Efficacy and safety of dupilumab in the treatment of CRSwNP in the real-life setting: a review of the literature.

INTRODUCTION: The recent approval of Dupilumab has profoundly revolutionized the management of patients affected by severe and recalcitrant Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). However, a review that summarizes the results of real-life studies and compares them to phase 3 studies SINUS-24 and 52 is still lacking. MATERIALS AND METHODS: A search of all real-life studies published from 2019 to 2023 was performed. Patients characteristics at baseline and 6 and 12 months after starting Dupilumab were extracted and compared to those from phase 3 trials: age, sex, smoking habits, comorbid asthma and aspirin-exacerbated respiratory disease (AERD), previous endoscopic sinus surgery (ESS), hematic eosinophils and total IgE, NasalAQ2 Polyps Score (NPS), smell, SNOT-22, adverse events (AEs), and response to treatment. RESULTS: 15 papers were included with an overall number of 1658 patients. A higher rate of comorbidities and previous ESS was found in patients from real-life studies. In addition, they had worse smell and SNOT-22 at baseline compared to patients from SINUS-24 and 52. Comorbid and post-ESS patients tended to have a faster NPS and SNOT-22 improvement, although the absolute values were not clinically relevant. A more extensive surgery and a number of ESS ≥ 2 were related to worse olfactory outcomes, probably due to iatrogenic damage. No correlation was found between hematic eosinophils and outcomes. AEs were reported by 12.4% of patients and 2.2% had to discontinue dupilumab. Weight gain was an emergent AE (0.8%), probably related to the restored sense of smell and taste. Non-responders were 3.5% and they were switched to systemic steroid, ESS, or another biologic. CONCLUSION: Despite some differences in prescription criteria between countries, dupilumab was demonstrated to be effective even in the real-life scenario. However, emerging AEs and possible unknown long-term AEs of a likely lifelong therapy should be considered.

Perception of Gender Bias in Otolaryngology and Head & Neck Surgery - A Comparative Study.

Introduction: To investigate the differences in the professional and personal life and the perception of gender-bias, among Italian female surgeons working in Otolaryngology-Head and Neck Surgery (OHNS), as compared to those involved in other surgical fields (overall group [OG]). Materials and Methods: An online survey was administered to female medical doctors working in all surgical fields in Italian hospitals. Results: Of the 1963 responders included, 153 (7.8%) were part of the ONHS group and 1810 (92.3%) of the OG. In both cohorts, female represented approximately one-third of the surgical staff. At least one female in the staff did not regularly attend the operating room (OR), especially in the OHNSG group. OHNS responders had to abandon the surgical activities in favour of outpatient services more than OG. A higher proportion of OHNS surgeons encountered gender-related difficulties in the OR. Discussion: Several gender-related issues emerged among OHNS responders, the most relevant being involvement in surgical activities and number/complexity of surgical cases.

Effects of Total Intravenous Versus Inhalational Anesthesia on Bleeding During Endoscopic Ear Surgery: Preliminary Results From a Case-Control Study.

OBJECTIVE: To assess the impact of the type of maintenance anesthesia on the bleeding conditions of the surgical field and hemodynamic parameters during endoscopic ear surgery (EES), comparing totally intravenous inhalational anesthesia (TIVA) with inhalational anesthesia (IA). STUDY DESIGN: Retrospective case-control study. SETTING: Tertiary referral center. PATIENTS: Fifteen consecutive EES cases performed with TIVA between 2019 and 2020 at our Institution were matched to a control group of patients who underwent EES with IA in the same period. Patients with American Society of Anesthesiologists IV grade, acute otitis before surgery, congenital or acquired coagulopathies, use of anti-inflammatory drugs, or antiaggregant or anticoagulant therapy in the 5 days before the intervention were excluded. INTERVENTIONS: Both primary and revision tympanoplasty and stapes surgery were considered. MAIN OUTCOME MEASURES: Surgical videos were reviewed to quantify the entity of bleeding according to the Modena Bleeding Score. Hemodynamic parameters during surgery were retrospectively collected. A comparison between the two groups was performed. RESULTS: No statistically significant differences between the two groups in terms of bleeding were found at any of time point evaluated. The tympanomeatal flap elevation resulted in the bloodiest step in both groups. Hemodynamic parameters were similar in both groups ( p > 0.05). CONCLUSIONS: These preliminary data do not support a significant difference in bleeding conditions and hemodynamic parameters between EES patients receiving TIVA and those receiving IA. Further studies involving a higher number of patients will improve our understanding on how maintenance anesthesia with TIVA may be beneficial in terms of bleeding control as compared with IA for patients undergoing EES.

"Hot" vs "Cold" endoscopic stapes surgery: a matched case-control study.

PURPOSE: To compare hearing results and complication rates between two groups of patients operated on by endoscopic stapes surgery (ESS) for otosclerosis, either with CO2 fiber laser or microdrill. METHODS: A case-control study was performed. All consecutive cases of CO2 fiber laser ESS operated at a single center during the period 2017-2020 (case group) were matched to a control group of patients operated by traditional technique, according to year of surgery, preoperative mean air-bone gap, sex and age. Audiological data from preoperative and postoperative examinations and complication rates were compared. RESULTS: 46 cases were included. Mean operative time was significantly longer in the laser cohort (65 min) than in the drill one (45 min) (p = 0.003). Similar results were found in the two groups regarding the mean postoperative BC-PTA. The high-frequency bone conduction resulted significantly higher in the laser group (p = 0.002), suggesting an overclosure effect in the laser group. Consistently, a significant improvement of the BC-PTA threshold at 2000 Hz postoperatively was found in the laser group (p = 0.034). The postoperative AC-PTA significantly improved in both groups at all frequencies (p < 0.05), except for the AC threshold at 8 kHz. Similar rates of complications were found in the two groups. CONCLUSION: This study is the first to compare hearing results and complications between CO2 fiber laser and microdrill in ESS. Our results demonstrated similar functional outcomes between the two groups, confirming ESS as safe and effective, regardless of the technique used.

Women in Surgery Italia: what are the opportunities in the operatory room? Results from a nationwide interdisciplinary survey.

Many studies documented the "glass ceiling" effect for women in surgery: achievements in academic and leadership positions are not consistent with the percentage of female surgeons in practice. A solid surgical case volume and expertise in high-complexity cases are required to pursue leadership positions. The aim of the study was to determine whether part of the difficulties encountered by female surgeons may lie in reduced surgical opportunities. This is the first study to investigate this issue in Italy. An online survey, conceived and promoted by Women in Surgery Italia, was administered through the RedCap platform, between November and December 2020, and female surgeons actively working in Italian academic and non-academic hospitals were invited to answer anonymously. A multivariate analysis was performed to evaluate the role of different factors on two main variables: overall procedures done and a sub-analysis of complex cases performed as first surgeon. 1810 respondents were included; the women who responded participated in 3% fewer cases on average, when compared to the mean staff case volume, and were significantly more often listed as the assistant surgeon and as primary surgeons in low-complexity cases. 36.5% of the respondents declared that at least one female physician on staff had to abandon the operatory room (OR) and does not regularly perform any surgical procedure. 73% female surgeons would like to spend more hours in the OR. While acquiring skills and surgical autonomy, many obstacles still exist for female surgeons. A portion of women are relegated to non-surgical activities, irrespective of their specialty, and these results confirm the theory that gender-biased underemployment still exists in surgical fields.

Step-by-Step Stapedotomy through Transcanal Exclusive Endoscopic Approach.

In recent years there has been an increasing trend in the use of the endoscope to treat a variety of middle ear pathologies, including otosclerosis. Several studies comparing traditional microscopic and endoscopic stapes surgery have reported similar hearing results and an overall low rate of complications. The endoscope has unraveled its full potential in demanding settings of stapes surgery, such as unfavorable anatomy of the oval window niche or revision cases. Reduced manipulation of the chorda tympani and low rate of post-operative dysgeusia are further benefits to mention for endoscopic stapes surgery. Being a one-handed technique, management of bleeding, positioning, and crimping of the prosthesis may be challenging for novice endoscopic surgeons, so some training in endoscopic ear surgery is recommended before performing endoscopic stapedotomy. The problem of sharing the surgical field between the endoscope and the operating instruments could be easily overcome if proper instruments positioning is understood. One-handed bleeding control in the narrow space of the ear canal may represent an issue during the elevation of the tympano-meatal flap, possibly discouraging the surgeon since the preliminary steps of surgery. Following appropriate technique to raise the flap and the collaboration with the anesthesiology team in keeping the blood pressure low guarantee an adequate bleeding control in most cases. The aim of this article is to describe the entire surgical procedure of a transcanal exclusive endoscopic stapedotomy, from operating room set up and patient positioning to post-operative care. A step-by-step description of the surgical maneuvers with technical hints is reported, to guide the surgeon across the procedure and allow any ear surgeon to perform stapes surgery endoscopically.

Taste impairment after endoscopic stapes surgery: Do anatomic variability of chorda tympani and surgical technique matter? : Post-operative dysgeusia after EStS.

PURPOSE: To investigate how the anatomical configuration of the oval window region (OWR) influences the management of the chorda tympani (ChT) and the curetting of adjacent bony structures, in a setting of patients undergoing endoscopic stapes surgery (EStS); to assess the incidence of early and late post-operative dysgeusia and to identify anatomical and surgical factors influencing taste function after EStS. METHODS: Surgical video recordings of 48 patients undergoing EStS for otosclerosis between January 2019 and July 2020 were retrospectively revised, to classify the anatomical variability of selected middle ear structures and the management strategies for the ChT. Clinical records of included patients were reviewed for subjective early and late post-operative taste impairment using a 5-point Likert-scale. RESULTS: The most common configuration of the OWR was type III. The extension of the bony curettage resulted inversely proportional to the exposure of the OWR. The long-term rate of preserved post-operative taste function was 85%. Displacement of the ChT was necessary in 43/48 cases (90%), mostly medially (36/48, 75%). CONCLUSION: Bone curetting during EStS does not correlate with post-operative taste impairment. Despite 100% ChT preservation rate, dysgeusia may occur in a minority of patients, with no apparent relationship to anatomical variability or intraoperative management of the ChT. The use of CO2 laser could have a role in increasing the risk of post-operative dysgeusia after EStS.

Disease-specific quality of life and psychological distress after endoscopic tympanoplasty.

PURPOSE: To assess the postoperative quality of life (QoL) of patients operated on for chronic otitis media (COM) and cholesteatoma by endoscopic approach, with respect to disease-specific complaints and psychological distress, using two validated questionnaires: Chronic Ear Survey (CES) and Depression Anxiety Stress Scale-21 (DASS-21). METHODS: Eighty-five consecutive patients operated on for cholesteatoma and COM by endoscopic tympanoplasty from March 2018 to February 2020 filled in CES and DASS-21, within one month prior to surgery. A second administration of each questionnaire was performed at the yearly postoperative evaluation. A multivariate analysis using a linear regression model was performed to evaluate the role of the different variables associated with the questionnaires' subscales and overall scores. RESULTS: A significant improvement was achieved in all CES and DASS-21 subscales after endoscopic tympanoplasty. No patient showed a DASS-21 score compatible with a psychological distress both at the pre- and postoperative assessments. At multivariate analysis, the only significant factors associated with postoperative improvement in CES scores were preoperative DASS-21 "depression" score and months of follow-up. CONCLUSION: Endoscopic tympanoplasty shows significantly improved QoL as assessed by disease-specific and psycho-emotional questionnaires. A subjective favourable effect of fully endoscopic ear surgery was demonstrated.

Functional Results and Learning Curve of Endoscopic Stapes Surgery: A 10-Year Experience.

OBJECTIVES/HYPOTHESIS: To assess hearing outcomes and complications of endoscopic stapes surgery by a single surgeon in a 10-year period, to compare these data with conventional microscopic procedures by the same operator, and to describe the learning curve of endoscopic stapedotomy. STUDY DESIGN: Retrospective study. METHODS: This is a retrospective study on patients who underwent endoscopic stapes surgery performed by the same senior surgeon, experienced both in microscopic and endoscopic techniques, between January 2009 and December 2018. Audiological data were compared, and intraoperative and postoperative complications were collected. The surgeon's last 30 cases of microscopic stapedotomy were enrolled as the control group. The results of the first 100 endoscopic stapes surgeries were analyzed separately to create a cumulative sum (CUSUM) control chart for learning curve assessment. RESULTS: One hundred seventy-eight endoscopic and 30 microscopic stapes surgeries were included. In the endoscopic group, the mean postoperative air-bone gap was 8.2 dB. No significant differences between the endoscopic and microscopic preoperative and postoperative values were reported. A total of eight complications (4.5%) were observed in the endoscopic cohort, although in the control group, no complication occurred. The mean surgical time was 51.9 minutes in the endoscopic group versus 48.2 minutes in the microscopic group (P > .05). No association between stapedotomy success and the increasing number of procedures was found. CONCLUSIONS: Our article demonstrates that functional results from endoscopic stapes surgery are similar to those from microscopic stapes surgery in terms of both safety and efficacy. After gaining endoscopic experience, the surgical duration of stapes surgery will be adequate starting from the first cases. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:885-891, 2021.

Complications in Endoscopic Ear Surgery.

OBJECTIVE: The aim of this study was to examine the premise that endoscopic ear surgery (EES) is associated with a low rate of complications (intraoperative and postoperative). STUDY DESIGN: Retrospective review at two institutions. SETTING: Tertiary referral center. PATIENTS: The study included 825 patients who underwent exclusive EES between 2008 and 2016 at the Otorhinolaryngology-Head and Neck Surgery Department of Modena University Hospital, and between 2014 and 2016 at the Otorhinolaryngology-Head and Neck Surgery Department of Verona University Hospital. INTERVENTIONS: Exclusive endoscopic ear surgery between 2008 and 2016 (tympanoplasties, second look or revision tympanoplasties, myringoplasties, stapedoplasties, canalplasties, ossiculoplasties, and exploratory tympanotomies). All surgical procedures were performed by two experienced surgeons. MAIN OUTCOME MEASURE: For each procedure, intraoperative, and early and delayed postoperative complications were evaluated. RESULTS: The most common ear pathologies for which patients were sent for EES were cholesteatoma (33.6%), chronic otitis media (36.3%) and otosclerosis (26.8%). There was no case of major intraoperative complications such as injury to the dura or vascular structures. We observed minor intraoperative complications in 4.1% of the cases. Only 1.3% of patients experienced early postoperative complications. Delayed complications affected less than 1% of the cohort. CONCLUSIONS: Data from this study confirm the safety of the endoscopic technique, with very low complication rates, indicating that EES is a reliable therapeutic option, in particular, for tympanoplasties, myringoplasties, and stapedoplasties, as well as second look procedures. We have reported our experience with EES morbidity so that it can be compared with data from other centers using the same surgical technique.