Abstract: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… Show more
“…Therefore, it cannot be removed since the lead would be too short. A previous study by Janssen et al has demonstrated that lead revision in the case of technical failure has good results on faecal incontinence [ 13 ]. Hence, for patients with SNM and an abdominally placed IPG, it would be an option to replace lead, extension and Interstim I by a new lead (gluteally placed) and Interstim II.…”
Aim
Due to the introduction of a new implantable pulse generator (IPG), the Interstim II, patients with either a dynamic graciloplasty or an abdominally placed IPG for sacral neuromodulation could not undergo surgery to replace their IPG in the case of end of battery life. For these patients, the Medtronic Replacement Adaptor 09106 was created. This retrospective case series aims to study safety and feasibility of the Medtronic Replacement Adaptor 09106 in patients with abdominally placed IPGs.
Methods
Seventeen patients (11 women, six men) received a replacement adaptor with a follow‐up of 6 months. Outcome measures consisted of a bowel habit diary. Adverse events were classified using the Clavien–Dindo classification.
Results
Outcome measures in the bowel habit diaries after replacement (feasibility) did not differ significantly from outcome measures before replacement. Adverse events occurred in four out of 17 patients (24%): two patients initially showed pocket site pain (Clavien–Dindo Grade I), which resolved without intervention. One patient suffered from poor wound closure (Clavien–Dindo Grade II) and one patient had persisting pocket pain (Clavien–Dindo Grade IIIa) for which a pocket revision was performed. Statistical analyses were performed making paired comparisons using a Wilcoxon signed rank test.
Conclusion
The Medtronic Replacement Adaptor 09106 is a valuable option for patients with dynamic graciloplasty or sacral neuromodulation and abdominal IPG and has complication rates similar to replacement of the Interstim without Replacement Adaptor 09106.
“…Therefore, it cannot be removed since the lead would be too short. A previous study by Janssen et al has demonstrated that lead revision in the case of technical failure has good results on faecal incontinence [ 13 ]. Hence, for patients with SNM and an abdominally placed IPG, it would be an option to replace lead, extension and Interstim I by a new lead (gluteally placed) and Interstim II.…”
Aim
Due to the introduction of a new implantable pulse generator (IPG), the Interstim II, patients with either a dynamic graciloplasty or an abdominally placed IPG for sacral neuromodulation could not undergo surgery to replace their IPG in the case of end of battery life. For these patients, the Medtronic Replacement Adaptor 09106 was created. This retrospective case series aims to study safety and feasibility of the Medtronic Replacement Adaptor 09106 in patients with abdominally placed IPGs.
Methods
Seventeen patients (11 women, six men) received a replacement adaptor with a follow‐up of 6 months. Outcome measures consisted of a bowel habit diary. Adverse events were classified using the Clavien–Dindo classification.
Results
Outcome measures in the bowel habit diaries after replacement (feasibility) did not differ significantly from outcome measures before replacement. Adverse events occurred in four out of 17 patients (24%): two patients initially showed pocket site pain (Clavien–Dindo Grade I), which resolved without intervention. One patient suffered from poor wound closure (Clavien–Dindo Grade II) and one patient had persisting pocket pain (Clavien–Dindo Grade IIIa) for which a pocket revision was performed. Statistical analyses were performed making paired comparisons using a Wilcoxon signed rank test.
Conclusion
The Medtronic Replacement Adaptor 09106 is a valuable option for patients with dynamic graciloplasty or sacral neuromodulation and abdominal IPG and has complication rates similar to replacement of the Interstim without Replacement Adaptor 09106.
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