Long-term follow-up of the German post-market study for upper airway stimulation for obstructive sleep apnea.

PURPOSE: Upper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA) in positive airway pressure (PAP) failure. Most reports have presented short-term data, so long-term safety and efficacy reports are rare. The German post-market study (G-PMS) has followed approximately 60 patients from three implanting centers for several years. METHODS: Patients with OSA and PAP failure qualified for the G-PMS by the absence of obesity class 2 an AHI between 15 and 65 events/h and absence of complete concentric collapse at the velum during drug-induced sleep endoscopy. Optional 2- and 3-year follow-ups after implantation were collected during routine clinical practice. We measured respiratory parameters such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) and daytime sleepiness using the Epworth sleepiness scale (ESS) in a per protocol analysis. Usage was calculated from device-downloaded reports. Device-related complications were documented. RESULTS: Of the 60 original patients, 41 returned for 2-year follow-up, and 38 for 3 years. About 76% at 2 years and 68% at 3 years met the criterion of therapy success defined as an AHI below 15/h. The median AHI was reduced from 28.6/h (baseline) to 9.0/h (2 years) and 10.0/h (3 years); whereas median ODI decreased from 27.0 to 6.3/h (2 years), and 8.3/h (3 years). Median ESS improved from baseline 13 points to 4 (2 years) and 6 (3 years). Usage was stable at approximately 45 h per week at 2 and 3 years. Serious device-related adverse events were rare, with two-device explantation between 12 to 36 months postoperatively. CONCLUSIONS: The German multi-center long-term outcomes compare favorably with previously published studies. Respiratory and sleepiness efficacy outcomes were sustained over 2 and 3 years, with a favorable safety profile, supporting the safety and efficacy of a chronic implantable therapy.

Tonsillectomy with Uvulopalatopharyngoplasty in Obstructive Sleep Apnea.

BACKGROUND: Obstructive sleep apnea (OSA) is a very common disorder (prevalence 2-7% in women, 7-14% in men). It impairs the quality of life and increases mortality. Conservative treatment with continuous positive airway pressure is highly effective, but patient compliance is variable. Surgical treatments are controversial, as only a few are supported by evidence from controlled clinical trials. METHODS: Adult patients with OSA, CPAP intolerance, and oropharyngeal obstruction were included in the trial. All underwent polysomnography (PSG) and were randomly allotted to one of two groups. Patients in the treatment group underwent tonsillectomy with uvulopalatopharyngoplasty (TE-UPPP) within one month. All patients had a follow-up PSG at three months, and all PSGs were evaluated in blinded fashion. The primary outcome variable was the apneahypopnea index (AHI) as determined by PSG. Other outcome variables were subjective symptoms (daytime sleepiness, quality of life), complications, and patient satisfaction. RESULTS: 42 patents were included in the trial (23 in the treatment group, 19 in the control group). The baseline AHI was 35.7 ± 19.4/hr in the control group and 33.7 ± 14.6/hr in the treatment group. The corresponding figures at 3 months were 28.6 ± 19.4/hr in the control group and 15.4 ± 14.1/hr in the treatment group (p = 0.036). The intervention also led to significant improvement in daytime sleepiness and in snoring, according to the patients' and their bed partners' assessment. 97% of the patients who underwent surgery were satisfied with the outcome. 65% of them needed no further treatment for OSA. CONCLUSION: TE-UPPP significantly improved apnea/hypopnea, daytime sleepiness, and snoring compared to control (i.e., no) treatment. It is a safe and effective treatment for OSA..

TGF-ß1 antisense impacts the SMAD signalling system in fibroblasts from keloid scars.

AIM: To identify the effect of a TGF-ß1 antisense treatment of keloid fibroblasts on the SMAD signalling system. MATERIAL AND METHODS: In this cross-sectional study, keloid and adjacent healthy tissue was harvested from 9 patients with keloid scars after otoplasty. Keloid fibroblasts were placed in monolayer cultures. Expression of SMAD2, -3, -4, -6, and SMURF2 were analysed by immunohistochemistry. Analysis of treatment with antisense oligonucleotides was conducted by immunohistochemistry, and RT-PCR. RESULTS: Immunohistochemical investigation demonstrated increased expression of SMAD2, -3 and -4, and decreased expression of SMURF2. TGF-ß1 antisense therapy significantly down-regulated SMAD2 and SMAD4, up-regulated SMURF2 and showed no effect on SMAD3 and SMAD6. CONCLUSION: TGF-ß1 led to elevated levels of the SMAD signalling cascade, indicating an abnormal sensitivity of keloid-derived fibroblasts to this cytokine. Abrogation correlated with potential suppression of the fibro-proliferative progress. There is growing evidence for an abnormal response to this cytokine in the intracellular signal transduction in keloid-derived fibroblasts.