Risk Factors for Infections Involving CIEDs

Study Questions:

What are the risk factors for infection in patients undergoing implantation of a cardiac implanted electronic device (CIED)?

Methods:

This was a post hoc analysis of data from 19,603 patients enrolled in a multicenter clinical trial of prophylactic antibiotic treatment during implantation of a CIED (PADIT [Prevention of Arrhythmia Device Infection Trial]). The primary outcome of the trial was hospitalization for device infection within 1 year. Risk factors for infection were identified and a risk score was developed.

Results:

Hospitalization for infection occurred in 177 patients (0.9%). Five independent predictors of infection were identified: age; number of prior procedures (odds ratio [OR], 3.43 for ≥2; glomerular filtration rate <30 ml/min (OR, 1.45); immunocompromised state (OR, 2.28); and procedure type (OR, 4.0 for revision/upgrade). A risk score that ranged from 0 to 15 was developed based on these five risk factors. The infection rates in the low risk (score 0-4), intermediate risk (5-6), and high risk (7-15) groups were 0.51%, 1.42%, and 3.41%, respectively.

Conclusions:

The risk score developed in this study identifies patients at highest risk of infection after implantation of a CIED.

Perspective:

It is important to note that all patients in the PADIT trial received prophylactic antibiotic therapy, either conventional prophylaxis with cefazolin, or more intense prophylaxis with cefazolin plus vancomycin, bacitracin pocket wash during implantation, and 2 days of post-implantation cefazolin. The infection rates were equally low with both prophylaxis regimens (1-1.2%). The risk score developed in the present study might be clinically useful in some situations. For example, if the risk score is very high, it might be decided to forego another replacement at implantable cardioverter-defibrillator (ICD) end-of-life in a patient with a primary prevention ICD who already has had 1-2 prior replacements and who has never required an ICD therapy.

Keywords: Anti-Bacterial Agents, Antibiotic Prophylaxis, Arrhythmias, Cardiac, Bacitracin, Cefazolin, Defibrillators, Implantable, Glomerular Filtration Rate, Infections, Pacemaker, Artificial, Primary Prevention, Risk Factors, Secondary Prevention, Terminal Care, Vancomycin


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