Abstract
Purpose
The objective of this study was to achieve uniform reporting of complications and failures in cochlear implantation, to analyze complications and failures and to identify risk factors for complications in a series of over 1300 cochlear implantations.
Methods
In a retrospective chart review and observational study, data from all cochlear implantations from 1987 to 2015 were entered in a custom-made database. Complications were classified using the contracted form of the Clavien–Dindo system and risk factors were identified by statistical analysis.
Results
A complication rate of 18.4% and a device failure rate of 2.9% were found. There was a higher rate of hematoma in patients with a clotting disorder and when a subtotal petrosectomy was performed, a higher rate of wound infections in patients who were not vaccinated against Streptococcus pneumoniae and a higher rate of meningitis in patients with an inner ear malformation.
Conclusions
The use of a strict definition of a medical complication and device failure—in combination with the Clavien–Dindo classification system—enables uniform and objective registration of adverse events and prevents any tendency to downgrade complications. Complication and failure rates in this series are comparable to those reported in the literature. These results stress the need for pneumococcal vaccination, which may prevent general wound infections, but is especially important for patients with inner ear malformation, who have an increased risk of (postoperative) meningitis.
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Acknowledgements
The authors thank Ms E. Dekkers for assistance with the data collection.
Funding
Cochlear Europe Ltd financially supported this study.
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Authors declare that they have no conflict of interest.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study formal consent is not required.
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Theunisse, H.J., Pennings, R.J.E., Kunst, H.P.M. et al. Risk factors for complications in cochlear implant surgery. Eur Arch Otorhinolaryngol 275, 895–903 (2018). https://doi.org/10.1007/s00405-018-4901-z
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DOI: https://doi.org/10.1007/s00405-018-4901-z