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Retrospective analysis of the results of implanting Nitinol pistons with heat-crimping piston loops in stapes surgery

  • Otology
  • Published:
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Abstract

The study presented here evaluates the hearing results after the implantation of a new nickel–titanium (Nitinol) prosthesis in stapes surgery; on heating, this prosthesis crimps itself around the long process of the incus. In addition, we compare the outcome with results published in the literature. The medical records of all patients who underwent surgery for otosclerosis with implantation of a Nitinol piston during the period 2004–2006 were evaluated retrospectively. 83 patients (58 women and 25 men), with a provisional diagnosis of otosclerosis that was confirmed during surgery in all but one of the cases, were treated by primary stapes surgery (85 ears). We were able to include 53 patients (55 ears) who had audiograms with air and bone conduction preoperatively and both 2–6 weeks and about 1 year after surgery. We found a mean air–bone gap (ABG) for the frequencies 0.5, 1, 2 and 4 kHz (ABG4000) of 10.4 ± 5.5 dB after a mean postoperative follow-up period of 24.5 ± 16 days, and of 7.4 ± 3.7 dB after 462 ± 119 days. For the frequencies 0.5, 1, 2 and 3 kHz (ABG3000), the results were 9.1 ± 4.8 and 6.4 ± 3.9 dB. The differences in preoperative versus postoperative air–bone gap, referred to as ABGC, after 25 and 462 days, respectively, were 19.4 ± 8.9 and 22.3 ± 8.8 dB for AGB4000, and 19.5 ± 8.8 and 22.2 ± 8.9 for ABG3000. Very good results were achieved with a new nickel–titanium prosthesis that crimps itself around the long process of the incus, thus facilitating stapes surgery and at the same time stabilizing the high quality of the results. However, no long-term results after 10 years or more, which would allow a final judgment, are yet available.

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References

  1. Huber AM, Ma F, Felix H, Linder T (2003) Stapes prosthesis attachment: the effect of crimping on sound transfer in otosclerosis surgery. Laryngoscope 113:853–858. doi:10.1097/00005537-200305000-00015

    Article  PubMed  Google Scholar 

  2. Kwok P, Fisch U, Strutz J, May J (2002) Stapes surgery: how precisely do different prostheses attach to the long process of the incus with different instruments and different surgeons? Otol Neurotol 23:289–295. doi:10.1097/00129492-200205000-00010

    Article  PubMed  Google Scholar 

  3. McGee TM (1981) The loose wire syndrome. Laryngoscope 91:1478–1483. doi:10.1288/00005537-198109000-00011

    Article  CAS  PubMed  Google Scholar 

  4. Duerig TW, Pelton AR, Stockel D (1996) The utility of superelasticity in medicine. Biomed Mater Eng 6:255–266

    CAS  PubMed  Google Scholar 

  5. Thierry B, Tabrizian M, Trepanier C, Savadogo O, Yahia L (2000) Effect of surface treatment and sterilization processes on the corrosion behavior of NiTi shape memory alloy. J Biomed Mater Res 51:685–693. doi:10.1002/1097-4636(20000915)51:4<685::AID-JBM17>3.0.CO;2-S

    Article  CAS  PubMed  Google Scholar 

  6. Van Moorleghem W, Chandrasekaran M, Reynaerts D, Peirs J, Van Brussel H (1998) Shape memory and superelastic alloys: the new medical materials with growing demand. Biomed Mater Eng 8:55–60

    PubMed  Google Scholar 

  7. Hornung J, Zenk J, Schick B, Wurm J, Iro H (2007) First experiences with a new nickel–titanium piston with a shape memory feature. HNO 55:104–108. doi:10.1007/s00106-006-1432-5

    Article  CAS  PubMed  Google Scholar 

  8. Rajan GP, Atlas MD, Subramaniam K, Eikelboom RH (2005) Eliminating the limitations of manual crimping in stapes surgery? A preliminary trial with the shape memory Nitinol stapes piston. Laryngoscope 115:366–369. doi:10.1097/01.mlg.0000154747.63561.52

    Article  PubMed  Google Scholar 

  9. Rajan GP, Eikelboom RH, Anandacoomaraswamy KS, Atlas MD (2005) In vivo performance of the Nitinol shape-memory stapes prosthesis during hearing restoration surgery in otosclerosis: a first report. J Biomed Mater Res B Appl Biomater 72:305–309. doi:10.1002/jbm.b.30165

    PubMed  Google Scholar 

  10. American Academy of Otolaryngology-Head and Neck Surgery Foundation, Inc (1995) Committee on hearing and equilibrium guidelines for the evaluation of results of treatment of conductive hearing loss. Otolaryngol Head Neck Surg 113:186–187. doi:10.1016/S0194-5998(95)70103-6

    Article  Google Scholar 

  11. Haeusler R (2000) 4th European Congress of Oto-Rhino-Laryngology, Head and Neck Surgery. Berlin, Germany, 13–18 May 2000. Laryngorhinootologie 79:S95–S139. doi:10.1055/s-2000-15920

    Article  Google Scholar 

  12. Shea JJ Jr (1958) Fenestration of the oval window. Ann Otol Rhinol Laryngol 67:932–951

    PubMed  Google Scholar 

  13. Farrior J, Sutherland A (1991) Revision stapes surgery. Laryngoscope 101:1155–1161. doi:10.1288/00005537-199111000-00003

    Article  CAS  PubMed  Google Scholar 

  14. Schimanski G (1997) Erosion and necrosis of the long process of the incus after otosclerosis operation. HNO 45:682–689. doi:10.1007/s001060050142

    Article  CAS  PubMed  Google Scholar 

  15. Huttenbrink KB (2003) Biomechanics of stapes plasty: a review. Otol Neurotol 24:548–557. doi:10.1097/00129492-200307000-00004 discussion 557-549

    Article  PubMed  Google Scholar 

  16. Blayney AW, Williams KR, Rice HJ (1997) A dynamic and harmonic damped finite element analysis model of stapedotomy. Acta Otolaryngol 117:269–273. doi:10.3109/00016489709117785

    Article  CAS  PubMed  Google Scholar 

  17. Brown KD, Gantz BJ (2007) Hearing results after stapedotomy with a nitinol piston prosthesis. Arch Otolaryngol Head Neck Surg 133:758–762. doi:10.1001/archotol.133.8.758

    Article  PubMed  Google Scholar 

  18. Harris JP, Gong S (2007) Comparison of hearing results of nitinol SMART stapes piston prosthesis with conventional piston prostheses: postoperative results of nitinol stapes prosthesis. Otol Neurotol 28:692–695

    PubMed  Google Scholar 

  19. Rajan GP, Diaz J, Blackham R, Eikelboom RH, Atlas MD, Shelton C, Huber AM (2007) Eliminating the limitations of manual crimping in stapes surgery: mid-term results of 90 patients in the Nitinol stapes piston multicenter trial. Laryngoscope 117:1236–1239. doi:10.1097/MLG.0b013e31805c9a5c

    Article  PubMed  Google Scholar 

  20. Sorom AJ, Driscoll CL, Beatty CW, Lundy L (2007) Retrospective analysis of outcomes after stapedotomy with implantation of a self-crimping Nitinol stapes prosthesis. Otolaryngol Head Neck Surg 137:65–69. doi:10.1016/j.otohns.2007.01.007

    Article  PubMed  Google Scholar 

  21. Gibbin KP (1979) The histopathology of the incus after stapedectomy. Clin Otolaryngol Allied Sci 4:343–354. doi:10.1111/j.1365-2273.1979.tb01763.x

    Article  CAS  PubMed  Google Scholar 

  22. Alberti PW (1963) The blood supply of the incudostapedial joint and the lenticular process. Laryngoscope 73:605–628

    CAS  PubMed  Google Scholar 

  23. Morgenstein KM, Manace ED (1968) Incus necrosis following stapedectomy. Laryngoscope 78:600–619

    CAS  PubMed  Google Scholar 

  24. Knox GW, Reitan H (2005) Shape-memory stapes prosthesis for otosclerosis surgery. Laryngoscope 115:1340–1346. doi:10.1097/01.mlg.0000172274.73365.11

    Article  PubMed  Google Scholar 

  25. Kasano F, Morimitsu T (1997) Utilization of nickel–titanium shape memory alloy for stapes prosthesis. Auris Nasus Larynx 24:137–142. doi:10.1016/S0385-8146(96)00026-0

    Article  CAS  PubMed  Google Scholar 

  26. Shabalovskaya SA (1996) On the nature of the biocompatibility and on medical applications of NiTi shape memory and superelastic alloys. Biomed Mater Eng 6:267–289

    CAS  PubMed  Google Scholar 

  27. Prince MR, Salzman EW, Schoen FJ, Palestrant AM, Simon M (1988) Local intravascular effects of the nitinol wire blood clot filter. Invest Radiol 23:294–300. doi:10.1097/00004424-198804000-00009

    Article  CAS  PubMed  Google Scholar 

  28. Babighian G, Fontana M, Caltran S, Ciccolella M, Amadori M, De Zen M (2007) The heat-activated stapes prosthesis ‘SMart’ Piston: technique and preliminary results. Adv Otorhinolaryngol 65:190–196

    PubMed  Google Scholar 

  29. Wever DJ, Veldhuizen AG, Sanders MM, Schakenraad JM, van Horn JR (1997) Cytotoxic, allergic and genotoxic activity of a nickel–titanium alloy. Biomaterials 18:1115–1120. doi:10.1016/S0142-9612(97)00041-0

    Article  CAS  PubMed  Google Scholar 

  30. Martin AD, Driscoll CL, Wood CP, Felmlee JP (2005) Safety evaluation of titanium middle ear prostheses at 3.0 T. Otolaryngol Head Neck Surg 132:537–542. doi:10.1016/j.otohns.2004.12.003

    Article  PubMed  Google Scholar 

  31. Casale M, De Franco A, Salvinelli F, Piazza F, Vincenzi A, Zini C (2003) Hearing results in stapes surgery using two different prosthesis. Rev Laryngol Otol Rhinol (Bord) 124:255–258

    CAS  Google Scholar 

  32. Lippy WH, Burkey JM, Schuring AG, Berenholz LP (2005) Comparison of titanium and Robinson stainless steel stapes piston prostheses. Otol Neurotol 26:874–877. doi:10.1097/01.mao.0000185070.27705.26

    Article  PubMed  Google Scholar 

  33. Mangham CA Jr, Neel J, Mangham HF (2008) Success of five stapes prostheses evaluated by Kaplan–Meier product-survival procedure. Otol Neurotol 29:900–904. doi:10.1097/MAO.0b013e318185faf4

    Article  PubMed  Google Scholar 

  34. Quaranta N, Besozzi G, Fallacara RA, Quaranta A (2005) Air and bone conduction change after stapedotomy and partial stapedectomy for otosclerosis. Otolaryngol Head Neck Surg 133:116–120. doi:10.1016/j.otohns.2005.03.011

    Article  PubMed  Google Scholar 

  35. Tange RA, Grolman W (2008) An analysis of the air–bone gap closure obtained by a crimping and a non-crimping titanium stapes prosthesis in otosclerosis. Auris Nasus Larynx 35:181–184

    Article  PubMed  Google Scholar 

  36. Tange RA, Grolman W, Dreschler WA (2004) Gold and titanium in the oval window: a comparison of two metal stapes prostheses. Otol Neurotol 25:102–105. doi:10.1097/00129492-200403000-00004

    Article  PubMed  Google Scholar 

  37. Velegrakis GA, Prokopakis EP, Karatzanis AD, Hatziioannou JK, Kyrmizakis DE, Helidonis ES (2002) Long-term results of a new stapedotomy prosthesis. ORL J Otorhinolaryngol Relat Spec 64:311–314. doi:10.1159/000066085

    PubMed  Google Scholar 

  38. Wengen DF (2007) A new self-retaining titanium clip stapes prosthesis. Adv Otorhinolaryngol 65:184–189

    PubMed  Google Scholar 

  39. Schimanski G, Steinhardt U, Eiber A (2007) Development of a new Clip-piston prosthesis for the stapes. In: Huber A, Eiber A (eds) Middle ear mechanics in research and otology. World Scientific Publishing Co. Pte. Ltd., Singapore, pp 237–245

    Chapter  Google Scholar 

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Correspondence to Joachim Albert Hornung.

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Hornung, J.A., Brase, C., Bozzato, A. et al. Retrospective analysis of the results of implanting Nitinol pistons with heat-crimping piston loops in stapes surgery. Eur Arch Otorhinolaryngol 267, 27–34 (2010). https://doi.org/10.1007/s00405-009-0999-3

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  • DOI: https://doi.org/10.1007/s00405-009-0999-3

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