Consensus Statements among European Sleep Surgery Experts on Snoring and Obstructive Sleep Apnea: Part 3 Palatal Surgery, Outcomes and Follow-Up, Complications, and Post-Operative Management.

Background/Objectives: Exploring and establishing a consensus on palatal surgery, the outcomes and follow-up after the palatal surgery, the complications of palatal surgery, and the post-operative management after palatal surgery for snoring and obstructive sleep apnea (OSA) among sleep surgeons is critical in the surgical management of patients with such conditions. Methods: Using the Delphi method, a set of statements was developed based on the literature and circulated among a panel of eight European experts. Responses included agreeing and disagreeing with each statement, and the comments were used to assess the level of consensus and to 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 over a total of five rounds. Results: The final set included a total of 111 statements, 27 of which were stand-alone questions and 21 of which contained 84 sub-statements. Of the 34 statements regarding palatal surgery, consensus was achieved among all eight, seven, and six panelists for 50%, 35.3%, and 5.9% of the questions, respectively. Of the 43 statements regarding the outcomes and follow-up after the palatal surgery, consensus was achieved among all eight, seven, and six panelists for 53.5%, 23.3%, and 4.7% of the questions, respectively. Of the 24 statements regarding complications after the palatal surgery, consensus was achieved among all eight, seven, and six panelists for 91.7%, 0%, and 4.2% of the questions, respectively. Of the 10 statements regarding post-operative management after palatal surgery, consensus was achieved among all eight, seven, and six panelists for 10%, 30%, and 30% of the papers, respectively. Conclusions: This consensus provides an overview of the work of European sleep surgeons to develop a set of statements on palatal surgery for the treatment of snoring and OSA, the outcomes and follow-up, the complications, and the post-operative management of palatal surgery. We believe that this will be helpful in everyday practice. It also indicates key areas for further studies in sleep surgery.

International expert consensus statement: surgical failure in obstructive sleep apnea.

PURPOSE: Upper airway (UA) surgery is commonly employed in the treatment of patients with obstructive sleep apnea (OSA). The intricate pathophysiology of OSA, variability in sites and patterns of UA collapse, and the interaction between anatomical and non-anatomical factors in individual patients may contribute to possible surgical failures. This clinical consensus statement aims to identify areas of agreement among a development group comprising international experts in OSA surgery, regarding the appropriate definition, predictive factors in patients, and management of surgical failure in OSA treatment. METHODS: A clinical consensus statement (CCS) was developed using the Delphi method by a panel of 35 contributors from various countries. A systematic literature review adhering to PRISMA guidelines was conducted. A survey consisting of 60 statements was then formulated and presented to the experts. RESULTS: Following two rounds of the Delphi process, consensus or strong consensus was achieved on 36 items, while 24 items remained without consensus. Specifically, 5 out of 10 statements reached consensus regarding on the 'Definition of Surgical Success/Failure after OSA Surgery'. Regarding the 'Predictive Factors of Surgical Failure in OSA Surgery', consensus was reached on 10 out of 13 statements. In the context of the 'Diagnostic Workup in OSA Surgery', consensus was achieved on 9 out of 13 statements. Lastly, in 'Treatment in Surgical Failure Cases', consensus was reached on 12 out of 24 statements. CONCLUSION: The management of OSA after surgical failure presents a significant clinical challenge for sleep specialists. This CCS provides valuable guidance for defining, preventing, and addressing surgical failures in the treatment of OSA syndrome.

Supine or non-supine sleep apnea events: which can be treated better with Barbed Pharyngoplasty?

PURPOSE: Among the treatment options for Obstructive Sleep Apnea (OSA), intrapharyngeal surgery has undergone significant changes and received solid scientific support. However, it is crucial to identify the best candidate. This study aims to present the results of the modified Alianza technique in our clinic to show the differences in the impact of surgery on supine and non-supine apnea levels in moderate-severe OSA patients. METHODS: Adult patients affected by moderate-severe OSA (Apnea-Hypopnea Index (AHI) > 15), having circular palatal collapse, and candidates for modified Alianza Tecnique were retrospectively enrolled. Each subject performed polysomnography pre- and post-operatively, and the follow-up check was performed after at least six months. RESULTS: This study enrolled 24 patients who underwent the Modified Alianza technique for sleep apnea. We found significant reductions in both supine and non-supine AH) after surgery. Non-supine AHI showed a greater reduction (from 20.89 to 11.64 episodes/hour, p = 0.0001) than supine AHI (from 42.51 to 25.93, p = 0.0003). We subsequently divided the patients into two groups based on whether they were affected by positional OSA before surgery. There was a lower percentage decrease in non-supine AHI compared to supine AHI after surgery in patients who were positional before surgery, but this difference was not statistically significant. Conversely, in the non-positional patient group, there was a higher decrease in non-supine AHI compared to supine AHI, although this was not statistically significant. CONCLUSION: The Modified Alianza Tecnique leads to notable enhancement in AHI among patients with OSA. Non-supine apneas exhibit a more favorable response to the surgery than supine apneas.

The Potential Effect of Changing Patient Position on Snoring: A Systematic Review.

Approximately 45% of adults snore occasionally, and 25% snore regularly, with a higher prevalence in men and an increase among postmenopausal women due to hormonal changes. Snoring is a health concern linked to vascular disease and decreased quality of life for both snorers and their bed partners. Effective snoring treatment, which aims to reduce or eliminate the sound, is challenging and depends on factors like age, comorbidities, disease severity, and anatomical features. This review aims to provide a systematic overview of the current literature on the effects of positional therapy (PT) on snoring. Various devices facilitate PT, including anti-snoring pillows and vibration alarms. PT devices maintain head and neck alignment to keep airways open, while head of bed elevation (HOBE) solutions reduce upper airway collapses by elevating the head and trunk. Studies show that PT and HOBE reduce snoring by increasing airway cross-sectional area and decreasing closing pressure. Despite their benefits, these non-surgical treatments have limitations, such as discomfort in certain sleeping positions and intolerance to prolonged head elevation. While reducing snoring intensity is critical for health reasons, further comparative studies between the different devices are needed to enhance snoring management.

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.

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.

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.

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.