TY - JOUR
T1 - Clinical Presentation, Timing, and Microbiology of CIED Infections
T2 - An Analysis of the WRAP-IT Trial
AU - Sohail, M. Rizwan
AU - Corey, G. Ralph
AU - Wilkoff, Bruce L.
AU - Poole, Jeanne E.
AU - Mittal, Suneet
AU - Kennergren, Charles
AU - Greenspon, Arnold J.
AU - Cheng, Alan
AU - Lande, Jeffrey D.
AU - Lexcen, Daniel R.
AU - Tarakji, Khaldoun G.
N1 - Funding Information:
This work was supported by Medtronic, Inc. Dr. Sohail has received honoraria/consultant fees from Medtronic and Aziyo Biologics, outside the submitted work. Dr. Corey has received honoraria/consultant fees from Medtronic, Arsanis, Basilea, Bayer, Contrafect, Melinta, Motif, Paratek, Pfizer, Quintiles, Tetraphase, The Medicines Company, Theravance, Bio2 Medical, Cempra, Meiji Seika Pharm Co., Novella, Regeneron, and SC Pharma. Dr. Wilkoff has received honoraria/consultant fees from Medtronic, Abbott, and Philips, outside the submitted work. Dr. Poole has received honoraria/consultant fees from Medtronic, Boston Scientific, Kestra, and EBR Solutions, outside the submitted work. Dr. Mittal has received honoraria/consultant fees from Medtronic, Abbott, and Boston Scientific, outside the submitted work. Dr. Kennergren has received honoraria/consultant fees from Medtronic, outside the submitted work. Dr. Greenspon has received honoraria, consultant fees, and a research grant from Medtronic; and has received honoraria from Boston Scientific, outside the submitted work. Dr. Tarakji has received honoraria/consultant fees from Medtronic and AliveCor, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2021 The Authors
PY - 2021/1
Y1 - 2021/1
N2 - Objectives: This study characterized the microbiology of major cardiac implantable electronic device (CIED) infections that occurred during the WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) study. Background: The WRAP-IT study offers a unique opportunity for further understanding of the pathogens involved in major CIED infections in a prospective dataset, with implications for clinical practice and infection management. Methods: A total of 6,800 patients randomized 1:1 to receive an antibacterial envelope or not (control subjects) were included in this analysis. Patient characteristics, infection manifestation (pocket vs. systemic), and infection microbiology were evaluated through all follow-up (36 months). Data were analyzed using Cox proportional hazards regression. Results: A total of 3,371 patients received an envelope, and 3,429 patients were control subjects. Major CIED infection occurred in 32 patients who received an envelope and 51 control subjects (36-month Kaplan-Meier estimated event rate, 1.3% and 1.9%, respectively; p = 0.046). A 61% reduction in major pocket infection was observed within 12 months of the procedure in the envelope group (hazard ratio: 0.39, 95% confidence interval: 0.21 to 0.73; p = 0.003). Among 76 patients with major infections who had a sample taken, causative pathogens were identified in 47 patients. Staphylococcus species were the predominate pathogen (n = 31) and envelope use resulted in a 76% reduction in Staphylococcus-related pocket infections (n = 4 vs. 17; p = 0.010). Envelope use was not associated with delayed onset of pocket infections and did not affect the presentation of infections. Conclusions: Antibacterial envelope use resulted in a significant reduction of major CIED pocket infections and was particularly effective against Staphylococcus species, the predominant cause of pocket infections. (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial [WRAP-IT]; NCT02277990)
AB - Objectives: This study characterized the microbiology of major cardiac implantable electronic device (CIED) infections that occurred during the WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) study. Background: The WRAP-IT study offers a unique opportunity for further understanding of the pathogens involved in major CIED infections in a prospective dataset, with implications for clinical practice and infection management. Methods: A total of 6,800 patients randomized 1:1 to receive an antibacterial envelope or not (control subjects) were included in this analysis. Patient characteristics, infection manifestation (pocket vs. systemic), and infection microbiology were evaluated through all follow-up (36 months). Data were analyzed using Cox proportional hazards regression. Results: A total of 3,371 patients received an envelope, and 3,429 patients were control subjects. Major CIED infection occurred in 32 patients who received an envelope and 51 control subjects (36-month Kaplan-Meier estimated event rate, 1.3% and 1.9%, respectively; p = 0.046). A 61% reduction in major pocket infection was observed within 12 months of the procedure in the envelope group (hazard ratio: 0.39, 95% confidence interval: 0.21 to 0.73; p = 0.003). Among 76 patients with major infections who had a sample taken, causative pathogens were identified in 47 patients. Staphylococcus species were the predominate pathogen (n = 31) and envelope use resulted in a 76% reduction in Staphylococcus-related pocket infections (n = 4 vs. 17; p = 0.010). Envelope use was not associated with delayed onset of pocket infections and did not affect the presentation of infections. Conclusions: Antibacterial envelope use resulted in a significant reduction of major CIED pocket infections and was particularly effective against Staphylococcus species, the predominant cause of pocket infections. (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial [WRAP-IT]; NCT02277990)
KW - Staphylococcus
KW - cardiac implantable electronic device (CIED)
KW - infection
KW - microbiology
KW - pathogens
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U2 - 10.1016/j.jacep.2020.07.021
DO - 10.1016/j.jacep.2020.07.021
M3 - Article
C2 - 33478712
AN - SCOPUS:85098494767
SN - 2405-500X
VL - 7
SP - 50
EP - 61
JO - JACC: Clinical Electrophysiology
JF - JACC: Clinical Electrophysiology
IS - 1
ER -