OBJECTIVE: 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.

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.

UNASSIGNED: Speech rehabilitation significantly contributes to the enhanced quality of life for patients who have undergone laryngectomy due to head and neck cancer. The initiation of tracheoesophageal speech early in the rehabilitation process has been associated with improved speech quality. Despite this, voice changes can carry a stigma due to communication challenges, even after successful voice restoration, potentially limiting the overall improvement in quality of life. Thus, our aim was to gain a profound understanding of the transition process from the selection to the adaptation of tracheoesophageal speech in patients with head and neck cancer.
UNASSIGNED: Participants, who had undergone laryngectomy for head and neck cancer, were recruited from peer support groups in Japan, resulting in the identification of thirteen tracheoesophageal speakers. The data were analyzed using grounded theory methodology, incorporating open, axial, and selective coding. Semi-structured interviews delved into tracheoesophageal speakers\' perceptions of their voices and the adaptive strategies employed for their preferred alternative communication methods.
UNASSIGNED: During the adaptation process, participants underscored the importance of communicating with their own voices. However, they also experienced anxiety about losing their natural voice, confronted the reality of living without a voice, and coped with their new voice. Eventually, participants came to recognize the changed voice as their own.
UNASSIGNED: The personal conviction associated with the notion of \"communicating with one\'s own voice\" is integral to the adaptation process for patients with head and neck cancer who undergo laryngectomies and utilize tracheoesophageal speech. Some aspects of tracheoesophageal speech can evoke feelings of hopelessness, emphasizing the importance of comprehensive support for professional speech rehabilitation.

UNASSIGNED: The Provox Vega High Performance (PVHP) is a newly developed voice prosthesis (VP) with an aim to achieve a longer and more predictable lifetime.
UNASSIGNED: This feasibility study aims to assess patient acceptance of the PVHP VP, evaluate adverse events, voice quality, and device lifetime.
UNASSIGNED: 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.
UNASSIGNED: 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%).
UNASSIGNED: 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.

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.
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®.

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.
Retrospective cohort study.
Tertiary hospital.
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.
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.
Based on our simulations, prophylactic replacement of voice prostheses is not feasible due to high inter- and intrapatient variation in device lifetime.

OBJECTIVE: 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.

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.

OBJECTIVE: To study voice prosthesis survival, complications, efficacy and impact on quality of life.
METHODS: 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).
RESULTS: 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 7.4sec. 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).
CONCLUSIONS: 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.

OBJECTIVE: 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.
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.