Antibiotic Envelopes for Cardiac Implants

Any cardiac implant comes with a risk of infection. Essentially, implants are foreign bodies placed into our bodies to help them function as they should be. Cardiac implants include pacemakers and defibrillators which serve to keep the heart beats at the right pace and deploy a charge to clear the electrical charge from the heart so that it can “start fresh”, respectively. There are three possible types of heart infections that can occur — endocarditis, myocarditis, and pericarditis. These infections can cause serious life-threatening symptoms. To prevent this, researchers have recently developed an antibiotic envelope for preventing infection for cardiac implants.

Bacterial infection is one of the most common causes of Cardiac Implantable Electronic Devices (CIEDs) complications and similar cases are on the rise. Over a 15-year period, the increase in chance of infection more than doubled in the number of implants performed. The increased rate of infections is likely due to more older patients receiving devices, more patient diseases, longer procedures, a changing mix of CIEDs, an increasing number of pulse generator replacements and upgrades, more resistant S Aureus and coagulase Staphylococcus species (Perfect Pocket Protection, Medtronic.com).

The TYRX Absorbable Antibacterial Envelope is the only fully absorbable antibacterial envelope made for cardiac implantable electronic devices (CIEDs), implantable cardioverter-defibrillators (ICDs), and pacemakers. This surgical mesh envelope contains minocycline and rifampin, which are two powerful antibiotics. According to Medtronic.com, infections occur in about 1%-4% of all CIED implantations, resulting in a 50% percent mortality rate in patients after 3 years. The TYRX Envelope has been shown to reduce risk by 70%-100%.

There is proven stabilization in holding CIEDs in place to reduce the chances of device migration, erosion, and Twiddler Syndrome. Minocycline and rifampin disperse locally into the tissue pocket enabling minimum inhibitory concentration (MIC) of the antibiotic drug levels in the tissue to be reached within 2 hours of implantation, which are maintained for a minimum of 7 day. Non-systemic dose TYRX Envelopes contain less than 5% of the recommended oral daily doses, 7.6 mg of minocycline & 11.9 mg of rifampin. It fully absorbs into the body in approximately 9 weeks. It requires no adjustment to standard surgical techniques during the replacement or revision procedure. After the absorption, there are no foreign body bacteria that can cause infection. The TYRX Envelope is made of large-pore knit filaments, similar to a 5.0 suture. It is coated in an amino acid tyrosine-based polymer, which disperses the antibiotics and breaks down over time, primarily through hydrolysis.

References

Lewis, S. (2019, November 06). Heart Infections. Retrieved from https://www.healthgrades.com/right-care/heart-health/heart-infections

Medtronic. (n.d.). Infection Control Products for Cardiac Implantable Devices — TYRX Antibacterial Envelopes. Retrieved from https://www.medtronic.com/us-en/healthcare-professionals/products/cardiac-rhythm/infection-control/tyrx-antibacterial-envelope.html

Top 10 medical innovations for 2020. (n.d.). Retrieved from https://www.mdlinx.com/internal-medicine/article/4934