The Impact of Changing Antiseptic Skin Preparation Agent used for Cardiac Implantable Electronic Device (CIED) Procedures on the Risk of Infection MOHAMMED QINTAR, M.D.,* OMEED ZARDKOOHI, M.D.,† MUHAMMAD HAMMADAH, M.D.,* AMY HSU, M.S.,‡ OUSSAMA WAZNI, M.D.,‡ BRUCE L. WILKOFF, M.D.,‡ and KHALDOUN G. TARAKJI, M.D., M.P.H.‡ From the *Department of Internal Medicine, Cleveland Clinic, Cleveland, Ohio; †Cardiac Electrophysiology and Cardiovascular Medicine, Cadence Physician Group, Winfield, Illinois; and ‡Section of Cardiac Pacing and Electrophysiology, Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio Background: Cardiac implantable electronic device (CIED) infection is a major complication that is associated with increased morbidity and mortality. Recent data suggested a relationship between the antiseptic agent used for skin preparation at time of CIED procedure and risk for infection. Methods: On April 30, 2011, we changed the antiseptic agent used for skin preparation at our tertiary care facility from chlorhexidine-alcohol to povidone-iodine for all CIED procedures. We retrospectively reviewed records of all patients who underwent CIED procedure 1 year before and after the change. CIED infection was defined as pocket or endovascular systemic infection that required removal within 1 year of the index procedure. We examined if the change affected the risk of CIED infection. Results: A total of 2,792 patients underwent 2,840 CIED procedures; 1,748 (61.5%) had implantable cardioverter defibrillator procedures and 1,092 (38.4%) had permanent pacemaker procedures. Chlorhexidine-alcohol agent was used in 1,450 (51.1%) procedures, and povidone-iodine agent was used in 1,390 (48.9%). After 1 year of follow-up, 31 patients (1.09%) developed CIED infection that required system removal. The 1-year infection rate was 1.1% among both antiseptic agent groups and there were no significant differences in the infection presentations among both groups (P = 0.950). Multivariate Cox proportional hazards regression model showed that risk factors for infection within 1 year included age, diabetes, and African American race. Conclusion: In one large cohort of patients undergoing CIED procedures, the antiseptic agent used for skin preparation (chlorhexidine-alcohol vs povidone-iodine) was not associated with increased risk of developing CIED infection. (PACE 2014; 00:1–7) Cardiac implantable electronic device, pacemaker, defibrillator, infection, complication, outcome Background Over the last few decades, there has been a growing evidence of the importance of car- diac implantable electronic devices (CIEDs) in improving both the quality of life and survival among patients with heart disease. 1,2 This body of evidence has led to a significant increase in the Disclosures: Bruce L. Wilkoff: Physician advisory boards: Medtronic, St. Jude Medical, and Spectranetics. Khaldoun G. Tarakji: Consulting fee: Medtronic. Other authors: no disclosures. Address for reprints: Khaldoun G. Tarakji, M.D., M.P.H., Section of Cardiac Pacing and Electrophysiology, Heart and Vascular Institute, Cleveland Clinic, 9500 Euclid Avenue/J2- 2, Cleveland, OH 44195. Fax: 216 445–6149; e-mail: tarakjk@ccf.org Received April 10, 2014; revised July 29, 2014; accepted August 7, 2014. doi: 10.1111/pace.12514 number of CIED implants and a higher awareness of its associated complications. 3,4 One of the most feared complications is CIED infection as it is associated with high morbidity and mortality. 4–6 In general, the risk of developing CIED infection is estimated to be around 0.5% for primary de novo implant and 1–5% for device replacement or upgrade procedures. 7–9 Predictors of CIED infections include the presence of an implantable cardioverter defibrillator (ICD) as opposed to per- manent pacemaker (PPM), secondary procedure (replacement or upgrade), multiple leads, renal failure, physician experience, fever within 24 hours prior to implant, temporary pacemaker, and early reintervention (hematoma evacuation, lead dislodgement, etc.). 7,8,10–14 Recent data from the REPLACE registry suggested a potential association between the antiseptic agent used for skin preparation and CIED infection. 14 In a substudy of the registry, institutions that used povidone-iodine agents for skin preparation had ©2014 Wiley Periodicals, Inc. PACE, Vol. 00 2014 1