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observe differences between valve types.665 The most consistent factors associated with an increased risk of IE following TPVI have been younger age, a previous history of IE, and a higher transvalvular residual gradient.93,663,665

12.3.2.1 Diagnosis

The diagnosis of IE in TPVI recipients may be challenging, and the use of intracardiac echocardiography and [18F]FDG-PET/CT has been shown to be useful in cases with a clinical suspicion and negative TTE/ TOE.34,93,210,660,665,670 S. aureus and oral group streptococci species are the most common microorganisms causing IE post-TPVI.660,664–666

12.3.2.2 Prognosis and treatment

New moderate or severe prosthetic valve stenosis occurs much more frequently (one-third to one-half of patients) in post-TPVI PVE than in aortic PVE, and the rate of surgical valve replacement therapy ranges from 26% to 56%.93,660,661,664,665 The possibility of a transcatheter therapy (valve-in-valve intervention) for treating severe prosthesis dysfunction in cases with healed endocarditis or as an urgent treatment (balloon dilatation) in severe valve stenosis cases has also been reported.660,665 A valve-in-valve intervention should be delayed at least 1–3 months following antibiotic treatment of the endocarditis episode. The mortality rate related to the IE episode ranges from 0% to 11%.93,660,661,664,665 This rate is much lower compared with TAVI patients, which is likely to be related to the younger and less co-morbid characteristics of the TPVI population.

12.4 Infective endocarditis affecting

cardiac implantable electronic devices Device-related infection is one of the most serious complications of CIED therapy and is associated with significant mortality and morbidity.671

12.4.1 Definitions of cardiac device infections

A recent EHRA consensus document has published criteria for CIED infection.130 Localized infections may be either superficial incisional infections (acute infection without involvement of the pocket or hardware) or isolated pocket infections (limited to the hardware in the pocket), and can be either acute or chronic. Systemic CIED infections may occur with or without pocket infection, and with or without visible vegetations on the tricuspid or pulmonary valves or pacing leads. Cardiovascular implanted electronic device-related IE is defined as evidence of CIED infection with clinical signs of pocket infection and/or imaging findings (lead vegetations, positive FDG-PET on the generator/leads etc.) which fulfil the criteria for valvular IE (see Section 5).

12.4.2 Pathophysiology and microbiology

Cardiovascular implanted electronic device-related IE occurs by two mechanisms. Local infection usually results from bacterial flora from the patient’s skin that is introduced into the pocket at the time of incision despite surgical preparation.672 Seeding via bacteraemia from a distant focus is less frequent.673–676 Whereas CoNS are most frequently the cause of chronic pocket infection, the most frequent agents identified with bacteraemia in CIED infection are S. aureus and CoNS.677,678 Other causative organisms are Enterococcus spp., β-haemolytic streptococci, oral streptococci group, Cutibacterium acnes, and Corynebacterium spp.674,678,679 More rarely, systemic infection is caused by Gram-negative (mainly P. aeruginosa or Serratia marcescens)680 or polymicrobial agents, whereas systemic fungal infections (Candida spp. and Aspergillus spp.)681 are exceptional. 12.4.3 Risk factors

Risk factors may be divided into patient-related, procedure-related, and device-related factors.118 The PADIT (Previous procedure on same pocket; Age; Depressed renal function; Immunocompromised; Type of procedure) study randomized 19 603 patients undergoing CIED implantation to conventional treatment (pre-procedural cefazolin infusion) vs. different regimens of incremental treatment.682 The primary outcome was 1-year hospitalization for device infection which was not significantly different between groups. A risk score for infection has been derived from the study (see Supplementary data online, Table S11)683 and has been validated externally.684 A web-based calculator is available (https://padit-calculator.ca).683

12.4.4 Prophylaxis

Antibiotic prophylaxis to prevent CIED-related IE before interventions, such as dental, respiratory, gastrointestinal, or genitourinary procedures, is not warranted as the risk is very low. Prevention of CIED infection at implantation hinges upon careful planning, pre-operative antibiotic prophylaxis, correction of modifiable risk factors, hygienic surgical environment and technique, ancillary measures in case of increased risk (e.g. use of an antibacterial envelope), and proper post-operative care. Correction of modifiable risk factors includes general measures such as postponing the procedure in cases of fever or signs of infection and avoiding temporary pacing. Routine administration of prophylactic systemic antibiotics within 1 h of incision is the standard of care.118 RCTs have used flucloxacillin (1–2 g i.v.)117 and first-generation cephalosporins, such as cefazolin (1–2 g i.v.).116 Vancomycin (1–2 g over 60–90 min) may be used in case of allergy to cephalosporins with other alternatives, including teicoplanin and clindamycin.117 Coverage of MRSA should be guided by the prevalence in the implanting institution. Haematoma is a major contributor to risk of infection, and all possible measures should be taken to avoid this complication.685,686 Another major risk factor is a revision with re-opening of the pocket (e.g. for lead repositioning). Technical aspects have recently been covered in detail in an EHRA consensus document on CIED implantation.687 It is generally not recommended to wash the pocket with antibiotics, nor to administer antibiotic treatment post-operatively, as shown by the PADIT trial.682 An antibiotic mesh envelope, which locally releases minocycline and rifampin for a minimum of 7 days and is fully absorbed in ∼9 weeks, may, however, be useful to reduce risk of infection in selected patients. The Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) showed that the mesh envelope significantly reduces the incidence of CIED infection in patients at increased risk (i.e. undergoing a pocket revision, generator replacement, system upgrade, or implantation of a cardiac resynchronization therapy [CRT]-implantable cardioverter defibrillator [ICD]).688 The number needed to treat was, however, high at 200, but is ∼50 in patients undergoing CRT reoperations (replacement/upgrade/revision) in a recent observational study.689

12.4.5 Diagnosis

Clinical presentation of CIED-associated IE is similar to valvular IE with patients frequently presenting with fever, chills, and embolic events. Signs of pocket infection (swelling, tenderness, erythema, purulent discharge etc.) may or may not be present. The probability that a positive blood culture in a CIED recipient represents underlying device infection depends on the organism type and duration of bacteraemia. Suspicion of CIED-associated IE should be particularly high in the event of S. aureus bacteraemia.675 CIED infection is less likely with Gram-negative bacteraemia, and in these instances, the pocket usually shows signs of infection.680,690,691 Downloaded from academic.oup.com/eurheartj/article/44/39/3948/7243107 by guest on 07 October 2026