Receiving a cardiac implantable device, such as a pacemaker or defibrillator, is a common procedure. These lifesaving technologies are electrical engineering marvels, but are associated with certain risks – like the danger of infection. Though infections only occur in about 1-4% of cardiac device implantations, they can lead to up to a 25% patient mortality at one year and an average treatment cost of $60,000.
Cardiovascular implantable electronic device (CIED) infections are generally considered in two categories: pocket infections and systemic infections. Systemic infection refers to infection involving the transvenous portion of the device leads, while pocket infection involves the subcutaneous pocket containing the pulse generator and the subcutaneous segment of the lead. The two types of infections are not mutually exclusive and may coexist.
Until now, giving the right antibiotics right before the procedure was the best way to prevent infection after implantation – despite this, infections continued to occur. Recent innovation in the space is allowing for electrophysiologists and patients to minimize the risk of infection with CIED placement.
The antibiotic envelopes, made from mesh material to prevent infection, are now available to surround cardiovascular implantable electronic devices (CIEDs) when surgically placed in the body. The envelopes are designed to elute a pair of antimicrobial drugs for 7 days after implementation. This week-long release of drug quells the risk of infection. The envelopes then dissolve into the body over a period of 9 weeks – leaving no trace of their presence.
The absorbable envelope received FDA clearance in 2013 and CE Mark in 2014, but healthcare professionals were awaiting results from the landmark worldwide randomized trial. Results from the nearly 7,000 patient trial were published in March 2019. In the study, after a mean follow-up of 20.7 months, a significant 40% lower 12 months rate of major infections in the group who received envelopes compared to control was observed.
Occurrence of pocket infection was reduced by 61%.These results demonstrate completion of the efficacy objective of the study. Allowing for better protection against infection, in addition to pre-operative antibiotics, the antibiotic envelopes are an important step toward safer CIED procedures.