Safety and efficacy of the mAXIS stapes prosthesis.
Middle-ear prosthesis
Otosclerosis, mAXIS stapes prosthesis
Stapedotomy
Stapes surgery
Journal
European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery
ISSN: 1434-4726
Titre abrégé: Eur Arch Otorhinolaryngol
Pays: Germany
ID NLM: 9002937
Informations de publication
Date de publication:
28 Jul 2024
28 Jul 2024
Historique:
received:
20
02
2024
accepted:
16
07
2024
medline:
29
7
2024
pubmed:
29
7
2024
entrez:
28
7
2024
Statut:
aheadofprint
Résumé
Otosclerosis leads to a fixed stapes footplate and thus to hearing loss. The predominant treatment method is surgery, with various types of stapes prostheses available. The aim of this study was to investigate the safety and efficacy of the new mAXIS Stapes Prosthesis. 34 cases of otosclerosis were implanted with the new mAXIS Stapes Prosthesis. Comprehensive clinical assessments, including pre- and postoperative pure tone audiometry was performed at short-term (ST) follow-up at 25 (± 15) days and mid-term (MT) follow-up at 181 (± 107) days. The pure tone average of 0.5, 1, 2 and 3 kHz (PTA4) was calculated. In all cases, the application of the prosthesis was successful and straightforward. The postoperative PTA4 air-bone gap was 10.7 ± 5.2 dB at ST follow-up (n = 34) and 8.3 ± 4.1 dB at MT follow-up (n = 18). In 61% of cases, the ABG-closure was within 10 dB and in 100% of cases within 20 dB at MT follow-up. Findings of this study support that the mAXIS Stapes Prosthesis is safe for implantation and shows promising audiological outcome. Future investigations will contribute its long-term efficacy and safety profile.
Identifiants
pubmed: 39069576
doi: 10.1007/s00405-024-08854-z
pii: 10.1007/s00405-024-08854-z
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s).
Références
Vincent R, Sperling NM, Oates J, Jindal M (2006) Surgical findings and long-term hearing results in 3,050 stapedotomies for primary otosclerosis: a prospective study with the otology-neurotology database. Otol Neurotol 27(8 Suppl 2):S25–47. https://doi.org/10.1097/01.mao.0000235311.80066.df
doi: 10.1097/01.mao.0000235311.80066.df
pubmed: 16985478
Shea JJ (1998) A personal history of stapedectomy. Am J Otol 19(5 Suppl):S2–12
pubmed: 9755788
House HP (1993) The evolution of otosclerosis surgery. Otolaryngol Clin North Am 26(3):323–333
doi: 10.1016/S0030-6665(20)30812-4
pubmed: 8341565
Dost P, Arweiler-Harbeck D, Jahnke K (2005) A prospective evaluation of the Essen titanium stapes prosthesis. Clin Otolaryngol 30(1):21–24. https://doi.org/10.1111/j.1365-2273.2004.00905.x
doi: 10.1111/j.1365-2273.2004.00905.x
pubmed: 15748184
Schwager K (2002) Titan als Material Zum Gehörknöchelchenersatz - Grundlagen und klinische Anwendung. Laryngorhinootologie 81(3):178–183. https://doi.org/10.1055/s-2002-25037
doi: 10.1055/s-2002-25037
pubmed: 11967769
Stupp CH, Stupp HF, Grün D (1996) Gehörknöchelchenersatz Mit Titan-Prothesen. Laryngorhinootologie 75(6):335–337. https://doi.org/10.1055/s-2007-997590
doi: 10.1055/s-2007-997590
pubmed: 8766379
Brown KD, Gantz BJ (2007) Hearing results after stapedotomy with a nitinol piston prosthesis. Arch Otolaryngol Head Neck Surg 133(8):758–762. https://doi.org/10.1001/archotol.133.8.758
doi: 10.1001/archotol.133.8.758
pubmed: 17709611
Fayad JN, Semaan MT, Meier JC, House JW (2009) Hearing results using the SMart piston prosthesis. Otol Neurotol 30(8):1122–1127. https://doi.org/10.1097/MAO.0b013e3181be645d
doi: 10.1097/MAO.0b013e3181be645d
pubmed: 19816231
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(5):692–695. https://doi.org/10.1097/MAO.0b013e3180340a1d
doi: 10.1097/MAO.0b013e3180340a1d
pubmed: 17414180
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(3):289–295. https://doi.org/10.1097/00129492-200205000-00010
doi: 10.1097/00129492-200205000-00010
pubmed: 11981383
Grolman W, Tange RA (2005) First experience with a new stapes clip piston in stapedotomy. Otol Neurotol 26(4):595–598. https://doi.org/10.1097/01.mao.0000178132.89353.54
doi: 10.1097/01.mao.0000178132.89353.54
pubmed: 16015152
Wegner I, Swartz JE, Bance ML, Grolman W (2016) A systematic review of the effect of different crimping techniques in stapes surgery for otosclerosis. Laryngoscope 126(5):1207–1217. https://doi.org/10.1002/lary.25586
doi: 10.1002/lary.25586
pubmed: 26333166
Committee on Hearing and Equilibrium guidelines for the evaluation of results of treatment of conductive hearing loss (1995) AmericanAcademy of Otolaryngology-Head and Neck surgery Ffoundation, Inc. Otolaryngol Head Neck Surg 113(3):186–187. https://doi.org/10.1016/S0194-5998(95)70103-6
doi: 10.1016/S0194-5998(95)70103-6
Jovanovic S, Schönfeld U, Scherer H (2006) Ein-Schuss-CO2-Laser-stapedotomie. HNO 54(11):842–850. https://doi.org/10.1007/s00106-005-1375-2
doi: 10.1007/s00106-005-1375-2
pubmed: 16479383
Huettenbrink K-B, Beutner D (2005) A new crimping device for stapedectomy prostheses. Laryngoscope 115(11):2065–2067. https://doi.org/10.1097/01.mlg.0000177988.05547.aa
doi: 10.1097/01.mlg.0000177988.05547.aa
pubmed: 16319626
Sevy A, Arriaga M (2018) The stapes Prosthesis: past, Present, and Future. Otolaryngol Clin North Am 51(2):393–404. https://doi.org/10.1016/j.otc.2017.11.010
doi: 10.1016/j.otc.2017.11.010
pubmed: 29502725
Huber AM, Schrepfer T, Eiber A (2012) Clinical evaluation of the NiTiBOND stapes prosthesis, an optimized shape memory alloy design. Otol Neurotol 33(2):132–136. https://doi.org/10.1097/MAO.0b013e31823e28cb
doi: 10.1097/MAO.0b013e31823e28cb
pubmed: 22215449
Roosli C, Huber AM (2013) Mid-term results after a newly designed Nitinol stapes prosthesis use in 46 patients. Otol Neurotol 34(7):e61–e64. https://doi.org/10.1097/MAO.0b013e318299a973
doi: 10.1097/MAO.0b013e318299a973
pubmed: 23921923
Sergi B, Lucidi D, de Corso E, Paludetti G (2016) Long-term follow-up after one-shot CO2 laser stapedotomy: is the functional outcome stable during the years? Eur Arch Otorhinolaryngol 273(11):3623–3629. https://doi.org/10.1007/s00405-016-3976-7
doi: 10.1007/s00405-016-3976-7
pubmed: 27007130
Strunk CL, Quinn FB (1993) Stapedectomy surgery in residency: KTP-532 laser versus argon laser. Am J Otol 14(2):113–117
pubmed: 8503481
Kasano F, Morimitsu T (1997) Utilization of nickel-titanium shape memory alloy for stapes prosthesis. Auris Nasus Larynx 24(2):137–142. https://doi.org/10.1016/S0385-8146(96)00026-0
doi: 10.1016/S0385-8146(96)00026-0
pubmed: 9134135
Sorom AJ, Driscoll CLW, 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(1):65–69. https://doi.org/10.1016/j.otohns.2007.01.007
doi: 10.1016/j.otohns.2007.01.007
pubmed: 17599567
Pudel EI, Briggs RJS (2008) Laser-assisted stapedotomy with a Nitinol heat-crimping prosthesis: outcomes compared with a platinum fluoroplastic prosthesis. Otolaryngol Head Neck Surg 139(1):51–54. https://doi.org/10.1016/j.otohns.2008.03.018
doi: 10.1016/j.otohns.2008.03.018
pubmed: 18585561
Kuo C-L, Wang M-C, Shiao A-S (2010) Superiority of nitinol piston over conventional prostheses in stapes surgery: first comparative results in the Chinese population in Taiwan. J Chin Med Assoc 73(5):241–247. https://doi.org/10.1016/S1726-4901(10)70052-6
doi: 10.1016/S1726-4901(10)70052-6
pubmed: 20685590
Huber AM, Veraguth D, Schmid S, Roth T, Eiber A (2008) Tight stapes prosthesis fixation leads to better functional results in otosclerosis surgery. Otol Neurotol 29(7):893–899. https://doi.org/10.1097/MAO.0b013e318184f4f0
doi: 10.1097/MAO.0b013e318184f4f0
pubmed: 18667934
Kwok P, Gleich O, Dalles K, Mayr E, Jacob P, Strutz J (2017) How to avoid a learning curve in Stapedotomy: A standardized Surgical technique. Otol Neurotol 38(7):931–937. https://doi.org/10.1097/MAO.0000000000001475
doi: 10.1097/MAO.0000000000001475
pubmed: 28604579
Husain Q, Lin KF, Selesnick SH (2018) Stapes prosthesis length and hearing outcomes. Laryngoscope 128(3):722–726. https://doi.org/10.1002/lary.26700
doi: 10.1002/lary.26700
pubmed: 28561306
Portmann D, Alcantara M, Vianna M (2007) La Longueur Du piston dans la chirurgie de l’otospongiose. Rev Laryngol Otol Rhinol (Bord) 128(1–2):55–58
pubmed: 17633666
Huber AM, Hornung J, Plontke S et al (2014) NiTiBOND, eine optimierte Steigbügelprothese zur chirurgischen Behandlung Der Otosklerose. Laryngorhinootologie 93(3):178–185. https://doi.org/10.1055/s-0033-1354378
doi: 10.1055/s-0033-1354378
pubmed: 24135825
Green JD, McElveen JT (2017) Next generation shape memory prosthesis (NiTiBOND) for stapedotomy: short-term results. Laryngoscope 127(4):915–920. https://doi.org/10.1002/lary.26114
doi: 10.1002/lary.26114
pubmed: 27296859
Laske RD, Röösli C, Chatzimichalis MV, Sim JH, Huber AM (2011) The influence of prosthesis diameter in stapes surgery: a meta-analysis and systematic review of the literature. Otol Neurotol 32(4):520–528. https://doi.org/10.1097/MAO.0b013e318216795b
doi: 10.1097/MAO.0b013e318216795b
pubmed: 21765384
Böhnke F, Arnold W (2007) Finite element model of the stapes-inner ear interface. Adv Otorhinolaryngol 65:150–154. https://doi.org/10.1159/000098793
doi: 10.1159/000098793
pubmed: 17245037
Rosowski JJ, Merchant SN (1995) Mechanical and acoustic analysis of middle ear reconstruction. Am J Otol 16(4):486–497
pubmed: 8588650
Hüttenbrink K-B (2003) Biomechanics of stapesplasty: a review. Otol Neurotol 24(4):548–557 discussion 557-9. https://doi.org/10.1097/00129492-200307000-00004
doi: 10.1097/00129492-200307000-00004
pubmed: 12851544