Updated scientific statement on cardiovascular implantable electronic device infections by AHA

"Major advances since then have occurred in the prevention, diagnosis, and management of these infections, necessitating a scientific statement update," Larry M. Baddour, Mayo Clinic, Rochester, MN, and colleagues wrote in their statement published in Circulation. The updated scientific statement highlights recent advances in prevention, diagnosis, and management, and how they may be incorporated in the complex care of patients with cardiovascular implantable electronic device infection.

An 11-member writing group was identified and included recognized experts in infectious diseases and cardiology, with a career focus on cardiovascular infections.

The writing group highlighted randomized trials focused on prevention, evolving knowledge on the utility of advanced imaging for diagnosis, and the emergence of newer devices— including subcutaneous implantable cardioverter-defibrillators (S-ICDs) and leadless pacemakers —that are expected to carry lower risks of infection.

Patients who develop CIED infections can be difficult to manage, and a team approach incorporating clinicians with a broad range of expertise including echocardiography, nuclear medicine, cardiovascular surgery, infectious diseases, and electrophysiology is critical. These patients are usually older have multiple comorbid conditions and deserve multispecialty care in larger-volume medical centres.

The updated statement covers three main areas: prevention, diagnosis, and management.

For prevention, two randomized trials have been conducted since 2010. PADIT evaluated compared incremental periprocedural antibiotics with conventional treatment in patients receiving CIEDs, with no difference in infection rates observed. A novel antibiotic-impregnated envelope used at the time of device placement in conjunction with standard prevention strategies reduced major infections by a relative 40% in WRAP-IT. According to the authors, the enveloped, may be considered in patients considered to be at high risk for CIED infection, including those who are at risk for perioperative hematoma formation.

In the area of diagnosis, the statement involves a discussion of the challenge of distinguishing between infected and noninfected devices, the use of various imaging modalities, the role of inflammatory markers, and laboratory advances in pathogen detection.

The update clarifies that questions have been raised about transesophageal echocardiography (TEE) used to identify infection in a patient with CIED. In recent years, there has been a growing use of positron emission tomography/computed tomography (PET/CT) imaging to aid in diagnosis. Echocardiography is still used but combining it with PET/CT has increased the specificity and sensitivity of diagnosis. According to the writing group, these tests, even combined, are not 100% accurate.

An important aspect of CIED infections for cardiologists is that there is a spectrum of organisms that are more likely to cause infection and stick to these devices and certain ones that are not, which will impact the pretest probability of diagnostic imaging.

Once the diagnosis of CIED infection is made, the entire system should be removed whenever possible, stresses the management section of the statement. The authors then address the optimal timing of implantation or reimplantation of a newer device, the role of percutaneous mechanical aspiration for vegetation removal, and strategies for treating patients in whom an infected CIED cannot be removed due to major comorbidities, limited life expectancy, or high extraction risk.

In select patients, percutaneous mechanical aspiration has been used demonstrating some benefit in reducing the risk of pulmonary embolism at the time of device extraction. The document also discusses a strategy of antimicrobial administration directly into an infected pocket.

The document also addresses some issues including the emergence of newer devices that might help mitigate the problem of CIED infection. Leadless pacemakers and S-ICDs have been evaluated in both prevention- and management-related studies.

Also, several risk scores can help estimate CIED infection risk and these may be useful in identifying potential candidates for incremental prevention measures, and alternative device platforms such as a leadless pacemaker or S-ICD.

The document stated, "Despite the advances made in the CIED infection, there is a need for much more randomized data to guide practising clinicians. The investigators pointed out the absence of RCTs in the areas of management and diagnosis. The lack of randomized data and the dependence on consensus opinion have led to some differences across various guidelines that have addressed CIED infections over the years.

"There is a need for prospective, randomized controlled trials to enhance the diagnosis and management of CIED infection," stressed the writing group.

Despite the need for more robust evidence to guide practice, the current statement aims to ease decision-making, with the supplemental material containing six case scenarios that lay out potential solutions to common clinical conundrums.

Reference:

Baddour LM, Esquer Garrigos Z, Sohail MR, Havers-Borgersen E, Krahn AD, Chu VH, Radke CS, Avari-Silva J, El-Chami MF, Miro JM, DeSimone DC; on behalf of the American Heart Association Council on Clinical Cardiology. Update on cardiovascular implantable electronic device infections and their prevention, diagnosis, and management: a scientific statement from the American Heart Association. Circulation. 2023;148:e•••–e•••. doi: 10.1161/CIR.0000000000001187