Voice Prostheses and Heat and Moisture Exchangers for Adults After Total Laryngectomy: An Updated Rapid Review

Key Messages

What Is the Issue?

• Total laryngectomy is a surgical procedure that removes the larynx. During the surgery, the trachea is diverted to an opening in the neck called a stoma. This change in breathing pattern is permanent, significantly impacting the ability to swallow, breathe, and speak, greatly impacting overall quality of life.
• Postlaryngectomy interventions include olfactory, voice, and swallowing rehabilitation and addressing the psychosocial aspects of patient recovery. Voice rehabilitation is an important aspect of postlaryngectomy care to restore vocal communication. An esophageal voice (EV), an artificial larynx (electrolarynx), and a tracheoesophageal voice (TEV) with voice prosthesis are options for restoring voice communication in adults following total laryngectomy.
• The population of patients in Canada undergoing total laryngectomy is relatively small. There is reported to be well established clinical care for postlaryngectomy voice rehabilitation, yet the current evidence is limited. A request for a review of the evidence to inform policy decisions related to voice prostheses (indwelling and nonindwelling devices) and heat and moisture exchangers (HME) for adults following total laryngectomy was submitted to Canada’s Drug Agency (CDA-AMC).

What Did We Do?

• This is an update of a Rapid Review report published in October 2024, It includes 1 additional systematic review and extends the Rapid Review methodology to include the engagement of clinical specialists and the lived experience of patients following a laryngectomy.
• We aimed to identify and summarize related evidence and recommendations from systematic reviews, health economic evaluations, and evidence-based guidelines with a contextual evaluation of clinical and patient experiences. The clinical research questions were codeveloped with the project requester.
• We searched journal databases and grey literature for relevant evidence published since January 2019. We used a 5-year search period for this review, considering that the identified systematic reviews had searched earlier periods. Three patients were interviewed to gain insight on their experience using these devices. One speech and language pathologist with experience working with patients following laryngectomy provided clinical expert review of this report.

What Did We Find?

• The use of voice prostheses and HMEs for adults following total laryngectomy is reported by clinicians to be common practice across Canada. Both patients and the speech and language pathologist who reviewed this report underscore the importance of these devices in supporting voice restoration, pulmonary rehabilitation, infection prevention, and quality of life following surgery.
• Nine eligible publications were identified, including 5 systematic reviews, 3 economic evaluations, and 1 evidence-based guideline. Owing to various methodological limitations, confidence in the evidence identified was determined to be very low.
• Three patients reported that using voice prostheses and HMEs after total laryngectomy is critical to their ability to communicate, maintain independence, and prevent lung infection. While there are challenges with maintaining the devices and additional costs for the supplies needed to support use, the benefits of these devices were seen to outweigh these challenges.
• Two systematic reviews compared TEV using voice prostheses with EV. Whereas 1 systematic review reported that TEV with voice prostheses may have a more positive impact on quality-of-life measures, 1 systematic review found no statistically significant differences in Voice Handicap Index (VHI) scores and voice-related quality of life (VRQoL). The speech and language pathologist who reviewed this report highlighted the difficulty associated with learning EV compared to voice prostheses. One of our patient partners agreed with this and mentioned they had not encountered patients within their community who used EV exclusively.
• One systematic review with network meta-analysis compared 10 voice prostheses (8 indwelling and 2 nonindwelling). This review did not compare indwelling and nonindwelling devices as 2 distinct groups. Critical methodological flaws with this systematic review were identified. Most comparisons between various voice prostheses showed no statistically significant differences in device replacements, device lifetime, airflow resistance, leakage, speech rate, maximum phonation time, patient device preference, phonatory effort, fundamental frequency, voice loudness, speech intelligibility, dislodgement, fistula problems, granulation, prosthesis inaccurate size, prosthesis deterioration, and survival rate. Many effect estimates were imprecise — that is, the confidence intervals were wide, including the potential that either of the devices being compared could be favoured.
• One systematic review reported that using HMEs, compared to no HMEs, significantly improved several clinical outcomes, including a decrease in mucus production, coughing, forced expectorations, the number of days requiring chest physiotherapy after surgery, tracheobronchitis or pneumonia episodes, and improved patient satisfaction.
• No evidence regarding the cost-effectiveness of voice prostheses versus no prostheses, indwelling versus nonindwelling prostheses, or comparisons among different nonindwelling prostheses for adults following laryngectomy was identified. From a US perspective, HMEs were reported to be cost-effective compared to alternative stoma covers (ASCs). These findings may not be generalizable to Canada due to differences in health care systems.
• One evidence-based guideline developed in Spain recommended replacing the prosthesis with a double-flanged one, such as Provox XtraSeal, adjusting the diameter and length, or placing a silicone sheet (or ring) on the tracheal side of the prosthesis to manage periprosthetic leakage. Our review did not identify any evidence-based guidelines regarding the use of HME for adults following total laryngectomy.

What Does It Mean?

• The clinical and patient community we engaged with consider voice prostheses and HMEs to be essential devices. The evidence base related to their benefit and cost-effectiveness is limited. The perspectives of speech and language pathologists working with patients, and of patients who have lived experience with these devices, may supplement decision-making by contextualizing the evidence currently available.
• Decisions regarding the choice of voice prosthesis should consider patients’ tracheoesophageal puncture (TEP) shape and size, patients’ values and preferences, accessibility, affordability, and other factors such as physical and mental capabilities, caregiver support, and patient motivation.
• While the evidence is limited, patients and clinicians report that adding HMEs could be beneficial in several clinical outcomes, such as mucus reduction, infection prevention, and reported patient satisfaction.
• Future systematic reviews should be planned and conducted in alignment with recognized methodological standards and should be transparently reported. As the certainty of evidence from high-quality systematic reviews relies, in part, on the risk of bias of their included studies, future primary studies should aim to draw from developed patient registries.