C5. Bacteremia and endocarditis
Oral Abstract Submission
Muhammad R. Sohail, MD
Physician
Mayo Clinic
Rochester, MN
Disclosure: Boston Scientific Corporation : Consultant, Honoraria
Mayo Foundation : Other Financial or Material Support, Prior research unrelated to this study
Medtronic: Consultant, Honoraria
Medtronic: Other Financial or Material Support, Prior research unrelated to this study
Spectranetics : Consultant, Honoraria
TyRx.: Other Financial or Material Support, Prior research unrelated to this study
G. Ralph Corey, MD
Infectious Disease Specialist
Duke Clinical Research Institute
Durham, NC
Disclosure: Nothing to disclose
Bruce L. Wilkoff, MD
Director of Cardiac Pacing and Tachyarrhythmia Devices
Cleveland Clinic
Cleveland, OH
Disclosure: Abbott: Scientific Research Study Investigator, Advisor or Review Panel member
Medtronic: Scientific Research Study Investigator, Advisor or Review Panel member
Philips: Scientific Research Study Investigator, Advisor or Review Panel member
Jeanne Poole, MD
Cardiologist, Professor of Medicine
University of Washington
Seattle, WA
Disclosure: Boston Scientific: Advisor or Review Panel member
EBR Solutions: Advisor or Review Panel member
Kestra: Consultant, Grant/Research Support
Medtronic: Speaker's Bureau
Suneet Mittal, MD
Director Electrophysiology, Associate Chief of Cardiology, Medical Director Snyder AF Center, Director of Cardiac Research
Valley Health System
Ridgewood, NJ
Disclosure: Medtronic: Consultant
Charles Kennergren, MD, PhD, FETCS, FHRS, FESC
Senior Consultant in Cardiothoracic Surgery and Associate Professor at the University of Göteborg
Hjärthälsan AB
Göteborg, Vastra Gotaland, Sweden
Disclosure: Nothing to disclose
Arnold J. Greenspon, MD
Cardiac Electrophysiologist
Thomas Jefferson University
Philadelphia, PA
Disclosure: Medtronic: Consultant, Grant/Research Support, Scientific Research Study Investigator
Alan Cheng, MD
Vice President, CRHF Clinical Research and Therapy Development
Medtronic
Mounds View, MN
Disclosure: Medtronic: Employee
Jeff Lande, PhD
Senior Principal Statistician
Medtronic
Mounds View, MN
Disclosure: Medtronic: Employee, Shareholder
Daniel R. Lexcen, PhD
Senior Clinical Program Manager
Medtronic
Mounds View, MN
Disclosure: Medtronic: Employee
Khaldoun Tarakji, MD, MPH
Associate Section Head, Cardiac Electrophysiology
Cleveland Clinic
Cleveland, OH
Disclosure: Medtronic: Consultant
Background :
Cardiovascular implantable electronic device (CIED) infections are associated with significant morbidity, mortality, and cost. There is limited evidence on antibiotic prophylactic strategies to prevent CIED infection. Recently, the TYRX Envelope, which elutes a combination of rifampin and minocycline for a minimum of 7 days, was shown to significantly reduce major CIED infections in the WRAP-IT trial. We sought to characterize the pathogens among patients who experienced an infection in the current era.
Methods :
All patients undergoing CIED replacement, upgrade, revision, or de novo cardiac resynchronization therapy (CRT-D) received standard of care antibiotic prophylaxis and were randomized 1:1 to receive TYRX or not. The primary endpoint was major CIED infection within 12 months of the procedure. Major infection was defined as an infection resulting in (1) system extraction or revision, (2) long-term suppressive antibiotic therapy, or (3) death. Data were analyzed using the Cox proportional hazards regression model.
Results :
A total of 6,983 patients were randomized worldwide with 3,495 randomized to receive an envelope and 3,488 randomized to the control. At 12 months, 25 major infections (0.7%) were observed in the envelope group and 42 major infections (1.2%) in the control group, resulting in a 40% reduction of major infections (HR: 0.60, 95% CI: 0.36-0.98, P=0.04). Of 63 infections assayed, causative pathogens were identified in 36 infections whereas cultures were negative in 27 cases. Staphylococcus species (n=22) were the predominate pathogens and a 53% reduction was observed with the use of TYRX (Fig 1). Moreover, there was only 1 CIED pocket infection with Staphylococcus species in the envelope group compared to 14 pocket infections in the control group. A comparison of timing of infection in the envelope group showed the presentation of 11 endocarditis/bacteremia infections at 103± 84 days compared to 14 pocket infections presenting at 70 ± 78 days from the procedure.
Conclusion :
In this large randomized trial, the use of the TYRX Envelope containing rifampin and minocycline resulted in a significant reduction of major CIED infections and was effective against staphylococcal species, which are the predominant cause of pocket infections.
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