Originally at: https://doctorstevenpark.com/a-tongue-pacemaker-for-sleep-apnea-high-tech-hope-or-hype?utm_source=rss&utm_medium=rss&utm_campaign=a-tongue-pacemaker-for-sleep-apnea-high-tech-hope-or-hype
Every few years, a revolutionary way of treating OSA comes out. Nineteen eighty (1981) was a pivotal year in sleep medicine when Dr. Colin Sullivan reported reversing a vacuum cleaner motor to provide positive pressure through a makeshift mask to treat severe obstructive sleep apnea. Dr. Shiro Fujita also described a palatal operation to treat obstructive sleep apnea in 1981. Later on, oral appliances were also introduced. Over the years, advances were made with positive air pressure as well as with multi-level soft tissue and jaw procedures.
In 2014, the Inspire hypoglossal nerve stimulation procedure received FDA approval for patients in the United States. In their pivotal trial with results published in the New England Journal of Medicine in 2014, they reported a 68% drop in the average apnea hypopnea index (AHI), 70% drop in the oxygen desaturation index (ODI), and with an overall “response” rate of 66% (more than 50% drop in the AHI and less than 20).
Having been involved years prior with similar technology through another company called Apnex, I was pleased to see that this technology had progressed to the point of being available to the general public. Due to the volatile nature of medical high-tech start-up companies, I was cautiously waiting to see how they would do and see what the results would show in the real world on a long term basis. In 2018, a group of surgeons performing this procedure published their 5 year outcomes. One hundred and twenty six patients were followed for 5 years, and 97 were included in the study, with 71 available sleep studies. Comparing from baseline to 12, 36 and 60 months, improvements across all measurements remained stable. The pre-treatment AHI was 32, dropping to 15, 11 and 12, at 12, 36 and 60 months, respectively. The functional outcome of sleep questionnaire (FOSQ, a validated sleep quality of life tool) increased significantly from 14 to 17, 17 and 18. The Epworth Sleepiness Scale dropped from 11.6 to 7 at all follow-up periods. Now, this procedure is being performed at over 300 centers in the United States and more and more insurance carriers are covering it, usually after a preauthorization process.
Technically, the pacemaker is implanted under the skin beneath the right collarbone, as opposed to a heart pacemaker, which is implanted on the left side. It’s a similar sized container. A small incision is made under the right chin, and the nerve that supplies the tongue (hypoglossal nerve) is exposed. This technique is very similar to a common procedure we perform in our field to remove the submandibular gland for stones, infections, or cancer. …