Troubleshooting: Voice Prosthesis Longevity

Tracheoesophageal speech is considered the gold standard for voice restoration post laryngectomy.¹ Voice prostheses (VP) are foreign objects to the body and require periodic replacement. VP device life is a primary factor contributing to patient and clinician satisfaction. Generally, VP device life averages two to four months. When VP device life is short, that is, the device needs to be replaced more frequently, the outcome is considered less than optimal by both the clinician and the patient. In general, the shortened device life of the VP impacts the patient’s ability to communicate. More severe issues related to prolonged, persistent failure of the VP can lead to aspiration pneumonia, voicing difficulties and lapse of the ability to communicate, impacting the patient’s psychosocial health, well-being and overall health-related quality of life.²

However, minor and significant VP issues are usually manageable in an outpatient setting. Prompt replacement can help reduce the risk of airway-related complications. The Voice Prosthesis Complication Evaluation Tool can be used as a guide to manage central leakage, peripheral leakage and dislodgement. Provox ActiValve is a viable troubleshooting option for early device failure due to central leakage with reportedly a median device life of 154 days.²

If you are interested in learning more about the voice prosthesis complication evaluation tool, contact your local Territory Sales Manager.

Case Study: This case study highlights the experience of a laryngectomy patient who encountered early failure with his voice prosthesis and the benefits of placing Provox ActiValve for long device life.

The patient is a 63-year-old female with a history of recurrent adenoid cyst carcinoma of the larynx. Adenoid cystic carcinoma is a rare, malignant tumor with an occurrence rate of less than 1% of tumors in the larynx. According to an article by Zyrko et al. in 2009, adenoid cystic carcinoma presents with slow progression, multiple recurrences and late distant metastasis.³ The patient underwent a total laryngectomy in 2013 with a primary tracheoesophageal puncture (TEP) and primary voice prosthesis placement. The patient is currently receiving treatment for lung metastasis.

In 2018, the patient reported difficulty swallowing. A Modified Barium Swallow study found esophageal narrowing, high esophageal pressures and aperistalsis, resulting in restricted bolus flow and post-swallow residue. She underwent esophageal dilation by the gastroenterologist to improve the patient's ability to tolerate the least restrictive diet. Post-dilation, she had improved esophageal clearance. Since the dilation, she has been tolerating a regular diet using compensatory swallow strategies of chewing food well and alternating liquids and solids. She eats slowly to facilitate esophageal clearance.

Clinical Decision-Making: Over the years, the patient had adequate VP device life with the 22.5Fr Provox Vega. TE voice was considered "good" with adequate tonicity, volume, fluency and intelligibility. Over the past year, she began requiring more frequent VP replacements (less than two months) with early central leakage due to biofilm formation and increased back pressure. Frequent and multiple VP replacements due to early central leakage was negatively impacting her quality of life, especially in the face of metastatic disease and ongoing oncologic treatment. The patient also had the burden of a 1.5-hour drive to the facility for TE management. The clinician considered available VP troubleshooting options that would provide this patient with a longer device life. The clinician decided to place Provox ActiValve — which is designed for patients who experience early leakage through the prosthesis. The blue fluoroplastic material of the valve flap and ring appears insusceptible to destruction by Candida.⁴  Two magnets prevent the valve flap from opening inadvertently when the user breathes or swallows.

Post-VP Replacement: Provox ActiValve with the light membrane was placed without difficulty. The patient had no evidence of leakage either around or through the prosthesis. TE voicing was fluent.

Long-Term Benefit: At the time of this writing, the Activalve has been in place for 14.5 months without evidence of leakage. Her TE voice continues to be excellent.

Improvement in Quality of Life: The speech-language pathologist (SLP) stated that the placement of ActiValve was “life-changing” for her patient. The patient is a grandmother who values her time and the ability to communicate with her loved ones.

Key benefits mentioned by the SLP were “increased safety – reduced aspiration risk, less cost to the patient (travel and other related expenses), and a significant impact on her overall health-related quality of life.⁵

Conclusion: Provox ActiValve is recognized as a robust and durable voice prosthesis option with an extended device life. The speech pathologist caring for this patient noted that Provox ActiValve should be acknowledged as a solution that can have a positive and significant impact on patients' quality of life.

References

• Tsao C-K, Marchi F, Kang C-J, Sampieri C, Lu Y-A, Huang S-F, Chen Y-T, Giordano G, Peretti G, Parrinello G, et al. Comprehensive Evaluation of Vocal Outcomes and Quality of Life after Total Laryngectomy and Voice Restoration with J-Flap and Tracheoesophageal Puncture. Cancers. 2022; 14(3):544. https://doi.org/10.3390/cancers14030544

• Pribuišis K, Pašvenskaitė A, Liutkevičius V, Pajėdienė G, Gaučė G, Uloza V. Factors affecting the lifetime of third-generation voice prosthesis after total laryngectomy. Journal of Voice. 2022 Mar 4.

• Zvrko E, Golubović M. Laryngeal adenoid cystic carcinoma. Acta Otorhinolaryngol Ital. 2009 Oct;29(5):279-82. PMID: 20162031; PMCID: PMC2821129.

• Timmermans AJ, Harmsen HJ, Bus-Spoor C, Buijssen KJ, van As-Brooks C, de Goffau MC, et al. Biofilm formation on the Provox ActiValve: Composition and ingrowth analyzed by Illumina paired-end RNA sequencing, fluorescence in situ hybridization and confocal laser scanning microscopy. Head Neck. 2015;38 Suppl 1:E432-40

• Mayo-Yáñez M, Chiesa-Estomba C, Lechien JR, Calvo-Henríquez C, Vaira LA, Cabo-Varela I. Long-term outcomes and cost-effectiveness of a magnet-based valve voice prosthesis for endoprosthesis leakage treatment. European Archives of Oto-Rhino-Laryngology. 2022 Aug;279(8):4167-72.