Automatic speaking valve in tracheo-esophageal speech: treatment proposal for a widespread usage.

PURPOSE: Aim of this study was to calculate the percentage of the Automatic Speaking Valve (ASV) use in a large cohort of laryngectomized patients with voice prosthesis (VP) and to analyze the main reasons for non-use. Subsequently, a specific rehabilitation training was proposed. METHODS: One hundred-ten laryngectomized patients with VP were enrolled in the first phase of the study (census). Among them, 57 patients were included in the second phase (intervention), in which a training based on moving phonatory exercises was proposed. Structured questionnaires were used before and after training in order to investigate ASV use rate (days/week and hours/day; reasons for impeding the ASV use), average adhesive life-time during ASV use; hands-free speech duration; skin irritation. Patients also expressed their degree of on a VAS scale from 0 to 100. RESULTS: In the census phase the percentage of use of ASV (everyday, without problems) was equal to 17.27% (19/110 patients). The main causes of disuse concerned excessive fatigue and poor durability of the adhesives. The analysis of the results pre vs. post-training showed a statistically significant increase (p < 0.05) in all the investigated parameters. Patients reported a good level of treatment compliance (average frequency of performing exercises equal to 4.2 ± 2.5 days/week for 1.4 ± 1.01 h/day) and high degrees of satisfaction. After treatment, the percentage of use of AVS increased by 43% reaching a rate of 60% (66/110 patients). CONCLUSION: A specific and targeted approach that simulate the phonatory and breathing difficulties of everyday life can increase the ASV usage rate.

Hybrid primary puncture in stapler-assisted total laryngectomy.

In Video S1, a new surgical technique for hybrid primary tracheoesophageal (TE) puncture in stapler-assisted total laryngectomy is shown. The video describes the surgical steps of the procedure and illustrates some tips and tricks. The procedure incorporates an upper mini-pharyngotomy to enable retrograde placement of the voice prosthesis (VP), eliminating the need for rigid esophagoscopy. This has made it possible to exploit, without additional risks, the potential of the stapler combined with primary TE puncture and VP placement. In our experience, this hybrid procedure in stapler-assisted total laryngectomy is not related to adverse events such as pharyngocutaneous fistula (PCF), hypertonicity, and functional complications. Therefore, it can be considered a valid technique that allows for easy insertion of a primary voice prosthesis also in case of mechanical sutures.

Perceptual Evaluation of the Tracheoesophageal Voice: Italian Validation of the Sunderland Tracheoesophageal Perceptual Scale.

OBJECTIVES: This study aimed to validate the Sunderland Tracheoesophageal Perceptual Scale (SToPS) in the Italian language by checking the inter- and intra-rater reliability. STUDY DESIGN: Scale validation METHODS: The validation of the tool involved the following steps: (1) translation and adaptation of the SToPS into Italian language; (2) recruitment of participants (60 laryngectomized patients with a voice prosthesis and 12 health professionals-six speech and language therapists (SLTs) and six ear, nose, and throat surgeons-classified into experienced (Exp) or not at assessing voice; (3) recording of patients' speech samples; (4) perceptual evaluation of recorded speech samples (test and retest) performed by the 12 health professionals; and (5) statistical analysis (quadratic weighted Cohen kappa and weighted kappa of Light coefficients). RESULTS: When all raters were considered as one group, an agreement ≥0.50 was reached for all parameters. The "ExpSLTs" group rated more reliably than the other groups, achieving a "good" intrarater agreement for 9/10 parameters. Despite the interrater coefficients were lower than the intrarater ones for all rater groups, "ExpSLTs" obtained the best levels of interrater agreement, achieving a level of agreement ≥0.50 for all parameters. Finally, considering intrarater+interrater agreement ("good + good" or "good + moderate"), the "ExpSLTs" group showed the greatest agreement, attaining all parameters that met the criteria for "good" or "moderate" agreement levels. CONCLUSIONS: The Italian version of SToPS can be considered a reliable tool. As in the original version, expert SLTs are the better judges for tracheoesophageal voice assessment.

Rehabilitation After Total Laryngectomy: An Integrated Protocol Remotely Delivered During COVID-19.

The aim of this paper was to evaluate the results of an integrated treatment delivered remotely to laryngectomized patients with voice prosthesis. Eighteen laryngectomized patients were treated remotely in groups co-led by a speech therapist and a psychologist ("Online Group"). The results were compared with those of 17 patients ("In-Person Group") previously studied. The two groups obtained comparable results on all parameters of the INFVo perceptual rating scale, in the DEP, ANX, PHO and HOS areas of the Symptom Check List-90-Revised questionnaire, and in the areas investigated by the WHOQOL-B questionnaire. The "In-Person Group" obtained statistically better results on the Italian Self-Evaluation of Communication Experiences after Laryngeal Cancer questionnaire. Although the in-person treatment favored the acceptance of the new voice and the development of conversational skills, telerehabilitation guaranteed an adequate level of assistance in terms of voice acquisition, prevention of anxiety and depression, and recovery of a good QoL.

Interventional Radiotherapy (Brachytherapy) for Nasal Vestibule: Novel Strategies to Prevent Side Effects.

Interventional radiotherapy (brachytherapy) has become the new therapeutic standard in the management of early stages nasal vestibule tumors; in fact it allows for high local control rates and low toxicity profiles. However, since more and more patients will receive interventional radiotherapy (brachytherapy) as primary treatment, it is desirable to implement novel strategies to reduce the dose to organs at risk with the future aim to result in further lowering long-term side effects. MATERIALS AND METHODS: We were able to identify two different strategies to reduce dose to the treatment volume, including the implantation technique (the implant can be interstitial, endocavitary or mixed and the catheters may be placed either using the Paris system rules or the anatomical approach) and the dose distribution within the implant (the most commonly used parameter to consider is the dose non-uniformity ratio). We subsequently propose two novel strategies to reduce dose to organs at risk, including the use of metal shields for fixed organs as in the case of the eyes and the use of a mouth swab to push away mobile organs, such in the case of the mandible. We used two different algorithms to verify the values namely the TG-43 and the TG-186. RESULTS: We provided an accurate literature review regarding strategies to reduce toxicity to the treatment volume, underlining the pros and cons of all implantation techniques and about the use dose non-uniformity ratio. Regarding the innovative strategies to reduce the dose to organs at risk, we investigated the use of eye shielding and the use of swabs to push away the mandible by performing an innovative calculation using two different algorithms in a series of three consecutive patients. Our results show that the dose reduction, both in the case of the mandible and in the case of eye shielding, was statistically significant. CONCLUSION: Proper knowledge of the best implantation technique and dose non-uniformity ratio as highlighted by existing literature is mandatory in order to reduce toxicity within the treatment volume. With regard to the dose reduction to the organs at risk we have demonstrated that the use of eye shielding and mouth swab could play a pivotal role in clinical practice; in fact, they are effective at lowering the doses to the surrounding organs and do not require any change to the current clinical workflow.

Treatment of Clival Chordomas: A 20-Year Experience and Systematic Literature Review.

Clival chordomas are rare but aggressive skull base tumors that pose significant treatment challenges and portend dismal prognosis. The aim of this study was to highlight the advantages and limitations of available treatments, to furnish prognostic indicators, and to shed light on novel therapeutic strategies. We conducted a retrospective study of clival chordomas that were surgically treated at our institution from 2003 to 2022; for comparison purposes, we provided a systematic review of published surgical series and, finally, we reviewed the most recent advancements in molecular research. A total of 42 patients underwent 85 surgeries; median follow-up was 15.8 years, overall survival rate was 49.9% at 10 years; meanwhile, progression-free survival was 26.6% at 10 years. A significantly improved survival was observed in younger patients (<50 years), in tumors with Ki67 ≤ 5% and when adjuvant radiotherapy was performed. To conclude, clival chordomas are aggressive tumors in which surgery and radiotherapy play a fundamental role while molecular targeted drugs still have an ancillary position. Recognizing risk factors for recurrence and performing a molecular characterization of more aggressive lesions may be the key to future effective treatment.

Training models and simulators for endoscopic transsphenoidal surgery: a systematic review.

Endoscopic transsphenoidal surgery is a novel surgical technique requiring specific training. Different models and simulators have been recently suggested for it, but no systematic review is available. To provide a systematic and critical literature review and up-to-date description of the training models or simulators dedicated to endoscopic transsphenoidal surgery. A search was performed on PubMed and Scopus databases for articles published until February 2023; Google was also searched to document commercially available. For each model, the following features were recorded: training performed, tumor/arachnoid reproduction, assessment and validation, and cost. Of the 1199 retrieved articles, 101 were included in the final analysis. The described models can be subdivided into 5 major categories: (1) enhanced cadaveric heads; (2) animal models; (3) training artificial solutions, with increasing complexity (from "box-trainers" to multi-material, ct-based models); (4) training simulators, based on virtual or augmented reality; (5) Pre-operative planning models and simulators. Each available training model has specific advantages and limitations. Costs are high for cadaver-based solutions and vary significantly for the other solutions. Cheaper solutions seem useful only for the first stages of training. Most models do not provide a simulation of the sellar tumor, and a realistic simulation of the suprasellar arachnoid. Most artificial models do not provide a realistic and cost-efficient simulation of the most delicate and relatively common phase of surgery, i.e., tumor removal with arachnoid preservation; current research should optimize this to train future neurosurgical generations efficiently and safely.

New standards for the management of nose vestibule malignancies.

BACKGROUND: Nasal vestibule squamous cell carcinoma (NVSCC) is an ill-defined underestimated condition. AIM/OBJECTIVE: To define the current standard of care. MATERIAL AND METHODS: We review recent acquisitions concerning clinical features and therapeutic approaches. RESULTS: The current AJCC staging system, which attributes to nasal vestibule the same topographic code as nasal cavity proper and the same T-classification criteria as ethmoid, appears inadequate.As for treatment of primary lesions without bone invasion, current evidence suggests that brachytherapy is at least equivalent to surgery and superior to external beams in terms of oncological outcomes, and superior to both modalities in terms of cosmesis and function. CONCLUSIONS: As for classification and staging, the nasal vestibule should be defined as a subsite of the nose and paranasal sinuses, distinct from the 'nasal cavity proper and ethmoid', with specific topographic code and T-classification criteria. This will improve the assessment of prognosis and prevalence, underestimated also because of misdiagnosis with skin cancers.Secondly, brachytherapy should become the new standard for the treatment of primary lesions without bone invasion. To optimize the advantages of brachytherapy, we propose novel anatomic criteria for the implantation. SIGNIFICANCE: Increasing evidence supports a paradigm shift in staging and treatment of NVSCC.

Improving Hands-Free Speech Rehabilitation in Laryngectomized Patients with a Moldable Adhesive.

OBJECTIVE: This study aims to assess the product performance of a new moldable peristomal adhesive with corresponding heating pad designed to facilitate and improve automatic speaking valve (ASV) fixation for hands-free speech in laryngectomized patients. METHODS: Twenty laryngectomized patients, all regular adhesive users with prior ASV experience, were included. Study-specific questionnaires were used for data collection at baseline and after two weeks of moldable adhesive use. The primary outcome parameters were adhesive lifetime during hands-free speech, use and duration of hands-free speech, and patient preference. Additional outcome parameters were satisfaction, comfort, fit, and usability. RESULTS: The moldable adhesive enabled ASV fixation adequate for hands-free speech in the majority of participants. Overall, the moldable adhesive significantly increased adhesive lifetime and duration of hands-free speech compared to participants' baseline adhesives (p < 0.05), regardless of stoma depth, skin irritation, or regular use of hands-free speech at baseline. The participants who preferred the moldable adhesive (55% of participants) experienced a significant increase in the adhesive lifetime (median of 24 h, range 8-144 h) and improved comfort, fit, and ease of speech. CONCLUSION: The moldable adhesive's lifetime and functional aspects, including the ease of use and custom fit, are encouraging outcomes and enable more laryngectomized patients to use hands-free speech more regularly. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:2965-2970, 2023.

Validation of the "Rome" Classification for Squamous Cell Carcinoma of the Nasal Vestibule.

Squamous cell carcinoma of the nasal vestibule is considered a rare malignancy that differs from other sinonasal malignancies in many respects. Four staging systems currently exist for this disease, the most recent addition being the "Rome" classification. This study assesses the use of this new classification and its prognostic value regarding various outcome measures. A retrospective multicenter cohort study of patients with a primary squamous cell carcinoma of the nasal vestibule who were treated in three tertiary head and neck oncology referral centers was conducted. A total of 149 patients were included. The median follow-up duration was 27 months. Five-year locoregional control (LRC), disease-specific survival (DSS), and overall survival (OS) were 81.6%, 90.1, and 62.5% respectively. A statistically significant association was observed between the Rome classification and all survival outcomes in both univariable and multivariable analyses. Moreover, it appeared to perform better than the Union for International Cancer Control TNM classification for tumors of the nasal cavity and paranasal sinuses. The new Rome classification can be used effectively and is associated with LRC, DSS, and OS. However, it requires further validation in a larger (prospective) study population.

Risk Factors Associated with Post-Operative Complications in Multidisciplinary Treatment of Descending Necrotizing Mediastinitis.

BACKGROUND: Descending necrotizing mediastinitis (DNM) is a severe, life-threatening complication of oropharyngeal infections with cervical necrotizing fasciitis. In this study, we aimed to identify any possible factors that correlate with favorable outcomes. METHODS: We retrospectively analyzed our series of 18 patients who underwent surgical treatment for DNM from a cervical abscess. Gender, age, symptoms, etiopathogenesis, comorbidities, time to surgery from diagnosis, degree of diffusion, identified microorganisms, surgical procedure, days in the intensive care unit, need for tracheostomy, complications, and surgical outcomes were reviewed. RESULTS: The main type of surgery was thoracotomy + cervicotomy in eight cases (50.0%), followed by cervicotomy +VATS in four (22.2%). Seven patients (38.9%) had two or more surgeries; a bilateral operation was necessary for four patients. Evaluating the risk factors associated with post-operative complications, age ≥ 60 years (p:0.031), cervicotomy alone as surgical approach (p = 0.040), and the bilateral approach (p = 0.048) resulted in significance in terms of the univariate analysis; age ≥ 60 years (p = 0.04) and cervical approach (p = 0.05) maintained their significance in terms of the multivariate analysis. CONCLUSIONS: The low mortality of our series emphasizes the importance of an extensive and immediate surgical drainage of both the neck and the mediastinum. Mediastinal drainage from cervicotomy seems to be a risk factor for post-operative complications. Minimally invasive surgery on the chest cavity, such as with Uniportal-VATS, could be a good approach above all in elderly patients and all those cases where bilateral access is required.

ORIFICE (Interventional Radiotherapy for Face Aesthetic Preservation) Study: Results of Interdisciplinary Assessment of Interstitial Interventional Radiotherapy (Brachytherapy) for Periorificial Face Cancer.

(1) Background: Periorificial face cancer (PFC), defined as both squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) arising around the eyelids, the nose vestibule and the lips, has very high incidence rates worldwide. The aim of our retrospective analysis, focusing on local control (LC) and patients' degree of satisfaction with the cosmetic outcome, is to present the results of a single institutional series of patients affected by PFC and treated by interventional radiotherapy (brachytherapy-IRT). (2) Methods: We retrospectively evaluated patients affected by PFC who were treated at our Interventional Oncology Center (IOC) with interstitial IRT from 2012 to 2021 with doses and volumes specific for each subsite considered. (3) Results: We report the results of 40 patients affected by PFC and treated by HDR interstitial IRT. The median follow-up was 24 months. The actuarial 3-year LC was 94%. Regarding patients' satisfaction, we found that 93% of patients were satisfied and only 7% of patients were not completely satisfied with the final cosmetic result. (4) Conclusions: Interstitial HDR IRT could be an effective therapeutic option providing adequate disease control and preventing potentially disfiguring surgical approaches. More numerous and standardized studies are warranted to confirm the available evidence.

Elective Neck Dissection during Salvage Total Laryngectomy: Personal Experience.

The role of elective neck dissection during salvage surgery in patients with a clinically negative neck (cN0) is still discussed. The main objective of this work was to estimate the prevalence and predictive factors of occult neck nodes metastasis; we therefore aimed to evaluate the survival rate and the main oncologic outcomes of cN0 patients who underwent salvage total laryngectomy and elective bilateral neck dissection. In this retrospective observational study, we enrolled 80 cN0 patients affected by recurrent laryngeal cancer and who underwent salvage total laryngectomy and bilateral selective elective neck dissection. Several parameters were collected in order to find prognostic factors; finally, postoperative complications were reviewed and survival analysis was performed. Occult lymph node metastases were reported in 18 out of 80 patients (22.5%). Significant statistical correlation between lymphovascular invasion (p = 0.007), perineural invasion (p = 0.025) and occult nodal metastasis was found. Other variables (glottic subsite of recurrence, clinical T, pathological T, previous chemotherapy) were not significantly predictive of occult nodal metastasis. The 5-year OS, DSS, and RFS were 50.4%, 64.7%, and 63.4%, respectively. In conclusion, our single-institution data on a large cohort of patients, suggest performing routinely elective selective bilateral neck dissection during salvage total laryngectomy in cN0 patients due to the biological attitude of the tumor to spread to cervical nodes, considering an acceptable complications rate.

Optimizing Pulmonary Outcomes After Total Laryngectomy: Crossover Study on New Heat and Moisture Exchangers.

OBJECTIVE: To evaluate the effects of new devices-heat and moisture exchangers (HMEs) and adhesives-on pulmonary symptoms, subject adherence, quality of life, dermatologic symptoms, and patient satisfaction after laryngectomy. STUDY DESIGN: Prospective crossover study. SETTING: Between December 2020 and April 2021, 40 patients were enrolled who had undergone laryngectomy, routinely used HMEs and adhesive, and were followed in our Department of Otolaryngology-Head and Neck Surgery. METHODS: Patients were allocated into group A (new products) or group B (usual care) for 6 weeks. Then the 2 groups reversed, and each patient acted as his or her own control. Patients kept a diary and cough tally sheet. At baseline and after each 6-week period, 2 questionnaires were administered: EQ-5D (European Quality of Life-5 Dimensions) and CASA-Q (Cough and Sputum Assessment Questionnaire). RESULTS: Six weeks of using new products resulted in the following effects for both groups: (1) a significant reduction in daily forced expectoration and dry coughs, (2) a significant improvement in all domains of the CASA-Q, (3) an increase in adherence to HME use, (4) a significant reduction in shortness of breath and skin irritation, and (5) significantly better scores in the anxiety/depression domain of the EQ-5D. CONCLUSION: Achieving this reduction in patients who were already highly adherent to HME use is clinically relevant and underscores the importance of using better-performing HMEs that can compensate for the humidification deficit. Improving pulmonary symptomatology could reduce patient restrictions in daily life and avoidance of social activity, with a consequent positive effect on quality of life.

Long-term voice outcomes and quality of life after open partial horizontal laryngectomy type II vs. total laryngectomy: A cross-sectional study.

OBJECTIVES: We aim to analyse long-term voice outcomes and quality of life (QoL) in patients undergoing open partial horizontal laryngectomy type II (OPHL type II) and to compare them to those obtained by patients undergoing total laryngectomy (TL) with voice prosthesis (VP). DESIGN: Cross-sectional cohort study. SETTING: Patients undergoing surgery for advanced laryngeal cancer, assessed during the usual follow-up consultations at the Phoniatric Unit (February 2020-December 2020). PARTICIPANTS: Forty-five patients were enrolled and divided into two groups: OPHL group and TL group. MAIN OUTCOMES MEASURES: Acoustic analysis, maximum phonation time, INFV0  scale, I-SECEL, UW-QoL-V4 and MDADI questionnaires were used to assess the long-term outcomes. RESULTS: Voices of patients undergoing OPHL Type II were worse than those of laryngectomised patients with VP. Nevertheless, scores in voice and dysphagia-related QoL were comparable and scores in the social domain of QoL were higher in OPHL group. CONCLUSIONS: Open partial horizontal laryngectomy Type II allows an acceptable voice recovery and a satisfactory QoL.

Oropharyngoesophageal Scintigraphy in a Case of Complex Swallowing Disorders After a Major Oral Surgery.

ABSTRACT: A 75-year-old woman had an occasional finding of a left tonsil mass for dysphagia, which resulted a high-grade squamous carcinoma. Therefore, the patient was sent to have a left pharyngectomy. After the pharyngectomy, the patient reported persistent swallowing disorders and nasal reflux. Consequently, she had an oropharyngoesophageal scintigraphy, demonstrating irregular oral and pharyngeal swallowing phases and confirming reflux episodes into the rhinopharynx and into the oropharynx. In line with these findings, the patient was send to rehabilitation; the abnormal functional mechanisms, previously identified by the scintigraphy, allowed to guide the speech therapy, with a progressive clinical improvement.

A Nasal Complication of Nasopharyngeal Swab for Reverse Transcription Polymerase Chain Reaction (RT-PCR) Detection of SARS-CoV-2 mRNA.

Nasopharyngeal (NP) and oropharyngeal (OP) specimens in the detection of the SARS-Cov-2 RNA are considered to have the highest diagnostic sensitivity and they have been recommended by the World Health Organization as the most reliable test. However, collecting NP specimens require specialized operators and adequate technique. We describe an intranasal breaking of the nasopharyngeal swab for anatomical reasons needing a surgical removing. We conclude that a safely procedure needs possibly a check for septal deviations or other causes of nasal obstruction.

Regenerative Strategy for Persistent Periprosthetic Leakage around Tracheoesophageal Puncture: Is It an Effective Long-Term Solution?

Autologous tissue-assisted regenerative procedures have been considered effective to close different types of fistula, including the leakage around tracheoesophageal puncture. The aim of this study was to retrospectively review 10 years of lipotransfer for persistent periprosthetic leakage in laryngectomized patients with voice prosthesis. Clinical records of patients who experienced periprosthetic leakage from December 2009 to December 2019 were reviewed. Patients receiving fat grafting were included. The leakage around the prosthesis was assessed with a methylene blue test. Twenty patients experiencing tracheoesophageal fistula enlargement were treated with fat grafting. At the one-month follow-up, all patients were considered improved with no leakage observed. At six months, a single injection was sufficient to solve 75% of cases (n 15), whereas 25% (n 5) required a second procedure. The overall success rate was 80% (n 16). Results remained stable for a follow-up of 5.54 ± 3.97 years. Fat grafting performed around the voice prosthesis, thanks to its volumetric and regenerative properties, is a valid and lasting option to solve persistent periprosthetic leakage.