Abstract
Objective
Surgical tongue advancement and stabilization is limited by morbidity and lack of adjustability. This study was designed to assess the feasibility and effectiveness of a novel titratable minimally invasive tongue advancement system. The objectives of the multicenter prospective study were to assess: 1) clinical effect on AHI, sleepiness and snoring, and 2) procedure morbidity.
Methods
Previously untreated patients (N=42) with evidence of tongue obstruction (BMI<32, AHI <60) underwent placement of a bone anchor attached to the mandible, tethered to a tissue anchor in the tongue base. Tissue anchor advancement was performed several weeks later under local or sedation anesthesia. Outcome measures included baseline and follow-up PSG, home sleep testing, and questionnaire data.
Results
Titration advanced the anchor up to 1.5 cm. There were no acute or long-term significant effects in speech, swallowing or taste. In 13 patients, tissue anchor barb fractures were observed on x-ray. AHI significantly decreased in the total group (29.1 to 23.1, p<0.01). The barb-intact group improved (29.6 to 22.1, p<0.01) but no change was observed in the barb fracture group (28.1 to 25.3, p = 0.17). Improvements were observed in snoring (7.3 to 3.6, p < 0.01), ESS (11.5 to 7.5, p < 0.01). Postoperative average pain scores decreased from 4.4 to 1.5 on day 5 (10 point scale).
Conclusions
Soft tissue anchor failure occurred and was associated with less effect and warrants correction prior to widespread application. Titrable tongue suspension is feasible, well tolerated, and significantly improves multiple measures of sleep apnea.
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