511. Infections associated with cardiac rhythm management device replacement: Results from the REPLACE Registry
Session: Poster Session: Hospital-acquired and Transplant Infections
Friday, October 30, 2009: 12:00 AM
Room: Poster Hall A
Background: Infection is a serious complication of cardiac rhythm management device (CRMD) implantation. The REPLACE Registry is a prospective multicenter registry undertaken to estimate the procedure-related complication rates following CRMD generator replacement without (Cohort 1) and with (Cohort 2) planned lead addition. This study describes findings specific to infectious complications in Cohort 1.
Methods: Patients undergoing elective CRMD generator replacement at 68 US centers were prospectively enrolled and followed with scheduled visits for six months after CRMD implantation. CRMD infection was defined using the Centers for Disease Control (CDC) definition for surgical site infection. All cases of infection were adjudicated by an independent blinded clinical events committee.
Results: 1031 patients undergoing CRMD replacement were enrolled. 51% had a permanent pacemaker (PPM) and 49% had an implantable cardioverter-defibrillator (ICD). The mean age was 71.1 ± 14.1 years and 62% were male. All patients received preoperative antibiotics and topical antiseptics. 45% of patients received postoperative parenteral antibiotics. Thirteen patients (1.3%) developed CRMD infection. The median time to infection was 15 days (range, 7 to 141 days). The incidence of infection among subjects receiving no postoperative antibiotics (0.5%) was lower than in those receiving parenteral antibiotics postop (2.3%). Skin preparation with povidone-iodine was associated with an increased rate of infection (2.5%) compared with chlorhexidine or other topical preparations (0.7%), p=0.016. Pocket irrigation with antibiotic solution, renal dialysis, and warfarin use were not associated with infection.
Conclusion: In this large multicenter prospective study, the incidence of CRMD infection after generator replacement was 1.3%. Addition of postoperative antibiotics did not decrease the rate of infection. A higher infection rate was associated with use of povidone-iodine skin preparation. These results provide new data regarding CRMD-related infections and raise issues regarding the use of certain infectious prophylactic practices.
Richard Borge, MD, Abington Medical Specialists, Abington, PA, Mina Chung, MD, Cleveland Clinic, Cleveland, OH, Dan Dan, MD, Piedmont Heart Institute, Atlanta, GA, Marye Gleva, MD, Venkateshwar Gottipaty, MD, South Carolina Heart Center, Columbia, SC, Richard Holcomb, PhD, None, Minnetonka, MN, Theofanie Mela, MD, Massachusetts General Hospital, Boston, MA, Jeanne Poole, MD, University of Washington, Seattle, WA, Timothy Shinn, MD, None, Ypsilanti, MI, Daniel Uslan, MD, Mayo Clinic, Rochester, MN, David Warren, MD, MPH, Washington University School of Medicine, St. Louis, MO and  D. Z. Uslan,
American Heart Association Role(s): Grant Investigator, Received: Research Grant, Research Support.
TyRx Pharma, Inc Role(s): Consultant, Received: Consulting Fee.
Biotronik, Inc Role(s): Scientific Advisor (Review Panel or Advisory Committee), Received: Consulting Fee.
Cubist Role(s): Speaker's Bureau, Received: Speaker Honorarium.
M. J. Gleva,
Biotronik Role(s): Research Relationship, Received: Research Support.
Medtronic Role(s): Research Relationship, Received: Research Support.
R. Holcomb, None. 
T. Mela,
Biotronik Role(s): Scientific Advisor (Review Panel or Advisory Committee), Received: Consulting Fee.
M. Chung,
Biotronik Role(s): Research Relationship, Received: Research Support.
Medtronic Role(s): Research Relationship, Received: Research Support.
Boston Scientific Role(s): Research Relationship, Received: Research Support.
St. Jude Role(s): Research Relationship, Received: Research Support.
R. Borge,
Biotronik Role(s): Scientific Advisor (Review Panel or Advisory Committee), Received: Research Support, Consulting Fee.
Boston Scientific Role(s): Research Relationship, Received: Research Support, Speaker Honorarium.
Medtronic Role(s): Research Relationship, Received: Research Support, Speaker Honorarium.
St. Jude Role(s): Research Relationship, Received: Speaker Honorarium.
V. Gottipaty,
Biotronik Role(s): Scientific Advisor (Review Panel or Advisory Committee), Received: Consulting Fee.
T. Shinn,
Biotronik Role(s): Scientific Advisor (Review Panel or Advisory Committee), Received: Consulting Fee.
D. Dan,
Biotronik Role(s): Scientific Advisor (Review Panel or Advisory Committee), Received: Consulting Fee.
D. Warren,
Biotronik Role(s): Scientific Advisor (Review Panel or Advisory Committee), Received: Consulting Fee.
J. Poole,
Biotronik Role(s): Research Relationship, Scientific Advisor (Review Panel or Advisory Committee), Received: Salary, Research Support.