Charles A Henrikson1, M Rizwan Sohail2, Helbert Acosta3, Eric E Johnson4, Lawrence Rosenthal5, Roman Pachulski6, Dan Dan7, Walter Paladino8, Farhat S Khairallah9, Kent Gleed10, Ibrahim Hanna11, Alan Cheng12, Daniel R Lexcen12, Grant R Simons13. 1. Knight Cardiovascular Institute, Oregon Health & Science University, Portland, Oregon. Electronic address: henrikso@ohsu.edu. 2. Divisions of Infectious Diseases and Cardiovascular Diseases, Mayo Clinic College of Medicine, Rochester, Minnesota. 3. Trinity Medical Center, Rock Island, Illinois. 4. Stern Cardiovascular Foundation, Germantown, Tennessee. 5. Division of Cardiovascular Medicine, UMass Memorial Medical Center, Worcester, Massachusetts. 6. South Texas Heartbeat, San Antonio, Texas. 7. Piedmont Medical Center, Atlanta, Georgia. 8. Catholic Health Partners, Youngstown, Ohio. 9. Tallahassee Memorial Hospital, Tallahassee, Florida. 10. Alegent Health, Omaha, Nebraska. 11. Princeton Baptist Medical Center, Birmingham, Alabama. 12. Medtronic plc, Minneapolis, Minnesota. 13. Division of Electrophysiology, Englewood Hospital and Medical Center, Englewood, New Jersey.
Abstract
OBJECTIVES: 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: 0.0% to 0.9%), 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 p = 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; [Centurion]; NCT01043861/NCT01043705).
OBJECTIVES: 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 ICDpatients, 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: 0.0% to 0.9%), 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 p = 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; [Centurion]; NCT01043861/NCT01043705).
Authors: Melissa Khalil; Kaveh Karimzad; Jean-Bernard Durand; Alexandre E Malek; Issam I Raad; George M Viola Journal: Open Forum Infect Dis Date: 2020-09-13 Impact factor: 3.835
Authors: Christoph Schukro; David Santer; Günther Prenner; Markus Stühlinger; Martin Martinek; Alexander Teubl; Deddo Moertl; Stefan Schwarz; Michael Nürnberg; Lukas Fiedler; Robert Hatala; Cesar Khazen Journal: Clin Cardiol Date: 2020-08-14 Impact factor: 2.882
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