Medtronic has announced new data from the WRAP-IT study published in Heart Rhythm, which it said demonstrate a significantly lower infection risk for patients who develop haematomas after cardiac implantable electronic devices (CIEDs) when the Tyrx absorbable antibacterial envelope (TYRX Envelope) is used at implant. The analysis showed an 82% reduction in major CIED infections among patients with the Tyrx Envelope who developed haematomas compared to patients in the control group who developed haematomas.
An estimated 1.5 million patients worldwide receive a CIED every year, with 1‒4% of these patients developing infections resulting in significant impacts on mortality, quality of life, healthcare utilisation, and cost to global healthcare systems.
The current WRAP-IT (Worldwide randomized antibiotic envelope infection prevention trial) analysis evaluated the incidence and consequences of haematomas and the association between Tyrx Envelope use, haematomas, and major CIED infections among study patients (3,429 patients in control group; 3,371 patients in Tyrx Envelope group). Patients with haematomas occurring within 30 days after the implant procedure were evaluated for subsequent infection risk. The incidence of haematomas was 2.2% (151 patients) and was similar among control and envelope patients.
The key findings, through 36 months of follow-up included that in the control group, there was a greater than 11-fold increase in the risk of major infection among patients with haematoma vs. those without haematoma (13.1% vs. 1.6%; p<0.001). Furthermore, in envelope patients, the use of the Tyrx Envelope reduced the risk of major infection among patients with haematoma: an 82% reduction in infection compared to control patients with hematoma (2.5% vs. 13.1%; p=0.03).
“Procedure-related hematomas are associated with serious consequences. This analysis sheds new light that these consequences can be significantly mitigated with the Tyrx Envelope,” said Rob Kowal, chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. “We look forward to additional data from WRAP-IT exploring the risk factors leading to procedure-related haematomas.”
The TYRX Envelope is an absorbable, single-use device that holds a cardiac implantable electronic device or implanted neurostimulator. It is designed to stabilise the device after implantation while releasing antibacterial agents, minocycline and rifampin, over a minimum of seven days. Constructed from a multifilament, knitted absorbable mesh, the envelope is fully absorbed by the body approximately nine weeks after implantation, according to Medtronic.
