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Results of the National Paediatric Bilateral Cochlear Implant Surgical Audit

Results of the National Paediatric Bilateral Cochlear Implant Surgical Audit. Mr Stephen Broomfield ENT Locum Consultant University Hospitals Bristol Southampton, April 2013. Acknowledgements. Co-ordinating team: Professor G O’Donoghue John Murphy, Steve Emmett, Dominik Wild

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Results of the National Paediatric Bilateral Cochlear Implant Surgical Audit

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  1. Results of the National Paediatric Bilateral Cochlear Implant Surgical Audit Mr Stephen Broomfield ENT Locum Consultant University Hospitals Bristol Southampton, April 2013

  2. Acknowledgements • Co-ordinating team: • Professor G O’Donoghue • John Murphy, Steve Emmett, Dominik Wild Nottingham University Hospitals NHS Trust • Working on behalf of: • The UK National Paediatric Cochlear Implant Surgical Audit Group

  3. 14 Contributing Centres Belfast Middlesbrough Birmingham Nottingham Bradford Oxford Bristol RNTNE Cambridge Southampton GOSH St George’s Manchester St Thomas’s

  4. Acknowledgement • Funding for surgical audit: • Supported by a grant from the Healthcare Quality Improvement Partnership (HQIP) www.hqip.org.uk

  5. Aims • To establish a large dataset of national paediatric cochlear implant procedures • To generate evidence for establishing future best surgical practice • Governance issues in early days of bilateral CI • Data for BCIG review of service • Data for NICE’s requirement to audit service

  6. Aims • To address the real concern about surgery/ anaesthesia of parents considering CI for their child • Although risk of complications low following CI, potential might be increased with bilateral simultaneous CI e.g. blood loss, vestibular impairment

  7. Methods • Prospective multi-centre audit • All CIs in children (birth to 18 yrs) included • Surgeon completed voluntary questionnaire • Collection Jan 2010 to Dec 2011 • Data collected including: • Demographics • Aetiology • Co-morbidity • Electrophysiology/ imaging • Complications • Length of stay

  8. Results - Demographics • 961 CI recipients (1397 implants) • 436 bilateral simultaneous • 394 bilateral sequential • 131 unilateral • Male:Female 474:462 (data missing n=25)

  9. Results – Change in Surgery • 8 cases (1.8%) of planned bilateral CI became unilateral: • Mucosal bleeding (n=3) • Cochlear obliteration (n=2) • Anaesthetic/medical concerns intra-op (n=2) • Anatomical difficulties (n=1)

  10. Results - Age • Age at Implantation (n=916) Years:Months • Mean age 6:1 (median 4:9, range 4m to 18y) • For congenitally deaf having bilateral CI (n=345):Mean age 3:1 (median 2:2, range 4m to 17:8) • For sequential CI (n= 383):Mean age 8:8 (median 8:2, range 7y to 18y)

  11. Results - Aetiology • Congenital n=799 (83%) • Majority unknown aetiology n=639 (80%) • Connexin 26 n=41 (4.2%) • Usher n=14 (1.8%) • Waardenburg n=12 (1.5%) • Pendred n=10 (1.3%) • Acquired n=141 (14.7%) • Meningitis n=55 (39.0%) • CMV n=35 (24.8%) • Not specified n=21 (2.2%)

  12. Results – Pre-op Imaging • Recorded in 925 cases (96.3%) • Both MRI and CT 511 (55.2%) • MRI alone 280 (30.2%) • CT alone 134 (14.5%)

  13. Results - Duration of Surgery Times in hours:minutes. Entering anaesthetic room to leaving theatre

  14. Results - Duration of Surgery Data for Bilateral Simultaneous CI (n=284)

  15. Results - Duration of Surgery Data for Bilateral Simultaneous CI (n=284)

  16. Results - Duration of Surgery • Duration of surgery for cases of bilateral simultaneous CI: • With trainee (n= 142) 4:36 • No trainee (n=136) 4:26 Extent of involvement/ complexity of cases not recorded

  17. Results – Intra-operative Tests • Documented in 910 cases (95%) • Telemetry to measure electrically evoked cortical action potential (ECAP) from auditory nerve in626 (69%) • CI integrity test without full ECAP in 55 (6%) • Stapedial reflexes in 129 (14%)

  18. Results – Post-op Imaging • Documented in 854 (89%) cases: • Post op X-ray n=603 (71%) • Intra-op X-ray n=111 (13%) • Both intra- and post-op n=75 (9%) • No imaging n=65 (8%)

  19. Results – Length of Stay n=795. Maximum length of stay was 9 days

  20. Complications Major Complication An adverse event occurring during or after surgery (short term) that necessitated a further major surgical intervention, admission to ITU, exposure to invasive intervention or a permanent disability such as persistent facial weakness Minor Complication An adverse event managed (short term) by medical measures or by a minor surgical procedure (e.g. aspiration of a haematoma) Bhatia K, et al. OtolNeurotol2004;25:730-739. Hansen S, et al.ActaOto-laryngologcia2010;130:540-549.

  21. Complications • Immediate • intra-operative or first week following surgery • Delayed • occurring after one week, within the period of the audit Immediate and delayed major complications recordedOnly immediate minor complications recorded

  22. Immediate Major Complications • CSF leak requiring lumbar drain 2 (0.2%) • Bleeding requiring transfusion 1 (0.1%) • Return to theatre to reposition 1 (0.1%) • No permanent facial palsy, no deaths

  23. Delayed Major Complications • Device failure 6 (0.6%) • Wound infection with explantation 2 (0.2%) • Meningitis 1 (0.1%) • Wound infection drained in theatre 1 (0.1%) • Theatre for air collection over implant 1 (0.1%) • Note range of follow up 0 to 24m, mean 12.5m • Overall major complication rate 1.6% (0.9% if device failures excluded)

  24. Immediate Minor Complications • Intra-op • CSF Leak 4 (0.4%) • Tip rollover – device changed 2 (0.2%) • Device not working – changed 1 (0.1%) • Device repositioned 1 (0.1%) • Post-op • Imbalance – prolonged stay 12 (1.3%) • Swelling – conservative mx 11 (1.1%) • Bleeding/ haematoma - cons mx 10 (1.0%) • Wound infection – abx 7 (0.7%) • Tip rollover – no revision 4 (0.4%) • Facial weakness – partial 2 (0.2%)

  25. Immediate Minor Complications • 62 reported overall (6.5%) • 12 cases of imbalance • 4 bilateral simultaneous, 5 sequential, 3 unilateral • Most (n=10) required one additional night • Maximum (n=2) required 3 nights • 2 cases of partial (House Brackmann grade 3) facial weakness • Both resolved

  26. Results - Complications • Patients presenting with complications spread evenly across centres • No differences detectable between bilateral simultaneous, sequential, unilateral

  27. Conclusion • Collaboration across the UK has allowed for one of the largest reported series to date • All UK centres employ a similar approach: • Experienced teams • Modern surgical practices • Centres with access to paediatric, anaesthetic and ICU support (RCS Guidelines) • Adherence to immunisation protocols • Intra-operative precautions • High vigilance for complications

  28. Conclusion – Areas for Improvement • Longer follow up • International consensus on reporting of complications • Improved reporting of all audit data points

  29. Conclusion • Overall major complication rate 1.6% (0.9% excluding device failures) • Comparable to other large series • No permanent facial palsies, no deaths • No evidence for increased complications following bilateral simultaneous compared to sequential or unilateral CI

  30. Conclusion This study provides evidence that bilateral paediatric cochlear implantation, whether simultaneous or sequential, is a safe procedure in cochlear implant centres in the UK, thus endorsing its role as a major therapeutic intervention in childhood deafness.

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