Device-related outcomes following hypoglossal nerve stimulator implantation.

STUDY OBJECTIVES: Hypoglossal nerve stimulation (HGNS) has been widely used to treat obstructive sleep apnea in selected patients. Here we evaluate rates of revision and explant related to HGNS implantation and assess types of adverse events contributing to revision and explant. METHODS: Post-market surveillance data for HGNS implanted between January 1, 2018 and March 31, 2022, were collected. Event rates and risk were calculated using the post-market surveillance event counts and sales volume over the same period. Indications were categorized for analysis. Descriptive statistics were reported and freedom from explant or revision curves were grouped by year of implantation. RESULTS: Of the 20,881 HGNS implants assessed, rates of explant and revision within the first year were 0.723% and 1.542%, respectively. The most common indication for explant was infection (0.378%) and for revision was surgical correction (0.680%). Of the 5,820 devices with three-year post-implantation data, the rate of explant was 2.680% and of revision was 3.557%. During this same interval, elective removal (1.478%) was the most common indication, and for revisions, surgical correction (1.134%). CONCLUSIONS: The efficacy of HGNS is comparable in the real world setting to published clinical trial data. Rates of explant and revision are low, supporting a satisfactory safety profile for this technology.

Hypoglossal Nerve Stimulation Therapy Outcomes in Apnea- Versus Hypopnea-Predominant Patients.

OBJECTIVES: The influence of apnea- and hypopnea-predominance on hypoglossal nerve stimulation therapy outcomes (HGNS) is still poorly defined. We assessed the significance of apnea- and hypopnea-predominance in HGNS outcomes. STUDY DESIGN: Case series with chart review. SETTING: Single-institution tertiary care center. METHODS: A total of 216 subjects were included, all of which had undergone drug-induced sleep endoscopy (DISE) and HGNS implantation. Demographic and polysomnographic data were collected. The 4% apnea-hypopnea criteria were used to calculate apnea-hypopnea index (AHI). Central apneas were omitted. Univariate logistic and linear regression were used to study the association between these data and apnea-predominance and hypopnea-predominance. Kruskal-Wallis rank sum test was used to compare medians between groups for DISE collapse patterns. RESULTS: Sixty-three patients were apnea-predominant, and 153 patients were hypopnea-predominant. These 2 groups were similar demographically (p > .20). There was no significant difference in HGNS outcomes between the groups assessed using Sher20 criteria at the 1-year mark using all-night, single-setting polysomnography or home sleep studies. Apnea index (AI)/AHI and reduction in AHI from preoperative to titration were significantly associated (p = .046). The median preoperative hypopnea index was significantly lower (p = .033) in subjects with no oropharyngeal collapse than patients with partial or complete oropharyngeal collapse. There were no significant relationships between AI/AHI and the different degrees of collapse at the velopharynx, oropharynx, tongue base, or epiglottis. CONCLUSIONS: In line with CPAP, tonsillectomy, and mandibular advancement therapy studies, we found there was largely no significant difference in DISE anatomy or in HGNS treatment outcomes between apnea- and hypopnea-predominant individuals.

Hyoid Suspension With UPPP for the Treatment of Obstructive Sleep Apnea.

This retrospective evaluation of surgical outcomes for hyomandibular suspension when performed with uvulopalatopharyngoplasty (UPPP) for the treatment of obstructive sleep apnea (OSA). Thirty-nine patients with moderate-to-severe OSA were treated with hyoid myotomy and suspension and uvulopalatopharyngoplasty. Patients underwent hyoid advancement and suspension to the mandible (Encore System) with either staged or concurrent UPPP. The primary outcome was a successful surgical result, defined as an apnea hypopnea index (AHI) lower than 20, and a 50% or greater decline in AHI on postoperative polysomnography. Successful surgical results were achieved in 30 (76.9%) out of 39 patients. The mean preoperative AHI improved 69.2% from 49.9 ± 25.6 to 15.4 ± 14.9 (P < .001) postoperatively. All patients reported clinical improvement of symptoms. There were 4 wound complications and one infection requiring removal of hardware. For patients with multilevel obstructive sleep apnea, hyoid advancement and suspension to the mandible appears efficacious when performed in conjunction with uvulopalatopharyngoplasty.

Does race-ethnicity affect upper airway stimulation adherence and treatment outcome of obstructive sleep apnea?

STUDY OBJECTIVES: Untreated obstructive sleep apnea (OSA) is associated with excessive daytime sleepiness, decreased quality of life, and cardiovascular disease. Positive airway pressure is the first-line therapy for OSA; however, adherence is difficult. Upper airway stimulation is a Food and Drug Administration-approved treatment of OSA. The objective of this study was to evaluate for a difference in treatment efficacy and adherence of upper airway stimulation therapy for OSA between individuals who are White and non-White using data from the ADHERE registry. METHODS: ADHERE registry is a multicenter prospective study of real-world experience of upper airway stimulation for treatment of OSA in the United States and Europe. Propensity score matching was used to create a balanced dataset between the White and non-White groups. t-Tests at a significance level of 5% were used to compare numeric values between groups. RESULTS: There were 2,755 participants of the ADHERE registry: 27 were excluded due to not having a race identified, 125 participants identified as non-White, 2,603 identify as White, and 27 did not provide race information. Propensity score matching was used to select 110 participants, with 55 White and 55 non-White for the noninferiority analysis. We did not find a difference in adherence, treatment apnea-hypopnea index, changes in Epworth Sleepiness Scale score, or clinical global impression after intervention score between White and non-White individuals. CONCLUSIONS: Our study found that there was no statistically significant difference in adherence or efficacy with upper airway stimulation therapy between White and non-White individuals. However, the percent of non-White people implanted is low, which suggests a need to expand access to this therapy for non-White populations with OSA who cannot tolerate positive airway pressure therapy. CITATION: Khan M, Stone A, Soose RJ, et al. Does race-ethnicity affect upper airway stimulation adherence and treatment outcome of obstructive sleep apnea? J Clin Sleep Med. 2022;18(9):2167-2172.

Identifying Patient Characteristics That Predict Drug-Induced Sleep Endoscopy Anatomy.

OBJECTIVE: To examine if age, sex, body mass index (BMI), neck circumference, or apnea-hypopnea index can predict whether a patient will demonstrate velopharyngeal complete circumferential (CC) collapse on drug-induced sleep endoscopy (DISE). STUDY DESIGN: Single-center retrospective review at The Ohio State Wexner Medical Center of 289 patients between March 2014 and June 2020. SETTING: Quaternary care hospital. METHODS: Patient characteristic and DISE information was extracted from charts and summarized with mean and standard deviation for continuous variables and count and percentage for categorical. CC collapse and patient characteristic associations were explored: 2-sample t test for continuous and chi-square test for categorical. Classification and regression tree (CART) analysis with 3-fold cross-validation was employed to search for the best CC collapse predictors. RESULTS: Male and female BMI and female neck circumference were correlated to velopharyngeal CC collapse, with BMI more strongly correlated. CART analysis for males showed that a BMI ≤34.8 kg/m2 is associated with an 89.4% chance of not demonstrating velopharyngeal CC collapse vs 48% for BMI >34.8 (area under the curve [AUC] = 0.705; AUC >0.7 is acceptable). For females, the CART analysis showed that a BMI ≤36.4 is associated with a 98.4% of not demonstrating velopharyngeal CC collapse vs 30.8% for BMI >36.4 (AUC = 0.73). For females, a neck circumference ≤38.05 cm is associated with a 100% chance of not demonstrating velopharyngeal CC collapse vs 18.4% for >38.05 cm (AUC = 0.72). CONCLUSION: The BMI values for males and females and the female neck circumference values established by the CART model may accurately predict DISE anatomy and possible candidacy for hypoglossal nerve stimulation.

A Noninferiority Analysis of 3- vs 2-Incision Techniques for Hypoglossal Nerve Stimulator Implantation.

OBJECTIVE: The only hypoglossal nerve stimulation (HNS) device available for US clinical use is implanted through 3 incisions. A recently proposed 2-incision modification moved the respiratory sensing lead from the fifth to the second intercostal space to eliminate the third lower chest incision. This study compared perioperative data and therapeutic outcomes between the techniques. STUDY DESIGN: Noninferiority cohort analysis of a retrospective and prospective registry study. SETTING: Tertiary care and community surgical centers. METHODS: Patients with obstructive sleep apnea underwent HNS implantation via a modified 2-incision technique (I2). A cohort previously implanted via the standard 3-incision technique (I3) were 1:1 propensity score matched for a noninferiority analysis of postoperative outcomes. RESULTS: There were 404 I3 patients and 223 I2 patients across 6 participating centers. Operative time decreased from 128.7 minutes (95% CI, 124.5-132.9) in I3 patients to 86.6 minutes (95% CI, 83.7-97.6) in I2 patients (P < .001). Postoperative sleep study data were available for 76 I2 patients who were matched to I3 patients. The change in apnea-hypopnea index between the cohorts was statistically noninferior (a priori noninferiority margin: 7.5 events/h; mean difference, 1.51 [97.5% CI upper bound, 5.86]). There were no significant differences between the cohorts for baseline characteristics, perioperative adverse event rates, or change in Epworth Sleepiness Score (P > .05). CONCLUSION: In a multicenter registry, a 2-incision implant technique for a commercially available HNS device had a statistically noninferior therapeutic efficacy profile when compared with the standard 3-incision approach. The 2-incision technique is safe and effective for HNS implantation.

Association between anxiety, depression, and emotional distress and hypoglossal nerve stimulator adherence.

PURPOSE: To evaluate relationships between hypoglossal nerve stimulator (HNS) adherence and the presence of anxiety, depression, and emotional distress. METHODS: This is a cross-sectional study of subjects with moderate to severe obstructive sleep apnea (OSA), who had HNS implanted and activated at The Ohio State University Medical Center (OSUMC). Patient usage data from the previous 6 months was obtained from 33 patients. Adherence was defined as ≥28 h of use per week. Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) were administered, and the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) score was calculated for all subjects. RESULTS: Sixty-five percent were adherent with average usage of 46.5±11.7 h per week vs 7.7±7.5 h per week in the non-adherent group. The average GAD-7 were 3.90±3.98 in the adherent group vs. 8.27±6.69 in the non-adherent group (p=0.049). PHQ-9 score was 6.15±4.31 vs. 10.09±7.53 (p=0.118), and PHQ-ADS was 10.05±7.49 vs. 19.20±9.80 (p=0.035). There were no statistically significant differences in age, gender, pre-treatment AHI, and post-treatment AHI between the two groups, though there was a trend to higher age in the adherent group. CONCLUSIONS: This study demonstrated higher GAD-7 and PHQ-ADS scores in the non-adherent group compared to those who were adherent to HNS supporting that anxiety and emotional distress may contribute to HNS therapy adherence. To our knowledge, this is the first study evaluating the relationship between anxiety, depression, emotional distress, and HNS adherence. Screening patients with the GAD-7 and PHQ-9 prior to implantation may be helpful when evaluating patient adherence to therapy.

Implantation of the hypoglossal nerve stimulator via left-sided, 2-incision approach.

This report is a case series of 5 patients who underwent implantation of a hypoglossal nerve stimulator for obstructive sleep apnea via a left-sided, 2-incision technique. This method represents a significant modification of the original right-sided, 3-incision technique. All 5 patients were successfully implanted with this technique variant with no adverse events or negative impact on device functionality, such as cardiac artifact. CITATION: Lin C, Olson MD, Huyett P, Chio EG. Implantation of the hypoglossal nerve stimulator via left-sided, 2-incision approach. J Clin Sleep Med. 2022;18(4):1219-1222.

Impact of Body Mass Index and Discomfort on Upper Airway Stimulation: ADHERE Registry 2020 Update.

OBJECTIVES/HYPOTHESIS: To provide the ADHERE registry Upper Airway Stimulation (UAS) outcomes update, including analyses grouped by body mass index (BMI) and therapy discomfort. STUDY DESIGN: Prospective observational study. METHODS: ADHERE captures UAS outcomes including apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), therapy usage, patient satisfaction, clinician assessment, and safety over a 1-year period. BMI ≤32 kg/m2 (BMI32 ) and 32 < BMI ≤35 kg/m2 (BMI35 ) group outcomes were examined. RESULTS: One thousand eight hundred forty-nine patients enrolled in ADHERE, 1,019 reached final visit, 843 completed the visit. Significant changes in AHI (-20.9, P < .0001) and ESS (- 4.4, P < .0001) were demonstrated. Mean therapy usage was 5.6 ± 2.2 hr/day. Significant therapy use difference was present in patients with reported discomfort versus no discomfort (4.9 ± 2.5 vs. 5.7 ± 2.1 hr/day, P = .01). Patients with discomfort had higher final visit mean AHI versus without discomfort (18.9 ± 18.5 vs. 13.5 ± 13.7 events/hr, P = .01). Changes in AHI and ESS were not significantly different. Serious adverse events reported in 2.3% of patients. Device revision rate was 1.9%. Surgical success was less likely in BMI35 versus BMI32 patients (59.8% vs. 72.2%, P = .02). There was a significant therapy use difference: 5.8 ± 2.0 hr/day in BMI32 versus 5.2 ± 2.2 hr/day in BMI35 (P = .028). CONCLUSIONS: Data from ADHERE demonstrate high efficacy rates for UAS. Although surgical response rate differs between BMI32 and BMI35 patient groups, the AHI and ESS reduction is similar. Discomfort affects therapy adherence and efficacy. Thus, proper therapy settings adjustment to ensure comfort is imperative to improve outcomes. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2616-2624, 2021.

Postoperative Prescriptions and Corresponding Opioid Consumption After Septoplasty or Rhinoplasty.

The objective of our study was to assess the relationship between postoperative opioid prescribing patterns and opioid consumption among patients who underwent septoplasty or rhinoplasty. A chart review of patients who underwent either septoplasty or rhinoplasty by 3 surgeons between July 2016 and June 2017 was performed, and pertinent clinical data were collected including the amount of narcotic pain medications prescribed. A telephone interview was then conducted to assess opioid usage and pain control regimen postoperatively. The number of opioid tablets prescribed and the number consumed were converted to total morphine milligram equivalent (MME) for uniform comparison. A total of 75 patients met the inclusion criteria, and 64 completed the telephone survey. Among these 64 patients, the mean (standard deviation [SD]) prescribed MME was 289.7 (101.3), and the mean (SD) consumed MME was 100.6 (109). Similarly, the mean (SD) number of opioid tablets prescribed was 42.4 (9.7), and the mean number of tablets consumed was 14.7 (16.3). Gender, procedure performed (septoplasty or rhinoplasty), use of Doyle splints, and surgeon were not associated with the amount of opioids prescribed or used. Subjective pain control was the only factor associated with an increase in opioid use (P = .0288). There was an overabundance of opioid pain medications prescribed compared to the amount consumed for pain control after septoplasty or rhinoplasty. Abuse of prescription opioids represents an important component of the nation's opioid crisis. Surgeons must be cognizant of the problem and adjust prescribing practices accordingly.

Evaluation of Surgical Learning Curve Effect on Obstructive Sleep Apnea Outcomes in Upper Airway Stimulation.

OBJECTIVE: An increasing number of facilities offer Upper Airway Stimulation (UAS) with varying levels of experience. The goal was to quantify whether a surgical learning curve exists in operative or sleep outcomes in UAS. METHODS: International multi-center retrospective review of the ADHERE registry, a prospective international multi-center study collecting UAS outcomes. ADHERE registry centers with at least 20 implants and outcomes data through at least 6-month follow-up were reviewed. Cases were divided into two groups based on implant order (the first 10 or second 10 consecutive implants at a given site). Group differences were assessed using Mann-Whitney U-tests, Chi-squared tests, or Fisher's Exact tests, as appropriate. A Mann-Kendall trend test was used to detect if there was a monotonic trend in operative time. Sleep outcome equivalence between experience groups was assessed using the two one-sided tests approach. RESULTS: Thirteen facilities met inclusion criteria, contributing 260 patients. Complication rates did not significantly differ between groups (P = .808). Operative time exhibited a significant downward trend (P < .001), with the median operative time dropping from 150 minutes for the first 10 implants to 134 minutes for the subsequent 10 implants. The decrease in AHI from baseline to 12-month follow-up was equivalent between the first and second ten (22.8 vs 21.2 events/hour, respectively, P < .001). Similarly, the first and second ten groups had equivalent ESS decreases at 6 months (2.0 vs 2.0, respectively, P < .001). ESS outcomes remained equivalent for those with data through 12-months. CONCLUSIONS: Across the centers' first 20 implants, an approximately 11% reduction operative time was identified, however, no learning curve effect was seen for 6-month or 12-month AHI or ESS over the first twenty implants. Ongoing monitoring through the ADHERE registry will help measure the impact of evolving provider and patient specific characteristics as the number of implant centers increases.

Laryngeal neuromas in a case of multiple endocrine neoplasia type 2B.

Mucosal neuromas of the larynx in the setting of multiple endocrine neoplasia type 2B (MEN-2B) are extremely rare; to the best of our knowledge, only 2 other cases have been previously reported in the world literature. We describe a new case, which occurred in a 30-year old woman who presented with dysphagia, dysphonia, and cough. On examination, she was found to have multiple laryngeal mucosal neuromas throughout the glottis and supraglottis. She underwent surgical resection of these lesions with resolution of her symptoms.

Comparison of outcomes and cost in patients undergoing tonsillectomy with electrocautery and thermal welding.

PURPOSE: To assess the morbidity and efficacy of thermal tissue welder instrument for tonsillectomy and compare it with monopolar electrocautery. MATERIALS AND METHODS: IRB approval was obtained at the Wexner Medical Center at Ohio State University for a prospective, randomized, single-blinded, controlled clinical study of 48 healthy adult volunteers undergoing tonsillectomy for chronic tonsillitis and tonsil hypertrophy. Subjects were randomized to the TW or EC group. Post-operative pain, pain medication use, return to normal oral intake, return to normal activity, and bleeding were measured on the post-operative log. We recorded operative time, operating room time, and blood loss. All procedures were performed by one surgeon to eliminate variations in time and experience. Operative and patient data were analyzed using a Student T-test and evaluated by cost analysis. RESULTS: There was a statically significant increase in operative time with the TW taking an average of 4min longer per procedure, p<0.001. However, when total anesthesia time was compared, this did not translate into a statistically significant increase in total operating room time and therefore did not translate into additional cost. The remaining categories were not significantly different between the two groups. In 3/23 TW cases, suction cautery was required for hemostasis. Two patients had 3 occurrences of secondary bleeding in the electrocautery group and none in the tissue welder group. TW cost increase per case was $167 per instrument but averaged $700 per case. CONCLUSIONS: While the tissue welder remains a viable option for the adult tonsillectomy procedure, it has not demonstrated in our study the necessary parameters intraoperatively, postoperatively, or via cost analysis to become the choice instrument at our institution. We cannot ignore the increase in cost that may be seen for short and routine procedures without an added benefit to the patient in terms of outcome or safety. A larger study is needed to determine if secondary bleeding rates are lower with this instrument.

A randomized, prospective, controlled study of forearm donor site healing when using a vacuum dressing.

OBJECTIVE: 1) Compare skin graft healing of the radial forearm free flap (RFFF) donor site when using a negative pressure dressing (NPD) versus a static pressure dressing (SPD). 2) Examine the association of graft size and medical comorbidities with healing of RFFF donor site. STUDY DESIGN: Randomized, controlled trial. SETTING: Tertiary care hospital. SUBJECTS AND METHODS: After the study was approved, consenting adults undergoing RFFF for head and neck reconstructions were randomized into two arms: SPD and NPD groups. Fifty-four patients were enrolled from March 2007 to August 2009. Pre- and postoperative data were collected, including medical comorbidities, graft size, and area of graft failure/tendon exposure. Data were collected at two postoperative time points. RESULTS: The overall wound complication rate was 38 percent (19/50). Wound complications at the first postoperative visit (44.4% [12/27] SPD and 30.4% [7/23] NPD) were not significantly different between groups (P = 0.816). Similarly, wound complications at the second visit (68.8% [11/16] SPD and 80% [12/15] NPD) were not significantly different (P = 0.55). Percentage of area of graft failure between the groups also showed no difference (4.5% SPD vs 7.2% NPD, P = 0.361). The association of graft size with wound complications was analyzed by dividing the data set into three groups (<50 cm(2), 51-100 cm(2), and >100 cm(2)). This difference was not found to be significant (P = 0.428). Finally, when evaluating comorbidities, 50 percent (8/16) of subjects with comorbidities experienced complications compared with 32.4 percent (11/34) without comorbidities, also not reaching significance (P = 0.203). CONCLUSIONS: Although an attractive option for wound care, the NPD does not appear to offer a significant improvement over an SPD in healing of the RFFF donor site.