Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement. Results of the Citadel and Centurion Studies

Charles Henrikson, M. Rizwan Sohail, Helbert Acosta, Eric E. Johnson, Lawrence Rosenthal, Roman Pachulski, Dan Dan, Walter Paladino, Farhat S. Khairallah, Kent Gleed, Ibrahim Hanna, Alan Cheng, Daniel R. Lexcen, Grant R. Simons

    Research output: Contribution to journalArticle

    15 Citations (Scopus)

    Abstract

    Objective: This study sought to determine whether the nonabsorbable TYRX Antibacterial Envelope (TYRX) reduces major cardiovascular implantable electronic device (CIED) infections 12 months after implant. Background: TYRX is a monofilament polypropylene mesh impregnated with minocycline and rifampin specifically designed to hold a CIED in place and elute antimicrobials over time. There are limited data on its ability to reduce CIED infections. Methods: We prospectively enrolled patients who underwent generator replacement with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy device (CRT), treated with TYRX. The primary endpoints were major CIED infection and CIED mechanical complications. Given the differences in infection rates among ICD and CRT patients, 3 different control populations were used: a published benchmark rate for ICD patients, and both site-matched and comorbidity-matched controls groups for CRT patients. Results: Overall, a major CIED infection occurred in 5 of 1,129 patients treated with TYRX (0.4%; 95% confidence interval: 0.00 to 0.90), significantly lower than the 12-month benchmark rate of 2.2% (p = 0.0023). Among the TYRX-treated CRT cohort, the major CIED infection rate was 0.7% compared with an infection rate of 1.0% and 1.3% (p = 0.38 and 0.02) in site-matched and comorbidity-matched control groups, respectively. Among the ICD group, the 12-month infection rate was 0.2% compared with the published benchmark of 2.2% (p = 0.0052). The most common CIED mechanical complication in study patients was pocket hematoma, which occurred in 18 of the 1,129 patients (1.6%; 95% confidence interval: 0.8 to 2.5), which is comparable with a published rate of 1.6%. Conclusions: Use of TYRX was associated with a lower major CIED infection rate. (TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD; [. NCT01043861/NCT01043705]).

    Original languageEnglish (US)
    JournalJACC: Clinical Electrophysiology
    DOIs
    StateAccepted/In press - Aug 29 2016

    Fingerprint

    Cardiac Resynchronization Therapy Devices
    Implantable Defibrillators
    Equipment and Supplies
    Infection
    Benchmarking
    Comorbidity
    Research Design
    Cardiovascular Infections
    Confidence Intervals
    Control Groups
    Minocycline
    Polypropylenes
    Rifampin
    Hematoma

    Keywords

    • Antibacterial envelope
    • Antibiotic prophylaxis
    • Implantable cardioverter-defibrillator
    • Infection
    • Pacemaker

    ASJC Scopus subject areas

    • Cardiology and Cardiovascular Medicine
    • Physiology (medical)

    Cite this

    Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement. Results of the Citadel and Centurion Studies. / Henrikson, Charles; Sohail, M. Rizwan; Acosta, Helbert; Johnson, Eric E.; Rosenthal, Lawrence; Pachulski, Roman; Dan, Dan; Paladino, Walter; Khairallah, Farhat S.; Gleed, Kent; Hanna, Ibrahim; Cheng, Alan; Lexcen, Daniel R.; Simons, Grant R.

    In: JACC: Clinical Electrophysiology, 29.08.2016.

    Research output: Contribution to journalArticle

    Henrikson, Charles ; Sohail, M. Rizwan ; Acosta, Helbert ; Johnson, Eric E. ; Rosenthal, Lawrence ; Pachulski, Roman ; Dan, Dan ; Paladino, Walter ; Khairallah, Farhat S. ; Gleed, Kent ; Hanna, Ibrahim ; Cheng, Alan ; Lexcen, Daniel R. ; Simons, Grant R. / Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement. Results of the Citadel and Centurion Studies. In: JACC: Clinical Electrophysiology. 2016.
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    abstract = "Objective: This study sought to determine whether the nonabsorbable TYRX Antibacterial Envelope (TYRX) reduces major cardiovascular implantable electronic device (CIED) infections 12 months after implant. Background: TYRX is a monofilament polypropylene mesh impregnated with minocycline and rifampin specifically designed to hold a CIED in place and elute antimicrobials over time. There are limited data on its ability to reduce CIED infections. Methods: We prospectively enrolled patients who underwent generator replacement with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy device (CRT), treated with TYRX. The primary endpoints were major CIED infection and CIED mechanical complications. Given the differences in infection rates among ICD and CRT patients, 3 different control populations were used: a published benchmark rate for ICD patients, and both site-matched and comorbidity-matched controls groups for CRT patients. Results: Overall, a major CIED infection occurred in 5 of 1,129 patients treated with TYRX (0.4{\%}; 95{\%} confidence interval: 0.00 to 0.90), significantly lower than the 12-month benchmark rate of 2.2{\%} (p = 0.0023). Among the TYRX-treated CRT cohort, the major CIED infection rate was 0.7{\%} compared with an infection rate of 1.0{\%} and 1.3{\%} (p = 0.38 and 0.02) in site-matched and comorbidity-matched control groups, respectively. Among the ICD group, the 12-month infection rate was 0.2{\%} compared with the published benchmark of 2.2{\%} (p = 0.0052). The most common CIED mechanical complication in study patients was pocket hematoma, which occurred in 18 of the 1,129 patients (1.6{\%}; 95{\%} confidence interval: 0.8 to 2.5), which is comparable with a published rate of 1.6{\%}. Conclusions: Use of TYRX was associated with a lower major CIED infection rate. (TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD; [. NCT01043861/NCT01043705]).",
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    author = "Charles Henrikson and Sohail, {M. Rizwan} and Helbert Acosta and Johnson, {Eric E.} and Lawrence Rosenthal and Roman Pachulski and Dan Dan and Walter Paladino and Khairallah, {Farhat S.} and Kent Gleed and Ibrahim Hanna and Alan Cheng and Lexcen, {Daniel R.} and Simons, {Grant R.}",
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    AU - Henrikson, Charles

    AU - Sohail, M. Rizwan

    AU - Acosta, Helbert

    AU - Johnson, Eric E.

    AU - Rosenthal, Lawrence

    AU - Pachulski, Roman

    AU - Dan, Dan

    AU - Paladino, Walter

    AU - Khairallah, Farhat S.

    AU - Gleed, Kent

    AU - Hanna, Ibrahim

    AU - Cheng, Alan

    AU - Lexcen, Daniel R.

    AU - Simons, Grant R.

    PY - 2016/8/29

    Y1 - 2016/8/29

    N2 - Objective: This study sought to determine whether the nonabsorbable TYRX Antibacterial Envelope (TYRX) reduces major cardiovascular implantable electronic device (CIED) infections 12 months after implant. Background: TYRX is a monofilament polypropylene mesh impregnated with minocycline and rifampin specifically designed to hold a CIED in place and elute antimicrobials over time. There are limited data on its ability to reduce CIED infections. Methods: We prospectively enrolled patients who underwent generator replacement with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy device (CRT), treated with TYRX. The primary endpoints were major CIED infection and CIED mechanical complications. Given the differences in infection rates among ICD and CRT patients, 3 different control populations were used: a published benchmark rate for ICD patients, and both site-matched and comorbidity-matched controls groups for CRT patients. Results: Overall, a major CIED infection occurred in 5 of 1,129 patients treated with TYRX (0.4%; 95% confidence interval: 0.00 to 0.90), significantly lower than the 12-month benchmark rate of 2.2% (p = 0.0023). Among the TYRX-treated CRT cohort, the major CIED infection rate was 0.7% compared with an infection rate of 1.0% and 1.3% (p = 0.38 and 0.02) in site-matched and comorbidity-matched control groups, respectively. Among the ICD group, the 12-month infection rate was 0.2% compared with the published benchmark of 2.2% (p = 0.0052). The most common CIED mechanical complication in study patients was pocket hematoma, which occurred in 18 of the 1,129 patients (1.6%; 95% confidence interval: 0.8 to 2.5), which is comparable with a published rate of 1.6%. Conclusions: Use of TYRX was associated with a lower major CIED infection rate. (TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD; [. NCT01043861/NCT01043705]).

    AB - Objective: This study sought to determine whether the nonabsorbable TYRX Antibacterial Envelope (TYRX) reduces major cardiovascular implantable electronic device (CIED) infections 12 months after implant. Background: TYRX is a monofilament polypropylene mesh impregnated with minocycline and rifampin specifically designed to hold a CIED in place and elute antimicrobials over time. There are limited data on its ability to reduce CIED infections. Methods: We prospectively enrolled patients who underwent generator replacement with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy device (CRT), treated with TYRX. The primary endpoints were major CIED infection and CIED mechanical complications. Given the differences in infection rates among ICD and CRT patients, 3 different control populations were used: a published benchmark rate for ICD patients, and both site-matched and comorbidity-matched controls groups for CRT patients. Results: Overall, a major CIED infection occurred in 5 of 1,129 patients treated with TYRX (0.4%; 95% confidence interval: 0.00 to 0.90), significantly lower than the 12-month benchmark rate of 2.2% (p = 0.0023). Among the TYRX-treated CRT cohort, the major CIED infection rate was 0.7% compared with an infection rate of 1.0% and 1.3% (p = 0.38 and 0.02) in site-matched and comorbidity-matched control groups, respectively. Among the ICD group, the 12-month infection rate was 0.2% compared with the published benchmark of 2.2% (p = 0.0052). The most common CIED mechanical complication in study patients was pocket hematoma, which occurred in 18 of the 1,129 patients (1.6%; 95% confidence interval: 0.8 to 2.5), which is comparable with a published rate of 1.6%. Conclusions: Use of TYRX was associated with a lower major CIED infection rate. (TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD; [. NCT01043861/NCT01043705]).

    KW - Antibacterial envelope

    KW - Antibiotic prophylaxis

    KW - Implantable cardioverter-defibrillator

    KW - Infection

    KW - Pacemaker

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