Selective patient experience with the Blom-Singer Dual Valve voice prosthesis.

OBJECTIVES/HYPOTHESIS: This study compares the overall durability, phonation effort, and speech quality achieved by the Blom-Singer Dual Valve prosthesis to the same characteristics achieved by the single-valve prosthesis used in a select population of total laryngectomy patients who have demonstrated single-valve prosthesis failure within 3 months of placement. STUDY DESIGN: Prospective phase IV study. METHODS: Fourteen patients who had previously experienced early valve failure using a single-valve prosthesis had a Dual Valve placed by a speech language pathologist. A total of seventeen Dual Valves were inserted during routine clinical visits for valve replacement. Time intervals from insertion to replacement of the Dual Valve, as well as the average lifespan of patients' three previous single valves were collected. Subjective, categorical responses to speech quality and phonation effort for the Dual Valve compared to the single valve were collected on a questionnaire upon failure of the device. RESULTS: The mean duration of the single valve was 60 days, with a median of 51 days, whereas the mean duration of the Dual Valve was 164 days, with a median duration of 84 days. Both sets of data were statistically significant, with a P value of .0131. Valve life was increased in 86% of patients, with 43% experiencing greater than 150 days improvement in valve duration when using the Dual Valve. Phonation effort was increased in 14% of patients, and speech quality was not significantly affected in any patients. CONCLUSIONS: In this select population, the Dual Valve offers improved durability over the single valve without sacrificing speech quality, making it a preferred prosthesis option for patients experiencing single-valve failure in less than 3 months. LEVEL OF EVIDENCE: 4. Laryngoscope, 128:422-426, 2018.

How do voice restoration methods affect the psychological status of patients after total laryngectomy?

OBJECTIVE: This study investigated the relationship between psychological well-being and different voice rehabilitation methods in total laryngectomy patients. METHODS: The study enrolled 96 patients who underwent total laryngectomy. The patients were divided into three groups according to the voice rehabilitation method used: esophageal speech (24 patients); a tracheoesophageal fistula and Provox 2 voice prosthesis (57 patients); or an electrolarynx (15 patients). The participants were asked to complete the Turkish version of the Voice Handicap Index-10 (VHI-10) to assess voice problems. They were also asked to complete the Turkish version of the Perceived Stress Scale (PSS), and the Hospital Anxiety and Depression Scale (HADS). The test scores of the three groups were compared statistically. RESULTS: Patients who used esophageal speech had a mean VHI-10 score of 10.25 ± 3.22 versus 19.42 ± 5.56 and 17.60 ± 1.92 for the tracheoesophageal fistula and Provox 2 and electrolarynx groups respectively, reflecting better perception of their voice. They also had a PSS score of 11.38 ± 3.92, indicating that they felt less stressed in comparison with the tracheoesophageal fistula and Provox 2 and electrolarynx groups, which scored 18.84 ± 5.50 and 16.20 ± 3.49 respectively. The HADS scores of the groups were not different, indicating that the patients' anxiety and depression status did not vary. CONCLUSION: Patients who used esophageal speech perceived less stress and were less handicapped by their voice.

Relationship between quality of life instruments and phonatory function in tracheoesophageal speech with voice prosthesis.

BACKGROUND: The use of tracheoesophageal speech with voice prosthesis (T-E speech) after total laryngectomy has increased recently as a method of vocalization following laryngeal cancer. Previous research has not investigated the relationship between quality of life (QOL) and phonatory function in those using T-E speech. This study aimed to demonstrate the relationship between phonatory function and both comprehensive health-related QOL and QOL related to speech in people using T-E speech. METHODS: The subjects of the study were 20 male patients using T-E speech after total laryngectomy. At a visit to our clinic, the subjects underwent a phonatory function test and completed three questionnaires: the MOS 8-Item Short-Form Health Survey (SF-8), the Voice Handicap Index-10 (VHI-10), and the Voice-Related Quality of Life (V-RQOL) Measure. RESULTS: A significant correlation was observed between the physical component summary (PCS), a summary score of SF-8, and VHI-10. Additionally, a significant correlation was observed between the SF-8 mental component summary (MCS) and both VHI-10 and VRQOL. Significant correlations were also observed between voice intensity in the phonatory function test and both VHI-10 and V-RQOL. Finally, voice intensity was significantly correlated with the SF-8 PCS. CONCLUSIONS: QOL questionnaires and phonatory function tests showed that, in people using T-E speech after total laryngectomy, voice intensity was correlated with comprehensive QOL, including physical and mental health. This finding suggests that voice intensity can be used as a performance index for speech rehabilitation.

Results of Voice Rehabilitation With Provox Prosthesis and Factors Affecting the Voice Quality.

OBJECTIVES: Voice prosthesis is the standard of care for postlaryngectomy voice rehabilitation. We aimed to assess functional outcomes of Provox voice prosthesis, to study the impact of several clinical factors (timing of Provox insertion, type of pharyngeal closure, requirement of reconstruction, performance of myotomy, and radiotherapy) on the functional outcomes, and to record the complications associated with Provox voice prosthesis. STUDY DESIGN: Prospective nonrandomized cross-sectional observational study. METHODS: Thirty patients with postlaryngectomy speech rehabilitation with Provox prosthesis were studied. After the procedure, the patients were evaluated by a speech-language pathologist and assessed at immediate postoperative period and 6-month and 1-year interval using the parameters of functional outcomes GRBAS scale, maximal phonatory duration (MPD), and words per breath (WPB). SPSS Version 19 was used for statistical analysis. RESULTS: All patients had average good voice at the end of 1 year after Provox insertion with voice quality results improving with time. Number of patients having MPD more than 7 was 21, 29, and 30 at 0 months, 6 months, and 1 year, respectively. At the end of 1 year, 11 patients had WPB score between 15 and 19. Seven patients had complications: periprosthetic leak (4), central leak (1), hypertonic segment (1), and stricture of the neopharynx (1). Primary Provox insertion, nonrequirement of postoperative radiation, cricopharyngeal myotomy, and primary and vertical closure of neopharynx had a better influence on the outcome; however, the results were not statistically significant. CONCLUSIONS: Provox voice prosthesis provides consistent and good voice results, which improve with time. Periprosthetic leak is the most common complication.

[Causes and indwelling times of multiple voice prosthesis replacements in patients after total laryngectomy--analysis of 184 replacements in 42 patients]. / Przyczyny i czas pomiedzy kolejnymi wymianami protez glosowych u chorych po laryngektomii--analiza 184 wymian u 42 chorych.

INTRODUCTION: Implantation of the indwelling voice prosthesis has become the preferred method of voice rehabilitation after total laryngectomy. Frequent prosthesis dysfunction remains the major problem. AIM: Analysis of the indwelling time and indications for multiple voice prosthesis replacements. METHODS: Forty two patients after total laryngectomy due to laryngeal cancer (6 women and 36 men, mean age 62.1 ± 6.7 years) were included. 184 voice prosthesis replacements were analyzed (1271 patient-months). RESULTS: Mean time between replacements was 260 ± 150 days. The indwelling time decreased from 267 days to the first replacement to 100-160 days at eighth and subsequent exchanges (p < 0.01). Most frequent indications for replacement were leakage of fluids through the prosthesis, phonation problems caused by mucosal overgrowth around the prosthesis, inaccurate sizing, deformation, and spontaneous extrusion. The lifetime of voice prostheses was positively correlated with patients' age. Mycological culture of the smear taken from tracheoesophageal fistula at first replacement was positive in 34/41 cases, at the second in 29/31 cases, the third in 29/31, and at the fourth and subsequent replacements in all specimens. Most patients indicated the following factors as possible causes of a shortened lifetime of the prosthesis: use of alcohol and coffee (34% of responders), inappropriate dietary habits (sweets and tough foodstuff - 17%), cleaning of voice prosthesis discordant with the recommendations of the manufacturer (14%). CONCLUSIONS: Although our results confirm common indications for voice prosthesis replacement we also showed that the time between exchanges is gradually getting shorter. This observation could have implications for the current reimbursement practices.

Comparison of speech parameters and olfaction using different tracheotomy speaking valves.

BACKGROUND: The objective of this work was to obtain a controlled subjective and objective in vivo clinical comparison of the Passy-Muir, Shiley, and Ball speaking valves. METHODS: Ten patients free of laryngeal pathology but dependent on tracheotomy for respiration were tested with each of the speaking valves. Olfaction was assessed for each patient using the University of Pennsylvania Smell Identification Test (UPSIT). Acoustic and perceptual analyses included subjective assessments, noninstrumental objective assessments (including maximum phonation time, and S:Z ratio), and instrumental objective assessments (including fundamental frequency:maximum phonation range, vocal intensity, perturbation, naturalness, and turbulence). Oxygen saturation was assessed by pulse oximetry. RESULTS: There was a highly significant statistical difference in olfaction and speech naturalness, in favor of the Ball valve (The Airway Company, Forest Hill, MD). The Ball valve's speech parameters were generally better than with the Passy-Muir and Shiley valves, including maximum phonation, S:Z ratio, jitter, noise, and turbulence, although the differences were not statistically significant. There were no differences among the valves in oxygen saturation levels. CONCLUSION: This study illustrates that olfaction and certain speech parameters, most noticeably speech naturalness, are significantly improved with the Ball valve as compared to the Passy-Muir and Shiley valves.

A prospective randomized multicenter clinical trial of the Provox2 and Groningen Ultra Low Resistance voice prostheses in the rehabilitation of post-laryngectomy patients: a lifetime and preference study.

To prospectively study patients' preference for and the lifetime of the Groningen Ultra Low Resistance (GULR) and Provox2 tracheo-esophageal shunt prosthesis (TESP, plural TESPs) in post-laryngectomy patients. Eighty post-laryngectomy patients were included in 4 oncological centers in the Netherlands. We used a repeated measures design study with 4 randomized groups in a partial cross-over design using 3 consecutive TESPs (3 intervals) in different orders. (Group 1: GULR-GULR-GULR; Group 2: GULR-GULR-Provox2; Group 3: Provox2-Provox2-GULR; and Group 4: Provox2- Provox2-Provox2). Replacement dates and reasons for replacement were monitored with questionnaires as were patients' preferences for GULR or Provox2. A great variability of lifetime within and between groups was seen. Mean lifetimes found (all groups and intervals added) were 106.2 and 102.7 days, and median lifetimes were 76 and 65 days for GULR and Provox2, respectively. Lifetime showed no significant differences between groups, intervals, and TESP types. Many patients dropped out due to reasons having to do with GULR-characteristics (n=21). The main dropout reason was "high phonating resistance (HPR)" (57.1%). Only 10 patients preferred GULR. A significantly larger number of patients (n=39, 79.6%) preferred Provox2 either by choice or by dropping out due to GULR-characteristics (P<0.001). The main replacement reasons were "leakage though TESP" (GULR 59.1%, Provox2 52.1%) and HPR (GULR 15.9%, Provox2 12.7%). No significant differences in lifetime between GULR and Provox2 were found. The patients' preference for Provox2 was significant (P<0.001). Patients' preference was a more important outcome measurement in TESP effectiveness than device lifetime.

[Laryngectomised patients with voice prostheses: influence of supra-esophageal reflux on voice quality and quality of life]. / Laryngektomierte Stimmprothesenträger: Einfluss eines supraösophagealen Refluxes auf Stimm- und Lebensqualität.

INTRODUCTION: We conducted a prospective study to assess the influence of supra-esophageal reflux on voice quality and quality of life in patients who had undergone laryngectomy and prosthetic voice rehabilitation. PATIENTS AND METHODS: We investigated 60 laryngectomised patients using 24-h dual-probe pH monitoring before and 6 months after oral anti-reflux treatment with proton pump inhibitors (PPIs). Quality of life was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. Voice quality was quantified using the voice handicap index (VHI10). Quality of life and voice quality parameters were then correlated with the severity of reflux disease. RESULTS: Patients with physiological reflux area index (RAI) scores had a mean VHI10 score of 46.4 (±11.4). VHI scores were found to increase to up to 64.1 (±9.6) with reflux severity (p=0.025). Total quality of life scores ranged from 115.8 (±24.7) in patients with physiological RAI scores to 131.0 (±33.1) in patients with highly pathological RAI scores (p=0.007). After 6 months of treatment with PPIs, VHI scores improved to a total score of 57.5 (±20.6, p=0.003). Quality of life scores improved to 123.3 (±29.0, p=0.045). CONCLUSION: Supra-esophageal reflux influences voice quality and quality of life in laryngectomised patients with voice prostheses. This can be explained, for example, by an increased incidence of periprosthetic leakage, the presence of edema in the pharyngo-esophageal segment (where speech is produced), and general reflux symptoms. Rigorous treatment with anti-reflux medications leads to an improvement in reflux parameters that can be assessed objectively (RAI) and in correlated quality of life and voice quality parameters. For this reason, we recommend rigorous oral treatment with PPIs in laryngectomised patients with a confirmed diagnosis of supra-esophageal reflux.

Surgical voice restoration after total laryngectomy: an overview.

Total laryngectomy is potentially a debilitative surgery resulting in compromise of some of the most basic functions of life including speech and swallowing. This may have a profound adverse effect on the patient's physical, functional, and emotional health, and may result in a decreased quality of life (QOL). Until the 1980s, total laryngectomy was regarded as a dreadful, but often, life-saving procedure for which there was little alternative, and was used as a last resort. At that time survival at any cost in terms of QOL was paramount and many laryngectomies were forced into an isolated life as a mute and dysphasic recluse. Most attempts at voice restoration produced inconsistent results and often techniques were laborious, expensive, and ineffective, particularly when carried out as a salvage procedure after failed radiotherapy. Progress in voice rehabilitation, following total laryngectomy, over the last 30 years, has made an enormous difference in the whole concept of the management of laryngeal cancers. Currently there are several options available for these patients, namely, esophageal speech, artificial larynx, and tracheoesophageal speech. The choice of speech rehabilitation varies from patient to patient, but tracheoesophageal voice has become the preferred method. This article provides a brief account of surgical voice restoration after total laryngectomy. Special emphasis has been given to the surgical technique, special considerations, complications, and the prevention / treatment of tracheoesophageal voice restoration.

[Use of adaptive devices by laryngectomees]. / Nutzung ausgewählter Hilfsmittel durch Laryngektomierte.

AIMS: This study is directed at the following questions: How many laryngectomees are using which adaptive devices how often? Which devices are they lacking? Which alaryngeal voice has the best results in terms of intelligibility? METHODS: 218 patients operated on in 6 ENT-clinics in Eastern Germany over the last 25 years were interviewed in person. Items from a German questionnaire for psychosocial adjustment after laryngectomy (FPAL) and from the quality of life questionnaire EORTC QLQ-H&N35 were used. Voice intelligibility was measured by an objective test, the Postlaryngectomy-Telephone-Intelligibility-Test (PLTT). RESULTS: The most common communication method in this group is the esophageal voice, only 20% use voice prostheses regularly, and 15% of the patients use electronic devices. 87% of the laryngectomees wear scarves to protect their stoma, and 82% use inhalers. Several patients lack tools for communication, some for protection of the tracheostoma and others devices for showering and swimming. The best speech results are gained with voice prostheses. Health related Quality of Life shows only poor correlation with the use of adaptive devices. CONCLUSION: In general the health care for laryngectomees in terms of device use can be seen as relatively good but not as optimal. Problematic is the fact that 15.5% of the patients could not acquire an adequate voice, that some devices are missed by patients despite the fact that they are available for purchase, and that some patients do not care for their tracheostoma. It could be useful to consider these findings within medical consultations.

Quality of life in prosthetic voice users.

OBJECTIVE: This study was designed to measure the efficacy of prosthetic voice restoration for laryngectomees in relation to various quality-of-life parameters. STUDY DESIGN AND SETTING: The University of Washington Quality of Life Scale, the Functional Assessment of Cancer Therapy Scale, and a demographic data form of our own design were completed by 16 laryngectomees who had undergone prosthetic voice restoration in our private practice by Blom-Singer methodology. RESULTS: More than 80% of the respondents were positive in their assessment of each category on all three surveys. CONCLUSION: Prosthetic voice restoration in private practice resulted in achieved expectations, satisfaction with speech, and good quality of life as measured by physical, functional, social, and emotional well-being parameters. SIGNIFICANCE: Laryngectomees may be offered prosthetic voice restoration with a high likelihood that they will be satisfied. EBM RATING: C.

Surgery for voice.

Preoperative assessment in a multidisciplinary voice clinic, using stroboscopy, is essential. In the treatment of benign vocal fold mucosal disorders precise phonosurgical techniques, using high magnification which respects the multilayered structured of the vocal fold, are mandatory. A paralysed vocal fold can be assessed by electromyography and medialization thyroplasty procedures offer excellent 'fine tuning' of the voice.

Complications of phonosurgery: results of a national survey.

OBJECTIVE: Medialization laryngoplasty (ML) and arytenoid adduction (AA) have become common treatments for vocal fold paralysis. The widespread use of these procedures has required many surgeons to learn these new surgeries through postgraduate education sources. Little is known regarding the efficacy of the learning methods and the types and incidence of complications in a large number of surgeons' experience. METHOD: A survey consisting of 23 questions regarding complications of ML and AA was sent to 7364 otolaryngologists. RESULTS: A 33% response rate resulted in 2436 returned surveys of which 43% stated they performed ML and/or AA (n = 1039). The survey represents 14,621 cases of ML. The average respondent performed 12 ML in the past 5 years. Forty-two percent of the respondents reported experience with one or more major complication. Airway complications requiring intervention occurred more frequently following AA than ML. The most common major complications were implant migration and failure to improve voice quality. The ML revision rate was 5.4% and the reported voice quality following revision was positive in 90% of cases. A statistically significant difference in major ML complication rate was found between surgeons with experience doing fewer than 10 MLs and those with experience doing more than 10 MLs. Similar findings showed that a higher major complication rate occurred for surgeons performing fewer than two MLs per year compared with counterparts who average two or more MLs per year. A near 1% implant extrusion rate was found. Most of the extrusions occurred into the airway. CONCLUSIONS: This is a study of the use and complications of ML/AA based on more than 14,000 procedures. Wide-spread use of ML for vocal fold paralysis was found. A notable rate of poor voice quality following ML/AA was identified and led to a 5.5% revision rate for ML. Revision ML resulted in an improved voice quality in more than 90% of the reported cases. There appears to be a "learning curve" for performing ML as well as an increased complication rate for those surgeons who perform fewer than two MLs per year and have a total career experience of fewer than 10 procedures. These findings suggest that ML may result in increased complications if the surgeon is not experienced or does not perform the surgery regularly.

Secondary tracheoesophageal puncture: factors predictive of voice quality and prosthesis use.

OBJECTIVE: To identify factors predicting prosthesis use and final speech quality in patients undergoing secondary tracheoesophageal puncture (TEP) for voice restoration alter laryngectomy. METHODS: We undertook a retrospective study of 168 patients who underwent secondary TEP at the Cleveland Clinic between June 1980 and October 1993. Factors examined were: patient demographics, extent of initial surgery, method of pharyngeal preparation, history of irradiation, insufflation test results, pharyngeal stricture, and concurrent medical conditions. Univariate and multivariate statistical analyses were performed to identify predictive factors. RESULTS: At last evaluation, 73.8% (124) of the patients were still using the prosthesis. Quality of speech was the only predictor of prosthesis use (p < .001). Phonation on the first day was achieved in 90% (151) of patients. Speech result improved significantly over the first 6 months (p < .001). Univariate analysis found that the need for reconstruction at laryngectomy (p = .04), the presence of pharyngeal stricture (p = .001), and continued prosthetic use (p < .001) were associated with the speech result. There was no significant advantage to the lack of approximation of the pharyngeal constrictors (p = .31). Stepwise logistic regression showed that only the absence of pharyngeal stricture was associated with a better-quality voice (p = .001). CONCLUSION: Tracheoesophageal puncture is a reliable method for restoring voice after laryngectomy. Prosthesis use decreases with time, and good voice quality is the only predictor of continued prosthesis use. In this series the absence of pharyngeal stricture was the only significant predictor of good to excellent speech.

Functional outcome after surgery for prevention of pharyngospasms in tracheoesophageal speakers. Part I: Speech characteristics.

The speech characteristics of 29 patients with primary tracheoesophageal puncture who received either a pharyngeal constrictor myotomy, a unilateral pharyngeal plexus neurectomy, or a unilateral pharyngeal plexus neurectomy with drainage myotomy limited to the cricopharyngeus were studied. All patients used a Blom-Singer low-pressure voice prosthesis. Audio recordings of each patient speaking with both the Blom-Singer tracheostoma valve and manual occlusion of the tracheostoma were recorded at 3 weeks, 6 months, and 12 months after surgery. The three surgical variations were equally effective at preventing pharyngospasms; only 1 patient (10%) in each group had some loss of fluency during the 12-month study period. Neurectomized patients produced significantly higher fundamental frequencies during reading than did patients in the other groups. Residual resting tone in the neurectomized pharyngoesophageal segment may contribute to more favorable speaking frequencies in this group.

Voice rehabilitation practices among head and neck surgeons.

Voice rehabilitation practices among head and neck surgeons were surveyed to determine the proportional contribution of various methods of speech support and the impact of recent developments in this field. Of the 400 head and neck surgeons contacted, 212 (53%) responded and 196 provided data. Noninvasive methods of speech support continue to predominate in this country. Esophageal speech is used by all surgeons in some of their patients. The introduction of tracheoesophageal puncture techniques for prosthetic placement has added a new dimension to speech rehabilitation and is used almost 30% of the time by those who use it (88% of surgeons surveyed). The proportional use of the most common methods of speech support is almost identical between head and neck surgeons of a general surgical background and otolaryngologists. The incidence of total failures to achieve voice rehabilitation is less than 10%.