Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Remote ischemic conditioning wikipedia , lookup
Cardiac contractility modulation wikipedia , lookup
Management of acute coronary syndrome wikipedia , lookup
Myocardial infarction wikipedia , lookup
Coronary artery disease wikipedia , lookup
Cardiac surgery wikipedia , lookup
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. Page 2 of 7 SHN case of need – IE vs 0.7 16th Sept 2011 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 Page 3 of 7 SHN case of need – IE vs 0.7 16th Sept 2011 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 Page 4 of 7 SHN case of need – IE vs 0.7 16th Sept 2011 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 Page 5 of 7 SHN case of need – IE vs 0.7 16th Sept 2011 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 Page 6 of 7 SHN case of need – IE vs 0.7 16th Sept 2011 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. Page 7 of 7 SHN case of need – IE vs 0.7 16th Sept 2011