Transcript Results of the National Paediatric Bilateral Cochlear

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
Nottingham University Hospitals NHS Trust
• Working on behalf of:
– The UK National Paediatric Cochlear Implant
Surgical Audit Group
14 Contributing Centres
Belfast
Birmingham
Bradford
Bristol
Cambridge
GOSH
Manchester
Middlesbrough
Nottingham
Oxford
RNTNE
Southampton
St George’s
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
Connexin 26
Usher
Waardenburg
Pendred
n=639 (80%)
n=41 (4.2%)
n=14 (1.8%)
n=12 (1.5%)
n=10 (1.3%)
• Acquired n=141 (14.7%)
– Meningitis
– CMV
• Not specified n=21 (2.2%)
n=55 (39.0%)
n=35 (24.8%)
Results – Pre-op Imaging
• Recorded in 925 cases (96.3%)
• Both MRI and CT
• MRI alone
• CT alone
511 (55.2%)
280 (30.2%)
134 (14.5%)
Results - Duration of Surgery
n=631
(66%)
Min
Max
Mean
Median
Bilateral
n=284
01:40
08:45
04:32
04:15
Sequential 01:00
n=262
07:25
02:25
02:15
Unilateral 01:25
n=85
09:45
02:44
02:30
Times in hours:minutes. Entering anaesthetic room to leaving theatre
Results - Duration of Surgery
10
9
8
7
6
Time 5
(hrs) 4
3
2
1
0
0
50
100
150
200
250
n
Data for Bilateral Simultaneous CI (n=284)
300
Results - Duration of Surgery
160
140
120
100
n 80
60
40
20
0
<=3
>3 to 4
>4 to 5
>5 to 6
>6 to 7
Surgical Time (Hours)
Data for Bilateral Simultaneous CI (n=284)
>7
Results - Duration of Surgery
• Duration of surgery for cases of bilateral
simultaneous CI:
– With trainee (n= 142)
– No trainee (n=136)
4:36
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 in
626 (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
– Intra-op X-ray
– Both intra- and post-op
– No imaging
n=603 (71%)
n=111 (13%)
n=75 (9%)
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 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. 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 recorded
Only immediate minor complications recorded
Immediate Major Complications
• CSF leak requiring lumbar drain
• Bleeding requiring transfusion
• Return to theatre to reposition
2 (0.2%)
1 (0.1%)
1 (0.1%)
• No permanent facial palsy, no deaths
Delayed Major Complications
•
•
•
•
•
Device failure
Wound infection with explantation
Meningitis
Wound infection drained in theatre
Theatre for air collection over implant
6 (0.6%)
2 (0.2%)
1 (0.1%)
1 (0.1%)
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
Tip rollover – device changed
Device not working – changed
Device repositioned
4 (0.4%)
2 (0.2%)
1 (0.1%)
1 (0.1%)
• Post-op
–
–
–
–
–
–
Imbalance – prolonged stay
Swelling – conservative mx
Bleeding/ haematoma - cons mx
Wound infection – abx
Tip rollover – no revision
Facial weakness – partial
12 (1.3%)
11 (1.1%)
10 (1.0%)
7 (0.7%)
4 (0.4%)
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
Kim
2008
China
1237*
4y 8m
NS
0.5
0.3
0
0
0.3
Korea
572
3y 6m*
0.3
0.2
0
NS
1.7*
Loundon
2010
Qiu
2011
France
434
NS*
(<14 y)
4y 7m
5y 6m
2.5
0.2
0.4
0.2
NS
China
416*
6y
2y 8m
0.5
0.2
NS
0.5
NS
Trotter
2009
Venail
2008
Bhatia
2004
Ciorba
2012
Black
2007
Kandogan
2005
Hansen
2010
Lescanne
2011
McJunkin
2010
Australia
402
NS
NS
0.7
NS
NS
NS
4.4
France
322
5y 7m
6y 9m
1.6
0.3
NS
NS
4.9
UK
300
5y 1m
4y
0.3
0.7
0
0
NS
Italy
298
4y 8m
3y 10m* NS*
0
0
NS*
NS*
UK
221
5y 2m
NS
2.3
0.5
0
0
NS
Turkey
205
NS
NS
0
0.4
0
0
NS
Denmark 187
2y 8m
3y
0
0.5
0
NS
NS
France
140
3y 7m
NS
1.4
0.7
0
NS
1.4
USA
136
> 3y
0.7
0
0.7
0
0.7
Arnoldner
2005
Austria
128
NS
(<18y)
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.