Otology & Neurotology 35:e146Ye152 Ó 2013, Otology & Neurotology, Inc.
Active Middle Ear Implant After Lateral Petrosectomy and Radiotherapy for Ear Cancer *Giovanni Cristalli, †Georg M. Sprinzl, †Astrid Wolf-Magele, *Paolo Marchesi, *Giuseppe Mercante, and *Giuseppe Spriano *Department of Otolaryngology Head and Neck Surgery, ‘‘Regina Elena,’’ National Cancer Institute Rome, Italy; and ÞDepartment of Otorhinolaryngology, University Hospital, Medical University Innsbruck, Innsbruck, Austria
Background: Tumor of the temporal bone is a rare disease with a very poor prognosis. Surgery and postoperative radiotherapy are usually the recommended treatments for squamous cell carcinoma (SCC) of the external and middle ear, which may cause conductive hearing loss. The purpose of this study was to evaluate the audiologic results and compliance of active middle ear implant (AMEI) and establish the feasibility of the procedure in a patient treated for middle ear cancer. Methods: A 73-year-old patient treated with lateral petrosectomy, neck dissection, reconstruction/obliteration by pedicled pectoralis major myocutaneous flap, and postoperative full dose radiotherapy for external and middle ear SCC was selected for AMEI. Preoperative audiometric and speech audiom-
etry tests were performed on both ears before and after the activation. Main Outcome Measures: Pure tone free field audiometry. Binaural free field speech audiogram. Results: Aided pure tone free field audiometry AMEI results show an increase in air conduction. Speech audiogram showed better discrimination scores in AMEI-aided situations. No complications were observed. Conclusion: AMEI after surgery followed by radiotherapy for middle ear cancer is feasible. Acoustic results in obliterated ear are satisfactory. Key Words: Active middle ear implantV CarcinomaVEar cancerVRadiotherapyVTemporal bone. Otol Neurotol 35:e146Ye152, 2014.
OBJECTIVE
undergoing rehabilitation has grown because of the development of new hearing aides. In the last several years, active middle ear implants (AMEIs) have evolved to a broader spectrum of conductive or mixed hearing loss (HL) indications (11,12). To overcome the limitation of a ventilated cavity, a subtotal petrosectomy was successfully carried out (13,14). After performing a subtotal petrosectomy, a floating mass transducer (FMT) could be placed onto the round window (15Y17) or to the stapes and the obliterated middle ear (18,19). This technique and results are reported in literature (13, 20); however, no experiences treating post full-dose radiotherapy have been reported. The purpose of this study was to evaluate the audiologic results in a patient treated for ear cancer to establish the feasibility of the procedure.
Cancer of the external auditory canal and temporal bone represents less than 0.2% of head and neck cancers with an annual incidence between 1 and 6 per million (1Y3). As reported in our previous published series, disease-free survival is 73.3%, and overall survival is 75.6% (4). These data are consistent with other results reported in literature (5,6). The increased survival rate reported over the last few years reflects an improvement in prognosis due to standardized microsurgical otologic procedures and advanced radiotherapy and chemotherapy protocols (7,8). The main adverse effects of treatment after undergoing lateral petrosectomy may include totally blocked residual conductive hearing and transmissive deafness; however, it is still possible to directly stimulate the round window membrane or the stapes (9,10). The number of patients
Patient A 73-year-old man with external auditory canal squamous cell carcinoma (SCC) extending into the middle ear (C2T3N0M0 stage III) (21) was treated by lateral petrosectomy (22), total parotidectomy, lateral neck dissection, and obliteration of the cavity by a pedicled
Address correspondence and reprint requests to Giovanni Cristalli, M.D., Department of Otolaryngology Head and Neck Surgery, Via Elio Chianesi, 53, 00144 Rome, Italy; E-mail: [email protected] The authors disclose no conflicts of interest. No funds to disclose.
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FIG. 1. A, Preoperative axial CT scan displaying left ear SCC. B, Operatory field at the end of the lateral temporal bone resection and total parotidectomy. C, Myocutaneous pedicled major pectoralis muscle flap to close the defect and obliterate the cavity.
pectoralis major myocutaneous flap (Fig. 1), followed by postoperative image modulated radiotherapy (64.5 Gy on the tumor region and 50 Gy on the neck) (Figs. 2 and 3). Preoperative and postoperative audiometric testing on both ears included pure-tone thresholds measured air conduction (AC) through headphones and bone conduction (BC) thresholds. Intervention A Vibrant Soundbridge (VSB) Model 502B (VSBY MED-EL GmbH, Innsbruck Austria) was implanted in the
FIG. 2.
left ear using a floating mass transducer (FMT) attached to the stapes by partial ossicular replacement prosthesis (PORP) (titan Vibroplasty clip-coupler 0.2 2.5 mm code 50284) (23). The pectoralis major myocutaneous flap, used during the previous operation to obliterate the cavity, was carefully elevated. In this case, a stapes superstructure was present and mobile. A sizer device was used to position and verify the bone bed of the implant transducer (FMT), and the receiver was secured by tie-down holes (24,25). The pectoralis major muscle was repositioned to
Conformational RT planning and calculation of radiation dose according to the risk areas to treat. Otology & Neurotology, Vol. 35, No. 4, 2014
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FIG. 3. Postoperative CT scan (A) axial plane and (B) coronal plane confirming no evidence of relapse of cancer and obliteration of the operative cavity.
obliterate the cavity again, and a bandage was applied for 1 day. A course of antibiotics was administered for 7 days, and the patient was discharged after 48 hours. The first fitting of the patient was scheduled 4 weeks postsurgery (Fig. 4). Main Outcome Measures Pure tone free field audiometry and binaural free field speech audiogram were used. RESULTS After the first surgery and administering radiotherapy, no complications were observed. Pure tone audiometry (PTA) frequencies of 5 dB at 0.25 and 0.5 KHz, 20 dB at 1 KHz, 10 dB at 2 kHz, and 5 dB at 4 KHz were recorded observing a decrease in bone conduction in the operated ear. No significant changes were observed regarding the BC threshold in the other ear. VSB activated pure tone free field audiometry with contralateral ear plugging and masking showed an increase in AC of 25 dB SPL at 0.25, 0.5, and 1 KHz and an increase in AC of 30 dB at 2 KHz. Frequencies of 4 and 8 KHz were not able to be evaluated without VSB activation; postactivation AC at 4 KHz and 8 KHz was 70 dB SPL in both frequencies. A postoperative binaural free field speech audiogram showed a discrimination score of 70% at SD 65 dB and 90% at SD80 dB in the presence of an activated VSB,
whereas the score was 30% at SD 65 dB and 50% at SD80 dB when the VSB was deactivated (Fig. 5). After 10 months of follow-up, none of the subsequent complications were observed: skin reactions, infection, extrusion, or any other complications. The patient immediately enjoyed the benefit of hearing improvement in the quality of sound and in daily conversation intelligibility. The patient predominantly relies on the implant and uses the contralateral hearing aid as support. Follow-up schedule for SCC recurrence relied on high-definition CT scan with contrast of head and neck every 6 months for the first 2 years and once a year thereafter together with undergoing a PET-CT scan every year. DISCUSSION Most advanced ear cancers require radical surgery followed by radiotherapy. This strategy limits the range of acoustical rehabilitation procedures offered. Radiation induced damage can affect all structures of the hearing organ from external, middle, and inner ear up to the central auditory pathways. In addition, complications may be related to dose and field (95 cm) (26,27). Cochlear implantation for postirradiated patients share the same complication risks compared with nonirradiated patients. However, it is important to consider that experiences reported in literature are conducted mainly in radiotherapy for treating nasopharynx carcinoma where the dose field differs entirely from the one applied in our case
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FIG. 4. AYB, FMT mass transduction anchored on the head of the stapes by Vibroplasty-Clip-Coupler Standard size 0.2 2.5 mm. C, Preparation for positioning the receiver similar to the procedure used in the cochlear implant. D, Patient at the moment of activation. E, X-ray postimplant.
(28). The application of a VSB after lateral petrosectomy surgery in malignancy differs substantially when addressing benign cancers. In fact, in the latter case, where full-dose radiotherapy is usually not indicated, surgery is less demolitive where no flap is generally used for repair or to eliminate the defect (13,14). The surgery procedure was divided into 2 distinctive stages. The first stage aimed at removing the tumor and the second one toward hearing rehabilitation. This 2-step procedure was mandatory mainly for 2 reasons. First, because recurrence must be excluded during the second stage and secondly, that the complete closure of the Eustachian tube must be properly carried out to avoid any possible infection of the nasopharynx. There is a very high rate of wound healing complication and infection after radiotherapy (29). There are no published data on ear implanted devices after radiotherapy, but the risk of wound infection and rejection of the implant within 6 months is believed to be very high. Potential problems in wound healing and infection in postirradiated patients must be considered. Our experience demonstrates that scaring, flap positioning, surgical exposure of meningeal layers, lateral sinus, or jugular bulb do not represent contraindications for AMEI procedure (30). Postirradiation sensory neural hearing loss (SNHL) occurs in about one-third of patients treated with definitive radiation including the inner ear for doses over 47 Gy (31,32). SNHL typically appears several months or years after completing treatment, as we observed in this case.
VSB was preferred as to a Bone-Anchored Hearing Aid (BAHA) based on the following 2 reasons: 1) the patient had a low BC, which is a contraindication to BAHA, and 2) the high risk of complications because of the osseointegration and skin infection in case of BAHA (11,33Y47). Data regarding the osseointegration of BAHA in the irradiated bone is currently lacking. However, the osseointegration rate is low in dental implant therapy in irradiated head and neck cancer patients with a long follow-up (48,49). Satisfactory hearing after lateral petrosectomy surgery presents a serious challenge. Our results reflect a high score after VSB activation even if additional BC PTA deterioration is recorded after tumor surgery and radiotherapy. In addition, VSB amplification indicates a good functional result bypassing the external and partially the middle ear. The speech audiogram shows a discrimination in a VSB-aided situation having a score of 70% at 65 dB SPL and 90% at 80 dB SPL. With the VSB deactivated, the score was 30% at 65 dB and 50% at 80 dB. Potential problems in wound healing and infection in postirradiated patients must be considered. Our experience demonstrates that there are no contraindications for the AMEI procedure. Our follow-up for detecting SCC recurrence adopted the use of a CT scan only because of the possible risk of dislocation or magnetization of the VSB after performing a magnetic resonance imaging (50,51), in the hope that this experience may represent the Otology & Neurotology, Vol. 35, No. 4, 2014
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FIG. 5. A, PTA preoperative (predemolitive surgery and radiotherapy). B, PTA postoperative first procedure (surgery and radiotherapy). C, PTA open space contralateral ear masked with plug; green line VSB not activated; blue line VSB activated. D, Postoperative speech audiogram disyllabic and mixed logotome list open space binaural; comparison of unfitted score and aided with VSB: r, VSB not activated; 0, VSB aided.
first step toward a wider use and more extensive use in the application of AMEI in patients with SCC extending into the middle ear and treated by surgery and radiotherapy. Acknowledgments: The authors thank Dr. Francesco Bianco for his contribution in the audiometric testing.
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5. Prasad S, Janecka IP. Efficacy of surgical treatments for squamous cell carcinoma of the temporal bone: a literature review. Otolaryngol Head Neck Surg 1994;110:270Y80. 6. Pfreundner L, Schwager K, Willner J, et al. Carcinoma of the external auditory canal and middle ear. Int J Radiat Oncol Biol Phys 1999;44:777Y88. 7. Graham MD, Sataloff RT, Kemink JL, Wolf GT, McGillicuddy JE. Total en bloc resection of the temporal bone and carotid artery for malignant tumors of the ear and temporal bone. Laryngoscope 1984;94:528Y33. 8. Goodwin WJ, Jesse RH. Malignant neoplasms of the external auditory canal and temporal bone. Arch Otolaryngol 1980;106: 675Y9. 9. Conley JJ, Novack AJ. Surgical treatment of cancer of the ear and temporal bone. Trans Am Acad Ophthalmol Otolaryngol 1960;64: 83Y92. 10. Fisch U. [Possibilities of microsurgery of the petrous bone and the base of the skull]. Ther Umsch 1987;44:102Y8. 11. Wagner F, Todt I, Wagner J, Ernst A. Indications and candidacy for active middle ear implants. Adv Otorhinolaryngol 2010;69: 20Y6.
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MIDDLE EAR IMPLANT AND EAR CANCER 12. Barbara M, Biagini M, Monini S. The totally implantable middle ear device ’Esteem’ for rehabilitation of severe sensorineural hearing loss. Acta Otolaryngol 2011;131:399Y404. 13. Verhaert N, Mojallal H, Schwab B. Indications and outcome of subtotal petrosectomy for active middle ear implants. Eur Arch Otorhinolaryngol 2013;270:1243Y8. 14. Linder T, Schlegel C, DeMin N, van der Westhuizen S. Active middle ear implants in patients undergoing subtotal petrosectomy: new application for the Vibrant Soundbridge device and its implication for lateral cranium base surgery. Otol Neurotol 2009; 30:41Y7. 15. Cuda D, Murri A, Tinelli N. Piezoelectric round window osteoplasty for Vibrant Soundbridge implant. Otol Neurotol 2009;30: 782Y6. 16. Colletti V, Soli SD, Carner M, Colletti L. Treatment of mixed hearing losses via implantation of a vibratory transducer on the round window. Int J Audiol 2006;45:600Y8. 17. Colletti V, Mandala M, Colletti L. Electrocochleography in round window Vibrant Soundbridge implantation. Otolaryngol Head Neck Surg 2012;146:633Y40. 18. Black B. Mastoidectomy elimination: obliterate, reconstruct, or ablate? Am J Otol 1998;19:551Y7. 19. Issing PR, Schonermark MP, Winkelmann S, Kempf HG, Ernst A. Cochlear implantation in patients with chronic otitis: indications for subtotal petrosectomy and obliteration of the middle ear. Skull Base Surg 1998;8:127Y31. 20. Filipo R, Barbara M. Rehabilitation of radical mastoidectomy. Am J Otol 1986;7:248Y52. 21. Arriaga M, Curtin H, Takahashi H, Hirsch BE, Kamerer DB. Staging proposal for external auditory meatus carcinoma based on preoperative clinical examination and computed tomography findings. Ann Otol Rhinol Laryngol 1990;99(9 Pt 1):714Y21. 22. Conley JJ, Novack AJ. The surgical treatment of malignant tumors of the ear and temporal bone. Part I. AMA Arch Otolaryngol 1960;71:635Y52. 23. Huber AM, Mlynski R, Muller J, et al. A new vibroplasty coupling technique as a treatment for conductive and mixed hearing losses: a report of 4 cases. Otol Neurotol 2012;33:613Y7. 24. Zahnert T, Bornitz M, Huttenbrink KB. Experiments on the coupling of an active middle ear implant to the stapes footplate. Adv Otorhinolaryngol 2010;69:32Y7. 25. Huttenbrink KB, Beutner D, Zahnert T. Clinical results with an active middle ear implant in the oval window. Adv Otorhinolaryngol 2010;69:27Y31. 26. Silva JJ, Tsang RW, Panzarella T, et al. Results of radiotherapy for epithelial skin cancer of the pinna: the Princess Margaret Hospital Experience, 1982Y1993. Int J Radiat Oncol Biol Phys 2000;47: 451Y9. 27. Jereczek-Fossa BA, Zarowski A, Milani F, Orecchia R. Radiotherapy-induced ear toxicity. Cancer Treat Rev 2003;29:417Y30. 28. Soh JM, D’Souza VD, Sareoaka GK, Ng WN, Ong CS, Low WK. Cochlear Implant outcomes: a comparison between irradiated and non-irradiated ears. Clin Exp Otorhinolaryngol 2012;5:s93Y8. 29. Momeni A, Kim RY, Kattan A, Tennefoss J, Lee TH, Lee GK. The effect of preoperative radiotherapy on complication rate after microsurgical head and neck reconstruction. J Plast Reconstr Aesthet Surg 2011;64:1454Y9. 30. Peled AW, Foster RD, Esserman LJ, Park CC, Hwang ES, Fowble B. Increasing the time to expander-implant exchange after postmastectomy radiation therapy reduces expander-implant failure. Plast Reconstr Surg 2012;130:503Y9. 31. Bhandare N, Jackson A, Eisbruch A, et al. Radiation therapy and hearing loss. Int J Radiat Oncol Biol Phys 2010;76:S50Y7. 32. Pan C, Eisbruch A, Lee JS, et al. Postirradiation sensorineural hearing loss: a common but ignored late radiation complication. Int J Radiat Oncol Biol Phys 1996;36:515Y7. 33. Soo G, Tong MC, Tsang WS, et al. The BAHA hearing system for hearing-impaired postirradiated nasopharyngeal cancer patients: a new indication. Otol Neurotol 2009;30:496Y501. 34. Dholam KP, Gurav SV. Dental implants in irradiated jaws: a literature review. J Cancer Res Ther 2012;8:S85Y93. 35. Liddelow G, Klineberg I. Patient-related risk factors for implant
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therapy. A critique of pertinent literature. Aust Dent J 2011;56: 417Y26. Nagorsky MJ. Radiation injury of the temporal bone. Clin Plast Surg 1993;20:531Y4. Hayter CR, Lee KH, Groome PA, Brundage MD. Necrosis following radiotherapy for carcinoma of the pinna. Int J Radiat Oncol Biol Phys 1996;36:1033Y7. de Wolf MJ, Hendrix S, Cremers CW, Snik AF. Better performance with bone-anchored hearing aid than acoustic devices in patients with severe air-bone gap. Laryngoscope 2011;121:613Y6. Marzo SJ, Benscoter B, Leonetti JP. Contemporary options for lateral skull base reconstruction following tumor extirpation. Curr Opin Otolaryngol Head Neck Surg 2011;19:330Y4. Hakansson B. The future of bone conduction hearing devices. Adv Otorhinolaryngol 2011;71:140Y52. Gluth MB, Eager KM, Eikelboom RH, Atlas MD. Long-term benefit perception, complications, and device malfunction rate of bone-anchored hearing aid implantation for profound unilateral sensorineural hearing loss. Otol Neurotol 2010;31:1427Y34. Pfiffner F, Caversaccio MD, Kompis M. Audiological results with Baha in conductive and mixed hearing loss. Adv Otorhinolaryngol 2011;71:73Y83. Snik AF, Mylanus EA, Cremers CW, et al. Multicenter audiometric results with the Vibrant Soundbridge, a semi-implantable hearing device for sensorineural hearing impairment. Otolaryngol Clin North Am 2001;34:373Y88. Huber AM, Ball GR, Veraguth D, Dillier N, Bodmer D, Sequeira D. A new implantable middle ear hearing device for mixed hearing loss: a feasibility study in human temporal bones. Otol Neurotol 2006;27:1104Y9. Huttenbrink KB, Zahnert T, Bornitz M, Beutner D. TORPvibroplasty: a new alternative for the chronically disabled middle ear. Otol Neurotol 2008;29:965Y71. Sprinzl GM, Wolf-Magele A, Schnabl J, Koci V. The active middle ear implant for the rehabilitation of sensorineural, mixed and conductive hearing losses. Laryngorhinootologie 2011;90:560Y72. Babighian G, Mazzoli M. Implantable middle-ear implants: our experience. Cochlear Implants Int 2005;6:65Y9. Tanaka TI, Chan HL, Tindle DI, Maceachern M, Oh TJ. Updated clinical considerations for dental implant therapy in irradiated head and neck cancer patients. J Prosthodont (in press). Carr AB. Implant location and radiotherapy are the only factors linked to 2-year implant failure. J Evid Based Dent Pract 2012; 12:217Y9. Wagner JH, Ernst A, Todt I. Magnet resonance imaging safety of the Vibrant Soundbridge system: a review. Otol Neurotol 2011;32: 1040Y6. Fisch U, Cremers CW, Lenarz T, et al. Clinical experience with the Vibrant Soundbridge implant device. Otol Neurotol 2001;22: 962Y72.
APPENDIX Patient In our institution, from 2003 until present, 37 ear malignancies have been treated by lateral petrosectomy and adjuvant radiotherapy. A 73-year-old man was selected and treated for external auditory canal squamous cell carcinoma (SCC) extended to the middle ear. The clinical stage according to Pittsburgh classification (21) was C2T3N0M0 stage III. On September 2009, the patient was treated by lateral petrosectomy (22), total parotidectomy, lateral neck dissection, and obliteration of the cavity by a pedicled pectoralis major myocutaneous flap (Fig. 1). From October to December 2010, the patient received postoperative image modulated radiotherapy: 64.5 Gy on the tumor region and 50 Gy on the neck (Fig. 2). High-definition CT scan was performed in axial Otology & Neurotology, Vol. 35, No. 4, 2014
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and sagittal plane before the positioning of the AMEI (Fig. 3). Preoperative and postoperative audiometric testing on both ears included pure-tone thresholds measured air conduction (AC) under headphones and bone conduction (BC) thresholds. The frequencies were tested from 0.125 to 8 KHz (Amplaid 309 audiometer). Speech audiometry test was performed using standardized disyllabic and mixed logotome list (Amplifon cd-Audio 1 cod.52111535) to assess the patient’s speech understanding in quiet free field silent booth binaurally before and after the AMEI activation. Percentage of speech perception with stimulus intensity of 65 dB SPL (SD65 dB) and 80 dB SPL (SD 80 dB) was determined. After final implantation, aided speech measurements with SD 65 dB and SD 80 dB were performed without contralateral ear masking. Intervention After informed consent was obtained by the patient, in March 2012, a Vibrant Soundbridge (VSB) Model 502B
(VSBYMED-EL GmbH, Innsbruck Austria) was implanted in the left ear using a floating mass transducer (FMT) attached to the stapes by partial ossicular replacement prosthesis (PORP) (titan Vibroplasty clip-coupler 0.2 2.5 mm code 50284) (23). All the devices were CE marked (approved in European Union). No local ethical committee approval was required for this study. The pectoralis major myocutaneous flap, used during the previous operation to obliterate the cavity, was carefully elevated. In this case, the superstructure of the stapes was present and mobile. A sizer device was used to perform a bony bed for the implant transducer (FMT), and the receiver was secured by tie-down holes (24,25). The pectoralis major muscle was repositioned to obliterate again the cavity and a bandage was applied for 1 day; antibiotic therapy was administered for 7 days, and the patient was discharged after 48 hours. The first fitting of the patient was scheduled 4 weeks postoperatively (Fig. 4).
Otology & Neurotology, Vol. 35, No. 4, 2014
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Active Middle Ear Implant After Lateral Petrosectomy and Radiotherapy for Ear Cancer *Giovanni Cristalli, †Georg M. Sprinzl, †Astrid Wolf-Magele, *Paolo Marchesi, *Giuseppe Mercante, and *Giuseppe Spriano *Department of Otolaryngology Head and Neck Surgery, ‘‘Regina Elena,’’ National Cancer Institute Rome, Italy; and ÞDepartment of Otorhinolaryngology, University Hospital, Medical University Innsbruck, Innsbruck, Austria
Background: Tumor of the temporal bone is a rare disease with a very poor prognosis. Surgery and postoperative radiotherapy are usually the recommended treatments for squamous cell carcinoma (SCC) of the external and middle ear, which may cause conductive hearing loss. The purpose of this study was to evaluate the audiologic results and compliance of active middle ear implant (AMEI) and establish the feasibility of the procedure in a patient treated for middle ear cancer. Methods: A 73-year-old patient treated with lateral petrosectomy, neck dissection, reconstruction/obliteration by pedicled pectoralis major myocutaneous flap, and postoperative full dose radiotherapy for external and middle ear SCC was selected for AMEI. Preoperative audiometric and speech audiom-
etry tests were performed on both ears before and after the activation. Main Outcome Measures: Pure tone free field audiometry. Binaural free field speech audiogram. Results: Aided pure tone free field audiometry AMEI results show an increase in air conduction. Speech audiogram showed better discrimination scores in AMEI-aided situations. No complications were observed. Conclusion: AMEI after surgery followed by radiotherapy for middle ear cancer is feasible. Acoustic results in obliterated ear are satisfactory. Key Words: Active middle ear implantV CarcinomaVEar cancerVRadiotherapyVTemporal bone. Otol Neurotol 35:e146Ye152, 2014.
OBJECTIVE
undergoing rehabilitation has grown because of the development of new hearing aides. In the last several years, active middle ear implants (AMEIs) have evolved to a broader spectrum of conductive or mixed hearing loss (HL) indications (11,12). To overcome the limitation of a ventilated cavity, a subtotal petrosectomy was successfully carried out (13,14). After performing a subtotal petrosectomy, a floating mass transducer (FMT) could be placed onto the round window (15Y17) or to the stapes and the obliterated middle ear (18,19). This technique and results are reported in literature (13, 20); however, no experiences treating post full-dose radiotherapy have been reported. The purpose of this study was to evaluate the audiologic results in a patient treated for ear cancer to establish the feasibility of the procedure.
Cancer of the external auditory canal and temporal bone represents less than 0.2% of head and neck cancers with an annual incidence between 1 and 6 per million (1Y3). As reported in our previous published series, disease-free survival is 73.3%, and overall survival is 75.6% (4). These data are consistent with other results reported in literature (5,6). The increased survival rate reported over the last few years reflects an improvement in prognosis due to standardized microsurgical otologic procedures and advanced radiotherapy and chemotherapy protocols (7,8). The main adverse effects of treatment after undergoing lateral petrosectomy may include totally blocked residual conductive hearing and transmissive deafness; however, it is still possible to directly stimulate the round window membrane or the stapes (9,10). The number of patients
Patient A 73-year-old man with external auditory canal squamous cell carcinoma (SCC) extending into the middle ear (C2T3N0M0 stage III) (21) was treated by lateral petrosectomy (22), total parotidectomy, lateral neck dissection, and obliteration of the cavity by a pedicled
Address correspondence and reprint requests to Giovanni Cristalli, M.D., Department of Otolaryngology Head and Neck Surgery, Via Elio Chianesi, 53, 00144 Rome, Italy; E-mail: [email protected] The authors disclose no conflicts of interest. No funds to disclose.
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FIG. 1. A, Preoperative axial CT scan displaying left ear SCC. B, Operatory field at the end of the lateral temporal bone resection and total parotidectomy. C, Myocutaneous pedicled major pectoralis muscle flap to close the defect and obliterate the cavity.
pectoralis major myocutaneous flap (Fig. 1), followed by postoperative image modulated radiotherapy (64.5 Gy on the tumor region and 50 Gy on the neck) (Figs. 2 and 3). Preoperative and postoperative audiometric testing on both ears included pure-tone thresholds measured air conduction (AC) through headphones and bone conduction (BC) thresholds. Intervention A Vibrant Soundbridge (VSB) Model 502B (VSBY MED-EL GmbH, Innsbruck Austria) was implanted in the
FIG. 2.
left ear using a floating mass transducer (FMT) attached to the stapes by partial ossicular replacement prosthesis (PORP) (titan Vibroplasty clip-coupler 0.2 2.5 mm code 50284) (23). The pectoralis major myocutaneous flap, used during the previous operation to obliterate the cavity, was carefully elevated. In this case, a stapes superstructure was present and mobile. A sizer device was used to position and verify the bone bed of the implant transducer (FMT), and the receiver was secured by tie-down holes (24,25). The pectoralis major muscle was repositioned to
Conformational RT planning and calculation of radiation dose according to the risk areas to treat. Otology & Neurotology, Vol. 35, No. 4, 2014
Copyright © 2014 Otology & Neurotology, Inc. Unauthorized reproduction of this article is prohibited.
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FIG. 3. Postoperative CT scan (A) axial plane and (B) coronal plane confirming no evidence of relapse of cancer and obliteration of the operative cavity.
obliterate the cavity again, and a bandage was applied for 1 day. A course of antibiotics was administered for 7 days, and the patient was discharged after 48 hours. The first fitting of the patient was scheduled 4 weeks postsurgery (Fig. 4). Main Outcome Measures Pure tone free field audiometry and binaural free field speech audiogram were used. RESULTS After the first surgery and administering radiotherapy, no complications were observed. Pure tone audiometry (PTA) frequencies of 5 dB at 0.25 and 0.5 KHz, 20 dB at 1 KHz, 10 dB at 2 kHz, and 5 dB at 4 KHz were recorded observing a decrease in bone conduction in the operated ear. No significant changes were observed regarding the BC threshold in the other ear. VSB activated pure tone free field audiometry with contralateral ear plugging and masking showed an increase in AC of 25 dB SPL at 0.25, 0.5, and 1 KHz and an increase in AC of 30 dB at 2 KHz. Frequencies of 4 and 8 KHz were not able to be evaluated without VSB activation; postactivation AC at 4 KHz and 8 KHz was 70 dB SPL in both frequencies. A postoperative binaural free field speech audiogram showed a discrimination score of 70% at SD 65 dB and 90% at SD80 dB in the presence of an activated VSB,
whereas the score was 30% at SD 65 dB and 50% at SD80 dB when the VSB was deactivated (Fig. 5). After 10 months of follow-up, none of the subsequent complications were observed: skin reactions, infection, extrusion, or any other complications. The patient immediately enjoyed the benefit of hearing improvement in the quality of sound and in daily conversation intelligibility. The patient predominantly relies on the implant and uses the contralateral hearing aid as support. Follow-up schedule for SCC recurrence relied on high-definition CT scan with contrast of head and neck every 6 months for the first 2 years and once a year thereafter together with undergoing a PET-CT scan every year. DISCUSSION Most advanced ear cancers require radical surgery followed by radiotherapy. This strategy limits the range of acoustical rehabilitation procedures offered. Radiation induced damage can affect all structures of the hearing organ from external, middle, and inner ear up to the central auditory pathways. In addition, complications may be related to dose and field (95 cm) (26,27). Cochlear implantation for postirradiated patients share the same complication risks compared with nonirradiated patients. However, it is important to consider that experiences reported in literature are conducted mainly in radiotherapy for treating nasopharynx carcinoma where the dose field differs entirely from the one applied in our case
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FIG. 4. AYB, FMT mass transduction anchored on the head of the stapes by Vibroplasty-Clip-Coupler Standard size 0.2 2.5 mm. C, Preparation for positioning the receiver similar to the procedure used in the cochlear implant. D, Patient at the moment of activation. E, X-ray postimplant.
(28). The application of a VSB after lateral petrosectomy surgery in malignancy differs substantially when addressing benign cancers. In fact, in the latter case, where full-dose radiotherapy is usually not indicated, surgery is less demolitive where no flap is generally used for repair or to eliminate the defect (13,14). The surgery procedure was divided into 2 distinctive stages. The first stage aimed at removing the tumor and the second one toward hearing rehabilitation. This 2-step procedure was mandatory mainly for 2 reasons. First, because recurrence must be excluded during the second stage and secondly, that the complete closure of the Eustachian tube must be properly carried out to avoid any possible infection of the nasopharynx. There is a very high rate of wound healing complication and infection after radiotherapy (29). There are no published data on ear implanted devices after radiotherapy, but the risk of wound infection and rejection of the implant within 6 months is believed to be very high. Potential problems in wound healing and infection in postirradiated patients must be considered. Our experience demonstrates that scaring, flap positioning, surgical exposure of meningeal layers, lateral sinus, or jugular bulb do not represent contraindications for AMEI procedure (30). Postirradiation sensory neural hearing loss (SNHL) occurs in about one-third of patients treated with definitive radiation including the inner ear for doses over 47 Gy (31,32). SNHL typically appears several months or years after completing treatment, as we observed in this case.
VSB was preferred as to a Bone-Anchored Hearing Aid (BAHA) based on the following 2 reasons: 1) the patient had a low BC, which is a contraindication to BAHA, and 2) the high risk of complications because of the osseointegration and skin infection in case of BAHA (11,33Y47). Data regarding the osseointegration of BAHA in the irradiated bone is currently lacking. However, the osseointegration rate is low in dental implant therapy in irradiated head and neck cancer patients with a long follow-up (48,49). Satisfactory hearing after lateral petrosectomy surgery presents a serious challenge. Our results reflect a high score after VSB activation even if additional BC PTA deterioration is recorded after tumor surgery and radiotherapy. In addition, VSB amplification indicates a good functional result bypassing the external and partially the middle ear. The speech audiogram shows a discrimination in a VSB-aided situation having a score of 70% at 65 dB SPL and 90% at 80 dB SPL. With the VSB deactivated, the score was 30% at 65 dB and 50% at 80 dB. Potential problems in wound healing and infection in postirradiated patients must be considered. Our experience demonstrates that there are no contraindications for the AMEI procedure. Our follow-up for detecting SCC recurrence adopted the use of a CT scan only because of the possible risk of dislocation or magnetization of the VSB after performing a magnetic resonance imaging (50,51), in the hope that this experience may represent the Otology & Neurotology, Vol. 35, No. 4, 2014
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FIG. 5. A, PTA preoperative (predemolitive surgery and radiotherapy). B, PTA postoperative first procedure (surgery and radiotherapy). C, PTA open space contralateral ear masked with plug; green line VSB not activated; blue line VSB activated. D, Postoperative speech audiogram disyllabic and mixed logotome list open space binaural; comparison of unfitted score and aided with VSB: r, VSB not activated; 0, VSB aided.
first step toward a wider use and more extensive use in the application of AMEI in patients with SCC extending into the middle ear and treated by surgery and radiotherapy. Acknowledgments: The authors thank Dr. Francesco Bianco for his contribution in the audiometric testing.
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APPENDIX Patient In our institution, from 2003 until present, 37 ear malignancies have been treated by lateral petrosectomy and adjuvant radiotherapy. A 73-year-old man was selected and treated for external auditory canal squamous cell carcinoma (SCC) extended to the middle ear. The clinical stage according to Pittsburgh classification (21) was C2T3N0M0 stage III. On September 2009, the patient was treated by lateral petrosectomy (22), total parotidectomy, lateral neck dissection, and obliteration of the cavity by a pedicled pectoralis major myocutaneous flap (Fig. 1). From October to December 2010, the patient received postoperative image modulated radiotherapy: 64.5 Gy on the tumor region and 50 Gy on the neck (Fig. 2). High-definition CT scan was performed in axial Otology & Neurotology, Vol. 35, No. 4, 2014
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and sagittal plane before the positioning of the AMEI (Fig. 3). Preoperative and postoperative audiometric testing on both ears included pure-tone thresholds measured air conduction (AC) under headphones and bone conduction (BC) thresholds. The frequencies were tested from 0.125 to 8 KHz (Amplaid 309 audiometer). Speech audiometry test was performed using standardized disyllabic and mixed logotome list (Amplifon cd-Audio 1 cod.52111535) to assess the patient’s speech understanding in quiet free field silent booth binaurally before and after the AMEI activation. Percentage of speech perception with stimulus intensity of 65 dB SPL (SD65 dB) and 80 dB SPL (SD 80 dB) was determined. After final implantation, aided speech measurements with SD 65 dB and SD 80 dB were performed without contralateral ear masking. Intervention After informed consent was obtained by the patient, in March 2012, a Vibrant Soundbridge (VSB) Model 502B
(VSBYMED-EL GmbH, Innsbruck Austria) was implanted in the left ear using a floating mass transducer (FMT) attached to the stapes by partial ossicular replacement prosthesis (PORP) (titan Vibroplasty clip-coupler 0.2 2.5 mm code 50284) (23). All the devices were CE marked (approved in European Union). No local ethical committee approval was required for this study. The pectoralis major myocutaneous flap, used during the previous operation to obliterate the cavity, was carefully elevated. In this case, the superstructure of the stapes was present and mobile. A sizer device was used to perform a bony bed for the implant transducer (FMT), and the receiver was secured by tie-down holes (24,25). The pectoralis major muscle was repositioned to obliterate again the cavity and a bandage was applied for 1 day; antibiotic therapy was administered for 7 days, and the patient was discharged after 48 hours. The first fitting of the patient was scheduled 4 weeks postoperatively (Fig. 4).
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