Risk Factors for Infections Involving Cardiac Implanted Electronic Devices

• Published in: Journal of the American College of Cardiology Vol. 74; no. 23; pp. 2845 - 2854
• Main Authors: Birnie, David H., Wang, Jia, Alings, Marco, Philippon, François, Parkash, Ratika, Manlucu, Jaimie, Angaran, Paul, Rinne, Claus, Coutu, Benoit, Low, R. Aaron, Essebag, Vidal, Morillo, Carlos, Redfearn, Damian, Toal, Satish, Becker, Giuliano, Degrâce, Michel, Thibault, Bernard, Crystal, Eugene, Tung, Stanley, LeMaitre, John, Sultan, Omar, Bennett, Matthew, Bashir, Jamil, Ayala-Paredes, Felix, Gervais, Philippe, Rioux, Leon, Hemels, Martin E.W., Bouwels, Leon H.R., Exner, Derek V., Dorian, Paul, Connolly, Stuart J., Longtin, Yves, Krahn, Andrew D.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 10.12.2019; Elsevier Limited
• Subjects: Adjudication; Age; Aged; Antibiotic Prophylaxis - methods; Antibiotics; Arrhythmia; Arrhythmias, Cardiac - therapy; Calibration; Canada - epidemiology; cardiac implantable electronic device; Cardiology; Confidence intervals; Cross-Over Studies; Defibrillators, Implantable - adverse effects; Diabetes; Electronic devices; Electronic equipment; Female; Health risks; Heart; Heart failure; Hospitalization; Hospitalization - statistics & numerical data; Humans; implantable cardioverter defibrillator; Incidence; infection; Infections; Male; Optimism; pacemaker; Pacemaker, Artificial - adverse effects; Patients; Prediction models; Prevention; Prosthesis-Related Infections - epidemiology; Prosthesis-Related Infections - prevention & control; Renal function; Risk analysis; Risk Assessment - methods; Risk Factors; Risk groups; Statistical analysis; Statistical methods; Variables; Canada; implantable cardioverter defibrillator; infection; pacemaker; CRT; CI; CIED; ICD; PADIT; antibiotics; cardiac implantable electronic device
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2019.09.060

Cardiac implantable electronic device infection is a major complication that usually requires device removal. PADIT (Prevention of Arrhythmia Device Infection Trial) was a large cluster crossover trial of conventional versus incremental antibiotics. This study sought to investigate independent predictors of device infection in PADIT and develop a novel infection risk score. In brief, over 4 6-month periods, 28 centers used either conventional or incremental prophylactic antibiotic treatment in all patients. The primary outcome was hospitalization for device infection within 1 year (blinded endpoint adjudication). Multivariable logistic prediction modeling was used to identify the independent predictors and develop a risk score for device infection. The prediction models were internally validated with bootstrap methods. Device procedures were performed in 19,603 patients, and hospitalization for infection occurred in 177 (0.90%) within 1 year of follow-up. The final prediction model identified 5 independent predictors of device infection (prior procedures [P], age [A], depressed renal function [D], immunocompromised [I], and procedure type [T]) with an optimism-corrected C-statistic of 0.704 (95% confidence interval: 0.660 to 0.744). A PADIT risk score ranging from 0 to 15 points classified patients into low (0 to 4), intermediate (5 to 6) and high (≥7) risk groups with rates of hospitalization for infection of 0.51%, 1.42%, and 3.41%, respectively. This study identified 5 independent predictors of device infection and developed a novel infection risk score in the largest cardiac implantable electronic device trial to date, warranting validation in an independent cohort. The 5 independent predictors in the PADIT score are readily adopted into clinical practice. (Prevention of Arrhythmia Device Infection Trial [PADIT Pilot]; NCT01002911) [Display omitted]