In use in Europe for sometime, and in the U.S. since 2004 as a treatment for snoring, the Pillar® procedure for palatal implants was given FDA approval in February 2004 as a treatment for mild to moderate cases of sleep apnea. However, a wide range of opinion exists in the medical community concerning its long-term value for obstructive sleep apnea treatment. Currently, Medicare may only provide limited coverage and most private health insurance do not cover the Pillar® procedure treatment costs of aprox. $2000 and up.
In the procedure, three small bars made of a soft polyester material are implanted into the roof of the mouth. After a month or two, as the body responds to the foreign substance by forming fibrous tissue around it, the palate becomes stiffer, making it less likely to collapse into the airway during sleep.
Since the mechanics of sleep apnea are complicated, involving the uvula, pharynx, tonsils, and tongue as well as the palate, the Pillar® procedure is not a cure-all. It is not indicated for use in the severely obese, defined as people with a Body Mass Index over 30. People who meet the weight criteria still might not be good candidates for the procedure, depending on their oral anatomy. Data from the clinical trials prior to FDA approval indicate that in about 50% of the cases of mild to moderate OSA, the procedure results in a “cure”. An additional 25% of OSA patients experience a reduction in apneas.
An authoritative and current view of the Pillar® procedure is contained within the text, “Practice Parameters for the Surgical Modifications of the Upper Airway for Obstructive Sleep Apnea in Adults” printed in the medical journal, SLEEP , Vol. 33, No. 10, 2010, on page 1412: “4.3.7 Palatal Implants: Palatal implants may be effective in some patients with mild obstructive sleep apnea who cannot tolerate or who are unwilling to adhere to positive airway pressure therapy, or in whom oral appliances have been considered and found ineffective or undesirable. There is limited research that adequately assesses the efficacy of palatal implants for the treatment of OSA. One RCT (randomized controlled trial) and 2 case series met the criteria for inclusion in the review and suggest marginal efficacy. Overall, this (data) represents very low quality evidence. This is a new treatment option that has emerged since the previous practice parameter. While this procedure may be an alternative mode of therapy for mild OSA, at the present time it is difficult to predict if it will be ultimately be found to be a reliably effective intervention.”
CONCLUSION: The Pillar® procedure is the newest in an array of surgical procedures for the treatment for obstructive sleep apnea. Therefore it has been well advertised and has captured media attention due to its seeming simplicity and one-time “cure-all.” However, the selection by the patient of the appropriate option for sleep apnea treatment should always be based on the recommendations of a knowledgeable Sleep Specialist.
LOWER PG&E RATE FOR CPAP USERS
PG&E has a financial assistance program for residential customers that have special energy needs due to certain qualifying medical conditions. PG&E considers CPAP as “life- support medical equipment.” As such, it qualifies for these reduced electricity rates.
Eligible customers may receive a “standard” Medical Baseline quantity of approximately 500 kWh of electricity at a lower rate. A member of the Support Group states, “After registering with PG&E as a CPAP user, I am saving several hundred dollars per year from my electricity bill.”
To obtain these rates, you must submit a form signed by your doctor. Information on the “Medical Baseline Program,” instructions and the application forms can be obtained from PG&E or their website at; www.pge.com/myhome/customerservice/financialassistance/medicalbaseline/index.shtml Fill out the form and mail it to your Respiratory physician for signature along with a stamped envelope addressed to PG&E. You may wish to follow up with PG&E to see how your approval is going. Eventually, your monthly PG&E bill should indicate that you are getting the medical baseline rate, which will be lower.
SLEEP & AGING TALK
At the Winter meeting of the Support Group, Dr. MacDannnald addressed the group on the subject of Sleep and Aging.
Pointing out that “severe daytime sleepiness at any age almost certainly indicates a sleep disorder,” he went on, “it is mistakenly thought of as part of the normal aging process.”
Sleep disordered breathing has the same symptoms and effects on the body in the elderly as well as in sleep apnea patients; snoring, daytime sleepiness, heart disease, hypertension and cognitive impairment. There are a number of age-dependent risk factors for sleep disordered breathing in the elderly; increased body mass, decreased muscle strength, increased airway collapsibility, decreased thyroid functions, decreased lung volume and decreased central respiratory drive. Dr. MacDannald offered the following 7 tips for older adults to reduce the effects of aging on sleep;
– Get regular exercise.
– Limit naps to one per day for no more than 30 minutes.
– Increase your light exposure by taking a walk in the afternoon or early evening.
– Check medications for effect on sleep.
– Avoid alcohol, caffeine and nicotine.
– Limit liquids in the evening.
– Keep regular hours for going to bed and arising.
The usual informative and responsive Question and Answer Session followed Dr. MacDannald’s presentation.
AMBIEN SAFE TO TAKE WITH TREATED SLEEP APNEA
If you and your physician have determined you need a sleep aid, Ambien is safe to take with Obstructive Sleep Apnea as long as your Sleep Apnea is being treated with CPAP. Although Ambien is a CNS (Central Nervous System) depressant and could slow down the body’s normal reaction to an apnea episode, the CPAP machine will overcome the apnea and quickly restore the airway to normal.
MOUTH LEAKS
Although breathing through the nose with the mouth closed would seem perfectly normal, studies have shown that 1/3 of the people using CPAP can not seal their mouths when sleeping and therefore leak air when using a nasal mask or nasal “pillows” thereby reducing the effectiveness of their treatment. In these cases a full face mask, which covers the mouth, will correct the problem.
THE DATA CARD
The Data Card is the most recent and useful. It is analogous to a memory card in a digital camera. All new machines should now have a removable memory card to track their treatment successfulness. The Data Card is provides a vital measure of patient benefit since it will track treatment performance every night that the machine is used. We ask every patient to please bring their Data Card every time they come in for a follow-up appointment now. The Data Card will indicate whether there are still significant problems. Some other innovations are:
– The machines have gotten small and quieter, and more transportable.
– There are many more enhancements
– Humidifiers used to be extra, but now are included
– Patient can now have a ramp function, so instead of starting right out on their fully prescribed treatment pressure, the machine will gradually ramp up the pressure to the goal pressure, if desired.
– There is a C-Flex setting, to drop pressure during exhalation, if desired.
– There is a much greater variety of mask sizes and configurations
– There are more options of headgear
– There are more manufacturers
– There are automatically adjusting machines that deliver the only the amount of pressure needed during the night to prevent apneas/hypopneas
– There are Bi-level machines now for those patient that are unable to breathe against a high pressure when they exhale.
– There are machines now for those patient that a plagued with central sleep apnea syndrome
There are Data Cards now to not only record how much the machine is being used but whether the patient is still experiencing apneas or hypopneas, and how many. We always wish for good memories.