Safety and effectiveness in explantation and re-implantation of hypoglossal nerve stimulation devices

Since 2001, hypoglossal nerve stimulators have been implanted in patients with obstructive sleep apnea around the world, initially in trial situations but more recently also in regular care settings. Medium term data indicate effectiveness and tolerability of treatment. However, when assessing the safety of the procedure, the safe feasibility of explantation or reimplantation must also be considered.

Nine patients with an implanted respiratory-driven hypoglossal nerve stimulator. We have evaluated the feasibility and safety of explantation or re-implantation with another stimulation system.

In 2012, nine patients were implanted with a respiratory-driven hypoglossal nerve stimulator as part of the Apnex Medical Pivotal Study. The study was ended in 2013. For a variety of reasons, the system was explanted from all nine patients by the year 2019. Three of these patients were re-implanted with a different system with respiratory sensing during the same session (mean incision to closure time for explantation 88.2 ± 35.01 min., mean incision to closure time for re-implantation 221.75 ± 52.73 min.). Due to extensive scar tissue formation, all procedures were technically challenging. Complication rate was significantly higher when re-implantation was performed or attempted in the same surgical session (0 of 5 patients with explantation versus 3 of 4 patients with attempted re-implantation; p = 0.018). There was no significant difference between the AHI values before and after implantation in patients with re-implantation.

Explantation and re-implantation are technically challenging though possible procedures. The single-staged equilateral reimplantation of another hypoglossal nerve stimulation system can, but need not, be successful.