Le nuove linee guida della prevenzione delle endocarditi: abbiamo sbagliato tutto fino ad ora? Oscar Gaddi

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1 Le nuove linee guida della prevenzione delle endocarditi: abbiamo sbagliato tutto fino ad ora? Oscar Gaddi Azienda Ospedaliera ASMN Reggio Emilia Unità Operativa di Cardiologia

2 L EI è gravata ancora da un elevata mortalità e morbilità. Negli Stati Uniti ma anche in Europa si stima che l incidenza di EI su valvole native vari dal 1.7 al 6.2 casi ogni 100,000 abitanti, con una prevalenza maggiore negli uomini rispetto alle donne. Modificazioni nell epidemiologia dell EI Due condizioni predisponenti fino alla fine degli anni 70: - valvulopatia reumatica - cardiopatie congenite cianogene Altri fattori predisponenti sono comparsi : -abuso di sostanze stupefacenti per via iniettiva venosa -impianto di protesi valvolari -sclerosi valvolari degenerative -l incremento delle procedure invasive comportanti rischio di batteriemie significative,

Modificazioni nell epidemiologia dell EI Due condizioni predisponenti fino alla fine degli anni 70: - valvulopatia reumatica - cardiopatie congenite cianogene Altri

3 La realizzazione delle raccomandazioni relative alla prevenzione dell EI, da parte dei membri del AHA si è basata su di un consenso di opinioni ( assenza di evidenze basate su studi sperimentali, fin dal 1955) Jones TD, Baumgartner L, Bellows MT, et al. Prevention of rheumatic fever, and bacterial endocarditis through control of streptococcal infection. Circulation 1955;21: Periodici update delle linee guida.

Jones TD, Baumgartner L, Bellows MT, et al.

4 -Indicazioni :non si discostano dalle precedenti -Mancanza di trials randomizzati placebo-controllo per valutare l'efficacia e la sicurezza della profilassi antibiotica in procedure invasive, odontoiatriche e non

per valutare l'efficacia e la sicurezza della

5 Indication ACC/AHA 1998 Valvular ACC/AHA 2006 Valvular ESC 2004 EI Hight-Risk Category Moderate-Risk Category

6 ACC/AHA 2006 Valvular

7 Endocarditis Profilaxis for Dental Procedure ACC/AHA 1998 Valvular ACC/AHA 2006 Valvular ESC 2004 EI

8 Endocarditis Profilaxis for Non Dental Procedure ACC/AHA 1998 Valvular ACC/AHA 2006 Valvular ESC 2004 EI

9 AHA 2007 EI

10 Primary Reasons for Revision of the IE Prophylaxis Guidelines 1 -The vast majority of cases of IE caused by oral microflora most likely result from random bacteremias caused by routine daily activities, such as chewing food, tooth brushing, flossing, use of toothpicks, use of water irrigation devices, and other activities. - Prophylaxis may prevent an exceedingly small number of cases of IE, if any, in individuals who undergo a dental, GI tract, or GU tract procedure. - Maintenance of optimal oral health and hygiene may reduce the incidence of bacteremia from daily activities and is more important than prophylactic antibiotics for a dental procedure to reduce the risk of IE. Meglio una costante igiene orale che una occasionale profilassi

- Prophylaxis may prevent an exceedingly small number of cases of IE, if any, in individuals who undergo a dental, GI tract, or GU tract procedure.

11 Primary Reasons for Revision of the IE Prophylaxis Guidelines 2 - The risk of antibiotic-associated adverse events exceeds the benefit, if any, from prophylactic antibiotic therapy. - Nonfatal adverse reactions,. these common adverse reactions are usually not severe and are self-limited. - Fatal anaphylactic reactions were estimated to occur in 15 to 25 individuals per 1 million patients who receive a dose of penicillin. - There has been a dramatic increase in the frequency of antimicrobial-resistant strains of enterococci to penicillins, vancomycin, and aminoglycosides. La profilassi non solo non è utile ma può anche essere dannosa

- Fatal anaphylactic reactions were estimated to occur in 15 to 25 individuals per 1 million patients who receive a dose of penicillin.

12 AHA 2007 EI Indication Revision 1 Table 3

13 MVP is the most common underlying condition that predisposes to acquisition of IE in the Western world; however, the absolute incidence of endocarditis is extremely low for the entire population with MVP, and it is not usually associated with the grave outcome associated with the conditions identified in Table 3. Thus, IE prophylaxis is no longer recommended for this group of individuals.

with MVP, and it is not usually associated with the grave outcome associated with the conditions

14 Endocarditis Profilaxis for Dental Procedure Revision 2

15 Endocarditis Profilaxis for Non Dental Procedure Antibiotic prophylaxis with a regimen listed in Table 5 may be considered (Class IIb, LOE C) for patients with the conditions listed in Table 3 who undergo an invasive procedure of the respiratory tract that involves incision or biopsy of the respiratory mucosa, such as tonsillectomy and adenoidectomy. This is in contrast to previous AHA guidelines that listed GI or GU tract procedures for which IE prophylaxis was recommended and those for which prophylaxisn was not recommended. Moreover, no studies exist that demonstrate that the administration of antimicrobial prophylaxis prevents IE in association with procedures performed on the GI or GU tract.

This is in contrast to previous AHA guidelines that listed GI or GU tract procedures for which IE prophylaxis was recommended and those for which prophylaxisn was not

16 Apparecchiature mediche impiantabili: pacemaker permanenti, defibrillatori (ICD), innesti vascolari,stents, protesi mammarie, cateteri tunnellizzati, protesi peniene. AHA 2003 : revisione delle suddette indicazioni. Per questa categoria di soggetti infatti non veniva più prevista la profilassi routinaria contro l infezione del device in caso di procedure odontoiatriche e non. Baddour LM, Bettman MA, Bolger AF, et al. Nonvalvular cardiovascular device-related infections. Circulation 2003;108:

Per questa categoria di soggetti infatti non veniva più prevista la profilassi routinaria contro l infezione del device in

17 Prophylactic antibiotic regimens

18 AHA 2007 EI

19 News from the Congress ESC 2007 Prevention of infective endocarditis: new US Guidelines bring major changes for at-risk patients Author: Dr Gilbert Habib Limits to applying American guidelines in Europe Before applying the American guidelines in Europe, we need to consider their limitations. First, the new guidelines are not based on randomised studies. Second, such radical modifications may be difficult to accept and understand by both patients and practitioners, and much effort will be required to explain them carefully, particularly so that patients understand the shift from focus on dental procedures towards a greater access to dental care and oral health for those with cardiac disease associated with the worst outcome after IE. Third, these guidelines probably will be followed by a reduction in the number of antibiotic prescriptions for preventing IE in the USA. It will be important to monitor the consequences on the epidemiologic profile of IE in the USA. Finally, prospective placebo-controlled double-blinded studied of antibiotic prophylaxis of IE in patients at risk of IE remain necessary, as well as additional prospective case-control studies. The ESC is developing a new version of the 2004 IE guidelines. These will focus on prevention, diagnosis and treatment of IE and are expected by 2009.

Second, such radical modifications may be difficult to accept and understand by both patients and practitioners, and much effort will be required to explain them carefully, particularly so that

20 BSAC 2006 British Society for Antimicrobial Chemotherapy

25 Le considerazioni fatte a proposito delle procedure dentarie non possono essere estese alle procedure GI e GU

26 Prophylaxis against infective endocarditis Implementing NICE guidance 2008 NICE clinical guideline 64

32 The committee recognizes that decades of previous recommendations for patients with most forms of VHD and other conditions have been abruptly changed by the new AHA guidelines. Because this may cause consternation among patients, clinicians should be available to discuss the rationale for these new changes with their patients, including the lack of scientific evidence to demonstrate a proven benefit for infective endocarditis prophylaxis. In select circumstances, the committee also understands that some clinicians and some patients may still feel more comfortable continuing with prophylaxis for infective endocarditis,particularly for those with bicuspid aortic valve or coarctation of the aorta, severe mitral valve prolapse, or hypertrophic obstructive cardiomyopathy. In those settings, the clinician should determinethat the risks associated with antibiotics are low before continuing a prophylaxis regimen.

33 Documento congiunto FIC SIMIT 2009

34 Età avanzata Iimmunodepressione locale o sistemica Diabete Dialisi Infezioni concomitanti con microorganismi potenzialmente responsabili di endocardite

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