Adverse events associated with device assisted hyoid and tongue base suspension for obstructive sleep apnea.

PURPOSE: Hyoid and tongue base suspension may treat obstructive sleep apnea (OSA). This study summarizes device-related adverse events associated with the AIRvance and AIRLIFT systems used for hyoid and tongue base suspension. MATERIALS AND METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports describing adverse events associated with hyoid or tongue base suspension from January 2012 to December 2022. RESULTS: 77 adverse events were identified. When performed separately, adverse events were equally as common with hyoid suspension as with tongue base suspension. More complications occurred postoperatively (51 [66.2 %]) than intraoperatively (26 [33.8 %]). The most reported adverse events were infection (23 [29.9 %]), broken screw (15 [19.5 %]), pain or discomfort (10 [13.0 %]), suture rupture (8 [10.4 %]), and dislodged screw (7 [9.1 %]). 10 infections required drainage or debridement; 12 required device explantation. CONCLUSIONS: The present study is the largest and most longitudinal review of adverse events associated with hyoid and tongue base suspension. Infection was the most common adverse event, and may require device explantation. While adverse events were most frequently attributed to device malfunction, broken screw, suture rupture, and broken needle were often attributed to operator error due to application of excessive force. Surgeon training to increase familiarity with hyoid and tongue base suspension may reduce adverse events caused by operator error. The MAUDE database is limited as a passive surveillance system. Standardized reporting may improve understanding of associated adverse events, enabling better informed comparisons between surgical treatment options for OSA.

Investigating surgical smoke in otolaryngology operating rooms.

Surgical smoke is a common chemical hazard produced from the use of electrocautery, laser, or ultrasonic scalpels during surgery. It has been proved harmful to medical personnel. Thus, it is important to monitor surgical smoke concentrations in the operating room. In the past decade, many researches regarding surgical smoke were discussed in different professional healthcare fields, but few showed the correlation between surgical smoke and otolaryngology surgery. In this study, the concentrations of particulate matter and formaldehyde were measured during thirty cases of several types of otolaryngology surgery in a regional research hospital in Taiwan. The concentrations of 0.3 µm and 0.5 µm particulate matter raised rapidly in the main knife range at the beginning of the electrocautery knife used, and then decreased by half after 5-10 min of use. The concentrations of formaldehyde were ranged from 1 to 2 ppm during the surgery, which is higher than the permissible exposure limit. While many medical staffs are working in the operating room and are exposed to the smoke hazard, effective strategies for collecting and eliminating the smoke should be taken in all medical facilities.

Clinical application of PEAK PlasmaBlade to remove distal tracheal granulation in patients after tracheostomy.

OBJECTIVE: Tracheal granulation is one of the common long term complications in patients after tracheostomy. Hypertrophic tracheal granulation may cause airway obstruction and further operation may be required to recreate an airway. Distal tracheal granulation is clinically challenging because of its position and surgical field limitation. This retrospective case review study evaluated the outcomes of PEAK PlasmaBlade-assisted tracheal surgery in patients with distal tracheal granulation. METHODS: This study retrospectively reviewed patients with distal tracheal granulation following long-term tracheostomy. All patients received PEAK PlasmaBlade assistance tracheal surgery (PATS) between February 2013 and December 2019. The surgery was performed using the PEAK PlasmaBlade with TnA type tip, powered by a PULSAR Generator, and guided by a 45 ° rigid endoscope. Patients were regularly followed up for a minimum of 12 months. RESULTS: A total 21 patients had completed PATS. None of the patients experience immediate life-threatening complications during or after the procedure. All the 21 patients were free of recurrent obstructive granulation within 12 months after operation. CONCLUSION: PATS is practical, effective, and safe for distal tracheal granulation and can be performed by single surgeon. Furthermore, it is technically less demanding than other surgical approaches and it has a rapid learning curve.

Implantable Doppler Removal After Free Flap Monitoring Among Head and Neck Microvascular Surgeons.

OBJECTIVE: Investigate current practice patterns of head and neck microvascular reconstructive surgeons when removing an implantable Doppler after free flap surgery. STUDY DESIGN: Cross-sectional survey study. METHODS: Survey distributed to head and neck microvascular reconstructive surgeons. Data regarding years performing free tissue transfer, case numbers, management of implantable Doppler wire, and complications were collected. RESULTS: Eighty-five responses were analyzed (38,000 cases). Sixty-six responders (77.6%) use an implantable Doppler for postoperative monitoring, with 97% using the Cook-Swartz Doppler Flow Monitoring System. Among this group, 65.2% pull the wire after monitoring was complete, 3% cut the wire, and 31.8% have both cut and pulled the wire. Of those who have cut and pulled the wire, 48% report cutting and pulling the wire with equal frequency, 43% formerly pulled the wire and now cut the wire, and 9% previously cut the wire but now pull the wire. Of those who pull the wire, there were two injuries to the pedicle requiring return to the operating for flap salvage, and one acute venous congestion. Of the nine who previously pulled the wire, six (67%) cited concerns with major bleeding/flap compromise as the reason for cutting the wire. CONCLUSION: In this study, most surgeons use an implantable Doppler for monitoring of free flaps postoperatively. In extremely rare instances, pulling the implantable Doppler wire has resulted in flap compromise necessitating revision of the vascular anastomosis. Cutting the wire and leaving the proximal portion in the surgical site has been adopted as a management option. LEVEL OF EVIDENCE: 4 Laryngoscope, 132:554-559, 2022.

Shikani Optical Stylet for Awake Nasal Intubation in Patients Undergoing Head and Neck Surgery.

OBJECTIVES: To evaluate the efficacy and safety of the Shikani optical stylet (SOS) versus fiberoptic bronchoscope (FOB) for awake nasal intubation in head and neck surgery patients with an anticipated difficult airway. STUDY DESIGN: Prospective randomized clinical trial. METHODS: This study involved 50 adult patients scheduled for elective head and neck surgery and presented with an anticipated difficult airway. Patients planned for awake nasotracheal intubation were randomly divided into two groups: FOB (n = 25) and SOS (n = 25). Patients were intubated under local anesthesia and sedation using the randomly assigned intubation device by anesthetists proficient in both airway devices. The time to successful intubation was regarded as the primary endpoint. RESULTS: The median time (interquartile range) to tracheal intubation in the FOB group was 74 seconds (57-108) and 38 seconds (27-60) in the SOS group (P < .001). Intubation success rates on the first attempt in the FOB and SOS groups were 96% and 92%, respectively (P > .999). Airway assisted maneuvers were required in six (24%) SOS intubations compared to 21 (84%) FOB intubations (P < .001). There were no significant differences between the groups in the incidences of oxygen desaturation and postoperative complications related to intubation. CONCLUSION: Compared to the FOB group, awake nasal intubation in the SOS group required significantly less time and fewer airway-assisted maneuvers on adult head and neck surgery patients with anticipated difficult airway. LEVEL OF EVIDENCE: 2 Laryngoscope, 131:319-325, 2021.

Endonasal endoscopic transsphenoidal approach robot prototype: A cadaveric trial.

BACKGROUND: The Endonasal Endoscopic Transsphenoidal Surgery (EETS) is a minimally invasive procedure to approach and remove pituitary tumors and other sellar lesions. The process causes less pain, faster recovery, and provides further minimal invasive access in critical cases. However, a slight deviation of tools from the target area can be fatal to the patients. The aim of this study is to design and develop a prototype robot to demonstrate neurosurgical robot-assisted EET approach. METHODS: The effectiveness of a prototype robot in executing a minimally invasive EET surgery was studied in 6 cadavers. The robot was associated with a multi-information integrated technique for surgery including QR code tracking. The robot was controlled and driven by the neurosurgeon. RESULTS: The standard procedure of EET was followed and the robot carried out the first stage of EET under the supervision of neurosurgeon. Finally, the sellar was reached by the neurosurgeon. The result was determined by qualitative analysis and was confirmed by the neurosurgeon. The time for the entire EET surgical procedure showed marked reduction compared to the traditional EET approach. CONCLUSION: The robot design was found to be technically feasible and hence can be used for assisting the EET procedure. The robot used was able to assist the neurosurgeon correctly to approach the sinus.

Is the Da Vinci Xi system a real improvement for oncologic transoral robotic surgery? A systematic review of the literature.

In this paper, we reviewed the current literature about TORS procedures performed with Xi system and we discussed the pros and cons of this robotic system comparing it to the previous Si model. A systematic literature review was conducted using the PubMed, Scopus, Web of Science and Cochrane databases for adequate published studies about TORS procedure performed with da Vinci Si and Xi models. Five papers on the TORS-Xi procedures met our inclusion and exclusion criteria. These papers showed results based on 74 subjects (mean age 60.51 ± 4.55 years old). The most common TORS procedure was performed to address the oropharynx (65 procedures). One case (1.35%) of a tongue base tumor was converted into a transmandibular approach. One subject (1.35%) had a positive margin, while two subjects (2.7%) had close/uncertain margins at final histology. Nine papers on the TORS-Si procedures met our inclusion and exclusion criteria. These papers showed results based on 128 subjects (mean age 59.79 ± 5.93 years old). The most common TORS procedure was performed to address the oropharynx (90 procedures). Three procedures (2.34%) were aborted due to inadequate exposure of the tumor. None of the subject had positive margins, while three subjects (2.34%) had close/uncertain margins at final histology. Despite its improved vision, easier docking and narrower robotic arms, the da Vinci Xi system has structural peculiarities that limit its applications for certain TORS procedures.

Equine Sinus Surgery.

The anatomy of the equine paranasal sinuses is critical to understand to assess the extent of the disease process, the optimal surgical approach, and the ability to drain through the normal nasomaxillary pathway. By following established anatomic landmarks, direct sinus access can be used to further explore the sinus compartments, remove compromised cheek teeth, remove any purulent debris or feed contamination, and establish drainage. Many complications can be avoided or minimized by thoroughly evaluating all sinus compartments and critically assessing the ability of the sinus to drain.

The challenge of performing mastoidectomy using the operating microscope with coronavirus disease 2019 personal protective equipment (PPE).

OBJECTIVE: Mastoidectomy is considered an aerosol-generating procedure. This study examined the effect of wearing personal protective equipment on the view achieved using the operating microscope. METHODS: ENT surgeons assessed the area of a calibrated target visible through an operating microscope whilst wearing a range of personal protective equipment, with prescription glasses when required. The distance between the surgeon's eye and the microscope was measured in each personal protective equipment condition. RESULTS: Eleven surgeons participated. The distance from the eye to the microscope inversely correlated with the diameter and area visible (p < 0.001). The median area visible while wearing the filtering facepiece code 3 mask and full-face visor was 4 per cent (range, 4-16 per cent). CONCLUSION: The full-face visor is incompatible with the operating microscope. Solutions offering adequate eye protection for aerosol-generating procedures that require the microscope, including mastoidectomy, are urgently needed. Low-profile safety goggles should have a working distance of less than 20 mm and be compatible with prescription lenses.

Clinical evidence based review and recommendations of aerosol generating medical procedures in otolaryngology - head and neck surgery during the COVID-19 pandemic.

BACKGROUND: Aerosol generating medical procedures (AGMPs) present risks to health care workers (HCW) due to airborne transmission of pathogens. During the COVID-19 pandemic, it is essential for HCWs to recognize which procedures are potentially aerosolizing so that appropriate infection prevention precautions can be taken. The aim of this literature review was to identify potential AGMPs in Otolaryngology - Head and Neck Surgery and provide evidence-based recommendations. METHODS: A literature search was performed on Medline, Embase and Cochrane Review databases up to April 3, 2020. All titles and abstracts of retrieved studies were evaluated and all studies mentioning potential AGMPs were included for formal review. Full text of included studies were assessed by two reviewers and the quality of the studies was evaluated. Ten categories of potential AGMPs were developed and recommendations were provided for each category. RESULTS: Direct evidence indicates that CO2 laser ablation, the use of high-speed rotating devices, electrocautery and endotracheal suctioning are AGMPs. Indirect evidence indicates that tracheostomy should be considered as potential AGMPs. Nasal endoscopy and nasal packing/epistaxis management can result in droplet transmission, but it is unknown if these procedures also carry the risk of airborne transmission. CONCLUSIONS: During the COVID-19 pandemic, special care should be taken when CO2 lasers, electrocautery and high-speed rotating devices are used in potentially infected tissue. Tracheal procedures like tracheostomy and endotracheal suctioning can also result in airborne transmission via small virus containing aerosols.

Is the ultrasonic scalpel recommended in head and neck surgery during the COVID-19 pandemic? State-of-the-art review.

BACKGROUND: Guidelines for ultrasonic devices use are imperative because infectious aerosols arising from airway procedures were a key etiologic factor in prior coronavirus outbreaks. This manuscript aims to summarize the available recommendations and the most relevant concepts about the use of ultrasonic scalpel during the SARS-CoV-2 pandemic. METHODS: Literature review of manuscripts with patients, animal models, or in vitro studies where the ultrasonic scalpel was used and the plume produced was analyzed in a quantitative and/ or qualitative way. DISCUSSION: Activated devices with tissue produce a biphasic bioaerosol composed (size 68.3-994 nm) of tissue particles, blood, intact and no viable cells, and carcinogenic or irritant hydrocarbons (benzene, ethylbenzene, styrene, toluene, heptene, and methylpropene). CONCLUSION: It is imperative to use an active smoke evacuator, to avoid ultrasonic scalpel use in COVID-19 positive patients and in upper airway surgery, as well as to follow the protection recommendations of the guidelines for management this type of patients.

Procedural precautions and personal protective equipment during head and neck instrumentation in the COVID-19 era.

BACKGROUND: Otolaryngologists represent a subset of health care workers uniquely vulnerable to COVID-19 transmission. Given the segmentation of extant guidelines concerning precautions and protective equipment for SARS-CoV2, we aimed to provide consolidated recommendations regarding appropriate personal protective equipment (PPE) in head neck surgery during the COVID-19 era. METHODS: Guidelines published by international and US governing bodies were reviewed in conjunction with published literature concerning COVID-19 transmission risk, testing, and PPE, to compile situation-specific recommendations for head and neck providers managing COVID-19 patients. RESULTS: High-quality data regarding the aerosolization potential of head and neck instrumentation and appropriate PPE during head and neck surgeries are lacking. However, extrapolation of recommendations by governing bodies suggests strongly that head and neck mucosal instrumentation warrants strict adherence to airborne-level precautions. CONCLUSION: We present a series of situation-specific recommendations for PPE use and other procedural precautions for otolaryngology providers to consider in the COVID-19 era.

"L" shape technique for endoscopic sinus surgery: An alternative method.

BACKGROUND: Several techniques for performing ethmoidectomy have been reported. We describe a safe, effective and efficient technique during functional endoscopic sinus surgery (FESS). We present text, images and videos to illustrate our preferred technique during an antero-posterior ethmoidectomy and to provide a multimedia tool for educational purpose. METHODS: A description of the technique without prospective or retrospective data is reported. A complete ethmoidectomy with an L-shape approach is described step-by-step, using the backbiting circular and miniature cutting forceps, with safe exposure of the lamina papyracea (LP) and skull base. RESULTS: In our hands, the L-shape approach for chronic rhinosinusitis with or without polyposis, performed with punch circular cutting and miniature cutting forceps, allowed for a reliably safe and efficient ethmoidectomy. CONCLUSION: The technique described can be added to the armamentarium of the endoscopic sinus surgeon.

Disección fría y coagulación bipolar versus disección con bisturí armónico en la cirugía de los tumores benignos de la glándula parótida / Cold knife dissection and bipolar diathermy Vs harmonic scalpel in parotid gland surgery for benign tumours

INTRODUCCIÓN: Las técnicas quirúrgicas para extirpación de tumores de la glándula parótida han evolucionado significativamente en los últimos años. Los datos publicados previamente sugieren que el uso del bisturí armónico disminuye el tiempo operatorio, la pérdida de sangre intraoperatoria, la producción del drenaje postoperatorio y la incidencia de lesión del nervio facial, en comparación con la disección con bisturí frío. MATERIAL Y MÉTODOS: Se realizó un análisis retrospectivo en 2grupos de pacientes operados con bisturí armónico y disección en frío más coagulación bipolar. El objetivo principal fue comparar el tiempo quirúrgico y la tasa de complicaciones posquirúrgicas: lesión del nervio facial, aparición de sialocele o formación de fístula salival después de la parotidectomía por tumores benigno de la glándula parótida. RESULTADOS: Se incluyó a 108 pacientes. Con respecto al tiempo quirúrgico, el tiempo medio para usar el bisturí armónico fue de 114 ± 39 minutos (mín.: 60/máx.: 240) y el tiempo medio de uso de la diatermia bipolar fue de 135 ± 38 minutos (mín.: 90/máx.: 285) y este fue el único parámetro en el que evidenciamos una diferencia significativa entre ambas técnicas (p = 0,049). CONCLUSIONES: El bisturí armónico es una herramienta segura y eficaz para realizar la cirugía de la parótida en tumores benignos. Sin embargo, la disminución del tiempo quirúrgico fue la única ventaja que encontramos en comparación con el método tradicional de disección en frío y coagulación bipolar

INTRODUCTION: Surgical techniques for extirpation of tumours of the parotid gland have evolved significantly in recent years. Previous data suggest the use of Harmonic Scalpel reduced operative time, intraoperative blood loss, postoperative drain production, and incidence of facial nerve injury, in comparison to cold scalpel dissection MATERIAL AND METHODS: retrospective analysis of 2group of patients operated using harmonic scalpel versus cold knife dissection and bipolar diathermy and compare operative time and post-surgical complication rate:, facial nerve injury, sialocele or salivary fístula formation, after parotidectomy for benign parotid tumours. RESULTS: 108 patients were included. Regarding surgical time, the mean time to using Harmonic Scalpel was 114 ± 39 (Min: 60/Max: 240), and the mean time using bipolar diathermy was 135 ± 38 (Min: 90/Max: 285) and this was the only significant difference between the 2 techniques (p = .049). CONCLUSIONS: Harmonic scalpel is a safe and effective tool to perform parotid surgery in benign tumours. However, a shorter surgical time was the only advantage found over the traditional cold dissection and bipolar dissection method

Using a 4K-3D Exoscope for Upper Airway Stimulation Surgery: Proof-of-Concept.

OBJECTIVE: Demonstrate the potential of the 4K-3D exoscope during upper airway stimulation surgery (UAS). METHODS: A proof-of-concept study was performed to evaluate the feasibility of the exoscope during three consecutive UAS. RESULTS: The exoscope was employed during UAS including cuff electrode and sensing lead placement. Three cases were successfully completed without adverse perioperative event; mean operative time was 200 minutes (range 188-218 minutes) with a successive reduction in operative time. CONCLUSION: This experience demonstrates the potential viability of the exoscope for UAS; it is a safe, innovative, and effective alternative or adjunct to existing visualization modalities. Notable advantages include improved ergonomics, unobstructed surgical field access, wide depth of field visualization, and short learning curve. Future technological enhancements could allow the exoscope to become a promising next-generation tool in the armamentarium of the contemporary sleep surgeon.