Barbed Pharyngoplasty simulation using a 3D-printed model: design and validation study.

PURPOSE: Learning how to use barbed sutures and perform Barbed Pharyngoplasty (BP) is challenging due to limited surgical training opportunities. This work aims to design, develop, and validate a new 3D surgical simulator to train ENT residents and specialists in performing BP. METHODS: The Barbed Pharyngoplasty Simulator (BPS) was designed using diagnostic images of the facial mass and testing different materials to replicate the mucosal and bony tissues. ENT specialists with experience in BP and ENT residents were included in the validation study and were asked to perform the Alianza BP. After the simulation, they compiled the Face and Content Validity Questionnaires. RESULTS: The BPS consists of a reusable cranial structure that contains the disposable palatopharyngeal structure, replicating the palatal structures and the tongue. Fifteen experienced ENT specialists and nine residents were included in the study. Findings demonstrated that the BPS faithfully replicated the muscular and fibrous-bony palatopharyngeal structures, with only 11% of residents having a negative opinion of the mucosal tissue. All the participants positively rated the sensation of using surgical instruments on the simulator. Also, ENT residents rated all aspects of the content validity test from normal to excellent, while specialists rated the BPS as a general training tool from normal to excellent; for lateral pharyngoplasty, BP, and Alianza, only 6.7% of participants disagreed with its usefulness, and 13.3% disagreed with it for anterior pharyngoplasty. CONCLUSION: The BPS proposed in this preliminary study can potentially be a valuable tool in BP surgical training for residents and young otolaryngologists.

Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 2 Decision-Making in Surgical Management and Peri-Operative Considerations.

Background: Reaching consensus on decision-making in surgical management and peri-operative considerations regarding snoring and obstructive sleep apnea (OSA) among sleep surgeons is critical in the management of patients with such conditions, where there is a large degree of variability. Methods: A set of statements was developed based on the literature and circulated among eight panel members of European experts, utilizing the Delphi method. Responses were provided as agree and disagree on each statement, and the comments were used to assess the level of consensus and develop a revised version. The new version, with the level of consensus and anonymized comments, was sent to each panel member as the second round. This was repeated for a total of five rounds. Results: The final set included a total of 71 statements: 29 stand-alone and 11 with 42 sub-statements. On the 33 statements regarding decision-making in surgical management, there was 60.6%, 27.3%, and 6.1% consensus among all eight, seven, and six panelists, respectively. On the 38 statements regarding the peri-operative considerations, there was 55.3%, 18.4%, and 15.8% consensus among all eight, seven, and six panelists, respectively. Conclusions: These results indicate the need for an expanded review of the literature and discussion to enhance consensus among the sleep surgeons that consider surgical management in patients with snoring and OSA.

An atlas of cells in the human tonsil.

Palatine tonsils are secondary lymphoid organs (SLOs) representing the first line of immunological defense against inhaled or ingested pathogens. We generated an atlas of the human tonsil composed of >556,000 cells profiled across five different data modalities, including single-cell transcriptome, epigenome, proteome, and immune repertoire sequencing, as well as spatial transcriptomics. This census identified 121 cell types and states, defined developmental trajectories, and enabled an understanding of the functional units of the tonsil. Exemplarily, we stratified myeloid slan-like subtypes, established a BCL6 enhancer as locally active in follicle-associated T and B cells, and identified SIX5 as putative transcriptional regulator of plasma cell maturation. Analyses of a validation cohort confirmed the presence, annotation, and markers of tonsillar cell types and provided evidence of age-related compositional shifts. We demonstrate the value of this resource by annotating cells from B cell-derived mantle cell lymphomas, linking transcriptional heterogeneity to normal B cell differentiation states of the human tonsil.

Clinical outcomes of expansion sphincter pharyngoplasty-a 17-year systematic review.

OBJECTIVES: To systematically review long-term (> 5 years) outcomes of ESP surgery for OSA treatment over 17 years. METHODS: Systemic review of MEDLINE, Google Scholar, Cochrane Library and Evidence Based Medicine Reviews to identify publications relevant to OSA and Expansion Pharyngoplasty and its variants. All relevant studies published between January 2007 and June 2023 were included. RESULTS: Twelve studies were included in this systematic review with a combined total of 1373 patients who had the ESP procedure were included. The clinical outcomes included encouraging long-term success rate, reductions in Epworth sleepiness scale, good mean disease alleviation, anatomical structural area and volume improvements, blood pressure reductions, biochemical improvements in acute phase reactants after ESP surgery, reductions in intra-ocular pressures, and post-operative reduction of sympathetic overdrive. CONCLUSIONS: Seventeen years on, the expansion sphincter pharyngoplasty has demonstrated not only increase in anatomical area and volume but significant desired improvements in polysomnographic, clinical and biochemical parameters post-surgery.

Ankyloglossia in Children, a Cause of Obstructive Sleep Apnoea: Case Report of Paediatric Ankyloglossia and Sleep Apnoea: DISE Resolves the Mystery.

Tongue mobility is an obstructive sleep apnoea (OSA) marker and myofunctional therapy (MFT) target. For this reason, all paediatric patients with sleep-disordered breathing should require a combined functional assessment from an ear, nose, and throat (ENT) specialist and a phonoaudiologist to confirm or rule out the presence of ankyloglossia. To our knowledge, this is the first case of a 13-year-old girl diagnosed with severe OSA and a significant decrease of 94% in her apnoea index (AI), requiring frenotomy with an immediate postoperative change in the tongue position. A drug-induced sleep endoscopy (DISE) was performed before and immediately postfrenotomy, and the anatomical changes provoked by this surgery during sleep were confirmed for the first time.

Use of Ultrasound to Verify the Impact of Telemedicine Myofunctional Therapy on Sleep Apnea Syndrome: Study Protocol Proposal.

The anatomy of the upper airways influences the risk of obstructive sleep apnea (OSA). The size of soft tissue structures, such as the tongue, soft palate, and lateral walls of the pharynx, contributes to the pathogenesis of OSA. New lines of treatment for sleep apnea, such as myofunctional therapy (MT), aim to strengthen the oropharyngeal musculature to improve the defining parameters of apnea. The present protocol uses ultrasound imaging to measure the size of the lingual musculature non-invasively and cost-effectively and evaluates the changes in its morphology. Eligible patients include those with OSA who have undergone submental cervical ultrasound and drug-induced sleep endoscopy before starting MT with the AirwayGym app. Follow-up evaluations are conducted at 3 months after beginning treatment. Patients diagnosed with OSA via questionnaires and polysomnography or respiratory polygraphy are evaluated anatomically and functionally using the Iowa Oral Performance Instrument, a tongue digital spoon, somnoscopy, and submental cervical ultrasound to assess their responses to the AirwayGym app. The lingual thickness (mm) and volume (cm3) and the distance between both lingual arteries (mm) are measured. The AirwayGym app helps users and therapists monitor the patient performance of MT. Incorporating submental ultrasound can be a useful non-invasive tool to evaluate OSA and MT.

Platelet-Rich Plasma for Patients with Olfactory Dysfunction: Myth or Reality? A Systematic Review.

BACKGROUND: With promising outcomes, platelet-rich plasma (PRP) has recently been suggested as a treatment for olfactory dysfunction (OD). METHODS: Clinical studies utilizing PRP in OD caused by COVID-19, trauma, anesthetic exposure, viral infection, and chronic rhinosinusitis were included in a systematic review. RESULTS: Ten clinical studies were qualitatively analyzed. Six of these studies used the PRP for OD caused by COVID-19, one on OD after functional endoscopic sinus surgery, and three on post-infectious or post-trauma OD. The population included 531 patients, ranging in age from 15 to 63. CONCLUSION: The use of PRP may be a risk-free and efficient therapeutic option with very encouraging outcomes. Indeed, it enhances olfactory perception in patients who not only exhibit COVID-19 infection aftereffects, but also in those who have lost their sense of smell due to trauma, rhinosinusitis, rhinitis, or even surgery. To evaluate the PRP's therapeutic benefits in OD patients and to compare the efficacy of different therapeutic protocols with regard to treatment schedules, there is an urgent need for focused controlled trials.

Risk of cancer in patients with sleep apnea: comparison of surgery versus CPAP in a long-term follow-up study.

PURPOSE: This study aimed to obtain a comprehensive view of the risk of developing cancer in patients with obstructive sleep apnea (OSA) and to compare this risk between patients receiving continuous positive airway pressure (CPAP) therapy versus upper airway surgery (UAS). METHODS: We used both local data and a global-scale federated data research network, TriNetX, to access electronic medical records, including those of patients diagnosed with OSA from health-care organizations (HCOs) worldwide. We used propensity score matching and the score-matched analyses of data for 5 years of follow-up, RESULTS: We found that patients who had undergone UAS had a similar risk of developing cancer than those who used CPAP [hazard ratio of 0.767 (95% CI 0.559-1.053; P = 0.100)]. CONCLUSION: Analysis of the large data sets collected from HCOs in Europe and globally lead us to conclude that in patients with OSA, neither CPAP nor UAS were associated with the development of cancer better than in non-treated patients.

Clinical Application of Pediatric Sleep Endoscopy: An International Survey.

OBJECTIVES: To investigate through an international survey the actual clinical application of drug-induced sleep endoscopy (DISE) in pediatric patients with obstructive sleep apnea (OSA) and to clarify the use, application, clinical indications, and protocol of pediatric DISE. METHODS: A specific survey about pediatric DISE was initially developed by five international otolaryngologists with expertise in pediatric sleep apnea and drug-induced sleep endoscopy and was later spread to experts in the field of sleep apnea, members of different OSA-related associations. RESULTS: A total of 101 participants who answered all the survey questions were considered in the study. Sixty-four sleep apnea experts, equivalent to 63.4% of interviewed experts, declared they would perform DISE in pediatric OSA patients. A total of 81.9% of responders agreed to consider the DISE as the first diagnostic step in children with persistent OSA after adenotonsillectomy surgery, whereas 55.4% disagreed with performing DISE at the same time of scheduled adenotonsillectomy surgery to identify other possible sites of collapse. In the case of young patients with residual OSA and only pharyngeal collapse during DISE, 51.8% of experts agreed with performing a velopharyngeal surgery. In this case, 27.7% disagreed and 21.4% were neutral. CONCLUSION: Pediatric DISE is internationally considered to be a safe and effective procedure for identifying sites of obstruction and collapse after adenotonsillectomy in children with residual OSA. This is also useful in cases of patients with craniofacial malformations, small tonsils, laryngomalacia or Down syndrome to identify the actual site(s) of collapse. Despite this evidence, our survey highlighted that pediatric DISE is not used in different sleep centers.

Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 1 Definitions and Diagnosis.

Seeking consensus on definitions and diagnosis of snoring and obstructive sleep apnea (OSA) among sleep surgeons is important, particularly in this relatively new field with variability in knowledge and practices. A set of statements was developed based on the literature and circulated among eight panel members of European experts, utilizing the Delphi method. Responses in agreement and disagreement on each statement and the comments were used to assess the level of consensus and develop a revised version. The new version with the level of consensus and anonymized comments was sent to each panel member as the second round. This was repeated a total of five rounds. The total number of statements included in the initial set was 112. In the first round, of all eight panelists, the percentage of questions that had consensus among the eight, seven, and six panelists were 45%, 4.5%, and 7.1%, respectively. In the final set of statements consisting of 99, the percentage of questions that had consensus among the 8, 7, and 6 panelists went up to 66.7%, 24.2%, and 6.1%, respectively. Delphi's method demonstrated an efficient method of interaction among experts and the establishment of consensus on a specific set of statements.

Reply to: Letter to the Editor of Journal of Otolaryngology regarding "Risk of diabetes in patients with sleep apnea: comparison of surgery versus CPAP in a long-term follow-up study".

A recent Letter published, in the Journal of Otolaryngology-Head & Neck Surgery in response to our original article "Risk of diabetes in patients with sleep apnea: comparison of surgery versus Continous Positive Airway Pressure in a long-term follow-up study" raised some issues we would like to address here. However, we thank the authors for their effort and time in analyzing our manuscript and we want to facilitate a balanced discussion on this topic with our reply.

Defining Epiglottic Collapses Patterns in Obstructive Sleep Apnea Patients: Francia-Lugo Classification.

Obstructive Sleep Apnea (OSA) is characterized by repetitive collapse of the upper airway during sleep. Drug-Induced Sleep endoscopy (DISE) is used to identify the collapse site. Among the possible sites of collapse, the epiglottis occurs more frequently than previously described. In this study, we reviewed DISE findings and classified different epiglottic collapse patterns. We found 104 patients (16.4%) with epiglottis collapse (primary 12.5% and secondary 3.9%). We described the following patterns of epiglottis collapse: Anterior-Posterior (AP) collapse with rigid component "trapdoor type" (48%); AP collapse with lax component "floppy type" (13.5%); Lateral- Lateral (LL) collapse with omega shape component "book type" (14.5%); and secondary due to lateral pharyngeal wall or tongue base collapse (24%). The identification of the epiglottic collapse pattern is crucial in decision-making when attempting to ameliorate OSA. These findings in OSA phenotyping could influence the type of treatment chosen.

A New Lighting System for Surgical Vision Optimization in Barbed Pharyngoplasty for OSA.

Obstructive sleep apnea (OSA) surgery is now a viable solution in selected patients and the "remodeling" palatopharyngeal surgery is the most common one. Recently, it has become less invasive with the introduction of barbed sutures (BS). An optimization of surgical techniques is represented by barbed pharyngoplasty (BP), which requires surgical precision and needs efficient and precise oropharyngeal visualization. Consequently, the lighting system is of pivotal importance in BP. The aim of this work is to describe the first experience on the use of a new lighting system, called KLAROTM in BP for OSA. We evaluated the KLARO™ system in 15 consecutives BP for OSA in comparison with conventional headlamp illumination. The visualization of palatopharyngeal muscle in the bottom of the tonsillar fossa, entry and exit needle, such as needle tip, were statistically better with KLAROTM than headlamp illumination for both the surgeon and resident (p < 0.05). No significant differences for the visualization of the posterior pharyngeal wall and uvula were reported. The KLAROTM lighting system allows a satisfied illumination of oral cavity and oropharynx in the majority of cases. We encourage the use of KLAROTM not only in BP for OSA, but in all oral and pharyngeal surgeries, including tonsillectomy and oncological surgery.

Potential Use of Vivascope for Real-Time Histological Evaluation in Endoscopic Laryngeal Surgery.

We aimed to assess the feasibility of using confocal laser scanning microscopy (CLSM) for the real-time ex vivo examination of histological samples of laryngeal lesions and to evaluate the correlation between CLSM and definitive histological results. This preliminary study included eight consecutive patients with "suspected" laryngeal lesions who were candidates for endoscopic laryngeal surgery. The obtained samples were evaluated using CLSM and classified as "inadequate" or "adequate" (high- and low-grade dysplasia, in situ and invasive carcinoma, positive surgical margin, and inflammatory outbreaks). CLSM showed the macro image in all cases and generated a digital version. All the samples were defined as adequate during CLSM and confirmed at histopathology: low-grade dysplasia (n = 5), low- and high-grade dysplasia (n = 2), and high-grade dysplasia (n = 1). Four samples had an involved resection margin, and three samples revealed the presence of inflammatory outbreaks. CLSM can be applied to larynx pathology with excellent agreement with final histological results.

Randomized Clinical Trial to Evaluate the Efficacy and Tolerability of Nebulized Hyaluronic Acid and Xylitol Based Solution after Septoturbinoplasty.

Septoplasty and turbinate surgery are among the most frequent surgical procedures to improve nasal obstruction and quality of life. These procedures usually imply the presence of congestion, secretions, and crusting related to the movement of the instruments during surgery. However, the use of nasal lavage may reduce this situation. The addition of Hyaluronic acid or Xylitol offers advantages in these washes. This study was a randomized, double-blind, controlled trial. All patients underwent endoscopic septoplasty with inferior turbinate submucosal resection without posterior nasal packing. SNOT-22, main VAS, NOSE, Modified Lund-Kennedy endoscopic scale, number of crusts and adhesions were quantified before and on the day of the surgery, visit three (seven days), visit four (fourteen days), and visit five (twenty-eight days). Forty-seven patients completed the study, divided into a standard saline arm (group 1, 22 patients) and normal saline plus HA and Xylitol arm (group 2, 27 patients). Both treatment groups improved their quality of life and objective parameters during the four weeks of the study. All patients tolerated the nasal irrigations well, and none discontinued the treatments. The study concludes that nasal washes of Aluneb Isotónico® offer several benefits to patients as a protective and preventative agent.

Could the use of a new novel bipolar radiofrequency device (Aerin) improve nasal valve collapse? A systematic review and meta-analysis.

BACKGROUND: Surgical treatment for nasal obstruction caused by nasal valve collapse requires a significant recovery period and risks of complications, while nasal dilators are uncomfortable. Recently, radiofrequency treatment of lateral walls has been used under local anesthesia as an office base surgery. This work aims to assess the efficacy of a new radiofrequency device, the Vivaer™ System (Aerin Medical, Sunnyvale, CA), to treat nasal obstruction through a systematic review and meta-analysis. METHODS: Two researchers independently reviewed the literature up to December 2021. Studies on patients seeking treatment for nasal obstruction due to nasal valve collapse were included in the analysis. RESULTS: Four studies (218 patients) met the inclusion criteria and treated the nasal valve regions bilaterally with the Aerin Medical Vivaer™ System. After the treatment, the NOSE score was reduced at three months postoperatively. Minor adverse events were reported in the included studies, and two showed no complications. None of the studies reported changes in the external appearance of the nose. CONCLUSION: The radiofrequency treatment using the Vivaer device can be useful for treating nasal valve collapse, improving significantly subjective breathing symptom scores. Further studies on a large scale are needed to confirm these results.

Comparison of Intranasal Steroid Application Using Nasal Spray and Spray-Sol to Treat Allergic Rhinitis: A Preliminary Investigation.

Allergic Rhinitis (AR) is a chronic inflammatory disease of sino-nasal mucosa, is IgE-mediated, and affects 10-40% of the global population. This study aimed to compare the efficacy of nasal administration of Beclomethasone Dipropionate (BDP) delivered via Spray-sol with nasal spray in patients suffering from AR. We included 28 AR patients assigned to one of the two following treatments: the Spray-sol group (BDP via Spray-sol) (n = 13) and the spray group (BDP using a common nasal spray) (n = 15). Both treatments were administered twice daily for 4 weeks. A nasal endoscopy evaluation and Total Nasal Symptom Score were performed at baseline and after treatment. The Spray-sol group showed better results than the spray group regarding nasal endoscopy (edema, p < 0.01; irritation, p < 0.01; secretion, p < 0.01) and nasal symptoms (nasal congestion, p < 0.05; rhinorrhea, p < 0.05; sneezing, p < 0.05; and total score, p < 0.05). No side effects were recorded. These data supported the fact that the use of BDP delivered with Spray-sol is more effective than BDP nasal spray in AR patients. Further studies are needed to confirm these encouraging results.

Assessment of Muscular Weakness in Severe Sleep Apnea Patients: A Prospective Study.

OBJECTIVE: There are no official diagnostic tools to evaluate the weakness of the genioglossus muscle. We have developed a protocol for muscular assessment in patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS) and evaluated its effectiveness. STUDY DESIGN: Case and controls prospective study. SETTING: Sleep Unit Hospital Quironsalud Marbella (Spain). METHODS: Twenty-nine cases and 20 controls were recruited. Patients were examined by a phonoaudiologist that performed biometric measurements and the Orofacial Myofunctional Evaluation With Scores (OMES), Friedman, and Epworth Sleepiness Scale (ESS). In addition, upper airway muscle strength measures were performed using the Iowa Oral Performance Instrument (IOPI) and Tongue Digital Spoon (TDS). RESULTS: The final cohort consisted of 49 subjects, including 29 cases and 20 controls. According to the univariate and multivariate logistic regression analyses, ESS, OMES protocol, IOPI score, and TDS were associated with severe OSAHS. Multivariate regression revealed an IOPI score below 48 kps with an adjusted odds ratio (OR) of 9.96 (95% confidence interval [CI] 2.5-39.1, p = .001), and a 0.72 specificity (Spe), a 0.79 sensitivity (Sens), and a 0.82 area under the curve (AUC). Similarly, an OMES score lower than 200 had an adjusted risk ratio of 4.02 (95% CI 2-7, p < .001), 1 Spe, 0.79 Sens, and 0.98 AUC; and finally, TDS scores lower than 201 g/cm2 showed an adjusted OR of 27 (95% CI 4.74-153.6, p = .0001), 0.66 Spe, a 0.93 Sens, and a 0.86 AUC. CONCLUSION: Our findings suggest that severe OSAHS patients present different muscle patterns than controls.

High-Definition 3D Exoscope-Assisted Barbed Pharyngoplasty for OSAS and Snoring: Better Than Live.

Recently, a high-definition 3D exoscope (VITOM), a new magnification system that provides a 3D image of the surgical field, has been introduced. This study aims to describe the first use of VITOM 3D technology in Barbed Pharyngoplasty (BP) for Obstructive Sleep Apnea (OSA). VITOM 3D technology is used to support visualization during BP in a male patient affected by severe OSA with a circular palatal collapse pattern at drug-induced sleep endoscopy. During the surgical procedure, this approach markedly improves the visualization of the surgical field through anatomic details of the oral cavity, facilitating surgical dissection and enhancing the teaching environment. It allows for a better involvement and more interactions during the surgery, as scrubbed and assistant nurses can see the surgical field and anticipate the surgeon's choice of instrument. VITOM 3D technology, by combining a telescope with a standard endoscope, has been successfully used in various surgical disciplines and could be very useful, especially in teaching hospitals. VITOM 3D can guarantee "a real immersive" surgical experience for all participants in the operating room. Economic and efficacy studies would be conducted to support the use of a VITOM-3D exoscope in common clinical practice.