(NIH.gov)
19 Mar. 2019. A mesh envelope infused with antibiotics holding an implanted cardiac device is shown in a large-scale clinical trial to reduce the number of infections associated with those devices. Researchers from the Cleveland Clinic in Ohio presented their findings on Monday at the annual scientific meeting of American College of Cardiology in New Orleans, and in the New England Journal of Medicine.
The team lead by Cleveland Clinic cardiologist Khaldoun Tarakji is seeking better ways to reduce the rate of infection from implanted cardiac devices, such as heart pacemakers. The authors estimate, from 10 year-old data, that 1.5 million people worldwide receive an implanted cardiac device each year. And while modern surgical practices, such as antibiotics before implantation, can prevent infections, the risk of a major infection remains a concern. Infections are most likely to occur within the first year after implantation, but can also happen when replacing the battery, leads, or the entire device.
Tarakji and colleagues tested a simple mesh sleeve infused with antibiotics as an alternative way to prevent these infections. The sleeve, called the TYRX absorbable antibacterial envelope, is made by medical device developer Medtronic, which also funded the study. TYRX is infused with 2 antibiotics, minocycline and rifampin, the same medications used to prevent implant infections. The biocompatible polymer mesh fabric disintegrates and is absorbed into the body after about 9 weeks. FDA cleared the TYRX envelope for marketing in 2013.
The post-marketing clinical trial recruited nearly 7,000 individuals scheduled to receive implanted cardiac devices at 181 sites worldwide to test the TYRX sleeve. Participants were randomly assigned to receive their implants either in a TYRX envelope or in the standard procedure without the mesh sleeve. The average age of participants was 70, and 72 percent were males.
The study team looked primarily for signs of major infections in the surgical pockets within 12 months following the procedure, whether it required more antibiotic treatments, further surgical repairs, or removal of the device. The researchers also looked for indicators of adverse effects, including minor infections or complications of any kind related to the implanted device.
The results show low rates of major infections in both groups, but fewer of these infections in the group receiving the TYRX envelope — 25, or 0.7 percent — than the comparison group without the TYRX, 42 or 1.2 percent, a large enough difference for statistical reliability. Occurrences of any complications or adverse effects were similar in both groups of participants, but still lower in the TYRX group, 6 percent, than the 7 percent reported for the comparison group, again a large enough difference for statistical reliability.
Tarakji calls the low infection rates throughout the study population “great news for all electrophysiologists and a testament for the quality of all participating centers in adhering to best practices to minimize infection,” in an American College of Cardiology statement. “Even so,” he notes, “using the antibiotic envelope led to an additional 40 percent 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.”
The research team plans a follow-up study assessing the cost-effectiveness of the TYRX envelope.
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