North West Clinical Neuroscience Partnership
The Management of People with
Subarachnoid Haemorrhage
A North West Clinical Framework
February 2001
Contents
Section 1
Section 2
Section 3
Section 4
Introduction
The North West Clinical Framework
Members of the Working Group
page 3
page 3
The Background
Subarachnoid haemorrhage
The rise of Interventional Radiology (Coiling)
Practical issues
page 4
page 5
page 6
The management of acute, non-traumatic
aneurysmal, subarachnoid haemorrhage
Presentation
Diagnosis
Transfer
Investigation
Treatment
Experience, Outcome and Training
Rehabilitation, Transfer and Discharge
page 8
page 8
page 9
page 11
page 11
page 13
page 16
Conclusions
North West Clinical Framework – Summary
Implications for the North West
page 18
page 21
Appendix 1 Neurovascular Workshops
Summary Report
Future management of Subarachnoid
Haemorrhage, A Molyneux & RSC Kerr
Changes in the management of intracranial
aneurysms, RJ Nelson & EA Varian
General Discussion
ISAT (overhead slides). Dr A Molyneux
page 23
page 24
page 25
page 28
page 29
page 31
Appendix 2 Working Group Report
Neurovascular Services in the North West
Region
page 35
Appendix 3 North West Neurovascular Network
page 45
Appendix 4 Proposed Minimum Standards for Accreditation
page 46
Appendix 5 North West Clinical Neuroscience Partnership
page 47
Appendix 6 Role of the Voluntary Agencies Group
page 49
References
page 50
2
Section 1
Introduction
The North West Clinical Framework
This guidance has been produced by the North West Clinical Neuroscience
Partnership as a Framework for the commissioning and provision of care for people
who have sustained a Subarachnoid haemorrhage.
The North West Clinical Neuroscience Partnership is a partnership between the 3
Zonal Commissioners of Specialised Services in the North West, working on behalf
of the Health Authorities and Primary Care Groups and Trusts in the North West, and
the 3 Specialist Neuroscience Provider Trusts. The Partnership works in close
cooperation with the North West Regional Specialised Commissioning Group and
also includes representation from the Specialised Health Commissioning Service in
Wales. The Partners have jointly agreed to develop a series of Clinical Frameworks
and to work together to develop a Region-wide commissioning process which will
ensure that the 7 million people of the North West and North Wales have access to a
high quality Clinical Neuroscience service. The details of the Partners and the
Partnership Agreement are included as Appendix 5.
A group of Neurosurgeons and Neuroradiologists met between Spring 1999 and
Autumn 2000 to produce the Framework and workshops were held in each of the 3
Specialist Provider Trusts at which external advice was a major feature. Following
the development of draft guidelines wider consultation will be undertaken including
voluntary agencies, staff of Acute General Hospitals, Primary and Community care.
The Partnership believes that the implementation of this Framework will improve the
care of people with subarachnoid haemorrhage giving better outcome and ensuring
that the service remains up-to-date, accessible and appropriate.
Members of the Working Group
Dr W Gunawardena Neuro-radiologist, Preston
Mr N Gurusinghe
Neurosurgeon, Preston
Mr J Holland
Neurosurgeon, Manchester
Dr R Laitt
Neuro-radiologist, Manchester
Dr T Nixon
Neuro-radiologist, Liverpool
Mr MDM Shaw
Neurosurgeon, Liverpool
Dr IR Williams
Project Director
The late Professor R Lye and Mr P Richardson attended some of the meetings as
deputies making very helpful contributions.
Mr K Lindsay, Dr A Molyneux and Mr R Nelson led the Trust workshops and
provided much valuable advice.
Comments from Dr CA Young and Dr A Luksza were helpful in drafting parts of the
Framework.
3
Section 2
The Background
Subarachnoid Haemorrhage
Subarachnoid haemorrhage (SAH) is a relatively infrequent event. It is variously
estimated to occur in 2–22.5 per 100,000 of the population each year in different
countries (Ingall et al1). Excluding the extremes of China (2) and Northern Finland
(22.5) most studies give figures between 6 and 11 per 100,000 per year (Bonita et
al2,Cesarini et al3, Ingall et al4). There are no good local figures but assuming an
incidence of 8-10 would give about 600 events per year in the North West of England
and North Wales. In the majority of people with SAH the cause is found to be an
aneurysm, a small balloon like swelling arising from an artery at the base of the
brain. Possibly as many as 35% of these people have other causes, die immediately
or are so badly damaged that no form of active treatment is considered (Cesarini et
al3). After initial diagnosis at the local DGH, the remaining 65% are transferred to a
Regional or Sub-regional Neurosurgery unit for further investigation and treatment.
At the time of transfer less than 50% of patients who survived the initial bleed are
free from neurological damage (Cesarini et al3).
Since 1931 the treatment has been surgical with open operation leading to the
placing of a metal clip across the neck of the aneurysm to prevent further bleeding.
Initial figures for outcome were poor but there has been a marked improvement with
the development of new surgical techniques and peri-operative care (Cesarini et al3).
Even so, depending on the way outcome is measured, 8 to 32 % of people who have
no persisting damage after the initial bleed will either die or be severely disabled.
For people with persisting damage after the initial bleed the outcome is much worse
(Cesarini et al3,Kassell et al5 , Roos6).
One of the major causes of death and morbidity following SAH is the failure of
normal control of blood flow to parts of the brain resulting in severe and often
irreversible damage (ischaemia). The reason for this is not understood and efforts to
find an effective prophylactic or therapeutic intervention have not so far been very
successful. However trials of treatment with a drug (Nimodipine) which was thought
to reduce ischaemic damage showed a convincing reduction in severe morbidity
following SAH although the mechanism is far from clear. (Pickard et al 7).
Modification of blood pressure, and circulation (Triple H therapy) in the setting of an
Intensive Care Unit (ITU) have also been shown to reduce complications (Kassell et
al8).
The other major cause of mortality and morbidity is re-bleeding of the aneurysm.
Such a re-bleed occurs in about 1% of people per day for the first 6 weeks after the
initial bleed: for many patients the re-bleed is fatal or severely disabling. Early
surgery has been advocated in an attempt to reduce this risk. Unfortunately other
risks seem to balance the risk of rebleeding giving no over-all advantage in outcome
for early surgery (Kassell et al9).
4
Until recently evidence suggested that the most appropriate management of people
with no persisting neurological damage after aneurysmal SAH was to start
Nimodipine as soon as the diagnosis had been established and to undertake surgery
within 3 days. Post-operative care should be in an ITU where problems will be
recognised and treated and Triple H therapy can be instituted as necessary. In spite
of this at least 8% (Cesarini et al3) and possibly 32% (Roos6) of people have a poor
outcome. More recent work shows that even this might be an under-estimate. Many
people who had been classed as having a good outcome using the standard
Glasgow Outcome Scale have quite considerable cognitive and psychological
impairment which prevent a return to employment or pre-morbid levels of function
(Buchanan et al10, Hackett et al11). For people with persisting damage after the initial
bleed the outcome is even worse (Kassell et al5).
Thus although SAH is not common it is a serious condition leading to death or
severe disability in more than half those affected, and disabling many survivors to a
greater or lesser extent. In these circumstances the search for alternative forms of
treatment, or ways to reduce the mortality and morbidity associated with current
treatment, is understandable and laudable.
The Rise of Interventional Radiology (Coiling)
Over the last 10 years Neuro-radiologists have been trying to find an effective and
safe way of occluding aneurysms from within the circulation (Guglielmi et al12). The
hope was that by avoiding the need for open operation the morbidity and mortality
would be reduced. Techniques have gradually evolved and results have improved.
The development of detachable platinum coils introduced through a catheter
threaded up the arteries from the groin and positioned precisely in the aneurysm is
seen as a real advance (Vinuela et al13). The technique appears to be at least as
safe as surgery and to have comparable results in the short and medium term
(Brilstra et al14, Byrne et al15, Lempert et al16). Long term results are not yet
available. In some centres these coils are now seen as the first line treatment for
SAH arising from aneurysms in some anatomical locations at the base of the brain.
The final place of coiling in the treatment of intracranial aneurysms is not yet clear.
A large MRC funded, international, multi-centre trial (ISAT) comparing open
operation with coiling began in 1997 and is due to report in 2002. In the meantime,
the studies referred to above have shown the technique to be at least as safe and
effective as open operation for aneurysms in the posterior part of the circulation
(Basilar aneurysms) and to have good short and medium term results in the
treatment of people with anterior circulation aneurysms. This evidence has led to
much wider use of the technique in some countries. For example in some centres in
France about 80% of people with aneurysmal SAH are treated by coiling: in some
UK cities the rate is almost as high (Nelson, personal communication.
Management is currently extremely variable across the North West Region and
differs considerably from some parts of the UK and Europe. Although the MRC trial
will not report until 2002 it is already clear that coiling aneurysms does have a part to
play in the management of aneurysmal sub-arachnoid haemorrhage. This is
particularly true for older people, those whose neurological or general medical
5
condition is poor and in those situations where surgical access would be difficult or
dangerous. Some patients in all parts of the Region will need rapid access to coiling,
or at least to have it considered as one of the options available for their acute
management.
Although no large randomised trial has yet defined the role of coiling and clipping
small trials have shown no over-all difference in outcome (Koivisto et al17). The
study of Claiborne Johnston18 suggests that whatever the outcome of ISAT there will
be a very considerable increase in the demand for coiling and that the time scale is
likely to be short. In a review of the management of over 9500 people with ruptured
aneurysms admitted to University Hospitals in the United States he concluded that
patients treated in hospitals that used coiling were less likely to die in hospital and
that the difference was not small. For every 10% of patients treated by coil
embolisation there was a 9% reduction in in-hospital mortality. “An institution using
coil embolization in 30% of cases would be expected to have 25% fewer in-hospital
deaths compared with one never using the technique.” Whatever the reason such
figures will be hard to ignore.
It was the clear advice of external advisors in the Workshops that we should expect
a rapid move to endovascular treatment (coiling) for 35-40% of patients even if the
ISAT trial shows that surgery is safer in situations where it is possible. If the trial
shows the 2 treatments to be equally effective and to have equal risk then in 2002 at
least 70% of patients would be expected to opt for coiling and only 30% would
require clipping. A result showing coiling to be as effective or more effective but
safer would lead to more than 80% of people with SAH being treated by coiling.
Thus we should not plan for less than 35% treated by coiling and could be faced with
the need to raise this to 70 or 80%. The detail of the presentations is included as
Appendix 1. The implications of such a change would be major and are considered
in Appendix 2. In summary the North West does not have sufficient numbers of
Radiologists with appropriate training and there is a shortage of trainees.
Cooperative working between the Trusts will be necessary even when additional
Radiologists have been appointed. This would have a consequential effect on
Neurosurgery, with reduced numbers of operations and fewer surgeons involved in
treatment of people with SAH, and thus on the provision of the whole service for
people with SAH.
Practical issues
The need to deliver a high quality of care for people afflicted by uncommon
conditions produces a tension between easy accessibility and the need to
concentrate relatively scarce skills and resources on a few sites. In a Region with
densely populated connurbations (Greater Manchester, Merseyside) and more
sparsely populated rural areas (Furness, Snowdonia) these tensions could lead to
the development of systems of care favouring one group at the expense of the other.
Throughout the preparation of this Framework the views of voluntary agencies have
been sought and they have been encouraged to seek wider views through their
membership and through the regional alliances of neurological charities. In
particular they considered the question of the balance between distance from a
Centre and level of experience and expertise in defining the quality of a service. The
recognition that neurosurgical or neuroradiological treatment for people who had
6
sustained a subarachnoid haemorrhage would involve travel to one or other of the
Centres was coupled with 5 very clear statements:
1)
Subarachnoid haemorrage has a profound effect on the lives of the
individual and the family that is long lasting. Treatment at the Centre,
important as it is, is frequently only a small part of the total picture.
2)
Care at the Centre should be demonstrably of a high standard and of a
nature that could not be provided more locally.
3)
Adequate facilities, including travel to and accommodation at the
Centre, should be available to relatives who should be kept fully
informed at every stage.
4)
Care should be continuous regardless of the number of locations in
which that care is provided and the number of people involved.
5)
Communication between professionals in the Centre and the home
District should be prompt and sufficiently detailed to allow care and
support to be provided whenever and wherever it is needed.
In all that follows the working group has tried to keep these points to the fore. It is
also important that they remain to the fore as this Framework is used to commission
and provide the service.
7
Section 3
The Management of Acute, Non-traumatic Subarachnoid
Haemorrhage
1)
Presentation
Non-traumatic SAH can occur at any age but in most series the average age is
around 50. It is more frequent in women. The common presenting features are:
Sudden, severe headache (“worst ever”)
Photophobia
Neck stiffness
Reduced level of consciousness
Neurological impairment.
When all are present there is rarely any serious differential diagnosis, but meningitis,
encephalitis, migraine and other forms of stroke can present in a similar way. If
meningitis is suspected antibiotic treatment should be started while waiting for the
results of the investigations. Sometimes, in spite of a very severe headache nothing
abnormal is found.
When subarachnoid haemorrhage is suspected the patient should be
admitted to hospital immediately.
2)
Diagnosis (Fig 1)
Diagnosis is made on the basis of the clinical presentation and the presence of blood
in the subarachnoid space. This can be demonstrated on a CT scan on the day of
the bleed and is still present in 50% of patients 1 week later (Edlow and Caplan 19).
The scan might also show blood in the ventricular system or within the brain itself as
an intra-cerebral haematoma.
If none of these radiological features is present blood or xanthochromia may be seen
in the CSF when a lumbar puncture is performed (van der Wee et al 20). Lumbar
puncture can be dangerous in the presence of an intracranial haematoma or
hydrocephalus. It should not be performed before a CT scan has excluded this risk.
Even in the presence of SAH the CSF can be normal for up to 12 hours after a bleed
and will return to normal after about 14 days if there is no further bleeding (Edow and
Caplan19). Spectrophotometry of the CSF is a more sensitive way of detecting
xanthochromia than naked eye inspection and should always be used where there is
no obvious xanthochromia in a patient with a story typical of SAH.
In the presence of a typical history, a normal CT and LP can occasionally be
misleading (Edlow and Caplan19). If the history is typical and both CT and naked eye
examination of the CSF are normal spectrophotometry of the CSF specimen should
be undertaken. If no alternative diagnosis is positively confirmed the diagnosis of
SAH should be kept in mind and further advice sought from the Neuroscience
Centre.
8
Because of the need to exclude infection (meningitis) and to establish appropriate
treatment for SAH these tests should be completed within 6 hours of admission to
the A&E department or hospital. Delays in diagnosis have been associated with a
poorer outcome (Hutchinson et al21). However the absence of blood in the CSF less
than 12 hours after the onset of symptoms does not exclude a bleed and it might be
necessary to re-examine the CSF, after discussion with the Neuroscience Centre, if
no alternative diagnosis has been reached.
If there is doubt about the diagnosis or the CT scan cannot be interpreted the images
should be transmitted to the Neuroscience Centre after discussion with the duty
Neurosurgeon.
Patients with suspected SAH should only be admitted to hospitals with
24 hour access to CT scanning and laboratory facilities and with image
transfer links to the Neuroscience Centre.
CT scanning should be performed in every patient suspected of having a
SAH. If the CT does not confirm the diagnosis or give an alternative
diagnosis CSF should be examined. CT and, if needed, LP should be
completed within 6 hours of arrival at the hospital.
Spectrophotometry of CSF should be available in the laboratory and
should be used when there is no xanthochromia in a patient with a story
typical of SAH.
When the story strongly suggests SAH the Neuroscience Centre should
be contacted if no diagnosis has been reached after CT and LP.
3)
Transfer
Following diagnosis the Regional Neurosurgical unit should be contacted and advice
sought on further management. It is likely that nimodipine treatment will be
recommended at this time and transfer to the unit arranged. If the patient is deemed
too ill or unsuitable for transfer clear reasons should be given and a management
plan discussed and agreed. This should include agreeing time intervals and
indications for further contact. The situation should be explained to the patient in as
much detail as is possible.
Doctors in the DGH must have clear lines of communication with the Neuroscience
Centre. On call staff in the Centre must be readily available to give advice to DGH
staff and to discuss arrangements for transfer. It is the Centre’s responsibility to
ensure that DGH staff are made aware of any need for interventions, investigations
or treatment prior to transfer and to define escort requirements. DGH staff then have
the responsibility for arranging transport and escorts as agreed and notifying the
admitting ward of the expected time of arrival. Relatives should also have the
situation clearly explained and be given every assistance in getting to the Centre.
9
Figure 1
Severe Headache
Photophobia ?
Neck Stiffness ?
Neurological Deficit ?
? SAH
Admit to
Hospital with
24 hr CT scan
&
Laboratories
CT
No Blood
Blood
Mass Effect
Contact
Neuroscience
Centre
Contact
Neuroscience
Centre
No Mass
Effect
CSF
(Lumbar
Puncture)
Abnormal
Contact
Neuroscience
Centre
Normal
Observe
? Repeat
CSF
Fails to
Improve
Or
Diagnosis
uncertain
Contact
Neuroscience
Centre
Improves
Discharge
10
Each Neuroscience Centre should agree with each DGH a protocol for
contacting the Centre, transferring images and transferring patients.
This should identify a named person who has overall responsibility for
the arrangements and give a single phone number as a contact point.
Relatives should be given every assistance to enable them to travel to
the Centre.
4)
Investigation
When the diagnosis has been confirmed the source of bleeding must be defined. In
most patients this will be an aneurysm of one of the arteries around the Circle of
Willis at the base of the brain. Arterio-venous malformations account for a small
proportion of SAH and in some patients no source is found. Identification of the
source depends on intra-arterial contrast angiography of the intra-cranial circulation.
This procedure carries a 1.5-3% risk of death or stroke (Kassell et al9) and should
only be performed by a Neuro-radiologist in a Neuroscience Centre. It is important
that the Neurosurgeon responsible for over-all management of the patient and the
Interventional Radiologist are available to discuss the images during the procedure
so that all necessary views are obtained.
Although many aneurysms can be seen on MR angiograms the detail is not yet good
enough to allow technical treatment decisions to be made.
In order to allow treatment to proceed angiography should be undertaken within as
short a time scale as possible. If no aneurysm is demonstrated other investigations
may be required depending on the clinical picture.
As endovascular techniques develop it will be helpful to be able to discuss images
with colleagues in other centres to seek their advice on the need for further
investigation or choice of treatment.
Angiography should only be carried out by experienced Neuroradiologists in a Neuro-radiology department.
Outcome, complications and incidents should be recorded promptly and
analysed every 6 months.
All Neuro-radiologists undertaking Angiography should be part of a
multi-centre benchmarking and audit programme.
All Neuro-radiology departments investigating patients with SAH in the
North West should have the ability to transfer images between Centres.
5)
Treatment
If an aneurysm is demonstrated treatment should be planned jointly by the patient,
relatives, the Neurosurgeon, the Interventional Neuro-radiologist and the
11
Neuroanaesthetist. Treatment plans for the management of people with SAH should
be developed and used as a basis for individual patient treatment plans generated
after assessment and discussion.
Nimodipine
A large randomised clinical trial has shown that nimodipine reduces the
number of people suffering permanent damage following aneurysmal SAH
(Pickard et al7). Unless there are medical contra-indications (See BNF for upto-date list) all patients should receive nimodipine intravenously or orally from
the time of diagnosis.
Trials and Consent
Truly informed consent to the performance of a procedure can only be given
when information on risk and outcome of that procedure, in that setting are
available. However, many questions about the nature and timing of treatment
remain unanswered. This should be explained and where appropriate,
patients should be informed of clinical trials and should be invited to be
included. Patients and/or their representatives should be informed fully about
the background to the trial, any known risks, and the nature of the procedures.
Consent must always be a pre-requisite to inclusion in a trial.
Choice of Treatment
Surgical clipping and endovascular coiling should both be available for
consideration in every patient. The choice of procedure will be made by the
patient or their legally nominated representative and will take into account
advice from the neurovascular team. This advice will depend on the site of
the aneurysm, its size, the condition of the patient and the availability of
facilities and skills. Consent to treatment should follow this process and
should be recorded in the case notes, witnessed and signed, with a copy
given to the patient or representative.
Timing
On the basis of large international trials the timing of surgery is not a critical
factor in determining the over-all outcome: the advantages of earlier surgery
are balanced by the increased risks (Kassell et al9). From the patient’s point
of view and in the interest of maximising the use of resources, treatment
should be undertaken as soon as the patient is fit enough to withstand the
procedure.
Anaesthesia
Anaesthesia for neurosurgical or interventional neuroradiological procedures
is a specialised task. All anaesthetics should be administered by, or closely
supervised by an experienced neuro-anaesthetist. Patients should have an
opportunity to meet the anaesthetist and ask questions prior to giving consent.
The anaesthetist should be satisfied that the risks of anaesthesia are
12
understood and are acceptable in the context of background risks inherent in
the natural history of SAH, and the anticipated outcome of treatment. The
neurosurgeon and the anaesthetist should hold a joint discussion with the
patient to reduce the potential for confusion.
Post-operative Care
With early surgery much of the delayed ischaemic damage associated with
subarachnoid haemorrhage occurs in the post-operative period (Kassell et
al9). It is important that patients are observed closely enough to detect
changes as early as possible. Monitoring of treatment has to be thorough if
further harm is to be avoided. (Cesarini et al3) It is unlikely that this detailed
monitoring could occur outside an Intensive Care Unit dedicated to
Neurological observation.
Management of patients in a Neuro-intensive care unit is a shared
responsibility. Nurses, anaesthetists/intensivists and surgeons/radiologists
should meet regularly to exchange information and to plan the management
of each patient.
Throughout this process the presence of relatives is likely to be of support to
the patient and is helpful to staff in ensuring that the situation is clearly
understood and that decisions are fully informed. They too are often in need
of support and information. Convenient facilities, including accommodation
must be available for relatives.
The treatment of patients with SAH should only take place in Centres
where:
Individual treatment plans (based on approved treatment plans for
SAH) are generated for each patient and a copy given to the
patient/relatives.
Consent is fully informed and a witnessed and signed copy of the
agreement is given to the patient and also filed in the case sheet.
Nimodipine is used in at least 95% of patients in whom there is no
contra-indication.
Both Surgical (clipping) and Radiological (Coiling) treatment can
be provided by specialists with adequate training and experience.
Skilled Neuro-anaesthesia is available.
Neuro-intensive care facilities exist with regular (at least twice
daily) multidisciplinary discussions of the patients and constant
availability of Neurosurgical and Critical Care consultants.
13
Appropriately trained nursing and PAM staff are available.
Convenient
accommodation
and
any
necessary
emotional/psychological support are available to relatives.
6)
Experience, Outcome and Training
There is no good published evidence linking outcome to volume of activity of an
individual practitioner for either clipping or coiling aneurysms. It is clear that there is
a learning curve for both procedures and that less experienced practitioners seek
advice from more experienced colleagues. Over a 13 year period MauriceWilliams22 showed a 35% reduction in his 1 year over-all mortality and an 80%
reduction in surgical mortality which he attributed to increasing operative experience.
Evidence in some other procedures does show a clear link between volume of
activity of an individual, or an institution, and outcome (Hannan et al23, Jollis et al24).
Solomon et al25 have shown a convincing link between outcome and institutional
volume of subarachnoid haemorrhage procedures at low levels of activity.
Intriguingly, as noted earlier Claiborne Johnston18, reporting on the outcome of over
9,000 procedures for ruptured aneurysms has shown a fall of 9% in mortality for
every 10% of patients treated by coil embolisation in an institution. An institution
using coil embolisation in 30% of cases would expect to have 25% fewer in-hospital
deaths compared with one never using the technique. He concludes: “… we found
that outcomes of the surgical care improve dramatically as a larger proportion of
cases are treated by endovascular techniques ……our results suggest that
multidisciplinary, specialised, neurovascular services offering endovascular services
are associated with reduced in-hospital mortality."
Until this year the Society of British Neurological Surgeons advised that aneurysm
surgery should only be undertaken by neurosurgeons who were responsible for at
least 25 operations each year26. Although these figures are not repeated in the 2000
edition of “Safe Neurosurgery”27 there is a clear acknowledgement of the link
between volume and outcome and of the changes in Neurovascular surgery. It is
accepted that for some more senior surgeons their training and experience will stand
them in good stead so that their skill will be maintained for some time with a lower
volume of activity than that needed for a less experienced or less well-trained
colleague.
In the light of the rapid changes occurring in neurovascular surgery it seems
reasonable to recommend that experience should be concentrated in the hands of as
few people as remains consistent with the provision of an accessible, urgent service.
Interventional Neuroradiologists have recommended a minimum of 80 cases per
year in an institution undertaking training and that a trainee should have performed
40 procedures before accreditation. It would be wise to ensure that these figures are
achieved within the Region in order to improve outcome, minimise risk and ensure
adequate numbers of trained staff for the future.
14
Unless adequate audit is undertaken it will not be possible to assess outcome. With
new procedures it is particularly important to generate information on outcome and
risk and to be able to assess performance. It is therefore essential that all clinicians
providing this service agree to keep adequate records and to collect and audit data
on every patient and procedure. This information should be shared with colleagues
in the other North West Centres and with Commissioners. Clinicians and Centres
should participate in all relevant national audits.
Outcome depends on the initial condition of the patient and on the investigative and
therapeutic interventions of many individuals. For each to understand the impact of
their contribution a regular review of outcome with Neurosurgeons, Neuroradiologists, Neuro-anaesthetists, Neuro-pathologists and Nursing and Therapy staff
will be necessary.
As the care of people with SAH becomes concentrated in the hands of fewer
Neurosurgeons and Neuro-radiologists it will be necessary to ensure that trainees in
both specialties have adequate exposure to the management of SAH. This will
require a review of training programmes across the North West to include rotations
to the Neurovascular service. During a period of change it is also important that all
clinicians keep up to date and maintain their skills. The annual appraisal should
focus on the use of continuing education and training, outcome, complaints and
adverse incidents with a view to enabling clinicians to practise to the highest
standard.
All Neurosurgeons and Neuroradiologists providing treatment for people
with SAH should be part of a North West Neurovascular Network which
will set professional and service standards and monitor outcome.
The network will also make recommendations to the North West Clinical
Neuroscience Partnership for any necessary change to achieve or
maintain these standards.
Neurosurgeons would be expected to be responsible for at least 20
operations each year and Neuroradiologists for 40 procedures each
year. The figures should be averaged over the previous 3 years.
It is expected that the Network will oversee a gradual change towards
concentration of the work in the hands of fewer surgeons who will work
closely with Interventional Neuro-radiologists as members of a
neurovascular team providing a service across the North West.
All members of the Network will be required to show through regular
audit and appraisal that they remain up to date and competent in their
knowledge and practice.
Multi-disciplinary reviews of outcome will take place at 3 month
intervals.
These reviews should include: Neurosurgeons, Neuroradiologists, Neuro-anaesthetists, Neuro-pathologists, Nursing and
Therapy staff from all Centres.
15
Centres and individual clinicians should participate in all relevant
national audits.
Trainees in Neurosurgery and Interventional Neuro-radiology in the
North West should only receive their training in the management of
Neuro-vascular disease from members of the Network.
7)
Rehabilitation, Transfer and Discharge
Up to 1/2 of those patients admitted to hospital with a SAH who survive will have
significant persisting disability (Hackett et al11). If no intervention is planned
management will depend on the condition of the patient but at the outset measures
should be taken to minimise subsequent disability through care to skin, bladder,
bowels mouth and limbs. Within 72 hours of admission or the completion of any
intervention, an assessment of the likely need for formal rehabilitation should be
made.
Rehabilitation is not just a set of activities but incorporates an approach to all
interactions between the patient, staff of all disciplines and relatives. This requires
planning followed by action agreed and carried out by all members of the team.
(Playford et al28, Hitchcock et al29). Formal therapy interventions should be coordinated as part of this process with clear goal setting. A regular review of progress
against these goals should be used to plan continuing treatment.
Many patients return to the DGH nearest to their home for continuing rehabilitation
after the acute phase of the illness. If the needs are complex it may be necessary to
consider a period in a Neuro-Rehabilitation Unit. Transfer must be a smooth process
with agreement between Centre and DGH or Neuro-Rehabilitation Unit facilitating
the transition. Prior to transfer or discharge from the Centre there should be a formal
assessment of the functional ability of the patient and plans for any continuation of
therapy should be agreed with those providing treatment and the patient and family.
A copy of the assessment and any plan for continuing treatment should be filed in
the notes, given to the patient and forwarded to the new team. Copies should also
be sent to the GP and the referring physician and neurosurgeon.
Some people will have continuing needs when they are to be discharged back into
the community. It is particularly important that community services and the family
are included in the discharge planning and that arrangements are acceptable to all.
As with transfer to the DGH copies of the assessment and agreed plans should be
given to the patient and forwarded to the new team. Advice on all aspects of
personal, social and family life and employment may be needed and should be
considered.
Staff working in the community or DGH are likely to have more contact with the
family and social services but to have less experience of managing patients with
SAH than Centre staff. Advice on a range of issues can improve care and reduce
anxiety. A clear statement from the Centre that requests for help and advice would
be welcome, accompanied by a reliable telephone contact number, could be
extremely helpful.
16
All Centres treating patients with SAH should have a multidisciplinary
Neuro-rehabilitation team.
Patients should have their rehabilitation needs assessed within 72 hours
of admission or completion of a treatment procedure and a treatment
plan should be agreed.
Patients, family and staff should all have written copies of the agreed
treatment plan.
Whenever a transfer of care occurs treatment should be discussed and
agreed by both teams and the patient and family.
Written accounts of treatment undertaken and treatment planned,
together with copies of the agreements should accompany the patient at
the time of transfer or discharge.
All doctors involved in care should be kept informed. The GP and
referring consultant should receive letters at the time of admission and
discharge.
All letters should be dispatched within 72 hours of
admission or discharge. The death of a patient should be notified to the
GP and the referring clinician within 24 hours.
Continuing support should be offered from the Centre to DGH and
Community staff. Written documentation from the Centre should give
clear details of reliable and rapid access to easily available support and
advice.
17
Section 4
Conclusions
A
North West Clinical Framework - Summary
Primary Care
When subarachnoid haemorrhage is suspected the patient should be
admitted to hospital immediately.
Secondary Care/DGH
Patients with suspected SAH should only be admitted to hospitals with
24 hour access to CT scanning and laboratory facilities and with image
transfer links to the Neuroscience Centre.
CT scanning should be performed in every patient suspected of having a
SAH. If the CT does not confirm the diagnosis or give an alternative
diagnosis CSF should be examined. CT and, if needed, LP should be
completed within 6 hours of arrival at the hospital.
Spectrophotometry of CSF should be available in the laboratory and
should be used when there is no xanthochromia in a patient with a story
typical of SAH.
When the story strongly suggests SAH the Neuroscience Centre should
be contacted if no diagnosis has been reached after CT and LP.
Each Neuroscience Centre should agree with each DGH a protocol for
contacting the Centre, transferring images and transferring patients.
This should identify a named person who has overall responsibility for
the arrangements and give a single phone number as a contact point.
Relatives should be given every assistance to enable them to travel to
the Centre
Angiography
Angiography should only be carried out by experienced Neuroradiologists in a Neuro-radiology department.
Outcome, complications and incidents should be recorded promptly and
analysed every 6 months.
All Neuro-radiologists undertaking Angiography should be part of a
multi-centre benchmarking and audit programme.
All Neuro-radiology departments investigating patients with SAH in the
North West should have the ability to transfer images between centres.
18
The Neuroscience Centre
The treatment of patients with SAH should only take place in Centres
where:
Individual treatment plans (based on approved treatment plans for
SAH) are generated for each patient and a copy given to the
patient/relatives.
Consent is fully informed and a witnessed and signed copy of the
agreement is given to the patient and also filed in the case sheet.
Nimodipine is used in at least 95% of patients in whom there is no
contra-indication.
Both Surgical (clipping) and Radiological (Coiling) treatment can
be provided by specialists with adequate training and experience.
Skilled Neuro-anaesthesia is available.
Neuro-intensive care facilities exist with regular (at least twice
daily) multidisciplinary discussions of the patients and constant
availability of Neurosurgical and Critical Care consultants.
Appropriately trained nursing and PAM staff are available.
Convenient
accommodation
and
any
necessary
emotional/psychological support are available to relatives.
The Neurovascular Network
All Neurosurgeons and Neuroradiologists providing treatment for people
with SAH should be part of a North West Neurovascular Network which
will set professional and service standards and monitor outcome.
The network will also make recommendations to the North West Clinical
Neuroscience Partnership for any necessary change to achieve or
maintain these standards.
Neurosurgeons would be expected to be responsible for at least 20
operations each year and Neuroradiologists for 40 procedures each
year. The figures should be averaged over the previous 3 years.
It is expected that the Network will oversee a gradual change towards
concentration of the work in the hands of fewer surgeons who will work
closely with Interventional Neuro-radiologists as members of a
neurovascular team providing a service across the North West.
19
All members of the Network will be required to show through regular
audit and appraisal that they remain up to date and competent in their
knowledge and practice.
Multi-disciplinary reviews of outcome will take place at 3 month
intervals.
These reviews should include: Neurosurgeons, Neuroradiologists, Neuro-anaesthetists, Neuro-pathologists, Nursing and
Therapy staff from all Centres.
Centres and individual clinicians should participate in all relevant
national audits.
Trainees in Neurosurgery and Interventional Neuro-radiology in the
North West should only receive their training in the management of
Neuro-vascular disease from members of the Network.
Rehabilitation
All Centres treating patients with SAH should have a multidisciplinary
Neuro-rehabilitation team.
Patients should have their rehabilitation needs assessed within 72 hours
of admission or completion of a treatment procedure and a treatment
plan should be agreed.
Patients, family and staff should all have written copies of the agreed
treatment plan.
Whenever a transfer of care occurs treatment should be discussed and
agreed by both teams and the patient and family.
Written accounts of treatment undertaken and treatment planned,
together with copies of the agreements should accompany the patient at
the time of transfer or discharge.
Communication
All doctors involved in care should be kept informed. The GP and
referring consultant should receive letters at the time of admission and
discharge.
All letters should be dispatched within 72 hours of
admission or discharge. The death of a patient should be notified to the
GP and the referring clinician within 24 hours.
Continuing support should be offered from the Centre to DGH and
Community staff. Written documentation from the Centre should give
clear details of reliable and rapid access to easily available support and
advice.
20
B
Implications for the North West
1)
The working group believes that the evidence for the effectiveness of
interventional radiology in the management of aneurysmal subarachnoid
haemorrhage is persuasive. By the end of 2001 we expect a minimum of 4050% of patients will be treated by neuroradiologists with a real possibility that
the figure should be higher. Change is likely to be rapid.
2)
To meet this demand there will need to be a minimum of 4 Interventional
Neuroradiologists in the North West. The Working Group suggests 2 in
Manchester/Salford, and 2 in Liverpool and an additional appointment in
Preston by 2002.
3)
It will not be possible for the present arrangement of admitting people with
subarachnoid haemorrhage to each of the three centres to continue unless
working practices change and new appointments are made as soon as
possible and not later than June 2002.
4)
The working group considers that there is no perfect solution which
guarantees ready access to specialist treatment close to people’s homes
every day of the year. In making its recommendations the group has taken
the view that the outcome of treatment is the most important measure and
that while distance travelled is extremely important, it must take second place.
5)
In order to plan and implement changes in working practice, recruitment and
training of staff and practical arrangements for service provision a
Neurovascular Network should be established and a lead clinician appointed
by the end of January 2001.
6)
Initially the network should include all neurosurgeons and neuroradiologists
who treat people with aneurysmal subarachnoid haemorrhage. By 2002 it is
anticipated that this work will be undertaken by a maximum of 3
neurosurgeons in Manchester/Salford, 3 in Liverpool and 2 in Preston.
Membership of the network will be dependent upon agreement to regular
audit and review of practice and outcome.
7)
The working group believes that all Neurovascular (neurosurgery and
neuroradiology) activity in Manchester/Salford should be united on the Hope
Hospital site as soon as is possible and in any event not later than the transfer
of services from Central Manchester in May 2001.
8)
The working group recommends that serious thought be given to
concentration of some of this work as the number of patients undergoing open
surgery for clipping decreases. By October 2002 a decision should be taken,
in the light of 18 months experience in the Network, on the number of
Neurovascular Centres which can be sustained in the North West.
9)
In the interim period it may not be possible to cover each site with skilled
personnel every day. Agreements will have to be reached between clinicians
and with Trusts and Health Authorities to ensure services of the expected
21
quality are available to all patients regardless of their address. The working
group recommends that members of the Network should have a
contract/appointment in each of the 3/4 Trusts allowing flexibility to work in
more than one site should this ever be necessary.
10)
By January 2002 it should be clear whether the number of patients
undergoing interventional radiology is likely to be greater than 50%. If this
figure is likely to be exceeded a further interventional radiologist will be
required and an appointment should be made. Given the shortage of trainees
the working group recommends that funding for a 1year fellowship in
interventional radiology should be sought in time for appointment early in
2001.
11)
Implementation of these changes will require much better information than is
currently available. Urgent action is required to develop an information
strategy which will provide information to and for the network early in 2001.
12)
The Network will need to address training issues early. Neurosurgical and
neuro-radiological training programmes will require considerable modification.
22
Appendix 1
Neurovascular Workshops
August 16th 2000
Hope Hospital, Salford
Preston Royal Hospital
Walton Centre for Neurology & Neurosurgery
Dr Andy Molyneux
Neuro-radiologist,Oxford
Mr Rick Nelson
Neurosurgeon, Bristol
Mr Ken Lindsay
Neurosurgeon, Glasgow
23
North West Clinical Neuroscience Partnership
The Management of People with Subarachnoid
Haemorrhage
Trust Workshops August 16th, 2000
Summary Report
The Project
As part of the North West Clinical Neuroscience Project a group of Neurosurgeons
and Neuroradiologists had been meeting for about a year to consider the
implications of changes in the management of people with subarachnoid
haemorrhage (SAH). They had reached a number of tentative conclusions which
would have far reaching implications for the provision of a service in the North West
and North Wales. In order to encourage further discussion of the options they had
constructed a case study to be considered at workshops in each Trust along with the
additional perspective of 3 nationally respected specialists from outside the Region.
The Workshops
The workshops were open to all clinicians, executive and non-executive directors in
the 3 Trusts providing In-patient clinical Neuroscience services in the North West. At
each of the 3 Trusts there was representation from all the groups and attendance
was good, especially for mid August.
At each venue the same programme was followed:
Local Welcome
Trust Chair or Chief executive
Coiling and the implications of ISAT
Dr AJ Molyneux
Implications for Neurosurgery
Mr R Nelson
Case Study/Discussion
Mr K Lindsay
A summary of the presentations follows:
24
Future Management of Subarachnoid Haemorrhage.
Implications of the International Subarachnoid Aneurysm Trial for patterns of care
resources and manpower.
AJ Molyneux & RSC Kerr
Background
Subarachnoid haemorrhage occurs with an incidence of approximately 10 – 15 per
100,000 per year and usually affects a middle-aged population – mean age
approximately 53 years.
The major cause for subarachnoid haemorrhage is rupture of an intracranial
aneurysm. Those patients surviving in good clinical condition have a significant risk
of re-bleeding in the first month following the procedure, about 20% at one month
declining over subsequent months. Re-bleeding is associated with a 60% mortality.
Early treatment of the aneurysm by either surgical clipping or endovascular coil
techniques is effective in preventing this re-bleed and thus reducing the mortality
associated with it.
Up until eight years ago, no alternative, other than surgical clipping was available for
the treatment of intracranial aneurysms. However now endovascular coil treatment
with detachable platinum coils is used in a proportion of patients, in particular, those
patients who present high surgical risk because of poor clinical condition, older
patients who tolerate craniotomy less well, and patients with aneurysms of the
posterior circulation, particularly those arising from the basilar artery. In the U.K
these patients are currently treated in most neurosurgical centres by endovascular
coil techniques rather than surgical clipping. This group amounts to approximately
30% of patients.
The International Subarachnoid Aneurysm Trial – ISAT, is a multi-centre Medical
Research Council, French Health Ministry and Canadian MRC funded trial testing
which method, surgery or coiling, results in better outcomes for patients, the primary
endpoint is death or disability at one year.
This trial commenced in 1997 as a full-scale study funded by the Medical Research
Council and has been re-funded to complete recruitment, which is planned to
continue until mid 2002. The trial is likely to report at the end of 2002 or early 2003
on the primary endpoints.
The trial currently has enrolled almost 1500 patients with a target of 2500. The
progress has been reviewed by the Data Monitoring Committee and they judged that
if the trial recruited of the order of 2500 patients, then the trial will “affect the
management of subarachnoid haemorrhage for many years to come”. The trial is
powered to detect a 25% difference in outcomes between the treatments at a 1%
significance level.
25
Currently in the U.K endovascular coil treatment is provided in most Neurosurgical
centres although there are some smaller centres where there is no availability for coil
treatment of aneurysms.
Most centres only have one or at most two
neuroradiologists capable of performing the procedure, which is performed in a
Digital angiography suite under general anaesthesia.
There is a very limited number of endovascular-trained operators in the U.K Interventional Neuroradiologists. Furthermore there are only a few centres that can
offer any kind of training in this field and in none of these centres are posts funded
specifically for training in this field.
Potential Impact of the Trial on Clinical Practice
There are three possible outcome scenarios following the reporting of the ISAT Trial.
The scenarios are as follows.
Scenario 1
Surgical treatment of the patient group enrolled in the trial, namely anterior
circulation aneurysms in good clinical condition (grade 1 and 2), is shown to be
safer. This outcome would suggest that approximately 70% of patients will be
treated by surgery and about 30% by coiling. Currently in the U.K approximately
40% of patients are treated by coiling. This proportion is rising towards 50% (data
from ISAT Trial Ascertainment Logs).
This scenario will mean that whilst all
Neurosurgical Centres should be able to offer coil treatment to patients, the switch to
coiling and the volumes will stabilise or reduce slightly from the current proportion
(about 40-45% in the UK).
Scenario 2
No significant difference between coiling and surgical clipping is shown on the
primary endpoint or a modest trend is seen. However secondary endpoints show coil
treatment superior, on endpoints such as length of stay, intensive care usage, overall
cost of care, duration off work, and neuropsychological effects. In this scenario it
would be anticipated that there would a progressive shift to coil treatment bearing in
mind that it does not involve craniotomy.
The secondary endpoints, such as length of time in Intensive Care and overall
hospital usage and costs (based on large scale US surveys 1, 2. ), are more likely to
be favourable to coiling. In these circumstances it is likely there will be a progressive
trend to coiling – reaching between 70% and 80% of patients.
Scenario 3
Coiling is shown to be safer than surgery with significantly reduced death and
disability at 1 year. The trial is powered to detect this at a high significance level (5%
or 1%)
If the trial shows significance level in this range or above for coiling then it will be
very difficult to offer surgical treatment to patients whose aneurysms are suitable for
26
endovascular coil occlusion immediately this finding becomes available to the clinical
community in the medical literature.
This would immediately result in centres, which were unable to offer coil treatment of
cerebral aneurysms, for whatever reason, no longer being able to treat patients with
aneurysmal subarachnoid haemorrhage, in that they would not be in a position to
offer the treatment proven to be significantly safer.
Those centres which can offer such treatment will still be limited by the availability of
skilled manpower and, in some cases, infra structure resources, such as nursing,
anaesthetic time in radiology and suitable digital angiographic room availability.
Whilst it is not possible to pre-judge the outcome of the trial and the data is blinded
to the Investigators and only available to the Data Monitoring Committee, much of
the clinical community believe the scenarios 2 and 3 are much more likely than
scenario 1. This is based not only on anecdotal data but and large-scale
observational evidence from the US University hospitals database published recently
1,2. However whatever the outcome it is vital that early contingency planning is made
to deal particularly with the manpower availability and resource issues.
It is probably too late to impact immediately the potential manpower situation,
however, the lack of proper training availability and funded posts for interventional
neuroradiology training remains a major issue which we believe should be given
immediate consideration if we are to be able to offer any kind of level of service to
patients of what then may be a technique proven at a high significance level.
This is the first time to our knowledge that a new minimally invasive procedure has
been subjected to such a rigorous evaluation in comparison with an existing surgical
technique, however unlike a proven drug therapy, this technique requires highly
skilled manpower and appropriate infrastructure resources to deliver the treatment.
The consequences of scenario’s 2 & 3 need urgent consideration.
References:
1. Johnston SC
Effect of Endovascular services on cerebral aneurysm
treatment outcomes. Stroke 2000 Jan 31(1) 111-117
2. Johnston SC Dudley RA Gress DR and Ono L Surgical and endovascular
treatment of unruptured cerebral
aneurysms at university hospitals.
Neurology 1999 Jun 10:52(9) 1799- 1805
27
Changes in the management of intracranial aneurysms:
implications for future service and training requirements in
the UK
RJ Nelson & EA Varian
Frenchay Hospital, Bristol
A summary of the presentation given by Mr RJ Nelson at workshops in the North
West Region on August 16th ,2000.
1)
The number of procedures for subarachnoid haemorrhage has increased from
35/million population to 45/million in England and Wales between 1992 and
1998. The rate is 25% higher in Scotland.
2)
The number of endovascular coiling procedures has increased from 0 in 1992
to 600 (OPCS figures) or 800 (manufacturer’s figures) in 1998.
3)
Expect approximately 50:50 clipping:coiling by 2003
4)
With no sub-specialisation in Neurosurgery
If 30% coils = 12/13 clips/surgeon/year
If 50% coils = 8/9 clips/surgeon/year
If 70% coils = 5/6 clips/surgeon/year
With sub-specialisation in Neurosurgery
If 30% coils = 20/27 clips/surgeon/year
If 50% coils = 15/19 clips/surgeon/year
If 70% coils = 10/12 clips/surgeon/year
5)
Units with combined surgical and endovascular teams will have to consider
sub-specialisation
6)
Inter-unit cross cover may be required
7)
Audit must specify severity
8)
In future surgery will be more complex than at present
9)
Training will be longer and may be more difficult to arrange
10)
Cost is approximately £1million/10% patients coiled
28
General Discussion
Although there were differences in emphasis, discussions in the 3 Centres came to
broadly similar conclusions:
1)
The situation is changing quickly and the service will need to change to reflect
this.
2)
Coiling (Neuroradiological intervention) is already seen to be the standard
form of treatment for aneurysms in the posterior circulation, for people in
poorer condition and probably for older people. This is about 30% of people
with SAH.
3)
The ISAT trial should give guidance on the treatment of younger, fitter people
with anterior circulation aneurysms.
4)
It is likely that the demand for coiling will increase and it would be unwise to
plan for less than 50% within the next 2 years. Many thought 70% would be
more realistic.
5)
There were not enough Interventional Neuroradiologists in the North West to
manage this workload. More should be recruited.
6)
Even if more radiologists were to be recruited, cooperation between the
Centres would be necessary to ensure cover during holidays and to provide
an on-call rota.
7)
The number of procedures for SAH was increasing. However, the number of
aneurysms treated by surgical clipping was likely to fall. In Bristol this had
been very marked.
8)
Unless sub-specialisation occurred the number of Clipping procedures per
Neurosurgeon would become too small to maintain or gain experience. Each
Centre identified the need to reduce the number of neurosurgeons involved in
the Neurovascular service. (Preston 2, Manchester and Liverpool 3–4).
9)
Cooperation between Centres would be required to ensure the availability of a
vascular neurosurgeon every day.
10)
The management of people with SAH required a dedicated team. This raised
the question of whether the team or the patient should travel when cover was
provided for more than one Centre. In general it was agreed that it should be
the patient that travelled in order to give continuity of care in the postoperative period.
11)
Any restructuring of the service to allow sub-specialisation for SAH would
have implications for the rest of Neurosurgery and Neuroradiology.
29
12)
There was discussion on the number of Centres to be involved in
Neurovascular work. Although there were strong arguments in favour of a 2
Centre solution it was recognised that this was not acceptable in the context
of the overall service and the current expectations of future developments.
13)
There would also be a profound effect on the training programme.
14)
A reduction in the surgical treatment of aneurysms changed the
Neurosurgeon’s perception of the specialty and would thus be a very difficult
issue for them to address. In assessing trainees the number of aneurysms
they had clipped had been a very important indicator of their overall
experience.
15)
In all 3 Centres neurosurgeons felt it unlikely that they would practise only 1
sub-specialty. They also felt that from time to time it would be appropriate for
colleagues to undertake emergency procedures in a sub-specialty other than
their own.
16)
The population of the North West and North Wales was seen as being large
enough to sustain a good service, a good training programme and good
research.
17)
Coils are expensive; their use has not so far led to reductions in other
expenditure. The introduction of coiling will thus have considerable cost
implications.
Conclusions
The need for change was acknowledged and many of the consequences of this were
identified. The working group undertook to complete their deliberations and to bring
a set of recommendations to commissioners and clinicians. These would be
presented at an open meeting to which clinicians from all 3 Trusts and interested
managers, executive and non-executive directors of Trusts and Health Authorities
would be invited. A date for the meeting would be identified on completion of the
report.
30
ISAT Primary Objective
To determine whether an Endovascular treatment policy
compared with a Neurosurgical treatment policy, reduces the
proportion of patients with a moderate or poor outcome
(Rankin 3 or worse) by 25% at one year.
Tertiary Objectives
ISAT - Secondary
Objectives.
To determine whether Endovascular coil treatment is:
•As effective as surgery at preventing re-bleeding
•Results in a better quality of life
•Is more cost effective
•Improves Neuropsychological outcome
International Subarachnoid Aneurysm Trial
Summary of Ascertainment Log data
July 2000
Criteria for entry to Ascertainment log:
• To examine the long term outcome over 5 years with
specific reference to re-bleed rates.
• To determine the long term significance of angiographic
results.
1. Proven SAH (C.T. or L.P.)
2. Proven aneurysm on angiography
3. Primary referral to Neurosurgical unit for
SAH management
July 2000
31
International Subarachnoid Aneurysm Trial
Summary of Ascertainment Log data
July 2000
International Subarachnoid Aneurysm Trial
Summary of Ascertainment Log data Oxford
Total SAH (40 months)
Number Randomised:
Reasons for Non randomisation
Anatomy unsuitable:
74
Location of aneurysm
Grade or Age of Pt.
Refusal of consent:
Not Stated
Non availability of Radiol
401
145
%
(18)
28
60
49
12
20
Total recorded SAH participating centres
N = 5372
Number Randomised
1228 (23%)
(7)
(15)
(12)
Total treated surgical
2625
579 ISAT
Total treated by coiling
2113
628 ISAT
(5)
No procedure
223
February 1998
International Subarachnoid Aneurysm Trial
Summary of Ascertainment Log data
Reasons for non randomisation July 2000
International Subarachnoid Aneurysm Trial
Summary of Ascertainment Log data
Reasons for non randomisation July 2000
Neurosurgical patients
Anatomy
Location
Refusal of consent
Grade or Age
Not stated/Incomplete
Total
2046
1121 (20%)
58
191
156
376
International Subarachnoid Aneurysm Trial
Ascertainment Log
Oxford Patients Final Treatment
Total in Log
Randomised
Rx Surgically
Rx Endovascularly
Non Randomised
Rx Surgically
Rx Endovascularly
Conservative
Data Missing
Total in Logs 5372
Sx 2625 Coiled
Endovascular coiled patients N/R
1485
Location
353
Anatomy
411
Grade or age
360
Refusal of consent
200
Summary of Ascertainment Log data Oxford Grade at angio and treatment
Grade 1
389
Grade 2
113
Grade 3
35
638 patients
206 (32%)
98
108
432
150
235
20
27
(34%)
(54%)
( 3%)
( 4%)
2113
Grade 4, 5 or Ventilated
Total
76
Sx
Sx
Coil
Sx
Coil
Sx
Coil
23
Coil
164
207
40
65
11
20
(30)
39
(42)
(53)
(35)
(57)
(31)
(57)
(51)
638
July 2000
Summary of Ascertainment Log data Clinical Grade at angio and Final treatment
All centres
Grade 1 & 2
3856
Grade
470
3
4,5 & Vent
Total
683
Sx
Coil
Cons
Sx
Coils
Cons
Sx
5009
375
Coil
Cons
Sx
Coil
2020 (52)
1522 (39)
126
210 (45)
185 (39)
31
Grade
(54)
324 (47)
59
(8)
52%
41%
International Subarachnoid Aneurysm Trial
Statistical Report # 6
Patient Baseline Assessment Prepared July 2000
WFNS Grade at time of Randomisation
Grade
Total
1
2
3
4
5
6 (Not assessable)
13
757 (63 %)
293 (24 %)
86
(7 %)
44
(4 %)
9
(1 %)
(1 %)
1202
32
International Subarachnoid Aneurysm Trial
Statistical Report # 6
Patient Baseline Assessment Prepared July 2000
International Subarachnoid Aneurysm Trial
Data Monitoring and Ethics
Number of Aneurysms detected at randomisation (N = 1202)
No
Count
Proportion
1
945
79 %
2
201
17 %
3
39
3%
4>
17
2%
Size of Aneurysms
< 6 mm
630
52 %
6 -10
473
39 %
>10
99
All Centres require local ethics (IRB) approval
UK requires Multicentre ethics approval and local
ethics approval
 Independent data monitoring and ethics committee
appointed by Medical Research Council to report
to Trial Steering Committee


8%
International Subarachnoid Aneurysm Trial
Data Monitoring and Ethics Committee
Report to Trial Steering Committee March 2000
International Subarachnoid Aneurysm Trial
Data Monitoring and Ethics Committee
Report of meeting: March 2000

Reviewed unblinded randomisation data on 1202
patients
 Reviewed 2 month outcome data on 1056 patients
by treatment allocation
 Reviewed 1 year data on 700 patients
 Reviewed information on re-bleeding





International Subarachnoid Aneurysm Trial
Data Monitoring and Ethics Committee
Report to Trial Steering Committee March 2000
“In the light of the the evidence we have seen with 2500
patients the trial we believe will usefully influence
clinical Practice for many years to come without the
endless controversy that we are currently witnessing. We
urge all collaborators to hasten efforts to recruit the
remaining 1100 or so patients” . “The quicker we recruit,
the quicker results will become available and the sooner
future patients will be managed in the light of the best
and most robust evidence”
Future management of subarachnoid haemorrhage
Post ISAT scenario’s
Trial shows surgery safer
Trial shows equivalence on Primary endpoints but
coiling better on secondary end points
 Trial shows coiling significantly safer P 0.05
 Trial shows coiling much safer P 0.01


Future management of subarachnoid haemorrhage
Post ISAT scenario’s
Future management of subarachnoid haemorrhage
Post ISAT scenario’s
 Surgery safer for Grade 1 & 2 patients with anterior
circulation aneurysms
 Posterior circulation aneurysm poor grade patients and
older patients will continue to be coiled
 Probable proportion coiled
35 - 40%
Noted that the recruitment rate was holding up but below
original target
This trial was likely to be the only large scale randomised
evidence of the comparison between clipping and coiling
Having reviewed the outcome data, it was our unanimous
opinion that there was no ethical or any other reason to stop
recruitment.
The trial procedures and data collection are all exemplary
It is vital to maintain and increase recruitment and keep all
patients on secure follow up




Surgery and coiling equal or trend to safer endovascular but
coiling better on secondary end points such as:
Higher return to work rates
Shorter lengths of stay and ICU time, less overall cost of care
and/or societal costs
Less rapid but significant shift to coiling of about 70 - 80% of
aneurysms
33
Future management of subarachnoid haemorrhage
Post ISAT scenario’s

Coiling shown to be safer by margin of P0.05 to P0.01 or >
 No longer reasonable practice to offer surgery if coiling
technically possible
 Immediate shift of management to coiling
 Centres not able to offer coiling may no longer be able manage
SAH
 80% + of aneurysms should be coiled
 Immediate consequences for neurosurgery & neuroradiology
Future management of subarachnoid haemorrhage
Impact of ISAT
Future management of subarachnoid haemorrhage
Post ISAT scenario’s
Timing of coil treatment does not affect outcome (Recent
Oxford data accepted for publication in Neurosurgery)
 Grade 4 & 5 patients with clot benefit from early coiling
and clot evacuation
 Need weekend and out of hours availability of service for
optimum care
 Need surgeon, interventionist and nursing support

Recent grant approval by MRC to extend recruitment
and continue follow up for 5 years
 Recruitment of further 1000 patients likely by June or
July 2002 (currently 1419)
 Report Primary outcome on basis of 2 month data on
all patients and 1 year on rest
 Timing of Primary outcome publication Lancet
probably late 2002
 Rest of detailed data to follow 2003 - 2004

34
Appendix 2
Neurovascular Services in the North West Region:
The effect of Developments in Interventional
Neuroradiology
Report of the Neurovascular Working Group
of the
North West Clinical Neuroscience Project
August 2000
35
Introduction and Background
Interventional Neuroradiology is now more than 20 years old during which time it has
expanded enormously. The formation of the World Federation of Interventional and
Therapeutic Neuroradiology (WFITN), the Interventional Neuroradiology Committee
of The European Society of Neuroradiology (ESNR), the United Kingdom
Neurointerventional Group (UKNG) and the publication of The International Journal
of Interventional Neuroradiology reflect this expansion and its world-wide impact.
Despite this many Neuroscience centres remain unaware of what can be achieved
and what should be expected in the practice of interventional neuroradiology.
Expansion of workload is particularly evident in the treatment of intracranial
aneurysms where Guglielmi Detachable Coils (GDC) are, in some centres,
considered the first line treatment for aneurysms in certain anatomical locations
(Lempert et al16). Other vascular lesions are increasingly being treated using the
endovascular route either as a definitive treatment or in combination with
Neurosurgery or stereotactic radiosurgery. These developments are leading to
increasing numbers of cases being treated in the North West Region (NWR).
However, other Regions in the UK, serving similar populations, have considerably
higher levels of activity (Molyneux30). Patients are treated on an inpatient basis with
Neurosurgical support. Many of these patients cases would previously have been
treated by open Neurosurgical procedures. Some patients would previously have
been managed conservatively, particularly older patients with complex lesions. The
workload thus includes both new work and work transferred from neurosurgery.
The change in practice has brought Interventional Neuroradiologists to the forefront
in the management of Neurovascular disease. This management is performed in
close collaboration with the admitting Neurosurgeon, Neuroanaesthetists, and where
possible with Neurologists who have an interest in Neurovascular disease. For some
lesions cooperation with Stereotactic Radiotherapists is also required. The concept
of such Neurovascular teams is new but they must be developed to ensure that
patients are given the most appropriate therapy and the best outcome (Claiborne
Johnston et al18).
The organisation of clinical neuroscience services and endovascular intervention
services within the Northwest are thus interdependent. There are currently four
centres in the Region where there is potential for provision of these services: Central
Manchester Healthcare Trust (CMHCT), Hope Hospital Salford, The Walton Centre,
Liverpool and Royal Preston Hospital. Currently there is endovascular intervention
on the first three sites but not at Preston. The reorganisation of Neurosciences in
Greater Manchester will result in single centre on the Hope site with transfer of
CMHCT in April 2001. There will therefore be three centres serving the
Neuroscience requirements of patients in the NWR and North Wales including
endovascular intervention. These centres must have the capacity to accommodate
predicted inevitable service expansion.
This document outlines the current levels of interventional neuroradiology activity in
the NWR and makes predictions of the likely expansion of the workload in the
36
intermediate and long term. This prediction is important in developing a strategic
plan for the management of neurovascular disease across the three sites.
The importance of developing a sensible strategic plan cannot be over emphasised.
Collaborative development across the region will be essential to provide quality,
continuity of service and on call cover and the opportunity must not be missed.
Current Regional Workload
The activity in adult endovascular neurointervention is increasing. Almost all
procedures are performed in the Neuroradiology department under GA requiring a
Consultant Anaesthetist, ODA and nursing support. Only modern angiography
equipment will have the resolution to allow coiling to be performed.
CENTRE
1995-6
1996-7
1997-8
1998-9
CMHCT
21
21
48
55
Hope
17
24
26
54
North Manchester
25
26
23
0
25*
25*
30
41*
40**
Walton Centre
Preston
TOTALS
63
96
163
179
TABLE 1 - Interventional activity by centre for the years 1995-99 (no. of cases)
*cases referred out of Region **cases referred to CMHCT
The figures in Table 1 are not complete but it is clear that endovascular intervention
is expanding year on year. Some of this increase is due to the International
Subarachnoid Aneurysm Trial (ISAT), which is comparing the outcome of treatment
by surgery with that from endovascular treatment, but some represents true change
in practice. The possibility that ISAT is constraining the development of endovascular
intervention should also be considered, as suitable aneurysms for this technique are
randomised to the Neurosurgical limb of the trial.
The infrastructure to perform interventional procedures is in place at CMHCT,
Salford and The Walton Centre. There is however a manpower problem with only
three part time interventionists available to perform the procedures. These
37
Consultants are located one at each site although there is close collaboration
between the CMHCT and Salford Consultants and some early collaboration between
CMHCT and The Walton Centre. This level of staffing becomes a problem in two
main areas. Firstly some procedures are complex and require two operators.
Secondly single handed practices do not allow for holiday and sickness cover or on
call provision.
There is currently no interventional service available on the Preston site and patients
are therefore transferred to other centres. Historically this has been to Oxford but in
the last eighteen months the service has been provided by CMHCT.
Interventional Capacity
The capacity to expand the endovascular service to meet increasing requirements is
dependent on the infrastructure and on available manpower. Within the region there
are currently three Diagnostic Neuroradiologists with an interest in endovascular
intervention. These clinicians spend increasing amounts of time involved in
intervention without any reduction in their diagnostic workload. Indeed this workload
is also increasing. The British Society of Neuroradiology recommends that for each
interventional procedure there should be two allocated clinical sessions, one for the
procedure itself and one for follow up including clinic visits and check imaging. If
each interventionist were to perform three cases per week this would equate to 6
fixed sessions which would put serious pressures on the diagnostic neuroradiology
service. This level of workload would allow only 360 procedures to be performed
across the NWR. In reality it will be impossible for three people to meet this workload
as often procedures need two operators and the destabilising effect on the
diagnostic workload would be unacceptable. As interventionists become more
experienced procedures become shorter, allowing more than one in each session.
On manpower grounds we predict that, with existing staff levels, we will be able to
perform 240 cases per year initially but this could rise to 300 if the procedures were
performed in the same centre.
Although many of the endovascular procedures replace a surgical procedure there is
some difficulty in obtaining Anaesthetic sessions. This is in part due to timing of
procedures, in part due to transfer of work between centres and in part due to
vacated theatre sessions being used for other neurosurgery. Any expansion in
endovascular procedures should therefore take into account the need for anaesthetic
sessions to be available. This again would be easier if all intervention occurred on
one site.
Investment is also required in a rolling capital replacement scheme for suitable
angiographic equipment. It is now increasingly recognised that intervention is more
safely performed on biplane angiographic equipment and that 3D reconstruction can
be helpful. We do not have access to this type of machine in the NWR. There are
particular problems at Hope where the present angiographic capacity is inadequate
for the anticipated workload following the transfer of the CMHCT service in April.
38
Predicted future workload
Interventional Neuroradiology has a considerable potential for expansion in the
NWR. It is clear from Table 1 that there has been a year on year growth and this is
likely to continue. The growth has been due to a combination of improved technology
and operator expertise. As a result there are increasing numbers of cases that can
be treated successfully via the endovascular route. Data from other more established
UK centres supports this but also suggests that activity may increase significantly
above its present rate if staffing and infrastructure are established. If ISAT reports
equivalence or better for endovascular treatment in the management of aneurysmal
subarachnoid haemorrhage there will be further pressures to expand the service.
Some of this pressure will come from patients who when given the choice will usually
opt for less invasive therapy i.e. endovascular treatment.
It is difficult to make accurate predictions about expansion. The total number of
patients requiring treatment for aneurysmal subarachnoid haemorrhage in the NWR
is approximately 400 cases per year. Of this total currently around 350 undergo
some form of intervention. It is expected that this proportion will increase as
endovascular techniques improve and become more widely available. Using these
figures, and assuming that between 50% and 75% of intracranial aneurysms will be
treated via the endovascular route as a minimum and a maximum figure the number
of endovascular interventions for SAH can be calculated. To this number of cases
must be added predicted figures for other endovascular procedures including AVM
treatment. It is likely that actual activity will lie between these two predicted extremes
(Table 2).
Year
2002
2005
2010
Min
250
325
400
Max
350
450
550
TABLE 2 – Predicted future Regional interventional workload
(includes AVMs etc)
To meet these predicted levels of activity would require 3 or 4 interventionists to
perform an average of 2 or 3 procedures each week.
Clearly this change in practice needs to be carefully managed and funded to enable
the most efficient and cost effective service to be provided. This is particularly
important in view of the close geographical proximity of the three centres and the
excellent motorway networks in the NWR. Development should be co-ordinated
between these three sites so that any provision is complementary. This will allow
39
sensible planning and provision of services and allow clinicians to work closely
together expanding their experience and improving patient outcome. There could
also be economic benefits from collaboration. Different service models should
therefore be explored in an effort to deliver the best service across the NWR. A
number of possible models for regional organisation of the service are outlined
below.
1. Completely independent development of services on the three sites with three
separate units.
2. A single Regional centre for all endovascular intervention and vascular
neurosurgery.
3. Two centres at Hope and the Walton Centre with transfer of patients form
Preston to these units.
4. Regional Neurovascular team or teams with treatment at all three sites.
i)
Staff at all three sites with a co-ordinated service to provide cross cover
when needed.
ii)
Staff providing a service across three centres when required.
Whatever service model is decided upon there will be a shortage of staff in the short
term. With growing realisation of the role of endovascular procedures there will be a
requirement for on call services. This can only be sensibly provided with a minimum
of 5 consultants. It is unlikely that the North West could recruit an additional 12
interventionists to allow an on call service on each site. In addition to maintain skill
levels and embrace constantly changing technology interventionists should ideally
perform at least 50 cases per year and have access to centres performing more
complex procedures. Even the optimistic projections for the region do not expect a
workload which could support more than 6 or 7 and could be met by 4 or 5
consultants.
The larger catchment areas covered by Hope and The Walton Centre will probably
generate a sufficient number of cases for at least two interventionists on each site.
The workload in Preston is less and it may only be possible to justify a single
interventionist on this site in the short and intermediate term. In view of this, if
interventional neuroradiology were to be available on site at all three centres, it
would be essential for operators across these sites to work closely together. In
addition there is the potential for the development of at least one and possibly two
regional training posts in intervention. This would be enhanced by close collaboration
between units. The potential for research and development is also increased
considerably with regional co-operation.
Neurosurgical Provision in the Future
The developments in endovascular techniques will have a profound effect upon
neurovascular surgery and in particular on intracranial aneurysm surgery. There are
approximately 45 procedures performed per million population per year for
aneurysmal subarachnoid haemorrhage in the NWR. If 66% of these patients are
treated via the endovascular route (as is the case in one UK unit currently, and which
40
is below the rate in France where it has become 80-85%) only 15 aneurysms per
million will need to be treated surgically. It has been suggested in the past by the
Society of British Neurological Surgeons that a Neurosurgeon should manage 25
cases per year to maintain competence.
If this is accepted, a vascular
Neurosurgeon would need to serve a population of almost 2 million. If only 15
operations a year were sufficient to maintain expertise each surgeon would need to
serve 1 million assuming a 66% coiling rate. Higher coiling rates would increase the
population base needed. Because it is necessary to provide a 24-hour, 7-day per
week, 365 day per year service, a minimum of 2 surgeons would be required. This
would however result in there being only one surgeon available, for 4 months of the
year because of annual, study and professional leave. A more likely estimate of the
number of surgeons required to provide full cover throughout the year, taking into
account the working time directive and the construction of an acceptable on-call rota,
is 4 – 6. Hence, the population base needed to ensure the quality of the
Neurovascular Surgical Service would be a minimum of about 6 million. As
subspecialisation increases in Neurosurgery, the NWR will need to move to this
position which will only be sustainable with co-operation between the Centres in
Salford, Preston and Liverpool.
As the Neurovascular surgeons will continue to be involved in the management of
patients undergoing coiling, for example in the management of delayed ischaemia, it
is essential that Neurovascular teams consisting of Interventional
Neuroradiologists and Vascular Neurosurgeons are formed. Later it would be
ideal to add a Neurologist with a vascular interest and a Radiotherapist to this team.
Rapid, high quality image transfer will be essential to allow such teams to work
together effectively across the sites and make appropriate management decisions
for the benefit of the patients in the NWR.
Though most Neurosurgeons to date have been trained in aneurysm surgery and
undertake it, rapidly many will become less skilled as the number of operations for
aneurysms falls. Unfortunately, those patients coming to surgery will have the more
technically difficult aneurysms. Inevitably this will result in further subspecialisation
and in trainees gaining less experience in aneurysm surgery. It is likely that in time
only a few trainees will be fully trained in vascular neurosurgery in order to deal with
the residual, technically difficult aneurysms. Even to gain basic principles of the
management of aneurysms, it will be necessary for Neurosurgical trainees to
rotate to the Neurovascular service.
Possible Service Models
1.
Independent development of Intervention and surgery on the three sites.
This will result in dilution of expertise and make on call provision of the service
impossible. Preston may only be able to justify one interventionist working in
isolation and 1 or 2 vascular neurosurgeons who will have no cover for holiday and
study leave periods. It is unlikely that either Liverpool or Manchester will employ
more than two interventionists in the intermediate term, which also makes local on
call provision impossible. Numbers of operations are also likely to be too low for
expertise to be maintained by the number of surgeons required for the on call rota
41
and for training to be undertaken. Audit and clinical governance will be of relatively
little value with such small numbers.
2.
A single regional centre for all endovascular intervention and vascular
neurosurgery
This would require a large redistribution of beds and nursing staff to the selected
site. It would also involve relocation of existing staff and would in certain situations
require patients to be transferred over relatively long distances. Concentration of
staff would, however, increase experience and would probably benefit patient
outcome. It would also simplify the provision of an out of hours service. However,
Neurosurgeons and Neuroradiologists usually have more than one subspecialty
interest and take part in general Neurosurgical and Neuroradiological emergency
cover. There are strong links between some Neurosurgical sub-specialties, for
example skull base surgery and vascular surgery. Unless there were to be only one
Neuroscience Centre in the North West, not all of these other interests and
responsibilities would be on the same site.
The infrastructure to provide Neurovascular services for the whole of the NWR is not
currently available on any one site. Movement of existing equipment or investment
in new equipment would be costly. This, together with the inevitable impact on other
aspects of Neurosurgery and Neuroradiology, makes it a difficult model to implement
in the short to medium term.
3.
Two centres at Hope and Walton with transfer of patients from Preston to
these sites
This model is closest to current practice for patients requiring endovascular
procedures but does not give the people of the North of the Region a “local” service.
Patients from Preston are transferred to CMHCT after investigation. This works well
for relatively small numbers when the time frame is not critical, although there is
pressure on access to beds and radiologist time in Manchester which does result in
delays. Inevitably delay would lead to a poorer outcome for some patients. Increased
collaboration with Liverpool could help to overcome these problems and could also
ensure that the service is more available. It has the disadvantage of not delivering a
service on the Preston site which would lead to the transfer of some patients for a
second time. If surgery remained on the Preston site but no endovascular work was
undertaken team working between radiologist and neurosurgeon could be difficult.
Unless surgeons from Preston were to take part in the neurovascular service in one
or both of the other centres there would be a de facto differentiation of the centres
and Preston might well provide a particular focus for other forms of neurosurgery.
Either outcome would necessitate the inclusion of all 3 centres in the planning and
provision of neurosurgical services. Thus it does not seem possible to construct a 2
site service without 3 site cooperation.
42
4.
Regional team or teams with cases performed on all three sites
In this model Neurovascular disease would be managed on all three Neuroscience
sites with local access to endovascular intervention and vascular neurosurgery. In
this model staff could either (i) be based at each of the three sites with a team
approach to covering the sites and sharing experience and expertise, or (ii) have a
commitment to provide the service on a regional basis. The first of these models
would probably be the best for continuity of care but will require careful selection of
staff and also capital investment in equipment on both the Hope and Preston sites. It
would be important for staff to share experience and take part in common audit.
Close collaboration would also make a regional on call service possible. The second
model involves staff working across three centres as required. This could necessitate
clinicians working in different centres and might be less attractive. A combination of
these two models may also be possible with regional staff supporting other staff
based at each centre.
Movement of patients would be minimised in all variants of this model as they
depend upon movement of the doctor rather than the patient. Clinics could be held
on each site in collaboration with the designated vascular Neurosurgeon.
Proposal
It is the recommendation of this group that collaboration across the three
Neuroscience centres in the NWR is essential in establishing an Interventional
Neuroradiology service and a Vascular Neurosurgical service to provide care
for people with aneurysmal subarachnoid haemorrhage. Independent
development on 3 sites would be to the detriment of patients and should be actively
discouraged. The ideal solution would be to have state of the art, high quality
services available to all three sites.
These aims preclude service models 1,2 and 3. Service model 4 with the
development of a regional specialist neurovascular team responsible for the
service at each site would seem the most sensible way forward. Members of the
team would have to collaborate closely sharing experience, providing cross-cover
when required and taking part in common audit and governance arrangements. It is
our view that the management of patients with neurovascular disease should only be
undertaken by members of the neurovascular team. The number of people in the
team will be governed by activity and outcome. Some members may have, or
develop, experience in different areas providing super-specialist services, for
example in the treatment of arteriovenous malformations. The growth of superspecialisation might take some time and in the short and intermediate term the team
will agree mechanisms which will provide the best service for patients.
There is an immediate need to provide a system for rapid transfer of
angiographic, MR and CT images between centres to enable clinicians to discuss
cases and make prompt and appropriate decisions. This will require teleradiology
links between the three centres and this should therefore be actively pursued at an
early stage. This will also be of value in other subspecialty areas.
43
Recommendations
1)
Interventional Neuroradiology and Vascular Neurosurgery must be available
to the population of the NWR
2)
Development of NWR endovascular intervention and vascular neurosurgery
across the three Neuroscience centres should be integrated. This requires
close collaboration between the three centres and between Neuroradiologists
and Neurosurgeons who should form a North West Neurovascular team.
3)
The number of Neurosurgeons clipping aneurysms should reduce with local
lead clinicians in this subspecialty becoming members of the regional team or
network.
4)
The Regional Clinical Neuroscience Project and commissioners should drive
this development with advice from local and national experts.
5)
Plans should be put into place to recruit further Interventionists as the
workload increases. This may require in house training across the region.
6)
Protected beds and anaesthetic sessions will be required.
7)
Teleradiology linkage of the three sites should be installed as a matter of
urgency.
8)
Regional training in Neurovascular surgery and interventional neuroradiology
should be organised.
44
Appendix 3
North West Neuro-vascular Network
The North West Neuro-vascular Network will be the mechanism for the provision of
care for people with non-traumatic sub-arachnoid haemorrhage, arterio-venous
malformations and other intracranial vascular lesions.
Neurosurgeons and
Neuroradiologists involved in the provision of such a service will have accepted the
working practice and standards of the Network and will work in accredited Centres.
The Network will consist of :
A
Neuro-radiologists who:
1)
2)
7)
Have been adequately trained in interventional techniques
Will collect and supply all activity and outcome information to the Network
Audit
Will participate in regular quarterly multidisciplinary audit of outcome and
complications
Will report all clinical incidents and near misses
Will perform on average more than 40 procedures each year, at least 20 of
which should be aneurysms
Will keep up to date by attendance at specialty society and post graduate
meetings
Will contribute to Neurosurgical and Neuroradiological training programmes
B
Neuro-surgeons who:
1)
2)
Have been adequately trained in Neurovascular techniques
Will collect and supply all activity and outcome information to the Network
Audit
Will participate in regular quarterly multidisciplinary audit of outcome and
complications
Will report all clinical incidents and near misses
Will keep up to date by attendance at specialty society and post graduate
meetings
Will be responsible for/perform on average 20 procedures each year
(averaged over 3 years)
Will contribute to Neurosurgical and Neuroradiogical training programmes
3)
4)
5)
6)
3)
4)
5)
6)
7)
The Network will be led by a clinician who will represent the interests of the
team/network in the Neuroscience Partnership and will in turn be responsible for
ensuring that the agreed goals and standards are met and that there is an agreed
programme of audit and appraisal.
Members of the network will have contracts which allow them to work in any one of
the 3 Centres should this be necessary.
45
Appendix 4
Proposed Minimum Standards for Accreditation
District General Hospitals
1)
A & E Department with 24 hour consultant staffing
2)
Observation ward or Acute admissions unit capable of 24 hour investigation
and neurological observation
3)
24 hour CT scan availability within 1 hour
4)
Image transfer facility to Neuroscience Centres
5)
24 hour access to biochemistry/pathology/microbiology laboratory (including
CSF spectrophotometry)
6)
Accredited junior staff posts with adequate supervision
7)
Affiliation to the Neuroscience partnership
Neuroscience Centres
1)
24 hour resident Neurosurgery and Neurology staff
2)
24 hour easy availability of consultant “Vascular” Neurosurgeon who is a
member of the Neurovascular Team/Network, Neuroradiologist (including
Interventional Neuroradiologist who is a member of the Neurovascular Team)
and Neurologist.
3)
Image transfer facilities (MR,CT,Angio) from DGHs and between Centres
4)
Neuro-ITU
5)
24 hour availability of fully staffed Theatre and Neuroradiology department
6)
Angiography and imaging equipment and staff training to an approved level
7)
Participation in audit and benchmarking scheme
8)
Participation in Regional Neuroscience training scheme
9)
Membership of the Neuroscience Partnership.
46
Appendix 5
North West Clinical Neuroscience Partnership
The Partnership came into being on September 1st 2000.
Goal
To minimise the impact of damage to the nervous system on the life of
individuals and society through:
1)
Seeking and using opportunities for prevention
2)
Ensuring prompt access to appropriate, expert care following acute
illness or injury
3)
Developing paths of care which guarantee appropriate, accessible and
sensitive care for people with chronic conditions
4)
Supporting all providers of care whether lay or professional
5)
Increasing understanding, in the NHS and wider society, of the impact
of damage to the nervous system on the lives of affected individuals
6)
Involving patients, carers and voluntary organisations in decision
making, planning and evaluation of services.
Working Together
Trusts and Commissioners will work together to develop strategies to achieve
the above goals. They will:
1)
Together agree a North West Service Framework for the provision of
Clinical Neuroscience services
2)
Together encourage the development of North West Commissioning
for the Clinical Neurosciences.
In order to achieve this they agree to:
1)
Share activity and outcome information
2)
Develop a joint programme of benchmarking and audit
47
3)
Develop a common understanding of manpower and training
requirements
4)
Ensure that proposals and job plans for new senior clinicians
(Consultants and Nurse Consultants) are shared at an early stage and
in all cases prior to appointment
5)
Share development plans and capital bids above £100,000 at an early
stage and at latest, prior to submission of a business case or service
plan
6)
Explore mechanisms for joint evaluation and introduction of new drugs
and technologies
7)
Define the information requirements to support co-operative working
and develop the information system to deliver them.
Monitoring
This is a co-operative venture and it is not anticipated that individual groups or
organisations will be less than fully committed. In the event of a dispute, the group
will determine an acceptable procedure, possibly involving the RSCG, to resolve the
issue.
Conclusion
This partnership represents an agreement between the three Tertiary Centre
Trusts and the three Zonal Neuroscience Commissioners to work together to ensure
that the population of the North West and North Wales has equitable access to a
Clinical Neuroscience service which will meet their needs and will be both effective
and efficient in its use of resources.
Members (As at Sept 1st, 2000)
Chief Executive, Preston Acute Hospitals NHS Trust
Chief Executive, Salford Royal Hospitals Trust
Chief Executive, Walton Centre for Neurology and Neurosurgery
Specialised Commissioning Lead, Neurosciences, Greater Manchester Zone
Specialised Commissioning Lead, Neurosciences, Lancashire and South Cumbria
Specialised Commissioning Lead, Neurosciences, Merseyside and Cheshire
Member, Specialist Health Services Commisioners for Wales
Regional Specialised Commissioning Manager, NW Regional Office, NHS
Clinical Director, Neurosciences, Preston
Director of Neurosciences, Greater Manchester
Medical Director, Walton Centre
Chief Executive of Health Authority as Chair, (Sefton nominated from 2000)
48
Appendix 6
North West Clinical Neuroscience Project
Role of Voluntary Agencies Group
The North West Clinical Neuroscience Project was initiated by a group of Providers
and Commissioners across the North West of England and North Wales. It seeks to
improve the quality, accessibility and equity of care for people with neurological
conditions.
The Voluntary Agencies Group was convened to be a source of information and
advice for the Project.
1)
They will provide background information on the experience of people
affected by damage to the nervous system (as patients, relatives or carers)
drawing attention to successes and failures in the present provision of care.
2)
They will also advise on unmet need and potential improvements
3)
All proposals for changes in the organisation or provision of services will be
brought to the Group for comment and discussion.
4)
It is expected that all members of the group will encourage wider discussion of
the issues as they are raised and will feed comments and suggestions into the
Group.
5)
The Project concludes in March 2001. The role and standing of the Voluntary
Agencies Group should be reviewed at that time.
6)
The Group should develop proposals for a continuation of a mechanism for
the inclusion of a user voice in the commissioning and provision of Clinical
Neuroscience Services.
49
References
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