Development of quaternary ammonium based acrylic copolymer antimicrobial coatings for polyurethane tracheoesophageal voice prostheses.

Tracheoesophageal voice prostheses (TEPs) are soft polymeric devices used to restore the voices of patients who have undergone total laryngectomy (TL). TEPs are implanted on the tracheoesophageal wall and come in direct contact with food, fluid and air. The environment of an implant is a budding ground for growth of microbes, leading to biofilm formation on the TEP surfaces. Biofilm formation is the leading cause of TEP failure because the biofilm affects its functioning by clogging the air passage over several weeks to a few months. Short useful lifespan of TEPs is a concern for patients undergoing total laryngectomy. To increase the useful lifespan of TEPs, it is imperative to prevent biofilm formation. This problem is addressed in the present study by developing a cationic crosslinked antimicrobial coating that prevents biofilm formation through contact killing. An acrylate-based tetracopolymer poly(methyl methacrylate [MMA]-co-nbutyl acrylate [BA]-co-dimethylaminoethyl methacrylate [DMAEMA]-co-2 hydroxyethyl methacrylate [HEMA]) was synthesized by free radical polymerization and was crosslinked by hexamethylene diisocyanate (THDI) trimer through urethane linkages. The crosslinked tetracopolymer coatings were subjected to quaternary ammonium formation through N-alkylation with iodooctane. Different variants of coatings were synthesized and the tetracopolymer with 22.5% MMA, 22.5% BA, 20% HEMA and 35% DMAEMA showed desirable results. The developed coatings were characterized and tested for safety as well as mechanical and antimicrobial efficacy. The final results showed that the developed coatings exhibited good cytocompatibility, haemocompatibility, mechanical properties and antimicrobial properties for 180 days against E. coli, S. aureus and C. albicans.

[Clinical observation of 16 years of use of a domestic voice prosthesis without replacement after complete removal of the larynx]. / Klinicheskoe nablyudenie 16-letnei ekspluatatsii otechestvennogo golosovogo proteza bez zameny posle polnogo udaleniya gortani.

This paper presents a unique clinical observation of 16 years of use without replacement of a domestic voice prosthesis in a patient after laryngectomy. Long-term recurrence-free survival was achieved as a result of treatment of laryngeal leiomyosarcoma.

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.

Enhancing prosthesis stability at the cricoid cartilage in equine laryngoplasty using 3-D-printed laryngeal clamps: An ex vivo model study.

OBJECTIVE: To assess a three-dimensional (3-D)-printed laryngeal clamp (LC) designed to enhance the anchoring of laryngeal prostheses at the cricoid cartilage. STUDY DESIGN: Ex vivo biomechanical study. SAMPLE POPULATION: A total of 22 equine larynges. METHODS: Two experimental groups included larynges with standard prosthetic laryngoplasty (PL; n = 10) and larynges with prosthetic laryngoplasty modified with laryngeal clamps (PLLC; n = 10). All constructs underwent 3000 cycles of tension loading and a single tension to failure. Recorded biomechanical parameters included maximum load, actuator displacement, and construct failure. Finite element analysis (FEA) was performed on one PL and one PLLC construct. RESULTS: The maximum load at single tension to failure was 183.7 ± 46.8 N for the PL construct and 292.7 ± 82.3 N for the PLLC construct (p = .003). Actuator displacement at 30 N was 1.7 ± 0.5 mm and 2.7 ± 0.7 mm for the PL and PLLC constructs, respectively (p = .011). The cause of PL constructs failure was mostly tearing through the cartilage whereas the PLLC constructs failed through fracture of the cricoid cartilage (p = .000). FEA revealed an 11-fold reduction in the maximum equivalent plastic strain, a four-fold reduction in maximum compressive stress, and a two-fold increase in the volume of engaged cartilage in PLLC constructs. CONCLUSION: The PLLC constructs demonstrated superior performance in biomechanical testing and FEA compared to standard PL constructs. CLINICAL SIGNIFICANCE: The use of 3-D-printed laryngeal clamps may enhance the outcomes of laryngoplasty in horses. In vivo studies are necessary to determine the feasibility of performing laryngoplasty using the laryngeal clamp in horses.

Modified method for tracheoesophageal fistula closure in intractable cases.

OBJECTIVE: Tracheoesophageal puncture (TEP) is one of the most established methods for voice reacquisition following total laryngectomy. The most difficult complication following TEP is the management of saliva leakage or secretion into the trachea due to TE fistula enlargement. In this study, we devised a new strategy to close TE fistulas and confirmed its safety and effectiveness. METHODS: Skin incision: If the tracheal mucosa around the voice prosthesis appears intact and normal, an arcuate incision, from 10 to 2 o'clock, is made on the skin 5 mm superior to the edge of the stoma. However, if the surrounding tracheal mucosa is fragile because of leaking, the incision is made on the superior edge of the stoma, with later reconstruction of the posterior tracheal wall. Separation of the trachea and esophagus: If the esophagotracheal spatium appears normal and is easy to dissect, the connective pipes can be found easily. After cutting the pipe, a ligature alone is sufficient for the tracheal side; however, the esophageal wall is closed with Gambee sutures. If the esophagotracheal spatium is compromised and the posterior tracheal wall is fragile (due to saliva leakage), we remove the posterior wall and reconstruct the area using the superior skin flap. We performed our novel method on four patients with intractable conditions; postradiotherapy for laryngeal cancer, total pharyngo-laryngo-esophagectomy (TPLE) with jejunum reconstruction, TPLE with gastric lifting reconstruction, and in a patient who underwent cervicothoracic incisional drainage for descending necrotizing mediastinitis. RESULTS: None of the cases showed postoperative leakage from the fistula, and oral intake was resumed without difficulty. CONCLUSION: This study showed that this strategy based on TE fistula conditions is effective even in difficult-to-treat cases.

Concordance in bacterial colonization profiles between voice prostheses and oral microbiota post-laryngectomy: An experimental study.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

A double-blind randomized clinical trial of inflammatory cytokine and pepsin levels in the saliva of patients with voice prostheses.

BACKGROUND: Tracheoesophageal speech is one of the most effective method used for voice rehabilitation after laryngectomy. The main limitation is the need for periodic voice prothesis (VP) replacements. The process of developing VP usage complications is still unexplored. The aim of this study was to assess the level of cytokines (IL-1ß, IL-6, IL-8, IL-10, TNFα) and pepsin in saliva as potential factors reducing VP longevity. METHODS: Prospective double-blind randomized clinical trial was conducted (NCT04268459). Patients were randomly divided into two groups depending on VP replacement regimen (regular-every 3 months, or irregular-when complications occur). Levels of IL-1ß, IL-6, IL-8, IL-10, TNFα, and pepsin in saliva samples (fasting and after eating) of laryngectomized patients were measured using ELISA tests. RESULTS: Fifty-two patients (26 in both groups) with control group (7 patients) participated in the study. The level of IL-1ß, IL-6, IL-8, IL-10, TNFα, and pepsin did not differ according to regularity of VP replacements (p = 0.301-0.801). IL-6 levels were significantly higher when VP complications occurs (p = 0.012). CONCLUSIONS: The saliva components were not significantly different depending on the frequency of VP replacements. IL-6 plays an important role in the development of VP use complications.

Evolution of the quality of life of total laryngectomy patients using electrolarynx.

OBJECTIVE: Therapy and vocal rehabilitation in laryngeal cancer impact patients' quality of life. The objective of this study was to evaluate the evolution of the quality of life of patients with laryngeal cancer submitted to total laryngectomy and using electrolarynx. METHODS: This is an observational study with a cross-sectional design and a quantitative approach. It was conducted between April 2022 and January 2023 in a Brazilian cancer hospital. For data collection, a quality of life questionnaire, validated for patients with head and neck cancer at the University of Washington, was applied in two phases: from 7 days after total laryngectomy and, subsequently, from 70 days after surgery using electronic larynx for at least 60 days. The inclusion criteria were patients undergoing total laryngectomy included on the Aldenora Bello Cancer Hospital's election list to receive the electronic larynx. Patients who did not sign the informed consent form were not included. RESULTS: The sample consisted of 31 patients, of which approximately 84% were men and approximately 93% at the age of 50 years or older. When comparing the phases, it is possible to observe that the item speech had the greatest progress, while chewing had the least. Only the item recreation, swallowing, taste, and saliva did not show any statistical significance. The score for the general quality of life questions increased. CONCLUSION: Electronic larynx is a viable and useful method of voice rehabilitation. Our data suggest that the use of the electrolarynx as a postlaryngectomy method of verbal communication is responsible for positive effects on patients' quality of life.

Development of iodine based sustained release antimicrobial coatings for polyurethane voice prostheses.

Voice prostheses are known to fail in few weeks to several months of implantation due to the clogging mainly caused by microbial biofilm formation, which is a cause of concern. Iodine is a known broad-spectrum biocide and is reported to easily form complexes with various polymers. For long term device disinfection, strong iodine complexation that offers sustained iodine release for a prolonged period is essential. The present research work deals with the synthesis of a poly(methyl methacrylate-n-butyl acrylate-N-vinyl-2-pyrrolidone) (poly[MMA-BA-NVP]) tercopolymer through free radical polymerization for surface coating thermoplastic polyurethane (TPU) based voice prostheses. The NVP content in the tercopolymer was varied from 20% to 50% to optimise iodine loading and subsequent release. Base TPU coated with the tercopolymer was treated with 4% aqueous iodine solution at room temperature (28 ± 3 °C) for two hours. It was observed that the tercopolymer containing 35% N-vinyl-2-pyrrolidone (NVP), 32.5% methyl methacrylate (MMA) and 32.5% butyl acrylate (nBA) gave a stable coating on TPUs together with sustained iodine release for a prolonged period. Furthermore, the tercopolymer coated and iodine loaded TPUs exhibited excellent antimicrobial activity against Candida albicans, Staphylococcus aureus and Escherichia coli.

Primary tracheoesophageal puncture in stapler-assisted laryngeal closure: a surgical modification.

With the advancements in the medical field, many innovations in medical devices have happened. Using a surgical stapler to close the laryngectomy defect without opening the pharynx is particularly advantageous in a total laryngectomy (TL). However, performing the tracheoesophageal puncture (TEP) during stapler closure of the larynx has not been widely advocated, due to the fear of complications related to the procedure.We treated two male patients with advanced glottic malignancy who underwent a TL. To restore their ability to speak, we performed a primary TEP and immediate voice prosthesis placement. After the TEP, we closed the larynx using a stapler. The surgical technique used in this procedure has been thoroughly explained.The use of a surgical stapler for pharyngeal closure during a TL has several advantages, particularly with regard to the duration of surgery. The current techniques appear to be promising in reducing TEP-related complications during stapler-assisted laryngeal closure.

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.

Coronavirus disease 2019 status and related anxiety levels in cases undergoing total laryngectomy.

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.

A custom device for managing recurrent tracheoesophageal voice prosthesis dislodgement and aspiration due to treatment refractory, severely enlarged puncture: A video case report.

We report the case of a laryngectomized patient with an enlarged tracheoesophageal puncture (TEP) that is refractory to standard treatments and culminating in life-threatening recurrent dislodgement and aspiration of custom fabricated dual extra-large flange voice prostheses (VP). The fabrication and use of a novel intraluminal prosthetic device to prevent dislodgement, lessen aspiration, and preserve TE voice is described. A custom device insetting a commercial VP into the posterior wall of a LaryTube (coined "inset-VP") was devised with the primary goal of eliminating chronic VP dislodgement and lessening aspiration while maintaining TE voice. Tools required to fabricate the device included a commercial laryngectomy tube, standard-flanged commercial indwelling voice prosthesis, felt-tip marker, 6 mm biopsy punch, and silk suture. After 7 months of using an inset-VP LaryTube device, the patient has experienced zero episodes of VP aspiration. Thin liquid aspiration control is equivalent or better than prior management with custom 24-30 mm dual collar prostheses. TEP voice is fluent and functional with device in place. Novel strategies are needed to manage the rare but devastating effects of a severely enlarged TEP. Solutions to manage symptoms need to be patient-specific, aligning with their anatomy, physiology, psychosocial needs, and goals. The inset-VP device described in this report may offer improved prosthetic retention in select patients with enlarged TE puncture and frequent VP dislodgements.

Primary fit tracheoesophageal puncture in primary versus salvage laryngectomy: Short-term and long-term complications and functional outcomes.

BACKGROUND: Primary fit tracheoesophageal puncture (TEP) is widely preferred for individuals who have not undergone prior radiation. However, there is no consensus on the relative utility of primary-fit TEP in the setting of salvage laryngectomy. METHODS: A retrospective, single-center review was conducted of individuals undergoing laryngectomy with primary fit TEP between 2012 and 2018. Multivariable analysis was conducted to compare short-term and long-term complications, as well as speech and swallowing outcomes, of those who underwent primary versus salvage laryngectomy. RESULTS: In this study, 134 patients underwent total laryngectomy with primary fit TEP. Aside from a higher rate of peristomal dehiscence (13.1% vs. 1.4%) found in the salvage group, there was no difference in incidence of all other complications, including pharyngocutaneous fistula formation. The groups had comparable speech and swallow outcomes. CONCLUSION: Primary fit TEP is a safe and effective surgical choice for individuals undergoing salvage laryngectomy who desire a voice prosthesis.

Acquired tracheobronchomalacia developed following voice prosthesis implantation.

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.

[Perioperative experience in a case of human laryngotracheal allotransplantation].

Loss of laryngeal function is a primary problem faced by patients after total laryngectomy. Although the voice function of the larynx can be partially compensated by some methods(such as implanting a voice prosthesis, using an electrolarynx and so on), and swallowing dysfunction can be improved by postoperative rehabilitation training, patients still need to breathe through the tracheostoma for life. Laryngeal transplantation, as the only therapeutic measure that has the potential to completely restore laryngeal function, has been the focus of attention in the field of otorhinolaryngology head and neck surgery both at home and abroad. In this article, we review a case of human laryngotracheal allotransplantation that was successfully completed in West China Hospital of Sichuan University, including case presentation, preoperative evaluation and preparation, surgical procedure, and postoperative management, which will provide a reference for the future development of clinical laryngeal transplantation.

Perforator-based chimeric ulnar forearm microvascular free tissue transfer reconstruction of post-radiated tracheoesophageal puncture fistulae.

Tracheoesophageal puncture (TEP) performed during total laryngectomy in the primary treatment of laryngeal cancer is the standard method for voice restoration. Following adjuvant radiotherapy, the TEP site can experience complications resulting in a tracheoesophageal fistula (TEF) with chronic leakage making oral alimentation unsafe due to aspiration. Here, we describe a technique using chimeric ulnar artery perforator forearm free flaps (UAPFF) in the reconstruction of these complex deformities. Four patients underwent chimeric UAPFF reconstruction of TEP site TEFs following primary TL with TEP and adjuvant radiotherapy. No flap failures or surgical complications occurred. Average time from end of radiotherapy to persistent TEF was 66 months (range 4-190 months). All patients had resolution in their TEF with average time to total oral diet achievement of 22 days (14-42 days). Chimeric UAPFF reconstruction is a safe and effective method to reconstruct recalcitrant TEP site TEFs.

Management of Enlarging Tracheoesophageal Fistula with Voice Prosthesis in Laryngectomized Patients.

Management of Enlarging tracheoesophageal fistula (TEF) with Voice Prosthesis in Laryngectomized Head and Neck Cancer Patients. OBJECTIVES: An enlarging TEF following voice prosthesis placement impacts patient quality of life, risks airway compromise, and can lead to aspiration pneumonia. Pharyngoesophageal strictures have previously been reported to be associated with TEF enlargement and leakage. We describe a series of patients with enlarging TEFs after Tracheoesophageal puncture (TEP) for voice prosthesis who required pharyngoesophageal reconstruction. METHODS: Retrospective case series of laryngectomized H&N cancer patients with primary or secondary TEP who underwent surgical management for enlarging TEF site between 6/2016-11/2022. RESULTS: Eight patients were included. The mean age was 62.8 years old. Seven patients had a history of hypothyroidism. Of seven with prior H&N radiation history, two had both historical and adjuvant radiation. Two of the eight TEPs were placed secondarily. Mean time from TEP to enlarging TEF diagnosis was 891.3 days. Radial forearm-free flaps were used in five patients. Six had stenosis proximal to the TEF whereas one had distal stenosis and one had no evidence of stenosis. Mean length of stay was 12.3 days. Mean follow-up was 400.4 days. Two required a second free flap for persistent fistula. CONCLUSION: Surgical reconstruction of enlarging TEFs due to TEP/VP placement is effective in combination with addressing underlying pharyngeal/esophageal stenosis contributing to TEF enlargement and leakage. Radial forearm-free flaps have the additional benefit of a long vascular pedicle to access more distant and less-irradiated recipient vessels. Many fistulae are resolved after the first flap reconstruction, but some may require subsequent reconstruction in case of failure. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:198-206, 2024.

Analysis of durability and replacement of vocal prostheses in total laryngectomy patients at a head and neck surgery referral center.

PURPOSE: The use of tracheoesophageal prostheses has become the gold standard in vocal rehabilitation of patients undergoing total laryngectomy. However, this method also has limitations, such as the need for frequent replacement of prostheses due to leakage or other complications. We have designed a study to access the clinical profile of patients using tracheoesophageal prostheses as vocal rehabilitation after total laryngectomy and to determine the average rate of changes, as well as the main causes of prostheses replacement. METHODS: A retrospective cohort study was performed based on patients who underwent rehabilitation with voice prostheses after total laryngectomy between 2008 and 2017. RESULTS: The sample consisted of 93 patients and 432 vocal prostheses replacement events. The median change of prostheses per patient was 210.25 days, (range 57.33 to 651.50). The most frequent cause of prostheses replacement was leakage through the prostheses, 218 (50.46%). Lower level of education was associated to higher prostheses replacement rate. CONCLUSION: The results of this study show that the median of prostheses durability is higher than that presented in the literature, the main cause of replacement was protheses leakage and that low educational level is associated to higher replacement rate.