0001)—and presented with significantly higher peak-to-peak amplitudes—115.67 ± 79.03 μV vs 90.77 ± 80.55 μV (WSR: p = 0.005)—than bipolar configurations. When polarity was swapped, configurations with the cathode distal to the anode showed significantly lower STs, 1.73 ± 0.91 V vs 1.85 ± 0.87 V (paired t-test: p = 0.003), and mean peak-to-peak amplitudes, 81.32 ± 72.82 μV vs 100.21 ± 90.22 μV (WSR: p = 0.0001). Cathodal changes resulted in more changes in sensory responses than anodal changes (χ2 test: p = 0.044). In cathodal changes only, peak-to-peak amplitudes were significantly higher when the distance between electrodes was maximally spread (WSR: p = 0.046). ConclusionsFrom a neurophysiological point of view, monopolar configurations stimulated more motor nerve fibers at lower STs, therefore providing more therapeutic efficiency. Swapping polarity or changing the position of the cathode led to different sensory and motor responses, serving as potential reprogramming options.

Intermittent Dorsal Root Ganglion Stimulation Is as Efficacious as Standard Continuous Dosing in Treating Chronic Pain: Results From a Randomized Controlled Feasibility Trial

IntroductionDorsal root ganglion stimulation (DRG-S) is a form of neuromodulation used to treat chronic pain. A spinal cord stimulation (SCS) method with paresthesia-free waveform used in the dorsal columns, burst-SCS, recently demonstrated efficacy using intermittent stimulation, where stimulation is cycled on and off for set durations. Tonic SCS is a paresthesia-based therapy that is ineffective at sub-perception levels and when delivered in a cycled manner. DRG-S also uses a tonic waveform, yet unlike tonic SCS, it is effective at sub-perception levels. This study aimed to determine whether the cycling of stimulation at the DRG could maintain DRG-S efficacy. Materials and MethodsThis study followed a prospective, randomized, and balanced, double-blinded (assessor) protocol. Twenty DRG-S responders were randomized to a sequence of three programs for consecutive two-week intervals: continuous stimulation; 1 minute on:1 minute off; or 1 minute on:2 minutes off. The primary outcome of this study was change in pain ratings with the cycled programs compared with continuous stimulation. Secondary outcomes included changes in function and scores for quality of life, and stimulation program preference. ResultsMean scores were similar at the end of each two-week stimulation program for Numerical Rating Scale pain (continuous = 2.9 ± 0.8, 1:1 on-off = 2.6 ± 0.7, and 1:2 on-off = 2.7 ± 0.7 cm, p = 0.39), disability (p = 0.72), and general health (p = 0.95). No clinically significant differences were found from the upper boundaries of the 95% confidence intervals of the mean difference in pain, disability, and general health for each intermittent stimulation program vs the continuous program. At the end of the study, the continuous stimulation, 1:1 on-off dosing, and 1:2 on-off dosing programs were preferred by a similar number of patients. ConclusionsIntermittent DRG-S produces comparable results to continuous stimulation over a two-week period. Intermittent delivery may extend battery life and facilitate a smaller implantable pulse generator.

Breast Cancer Incidentally diagnosed during Implantable Pulse Generator Replacement in a Patient treated with Deep Brain Stimulation : Importance of Breast Cancer Screening in Patients with Implantable Pulse Generator

Breast Cancer Incidentally diagnosed during Implantable Pulse Generator Replacement in a Patient treated with Deep Brain Stimulation : Importance of Breast Cancer Screening in Patients with Implantable Pulse Generator

POSA296 Optimizing Healthcare Expenditure for Spinal Cord Stimulation in Italy: Value of Battery Longevity Improvement and a Direct-to-Implant Approach

Spinal Cord Stimulation (SCS) is a treatment for chronic intractable pain powered by an implantable pulse generator with a rechargeable or non-rechargeable (NR) battery. SCS is performed in two stages (a trialling phase, followed by permanent device implantation); however, this necessitates two hospitalizations and may increase infection risk. This analysis explores the cost impact of both improvements in battery longevity and the adoption of a 1-step (direct-to-implant) SCS approach within the Italian National Health System (NHS).

Double-blind cross-over pilot trial protocol to evaluate the safety and preliminary efficacy of long-term adaptive deep brain stimulation in patients with Parkinson’s disease

IntroductionAfter several years of brain-sensing technology development and proof-of-concept studies, adaptive deep brain stimulation (aDBS) is ready to better treat Parkinson’s disease (PD) using aDBS-capable implantable pulse generators (IPGs). New...

Real world experience with minimally invasive wireless percutaneous neuromodulation in a tertiary care centre.

Wireless percutaneous nerve stimulation (PNS) for chronic pain is rapidly evolving in the ever expanding neuromodulation paradigm. Safety and lower risks with a potential of long-term analgesia cannot be over emphasised especially with the ongoing opioid pandemic. PNS with an implanted pulse generator (IPG) has also been shown to provide good benefit, without often unpleasant widespread paraesthesia from conventional spinal cord stimulators. We retrospectively extracted data on all wireless PNS implants in our highly specialised pain neuromodulation centre since initiation of wireless PNS service in August 2019. Patient demographics, pain history, analgesic intake and details on implant follow-up data within 1year post-implant including pain relief, EuroQol-5 Dimension (EQ-5D) and Patients' Global Impression of Change (PGIC) scores were extracted. The cases are presented in a narrative format. A total of five patients were implanted with wireless (Stimwave®) PNS from August 2019 to February 2020. Neuropathic pain was the most common presenting diagnosis. All patients showed >50% pain relief at 3months. EQ-5D and PGIC did not show any improvement in the subjects. Two of the patients managed to decrease their analgesics after implantation. Similar sustained benefits could not be demonstrated after 1year. PNS can provide analgesia in appropriately selected cases. Naivety of the technique and procedure might cause some degree of uncertainty. External pulse generator with wireless transmission avoids IPG and tunnelling related side effects, but requires individualised special wearable technology to power the lead. Minimally invasive nature of the technique might be attractive and preferable for patients with complex medical issues, nickel allergy and poor general health who may otherwise be unsuitable for Spinal Cord Stimulation (SCS) with conventional hardware. Robust prospective controlled studies and RCTs in future might provide further insights on utility in other neuropathic pain diagnosis, long-term outcomes and acceptability compared to conventional SCS.

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

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. Records were queried at a single academic tertiary referral centre between January 2019 and June 2021. 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. 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.

Factors Associated With Implantable Pulse Generator Site Pain: A Multicenter Cross-Sectional Study

Implantable pulse generator (IPG) site pain following neuromodulation procedures is a recognized complication. The site of the IPG placement varies depending on the neuromodulation type and physician preference. The incidence of IPG site pain as a function of the site of IPG implantation has not been studied systematically. We performed a multicenter cross-sectional survey of the incidence, severity, and quality of IPG site pain, location of the IPG, the pain management needs, functional impairment, and cosmetic appearance related to the IPG placement. Contingency table analysis was conducted for categorical variables, and logistic regression analysis and linear regression model was used. The survey response rate was 60.5% (n=510). Overall, 31.0% of patients reported pain at the IPG site in the last 72 hours with 31.4% reporting moderate to severe pain and 7.6% reporting severe pain. Older age was inversely associated with IPG-related pain (OR=0.97, 95% CI=0.96-0.99, p=0.001). IPG implantation site did not have a statistically significant interaction with IPG site pain (p > 0.05). The most important factor for IPG site-associated pain was having a spinal cord stimulator implanted as compared to a deep brain stimulator, or sacral nerve stimulator. Most subjects reported no functional impairment related to IPG site pain (91%), found the IPG site pain as expected (80%), and found IPG site cosmetic appearance as expected (96%). The incidence of IPG site pain is an important complication of invasive neuromodulation. The anatomic location of the IPG placement does not appear to affect the incidence or severity of IPG site pain. However, the presence of a pre-implant chronic pain disorder does appear to affect the frequency and severity of IPG site pain.

Implantable Pulse Generator Site May Be Associated With Spinal Cord Stimulation Revision Surgeries

The use of implantable pulse generators (IPG) for spinal cord stimulation (SCS) in patients with chronic pain has been well established. Although IPG-related complications have been reported on, the association between IPG site and SCS complications has not been well studied. To investigate whether IPG placement site in buttock or flank is associated with SCS complications and, hence, revision surgeries. A retrospective cohort study was performed that included 330 patients (52% female) treated at a single institution who underwent permanent implantation of an SCS system between 2014 and 2018. Patients ranged between 20 and 94 years of age (mean: 57.54 ± 13.25). Statistical analyses were conducted using IBM SPSS Statistics. Tests included independent samples t test, chi-square test, Mann-Whitney U test, Spearman's rank correlation coefficient, and logistic regression. There was a total of 93 revision surgeries (rate of 28%), where 71 out of 330 patients (rate of 21.5%) had had at least one revision surgery. Univariate tests demonstrated a significant association between IPG site and revision surgeries (p=0.028 [chi-square test] and p=0.031 [Mann-Whitney U test]); however, multivariate logistic regression demonstrated that neither IPG site was more likely than the other to require revision surgeries (p=0.286). Although this study found a significant association between IPG site and revision surgeries, the effect of IPG site was not found to be predictive. The IPG site likely influences whether a patient will require revision surgery, but further investigation is required to establish this association.

Tissue Temperature Increases by a 10 kHz Spinal Cord Stimulation System: Phantom and Bioheat Model

A recently introduced Spinal Cord Stimulation (SCS) system operates at 10 kHz, faster than conventional SCS systems, resulting in significantly more power delivered to tissues. Using a SCS heat phantom and bioheat multi-physics model, we characterized tissue temperature increases by this 10 kHz system. We also evaluated its Implanted Pulse Generator (IPG) output compliance and the role of impedance in temperature increases. The 10 kHz SCS system output was characterized under resistive loads (1-10 KΩ). Separately, fiber optic temperature probes quantified temperature increases (ΔTs) around the SCS lead in specially developed heat phantoms. The role of stimulation Level (1-7; ideal pulse peak-to-peak of 1-7mA) was considered, specifically in the context of stimulation current Root Mean Square (RMS). Data from the heat phantom were verified with the SCS heat-transfer models. A custom high-bandwidth stimulator provided 10 kHz pulses and sinusoidal stimulation for control experiments. The 10 kHz SCS system delivers 10 kHz biphasic pulses (30-20-30 μs). Voltage compliance was 15.6V. Even below voltage compliance, IPG bandwidth attenuated pulse waveform, limiting applied RMS. Temperature increased supralinearly with stimulation Level in a manner predicted by applied RMS. ΔT increases with Level and impedance until stimulator compliance was reached. Therefore, IPG bandwidth and compliance dampen peak heating. Nonetheless, temperature increases predicted by bioheat multi-physic models (ΔT = 0.64°C and 1.42°C respectively at Level 4 and 7 at the cervical segment; ΔT = 0.68°C and 1.72°C respectively at Level 4 and 7 at the thoracic spinal cord)-within ranges previously reported to effect neurophysiology. Heating of spinal tissues by this 10 kHz SCS system theoretically increases quickly with stimulation level and load impedance, while dampened by IPG pulse bandwidth and voltage compliance limitations. If validated in vivo as a mechanism of kHz SCS, bioheat models informed by IPG limitations allow prediction and optimization of temperature changes.

Clinical efficacy of spinal cord stimulation for the patients with diabetic foot

Objective: To observe the clinical efficacy of spinal cord stimulation (SCS) in the treatment of diabetic foot (DF). Methods: Sixteen patients who were diagnosed with DF and treated with SCS from the Department of Pain Medicine of the First Affiliated Hospital, China Medical University from October 2015 to October 2018 were retrospectively analyzed. Visual analogue scale (VAS), 36-item short form health survey (SF-36), transcutaneous oxygen partial pressure (TcPO2) and skin temperature of lower limbs were compared before and after treatment, and the complications were recorded. Results: Among the 16 patients, 14 were equipped with implantable pulse generator (IPG). The VAS scores decreased significantly from 7.5±1.2 before treatment to 2.6±0.8, 2.0±0.7, 1.6±0.6, 1.0±0.9, 0.9±0.9 at 1 day, 1 week, 3 months, 6 months and 12 months after electrode implantation respectively (all P<0.05). At 12 months after treatment, the parameters of SF-36 were significantly different from those before treatment (all P<0.05). The TcPO2 was (23±5) mmHg before treatment and (38±6) mmHg at 1 week after treatment, with a statistical difference (P<0.05), and the temperature of lower limbs increased significantly (P<0.05). No serious complications were observed in all patients. Conclusion: SCS can relieve the pain of patients with DF, improve the microcirculation and blood supply of lower limbs, and thus promote the quality of life, with rare serious complications.

P.150 Use of Antibacterial Envelopes for Prevention of Infection in Neuromodulation

Background: Neuromodulation unit placement carries a historic infection rate as high as 12%. TYRX antibacterial envelopes (Medtronic Inc., Minneapolis, MN), which are absorbable mesh envelopes that elute minocycline and rifampin, have been used in implantable cardiac devices with substantial risk reduction for infection. Methods: We conducted a retrospective cohort study of consecutive implantable pulse generator (IPG) and intrathecal pump unit implantation with a TYRX antibacterial envelope©. This cohort was then compared to a historical cohort of consecutive patients undergoing IPG or pump placement or revision prior to the use of the envelopes. Results: In the pre-envelope cohort of 151 IPGs in 116 patients, the infection rate was 18/151 (11.9%). In the antibacterial envelope cohort of 233 IPGs in 185 patients, the infection rate was (2.1%). The absolute risk reduction was 4.6% (95% CI, 0.045-0.048), The pre-envelope cohort of 41 pumps in 39 patients, the infection rate was 6/41 (14.6%). In the antibacterial envelope cohort of 59 pumps in 54 patients, the infection rate was (1.7%). The absolute risk reduction was 12.9% (95% CI 1.6-24.3). Conclusions: Usage of an antibacterial envelope for neuromodulation has resulted in a lower infection rate at our center. Based on these results, we recommend the use of antimicrobial envelopes.