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Objective: The complications related to voice prosthesis usage substantially affect the physical and social functioning of patients after total laryngectomy, which influences their quality of life. Leakage dysfunction is the most common, causing uncertainty and requiring unscheduled hospital visits. Our study was designed to estimate the benefit of regular versus leakage-related replacement of the voice prosthesis. Study Design. Randomized case−controlled trials. Setting. Tertiary hospital. Methods: The study included patients who underwent total laryngectomy with primary voice prosthesis insertion between 2020 and 2021 and were randomly assigned to one of two arms: regular exchange (REA) every 3 months or leakage-dependent exchange (LEA). The control treatment was continued for 12 months. The primary outcome measure was the comparison of complication rates in both arms, including periprosthetic leakage, granulation or atrophy of mucosa around the fistula, and dislocation of the prosthesis. The secondary outcome measures were the mean number of exchanges per year and patient satisfaction. Results: Thirty-six patients continued the study according to the protocol, with 16 in REA and 20 in LEA. A total of 153 voice prostheses were replaced during the study period, including 98 in REA and 55 in LEA. Comparative analysis of REA and LEA revealed a significantly longer time between replacements in the LEA group (p = 0.023) and a significantly lower rate of complications in the REA group (p = 0.029). Periprosthetic leakage was the most common complication associated with the use of voice prostheses, occurring in 3.06% of patients in REA and 9.09% in LEA, but this difference was statistically insignificant (p = 0.137). The analysis of factors predisposing patients to leakage failure revealed that treatment schemes, concomitant diseases, dental conditions, and diet or alcohol consumption significantly affect the longevity of voice prostheses. The relative and absolute risks (RRR and ARR) of complications in the REA group were reduced by 69.39% and 13.88%, respectively. The number of replacements (NNTs) that should be performed in the REA scheme to prevent one complication over the LEA scheme is 721. Conclusion: The replacement of regular voice prostheses improved the overall complication rate over the scheme based on leakage demand; however, it did not yield superior benefits in terms of patient satisfaction or economic aspects. Clinical Trial Registration: https://clinicaltrials.gov/study/NCT04268459 , identifier NCT04268459. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to evaluate rate of the COVID-19 disease, its severity, mortality rate and anxiety levels in subjects who underwent total laryngectomy. Methods: The subjects who underwent total laryngectomy were included in the study. The data were first obtained retrospectively and then a telephone survey was applied. Anxiety levels was evaluated by the Coronavirus Anxiety Scale (CAS). Results: A total of 54 subjects were included in the study. Nine (16.7%) males were reported to be infected with SARS-CoV-2. Five (55%) of them were hospitalized; 2 of them (22%) were taken to intensive care units, and one subject (11%) died. Although a tendency to increase risk of COVID-19 disease in the tracheoesophageal voice prosthesis users (23.1% vs 14.63%) was observed, statistically difference was not significant. The average total CAS score was significantly higher in those who had COVID-19. Conclusion: The data documented that people who underwent total laryngectomy developed more frequent and more severe COVID-19 disease and had a higher mortality rate. Although no obvious variable was found, our data suggest that using a tracheoesophageal voice prosthesis may be somewhat effective. Besides, our subjects presented very low anxiety about COVID-19. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

ObjectiveThe complications related to voice prosthesis usage substantially affect the physical and social functioning of patients after total laryngectomy, which influences their quality of life. Leakage dysfunction is the most common, causing uncertainty and requiring unscheduled hospital visits. Our study was designed to estimate the benefit of regular versus leakage-related replacement of the voice prosthesis. Study Design. Randomized case−controlled trials. Setting. Tertiary hospital.MethodsThe study included patients who underwent total laryngectomy with primary voice prosthesis insertion between 2020 and 2021 and were randomly assigned to one of two arms: regular exchange (REA) every 3 months or leakage-dependent exchange (LEA). The control treatment was continued for 12 months. The primary outcome measure was the comparison of complication rates in both arms, including periprosthetic leakage, granulation or atrophy of mucosa around the fistula, and dislocation of the prosthesis. The secondary outcome measures were the mean number of exchanges per year and patient satisfaction.ResultsThirty-six patients continued the study according to the protocol, with 16 in REA and 20 in LEA. A total of 153 voice prostheses were replaced during the study period, including 98 in REA and 55 in LEA. Comparative analysis of REA and LEA revealed a significantly longer time between replacements in the LEA group (p = 0.023) and a significantly lower rate of complications in the REA group (p = 0.029). Periprosthetic leakage was the most common complication associated with the use of voice prostheses, occurring in 3.06% of patients in REA and 9.09% in LEA, but this difference was statistically insignificant (p = 0.137). The analysis of factors predisposing patients to leakage failure revealed that treatment schemes, concomitant diseases, dental conditions, and diet or alcohol consumption significantly affect the longevity of voice prostheses. The relative and absolute risks (RRR and ARR) of complications in the REA group were reduced by 69.39% and 13.88%, respectively. The number of replacements (NNTs) that should be performed in the REA scheme to prevent one complication over the LEA scheme is 721.ConclusionThe replacement of regular voice prostheses improved the overall complication rate over the scheme based on leakage demand; however, it did not yield superior benefits in terms of patient satisfaction or economic aspects.Clinical Trial Registrationhttps://clinicaltrials.gov/study/NCT04268459, identifier NCT04268459.

The article in the Laryngoscope journal discusses a modified technique for retrograde placement of the tracheoesophageal voice prosthesis in patients with challenging tracheoesophageal puncture (TEP) tracts. The updated technique involves utilizing the preexisting prosthesis as a guiding conduit for reliable voice prosthesis exchange in patients with difficult TEP tracts. The method has been successfully used in patients with flap reconstruction, esophageal strictures, and stomal stenosis, with no complications reported. This technique offers a safe and reliable option for voice prosthesis placement in challenging cases, maintaining TEP tract patency throughout the procedure. [Extracted from the article]

Knowledge about voice prosthesis microbial colonization is vital in laryngectomized patients' quality of life (QoL). Herein, we aimed to explore the relationship between oral microbial patterns, demographic variables and voice prosthesis performance. Thirty laryngectomy patients were assessed for microbial colonization in their voice prostheses and oral cavities. Factors like age, proton pump inhibitor (PPI) usage, and alcohol consumption were considered. Participants' average age was 74.20 ± 7.31 years, with a majority on PPIs. Staphylococcus aureus was the most common bacterium in prostheses (53 %), followed by Pseudomonas aeruginosa (27 %). Candida albicans was the primary fungal colonizer (67 %). A statistically significant moderate correlation was found between fungal species before and after oral rinsing (p = 0.035, Phi=0.588, Cramer's V = 0.416). Voice prosthesis and oral cavity microbiota profiles showed significant concordance (kappa=0.315, p < 0.004). Among subgroup analyses, bacterial patterns of colonization did not significantly influence VHI (p = 0.9555), VrQoL (p = 0.6610), or SF-36 (p = 0.509) scores. Conversely, fungal patterns of VP colonization significantly impacted subjective voice scores, with Candida krusei demonstrating better VHI (35.25 ± 3.63 vs. 44.54 ± 6.33; p = 0.008), VrQoL (7.13 ± 1.69 vs. 10.73 ± 2.00; p = 0.001), and SF-36 (69.36 ± 7.09 vs. 76.50 ± 7.73; p = 0.051) scores compared to C. albicans. There was a significant correlation between the oral microbiota and voice prosthesis colonization. These insights can inform improved care strategies for voice prostheses, enhancing patient outcomes. [ABSTRACT FROM AUTHOR]

Acquired tracheobronchomalacia (ATBM) is a condition in which the tracheobronchial wall and cartilage progressively lose their rigidity, resulting in dynamic collapse during exhalation. In this report, we present a case of ATBM that developed following voice prosthesis implantation. To the best of our knowledge, this is the first documented case of such a condition in the medical English literature based on a PubMed search. A 63-year-old man was referred to National Kyushu Cancer Center in Japan with complaints of pharyngeal pain and a laryngeal tumor. The tumor was diagnosed as laryngeal cancer, and the patient underwent laryngectomy. Three months after the surgery, we implanted a voice prosthesis through a tracheoesophageal puncture. Two months after implantation, the patient experienced dyspnea. This condition was subsequently diagnosed as ATBM through computed tomography and bronchofiberscope examinations. After the removal of the voice prosthesis, there has been no progression of ATBM for over five years. While ATBM may not be a common occurrence in the practice of head and neck surgeons, it should be considered as a potential complication when patients report dyspnea following voice prosthesis implantation. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Granulomatous diseases, foreign bodies, trauma, surgical procedures, and the use of high pressure intubation tubes are the most common causes of acquired benign tracheoesophageal fistula (TEF). More frequent use of invasive procedures such as intubation, tracheostomy and mechanical ventilation increases the frequency of benign tracheoesophageal fistula development, especially in intensive care patients. In this case report, the patient with a history of total laryngectomy operation, aspirated the audio device secondary to the use of excessive force and the connection of the device to the gastrointestinal system due to the existing tracheoesophageal shunt. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Tracheoesophageal shunt insufficiency (TESI) is a common and potentially life-threatening complication after laryn(-gopharyn)gectomy (L(P)E). We investigated whether TESI could be the result of a specific shunt location. Methods: A monocentric, retrospective cohort analysis of 171 consecutively treated L(P)E patients was performed. Patients with a secondary prosthesis instillation and patients with insufficient postoperative imaging were excluded. Disease related data as well as location of primary voice prosthesis were assessed. Results: The cohort was divided into 62 TESI-positive and 109 TESI-negative individuals. The mean time from surgery to TESI was 32 months. No differences were observed in gender, age, tumor localization, T/R/M-status. Surgery without adjuvant therapy was more often performed in TESI-negative individuals when compared with their positive counterparts. However, Cox regression including T/N status, therapy and categorized distance of the tracheoesophageal shunt to the manubrium (≤1.5 cm vs. >1.5 cm) revealed that a distance of ≤1.5 cm was associated with a 2.1-fold increased risk of TESI, while all other parameters did not influence the event-free survival. Conclusions: Primary shunt positioning ≤1.5 cm to the ridge of the manubrium is associated with an increased risk of TESI. In these individuals secondary shunt operation resulting in a position >1.5 cm distant to the manubrium should be recommended. [ABSTRACT FROM AUTHOR]

Tracheoesophageal puncture and voice prosthesis placement is the preferred method of voice restoration following total laryngectomy. Although this is a safe and effective means of optimizing voice, severe complications can occur. We present the case of a patient who developed cerebritis and ventriculitis secondary to a tracheoesophageal prosthesis eroding his cervical vertebrae 20 years following pharyngo-laryngo-esophagectomy. Despite optimal antimicrobial therapy, he deteriorated and succumbed to his disease. Although tracheoesophageal prostheses are a safe and effective means of voice restoration, life-threatening complications can occur. This case report highlights a rare but severe case of cervical osteomyelitis, epidural abscess, and cerebritis and ventriculitis secondary to tracheoesophageal prosthesis. Clinicians must be aware of this severe complication in postlaryngectomy patients with tracheoesophageal prostheses. [ABSTRACT FROM AUTHOR]

To conduct a systematic review of the use and results of the Provox®VegaTMXtraSealTM in the prevention of periprosthetic leakage and to propose a management protocol for this voice prosthesis. Systematic search based on the PRISMA Statement during February 2020. Keywords were double flange, periprosthetic leakage, voice prosthesis, and laryngectomy. Four articles with 315 voice prosthesis (94 XtraSeal and 221 controls) in 55 patients were found. The XtraSeal mean duration was 114.28 ± 73.2 (CI 95%, 98.29–130.26) days compared to 102.98 ± 17.74 (CI 95%, 100.62–105.35) days of the control group. Out of 266 replacements, endoprosthetic leakage was the most frequent cause in both groups (62.41%). Periprosthetic leaks were less frequent in the XtraSeal (9.62%) than in the control group (22.43%). The XtraSeal could be effective in preventing periprosthetic leakage and lengthening the time between replacements. Studies with a robust methodology are necessary to confirm these results. Managing voice prosthesis is complex and requires a multidisciplinary and systematic approach by experienced professionals to reduce replacements and complications. Incorrect placement of the XtraSeal could cause a foreign body reaction and consequently inflammation, extrusion, or pressure lesions. The Tower of Hercules protocol: (1) Measurement of the tracheoesophageal fistula using the Provox® Measure, (2) Minimization of XtraSeal slack by avoiding the complete visualization of the prosthesis' blue ring, (3) Nasofibroscopic examination of the oesophageal wall confirming both flanges are in correct position; could prevent or minimize complications derived from the use of the XtraSeal. [ABSTRACT FROM AUTHOR]

Tracheoesophageal (TE) puncture with voice prosthesis placement is a common method for vocal rehabilitation in patients who have undergone total laryngectomy. Tracheoesophageal voice prosthesis (TEP) placement after laryngectomy, known as secondary TE puncture, is traditionally done in the operating room, using rigid esophagoscopy. Traditional secondary TEP placement carries a number of downsides including risks associated with general anesthesia, high cost, and technical challenges associated with anatomical variables. As a result, in‐office secondary TE puncture has become an increasingly utilized procedure with many advantages but currently lacks standardization. Here, we describe a kit‐based, awake, in‐office secondary TE puncture with primary TEP placement technique. This technique calls for an endoscopic snare in the event there is difficulty passing the guidewire in the cranial trajectory. No surgical technique videos demonstrating in‐office secondary TE puncture currently exist. Here, we present a video tutorial of our technique, breaking down the procedure into 10 steps from analgesia to voicing. [ABSTRACT FROM AUTHOR]

Loss of speech function is one of the most important problems that arise in the treatment of laryngeal carcinoma by total laryngectomy. Implantation of a voice prosthesis in a surgically formed tracheoesophageal fistula is currently accepted as the gold standard. The purpose of the study was to analyze the results of our own modified methodology for tracheoesophageal puncture and voice prosthesis implantation, regarding the effectiveness of the method, the frequency and type of complications. A retrospective non-interventional two-center clinical study that included 51 patients who underwent tracheoesophageal fistulization for voice prosthesis implantation was performed. The study is part of a large-scale study, and the study protocol includes a detailed description of the design, inclusion and exclusion criteria, diagnostic and therapeutic procedures. The presented innovative modified technique for secondary TEP and fistula implementation based on Lichtenberger EENC is precise, safe and easier to perform compared to the original technique. Voice production in Bulgarian laryngectomized patients after TEP and voice prosthesis implantation is significantly superior to esophageal voice in terms of mean duration of phonation with one air bolus, number of words uttered with one bolus, tempo and expressiveness of speech. Voice rehabilitation through TEP and implantation of a voice prosthesis allows a significant increase in the quality of patients' lifestyle. Based on the presented results, the effectiveness of laryngeal prosthetics after laryngectomy is an undeniable factor improving the quality of life and giving good results compared to its alternatives. At а national level, it is necessary to create an information program and reimburse the voice prostheses by the NHIF. This would allow Bulgarian patients to have alternatives and make an informed choice. [ABSTRACT FROM AUTHOR]

Abstract Background An enlarged tracheoesophageal puncture (TEP) site is a grave complication of voice prosthesis rehabilitation. Case presentation We report a case of periprosthetic leakage with an enlarged tracheoesophageal fistula causing aspiration, not responding to conservative management and primary closure. Internal mammary artery perforator (IMAP) flap was subsequently used in the management. The flap was successfully taken up at the recipient site with no leak post-operatively as confirmed by barium swallow, thereby preventing further aspiration. Conclusion Though minor degrees of TEP leak usually respond to conservative management, the recalcitrant ones require active intervention which one should be aware of.

The Provox Vega High Performance (PVHP) is a newly developed voice prosthesis (VP) with an aim to achieve a longer and more predictable lifetime. This feasibility study aims to assess patient acceptance of the PVHP VP, evaluate adverse events, voice quality, and device lifetime. Laryngectomized patients previously using a Provox Vega or ActiValve Light were included. Acceptance and voice outcomes were evaluated at two-time points with a 2-week interval. Baseline measurements were taken with the standard VP, followed by placement of the PVHP for the 2-week assessment. Fifteen participants completed the study, with thirteen being initial Vega-users. PVHP acceptance was 87% 2 weeks after placement. Median device lifetime for all VPs was 64 d (range 14–370). In the subgroup without periprosthetic leakage, the median device lifetime was 101 d (range 31–370). Acceptance dropped to 40% after device failure. Voice quality did not differ between PVHP and baseline VP. The most reported adverse event was PVHP valve stickiness (46%). Acceptance of the PVHP is largely dependent on device lifetime, decreasing from 87% to 40% after leakage or replacement. Voice quality remains consistent across different VPs. Developing a long-lasting VP remains a challenge. [ABSTRACT FROM AUTHOR]

After a total laryngectomy, voice rehabilitation is essential for a patient to successfully reintegrate into society. The implantation of a voice prosthesis (VP) is the gold standard to achieve this goal. Thus, the primary disadvantage of using VP is the fluid blockage and degradation caused by biofilm colonization, which requires frequent replacements, associated with a poor quality of life for the patient. Many scientists have centered their research on coming up with novel and efficient ways to combat polymicrobial biofilms, both in terms of preventing microbial adhesion and rupturing established biofilms in order to overcome this limitation. This paper aims to present the current state of the art regarding biofilm formation on VPs and composition of VPs, and to review the current anti-biofilm strategies that have proven to be successful, as well as pointing possible novel perspectives of improvement. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Tracheoesophageal speech with a voice prosthesis is considered the rehabilitation treatment of choice in laryngectomized patients. The main reasons for prosthesis failure are endoprosthetic leakage and periprosthetic leakage. The Provox XtraSeal® stent incorporates an additional double flange on the esophageal side to prevent periprosthetic leakage. The objective of this study is to compare the duration and costs of the Provox Vega® and Provox XtraSeal® prostheses used in these patients in a tertiary university hospital. Materials and methods: A prospective crossover case study of laryngectomees with Provox Vega® who underwent Provox XtraSeal® placement due to recurrent periprosthetic leaks and decreased theoretical prosthesis life. The duration and possible factors affecting voice prostheses were studied using Kaplan–Meier curves and Cox regression. A cost-effectiveness analysis was carried out from the perspective of the Spanish National Health System with an incremental cost-effectiveness calculation. Results: A total of 38 patients were recruited, 35 men and 3 women, with a mean age of 66.26 ± 9.36 years old. Information was collected from 551 voice prostheses, 484 Provox Vega® and 68 Provox XtraSeal®. The mean duration of Provox Vega® was 119.75 ± 148.8 days and that of Provox XtraSeal® was 181.99 ± 166.07 days (p = 0.002). The most frequent reason for replacement was endoprosthetic leakage in both groups: 283 (60.86%) in the case of Provox Vega® and 29 (48.33%) in that of XtraSeal® (p < 0.000). To obtain no cost differences (ICE ~ 0) between Provox Vega and Provox XtraSeal, the latter should cost EUR 551.63. Conclusions: The Provox XtraSeal® is a cost-effective option in patients with increased prosthesis replacements due to periprosthetic leakage, reducing the number of replacements, increasing the duration of the prosthesis, and providing savings compared to Provox Vega®. [ABSTRACT FROM AUTHOR]

Voice rehabilitation following laryngectomy often utilizes speech valves, where a valve is placed in a surgically created tracheoesophageal fistula. The most significant complication of this procedure being leakage around the speaking tube through a widened puncture site. Ultimately, surgical closure of a problematic fistula may be required, and three-layer closure techniques are the most widely recognized.We would like to report a novel technique of injection repair of a leaking fistula using a porcine dermal collagen paste. This injection technique prevents leakage by bulking the tissue surrounding the valve and thus narrowing or tightening the fistula.

Vocal rehabilitation post total laryngectomy (TL) lacks clinical guidelines, especially with the presence of multiple modalities. To describe the tendencies of vocal rehabilitation post TL in France and compare it with other countries. We try to identify the most practiced modalities and recognize statistically significant influencing factors. An electronic anonymous survey was answered by 75 ENT surgeons from France. The survey outlined the common practiced vocal rehabilitation modalities and had two versions depending on if the participant practices the tracheoesophageal speech (TES) or not. 96% use TES in their practice. Single modality TES and double modality TES with esophageal speech (ES) are the two most practiced modalities. 99% agreed that there is no age limit for the TES. Single modality ES was offered 92% more when more than 10 TL were performed per year (p <.05). No influencing factors found for single modality TES or double modality TES with ES (p >.05). Conclusion: In line with tendencies from other countries, the TES is the most practiced modality of vocal rehabilitation coupled or not with the ES. TES has no age limit as per our participants. The least practiced modality is the singe modality ALS. [ABSTRACT FROM AUTHOR]

Objective: Voice prosthesis leakage significantly affects the quality of life of patients undergoing laryngectomy, causing insecurity and frequent unplanned hospital visits and costs. In this study, the concept of prophylactic voice prosthesis replacement was explored to prevent leakages. Study Design: Retrospective cohort study. Setting: Tertiary hospital. Methods: This study included all patients who underwent laryngectomy between 2000 and 2012 in the Netherlands Cancer Institute. Device lifetimes and voice prosthesis replacements of a retrospective cohort were used to calculate the number of needed voice prostheses per patient per year to prevent 70% of the leakages by prophylactic replacement. Various strategies for the timing of prophylactic replacement were considered: adaptive strategies based on the individual patient's history of replacement and fixed strategies based on the results of patients with similar voice prosthesis or treatment characteristics. Results: Patients used a median 3.4 voice prostheses per year (range, 0.1‐48.1). We found high inter‐ and intrapatient variability in device lifetime. When prophylactic replacement is applied, this would become a median 9.4 voice prostheses per year, which means replacement every 38 days, implying >6 additional voice prostheses per patient per year. The individual adaptive model showed that preventing 70% of the leakages was impossible for most patients and only a median 25% can be prevented. Monte‐Carlo simulations showed that prophylactic replacement is not feasible due to the high coefficient of variation (SD/mean) in device lifetime. Conclusion: Based on our simulations, prophylactic replacement of voice prostheses is not feasible due to high inter‐ and intrapatient variation in device lifetime. [ABSTRACT FROM AUTHOR]

Background. Voice rehabilitation in patients undergoing total laryngectomy is fundamental for the social reinsertion of the patient. The gold standard to fulfill this objective is the implantation of a voice prosthesis (VP). The main limitation of VP use is the blockage with fluids and deterioration due to biofilm colonization, which leads to frequent replacements. Objectives. The purpose of the study is to identify the microorganisms that develop within the biofilm colonizing the collected VPs surfaces and the implantation situ and to determine whether that biofilm formation is the main reason for deterioration of VP proper function, leading to frequent replacements of VP. Material and methods. In our retrospective observational study we assessed the biofilm composition of 41 dysfunctional VP from 10 laryngectomized patients by collecting samples for microbiologic tests. The morphology of the biofilm was also observed using scanning electron microscopy, a precious tool for providing an extensive understanding of the microbial colonizing the behavior of the medical device. Outcomes. The microbiologic evaluation revealed a complex, mixed bacterial-fungal multispecies composition and the average time of exploitation for each VP was established. Deterioration of the silicone properties contributes to a large extent to the malfunction of VP. Conclusions. Further research in the medical engineering field and innovative approaches are expected to improve the device lifespan, by proving anti-biofilm properties and thus enhancing the quality of life for laryngectomized patients.

Vocal rehabilitation with implantation of voice prosthesis has been recognized as one of the most popular intervention for patients after total laryngectomy. The main threat to its users is leakage through the tracheo-esophageal fistula caused by prosthesis deformation and damage to the valve mechanism due to colonization with fungal or bacterial/fungal biofilms. The uniqueness of the described case represents the use of the same Provox voice prosthesis during the period of almost 10 years.

This study aims to propose a novel surgical technique to rehabilitate patients with long term complication of trachea-esophageal puncture and stomal stenosis. Ours is retrospective study. Ten patients with tracheo-esophageal puncture who developed long term complications and who failed conservative management were included in our study. Majority of our patients were males within the age group of 50–70 years of age. Most of our patients had received adjuvant radiotherapy (8/10). All patients had multiple change of prosthesis. Nine patients suffered from multiple complications of TEP. Most common complication was that of progressive thinning of trachea-esophageal wall. All the patients who underwent this procedure healed well without any major complications. Long term trachea-esophageal puncture may undergo significant modification in terms of position and size. This technique gives a satisfactory and viable method of excising the altered anatomy and establishes speech & swallowing in such patients who fail conservative management. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate the problems in daily life of Provox® users in Japan with the use of a questionnaire survey and to consider future guidance methods for these patients. We mailed questionnaires to 190 members of a Japanese laryngectomized patient group. We received 118 questionnaires with valid responses. The total voice handicap index (VHI) score was 44.1. Patients were allocated to two groups based on the type of surgery they underwent—laryngectomy or jejunum reconstruction. The VHI score was significantly lower in the simple laryngectomy group than that in the free jejunum reconstruction group (p < 0.01). Only 55.9% of the patients reported having received voice rehabilitation therapy. For other problems of daily life, many patients answered "bad/very bad" for the "smelling," "eating/drinking hot foodstuffs," "blowing nose," and "quantity of sputum" categories. Based on our results, there is a requirement for an effective rehabilitation therapy and appropriate guidance for patients with the Provox® voice prosthesis. [ABSTRACT FROM AUTHOR]

Introduction: In patients who undergo a total laryngectomy, one of the most common techniques for voice rehabilitation is a tracheoesophageal prosthesis. Typically, this is accomplished using an endoscope down the oesophagus to visualise puncturing of the posterior tracheal wall; however, we present a case in which the use of an endoscope was not feasible, and a novel technique had to be utilised. Case report: A mid-70s male who had a total laryngectomy secondary to laryngeal carcinoma was undergoing tracheoesophageal puncture for prosthesis placement, when it was noted that he had significant stenosis of his proximal oesophagus, precluding the use of an endoscope. The senior author decided to use intraoperative ultrasound to visualise the oesophageal lumen for proper placement of the puncture. Discussion: This case demonstrates the ability of intraoperative ultrasound to visualise the oesophageal lumen and accurately place the tracheoesophageal puncture in cases where an endoscope cannot be used. Conclusion: We present a novel technique in which ultrasound was used to visualise the oesophageal lumen and identify the needle puncturing the posterior tracheal wall for placement of a tracheoesophageal prosthesis. [ABSTRACT FROM AUTHOR]

Objective: To present a new procedure for inserting a secondary voice prosthesis from the inside to the outside, which improves on the method previously reported by Fukuhara et al.Methods: A flexible nasopharyngoscope was used to puncture pharynx (or transplanted jejunum) from the inside to the outside. In this method, it was possible to use the PROVOX® VegaTM Puncture Set as it is used for the placement of the voice prosthesis.Results: We were able to place the PROVOX® VegaTM in all cases we experienced. Most of the cases had a history of radiation therapy. The time required for surgery ranged from 11-59 minutes (mean: 29 minutes) and there was no measurable amount of bleeding.Conclusion: This new method using the PROVOX® VegaTM Puncture Set, which is designed for the original purpose of voice prosthesis implantation, was therefore found to be safe and effective. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: In the present study, we assess the feasibility and success outcomes of voice prosthesis (VP) changes when performed by a speech-language pathologist (SLP). Methods: Patients treated with total laryngectomy (TL) from January 2020 to December 2020 were prospectively recruited from our medical center. Patients benefited from tracheoesophageal puncture. The VP changes were performed by the senior SLP and the following data were collected for each VP change: date of placement; change or removal; VP type and size; reason for change or removal; and use of a washer for periprosthetic leakage. A patient-reported outcome questionnaire including six items was proposed to patients at each VP change. Items were assessed with a 10-point Likert-scale. Results: Fifty-two VP changes were performed by the senior SLP during the study period. The mean duration of the SLP consultation, including patient history, examination and VP change procedure, was 20 min (range: 15–30). The median prosthesis lifetime was 88 days. The main reasons for VP changes were transprosthetic (n = 34; 79%) and periprosthetic (n = 7; 21%) leakages. SLP successfully performed all VP changes. He did not change one VP, but used a periprosthetic silastic to stop the periprosthetic leakages. In two cases, SLP needed the surgeon's examination to discuss the following indication: implant mucosa inclusion and autologous fat injection. The patient satisfaction was high according to the speed and the quality of care by the SLP. Conclusions: The delegation of VP change from the otolaryngologist–head and neck surgeon to the speech-language pathologist (SLP) may be achieved without significant complications. The delegation of VP change procedure to SLP may be interesting in some rural regions with otolaryngologist shortages. [ABSTRACT FROM AUTHOR]

Tracheoesophageal puncture (TEP) with voice prosthesis (VP) placement is commonly used to restore voice in laryngectomy patients. The conventional procedure utilizes a rigid esophagoscope to open and visualize the pharyngeal inlet. However, this approach is challenging in patients with postradiation changes, reduced neck extension, or trismus. Here, we demonstrate a modified technique involving flexible endoscopy and endotracheal tube placement to reestablish the TEP tract in a patient with a challenging anatomic profile. This step-by-step video demonstrates retrieval of a dislodged prosthesis and TEP/VP placement under general anesthesia, which results in effective voice restoration. This modified technique can safely and effectively restore voice in patients with difficult exposure., (© 2025 Wiley Periodicals LLC.)

Introduction: Tracheoesophageal speech is a preferred method of alaryngeal voice rehabilitation in persons with a laryngectomy. Periodic replacements, troubleshooting, and stringent care are required to successfully use this device. There is a dearth of information on the perspectives of TE speakers from developing countries regarding the use and handling of this type of pseudo-voice. The current study aims to understand patient's viewpoints regarding their restored voice. Method: The Voice Prosthesis Questionnaire (VPQ) developed by Kazi (2006) was translated into 2 regional languages with the addition of four questions and was used in this study. The questionnaire focused on aspects related to the use and care of the prosthesis device, problems faced, management strategies used, and overall satisfaction. Results: The results indicated the following issues: the cost was a major concern; high tolerance for leakage; not seeking medical advice until serious complications arose; concerns about the physical distance to laryngectomy rehabilitation centers; and absence of trained professionals near their place of stay. Further, it was interesting to note the indigenous solutions for enhanced prosthetic life and humidification of inhaled air. Conclusion: Most participants of this study were satisfied with their restored voices as they believed that the alaryngeal mode of communication improved their quality of life. There is a need to develop indigenous humidification and hands-free speech systems that are affordable and feasible for the climatic conditions of India.

Aim: To determine success in use of voice prosthesis, prosthesis lifetime and long-term complications after total laryngectomy with primary tracheoesophageal puncture and to describe our approach to periprosthetic leakage. Introduction: Voice restoration after total laryngectomy is usually performed by placing a silicone voice prosthesis in an artificially formed tracheoesophageal fistula. Methods: We performed a retrospective study on 187 laryngectomies with primary tracheoesophageal puncture in the 15-year period, treated in our hospital. Results: In the group of patients with more than 1 year follow up, 87.8% of patients had successful voice restoration. Average prosthesis lifetime was 8 months. Long-term complications developed in 17.5% of patients. Periprosthetic leakage was the most common. We were able to successfully resolve long-term complications in 19/24 patients and they continued to use their vocal prostheses. Conclusion: The primary placement of the voice prosthesis is successful and safe way to restore a voice after a total laryngectomy. Complications are commonly treatable in an outpatient clinic or with minor surgery.

Objectives: Voice rehabilitation after laryngectomy is by tracheo esophageal puncture (TEP) and prosthesis insertion. Secondary TEP is very difficult due to neck fibrosis. Puncture under local anaesthesia with endoscopy guidance is a feasible option. Methods: Retrospective review of all laryngectomy patients from March 2009 till March 2019 was done and the methods of voice rehabilitation were assessed. The patients undergoing the procedure were classified according to the timing of insertion and type as primary insertion under general anaesthesia (Group P), secondary insertion under local anaesthesia (Group L), secondary insertion under general anaesthesia (Group G). The speech outcome and the procedure outcome were compared. Results: There were 148 patients who underwent laryngectomy, of which groups P, G, L were 12, 12 and 11. The rate of successful insertion was 100% in primary, 91.6% in secondary in general anaesthesia and 91% in secondary under local anaesthesia. All secondary TEP were done after surgery and radiotherapy. Complications related to the insertion techniques were minimal. Speech outcome were similar on intelligibility rating scale and longevity was not affected by the method. Conclusion: TEP in local anaesthesia is feasible and has comparable outcome with TEP in general anaesthesia. Financial burden was very much less in group L compared to the other two groups. [ABSTRACT FROM AUTHOR]

To study voice prosthesis survival, complications, efficacy and impact on quality of life. A single-center observational study was performed in patients treated for squamous cell carcinoma of the larynx or hypopharynx by total (pharyngo)-laryngectomy between 2010 and 2015. Study data comprised: maximum phonation time (sec), number of and reasons for prosthesis exchanges (leakage through or around the prosthesis, expulsion or inclusion of the prosthesis), plus 2 quality of life questionnaires (QLQ-C30, QLQ-H&N35) and the Voice Handicap Inventory (VHI 30). Forty-nine patients were included. The most common causes of prosthesis exchange were leakage through (73.2%) or around the prosthesis (18.5%). The median time between exchanges was 4 months. Global quality of life status on the QLQ-C30 was 63.5. Mean maximum phonation time was 7.4 sec. Mean VHI was 46/120; 10 patients had a mild voice handicap, 12 moderate and 10 severe. No relation emerged between the number of prosthesis exchanges per year and quality of life. Voice handicap significantly decreased quality of life, with QLQ-C30 72.3 for the 22 patients with mild to moderate voice handicap and 44.2 for the 10 patients with severe voice handicap (P = 0.001). Voice restoration by tracheoesophageal prosthesis after total (pharyngo)-laryngectomy is a reliable technique that decreases voice handicap and, despite potentially serious complications, has little negative impact on quality of life. [ABSTRACT FROM AUTHOR]

Introduction. The aim of this article is to present the advantages of tracheoesophageal puncture using secondary placement of the voice prosthesis, at present the “gold standard” for voice rehabilitation in the laryngectomized patient with advanced cancer following total laryngectomy. Absence of voice and, therefore, inability to verbally communicate, constitutes one of the greatest challenges for laryngeal cancer patients, having a major impact on their quality of life. Case report. The authors illustrate the case of a 61-year-old patient diagnosed with advanced laryngeal cancer, who underwent total laryngectomy. After approximately one year, a voice prosthesis is installed. Phonation was immediate and close to natural laryngeal speech. Conclusions. From a functional, as well as psychological and social point of view, a laryngeal cancer diagnosis can have devastating consequences on all aspects of a patient’s life. Phonation recovery is thus essential for psychological well-being, labour and social reintegration. Correct understanding and management of this pathology and treatment options is of utmost importance in obtaining the best possible medium and long-term outcomes. Secondary placement of the voice prosthesis provides greater oncological safety as well as avoids common post-radiotherapy side effects.

Abstract With the COVID-19 pandemic, there has been significant changes and challenges in the management of oncology patients. One of the major strategies to reduce transmission of the virus between patients and healthcare workers is deferral of follow-up visits. However, deferral may not be possible in total laryngectomy patients. Urgent procedures may be necessary to prevent complications related to ill-fitting tracheoesophageal puncture (TEP) voice prostheses, such as aspiration or loss of voicing. In this paper, we describe the Princess Margaret Cancer Center’s approach to managing this unique patient population.

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. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Surgical closure of persistent tracheoesophageal fistulas (TEFs) is complex. Most patients present with multiple risk factors, which may negatively impact the outcome and influence the treatment strategies. PATIENTS AND METHODS: This retrospective study included 22 patients presenting with persistent TEFs. Preoperative RT, comorbidities, tissue conditions of the TEFs and neck skin, and surgical techniques were evaluated regarding a possible impact on success rates and outcome. RESULTS: 21 patients were operated, 95.45% with final success. However, in 52.39% repeated surgery was needed. Final closure of TEFs was achieved in 91.47% only after more invasive surgery was performed. The surgical technique applied had the most significant impact on success rates and outcome compared to all other risk factors analyzed. Our own data and that of the literature point out that the surgical strategy should be adapted to the patients' individual risk factors. CONCLUSIONS: According to the literature, surgical closure of persistent TEFs is demanding. Our data suggest that, considering that the majority of patients with persistent TEFs exhibit multiple risk factors, early performance of more invasive surgery seems associated with a better outcome. [ABSTRACT FROM AUTHOR]