Medtronic touts reduced infections in Tyrx cardiac device envelope trial
Medtronic (NYSE:MDT) yesterday released data from a study of its Tyrx absorbable antibacterial envelope exploring its use with cardiac implantable electronic devices, touting a reduction in major infections and pocket infections.
Results from the trial were presented at the American College of Cardiology 68th Annual Scientific Sessions in New Orleans and simultaneously published in the New England Journal of Medicine, Fridley, Minn.-based Medtronic said.
“Studies show that even when the device infection is managed properly with successful extraction procedure and the proper antibiotic therapy, short- and long-term mortality remain high in this group of patients. Prevention is the cornerstone for addressing device infection. Until now, in addition to adhering to strict sterile surgical techniques, preoperative antibiotics have been the only intervention proven in randomized controlled trial to minimize infection risk. Knowing the consequences, minimizing risk isn’t good enough—our goal should be to get the infection rate as close to zero as we can,” study lead author Dr. Khaldoun Tarakji of the Cleveland Clinic Heart and Vascular Institute said in a prepared release.
Investigators in the WRAP-IT trial, which the company touted as the first rigorously designed randomized study to demonstrate the safety and effectiveness of the Tyrx envelope, examined data from 6,983 patients across 25 countries. Average subject age in the trial was 70 and participants were 72% male.
Most patients in the trial were undergoing a revision, replacement or upgrade of their implanted devices, study researchers reported. Patients were assigned to either receive device implantation with or without the Tyrx envelope. Patients were followed for one year and then every six months until the end of the study, with an average follow-up length of 20.7 months.
To minimize infection risk, patients in both cohorts were treated with preoperative antibiotics and surgical teams in the trial were required to use strict, sterile surgical techniques for every procedure.
The study’s primary endpoint was major device-related infection resulting in extraction or revision of the device system, long-term antibiotic treatment or death, researchers said.
Of the patients in the Tyrx cohort, 0.7% developed a major device infection within a year, compared to 1.2% of patients in the control group, investigators reported.
“The overall infection rate was lower than expected. This is great news for all electrophysiologists and a testament for the quality of all participating centers in adhering to best practices to minimize infection. Even so, using the antibiotic envelope led to an additional 40% reduction in major device-related infection during the first year after implantation. And we saw no increase in complications with the use of the envelope, indicating that it is safe to use,” Tarakji said in a prepared statement.
Study researchers warned that the use of the envelope should not replace standard protocols for procedure safety, patient selection or use of preoperative antibiotics and proper surgical techniques.
Investigators said they plan to conduct a follow-up study of the cost-effectiveness of the Tyrx envelope.
“We now have a wonderful and rich source of information that we can use to educate ourselves about the association of different practices and variables with device infection,” Tarakji said in prepared remarks.
“These data provide strong evidence that the Tyrx envelope can help prevent major infection without increasing complications. This is the largest CIED trial ever conducted globally, demonstrating Medtronic’s commitment to generating high-quality evidence supporting the use of our products and therapies to improve patient outcomes,” cardiac rhythm and heart failure division chief medical officer Dr. Rob Kowal said in a press release.