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Sussex Heart Network - Sussex Cardiac Clinical Network Group vs 0.7
Case of Need – Antibiotic prophylaxis to prevent Infective Endocarditis
Issue
The principal of prophylaxis for Infective Endocarditis (IE) was developed on
the basis of observational studies in the early 20th century. This was
strengthened by the results from animal experiments when prior treatment of
antibiotics prevented endocarditis. The practice of antibiotic prophylaxis,
however, has not been scrutinised in a prospective randomised controlled
trial.
Dental procedures result in detectable bacteraemias in individuals. The
reported incidence is highly variable (10 to 100%) and in part, reflects differing
analytical methods and sampling procedures. Transient bacteraemias also
occur following daily activities e.g. teeth brushing, flossing and even chewing.
Such bacteraemias are potentially greater in individuals with poor dentition.
Therefore, it is possible that individuals are exposed to important
bacteraemias during activities of daily living.
Prior to 2008, guidelines recommended antibiotics to be given prior to dental
procedures in high risk patients, including those with native valve disease. In
2008 the National Institute for Health and Clinical Excellence in England and
Wales (NICE) issued guidance recommending that antibiotic prophylaxis was
no longer required.
Background/Position in Sussex
Infective endocarditis (IE) is, thankfully, an uncommon condition with
approximately 4 cases diagnosed per 100,000 person years. The incidence
increases with age. There is a significant morbidity associated with the
condition (e.g. 15% acute stroke rate) and a mean in hospital mortality of 16%
(range 10-25%).and 30-40% mortality at one year follow up. Despite the
diagnostic and therapeutic advances in the past 30 years, the mortality from
endocarditis remains unchanged. Furthermore, the condition necessitates a
protracted hospital stay due to lengthy antibiotic regimes required and 25-30%
of individuals require cardiac surgery during the acute phase. Up to 40% of
individuals require cardiac surgery in the convalescent phase.
NICE clinical guideline 64, published in March 2008, recommended the
cessation of routine prophylactic antibiotics for dental work and other routine
medical interventions. This was on the grounds of no clear evidence of benefit
and the decision that any benefit was outweighed by the risks of adverse
reaction and antibiotic resistance. Instead, the NICE emphasised the
importance of good dental hygiene rather than antibiotic prophylaxis for those
at risk of IE undergoing dental or other interventions.
Dentists were directed by Sussex PCTs to follow the NICE guidance.
However, dentists were still able, in individual circumstances and on the
advice of a cardiac or other secondary care specialist and in consultation with
the patient, to ensure antibiotic cover.
Cardiac specialists in Sussex and many other cardiac networks in England
have been pro-active in advising patients, their dentists and GPs to arrange
prophylactic cover in individual cases when their expertise has been sought
for invasive dental procedures (extractions, scaling or periodontal surgery), in
addition to education about the importance of maintaining good dental
hygiene.
Since the European guidelines recommend antibiotic prophylaxis for three
highly selected groups of individuals, the actual numbers of patients where
prophylaxis is still felt to be applicable is small.
The NICE guidance represented a major change in practice which has
potentially influenced IE rates. IE is not a notifiable disease and hence
change in disease incidence is not easily apparent. NICE are due to review
their IE guidance during 2011.
At the Sussex Cardiac Centre, an audit of endocarditis figures covering the
time period 1st March 2006 (pre NICE guidance) to Dec 2010 was undertaken
to determine if the number of patients admitted with endocarditis had changed
since the NICE guidance was published. Indeed, careful monitoring of the
incidence and presentation of IE (particularly in high risk groups) is
recommended by national guidance. The Sussex Cardiac Centre audit
indicated no marked increase pre & post NICE guidance but the patient
numbers were small and statistical significance is difficult.
The audit also found difficulties relating to patient identification through
coding. Of the 85 cases of endocarditis audited over a 60 month period, only
31 were ICD coded as endocarditis and yet had been treated for the condition.
There is therefore a lack of accurate data to determine the local situation.
This issue is being pursued by the centre.
The audit found that the number of cases of IE was 1.7cases/month pre NICE
and 1.3 cases/month post NICE but the sample numbers pre and post NICE
were not of equivalent time periods. 27 of the total patient sample died and
those with prosthetic valve endocarditis related to a tissue valve replacement
were at particularly high risk of death.
Proposal
The Sussex Cardiac Clinical Network Group (SCCN), the clinical reference
group for the Sussex Heart Network, wishes to provide clear guidance on this
antibiotic prophylaxis for patients at risk of IE, working with the local PCTs and
their Clinical Executive Committees, the Local Dental Committees the and the
new developing GP Commissioning Consortia.
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The advice of the SCCN is based on the more recent guidance issued by the
European Society of Cardiology (ESC): Guidelines on the prevention,
diagnosis, and treatment of infective endocarditis. These guidelines are
similar to earlier ones by the American Heart Association (Circulation 2007).
In particular, the SCCCN supports the new ESC guideline for antibiotic
prophylaxis in patients in three particularly high-risk groups:



Previous IE
Cyanotic heart disease
Prosthetic valve or prosthetic material used for cardiac valve repair
In these groups endocarditis carries the greatest risk of adverse outcome.
Individuals with other forms of structural heart disease and native valve
disease are at increased risk of endocarditis, above the normal population,
and they should receive education re the importance of good dental hygiene.
Antibiotics for prophylaxis should be the same as those recommended preNICE:
 Amoxicillin 3g orally one hour pre-procedure (adult) or
 Clindamycin 600mg orally one hour pre-procedure (adult if penicillin
allergic).
To estimate the total number of patients within the SHN that fall into the
particularly high risk groups above the following review was undertaken:
 Published data indicates an incidence of about 20 IE cases per million
per year in the UK, which is equivalent to about 30 per annum in the
whole of Sussex. But this includes drug users and those with poor
immune systems including HIV. Literature suggests only 10% of these
are preventable with antibiotic prophylaxis targeted at high risk groups.
This means there are probably about 500 people alive in Sussex who
have had previous IE. There is no estimate of what their risk of
reinfection is in the literature, just a suggestion that it is higher than the
general population
 There are around 4/1000 live births with cynanotic heart disease, but
they do not all have good life expectancy because associated with
other genetic or congenital problems as well as the heart, eg Downs.
This would mean an approximate of 2000 in Sussex
 The local prosthetic valve replacement rates could be explored using
HES data. There is an American study which claims a population
prevalence of 1.1 per 1000 in the US which extrapolated would mean
about 1500 in Sussex.
 This collation of evidence suggests approximately 4000 people would
be included within the high risk group needing antibiotic prophylaxis
every time they go to the dentist.
In light of the European Society of Cardiology recommendations, it is the view
of the SCCN clinicians that individuals in the above groups should continue to
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receive antibiotic prophylaxis. The SCCN clinicians will therefore work with
clinical practitioners in primary care and dental services to ensure that they
are aware of when advising particular patients of the need for antibiotic
prophylaxis cover. The SCCN Clinicians have given considerable thought to
the most appropriate route for both the patient and patient’s GP and dentist to
be aware of their clinical guidance and this is outlined in the next section.
What activity/resources are required?
 Publication of the SCCN clinical guidance will be included with other
clinical guidelines on the Sussex Heart Network website; patients that
the cardiologists or cardiac surgeons assess at risk will be provided
with a patient held card within cardiology clinics GPs will be advised by
cardiologists of patients at risk, in writing, and notified that patients
have received a patient held record card.
 Cardiologists to stress the importance of good dental hygiene by
adding to the bottom of cardiology & cardiothoracic letters from the
units a sentence at the end of each letter along the lines of good teeth
hygiene, stressing the importance of regular dental review & avoiding
body tattoos & piercings ( as referenced on page 8 NICE CG 64).
 Letter of explanation of the expert SCCN clinical view on this issue for
particular patients at risk, to be provided to LMC and LDC so that both
committees are aware of the patient held card being issued
 The SHN team will provide practical and project support by ensuring
distribution of patient held cards to cardiologists in SHN, that
agreement on standard strap line for clinic letters drafted (content as
above) issuing advice and in ensuring method of issue is agreed with
all stakeholders below.
Which key stakeholders are involved?
Acute Trust cardiology teams, GPs, GP commissioning consortia, PCTs,
Sussex Cluster PCT, Public Health Teams, Local Medical Committees and
Local Dental Committees within the SHN. BSUH microbiology department
has indicated support to these recommendations.
What are the expected outcomes?
 Reduction in IE cases in patients at particular risk (previous IE;
Cyanotic heart disease; Prosthetic valve or prosthetic material used for
cardiac valve repair;
 Reduction in costs of caring for patients that contract IE.
Are there any initial or recurring cost implications for organisations?
The NICE guidance identified potential harm in unnecessary antibiotic
prescribing. NICE found no evidence as to whether prophylaxis is effective or
ineffective in preventing cases of IE in people at increased risk who are about
to undergo an invasive dental procedure. There have been no randomised
trials of prophylaxis. Ethically practitioners need to discuss the potential
benefits and harms of antibiotic prophylaxis (including the very small risk of
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SHN case of need – IE vs 0.7
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anaphylaxis) with their patients before a decision is made about
administration. However, there has been no report of fatal anaphylaxis in the
literature from oral amoxicillin administration for prophylaxis (Eur Heart J
2009). There is a cost implication of a single dose of antibiotic but this cost
needs to be compared to the high financial burden to the NHS of a single case
of endocarditis.
See Appendix 1 for estimated cost of IE cases.
Options appraisal
1) status quo – impact of doing nothing
2) change practice – impact of introduction of recommendation
Risks and constraints
 The risk of not proceeding is that patients may contract IE
needlessly.
 Implementation is dependent on all stakeholders agreeing
advice and method of communication.
Impact on other services
The impact of delivery of the prophylactic antibiotics for appropriate patients
has minimal affect on other acute hospital departments – it will involve
cardiologists, clinical nurse specialists with regards to patient information and
informed choice and pharmacy departments. Externally GPs, GP Consortia,
Public Health Teams, Sussex Cluster PCT, Local Medical Committees and
Local Dental Committees will all wish to be aware of the recommendations
and method of implementing this advice.
Timetable/implementation plan
Key milestones:
 Finalise format of advice
 Agree format of advice with above stakeholders
 Issue advice
Review and evaluation
The implementation will be assessed to ensure delivered intended outcomes
and mitigate against any risks
References
Mylonakis E and Calderwood SB. Infective endocarditis in adults. N Engl J
Med 2001; 345: 1318-1330
Moreillon P and Que Y-A Infective endocarditis. Lancet 2004 ; 363 : 139-149
Guidelines on the prevention, diagnosis and treatment of infective
endocarditis. Eur Heart J 2009; 30: 2369-2413
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Prevention of infective endocarditis: guidelines from the American Heart
Association: A guideline from the American Heart Association rheumatic fever,
endocarditis and Kawasaki disease committee. Circulation 2007; 116: 17361754
Version Control
Version
0.1
Sent To
BSUH Consultant Cardiologist
SHN Manager
Comments
IE Briefing paper for SHN Board forms
basis of content
Date
16th February
2011
0.2
BSUH Consultant Cardiologist
SHN Manager; Lead Cardiology
clinicians ESHT, WSHT BSUH;
members of the Sussex Cardiac
Clinical Network Group
SHN Manager, Eric
McWilliams, Rachael James
Audit results sent by Dr R James
included within draft
21st March
Author
Deborah
Tomalin
Director Sussex
Managed
Clinical
Networks
DT
Inclusion of comments from SCCCN
Group; lead consultant BSUH; more
process clarification from DT; costing
suggestion from Eric McWilliams/David
Robertson
Further amendments from above
included – sent out for further comments
and amendment to those listed to the left
Inclusion of PH issues and further
consideration to best method of issue.
6th April
DT
11th April
DT
14th April
DT
Final comments included within. Sent to
SHN Board for agreement
Reviewed Document with costings and
developed protocol to support
20th April
DT
Sept 2011
JO
0.3
0.4
SHN Clinical Leads; SCN Public
Health Director
0.5
0.6
Sussex Cardiac Clinical Network
Group members; SHN
management leads; SHN clinical
group Chairs; PCT cardiac
commissioning leads; SHN
Clinical Leads; SCN Public
Health Director
SHN Board
0.7
SHN Board and Commissioners
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Appendix 1
Proposed costing template for IP Treatment Vs Prophylactic antibiotics
In patient treatment costs per case
Pathway step
42 days acute hospital care @ tariff XXXX
Cost (£)
£6974 (LOS trim point
78 days)
£ 478.80
£ 129.36
6 weeks of 4 hourly Benzyl Penicillin
4 weeks IV Gentamicin
(variable costs of drug
levels/doses etc)
Proportion of cases on Linezolid = £YYY X cases
prescribed divided by
total cases admitted
Sub - total
Cost of single valve (40% patients)
MFF for BSUH 7.4391%
Sub Total
Total cost of IP management of IE per case
Total cost of IP management of I.E. and valve
surgery per case
Cost per case *
Estimated number of IE admissions p.a. base on
3/100,000 of 1.6m Sussex population
annual cost of hospital treatment
Cost of prophylaxis formula
Pathway step
R
Number of patients in Sussex in high-risk
groups
E
Average annual exposures to risk (dental and
other invasive procedures)
P
R * N equals prophylactic courses prescribed
to protect Sussex population
D
Cost of course of prophylaxis
Amoxycillin 3g orally
Or Clindamycin 60mmg orally
£ 1246 (BD x 14 days
£ 8,826.16
£12,899.
£ 959.50
£ 13,858.50
£ 8,826.16
£ 22, 684.66
£ 423,655 – medical
£ 1088,863 – with valve
Number
48 / pa
Cost (£)
1 per
patient
48 x £9.30
£446
48 x £7.25
£348
1.
1.
£9.30
£7.25
P* D is cost of prophylaxis for Sussex atrisk population
Evaluation
The cost of prophylactic antibiotics to prevent I.E is minimal at £7.25 – £9.30 per
patient compared to in patient costs of £8,826 minimum per patient, potentially rising
to £22,684 for a patient needing valve surgery.
A costing model does not account for the devastating socioeconomic impact a patient
and their family has to endure due to a protracted hospital stay, potential
complications and mortality associated with infective endocarditis.
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