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.

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.

Complications and side effects after barbed pharyngoplasty: a systematic review.

BACKGROUND: Recently, the use of barbed pharyngoplasty (BP) has become widespread in snoring and obstructive sleep apnoea (OSA) palatal surgery, but there are no studies regarding the short- and long-term complications resulting from these different techniques. This systematic review aimed to report the complications and side effects of different BP techniques. METHODS: An electronic search was performed on PubMed/MEDLINE, Google Scholar, and Ovid databases. The PRISMA statement was followed. Databases were searched from inception through September 2, 2021. RESULTS: We included 14 prospective clinical studies consisting of 769 patients aged 23 to 81 years. The associated intra-operative complications of BP were as follows: partial thread extrusion (2.9%), self-limited bleeding (2.9%), broken needle (1.0%), and suture rupture (1.0%). Short-term complications were as follows: thread/knot extrusion (12.4%), dysphagia (5.6%), bleeding (1.5%), velopharyngeal insufficiency (1.5%), anterior pharyngoplasty dehiscence (1.2%), tonsillar haemorrhage (1.0%), excessive postnasal discharge (1.0%), barbed suture failure (0.5%), acute infection (0.2%), mucosal granulomas (0.2%), chipped tooth caused by mouth gag displacement (0.2%), and fibrous scar (0.2%). Long-term complications were as follows: foreign body sensation (7.8%), sticky mucus in throat (5.9%), dysphagia (3.6%), rhinolalia (3.1%), throat phlegm (1.1%), nose regurgitation (0.8%), dry throat (0.6%), and throat lump (0.3%). CONCLUSION: BP is a safe technique free of significant side effects and major complications. However, in this review, patients undergoing BP were very heterogeneous in terms of characteristics of patients chosen and severity of diseases, surgical technique used (myoresective vs non-myoresective), time of follow-up, and mono level vs multilevel surgery. More studies on a larger scale with long-term follow-up are needed to confirm these promising results.

New diagnostic tools to screen and assess a still too underestimated disease: the role of the wrist-worn peripheral arterial tonometry device-a systematic review.

PURPOSE: Home sleep apnea testing devices aim to overcome the drawbacks of polysomnography (PSG). Among these, the WatchPAT (WP) (Itamar Medical Ltd., Caesarea, Israel) has recently been introduced on the market for diagnosis of Obstructive Sleep Apnea (OSA). The aim of this review was to provide a comprehensive overview of the studies validating the WP for the diagnosis of sleep-disordered breathing through comparison with PSG. METHODS: A systematic review was performed to identify all clinical studies concerning WP validation compared with PSG as diagnostic tools. A qualitative analysis of the data was conducted. RESULTS: In this review, 18 studies were included for a total of 1049 patients, aged 8 to 70 years old, with 74 of these being pediatric patients. In most studies, patients completed an overnight PSG and simultaneously wore WatchPAT in a sleep laboratory, while others compared the results obtained on two different nights. Both protocols showed good results in terms of AHI, ODI, RDI, and SO2. Moreover, some studies calculated the sensitivity and specificity of the WP ranging from 87 to 96% and from 66 to 80%, respectively. Excellent results were found also in pediatric patients. CONCLUSION: The WP represents an effective and convenient tool for OSA diagnosis compared to standard reference systems.

No-cutting remodelling intra-pharyngeal surgery can avoid CPAP in selected OSA patients: myth or reality?

INTRODUCTION: Oropharyngeal surgery for Obstructive Sleep Apnea (OSA) has evolved from a radical excision of "redundant" soft tissue for the enlargment of the airway to a minimally invasive reconstruction to fulfill both preservation of pharyngeal function and improvement of sleep apnea. Recently, Alianza surgical technique has been successfully introduced as a new, non-resective procedure aimed to treat concentric pharyngeal collapse at the velum using Barbed Sutures. The aim of this study was to show the effectiveness and safety of Alianza technique as standalone surgical treatment in selected patients with moderate-severe OSA and concentric pharyngeal collapse that refused or did not tolerate Continuous Positive Airway Pressure therapy. MATERIALS AND METHODS: Effectiveness of the surgical procedure was assessed by means of the Epworth Sleepiness Scale (ESS), Home Sleep Test, and a 0-10 snoring VAS. RESULTS: At the end of our selection process, 26 patients were enrolled, with a mean age of 52.7 ± 9.2 years, that undergone Alianza tecnique. There was a statistically significant reduction in mean post-operative apnea-hypopnea indexes (34.1 ± 11.5-16.3 ± 10.3; p <0.01), mean oxygen desaturation index (29.0 ± 14.5-13.1 ± 9.2; p < 0.01), and mean ESS scores (12.1 ± 5.8 and 5.8 ± 4.4; p < 0.01).There was also a significant decrease in mean post-operative snoring VAS scores (7.85 ± 1.23 vs 3.2 ± 1.7, p < 0.01). There were no major complications. CONCLUSIONS: Our preliminary results suggest that Alianza technique is a safe and repeatable surgery. Further studies on a larger scale are needed to confirm these encouraging data supporting the role of Alianza alone or in OSA multilevel surgery in selected OSA patients.

Sleep medicine in otolaryngology units: an international survey.

PURPOSE: No study to date has described the overall landscape of sleep disorders management and training in otolaryngology departments of different countries. The aim of our study was to investigate and compare settings, diagnostic and therapeutic approaches and training programmes. METHODS: An international online survey was developed with the collaboration of the YO-IFOS (Young Otolaryngologists-International Federation of Otorhinolaryngological Societies) to assess the current practice of otolaryngologists in the management of sleep disorders. The survey also included a session dedicated to training. RESULTS: A total of 126 otolaryngologists completed the survey. The larger part of responses was collected from Central/South America and Europe. The majority of responders from South/Central America (97%) declared to be certified as sleep specialist while 49% of Europeans stated the opposite. Of responders 83% perform a drug-induced sleep endoscopy (DISE) before planning a possible surgical intervention. Soft palate and base of tongue interventions were the most common procedure, respectively performed in 94% and 79% of the cases. Residents were allowed to perform soft palate surgery in 77% of the cases. Upper airway stimulation (26% vs 10%), trans-oral robotic surgery (36% vs 11%) and radiofrequency of the base of the tongue (58% vs 25%) were preferred more frequently by European responders. The highest caseloads of soft palate surgery and bi-maxillary advancement were registered in the academic institutions. CONCLUSION: Significant concordance and few interesting divergences in diagnosis and treatment of sleep disorders were observed between nationalities and types of institution. Economic resources might have played a significant role in the therapeutic choice. Trainees' lack of exposure to certain interventions and to a sufficient caseload appeared to be the main burden to overcome.

Modifications in Upper Airway Collapsibility during Sleep Endoscopy with a Mandibular Positioner: Study in Snorers and Obstructive Sleep Apnea Patients.

BACKGROUND: Mandibular advancement devices (MADs) are an effective treatment for patients with sleep-related breathing disorders, with variable response. Increasingly more research points to the predictive value of Drug-Induced Sleep Endoscopy (DISE) in patient selection. This study aims to analyze the changes in upper airway collapsibility using a titratable MAD simulator during DISE. METHODS: This study included 104 patients with simple snoring and obstructive sleep apnea (OSA). The VOTE scale was used to assess the presence of collapses during the DISE both without and with the MAD simulator. RESULTS: In snorers, there was a decrease in collapses at the level of the soft palate and oropharynx when the advancement was achieved. Patients with mild OSA also showed a decrease in collapses at the base of the tongue. Patients with moderate/severe OSA exhibited significant amelioration at all levels. The levels at which there were residual collapses despite the maneuver were, in order, the velopharynx, oropharynx, epiglottis, and tongue. CONCLUSIONS: The MAD simulator reduces collapsibility at all levels and in all severity groups. Residual collapses suitable for combined treatments were able to be identified. This highlights the need for individualized patient selection, as upper airway collapsibility exhibits variable improvement or worsening with the MAD simulator regardless of the severity of the condition.

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.

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.

Barbed Pharyngoplasty for Snoring: Does It Meet the Expectations? A Systematic Review.

To date, the use of barbed sutures for the surgical management of patients suffering from obstructive sleep apnea and snoring with retropalatal collapse and vibration has significantly increased. A systematic review was carried out, which included clinical studies that used barbed sutures for the treatment of snoring. A qualitative analysis, including six clinical studies, was conducted. Of these, five were studies on barbed pharyngoplasties, and one study involved a minimally invasive surgical procedure. The population consisted of 176 patients, aged 26 to 58 years old. Overall, the included studies showed a mean gain in the snoring Visual Analog Scale of 5.67 ± 1.88, with a mean preoperative value of 8.35 ± 1.17 and a postoperative value of 2.68 ± 1.27. No major complications were described. Given the lack and heterogeneity of this evidence, the conclusion calls for being cautious. In carefully selected snorers and obstructive sleep apnea patients, the use of barbed sutures could represent a valid therapeutic strategy for snoring, ensuring a statistically significant improvement in the subjective parameters. Further studies on a larger scale that assess the role of barbed pharyngoplasties in snoring surgery and more extended follow-up studies are needed in order to confirm these promising results.

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.

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.

Palatopharyngeal Arch Staging System (PASS): Consensus about Oropharyngeal Evaluation.

Intraoral examinations are essential in the evaluation of the upper airway in patients with obstructive sleep apnea (OSA). The morphology of the anatomic structures of the soft palate, the tonsillar fossae, and the palatoglossus and palatopharyngeal muscles is an important determinant of the size and collapsibility of the velum and oropharynx. The Palatopharyngeal Arch Staging System (PASS) is a systematic way to explore the oropharynx and report anatomic variations in the visible part of the palatopharyngeal muscle. In this prospective study, 30 sleep surgeons evaluated the reliability of the PASS using a selection of 23 videos of oropharyngeal examinations of healthy patients. The corresponding score on the PASS scale was graded for each examination. For internal structure and internal agreement, the Cronbach and Krippendorff alpha values were 0.96 and 0.46, which corresponded to a nearly perfect interrelationship and a moderate agreement, respectively. These findings suggest that the PASS is a valuable tool for evaluating the position of the palatopharyngeus muscle during oropharyngeal examinations and may be useful for creating a common language for sleep surgeons when evaluating the palatopharyngeal muscle.

Machine Learning Identification of Obstructive Sleep Apnea Severity through the Patient Clinical Features: A Retrospective Study.

OBJECTIVES: To evaluate the role of clinical scores assessing the risk of disease severity in patients with clinical suspicion of obstructive sleep apnea syndrome (OSA). The hypothesis was tested by applying artificial intelligence (AI) to demonstrate its effectiveness in distinguishing between mild-moderate OSA and severe OSA risk. METHODS: A support vector machine model (SVM) was developed from the samples included in the analysis (N = 498), and they were split into 75% for training (N = 373) with the remaining for testing (N = 125). Two diagnostic thresholds were selected for OSA severity: mild to moderate (apnea-hypopnea index (AHI) ≥ 5 events/h and AHI < 30 events/h) and severe (AHI ≥ 30 events/h). The algorithms were trained and tested to predict OSA patient severity. RESULTS: The sensitivity and specificity for the SVM model were 0.93 and 0.80 with an accuracy of 0.86; instead, the logistic regression full mode reported a value of 0.74 and 0.63, respectively, with an accuracy of 0.68. After backward stepwise elimination for features selection, the reduced logistic regression model demonstrated a sensitivity and specificity of 0.79 and 0.56, respectively, and an accuracy of 0.67. CONCLUSION: Artificial intelligence could be applied to patients with symptoms related to OSA to identify individuals with a severe OSA risk with clinical-based algorithms in the OSA framework.

Optimizing Mandibular Advancement Maneuvers during Sleep Endoscopy with a Titratable Positioner: DISE-SAM Protocol.

Mandibular advancement devices (MAD) are an effective alternative treatment to CPAP. Different maneuvers were performed during drug sleep-induced endoscopy (DISE) to mimic the effect of MAD. Using the Selector Avance Mandibular (SAM) device, we aimed to identify MAD candidates during DISE using a titratable, reproducible, and measurable maneuver. This DISE-SAM protocol may help to find the relationship between the severity of the respiratory disorder and the degree of response and determine the advancement required to improve the collapsibility of the upper airway. Explorations were performed in 161 patients (132 males; 29 females) with a mean age of 46.81 (SD = 11.42) years, BMI of 27.90 (SD = 4.19) kg/m2, and a mean AHI of 26.51 (SD = 21.23). The results showed no relationship between severity and MAD recommendation. Furthermore, there was a weak positive relationship between the advancement required to obtain a response and the disease severity. Using the DISE-SAM protocol, the response and the range of mandibular protrusion were assessed, avoiding the interexaminer bias of the jaw thrust maneuver. We suggest prescribing MAD as a single, alternative, or multiple treatment approaches following the SAM recommendations in a personalized design.

Awake examination versus DISE for surgical decision making in patients with OSA: A systematic review.

OBJECTIVE: Traditionally, upper airway examination is performed while the patient is awake. However, in the past two decades, drug-induced sleep endoscopy (DISE) has been used as a method of tridimensional evaluation of the upper airway during pharmacologically induced sleep. This study aimed to systematically review the evidence regarding the usefulness of DISE compared with that of traditional awake examination for surgical decision making in patients with obstructive sleep apnea (OSA). DATA SOURCES: Scopus, PubMed, and Cochrane Library databases were searched. REVIEW METHODS: Only studies with a primary objective of evaluating the usefulness of DISE for surgical decision making in patients with OSA were selected. The included studies directly compared awake examination data with DISE outcome data in terms of possible influences on surgical decision making and operation success. RESULTS: A total of eight studies with 535 patients were included in this review. Overall, the surgical treatment changed after DISE in 50.24% (standard deviation 8.4) cases. These changes were more frequently associated with structures contributing to hypopharyngeal or laryngeal obstruction. However, these differences do not automatically indicate a higher success rate. CONCLUSION: This review emphasized the direct impact of DISE compared with that of awake examination on surgical decision making in OSA patients. However, it is also clear that the available published studies lack evidence on the association between this impact and surgical outcomes. Laryngoscope, 126:768-774, 2016.