M Rizwan Sohail1, G Ralph Corey2, Bruce L Wilkoff3, Jeanne E Poole4, Suneet Mittal5, Charles Kennergren6, Arnold J Greenspon7, Alan Cheng8, Jeffrey D Lande8, Daniel R Lexcen8, Khaldoun G Tarakji9. 1. Department of Medicine and Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, Rochester, Minnesota, USA. Electronic address: sohailmd@mac.com. 2. Department of Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA. 3. Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA. 4. Division of Cardiology, University of Washington School of Medicine, Seattle, Washington, USA. 5. Valley Health System, Ridgewood, New Jersey, USA. 6. Cardiothoracic Surgery, Sahlgrenska University Hospital, Göteborg, Sweden. 7. Division of Cardiology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA. 8. Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, Minnesota, USA. 9. Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Abstract
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).
RCT Entities:
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).
Authors: Giuseppe Boriani; Marco Proietti; Matteo Bertini; Igor Diemberger; Pietro Palmisano; Stefano Baccarini; Francesco Biscione; Nicola Bottoni; Antonio Ciccaglioni; Alessandro Dal Monte; Franco Alberto Ferrari; Saverio Iacopino; Marcello Piacenti; Daniele Porcelli; Stefano Sangiorgio; Luca Santini; Michele Malagù; Giuseppe Stabile; Jacopo Francesco Imberti; Davide Caruso; Massimo Zoni-Berisso; Roberto De Ponti; Renato Pietro Ricci Journal: J Pers Med Date: 2022-01-11
Authors: Fatehi Elzein; Eid Alsufyani; Yahya Al Hebaishi; Mohammed Mosaad; Moayad Alqurashi; Ahmed Al Fagih Journal: Ann Med Surg (Lond) Date: 2021-07-16