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.

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.

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.

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.

Is Continuous Positive Airway Pressure a Valid Alternative to Sildenafil in Treating Sexual Dysfunction among OSA Patients? A Systematic Review and Meta-Analysis.

Background and Objectives: This study aimed to assess the comparative effectiveness of continuous positive airway pressure (CPAP) therapy and sildenafil pharmacological therapy in improving sexual function among patients with obstructive sleep apnea (OSA) and erectile dysfunction (ED). Materials and methods: Population: Patients affected by OSA and ED; Intervention: CPAP therapy vs. Comparison: Sildenafil pharmacological therapy; Outcomes: Improvement in erectile function, as measured by the International Index of Erectile Function 5 (IIEF-5) scoring system; Time: A systematic review of the literature from the past 20 years; Study Design: Observational studies comparing erectile function improvements after OSA treatment. Results: A total of eight papers were included in the qualitative summary, involving four hundred fifty-seven patients with ED and OSA. Erectile function improvements were observed in both treatment groups. After sildenafil and CPAP treatment, the mean IIEF-5 domain scores were 37.7 and 27.3, respectively (p < 0.001). Sildenafil 100 mg demonstrated a higher therapeutic impact compared to CPAP treatment. Conclusions: CPAP therapy significantly improved sexual parameters in most studies for OSA patients with ED. The findings suggest that CPAP therapy effectively alleviates erectile dysfunction symptoms, resulting in improved sexual performance in OSA patients. The comparison of the two treatments indicates that sildenafil has a more substantial therapeutic impact on erectile function than CPAP therapy; however, a combined treatment will provide a cumulative effect.

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.

Odontogenic Sinusitis with Oroantral Communication and Fistula Management: Role of Regenerative Surgery.

Objective: The aim of this study is to show our experience with the correct management of patients suffering from odontogenic sinusitis with oroantral communication and fistula. Methods: According to the inclusion criteria, 41 patients were enrolled in this retrospective study with a diagnosis of odontogenic sinusitis with oroantral communication and fistula; 1 patient with pre-implantological complication, 14 with implantological complications, and 26 with classical complications. Results: Two patients were treated with a fractioned combined approach, 13 patients were treated with an oral approach only, and 26 patients were treated with a combination. There was a complete resolution of the symptoms and closure of the fistula in all the patients enrolled. Conclusions: In our study, in all 41 patients, there was a surgical success. The best option is to use a multidisciplinary approach for patients suffering from odontogenic sinusitis.

Odontogenic Sinusitis from Classical Complications and Its Treatment: Our Experience.

Odontogenic sinusitis (ODS) refers to the maxillary sinus infection, which is secondary to either adjacent infectious dental pathologies or procedures. The aim of this retrospective study is to report the experiences of the department of integrated therapies in otolaryngology (Campus Bio-Medico Foundation, Rome, Italy) in classifying and treating patients that are affected by odontogenic sinusitis derived from "classic complications". A total of 68 patients responding to the criteria and to the definition as a classical odontogenic complication were included. The surgical therapy consisted of a combined oral and nasal simultaneous approach for 28 patients (43%), a combined non-simultaneous approach for 4 patients (6%), a nasal only approach for 14 patients (21%), and an oral only approach for 20 patients (30%). All the patients presented a complete resolution of the symptoms. The choice of performing a nasal, oral, or combined approach is based on the presence of anatomical elements that facilitate sinusitis and reinfection occurrence, such as deviated nasal septum, concha bullosa, or obstructed osteo-meatal complex. The correct use of validated classification, the pre-operative CT scan, a multidisciplinary approach, and an appropriate presurgical examination are the necessary elements to obtain a good success rate.

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.

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.

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 non-invasive electrical stimulation devices for treatment of snoring and obstructive sleep apnoea: a systematic review.

INTRODUCTION: Recently, new non-invasive electrical stimulation devices have been developed with the aim to increase the tongue muscle tone for patients with obstructive sleep apnoea (OSA) and snorers. The aim of this study was to provide a review of the first results found in the literature regarding the efficacy of non-invasive electric stimulation devices for the treatment of primary snoring and OSA. MATERIAL AND 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, 2021. RESULTS: Four studies met the criteria for inclusion in this review, for a total of 265 patients. Two devices were included in this review, Apone-Stim 400 Muscle Stimulator and eXciteOSA. All studies suggested that these new devices are effective in improving snoring by approximately 50% after device training, without major complications. However data regarding OSA improvement are conflicting. CONCLUSIONS: Intraoral non-invasive electrical stimulation devices can be considered a valid option to current therapies for snoring. Further studies are needed to support these interesting new devices for treatment of OSA.

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.

A Critical Analysis of Pharyngeal Patterns of Collapse in Obstructive Sleep Apnea: Beyond the Endoscopic Classification Systems.

(1) Background: Drug-Induced Sleep Endoscopy (DISE) enables the three-dimensional and dynamic visualization of the upper airway (UA) during sleep, which is useful in selecting the best treatment option for obstructive sleep apnea (OSA) patients, particularly for surgical procedures. Despite international consensus statements or position papers, a universally accepted DISE methodology and classification system remain a controversial open question. (2) Methods: A review of the English scientific literature on DISE related to endoscopic classification systems and surgical outcome predictors (3) Results: Of the 105 articles, 47 were included in the analysis based on their content's relevance to the searched keywords. (4) Conclusions: A final report and scoring classification system is not universally accepted; the most internationally applied endoscopic classification system during DISE does not cover all patterns of events that occur simultaneously during the endoscopic examination, highlighting that several configurations of collapse and obstruction at different UA levels could be observed during DISE, which should be described in detail if DISE has to be considered in the decision-making process for the UA surgical treatment in OSA patients and if DISE has to have a role as a predictive factor for surgical outcomes analysis.