Incidence of Lead Tip Fracture and Retention After Percutaneous Lead Implantation for Peripheral Nerve Stimulation With an External Pulse Generator: A Multicenter Comparative Analysis of 456 Lead Implants Across Two Lead Hardware Generations.

Objectives: Lead fracture and retention are potential adverse events that can occur after peripheral nerve stimulator (PNS) lead implantation, although recent technologic advancements in PNS hardware have been implemented to avert this risk. We aim to quantify the current incidence of temporary PNS lead fracture/retention and compare this with rates before changes in lead hardware design of temporary PNS.

Materials and methods: A multicenter, retrospective observational study was conducted for patients implanted with a temporary PNS system (SPR© Therapeutics, Cleveland, OH) between June 1, 2018 and August 1, 2024. Patients were included if they underwent a temporary percutaneous PNS system implantation with planned lead removal at 60 days. Patients were excluded if there was ambiguity regarding the status of the lead tip at time of removal (intact vs fractured) or if there was inadvertent lead removal by the patient during the 60-day treatment. The primary objectives of this study were 1) to quantify the incidence of lead retention with removal of temporary percutaneous PNS and 2) to compare the rates of lead retention in the original lead design (version 1.0) and the revised lead design (version 2.0). Secondary objectives included analysis of lead retention rates based on the following covariates: body mass index (BMI), patient age, location of lead placement, or duration of lead implant.

Results: Within the studied timeframe, 337 patients were implanted with a total of 456 leads. Of 337 patients, 40.4% (n = 136) were implanted with lead version 1.0, and 59.6% (n = 201) were implanted with lead version 2.0. Overall, 7.5% of implanted leads (34/456) were retained, affecting 10.1% of patients. Of 194 implanted version 1.0 leads, 13.4% of leads (n = 26) were retained, whereas of 262 version 2.0 leads, 3.1% (n = 8) were retained (p < 0.001). These results showed a reduction in retained leads per patient from 19.1% with lead version 1.0 to 4.0% with revised lead version 2.0. Covariates including BMI, patient age, location of lead placement, or duration of lead implant did not predict lead retention rates.

Conclusions: Retention and fracture of temporary PNS leads remain prevalent, affecting 7.5% of all implanted leads, although we also observed a significant decrease in rates (3.1% vs 13.4%) with implementation of the revised lead version 2.0 hardware design.