Overall survival, disease-free survival and quality of life in patients affected by HPV mediated p16+ oropharyngeal squamous cell carcinoma treated with upfront trans-oral robotic surgery vs radiotherapy or chemoradiotherapy.

PURPOSE: Treatment de-intensification for p16 + oropharyngeal squamous cell carcinoma (OPSCC) is an area of active research to reduce the side effects and improve patients' quality of life (QoL). In this paper we evaluated the Overall Survival (OS), the Disease-Free Survival (DFS) and the QoL of patients affected by p16 + OPSCC according to their prognostic stage group (PSG) and different treatments. METHODS: Patients were selected retrospectively through our Electronic Tumor Board Database according to prespecified inclusion criteria. Basic data of eligible patients were recorded and analyzed. Then, OS and DFS were evaluated according to the PSG and the treatments performed. Patients alive completed three questionnaires: the QoL Questionnaire Core 30 (QLQ-C30), the QoL Questionnaire Head & Neck 43 (QLQ-HN43) and the MD Anderson Dysphagia Inventory (MDADI) questionnaire. RESULTS: Sixty-one patients were included in this study. Eight patients died from the disease and the remaining 53 patients completed the 3 questionnaires. Fifteen (25%) patients were treated with upfront surgery, 6 (10%) patients with definitive radiotherapy and 40 (65%) patients with concomitant chemoradiotherapy. Comparing the DFS and the OS of PSG I patients by the different treatments performed, no statistically significant difference was identified. Patients treated with upfront surgery showed better outcomes in some aspects of their QoL. CONCLUSION: For p16 + OPSCC PSG I patients, upfront surgery can be considered a valid alternative to radiotherapy or chemoradiotherapy while maintaining a comparable DFS and OS and giving patients better results in terms of specific aspects of their QoL.

Functional outcomes and complications in refractory dysthyroid optic neuropathy management: Experience with 3 different surgical protocols.

INTRODUCTION: Dysthyroid optic neuropathy (DON) is the most severe complication of Graves' orbitopathy (GO) and its management may require decompression surgery. Clear recommendations do not exist about which surgery should be performed and how extended the decompression should be. In this paper we present our experience regarding the management of DON via 3 different surgical protocols: a modified extended orbital apex decompression, a 2 walls decompression (inferior and lateral) and a 3 walls decompression (inferior, lateral and medial) and evaluate the functional outcomes. METHODS: Retrospective evaluation of subjects affected by DON not responding to medical therapy has been performed. All patients were submitted to pre- and post-operative ophthalmologic evaluations and orbital and sinuses CT scan in order to evaluate functional and surgical outcomes. RESULTS: 27 patients were enrolled in the study. Surgical procedures were performed on 42 orbits. A statistically significant post-operative improvement was recorded in visual acuity, proptosis, color vision and fundus oculi evaluation for all groups. No patient developed major or minor complications after surgery. CONCLUSIONS: Extended endonasal approach and 3 walls decompression have been proved effective in the management of DON. The choice between them is done according to degree of proptosis, general status and eye-surface damages.

Incidence and types of laryngotracheal sequelae of prolonged invasive ventilation in COVID-19 patients.

PURPOSE: The COVID-19 outbreak has led to an increasing number of acute laryngotracheal complications in patients subjected to prolonged mechanical ventilation, but their incidence in the short and mid-term after ICU discharge is still unknown. The main objective of this study is to evaluate the incidence of these complications in a COVID-19 group of patients and to compare these aspects with non-COVID-19 matched controls. METHODS: In this cohort study, we retrospectively selected patients from November 1 to December 31, 2020, according to specific inclusion and exclusion criteria. The follow-up visits were planned after 6 months from discharge. All patients were subjected to an endoscopic evaluation and completed two questionnaires (VHI-10 score and MDADI score). RESULTS: Thirteen men and three women were enrolled in the COVID-19 group while nine men and seven women were included in the control group. The median age was 60 [56-66] years in the COVID-19 group and 64 [58-69] years in the control group. All the patients of the control group showed no laryngotracheal lesions, while five COVID-19 patients had different types of lesions, two located in the vocal folds and three in the trachea. No difference was identified between the two groups regarding the VHI-10 score, while the control group showed a significantly worse MDADI score. CONCLUSIONS: COVID-19 patients subjected to prolonged invasive ventilation are more likely to develop a laryngotracheal complication in the short and medium term. A rigorous clinical follow-up to allow early identification and management of these complications should be set up after discharge.

Experimental Assessment of Cuff Pressures on the Walls of a Trachea-Like Model Using Force Sensing Resistors: Insights for Patient Management in Intensive Care Unit Settings.

The COVID-19 outbreak has increased the incidence of tracheal lesions in patients who underwent invasive mechanical ventilation. We measured the pressure exerted by the cuff on the walls of a test bench mimicking the laryngotracheal tract. The test bench was designed to acquire the pressure exerted by endotracheal tube cuffs inflated inside an artificial model of a human trachea. The experimental protocol consisted of measuring pressure values before and after applying a maneuver on two types of endotracheal tubes placed in two mock-ups resembling two different sized tracheal tracts. Increasing pressure values were used to inflate the cuff and the pressures were recorded in two different body positions. The recorded pressure increased proportionally to the input pressure. Moreover, the pressure values measured when using the non-armored (NA) tube were usually higher than those recorded when using the armored (A) tube. A periodic check of the cuff pressure upon changing the body position and/or when performing maneuvers on the tube appears to be necessary to prevent a pressure increase on the tracheal wall. In addition, in our model, the cuff of the A tube gave a more stable output pressure on the tracheal wall than that of the NA tube.

Transoral robotic tongue base reduction and supraglottoplasty combined with maxillomandibular advancement: a new option for selected sleep apnea patients? Preliminary report.

PURPOSE: Transoral robotic surgery (TORS) and maxillo-mandibular advancement (MMA) are effective options for obstructive sleep apnea patients. Identification of the correct candidate is by far the most important item in achieving a succesful outcome. As a consequence, not all patients can be managed successfully via one or the other procedure. To overcome the limits of any single procedure we have combined, in a very selected population of patients, TORS tongue base reduction and MMA. Preliminary data are encouraging, in terms of both AHI and ESS. METHODS: A retrospective cohort study was conducted on five patients treated with combined TORS-MMA surgery. Demographic and clinical data, pre-operative and post-operative PSG and ESS were collected. RESULTS: Three of five patients were recruited. All patients presented severe OSAHS. Mean AHI and ESS went respectively from 48 and 12 pre-operatively to 19 and 4 post-operatively. Minor bleeding occurred in two patients. No significant sequelae have been reported. CONCLUSIONS: Combined TORS and MMA is feasible and safe. Our very preliminary data are encouraging, in terms of both AHI and ESS. Long-term follow-up and a larger amount of subjects are needed to confirm this surgical approach as a valuable option for selected OSAHS patient.

Frey Syndrome, First Bite Syndrome, great auricular nerve morbidity, and quality of life following parotidectomy.

PURPOSE: Parotidectomy may be burdened by numerous complications that may worsen subjects' quality of life (QoL). These include paresis or paralysis of the facial nerve, face profile asymmetry, keloids, salivary fistula, Frey Syndrome (FS), First Bite Syndrome (FBS), and hypo-anaesthesia of the skin. This study is an effort to assess the incidence of complications following parotidectomy and their impact on subjects' QoL. METHODS: Subjects undergoing parotidectomy for benign neoplasms from 2012 to 2015 were selected and invited to attend our outpatient clinic. After a brief anamnesis, the medical examiners tested their tactile perception and performed the Minor test for FS. Depending on the complications showed, subjects were asked to complete from 1 to 4 questionnaires about their QoL. RESULTS: 76 subjects completed the medical examination. The most frequent complication was the hypo-anaesthesia of the skin (71%). 21 subjects (28%) were positive to the Minor test, while 8 subjects (11%) reported FBS-compatible symptoms. Two subjects (3%) showed a facial nerve paralysis. Free abdominal fat graft was used in 16 subjects (21%) and it was associated with a lower incidence of FS. Surgery of the deep lobe of the parotid was associated with FBS. CONCLUSIONS: FBS appears to have a greater influence on subjects' QoL than FS and hypo-anaesthesia of the skin. Moreover, this work confirms that surgery of the deep lobe of the parotid is a risk factor for developing FBS and the free abdominal fat graft is a reliable technique to prevent FS.

Endoscopic-assisted transoral-transpharyngeal approach to parapharyngeal space and infratemporal fossa: focus on feasibility and lessons learned.

The parapharyngeal space (PPS) is a challenging anatomical region, rich in vascular and nervous vital structures. Surgery is considered the treatment of choice for the majority of PPS lesions. Herein, we present a retrospective evaluation on ten patients with various types of lesions of the parapharyngeal and infratemporal fossa (ITF) regions operated on via an endoscopic-assisted transoral-transpharyngeal approach (EATTA), focusing on feasibility and safety. A retrospective evaluation of patients treated by means of EATTA to PPS and/or ITF lesions was carried out. The clinical records of patients who were operated on with EATTA for PPS and/or ITF lesions between March 2009 and October 2015 at two referral centres were reviewed and the intra-operative and post-operative complications were analysed. Ten patients who underwent EATTA on the PPS and ITF were included in this series. The procedure was performed in six patients for tumour removal, in three patients for diagnostic purposes and in one patient for pain control. No major complications occurred. No conversion to external approach was required. We observed only two minor complications which were promptly solved. No dysphagia or other problems during the food intake were observed in our series. One day after surgery all patients, except one, referred a value of VAS minor than 4. To date, no evidence of disease recurrence has been assessed in all six oncological cases. Although preliminary, our experience seems to demonstrate the feasibility and safety of EATTA when properly planned and performed.

The Role of Bone-Anchored Hearing Devices and Remote Microphones in Children with Congenital Unilateral Hearing Loss.

Congenital unilateral hearing loss (UHL) represents a contemporary audiologic challenge. Children with UHL can struggle with understanding speech in noise, localizing sounds, developing language, and maintaining academic performance, leading to low self-esteem, anxiety, and decreased social support. Two specific conditions related to UHL in children are single-sided deafness (SSD) and unilateral auris atresia (UAA). This was a retrospective observational study on a group of children with UHL. The Simplified Italian Matrix Sentence Test was used for the assessment of speech reception threshold (SRT) in different conditions: speech and noise from the front (S0N0), speech at 45° from the side of the better ear and noise at 45° from the opposite side (SbNw), and vice versa (SwNb). Each test was conducted unaided, with a bone-anchored hearing device (BAHD), and with a remote microphone (RM) system. The use of a BAHD and RM led to an improvement in SRT in S0N0 and SwNb conditions. The SSD subgroup demonstrated significant benefits with both devices in SwNb, and the UAA subgroup from the use of BAHD in S0N0. In conclusion, the study underscores the potential benefits of both devices in enhancing speech perception for UHL children, providing insights into effective intervention strategies for these challenging cases.

Acute Otitis Media and Facial Paralysis in Children: A Systemic Review and Proposal of an Operative Algorithm.

Acute otitis media (AOM) is one of the most common ENT diseases in children. In the antibiotic/post-antibiotic era, facial paralysis is a very rare complication of AOM (0.004-0.005%). Despite the rarity of this complication, it should be known by all physicians for proper therapeutic management to avoid serious sequelae. The aim of this review is to provide a management guide based on the current literature. MATERIALS AND METHODS: Fifteen studies published between 2000 and 2022 were selected, including 120 patients (62 M/58 F) with an average age of 4.96 years old (range = 4 months-16 years; SD: 4.2). The paralysis frequently has a sudden onset and is of a severe grade (medium House-Brackmann (HB) score at onset: 4.68; SD: 0.5); however, it tends to have an almost complete recovery in most patients (88.49% HB 1 at follow-up). RESULTS: Its first-line treatment must be based on the use of antibiotics (beta-lactam antibiotics as penicillins or cephalosporins). Corticosteroids should be used concomitantly for their anti-inflammatory and neuroprotective actions; however, there is no unanimity between authors about their application. Myringotomy, with or without ventilation tube insertion, is indicated in cases where the tympanic membrane is intact. Other kinds of surgery should be performed only in patients who have a worsening of their AOM symptoms or a worsening in HB score even with clinical treatment. CONCLUSIONS: The obtained data show that a conservative treatment can be sufficient for complete recovery in most patients, and it is preferred as the first-line therapy. Mastoidectomy should be performed only in patients with acute mastoiditis and without symptom improvement after a conservative approach. There are insufficient data in the current literature to provide clear selection criteria for patients who need to undergo mastoidectomy with facial nerve decompression. The choice of this treatment is based on an individual center expertise. Further studies are needed to clarify the role of corticosteroids and the role of facial nerve decompression in this clinical scenario.

Conservative management of orbital involvement in malignant tumors: is the paradigm evolving? A critical review.

PURPOSE OF REVIEW: Review the recent literature regarding conservative management of orbital invasion in sinonasal cancers. RECENT FINDINGS: Recent data seem to confirm the possibility to preserve the orbital content in a significant number of patients. MRI is the best available imaging tool for evaluating orbital invasion. Limited periorbital and extraconal fat invasion should not be considered an indication for orbital cleaning. Histology-driven neoadjuvant chemotherapy should be attempted whenever possible, and could act as a prognosticator. SUMMARY: Orbital preservation strategy can be attempted even in case of limited extraconal fat invasion. When extraocular muscles, massive extraconal fat, lateral wall of the lacrimal sac, eyelids or even optic nerve/globe are invaded, a conservative procedure cannot be offered. Induction chemotherapy and postoperative radiotherapy are invaluable tools for maintaining oncological outcome while preserving ocular function. Frozen section should be used for guiding surgical procedures in borderline situations.

Battery Lifespan of an Implantable Middle Ear Device.

BACKGROUND: The Carina system (Cochlear Ltd., Sydney, Australia) is a totally implantable device providing acoustic amplification in adult patients with moderate-to-severe sensorineural or mixed hearing loss. One of the main concerns about such a totally implantable device has been represented by the subcutaneous battery lifespan. The aim of this article is to report the analysis of battery performances in a series of Carina-implanted patients after a long follow up. METHODS: In this retrospective study, the technical data of a series of patients implanted with the Carina middle ear implant in our clinic have been analysed, extracting the data from the log of telemetric measures. RESULTS: The mean lifespan cutback was 0.43 h/years (from 0 to 0.71 h/year), with a strong negative significant correlation between the follow-up period and the percentage of battery residual lifespan. CONCLUSION: The lifespan of the Carina's battery seems consistent with the manufacturer statement of a pluri-decennial lifespan, avoiding the need of an early surgical substitution and providing a full day of use of the system even after up to 12 years from the implantation.

Nasopharyngeal sarcoidosis: case reports and literature review.

Sarcoidosis is a multisystemic inflammatory chronic disease characterized by the presence of noncaseating granulomas most frequently in lungs and in intrathoracic lymph nodes. The nasopharyngeal form is unusual and noncommon in the ENT practice. Background and objectives: In order to establish a correct knowledge about this rare disease, we report two different cases of nasopharyngeal sarcoidosis moreover all the available literature is reviewed. Materials and Methods: A systematic literature review was made through PubMed databases, according to the PRISMA guidelines (1), combining the following key words: Nasopharyngeal, Rhinopharynx, Sarcoidosis, in publications between 1951 and 2020. In addition, we reported our personal experience on the disease by describing two clinical cases that occurred at our clinic in November 2018 and June 2019. Results: 16 articles reported 27 cases of nasopharyngeal sarcoidosis. The number of males was 13 (48,2%) and the number of females was 14 (51,8%) with a mean age at the diagnosis of 35,28 ± 13.05 years old (range 5 - 64). In 16 (59,3%) cases nasopharyngeal sarcoidosis was associated with lungs and/or intrathoracic lymph nodes involvement; nasal obstruction was the most frequently reported symptom (51,8% of subjects). Conclusions: Nasopharyngeal sarcoidosis can mimic several disorders of the upper airway respiratory tract and it must therefore be considered in the differential diagnosis. A biopsy of nonspecific lesions in the nasopharynx is advisable to permit several early diagnosis of upper airway respiratory tract disorders including sarcoidosis.

Inflammatory Profiles of Tracheal Biopsies From SARS-CoV-2 Patients.

Purpose: An increasing number of laryngotracheal complications in mechanically ventilated COVID-19 patients has been reported in the last few months. Many etiopathogenetic hypotheses were proposed but no clear explanation of these complications was identified. In this paper we evaluated the possibility that the tracheal mucosa could be a high viral replication site that could weaken the epithelium itself. Methods: Subjects for the COVID-19 group and the control group were selected retrospectively according to specific criteria. Patients' basic and clinical data were recorded and analyzed. Tracheal samples of both groups were collected during surgical tracheostomies and then analyzed from a histological and genetic-transcriptional point of view. Results: Four COVID-19 patients were enrolled in this study and compared with four non-COVID-19 patients. No laryngotracheal complications were identified in both groups. The SARS-CoV-2 was detected in one out of four COVID-19 samples. A subepithelial inflammatory lymphomonocyte infiltrate was observed in all patients but two cases of the COVID-19 group showed vasculitis of small subepithelial vessels associated with foci of coagulative necrosis. Two gene sets (HALLMARK_INFLAMMATORY_RESPONSE and HALLMARK_ESTROGEN_RESPONSE_LATE) were significantly deregulated in COVID-19 patients compared to the control group. Conclusion: The altered inflammatory response of the COVID-19 patients could be another possible explanation of the increasing number of laryngotracheal complications.

Bone-Anchored Hearing Aids Fitted According to NAL and DSL Procedures in Adults with Mixed Hearing Loss.

BACKGROUND: Bone-anchored hearing aids represent a valid alternative for patients with conductive/mixed hearing loss who cannot use hear- ing aids. To date, these devices have given good audiological results, thanks to various fitting prescription programs (i.e., National Acoustic Laboratories and Desired Sensation Level). The aim of this study is to compare 2 types of fitting algorithms (National Acoustic Laboratories and Desired Sensation Level) implemented for bone-anchored hearing devices. METHODS: We retrospectively enrolled 10 patients followed at our operative unit, suffering from bilateral symmetrical mixed hearing loss and who underwent bone-anchored hearing aid implantation. All patients experienced each prescriptive procedure, National Acoustic Laboratories and Desired Sensation Level, for 7 months (on average), and they were subjected to audiological tests and questionnaires to evaluate the best program. RESULTS: National Acoustic Laboratories and Desired Sensation Level prescriptions yielded similar results. Desired Sensation Level allowed less amplification of the low frequencies than the National Acoustic Laboratories prescription, and these differences were the only statistically sig- nificant. Desired Sensation Level allowed better disyllabic word and sentence recognition scores only in quiet and not in noisy conditions. The subjective questionnaires showed similar results. At the end of the trial sessions, more patients (60%) definitively chose the Desired Sensation Level program for their device. These patients were those with a worse hearing threshold. CONCLUSION: The 2 prescriptive programs allowed similar results although patients with a worse threshold seem to prefer the DSL program. This is the first evaluation of the 2 prescriptive programs, National Acoustic Laboratories versus Desired Sensation Level, for bone conduction devices available in the literature. Further studies are needed to confirm this initial finding.

Endoscopic-assisted transorbital surgery: Where do we stand on the scott's parabola? personal considerations after a 10-year experience.

Transorbital approaches are genuinely versatile surgical routes which show interesting potentials in skull base surgery. Given their "new" trajectory, they can be a very useful adjunct to traditional routes, even being a valid alternative to them in some cases, and add valuable opportunities in selected patients. Indications are constantly expanding, and currently include selected intraorbital, skull base and even intra-axial lesions, both benign and malignant. Given their relatively recent development and thus unfamiliarity among the skull base community, achieving adequate proficiency needs not only a personalized training and knowledge but also, above all, an adequate case volume and a dedicated setting. Current, but mostly future, applications should be selected by genetic, omics and biological features and applied in the context of a truly multidisciplinary environment.

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.

Experience in Transoral Robotic Surgery in Pediatric Subjects: A Systematic Literature Review.

Pediatric transoral robotic surgery (TORS) has improved from 2007 to 2020, widening its indications and feasibility. This article aims to systematically analyze the procedures performed from the first use until the current year, observing their evolution over time. A systematic literature review was performed using PubMed, Scopus, Web of Science, and Cochrane databases between March 1, 2000, and April 1, 2020. We selected studies that were written only in English and were performed in live human subjects. About 16 studies were found with a total of 73 subjects treated, among them 41 were men and 32 were women with an average age of 6.8 ± 4.99 years. There have been four (5.47%) conversions. Both functional and benign-malignant diseases have been treated in the series. Eleven (15.06%) pre-operative tracheostomy and zero post-operative tracheostomy were performed. The bleeding data was only reported in 9 studies and was <50 ml. Only one (1.36%) intra-operative complication and 10 (12.32%) postoperative complications were reported. We consider the TORS procedures in pediatric subjects safe, feasible and with good surgical outcomes up to the laryngeal region.

Functional and aesthetic outcomes of pedicled temporalis muscle flap for mesostructure reconstruction.

The purpose of this work is to analyse the soundness of the Temporalis Muscle Flap as a safe and reliable flap to restore the aesthetic and functions of the facial mesostructure after its partial resection. Subjects were selected retrospectively and were invited to come to our outpatient clinic. Here, subjects completed a clinical evaluation in which the medical examiners evaluated the aesthetic outcome, the phonation, the ocular motility and the swallowing. Twenty-two subjects were enrolled in this study and completed the clinical evaluation. The mean value of the score obtained for the aesthetic outcome was 2.91 ± 0.92, slightly less than good. The VHI-30 questionnaire for voice evaluation obtained a mean score of 22.5 ± 11.5, pointing out minor voice problems. The mean value of the P-score evaluated during Fiberoptic Endoscopic Evaluation of Swallowing was 4.64 ± 0.95, highlighting the near absence of endoscopic signs of dysphagia. On the evaluation of ocular function, only one subject showed an inferior displacement of his right eyeball without vertical diplopia. The Temporalis Muscle Flap is a safe and reliable flap that can be used to reconstruct numerous surgical defects of the maxilla, giving an excellent recovery of physical aspect, phonation, and swallowing.

Evaluation of the Incidence and Potential Mechanisms of Tracheal Complications in Patients With COVID-19.

Importance: Full-thickness tracheal lesions and tracheoesophageal fistulas are severe complications of invasive mechanical ventilation. The incidence of tracheal complications in ventilated patients with coronavirus disease 2019 (COVID-19) is unknown. Objective: To evaluate whether patients with COVID-19 have a higher incidence of full-thickness tracheal lesions and tracheoesophageal fistulas than matched controls and to investigate potential mechanisms. Design, Setting, and Participants: This is a retrospective cohort study in patients admitted to the intensive care unit in a tertiary referral hospital. Among 98 consecutive patients with COVID-19 with severe respiratory failure, 30 underwent prolonged (≥14 days) invasive mechanical ventilation and were included in the COVID-19 group. The control group included 45 patients without COVID-19. Patients with COVID-19 were selected from March 1 to May 31, 2020, while the control group was selected from March 1 to May 31, 2019. Exposures: Patients with COVID-19 had severe acute respiratory syndrome coronavirus 2 infection diagnosed by nasopharyngeal/oropharyngeal swabs and were treated according to local therapeutic procedures. Main Outcomes and Measures: The primary study outcome was the incidence of full-thickness tracheal lesions or tracheoesophageal fistulas in patients with prolonged invasive mechanical ventilation. Results: The mean (SD) age was 68.8 (9.0) years in the COVID-19 group and 68.5 (14.1) years in the control group (effect size, 0.3; 95% CI, -5.0 to 5.6). Eight (27%) and 15 (33%) women were enrolled in the COVID-19 group and the control group, respectively. Fourteen patients (47%) in the COVID-19 group had full-thickness tracheal lesions (n = 10, 33%) or tracheoesophageal fistulas (n = 4, 13%), while 1 patient (2.2%) in the control group had a full-thickness tracheal lesion (odds ratio, 38.4; 95% CI, 4.7 to 316.9). Clinical and radiological presentations of tracheal lesions were pneumomediastinum (n = 10, 71%), pneumothorax (n = 6, 43%), and/or subcutaneous emphysema (n = 13, 93%). Conclusions and Relevance: In this cohort study, almost half of patients with COVID-19 developed full-thickness tracheal lesions and/or tracheoesophageal fistulas after prolonged invasive mechanical ventilation. Attempts to prevent these lesions should be made and quickly recognized when they occur to avoid potentially life-threatening complications in ventilated patients with COVID-19.