Device Life of the Tracheoesophageal Voice Prosthesis Revisited.

Importance: Voice prosthesis (VP) device life is a limiting factor of tracheoesophageal (TE) voice restoration that drives patient satisfaction, health care costs, and overall burden. Historic data suggest that TE VPs have an average device life of generally 3 to 6 months, but these data are typically derived from small samples using only 1 or 2 devices. Objective: To reexamine current device life in a large, contemporary cancer hospital in the United States that uses a wide assortment of VPs. Design, Setting, and Participants: This retrospective observational study included 390 laryngectomized patients with a tracheoesophageal puncture (TEP) who had VP management at MD Anderson Cancer Center between July 1, 2003, and December 31, 2013. Main Outcomes and Measures: Tracheoesophageal voice-related outcomes were: (1) device life duration to VP removal, and (2) treatment-related and prosthetic-related factors influencing device failure. Primary independent variables included treatment history (extent of surgery and radiation history), VP type (indwelling vs nonindwelling, size, specialty features), and reason for removal (leakage, complication, other). Duration was examined using Kaplan-Meier analysis. Disease, treatment, and patient-specific factors were analyzed as predictors of duration. Results: Overall, 3648 VPs were placed in the 390 patients (median [range] age, 62 [34-92] years). Indwelling prostheses accounted for more than half (56%) of the devices placed (55%, 20-Fr diameter; 33%, 8-mm length). More than two-thirds (69%) of prostheses were removed because of leakage, while the rest were removed for other reasons. Median device life was 61 days for all prostheses. Indwelling and nonindwelling VPs had median device lives of 70 and 38 days, respectively. There was no significant difference between specialty prostheses compared with standard devices (median duration, 61 vs 70 days, respectively). The Provox ActiValve (Atos Medical) had the longest life. Neither radiation therapy nor extent of surgery had a meaningful impact on device life. Conclusions and Relevance: Our data suggest that VP duration demonstrates a lower durability than historically reported. This may reflect the intensification of treatment regimens that complicate TEP management in an era of organ preservation; however, further investigation is needed.

[The use of the lactate-fortified milk whey for the prolongation of the functional life of the voice prostheses].

The objective of the present study was to develop the method for the prolongation of the functional life of the voice prostheses in the patients who underwent laryngectomy with special reference to the decrease of the risk of mycotic infection in the laryngo-oesophageal region. The original method is proposed with the application of the lactate-fortified milk whey that makes it possible to maintain the high concentration of living lactic acid bacteria in the laryngo-oesophageal segment where the voice prosthesis is located. The method was tested on 73 patients. It permitted to significantly prolong the functional life of the voice prostheses (from 12 to 20 months) and prevent mycotic infection. It is concluded that the proposed method promotes the improvement of the patients' quality of life following laryngectomy for the treatment of cancer.

Adjustable laryngeal implant for unilateral vocal cord paralysis.

BACKGROUND: Laryngeal framework surgery has been widely accepted as a definitive treatment for unilateral vocal cord paralysis (UVCP). An adjustable laryngeal implant has been developed for precise medialization of the paralyzed vocal cord. OBJECTIVES: To describe the implant and surgical technique and to evaluate the effect of vocal cord medialization using an adjustable laryngeal implant on the quality of life of patients with UVCP. PATIENTS AND METHODS: Fifty-three patients with UVCP who had undergone medialization with the adjustable laryngeal implant were identified. All patients completed the Voice Handicap Index (VHI) quality of life questionnaire. Preoperative and postoperative scores were compared. RESULTS: Major advantages over other accepted implants are the stability of the implant, excellent biocompatibility, precise medialization with a micrometric screw, and ease of secondary adjustment. Mean VHI score in all handicap domains was significantly improved following vocal fold medialization (p < .01). Although no difference was found in regard to gender, younger patients had higher handicap scores than older patients preoperatively (p < .05). This difference was not present following medialization. CONCLUSIONS: The adjustable laryngeal implant offers many advantages over other techniques. Vocal cord medialization using the adjustable laryngeal implant significantly improves quality of life as measured by the VHI.

Application of spectral subtraction method on enhancement of electrolarynx speech.

Although electrolarynx (EL) serves as an important method of phonation for the laryngectomees, the resulting speech is of poor intelligibility due to the presence of a steady background noise caused by the instrument, even worse in the case of additive noise. This paper investigates the problem of EL speech enhancement by taking into account the frequency-domain masking properties of the human auditory system. One approach is incorporating an auditory masking threshold (AMT) for parametric adaptation in a subtractive-type enhancement process. The other is the supplementary AMT (SAMT) algorithm, which applies a cross-correlation spectral subtraction (CCSS) approach as a post-processing scheme to enhancing EL speech dealt with the AMT method. The performance of these two algorithms was evaluated as compared to the power spectral subtraction (PSS) algorithm. The best performance of EL speech enhancement was associated with the SAMT algorithm, followed by the AMT algorithm and the PSS algorithm. Acoustic and perceptual analyses indicated that the AMT and SAMT algorithms achieved the better performances of noise reduction and the enhanced EL speech was more pleasant to human listeners as compared to the PSS algorithm.

[Clinical use of a voice prosthesis with a flap valve containing silver oxide (Blom-Singer Advantage), biofilm formation, in-situ lifetime and indication]. / Klinische Anwendung einer Stimmprothese mit silberoxidhaltigem Ventil (Blom-Singer Advantage)--Biofilmresistenz, Prothesenverweildauer und Indikation.

BACKGROUND: Fungal growth and the resulting leakage through an indwelling voice prosthesis remains the most frequent reason of prosthesis failure and renewal. In some patients leakage caused by fungal growth occurs in very short intervals (below 12 weeks in-situ lifetime) and causes frequent treatments and high costs. METHODS: The Blom-Singer(R) Advantage voice prosthesis is a new prosthesis type with a modified flange design, a flap valve containing 7 % silver oxide in the silicon matrix and is expected to be resistant against biofilm formation and fungal growth. PATIENTS: In a clinical trial we used the Blom-Singer(R) Advantage prosthesis in 33 patients with short in-situ lifetimes of their voice prosthesis and analysed the effects on in-situ lifetime and complications statistically. RESULTS: The clinical use of the Blom-Singer(R) Advantage prosthesis was similar to other types of indwelling voice prosthesis (Provox(R) II, Blom-Singer Indwelling(R)) and did not cause any special problems. Prosthesis specific side effects (i. e. allergy against silver oxide) did not occur. Statistical analysis of the aquired data showed an interindividually changing, but significantly longer in-situ lifetime for the Blom-Singer(R) Advantage prosthesis. The mean device lifetime increased from 36 days (median 36 days) to a mean lifetime of 110 days (median 87 days) with the use of the Blom-Singer(R) Advantage prosthesis. CONCLUSIONS: Using a voice prosthesis with a valve containing silver oxide can normalize and even increase the in-situ lifetime in patients with frequent changing procedures caused by fungal growth on the valve. Therefore we recommend the use of this type of voice prosthesis for those patients as reduction of costs and effort results.

Voice and speech after laryngectomy.

The aim of the investigation is to compare voice and speech quality in alaryngeal patients using esophageal speech (ESOP, eight subjects), electroacoustical speech aid (EACA, six subjects) and tracheoesophageal voice prosthesis (TEVP, three subjects). The subjects reading a short story were recorded in the sound-proof booth and the speech samples were acoustically analysed. Speech sound production was judged by 15 students of phonetics. The following variables were considered: (1) voice quality: fo, jitter, shimmer and harmonic-to-noise ratio, (2) speech sound production: number of recognized VCV syllables, and (3) temporal organization of speech: duration of the phonetic block, number of syllables in the phonetic block, rate of speech, rate of articulation and number of syllables in the longest phonetic block. The results showed that nearly normal air-stream source (lungs) in speech production of speakers with tracheoesophageal prosthesis significantly contributed to the speech timing and speech intelligibility of the alaryngeal speakers.

Voice restoration with the advantage tracheoesophageal voice prosthesis.

OBJECTIVES: To determine whether the Blom-Singer indwelling Advantage tracheoesophageal voice prosthesis (TEP) extends prosthesis life span significantly in patients with documented premature device failure due to fungal colonization. STUDY DESIGN AND SETTING: Data were collected in a prospective manner on a total of 42 standard indwelling TEP users who exhibited early device failure, that is, between 2 weeks and 6 months, due to fungal colonization of the flap valve despite appropriate use of oral antifungal agents. There were 29 men and 13 women, whose ages ranged from 36 years 10 months to 86 years 8 months. METHODS: Baseline data were derived from the average number of days 3 previous standard indwelling prostheses functioned before leaking. An Advantage indwelling TEP was placed after the third change, oral antifungal agents stopped, and routine care implemented, that is, flush and brush the device in situ twice each day. Each participant was assigned to 1 of 3 groups. Group 1 had device failure equal to or less than 2 months (n = 12). Group 2 had device failure between 2 and 4 months (n = 19). Group 3 had device failure between 4 and 6 months (n = 11). RESULTS: Groups 1 and 2 exhibited significantly longer device life span, that is, 77 and 82 days, respectively (P < 0.01), and group 3 exhibited device life span that was longer but not significantly so, that is, 12 days (P > 0.05), after the change from standard to Advantage TEP. Individual data indicated that the majority of participants, that is, 32 of 42 (76.2%), experienced longer device life span after changing to the Advantage prosthesis. Specifically, 9 of 12 (75.0%) users in group 1, 17 of 19 (89.5%) users in group 2, and 6 of 11 (54.5%) users in group 3 exhibited longer device life span. The combination of using an Advantage TEP, discontinuing oral antifungal agents, and reducing the number of both TEP changes and clinic visits resulted in overall cost benefits for both the user and the health care system. The cost benefit for group 1 was dollar 520.00; group 2, dollar 393.00; and group 3, dollar 204.25. CONCLUSIONS: The Advantage TEP extended device life span significantly for standard indwelling device users with documented premature device failure due to fungal colonization, reduced costs associated with tracheoesophageal voice restoration rehabilitation, and enhanced user satisfaction by eliminating use of oral antifungal agents and reducing clinic visits. SIGNIFICANCE: Use of an Advantage indwelling voice prosthesis is warranted from both cost and user satisfaction perspectives when early and repeated device failure occurs as a result of fungal colonization. EBM RATING: B-3.

Reabilitação vocal pós-laringectomia total: resultados em longo prazo com prótese fonatória Blom-Singer® de longa permanência / Speech rehabilitation after total laryngectomy: long-term results with indwelling voice prosthesis Blom-Singer®

Avaliar o uso em longo prazo de próteses fonatórias (PF) para reabilitação fonatória de pacientes submetidos à laringectomia total (LT). Foram estudados a influência do tempo de realização da punção tráqueo-esofágica (PTE), o uso de radioterapia pós-operatória (RTXpos-op), idade e seguimento do paciente, sobre a taxa de sucesso de uso da PF. FORMA DE ESTUDO: Clínico prospectivo. MATERIAL E MÉTODOS: Setenta e um pacientes submetidos à LT e reabilitados com PF de longa permanência. Todos foram avaliados por otorrinolaringologista e fonoaudióloga, quanto aos aspectos funcionais vocais, durante o seguimento. Os dados relativos a tempo de colocação da PF, tempo de utilização da PF, uso de RTXpos-op, idade do paciente, tempo de seguimento e tempo de duração de cada PF foram anotados. RESULTADOS: Houve 87 por cento de pacientes com PTE primária e 13 por cento com secundária. O tempo de seguimento variou de 12 a 87 meses, com média de 38 meses para a PTE primária e 51 meses para a secundária. Houve 59 por cento de pacientes submetidos a RTXpos-op. A taxa de sucesso geral foi de 94 por cento. Na PTE primária foi de 97 por cento e na secundária 78 por cento (p=0,07) e, após dois anos, foi de 96 por cento na PTE primária e 75 por cento na secundária (p=0,07). Utilização de RTXpos-op e idade do paciente não influenciaram no sucesso de utilização de PF, independentemente do tempo de seguimento. CONCLUSÕES: Houve tendência de maior sucesso na reabilitação vocal de pacientes submetidos à LT com a PTE primária. O uso de RTXpos-op e idade não influenciou nesta taxa de sucesso.

Alaryngeal speech aid using an intra-oral electrolarynx and a miniature fingertip switch.

We developed and evaluated an intra-oral electrolaryngeal speech aid system for those who could not acquire common alaryngeal speech or for early post-surgery speech rehabilitation. Our system consisted of a denture-base intra-oral vibrator, a wireless miniature fingertip switch and a controller. To produce natural speech, the fingertip switch produced binary commands of voicing and accent and the controller implemented the pitch generation model using the commands. We first estimated the intelligibility of consonant-vowel syllables produced by our system. We then obtained the feedback about the system from the Japanese users on the basis of their daily life use, and evaluated the possibility and acceptability as an alaryngeal speech aid. Although the users were less satisfied at the intra-oral electrolarynx, the intelligibility of the intra-oral electrolarygeal speech was comparable to that of transcervical electrolaryngeal speech, and most of them were willing to employ it if they lost their current electrolaryngeal speech. According to the feedbacks from the users, a completely wire-free system and less eye-catching designs would make the prosthesis more acceptable. These results placed the intra-oral electrolarynx as a useful option of alaryngeal speech aids and encouraged the further development of the intra-oral electrolarynx.

Speech rehabilitation after total laryngectomy: long-term results with indwelling voice prosthesis Blom-Singer.

UNLABELLED: To evaluate long-term use of indwelling Blom-Singer voice prosthesis (VP) for vocal rehabilitation of patients submitted to total laryngectomy (TL). We studied the influence of time of performance of tracheo-esophageal puncture (TEP), use of radiotherapy (XRT), patients' age and length of follow-up, on the rate of success of use of VP. STUDY DESIGN: Clinical prospective. MATERIAL AND METHOD: Seventy-one patients were submitted to TL and rehabilitated with indwelling VP. Both otolaryngologist and speech pathologist evaluated all patients for the vocal functional issues during the follow-up. The relative data on time of placement of VP, time of use of PF, use of XRT, age, length of follow-up and interval of duration of each VP were recorded during the follow-up. RESULTS: There was 87% of patients with primary TEP and 13% with secondary. The follow-up varied from 12 to 87 months, with average of 38 months for primary and 51 months for secondary TEP. There were 59% of patients submitted to XRT. The general rate of success was of 94%. In primary TEP it was of 97% and in the secondary, it was 78% (p=0.07) and after two years, the success rate was of 96% in primary TEP and 75% in secondary TEP (p=0.07). The use of XRT and patient age did not influence the success of use of VP among primary and secondary TEP, independently of length of follow-up. CONCLUSION: Tendency to greater success rate in voice rehabilitation after TL with primary TEP was observed. Postoperative XRT and age did not influence success rate.

[Clinical and acoustic characteristics of tracheoesophageal bypass with prosthesis]. / Klinicheskie i akusticheskie kharakteristiki trakheopishchevodnogo shuntirovaniia s protezirovaniem.

The authors analyse different aspects of tracheoesophageal bypass with prosthesis, how to prolong operation of voice prostheses. It is shown that replacement of the prostheses is frequently necessary not because of wear but rather due to fungal or microfloral affection. Radiotherapy had no adverse effects on prosthesis. Complications of tracheoesophageal bypass with prosthesis, acoustic characteristics of the repaired voice are described.

Voice handicap of laryngectomees with tracheoesophageal speech.

The evaluation of diagnostics and therapies includes more and more subjective, i.e. emotional and social aspects. Focussing on the handicap experienced by dysphonic patients, the Voice Handicap Index (VHI) has previously been found to be of significant clinical and scientific value for different voices. In this study the VHI questionnaire was applied to demonstrate the voice handicap of 20 male laryngectomees using tracheoesophageal voice (Provox), aged 65.5 +/- 8.7 years. Their VHI was 45.5 +/- 24.1, which was significantly higher than the score of patients with functional voice disorders, but differed only slightly from patients with organic laryngeal dysphonia. Focussing on individual data, VHI scores ranged from values similar to persons without voice disorder to maximum handicap of 101. Comparing the VHI scores with the laryngectomees' gradual self-perception of voice disorder severity, no consistent relationship was found. Considering the large interindividual differences, the VHI may serve as a valuable instrument for the assessment of individual interventional needs rather than for the identification of a general laryngectomees' handicap.

The artificial throat: a new method for standardization of in vitro experiments with tracheo-oesophageal voice prostheses.

After total laryngectomy, the voice can be restored successfully with a silicone tracheo-oesophageal voice prosthesis. Biofilm formation and subsequent deterioration of the silicone material of the prosthesis often limit the mean life of the device to an average of 3-5 months. Although device replacement can be considered an easy outpatient procedure, frequent replacements are inconvenient for the patient and may lead to malfunction of the tracheo-oesophageal fistula. Further understanding of the process of development and inhibition of the colonization of these polymer surfaces requires several comprehensive clinical studies. However, in vivo research of the biomaterials of the voice prostheses is difficult and time consuming. In order to simulate the natural process of biofilm development under dynamic nutrient conditions, an artificial throat was developed. Biofilm developed on Groningen button voice prostheses in vitro could not be distinguished from that formed over several months in vivo. This method can be used as a standardized approach for studying functional and structural aspects of all commercially available indwelling and non-indwelling voice prostheses, including the Groningen button, Provox, Voice Master, Blom-Singer and others under various laboratory conditions.

Comparison of ratings of four artificial larynges.

Fifty-six tape-recorded readings of the "Rainbow Passage" were played to 29 naive listeners for judgments regarding acceptability of artificial larynx speech. Both intraoral and neck-type devices were used, with comparisons among brands of particular interest. The Cooper-Rand, orally adapted Servox, AT&T 5 C, and the neck Servox were used in eliciting speech samples from 14 male esophageal speakers. Listeners rated acceptability using a seven-point equal-appearing interval scale. All devices were rated similar in fluency acceptability, inflection, and overall communicative effectiveness. Speaking rates were judged more acceptable with the oral Servox and least acceptable with the Cooper-Rand. Pitch/quality was more acceptable with intraoral devices than with neck devices, with the oral Servox rated highest. Clinical implications regarding the perceptual findings are discussed, with information about specific brands provided for patient counseling.