Comparing 3-year outcomes between staged vs full sacral neuromodulation implants

Objectives: To compare rates of device removal, revision or replacement following staged sacral neuromodulation (SNM) implant compared with office percutaneous nerve evaluation (PNE) followed by a full SNM implant in women ≥ 65 over 3 years following index SNM device placement.

Methods: The 2010-2019 Medicare 100% Outpatient Limited Dataset was used to identify women ≥ 65 who underwent SNM with a history Overactive Bladder (OAB), fecal incontinence (FI) and/or idiopathic urinary retention (UR) with at least 12 months of Part B coverage prior to their initial SNM procedure. The primary outcome was removal, revision or replacement of the device (CPT 64585, 64595, 64590) within 3 years of initial SNM device placement. Other outcomes of interest included removal/revision of device within 30 days of implant (CPT 64585, 64595) as well as mechanical breakdown (ICD 10 T85.1, ICD9 996.2) over 3 years following the initial SNM implantation. We compared outcomes between women undergoing staged SNM and PNE/full implant.

Results: During the study period, 26,863 women underwent an SNM procedure; 7,301 (27%) underwent a staged procedure and 19,462 (73%) underwent a PNE/full implant. Table 1 shows the characteristics of the cohort as well as differences between the stage and full implant groups. The mean age of the overall cohort was 74 years of age (±standard deviation 6.3); no difference was noted between the age of patients undergoing staged vs PNE/full implant (p=0.2). Patients who underwent the staged procedure were more likely to have the diagnosis of FI (31% vs 17%, p< .001) or UR (11% vs 7%, p< .001). Women undergoing staged procedures were more likely to undergo removal/revision of the neurostimulator (11.7% vs 10.5%, p=0.005) or removal of device within 30 days (3.3% vs 1.0%, p= 0.02); however, women undergoing PNE/full implant were more likely to undergo a replacement of the neurostimulator (15.6% vs 9.1%, p< .001). After controlling for age, indication for SNM therapy and region, compared with PNE/full implant, staged SNM procedure was associated with a lower likelihood of undergoing a replacement of the neurostimulator device (aOR 0.52, 95%CI 0.47-0.56), but an increased likelihood of undergoing a removal of the SNM device within 30 days of the initial SNM implant (aOR 3.4, 95%CI 2.8-4.1).

Conclusions: In the 3 years following SNM, the rates of device related complications among female Medicare beneficiaries are low; however, staged procedures in this population were associated with a 3.4-times increased odds of undergoing removal/revision of the SNM device within 30 days of initial implant, but a 48% decreased odds of requiring replacement of the neurostimulator device within 3 years of the initial implant.