Prevention of periprosthetic leakage with double flange voice prosthesis: a systematic review and management protocol proposal

References

• van Sluis KE, van der Molen L, van Son RJJH, et al. Objective and subjective voice outcomes after total laryngectomy: a systematic review. Eur Arch Otorhinolaryngol. 2018;275(1):11–26.
   PubMed Web of Science ®Google Scholar
• Mayo-Yáñez M, Cabo-Varela I, Dovalo-Carballo L, et al. Provox 2® and Provox Vega® device life-time: a case-crossover study with multivariate analysis of possible influential factors and duration. Eur Arch Otorhinolaryngol. 2018;275(7):1827–1830.
   PubMed Web of Science ®Google Scholar
• Serra A, Spinato G, Spinato R, et al. Multicenter prospective crossover study on new prosthetic opportunities in post-laryngectomy voice rehabilitation. J Biol Regul Homeost Agents. 2017;31(3):803–809.
   PubMed Web of Science ®Google Scholar
• Petersen JF, Lansaat L, Timmermans AJ, et al. Postlaryngectomy prosthetic voice rehabilitation outcomes in a consecutive cohort of 232 patients over a 13-year period. Head Neck. 2019;41(3):623–631.
   PubMed Web of Science ®Google Scholar
• Lewin JS, Baumgart LM, Barrow MP, et al. Device life of the tracheoesophageal voice prosthesis revisited. JAMA Otolaryngol Head Neck Surg. 2017;143(1):65–71.
   PubMed Web of Science ®Google Scholar
• Lorenz KJ. The development and treatment of periprosthetic leakage after prosthetic voice restoration. A literature review and personal experience. I. The development of periprosthetic leakage. Eur Arch Otorhinolaryngol. 2015;272(3):641–659.
   PubMed Web of Science ®Google Scholar
• Graville DJ, Palmer AD, Andersen PE, et al. Determining the efficacy and cost-effectiveness of the activalve: results of a long-term prospective trial. Laryngoscope. 2011;121(4):769–776.
   PubMed Web of Science ®Google Scholar
• Lorenz KJ. The development and treatment of periprosthetic leakage after prosthetic voice restoration: a literature review and personal experience. II. conservative and surgical management. Eur Arch Otorhinolaryngol. 2015;272(3):661–672.
   PubMed Web of Science ®Google Scholar
• Parrilla C, Longobardi Y, Galli J, et al. Periprosthetic leakage in tracheoesophageal prosthesis: Proposal of a standardized therapeutic algorithm. Otolaryngol Neck Surg. 2021;165(3):446–454.
   PubMed Web of Science ®Google Scholar
• Parrilla C, Longobardi Y, Paludetti G, et al. A one-year time frame for voice prosthesis management. What should the physician expect? Is it an overrated job? Acta Otorhinolaryngol Ital. 2020;40(4):270–276.
   PubMed Web of Science ®Google Scholar
• Mayo-Yáñez M, Cabo-Varela I, Suanzes-Hernández J, et al. Use of double flange voice prosthesis for periprosthetic leakage in laryngectomized patients: a prospective case-crossover study. Clin Otolaryngol. 2020;45(3):389–393.
   PubMed Web of Science ®Google Scholar
• Danic Hadzibegovic A, Kozmar A, Hadzibegovic I, et al. Influence of proton pump inhibitor therapy on occurrence of voice prosthesis complications. Eur Arch Otorhinolaryngol. 2020;277(4):1177–1184.
   PubMed Web of Science ®Google Scholar
• Lorenz KJ, Kraft K, Graf F, et al. Role of reflux-induced epithelial-mesenchymal transition in periprosthetic leakage after prosthetic voice rehabilitation. Head Neck. 2015;37(4):530–536.
   PubMed Web of Science ®Google Scholar
• Petersen JF, Lansaat L, Hilgers F, et al. Solving periprosthetic leakage with a novel prosthetic device. Laryngoscope. 2019;129(10):2299–2302.
   PubMed Web of Science ®Google Scholar
• Lorenz KJ. Treatment of periprothetic leakage in laryngectomized patients- first experience with the provox xtraseal. Laryngo-Rhino-Otol. 2019;98(S02):S264.
   Google Scholar
• Provox® VegaTM. Voice prosthesis with insertion system. Instructions for use clinician’s (Internet). [cited 2020 Apr 04]. Available from: https://www.atosmedical.es/wp-content/uploads//2015/10/11086_clin.ifu-provox-vega_2017-06-15_web-3.pdf Accessed Apr 2020.
   Google Scholar
• Moher D, Liberati A, Tetzlaff J, PRISMA Group, et al. Preferred reporting items for systematic reviews and Meta-Analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097.
   PubMed Web of Science ®Google Scholar
• O'Sullivan D, Wilk S, Michalowski W, et al. Using PICO to align medical evidence with MDs decision making models. Stud Health Technol Inform. 2013;192:1057.
   PubMedGoogle Scholar
• Provox® VegaTM XtraSealTM. Voice Prosthesis with SmartInserter. Clinician's manual (Internet). [cited 2020 Apr 04]. Available from: https://www.atosmedical.es/wp-content/uploads//2018/02/10895_vega-xtraseal-clinician-ifu-_201612a_web.pdf Accessed Apr 2020.
   Google Scholar
• OCEBM Levels of Evidence Working Group. The Oxford Levels of Evidence 2. Oxford Centre for Evidence-Based Medicine. Available from: https://www.cebm.ox.ac.uk/resources/levels-of-evidence/ocebm-levels-of-evidence. [Accessed Apr 2020].
   Google Scholar
• National Institute for Health and Care Excellence. Methods for the development of NICE public health guidance. 3rd ed. London: National Institute for Health and Care Excellence (NICE); 2012.
   Google Scholar
• Mayo-Yáñez M, Cabo-Varela I. Management of complicated enlarged tracheoesophageal fistula in a radiated patient. Acta Otorrinolaringol Gallega. 2020;13:15–26.
   Google Scholar
• Summers L. Social and quality of life impact using a voice prosthesis after laryngectomy. (miscellaneous article). Curr Opin Otolaryngol Head Neck Surg. 2017;25(3):188–194.
   PubMed Web of Science ®Google Scholar
• Hutcheson KA, Lewin JS, Sturgis EM, et al. Enlarged tracheoesophageal puncture after total laryngectomy: a systematic review and Meta-analysis. Head Neck. 2011;33(1):20–30.
   PubMed Web of Science ®Google Scholar
• Hutcheson KA, Lewin JS, Sturgis EM, et al. Multivariable analysis of risk factors for enlargement of the tracheoesophageal puncture after total laryngectomy. Head Neck. 2012;34(4):557–567.
   PubMed Web of Science ®Google Scholar
• Maclure M, Mittleman MA. Should we use a case-crossover design? Annu Rev Public Health. 2000;21:193–221.
   PubMed Web of Science ®Google Scholar
• Mayo-Yáñez M. Analysis of factors affecting the longevity of voice prosthesis following total laryngectomy with a review of literature. Indian J Surg Oncol. 2019;10(1):219.
   PubMed Web of Science ®Google Scholar
• Soolsma J, van den Brekel MW, Ackerstaff AH, et al. Long-Term results of provox ActiValve, solving the problem of frequent candida- and “underpressure”-related voice prosthesis replacements. Laryngoscope. 2008;118(2):252–257.
   PubMed Web of Science ®Google Scholar
• Provox® ActiValveTM (Internet). [cited 2020 Apr 02]. Available from: https://www.atosmedical.es/wp-content/uploads/2015/10/10648_activalve-patient_s-ifu_2019-11-26_web.pdf.
   Google Scholar
• Hilgers FJM, Soolsma J, Ackerstaff AH, et al. A thin tracheal silicone washer to solve periprosthetic leakage in laryngectomies: direct results and long-term clinical effects. Laryngoscope. 2008;118(4):640–645.
   PubMed Web of Science ®Google Scholar
• Kress P, Schäfer P, Schwerdtfeger FP. [Clinical use of a voice prosthesis with a flap valve containing silver oxide (Blom-Singer advantage), biofilm formation, in-situ lifetime and indication]. Laryngorhinootologie. 2006;85(12):893–896.
   PubMed Web of Science ®Google Scholar
• Al Kadah B, Papaspyrou G, Schneider M, et al. Novel modification of voice prosthesis. Eur Arch Otorhinolaryngol. 2016;273(3):697–702.
   PubMed Web of Science ®Google Scholar
• Lewin JS, Hutcheson KA, Barringer DA, et al. Customization of the voice prosthesis to prevent leakage from the enlarged tracheoesophageal puncture: results of a prospective trial. Laryngoscope. 2012;122(8):1767–1772.
   PubMed Web of Science ®Google Scholar
• Bunting GW. Voice following laryngeal cancer surgery: troubleshooting common problems after tracheoesophageal voice restoration. Otolaryngol Clin North Am. 2004;37(3):597–612.
   PubMed Web of Science ®Google Scholar
• Provox® Measure (Internet). [cited 2021 Jul 20]. Available from: https://d1a743corqz1mw.cloudfront.net/wp-content/uploads/2015/10/90727_provox_measure_2020-04-14_web.pdf
   Google Scholar