Device Life of the Tracheoesophageal Voice Prosthesis Revisited | Head and Neck Cancer | JAMA Otolaryngology–Head & Neck Surgery | JAMA Network
[Skip to Navigation]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address 35.175.212.130. Please contact the publisher to request reinstatement.
1.
Pawar  PV, Sayed  SI, Kazi  R, Jagade  MV.  Current status and future prospects in prosthetic voice rehabilitation following laryngectomy.  J Cancer Res Ther. 2008;4(4):186-191.PubMedGoogle ScholarCrossref
2.
Schwandt  LQ, van Weissenbruch  R, van der Mei  HC, Busscher  HJ, Albers  FW.  Effect of dairy products on the lifetime of Provox2 voice prostheses in vitro and in vivo.  Head Neck. 2005;27(6):471-477.PubMedGoogle ScholarCrossref
3.
Lewin  JS, Portwood  MA, Wang  Y, Hutcheson  KA.  Clinical application of the Provox NiD voice prosthesis: a longitudinal study.  Laryngoscope. 2014;124(7):1585-1591.PubMedGoogle ScholarCrossref
4.
Hancock  KL, Lawson  NR, Ward  EC.  Device life of the Provox Vega voice prosthesis.  Eur Arch Otorhinolaryngol. 2013;270(4):1447-1453.PubMedGoogle ScholarCrossref
5.
Graville  DJ, Palmer  AD, Andersen  PE, Cohen  JI.  Determining the efficacy and cost-effectiveness of the ActiValve: results of a long-term prospective trial.  Laryngoscope. 2011;121(4):769-776.PubMedGoogle ScholarCrossref
6.
Kress  P, Schäfer  P, Schwerdtfeger  FP, Rösler  S.  Are modern voice prostheses better? A lifetime comparison of 749 voice prostheses.  Eur Arch Otorhinolaryngol. 2014;271(1):133-140.PubMedGoogle ScholarCrossref
7.
Hilgers  FJ, Ackerstaff  AH, Jacobi  I, Balm  AJ, Tan  IB, van den Brekel  MW.  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):1135-1143.PubMedGoogle Scholar
8.
Delsupehe  K, Zink  I, Lejaegere  M, Delaere  P.  Prospective randomized comparative study of tracheoesophageal voice prosthesis: Blom-Singer versus Provox.  Laryngoscope. 1998;108(10):1561-1565.PubMedGoogle ScholarCrossref
9.
Ramalingam  W, Chikara  D, Rajagopal  G, Mehta  AR, Sarkar  S.  Tracheo-esophageal puncture (TEP) for voice rehabilitation in laryngectomised patients Blom-Singer® vs Provox® Prosthesis: our experience.  Med J Armed Forces India. 2007;63(1):15-18.PubMedGoogle ScholarCrossref
10.
Ackerstaff  AH, Hilgers  FJ, Meeuwis  CA,  et al.  Multi-institutional assessment of the Provox 2 voice prosthesis.  Arch Otolaryngol Head Neck Surg. 1999;125(2):167-173.PubMedGoogle ScholarCrossref
11.
Lequeux  T, Badreldin  A, Saussez  S, Thill  MP, Oujjan  L, Chantrain  G.  A comparison of survival lifetime of the Provox and the Provox2 voice prosthesis.  J Laryngol Otol. 2003;117(11):875-878.PubMedGoogle ScholarCrossref
12.
Sweeny  L, Golden  JB, White  HN, Magnuson  JS, Carroll  WR, Rosenthal  EL.  Incidence and outcomes of stricture formation postlaryngectomy.  Otolaryngol Head Neck Surg. 2012;146(3):395-402.PubMedGoogle ScholarCrossref
13.
Hutcheson  KA, Sturgis  EM, Lewin  JS.  Early risk factors for enlargement of the tracheoesophageal puncture after total laryngectomy: nodal metastasis and extent of surgery.  Arch Otolaryngol Head Neck Surg. 2012;138(9):833-839.PubMedGoogle ScholarCrossref
14.
Lewin  JS, Barringer  DA, May  AH,  et al.  Functional outcomes after laryngopharyngectomy with anterolateral thigh flap reconstruction.  Head Neck. 2006;28(2):142-149.PubMedGoogle ScholarCrossref
15.
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.PubMedGoogle ScholarCrossref
16.
Soolsma  J, van den Brekel  MW, Ackerstaff  AH, Balm  AJ, Tan  B, Hilgers  FJ.  Long-term results of Provox ActiValve, solving the problem of frequent candida- and “underpressure”-related voice prosthesis replacements.  Laryngoscope. 2008;118(2):252-257.PubMedGoogle ScholarCrossref
Original Investigation
January 2017

Device Life of the Tracheoesophageal Voice Prosthesis Revisited

Author Affiliations
  • 1Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston
JAMA Otolaryngol Head Neck Surg. 2017;143(1):65-71. doi:10.1001/jamaoto.2016.2771
Key Points

Question  What is the duration of device life and how is this influenced by tracheoesophageal (TE) voice prostheses?

Findings  In this retrospective study of 390 laryngectomized patients with TE puncture (3648 total prosthesis replacements), median device life was 61 days for all prostheses. Most prostheses (69%) were replaced because of leakage. Neither radiation nor extent of surgery had a meaningful effect on device life.

Meaning  Voice prothesis duration demonstrates lower durability than historically reported, highlighting the need for better voice prothesis design and proper patient counseling to ensure appropriate TE puncture candidate selection and accurate patient expectations for successful TE speech outcomes.

Abstract

Importance  Voice prosthesis (VP) device life is a limiting factor of tracheoesophageal (TE) voice restoration that drives patient satisfaction, health care costs, and overall burden. Historic data suggest that TE VPs have an average device life of generally 3 to 6 months, but these data are typically derived from small samples using only 1 or 2 devices.

Objective  To reexamine current device life in a large, contemporary cancer hospital in the United States that uses a wide assortment of VPs.

Design, Setting, and Participants  This retrospective observational study included 390 laryngectomized patients with a tracheoesophageal puncture (TEP) who had VP management at MD Anderson Cancer Center between July 1, 2003, and December 31, 2013.

Main Outcomes and Measures  Tracheoesophageal voice–related outcomes were: (1) device life duration to VP removal, and (2) treatment-related and prosthetic-related factors influencing device failure. Primary independent variables included treatment history (extent of surgery and radiation history), VP type (indwelling vs nonindwelling, size, specialty features), and reason for removal (leakage, complication, other). Duration was examined using Kaplan-Meier analysis. Disease, treatment, and patient-specific factors were analyzed as predictors of duration.

Results  Overall, 3648 VPs were placed in the 390 patients (median [range] age, 62 [34-92] years). Indwelling prostheses accounted for more than half (56%) of the devices placed (55%, 20-Fr diameter; 33%, 8-mm length). More than two-thirds (69%) of prostheses were removed because of leakage, while the rest were removed for other reasons. Median device life was 61 days for all prostheses. Indwelling and nonindwelling VPs had median device lives of 70 and 38 days, respectively. There was no significant difference between specialty prostheses compared with standard devices (median duration, 61 vs 70 days, respectively). The Provox ActiValve (Atos Medical) had the longest life. Neither radiation therapy nor extent of surgery had a meaningful impact on device life.

Conclusions and Relevance  Our data suggest that VP duration demonstrates a lower durability than historically reported. This may reflect the intensification of treatment regimens that complicate TEP management in an era of organ preservation; however, further investigation is needed.

×