Sacral nerve stimulation—hidden costs (uncovered)

Zeiton, Moez; Faily, Sara; Nicholson, James E.; Telford, Karen; Sharma, Abhiram

doi:10.1007/s00384-016-2512-y

Cited by 20 publications

(13 citation statements)

References 28 publications

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“…43 A British study reported reoperations in 28.8% of their patients after a shorter follow-up period. 19 This analysis shows that, in most cases, SNM therapy can be sustained by reinterventions. In many cases, adverse events such as infections or IPG dislocation can be successfully managed.…”

Section: Discussionmentioning

confidence: 91%

“…Using Kaplan-Meier analysis, we determined that median battery life of the InterStim II IPG was 5.9 years, which corresponds well with the results of a smaller study reporting a mean battery life of 5.4 years; however, that study did not indicate the type of stimulator that was used. 19 Another larger study included InterStim I IPGs and the Kaplan-Meier curve for the InterStim II IPG did not reach the 50% threshold to calculate the median battery life. By extrapolation, a median survival of approximately 6.5 years might be expected.…”

Section: Discussionmentioning

confidence: 99%

“…Surgical reintervention rates are high, increase over time and are likely to be underreported. [17][18][19] The aim of this study was to assess the sustainability of SNM success in patients with FI and constipation. Additionally, the rates of adverse events and reinterventions were recorded, and the effects of adverse events and reintervention on treatment success were evaluated.…”

Section: Introductionmentioning

confidence: 99%

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Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study

Widmann

Galata

Warschkow

et al. 2019

J Neurogastroenterol Motil

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Background/AimsThe aim of this study was to evaluate the sustainability of sacral neuromodulation (SNM) success in patients with fecal incontinence (FI) and/or constipation.MethodsThis is a retrospective analysis of a prospective database of patients who received SNM therapy for FI and/or constipation between 2006 and 2015. Success rates, complications and reintervention rates were assessed after up to 10 years of follow-up.ResultsElectrodes for test stimulation were implanted in 101 patients, of whom 79 (78.2%) received permanent stimulation. The mean follow-up was 4.4 ± 3.0 years. At the end of follow-up, 57 patients (72.2%) were still receiving SNM. The 5-year success rate for FI and isolated constipation was 88.2% (95% confidence interval [CI], 80.1–97.0%) and 31.2% (95% CI, 10.2–95.5%), respectively (P < 0.001). In patients with FI, involuntary evacuations per week decreased > 50% in 76.1% of patients (95% CI, 67.6–86.2%) after 5 years. A lead position at S3 was associated with an improved outcome (P = 0.04). Battery exchange was necessary in 23 patients (29.1%), with a median battery life of 6.2 years. Reinterventions due to complications were necessary in 24 patients (30.4%). For these patients, the 5-year success rate was 89.0% (95% CI, 75.3–100.0%) compared to 78.4% (95% CI, 67.2–91.4%) for patients without reintervention.ConclusionsSNM offers an effective sustainable treatment for FI. For constipation, lasting success of SNM is limited and is thus not recommended. Reinterventions are necessary but do not impede treatment success.

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Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study

Widmann

Galata

Warschkow

et al. 2019

J Neurogastroenterol Motil

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“…However, other studies defined loss of efficacy as a reduction in therapeutic effect unresponsive to dietary changes, medical therapies, or reprogramming of the stimulator [8]. Furthermore, there are also studies that do not mention a definition of loss of efficacy [1,11]. Reports on loss of efficacy should therefore be compared with care.…”

Section: Discussionmentioning

confidence: 99%

Clinical efficacy of lead revisions during the test phase in sacral neuromodulation for fecal incontinence

Janssen

Melenhorst

Stassen

et al. 2019

Int J Colorectal Dis

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Background Success rates of up to 80% have been reported for the SNM screening period in the treatment of fecal incontinence (FI). Some patients who have an unsuccessful index implantation are successfully treated with SNM after a lead revision. There is a lack of studies comparing the outcomes of successful index implantations and successful lead revision. Therefore, the results of index implantations were compared with lead revisions in a single-center cohort. Methods Patients treated with SNM for FI between 2008 and 2016 were retrospectively reviewed. Patients with a successful index implantation were compared with patients who underwent lead revision after SNM screening. Primary outcome was a decrease in episodes of fecal incontinence of ≥ 50% documented by a 3-week bowel habit diary. Results Two hundred sixty-one patients (232 index group, 29 revision group) were eligible for SNM. Two hundred thirty-one patients (208 index group, 23 revision group) received permanent SNM. Follow-up was 68.8 months for the index group and 62.2 months for the revision group. The number of episodes of FI decreased from 20.6 (SD 19.3) to 3.4 (SD 4.2) in the index group and from 12.6 (SD 5.8) to 2.0 (SD 2.3) in the revision group. This effect was maintained up to 5 and 2 years in the index and revision group, respectively. Adverse events such as loss of efficacy which required surgical intervention did not differ between the two groups. Conclusion Lead revision during the test phase is a valid option in patients with FI treated by SNM who suffer from loss of efficacy of the index electrode.

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“…Although considered cost-effective, SNM is a relatively costly treatment. Lead-related problems account for almost two-thirds (58.8%) of unplanned surgical procedures after implantation [12]. Therefore, minimizing loss of efficacy due to technical failure, for example lead migration, is important.…”

Section: Most Centers Give Their Patients Physical Instructions To Avoidmentioning

confidence: 99%

Patterns of tined lead migration in sacral nerve modulation

Ezra

Siilin

Gulobovic

et al. 2020

Int J Colorectal Dis

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Aim Lead migration is a common cause of loss of efficacy in sacral nerve modulation. Our aim was to systematically study the migration pattern of tined leads in sacral nerve modulation. Our hypothesis was that tined leads may promote forward migration because of their configuration. Method Consecutive patients treated with sacral nerve modulation with a tined lead electrode, who had experienced loss of efficacy and had radiographs both at baseline and after loss of efficacy between 2005 and 2016 were eligible for inclusion. Results Twenty-five patients out of 70 with loss of efficacy were studied. Lead migration was measured as percent electrode movement in relation to sacral cortex at lateral projection. All had some degree of lead migration, ranging from 35% backward to 74% forward migration. Sixteen (64%) had forward migration while nine (36%) had backward migration. In seven patients (28%), loss of efficacy was associated with an episode of perceived mechanical strain on the electrode. Fifty percent (4/8) who associated their loss of efficacy with an adverse event had forward migration of the electrode. Conclusions Forward lead migration with concomitant loss of efficacy seems to be a common event in patients with tined leads, hence supporting our hypothesis. The retrospective design and that some of the patients with loss of efficacy could not be included because of incomplete data, which is a limitation to the study. Further studies are needed to confirm to what extent the direction and magnitude of the migration relate to loss of efficacy. Trial registration

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Sacral nerve stimulation—hidden costs (uncovered)

Abstract: A considerable proportion of patients treated with SNS therapy require surgical revision. These unplanned procedures are associated with substantial unexpected costs that financially burden SNS services.

Cited by 20 publications

References 28 publications

Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study

Success and Complication Rates After Sacral Neuromodulation for Fecal Incontinence and Constipation: A Single-center Follow-up Study

Clinical efficacy of lead revisions during the test phase in sacral neuromodulation for fecal incontinence

Patterns of tined lead migration in sacral nerve modulation

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