Upper airway stimulation device failure: A 7-year single center experience

Area of Science:

• Medical Devices
• Otolaryngology
• Sleep Medicine

Background:

• Obstructive sleep apnea (OSA) is a prevalent condition.
• Upper airway stimulation (UAS) therapy offers an alternative treatment for OSA.
• Device-related failures can impact treatment efficacy and patient outcomes.

Purpose of the Study:

• To report the incidence and causes of upper airway stimulator (UAS) device failures.
• To analyze the types of failures and the need for revision surgery in a single center.
• To identify the leading cause of UAS device malfunction.

Main Methods:

• Retrospective case series of 348 patients who underwent UAS surgery with an Inspire device.
• Data collected from 2016 to 2023 at a single tertiary academic center.
• Analysis included patient demographics, comorbidities, and reasons for device revision surgery.

Main Results:

• 16 out of 348 patients (4.6%) required revision surgery due to device failure.
• The average interval between implantation and revision was 772 days (approximately 2 years).
• Respiratory sensing lead damage (68.8%) was the most common failure, followed by IPG replacement (12.3%) and lead migration (6.3%).

Conclusions:

• Respiratory sensing lead fracture is the primary cause of UAS device failure in this cohort.
• Device failures, particularly lead fractures, may be linked to the time elapsed since implantation.
• Addressing lead integrity is crucial for long-term UAS therapy success.