Pillar implants relative to a dime

Lawrence Davis, Splash Magazines Worldwide's publisher and editor-in-chief, was constantly waking up in the middle of the night at least once every night for as long as he can remember. While asleep, he could feel his lungs cease to inhale or exhale. This lapse in breath was followed by loud gasps for air and his body suddenly jerking itself awake. He snored heavily and his struggled breathing often startled not only himself, but his then girlfriend as well. 'I would wake up with a shocking jolt that was so surprising and frightening that I just couldn't go back to sleep,' Davis describes, 'I would wake up gasping for air. It felt like my heart had stopped.' Davis was unknowingly suffering from Obstructive Sleep Apnea (OSA).

OSA is very common, as common as adult diabetes, and affects more than twelve million Americans, according to the National Institutes of Health. It occurs two to three times more often in older adults and is twice as common in men as in women. In fact, 1 in every 20 men and one in every 30 women live with sleep apnea. While risk factors for OSA include being male, overweight, and over the age of forty, OSA can strike anyone at any age, even children.

OSA is caused by a blockage of the airway, usually when the soft tissue in the rear of the throat collapses and closes during sleep. In central sleep apnea, the airway is not blocked but the brain fails to signal the muscles to breathe. Mixed apnea, as the name implies, is a combination of the two. With each apnea event, the brain briefly arouses people with sleep apnea in order for them to resume breathing, but consequently sleep is extremely fragmented and of poor quality.

Moreover, OSA is a potentially life-threatening condition that requires immediate medical attention. The risks of undiagnosed obstructive sleep apnea include heart attacks, strokes, impotence, irregular heartbeat, high blood pressure, heart disease, headaches, and weight gain. Yet, because of the lack of awareness by the public and healthcare professionals, the vast majority remain undiagnosed and therefore untreated, despite the fact that this serious disorder can have significant and potentially grave consequences.

The damaging effects of sleep apnea extend far beyond health risks of the person afflicted. OSA causes daytime sleepiness that can result in accidents, lost productivity and interpersonal relationship problems. The National Commission on Sleep Disorders estimates that sleep deprivation costs $150 billion a year in higher stress and reduced workplace productivity. The National Sleep Foundation has suggested that social problems such as road rage may be caused, in part, by a national epidemic of sleepiness.

OSA may also be responsible for motor vehicle crashes. According to the National Highway Traffic Safety Administration, over 100,000 automobile accidents a year are caused by driver fatigue: a number that includes over 1,550 dead and 71,000 injured. Figures suggest that driver fatigue contributes to 30% to 40% of all heavy truck accidents. In a study published in the British journal Occupational and Environmental Medicine, researchers in Australia and New Zealand report that sleep deprivation can have some of the same hazardous effects as being drunk. They found that people who drive after being awake for 17 to 19 hours performed worse than those with a blood alcohol level of .05%. That's the legal limit for drunk driving in most western European countries.

Davis had been battling with Gastroesophageal Reflux Disease (GERD), the back up of gastric juices into the esophagus, and adult-onset asthma for years before he was diagnosed with OSA. He thought that his fragmented sleep was the result of GERD and asthma, and instead focused on trying to find the best treatments for these two disorders rather than searching for a treatment for the sleeping problems themselves.

Although scientific research did not yet support his theory, Davis was insistent upon the idea that the development of his asthma was a result of GERD. To his dismay, Davis' physician at the time was resistant to accepting, or hearing, his theory. Currently, there is a wealth of research that provides data in support of Davis' personal hypothesis: long-term acid reflux causes esophageal inflammation that can result in scarring and even asthma! Davis continued to spend years searching for a remedy for his GERD and asthma, with little success.

Five years ago at yet another doctor's appointment, Davis described his sleeping problems to his physician. 'People lay down to rest so that they can feel better,' he vividly remembers explaining to his doctor, 'but I feel horrible when I lay down!' He could not manage to get a full breath of air while lying down. Davis, like his theory about the correlation between GERD and asthma, followed his instincts and asked his doctor to administer a spirometry test.  However, his doctor performed the exam while Davis was sitting up. 'He told me everything was fine,' says Davis, 'but I didn't have a problem breathing when I was sitting up. It was only when I was lying down. So, I asked him to perform the exam while I was lying down.' Just as Davis suspected, the exam results when sitting up were strikingly different when lying down. The doctor promptly made the diagnosis: Obstructive Sleep Apnea.

Fortunately for all sufferers like Davis, OSA is treatable. However, until the advent of the Pillar Implants, treatment options were incredible limited and were quite unable to significantly improve the quality of life, or sleep, for sufferers of OSA. Before Pillar Implants became available to the public, treatment options include: surgery which only has a 50% chance of being effective, insertion of oral devices, sleeping in an elevated position, avoiding alcohol and other depressants that effect the central nervous system, weight loss, or using a Continuous Positive Airway Pressure (CPAP) which is the most commonly prescribed treatment.

CPAP mask

Like most people with OSA, Davis received a prescription for the CPAP. The CPAP works by gently blowing pressurized room air through the airway at a pressure high enough to keep the throat open. This pressurized air acts as a "splint." The pressure is set according to the patient's needs at a level that eliminates the apneas and hypopneas that cause awakenings and disruptive sleep. A CPAP device has a mask, tubes and a fan. To use the machine, a small mask is fitted over the nose leaving the mouth uncovered. Patients must sleep with their mouths closed, aided by a chinstrap, while the machine gently blows air into the nose at a pressure slightly higher than the surrounding air pressure.

'I felt like a jet pilot,' says Davis about his CPAP machine, 'I felt totally restricted. You can't travel with it, it's uncomfortable, and it's sort of noisy. People just won't use it.' It's no wonder that Davis felt constricted while wearing his mask and chose to discontinue using his CPAP! With a plastic tube protruding from the nose that drapes across the body, the mask covering the nose and chin area, and a chin strap extending from the chin to the top of the head in order to keep the mouth closed, it is not surprising that people feel restrained from sleeping on their side, let alone reaching the opposite side of the bed. They are restricted to one position: straightly lying on their back. 'I can imagine how it would be very embarrassing for people to wear this when they are beginning to sleep with their new partner,' says Davis.

Davis is not alone in his critiques of the CPAP. In fact, users of CPAP have frankly voiced their complaints about the machines: the mask feels uncomfortable, your nose feels dry and stuffy, your nose feels blocked up, the mask bothers your skin and nose, the mask leaks air, you don't like the pressure, you may find that breathing out against the air pressure keeps you from sleeping deeply, or you take the mask off during your sleep or don't wear it every night. Nearly 50% of people who are prescribed a CPAP stop using it.

Location of Pillar implants

Pillar inserts are made of material used in implantable medical devices for more than 50 years. They are designed to be invisible and should not be felt or interfere with swallowing or speech. Most patients soon report a noticeable, lasting reduction in sleep apnea and snoring. In long-term (one year) clinical studies, sleep apnea was reduced in nearly 80% of the patients; for patients suffering from disruptive snoring, bed partner satisfaction was as high as 90%. Patients also experienced less daytime sleepiness.

Insertion of the Pillar implants

After much research and too many frustrating nights of too little sleep, Davis decided to give the Pillar Procedure a try. He went to see Jason Van Tassel, MD at Pacific Specialists in Los Angeles who is an expert in treating ear, nose and throat disorders.

Dr. Van Tassel inserts Pillar implants

For Davis, the Pillar Procedure went smoothly. Dr. Van Tassel administered lidocaine, a local anesthetic, to the hard palate-soft palate junction. Then, he used a special device to insert 3 Dacron implants to Davis' palate. Because of the lidocaine, Davis says, 'the top of my throat felt numb,' and 'as he [Dr. Van Tassel] was pushing the Dacron implants in, it felt like they were going deep into my throat.' However, other than the needle pricks and pressure upon the palate, Davis experience very mild pain, 'like a sore throat,' Davis reports.

Special device used to implant the Pillar implants

While physicians claim that patients who receive the Pillar implants can return to work or their usual daily activities as soon as the procedure is complete, Davis felt otherwise. 'After the pain medication wore off, I could really feel the pain of a sore throat,' says Davis. 'I just went home and took a nap. But, I was back to normal the next day.' In addition to mild pain medication, Dr. Van Tassel prescribed Davis a one week dose of antibiotics in order to prevent an infection from developing. Davis did not feel a need to continue using the prescribed pain medication after the day of the procedure.

Dr. Van Tassel performs the Pillar Procedure

Davis began to see improvement almost immediately. The night of the procedure, he was able to sleep through the night, something that he had not been able to do in years! Throughout the week following the procedure, Davis experienced a mild sore throat during the night and had some difficulty swallowing due to the swelling at the site of the implants. 'I could swallow, but it felt like there was always a little something left over,' Davis describes. However, these slight side effects went away after about 10 days. At his follow-up appointment 1 week after the procedure, Davis was healing perfectly and well on his way to a full recovery.

Dr. Van Tassel numbs Larence Davis' palate

For Davis, the Pillar implants have made a significant difference in more than just his sleep. He has also noticed a difference in his GERD and asthma symptoms. 'This is the height of allergy season. My asthma should be worse,' explains Davis, 'but I'm not experiencing any of my usual asthma symptoms!' Davis believes that his OSA causes or contributes to his GERD, which in turn causes asthma. He may be right because 2 weeks after the Pillar procedure, Davis is sleeping better, experiencing a significant decrease in the symptoms associated with GERD, and has not had any of his usual asthma attacks. Although Dr. Van Tassel says that it usually takes about 3 months for the full benefits of the Pillar implants to take effect, Davis is happy with the results now. Every day, Davis reports feeling a little better than before. He is excited to see what the results will be like in 3 months from now!

Dr. Van Tassel inserts Pillar implants

The Pillar Procedure is still considered to be 'investigational' until after until a body of scientific evidence on the clinical effectiveness of the procedure is published in peer-reviewed journals. Until then, insurance companies are unlikely to cover the cost of the procedure. Yet, it is still possible your health insurance provider may cover the Pillar Procedure on a case-by-case basis. The cost of the procedure with Dr. Van Tassel is $1700. According to Davis, the improvement in his quality of life and sleep is well worth every penny.

Dr. Jason Van Tassel and Lawrence Davis after the procedure

For more information about the Pillar implant, click here.

To schedule an evaluation with Dr. Van Tassel, call (310) 477-5558

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