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Results of the National Paediatric Bilateral Cochlear Implant
Surgical Audit
Mr Stephen BroomfieldENT Locum Consultant
University Hospitals Bristol
Southampton, April 2013
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
14 Contributing Centres
Belfast MiddlesbroughBirmingham NottinghamBradford OxfordBristol RNTNECambridge SouthamptonGOSH St George’sManchester St Thomas’s
Acknowledgement
• Funding for surgical audit:
– Supported by a grant from the Healthcare Quality Improvement Partnership (HQIP)
www.hqip.org.uk
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
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
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
Results - Demographics
• 961 CI recipients (1397 implants)
– 436 bilateral simultaneous– 394 bilateral sequential– 131 unilateral
• Male:Female 474:462 (data missing n=25)
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)
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)
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%)
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%)
Results - Duration of Surgeryn=631 (66%)
Min
Max Mean Median
Bilateraln=284
01:40 08:45 04:32 04:15
Sequentialn=262
01:00 07:25 02:25 02:15
Unilateraln=85
01:25 09:45 02:44 02:30
Times in hours:minutes. Entering anaesthetic room to leaving theatre
Results - Duration of Surgery
Data for Bilateral Simultaneous CI (n=284)
0123456789
10
0 50 100 150 200 250 300
n
Time (hrs)
0
20
40
60
80
100
120
140
160
<=3 >3 to 4 >4 to 5 >5 to 6 >6 to 7 > 7
Surgical Time (Hours)
n
Results - Duration of Surgery
Data for Bilateral Simultaneous CI (n=284)
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
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%)
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%)
Results – Length of Stay
Day Case n=50 (6.3%)
24 Hours n=642 (80.8%)
48 Hours n=74 (9.3%)
72 Hours n=15 (1.9%)
> 72 Hours n=14 (1.8%)
n=795. Maximum length of stay was 9 days
Complications
Major ComplicationAn 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 ComplicationAn adverse event managed (short term) by medical measures or by a minor surgical procedure (e.g. aspiration of a haematoma)
Bhatia K, et al. Otol Neurotol 2004;25:730-739.Hansen S, et al. Acta Oto-laryngologcia 2010;130:540-549.
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
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
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)
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%)
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
Results - Complications
• Patients presenting with complications spread evenly across centres
• No differences detectable between bilateral simultaneous, sequential, unilateral
Author Location N= Mean Age
Mean F-up
Wound explant %
Facial paresis %
Meningitis %
CSF Leak
%
Device Failure%
Current Study 2013
UK 961 6y 1y 0.2 0.2 0.1 0.2 0.6
Ding 2009
China 1237* 4y 8m NS 0.5 0.3 0 0 0.3
Kim2008
Korea 572 NS*(<14 y)
3y 6m* 0.3 0.2 0 NS 1.7*
Loundon 2010
France 434 4y 7m 5y 6m 2.5 0.2 0.4 0.2 NS
Qiu2011
China 416*
6y 2y 8m 0.5 0.2 NS 0.5 NS
Trotter 2009
Australia 402 NS NS 0.7 NS NS NS 4.4
Venail 2008
France 322 5y 7m 6y 9m 1.6 0.3 NS NS 4.9
Bhatia 2004
UK 300 5y 1m 4y 0.3 0.7 0 0 NS
Ciorba2012
Italy 298 4y 8m 3y 10m* NS* 0 0 NS* NS*
Black2007
UK 221 5y 2m NS 2.3 0.5 0 0 NS
Kandogan 2005
Turkey 205 NS NS 0 0.4 0 0 NS
Hansen 2010
Denmark 187 2y 8m 3y 0 0.5 0 NS NS
Lescanne 2011
France 140 3y 7m NS 1.4 0.7 0 NS 1.4
McJunkin 2010
USA 136 NS (<18y)
> 3y 0.7 0 0.7 0 0.7
Arnoldner 2005
Austria 128 5y NS 0 0.8 0 0 14
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
Conclusion – Areas for Improvement
• Longer follow up
• International consensus on reporting of complications
• Improved reporting of all audit data points
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
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.