Additional palatal implants for refractory snoring.

OBJECTIVE: To evaluate safety and efficacy of additional palatal implants for snoring treatment. STUDY DESIGN AND SETTING: A prospective case series at two clinical sites in an office setting. Patients who did not have an acceptable reduction in snoring intensity after an initial 3 implant procedure received additional implants. Bed partners rated snoring intensity on a 10 cm visual analog scale (VAS) at baseline and 90 days postprocedure. RESULTS: Snoring intensity VAS decreased significantly from 6.4 +/- 2.3 to 4.6 +/- 2.9 (P < 0.01) for patients who received an additional fourth implant, and to 4.1 +/- 2.8 after the 5th implant (P<0.01). Epworth sleepiness scale scores also decreased significantly for patients who received additional fourth or fifth implants. There were no adverse events. CONCLUSIONS: Additional palatal implants for snoring treatment were safe and effective in this case series. SIGNIFICANCE: Additional implants may offer relief for snorers not responding to the initial 3 implant procedure.     

Long-term results of palatal implants for primary snoring.

OBJECTIVE: To determine the safety and efficacy of the Pillar Palatal Implant System over a 1-year follow-up period. STUDY DESIGN AND SETTING: In this prospective study, 40 healthy adult patients with primary snoring due to palatal flutter were treated after clinical, polysomnographic, and endoscopic examination. Under local anesthesia 3 implants were placed into the soft palate. Postoperative morbidity and functional parameters were assessed. Snoring and daytime sleepiness were assessed before and 90, 180, and 360 days after surgery. Objective data were obtained by polysomnography and SNAP-recording before and 90 days after treatment. RESULTS: All implants were placed without complications. A total of 13 implants partially extruded uneventfully in 10 patients. Functional parameters remained unchanged. After 1 year, snoring was reduced from 7.1 +/- 1.9 to 4.8 +/- 2.5 (Visual-Analogue-Scale, P < 0.05) and daytime sleepiness from 6.1 +/- 3.2 to 4.9 +/- 3.1 (Epworth-Sleepiness-Scale, P < 0.05). SNAP data and polysomnography parameters showed clinically irrelevant changes. CONCLUSION: Our data demonstrate a significant decrease in snoring and daytime sleepiness over a period of one year.     

Consequences of increased rigidity in palatal implants for snoring: a randomized controlled study.

OBJECTIVE: Palatal implants have seen an increased role in the treatment of snoring. In this study, we evaluate the safety and possible treatment effect of adding further stiffness to the palate through the use of a more rigid implant. STUDY DESIGN: Randomized double-blind study of 20 patients with primary snoring. Three polyethylene teralphate implants were placed in the soft palate with the patient under local anesthesia. Ten patients received regular implants (rigidity 1.0) and 10 patients received stiffer implants (rigidity 1.8). The patients and their bed partners were followed for 6 months with questionnaires and office visits. A sleep study was performed preoperatively and at the last follow-up. RESULTS: Four of the 10 patients with stiffer implants had 5 partial extrusions in the observation period. There was a nonsignificant reduction in snoring intensity from 8.1 to 6.1 evaluated by the bed partner on a visual analogue scale in this group. No extrusions were seen in the group with regular implants. This group showed a significant reduction in snoring intensity from 7.7 to 4.7. No other major adverse events were observed. CONCLUSIONS AND SIGNIFICANCE: Rigid implants cause short time extrusions with loss of treatment effect. Regular implants reduce palatal snoring intensity with high patient and bed partner satisfaction. EBM rating: A-1b.     

Palatal implants for the treatment of snoring: long-term results.

OBJECTIVE: To evaluate the safety and long-term effectiveness of a new treatment for snoring using permanent palatal implants. STUDY DESIGN: Prospective study with 35 patients referred to the clinic for the treatment of snoring. The patients were followed for 1 year, and a sleep analysis was performed and repeated at 360 days. During the procedure, 3 braided polyethylene terephthalate implants were placed in the palate of each patient. RESULTS: The average duration for nonnarcotic analgesics was 1.3 days. No adverse events were observed. The mean snoring intensity was reduced from 7.1 at baseline to 4.8 at 1 year (P < 0.001). Bed partner satisfaction rate was very high at 70.6% after 1 year. Six patients (17.8%) experienced a total of 9 partial extrusions. CONCLUSIONS: The palatal implant system is safe, and the effectiveness in treating snoring is comparable to other surgical methods. Advantages are virtually no tissue damage and minimal patient discomfort as a result of one standardized, low-cost procedure. EBM rating: C-4.     

Palatal implants for the treatment of snoring: Long-term results

Objectives: The purpose of this study was to evaluate the safety and long-term effectiveness of a new treatment for snoring using permanent palatal implants.Methods: In this prospective study, the population was comprised of 34 patients that were referred to the clinic for the treatment of habitual snoring. The patients had a baseline medical examination, and evidence of snoring-related symptoms and signs were collected. The patients were followed for 1 year, and an overnight sleep analysis was performed and repeated at 360 days. During the procedure, 3 braided PET implants were placed in the palate of each patient with a delivery device under local anesthesia.Results: The average time for the procedure was 8 minutes. Twenty-four percent of the patients needed no postoperative analgesics, and the average duration for nonnarcotic analgesics was 1.3 days postprocedure. No adverse events were observed. The mean snoring intensity was reduced from 7.1 at baseline to 4.8 at 1 year (P < 0.001). The bed partner satisfaction rate was very high at 70.6% after 1 year. The Epworth Sleepiness Score (ESS) saw a statistically significant drop from 9.3 to 4.6 at 1 year (P < 0.001). Six patients (17.8%) experienced a total of 9 partial extrusions.Conclusions: The palatal implant system is safe and associated with very low patient morbidity. The effectiveness in treating snoring is comparable to other surgical methods and can be further improved by more careful patient selection. The advantages are virtually no tissue damage and minimal patient discomfort as a result of one standardized, low-cost procedure.     

Extended follow-up of palatal implants for OSA treatment.

OBJECTIVE: Evaluate long-term safety and outcomes of palatal implants for patients with mild to moderate obstructive sleep apnea (OSA). STUDY DESIGN AND SETTING: Continuation of a prospective case series of patients with palatal implants. Polysomnography, daytime sleepiness, and snoring intensity were measured at baseline, 90 days, and extended follow-up. RESULTS: Twenty-two (42%) patients from the previous study were followed for a median of 435.5 days. Thirteen were classified as responders, based on their 90-day evaluation. 76.9% of initial responders maintained improvements in apnea-hypopnea index (AHI), daytime sleepiness, and snoring at extended follow-up. Nine patients were initial nonresponders for AHI and daytime sleepiness and remained unchanged at extended follow-up. However, snoring for these nine patients initially improved, and the improvement continued through extended follow-up. CONCLUSION: Initial response or nonresponse to palatal implants remains stable over an extended period. The generalizability of these results is unknown because of significant loss to follow-up. SIGNIFICANCE: Study results report safety and beneficial long-term outcomes of palatal implants for mild to moderate OSA treatment in selected patients.     

One-year results: palatal implants for the treatment of obstructive sleep apnea.

OBJECTIVE: To evaluate long-term effectiveness of palatal implants for treatment of mild to moderate obstructive sleep apnea (OSA). STUDY DESIGN: A prospective study of 26 referred patients with a pretreatment apnea-hypopnea index (AHI) of 10 to 30 and a body mass index of < or =30, representing an extended follow-up of a subset of 41 patients enrolled in previous short-term trials. RESULTS: Twenty-one of 26 patients (80.8%) experienced a decrease in AHI. Fifteen of 26 patients (57.7%) had a follow-up AHI <10 at 1 year, whereas 13 patients (50%) had a 50% or greater reduction to an AHI <10 at 1 year. Mean AHI was reduced from 16.5 +/- 4.5 at baseline to 12.5 +/- 10.5 at 3 months (P < 0.014) and to 12.3 +/- 12.7 at 1 year (P < 0.019). CONCLUSIONS: Patients initially responding to palatal implants with improved AHI maintained improvement through long-term follow-up at 1 year.     

Palatal implants for the treatment of snoring and obstructive sleep apnea/hypopnea syndrome.

OBJECTIVE: Randomized, double-blinded, placebo-controlled, clinical trial to determine the effectiveness of palatal implants for treatment of mild/moderate obstructive sleep apnea/hypopnea syndrome (OSAHS). STUDY DESIGN AND SETTING: Sixty-two non-obese adults with history of snoring, daytime sleepiness, and mild/moderate OSAHS, were randomized to receive palatal implants (n = 31) or placebo procedure (n = 31). Complete follow-up including quality of life (QOL, SF-36), snoring visual analog scale (VAS), and Epworth Sleepiness Scale (ESS) data were obtained in 62 patients. Seven patients refused follow-up polysomnography for a total of 55 patients (29 implant and 26 placebo). RESULTS: The treatment group (change in score of -7.9 +/- 7.7) was significantly improved compared with the placebo group (change in score of 0.9 +/- 4.3) for apnea/hypopnea index (AHI) (P < 0.0001), QOL, SF-36 (P < 0.0001), snoring VAS (P < 0.0001), and ESS (P = 0.0002). CONCLUSIONS: Palatal implants improve AHI, QOL, snoring intensity, and daytime sleepiness for selected patients with mild/moderate OSAHS.     

Evaluation of palatal snoring surgery in an animal model.

OBJECTIVE: We introduce an animal model to reproduce and measure palatal snoring and to assess the effectiveness of cautery-assisted palatal stiffening operation and injection snoreplasty versus a control (no palatal intervention) on treatment of palatal flutter snoring.Study design and setting An anesthetized laboratory canine model uses 2 simultaneous temporary tracheotomies. An inferior tracheotomy is cannulated with an endotracheal tube for ventilation. A superior tracheotomy is cannulated with a tube passed cephalad and seated in the hypopharynx. Negative pressure applied to the upper tube leads to partial collapse of the upper airway with palatal fluttering, and the anesthetized dog snores. Videostroboscopy records palatal flutter frequency before and after surgical intervention. Preoperative and postoperative palatal assessments are made on 15 beagles. RESULTS: Cautery-assisted palatal stiffening operation and injection snoreplasty objectively stiffen the canine soft palate with diminished snoring compared with controls.Conclusion and significance We provide a reproducible animal model to experimentally measure new interventions to treat palatal flutter snoring.     

Comparative study of four radiofrequency generators for the treatment of snoring.

OBJECTIVE: To compare the efficacy and safety of four radiofrequency generators (Ellman, Select Sutter, Coblator, Somnus) for the treatment of simple snoring. MATERIALS AND METHODS: Multicenter, randomized, prospective single-blind study on 120 selected patients with simple snoring (apnea/hypopnea index <10/h of sleep). Snoring sound intensity was measured on a visual analog scale and the partner's short-term satisfaction rate was evaluated after two treatment sessions maximum. Discomfort, pain, and medication intake were compared. RESULTS: Radiofrequency decreased the snoring sound intensity from 7.9 +/- 1.7 to 4.4 +/- 2.7 (P < 0.0001). The four radiofrequency generators had a statistically comparable efficacy. The Ellman generator caused less discomfort and required less anti-inflammatory drugs. CONCLUSION: Despite different technical characteristics, the four generators had a comparable efficacy with good safety. The Ellman generator induced the least discomfort.     

Long-term results of the pillar palatal implant system for primary snoring

Objectives: Three-month results could demonstrate the safety and efficacy of the Pillar® Palatal Implant System in the treatment of primary snoring in a limited number of patients. The aim of this study was to determine the results over a 1-year follow-up period in an extended patient group.Methods: Forty-one healthy patients with primary snoring due to palatal flutter were enrolled into this prospective study after clinical and endoscopic examination (42.3 ± 9.0 years, body-mass-index 25.3 ± 2.6 kg/m2, apnea-hypopnea-index 3.4 ± 2.3). Under local anesthesia, 3 implants intended for permanent implantation were placed into the soft palate as close to the midline as possible. Snoring (evaluated by the bedpartner), postoperative morbidity, and daytime sleepiness (evaluated by the patient) were assessed by visual analog scale (VAS) before and 90, 180, and 360 days after surgery.Results: All implants could be placed without any complications or remarcable postoperative pain. During the first year, 12 implants were partially extruded in 10 patients without any airway compromise. Four patients had them reimplanted as they realized an increase of their snoring after the implant removal. Speech, swallowing, and taste remained unchanged. Snoring was reduced from 7.1 ± 1.9 to 4.2 ± 2.7 and finally 4.0 ± 2.6 (VAS, P < 0.001). Daytime sleepiness dropped significantly from 2.8 ± 2.6 to finally 1.2 ± 1.2 (VAS, P < 0.001).Conclusions: The Pillar® Palatal Implant System is a new surgical tool for the reduction of snoring. Our subjective data demonstrated its safety and efficacy as well as good patients’ acceptance over a period of 1 year.     

Surgical relief of snoring due to palatal flutter: a preliminary report.

We describe our experience in the surgical treatment of 32 patients with severe snoring. In the first 16 patients we used the standard surgical procedure of uvulopalatopharyngoplasty (UPP) but found this unsatisfactory because of its radical nature, complications and uncertain outcome. We therefore investigated the mechanics of snoring in the laboratory as a help in devising a more effective operation. These studies have shown that there are several methods by which snoring can be generated but that palatal flutter is probably the most important. The dominant parameters in the generation of flutter of the palate are its length and stiffness. Any removal of tissue to shorten the palate as in UPP inevitably risks impairing its function, so we chose the stiffening alternative. Using the laser, a central longitudinal strip of mucosa was removed from the surface of the soft palate which healed by fibrosis, producing the required stiffening. The early results of this new procedure show that snoring has been eliminated or greatly reduced in 14 of 16 patients and that apart from local pain there have been no complications.     

Radiofrequency versus LAUP for the treatment of snoring.

OBJECTIVE: To compare efficacy and tolerance of controlled temperature radiofrequency and laser-assisted uvulopalatopharyngoplasty (LAUP) for the treatment of snoring. METHODS: This was a prospective, nonrandomized study on 30 patients who snored. All patients had a sleep night study. Only patients with simple snoring or mild sleep apnea and soft palate obstruction were included. Efficacy was subjectively evaluated by the bed partner 2 months after the last treatment. Tolerance was estimated daily by the patient during 18 first postoperative days. Discomfort, pain, medication intake, diet, and number of days off from work were assessed. RESULTS: Both treatments were effective on snoring. Mean discomfort and pain as well as mean intake of analgesics were significantly greater with laser-assisted uvulopalatopharyngoplasty. CONCLUSION: Controlled temperature radiofrequency was as effective as laser-assisted uvulopalatopharyngoplasty on snoring on a short-term basis but was better tolerated.     

Modified cautery-assisted palatal stiffening operation: new method for treating snoring and mild obstructive sleep apnea.

OBJECTIVE: To assess a new method (modified cautery-assisted palatal stiffening operation [CAPSO]) to treat snoring and mild obstructive sleep apnea (OSA). DESIGN: A prospective, nonrandomized trial. METHODS: Thirteen patients with simple snoring and mild OSA underwent the modified CAPSO under local anaesthesia. All patients had preoperative polysomnography and at 3 months postoperatively. RESULTS: All patients were Friedman stage II and III, with tonsil size 0, 1, or 2. All patients had improvement in their snoring. Eighty-four percent of the patients had improvement in the Epworth Sleepiness Scale, from 12.2 to 8.9. Objective success on the polysomnogram was noted in six out of the eight patients (75%) with mild OSA. The AHI improved from 12.3% to 5.2% (P < 0.05), and the LSAT improved from 88.3% to 92.5% (P < 0.05). CONCLUSION: The modified CAPSO is a simple, low-cost, and effective office-based method to treat snoring and mild obstructive sleep apnea.     

Palatal implants for primary snoring: short-term results of a new minimally invasive surgical technique.

OBJECTIVE: To determine the safety and efficacy of a new soft palate implant procedure for the reduction of snoring. STUDY DESIGN AND SETTING: Fifteen healthy patients with primary snoring due to palatal flutter were enrolled into this prospective study after clinical and endoscopic examination and polysomnography. The average age of the patients was 41.2 +/- 8.6 years with a body mass index of 26.2 +/- 2.5 kg/m2. The Anti-Snoring Device consists of a delivery tool with a cylindrical implant of braided polyester filaments. Under local anesthesia, three implants intended for permanent implantation were placed into the soft palate. Snoring-related symptoms were assessed by visual analogue scales (VAS), polysomnography, and the SNAP system at baseline and 90 days postoperatively. RESULTS: All implants were placed without complications. Only minor discomfort was reported in four cases within the first three days postprocedure. At the 90-day follow-up snoring was reduced from 7.3 +/- 1.6 to 2.5 +/- 2.1 (VAS, P < 0.01) and from 347 +/- 239 to 264 +/- 168 snoring sounds/hour (SNAP, P > 0.05). Polysomnography did not show any deterioration of sleep or breathing. Speech, swallowing, and taste were unchanged. CONCLUSION: The Anti-Snoring Device is a new surgical tool offering a simple and minimally invasive procedure. Our data demonstrate that the treatment is safe and effective with good patient acceptance. Further patient follow-ups are needed to evaluate the long-term results.     

Evaluation of the tolerability of Hydrogel breast implants: a pilot study

BACKGROUND: During the 90s the widely publicised controversy regarding the use of silicone gel breast implants stimulated research into alternative alloplastic filling materials. In this context, a new type of breast implant, containing Carboxymethylcellulose at 3.7% in the form of Hydrogel, was introduced into the European market. METHODS: A preliminary pilot study was carried out to evaluate the tolerability and reliability of breast implants pre-filled with Hydrogel. A group of 12 consecutive patients was recruited for this purpose and underwent plastic surgery for breast augmentation or reconstruction (20 implants) at the Department of Plastic and Reconstructive Surgery at the University of Genoa between December 1996 and October 1997. All patients were then followed up for a minimum of 3.5 years. The mean age of patients was 50 years and ranged from 28 to 67 years old. After surgery the patients were examined at 4 weeks (evaluation of any immediate complications), 3 months, 6 months and 1 year (evaluation of any delayed complications). RESULTS: No immediate complications were reported in any patient. After 3.5 years of follow-up, the degree of capsular contraction according to Baker in these patients varies between 1 and 2. In general, the implants were very soft to touch even some time after surgery, above all in patients undergoing breast augmentation. Four implants (20%) were removed from 3 patients for reasons unconnected to the implants themselves (because of neoplasm in one case and due to inadequate volume in the other two patients). No case of rupture has been reported. CONCLUSIONS: This pilot study appears to confirm the validity of implants prefilled with Hydrogel in reconstructive or cosmetic breast surgery. A larger population and longer periods of minimum follow-up are obviously required to confirm these results over the long term.     

Hydroxyurea treatment of meningiomas: a pilot study.

OBJECTIVES: To present a pilot study of hydroxyurea chemotherapy in the management of surgically difficult meningiomas. DESIGN: Prospective case series. SETTING: Tertiary referral center. PARTICIPANTS: Six patients were enrolled: five had symptomatic recurrent or residual WHO Grade I meningiomas and one had an unoperated anterior clinoidal meningioma. MAIN OUTCOME MEASURES: MRI volumetry before and after treatment, hematological state, progression to surgery. RESULTS: Hydroxyurea was administered for 1 year, starting at a dose of 15 mg/kg/day. No tumors reduced in size on treatment and one continued to grow rapidly. Three remained stable. Full volumetry was unavailable on two patients. One patient was withdrawn from the study because of myelosuppression and underwent further surgery. Three experienced significant drug-related side effects. Two patients underwent further surgery. CONCLUSIONS: From this small pilot study we conclude that although hydroxyurea may be associated with disease stabilization in some patients, it did not reduce tumor mass and it caused significant side effects in some of our subjects.     

Transoral radiofrequency treatment of snoring.

OBJECTIVES/HYPOTHESIS: Radiofrequency ablation (RFA) may effectively treat snoring with acceptable patient tolerance. STUDY DESIGN: A cohort of patients with unacceptable snoring underwent RFA to the soft palate between October 1997 and May 2000. Before the therapy, a family member or significant other person was interviewed to rate snoring loudness. METHODS: Snoring was rated on a visual analog scale of 0 to 10 (in which 0 was no snoring and 10 was horrific snoring) before and after therapy. All patients were treated with transoral RFA administered under local anesthesia at 6-week intervals. RESULTS: Complete data were available for 60 of the 75 treated patients. The average number of treatment sessions per patient was 1.8. These patients received an average energy of 1845 J. Overall the average snoring score was 8.9 before therapy and 3.5 after therapy. Fifty-one patients (85%) were considered to have major improvement in snoring loudness. A total of 9 patients (15%) were nonresponders. CONCLUSIONS: RFA to the soft palate is a viable option to treat socially unacceptable snoring. Inadequate response to therapy may reflect misdiagnosis or delivery of an insufficient amount of energy.