Lead Breakage Research Articles

Preventing technique-related complications in spinal cord stimulation trials: The Dural Substitute Confetti technique. A retrospective monocentric analysis.

Spinal Cord Stimulation (SCS) is an established therapy for chronic pain, employing screening trials to identify suitable candidates before implantation. However, complications arising from both technique and medical factors present challenges to this practice. This study introduces the Dural Substitute Confetti technique, which addresses technique-related complications during SCS implantation by preventing scar-induced lead migration or breakage and reducing operating times. We conducted a retrospective analysis on 174 patients treated with SCS trials from 2017 to 2022 at our institution. Of these, 85.1% proceeded to permanent implantation. During trial surgery, synthetic dural substitutes (DS) were used to protect leads, which remained connected to an external pulse generator (EPG) for 20-28 days (mean 21.4 days). Utilizing the DS Confetti technique, leads were easily dissected from the DS during the second surgery and connected to an internal pulse generator (IPG). We compared complications and surgical times before and after the introduction of this technique in 2017. Following the complete SCS trial, patients experienced over 50% pain relief, with an implant-to-trial ratio of 85.1% and a mean follow-up of 52 months. No technique-related complications occurred during the trial period post-2017, while the pre-2017 group had a 3.9% lead migration rate due to scarring, necessitating re-implantation. The average surgery duration decreased from 54 min pre-2017 to 32 min post-2017. Medical-related complications included infections (2.1%) and wound dehiscence (1.3%). The DS Confetti technique prevents scar adhesion formation during screening trials, thereby facilitating and expediting the definitive SCS implantation. Additionally, it may also reduce the risk of lead migration and iatrogenic damage, potentially lowering technique-related complications.

LIMITATIONS IN THE USE OF SUBCUTANEOUS DEFIBRILLATOR IN PATIENTS WITH LOW BODY MASS INDEX

Abstract Introduction Subcutaneous defibrillator is an effective and widely used tool in clinical practice but the presence of large fluctuations in the body mass index and the reduction of subcutaneous tissue may limit its application to all patients. Case Report In 2014, a 51–year–old woman underwent implantation of a dual–chamber transvenous defibrillator with left subclavian vein approach in secondary prevention for long Qt syndrome (LQT3). About 6 years after implantation she presented a ventricular lead breakage due to subclavian crush syndrome and was subjected to multiple inappropriate shocks due to lead failure. For this reason, the transvenous defibrillator was replaced with a single–chamber pacemaker for atrial stimulation and a subcutaneous defibrillator was implanted (Fig.1). In the following years the patient lost 14 kg and in the first months of 2022 she complained of the onset of stabbing pain in the precordial region near the upper face of the left sixth rib on the midclavicular line (Fig.2). Over the months, this symptomatology has become increasingly limiting and poorly responsive to normal analgesics but only to opiates; furthermore the pain has also occurred after a few weeks at the left parasternal level along the course of the distal portion of the subcutaneous catheter. For this reason, after discussing the case with the patient, we proceeded to implant a new transvenous lead via left subclavian vein and upgrade to a dual–chamber defibrillator. Subsequently, in the same operating session, the subcutaneous defibrillator was removed, finding only a modest traction resistance of the catheter in the parasternal area, resolved with the use of a 10 French introducer used as a sheet to debride the course of the same from the fibrotic adhesions (Fig .3). In the days following the procedure, the patient reported a progressive total disappearance of the pain symptoms. Reassessed after one year, the patient reports subjective well–being with total absence of chest pain and good quality of life. Conclusions The subcutaneous defibrillator represents an important resource for the management of the main ventricular arrhythmias, especially in patients with a high risk of infection and with a long life expectancy. The presence of a stable amount of subcutaneous tissue is a necessary condition to guarantee the tolerance of the lead over time and to avoid chronic pain situations that can lead to its removal.

Real-World Outcomes in USA using DBS Systems with Directionality and Multiple Independent Current Control (P5-11.017)

Real-World Outcomes in USA using DBS Systems with Directionality and Multiple Independent Current Control (P5-11.017)

Vagus nerve stimulator revision in pediatric epilepsy patients: a technical note and case series.

Vagus nerve stimulation (VNS) is an adjunctive treatment in children with intractable epilepsy. When lead replacement becomes necessary, the old leads are often truncated and retained and new leads are implanted at a newly exposed segment of the nerve. Direct lead removal and replacement are infrequently described, with outcomes poorly characterized. We aimed to describe our experience with feasibility of VNS lead removal and replacement in pediatric patients. Retrospective review examined 14 patients, at a single, tertiary-care, children's hospital, who underwent surgery to replace VNS leads, with complete removal of the existing lead from the vagus nerve and placement of a new lead on the same segment of the vagus nerve, via blunt and sharp dissection without use of electrocautery. Preoperative characteristics, stimulation parameters, and outcomes were collected. Mean age at initial VNS placement was 7.6years (SD 3.5, range 4.5-13.4). Most common etiologies of epilepsy were genetic (5, 36%) and cryptogenic (4, 29%). Lead replacement was performed at a mean of 6.0years (SD 3.8, range 2.1-11.7) following initial VNS placement. Reasons for revision included VNS lead breakage or malfunction. There were no perioperative complications, including surgical site infection, voice changes, dysphagia, or new deficits postoperatively. Stimulation parameters after replacement surgery at last follow-up were similar compared to preoperatively, with final stimulation parameters ranging from 0.25mA higher to 1.5mA lower to maintain baseline seizure control. The mean length of follow-up was 7.9years (SD 3.5, range 3.1-13.7). Removal and replacement of VNS leads are feasible and can be safely performed in children. Further characterization of surgical technique, associated risk, impact on stimulation parameters, and long-term outcomes are needed to inform best practices in VNS revision.

Occipital Nerve Stimulation for Recurrent Trigeminal Neuralgia Without Occipital Pain

ObjectivesTrigeminal neuralgia (TN) is a severe, debilitating pain condition causing physical and emotional distress. Although the management of TN is well codified with medical and then surgical treatments, 15% to 30% of patients will experience intractable pain. Neuromodulation techniques have been scarcely used for refractory TN, with only small case series and short-term follow-up. Materials and MethodsWe conducted a retrospective study of patients treated with occipital nerve stimulation (ONS) for medically and surgically resistant TN without painful trigeminal neuropathy. The effectiveness of the ONS was evaluated using the Barrow Neurological Institute (BNI) pain score and the pain relief (0%–100%) at best and at last follow-up. ResultsSeven patients who have refractory TN were included. The mean age at ONS was 49 years. The mean pain duration was 8.6 years. The mean number of medical and surgical treatments before ONS was six and five, respectively. A percutaneous trial was performed in five of seven patients; all responded (pain relief > 40%), and four of five patients experienced pain recurrence after explantation. Eventually, six patients had a permanent ONS implantation. The average BNI pain score before implantation was V. The mean follow-up after implantation was 59 months. All patients reported an improvement after implantation. The average BNI score and mean pain relief at best were IIIa and 86.7%, respectively. At last follow-up, the average BNI score and mean pain relief were IIIa and 58.0%, respectively, with three patients experiencing pain recurrence. Adverse events were reported for four patients who required surgical revision for lead breakage (1), erosion (1), migration (1), or hardware-related discomfort (1). One patient finally underwent explantation because of infection. ConclusionsAlthough ONS is not validated in this indication, these results suggest that it can induce an improvement in TN recurring after several surgical treatments, and the benefit of the stimulation can be sustained in the long term. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT01842763.

Superior Cluneal Nerve Stimulator Lead Displacement to the Thigh: A Case Report and Management Recommendations.

An 82-year-old man with a history of lumbar spinal stenosis and prior laminectomy presented with chronic lower back pain and was treated with placement of bilateral superior cluneal nerve stimulators. At the 2-week follow-up, the patient reported loss of efficacy and new-onset paresthesia of the left lower extremity. Fluoroscopic evaluation revealed lead breakage and distal migration of the left-sided stimulator lead to the left anteromedial thigh. Lead breakage and migration remains a challenge in peripheral nerve stimulation. This report illustrates the case of a nerve stimulator lead breakage and migration resulting in treatment failure and new-onset sensory disturbance.

Early reimplantation of a spinal cord stimulation device due to lead breakage in a patient with morbid obesity (body mass index: 47.8): a case report

Early reimplantation of a spinal cord stimulation device due to lead breakage in a patient with morbid obesity (body mass index: 47.8): a case report

Sacral neuromodulation for faecal incontinence – 10 years experience and long-term outcomes of a specialized centre

Sacral neuromodulation/sacral nerve stimulation (SNM/SNS) has become the most successful method for treatment of faecal incontinence (FI) in the last 10 years. The high efficiency of SNM is based on the electrical stimulation of the external anal sphincter and moreover the mechanism of action of SNS can be explained by the modulation of somatovisceral reflexes and perceptions of afferent information. Therefore the mechanism of action is more complex in contrast to other methods of treatment. In the Czech Republic, the SNM was implemented for the first time in 2010 with the financial support of the IGA grant of the Ministry of Health of the Czech Republic. Since 2018, two specialized centres for the treatment of FI using the SNM method have been established in the Czech Republic. In the years 20102020, 35 patients were indicated for SNM. The ratio of women to men was 34:1. The mean age at implantation was 62 years (range 4675). Most patients were in the 6th and 7th decade. Two diagnostic procedures were performed in all patients, percutaneous evaluation of the S2S4 sacral nerves, implantation of the Medtronic 3889 28cm stimulation tined lead electrode and its connection to an external stimulator and subsequent subchronic stimulation for 24 weeks. The criteria for permanent neurostimulator implantation were a minimum 50% reduction in the number of FI episodes per week or a 50% reduction in incontinence score. Patients were then implanted with a Medtronic InterStim II 3058 permanent neurostimulator. A permanent neurostimulator was implanted in 33 of 35 patients (94%). No patient died. The complication rate was 11.4%. In 2 patients it was an infectious complication. In one patient malposition of the stimulator occurred after falling down and in one patient we observed lead breakage with subsequent malfunction of the stimulator after falling down. All complications were successfully resolved by reoperation. The longterm effect of SNM was evaluated in the group of the first 15 implanted patients from 20102011. Of these, 9 patients were available, in whom a new neurostimulator was reimplanted due to loss of battery power in 20182020. The mean length of follow-up was 112 months (99124). The mean number of FI episodes per week was 1.9 (013) after neurostimulator implantation compared to 13.6 (325) before implantation. The Cleveland Clinic Incontinence Score (CCIS) was 8.3 (316) after neurostimulator implantation compared to CCIS 18.8 (1520) before implantation. Both FI episode counts and CCIS scores were significantly lower (p.

A simple electrical approach to diagnosing a suspected lead break in patients with implanted vagus nerve stimulators – Technical note

PurposeVagus nerve stimulation (VNS) is an effective adjunctive treatment for patients with drug-resistant epilepsy (DRE) or difficult-to-treat depression (DTD). The implanted system consists of a titanium-cased generator and a lead with platinum electrodes, placed around the cervical vagus nerve. In rare cases a lead may break, causing the patient to receive insufficient therapy or no therapy at all, with potentially dangerous consequences. In order to confirm a suspected lead breakage, physicians have the option to perform x-rays. However, x-rays often do not show a clear, unmistakable lead break. In this technical note an additional method to verify lead integrity electrophysiological is described in detail to provide the highest degree of certainty on the integrity of the lead when a broken lead is suspected before proceeding to revision surgery. MethodsWhen patients introduce themselves with symptoms indicating a suspected lead breakage, a systematic lead break management is required. This includes, beside the clinical anamneses, performing VNS Therapy® System Diagnostics (SD). If an unacceptable HIGH lead impedance is observed, performing x-rays (anteroposterior and lateral views) may help to confirm a lead breakage. Additionally, EMG recording equipment can be used to analyse the VNS stimulus waveform from the neck for verification of an electrical discontinuity. ResultsA differentiated VNS waveform with narrowed pulses or no waveform at all can confirm lead discontinuity. ConclusionThis Technical Note describes an easy but underused electrophysiological procedure to be included in the standardized protocol for identifying VNS lead breakage.

Removal of sacral neuromodulation quadripolar tined-lead using a straight stylet: description of a surgical technique

BackgroundUp to 7.5% of tined-lead removals in patients having sacral neuromodulation (SNM) therapy are associated with a lead breakage. It is still unclear what adverse effects can be caused by unretrieved fragments. The aim of our study was to describe the lead removal technique we have been using for the last 2 years in our centre.MethodsWe retrospectively enrolled patients who had lead removal between January 2018 and January 2020 using our standardized technique. The novelty of the technique is in the use of the straight stylet, which is available in the quadripolar tined-lead kit. The stylet gives the electrode greater stiffness, reducing interactions with surrounding tissues and probability of damage or breakage during removal.ResultsIn 59 patients (42 women, mean age 57.2 years [range 40–79 years]) the lead was removed using our standardized technique. In 44 of 59 patients, the tined-lead was removed within 2 months from the SNM-test, due to lack of beneficial effects. In 15 patients the electrode was removed because of failure of definitive implantation. Meantime from definitive implantable pulse generator (IPG) implantation to lead removal was 67.9 months. We recorded only 1 case of lead-breakage during removal: a female patient with a non-tined lead fixed on sacral bone, placed 18 years previously using an open technique.ConclusionsLead breakage during removal is not uncommon and adverse effects of retained fragments may occur. Our technique has been safely used for the last 2 years in our centre, with no episodes of lead breakage or retained fragments, except for one non-tined electrode.

Spinal Cord Stimulation for Chronic Refractory Neuropathic Pain: A Technical Note Initial Experience of Two cases

AbstractSpinal cord stimulation is an established procedure for relieving chronic neuropathic pain conditions. Although it has been over five decades since the first spinal cord stimulation (SCS) was developed, it has only been used in a few cases in India. It is primarily based on the “Gate Theory” of pain. The mechanism of its action is not exactly clear, but reports have suggested that it plays the main role in selectively stimulating the large diameter pain fibers in the dorsal aspect of spinal cord. SCS procedure involves a very careful case selection, and current evidence suggests that only a few conditions of chronic refractory neuropathic pain are its established indications. In these patients too, the efficacy rate remains around 50 to 75%. The overall pain relief observed is around 50% decrease in visual analog scale (VAS) scores. It is a technically simple procedure involving placement of electrodes over the dorsal aspect of spinal cord in the epidural space. The procedure is a staged one in which trial lead electrodes are first implanted and stimulated with an external pulse generator (EPG). If the trial is successful and patient has acceptable pain relief over 1 week of stimulation at various settings, the patient undergoes the permanent implantation of electrodes at the same position. The permanent electrodes are then stimulated by an implantable pulse generator (IPG) in the subcutaneous pocket (abdominal or gluteal). Complications are rare and are more related to hardware like lead migration and breakage. Since it is does not damage the cord per se, its acceptance as a procedure for pain is known quite well in the Western world. Its availability and cost of implants is the major hurdle in its use in a developing nation like India. Here, we present a technical note and our experience of two cases of thoracic spinal cord stimulation for chronic neuropathic pain at our institution.

Non-invasive massage technique to aid in removal of a tined sacral neuromodulation lead.

Describe a novel technique for retrieval of the Interstim lead in part based on techniques used in massage therapy. Retrospective review of patients (single surgeon) identified by CPT code 64585 over 10years. Exclusion criteria included patients who (1) had explantation for active infection or (2) did not proceed with a stage 2 implant (in the event of a staged procedure). To effect removal, the surgeon applies a focused massage with firm deliberate pressure in deep circular motions to the insertion site and surrounding tissue. At the same time, gentle steady traction is applied to the lead (from the IPG pocket) by the surgeon. Sixty women were identified. Mean implant duration was 24 (6-60) months. There were three lead fractures at retrieval (5%). In all three occurrences, the inner conductor wire was removed despite leaving the tined fragment in place. The author did not perform a cutdown to retrieve the retained fragment. There were no peri- or postoperative complications. Lead removal is safely accomplished in a matter of a few minutes with the presented technique without the need for a cutdown. Lead breakage was 5% and similar to more invasive techniques.

Letter: Evaluation and Surgical Treatment of Functional Neurosurgery Patients With Implanted Deep Brain Stimulation and Vagus Nerve Stimulation Pulse Generators During the COVID-19 Pandemic.

Author(s): Gross, Robert E; Buetefisch, Cathrin M; Miocinovic, Svjetlana; Bullinger, Katie L; Okun, Michael S; Ostrem, Jill L; Foote, Kelly D; Starr, Phillip A

An Implantable System For Chronic In Vivo Electromyography

Electromyography (EMG) measures the muscle response to electrical stimulation or spontaneous activity of motor units and plays an important role in assessing neuromuscular function. Chronic recording of EMG activity reflecting a muscle's reinnervation status after nerve injury has been limited, due to the invasive nature of traditional EMG recording techniques. In this regard, an implantable system is designed for long-term, in vivo EMG recording and nerve stimulation. It has been applied and tested in a study on reinnervation of laryngeal muscles. This system consists of 1) two bipolar electrode nerve cuffs and leads for stimulating each of two nerves: the recurrent laryngeal nerve (RLN) and internal branch of the superior laryngeal nerve (SLN); 2) two EMG recording electrodes and leads for each of the two laryngeal muscles: posterior cricoarytenoid (PCA) muscle and thyroarytenoid-lateral cricoarytenoid (TA-LCA) muscle complex; and 3) a skin receptacle interfacing all implanted lead terminals to an external recording preamplifier and stimulator using a connection cable. The wire leads are Teflon-coated, multi-filament, type 316 stainless steel. They are coiled and can stretch during body movement of the awake animal to prevent lead breakage and electrode migration. This system is implanted during an aseptic surgery. Afterwards, baseline EMG recordings are performed before the RLN is transected in the second surgery to study muscle reinnervation. Throughout the study, multiple physiological sessions are conducted in the anesthetized animal to obtain evoked and spontaneous EMG activity that reflects the reinnervation status of laryngeal muscles. The system is compact, free of infection over the course of the study, and highly durable. This implantable system can provide a reliable platform for research in which long-term recording or nerve stimulation is required in an anesthetized or freely moving animal.

17-Year Single Center Retrospective Review of Rate, Risk Factors and Outcomes of Lead Breakage during Sacral Neuromodulation Lead Removal

One risk of removal of a tined sacral neuromodulation lead is breakage, resulting in a retained lead fragment. We report lead breakage rates, risk factors and outcomes of retained fragments. We report on 464 tined lead removals from 2002 to 2018. Clinical and surgical factors were reviewed and appropriate statistical analysis performed. Retained fragments were reviewed for fragment description and long-term complications. A total of 464 tined lead removals were included, with 35 lead breaks identified, for a rate of 7.5% (35). Factors associated with breakage included male gender (OR 6.58, 95% CI 2.54-17.01, p=0.001) and diabetes (OR 2.42, 95% CI 1.05-5.58, p=0.019). A shorter time since implantation was protective (OR 0.86, 95% CI 0.76-0.98, p=0.002). There was no difference in breakage rate based on age, weight, history of prior revision, bilateral leads, reason for lead removal, surgical technique or surgeon. Of the 35 breaks 27 had imaging available. Of these 66% (18) broke in the tined region and 81% (22) were ghost leads. Most patients (80%, 28 of 35) with retained lead fragments received another implant. Only 1 patient had a related complication of additional surgery for pain related to the fragment. There is a low rate of tined lead breakage during lead removal. However, it is higher than the manufacturer estimate. Protective factors include a shorter time between implant and lead revision. The most common location for lead breakage is in the region of the tines, most are ghost fragments and long-term complications are uncommon.

PD36-03 12 YEAR SINGLE CENTER RETROSPECTIVE REVIEW OF RISK FACTORS AND RATE OF TINED LEAD BREAKAGE DURING SACRAL NEUROMODULATION LEAD EXPLANT

INTRODUCTION AND OBJECTIVES:The tined lead for use with InterStim sacral neuromodulation (SNM) was introduced in 2002. However, little data on lead breakage has been published. In 2010 the manufact...

PD36-05 RATE AND RISK FACTORS FOR SACRAL NERVE STIMULATOR LEAD BREAKAGE AT THE TIME OF LEAD REVISION OR EXPLANTATION

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I1 Apr 2016PD36-05 RATE AND RISK FACTORS FOR SACRAL NERVE STIMULATOR LEAD BREAKAGE AT THE TIME OF LEAD REVISION OR EXPLANTATION javier Pizarro-Berdichevsky, Marisa M Clifton, Elodi J Dielubanza, Bradley C Gill, Henry T Okafor, Anna E Faris, Raymond R Rackley, Courtenay K Moore, Sandip P Vasavada, Howard B Goldman, and Adrienne Quirouet javier Pizarro-Berdichevskyjavier Pizarro-Berdichevsky More articles by this author , Marisa M CliftonMarisa M Clifton More articles by this author , Elodi J DielubanzaElodi J Dielubanza More articles by this author , Bradley C GillBradley C Gill More articles by this author , Henry T OkaforHenry T Okafor More articles by this author , Anna E FarisAnna E Faris More articles by this author , Raymond R RackleyRaymond R Rackley More articles by this author , Courtenay K MooreCourtenay K Moore More articles by this author , Sandip P VasavadaSandip P Vasavada More articles by this author , Howard B GoldmanHoward B Goldman More articles by this author , and Adrienne QuirouetAdrienne Quirouet More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1110AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Sacral neuromodulation is a highly effective therapy; however, up to 30% of patients who undergo sacral nerve stimulator (SNS) implantation will require lead revision within 5 years. Lead breakage can occur during revision, but the rate of breakage and the risk factors associated with it are not well described in the literature. The aim of this study is to describe the rate of lead breakage in our institution and identify potential risk factors for breakage. METHODS A retrospective review of all SNS lead revisions or explantations performed in the urology department at a tertiary care center between 2010 and 2015 was performed. The clinical, demographic characteristics and lead breakage rate were analyzed. Descriptive statistics are presented as percentages, mean±SD or median (interquartile range). T-test, Mann-Whitney U, Chi-Square or Fisher exact tests were used as appropriate. A logistic regression analysis was performed for incomplete lead removal as the dependent variable that included variables with p values < 0.1 in the univariate analysis as well as other clinically relevant variables. p<0.05 was considered statistically significant. RESULTS Between 2010 and 2015, 119 patients underwent a lead revision or explantation. 116 patients were included in analysis. Patients were predominantly female (91.2%) with a mean age of 56.2±16.2 and mean BMI 29.6±7.6. Overactive bladder (OAB) was the most common indication for SNS (82.3%). The lead was removed intact in 81.9%. On univariate analysis, months since initial implantation –35.2 (15.2-59.6) vs 56.6 (52.3-79.8), p=0.003; diabetic status –11.6% vs 33.3%, p=0.029; and provider - rate of incomplete removal ranging between 0-20%, p=0.05 were independent risk factors for lead breakage. On multivariable analysis that included age, gender, BMI, time since implant, diabetic status and provider, only time since implantation and diabetic status were statistically significant risk factors (OR 0.98, CI 95% 0.96-0.99 and OR 3.5, CI 95% 1.05-11.5, respectively). CONCLUSIONS The overall risk of lead breakage at the time of revision or explantation is approximately 18%. Significant risk factors that increase the rate of breakage are increased time since implantation and diabetes. These findings may be valuable for patient counseling before SNS revision. Prospective studies are needed to better identify other risks factors and to develop prevention strategies. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e851 Advertisement Copyright & Permissions© 2016MetricsAuthor Information javier Pizarro-Berdichevsky More articles by this author Marisa M Clifton More articles by this author Elodi J Dielubanza More articles by this author Bradley C Gill More articles by this author Henry T Okafor More articles by this author Anna E Faris More articles by this author Raymond R Rackley More articles by this author Courtenay K Moore More articles by this author Sandip P Vasavada More articles by this author Howard B Goldman More articles by this author Adrienne Quirouet More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

PD36-07 INFECTION RATE AFTER SACRAL NEUROMODULATION SURGERY: A REVIEW OF 1033 INTERSTIM PROCEDURES

INTRODUCTION AND OBJECTIVES: Sacral neuromodulation is a highly effective therapy; however, up to 30% of patients who undergo sacral nerve stimulator (SNS) implantation will require lead revision within 5 years. Lead breakage can occur during revision, but the rate of breakage and the risk factors associated with it are not well described in the literature. The aim of this study is to describe the rate of lead breakage in our institution and identify potential risk factors for breakage. METHODS: A retrospective review of all SNS lead revisions or explantations performed in the urology department at a tertiary care center between 2010 and 2015 was performed. The clinical, demographic characteristics and lead breakage rate were analyzed. Descriptive statistics are presented as percentages, mean SD or median (interquartile range). T-test, Mann-Whitney U, Chi-Square or Fisher exact tests were used as appropriate. A logistic regression analysis was performed for incomplete lead removal as the dependent variable that included variables with p values < 0.1 in the univariate analysis as well as other clinically relevant variables. p<0.05 was considered statistically significant. RESULTS: Between 2010 and 2015, 119 patients underwent a lead revision or explantation. 116 patients were included in analysis. Patients were predominantly female (91.2%) with a mean age of 56.2 16.2 and mean BMI 29.6 7.6. Overactive bladder (OAB) was the most common indication for SNS (82.3%). The lead was removed intact in 81.9%. On univariate analysis, months since initial implantation e35.2 (15.2-59.6) vs 56.6 (52.3-79.8), p1⁄40.003; diabetic status e11.6% vs 33.3%, p1⁄40.029; and provider rate of incomplete removal ranging between 0-20%, p1⁄40.05 were independent risk factors for lead breakage. Onmultivariable analysis that included age, gender, BMI, time since implant, diabetic status and provider, only time since implantation and diabetic status were statistically significant risk factors (OR 0.98, CI 95% 0.96-0.99 and OR 3.5, CI 95% 1.05-11.5, respectively). CONCLUSIONS: The overall risk of lead breakage at the time of revision or explantation is approximately 18%. Significant risk factors that increase the rate of breakage are increased time since implantation and diabetes. These findings may be valuable for patient counseling before SNS revision. Prospective studies are needed to better identify other risks factors and to develop prevention strategies.

Prospective Evaluation of Sacral Neuromodulation in Children: Outcomes and Urodynamic Predictors of Success

Sacral neuromodulation has been demonstrated to improve refractory bowel bladder dysfunction in children. The purpose of the current study was to determine whether results are durable in children after longer followup, whether children with a lower body mass index are at risk for device failure and whether pretreatment urodynamic evaluation can predict posttreatment outcome. Pediatric patients with refractory bowel bladder dysfunction were enrolled following informed consent and followed prospectively. All patients underwent preoperative videourodynamic evaluation and a 2-stage implantation procedure. Validated questionnaires were used to assess symptom severity and quality of life. Complications were analyzed with regard to treatment required and patient body mass index. During 45 months 30 patients were enrolled. Median age was 8.3 years at enrollment. Median followup was 14.8 months. Patients had significant improvement in quality of life and symptom scores, which persisted at the most recent followup. Patients who had uninhibited detrusor contractions on preoperative urodynamic assessment had significantly greater improvement in symptoms. Of the patients 23% had a complication requiring reoperation, most commonly neurostimulator lead breakage in those with a significantly lower body mass index. Sacral neuromodulation significantly improves quality of life and symptom severity in children with refractory bowel bladder dysfunction. Children gain greater benefit if they show uninhibited bladder contractions on preoperative urodynamic evaluation. Children have a high rate of lead breakage requiring operative revision, which was seen after minor trauma in those with a lower body mass index.

Novel Approach to Securing Deep Brain Stimulation Leads: Technique and Analysis of Lead Migration, Breakage, and Surgical Infection

Background: Fixation of the electrode during deep brain stimulation (DBS) surgery is an important aspect of the procedure. We have developed an alternative method for securing leads that utilizes a titanium hemoclip and cement. This technique is described, and the rates of complications are compared to conventional methods of securing leads. Methods: A total of 291 DBS operations performed by a single surgeon were retrospectively analyzed. We reviewed medical records to look for complications. We compared rates of complications based on the technique used. Re sults: 9 patients (3.1%) developed surgical site infections (SSIs), 4 (1.3%) with SSI of the internal pulse generator pocket. Of the 5 SSIs around the leads, none occurred with StimLoc and 5 (1.1%) with the novel technique. Eight patients (2.7%) required surgical readjustment of the DBS leads due to suboptimal clinical benefit; all 8 (1.8%) occurred with the novel technique. Four patients (1.4%) had lead fractures, 2 (2.2%) with StimLoc and 2 (0.5%) with the novel technique. Conclusions: We described a method for securing DBS leads and showed an acceptable incidence of hardware complications when compared to the conventional method. We feel this technique has improved cosmetic results and should be considered as a method for securing DBS leads.