Long-Term Generator Replacement Experience in Hypoglossal Nerve Stimulator Therapy Recipients With CPAP-Intolerant...

Area of Science:

• Medical Devices
• Sleep Medicine
• Neurosurgery

Background:

• Hypoglossal nerve stimulation (HNS) is an established therapy for obstructive sleep apnea (OSA).
• Patients with initial HNS implants are approaching the expected battery depletion period (8-12 years).
• Surgical experience and long-term outcomes of IPG replacement in HNS therapy are not well-documented.

Purpose of the Study:

• To evaluate the surgical outcomes of implantable pulse generator (IPG) replacement in patients with HNS for OSA.
• To assess the long-term efficacy and adherence of HNS therapy following IPG replacement.
• To analyze complications and operative times associated with serial IPG replacements.

Main Methods:

• Retrospective analysis of patients from original HNS clinical trials and the ADHERE registry.
• Cross-referencing databases to identify patients requiring IPG replacement.
• Data collection included demographics, apnea-hypopnea index (AHI), therapy use, operative times, and adverse events.

Main Results:

• Fourteen patients underwent IPG replacement approximately 8.3 years post-initial implantation.
• IPG replacement operative time was significantly shorter than initial implantation (63 vs. 154 minutes).
• Long-term follow-up (8.7 years) showed a -50.06% mean change in AHI and 7.2 hours/night therapy use, indicating sustained efficacy and adherence.

Conclusions:

• IPG replacement surgery for HNS therapy is associated with low complication rates and reduced operative times.
• HNS therapy maintains stable adherence and efficacy in patients for up to 9 years post-implantation, even after IPG replacement.
• This study supports the long-term viability of HNS as a treatment for obstructive sleep apnea.