gms | German Medical Science

Objective: Occipital nerve stimulation (ONS) provides pain relief in patients with primary headache disorders. Despite its low invasiveness, this neuromodulation technique is prone to technical difficulties with the implants. The mobility of the head-neck region can cause patient discomfort at the implantation sites, especially when conventional non-stretchable SCS leads are used in ONS. We therefore investigated a new flexible, body compliant lead (AnkerStim™, Medtronic) in a series of patients regarding efficacy, complications and overall outcome. This quadripolar electrode has small tined anchors to prevent dislocation and reduce the necessity for additional fixation.

Methods: We present a series of 34 patients (20f, 14m; age: range 27-73y, mean 43.1 y) suffering from chronic migraine (CM) (n=15), chronic cluster headache (CCH) (n=17) and cervical pain (n=2), who underwent bilateral ONS lead implantation with two extensions and a permanent RC IPG (Intellis™, Medtronic). Patients were evaluated at baseline and at 6 months follow-up respectively regarding quality of life (EQ5D), pain level (VAS) and frequency of headache attacks

Results: 6 mo f/u data was available in 11/17 CCH patients (further 6 expected within 3 mo). 5/11 patients reported a marked reduction in headache attacks per day, 4 reported a decrease in pain intensity. In the CM patients, f/u data was available in 12 patients, 9/12 reported a clinical significant reduction in migraine days or intensity. Decrease in pain or reduction of headache attacks led to an improvement in functional capacity at the 6 mo f/u (EQ5D 49,3 at baseline vs. 56,6 at 6 mo f/u). 4 systems had to be explanted due to infection. Revision surgery for lead dislocations were required in two patients. No bow-stringing was observed.

Conclusion: There is an ongoing debate about optimal implant technique, indications and outcome measurement of ONS. By using a stretchable lead, mechanical complications can be reduced. Due to delayed effect of the treatment, we use an all-in-one approach. This series of implants shows the technical advantages of the body compliant leads and small size pulse generator. Our results confirm the advantages of ONS for a continuous pain relief in CM and CCH.These new devices are safe and efficient and harbor the potential to reduce complications in ONS. Especially complication data should be collected in large, multicenter trials. All patients were therefore part of the ongoing product surveillance registry (PSR), conducted by Medtronic.