Researchers find that inserting three matchstick sized pieces of
polyester material in the upper palate is a simple, low cost, and easily
tolerated office procedure that provides effective snoring relief.
In a stress filled society, sleep is precious. When your partner or roommate has loud and habitual snoring, finding an effective, minimally invasive and cost-effective treatment becomes critical. Surgery is one option, particularly the uvulopalatopharyngoplasty (UPPP) and laser-assisted uvuloplasty (LAUP), which reduces the pharyngeal tissue volume and increases palatal stiffness through postoperative scarring. However, these procedures are painful and may cause considerable morbidity [define] and functional changes.
Recently developments have resulted in more targeted procedures to stiffen the palate and cause less surgical trauma for patients. These procedures include radiofrequency and injection sclerotherapy of the palate. However, these regimens often require more than one treatment for optimal palatal stiffening, and occasional tissue damage can cause mucosal breakdown and fistulas.
The public has recently been introduced to a new palatal implant system designed to achieve palatal stiffening without tissue damage and volume reduction. This system reduces snoring through placement of permanent implants, which cause fibrosis and submucosal scarring in a single procedure. The implant itself is a segment of braided, polyethylene terephthalate (PET), which has a long history of human implantation. Advantages of this system are expected to be low morbidity, simplicity, and low cost.
But does the palatal system actually work? A research team from Norway set out to evaluate the safety and efficacy of this new treatment for snoring through long-term follow-up. The authors of "Palatal Implants for the Treatment of Snoring: Long Term Results," are St�le Nordg�rd MD PhD, Brit Kari Stene Md, Ketil Wichmann Skj�stad MD, and Vegard Bugten MD, all with the Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital, Trondheim; and Nina Vanvik Hansen, a research nurse, all in Norway. Their findings are being presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation Annual Meeting & OTO EXPO, being held September 19-22, 2004, at the Jacob K. Javits Convention Center, New York City, NY.
Methodology: Thirty-five patients referred to St. Olav University Hospital in Trondheim for habitual snoring were included in this prospective, non-randomised study. A complete medical history and physical ENT examination was conducted on each subject. The patient and his/her bed partner completed questionnaires to evaluate the severity, intensity, duration, and social effects of the snoring. The intensity of snoring and the degree of pain, speech, and swallowing problems were recorded on a visual analogue scale (VAS) from 0 to 10. For snoring intensity, 0 was no snoring and 10 related to an intensity that causes the partner to leave the bedroom. The Epworth Sleepiness Score (ESS) was used to describe the patient's daytime sleepiness. To evaluate the satisfaction rate, the patients and their partners were asked if they would recommend the procedure to a friend or a family member based on how they felt at the time of follow-up.
The ambulatory, nocturnal polysomnography was performed; follow-up office visits were performed at 2-3 days, 14 days, 30 days, 90 days, 180 days, and 360 days after treatment. These follow-ups consisted of a physical examination and the completion of questionnaires to evaluate the safety and efficacy for the procedure. A polysomnography was repeated at 360 days.
The Palatal Implant System (Pillar� System) was used in this research study. The implant is 18 mm long and 1.5 mm in diameter. The implant is designed to be permanent while the delivery system is disposable.
Results: The study group comprised 26 men and eight women with a mean age of 43.7 years (range 23-67 years). The mean BMI was 26.1 and did not change significantly after one year (BMI 26.3). Four patients did not repeat the polysomnography, leaving 30 pairs of data for comparison of the sleep study results. There was no significant change in mean AHI (Apnea/Hypopnea Index (AHI), the number of apneas and hypopneas that occur during the night and dividing by the time in bed). None of the patients withdrew from the study; all completed their follow-up visits at 2, 14, 30, 90, 180 and 360 days postoperatively.
These implants offered a new philosophy of stiffening the palate to reduce snoring. Unlike UPPP, LAUP, RF, CAPSO and injection snoreplasty where scarring takes place after tissue resection or ablation, this procedure causes virtually no tissue damage and the implants serve as a template for fibrous ingrowths. This is reflected in the very low patient morbidity observed in this study. No mucosal breakdown, palatal swelling, discomfort or fistulae, as reported for radiofrequency and injection snoreplasty, were noted with the palatal implant system. In this study, pain was not registered at a day-to-day basis, but the objective data related to analgesic use places it at least similar to the most favourable results from radiofrequency. Six patients (17.8 percent) did experience a total of nine partial extrusions.
In a one-year follow-up after the palatal implantation, 70 percent of patients' bedmates reported that snoring was no longer a problem, compared to 92 percent at four to six weeks. This is approximately equal to the satisfaction reported in surgical and less invasive procedures.
Conclusions: The palatal implant system is safe and the procedure is associated with a very low patient morbidity and virtually no tissue damage. The effectiveness in treating snoring is comparable to other surgical methods but can be further improved through better patient selection. Partial extrusion of one or two implants, the most frequently observed adverse reaction, does not affect the overall treatment results. The advantages when compared to other methods are simplicity, low cost and minimal patient discomfort from only a single procedure where the majority of bed partners remained satisfied long term.
American Academy of Otolaryngology Head and Neck Surgery (AAOHNS)
One Prince St.
Alexandria, VA 22314
United States
Phone 703-519-1563
Fax 703-519-1587
http://www.entnet.org/ent-press/index.cfm
In a stress filled society, sleep is precious. When your partner or roommate has loud and habitual snoring, finding an effective, minimally invasive and cost-effective treatment becomes critical. Surgery is one option, particularly the uvulopalatopharyngoplasty (UPPP) and laser-assisted uvuloplasty (LAUP), which reduces the pharyngeal tissue volume and increases palatal stiffness through postoperative scarring. However, these procedures are painful and may cause considerable morbidity [define] and functional changes.
Recently developments have resulted in more targeted procedures to stiffen the palate and cause less surgical trauma for patients. These procedures include radiofrequency and injection sclerotherapy of the palate. However, these regimens often require more than one treatment for optimal palatal stiffening, and occasional tissue damage can cause mucosal breakdown and fistulas.
The public has recently been introduced to a new palatal implant system designed to achieve palatal stiffening without tissue damage and volume reduction. This system reduces snoring through placement of permanent implants, which cause fibrosis and submucosal scarring in a single procedure. The implant itself is a segment of braided, polyethylene terephthalate (PET), which has a long history of human implantation. Advantages of this system are expected to be low morbidity, simplicity, and low cost.
But does the palatal system actually work? A research team from Norway set out to evaluate the safety and efficacy of this new treatment for snoring through long-term follow-up. The authors of "Palatal Implants for the Treatment of Snoring: Long Term Results," are St�le Nordg�rd MD PhD, Brit Kari Stene Md, Ketil Wichmann Skj�stad MD, and Vegard Bugten MD, all with the Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital, Trondheim; and Nina Vanvik Hansen, a research nurse, all in Norway. Their findings are being presented at the American Academy of Otolaryngology-Head and Neck Surgery Foundation Annual Meeting & OTO EXPO, being held September 19-22, 2004, at the Jacob K. Javits Convention Center, New York City, NY.
Methodology: Thirty-five patients referred to St. Olav University Hospital in Trondheim for habitual snoring were included in this prospective, non-randomised study. A complete medical history and physical ENT examination was conducted on each subject. The patient and his/her bed partner completed questionnaires to evaluate the severity, intensity, duration, and social effects of the snoring. The intensity of snoring and the degree of pain, speech, and swallowing problems were recorded on a visual analogue scale (VAS) from 0 to 10. For snoring intensity, 0 was no snoring and 10 related to an intensity that causes the partner to leave the bedroom. The Epworth Sleepiness Score (ESS) was used to describe the patient's daytime sleepiness. To evaluate the satisfaction rate, the patients and their partners were asked if they would recommend the procedure to a friend or a family member based on how they felt at the time of follow-up.
The ambulatory, nocturnal polysomnography was performed; follow-up office visits were performed at 2-3 days, 14 days, 30 days, 90 days, 180 days, and 360 days after treatment. These follow-ups consisted of a physical examination and the completion of questionnaires to evaluate the safety and efficacy for the procedure. A polysomnography was repeated at 360 days.
The Palatal Implant System (Pillar� System) was used in this research study. The implant is 18 mm long and 1.5 mm in diameter. The implant is designed to be permanent while the delivery system is disposable.
Results: The study group comprised 26 men and eight women with a mean age of 43.7 years (range 23-67 years). The mean BMI was 26.1 and did not change significantly after one year (BMI 26.3). Four patients did not repeat the polysomnography, leaving 30 pairs of data for comparison of the sleep study results. There was no significant change in mean AHI (Apnea/Hypopnea Index (AHI), the number of apneas and hypopneas that occur during the night and dividing by the time in bed). None of the patients withdrew from the study; all completed their follow-up visits at 2, 14, 30, 90, 180 and 360 days postoperatively.
These implants offered a new philosophy of stiffening the palate to reduce snoring. Unlike UPPP, LAUP, RF, CAPSO and injection snoreplasty where scarring takes place after tissue resection or ablation, this procedure causes virtually no tissue damage and the implants serve as a template for fibrous ingrowths. This is reflected in the very low patient morbidity observed in this study. No mucosal breakdown, palatal swelling, discomfort or fistulae, as reported for radiofrequency and injection snoreplasty, were noted with the palatal implant system. In this study, pain was not registered at a day-to-day basis, but the objective data related to analgesic use places it at least similar to the most favourable results from radiofrequency. Six patients (17.8 percent) did experience a total of nine partial extrusions.
In a one-year follow-up after the palatal implantation, 70 percent of patients' bedmates reported that snoring was no longer a problem, compared to 92 percent at four to six weeks. This is approximately equal to the satisfaction reported in surgical and less invasive procedures.
Conclusions: The palatal implant system is safe and the procedure is associated with a very low patient morbidity and virtually no tissue damage. The effectiveness in treating snoring is comparable to other surgical methods but can be further improved through better patient selection. Partial extrusion of one or two implants, the most frequently observed adverse reaction, does not affect the overall treatment results. The advantages when compared to other methods are simplicity, low cost and minimal patient discomfort from only a single procedure where the majority of bed partners remained satisfied long term.
American Academy of Otolaryngology Head and Neck Surgery (AAOHNS)
One Prince St.
Alexandria, VA 22314
United States
Phone 703-519-1563
Fax 703-519-1587
http://www.entnet.org/ent-press/index.cfm
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