Marc Bernard Blumen MD (presenter); Bernard Fluery MD; Chantal Housser-Hauw MD; Fredric Chabolle MD
Suesnes France
Objectives: To evaluate prospectively the efficacy of Somnoplasty applied on the soft palate for the treatment of obstructive sleep apnea.
Methods: Patients referred or self-referred to our center for the treatment of snoring/daytime sleepiness/witnessed apnea underwent an otolaryngologic examination. A night recording was performed in all subjects. Patients who had a respiratory disturbance index (RDI) between 10 and 30 events per hours of sleep and a retrovelar site of obstruction were included. Three different treatment protocols were consecutively used: protocol A, 700 J in the midline, 350 J on each side; protocol B, 2 times 700 J just lateral to the midline and 700 J on each side; and protocol C, 700 J on the midline, 700 J on each side. We provided at most 3 treatment sessions. All patients were asked to undergo a night recording. It was performed at least 5 months after the last treatment session.
Results: Four patients in protocol A, 30 patients in protocol B, and 22 patients in Protocol C were included and treated. Some patients were lost to follow-up. Some patients refused follow-up polysomnography. Results were evaluated based on the following criteria: subjective snoring volume, Epworth sleepiness scale, RDI, lowest oxygen saturation, and body weight. Cure was defined as an RDI of less than 20/hour and a 50% reduction in the preoperative RDI.
Conclusion: In some cases, Somnoplasty applied on the soft palate may be beneficial in the treatment of sleep apnea syndrome.
in Obstructive Sleep Apnea Surgery
Lionel M Nelson MD (Presenter)
San Jose, CA
Objective: Obstructive sleep apnea syndrome (OSAS) is frequently associated with upper airway obstruction at multiple levels. The best method to treat a retroglossal level remains controversial, and until recently, available procedures involved invasive surgery, which many patients and surgeons were reluctant to undertake. Temperature-controlled radiofrequency tongue base reduction (Somnoplasty) may be a less morbid alternative. Although tongue base Somnoplasty has been evaluated as a separate procedure, it has not been formally tested as an initial combined component of site-directed multilevel OSA surgery. This study is designed to investigate the safety, feasibility, and efficacy of using simultaneous tongue base Somnoplasty with other multilevel operative procedures for OSAS
Methods: This was a prospective, nonrandomized study of 10 OSAS patients with multilevel obstruction based on physical examination with supine pharyngoscopy, cephalometrics, and acoustic reflection. All patient underwent simultaneous uvulopalatopharyngoplasty (UPPP), nasal septoplasty/turbinate reduction when indicated, and tongue base Somnoplasty under general anesthesia. Two additional tongue base Somnoplasties under local anesthesia followed in-office, bringing the total tongue base radiofrequency energy delivered to 12,000 J. Perioperative morbidity was compared to that of a control group undergoing nasal correction and UPPP without tongue base Somnoplasty. Follow-up examination and questionnaire regarding treatment morbidity and OSA symptoms were conducted at 1, 3, and 7 days, and 1, 2, and 6 months, including repeat sleep studies at 2 months.
Results: At the time of this abstract submission, 4 patients have been assessed at 2 months. There is an average apnea-hypopnea index reduction of 54% to 17.3/hour and minimum oxygen saturation increase from 79% to 87%. The Epworth score went from an average of 11.25 to 5.25, daytime sleepiness from 5.5 to 1.8 and snoring from 8.1 to 1.3. Acoustic reflection showed obstructions (<2 cm_ at specific airway level) decreased from 4 to 1 at the palate and from 4 to 0 at the tongue base. There were no operative complications, and perioperative pain and dysphagia were similar to those of the control group. Data on the additional study patients and follow-up to 6-months will be presented.
Conclusion: Tongue base Somnoplasty performed simultaneously with UPPP and septoplasty/turbinate reduction is both safe and feasible in planned multilevel OSA surgery. It appears to effectively reduced the retroglossal obstructive component in selected patients.
B. Tucker Woodson MD (presenter); Tod C Huntley MD; Samuel A Mickelson MD; Lionel M Nelson MD.
Menomonee Falls WI; Indianapolis IN; Atlanta GA; San Jose CA
Objective: It is a speculated that reducing tongue base volume will improve surgical treatment outcomes for obstructive sleep apnea (OSA). Prior studies have demonstrated that partial glossectomies may reduce OSA severity. Somnoplasty (temperature-controlled submucosal radiofrequency tissue ablation) has been advocated as a minor ambulatory surgical procedure to treat tongue base. The goals of this study are to assess treatment outcomes of the procedure.
Methods: In total, 113 patients participated in a multi-institutional study of OSA treatment effectiveness. Sixty-nine patients with mild to sever OSA, despite treatment of palate and nasal obstruction, were openly enrolled. Base-of-tongue Somnoplasty was performed with patients under local anesthesia. Polysomnography and self-reported outcome measures assessed respiratory, general health, disease specific, and peri-operative quality-of life outcomes. Forty-four patients having similar inclusion criteria were nonrandomly enrolled in a nasal continuous positive airway pressure (CPAP) comparison treatment arm, which assessed sleep and quality-of life outcomes.
Results: Eighteen Somnoplasty patients have completed polysomnography follow-up. The respiratory disturbance index increased form 45.3 + 21.1 to 33.3 + 26.6 events per hour (p = 0.0061). Epworth Sleepiness Scale, (ESS) decreased from 11.9 + 5.6 to 7.8 + 4.7 (n = 29 patients, P = 0.0005). Snoring decreased from 6.2 + 2.8 to 3.5 + 3.3 (p = 0.0077). In the nasal CPAP comparison group, ESS decreased from 12.0 + 4.3 to 7.9 + 3.7 (n = 44 patients, p < 0.0001). ESS change was similar in both Somnoplasty and CPAP groups (4.2 + 4.1 vs 4.1 + 4.4, and treatment effect 0.89 vs 0.93, respectively). In the completed group, mean energy applied was 15,696 J. In 344 treatments, 11 serious treatment-related events occurred (3.2%). There were 5 suppurative tongue infections (1.4%), with 3 requiring incision and drainage.
Conclusion: Somnoplasty is a well-tolerated minor surgical procedure. It results in both significant reduction in respiratory disturbance index and clinical improvement in sleepiness. Improvement in clinical outcomes measures are similar to nasal CPAP.
NB Powell, RW Riley, C Guilleminault
Objective: This pilot study investigates the new technology of radiofrequency energy (RFe), as applied to the tongue base, for the purpose of assessing feasibility, safety, and possible efficacy in the treatment of sleep-disordered breathing (SDB).
Methods: Eighteen patients with SDB, in whom at least palatopharyngoplasty had failed, were entered in this study. The mean respiratory disturbance index was 39.6, with a mean nadir oxygen (SaO2) of 81.9%. A radiofrequency electrode delivered energy to the subsurface tongue base with local anesthetic. Polysomnography, quantitative speech and swallowing studies, questionnaires, and visual analog scales were used to assess outcomes. MRI assessed changes in tongue volume.
Results: Separate RFe treatments (mean 5.5) at 4-week intervals were given (mean 1543 J for 9 minutes at 80o C), for a mean energy total of 8490 J per patient. The posttreatment mean respiratory disturbance index was 17.8, and the SaO2 nadir was 88.3%. Weight increased slightly; speech and swallowing did not change. Questionnaires and visual analog scale scores showed improvement in study variables. Tongue volume was reduced by a mean of 17%. Pain was controlled by hydrocodone for 3 to 4 days. One infection was seen and resolved with incision and drainage.
Conclusion: This pilot study demonstrates feasibility, safety, and efficacy in reducing tongue volume using RFe. Additional cumulative energy may improve the cure rate for SDB.
Otolaryngology-Head and Neck Surgery, 1999, Vol. 120, No. 8, 656-664.
Radiofrequency Volumetric Reduction of the Tongue, A porcine pilot study for the treatment of obstructive sleep apnea syndrome.
NB Powell, RW Riley, RJ Troell, MB Blumen, C Guilleminault
Study Objective: To investigate, in an animal model, the feasibility of radiofrequency (RF) volumetric tongue reduction for the future purpose of determining its clinical applications in obstructive sleep apnea syndrome (OSAS).
Design: The study was performed in three stages, on in vitro bovine stage and two in vivo porcine stages. The last stage was a prospective investigation with histologic and volumetric analyses to establish outcomes.
Setting: Laboratory and operating room of veterinary research center.
Participants: A homogeneous population of porcine animal models, including seven in stage 2, and 12 in stage 3.
Intervention: RF energy was delivered by a custom-fabricated needle electrode and RF generator to the tongue tissue of both the in vitro and in vivo models.
Measurements and results: Microultrasonic crystals were used to measure three-dimensional changes (volumetric reduction). Lesion size correlated well with increasing RF energy delivery (Sperman correlation coefficient of 0.986; p=0.0003). Histologic assessments done serially over time (1 h through 3 weeks) showed a well-circumscribed lesion with a normal healing progression and no peripheral damage to nerves. Volumetric analysis documented a very mild initial edematous response that promptly tapered at 24 h. At 10 days after RF, a 26.3% volume reduction was documented at the treatment site (circumscribed by the microultrasonic crystals).
Conclusion: RF, in a porcine animal model, can safely reduce tongue volume in a precise and controlled manner. Further studies will validate the use of RF in the treatment of OSAS.
CHEST, 1998, 111:1348-1355.
[Scientific Session] Radiofrequency Treatment of Turbinate Hypertrophy to Improve Nasal CPAP Usage
Nelson B Powell, MD; Robert W Riley, MD, DDS; Adriane I Zonato, MD (presenter); Kasey K Li, MD, DDS; Robert J Troell, MD; Sao Paulo, Brazil; Palo Alto, CA
Objective: To investigate the use of radio frequency (RF) treatment to improve the use of nasal CPAP in subjects complaining of nasal congestion refractory to medical management of diagnosed turbinate hypertrophy. Methods: A prospective randomized double-blind placebo controlled study in which 22 subjects underwent pretreatment (2 weeks) and posttreatment (4 weeks) rhinoscopy and visual analog scales (VAS) of nasal obstruction and CPAP tolerance, with metered (objective) compliance of CPAP use time. RF turbinate ablation was via a Somnus instrument for a single outpatient treatment session. Randomized placebos (n = 5) received blinded treatment without energy delivery. Reevaluation (n =22) was at 1 day, 2 to 3 days, 1 week, 4 weeks following treatment. Results: Twenty-two patients (12 women, mean age 54.3 years, BMI 29.3 kg/m^{2}, and RDI 33.5) started and finished the protocol. A mean of 413 J of RF energy was given to each turbinate. Investigators (before and after treatment) found an overall mean clinical change of 27.0% (right and left turbinates) compared with patients’ (n = 17) subjective (VAS) change in nasal obstruction, which was 48.0%. The placebo (n = 5) change by investigators was 27.0% and by patients 28.7%, respectively. Tolerance (n = 17) to CPAP improved 28.9% (VAS, 4.92 – 6.34) versus placebo (n = 5) decrease of 10.4% (VAS, 4.36 – 3.32). Computer-metered CPAP compliance in treated was pretreatment 5.6 hours/days to post treatment 5.8 hour/day verse the placebo of 4.11 hours/day to 3.75 hours/day. Conclusion: Tolerance of CPAP was subjectively improved 28.9% in patients after treatment. This finding paralleled our anatomic clinical nasal findings and those of patients’ VAS scores for nasal turbinate obstruction, suggesting increased airway size may improve ease of CPAP use. This positive outcome was even in light of the fact that objective CPAP compliance in this group was not significantly changed with RF treatment. The outcomes of the placebo controls were further evidence to support our conclusions and strengthen the need to continue usage of randomized placebo-controlled studies for such treatment outcomes.
Simultaneous Uvulopalatopharyngoplasty (UPPP) and Base of Tongue (BOT) Radiofrequency Ablation (Somnoplasty®) for the treatment of Obstructive Sleep Apnea (OSA)
NT Feldman1, J Berrios2
(1) , Palms of Pasadena Hospital, St. Petersburg, FL (2) , Helen Ellis Memorial Hospital, Tarpon Springs, FL.
Introduction: Palatal surgery procedures leave the majority of OSA patients inadequately treated.
Reports of the efficacy of BOT Radiofrequency ablation, Somnoplasty, in OSA have been limited to small numbers of patients who had previously undergone palatal procedures (Powell et al 1999) We
Have prospectively enrolled 35 patients dissatisfied with nasal continuous positive air pressure (CPAP)
in a protocol utilizing simultaneous UPPP and BOT Somnoplasty under general anesthesia.
Methods: To date, 35 patients who have with an apnea-hypopnea index (AHI) greater than 10/hour who expressed dissatisfaction with CPAP have undergone simultaneous UPPP and BOT Radiofrequency ablation under general anesthesia. As our confidence in the safety of the procedure has grown, we now initially administer a total of 4,000 joules of energy in 4 lesions. The patients are monitored in the hospital overnight utilizing CPAP for airway protection. Four to 6 weeks later, BOT Somnoplasty is repeated,
with an additional 4,000 joules of energy divided into 4 lesions. Follow-up sleep studies are obtained
2 months later.
Results: Nine patients have completed the protocol for the follow-up sleep study. Their body mass index (BMI) ranged from 25 to 41 with a mean of 31.8 Seven of the 9 were treated successfully with a marked reduction in AHI. The mean Epworth Sleepiness Scale (ESS) in the 9 patients dropped from 12.2 to 4.7 (p=<0.1). Interestingly, loud snoring persisted in 2 of the 7. Three patients experienced minor superficial tongue ulcerations with infection that responded to oral antibiotics. The remaining 26 patients have undergone the initial surgery, but have not yet completed the protocol. The pre-and post-treatment AHI
are shown below. (Fig 1)
Figure 1
Conclusions: Simultaneous UPPP and BOT radiofrequency ablation can be performed safely with an acceptable success rate at short-term follow-up. This protocol allows 8,000 joules to be delivered in just two treatment sessions. Post-operative fiberoptic examination in the 2 patients failed the treatment suggests that persistent lateral pharyngeal wall obstruction may explain the result.
Presented at Associated Professional Sleep Societies, June 2000, Las Vegas, NV (abstract)
Timothy L. Smith, MD, MPH; Alex J. Correa, MD; Tim Kuo; Lou Reinisch, PhD
Objectives: The objective of this clinical trial was to assess the safety and efficacy of radiofrequency (RF) tissue ablation of the inferior turbinates in the treatment of nasal obstruction using an RF energy delivery system with a thermocouple feedback electrode. Methods: A prospective, nonrandomized study of 11 patients (mean age, 47 ± 12y) with chronic nasal obstruction was conducted. Using patient-based visual analogue scales (VAS), symptom parameters were assessed. These included degree of nasal obstruction, frequency of nasal obstruction, and pain. Physician assessment of nasal obstruction was also collected by the principle investigator. Follow-up was conducted at 24 hour, 1 week, 4 weeks, 8 weeks, and 1 year. ANOVA was carried out to determine statistically significant differences in the data. Data were fit to a regression model, and confidence intervals were determined from a 95% confidence level. Results: In patient-assessed degree of nasal obstruction, statistical significance was seen among baseline and 4 weeks, 8 weeks, and 1 year (P<. 0001, and P<. 0008, respectively). There was no difference between 8 weeks and 1 year (P<. 15). The data appeared to follow an exponential decay to a constant value. The pretreatment baseline average degree of obstruction was 7.5 ± 0.5 on a scale of 0 to 10. The degree of obstruction after 8 weeks was 2.7 ± 0.6. The time constant for this change was 21 days to reach 90% of the final value. At 1 year, degree of obstruction was 3.3 ± 0.7. For frequency of nasal obstruction, statistical significance was seen among baseline and 4 weeks, 8 weeks, and 1 year (P<. 0001, P<. 0001, and P<. 0001, respectively). There was no difference between 8 weeks and 1 year (P<. 15). The pretreatment baseline average frequency of obstruction was 7.8 ± 0.5. The remaining frequency of obstruction after 8 weeks was 2.9 ± .06. The time constant was 18 days. At 1 year, frequency obstruction was 3.3 ± 0.6. Physician assessment of nasal obstruction revealed statistical significance among baseline and 4 weeks, and baseline and 8 weeks (P<. 0055 and P<. 0056, respectively). There was no difference between 4 weeks and 8 weeks (P<. 24). The average initial obstruction was 83% ± 4%. The remaining obstruction after 8 weeks was 58% ± 5%. The time constant was 14 days. Mild pain was reported by 55% of patients during the procedure; the remaining 45% reported no pain. Only one patient required pain medication consisting of acetaminophen after the procedure. There were no significant complications. Conclusions: Degree and frequency of nasal obstruction, as reported by patients, decreased following RF tissue ablation of the inferior turbinates. This improvement in symptoms was still evident after 1 year (P<. 001). Physician assessment of obstruction also correlated with patient reports for the initial 8-week study period. The procedure was safe and well tolerated. Thermocouples within the active electrode provided additional feedback to the operation surgeon allowing the use of relatively lower tissue temperatures, power, and energy as compared with traditional techniques. These results support the need for continued research to evaluate this modality as a treatment for chronic nasal obstruction. Key Words: Radiofrequency, thermocouple, feedback, turbinate, hypertrophy, nasal obstruction.
Layngoscope, 109: 1760-1765, 1999
Radiofrequency Energy Tissue Ablation for the Treatment of Nasal Obstruction Secondary to Turbinate Hypertrophy.
D Utley, R Goode, et al.
Objective/Hypothesis: We hypothesized that the success rate of radiofrequency energy (RFe) tissue ablation of the inferior turbinate for nasal obstruction achieved by previous investigators would be improved by using a longer needle electrode and creating two lesions per turbinate.
Methods: Ten patients with nasal obstruction secondary to inferior turbinate hypertrophy were prospectively enrolled. A 40-mm needle delivered RFe to two sites in each inferior turbinate. Patients used a visual analog scale (VAS) to grade nasal obstruction preoperatively and at 1 week and 8 weeks after surgery. Preoperative and postoperative digital images of the nasal cavity were graded for obstruction (0% to 100%) in a blinded manner.
Results: All patients (100%) were subjectively improved at 8 weeks. Mean obstruction (VAS) improved from 50% ± 21% to 16% ± 15% (right side) and from 53% ± 29% to 13% ± 13% (left side). Mean improvements were 68% (right side) (P=.004) and 75% (left side) (P=.001). Mean obstruction graded during blinded review of nasal cavity images improved from 73.5% ± 8% to 51% ± 8% (right side) and from 76% ± 6% to 64% ± 7% (left side). Of nine patients using medications for nasal obstruction before treatment, eight (89%) noted no further need for medications at 8 weeks.
Conclusion: The use of RFe for submucosal tissue ablation in the hypertrophied inferior turbinate is an effective modality for reducing symptoms of nasal obstruction. Improved results may occur by using a longer needle and creating two lesions per turbinate. Of patients in this study, 100% reported improvement of nasal obstruction.
Laryngoscope, 109:683-686, 1999.
Radiofrequency volumetric tissue reduction for treatment of turbinate hypertrophy: A pilot study.
KK Li, NB Powell, RW Riley, RJ Troell, C Guilleminault
Objectives: Ideal treatment for nasal obstruction caused by turbinate hypertrophy remains in question. Medical therapy is often ineffective. Surgical procedures have associated morbidity including pain, bleeding, crusting, adhesion, infection, and dryness. Radiofrequency has recently been shown to be safe and effective in volumetric tissue reduction of the tongue in the animal model and of the palate in human beings. We prospectively evaluate the safety and effectiveness of radiofrequency volumetric tissue reduction (RFVTR) for the treatment of nasal obstruction caused by inferior turbinate hypertrophy.
Methods: Twenty-two consecutive patients with nasal obstruction and associated inferior turbinate hypertrophy refractory to medical therapy were evaluated for RFVTR. The study design limited the region of treatment to the anterior third of the inferior turbinate. The procedures were performed in an ambulatory facility with patients under local anesthesia. Clinical examinations, patient questionnaires, and visual analog scales were used to assess treatment outcomes.
Results: No adverse effects were encountered, including bleeding, crusting, dryness, infection, adhesion, or a worsening of obstruction. Mild edema was noted in all patients but was of short duration (24 to 48 hours). Posttreatment discomfort was well controlled with acetaminophen. Eight weeks after treatment, nasal breathing improved in 21 of 22 patients, with a 58.5% reduction in severity and a 56.5% decrease in the frequency of nasal obstruction.
Conclusion: The results of this study demonstrate that RFVTR of the hypertrophic inferior turbinate is associated with minimal adverse effects. Furthermore, this new treatment modality achieves subjective improvement in patients with symptoms of nasal obstruction. However, because of the small sample size and short follow-up, future investigations are needed to fully evaluate the use of RFVTR in the treatment of nasal obstruction caused by turbinate hypertrophy.
Otolaryngology – Head and Neck Surgery, 119:6:569-573, 1998.
Nasal Turbinate SomnoplastySM: Utilization of Radiofrequency to Treat Chronic Nasal Obstruction and Congestion.
M Madani, BM Smith
Introduction: More than 1.5 billion people on Earth suffer from some type of chronic rhinitis and nasal obstruction, frequent symptoms of perennial (year-round) allergic rhinitis and seasonal rhinitis (i.e. hay fever). Allergic Rhinitis occurs when an individual is exposed to allergens (molds, pollens, dust, ragweed or animal dander). Vasomotor Rhinitis, a non-allergic condition, is caused by sudden changes in the air we breathe. Smells, temperature, humidity and even eating can cause some people to have a runny nose. Irritative Rhinitis occurs when the nose becomes hyperreactive to irritants such as cigarette smoke, chemicals, dust or strong odors. Drug-induced Rhinitis is usually due to excessive use of nasal sprays or nose drops administered in response to nasal obstruction.
Chronic enlargements (hypertrophy) of the turbinates are irreversible except with surgical intervention. A chronic stuffy nose can impair normal breathing, force patients to breathe through the mouth and turn the simple acts of eating, drinking and speaking into an annoying and sometimes painful experience. Many cases of nasal congestion and allergies will respond to medical therapy alone. These therapies include antibiotics, decongestants, antihistamines, steroids, topical treatments or injections and allergy therapies. More invasive surgical procedures include Septoplasty and Turbinectomy with laser, or knife. The somnoplasty procedure is the newest method for volumetric reduction of tissues in the uvula and soft palate and inferior turbinates for the treatment of snoring and chronic nasal congestion. The procedure is performed under local anesthesia and done in an outpatient setting taking less than ten minutes. For people with chronic nasal congestion or runny noses, a new procedure called Turbinate Somnoplasty (Thermal Ablation) using radiofrequency can now change their lives. This procedure is directed to the inferior turbinates causing atrophy and eliminating major surgery.
Methods: A preliminary result of RF Treatment will be presented on 135 patients with follow up time of 6-12 months following treatment. Patients who suffer from chronic nasal obstruction due to enlarged inferior turbinates, chronic sinusitis or structural nasal problems (i.e., a grossly deviated septum) were selected for this procedure. In more severe cases they were informed that traditional septoplasty may also be needed. The nasal somnoplasty was performed under local anesthesia. Patient was grounded as with any other RF units. A specialized device connected to the RF generator was placed into the inferior nasal turbinate. The somnoplasty device tip has two compartments: a 2.5-mm uninsulated tip (with maximum temp. of 80o C) and a 2.5-mm insulated tip (with much lower temp. to protect the delicate tissue surface). RF energy is applied through the electrodes and is delivered for 90 seconds (up to five minutes), heating the tissues in a limited area around the electrode. The patient experiences only minimal discomfort during the procedure. Over a period of three to six weeks, the body naturally absorbs the lesion resulting in volumetric reduction of tissues. In turn, the obstructive tissues are reduced and tightened and the congestion minimized. Most patients do not require any postoperative pain medication and no nasalpacking was required. After the radiofrequency procedure, the nose is stuffy, like having a cold for a week. Once the nose is healed, patients can breathe freely, sleep better, and have less nasal secretion.
Conclusion: A number of problems result when the normal function of the nose is disrupted. Poor nasal airflow results in chronic mouth breathing which in turn often leads to sore throat, hoarseness, plugged or popping ears, post-nasal drainage, voice changes, and a sense of a "lump" in the throat. For individuals who snore, the snoring intensity is much higher with nasal congestion. In severe cases of obstructive sleep apnea, a poor nasal airway may drastically worsen the problem. A new minimally invasive method of treatment for correction of chronic nasal congestion is described. Although RF energy is only approved for volumetric reduction of the soft palate, uvula, nasal turbinates and tongue at the present time, we foresee that the future application of RF energy will become widely accepted for treatment of sleep apnea. This procedure is intended for tissue coagulation (thermal ablation) in the inferior turbinates, which serves a baffles to warm and humidify air to treat the symptoms of nasal obstruction due to chronic turbinate enlargement. Patients report 60-80% improvement in the symptoms of obstruction, congestion and watery nasal drainage resulting from either allergic or vasomotor rhinitis following radiofrequency treatment. This procedure is simple, requires minimal equipmentations and could be done in an oral and maxillofacial surgeon’s office under local anesthesia.
ACOMS, 1999 (abstract).
Radiofrequency Thermoablation of the Inferior Turbinate in Nasal Obstruction
Y Fischer, J Gosepath, R Amedee, W Mann
Persistent hypertrophy of the inferior turbinate is one of the most common causes of nasal obstruction. With the introduction of the Somnoplasty device, a new tool has been developed for tissue reduction which is also suitable for turbinate surgery. Compared to surgical submucosal resection or laser application complications such as delayed bleeding, synechia formation or crusting are rare. Postoperative pain is virtually absent, so application of radiofrequency to the turbinate in children under local anesthesia is feasible. So far, 24 patients (age 6 to 67) have been treated by delivery of an average of 400 Joules to each inferior turbinate. Patients have been followed using anterior rhinomanometry and acoustic rhinometry pre- and postoperatively. These objective tests demonstrated marked improvement of nasal patency after an average of two weeks, lasting for at least 10 months. Complication in this small group of patients included one delayed bleeding and synechia formation in 2 patients. Crusting usually persists for two weeks and requires the use of topical steroids, nasal rinsing and the application of topical ointments. Postoperative pain medication was never utilized. The disadvantages of this new method are the high costs for the equipment and the disposable electrodes.
COSM, 1999, (abstract).
Radiofrequency waves, report of a new treatment for turbinate reduction.
HP Rodriguez
Objective: To analyze the efficacy and safety of radiofrequency tissue volume reduction (RFTVR) for the treatment of nasal obstruction secondary to turbinate hypertrophy. Twenty five patients (N=25), received between 1 and 3 needle applications of radiofrequency energy to the anterior and mid portions of the inferior turbinate. Dosages administered ranged between 750 to 1000 joules per single dose. Patients were compared to a recent publication by the same author in which single application of 500 joules of energy was applied to the anterior portion of the inferior turbinate.
Methods: Prospective single arm study with historical controls. Physical examination, acoustic rhinometry and patients assessment of the degree of nasal obstruction are documented prior to the application of radiofrequency energy and repeated on day 3, 1 week, 1 and 2 months after the procedure. Edema, congestion, bleeding and crusting after the procedure as well as the technique and its untoward side effects are presented.
Results: Twenty of twenty five patients (80%) had symptomatic improvement of their nasal obstruction, 10/25 (40%) had objective reduction in size of the inferior turbinates. Acoustic rhinometric changes were apparent in only 4/25 (16%) patients, all of which had an objective reduction in the size of the turbinate. Untoward effects during and post procedural occurred in 14/25 (56%) of patients, all of which were self limited and resolved in a period of 10 days.
Conclusion: Radiowave energy is safe and effective in improving nasal obstruction secondary to turbinate hypertrophy. Increase dosages applied in this group of patients correlated with an increase response rate than that of historical controls. It was also burdened with a higher degree of perioperative self limited untoward side effects.
AAO-HNS, 1998 (abstract).
Marc Bernard Blumen MD (presenter); Isabelle Wagner MD; Ludovic Chartier MD; Fredric Chabolle MD
Suresnes France
Objective: To evaluate the efficacy of Somnoplasty applied to the soft palate for the treatment of snoring 12 to 18 months after the last treatment.
Methods: Fifteen patients with sleep-disordered breathing were treated with Somnoplasty from March to December 1998. A 3-lesion protocol was performed, 700 J on the midline and 350 J on each side. Three sessions at the most were provided. Patients were evaluated 6 to 8 weeks after the last session are re-evaluated 12 to 18 months afterwards by clinical questionnaires and visual analog scales to subjectively assess snoring. Questionnaires were sent to the patients and returned by mail. If no answer was received, patients were contacted by phone, and results were retrieved. Success was defined by a snoring volume of 3 or less and satisfaction of the bed partner.
Results: The mean snoring volume was 1.7 compared to 8.1 prior to treatment. The short-term overall satisfaction rate was 86.6%. The success rate was 80%. Twelve to 18 months after treatment, 13 patients were evaluated, 1 successful patient initially was lost to follow-up, and 1 failure was treated with LAUP. The mean snoring volume was 3.7, and 46%of the results remained. For 7 patients, modification of respiration volume occurred: 6 patients’ conditions worsened, and 1 patient’s condition improved. The long-term overall satisfaction rate was 69.2% (9/13). The success rate was 53.8%. The mean body weight was not statistically different, even for the patients who had a relapse.
Conclusion: This study suggests that relapse of snoring occurs 12 to 18 months after treatment with Somnoplasty, despite an absence of weight gain. The recurrence rate is comparable to rate of other surgical treatments. Loosening of the soft tissue under stretching conditions is a natural evolution. Recurrence should probably not be considered a failure if an additional treatment can be applied; this is probably the case with Somnoplasty, given the minimal invasiveness of radiofrequency and its good tolerance.
Emery BE, Flexon PB
Division of Otolaryngology--Head and Neck Surgery, University of Maryland Medical System, Baltimore 21201, USA.
[Medline record in process]
OBJECTIVE/HYPOTHESIS: Current options for the treatment of snoring have limited acceptance because of intolerance, expense, pain, or need for general anesthesia. A clinical trial using a new application of a previously known technology-radiofrequency energy-was investigated to determine its efficacy in the treatment of snoring. Effects of treatment on speech, swallowing, pain, snoring, and degree of sleepiness were evaluated. These effects were evaluated by post-treatment questionnaires. METHODS: Prospective nonrandomized study. All included subjects snored at a level considered bothersome to their bed partner. A total of 43 patients were enrolled at the University of Maryland (UM) and the Georgia Ear Institute (GEI). Polysomnography was performed before treatment to eliminate patients with significant sleep apnea who had respiratory disturbance indices (RDIs) greater than 15 or nadir desaturations less than 80%. The mean pretreatment RDI for all patients who entered the protocol at UM was 6.7 +/- 4.7. Nine patients completed the study in this group in all other aspects, but did not return for their scheduled post-treatment polysomnogram. At GEI, pretreatment polysomnograms revealed a mean RDI of 8.9 +/- 3.8. Eleven patients at GEI completed the study in all other aspects but did not return for their scheduled post-treatment polysomnogram. Radiofrequency energy was delivered to the soft palate either in the midline (19 patients) at a mean of 698 +/- 52 J per treatment at UM or in the midline and lateral soft palate (24 patients) at a mean of 1,254 +/- 191 J per treatment at GEI. At UM the mean age was 44.3 +/- 8.4 years, with a range from 29 to 59 years. Eighty-four percent of the patients were men. The mean body mass index (BMI) was 28.5 +/- 3.2. Twenty-four patients were enrolled at GEI. The mean age was 44.0 +/- 10.9 years, with a range from 23 to 63 years. Seventy-four percent of patients were men. The mean BMI was 27.7 +/- 3.8. Snoring, pain, swallowing, and speech were assessed after each treatment at post-treatment day 1, 2, or 3; week 1; week 4; and week 7. Daytime sleepiness was assessed by the Epworth Sleepiness Scores (ESS) obtained at the same intervals. RESULTS: Snoring was improved in 77% of patients after three treatments or less. Seventy-nine percent of patients treated with the midline technique at UM and 96% of patients treated with the midline and left and right lateral palate technique at GEI achieved an improvement in their snoring to a level that was no longer bothersome to their bed partner. No persistent negative impact was noted concerning speech or swallowing. Improvements in degree of sleepiness were observed by comparing pretreatment and post-treatment ESS. ESS was significantly reduced (P < .005) after treatment from 10.2 +/- 6.1 to 6.1 +/- 4.7 at UM, and at the GEI, from 8.75 +/- 4.4 to 5.3 +/- 3.2. After a treatment, 27% of the patients at UM and 29% at GEI required analgesics. CONCLUSIONS: This clinical trial demonstrates the efficacy, safety, and lack of pain encountered when using radiofrequency energy delivered to the palate for the treatment of snoring. The tolerability, lack of pain, and ability to perform the procedure with the patient under local anesthesia in the office make the use of this technology an excellent option for the treatment of snoring.
Laryngoscope 2000 Jul;110(7):1092-8
Radiofrequency Tissue Volume Reduction
of the Soft Palate in Simple Snoring
Craig A. Hukins, MD, FRACP; Ian C. Mitchell, MD, FRACS; David R.
Hillman, MD, FANZCA
Background Snoring is common and often associated with social morbidity. Current therapies are generally unsatisfactory, but radiofrequency tissue volume reduction (RFTVR) palatoplasty offers a new approach.
Objective To assess the outcomes and morbidity associated with RFTVR palatoplasty.
Design Open, prospective trial.
Setting Tertiary referral center.
Patients 20 adults with loud habitual snoring without clinically significant obstructive sleep apnea.
Interventions Three treatments with RFTVR to the middle, distal, and proximal thirds of the midline of the soft palate.
Main Outcome Measures Clinical assessment (visual analog scores) before and after each treatment, polysomnography (with sound intensity measurements), and lateral cephalometry performed prior to the first treatment and 2 months following the final treatments.
Results After treatment, there was a significant overall improvement in the snoring visual analog score (7.5 <<...>> 1.5 to 4.6 <<...>> 2.5; P<.001), a small reduction in the proportion of sleep spent snoring at 50 to 60 dB (P=.03), and mild pain that was controlled with simple analgesia. There were
no long-term adverse effects. Individual response could not be predicted by demographic, polysomnographic, or cephalometric data. Treatment of the proximal third of the soft palate was associated with fewer adverse effects but also seemed less effective than at the other sites.
Conclusions (1) The RFTVR palatoplasty is well tolerated with very low morbidity. (2) It is associated with subjective improvement in snoring in most patients. (3) Placement of lesions seems to influence outcome. (4) The improvement is accompanied by a marginal change in objective measurements, suggesting either an acoustic change independent of sound intensity or a placebo effect. (5) A randomized controlled trial is needed to further evaluate this therapy.
Arch Otolaryngol Head Neck Surg. 2000;126:602-606
Radiofrequency Tissue Volume Reduction
of the Soft Palate in Simple Snoring
Craig A. Hukins, MD, FRACP; Ian C. Mitchell, MD, FRACS; David R.
Hillman, MD, FANZCA
Background Snoring is common and often associated with social morbidity. Current therapies are generally unsatisfactory, but radiofrequency tissue volume reduction (RFTVR) palatoplasty offers a new approach.
Objective To assess the outcomes and morbidity associated with RFTVR palatoplasty.
Design Open, prospective trial.
Setting Tertiary referral center.
Patients 20 adults with loud habitual snoring without clinically significant obstructive sleep apnea.
Interventions Three treatments with RFTVR to the middle, distal, and proximal thirds of the midline of the soft palate.
Main Outcome Measures Clinical assessment (visual analog scores) before and after each treatment, polysomnography (with sound intensity measurements), and lateral cephalometry performed prior to the first treatment and 2 months following the final treatments.
Results After treatment, there was a significant overall improvement in the snoring visual analog score (7.5 <<...>> 1.5 to 4.6 <<...>> 2.5; P<.001), a small reduction in the proportion of sleep spent snoring at 50 to 60 dB (P=.03), and mild pain that was controlled with simple analgesia. There were
no long-term adverse effects. Individual response could not be predicted by demographic, polysomnographic, or cephalometric data. Treatment of the proximal third of the soft palate was associated with fewer adverse effects but also seemed less effective than at the other sites.
Conclusions (1) The RFTVR palatoplasty is well tolerated with very low morbidity. (2) It is associated with subjective improvement in snoring in most patients. (3) Placement of lesions seems to influence outcome. (4) The improvement is accompanied by a marginal change in objective measurements, suggesting either an acoustic change independent of sound intensity or a placebo effect. (5) A randomized controlled trial is needed to further evaluate this therapy.
Otolaryngol Head Neck Surg 2000 Mar;122(3):410-4
Radiofrequency volumetric reduction
of the palate: An extended follow-up study.
Li KK, Powell NB, Riley RW, Troell RJ, Guilleminault C
Stanford University Sleep Disorders and Research Center.
OBJECTIVE: The goal was to evaluate the effect of radiofrequency (RF) of the palate on speech, swallowing, taste, sleep, and snoring 12 to 18 months after treatment. METHODS: Twenty-two patients were evaluated by clinical examination, questionnaires, and visual analog scales. The patients with relapse of snoring were offered further RF treatment. RESULTS: After a mean follow-up of 14 months, no adverse effect was reported. Subjective snoring scores relapsed by 29% overall. Nine patients (41%) noted relapse of snoring from 2.1 +/- 1. 1 to 5.7 +/- 2.7 (P < 0.001). Eight of the patients underwent further RF treatment with a reduction of snoring from 5.8 +/- 2.9 to 3.3 +/- 3.1 (P = 0.01). CONCLUSION: The success of RF volumetric reduction of the palate diminishes with time, as with other surgical procedures of the palate. However, the minimal invasiveness of the RF provided a high patient acceptance for retreatment, and relapse of snoring can be improved.
Otolaryngol Head Neck Surg 2000 Mar;122(3):387-94
Midline radiofrequency tissue reduction of the palate for bothersome snoring and sleep-disordered breathing: A clinical trial.
Coleman SC, Smith TL
Department of Otolaryngology, Vanderbilt Bill Wilkerson Center for Otolaryngology and Communication Sciences; and the Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin.
This study is a prospective, nonrandomized clinical trial initiated to assess the safety and efficacy of radiofrequency tissue reduction of the palate for the treatment of bothersome snoring and sleep-disordered breathing. Twelve healthy volunteers with socially disruptive snoring underwent a baseline polysomnogram along with a battery of visual analog scales (VASs) to measure daytime sleepiness, snoring level, pain, and disturbances of speech and swallowing. After radiofrequency tissue reduction of the palate, they were re-evaluated with a mean follow-up after the final procedure of 15.7 +/- 5.1 (mean +/- SD) weeks. As rated by the bed partner, a significant reduction in the level of snoring occurred in all 12 patients, with a mean pretreatment snoring level of 8.3 +/- 2.1 to a mean posttreatment snoring level of 2.1 +/- 1.4. (Student t test, P < 0.0001) These patients required an average of 2.3 treatment sessions each. Nine of 12 had a reduction in snoring from a bothersome level (VAS range 5-10) to a nonbothersome level (VAS range 0-3). Daytime sleepiness as measured by the Epworth Sleepiness Scale (0-24) decreased from 10.8 +/- 4.4 to 8.3 +/- 4.1 (P = 0.011). Posttreatment pain was considered absent or minimal in 11 of 12 patients and was managed with acetaminophen. No significant adverse events or complications were reported.
Otolaryngol Head Neck Surg 2000 Mar;122(3):402-9
Comparison of postoperative pain between laser-assisted uvulopalatoplasty, uvulopalatopharyngoplasty, and radiofrequency volumetric tissue reduction of the palate
Troell RJ, Powell NB, Riley RW, Li KK, Guilleminault C
Stanford University Sleep Disorders Clinic, Center of Excellence, Stanford, California, USA.
OBJECTIVES: This study compares the posttreatment discomfort between laser-assisted uvulopalatoplasty (LAUP), uvulopalatopharyngoplasty (UPPP), and radiofrequency volumetric tissue reduction (RFVTR) of the palate through the use of visual analog pain scales and a quantitative assessment of the analgesic medication taken. METHODS: In one group, LAUP (n = 10) or UPPP (n = 9) was used to treat patients' snoring or sleep-disordered breathing (SDB), and the other group underwent RFVTR (n = 22). RESULTS: The mean numbers of days with pain after RFVTR, LAUP, and UPPP were 2.6, 13.8, and 14.3 days, respectively. Narcotic analgesics were required in the RFVTR, LAUP, and UPPP groups in 9%, 100%, and 100% of the subjects, respectively. The mean number of these days requiring narcotic pain medications for RFVTR, LAUP, and UPPP was 0.2, 11.8, and 12.4 days, whereas the total narcotic equivalent was 0.3, 7.4 and 29.6 days, respectively. CONCLUSION: RFVTR of the soft palate produced less posttreatment pain than LAUP or UPPP. LAUP and UPPP appeared to show little difference in the severity or duration of posttreatment discomfort.
Radiofrequency ablation of the soft palate (somnoplasty). A new method in the treatment of habitual and obstructive snoring
[Article in German]
Fischer Y, Hafner B, Mann WJ
Universitats-HNO-Klinik Mainz (Direktor: Prof. Dr. W.J. Mann).
Twenty-nine patients (26 male and 3 female) with habitual or obstructive snoring and socially disturbing character were followed over a ten week period. All patients were treated with radiofrequency volumetric tissue reduction (RFVTR) of the soft palate. In 21 patients this operation was combined with other surgery of the upper airway, eight patients had soft palate reduction with RFVTR exclusively. With this method an electrode is positioned in the musculature of the soft palate submucosally. RFVTR may be performed under local anesthesia and has to be repeated if necessary. Ten weeks postoperatively 24 of 29 patients, respectively their social-partners, reported subjective reduction of snoring after the first treatment. Markable improvement of snoring was seen in 20 of 29 patients postoperatively and reduction of the respiratory-disturbance-index (RDI) for more than 10 was noticed in 7/29 patients polysomnographically. 5/8 patients who were treated with RFVTR exclusively, showed reduction of snoring and 3/8 patients had RDI-reduction for more than 10. We conclude, that RFVTR of the soft palate is successful in the treatment of snoring and may be helpful in the treatment of mild obstructive-sleep-apnea-syndrome (OSAS).
HNO 2000 Jan;48(1):33-40
Analisys and comparation of post-operative pain in LAUP and radiofrequencypatients trated for snoring
ANALISE E COMPARACAO DA DOR POS-OPERATORIA EM PACIENTES OPERADOS POR LAUP E RADIOFREQUENCIA PARA TRATAMENTO DO RONCO
Silva MN; De Oliveira JAA; Fomin DS; Vallejo JC
Dr. J.A.A. De Oliveira, Depto. Oftamol. Otorrinolaringologia, Hosp. das Clinicas de Ribeirao Preto, Avenida dos Bandeirantes, 3900, 14096-900 Ribeirao Preto/SP , Brazil
Revista Brasileira de Otorrinolaringologia ( REV. BRAS. OTORRINOLARINGOL. ) (Brazil) , 1999 , 65/6 (504-508)
Language: PORTUGUESE Summary Language: ENGLISH; PORTUGUESE
Abstract: Introduction: The snoring and mild obstructive sleep apnea can be surgically treated with Laser Assisted Uvulopalatoplasty (LAUP) or application of Radiofrequency (RF) in the soft palate. Objective: analysis the post-operative pain in 41 patients underwent to the surgery: 27 LAUP and 14 RF. Material and Methods: We considered trans-operative (TO) and postoperative (PO) pain, onset, level, intensity and the total duration of pain. Results: In the TO seven patients (26%) in the LAUP group and four patients (29%) in the RF group reported pain. In the LAUP group the PO pain was present in 25 patients (93%) and in the RF group in three patients (21%). In the LAUP group the pain begin after 14 h., in the RF group after 11 h. The PO's maximum level pain was in the LAUP group after 39 h. PO, in the RF group after 27 h. The PO intensity pain in the LAUP group was of stage III (severe) in 11 patients (41%), stage II (moderate) in 11 patens (41%), stage I (mild) in three patients (11%) and stage 0 (nule) in two patients (7%). In the RF's group one patient (7%) had PO pain stage II, two (14%) stage I and 11 (79%) stage 0. In the LAUP group, the pain duration average was of six days, in the RF group was of five days. Conclusions: The soft palate RF application produce a mild pain. The post-LAUP pain is an important problem and we have to indicate the best analgesia. (11 References)
Radiofrequency volumetric reduction of the palate in subjects with sleep-disordered breathing.
NB Powell, RW Riley, RJ Troell, K Li, MB Blumen, C Guilleminault
Study Objectives: To evaluate pain, swallowing, speech, edematous response, tissue shrinkage, sleep, snoring, and safety (energy limits and adverse effects) following radiofrequency (RF) treatment to the palate in 22 subjects with sleep-disordered breathing.
Design: This investigation is a prospective nonrandomized study. Polysomnography, radiographic imaging, and infrared thermography, along with questionnaires and visual analog scales, were used to evaluate the effects of RF treatment to the palate.
Setting: Treatments were delivered on an outpatient basis at Stanford University Medical Center.
Patients: Twenty-two healthy patients (18 men), with a mean age of 45.3 ± 9.1 years, were enrolled. All were snorers seeking treatment and met predetermined criteria: a respiratory disturbance index £ 15, oxygen saturation 85%, and a complaint of daytime sleepiness.
Intervention: RF was delivered to the submucosa of the palate with a custom-fabricated elecrode for a mean duration of 141 ± 30 s with a mean of 3.6 ± 1.2 treatments per patient. Reduction of their snoring scores determined the end point of the study.
Results: Neither speech nor swallowing was adversely affected. Pain was of short duration (0 to 48 h) and was controlled with acetaminophen. There were no infections. Although there was documented edema at 24 to 48 h, there were no clinical airway compromises. Polysomnographic data showed improvement in esophageal pressure measurements of the mean nadir and the 95th percentile nadir (p=0.031, p=0.001) respectively, as well as the mean sleep efficiency index (p=0.002). Radiographic imaging showed a mean shrinkage of 5.5 ± 3.7 mm (p£ 0.0001). Subjective snoring scores fell by a mean of 77% (8.3 ± 1.8 to 1.9 ± 1.7, p=0.0001) accompanied by improved mean Epworth sleepiness scores (8.5 ± 4.4 to 5.2 ± 3.3, p=0.0001).
Conclusion: The results of this investigation allowed the formulation of safety parameters for RF in this defined population with mild sleep-disordered breathing. There was a documented tissue reduction and improvement in symptoms in all subjects. However, given the small sample size and short-term follow-up, these results should be confirmed by further investigation.
CHEST, 1998, 113:1163-1174.
Somnoplasty: A Treatment for Snoring: Chapter 9: Office-Based Surgery in Otolaryngology
P Flexon
"Somnoplasty is a new office-based procedure for snoring that makes use of the technique of radiofrequency tissue volume reduction (RFTVR). It utilizes a custom needle electrode applied to the soft palate to transmit high frequency alternating current to targeted adjacent tissue. Redundant bulky submucosal palate tissue is ablated by heat desiccation where tissues are heated via frictional energy, resulting from ionic agitation rather than direct heat from the electrode. This ablation results in a clearer line of demarcation between desiccated and healthy tissue.. Further, the energy delivered to tissues is one third to one half the amount of energy supplied to tissues with electrocautery or laser techniques."
Chapter 9: Office-Based Surgery in Otolaryngology, ed. Krause, WB Saunders, 79-86, 1999 (selection).
Histologic and physiologic Effects of Electrocautery, CO2 Laser, and Radiofrequency Injury in the Porcine Soft Palate
Mark S. Courey, MD; Denilson Fomin, MD; Timothy Smith, MD, MPh; Shan Huang, MD; David Sanders; Lou Reinisch, PhD
Objectives: This study was undertaken to compare the effects of electrosurgery, CO2 laser, and radiofrequency on the histological structure and physiological properties of the soft palate. These surgical techniques are used for stiffening and reducing the soft palate in the treatment of snoring and mild sleep apnea. Study Design: Fifteen pigs were divided into five groups. Methods: group 1 underwent electrosurgery incision of the lateral soft palate and excision of the uvula. Group 2 underwent the same procedure with the CO2 laser. Group 3 underwent CO2 laser ablation of the midline soft palate mucosa. Group 4 underwent radiofrequency volumetric reduction. Group 5 served as control. After 5 weeks the animals were sacrificed. Soft palate mucosa and muscle were subjected to tensiometric and histological analysis. Statistical analysis of tensiometric measurements was done with an ANOVA using a Bonferroni-Dunn correction. Results: Tensiometric measurements of the mucosa were increased over the normal controls when surgical technique resulted in primarily muscle disruption. When the surgical technique resulted in primarily muscle disruption (radiofrequency) tensiometric measurements of the muscle were increased over control. Histological analysis demonstrated normal remucosalization in all specimens, with fibrosis increased at the site of the primary injury. Conclusions: The type of injury produced resulted in identifiable patterns of physiological and techniques is important in guiding our choice of surgical approach and allows us to better counsel our patients on their surgical options. Key Words: Snoring, sleep apnea, radiofrequency, electrosurgery, soft palate.
Laryngoscope, 109:1316-1319, 1999
[Scientific Session] Radiofrequency vs. LAUP for the treatment of Snoring
Marc Bernard Blumen MD(presenter); Serge Dahan MD; Pierre Drewski MD; Frederic Chabolle MD; Surnes France
Objectives: Laser-assisted uvulopalatopharyngoplasty (LAUP) is efficacious in treating snoring but it is painful. Radiofrequency (RF) reduces tissue volume and stiffens it. Its application on the soft palate may be as efficacious as LAUP but better tolerated because it spares the mucosa. We prospectively compared RF to LAUP for short-term subjective efficacy on snoring and for tolerance as regards to pain, medication consumption, and diets. Methods: Fourteen consecutive patients were treated with RF, and then 7 consecutive patients were treated with LAUP. All patients underwent preoperative physical examinations and level I or level III polysomnography. The soft palate was the only site of obstruction. Patients were all simple snorers or had mild sleep apnea with an apnea-hypopnea index below 20/hour. Snoring was evaluated on a visual analog scale (VAS) by the bed partner before and 6 weeks after the last procedure. Pain and discomfort were evaluated daily on a VAS, as were medication (analgesics, steroids, antibiotics) and diet (normal, liquid). Patients could not have more than 3 sessions of either treatment. A Mann-Whitney test was used to evaluate efficacy within each group, and a t test was used to compare both groups. A P value of 0.05 was considered significant. Results: The 2 Populations did not differ in age, sex ratio, snorers/sleep apneics ratio, or severity of sleep apnea when present. RF significantly improved snoring, with a mean score of 1.6 after a mean of 2.6 treatments compared with a score of 8.1 before surgery. Efficacy of LAUP was not significantly different. Mean discomfort and mean pain for the first 7 days were, respectively, 3 and 4 times worse for LAUP than for RF. Doses of anti-inflammatory drugs used were the same. Abnormal diet duration was significantly higher for LAUP than for RF. Conclusions: RF, in our stuffy, was as efficacious for a short-term period as LAUP but was better tolerated. These results must be confirmed in a larger population.
Current Claims: Somnoplasty and oral appliances both reduce loud snoring in non-apneic patients. A comparison of treatments for snoring: Somnoplasty vs oral appliances.
R Cartwright, D Caldarelli, TK Venkatesan, F Diaz
Introduction: Many treatments aimed at the reduction or elimination of loud snoring have been developed recently but few have undergone comparative testing. One issue has been the question of an appropriate criterion measure. This was pointed out by Hoffstein et al (1994) as "snoring is in the ear of the beholder." Should the effectiveness be measured by spouse report, technician’s rating or some more objective recording device?
Method: This study addresses whether somnoplasty is more effective than oral appliances for the control of loud snoring as measured objectively in the laboratory by a MESAM 4 device, and the relation of the MESAM count to the bed partner’s rating of loudness.
Subjects: 31 subjects, 8 females and 23 males all complaining of loud snoring, as reported by the bed partner, with EDS and/or fragmented sleep of the subject. All were screened with one night of 12 channel PSG and found to have A+HI,15 and SaO2>85%. These were offered treatment at no cost. 10 elected somnoplasty, 7 were treated with Rest Assured that moves the mandible forward and 14 used Snorex, which holds the tongue forward. The 21 0A pts all had two nights of testing, one with and one without the OA device. The MESAM 4 used a program, which counted the percent of sleep time in loud snoring, soft snoring and time without snoring. The somnoplasty patients were recorded with MESAM only once at 8 weeks past their last treatment (5 patients had a single treatment to 3 sites, and 5 had 2 treatments to 3 sites). However there were bed partner snoring ratings before and after treatment on a 10 point scale.
Results: Table 1 gives the mean % time in loud snoring and no snoring for the 21 OA patients at baseline and after treatment and the %s for the 10 somnoplasty patients after treatment on MESAM4.
Table 1
Baseline Treatment OA Treatment Somnoplasty
% Mean S.D. Mean S.D. Mean S.D.
Loud 12.75 (12.05) 7.68 (11.07) 8.03 (10.10)
No snoring 71.61 (15.95) 77.98 (17.65) 76.36 (17.67)
1) Paired t test shows a significant difference between baseline loud and OA loud 2.414 p. 02.
2) There was no difference between OA and somnoplasty post treatment results on the MESAM.
3) For the somnoplasty group bed partners’ rating on a 10 pt. Scale, snoring dropped from a mean of 7.30 (2.35) to mean of 2.65 (2.16) t=4.574 df 9, p.001.
4) The correlation of % loud snoring by MESAM 4 and spouse report was significant r=.777 p. 008.
5) Comparing the time in sleep with no snoring at baseline, and after both OA and somnoplasty, shows the % time >.90, 5% Baseline 25% after OA and 44% after somnoplasty. While the percent of <50% no snoring sleep time was 10% at baseline, 10% wearing an OA, and 0% after somnoplasty.
Conclusion: OAs are effective at reducing loud snoring objectively and somnoplasty is effective in terms of the spouse report. Since these two measures had good agreement for the 10 somnoplasty patients, and there was no difference in loud snoring post treatment, it seems likely that the choice of treatment should be based on other factors such as cost, comfort, convenience.
Support: This study was partially funded by Somnus Medical Technology to Rush Sleep Center.
APPS, 1999 (abstract).
Radiofrequency tissue volume reduction (RF) (SomnoplastySM) of the soft palate for the treatment of Snoring.
W. Hohenhorst, P. Van De Heyning, and European Somnoplasty Study Group
Introduction: RF therapy was introduced as minimally invasive procedure for the treatment of sleep related breathing disorders by Powell, Riley, and Guilleminault in 1996. Tissue is heated in a controlled fashion using low levels of radiofrequency energy applied through a needle electrode. Tissue temperature can be adjusted between 60 and 90o C. The controlled hyperthermia at the needle tip coagulates surrounding tissue while the proximal needle is insulated to prevent mucosal damage. In that way the applied energy, in contrast to laser and electrocautery, can be used for creating precisely defined tissue lesions. We are presenting the results of a multi-center European clinical study which was carried out to determine the efficacy of RF.
Methods: A prospective, non-randomized, multi-clear European clinical study was carried out to determine the efficacy of RF. In the study protocol, the number of RF procedures per patient was limited to 3 and a maximum energy of 700 Joules was applied to create one midline lesion in the soft palate. Outpatient RF-treatment under local anesthesia was carried out midline, approximately 1 cm below the hard palate in the soft palate. Polysomnography (PSG) was performed at baseline and 8 weeks after the last RF-treatment. Snoring data from PSG and subjective, semiquantitative scales were used to assess the change in snoring frequency and loudness after RF. 52 patients completed treatment according to the study protocol. The mean number of treatments per patient was 2.7 ± 0.5, the mean energy applied per treatment was 598 ± 89 Joules, and the mean total energy per patient was 1703 ± 608 Joules.
Results: A significant reduction in snoring symptoms was obtained using RF. The snoring index (visual analog snoring scale 0-10) was improved in 86.7% of the patients after RF treatment and the mean snoring index was reduced from 7.8 ± 2.0 to 4.1 ± 2.9 (p=?). The mean Epworth Sleepiness Score was reduced from 8.1 ± 4.5 to 6.2 ± 4.1 (p=?). Since all patients were non-apneic snorers with a mean Respiratory Disturbance Index (RDI) of 4.9, no significant changes (abnormal respiratory events or measures of oxygenation) were observed during PSG at follow-up. No severe adverse events like bleeding or infections were observed.
Perspective: RF is a safe and almost painless procedure to treat snoring in an outpatient. The efficacy of the method could be increased using patient-anatomy-specific sites of application and by increasing the number of lesions and total applied energy per treatment.
Europe ENT, Oct. 1999 (abstract).
Clinical Experience Using Radiofrequency Tissue Volume Reduction (RFTVR), SomnoplastySM for the treatment of Snoring
M. Clarke
Purpose: This is a preliminary, retrospective study to determine the effectiveness and patient perception of RFTVR treatment of the soft palate for snoring, as well as the number of treatments necessary per patient.
Methods: Prior to treatment 53 patients had a home sleep study to rule out severe sleep apnea and an upper airway examination using nasopharyngoscopy. The RFTVR procedures were performed under local anesthesia in an outpatient clinic. An RF generator with a single electrode handpiece (Somnus Medical Technologies, CA) was used to create lesions in the soft palate. The tissue temperature (maximum of 85 C) and amount of energy delivered were monitored to prevent mucosal injury. Patients were reevaluated after 8 weeks and retreated as necessary. Patients were asked to evaluate their treatment as follows:
1. Perception of the procedure: 0 (very difficult) – 10 (very easy).
2. Spouse’s assessment of the improvement: 0 (none) – 10 (greatly improved).
3. Quality of sleep, pre and post treatment: 1 (very poor) – 10 (very good).
Results: Thirty-four of the 53 patients responded to the telephone questionnaire and 19 were unavailable for follow-up. Results were as follows:
Question Mean Range
1. Perception of Procedure 8.4 4-10
2. Spouse’s assessment of improvement 7.1 0-10
3. Patient’s quality of sleep – pre treatment 3.6 1-10
4. Patient’s quality of sleep – post treatment 7.6 3-10
5. Number of treatments 1.7 1-3
Conclusion: RFTVR is an effective, new treatment for snoring. Patients perceive the treatment as easy and relatively comfortable. Patients and their spouses report significant improvement in overall sleep quality and decreased snoring levels.
ACOMS, 1999 (abstract).
Somnoplasty for snorers: risks and rewards.
R. Cartwright, TK Venkatesan, D Caldarelli
Aims: To test the effectiveness of Radio Frequency volume reduction method applied to the soft palate for the control of non-apneic snoring.
Method: Ten subjects all complaining of socially disruptive snoring who had been studied by all night PSGs and found to have RDI<15 signed informed consent for this procedure, 9 were males, 1 female. RF procedure was done delivering 600 joules at midline and 300 at each side of the soft palate. This took approximately 10 minutes as an outpatient procedure. Subjects were followed at 3 days, 4 weeks, 8 weeks following with examination of the treatment site and questionnaires regarding difficulties with pain, speech, swallowing, and estimates of daytime sleepiness and snoring loudness by spouse report. Four subjects found dramatic reduction in snoring following 1 treatment. Five subjects requested a second treatment. One is incomplete due to an unrelated medical problem.
On restudy in the sleep laboratory a MESAM 4 was added to the standard 12 channel montage. This equipment has been programmed to count percent of time in loud, soft, and no snoring. Comparing these results against the spouse report of snoring loudness shows reasonable reliability.
(Table next page.)
1st Treatment Spouse Report Scale 1-10 PSG MESAM
Subject Baseline 3 days 4 weeks 8 weeks 8 weeks
% Loud % Soft
1 6 5 3 3 8.11 24.4
2 8 9 6 0 5.3 30.8
3 5 8 2 1 .5 5.1
4 3 4 2 2 1.1 6.4
Range (3-8)
2nd Treatments To be done
Following 2nd treatment
5 10 9 9 8
6 7 9 8 7.5
7 8 9 5 3.5
8 6 5 3 6
9 10 4.5 4 5
10 10 9 5.5
Range (6-10)
Conclusion: When snoring is moderate in loudness somnoplasty appears to be effective with one treatment. When it is severe, two or more treatments may be needed to be effective. There is less pain, swelling, speech and swallowing disturbance with the second treatment. Long term effectiveness is to be established.
Midwest Sleep congress, 1998 (abstract).
What is the best snoring surgery?
E Mair, B Emery, et al
Educational Objectives:
1. Describe, compare, and contrast various classic and new palatal surgical therapies in the treatment of snoring and mild obstructive sleep apnea syndrome.
2. Provide interactive teaching with case presentations and discussion from recognized leaders of diverse surgical perspectives.
Description of Symposium: The surgical treatment of snoring and mild obstructive sleep apnea syndrome (OSAS) has evolved significantly in recent years. From uvulopalatoplasty (UPPP) to laser-assisted uvulopalatoplasty (LAUP), cautery-assisted palatal stiffening operation (CAPSO), and radiofrequency thermal ablation (somnoplasty), today’s otolaryngologist may easily become confused as to which surgery best diminishes excessive snoring and accommodates practice parameters. This symposium brings recognized experts from each of these surgical persuasions together in a lively controversial discussion. Presented topics include: clinical "How I Do It" pearls, advantages and limitations of each technique, patient selection, preoperative and postoperative care, results and complications, cost analysis, case presentations, and an interactive question and answer session with the audience.
The purpose of this conference is to provide up-to-date clinically-relevant information to help the otolaryngologist determine which surgeries are best suited to diminish tumultuous snoring and mild OSAS given specific patient and practice settings.
AAO-HNS, 1998, (abstract).
New outpatient procedure significantly reduces habitual snoring.
SomnoplastySM is a relatively painless procedure that can deliver controlled radiofrequency energy into the soft palate for the treatment of habitual snoring. A study of 76 patients reveals that this simple, office-based procedure significantly reduces snoring that is produced by the vibration of excess soft palate tissue during sleep. Many patients in this study were able to return to normal activities the same day as surgery without pain medication.
Somnus Medical Technologies, Inc. White Paper, 1998.
Smith, T. L.; Smith, J.M.
Although most otolaryngologists use electrosurgical instruments routinely, many are not familiar with the basic principles as to how these instruments produce their effect. This problem is compounded not only by numerous recent advances in otolaryngology applications of electrosurgery, but also by improper terminology propagated in the literature. This article presents a review of the history, physics techniques, and histological effects of electrosurgery specifically relating to the radiofrequency needle ablation technique.
Op Tech Otolaryn Head Neck Surg, 2000 11:1 66-70
Principles of Radiofrequency Thermal Ablation
Radiofrequency Tissue Volume Reduction (RFTVR) with temperature monitoring and control is a surgical method which uses radiofrequency heating to create targeted coagulative submucosal lesions resulting in tissue volume reduction. RFTVR uses very low levels of radiofrequency energy to create finely controlled necrotic lesions in soft tissue structures. Following the general pattern of wound healing, the necrosis leads to scar formation and retraction of tissue, resulting in an overall reduction of volume in the treated area. Over time, the scar tissue is partially resorbed by the body, causing further volume reduction. This paper describes the principles upon which temperature controlled RFTVR is based.
Somnus Medical Technologies, Inc. White Paper, 1997.
F. Javier Nieto, MD, PhD; Terry B. Young, PhD; Bonnie K. Lind, MS; Eyal Shahar, MD, MPH; Jonathan M. Samet, MD, MS; Susan Redline, MD, MPH; Ralph B. D'Agostino, PhD; Anne B. Newman, MD, MPH; Michael D. Lebowitz, PhD; Thomas G. Pickering, MD; for the Sleep Heart Health Study
Context Sleep-disordered breathing (SDB) and sleep apnea have been linked to hypertension in previous studies, but most of these studies used surrogate information to define SDB (eg, snoring) and were based on small clinic populations, or both.
Objective To assess the association between SDB and hypertension in a large cohort of middle-aged and older persons.
Design and Setting Cross-sectional analyses of participants in the Sleep Heart Health Study, a community-based multicenter study conducted between November 1995 and January 1998.
Participants A total of 6132 subjects recruited from ongoing population-based studies (aged 40 years; 52.8% female).
Main Outcome Measures Apnea-hypopnea index (AHI, the average number of apneas plus hypopneas per hour of sleep, with hypopnea defined as a 30% reduction in airflow or thoracoabdominal excursion accompanied by a 4% drop in oxyhemoglobin saturation), obtained by unattended home polysomnography. Other measures include arousal index; percentage of sleep time below 90% oxygen saturation; history of snoring; and presence of hypertension, defined as resting blood pressure of at least 140/90 mm Hg or use of antihypertensive medication.
Results Mean systolic and diastolic blood pressure and prevalence of hypertension increased significantly with increasing SDB measures, although some of this association was explained by body mass index (BMI). After adjusting for demographics and anthropometric variables (including BMI, neck circumference, and waist-to-hip ratio), as well as for alcohol intake and smoking, the odds ratio for hypertension, comparing the highest category of AHI ( 30 per hour) with the lowest category (<1.5 per hour), was 1.37 (95% confidence interval [CI], 1.03-1.83; P for trend=.005). The corresponding estimate comparing the highest and lowest categories of percentage of sleep time below 90% oxygen saturation ( 12% vs <0.05%) was 1.46 (95% CI, 1.12-1.88; P for trend <.001). In stratified analyses, associations of hypertension with either measure of SDB were seen in both sexes, older and younger ages, all ethnic groups, and among normal-weight and overweight individuals. Weaker and nonsignificant associations were observed for the arousal index or self-reported history of habitual snoring.
Radiofrequency volumetric reduction of the palate: An extended follow-up study.
Lee D. Eisenberg, MD, FACS
Abstract: In order to assist the physician in obtaining reimbursement for the treatment of patients with sleep disordered breathing, this article presents a few simple guidelines on insurance coding for various procedures.
Conclusion: In today’s milieu of managed care, even the best preparation does not assure payment. It cannot be overemphasized that most of evaluation and treatment of obstructive sleep apnea is not urgent, so the physician must take the time to interact with the insurance carrier before embarking on any surgical treatment. Such a precaution will best serve you and your patient.
ENT Journal 1999 November; 78(11):858-9
Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome.
Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP
Center for Sleep Education and Research, Case Western Reserve University, Cleveland, Ohio, USA
BACKGROUND: Although sleep apnea is common, it often goes undiagnosed in primary care encounters. OBJECTIVE: To test the Berlin Questionnaire as a means of identifying patients with sleep apnea. DESIGN: Survey followed by portable, unattended sleep studies in a subset of patients. SETTING: Five primary care sites in Cleveland, Ohio. PATIENTS: 744 adults (of 1008 surveyed [74%]), of whom 100 underwent sleep studies. MEASUREMENTS: Survey items addressed the presence and frequency of snoring behavior, waketime sleepiness or fatigue, and history of obesity or hypertension. Patients with persistent and frequent symptoms in any two of these three domains were considered to be at high risk for sleep apnea. Portable sleep monitoring was conducted to measure the number of respiratory events per hour in bed (respiratory disturbance index [RDI]). RESULTS: Questions about symptoms demonstrated internal consistency (Cronbach correlations, 0.86 to 0.92). Of the 744 respondents, 279 (37.5%) were in a high-risk group that was defined a priori. For the 100 patients who underwent sleep studies, risk grouping was useful in prediction of the RDI. For example, being in the high-risk group predicted an RDI greater than 5 with a sensitivity of 0.86, a specificity of 0.77, a positive predictive value of 0.89, and a likelihood ratio of 3.79. CONCLUSION: The Berlin Questionnaire provides a means of identifying patients who are likely to have sleep apnea.
Ann Intern Med 1999 Oct 5;131(7):485-91