Artikel
Complication rates of spinal cord stimulation – A multicenter study
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Veröffentlicht: | 8. Juni 2016 |
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Gliederung
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Objective: Spinal cord stimulation (SCS) is stepless treatment for various chronic pain syndromes. In general, the percutaneously implanted lead is put into place first and is then externalized. Upon successful trial with an external pulse generator, the neurostimulator is implanted. Amongst all the complications possible, the most discussed and most serious ones are implant infections, lead dislocations and epidural hematomas. Migration rates of up to 30% for percutaneously implanted leads and infection rates of up to 22% have been reported previously.
Method: Data was collected retrospectively in four high volume centers. Patients were implanted with cylindrical or paddle type leads via a percutaneous implantation approach and leads were fixed with an anchoring device. All implantations were performed under local anesthesia. Prior to the final implantation of the neurostimulator, all patients underwent approximately seven days of trial stimulation. The perioperative antibiotic protocol varied between centers. If anticoagulants were taken, these were stopped prior to surgery.
Results: 681 patients have been implanted so far. All suffered from failed back surgery syndromes with a combined leg and lower back pain. Median follow-up was 2.4 years. Maximal follow-up was 6 years. No epidural hematoma occurred. Rate of migration was 1.17% (n=8). Implant infections requiring removal of the SCS system occurred in 4.1% (n=28).
Conclusions: This is the largest known multi center analysis of complication rates of spinal cord stimulation. Our data shows percutaneously implanted leads to be safe. With sufficient hemostasis there is no statistical risk for the occurrence of an epidural hematoma. In combination with an anchoring system, the percutaneous implantation approach is found to be only minimally affected by lead migration. The rate of infection is lower than previously described in the literature. Strict asepsis, peri- and postoperative prophylactic antibiosis may reduce the rate of implant infections efficiently.