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• W2007155193 abstract "In the January 1995 issue of CHEST,1Penek J. Laser-assisted uvulopalatoplasty—the cart before the horse [editorial].Chest. 1995; 107: 1-3Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar an editorial warned of the widespread application of laser-assisted uvulopalatoplasty (LAUP) for the treatment of obstructive sleep apnea (OSA) because of the lack of objective documentation of its efficacy. At the time, public interest in LAUP was intense, due partly to skillfully crafted marketing techniques targeted directly at patients or at physicians who did not specialize in treating patients with sleep-disordered breathing. Subjective data suggested that LAUP was effective as a treatment of snoring,2Carenfelt C. Laser uvulopalatoplasty in treatment of habitual snoring.Ann Otol Rhinol Laryngol. 1991; 100: 451-454Crossref PubMed Scopus (81) Google Scholar which led to a subtle expansion of the indications for LAUP to include OSA treatment. LAUP is an outpatient procedure, performed in an office under local anesthesia, two favorable characteristics. Since 1995, the published data suggest that LAUP is not effective for the treatment for OSA. The largest trial comparing pre- and posttreatment polysomnographic measures in 58 LAUP patients showed a worsened posttreatment apnea-hypopnea index (AHI) in mild or moderate OSA patients, and the persistence of severe OSA.3Laurentano AM Khosla RK Richardson G et al.Efficacy of laser-assisted uvulopalatoplasty.Lasers Surg Med. 1997; 21: 109-116Crossref PubMed Scopus (48) Google Scholar This lack of efficacy has precluded most third-party payers from providing compensation for the use of LAUP to treat OSA. Unfortunately, many OSA patients received LAUP over the previous few years, and it is likely that these patients remain inadequately treated.The search to find better surgical treatment for OSA continues. This issue of CHEST (see page 1163) contains a study by Powell and coauthors that evaluates the safety, comfort, and efficacy of a novel procedure called Somnoplasty (Somnus Medical Technologies Inc; Sunnyvale, Calif). Somnoplasty is an outpatient surgical technique in which a midline soft palate submucosal scar is created by the use of a needle electrode inserted near the border of the hard palate and directed toward the uvula. A generator delivers pulses of radiofrequency energy, which cause tissue necrosis and needle tract fibrosis over subsequent weeks to months. The study by Powell and colleagues demonstrates no major complications for this novel application of radiofrequency ablation to the soft-palate in 22 patients. In another trial of 18 patients, complications included two patients with uvular sloughing and one patient with a submucosal fistula.4Emery BE. Clinical outcomes for Somnoplasty in the treatment of habitual snoring.Presented at the First Physician Training Conference on Somnoplasty. Chapel Hill, NC1997Google Scholar The study of Powell and coauthors suggests an advantage of Somnoplasty over LAUP or uvulopalatopharyngoplasty with respect to postoperative pain, which may be a result of the avoidance of mucosal transection.A prudent marketing strategy for manufacturers of various OSA treatments in the United States is to gain Food and Drug Administration (FDA) approval for the indication of snoring. Since snoring poses no definitively established health hazards, less intense scrutiny by the FDA is focused on the evaluation of a manufacturer's claim of treatment efficacy. Along this line, most studies evaluating efficacy of snoring treatments are case series and measure subjective outcomes.5Hoffstein V. Snoring.Chest. 1996; 109: 201-222Abstract Full Text Full Text PDF PubMed Scopus (136) Google Scholar These types of studies fail to control for placebo effect and are also flawed by the inability of sleeping patients to accurately assess possible changes in snoring. The study by Powell and colleagues suffers from these deficiencies. The take-home message is that if snoring alone is a serious enough condition to warrant surgical treatment, we must develop and apply standardized, objective measures to assess the adequacy of snoring treatment.Because snoring treatment is not typically covered by third-party payers, patients are less apt to pay out of pocket for relatively expensive snoring treatments such as palatal surgeries, and more apt to try less expensive therapies such as external nasal dilators. The ultimate goal of most device manufacturers is to market an upper airway surgery for the treatment of OSA, which is more likely to result in compensation by third-party payers. To their credit and in compliance with FDA regulation, the manufacturers of the equipment used to perform Somnoplasty demonstrated restraint by marketing this technique only for the treatment of snoring. It is now the responsibility of our surgical brethren to avoid the temptation of using Somnoplasty to treat OSA patients without peer-reviewed, published data demonstrating adequate objective improvement of widely accepted polysomnographic measurements such as the AHI. By design, the current study does not address the efficacy of Somnoplasty for the treatment of OSA. Past mistakes of operating on snoring patients without screening for the presence of OSA with polysomnography must be remedied by the education of our snoring patients and by the guidance of our physician colleagues. The responsibility of educating patients and guiding less-experienced physicians falls jointly on the shoulders of medical device manufacturers, medical professional societies, and individual physicians who are routinely involved in providing care to sleep-disordered breathing patients.How effective will palatal Somnoplasty be for the treatment of OSA? A recent review article6Sher AE Schechtman KB Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome.Sleep. 1996; 19: 156-177Crossref PubMed Scopus (978) Google Scholar suggests a maximum success rate of 50% (as defined by a posttreatment AHI ≤10 and <50% reduction from the pretreatment AHI) for uvulopalatopharyngoplasty when isolated palatal obstructors are identified as surgical candidates. For unselected patients receiving palatal surgeries for OSA, success rates of 20 to 30% are to be expected.The study by Powell and coauthors suggests that Somnoplasty may be most effective in the treatment of upper airway resistance syndrome (UARS) patients, although individual patient data are not presented. Demonstration of postsurgical improvement in the severity of esophageal pressure swings in UARS patients despite a relatively small number of study subjects may be further confirmation that UARS patients tend to obstruct more frequently at the level of the palate7Loube DI Andrada T. Upper airway resistance syndrome patients increase resistance at the level of the velopharynx during sleep [abstract].Chest. 1997; 112: 10SGoogle Scholar compared to OSA patients who obstruct with approximately equal frequency at the level of the palate or the base of the tongue.8Hudgel DW. Variable site of airway narrowing among obstructive sleep apnea patients.J Appl Physiol. 1986; 61: 1403-1409Crossref PubMed Scopus (203) Google Scholar Radiofrequency tissue ablation or other novel procedures for the treatment of OSA could ultimately be most useful when applied to base of tongue obstruction, as other surgeries addressing this level of obstruction, such as midline glossectomy, have unacceptably low success rates and result in severe postoperative pain.9 In the January 1995 issue of CHEST,1Penek J. Laser-assisted uvulopalatoplasty—the cart before the horse [editorial].Chest. 1995; 107: 1-3Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar an editorial warned of the widespread application of laser-assisted uvulopalatoplasty (LAUP) for the treatment of obstructive sleep apnea (OSA) because of the lack of objective documentation of its efficacy. At the time, public interest in LAUP was intense, due partly to skillfully crafted marketing techniques targeted directly at patients or at physicians who did not specialize in treating patients with sleep-disordered breathing. Subjective data suggested that LAUP was effective as a treatment of snoring,2Carenfelt C. Laser uvulopalatoplasty in treatment of habitual snoring.Ann Otol Rhinol Laryngol. 1991; 100: 451-454Crossref PubMed Scopus (81) Google Scholar which led to a subtle expansion of the indications for LAUP to include OSA treatment. LAUP is an outpatient procedure, performed in an office under local anesthesia, two favorable characteristics. Since 1995, the published data suggest that LAUP is not effective for the treatment for OSA. The largest trial comparing pre- and posttreatment polysomnographic measures in 58 LAUP patients showed a worsened posttreatment apnea-hypopnea index (AHI) in mild or moderate OSA patients, and the persistence of severe OSA.3Laurentano AM Khosla RK Richardson G et al.Efficacy of laser-assisted uvulopalatoplasty.Lasers Surg Med. 1997; 21: 109-116Crossref PubMed Scopus (48) Google Scholar This lack of efficacy has precluded most third-party payers from providing compensation for the use of LAUP to treat OSA. Unfortunately, many OSA patients received LAUP over the previous few years, and it is likely that these patients remain inadequately treated. The search to find better surgical treatment for OSA continues. This issue of CHEST (see page 1163) contains a study by Powell and coauthors that evaluates the safety, comfort, and efficacy of a novel procedure called Somnoplasty (Somnus Medical Technologies Inc; Sunnyvale, Calif). Somnoplasty is an outpatient surgical technique in which a midline soft palate submucosal scar is created by the use of a needle electrode inserted near the border of the hard palate and directed toward the uvula. A generator delivers pulses of radiofrequency energy, which cause tissue necrosis and needle tract fibrosis over subsequent weeks to months. The study by Powell and colleagues demonstrates no major complications for this novel application of radiofrequency ablation to the soft-palate in 22 patients. In another trial of 18 patients, complications included two patients with uvular sloughing and one patient with a submucosal fistula.4Emery BE. Clinical outcomes for Somnoplasty in the treatment of habitual snoring.Presented at the First Physician Training Conference on Somnoplasty. Chapel Hill, NC1997Google Scholar The study of Powell and coauthors suggests an advantage of Somnoplasty over LAUP or uvulopalatopharyngoplasty with respect to postoperative pain, which may be a result of the avoidance of mucosal transection. A prudent marketing strategy for manufacturers of various OSA treatments in the United States is to gain Food and Drug Administration (FDA) approval for the indication of snoring. Since snoring poses no definitively established health hazards, less intense scrutiny by the FDA is focused on the evaluation of a manufacturer's claim of treatment efficacy. Along this line, most studies evaluating efficacy of snoring treatments are case series and measure subjective outcomes.5Hoffstein V. Snoring.Chest. 1996; 109: 201-222Abstract Full Text Full Text PDF PubMed Scopus (136) Google Scholar These types of studies fail to control for placebo effect and are also flawed by the inability of sleeping patients to accurately assess possible changes in snoring. The study by Powell and colleagues suffers from these deficiencies. The take-home message is that if snoring alone is a serious enough condition to warrant surgical treatment, we must develop and apply standardized, objective measures to assess the adequacy of snoring treatment. Because snoring treatment is not typically covered by third-party payers, patients are less apt to pay out of pocket for relatively expensive snoring treatments such as palatal surgeries, and more apt to try less expensive therapies such as external nasal dilators. The ultimate goal of most device manufacturers is to market an upper airway surgery for the treatment of OSA, which is more likely to result in compensation by third-party payers. To their credit and in compliance with FDA regulation, the manufacturers of the equipment used to perform Somnoplasty demonstrated restraint by marketing this technique only for the treatment of snoring. It is now the responsibility of our surgical brethren to avoid the temptation of using Somnoplasty to treat OSA patients without peer-reviewed, published data demonstrating adequate objective improvement of widely accepted polysomnographic measurements such as the AHI. By design, the current study does not address the efficacy of Somnoplasty for the treatment of OSA. Past mistakes of operating on snoring patients without screening for the presence of OSA with polysomnography must be remedied by the education of our snoring patients and by the guidance of our physician colleagues. The responsibility of educating patients and guiding less-experienced physicians falls jointly on the shoulders of medical device manufacturers, medical professional societies, and individual physicians who are routinely involved in providing care to sleep-disordered breathing patients. How effective will palatal Somnoplasty be for the treatment of OSA? A recent review article6Sher AE Schechtman KB Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome.Sleep. 1996; 19: 156-177Crossref PubMed Scopus (978) Google Scholar suggests a maximum success rate of 50% (as defined by a posttreatment AHI ≤10 and <50% reduction from the pretreatment AHI) for uvulopalatopharyngoplasty when isolated palatal obstructors are identified as surgical candidates. For unselected patients receiving palatal surgeries for OSA, success rates of 20 to 30% are to be expected. The study by Powell and coauthors suggests that Somnoplasty may be most effective in the treatment of upper airway resistance syndrome (UARS) patients, although individual patient data are not presented. Demonstration of postsurgical improvement in the severity of esophageal pressure swings in UARS patients despite a relatively small number of study subjects may be further confirmation that UARS patients tend to obstruct more frequently at the level of the palate7Loube DI Andrada T. Upper airway resistance syndrome patients increase resistance at the level of the velopharynx during sleep [abstract].Chest. 1997; 112: 10SGoogle Scholar compared to OSA patients who obstruct with approximately equal frequency at the level of the palate or the base of the tongue.8Hudgel DW. Variable site of airway narrowing among obstructive sleep apnea patients.J Appl Physiol. 1986; 61: 1403-1409Crossref PubMed Scopus (203) Google Scholar Radiofrequency tissue ablation or other novel procedures for the treatment of OSA could ultimately be most useful when applied to base of tongue obstruction, as other surgeries addressing this level of obstruction, such as midline glossectomy, have unacceptably low success rates and result in severe postoperative pain.9" @default.
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• W2007155193 title "Radiofrequency Ablation for Sleep-Disordered Breathing" @default.
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