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 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.

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.

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.

Multiple-access versus telemedicine home-based sleep apnea testing for obstructive sleep apnea (OSA) diagnosis: a cost-minimization study.

PURPOSE: The aim of the present study was to compare two clinical pathways: the multiple-access outpatient pathway versus the telemedicine pathway. METHODS: The multiple-access outpatient pathway and the telemedicine pathway were both performed with WatchPAT and implemented in a real-life healthcare scenario, adopting a cost-minimization approach. A cost-minimization analysis was undertaken to assess the economic impact of the two alternatives. The cost analyses were performed in euros for the year 2021 adopting the patient, the hospital, and the societal perspectives. Given the chosen perspectives, direct medical costs, direct nonmedical costs, and indirect costs were considered. In addition, a univariate sensitivity analysis was conducted. RESULTS: From a hospital perspective, the telemedicine approach was estimated to cost €49 more than the multiple-access alternative. Considering the patient perspective, the telemedicine approach was estimated to cost €167 less than the multiple-access pathway. Considering the societal perspective, the telemedicine approach is estimated to cost €119 less than the multiple-access pathway. CONCLUSION: The adoption of telemedicine home sleep apnea testing could improve the efficiency of the healthcare processes if considering the direct and indirect costs incurred by patients and not only by healthcare providers.

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.

Surgical anatomy of the lingual nerve for palate surgery: where is located and how to avoid it.

PURPOSE: To describe the anatomic relationship of the lingual nerve with the lateral oropharyngeal structures. METHODS: An anatomic dissection of the lateral oropharyngeal wall was conducted in eight sides from four fresh-frozen cadaveric heads. Small titanium clips were placed along the lingual nerve and the most anterior and medial border of the medial pterygoid muscle. Radiological reconstructions were employed for optimal visualization; the coronal view was preferred to resemble the surgical position. The distance between the lingual nerve and the medial pterygoid muscle at its upper and lower portion was measured radiologically. The trajectory angle of the lingual nerve with respect to the pterygomandibular raphe was obtained from the intersection between the vector generated between the clips connecting the upper and lower portion of the medial pterygoid muscle with the vector generated from the lingual nerve clips. RESULTS: The mean distance from the upper portion of the medial pterygoid muscle and superior lingual nerve clips was 10.16 ± 2.18 mm (mean ± standard deviation), and the lower area of the medial pterygoid muscle to the lingual nerve was separated 5.05 ± 1.49 mm. The trajectory angle of the lingual nerve concerning to the vector that describes the upper portion of the most anterior and medial border of the medial pterygoid muscle with its lower part was 43.73º ± 11.29. CONCLUSIONS: The lingual nerve runs lateral to the lateral oropharyngeal wall, from superiorly-inferiorly and laterally-medially, and it is closer to it at its lower third.

Hypoglossal nerve stimulation long-term clinical outcomes: a systematic review and meta-analysis.

OBJECTIVE: To perform a systematic review and meta-analysis for studies evaluating hypoglossal nerve stimulation (HNS) clinical outcomes in the treatment of moderate to severe obstructive sleep apnea (OSA). METHODS: Two authors conducted a literature search to identify prospective studies in PubMed/MEDLINE, Google Scholar, and Cochrane Library databases. The last search was performed on November 17, 2018. RESULTS: A total of 350 patients (median age 54.3 (IQR 53-56.25) years, BMI 29.8 (IQR 28.8-31.6) kg/m2) from 12 studies were included. The procedure has obtained a surgical success rate of 72.4% (Inspire), 76.9% (ImThera), 55% (Apnex) at 12 months, and 75% (Inspire) at 60-month follow-up. At 12 months, the apnea-hypopnea index (AHI) mean differences was - 17.50 (Inspire; 95% CI: - 20.01 to - 14.98, P < 0.001), - 24.20 (ImThera; 95% CI: - 37.39 to 11.01, P < 0.001), and - 20.10 (Apnex; 95% CI: - 29.62 to - 10.58, P < 0.001). The AHI mean reduction after 5 years was - 18.00 (Inspire, - 22.38 to - 13.62, P < 0.001). The Epworth sleepiness scale (ESS) mean reduction was - 5.27 (Inspire), - 2.90 (ImThera), and - 4.20 (Apnex) at 12 months and - 4.40 (Inspire) at 60 months, respectively. Only 6% of patients reported serious device-related adverse events after 1- and 5-year follow-up. CONCLUSION: HNS has obtained a high surgical success rate with reasonable long-term complication rate related to the device implanted. The procedure represents an effective and safe surgical treatment for moderate-severe OSA in selected adult patients who had difficulty accepting or adhering to CPAP treatment.

Different barbed pharyngoplasty techniques for retropalatal collapse in obstructive sleep apnea patients: a systematic review.

BACKGROUND: The use of barbed sutures (BS) for the treatment of retropalatal collapse and vibration in patients suffering from snoring and obstructive sleep apnea (OSA) has significantly increased in the last few years. Many surgeons have discovered the advantages and unique properties of the BS and allowed the popular surgical pharyngoplasty techniques to be updated and improved. METHODS: A systematic review was performed to identify all the clinical studies concerning the different barbed pharyngoplasty (BP) techniques used for the treatment of palatal collapse in snoring and OSA patients. A qualitative analysis of data extracted was conducted. RESULTS: We included 12 studies of which 10 are prospective and 2 retrospective: 9 single-arm studies on the efficacy of a specific BP technique, 1 randomized clinical trial on the comparison between BP and control groups, and 2 studies on the correlation between two different BP techniques. To date, in the literature, 5 different types of BP techniques have been described: barbed snore surgery, barbed reposition pharyngoplasty, barbed expansion sphincter pharyngoplasty, barbed suture suspension, and barbed soft palate posterior webbing flap pharyngoplasty. All the studies showed an overall improvement in the primary efficacy parameters investigated (apnea-hypopnea index, oxygen desaturation index, and Epworth sleepiness scale) in each of the surgical techniques performed without any major complications. CONCLUSIONS: Given the extreme heterogeneity of the studies analyzed, it is necessary to perform more randomized and control studies on large samples aimed to define the best BP technique based on its effectiveness, surgical success rate, patient's compliance, and complications.

Management of Parapharyngeal Space Tumor Using Transoral Robotic Surgery: The Tonsillar Fossa Battlefield.

INTRODUCTION: The management of parapharyngeal space (PPS) tumors is surgical, but the approach remains a challenge. Attention should be paid to avoid intra-operative bleeding, cranial nerves damage, and external scars. PRESENTATION OF CASE: The authors report a case of a 23-year-old female, with complaint of progressive, painless swelling just below the right angle of the mandible of 6-month's duration. Magnetic resonance imaging images reported the presence of an oval-shaped expansive lesion (maximum diameter 3 cm), from the lower polar region of the parotid gland while fine needle aspiration cytology (FNAC) was not diagnostic. We performed a Trans Oral Robotic surgical excision of the tumors with Da Vinci Robot. DISCUSSION: Thanks to a detailed magnification, the authors were able to reach the PPS region through the tonsillar fossa saving the palatine tonsil without any significant bleeding or nerve lesions. The histological examination confirmed the diagnosis of pleomorphic adenoma of parotid gland. The decision on which surgical approach to be used is determined by site, size vascularity, histology of the tumor, and knowledge of radiological images. CONCLUSION: There is not only 1 surgical approach for PPS tumors but the surgeon must know all the different options and possible outcomes. Transoral Robotic Surgery approach with Da Vinci could represent a valid option with a good knowledge of Robot surgical instruments and a detailed preoperative plan.

Ex-vivo surgical model for "Barbed Snore Surgery": a feasibility study.

INTRODUCTION: The "Barbed Snore Surgery" is one of the last technical innovations in palatal surgery for Obstructive Sleep Apnea. The availability of a low-cost surgical model able to replicate tissue consistency and main anatomical structures could be fundamental for the spreading of this surgery. The aim of this study was to assess the feasibility of an ex-vivo ovine model in the surgical training of BSS. METHODS: After adequate preparation of adult lamb heads, a post-graduate student with no surgical expertise was guided by a skilled surgeon in the execution of two BSS procedures: "Barbed Roman Blinds Technique" and "Barbed Anterior Pharyngoplasty". Anatomical limitations and similarity with the human tissue were assessed and recorded during the simulation. RESULTS: All the procedures were successfully completed. Despite proportional differences, the palatal tissue was assessed as similar in consistency and thickness to the human tissue. The simulation was considered satisfactory and suitable for surgical training. CONCLUSION: This ex-vivo ovine surgical model could represent the right tool for BSS training thanks to readily available and inexpensive specimens. Moreover, it appears to present the realistic anatomy and tissue consistence essential for an adequate surgical simulation.

"Barbed snore surgery" simulator: a low-cost surgical model.

BACKGROUND: "Barbed snore surgery" (BSS) represents one of the last innovation for obstructive sleep apnea syndrome (OSAS) surgical management. Although this technique represents an effective and minimally invasive surgery, it is not still widespread in many ENT centers. The aim of our study was to develop an inexpensive surgical simulator useful to expedite the surgical learning curve for BSS in untrained ENT surgeons. MODEL ASSEMBLY: The simulator is a simple model composed of a manually shaped silicone palate (3 × 4 × 1 cm) fixed on a resin skeleton (21 × 16 × 12 cm) using a transparent silicon rubber. The mandible is fixed bilaterally with the aid of two screws allowing for modular inter-incisive distance. SIMULATION: Barbed anterior pharyngoplasty (BAPh) was readily performed on the simulator to show the feasibility of this BSS model. All surgical steps were carried out determining a lift and a shortening of the palate as in real surgery. CONCLUSIONS: This is the first surgical model that provides a realistic, easily repeatable training in the performance of BSS. Our BSS surgical model is very inexpensive with a cost of approximately 19.25$ dollars and it is manufactured to facilitate a worldwide diffusion of this promising palatal surgery for OSAS.

Maxillary Sinus Mass as First Presentation of Silent Metastatic Renal Cell Carcinoma.

Renal cell carcinoma accounts for more than 3% of all malignant diseases. Metastatic disease to the head and neck ranges from 15% to 30%. The 5-year survival rate after nephrectomy is 60% to 75%, but with multiorgan metastases the 5-year survival rate is significantly lower, 0% to 7%. The authors present the case of a patient with a progressive, painless right facial swelling over the maxillary area of 3-month's duration associated with a considerable decrease of right visual acuity. Cranial computed tomography scan and magnetic resonance imaging showed a maxillary sinus mass extending to the orbital cavity and 2 choroidal and retinal thickenings. The mass biopsy was performed by Caldwell-Luc procedure and pathology report suggested metastatic renal cell carcinoma. Following histological findings, a total body computed tomography scan showed a heterogeneous mass at the middle-lower portion of the right kidney measuring approximately 8 × 12 × 4 cm with associated ipsilateral renal vein thrombosis. The patient was referred to the Oncology Department for further treatment. Unfortunately, 3 months after the mass biopsy, the patient died due to complications of multiorgan failure. Although metastases of renal cell carcinoma to the head and neck are very rare, it should be first suspected when investigating a metastatic tumor in this region.

The (templar) knight cap: a new and simple way to prevent hair interference during ear surgery.

INTRODUCTION: Hair interference is a critical problem in ear surgery. The hair around the surgical area can get stuck unwantedly, making the surgeon habitually struggling with this hair rather than the surgery itself. Hair shaving can cause psychological discomfort, especially for women and data about shaving efficacy are conflicting. With the aim of solving this problem, we developed a new way to clear hair from the operating field named "The (Templar) Knight cap". TECHNICAL DESCRIPTION: This is a medical elastic stocking open at the ear to be treated and at the face that recalls the typical cap worn by Templar knight. This cap allows good hair retention and marks the surgical site. It is easy to wear does not require additional time for clinical staff. CONCLUSIONS: The described cap could be a valid instrument during ear surgery with a low cost pricing, making it applicable in very poor settings, such as developing countries.

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.