About My Health Careers Internship MedBlogs Contact us
Medindia LOGIN REGISTER
Advertisement

TYRX Antibacterial Envelope Use Reduces Cardiac Device Infection Rates

by Bidita Debnath on May 13, 2013 at 11:06 PM
Font : A-A+

 TYRX Antibacterial Envelope Use Reduces Cardiac Device Infection Rates

In patients undergoing Cardiovascular Implantable Electronic Device (CIED) replacement procedures compared to similar high-risk cohorts, use of TYRX, Inc.'s AIGISRx® Antibacterial Envelope reduced major infection rates by more than 90%.

This is according to the CITADEL & CENTURION clinical study results presented at the Late Breaking Clinical Trials session at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions.

Advertisement

CITADEL / CENTURION is a prospective, multicenter clinical study to evaluate the major device infection and mechanical complication rates in the 12 months after implantation, in patients at high risk for CIED infection who have their CIED implanted with an AIGISRx Antibacterial Envelope. Study patients were enrolled at 55 US centers, and were at high-risk for infection because they were undergoing a CIED replacement procedure with an implantable cardioverter-defibrillator (ICD), (CITADEL), or a cardiac resynchronization therapy (CRT) device (CENTURION). The results from a planned interim analysis of the primary endpoints for the first 1000 eligible patients after 90 days of follow up were presented by Dr. Charles A. Henrikson, the Chief of Electrophysiology at the Oregon Health Sciences University.

Key study findings include:
  • The CITADEL / CENTURION cohort at 90 days of follow-up had 95% fewer major CIED infections than the pre-defined published control cohort of 533 ICD and CRT replacement procedures (Gould et al. JAMA 2006, 295(16); 1907-1911) which had a major CIED infection rate of 1.88% at a mean follow-up of 81 days (0.1% vs. 1.88%; P<0.001).
  • The CITADEL / CENTURION cohort at 90 days of follow-up had 94% fewer major infections than the 45-day major infection rate of 1.7% reported for the cohort of 1081 ICD/CRT replacement procedures in the Ontario ICD Database (Krahn et al. Circulation Arrhythmia and Electrophysiology 2011 4(2) 136-42 (0.1% vs. 1.7%; P<0.001).
  • There was 1 major infection (0.1%), the primary efficacy endpoint of the study, after 90 days of follow-up. There were 11 minor infections (limited to the incision and skin) (1.1%).
  • The incidence of the most common mechanical complication, major hematomas (1.5%), was not significantly different than the pre-defined control cohort (2.3%; P = NS).
  • There were no unanticipated serious AIGISRx-related adverse events. There were 20 (2%) deaths, none related to the AIGISRx.
"CIED infections are increasing in frequency, are associated with substantial morbidity, mortality, and cost, and present significant challenges to patients and for the physicians who provide care for them," stated Charles A. Henrikson, MD, FHRS, Oregon Health Sciences University, Portland, Oregon. "The CITADEL & CENTURION are large prospective studies enrolling patients at community, academic, and VA medical centers which will provide us with useful clinical information on the use of the AIGISRx Envelope in a variety of patients who are at high risk for CIED infection."The CITADEL (NCT01043861) & CENTURION (NCT01043705) studies are registered in the ClinicalTrials.gov registry of federally and privately supported clinical trials conducted in the US and around the world.

Source: Eurekalert
Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Advertisement
News Category
What's New on Medindia
Top 7 Benefits of Good Oral Hygiene
Healthy and Safer Thanksgiving 2021
Long-Term Glycemic Control - A Better Measure of COVID-19 Severity
View all

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Palpitations And Arrhythmias Flu Statins Cardiomyopathy 

Recommended Reading
On-site Cardiology Team Improves Care for Heart Attack Patients
The in -site, around-the-clock interventional cardiology program launched by Loyola hospital proves ...
Revolution in Cardiology- Absorbable Stents to Replace the Metallic Stents
Cardiologists are looking forward to replace the metallic stent used for clearing blockages in an .....
Madras Medical Mission Introduces Advanced Cardiology Device
In a first of its kind development, the Madras Medical Mission has introduced a state-of-the-art ......
Performance Intervention at Outpatient Cardiology Practices Improves Heart Failure Care
A new performance intervention to help improve adherence to national guideline-recommended ......
Cardiomyopathy
Cardiomyopathy weakens the heart muscles and the heart loses strength to pump blood throughout the b...
Palpitations And Arrhythmias
Palpitations are unpleasant sensation of one’s own heartbeat....
Statins
Statins are new wonder drugs that are proving to be efficacious, not merely in relieving symptoms bu...

Disclaimer - All information and content on this site are for information and educational purposes only. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. Always seek the advice of a qualified physician for medical diagnosis and treatment. Full Disclaimer

© All Rights Reserved 1997 - 2021

This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use