Abstract
This study reports on the use of injectable soft-tissue fillers for the treatment of tracheoesophageal prosthesis enlargement and periprosthetic leakage.
Tracheoesophageal voice restoration is currently the preferred surgical method for alaryngeal speech production. While it is a safe procedure with a high success rate, minor adverse consequences have been described, including enlargement of the tract around the tracheoesophageal prosthesis (TEP). This can result in periprosthetic leakage, which has been shown to increase the risk of pneumonia, voice prosthesis enlargement, and aspiration of the prosthesis. Frequently, a combination of nonsurgical and surgical strategies are used to effectively address this. Tissue augmentation around the tract has been described using a variety of injectable substances with varying degrees of success. The objective of this study was to determine the effectiveness of injectable augmentation with either nonresorbable calcium hydroxyapatite (CaHA) or resorbable hyaluronic acid (HA) in the treatment of TEP puncture site enlargement after total laryngectomy.
Methods
After appropriate institutional review board approval from Massachusetts Eye and Ear Infirmary, a retrospective medical review was performed for patients who had undergone soft-tissue filler injection to manage periprosthetic leakage between January 2008 and March 2015. Patients provided written informed consent. All patients underwent office-based injection by the senior author (D.G.D.) of either CaHA or HA after leakage was confirmed by a speech language pathologist. Injection was performed with the prosthesis removed. The TEP site was examined, and 3 to 4 sites of augmentation were selected. Each site was injected until submucosal filling was seen (Figure, A). The volume of filler injected ranged from 0.1 to 0.3 mL per site of injection.
Figure. Injection Technique and Prosthesis Fitting After Injection.
A, A small aliquot of filler injected in 3 to 4 areas until submucosal plumping is seen. B, The prosthesis was replaced, and fit was optimized after injection.
After injection, patients were observed for 15 to 20 minutes with an open tract, suctioning as necessary (Figure, B). The prosthesis was replaced. Patients were assessed for voice quality and leakage on swallow by certified speech and language pathologists, who recorded outcomes.
Results
Fifteen patients underwent 23 injections of either CaHA (n = 11) or HA (n = 12). Patient demographics and risk factors and outcomes are summarized in the Table. Patients were followed for an average of 6.3 years (range, 0.7-16.0 years) after initial TEP placement. Five patients required multiple injections owing to recurrent leakage, and all of the patients required prosthesis customization in addition to the injection(s). Eleven patients (73%) achieved fluent voice after injection. Nine patients (60%) achieved adequate swallow function with no leakage around the TEP, with an average time of durable effect of 4.4 years (range, 0.6-6.7 years) from the last injection. One patient did not tolerate the injection well, vomiting during and after the procedure. There were no other adverse consequences. Two of the 6 patients who did not achieve resolution of leakage developed second primary cancers during the course of their follow-up period. One patient died of esophageal cancer, and the other was placed in hospice after being found to have widely metastatic cancer.
Table. Characteristics and Outcomes of the 15 Study Patients.
| Characteristic | No. (%)a |
|---|---|
| Age at time of TL, mean (range), y | 61.7 (54.0-72.0) |
| Sex | |
| Male | 11 (73) |
| Female | 4 (27) |
| Risk factors | |
| Diabetes | 4 (27) |
| Hypothyroidism | 8 (53) |
| Reflux | 11 (73) |
| Esophageal stricture | 4 (27) |
| History of smoking | 15 (100) |
| History of radiation | |
| Preoperative | 12 (80) |
| Postoperative | 4 (27) |
| TEP placement | |
| Primary | 10 (67) |
| Secondary | 5 (33) |
| Reconstruction | 6 (40) |
| Outcomes | |
| Follow-up length, mean (range), y | 6.3 (0.7-16.0) |
| Patients requiring >1 injection | 5 (33) |
| Fluent voice after injection | 11 (73) |
| Adequate swallow function | 9 (60) |
| Time of effect, mean (range), y | 4.4 (0.6-6.7) |
| Adverse effects | 1 (0) |
Abbreviations: TEP, tracheoesophageal prosthesis; TL, total laryngectomy.
Percentages may not total 100% owing to rounding.
Discussion
Tracheoesophageal voice restoration is a widely used method for alaryngeal voice production, with success rates reported in the range of 74% to 95%. Enlargement of the tract around the prosthesis, resulting in periprosthetic leakage, is one of the more challenging complications to effectively address.
To our knowledge, this is the largest series to date to describe the use injectable soft-tissue fillers for the treatment of TEP enlargement and periprosthetic leakage. The average follow-up period of more than 6 years allowed for the assessment of swallow and voice outcomes. Resolution was typically achieved with a combination of prosthesis customization and soft-tissue augmentation. After ruling out recurrent disease, optimizing medical conditions (diabetes, hypothyroidism, malnutrition), using alternate or modified prostheses, soft-tissue augmentation with appropriate prosthesis customization can provide lasting cessation of TEP site leakage with functional voice restoration with a mean duration of effect of more than 4 years after the last injection.
References
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