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CPAP/SLEEP


Issue: July 2007
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In Case of a Compliance Meltdown ...

by Michael Friedman, MD, FACS

Understanding the Pillar Procedure can help you educate patients and make the referral process a two-way street for patients who reject CPAP.

Three cases involving sleep-disordered breathing and obstructive sleep apnea (OSA) demonstrate the Pillar Procedure as an effective treatment for some patients who reject CPAP.

It is estimated that more than 25% of the population in the United States suffers from some level of obstructive sleep apnea-hypopnea syndrome (OSAHS).1-2 It is well established that patients with severe evidence of the disease have significant symptomatology demanding intervention such as CPAP therapy. However, recent studies have shown that even patients with relatively mild or moderate cases of obstructive sleep apnea have potential for serious long-term sequelae. These studies demonstrate that the risk of developing hypertension and stroke doubles in patients who snore and have mild sleep apnea.3-9

In addition to these long-term effects experienced by even the most mild sleep apnea patients, other aspects of sleep-disordered breathing have recently been identified. Bed partners of patients who snore are also victims of this disease. Studies reveal that bed partners lose approximately 25% of their sleep as a secondary effect from snoring.10-13 Most Americans suffer from a mild degree of sleep deprivation and cannot afford to have further sleep loss as a result of bed-partner snoring. This additional sleep loss often creates significant interpersonal relationship and social issues. Very often both snorer and bed partner are fatigued and irritable, and these effects can interfere with their relationship.

In addition to the classic symptoms of OSA, there is evidence that even mild-to-moderate sleep apnea can affect mood and be associated with depression, especially in women.14-15 The following three cases represent patients with relatively mild disease who were suffering the effects of snoring and OSA. All had resolution of symptoms and apnea using the Pillar Procedure technique.

The Pillar Procedure is approved by the Food and Drug Administration as a minimally invasive, first-line treatment for snoring and OSA. In less than 15 minutes, three polyester inserts (approximately 18 mm in length each, with an outer diameter of 2 mm) are implanted into the patient's soft palate to cause a stiffening effect and thereby allow air to flow more freely through the patient's airway.

CASE 1: THE PILOT

A 47-year-old, 6-foot-tall, 220-pound male commercial airline pilot with a long history of loud snoring and disrupted breathing was urged to seek help at the insistence of his wife who was suffering from poor sleep secondary to snoring. In addition, she was concerned about observed apnea, although the patient himself was unaware of any symptoms of daytime somnolence, fatigue, or exhaustion. His Epworth Sleepiness Scale based on his wife's observations was 14. He did complain of chronic nasal stuffiness.

He underwent initial testing that revealed evidence of a turbinate hypertrophy and an abnormal Müller maneuver at the level of the soft palate. He had Friedman tongue position II and tonsil size I. He underwent a polysomnogram that confirmed OSA with an apnea-hypopnea index (AHI) of 22 and oxygen levels that stayed above 91%.

As an airline pilot, the patient was unwilling to accept continuous treatment with CPAP therapy. He was treated with a combination of radio-frequency turbinate reduction and a palate-stiffening procedure utilizing pillar implants, ie, the Pillar Procedure. Both the radio-frequency turbinate reduction and the Pillar Procedure were performed on an outpatient basis under local anesthesia. On the follow-up assessment, his snoring level—previously graded as 9/10 by his wife—had diminished to 2/10. Although he denied having previous fatigue, he noticed that he did have better sleep and improved energy levels postprocedure. The patient's Epworth Sleepiness Scale at this point had reduced to 8. A follow-up polysomnogram at 6 months after the procedure showed an AHI of 4.3.

CASE 2: THE NEWLYWED

A 39-year-old, 5-foot-6-inch-tall, 140-pound woman with a history of loud snoring and clinical depression sought treatment. The patient was recently married, and her snoring disrupted her husband's sleep—creating tension between them that further added to her depression. In addition, she felt that her depressive medications were not completely effective in resolving her overall symptoms. Her symptoms included significant daytime fatigue with some somnolence. Her Epworth Sleepiness Scale was 12, and her snoring was judged as 7/10 by her husband. She had no history of hypertension. She underwent initial assessment, which showed an AHI of 26 with oxygen levels above 92%. She had Friedman tongue position II and tonsil size I with evidence of a 100% closure on Müller maneuver at the level of the velopharynx. She had no other symptoms. She underwent palatal stiffening with the Pillar Procedure. Three months after surgery, she had almost complete elimination of snoring and had considerable improvement in her general sense of well-being. Her Epworth Sleepiness Scale was 8, and her husband judged her snoring as 3/10. She felt significantly more refreshed in the morning with better sleep, and felt substantially less depressed. Her postoperative AHI was 5.2 with oxygen levels over 95%.

CASE 3: THE HEART PATIENT

A 43-year-old, 5-foot-11-inch, 200-pound man was encouraged by his wife to undergo evaluation because of loud disruptive snoring and a history of OSAHS. The patient felt his daytime somnolence was a normal result of hard work. He had an Epworth Sleepiness Scale of 16. He was on medication for hypertension with hyperlipidemia and had a history of coronary artery disease. He had undergone a previous angioplasty. Because of a long history of mouth breathing with chronic nasal obstruction, he underwent a nasal septoplasty and laser-assisted uvulopalatoplasty in an attempt to treat the snoring and OSAHS. Although his snoring improved after the procedure, all symptoms returned after 1 year. Initial assessment revealed multilevel obstruction including:

  1. nasal valve collapse;
  2. soft palate obstruction (100% closure on Müller maneuver); and
  3. hypopharyngeal obstruction at the base of the tongue.

Friedman tongue position was III. His polysomnogram results indicated an AHI of 29.4 with minimal oxygen levels of 82%. He had tried CPAP on multiple occasions, but was unable to comply with CPAP therapy. He underwent combined minimally invasive multilevel treatment including bilateral nasal valve repair, palatal stiffening with the Pillar Procedure, and tongue base radio-frequency reduction. Post-treatment symptoms improved. His Epworth Sleepiness Scale was 10, and he had an AHI of 14 with oxygen minimum at 91%. His snoring level was reduced from a 9/10 to a 4/10 as judged by his wife.

UNWILLING TO COMPLY WITH CPAP

OSAHS is an extremely common problem. Many patients do not recognize symptoms or are in denial. A small percentage of patients use CPAP therapy on a consistent basis. There could be as many as 40 million Americans who suffer from snoring and/or mild to moderate OSAHS who are unwilling to accept or comply with CPAP, nor are they willing to undergo surgery. Many of these patients may benefit from multilevel minimally invasive procedures. Nasal procedures, palatal stiffening using the Pillar Procedure, and tongue base radio-frequency reduction can improve the airway in three regions commonly associated with OSAHS.

Michael Friedman, MD, FACS, is the medical director of the Advanced Center for Specialty Care and an otolaryngologist-head and neck surgeon practicing in the Chicago area since 1977. He is a professor and chairman of the Section of Head and Neck Surgery in the Department of Otolaryngology and Bronchoesophagology at the Rush Medical College and is considered an expert on head and neck cancer, endoscopic sinus surgery, thyroid surgery, and sleep disorders. He has been involved in training other surgeons, fellows, residents, and medical students for the past 30 years, and has published more than 150 scientific articles, as well as coauthored 28 book chapters or textbooks in his specialty. He is also editor-in-chief of the journal Operative Techniques in Otolaryngology—Head & Neck Surgery and a member of the Clinical Sleep Society and the American Sleep Disorders Association. He can be reached via the editor: .

References

  1. Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle aged men and women. Sleep. 1997;9:705-706.
  2. Rowley JA. Obstructive sleep apnea and hypopnea syndrome. Available at: www.emedicine.com/med/topic2697.htm. Accessed January 23, 2007.
  3. Shiina K, Tomiyama H, Takata Y, et al. Concurrent presence of metabolic syndrome in obstructive sleep apnea syndrome exacerbates the cardiovascular risk: a sleep clinic cohot study. Hypertens Res. 2006;29:433-441.
  4. Coccagna G, Pollini A, Provini F. Cardiovascular disorders and obstructive sleep apnea syndrome. Clin Exp Hypertens. 2006;28:217-224.
  5. Sasanabe R, Banno K, Otake K, et al. Metabolic syndrome in Japanese patients with obstructive sleep apnea syndrome. Hypertens Res. 2006;29:315-322.
  6. Makino S, Iwata M, Fujiwara M, Ike S, Tateyama H. A case of sleep apnea syndrome manifesting severe hypertension with high plasma norepinephrine levels. Endoc J. 2006;53:363-369.
  7. Duchna HW, Myslinski W, Dichmann M, Rasche K, Schultze-Werninghaus G, Orth M. Cardiac structure and function in patients with obstructive sleep apnea syndrome and co-prevalent arterial hypertension. Influence of CPAP therapy [in German]. Med Klin. 2006;101:1-8.
  8. Kokturk O, Ciftci TU, Mollarecep E, Ciftci B. Elevated C-reactive protein levels and increased cardiovascular risk in patients with obstructive sleep apnea syndrome. Int Heart J. 2005;46:801-809.
  9. Dursunoglu N, Dursunoglu D. Obstructive sleep apnoea syndrome, endothelial dysfunction and coronary atherosclerosis [in Turkish]. Tuberk Toraks. 2005;53:299-306.
  10. Virkkula P, Bachour A, Hytonen M, Malmberg H, Salmi T, Maasilta P. Patient- and bed-partner reported symptoms, smoking, and nasal resistance in sleep-disordered breathing. Chest. 2005;128:2176-2182.
  11. Doherty LS, Kiely JL, Lawless G, McNicholas WT. Impact of nasal continuous positive airway pressure therapy on the quality of life of bed partners with obstructive sleep apnea syndrome. Chest. 2003;124:2209-2214.
  12. Bregelmans JG, Ford DE, Smith PL, Punjabi NM. Differences in patient and bed partner assessed quality of life in sleep disordered breathing. Am J Respir Crit Care Med. 2004;179:547-552.
  13. Beninati W, Harris CD, Herold DL, Shepard JW. The effect of snoring and obstructive sleep apnea on the sleep quality of bed partners. Mayo Clin Proc. 1999;74:955-958.
  14. Peppard PE, Szklo-Coxe M, Hla KM, Young T. Longitudinal association of sleep-related breathing disorder and depression. Arch Intern Med. 2006;166:1709-1715.
  15. Decary A, Rouleau I, Montplaiser J. Cognitive deficits associated with sleep apnea syndrome. Sleep. 2000;23:369-381.

CPAP: All About Compliance


New features and technologies are boosting compliance rates.

As many as 25% to 54% of patients discontinue PAP therapy. Why do patients stop therapy?

  • Headgear and flow generator interfaces are uncomfortable.
  • Patients feel claustrophobic while using the devices.
  • Interfaces and machines are perceived as complicated.
  • The device is perceived as too cumbersome to take on trips.
  • Side effects such as congestion are bothersome.

For some manufacturers, the answer is improving pressure relief so that the patient's breathing pattern feels more natural. Two pressure-relieving technologies dominate the market today. "C-Flex™" for CPAP is a proprietary pressure relieving system developed by Respironics Inc, Murrysville, Pa.

EPR™ (Expiratory Pressure Relief) is a patented pressure relief system created by ResMed Corp, Poway, Calif, for select flow generators. ResMed recently introduced an auto-adjusting bilevel technology called VPAP Malibu; it has a smoother inhalation and exhalation waveform than EPR, which the company claims is more natural and feels better for patients. The Malibu's algorithms provide varying inspiratory PAP and expiratory PAP levels that can increase or decrease based on the presence of apneas, snoring, and other flow limitations.

Similarly, Respironics has introduced "A-Flex," a pressure relief algorithm designed for its REMstar Auto M unit. If breathing events occur, the auto algorithm raises the A-Flex pressure profile to eliminate those events, while simultaneously making sure that pressure never rises to a level that is uncomfortably high. In addition, Respironics has a B-flex algorithm available for its Bi-level units.

Fisher & Paykel's solution to better patient comfort and compliance is optimizing its humidification technology.

The result of Fisher and Paykel's humidification focus was last year's introduction of ThermoSmart, a heated breathing tube that delivers high customized humidity levels that are independent of ambient temperature changes. ThermoSmart is also designed to prevent condensation within the tube.

For Viasys Healthcare Respiratory Care, Yorba Linda, Calif, comfort and portability are key components to improving patient compliance. Its BreathX CPAP from its recently acquired subdivision, Hoffman Laboratories, Chatsworth, Calif, is a portable CPAP system that the patient can wear like a U-shaped neck pillow. The unit is lightweight, runs cool, and can use a rechargeable 12-hour battery power throughout the night, so there are no electrical cords. Because of its U-shaped, self-contained design, there are no air hoses reaching across to a night table. Instead, the entire CPAP and interface rests on the patient's chest and face. Steve Birch, director of marketing for sleep diagnostics and therapy at Viasys says that the BreathX unit is ideal for active sleepers as well as business travelers.

— Tor Valenza, staff writer for HME Today


Related Articles - CPAP/SLEEP

Don't Follow the Herd - August 2008

Strange Bedfellows - July 2008

Don't Neglect the Human Touch - June 2008

Latest on Home Sleep Testing - May 2008

CMS Approves In-Home CPAP Qualification - April 2008

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