Tracheo-esophageal (TE) voice prostheses allow laryngectomized patients to produce TE speech by shunting air from the lungs into the esophagus and vibrating the esophageal tissue. Blom and Singer were the first to use TE voice prosthesis for voice rehabilitation following total laryngectomy. Panje designed a similar prosthesis with an extra flange that helped to secure the prosthesis in the fistula. This fixation method is now known as indwelling or semi-permanent fixation.

Tracheo-esophageal voice prostheses have been shown to provide good voice and speech results following total laryngectomy as a consequence of disease (e.g., laryngeal tumors). The procedures for restoring phonation after total laryngectomy, usually performed under general or local anesthesia, entail puncturing the back wall of the trachea to form a passage with the front wall of the esophagus. After creation of a hole (tracheostoma), the Blom-Singer or another type of TE prosthesis is inserted and secured using the flanges of the prosthesis. To speak, the patient inhales deeply and as the patient exhales, air is shunted into the esophagus, producing TE speech. There is a 1-way valve on the distal tip of the prosthesis, which is inserted into the esophagus. This allows air to pass from the trachea through the prosthesis and into the esophagus. The valve prevents aspiration from the esophagus into the trachea. In older models of TE voice prosthesis, the patient had to cover the tracheostoma with his/her thumb to speak. Studies have reported that the short-term success rate for TE speech rehabilitation to be 80 to 90 %; however, the long-term success rate is reported to be approximately 70 %.

It is important that patients have the manual dexterity to clean the prosthesis 2 to 3 times every day. They should have adequate pulmonary function to force air from the trachea through the prosthesis into the esophagus. Thus, patients who have poor manual dexterity (e.g., individuals with severe rheumatoid arthritis, amputations, or deformities of the upper extremities) or those with severe pulmonary disease and/or repeated pneumonitis are poor candidates for TE voice prosthesis under accepted guidelines. Furthermore, patients should also be motivated in using the prosthesis.

Leakage of fluid (saliva, reflux) through or around a voice prosthesis as well as increased airflow resistance are the main indications to remove the prosthesis for inspection and, if necessary, for replacement. The general life span of TE voice prosthesis is 3 to 6 months. Variations in diet as well as compliance with daily maintenance affect the durability of the prosthesis. Replacement of TE voice prosthesis should only be carried out by a physician or a speech-language pathologist; and is usually performed in an outpatient setting.

Non-Indwelling Voice Prothesis (e.g., the Provox NiD)

Hancock et al (2005) examined the feasibility of and patient satisfaction with the Provox NiD non-indwelling voice prosthesis. Pre- and post-study questionnaires were used to evaluate the patients' former voice prosthesis and the Provox NiD voice prosthesis. In addition, measurements of pull-out force, maximum phonation time and loudness were made for both voice prostheses. In-vitro measurements of airflow characteristics were also made. Following a 6-week trial, all patients provided feedback on the new voice prosthesis and the results were used to further improve the Provox NiD. This final version of the new voice prosthesis was subsequently tried and evaluated by 10 patients 6 months later. Overall results showed that patient satisfaction with the Provox NiD non-indwelling voice prosthesis was favorable. The pull-out force for the new prosthesis was significantly higher than that for the formerly used prosthesis and its aerodynamic characteristics were better. The authors concluded that the new Provox NiD non-indwelling voice prosthesis investigated in this study provided a good option for laryngectomized patients using non-indwelling voice prostheses and can potentially improve safety and increase patients' satisfaction with their voice and speech.

In a longitudinal retrospective cohort study, Lewin and colleagues (2014) evaluated the indications, complications, and device life of the Provox NiD in a large cohort at a tertiary US cancer center. These investigators reviewed the records of patients who used the NiD prosthesis (2005 to 2011) for general indicators, device life, and complications. A total of 186 patients who used the NiD were included (median follow-up of 21.4 months). The NiD was placed at initial fit in 41 (22 %) patients, whereas 145 (78 %) tried a NiD after using another type of prosthesis. Most patients used the NiD similarly to an indwelling device. Median NiD device life was significantly longer than that of other non-indwelling prostheses (45 versus 29 days, p = 0.0061), and did not significantly differ from that of standard indwelling devices (45 versus 50 days, p = 0.4263); 38 % (71 of 189) of NiD users had a history of early leakage (less than 8 weeks) using a different prosthesis before trying the NiD. Among patients with a pre-existing history of early leakage, almost 90 % of NiD prostheses outperformed the device life of other products. The authors concluded that the NiD prosthesis offered satisfactory device life on a par with indwelling prostheses in this cohort of NiD users. Coupled with favorable published airflow characteristics and satisfactory trachea-esophageal voice, these data suggested that the NiD offered a durable, low-cost prosthetic alternative in contemporary practice. A unique indication for NiD may be improved device life in some patients with a history of early leakage.

Device Life of the Tracheoesophageal Voice Prosthesis

Primary independent variables included treatment history (extent of surgery and radiation history), VP type (indwelling versus non-indwelling, 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. Overall, 3,648 VPs were placed in the 390 patients (median [range] age, 62 [34 to 92] years). Indwelling prostheses accounted for more than half (56 %) of the devices placed (55 %, 20-Fr diameter; 33 %, 8-mm length). More than 2/3 (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 non-indwelling 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 versus 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. The authors concluded that these findings suggested that VP duration showed a lower durability than historically reported. This may reflect the intensification of treatment regimens that complicated TEP management in an era of organ preservation; however, further investigation is needed.

The Use of a Tracheoesophageal Voice Prosthesis Insufflator for Speech Production After Total Laryngectomy

Starmer and colleagues (2017) noted that there may have a variety of reasons why patients are unable to produce TE speech after total laryngectomy (TL) including poor pulmonary reserve or other co-morbidities that prevent adequate stoma occlusion and intra-tracheal pressure to voice. Other patients find it difficult, uncomfortable, or socially awkward to manually occlude the stoma with the finger or thumb. This study aimed to assess the feasibility of achieving TE speech with a prototype TE voice prosthesis insufflator (TEVPI). These researchers prospectively assessed the feasibility of achieving TE speech with a commercially available continuous positive airway pressure (CPAP) device in 6 TL patients. The intervention was the use of a prototype TEVPI. A battery of acoustic and perceptual metrics were obtained and compared between TEVPI speech and standard TE voice prosthesis (TEVP) speech. Voicing was accomplished with the TEVPI in 5 of 6 participants. On average, the duration of phonation with TEVPI was shorter, not as loud, and perceived to be more difficult to produce compared to TEVP speech. The authors concluded that the TEVPI was a feasible, hands-free solution for restoring speech after TL. Moreover, they stated that although the current model produced inferior acoustic metrics compared with standard TEVP speech, further modification and refinement of the device has the potential to produce much improved speech.

Flexible Esophagoscopy for Placement of a Secondary Tracheo-Esophageal Voice Prosthesis

Tkaczuk and colleagues (2018) noted that TEP for post-laryngectomy speech rehabilitation can be performed at the time of laryngectomy (primary) or at a subsequent time (secondary). Traditionally, the secondary procedure is performed using a rigid esophagoscope. Diseases like esophageal stricture, limited neck extension, and soft-tissue fibrosis can make this procedure technically challenging or impossible. In a preliminary feasibility study, these researchers stated that they developed a novel device to perform a secondary tracheoesophageal puncture using a flexible esophagoscope. These investigators tested the feasibility of a novel device used to create a secondary TEP in post-laryngectomy cadavers. These researchers performed a total laryngectomy on 3 fresh cadavers to establish the feasibility of their prototype. In each cadaver, a flexible esophagoscope was passed into the pharynx with the prototype. The prototype was passed through a working port and deployed to distend the esophagus. The puncture was visualized and a wire was passed via the newly established fistula. The device was activated, securing the wire, and then the esophagoscope and device were removed. There was 100 % successful deployment of the prototype device, allowing rapid creation of the puncture and security of the guide-wire in each cadaver. There was no evidence of collateral mucosal injury or esophageal perforation. The authors concluded that the prototype device offered an alternative method to safely and efficiently perform a secondary TEP without the requirement of rigid esophagoscopy that can periodically be technically impossible in this patient population.

Pneumatic Bionic Voice Prostheses

Ahmadi and associates (2018) stated that despite emergent progress in many fields of bionics, a functional Bionic Voice prosthesis for laryngectomy patients (larynx amputees) has not yet been achieved, leading to a lifetime of vocal disability for these patients. These researchers introduced a novel framework of Pneumatic Bionic Voice Prostheses as an electronic adaptation of the Pneumatic Artificial Larynx (PAL) device. The PAL is a non-invasive mechanical voice source, driven exclusively by respiration with an exceptionally high voice quality, comparable to the existing gold standard of TE voice prosthesis. The investigators stated that, following PAL design closely as the reference, Pneumatic Bionic Voice Prostheses appeared to have a strong potential to substitute the existing gold standard by generating a similar voice quality while remaining non-invasive and non-surgical. These investigators designed the first Pneumatic Bionic Voice prosthesis and evaluated its onset and offset control against the PAL device through pre-clinical trials on 1 laryngectomy patient. The evaluation on a database of more than 5 hours of continuous/isolated speech recordings showed a close match between the onset/offset control of the Pneumatic Bionic Voice and the PAL with an accuracy of 98.45 ± 0.54 %. When implemented in real-time, the Pneumatic Bionic Voice prosthesis controller had an average onset/offset delay of 10 milliseconds compared to the PAL. The authors concluded that the Pneumatic Bionic Voice prosthesis addressed a major disadvantage of previous electronic voice prostheses, including myoelectric Bionic Voice, in meeting the short time-frames of controlling the onset/offset of the voice in continuous speech. They stated that the PAL can be considered as a simple model of the human larynx with a fixed pair of vocal folds driven exclusively by the variations of the intraoral and subglottal pressure values and without any neural/neuro-muscular input from the missing larynx. The quality of PAL speech is comparable to the existing gold standard of TE voice prostheses and far better than the Electrolarynx. The traditional PAL also holds a significant advantage over the existing gold standard as being non-invasive. They noted that these advantages advocate defining a new pathway in designing Pneumatic Bionic Voice prosthesis as electronic adaptations of the PAL. This study aimed to be the first in this direction and provided a model that describes the PAL voice onset/offset control with a low computational cost suitable for real-time implementations. The next step for these researchers is to combine this solution with a PAL pitch modulation model in real-time and evaluate the quality of the resulting speech against the PAL and the existing gold standard.

Ultrasonography for Sizing Tracheoesophageal Puncture Prostheses

Smith and co-workers (2017) stated that TEP with voice prosthesis placement is the gold standard voice rehabilitation following total laryngectomy. Ultrasonography may be useful to determine tracheoesophageal wall thickness, guiding prosthesis choice. In this study, a total of 14 patients undergoing total laryngectomy and TEP or prosthesis change with 16-mHz ultrasound measurement of the posterior tracheal wall were included; 7 patients underwent secondary TEP, 3 primary TEP, and 4 TEP changes; 6 patients underwent flap reconstruction, while 8 patients were closed primarily. Average party wall thickness was 9.6 ± 1.7 mm, without a difference (p = 0.08) between primary closure (10.3 ± 1.7 mm) and flap reconstruction (8.6 ± 1.4 mm). Change from the hypothesized sizing was noted in 11 patients (79 %). Prosthesis size did not correlate with age (-0.19, p = 0.51), height (-0.12, p = 0.69), weight (0.26, p = 0.38), body mass index (0.22, p = 0.46), or flap status (-0.48, p = 0.079). The authors concluded that these findings suggested that ultrasonography is beneficial in patients with distorted or less predictable anatomy (e.g., flap reconstruction); but also important for those patients undergoing primary closure. These preliminary findings need to be validated by well-designed studies.

Provox Vega XtraSeal Double Flange Voice Prosthesis

Mayo-Yanez et al (2022a) carried out a systematic review of the use and results of the Provox Vega XtraSeal in the prevention of peri-prosthetic leakage and proposed a management protocol for this voice prosthesis. This systematic search was based on the PRISMA Statement during February 2020. Keywords were double flange, peri-prosthetic leakage, voice prosthesis, and laryngectomy. A total of 4 articles with 315 voice prosthesis (94 XtraSeal and 221 controls) in 55 patients were found. The XtraSeal mean duration was 114.28 ± 73.2 (95 % CI: 98.29 to 130.26) days compared to 102.98 ± 17.74 (95 % CI: 100.62 to 105.35) days of the control group. Out of 266 replacements, endoprosthetic leakage was the most frequent cause in both groups (62.41 %). Peri-prosthetic leaks were less frequent in the XtraSeal (9.62 %) than in the control group (22.43 %). The authors concluded that the XtraSeal could be effective in preventing peri-prosthetic leakage and lengthening the time between replacements. Studies with a robust methodology are needed to confirm these findings. Managing voice prosthesis is complex and requires a multi-disciplinary 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 3-component Tower of Hercules Protocol: First -- measurement of the trachea-esophageal fistula using the Provox Measure; second -- minimization of XtraSeal slack by avoiding the complete visualization of the prosthesis' blue ring; and third – nasofibroscopic examination of the esophageal wall confirming both flanges are in correct position; could prevent or minimize complications derived from the use of the XtraSeal.

Provox ActiValve (a Magnet-Based Valve Voice Prosthesis)

Mayo-Yanez et al (2022b) noted that tracheoesophageal speech is considered the gold standard for rehabilitation following total laryngectomy. The main reason of voice prosthesis failure is the endoprosthesis leakage. Provox ActiValve incorporates a magnet-based valve system to achieve active closure of the valve to treat these leakages, with the drawback of being significantly more expensive. In a prospective, case-crossover study, these researchers compared the Provox Vega and Provox ActiValve duration and costs in patients with replacements increase due to endoprosthetic leakage. This trial enrolled laryngectomized patients with Provox Vega and endoprosthesis leakage to whom a Provox ActiValve was placed. Survival and possible factors that affect voice prosthesis were studied using Kaplan-Meier curves and Cox Proportional Hazards Regression. Cost-effectiveness analysis from the perspective of the Spanish Public National Health System with incremental cost-effectiveness calculation was performed. A total of 159 prostheses were evaluated. The most frequent reason for replacement was the endoprosthesis leakage (n = 129; 83.77 %) in both models. The mean duration-time of Provox Vega was 44.77 ± 2.82 days (95 % CI: 39.18 to 50.35; median of 36 days), and 317.34 ± 116.8 days (95 % CI: 86.66 to 548; median of 286 days) for the Provox ActiValve (p < 0.000). For every replacement not made thanks to the Provox ActiValve there was saving of €133.97. The authors concluded that the Provox ActiValve was a cost-effective solution in patients with increased prosthesis replacements due to endoprosthetic leakage, reducing the number of changes and cost compared to Provox Vega.

Proton Pump Inhibitor Therapy for Reducing Occurrence of Voice Prosthesis Complications

Hadzibegovic and colleagues (2020) stated that it has been shown that the reflux of the gastric content to the proximal esophagus influenced incidence of VP complications in laryngectomized patients. In a prospective, randomized study, these investigators examined the relationship between pepsin concentration in saliva and occurrence of VP complications before and after 3 months of proton pump inhibitor (PPI) therapy. A total of 60 laryngectomized patients with VP and 30 controls were included in the study. Saliva samples were collected in the morning and concentration of pepsin were measured by Human Pepsin (PG) ELISA kit; 34 (57 %) patients reported 1 or more VP complication and were randomized into 2 groups, with and without PPI therapy, 40-mg pantoprazole per day for 3 months. Patients who had longer time since last VP change had higher incidence of peri-prosthetic and trans-prosthetic leakage and Candida colonization. Pepsin was found in all saliva samples. Median saliva pepsin concentration level did not significantly differ between laryngectomized patients and control subjects, or between patients with and without VP complications, and there was no correlation between saliva pepsin concentration levels and type of VP complication. After 3 months pf PPI therapy, there was no difference in median saliva pepsin level or incidence of VP complication between patients with and without PPI therapy. The authors concluded that although reflux was proposed to be associated with VP complications and pepsin was proven as a most sensitive and specific marker of extraesophageal reflux (EER), these researchers did not find any statistically significant correlation between pepsin levels and occurrence of VP complications; and a 3 months 40-mg pantoprazole therapy was ineffective in reducing VP complications in this study group.

Management of the Embedded Tracheoesophageal Prosthesis: Retrograde Removal and Replacement

Burks and colleagues (2021) described the retrograde removal of a TE prosthesis embedded in the common wall between the trachea and esophagus with preservation of the original TEP tract with subsequent placement of new TEP for voice restoration. The Blom-Singer TEP Set (InHealth Technologies, Carpinteria, CA) was used to facilitate this procedure. The coated wire leader cable was threaded via the small opening in the posterior tracheal wall and into the lumen of the old TE prosthesis. The wire was pulled through the mouth in retrograde fashion -- bringing the old TE prosthesis out with it and dilating the existing TEP tract. A new prosthesis was then placed over the end of the wire and returned through the stoma, delivering the prosthesis via the TE tract and into the stoma. This approach resulted in safe, voice restoration with avoidance of need for multiple procedures. The authors concluded that removal of an embedded prosthesis and simultaneous replacement of a new prosthesis was safely achieved using a retrograde technique that maintained the patency of the prior TE tract and restored voice.

Prophylactic Replacement of Voice Prosthesis

In a retrospective, cohort study, Pribuisis et al (2022) examined the impact of different variables on the longevity of VP in patients after TL. This trial was based on data about a continuous series of 328 third-generation VP, which were implanted between 2016 and 2020. Data regarding the VP users' age, sex, place of residence, laryngeal tumor stage, neck irradiation, VP size, and the use of heat and moisture exchanger (HME) were obtained and analyzed. The effect of these variables on VP lifetime was determined. The median lifetime of VPs in patients 65 years old and above was 182 days (95 % CI: 168 to 196), versus 146 days (95 % CI: 130 to 162) (p = 0.033) in patients younger than 65. Neck irradiation was associated with a longer VP median lifetime of 161 days (95 % CI: 142 to 180) compared to 126 days (95 % CI: 100 to 152) with no prior neck irradiation (p = 0.046). HME usage was associated with significantly increased longevity of VPs: 182 days (95 % CI: 156 to 208) with HME and 149 days (95 % CI: 132 to 166) without HME usage (p = 0.039). The authors concluded that 4he findings of this study suggested that neck irradiation, and routine use of use of HME were positively associated with the longevity of VPs.

Heirman et al (2023) noted that VP leakage significantly affects the quality of life (QOL) of patients undergoing laryngectomy, causing insecurity and frequent unplanned hospital visits and costs. In a retrospective, cohort study, these investigators examined the concept of prophylactic VP replacement to prevent leakages. This study included all patients who underwent laryngectomy between 2000 and 2012 in the Netherlands Cancer Institute. Device lifetimes and VP replacements of a retrospective cohort were used to calculate the number of needed VPs 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 VP or treatment characteristics. Patients used a median 3.4 VPs per year (range of 0.1 to 48.1). These investigators found high inter- and intra-patient variability in device lifetime. When prophylactic replacement was applied, this would become a median 9.4 VPs per year, which meant replacement every 38 days, implying more than 6 additional VPs 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 was not feasible due to the high coefficient of variation (SD/mean) in device lifetime. The authors concluded that based on this simulations, prophylactic replacement of VP was not feasible due to high inter- and intra-patient variation in device lifetime.

Appendix

The following selection criteria apply to an indwelling or non-indwelling TE voice prosthesis for voice rehabilitation following total laryngectomy:

Scope of Policy

This Clinical Policy Bulletin addresses voice prosthesis for voice rehabilitation following total laryngectomy.

Medical Necessity

Experimental and Investigational

Aetna considers the following experimental and investigational because their clinical value has not been established: