Cardiovascular Implantable Electronic Device Replacement Infections and Prevention: Results from the REPLACE Registry

Authors


  • This study was supported by BIOTRONIK, Inc., Lake Oswego, Oregon.

  • Disclosures have been made by all the authors, and details are on file. All have received direct or indirect support from Biotronik. Most have also received support from other CIED manufacturers and/or technology companies and/or pharmacologic companies.

Daniel Z. Uslan, M.D., Division of Infectious Diseases, David Geffen School of Medicine at UCLA, 10833 LeConte Ave, 37-121 CHS, Los Angeles, CA 90095. Fax: 310-825-3632; e-mail: duslan@mednet.ucla.edu Clinical Trials Registration: ClinicalTrials.gov; NCT00395447.

Abstract

Background:Infection following cardiovascular implantable electronic device (CIED) replacement is a serious complication, and rates of infection have increased. Analysis of procedural and clinical data from device replacement procedures collected by the REPLACE Registry may provide insights into infection prevention strategies and outcomes.

Methods:We prospectively evaluated procedural complications in patients undergoing CIED replacement over 6 months from 72 U.S. sites. Major and minor infections were predefined and adjudicated by an independent blinded clinical events committee. Data regarding infection prevention strategies and infectious outcomes were analyzed for their potential relationships.

Results:A total of 1,744 patients were included in REPLACE. All patients received preoperative intravenous antibiotics and 68.7% received postoperative systemic antibiotic therapy. CIED infection developed in 22 patients (1.3%), of which 14 cases were major (0.8%, 95% confidence interval [CI] 0.4%–1.3%) and eight were minor (0.5%, 95% CI 0.2%–0.9%). Patients with infections were more likely to have had postoperative hematomas (five of 22 [22.7%] vs 17 of 1,722 [0.98%], P = 0.002). Participating sites experiencing infection rates >5% were more likely to use povidone-iodine for topical antisepsis, had lower implantation volume, and had patients with higher Charlson Comorbidity Index (2.79 vs 2.32, 95% CI for difference 0.08–0.86, P = 0.019).

Conclusions:In this multicenter prospective study with 6 months of follow-up, infections associated with CIED replacements were surprisingly infrequent, possibly due to the use of preoperative antibiotics. Patients with infections were more likely to have had a postoperative hematoma, and sites with higher infection rates had sicker patients and lower overall procedural volume. (PACE 2012; 35:81–87)

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