New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2022.

Objective: To review new drugs and devices relevant to otolaryngology approved by the Food and Drug Administration (FDA) in 2022. Data Sources: Publicly available FDA data on drugs and devices approved in 2022. Review Methods: A preliminary screen was conducted to identify drugs and devices relevant to otolaryngology. A secondary screen by members of the American Academy of Otolaryngology-Head and Neck Surgery's (AAO-HNS) Medical Devices and Drugs Committee differentiated between minor updates and new approvals. The final list of drugs and devices was sent to members of each subspecialty for review and analysis. Conclusion: A total of 1251 devices and 37 drugs were identified on preliminary screening. Of these, 329 devices and 5 drugs were sent to subspecialists for further review, from which 37 devices and 2 novel drugs were selected for further analysis. The newly approved devices spanned all subspecialties within otolaryngology. Many of the newly approved devices aimed to enhance patient experience, including over-the-counter hearing aids, sleep monitoring devices, and refined CPAP devices. Other advances aimed to improve surgical access, convenience, or comfort in the operating room and clinic. Implications for Practice: Many new devices and drugs are approved each year to improve patient care and care delivery. By staying up to date with these advances, otolaryngologists can leverage new innovations to improve the safety and quality of care. Given the recent approval of these devices, further studies are needed to assess long-term impact within the field of otolaryngology.

Bell's Palsy and COVID-19: Insights from a Population-Based Analysis.

Background: Coronavirus disease 2019 (COVID-19) has been linked to Bell's palsy and facial paralysis. Studies have also shown increased risk of Bell's palsy in unvaccinated COVID-19 patients. Objective: To compare the relationship between Bell's palsy and COVID-19 infection and vaccination. Design: This is a retrospective longitudinal study. Methods: The COVID-19 research network was used to identify patients with facial palsy presenting to 70 health care organizations in the United States. The incidence of Bell's palsy was measured within an 8-week window after COVID-19 test or vaccination event in identified patients. Results: Incidence of facial palsy diagnosis (0.99%) was higher than the background rate within 2 months of COVID-19 infection. When compared with their negative counterparts, patients with COVID-19 infection had significantly higher risk of Bell's palsy (risk ratio [RR] = 1.77, p < 0.01) and facial weakness (RR = 2.28, p < 0.01). Risk ratio was also amplified when evaluating Bell's palsy (RR = 12.57, p < 0.01) and facial palsy (RR = 44.43; p < 0.01) in COVID-19-infected patients against patients who received COVID-19 vaccination. Conclusion: In our patient population, there is a higher risk of developing facial palsy within 2 months of COVID-19 infection versus vaccination. Vaccinated patients are not at higher risk of developing facial palsy.

Insights on in-office scar revision and resurfacing procedures.

Objective: Many facial plastic surgery procedures can be performed in an office-based setting, ranging from simple chemical peels to reconstructive surgeries to assist with scar revision. The aim of this review is to summarize the current state of facial plastics in-office surgical procedures, including scar revision, dermabrasion, lasers, and chemical peels. Methods: A literature review was conducted with the PubMed search engine with the following keywords: facial plastics, scar revision, dermabrasion, lasers, chemical peels, face, office, and outpatient. The literature was surveyed for relevance, with a focus on realistically which procedures were performed in a facial plastics surgery outpatient clinic. These were then used to compile a review of the current state of this field. Results and Conclusions: There are various scar revision procedures that can be performed in the office setting, including z-plasty, w-plasty, and geometric broken line closure techniques, as well as various nonmedical treatment options to improve the appearance of a scar. Dermabrasion can also be performed to assist with elevated scars. Various lasers are available to enhance cell turnover in the field of facial rejuvenation, scarring, and sun damage. Chemical peels are also available to assist with facial rejuvenation. With the appropriate counseling of the patient and medical staff, these can be safely performed in the office.

Examining the relationship between COVID-19 and Bell's palsy: Experience of a single tertiary care center.

BACKGROUND: While the etiology of Bell's palsy (BP) is largely unknown, current evidence shows it may occur secondary to the immune response following a viral infection. Recently, BP has been reported as a clinical manifestation of coronavirus disease (COVID-19). OBJECTIVES: To investigate an association between COVID-19 infection and BP. Additionally, to evaluate the need for COVID-19 testing in patients who present with BP. METHODS: Hospital records of patients who presented to a single tertiary care center with BP in 2020 and 2021 were reviewed for presenting symptoms, demographics, COVID-19 infection and vaccination status. RESULTS: There was no statistically significant difference between patients with BP who had a positive or negative COVID test in terms of sex, BMI, age, race, smoking history or alcohol use. All 7 patients with BP and a positive COVID test were unvaccinated. Of the total cohort of 94 patients, 82 % were unvaccinated at the time of the study. None of the 17 patients who were vaccinated had a positive COVID test. A history of BP showed no statistical significance (10.3 % vs 14.3 %, p-value 0.73). CONCLUSION: We discovered a limited cohort of patients who underwent COVID-19 testing at the time of presentation for BP. Though there have been recent studies suggesting a COVID-19 and BP, we were unable to clearly identify a relationship between COVID-19 and BP. Interestingly, all patients with facial paralysis and COVID-19 were unvaccinated. To further study this relationship, we recommend consideration of a COVID-19 test for any patient that presents with facial paralysis.

Superior Labial Mucosal Flap for Buccal Defect Reconstruction.

The superior labial artery mucosal (SLAM) flap is a regional axial flap based on the superior labial artery, utilized in complex cases of nasal reconstruction involving the nasal lining.1 We present a novel case of this flap used for buccal cavity reconstruction. This report highlights the versatility of the SLAM flap as an option for oral buccal defects.

Facial Nerve Preservation With Inferior Long-Axis Dissection of Large Vestibular Schwannomas.

OBJECTIVE: To describe a tumor resection using the inferior long-axis (ILA) technique for cisternal facial nerve dissection in large vestibular schwannomas (VS). STUDY DESIGN: Retrospective case series from 2018 to 2021. SETTING: Tertiary academic medical center. PATIENTS: Patients who underwent surgical resection with ILA facial nerve dissection of VS (>2.0 cm measured parallel to the petrous ridge) and had at least 3-month follow-up. INTERVENTIONS: Cisternal facial nerve dissection during retrosigmoid or translabyrinthine approach using standardized ILA technique developed by author R.N. MAIN OUTCOME MEASURES: Immediate postoperative and last follow-up facial nerve function with House-Brackmann scores of I to II defined as "good" facial nerve function and House-Brackmann scores III to VI defined as "poor" function. Extent of resection was also assessed. RESULTS: A total of 48 patients underwent large VS resection with ILA dissection of tumor off of the facial nerve from 2018 to 2021. Mean (standard deviation) tumor size was 3.11 (0.76) cm. Mean (standard deviation) follow-up was 9.2 (9.0) months. Gross-total resection or near-total resection were achieved in 75% (radiographic estimate) to 83% (surgeon estimate) of cases. End-of-case facial nerve stimulation at 0.05 mAmp with a response of at least 240 mV was achieved in 80.4% of patients. Good facial nerve function was observed in 72% immediately postoperatively, 70% 1-month postoperatively, and 82% of patients at last follow-up. CONCLUSIONS: The ILA technique is now the method of choice of the senior surgeon (R.N.) when performing microsurgical dissection of the cisternal facial nerve, with which he has achieved high rates of total or near-total resection with excellent facial nerve preservation.

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021.

Objective: To evaluate new medical devices and drugs pertinent to otolaryngology-head and neck surgery that were approved by the Food and Drug Administration (FDA) in 2021. Data Sources: Publicly available FDA device and drug approvals from ENT (ear, nose, and throat), anesthesia, neurosurgery, plastic surgery, and general surgery FDA committees. Review Methods: FDA device and therapeutic approvals were identified and reviewed by members of the American Academy of Otolaryngology-Head and Neck Surgery's Medical Devices and Drugs Committee. Two independent reviewers assessed the relevance of devices and drugs to otolaryngologists. Medical devices and drugs were then allocated to their respective subspecialty fields for critical review based on available scientific literature. Conclusions: The Medical Devices and Drugs Committee reviewed 1153 devices and 52 novel drugs that received FDA approval in 2021 (67 ENT, 106 anesthesia, 618 general surgery and plastic surgery, 362 neurosurgery). Twenty-three devices and 1 therapeutic agent relevant to otolaryngology were included in the state of the art review. Advances spanned all subspecialties, including over-the-counter hearing aid options in otology, expanding treatment options for rhinitis in rhinology, innovative laser-safe endotracheal tubes in laryngology, novel facial rejuvenation and implant technology in facial plastic surgery, and advances in noninvasive and surgical treatment options for obstructive sleep apnea. Implications for Practice: FDA approvals for new technology and pharmaceuticals present new opportunities across subspecialties in otolaryngology. Clinicians' nuanced understanding of the safety, advantages, and limitations of these innovations ensures ongoing progress in patient care.

Orbital Complications of Acute Sinusitis in Pediatric Patients: Management of Chandler III Patients.

Background: Surgery is often avoided in the setting of pediatric orbital complications from acute sinusitis unless necessitated by alarming ophthalmological signs. Criteria for surgical intervention are not well-defined. Objective: We aim to review our experiences, management practices and patient outcomes over a ten-year period for Chandler III patients. Methods: A retrospective review was performed from January 1, 2007 through December 31, 2016 of patients treated for orbital symptoms secondary to acute sinusitis at a free-standing tertiary-care pediatric hospital. Results: Of the 186 patients reviewed, 42 Chandler III patients were included. Average age was 82.6 months (SD 50.6) with a slight male predominance (M to F, 1.8 to 1). 27 patients (64.3%) underwent intervention including endoscopic sinus surgery (ESS) with or without orbitotomy. Late surgical intervention (>48hrs from admission) demonstrated significant increase in overall length of stay (LOS) when compared with early surgical intervention and/or medical management (median, 6.9 vs 3.6 vs 3.7 days; p < 0.01). Postoperative LOS was also higher in the late surgery group compared with patients who had surgery within 48 hours of admission, but this did not reach statistical significance [median, 3.8 vs 2.8 days, p= 0.12]. There was no significant difference in overall abscess volume between patients who underwent intervention and those who did not (1019 mm3 vs 805 mm3, p = 0.5), but abscess width ≥ 1.2 cm was associated with higher rates of intervention. An alarming extraocular exam was the most common factor associated with surgical intervention. Conclusion: Pediatric subperiosteal orbital abscess may prompt surgical intervention by ESS. An alarming ophthalmologic exam should prompt consideration of early intervention, which may lead to decreased overall and post-operative length of hospital stay. Level of Evidence: 4. Meeting Information: American Rhinologic Society, Fall National Meeting. Chicago, IL, USA. September 8-9, 2017.

Facial Artery Musculomucosal Flap Operative Techniques.

SUMMARY: Regional flaps are an important component of the reconstructive ladder and represent a versatile option in reconstructing various oral cavity defects. An axial buccal flap based on the facial artery, the facial artery musculomucosal flap, was first described by Pribaz et al. and has been shown to have good functional outcomes with minimal morbidity. Indeed, other surgeons have praised its favorable arc of rotation, reliability, and role as an alternative to free tissue transfer, with shorter duration of general anesthesia and allowance for earlier postoperative mobilization. The facial artery musculomucosal flap has significant versatility, as it can be superiorly or inferiorly based and can be performed in either single- or two-stage fashion. It is of particular advantage for reconstruction of the oral cavity (retromolar trigone, hard palate, alveolar ridge, lip, tongue, and floor of mouth), oropharynx (tongue base, lateral pharynx, and soft palate), and sinonasal structures. Despite its advantages, its widespread use has been limited by a lack of familiarity and difficulty in safely raising a reliable flap consistently. The senior author (S.C.D.) has successfully utilized a high volume of facial artery musculomucosal flaps with a low complication rate in a broad array of oral cavity and oropharyngeal defects. In this article, the authors share technical details on how to harvest and inset this flap by incorporating key landmarks in a reliable fashion.

Hürthle cell neoplasms of the thyroid: Pathologic outcomes and ultrasonographic analysis.

BACKGROUND: Fine-needle aspiration (FNA) of thyroid nodules suspicious for Hürthle cell neoplasms (HCN) have uncertain rate of malignancy. We aim to characterize rate and predictors of malignancy at our institution and compare these findings with established literature to help guide management. METHODS: Single tertiary-referral center, retrospective study of 166 adults who underwent hemithyroidectomy or total thyroidectomy following FNA suspicious for HCN from 1998-2018. Demographic information and surgical histopathologic results were collected. Preoperative ultrasonography was independently scored on the American College of Radiology Thyroid Imaging Reporting and Data System (TI-RADS) by a board-certified head and neck radiologist. RESULTS: There were 39 males and 127 females. Overall, 25 (15.1%) patients had carcinoma, with 15 (9%) being Hürthle cell carcinoma (HCC). Men had higher incidence of carcinoma (25.6% v. 11.8%, P = .035), and especially older males. Contralateral carcinoma was seen in 3 of 13 (23.1%) patients that underwent completion thyroidectomy. Patients with carcinoma had larger nodules (average diameter 3.3 cm versus 2.5 cm, respectively, P = .01), but no association with TI-RADS. CONCLUSION: Adults with nodules suspicious for HCN have significant risk of malignancy consistent with prior studies. Older males and larger nodule diameter are associated with malignancy in this cohort, but TI-RADS grade is not. These findings provide a framework for management and counseling for lesions suspicious for HCN.

The association of weather, temperature, and holidays on pediatric maxillofacial trauma.

OBJECTIVE: To evaluate the association of weather, seasons, months and holidays on the frequency and pattern of pediatric facial fractures. METHODS: Retrospective review of pediatric patients treated for facial fractures at two Level I trauma centers in a midsize Midwestern US city over a 5-year period. Patients were included only if presentation was within 3 hours of inciting trauma, transfers from other facilities were excluded. Demographic characteristics, fracture patterns, operative interventions, weather data, and local public school schedules were acquired and associations were analyzed with unpaired t tests, χ2, multivariate and binomial regression model analyses. RESULTS: Two hundred and sixty patients were included. The average age (SD) was 11.8 (5.0) years, with 173 males and 87 females. The highest distribution of presentations occurred in the summer season (35.0%), on weekends and holidays (58.1%), and when the weather was described as clear (48.5%). The most common mechanisms of injury were motor vehicle collisions (25.8%), followed by sports-(21.5%) and assault-(16.5%) related injuries. Mechanisms were significantly associated with certain fracture patterns. Older age was associated with fewer orbital fractures (P < .01). Seventy-five patients (28.8%) required operative intervention. Age was found to impact the likelihood of operative intervention (Exp(ß) = 1.081, P = .03) while weather, temperature, and mechanism did not. CONCLUSION: Pediatric facial fractures are linked to warmer weather with clear skies and warmer season. Age predicts some fracture patterns and need for operative intervention. These results can be used to inform public health interventions, policymaking, and trauma staffing.Level of Evidence: Level 2b (retrospective cohort).

Flap demise reversed after central venous access device removal: A case report.

Patients undergoing head and neck free flap reconstruction should be evaluated for radiation-induced venous stenosis and presence of central venous port as a potential risk for flap failure.

Intraoperative ketorolac for pediatric tonsillectomy: Effect on post-tonsillectomy hemorrhage and perioperative analgesia.

OBJECTIVE: Determine the impact of ketorolac on post-tonsillectomy hemorrhage (PTH) and narcotic administration in children undergoing tonsillectomy. METHODS: Retrospective case series from 2013 to 2017. Patients younger than 18 years undergoing tonsillectomy were included. PTH was the primary outcome measured. Secondary measures include percentage of patients requiring surgical intervention for PTH, average time to PTH, the number of post-operative opioid doses, and average post-operative opioid dose. Statistical methods include Chi-square, Wilcoxon rank sum, and binary logistic regression analyses. RESULTS: During the study period, 669 patients received a single intraoperative dose of ketorolac (K+) and 653 patients did not receive ketorolac (K-). No differences were found in the rate of PTH (K- 6.5% vs. K+ 5.3%, RR = 0.82, 95% CI = 0.53 to 1.29, p = 0.40), surgical control of PTH (K- 4.0% vs. K+ 3.5%, RR = 0.87, CI = 0.51 to 1.51, p = 0.62), or average time [SD] to PTH (K- 6.0 [4.2] vs. K+ 5.2 [4.9] days; difference = 0.8 days; 95% CI, -1.3 to 2.9; p = 0.45). K+ patients had fewer post-operative opioid doses [SD] (K- 1.86 [1.14] vs. K+ 1.59 [1.23]; difference = -0.27; 95% CI, -0.053 to -0.49, Cohen d = 0.23) and a lower average opioid dose [SD] (K- 0.041 [0.032] vs. K+ 0.035 [0.030] mg/kg; difference = -0.006 mg/kg; 95% CI, -0.0003 to -0.012; Cohen d = 0.19). CONCLUSION: Ketorolac did not increase risk of hemorrhage following tonsillectomy and decreased narcotic use.

Patient satisfaction survey experience among American otolaryngologists.

BACKGROUND: Patient Satisfaction (PS) is a commonly used metric in health care settings to assess the quality of care given by physicians. Monitoring physicians in this way may impact physician quality of life. Studies evaluating this impact are not available. This study sought to examine the physician experience of measuring PS among practicing otolaryngologists. METHODS: Using an online survey platform, a 34-item survey was given to practicing otolaryngologists through email distribution. The survey included questions about physician, practice and patient demographics, as well as inquiries regarding the way in which PS was measured and how it affected physician work and personal life. Data from these questions were reviewed and analyzed. RESULTS: 174 otolaryngologists responded to the survey. A majority of physicians' (55.3%) PS scores had been tracked with 89.9% reporting being tracked for a length of at least 1 year. PS scores for individual physicians were noted to be inconsistent and vary significantly between reports. Measuring patient satisfaction led to increased occupational stress, yet most physicians (63.8%) felt the monitoring did not lead to improvements in their practice. Some physicians (36.2%) reported that the collection of patient satisfaction scores had negatively influenced the way they practiced medicine, including the pressure to order superfluous tests or to prescribe unnecessary medications. CONCLUSION: Overall, physicians are negatively affected by the tracking of patient satisfaction scores. Occupational stress caused by the collection of patient satisfaction scores may contribute to physician burnout.

Hair-bearing human skin generated entirely from pluripotent stem cells.

The skin is a multilayered organ, equipped with appendages (that is, follicles and glands), that is critical for regulating body temperature and the retention of bodily fluids, guarding against external stresses and mediating the sensation of touch and pain1,2. Reconstructing appendage-bearing skin in cultures and in bioengineered grafts is a biomedical challenge that has yet to be met3-9. Here we report an organoid culture system that generates complex skin from human pluripotent stem cells. We use stepwise modulation of the transforming growth factor ß (TGFß) and fibroblast growth factor (FGF) signalling pathways to co-induce cranial epithelial cells and neural crest cells within a spherical cell aggregate. During an incubation period of 4-5 months, we observe the emergence of a cyst-like skin organoid composed of stratified epidermis, fat-rich dermis and pigmented hair follicles that are equipped with sebaceous glands. A network of sensory neurons and Schwann cells form nerve-like bundles that target Merkel cells in organoid hair follicles, mimicking the neural circuitry associated with human touch. Single-cell RNA sequencing and direct comparison to fetal specimens suggest that the skin organoids are equivalent to the facial skin of human fetuses in the second trimester of development. Moreover, we show that skin organoids form planar hair-bearing skin when grafted onto nude mice. Together, our results demonstrate that nearly complete skin can self-assemble in vitro and be used to reconstitute skin in vivo. We anticipate that our skin organoids will provide a foundation for future studies of human skin development, disease modelling and reconstructive surgery.

Management of Large Facial Defects.

There is considerable variation in the surgical management of patients with large facial defects after excision of skin malignancy. The surrounding facial subunits as well as local, regional, and distant soft-tissue flaps can be considered in more complicated facial defects. We place an emphasis on the versatility of adjacent tissue advancement and transposition flaps in the treatment of these defects. We also focus on the secondary reconstructive efforts necessary to achieve the best functional and aesthetic outcomes for patients.