Evaluation of Sacral Nerve Stimulation Device Revision and Explantation in a Single Center, Multidisciplinary Study

Gevelinger, Matthew; Sanderson, Derrick J.; Jaworski, Elaine; Doyle, Paula

doi:10.1111/ner.13050

Cited by 6 publications

(6 citation statements)

References 36 publications

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“…In this subanalysis of a larger observational study, 30 we found that patients who underwent placement of a SNM device for treatment of FI had an improvement of their PROMIS depression scores. On average, post implantation scores improved 4.5 points (95% CI −8.7 to −0.3; p = 0.04).…”

Section: Discussionmentioning

confidence: 76%

“…This is a subanalysis investigating changes in PROMIS t ‐scores before and after successful implantation of a SNM device (InterStim, Medtronic, Minneapolis, MN) for treatment of FI. Data were originally collected under Institutional Review Board (IRB) RSRB00069994, which approved data collection for a retrospective cohort to investigate factors associated with removal and revision of implanted SNM devices for treatment of both lower urinary tract symptoms and FI 30 . The data were collected using the current procedural terminology codes (64,561, percutaneous implantation of neurostimulator electrode array; 64,581, incision for implantation for neurostimulator; 64,590, insertion or replacement of peripheral neurostimulator pulse generator; 6495, revision or removal of peripheral neurostimulator pulse generator or receiver) from January 2013 to October 2017.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Improvements in Self-Reported Depression Following Treatment of Fecal Incontinence with Sacral Neuromodulation

Gevelinger

Jaworski

Speranza

et al. 2020

Neuromodulation: Technology at the Neural Interface

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Section: Discussionmentioning

confidence: 76%

Section: Methodsmentioning

confidence: 99%

Improvements in Self-Reported Depression Following Treatment of Fecal Incontinence with Sacral Neuromodulation

Gevelinger

Jaworski

Speranza

et al. 2020

Neuromodulation: Technology at the Neural Interface

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“…Common AE related to electrical stimulation include pain, discomfort (often affecting the buttock or leg), transient electric shocks, unwanted vaginal or penile sensation, and unintentional changes in voiding or defecation. Reported predictors of AE include a history of trauma, change in body mass index, anxiety, patient age under 55, enrollment in a pain clinic, and a history of other AE ( 71 , 72 , 73 ).…”

Section: Guidance For Problem‐solving In Snm Troub...mentioning

confidence: 99%

“…In the literature, rates for revision due to loss of efficacy or AE vary greatly, from 3% to 35%, even in recent large prospective studies ( 21 , 40 , 43 , 73 , 74 , 75 , 77 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 ) (Table 3 ). These differences depend on the length of follow‐up, the devices used (smaller IPG, tined lead type, evolution of implantation techniques), the extent of thoughtful reprogramming ( 13 ), and the clinician or patient's willingness to proceed with further surgical intervention in an attempt to optimize outcome ( 77 ).…”

Section: Surgical Revision After Snm Implantation—...mentioning

confidence: 99%

Reprogramming Sacral Neuromodulation for Sub-Optimal Outcomes: Evidence and Recommendations for Clinical Practice

Dudding

Lehur

Sörensen

et al. 2021

Neuromodulation: Technology at the Neural Interface

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Objectives: In some patients treated for urinary or fecal incontinence with sacral neuromodulation (SNM) persistence of symptoms, a reduction in efficacy or adverse effects of stimulation can occur. In such situations, further programming of the SNM device can help resolve problems. Infrequently hardware failure is detected. This article aims to provide practical guidance to solve sub-optimal outcomes (troubleshooting) occurring in the course of SNM therapy. Materials and Methods:A systematic literature review was performed. Collective clinical experience from an expert multidisciplinary group was used to form opinion where evidence was lacking.Results: Circumstances in which reprogramming is required are described. Actions to undertake include changes of electrode configuration, stimulation amplitude, pulse frequency, and pulse width. Guidance in case of loss of efficacy and adverse effects of stimulation, developed by a group of European experts, is presented. In addition, various hardware failure scenarios and their management are described.Conclusions: Reprogramming aims to further improve patient symptoms or ensure a comfortable delivery of the therapy. Initial changes of electrode configuration and adjustment of stimulation parameters can be performed at home to avoid unnecessary hospital visits. A logical and stepwise approach to reprogramming can improve the outcome of therapy and restore patient satisfaction.

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“…Approximately 20-30% of SNM-implanted patients require surgical revision, whilst 15-18% of them have definitive explantation [3][4][5][6][7][8][9][10][11]. It is estimated that, regardless of the indication for the procedure, quadripolar lead removal carries a 7.5% risk of lead breakage and permanence of fragments within the pelvis or proximal to the sacral bones [12].…”

Section: Introductionmentioning

confidence: 99%

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

2021

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Background Up 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. Methods We 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. Results In 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. Conclusions Lead 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.

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Evaluation of Sacral Nerve Stimulation Device Revision and Explantation in a Single Center, Multidisciplinary Study

Cited by 6 publications

References 36 publications

Improvements in Self-Reported Depression Following Treatment of Fecal Incontinence with Sacral Neuromodulation

Improvements in Self-Reported Depression Following Treatment of Fecal Incontinence with Sacral Neuromodulation

Reprogramming Sacral Neuromodulation for Sub-Optimal Outcomes: Evidence and Recommendations for Clinical Practice

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

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