Objectives: Assessment of the immediate results and long-term clinical effects of a thin silicone washer placed behind the tracheal flange of voice prostheses to treat periprosthetic leakage.Patients and Methods: Three year retrospective analysis of 32 laryngectomized patients with 107 periprosthetic leakage events (PLEs). Custom-made silicone washers (outer diameter 18 mm, inner diameter 7.5 mm, thickness 0.5 mm) were placed behind the tracheal flange either in combination with prosthesis replacement or later.Results: There was immediate resolution of periprosthetic leakage in 88 PLEs (median, 38 d; mean, 53 d; range, 8 -330 d) and in 6 PLEs with the washer still in situ at the date of analysis (median, 75; mean, 97 d; range, 38 -240 d). There was no resolution for periprosthetic leakage in 13 PLEs. Thus, in total, 94 of 107 PLEs (88%) were successfully resolved. In 29 of 32 (91%) patients, the washer resolved the problem at least in one PLE successfully. Twelve of 32 patients, including all 3 with washer failures, also required other interventions to ultimately solve the problem. The vast majority of patients (80%) did not consider placement of the washer to be inconvenient.Conclusions: In consideration of the high success rate and limited inconvenience for patients, this simple thin silicon washer application provides a good first option for the treatment of periprosthetic leakage.

Long-term results of Provox General rightsIt is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulationsIf you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: http://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. Results: Median device-related lifetime of Provox ActiValve, replaced for leakage through the device and those still in situ at the date of data collection (N=32), was 337 days (mean 376 days): a statistically significant 16-fold increase compared to Provox2 (P<0.001). In 10 patients replacement was fistula-related (median after 86 days): esophageal pouch (N=4), fistula granulation (N=3), extrusion of the device (N=2), and periprosthetic leakage (N=1).86% of patients used a special lubricant to diminish 'stickiness' of the valve. ProvoxActiValve was preferred by 90% of the patients completing the trial specific questionnaire.Conclusions: For patients requiring frequent device-related replacements, Provox ActiValve, also long-term, provides a true solution and thereby is a valuable addition to prosthetic voice rehabilitation.