Unlocking tracheoesophageal speech from pharyngoesophageal spasm: preliminary results of a videofluoroscopic-guided botulinum toxin A injection technique.

PURPOSE: The tracheoesophageal puncture for the voice prosthesis (VP) placement is the recognized gold standard in post-laryngectomy voice rehabilitation. Despite the development of specific intraoperative techniques, a subset of patients will suffer from poor functional outcomes due to pharyngoesophageal spasms (PES). This paper evaluates the functional outcomes after transcutaneous botulinum toxin type A (BTX-A) infiltration for PES with a videofluoroscopy-guided technique. METHODS: Since 2022, eight consecutive patients with VP and affected by PES were treated with BTX-A injection by a standard videofluoroscopic guided technique at the European Institute of Oncology, IRCCS (IEO) in Milan. A lidocaine test was performed pre-operatively to evaluate the potential effect of chemical neurectomy. All patients with positive lidocaine tests were injected with 50 IU of BTX-A (Allergan, Irvine, CA) according to the sites marked during the videofluoroscopy. Reported symptoms (VHI, SECEL), perceptual (INFVo), aerodynamic (MPT) and manometric parameters were collected before and after treatment. RESULTS: In all cases, BTX-A was performed as an outpatient procedure without complications. For seven patients, only one BTX-A injection was needed, while one patient required a re-injection. Subjective and perceptive improvement after BTX-A was significant for VHI, SECEL and INFVo. MPT showed significant improvement after a chemical neurectomy. After a mean follow-up of 6 months, all patients maintained a good TES quality. CONCLUSION: The videofluoroscopic guided BTX-A injection of the pharyngoesophageal tract showed to be a feasible and reproducible technique in all cases. The pharyngoesophageal videofluoroscopy allows defining of patients' anatomical landmarks that help the surgeon to perform a homogeneous injection, empowered by post-injection massage.

Voice quality after open partial horizontal laryngectomy vs. total laryngectomy with voice prosthesis: a comparative study.

OBJECTIVES: The aim of this study is to compare voice outcomes in open partial horizontal laryngectomy vs. total laryngectomy (TL) with voice prosthesis. METHODS: In this retrospective monocentric study patients undergoing OPHL or TL with voice prosthesis were enrolled during the usual oncological follow-up consultations at the Otolaryngology and Audiology Unit of a University Hospital in the period between July 2022 and June 2023. Acoustic analysis (F0, HNR, NHR), maximum phonation time, I-SECEL and INFV0 scale were used to assess voice outcome. RESULTS: Forty-three patients were enrolled. Voices of patients undergoing LT were better in quality of voice (V0) at INFV0 scale. The scores in I-SECEL and acoustic analysis were comparable. CONCLUSIONS: Voice quality could be slight better in patients undergoing TL with voice prosthesis than those undergoing OPHL.

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.

Tissue augmentation treatment for periprosthetic leakage in patients who have undergone a total laryngectomy: A systematic review.

OBJECTIVES: Tracheoesophageal puncture (TEP) is considered the gold standard for voice rehabilitation after total laryngectomy. One of the main causes of treatment failure, and a potentially serious complication, is the TEP enlargement and/or leakage around the voice prosthesis. The injection of biocompatible material to increase the volume of the puncture surrounding tissue has been studied as a popular option for conservative treatment of enlarged tracheoesophageal fistula. The aim of this paper was to perform a systematic review of the efficacy and safety of such treatment. DESINGN: Search conducted in PubMed/MEDLINE, the Cochrane Library, Google Scholar, Scielo and Web of Science and through the meta-searcher Trip Database based on Preferred Reporting Items for a Systematic Review and Meta-analysis (PRISMA) statement. SETTINGS: Human experiments published in peer-reviewed journals, where investigators assessed the use of peri-fistular tissue augmentation for periprosthetic leakage were evaluated. PARTICIPANTS: Laryngectomized patients with voice prosthesis, presenting periprosthetik leak due to enlarged fistula. MAIN OUTCOMES MEASURES: mean-duration without new leak. RESULTS: A total of 196 peri-fistular tissue augmentation procedures in 97 patients were found in the 15 selected articles. The 58.8% of patients had a time without periprosthetic leak after treatment of >6 months. The 88.7% of tissue augmentation treatments resulted in periprosthetic leakage cessation. The general level of evidence of the studies included in this review was low. CONCLUSIONS: Tissue augmentation treatment is a minimally invasive, biocompatible and safe solution that temporarily resolves periprosthetic leaks in many cases. There is no standard technique or material, and treatment needs to be individualised according to the experience of the practitioner and the characteristics of the patient. Future randomised studies are needed to confirm these results.

Sustained release varnish containing chlorhexidine for prevention of Streptococcus mutans biofilm formation on voice prosthesis surface: an in vitro study.

OBJECTIVES: In this study, we aimed to develop a novel, sustained release varnish (SRV) for voice prostheses (VP) releasing chlorhexidine (CHX), for the prevention of biofilm formation caused by the common oral bacteria Streptococcus mutans on VP surfaces. METHODS: This study was performed in an in vitro model as a step towards future in vivo trials. VPs were coated with a SRV containing CHX (SRV-CHX) or SRV alone (placebo-SRV) that were daily exposed to S. mutans. The polymeric materials of SRV were composed of ethylcellulose and PEG-400. Biofilm formation was assessed by DNA quantification (qPCR), crystal violet staining, confocal laser scanning microscopy (CLSM), scanning electron microscopy (SEM), and kinetics experiments. RESULTS: The amount of DNA in the biofilms formed by S. mutans on VP surfaces coated once with SRV-CHX (1.024 ± 0.218 ng DNA/piece) was 58.5 ± 8.8% lower than that of placebo-SRV-coated VPs (2.465 ± 0.198 ng DNA/piece) after a 48-h exposure to S. mutans (p = 0.038). Reduced biofilm mass on SRV-CHX-coated VPs was visually confirmed by CLSM and SEM. CV staining of SRV-CHX single-coated VPs that have been exposed to S. mutans nine times showed a 98.1 ± 0.2% reduction in biofilm mass compared to placebo-SRV-coated VPs (p = 0.003). Kinetic experiments revealed that SRV-CHX triple-coated VPs could delay bacterial growth for 23 days. CONCLUSIONS: Coating VPs with SRV-CHX has an inhibitory effect on biofilm formation and prevents bacterial growth in their vicinities. This study is a proof-of-principle that paves the way for developing new clinical means for reducing both VPs' bacterial biofilm formation and device failure.

Prosthetic voice rehabilitation after laryngoesophagectomy: surgical and functional outcomes.

PURPOSE: Quality of Life (QoL) after extensive head and neck resections is of paramount importance, especially after pharyngolaryngectomy or pharyngolaryngoesophagectomy where complex digestive tract reconstruction is required (with gastric pull-up or colon transposition). Tracheodigestive puncture (TDP) is the only vocal restoration option in this group of patients. The aim of this study is to evaluate postoperative complications, vocal outcomes, voice-related and swallowing-related QoL after secondary TDP in this cohort of patients. METHODS: A retrospective study was conducted in the tertiary referral center of Verona Hospital between June 2014 and June 2020. Patient demographics, clinical and surgical data were assessed. Speech objective and subjective evaluation was performed. QoL was assessed with Voice Handicap Index-10 (VHI-10) and M.D. Anderson Dysphagia Inventory (MDADI) questionnaires. RESULTS: Seven patients met the inclusion criteria, but two had died before questionnaires were administered. No intraoperative complications were noted after TDP surgery. There were delayed complications in four cases (57.1%) and all were treated with restoration. Intelligible voice was restored in all patients. Maximum phonation time and maximal voice intensity recorded were 5.42 ± 3.27 s and 65.20 ± 5.45 dB, respectively. Acceptable average VHI-10 and MDADI scores were obtained in all patients. CONCLUSIONS: Secondary TDP performed after gastric pull-up or colon transposition reconstructions are feasible and effective procedures. An intelligible voice was restored in all patients, with satisfactory patient-perceived voice-related and dysphagia-related quality-of-life outcomes.

Long-term outcomes and cost-effectiveness of a magnet-based valve voice prosthesis for endoprosthesis leakage treatment.

PURPOSE: Tracheoesophageal speech is considered the gold standard for rehabilitation following total laryngectomy. The main reason of voice prosthesis failure is the endoprosthesis leakage. Provox ActiValve® incorporates a magnet-based valve system to achieve active closure of the valve to treat these leakages, with the drawback of being significantly more expensive. The aim of the study was to compare the Provox Vega® and Provox ActiValve® duration and costs in patients with replacements increase due to endoprosthetic leakage. METHODS: Prospective case-crossover study in laryngectomized patients with Provox Vega® and endoprosthesis leakage to whom a Provox ActiValve® was placed. Survival and possible factors that affect voice prosthesis were studied using Kaplan-Meier curves and Cox Proportional Hazards Regression. Cost-effectiveness analysis from the perspective of the Spanish Public National Health System with incremental cost-effectiveness calculation was performed. RESULTS: A total of 159 prostheses were evaluated. The most frequent reason for replacement was the endoprosthesis leakage (N = 129; 83.77%) in both models. The mean duration-time of Provox Vega® was 44.77 ± 2.82 days (CI 95%, 39.18-50.35; median 36 days), and 317.34 ± 116.8 days (CI 95% 86.66-548; median 286 days) for the Provox ActiValve® (p < 0.000). For every replacement not made thanks to the Provox ActiValve® there was saving of 133.97€ CONCLUSIONS: The Provox ActiValve® is a cost-effective solution in patients with increased prosthesis replacements due to endoprosthetic leakage, reducing the number of changes and cost compared to Provox Vega®.

In vitro Inhibition of Biofilm Formation on Silicon Rubber Voice Prosthesis: Α Systematic Review and Meta-Analysis.

INTRODUCTION: Biofilm formation on voice prostheses is the primary reason for their premature implant dysfunction. Multiple strategies have been proposed over the last decades to achieve inhibition of biofilm formation on these devices. The purpose of this study was to assess the results of the available in vitro biofilm inhibition modalities on silicone rubber voice prostheses. METHODS: We conducted a systematic search in PubMed, Embase, and the Cochrane Central Register of Controlled Trials databases up to February 29, 2020. A total of 33 in vitro laboratory studies investigating the efficacy of different coating methods against Candida, Staphylococcus, Streptococcus, Lactobacilli, and Rothia biofilm growth on silicone rubber medical devices were included. Subgroup analysis linked to the type of prevention modality was carried out, and quality assessment was performed with the use of the modified CONSORT tool. RESULTS: Data from 33 studies were included in qualitative analysis, of which 12 qualified for quantitative analysis. For yeast biofilm formation assessment, there was a statistically significant difference in favor of the intervention group (standardized mean difference [SMD] = -1.20; 95% confidence interval [CI] [-1.73, -0.66]; p < 0.0001). Subgroup analysis showed that combined methods (active and passive surface modification) are the most effective for biofilm inhibition in yeast (SMD = -2.53; 95% CI [-4.02, -1.03]; p = 0.00001). No statistically significant differences between intervention and control groups were shown for bacterial biofilm inhibition (SMD = -0.09; 95% CI [-0.68, 0.46]; p = 0.65), and the results from the subgroup analysis found no notable differences between the surface modification methods. After analyzing data on polymicrobial biofilms, a statistically significant difference in favor of prevention methods in comparison with the control group was detected (SMD = -2.59; 95% CI [-7.48, 2.31]; p = 0.30). CONCLUSIONS: The meta-analysis on biofilm inhibition demonstrated significant differences in favor of yeast biofilm inhibition compared to bacteria. A stronger inhibition with the application of passive or combined active and passive surface modification techniques was reported.

Biocompatible Materials in Otorhinolaryngology and Their Antibacterial Properties.

For decades, biomaterials have been commonly used in medicine for the replacement of human body tissue, precise drug-delivery systems, or as parts of medical devices that are essential for some treatment methods. Due to rapid progress in the field of new materials, updates on the state of knowledge about biomaterials are frequently needed. This article describes the clinical application of different types of biomaterials in the field of otorhinolaryngology, i.e., head and neck surgery, focusing on their antimicrobial properties. The variety of their applications includes cochlear implants, middle ear prostheses, voice prostheses, materials for osteosynthesis, and nasal packing after nasal/paranasal sinuses surgery. Ceramics, such as as hydroxyapatite, zirconia, or metals and metal alloys, still have applications in the head and neck region. Tissue engineering scaffolds and drug-eluting materials, such as polymers and polymer-based composites, are becoming more common. The restoration of life tissue and the ability to prevent microbial colonization should be taken into consideration when designing the materials to be used for implant production. The authors of this paper have reviewed publications available in PubMed from the last five years about the recent progress in this topic but also establish the state of knowledge of the most common application of biomaterials over the last few decades.

Autologous platelet-rich fibrin: a novel method for tracheoesophageal puncture site closure: a case report.

Closure of a tracheoesophageal puncture site performed during voice prosthesis implantation may sometimes be required. Besides local techniques, more elaborate procedures, such as closure by means of free microvascular flaps, have been advocated. In this report, we describe a case of local treatment of a hard-to-heal fistula with local application of autologous platelet-rich fibrin matrix in a 77-year-old male patient. At one-week follow-up, the size of the fistula had decreased dramatically but some leakage remained when drinking. After one month, the patient was able to drink and eat normally without any leakage. There was no recurrence of the leakage at two years' follow-up. In summary, local application of platelet-rich fibrin seems to be a simple, safe and effective procedure for tracheoesophageal fistula closure.

Voice Prosthesis Coated with Sustained Release Varnish Containing Clotrimazole Shows Long-Term Protection against Candida albicans: An In Vitro Study.

Fungal biofilm formation on voice prosthesis (VP) is a major health problem that requires repeated replacement of the prosthesis. Candida albicans is one of the pathogens that frequently inhabits the VP. We proposed that coating VPs with sustained-release varnish (SRV) containing clotrimazole (CTZ) might prevent fungal biofilm formation. The long-term antifungal activities of SRV-CTZ- versus SRV-placebo-coated VPs was tested daily by measuring the inhibition zone of C. albicans seeded on agar plates or by measuring the fungal viability of C. albicans in suspension. The extent of biofilm formation on coated VPs was analyzed by confocal microscopy and scanning electron microscopy. We observed that SRV-CTZ-coated VPs formed a significant bacterial inhibition zone around the VPs and prevented the growth of C. albicans in suspension during the entire testing period of 60 days. Fungal biofilms were formed on placebo-coated VPs, while no significant biofilms were observed on SRV-CTZ-coated VPs. HPLC analysis shows that CTZ is continuously released during the whole test period of 60 days at a concentration above the minimal fungistatic concentration. In conclusion, coating VPs with an SRV-CTZ film is a potential effective method for prevention of fungal infections and biofilm formation on VPs.

Complications following secondary voice prosthesis insertion and impact of previous irradiation on their appearance.

OBJECTIVE: The aim of this study was to analyze the complications following secondary voice prosthesis insertion and impact of previous irradiation on their appearance. METHODS: This study included 106 totally laryngectomized patients who underwent secondary Provox 2 voice prosthesis insertion. Among them, 79 (74.5%) were irradiated. Surgery, prosthesis, fistula, and voice-related complications were analyzed and presented. RESULTS: Complications occurred in 23 (22%) patients. Fifteen of them were previously irradiated. There were no surgery-related complications. In the group of prosthesis-related complications, one patient had increased negative pressure during swallowing with extremely short prosthesis life time. There were 17 complications in the group of fistula related ones; 3 patients had excessive granulation tissue around the fistula and 14 patients experienced prosthesis displacement (7 had closed esophageal end of the fistula, 5 had the prosthesis turned sideways in an open fistula, one patient inhaled and one ingested the prosthesis). Tracheoesophageal voice was not established in 5 patients. Previous irradiation had no statistically significant influence on the complication rate (P = 0,251). CONCLUSIONS: The majority of complications following secondary voice prosthesis insertion are fistula-related ones, among which, displacement of the voice prosthesis is the most common. Previous irradiation does not significantly increase the risk of developing complications.

Complications associated with tracheoesophageal voice prostheses from 2010 to 2020: A MAUDE study.

PURPOSE: Tracheoesophageal puncture with voice prosthesis placement remains the gold standard for voice restoration following total laryngectomy, but may cause various complications. This study aims to summarize patient-related and device-related adverse events associated with tracheoesophageal puncture and voice prosthesis placement. MATERIALS AND METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to tracheoesophageal puncture with voice prosthesis placement from January 1, 2010, to April 30, 2020. Data were extracted from reports pertaining to tracheoesophageal prostheses. RESULTS: Seventy-seven reports involving tracheoesophageal voice prostheses were identified, from which 111 adverse events were extracted. Of these, 58 (52.3%) were patient-related, while 53 (47.7%) were device-related. The most frequently reported patient-related adverse events were aspirated prosthesis (24 [41.4%]), foreign body during placement (11 [19.0%]), aspiration pneumonia (9 [15.5%]), and aspirated brush tip (8 [13.8%]). The most common device-related adverse events were detached brush tip (15 [28.3%]), leak (14 [26.4%]), and torn esophageal flange (11 [20.8%]). CONCLUSIONS: While tracheoesophageal puncture with voice prosthesis placement has revolutionized voice rehabilitation following total laryngectomy, the procedure may be associated with adverse events both at the time of placement and later. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further research is needed to clarify optimal approaches to education.

Influence of proton pump inhibitor therapy on occurrence of voice prosthesis complications.

PURPOSE: It has been shown that the reflux of the gastric content to the proximal oesophagus influences incidence of voice prosthesis (VP) complications in laryngectomized patients. We conducted prospective randomised study to investigate the relationship between pepsin concentration in saliva and occurrence of VP complications before and after 3 months of proton pump inhibitor (PPI) therapy. METHODS: 60 laryngectomized patients with VP and 30 controls were included in the study. Saliva samples were collected in the morning and concentration of pepsin were measured by Human Pepsin (PG) ELISA kit. Thirty-Four (57%) patients reported one or more VP complication and were randomised in two groups, with and without PPI therapy, 40 mg pantoprazole per day for 3 months. RESULTS: Patients who had longer time since last VP change had higher incidence of periprosthetic and transprosthetic leakage and Candida colonisation. Pepsin was found in all saliva samples. Median saliva pepsin concentration level did not significantly differ between laryngectomized patients and control subjects, or between patients with and without VP complications, and there was no correlation between saliva pepsin concentration levels and type of VP complication. After 3 months therapy, there was no difference in median saliva pepsin level or incidence of VP complication between patients with and without PPI therapy. CONCLUSION: Although reflux was proposed to be associated with VP complications and pepsin was proven as a most sensitive and specific marker of EER, we did not find any statistically significant correlation between pepsin levels and occurrence of VP complications. A 3 months 40 mg pantoprazole therapy was ineffective in reduction of VP complications in our study group.

Factors contributing to clinician training and development in the clinical area of laryngectomy and tracheoesophageal voice.

BACKGROUND: It has long been recognized that tracheoesophageal speech (TES) rehabilitation after laryngectomy is a specialized area of practice for speech and language therapist (SLTs) due to the complex nature of patient presentation and the invasive components of the SLT's role in this area. Therefore, postgraduate experience and training is required to work competently and safely in this clinical area. However, it is generally acknowledged that the steps and processes followed by individual clinicians to achieve this training and clinical skill development are inconsistent and vary widely across services. There is a need to identify critical elements deemed most beneficial to clinical skill development in order to inform future training models. AIMS: To explore clinicians' perceptions of factors that contribute to training and clinical skills development in the area of TES rehabilitation post-laryngectomy. METHODS & PROCEDURES: All participants were SLTs working in an Australian clinical service, with a current or recent clinical caseload that included patients using TES. A total of 36 SLTs were recruited and then grouped by level of experience (novice n = 15, intermediate n = 7, experienced n = 14). Each participant took part in one small focus group with other participants of similar experience level. Ten focus groups were conducted, each of approximately 60 min in duration. A semi-structured interview guide was used to facilitate the discussion of issues relating to training in this area. Thematic analysis was used to analyse transcripts and identify themes. OUTCOMES & RESULTS: Interviews identified six key themes, including: Learning with and from others; Formal programmes; Hands-on learning; Processes that influence training; and Individual influences. SLTs reported both positive issues and elements that were challenging across all five themes. The final (sixth) theme was identified regarding clinician perceptions of how this area differed to specialized training in other areas of the profession. The majority of themes were discussed equally by clinicians across all three experience levels. CONCLUSIONS & IMPLICATIONS: Participants across all experience levels identified that multiple factors contributed to clinicians successfully gaining skills, understanding and competency when working in TES rehabilitation post-laryngectomy. These factors, when fully considered and incorporated into future SLTs training pathways and opportunities, have the potential to optimize competency, skill acquisition and maintenance in this area. What this paper adds What is already known on this subject While studies have considered the training, preparation and knowledge base of SLTs working in the clinical area of TES, the focus has predominantly been at the immediate postgraduate level or assessment of university course work. No studies have used a qualitative methodology to consider the reflections and perceptions of clinicians' training pathways and training needs across all levels of experience for this clinical area. What this paper adds to existing knowledge The results of this study build upon the existing body of literature regarding education and training in this area, determining factors SLTs feel are required to successfully gain skills, understanding and competency when working in TES rehabilitation. The findings highlight that training pathways and methods in this clinical area are an ongoing consideration for SLTs regardless of experience level and have the ability to impact on future competency programmes, training opportunities and delivery methods in this area. What are the potential or actual clinical implications of this work? Effective and ongoing postgraduate training programmes and professional development opportunities have the potential to positively impact on professional competence and confidence, patient safety and overall service delivery. Hence, the themes generated from this research highlight essential factors to include within training and professional development programmes for SLTs in TES rehabilitation. This information can be used to help optimize current training pathways for all experience levels.

Speech and language therapists' reflections on developing and maintaining confidence in tracheoesophageal speech rehabilitation.

BACKGROUND: The management of tracheoesophageal speech (TES) rehabilitation is an area of speech and language therapists' (SLTs) clinical practice where knowledge and skills are primarily developed through postgraduate workplace experience and training. Although recent research suggests clinicians in Australia perceive there is adequate access to workplace training, little is known about how clinicians develop and/or maintain clinical confidence when working in this specialist caseload. AIMS: To investigate factors that contribute to development of clinician confidence as well as the factors that impact on improving and maintaining confidence when working in the clinical area of TES rehabilitation. METHODS & PROCEDURES: SLTs working in an Australian clinical service and in a current or recent caseload including patients using TES were eligible to participate. A total of 36 SLTs were recruited and then grouped by level of experience (novice n = 15, intermediate n = 7, experienced n = 14). Ten focus groups of 60-min duration were conducted each with three to four participants from the same experience level. A semi-structured interview guide was used to facilitate the discussion of issues relating to training and confidence; however, only the content pertaining to clinical confidence is reported. Thematic analysis was used to analyse the transcripts. OUTCOMES & RESULTS: Four themes were identified as contributing to the development of confidence: training, exposure, accessing support and mentorship, and leadership opportunities. Three themes were identified as critical for improving or maintaining clinical confidence: ongoing management of a caseload, ongoing support and further learning. An additional overarching theme was the desire for SLTs to classify or quantify their level of confidence, typically using a numeric scale or in years of clinical experience. The impact of varying contexts and caseloads on confidence levels was highlighted by all participants, but particularly those in the novice focus groups. CONCLUSIONS & IMPLICATIONS: The findings highlight the fact that the acquisition and maintenance of confidence is an ongoing consideration for SLTs, both those starting out and those with years of clinical experience. With patient presentation increasing in complexity, the importance of understanding contributing factors for gaining and maintaining confidence should be considered alongside postgraduate training and the provision of ongoing support for SLTs working in this specialized clinical area, regardless of experience level.

Use of double flange voice prosthesis for periprosthetic leakage in laryngectomised patients: A prospective case-crossover study.

INTRODUCTION: Tracheoesophageal speech is considered the gold standard for rehabilitation following total laryngectomy. One of the main problems of voice prosthesis is the periprosthesis leakage. Provox Vega XtraSeal incorporates a double flange on the pharyngeal side of the prosthesis in order to avoid these failures. The aim of the study is to compare the device lifetime between the Provox Vega and Provox Vega XtraSeal and to examine possible related factors that influence their duration. METHODS: Prospective case-crossover study in 20 laryngectomised patients with Provox Vega and periprothesis leakage to whom a Provox Vega XtraSeal was placed. Survival and possible factors that affect voice prosthesis were studied using Kaplan-Meier curves and Cox Proportional Hazards Regression with Schoenfeld residuals to test the possible assumptions. RESULTS: A total of 230 prostheses were evaluated. The most frequent reason for replacement was due to an endoprosthesis leakage (n = 146, 67%) in both models. Mean lifetime of Provox Vega was 104.474 ± 7.29 days (CI 95% 90.19-118.76) and of Provox XtraSeal was 176.76 ± 26.46 days (CI 95% 124.9-228.61) (P = .012). Complementary treatment with radiotherapy demonstrated a higher device survival (P = .007). DISCUSSION: Provox XtraSeal seems to be effective reducing the number of changes due to periprosthetic leakage, thus increasing the survival of voice prosthesis.

The Difficult Secondary Tracheoesophageal Puncture: A Technique for Safe Insertion.

BACKGROUND/AIMS: The tracheoesophageal prothesis (TEP) has become the primary modality for laryngeal communication after total laryngectomy due to high success rates, minimal morbidity, and more natural pulmonary driven speech. Fibrosis, kyphosis, and post-radiation contracture may preclude TEP placement through rigid esophagoscopy, and certain patients may not tolerate an in-office awake procedure. For such patients, a technique for flexible esophageal stenting and TEP placement is necessary. METHODS: We performed a retrospective review of 3 patients who underwent TEP placement through endotracheal-tube esophageal stenting at the Massachusetts Eye and Ear Infirmary. RESULTS: All 3 patients underwent laryngectomy after prior chemoradiotherapy for laryngeal cancer with resulting neck contracture and fibrosis preventing rigid esophagoscopy. All patients underwent successful TEP placement through endotracheal stenting without complication and developed excellent tracheoesophageal speech. Specific technical details are highlighted. CONCLUSIONS: In patients with anatomical constraints preventing traditional TEP placement through rigid esophagoscopy, fiberoptic guidance through an endotracheal tube stent provides a safe and efficient approach for TEP placement.

Double Blind Study Investigating the Effect of Different Voice Prostheses on Ease of Swallowing and Residue Post Laryngectomy.

Voice prostheses have been examined for their effect on voice production but there is little datum on their effect on swallow function. This study investigated the difference between six commonly available voice prostheses in terms of swallowing. Laryngectomy patients had up to six voice prostheses placed in a random order over two visits. Swallowing was evaluated for each prosthesis using FEES (Fibreoptic Endoscopic Evaluation of Swallowing). After each prosthesis trial, patients self-evaluated their experience of swallowing. Three independent experts indicated which prosthesis they considered best for swallowing for each patient and judged residue on the voice prosthesis and in the upper esophagus. Raters were blinded to participant details, voice prosthesis type and scores of other raters. On patient self-evaluation, scores were equally distributed across all prostheses for swallowing. Experts most frequently chose the Blom Singer Low pressure and Blom Singer Classic Indwelling voice prostheses as best for swallowing but consensus was poor for most patients. Experts found that the Blom Singer Classic Indwelling and the Provox Vega had least residue on the voice prosthesis on thin liquid (p ≤ 0.001) and soft (p = 0.001), respectively. Experts also found that the Blom Singer Low Pressure had least residue in the upper esophagus on soft consistency (p ≤ 0.001). While self-evaluation by patients did not identify a consistently preferred prosthesis for swallow, many patients expressed personal preferences, suggesting benefits to involving patients in the choice of prosthesis. Some voice prostheses may be associated with lower levels of residue on the prosthesis and upper esophagus with certain consistencies.

Provox 2® and Provox Vega® device life-time: a case-crossover study with multivariate analysis of possible influential factors and duration.

INTRODUCTION: Tracheoesophageal speech is considered the gold standard for rehabilitation following total laryngectomy. Current literature is limited and contradictory about the possible causes of device failure. The aim of the study is to compare the device life-time between the Provox 2 and Provox Vega and to examine possible related factors that influence their duration. METHODS: Retrospective case-crossover study in 34 laryngectomized patients who had undergone tracheoesophageal voice rehabilitation using indwelling Provox 2 and Provox Vega voice prostheses between 2010 and 2016 in a tertiary care centre. RESULTS: A total of 440 prostheses were evaluated. The most frequent reason for replacement was due to an endoprosthesis leakage (n = 221, 64.2%) in both models. Radiotherapy increases the risk of prosthesis replacement (IRR = 1.88, p = 0.007) as well as bilateral neck dissection (IRR = 1.56, p = 0.017) in Provox 2. Age and unilateral neck dissection do not seem to influence the duration of the prosthesis. Mean life-time of Provox 2 was 106.64 days and 124.19 days for Provox Vega (p = 0.261). Complementary treatment with radiotherapy demonstrated a lower device survival (p < 0.001). DISCUSSION: Results confirmed the non-significant differences on device life between Provox Vega and Provox 2, as well as the relevant role of radiotherapy treatment in the increase of replacements and diminution of the device duration.