What are the risks of Inspire surgery for Obstructive Sleep Apnea (OSA)?

Risks of Inspire Hypoglossal Nerve Stimulation Surgery

Inspire surgery carries a 34.2% risk of infection, 15.1% risk of nerve injury (neuropraxia), and 11.6% risk of hematoma/seroma formation, with 42.3% of adverse events requiring reoperation. 1

Surgical and Perioperative Risks

Common Complications

• Infection is the most frequently reported adverse event, occurring in approximately one-third of cases requiring intervention 1
• Temporary nerve injury (neuropraxia) affects approximately 15% of patients, though permanent nerve damage is rare 1
• Hematoma or seroma formation occurs in about 12% of cases 1
• Wound dehiscence has been reported in 3% of patients undergoing hypopharyngeal procedures 2
• Transient dysphagia occurs in approximately 3% of cases 2
• Transient lower jaw paresthesia affects about 6% of patients 2

Reoperation Requirements

• Device repositioning or lead revision is necessary in approximately 37% of patients experiencing adverse events 1
• Complete device explantation is required in 46% of patients with significant complications 1
• Device replacement due to malfunction occurs in about 56% of device-related failures 1

Anesthesia-Related Risks

Airway Management Concerns

• Difficult intubation occurs in approximately 18.6% of OSA surgery patients, with positive correlation to neck circumference >45.6 cm and skeletal deficiency 3
• Transient airway obstruction can occur during extubation, though serious events are rare with proper management 3
• Patients with OSA have inherent anatomical abnormalities that predispose them to intubation difficulties 4

Cardiovascular Risks

• Postoperative hypertension requiring intravenous antihypertensive medications occurs in approximately 70.5% of OSA surgery patients 3
• Patients with preoperative hypertension have significantly increased risk (p<0.01) of requiring intraoperative and postoperative blood pressure management 3
• Cardiac arrhythmias have been reported in OSA surgical patients 3
• Angina is a rare but documented complication 3

Device-Specific Malfunctions

• Device malfunction requiring intervention occurs in a subset of patients, with replacement being the most common corrective procedure 1
• Overall, 42.3% of all adverse events necessitate some form of reoperation 1

Important Clinical Considerations

Patient Selection Impact on Risk

• Strict adherence to patient selection criteria (AHI 15-65/100, BMI <32-40 kg/m², absence of complete concentric collapse) is crucial for minimizing complications 5
• Only approximately 10% of screened patients typically meet all eligibility criteria, emphasizing the importance of careful candidate selection 5

Comparative Safety Context

• These complication rates are notably lower than traditional multilevel OSA surgeries, which carry a 1.5% incidence of serious life-threatening complications and 0.2% mortality rate 4
• Long-term side effects from traditional surgeries (UPPP) persist in 58% of patients, including velopharyngeal insufficiency and dysphagia 4

Risk Mitigation Strategies

• Fiberoptic intubation should be used in patients with increased neck circumference and skeletal deficiency to reduce airway risks 3
• Awake extubation with full reversal of neuromuscular blockade is strongly recommended 4
• Semi-upright positioning during extubation and recovery reduces airway obstruction risk 4
• Adequate postoperative monitoring in appropriate settings is essential given the cardiovascular risks 3