[Combined therapy of severe obstructive sleep apnea]. / Kombinierte Therapie eines schwergradigen obstruktiven Schlafapnoesyndroms.

Obstructive sleep apnea is the most common breathing-related sleep disorder. The spectrum of therapy is wide ranging. The symptom of persistent daytime sleepiness can be an important indicator for reviewing the existing treatment. If polygraphic monitoring shows inadequate treatment under ongoing therapy, a combination of therapies should be considered.

Multi-level surgery for obstructive sleep apnea. Lingual tonsillectomy vs. hyoid suspension in combination with radiofrequency of the tongue base.

PURPOSE: The aim of this study was to compare results in patients with obstructive sleep apnea (OSA) undergoing multi-level surgery with two different surgical approaches to treat tongue base obstruction. STUDY DESIGN: This is a prospective, controlled clinical trial at a tertiary referral center. METHODS: Altogether, 108 patients were separated into two groups according to the findings during drug-induced sleep endoscopy. Patients with enlarged lingual tonsils (N = 58; group A) underwent a lingual tonsillectomy (LT). Patients with small or absent lingual tonsils (N = 50; group B) underwent a hyoid suspension type 2 (HS) in combination with a radiofrequency treatment of the base of the tongue (RFT TB). In addition, all patients underwent an uvulopalatopharyngoplasty with tonsillectomy. RESULTS: At baseline, there were no significant differences between the groups. In group A, the mean apnea hypopnea index (AHI) decreased by 49.7 %, and in group B by 48.3 %. Patients with simultaneous tonsillectomies showed significant better results as compared to patients after prior tonsillectomies (success rate 76.6 vs. 27.3 %). By comparing subgroups (with and without simultaneous tonsillectomy), patients in group A showed better results in terms of AHI reduction than patients in group B, indicating that LT may be superior to HS + RFT TB in treating OSA within our multi-level surgery concept. CONCLUSION: Simultaneous tonsillectomy has a significant impact on objective results of multi-level surgery (MLS). Study results should be adjusted for this parameter. Having done this, MLS with LT seems to produce superior results as compared to HS + RFT TB. Nevertheless, our approach to treat patients differently according to their tongue base tonsil size did not substantially improve our surgical outcome as compared to a previous study.

Diagnosis and treatment of snoring in adults-S2k Guideline of the German Society of Otorhinolaryngology, Head and Neck Surgery.

OBJECTIVES: This guideline aims to promote high-quality care by medical specialists for subjects who snore and is designed for everyone involved in the diagnosis and treatment of snoring in an in- or outpatient setting. DISCUSSION: To date, a satisfactory definition of snoring is lacking. Snoring is caused by a vibration of soft tissue in the upper airway induced by respiration during sleep. It is triggered by relaxation of the upper airway dilator muscles that occurs during sleep. Multiple risk factors for snoring have been described and snoring is of multifactorial origin. The true incidence of snoring is not clear to date, as the incidence differs throughout literature. Snoring is more likely to appear in middle age, predominantly in males. Diagnostic measures should include a sleep medical history, preferably involving an interview with the bed partner, and may be completed with questionnaires. Clinical examination should include examination of the nose to evaluate the relevant structures for nasal breathing and may be completed with nasal endoscopy. Evaluation of the oropharynx, larynx, and hypopharynx should also be performed. Clinical assessment of the oral cavity should include the size of the tongue, the mucosa of the oral cavity, and the dental status. Furthermore, facial skeletal morphology should be evaluated. In select cases, technical diagnostic measures may be added. Further objective measures should be performed if the medical history and/or clinical examination suggest sleep-disordered breathing, if relevant comorbidities are present, and if the subject requests treatment for snoring. According to current knowledge, snoring is not associated with medical hazard, and generally, there is no medical indication for treatment. Weight reduction should be achieved in every overweight subject who snores. In snorers who snore only in the supine position, positional treatment can be considered. In suitable cases, snoring can be treated successfully with intraoral devices. Minimally invasive surgery of the soft palate can be considered as long as the individual anatomy appears suitable. Treatment selection should be based on individual anatomic findings. After a therapeutic intervention, follow-up visits should take place after an appropriate time frame to assess treatment success and to potentially indicate further intervention.

Diagnosis and treatment of snoring in adults--S1 guideline of the German Society of Otorhinolaryngology, Head and Neck Surgery.

INTRODUCTION: Snoring has received increased attention over the last years. Given its high prevalence and its impact on quality of life, diagnosis and treatment of snoring are of major importance. AIM OF THE GUIDELINE: This guideline aims to promote high-quality care by medical specialists for adults who snore. DIAGNOSTIC MEASURES: Before every intervention, a medical history, clinical examination and sleep test need to be performed. INTERVENTIONS: There is no need to treat snoring unless requested by the snorer. Invasive treatments should be selected with care; for surgical treatment, minimally invasive procedures are preferred. Weight reduction; the avoidance of sleeping pills, alcohol and nicotine; and a regular sleep-wake cycle can be recommended, although convincing evidence is lacking. Since currently, there is not enough evidence to confirm the effectiveness of muscle stimulation or other forms of muscle training, these treatments cannot be recommended. Snoring can be treated successfully with intraoral devices, but it is essential to select suitable subjects. Devices preventing sleep in the supine position can also be helpful in selected cases. The data on the success rates of surgical intervention are often limited to short-term follow-up studies, and not all interventions have been sufficiently evaluated. The techniques used to treat nasal obstruction in snorers are identical to those used for general nasal obstruction. Nasal surgery is only indicated when subjects complain about nasal obstruction. A significant amount of data is available for laser-assisted resection of excessive mucosa; however, resections can be performed with other tools. The efficacy of radiofrequency surgery at the soft palate has been documented in placebo-controlled trials. Soft palate implants can reduce snoring. Tonsillectomy or uvulopalatopharyngoplasty should be selected with care, especially as less invasive alternatives are available.

Polydimethylsiloxane in the human vocal fold: description of partial explantation.

We describe here for the first time a partial explantation of polydimethylsiloxane in a patient 7 years after implantation caused by faulty positioning of the implant. The histopathologic examination demonstrated that the material that displayed green autofluorescence in hematoxylin-eosin staining was biologically inert and stable. Major inflammatory reaction could not be ascertained.

A mandibular advancement device for the ENT office to treat obstructive sleep apnea.

OBJECTIVE: To prospectively evaluate the efficacy of the mandibular advancement device (MAD) Somnoguard in the treatment of OSA patients. STUDY DESIGN AND SETTING: Forty-four patients with OSA and noncompliant to continuous positive airway pressure were enrolled in this case series. Somnoguard is made of thermoplastic material. Direct intraoral fitting was done by an otorhinolaryngologist. Polysomnographic data concerning sleep and respiration were assessed at baseline and after familiarization with the MAD. RESULTS: Sleep efficiency and sleep stages distribution did not change significantly. The RDI could be reduced from 31.5+/-17.6 to 18.2+/-17.0 (P<0.05), the minimal oxygen saturation increased from 78+/-12.9 to 82+/-12.5% (P<0.05). According to standard criteria, 18 patients were cured, 12 were improved, 8 remained unchanged, and 6 worsened. Snoring time decreased from 223+/-132 to 183+/-134 minutes (P<0.05). CONCLUSION AND SIGNIFICANCE: With Somnoguard 68% of the enrolled OSA patients could be cured or substantially improved. It is a simple MAD for the otolaryngologist.

Soft palate implants as a minimally invasive treatment for mild to moderate obstructive sleep apnea.

CONCLUSION: The palatal implant method originally designed to reduce snoring can significantly reduce the apnea-hypopnea index (AHI) in some patients with mild to moderate obstructive sleep apnea (OSA) in a single office-based procedure. OBJECTIVE: An initial study designed to evaluate the short-term efficacy and safety of palatal implants as primary treatment for patients with mild to moderate OSA. MATERIALS AND METHODS: This was a prospective, non-randomized study of 16 previously untreated and undiagnosed patients with sleep apnea. The inclusion criteria were an AHI of 10-30/h and a body mass index (BMI) < or = 30. RESULTS: The mean AHI was reduced following implantation, from 16.1 to 11.8 (p<0.01). A reduction in AHI was achieved in 13 patients (81%). Ten of 16 patients had their AHI reduced to <10.0. Snoring intensity decreased from 8.3+/-1.8 to 4.7+/-2.5 on a visual analog scale (p<0.001) and daytime sleepiness dropped from 7.2+/-2.5 to 4.6+/-3.2 on the Epworth Sleepiness Scale (p<0.05). No significant adverse events were reported.

Multilevel surgery for obstructive sleep apnea: short-term results.

OBJECTIVE: To determine the efficacy of a new multilevel surgical protocol for obstructive sleep apnea (OSA). STUDY DESIGN AND SETTING: Sixty patients with moderate to severe OSA because of multilevel pharyngeal obstruction were enrolled into this prospective, controlled clinical trial after clinical examination, endoscopy, and polysomnography. Surgery included uvulaflap, tonsillectomy, hyoid suspension, and radiofrequency treatment of the tongue base (group A). A second group did not receive hyoid suspension (group B). In both groups, nasal surgery was performed if necessary. Polysomnography and Epworth Sleepines Scale (ESS) were recorded at baseline and 2 to 15 months after surgery. RESULTS: In group A, the mean apnea-hypopnea index (AHI) decreased significantly after surgery (38.9 +/- 20.0 vs 20.7 +/- 20.6, P < 0.0001), whereas in group B the AHI did not. All secondary variables (minimal oxygen saturation, mean oxygen saturation, arousal index), and the ESS significantly improved in group A with only changes in arousal index and ESS reaching levels of significance in group B. CONCLUSION: The presented protocol including the hyoid suspension proved to be effective in the treatment of OSA, whereas surgery without hyoid suspension was less successful. EBM RATING: B-2b.

Management of radiation-induced tracheocutaneous tissue defects by transplantation of an ear cartilage graft and deltopectoral flap.

Patients suffering from head and neck cancer often require temporary tracheostomy during therapy. The tracheostomy can usually be closed when postoperative swelling decreases and swallowing ability recovers. However, some patients, especially after adjuvant radiotherapy, may develop severe chronic wounds resulting in persistent tracheocutaneous fistula. Local wound care and plastic reconstruction strategies are required in such cases. We present two patients with head and neck cancer treated with primary surgical regimen including temporary tracheostomy and adjuvant radiotherapy. Both patients developed a persistent, poorly healing wound with persistent tracheocutaneous tissue defect. After local debridement and wound care, the peristomal necrotic tissue was excised down to the level of the trachea. The defect of the anterior tracheal wall was closed with a autogenous ear cartilage graft. The graft was harvested from the cavum conchae and sutured to the tracheal defect. The soft tissue defect was covered by transposition of a well-vascularized, fasciocutaneous deltopectoral flap. In both cases, the flaps healed satisfactorily. The donor defect was closed primarily. Complications were not observed in these two cases. A flexible tracheo-bronchoscopy showed no stenosis of the trachea at the site of cartilage graft transplantation. In conclusion, treatment of persistent radiated tracheocutaneous defects by cartilage graft and deltopectoral flap turned out to be a safe and reliable procedure which can be performed as a one-stage method with low morbidity at the donor site.

A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility.

OBJECTIVE: Many cases of obstructive sleep apnea (OSA) involve collapse of the tongue base and soft palate during sleep, causing occlusion of the upper airway and leading to oxygen desaturation. Existing therapies can be effective, but they are plagued by patient adherence issues and the invasiveness of surgical approaches. A new, minimally invasive implant for OSA has been developed, which is elastic and contracts a few weeks after deployment, stabilizing the surrounding soft tissue. The device has had good outcomes in preclinical testing; this report describes the preliminary feasibility and safety of its implementation in humans. PATIENTS AND METHODS: A prospective, multicenter, single-arm feasibility study was conducted. Subjects were adults with moderate-to-severe OSA who had previously failed or refused conventional continuous positive airway pressure treatment. Intraoperative feasibility data, postoperative pain, and safety information were collected for a 30-day postoperative period. RESULTS: Forty subjects participated (37 men, three women; average age of 46.1 years); each received two tongue-base implants and two soft-palate implants. Surgical procedure time averaged 43 minutes. Postsurgical pain resolved readily in most cases; at 30 days post implantation, <20% of subjects reported pain, which averaged less than two out of ten. Adverse events were generally the mild and expected sequelae of a surgical procedure with general anesthesia and intraoral manipulation. The device was well tolerated. Implant extrusions were reported with soft-palate implants (n=12), while tongue-base implants required few revisions (n=2). Quantitative and qualitative sleep effectiveness outcomes (including full-night polysomnographic and quality-of-life measures) will be presented in a subsequent report. CONCLUSION: Implantation of the device was feasible. Although a relatively high rate of extrusions occurred in the now-discontinued palate implants, tongue-base implants were largely stable and well tolerated. The minimally invasive and maintenance-free implant may provide a new alternative to higher morbidity surgical procedures.

Radiofrequency surgery of the soft palate in the treatment of snoring. A placebo-controlled trial.

STUDY OBJECTIVES: Recent publications have demonstrated a reduction in snoring with radiofrequency (RF) surgery of the soft palate. Yet so far, all published data has been based on non-controlled trials. DESIGN: Aim of this study was to assess the efficacy of RF surgery of the soft palate in a randomized, placebo-controlled trial. SETTING: Outpatients department at university hospital, department of otorhinolaryngology. PATIENTS: 26 patients with primary snoring (AHI < 15, BMI < 35). INTERVENTIONS: Patients were treated with temperature-controlled RF surgery of the soft palate under local anesthesia. In accord with a randomization protocol they received 2 sessions of RF surgery (total amount of energy: 3.300 Joule) or placebo (insertion of device needle without energy delivery). MEASUREMENTS AND RESULTS: Snoring was evaluated by the bed partner with 10 cm visual analogue scales. 23 patients completed the study; 12 received RF-surgery and 11 received placebo. Snoring scores did not change in the placebo group (8.4 +/- 1.6 to 8.0 +/- 2.3) while improving in the RF-group (8.1 +/- 1.3 to 5.2 +/- 2.4). The difference between the groups was statistically significant (p < 0.05). CONCLUSION: RF-surgery was significantly better than placebo, although the reduction in snoring was only moderate in our group of patients. This study underlines the necessity for well-controlled clinical trials in the treatment of snoring.

Immunohistochemical analysis of radiation-induced non-healing dermal wounds of the head and neck.

Persistent, poorly healing wounds are a significant clinical problem in patients who have had previous irradiation. The pathology of chronic dermal ulcers is characterised by excessive proteolytic activity which degrades the extracellular matrix (required for cell migration) and growth factors and their receptors. Interestingly, the molecular basis of radiation-induced dermal wounds is poorly understood. The aim of this study was to investigate, by immunohistochemistry, the expression of the endothelial marker vWF, of angiogenic bFGF, VEGF and IL-8, of collagenases MMP-2 and MMP-9 and their inhibitors TIMP-1 and TIMP-2, in tissue samples from radiation-induced chronic dermal wounds and healthy control skin. Performing immunohistochemical detection of microvessels, an equivalent density of microvessels was observed within tissue samples from normal healthy skin and from radiation-induced non-healing cutaneous wounds. Investigation of angiogenic bFGF and VEGF demonstrated a decreased expression of both factors in the radiation-induced dermal wounds. The expression of angiogenic IL-8 was weak in both the healthy skin samples and the radiation-induced wounds. In addition, an increased expression of collagenases MMP-2 and MMP-9 protein within the radiation-induced wounds was demonstrated. While the expression of TIMP-1 showed no difference of expression between normal control skin and tissue samples from radiation-induced wounds, TIMP-2 expression was slightly increased compared to healthy controls. Our data suggest that radiation-induced dermal injuries often fail to heal because of decreased angiogenesis and persistently high concentrations of MMPs with an imbalance of their tissue inhibitors. The basic mechanisms of wound healing in radiation-induced dermal wounds at the molecular level need to be understood further for the development of innovative treatment strategies.

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.

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.

Anatomic changes after hyoid suspension for obstructive sleep apnea: an MRI study.

OBJECTIVE: To assess the effects of isolated hyoid suspension on subjective and objective parameters of obstructive sleep apnea and to evaluate changes in upper airway anatomy with the help of standardized magnetic resonance imaging. STUDY DESIGN AND SETTING: Fifteen patients received isolated hyoid suspension. Changes in respiratory disturbance index were assessed with polysomnography, and anatomical changes with standardized magnetic resonance imaging. Snoring, daytime sleepiness, and functional parameters were assessed with questionnaires. Lateral x-ray cephalometry was performed preoperatively. RESULTS: Mean respiratory disturbance index was reduced from 35.2 +/- 19.1 to 27.4 +/- 26.2. Forty percent of the patients were classified as responders. Daytime sleepiness improved significantly. Relevant changes in upper airway anatomy could not be detected. There were no remarkable differences between responders and nonresponders in regard to imaging. CONCLUSIONS: Hyoid suspension is effective only in a subgroup of patients and does not lead to relevant changes in airway diameters in the awake patient. Magnetic resonance imaging and x-ray cephalometry do not add additional information for patient selection. SIGNIFICANCE: The reported clinical effects of hyoid suspension are more likely due to functional changes in airway collapsibility than to an enlargement of the upper airway.

Volumetric tissue reduction in radiofrequency surgery of the tongue base.

OBJECTIVES: Radiofrequency surgery is a minimally invasive technique for the treatment of the tongue base in sleep-disordered breathing. The aim of this study was to evaluate the changes in upper airway anatomy induced by radiofrequency surgery with MRI. STUDY DESIGN AND SETTING: 10 patients with sleep-disordered breathing were treated with radiofrequency surgery at tongue base. MRI measurements were performed before and after surgery with the help of a recently published protocol. RESULTS: The mean total number of energy delivered per patient was 4750 +/- 1641 Joule. Relevant changes could be observed neither for tongue volume or dimension nor for retrolingual space. CONCLUSIONS: Changes in upper airway anatomy could not be demonstrated. The effects of radiofrequency surgery of the tongue base may more likely be a result of changes in upper airway collapsibility. SIGNIFICANCE: Functional effects of surgical interventions in sleep-disordered breathing should be considered in addition to mechanistic concepts alone.

In vitro analysis of matrix proteins and growth factors in dedifferentiating human chondrocytes for tissue-engineered cartilage.

CONCLUSIONS: With ongoing culture and dedifferentiation of chondrocytes, significant changes in the expression patterns of various collagens and the insulin-like growth factor (IGF) receptor were detected. The latter could play an important role in the differentiation of human chondrocytes. OBJECTIVE: Tissue engineering represents a promising method for the construction of autologous chondrogenic grafts for reconstructive surgery. So far, little is known about the expression of markers for cell proliferation and differentiation in cultured chondrocytes. MATERIAL AND METHODS: Human chondrocytes were isolated from septal cartilage (n=5) and held in primary cell culture. Cells were harvested after 24 h and 6 days. Proliferation was analyzed using an Alamar Blue assay. The differentiation of the cells was investigated using bright field microscopy, the expression patterns of various proteins using immunohistochemistry and the expression of distinct genes using a microarray technique. RESULTS: The chondrocytes showed strong proliferation (Day 0: 16.7+/-0.7 fluorescent units; Day 5: 52.4+/-2.2 fluorescent units) from the third day of cell culture in medium without growth factors. From this point onwards, a dedifferentiation of the chondrocytes could be observed. In cell culture, the chondrocytes expressed collagen 1 and 10 without expression of collagen 3. After 6 days of cell culture, they expressed collagen 2. The chondrocytes showed constant low expression of the fibroblast growth factor-2 receptor, but constant high expression of vascular endothelial growth factor, matrix metalloproteinase (MMP)2 and MMP9. The cells never expressed the epidermal growth factor receptor. The proportion of IGF receptor-expressing cells diminished significantly during cell culture.

Radiofrequency surgery of the soft palate in the treatment of snoring: a review of the literature.

STUDY OBJECTIVES: Radiofrequency surgery of the soft palate presents a promising alternative for the treatment of snoring. The aim of this study was to give an overview of the current literature and to quantify the results in terms of a meta-analysis of treatment efficacy. METHODS: Current databases were searched for publications concerning the treatment of snoring with radiofrequency surgery up to January 2003. Only original articles published in peer-reviewed journals were taken into consideration. RESULTS: The review is based on 22 publications, mostly consisting of prospective noncontrolled clinical trials. Snoring was assessed with the help of visual analogue scales or snoring scores provided by the bed partner. In all these trials, a significant reduction of snoring was reported. Postoperative morbidity was low, but complication rates differed substantially. CONCLUSIONS: According to all of the published material, radiofrequency surgery of the soft palate leads to a significant reduction of subjective snoring, and snoring is reduced to a tolerable level. Nevertheless, these findings will have to be confirmed by controlled clinical trials.