Dispositivo auditivo totalmente implantable Carina®: revisión sistemática
Barra lateral del artículo
Contenido principal del artículo
Resumen
Objetivos: Revisar/resumir indicaciones, resultados audiológicos y de calidad de vida del dispositivo totalmente implantable Carina®. Diseño: Revisión sistemática. Métodos: Se realizó una búsqueda sistemática de la literatura entre junio/2011 y enero/2012 en bases de datos: Medline, OVID, Embase, Pro Quest, Biblioteca Cochrane. También se revisó literatura gris (Sigle) en búsqueda de información no publicada. No hubo restricción de lenguaje o límite temporal, y se incluyeron estudios en humanos con mediciones antes/después de la intervención. Se excluyeron reportes de un caso y estudios con pacientes prelinguales. Se evaluó heterogeneidad estadística (prueba Der Simonian-Laird), y la ganancia funcional combinada (GFC) se estimó con un modelo de efectos aleatorios. Se evaluó sesgo de publicación (gráfica de embudo y prueba Eggs). Resultados: Se identificaron 155 publicaciones, 43 enfocadas en el tema de investigación; ocho cumplieron criterios de inclusión/exclusión, que reportan 110 pacientes. La GFC fue 27,24 dB [IC 95% = 21,66-32,83 dB], I2 = 85%. El reconocimiento de palabras (65 dB-SPL) se incrementó con Carina® entre 35 y 70%, y hubo mejoría en calidad de vida (escala Aphab). La complicación más frecuente fue extrusión (2,7%). Se encontró sesgo de publicación (Eggs = 0,0011). Conclusiones: Se encontró heterogeneidad clínica y bajo nivel de evidencia publicada. La GFC fue considerable con el implante.
Descargas
Detalles del artículo
Este artículo es publicado por la Revista Acta de Otorrinolaringología & Cirugía de Cabeza y Cuello.
Este es un artículo de acceso abierto, distribuido bajo los términos de la LicenciaCreativeCommons Atribución-CompartirIgual 4.0 Internacional.( http://creativecommons.org/licenses/by-sa/4.0/), que permite el uso no comercial, distribución y reproducción en cualquier medio, siempre que la obra original sea debidamente citada.
eISSN: 2539-0856
ISSN: 0120-8411
Citas
Bruschini L, Forli F, Santoro A, Bruschini P, Berrettini S. Fully implantable Otologics MET Carina device for the treatment of sensorineural hearing loss. Preliminary surgical and clinical results. Acta Otorhinolaryngol Ital, 2009; 29:79-85.
Wagner F, Todt I, Wagner J, Ernst A. Indications and candidacy for active middle ear implants. Adv Otorhinolaryngol, 2010; 69: 20-26.
Haynes DS, Young JA, Wanna GB, Glasscock ME 3rd. Middle ear implantable hearing devices: an overview. Trends Amplif, 2009; 209; 13: 206-214.
Jenkins HA, Atkins JS, Horlbeck D, Hoffer ME, Balough B, Alexiades G, et al. Otologics fully implantable hearing system: Phase I trial 1-year results. Otol Neurotol, 2008; 29: 534-541.
Jenkins HA, Atkins JS, Horlbeck D, Hoffer ME, Balough B, Arigo JV, et al. U.S. Phase I preliminary results of use of the Otologics MET Fully-Implantable Ossicular Stimulator. Otolaryngol Head Neck Surg, 2007; 137: 206-212.
Jenkins HA, Niparko JK, Slattery WH, Nehlv JG, Fredrickson JM. Otologics Middle Ear Transducer Ossicular Stimulator:Performance Result with Varying Degrees of Sensorineural Hearing Loss. Acta Otolaryngol, 2004; 124: 391-394.
Niemczyk K, Morawski K, Lachowska M, Bartoszewicz R, Sokotowski J, Karchier E. Fully Implantable Middle Ear Implant - Indications, surgical technique and first results. Otolaryngologia Polska, 2011; 6: 236-240.
Siegert R, Mattheis S, Kasic J. Fully Implantable Hearing Aids in Patients With Congenital Auricular Atresia. Laryngoscope, 2007; 117: 336-340.
Verhaert N, Fuchsmann C, Tringali S, Lina-Granade G, Truy E. Strategies of Active Middle Ear Implants for Hearing Rehabilitation in Congenital Aural Atresia. Otol Neurotol, 2011; 32: 639-645.
Tringali S, Pergola N, Ferber-Viart C, Truy E, Berger P, Dubreuil C. Fully implantable hearing device as a new treatment of conductive hearing loss in FranceschettiM syndrome. Int J Pediatr Otorhinolaryngol, 2008; 72: 513-517.
Bruschini L, Forli F, Passetti S, Bruschini P, Berrettini S. Fully implantable Otologics MET Carina (TM) device for the treatment of sensorineural and mixed hearing loss: Audiootological results. Acta Otolaryngol, 2010; 130: 1147-1153.
Martin C, Deveze A, Richard C, Lefebvre PP, Decat M, Ibáñez LG, et al. European results with totally implantable carina placed on the round window: 2-year follow-up. Otol Neurotol, 2009; 30: 1196-1203.
Snik AFM, Van Duijnhoven NTL, Mylanus EAM, Cremers CWRJ. Estimated cost-effectiveness of active middle-ear implantation in hearing-impaired patients with severe external otitis. Arch Otolaryngol Head Neck Surg, 2006; 132: 1210-1215.
Venail F, Lavieille JP, Meller R, Deveze A, Tardivet L, Magnan J. New Perspectives for Middle Ear Implants: First Results in Otosclerosis With Mixed Hearing Loss. Laryngoscope, 2007; 117: 552-555.
Bassim MK, Fayad JN. Implantable Middle Ear Hearing Devices: A Review. Semin Hear, 2010; 31: 28-36.
Burmeister HP, Bisdas S, Baltzer PAT, Schwab B, Becker H. Three dimensional imaging of active and passive middle ear prostheses using multislice computed tomography. J Comput Assist Tomogr, 2008; 32: 304-312.
Deveze A, Koka K, Tringali S, Jenkins HA, Tollin DJ. Active middle ear implant application in case of stapes fixation: a temporal bone study. Otol Neurotol, 2010; 31: 1027-1034.
Deveze A, Rameh C, Sanjuan M, Lavieille J, Magnan J. A middle ear implant with a titanium canal wall prosthesis for a case of an open mastoid cavity. Auris Nasus Larynx, 2010; 37: 631-635.
Deveze A, Rameh C, Puchol M, Lafont B, Lavieille J, Magnan J. Rehabilitation of canal wall down mastoidectomy using a titanium ear canal implant. Otol Neurotol, 2010; 31: 220-224. 20. Gan RZ, Dai C, Wang X, Nakmali D, Wood MW. A totally implantable hearing system design and function characterization in 3D computational model and temporal bones. Hear Res, 2010; 263: 138-144.
Horlbeck D. Fully implantable ossicular stimulator, 2010; 21: 207 210.
Jenkins HA, Pergola N, Kasic J. Intraoperative ossicular loading with the otologics fully implantable hearing device. Acta Otolaryngol, 2007; 127: 360-364.
Jenkins HA, Pergola N, Kasic J. Anatomical vibrations that implantable microphones must overcome. Otol Neurotol, 2007; 28: 579-588.
Koka K, Holland NJ, Lupo JE, Jenkins HA, Tollin DJ. Electrocochleographic and mechanical assessment of round window stimulation with an active middle ear prosthesis. Hear Res, 2010; 263: 128-137.
Kontorinis G, Giesemann AM, Witt T, Goetz F, Schwab B. Controlling the position and the dislocation of the middle ear transducer with high resolution computed tomography and digital volume tomography: implications for the transducers’ design. Europ Arch Otorhinolaryngol, Sep 22 2011 [Epub ahead of print].
Kontorinis G, Lenarz T, Schwab B. Anatomic limitations in implantation of middle ear transducer and Carina middle ear implants. Laryngoscope, 2010; 120: 2289-2293.
Lefebvre PP, Martin C, Dubreuil C, Decat M, Yazbeck A, Kasic J, et al. A pilot study of the safety and performance of the Otologics fully implantable hearing device: transducing sounds via the round window membrane to the inner ear. Audiol Neurootol, 2009; 14: 172-180.
Lim H, Yoon Y, Lee C, Park I, Song B, Cho J. Implementation of a transcutaneous charger for fully implantable middle ear hearing device. Conf Proc IEEE Eng Med Biol Soc, 2005; 7: 6813-6816.
Lupo JE, Koka K, Hyde BJ, Jenkins HA, Tollin DJ. Physiological Assessment of Active Middle Ear Implant Coupling to the Round Window in Chinchilla lanigera. Otolaryngol Head Neck Surg, 2011; 145: 641-647.
Lupo JE, Koka K, Holland NJ, Jenkins HA, Tollin DJ. Prospective electrophysiologic findings of round window stimulation in a model of experimentally induced stapes fixation. Otol Neurotol, 2009; 30: 1215 1224.
Maurer J. [Fully implantable hearing systems]. HNO, 2009; 57: 199 207.
Maurer J, Savvas E. The Esteem system: A totally implantable hearing device. Adv Oto-Rhino-Laryngol, 2010; 69: 59-71.
Nakajima HH, Merchant SN, Rosowski JJ. Performance considerations of prosthetic actuators for round-window stimulation. Hear Res, 2010; 263: 114-119.
Praetorius M. [Active middle ear implants: more than “just” a hearing aid]. HNO, 2007; 55: 681-683.
Radeloff A, Shehata-Dieler W, Rak K, Scherzed A, Tolsdorff B, Hagen R, et al. Intraoperative monitoring of active middle ear implant function in patients with normal and pathologic middle ears. Otol Neurotol, 2011; 32: 104-107.
Shinners MJ, Hilton CW, Levine SC. Implantable hearing devices. Curr Opin Otolaryngol Head Neck Surg, 2008; 16: 416-419.
Tringali S, Koka K, Deveze A, Ferber AT, Jenkins HA, Tollin DJ. Intraoperative adjustments to optimize active middle ear implant performance. Acta Otolaryngol, 2011; 131: 27-35.
Tringali S, Koka K, Deveze A, Holland NJ, Jenkins HA, Tollin DJ. Round window membrane implantation with an active middle ear implant: a study of the effects on the performance of round window exposure and transducer tip diameter in human cadaveric temporal bones. Audiol Neurotol, 2010; 15: 291-302.
Tringali S, Pergola N, Berger P, Dubreuil C. Fully implantable hearing device with transducer on the round window as a treatment of mixed hearing loss. Auris Nasus Larynx, 2009; 36: 353-358.
Tringali S, Perrot X, Berger P, Granade GL, Dubreuil C, Truy E. Otologics Middle Ear Transducer With Contralateral Conventional Hearing Aid in Severe Sensorineural Hearing Loss: Evolution During the First 24 Months. Otol Neurot, 2010; 31: 630-636.
Verhaegen VJO, Mylanus EAM, Cremers CWRJ, Snik AFM. Audiological Application Criteria for Implantable Hearing Aid Devices: A Clinical Experience at the Nijmegen ORL Clinic. Laryngoscope, 2008; 118: 1645 1649.
Verhaert N, Fuchsmann C, Tringali S, Lina-Granade G, Truy E. Strategies of Active Middle Ear Implants for Hearing Rehabilitation in Congenital Aural Atresia. Otol Neurot, 2011; 32: 639-645.
Zenner HP, Rodríguez Jorge J. Totally implantable active middle ear implants: ten years’ experience at the University of Tübingen. Adv Otorhinolaryngol, 2010; 69: 72-84.
Tysome JR, Moorthy R, Lee A, Jiang D, O’Connor AF. Systematic review of middle ear implants: Do they improve hearing as much as conventional hearing aids? Otol Neurotol, 2010; 31: 1369-75.
Stamatiou GA, Kyrodimos E, Sismanis A. Complications of cochlear implantation in adults. Ann Otol Rhinol Laryngol, 2011; 120: 428-32.
Badran K, Arya AK, Bunstone D, Mackinnon N. Long-term complications of bone-anchored hearing aids: A 14-year experience. J Laryngol Otol, 2009; 123: 170-6.