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.

Improvement in Quality of Life after Septoplasty in Children: a Systematic Review.

KEY POINTS: Septoplasty for nasal obstruction in the pediatric population shows positive outcomes in objective and subjective post-operative measurements. Septoplasty in children results in disease-related improvement in quality of life. Higher level studies are needed to confirm these results.

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.

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020.

OBJECTIVES: To evaluate new drugs and devices relevant to otolaryngology-head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2020. DATA SOURCES: Publicly available device and therapeutic approvals from ENT (ear, nose, and throat), anesthesia, neurology (neurosurgery), and plastic and general surgery FDA committees. REVIEW METHODS: Members of the American Academy of Otolaryngology-Head and Neck Surgery's Medical Devices and Drugs Committee reviewed new therapeutics and medical devices from a query of the FDA's device and therapeutic approvals. Two independent reviewers assessed the drug's or device's relevance to otolaryngology, classified to subspecialty field, with a critical review of available scientific literature. CONCLUSIONS: The Medical Devices and Drugs Committee reviewed 53 new therapeutics and 1094 devices (89 ENT, 140 anesthesia, 511 plastic and general surgery, and 354 neurology) approved in 2020. Ten drugs and 17 devices were considered relevant to the otolaryngology community. Rhinology saw significant improvements around image guidance systems; indications for cochlear implantation expanded; several new monoclonal therapeutics were added to head and neck oncology's armamentarium; and several new approvals appeared for facial plastics surgery, pediatric otolaryngology, and comprehensive otolaryngology. IMPLICATIONS FOR PRACTICE: New technologies and pharmaceuticals offer the promise of improving how we care for otolaryngology patients. However, judicious introduction of innovations into practice requires a nuanced understanding of safety, advantages, and limitations. Working knowledge of new drugs and medical devices approved for the market helps clinicians tailor patient care accordingly.

Multi-institutional Comparison of Temporal Bone Models: A Collaboration of the AAO-HNSF 3D-Printed Temporal Bone Working Group.

OBJECTIVE: The American Academy of Otolaryngology-Head and Neck Surgery Foundation's (AAO-HNSF's) 3D-Printed Temporal Bone Working Group was formed with the goal of sharing information and experience relating to the development of 3D-printed temporal bone models. The group conducted a multi-institutional study to directly compare several recently developed models. STUDY DESIGN: Expert opinion survey. SETTING: Temporal bone laboratory. METHODS: The working group convened in 2018. The various methods in which 3D virtual models had been created and printed in physical form were then shared and recorded. This allowed for comparison of the advantages, disadvantages, and costs of each method. In addition, a drilling event was held during the October 2018 AAO-HNSF Annual Meeting. Each model was drilled and evaluated by attending-level working group members using an 15-question Likert scale questionnaire. The models were graded on anatomic accuracy as well as their suitability as a simulation of both cadaveric and operative temporal bone drilling. RESULTS: The models produced for this study demonstrate significant anatomic detail and a likeness to human cadaver specimens for drilling and dissection. Models printed in standard resin material with a stereolithography printer scored highest in the evaluation, though the margin of difference was negligible in several categories. CONCLUSION: Simulated 3D temporal bones created through a number of printing methods have potential benefit in surgical training, preoperative simulation for challenging otologic cases, and the standardized testing of temporal bone surgical skills.

Lipoblastomatosis: An unusual midline neck mass in a young child.

Lipoblastomatosis is an extremely rare condition and is often not recognized prior to final pathologic analysis. In this case, a two-year-old female child presented with a non-tender, submental midline neck mass which had enlarged very slowly over the course of five months. The differential diagnosis included lipoma, lymphatic malformation, and thyroglossal duct cycst and a surgical excision was planned. The child was consented for a possible Sistrunk procedure if necessary. Intraoperatively, the mass was adherent to the hyoid bone and clear mucoid drainage was noted during resection leading the team to further weight the possibility of thyroglossal duct cyst and proceed with a Sistrunk procedure. Ultimately, final pathology revealed the diagnosis of lipoblastomatosis.

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2019.

OBJECTIVE: To review new devices and drugs relevant to otolaryngology-head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2019. DATA SOURCES: Approval notifications for 2019 were extracted from the ENT (ear, nose, and throat) and general and plastic surgery sections of the FDA's medical devices and therapeutics listings. REVIEW METHODS: New therapeutics and medical devices identified from the query were analyzed by members of the American Academy of Otolaryngology-Head and Neck Surgery's Medical Devices and Drugs Committee. Technologies were assessed by 2 independent reviewers to ascertain relevance to otolaryngology, prioritized, and classified to subspecialty field with critical review based on extant scientific literature. CONCLUSIONS: Query of the FDA drug and device database returned 105 ENT devices (50 cleared, 55 with premarket approval, and 0 de novo), 543 general and plastic surgery devices (372 cleared, 170 with premarket approval, and 1 de novo), and 46 new otolaryngology-relevant drug approvals that occurred in 2019. Advances spanned all subspecialty areas with otology predominating, primarily due to hearing-related technologies. While scientific evidence was available for all new devices, there was significant heterogeneity in rigor of supporting scientific data. IMPLICATIONS FOR PRACTICE: Technological and pharmaceutical innovation is an important catalyst for advances in the surgical specialties. Familiarity with new devices and therapeutics in otolaryngology-head and neck surgery ensures that clinicians keep abreast of developments with potential to improve prevailing standards of care.

Congenital Midline Cervical Cleft: First Report and Genetic Analysis of Two Related Patients.

OBJECTIVES: Congenital midline cervical cleft (CMCC) is a rare congenital anterior neck anatomical anomaly. We present the case of two related patients (grandchild and maternal grandmother) who were both born with a congenital midline cervical cleft along with genetic analysis. METHODS: Clinical examination of both patients and surgical excision of the grandchild was performed. Genetic analysis with exome sequencing (ES) was conducted for both patients. RESULTS: Genetic analysis with exome sequencing (ES) revealed apparently novel single nucleotide variants in 66 genes present in both proband and grandmother. Five of these variants are predicted to cause frameshifting in the coding region of the respective genes and truncated proteins (OVGP1, TYW1B, ZAN, SSPO, FOLR3). Two of these genes (TYW1B and SSPO) have homozygous indel mutations in both patients. CONCLUSIONS: To our knowledge, this is the first case of two related patients with a congenital midline cervical cleft. The results of our genetic analysis reveal potential relevance to CMCC development.

Development of augmented-reality applications in otolaryngology-head and neck surgery.

OBJECTIVES/HYPOTHESIS: Augmented reality (AR) allows for the addition of transparent virtual images and video to one's view of a physical environment. Our objective was to develop a head-worn, AR system for accurate, intraoperative localization of pathology and normal anatomic landmarks during open head and neck surgery. STUDY DESIGN: Face validity and case study. METHODS: A protocol was developed for the creation of three-dimensional (3D) virtual models based on computed tomography scans. Using the HoloLens AR platform, a novel system of registration and tracking was developed. Accuracy was determined in relation to actual physical landmarks. A face validity study was then performed in which otolaryngologists were asked to evaluate the technology and perform a simulated surgical task using AR image guidance. A case study highlighting the potential usefulness of the technology is also presented. RESULTS: An AR system was developed for intraoperative 3D visualization and localization. The average error in measurement of accuracy was 2.47 ± 0.46 millimeters (1.99, 3.30). The face validity study supports the potential of this system to improve safety and efficiency in open head and neck surgical procedures. CONCLUSIONS: An AR system for accurate localization of pathology and normal anatomic landmarks of the head and neck is feasible with current technology. A face validity study reveals the potential value of the system in intraoperative image guidance. This application of AR, among others in the field of otolaryngology-head and neck surgery, promises to improve surgical efficiency and patient safety in the operating room. LEVEL OF EVIDENCE: 2b Laryngoscope, 129:S1-S11, 2019.

Transoral robotic surgery for upper airway pathology in the pediatric population.

OBJECTIVES/HYPOTHESIS: The purpose of this study is to present one of the largest case series of pediatric transoral robotic surgery (TORS) in the upper airway demonstrating a wide range of ages and indications. STUDY DESIGN: A retrospective case series at an academic tertiary referral center from August 2010 to September 2014. METHODS: The da Vinci surgical robot (Intuitive Surgical, Inc., Sunnyvale, CA) was used on 16 pediatric patients for 18 procedures. A variety of upper airway pathologies and reconstructions in children with a wide range of ages and weights were treated. No lingual tonsillectomies or base-of-tongue reductions were included. RESULTS: Sixteen children (6 males) underwent 18 TORS procedures, including resection of hamartoma (n = 1), repair of laryngeal cleft (n = 7), removal of saccular cyst (n = 2), release of pharyngeal or esophageal strictures (n = 2), and excision of lymphatic malformations (n = 4). Patient ages ranged from 14 days to 15 years. There were no intraoperative complications. All patients had successful robotic access, and no patients had conversions to open or traditional endoscopic surgery. Hospital courses varied with duration ranging from 1 to 20 days. The median follow up was 22 months. CONCLUSION: Applying TORS to the pediatric population can be feasible and safe for appropriate airway pathologies. Because many patients are small in size, there is inherent risk in using robotic instruments and scopes transorally. Pearls in this series include a standardized two-robot experienced attending team and longitudinal airway follow-up. LEVEL OF EVIDENCE: 4 Laryngoscope, 127:247-251, 2017.

Pre-operative simulation of pediatric mastoid surgery with 3D-printed temporal bone models.

OBJECTIVES: As the process of additive manufacturing, or three-dimensional (3D) printing, has become more practical and affordable, a number of applications for the technology in the field of pediatric otolaryngology have been considered. One area of promise is temporal bone surgical simulation. Having previously developed a model for temporal bone surgical training using 3D printing, we sought to produce a patient-specific model for pre-operative simulation in pediatric otologic surgery. Our hypothesis was that the creation and pre-operative dissection of such a model was possible, and would demonstrate potential benefits in cases of abnormal temporal bone anatomy. METHODS: In the case presented, an 11-year-old boy underwent a planned canal-wall-down (CWD) tympano-mastoidectomy for recurrent cholesteatoma preceded by a pre-operative surgical simulation using 3D-printed models of the temporal bone. The models were based on the child's pre-operative clinical CT scan and printed using multiple materials to simulate both bone and soft tissue structures. To help confirm the models as accurate representations of the child's anatomy, distances between various anatomic landmarks were measured and compared to the temporal bone CT scan and the 3D model. RESULTS: The simulation allowed the surgical team to appreciate the child's unusual temporal bone anatomy as well as any challenges that might arise in the safety of the temporal bone laboratory, prior to actual surgery in the operating room (OR). There was minimal variability, in terms of absolute distance (mm) and relative distance (%), in measurements between anatomic landmarks obtained from the patient intra-operatively, the pre-operative CT scan and the 3D-printed models. CONCLUSIONS: Accurate 3D temporal bone models can be rapidly produced based on clinical CT scans for pre-operative simulation of specific challenging otologic cases in children, potentially reducing medical errors and improving patient safety.

Multi-material 3D Models for Temporal Bone Surgical Simulation.

HYPOTHESIS: A simulated, multicolor, multi-material temporal bone model can be created using 3-dimensional (3D) printing that will prove both safe and beneficial in training for actual temporal bone surgical cases. BACKGROUND: As the process of additive manufacturing, or 3D printing, has become more practical and affordable, a number of applications for the technology in the field of Otolaryngology-Head and Neck Surgery have been considered. One area of promise is temporal bone surgical simulation. METHODS: Three-dimensional representations of human temporal bones were created from temporal bone computed tomography (CT) scans using biomedical image processing software. Multi-material models were then printed and dissected in a temporal bone laboratory by attending and resident otolaryngologists. A 5-point Likert scale was used to grade the models for their anatomical accuracy and suitability as a simulation of cadaveric and operative temporal bone drilling. RESULTS: The models produced for this study demonstrate significant anatomic detail and a likeness to human cadaver specimens for drilling and dissection. CONCLUSION: Simulated temporal bones created by this process have potential benefit in surgical training, preoperative simulation for challenging otologic cases, and the standardized testing of temporal bone surgical skills.

Comprehensive quality of life outcomes for pediatric patients undergoing endoscopic sinus surgery.

BACKGROUND: Limited quality of life data exist for pediatric chronic rhinosinusitis (CRS) patients undergoing endoscopic sinus surgery (ESS). Further exploration of the following areas will enhance understanding and support clinical decision-making: baseline and post-ESS general and disease-specific quality of life, parent vs. child report, and correlation of nasal endoscopy to sinus CT scores. METHODOLOGY: A prospective cohort study evaluated CRS patients age 5-18 undergoing ESS. Surveys were completed at two timepoints: (1) pre-ESS and (2) 30-90 days post-ESS, with parents completing general (PedsQLTM) and CRS-specific (SNOT-16 and SN-5) quality of life surveys and children completing PedsQLTM and SNOT-16 surveys. Preoperative Lund-Kennedy nasal endoscopy and Lund-Mackay sinus CT scores were calculated. Where appropriate, outcomes were stratified by cystic fibrosis status. RESULTS: Impaired preoperative general quality of life was evidenced by parent proxy-report of PedsQLTM scores in 10 cystic fibrosis and 11 non-CF patients. ESS was associated with decreased sinus symptoms at 1-3 months postoperatively with SN-5 change scores of -1.85 and -2.2, in CF and non-CF patients, respectively. Parents reported worse CRS symptoms via higher preoperative SNOT-16 scores than their children did. Nasal endoscopy and sinus CT scores correlated with a Spearman correlation coefficient of 0.51. Scores not reaching statistical significance included CF-related CRS SNOT-16 change scores and PedsQLTM general quality of life change scores. CONCLUSION: In pediatric patients with CRS electing ESS, general quality of life is impaired preoperatively and sinus symptoms improve significantly 1-3 months after sinus surgery. Parents report statistically worse CRS symptom scores than their children do. Nasal endoscopy scores in this cohort correlated with sinus CT scores.

Surgical management of chronic sialorrhea in pediatric patients: 10-year experience from one tertiary care institution.

BACKGROUND: Chronic sialorrhea is a common problem for pediatric patients with disorders that affect swallowing. While many patients are successfully treated with medical therapies such as Robinul and Scopolamine, a number of such children are not able to tolerate the side effects of these medications. In these cases, surgical treatments can include Botulinum toxin A (Botox) injections into the major salivary glands, sublingual or submandibular gland excision (SMGE), submandibular duct ligation, parotid duct ligation (PDL), or any combination of the above procedures. The purpose of this study is to report on the 10-year experience with the surgical management of chronic sialorrhea at one tertiary care institution, and compare the efficacy of open surgical procedures versus Botox injections for reduction in salivary flow. METHODS: A retrospective chart review identified 27 pediatric patients with chronic sialorrhea; 21 of whom underwent Botox injections and 15 of whom underwent surgical procedures. Preoperative and follow-up clinic notes were reviewed to determine the level and severity of drooling as well as the effectiveness of sialorrhea reduction, as assessed by the Teacher Drooling Scale (TDS). RESULTS: 42% of those receiving Botox injections reported a reduction in drooling, with the average pre- and post-Botox TDS of 4.3 and 3.9, respectively (p=0.02 by the Wilcoxon signed rank test). Nine of the patients receiving Botox injections (43%) required multiple injections, with an average duration of effect of 3.9 months, and 7 patients (33%) eventually required surgery. All of the children who underwent surgery (7 bilateral SMGE with PDL, 6 SMGE only, and 2 PDL only) experienced a reduction in drooling, with average pre- and post-operative TDS of 4.5 and 2.2, respectively. This reduction was significant by the Wilcoxon signed rank test (p=0.001). CONCLUSIONS: The ten-year experience at our institution demonstrates the safety, efficacy and long-term control of drooling in the patients undergoing surgery for intractable sialorrhea.

Expression of protease-activated receptors in allergic fungal rhinosinusitis.

BACKGROUND: The etiology of the intense inflammatory response showed by patients with allergic fungal rhinosinusitis (AFRS) remains a mystery. Potential sources of this inflammation may include fungal proteases. Protease-activated receptors (PARs) are components of the innate immune response that are modulated by proteolytic activity and are involved in potentiating T helper 2 (Th2) responses. The objective of the study was to determine whether there is differential expression of PARs in patients with AFRS compared to controls. METHODS: The study was designed as a comparison of gene expression profiles in patients with AFRS vs diseased and nondiseased controls. Twenty-five patients were enrolled. Patients with AFRS (n = 15) were compared to nondiseased controls (n = 5) undergoing minimally invasive pituitary surgery (MIPS) and patients with chronic rhinosinusitis with nasal polyps (CRSwNP, n = 5) undergoing functional endoscopic sinus surgery (FESS). Ethmoid mucosa RNA was hybridized to 4 × 44 K microarray chips. Four gene probes (PAR1, PAR2, PAR3, and PAR4) were used to assess for differential expression. A linear-mixed model was used to account for some patients having multiple samples. Significance level was determined at p < 0.05. RESULTS: Of the 4 probes, only PAR3 showed statistically significant differential expression between AFRS and nondiseased control samples (p = 0.03) as well as a 2.21-fold change. No additional statistical difference in PAR expression among the comparison groups was noted. CONCLUSION: PARs have been shown to enhance production of inflammatory cytokines and potentiate Th2 responses. In this initial report, patients with AFRS have a significantly increased expression of PAR3 compared to nondiseased controls.

Chronic rhinosinusitis in children.

Chronic rhinosinusitis (CRS) affects nearly 37 million people in the United States each year and accounts for approximately $6 billion in direct and indirect health care costs. Despite its prevalence and significant impact, little is known about its exact cause and pathophysiology, and significant controversy remains regarding appropriate treatment options. Basic science research, however, has shown recent promise toward improving understanding of the innate and environmental factors underlying the pathophysiology of CRS. The hope is that this will also lead to advances in treatment for children adversely affected by this common yet complicated disease.

Allergic fungal sinusitis in children.

Allergic fungal sinusitis (AFS) is a subtype of eosinophilic chronic rhinosinusitis (CRS) characterized by type I hypersensitivity, nasal polyposis, characteristic computed tomography scan findings, eosinophilic mucus, and the presence of fungus on surgical specimens without evidence of tissue invasion. This refractory subtype of CRS is of the great interest in the pediatric population, given the relatively early age of onset and the difficulty in managing AFS through commercially available medical regimens. Almost universally, a diagnosis of AFS requires operative intervention. Postoperative adjuvant medical therapy is a mainstay in the treatment paradigm of pediatric AFS.