Biological and hardware-related spinal cord stimulation complications and their management: A single-center retrospective analysis of the implantation of nonrechargeable implantable pulse generators in different pain conditions.

Abstract

Background: We present our experience with spinal cord stimulation (SCS) for patients suffering from different pain conditions who subsequently developed hardware-related complications after SCS surgery. The SCS hardware-related complications may compromise the continuous SCS therapy due to partial or total hardware removal. Such situations should be avoided, and possible predisposing factors for their development should be minimized. The present study aimed to evaluate the frequency of hardware-related complications and their proper neurosurgical management.

Methods: The study is designed as a retrospective analysis of all hardware-related complications of SCS procedures for pain patients who underwent the implantation of the nonrechargeable PrimeAdvanced^™ SureScan^™ magnetic resonance imaging (MRI) neurostimulator (Medtronic, Minneapolis, United States). This neurostimulator allows patients safe access to MRI scans anywhere on the body. The PrimeAdvanced^™ SureScan^™ MRI neurostimulator can deliver stimulation through one or more leads in the epidural space. From December 2017 to December 2021, 20 patients with SCS implantations and a minimum postoperative follow-up of 3 months were included. All patients were operated on using identical surgical and intraprocedural techniques. The same SCS hardware was implanted (nonrechargeable PrimeAdvanced^™ SureScan^™ MRI neurostimulator) in all patients. We examined numerous preoperative variables (i.e., sex, age at surgery, diabetes, body mass index, and type of pain syndrome) to detect any correlation between them and the incidence of postoperative hardware-related complications.

Results: Among 20 patients, 8 (40%) patients were affected by hardware-related complications. The most common complications were skin erosion found in 5 patients (25%) and incorrect functioning of the implantable pulse generator (IPG) affecting 2 patients (10%). There were 1 case of an IPG migration (5%) and 1 hardware infection (5%) due to a staphylococcal wound. A total number of 16 revision surgeries were performed to manage all hardware-related complications in these patients adequately. Most of the patients (5 of them) were troubled by more than one hardware-related complication episode. Three patients had 3 revision surgeries, 2 patients had 2 revision surgeries, and 3 patients had 1 revision surgery. Among 8 patients with complications, 3 patients had no further continuation of SCS therapy due to hardware-related complications. Among these 3 patients who stopped their SCS therapy, 1 patient had 3 hardware-related episodes, and the remaining 2 patients were troubled by two hardware-related episodes before discontinuation of SCS therapy.

Conclusion: Our results indicate that patients treated by the SCS technique are at higher risk for the development of skin-related complications, especially skin erosions and less common skin infections, notably in cases when large (high profile) IPGs are utilized. The use of smaller IPGs could reduce the number of these biological as well as hardware-related complications and associated revision surgeries.