How we measure hypoglossal nerve stimulator outcome matters: titration versus single amplitude efficacy sleep studies.

STUDY OBJECTIVES: Hypoglossal nerve stimulation (HGNS) is a common treatment for obstructive sleep apnea (OSA). Objective assessment of HGNS efficacy measures apnea-hypopnea index (AHI) by multi-amplitude titration polysomnography (tPSG) and/or a single amplitude efficacy sleep study (eHST). Both tests have been used to determine efficacy despite significantly different protocols. This project's aim was to determine differences in objective outcomes in HGNS patients who underwent both tPSG and eHST post-operatively. METHODS: Data from 379 consecutive HGNS patients were retrospectively reviewed. Inclusion requirements were a pre-operative sleep study, a post-operative tPSG, and then an eHST, which at our institution is a type 3 home study. AHI mean and differences were calculated. Wilcoxon rank sum tests were used to analyze differences between tPSG and eHST. Sher15 criteria (post-operative AHI≤15 events/hour and ≥50% reduction from baseline) was calculated and compared by χ2 tests. RESULTS: Ultimately 61 patients met inclusion criteria with an average pre-operative AHI=33.2. When comparing the subject's tPSG versus eHST, tPSG AHI was significantly lower (AHI=8.8 versus AHI=17.6; respectively, p<0.001). There was also a difference in the percentage of patients that met Sher15 criteria when using tPSG (80.3%) versus eHST AHI (45.9%). CONCLUSIONS: HGNS patient's postoperative tPSG AHI was significantly lower than their eHST outcome. This work highlights the importance of reporting the type of post-operative study used in evaluating HGNS efficacy and the need for single amplitude, full-night studies to assess HGNS efficacy more accurately.

Transoral Robotic Surgery Versus Hypoglossal Nerve Stimulation for OSA: A Cost Analysis Study.

BACKGROUND: Transoral robotic surgery (TORS) lingual tonsillectomy and hypoglossal nerve stimulation (HGNS) are effective surgical interventions for well-selected patients with obstructive sleep apnea (OSA) intolerant to continuous positive airway pressure (CPAP) therapy. Previous publications have demonstrated that HGNS patients have a lower postoperative apnea-hypopnea index (AHI) and length of hospital stay than TORS patients. No prior study has investigated the differences in costs between HGNS and TORS. OBJECTIVES: This study aims to compare surgery-related costs in patients undergoing HGNS versus TORS lingual tonsillectomy for OSA intolerant to CPAP. METHODS: A retrospective study on OSA patients intolerant to CPAP that underwent HGNS or TORS from 2015 to 2022 at a tertiary care center. Cost was defined as the dollar amount associated with providing a specific service prior to the application of insurance. RESULTS: This study included 395 patients (375 UAS and 20 TORS). Average total cost was significantly higher in the UAS group than the TORS group (UAS: $25,582.60; TORS: $5832.60; p < 0.001). Operating room costs were also significantly higher in the UAS group (UAS: $1978.20; TORS: $1490.90; p = 0.001). The TORS cohort averaged higher costs for pharmacy (UAS: $201.30; TORS: $416.60; p < 0.001) and anesthesia (UAS: $139.00; TORS: $307.60; p < 0.001). DISCUSSION: The total cost was significantly higher in the UAS group compared to the TORS group. When making management decisions, it is important to consider the cost of care provided as well as patient-centered outcomes to optimize the value of care. LEVEL OF EVIDENCE: N/A Laryngoscope, 2024.

Clinical Outcomes of Transcatheter Aortic Valve Replacement (TAVR) vs Surgical Aortic Valve Replacement (SAVR) in Patients With Sarcoidosis.

Introduction Data regarding clinical outcomes after transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) in patients with sarcoidosis is lacking. This study aims to clarify the clinical outcomes of TAVR vs SAVR in patients with sarcoidosis. Methods Data was collected from the National Inpatient Sample database from 2016-2019 using validated ICD-10-CM codes for sarcoidosis, TAVR, and SAVR. Patients were divided into two cohorts: those who underwent TAVR and those who underwent SAVR. Statistical analysis was performed using Pearson's chi-squared test to determine clinical outcomes of TAVR vs SAVR in patients with sarcoidosis. Results The prevalence of sarcoidosis was 0.23% among total study patients (n=142,420,378). After exclusions, the prevalence of TAVR was 650 (49%) and SAVR was 675 (51%) in patients with sarcoidosis. Patients who underwent TAVR were on average older (74 vs 65 years old, p=0.001), and more likely to be female (57 vs 40%, p<0.001) compared to patients who underwent SAVR. The TAVR cohort had higher rates of congestive heart failure (CHF) (77.7 vs 42.2%, p=0.001), chronic kidney disease (CKD) (42.3 vs 24.4% p=0.001), anemia (5.4 vs 2.2%, p=0.004), percutaneous coronary intervention (PCI) (1.5 vs 0%, p=0.004), and hypothyroidism (31.5 vs 16.3%, p=0.001) compared to the SAVR cohort. Inpatient mortality post-procedure was higher in the SAVR cohort compared to the TAVR cohort (15 vs 0, p=0.001). Regarding post-procedure complications, respiratory complications were more common in the SAVR cohort (4.4 vs 0%, p=0.001), while TAVR was associated with a higher incidence of permanent pacemaker (PPM) insertion (2.15 vs 0.8%, p=0.001). There was no statistical difference in the development of acute kidney injury (AKI) (0.8 vs 1.5%, p=0.33), AKI requiring hemodialysis (0 vs. 0.7%, p=0.08), or stroke (0.8 vs 0.7, p=1) post-procedure between the two cohorts. Conclusion This study found that in the sarcoidosis population, TAVR was associated with reduced mortality, shorter hospital length of stay, and lower hospitalization costs in comparison to SAVR.

Transoral robotic surgery with free flap reconstruction: Functional outcomes of 241 patients at a single institution.

BACKGROUND: Transoral robotic surgery (TORS) for oropharyngeal malignancy optimizes oncologic outcomes while preserving functionality. This study identifies patterns of functional recovery after TORS with free flap reconstruction (FFR). METHODS: Retrospective cohort study at a tertiary care center of patients with primary oropharyngeal tumors treated with TORS with FFR between 2010 and 2022. Patients were categorized into: adjuvant chemoradiation or radiation, or no adjuvant therapy (NAT). Functional outcomes were measured by functional oral intake scale (FOIS). RESULTS: 241 patients were included. FOIS declined at first postoperative appointment (median = 7.0 to 2.0, IQR = [7.0, 7.0], [2.0, 4.0]), and progressively improved to 6.0 (5.0, 6.0) after 1 year, with NAT having the highest FOIS (7.0, p < 0.05). Predictors of poor long-term FOIS included RT and hypoglossal nerve (CN XII) involvement (p < 0.05). CONCLUSIONS: TORS with FFR leads to good long-term function with minimal intake restrictions. Radiation therapy and CN XII involvement increase risk of worse functional outcomes.

Troubleshooting Upper Airway Stimulation Therapy Using Drug-Induced Sleep Endoscopy.

OBJECTIVE: This study assesses the utility of drug-induced sleep endoscopy (DISE) in guiding further treatment for patients with obstructive sleep apnea (OSA) who have difficulty tolerating upper airway stimulation (UAS) or have inadequate response to therapy. STUDY DESIGN: We conducted a retrospective analysis of UAS patients at our institution who underwent DISE, post-UAS, and evaluated the efficacy of different electrode configurations and maneuvers. SETTING: A tertiary care hospital. METHODS: Out of 379 patients who received UAS therapy, 34 patients who underwent DISE post-UAS (DISE-UAS) were included. Palatal coupling (PC) was assessed with UAS stimulation alone, jaw thrust alone, and both simultaneously during DISE. RESULTS: Among 34 patients, 5 had suboptimal adherence to UAS therapy, 19 had suboptimal therapy efficacy with residual OSA burden, and 10 had both. During DISE-UAS, PC was observed in 7 patients (21%) with UAS stimulation alone, 9 patients (26%) with jaw thrust alone, and 8 patients (24%) with both maneuvers combined. Notably, 10 patients (29%) did not exhibit PC with any maneuver. Based on DISE-UAS findings, 13 patients were recommended oral appliance therapy (OAT), and 8 patients underwent further surgical interventions. CONCLUSION: DISE-UAS is a valuable adjunct in troubleshooting UAS therapy for patients intolerant to CPAP or with suboptimal therapy efficacy. This study provides an algorithm for targeted multimodality therapy based on DISE findings, facilitating personalized management approaches.

Efficacy of Dose-Escalated Hypofractionated Radiosurgery for Arteriovenous Malformations.

There is considerable controversy about the management of arteriovenous malformations (AVMs) that are high risk for surgical resection. Stereotactic radiosurgery (SRS) has a reported success rate of less than 50% with unacceptably high rates of radiation necrosis with larger AVM volumes. Neither volume staging nor hypo-fractionated SRS have conclusively been demonstrated to improve results. We hypothesized that the failure of previous hypo-fractionation SRS trials was due to an insufficient biologically effective dose (BED) of radiation. We initiated a pilot study of treating AVM patients with a total dose divided into three or five fractions designed to deliver the equivalent BED of 20 Gy in a single fraction (α/ß =3). We performed a retrospective analysis of 37 AVM patients who had a minimum of two years of follow-up or underwent obliteration. Patients were treated with 30 Gy/3 fractions, 33 Gy/3 fractions, or 40 Gy/5 fractions using a CyberKnife device (Accuracy Incorporated, Madison, Wisconsin, United States). The primary endpoint was complete AVM obliteration, determined by MRA imaging. Most obliterations were confirmed with diagnostic cerebral angiography. Secondary endpoints were post-radiosurgery hemorrhage and radiation-related necrosis. Kaplan-Meier analysis was used to determine obliteration rates. From 2013 to 2021, 37 patients fitting inclusion criteria were identified (62% male, average age at treatment = 48.88 years). Fifteen (41%) patients had prior treatment (surgery, radiosurgery, embolization) for their AVM, 32 (86%) had AVMs in eloquent locations, 17 (46%) had high-risk features, and 14 (38%) experienced AVM rupture prior to treatment. The average modified radiosurgery-based AVM score (mRBAS) was 1.81 (standard deviation (SD)= 0.52), and the mean AVM volume was 6.77 ccs (SD = 6.09). Complete AVM obliteration was achieved in 100% of patients after an average of 26.13 (SD = 14.62) months. The Kaplan-Meier analysis showed AVM obliteration rates at one, two, and three years to be 16.2%, 46.9%, and 81.1%, respectively. Post-operative AVM rupture or hemorrhage occurred in one (2.7%) patient, after nine months. Radiation necrosis occurred in four (11%) patients after an average period of 17.3 (SD =14.7) months. The SRS dose used in this study is the highest BED of any AVM hypofractionation trial in the published literature. This study suggests that dose-escalated hypofractionated radiosurgery can be a successful strategy for AVMs with acceptable long-term complication rates. Further investigation of this treatment regimen should be performed to assess its efficacy.

A Pilot Study of Hypofractionated Radiosurgery for Trigeminal Neuralgia.

The primary late toxicity of radiosurgery treatment for trigeminal neuralgia (TN) is facial numbness due to trigeminal nerve dysfunction. Although most patients prefer loss of facial sensation to TN, severe loss of facial sensation can be debilitating. In order to try to obtain high pain control rates while minimizing the risk of late facial numbness, we elected to treat patients on the distal trigeminal nerve with a three-fraction regimen over consecutive days instead of one fraction. Our goal was to relieve the pain while also allowing the trigeminal nerve time to repair radiation damage between treatments in an attempt to minimize the risk of permanent facial numbness. Patients in a pilot study, approved by an Institutional Review Board (IRB), received a treatment regimen of 99 Gy, administered in three consecutive daily fractions of 33 Gy each, with the dosage targeted to the 80% line. This dose was selected to approximate a biologically equivalent dose of 80 Gy maximal dose to the trigeminal nerve. Forty-eight patients were treated with CyberKnife Radiosurgery (CKRS; 99 Gy/3 fractions) for TN from 2016 to 2022, with at least one year of follow-up. The Barrow Neurological Institute (BNI) scale was used to assess facial pain, and Kaplan-Meier analysis was used to assess adequate pain relief. Thirty-eight (84%) patients experienced adequate pain relief, defined as a BNI score of I-IIIb, after a median of 1.5 months following CKRS. Treatment failure (BNI=IV-V) occurred in 12 (25%) patients after a median of 6 months following initial pain relief. The actuarial probability of pain relief at 6, 12, and 24 months post-CKRS were 87.4%, 83.7%, and 83.7%, respectively. Facial numbness was experienced in 24 (50%) cases after a median of 10 months following CKRS. Typical facial pain (p=0.034) and vascular compression (p=0.039) were the only predictors of better treatment outcomes using univariate Cox survival analysis, and vascular compression (p= 0.037) was the only predictor in multivariate Cox survival analysis. Hypofractionated treatment to the distal trigeminal nerve segment does not appear to offer an advantage in treating TN, due to similar rates of pain relief but with an unacceptably high rate of late facial numbness.

Reduced usage of upper airway stimulation therapy in patients with comorbid insomnia and obstructive sleep apnea.

STUDY OBJECTIVES: Upper airway stimulation (UAS) is a hybrid surgical-medical device used to treat moderate-to-severe obstructive sleep apnea (OSA). Comorbid insomnia and OSA (COMISA) is present in ∼50% of these patients. Our aim was to study UAS outcomes and adherence in patients with COMISA. METHODS: A retrospective review of 379 patients with OSA who underwent UAS implantation at a single institution between 2014 and 2021. Demographics, OSA severity metrics, and insomnia data were collected. Patients were categorized into OSA alone (OSAa) or COMISA. Objective adherence data were collected from device downloads during follow-up. Data were analyzed with using R Studio (R Foundation for Statistical Computing, Vienna, Austria) and Prism (Boston, MA, USA). RESULTS: Of the 274 patients included, 148 had COMISA (54.0%) and 126 OSAa (46.0%). Average follow-up time was 2.5 years and OSAa had more males than COMISA (P < .001). Patients with COMISA had higher insomnia severity index scores than OSAa preoperatively (16 vs 8.7; P = .003). All groups showed significant decreases in objective and self-reported OSA outcomes postoperatively, but there was no difference between COMISA and OSAa. Patient with COMISA had decreased device usage (4.9 vs 5.8 h/night; P = .015) and paused therapy more often than patients with OSAa (1.4 vs 0.4 pauses/night; P < .001). Multivariate linear regression, when controlling for sex as a covariate, showed insomnia to be an independent predictor of lower UAS hours/night and more pauses/night (P < .01). CONCLUSIONS: Patients with COMISA use UAS therapy for shorter durations and require more breaks from therapy when compared with those with OSAa. Future research is needed to explore the underlying mechanism and improve UAS treatment adherence in patients with COMISA. CITATION: Kaffenberger TM, Chandna M, Kaki P, et al. Reduced usage of upper airway stimulation therapy in patients with comorbid insomnia and obstructive sleep apnea. J Clin Sleep Med. 2023;19(12):1997-2004.

Concurrent Radiation and Targeted Therapy for Papillary Craniopharyngioma: A Case Report.

Craniopharyngiomas are rare epithelial malformations in the sellar or suprasellar regions of the craniopharyngeal ducts. Complete surgical resection is difficult due to the location of the base of the skull and the risk of injury to vital neurological structures. Fractionated radiation is effective in controlling residual tumors, but craniopharyngiomas can progress during treatment. The papillary subtype is driven by BRAF V600E mutations. Treatment with BRAF and MEK inhibitors alone has a response rate of 90% but a median progression-free survival of only 12 months. A 57-year-old female presented in May 2017 with complaints of headaches and blurriness in her right eye. Brain MRI demonstrated a 2 cm suprasellar mass engulfing the right optic nerve and optic chiasm. The patient underwent a transsphenoidal hypophysectomy with pathology consistent with a benign pituitary adenoma. Follow-up imaging in August, however, showed recurrence, and a re-resection was performed which surprisingly demonstrated papillary craniopharyngioma. Due to subtotal resection, the patient elected to proceed with intensity-modulated radiation therapy (IMRT) to the tumor bed in April of 2018 with an intended dose of 5400 cGy. After treatment with 2160 cGy in 12 fractions, the patient experienced visual deterioration and progression of the cystic tumor. The patient underwent another debulking procedure but due to rapid recurrence, an endoscopic transsphenoidal fenestration was performed. On postoperative imaging, a cystic mass was still engulfing the right optic nerve and chiasm. Due to the extended break and limited radiation tolerance of the optic chiasm, we elected to re-treat the tumor with an additional 3780 cGy IMRT in conjunction with one cycle of Taflinar and Mekinist, which was completed in August 2018. The cumulative dose to the optic chiasm was 5940 cGy.The patient had an excellent clinical response to treatment with the improvement of vision in her right eye. A brain MRI on 3/29/2019 demonstrated no residual craniopharyngioma. Four-year follow-on CT scan showed no evidence of tumor recurrence. The patient had preservation of vision and did not suffer any late neurological toxicity or new endocrine deficiency. Surgical resection and radiation were ineffective at treating our patient's craniopharyngioma due to rapid cystic progression. This is the first case report in the literature detailing concurrent radiation therapy with BRAF and MEK inhibitors for papillary craniopharyngioma. Despite a suboptimal dose of radiation, our patient had no tumor recurrence and no late toxicity four years after treatment. This represents a potentially novel treatment strategy in this challenging entity.