Nico de Vries

Upper airway stimulation for obstructive sleep apnea

BACKGROUND Obstructive sleep apnea is associated with considerable health risks. Although continuous positive airway pressure (CPAP) can mitigate these risks, effectiveness can be reduced by inadequate adherence to treatment. We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea. METHODS Using a multicenter, prospective, single-group, cohort design, we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy. The primary outcome measures were the apnea-hypopnea index (AHI; the number of apnea or hypopnea events per hour, with a score of ≥15 indicating moderate-to-severe apnea) and the oxygen desaturation index (ODI; the number of times per hour of sleep that the blood oxygen level drops by ≥4 percentage points from baseline). Secondary outcome measures were the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the oxygen saturation less than 90%. Consecutive participants with a response were included in a randomized, controlled therapy-withdrawal trial. RESULTS The study included 126 participants; 83% were men. The mean age was 54.5 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 28.4. The median AHI score at 12 months decreased 68%, from 29.3 events per hour to 9.0 events per hour (P<0.001); the ODI score decreased 70%, from 25.4 events per hour to 7.4 events per hour (P<0.001). Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life. In the randomized phase, the mean AHI score did not differ significantly from the 12-month score in the nonrandomized phase among the 23 participants in the therapy-maintenance group (8.9 and 7.2 events per hour, respectively); the AHI score was significantly higher (indicating more severe apnea) among the 23 participants in the therapy-withdrawal group (25.8 vs. 7.6 events per hour, P<0.001). The ODI results followed a similar pattern. The rate of procedure-related serious adverse events was less than 2%. CONCLUSIONS In this uncontrolled cohort study, upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea. (Funded by Inspire Medical Systems; STAR ClinicalTrials.gov number, NCT01161420.).

Drug-induced sleep endoscopy: the VOTE classification

The surgical evaluation of obstructive sleep apnea is designed to characterize the pattern of upper airway obstruction in order to develop an effective treatment plan for an individual patient. Drug-induced sleep endoscopy (DISE) is one evaluation technique that involves assessment of individuals under pharmacologic sedation designed to simulate natural sleep, utilizing fiberoptic endoscopy to examine the upper airway. Developed in multiple centers throughout Europe, DISE was first described in 1991 and is performed widely around the world. Although multiple studies support a potential role for DISE in evaluation for treatment with surgery and mandibular repositioning appliances, important clinical questions remain unanswered. A major limitation in advancing our understanding of drug-induced sleep endoscopy has been the multiplicity and, in many cases, the complexity of classification systems that prevent the comparison of results across the studies and centers. We present the VOTE classification, a method for characterizing DISE findings that focuses on its core feature, the specific structures that contribute to obstruction.

One hundred consecutive patients undergoing drug-induced sleep endoscopy: Results and evaluation†‡

Polysomnography (PSG) is mandatory in the diagnostic workup of obstructive sleep apnea (OSA); drug‐induced sleep endoscopy (DISE) is a valid addition. DISE is a dynamic, safe, easy‐to‐perform technique that visualizes the anatomic sites of snoring or apneas and guides the making of a tailor‐made treatment plan in individual cases. The aim of this prospective study was to document the results of 100 consecutive DISE procedures and investigate associations between PSG and DISE findings.

European position paper on drug-induced sedation endoscopy (DISE)

BackgroundAlthough drug-induced sedation endoscopy (DISE) represents the most widespread diagnostic tool for upper airway endoscopic evaluation of snoring and obstructive sleep apnea hypopnea syndrome (OSAHS), many controversies exist about how to perform the sedation, the indications for DISE, and how to report DISE findings. The present position paper reports on a consensus as proposed by a group of European experts in the field of DISE after discussion during a recent dedicated meeting.MethodsThe authors have evaluated all the available evidence reported in the literature and have compared experience among various departments in leading European centers in order to provide a standardization of the DISE procedure and an in-depth insight in the main aspects of this technique.ResultsA proposal of the DISE procedure standardization has been achieved with a general agreement concerning the terminology, indications, contraindications, required preliminary examinations, setting, technical equipment required, staffing, local anesthesia and nasal decongestion, patient positioning, basis and special diagnostic maneuvers, and the applied sedation drugs and observation windows. Otherwise, no consensus has been reached on a scoring and classification system.ConclusionsAlthough consensus has been reached on several aspects of the DISE procedure, some topics remain open to future research, such as a better analysis of the importance of positional aspects during DISE and a further comparison of the differences in degree, level and pattern of upper airway collapse observed during DISE versus during natural sleep and awake endoscopy. Finally, a universally accepted scoring and classification system is lacking.

Sleep endoscopy versus modified mallampati score in sleep apnea and snoring

Objectives/Hypothesis: The aim of this study is to quantify the correlation between a large tongue classified by the modified Mallampati score (MMS) and obstruction at the tongue base observed during sleep endoscopy in patients with socially unacceptable snoring (SUS) and obstructive sleep apnea syndrome (OSAS).

Three-Year Outcomes of Cranial Nerve Stimulation for Obstructive Sleep Apnea The STAR Trial

Objective To describe the 36-month clinical and polysomnography (PSG) outcomes in an obstructive sleep apnea (OSA) cohort treated with hypoglossal cranial nerve upper airway stimulation (UAS). Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical setting. Subjects Participants (n = 116) at 36 months from a cohort of 126 implanted participants. Methods Participants were enrolled in a prospective phase III trial evaluating the efficacy of UAS for moderated to severe OSA. Prospective outcomes included apnea-hypopnea index, oxygen desaturation index, other PSG measures, self-reported measures of sleepiness, sleep-related quality of life, and snoring. Results Of 126 enrolled participants, 116 (92%) completed 36-month follow-up evaluation per protocol; 98 participants additionally agreed to a voluntary 36-month PSG. Self-report daily device usage was 81%. In the PSG group, 74% met the a priori definition of success with the primary outcomes of apnea-hypopnea index, reduced from the median value of 28.2 events per hour at baseline to 8.7 and 6.2 at 12 and 36 months, respectively. Similarly, self-reported outcomes improved from baseline to 12 months and were maintained at 36 months. Soft or no snoring reported by bed partner increased from 17% at baseline to 80% at 36 months. Serious device-related adverse events were rare, with 1 elective device explantation from 12 to 36 months. Conclusion Long-term 3-year improvements in objective respiratory and subjective quality-of-life outcome measures are maintained. Adverse events are uncommon. UAS is a successful and appropriate long-term treatment for individuals with moderate to severe OSA.

Results of uvulopalatopharyngoplasty after diagnostic workup with polysomnography and sleep endoscopy: a report of 136 snoring patients

Abstract. We subjectively and objectively evaluated 136 patients with socially unacceptable snoring (SUS) or obstructive sleep apnoea syndrome (OSAS) treated with uvulopalatopharyngoplasty (UPPP) after a diagnostic workup by sleep registration (polysomnography, PSG) and sleep endoscopy. Of the 136 patients, there were 88 with OSAS and 48 with SUS. The results of the procedure were considered subjectively to be an improvement in 38 (79%) of the SUS patients and in 74 (84%) of the patients with OSAS. In 36 (40%) of the 88 patients with OSAS, repeating PSG postoperatively was considered unnecessary because of obvious improvement. Of the 52 patients with a measurement after UPPP, a decrease in the apnoea hypopnoea index (AHI) was found in 38 (73%; median decrease: 48%), and AHI dropped below 20 in 32 (62%). The apnoea index (AI) was available in 49 (56%) patients and was reduced in 31 (63%; median decrease: 73%). An overall positive result in the 88 patients with OSAS (combining available data on subjective and objective results) was therefore found in 61 (69%; positive subjective result and AHI <15) or 71 (81%; positive subjective result and decrease in AHI), respectively, depending on the definition. We conclude that after diagnostic workup by sleep registration and sleep endoscopy, the success rate of UPPP increases as compared to historical controls.

Surgery for obstructive sleep apnea: Sleep endoscopy determinants of outcome

Although drug‐induced sleep endoscopy is often employed to determine the site of obstruction in patients with obstructive sleep apnea (OSA) who will undergo upper airway surgery, it remains unknown whether its findings are associated with surgical outcome. This study tested the hypothesis that drug‐induced sleep endoscopy variables can predict the outcome of upper airway surgery in OSA patients.

Evaluation of Drug-Induced Sleep Endoscopy as a Patient Selection Tool for Implanted Upper Airway Stimulation for Obstructive Sleep Apnea

STUDY OBJECTIVES To study the possible predictive value of drug-induced sleep endoscopy (DISE) in assessing therapeutic response to implanted upper airway stimulation (UAS) for obstructive sleep apnea (OSA). METHODS During DISE, artificial sleep is induced by midazolam and/or propofol, and the pharyngeal collapse patterns are visualized using a flexible fiberoptic nasopharyngoscope. The level (palate, oropharynx, tongue base, hypopharynx/epiglottis), the direction (anteroposterior, concentric, lateral), and the degree of collapse (none, partial, or complete) were scored in a standard fashion. RESULTS We report on the correlation between DISE results and therapy response in 21 OSA patients (apnea-hypopnea index [AHI] 38.5 ± 11.8/h; body mass index [BMI] 28 ± 2 kg/m(2), age 55 ± 11 y, 20 male/1 female) who underwent DISE before implantation of a UAS system. Statistical analysis revealed a significantly better outcome with UAS in patients (n = 16) without palatal complete concentric collapse (CCC), reducing AHI from 37.6 ± 11.4/h at baseline to 11.1 ± 12.0/h with UAS (p < 0.001). No statistical difference was noted in AHI or BMI at baseline between the patients with and without palatal CCC. In addition, no predictive value was found for the other DISE collapse patterns documented. CONCLUSIONS The absence of palatal CCC during DISE may predict therapeutic success with implanted UAS therapy. DISE can be recommended as a patient selection tool for implanted UAS to treat OSA.

Hyoidthyroidpexia: A Surgical Treatment for Sleep Apnea Syndrome

Objectives/Hypothesis: The aim of this study is to evaluate the results of primary hyoidthyroidpexia (HTP) and HTP after previous uvulopalatopharyngoplasty (UPPP) in patients with obstructive sleep apnea syndrome (OSAS).