Abstracts

1. Radiofrequency Tongue Base Reduction in Sleep-Disordered Breathing: A Pilot Study
Nelson B. Powell, MD, Robert W. Riley, MD
Otolaryngology - Head and Neck Surgery, 1999, Vol. 120, No. 8, 656-664

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 80° C), for a mean energy total of 8490 J per patient. The post-treatment 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.

2. Radiofrequency Volumetric Reduction of the Tongue: A Porcine Pilot Study for the Treatment of
Obstructive Sleep Apnea Syndrome
Nelson B. Powell, MD; Robert W. Riley, MD; Robert J. Troell, MD; Marc B. Blumen, MD; and
Christian Guilleminault, MD
CHEST, 1998, 111:1348-1355

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, one 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 hr 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 hrs. 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.

3. Radiofrequency Treatment of Turbinate Hypertrophy to Improve Nasal CPAP Usage
Nelson B. Powell, MD
AAO-HNS, 1999 (abstract)

Objectives: To investigate the use of radiofrequency (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 where 22 subjects underwent pre (2 wk.) and post treatment (4 wk.), 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. Re-evaluation (n=22) was at one, 2-3 days, 1 week and the final evaluation was at 4 weeks following treatment.
Results: Twenty two patients (12 women), mean age of 54.3 years, BMI 29.3 (kg/m2), and an RDI of 33.5 started and finished the protocol. A mean of 413 joules of RF energy was given to each turbinate. Investigators (pre/post treatment) found the overall mean clinical change of 27.0% (R+L turbs) compared to patient’s (n=17) subjective (VAS) change in nasal obstruction of 48.0%. The placebo (n=5) change by investigators was 27.0% and by patient 28.7%, respectively. Tolerance (n=17) to CPAP improved 28.9%, (VAS: 4.92 to 6.34) versus placebo (n=5) decrease of 10.4% (VAS: 4.36 to 3.32). Computer metered CPAP compliance in treated subjects was pre-treatment 5.6 hr/day to post treatment 5.8 hr/day versus the placebo of 4.11 hr/day to 3.75 hr/day.
Conclusion: Tolerance of CPAP was subjectively improved 28.9% in patients after treatment. This finding paralleled the investigators anatomic clinical nasal findings and those of patient’s 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.

4. Radiofrequency Energy Tissue Ablation for the Treatment of Nasal Obstruction Secondary to Turbinate Hypertrophy
David S. Utley, MD; Richard L. Goode, MD; Ishrat Hakim, MD
Laryngoscope, 109:683-686, 1999

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.

5. Radiofrequency Tissue Volume Reduction for Turbinate Hypertrophy
Kasey K. Li, MD DDS, Robert W. Riley, MD DDS; Nelson B. Powell, MD; Robert J. Troell, MD
Otolaryngology – Head and Neck Surgery, 119:6:569-573, 1998

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). Post-treatment 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.

6. Nasal Turbinate Somnoplasty: Utilization of Radio Frequency to Treat Chronic Nasal
Obstruction and Congestion
Mansoor Madani, DMD; Brian M. Smith, DMD
ACOMS, 1999 (abstract)

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.

7. Radiofrequency Thermoablation of the Inferior Turbinate in Nasal Obstruction
Yvonne Fischer, MD; Jan Gespath, MD; Ronald Amedee, MD; W. Mann, MD
COSM, 1999 (abstract)

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 post-operatively. 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.

8. Radiofrequency Waves Report of a New Treatment for Turbinate Reduction
Hector P. Rodriguez, MD
AAO-HNS, 1998 (abstract)

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 patient’s 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. Increased dosages applied in this group of patients correlated with an increased response rate than that of historical controls. It was also burdened with a higher degree of perioperative self limited untoward side effects.

9. Radiofrequency Volumetric Tissue Reduction of the Palate in Subjects with Sleep-Disordered
Breathing
Nelson B. Powell, MD; Robert W. Riley, DDS, MD; Robert J. Troell, MD; Kasey Li, DDS, MD;
Marc B. Blumen, MD; and Christian Guilleminault, MD
CHEST, 1998, 113:1163-1174

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 greater than/equal to 85%, and a complaint of daytime sleepiness.
Intervention: RF was delivered to the submucosa of the palate with a custom-fabricated electrode 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.

10. Somnoplasty: A Treatment for Snoring
Phillip Flexon, ed. Krause, W.B. Saunders
Chapter 9: Office-Based Surgery in Otolaryngology, 79-86, 1999 (selection)

"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."

11. 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, T.K. Vanketesen, and F. Diaz
APPS, 1999 (abstract)

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 OA patients 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 MESAM 4.

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 a 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, or convenience.
Support: This study was partially funded by Somnus Medical Technology to Rush Sleep Center.

12. Radiofrequency Reduction of the Palate: An Extended Follow-up Study
N.B. Powell, MD
AAO-HNS, 1999 (abstract)
Objective: To evaluate the effect of radiofrequency (RF) volumetric reduction (by Somnus probe) of the palate on snoring, speech, swallowing, taste, and sleep 12 to 18 months following treatment. This investigation is a follow-up of the previously reported study on RF treatment of the palate in subjects with sleep-disordered breathing.
Methods: Twenty two patients with sleep-disordered breathing treated with RF volumetric reduction of the palate 12 to 18 months prior were evaluated by clinical examination, questionnaires and visual analog scales (VAS) to subjectively assess snoring, speech, swallowing, taste, and sleep. Patients with relapse of snoring were offered further RF treatment. The above variables were evaluated following the completion of re-treatment.
Results: After a mean follow-up period of 14 months (range 12-18 months), there was no adverse effect on speech, swallowing, or taste reported. Subjective snoring score relapsed by a mean of 29% overall. Thirteen patients (59%) demonstrated continual success without relapse of snoring or daytime sleepiness. Nine patients (41%) noted relapse of snoring (VAS 0-10) from 2.1 ± 1.1 to 5.7 ± 2.8 accompanied by worsening of Epworth Sleepiness Score (ESS) from 5.4 ± 3.2 to 7.8 ± 5.3. Eight of the patients underwent further RF treatment. Following re-treatment, the snoring score fell from 5.8 ± 2.9 to 3.3 ± 3.1 with improved ESS from 7.8 ± 5.6 to 6.3 ± 4.6. No adverse effect on speech, swallowing or taste were reported following re-treatment.
Conclusion: This investigation suggests that the success of RFVR of the palate diminishes with time, as with other surgical procedures of the palate. The 12 to 18 months follow-up outcomes variables are comparable to laser assisted uvulopalatoplasty or traditional uvulopalatoplasty. However, the minimal invasiveness of the RF treatment provided a high patient acceptance for re-treatment, and relapse of snoring can be improved after re-treatment.

13. Radiofrequency Tissue Volume Reduction (RF) (Somnoplasty™) of the Soft Palate for the
Treatment of Snoring
W. Hohenhorst, P. Van De Heyning, and the European Somnoplasty Study Group
Europe ENT, Oct. 1999 (abstract)

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&Mac176; 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. The mean Epworth Sleepiness Score was reduced from 8.1 ± 4.5 to 6.2 ± 4.1. 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 ofoxygenation) 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.

14. Clinical Experience Using Radiofrequency Tissue Volume Reduction (RFTVR), Somnoplasty™
for the Treatment of Snoring
Michael E. Clarke, DDS, MS
ACOMS, 1999

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&Mac176; 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.

15. Somnoplasty for Snorers: Risks and Rewards
Rosalind Cartwright, T.K. Vankatasin, David Caldarelli
Midwest Sleep congress, 1998

Aims: To test the effectiveness of Radiofrequency 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.

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

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.

16. Pain Comparison Between LAUP, UPPP, and Radiofrequency of the Soft Palate
Robert J. Troell, MD; Robert W. Riley, MD, DDS; Nelson B. Powell, MD; Kasey K. Li, MD, DDS
AAO-HNS, 1998

Objective: Primary snoring, upper airway resistance syndrome (UARS) and obstructive sleep apnea syndrome (OSAS) encompass a spectrum of upper airway obstruction. Several procedures have been used to address the velopharyngeal component of this obstruction including the laser-assisted uvulopalatoplasty (LAUP), uvulopalatopharyngoplasty (UPPP) and the newly implemented, radiofrequency volumetric reduction of the palate (RF).
Methods: This prospective study evaluates post-treatment discomfort by interpretation of the subjective perception of pain through the use of a visual analog scale and a quantity assessment of the analgesic medication needed. The total number of patients examined included 10 after the initial stage LAUP, nine for the UPPP and twenty-two for RF.
Results: The mean number of days needing narcotic analgesics after LAUP, UPPP and RF was 13.5 days (S.D. 4.0), 14.3 days (S.D. 5.7), and 3.0 days (S.D. 0.0), respectively. All of the patients undergoing LAUP and UPPP needed narcotic analgesics, while 9% of RF patients required narcotic therapy.
Conclusion: There are a variety of soft palatal procedures available for treating velopharyngeal redundancy and collapse. Comparing the postoperative pain as a result of these procedures, the radiofrequency soft palate reduction procedure of the soft palate dramatically reduced the severity and duration of pain. The pain after the initial stage of LAUP and after UPPP appeared to show little difference in perceived severity or duration. RF of the palate is an available option for treating a redundant soft palate with minimal postoperative discomfort.

17. Radiofrequency Tissue Volume Reduction of the Palate for Snoring
Sean C. Coleman MD; Timothy L. Smith
AAO-HNS, 1998

Objective: This prospective clinical trial was designed to assess the safety and efficacy of radiofrequency tissue volume reduction of the palate ("somnoplasty") for the treatment of bothersome snoring.
Methods: Following Institutional Review Board approval, eleven (11) eligible patients with bothersome snoring were enrolled. Eight men and three women with a mean age of 55 years and a mean BMI of 26.6 underwent polysomnography to rule out significant obstructive sleep apnea. Using subjective questionnaires, clinical parameters were assessed including snoring, pain, speech, and swallowing. Patients were treated with 1 to 3 treatments, depending on response to treatment. Treatments required local anesthesia in an outpatient setting. Follow-up occurred at 24 hours, 1 week, 4 weeks, and 8 weeks.
Results: Preliminary data reveal that snoring, as reported by patient questionnaires, decreased in 10 of 11 patients. The mean pre-treatment snoring score was 8.2 (0-10 scale) while the mean post-treatment snoring score was 4.1. Mild pain during the procedure was reported by 55% of patients. 45% of patients required Tylenol in the post-treatment period. Mucosal erosion occurred in 27% of patients and required 2-4 weeks to resolve.
Conclusion: Snoring, as reported by subjective questionnaires, decreased following radiofrequency tissue volume reduction of the palate. The procedure was safe and well tolerated. More clinical trials and longer follow-up are necessary to evaluate this modality for the treatment of upper airway obstruction.

18. Miniseminar: What’s the Best Snoring Surgery?
Eric A. Mair, MD; Brian E. Emery, MD; Eric J. Furst MD; David N.F. Fairbanks, MD; Ari DeRowe, MD
AAO-HNS, 1998

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 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.

19. New Outpatient Procedure Significantly Reduces Habitual Snoring
Somnus Medical Technologies, Inc. White Paper, 1998

Somnoplasty™ 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, Somnoplasty and the Somnus Medical Technologies logo are trademarks of Somnus Medical Technologies, Inc. Patents pending.