Cymetra^TM Injections to Treat Leakage around a Tracheoesophageal Puncture

Abstract

Tracheoesophageal puncture (TEP) is a commonly used method of voice restoration following total laryngectomy, but leakage around the prosthesis is prevalent. Several treatments for leakage have been proposed in the literature, but with varying success. This paper examines the efficacy of Cymetra^TM to help shrink the TEP site and stop leakage. Six patients with leaking TEP sites refractory to downsizing and/or cautery were selected for the study. Injection sites were determined based on the primary sites of leakage. Cymetra was rehydrated with 1.0 % lidocaine saline solution and injected via a 23-gauge needle a few millimeters deep to the mucosa, approximately 2 mm from the edge. The patients were followed for up to 13 months. Following 1 trial of Cymetra injection, 4 patients achieved successful results. Only 1 patient has not yet achieved full resolution of leakage. Cymetra may provide a safer and more effective option for resolution of leakage than other methods currently employed.

Enlarged tracheoesophageal puncture after total laryngectomy: A systematic review and meta‐analysis

“…The types of injectable materials applied are shown in Table 1. Two reported injecting around the VP in situ, 21, 22 1 reported injecting both into an open TE tract and with the VP in situ, 23 and the remaining 5 authors did not specify. 4, 13, 24–26 Most patients had between 1 and 3 injections 21–23, 25, 26 regardless of the injectable material used.…”

“…We agree with those authors who advocate assessment and resizing of the TEP as the initial step in the hierarchic process of managing leakage around the VP. 4, 6, 22 …”

“…Although it is difficult to compare the effectiveness of treatments, it seems clear that the success of conservative treatment methods is often temporary, as many studies reported the need for repeated treatments. Temporary VP removal, 9 electrocautery, 10 TEP site injections, 22, 23, 26 and purse-string sutures around the TEP 6 were repeated for recurrent leakage after the initial treatment in 30% to 67% of the patients studied.…”

Regeneration of mature dermis by transplanted particulate acellular dermal matrix in a rat model of skin defect wound

“…Human acellular dermal matrix (ADM) in both sheet (AlloDerm) and particulate (Cymetra) forms are increasingly utilized for substituting dermal defect [6, 7], soft tissue augmentation [8–10], dermatology [11], otolaryngology [12], and sinus tracts [13, 14]. …”

Minimally invasive approach for the management of the leaking tracheoesophageal puncture

“…The management of a leaking and enlarged TEP site is complex, and strategies include surgical closure, surgical reconstruction, and customized prostheses 6. An approach that has received increasing attention in the literature is a minimally invasive injection into the puncture site to decrease the diameter size and allow a more secure fit for the prosthesis 6, 9–13. In this study, we report the clinical outcomes of patients treated at our institution with office‐based TEP injection (TEP‐I) for the management of symptomatic enlarged TEP sites.…”