Tracheoesophageal (TE) voice remains the most widely used method of communication following total laryngectomy. Although it is now considered the gold standard for voice restoration, the journey to achieving reliable and functional TE speech has been marked by decades of innovation and refinement. Surprisingly, the tracheoesophageal puncture (TEP) and voice prostheses are relatively recent developments in the history of laryngectomy rehabilitation. In 1973, the very first voice prosthesis (VP) was described by Mozolewski in a Polish article.1 Since then, both the VP and the insertion methods have evolved.
The first VPs were non-indwelling or patient-maintained devices that coud be removed and replaced by someone who has undergone a total laryngectomy or a caregiver. In 1990, the first Provox VP was introduced in Europe and could be placed retrograde during a primary puncture. The prosthesis was packaged with a scalpel and disposable guidewire. The guidewire had a connector that allowed the prosthesis to be removed transorally after the tracheal flange was removed. Subsequent replacements were performed in the office using the guidewire with the prosthesis removed transorally as well. Provox Guidewire was introduced to the market in 1992 and was packaged separately. Provox Guidewire still remains on the market today and is compatible with any Provox voice prosthesis with the exclusion of Provox NiD.
Retrograde insertion was eventually replaced by an anterograde insertion method with the introduction of Provox2 in 1997. Provox2 was designed for retrograde placement in the operating room during a primary or secondary puncture and for anterograde placement during subsequent replacements using a loading tool and inserter. It has thinner, more flexible flanges that allow for easier removal from the TE tract and enables anterograde placement. In a study of the new prosthesis and insertion method, Hilgers et al. (1996) found that all 44 patients underwent successful placement using the new system and that stenosis no longer interfered with placement. From the patient perspective, 91% did not find the replacement uncomfortable at all, while 9% found it slightly uncomfortable. In comparison, 30% of patients found retrograde replacement uncomfortable. This change to an anterograde insertion system significantly improved the patient experience as well as made making the process more simplified for clinicians. This insertion system is still currently used for Provox2 and Provox ActiValve which was released in 2003.
Of note, retrograde insertion still has a role when troubleshooting difficult placement caused by TE tract issues. These issues include, but are not limited to, a low puncture, a separated party wall, a prolapsing tract, significant stomal stenosis, or a partially/fully extruded prosthesis. Patients with severe trismus or a stricture may not be candidates for retrograde insertion because the guidewire must pass through the TEP into the neopharynx and then out through the patient’s mouth. The prosthesis is then attached to the connector and pulled through the mouth and neopharynx into the TEP. There must be sufficient space in both the mouth and the neopharynx for the prosthesis to pass. For more information about Provox Guidewire and retrograde insertion, please refer to the Instructions for Use.
The Smart Inserter was introduced with Provox Vega voice prosthesis in 2009. Provox Vega was designed by Atos engineers to improve voice prosthesis performance and optimize tracheoesophageal (TE) voice outcomes. Key design enhancements included improved airflow through a larger internal diameter and an angled valve, resulting in easier phonation and reduced airflow resistance. In a study published in 2010, all 33 voice prostheses were placed successfully. Placement was rated as not difficult in 22 patients and as slightly (n = 5), rather (n = 5), or very difficult (n = 1) in the remaining 11. Challenges included a narrow stoma, an esophageal pocket, the need for additional force, and clinician inexperience (3). The authors identified a learning curve but reported shorter placement times than with Provox2 and greater procedural control. This system was also found to take less time than Provox2, and the authors concluded that the Smart Inserter was an improvement as there was better control over the procedure. Despite these improvements, a more versatile insertion system was needed to enhance the clinician and patient experience. The Smart Inserter is no longer available and was replaced by the Provox Vega Insertion System.
The Provox Vega Insertion System was released in 2017–2018, offering three methods of insertion with a single system. This insertion system allows the clinician flexibility to choose the best insertion method for their patient’s anatomy as well as their own clinical preference. The system, tube, and capsule methods can be used with the Provox Vega. However, Provox Vega XtraSeal requires full esophageal deployment to ensure correct seating of the concave esophageal flange, so the capsule insertion should not be used with this prosthesis. Additionally, the loading tube was redesigned in 2022 with a more tapered tip to allow for easier introduction of the tip into the puncture, to reduce the “pushback” experienced by some clinicians, and improve visibility during placement. In a survey of 33 clinicians who each completed an average of 5 replacements each, 97% of the clinicians preferred the improved insertion system. The three insertion methods and practical tips are listed at the end of the article. Training on all 3 insertion methods is highly recommended to allow options when managing patients VPs.
Voice prosthesis insertion has evolved to improve patient comfort, simplify placement, and give clinicians greater flexibility when navigating anatomical differences and challenging TE tracts. Understanding the advantages and limitations of each method allows clinicians to select the most appropriate approach for each clinical scenario and to support successful placement. Combining this knowledge with hands-on experience can help clinicians approach both straight forward and challenging placements with greater success and confidence.
Method
Compatible VPs
Description
• Provox Vega
• Provox Vega XtraSeal
This method is designed for straightforward, easily accessible punctures. It uses a blue folding tool that remains in place to provide stability during insertion.
• Provox Vega
• Provox Vega XtraSeal
This method uses the blue folding tool to fold the prosthesis; the tool is then removed during placement. This method is ideal for difficult-to-reach or angled punctures and allows for better visibility and maneuverability during insertion.
Tips for System and Tube Insertion
- Brace your hand against the patient
- Place your thumb on the ridges of the insertion pin
- Continue advancing until your thumb reaches the blue folding tube (System Insertion) or loading tube (Tube Insertion)
- Pull back until the esophageal flange engages the esophageal wall before releasing the white insertion pin
• Provox Vega
This method is designed for patients with a narrow stoma or esophagus, or other anatomical variations. It uses Provox TwistLock to enable easy, hygienic placement without manually folding the esophageal flange.
Tips for Capsule Insertion with Provox TwistLock
- Apply firm, steady pressure to the insertion pin when pushing the capsule into Provox TwistLock
- Keep your hand as close to the prosthesis as possible for added stability during placement of the prosthesis.
- Before insertion, consider dilating one French size larger than the diameter of the voice prosthesis (i.e., dilate to 22 Fr when placing a 20 Fr prosthesis)
References:
1. Mozolewski E, Zietek E, Jach K. Surgical rehabilitation of voice and speech after laryngectomy. Polish Medical Sciences and History Bulletin. 1973 Jul-Aug;15(4):373-377. PMID: 4784371.
2. Hilgers, F.J.M., et al., Development and clinical evaluation of a second-generation voice prosthesis (Provox 2), designed for anterograde and retrograde insertion. Acta Otolaryngol, 1997. 117(6): p. 889-896
3. Hilgers, F.J., et al., Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20 Fr) and a novel anterograde insertion device (Provox Smart Inserter). Laryngoscope, 2010. 120(6): p. 1135-1143. Prosthetic voice rehabilitation-5th edition