Khaldoun Tarakji, MD, MPH: WRAP-IT Results

Data from the largest randomized, controlled international trial to assess cardiac implantable electronic reported positive benefits for the unique TYRX Envelope in reducing a patient’s risk of device infection—a condition that could have fatal implications if left untreated.

The WRAP-IT trial results, presented at the American College of Cardiology (ACC) 2019 Annual Meeting in New Orleans, LA, this weekend, could give cardiologists and electrophysiologists another tool better their campaign towards limited complications from device implantation. The implications can be major in both patient population size, and individual outcomes, Khaldoun Tarakji, MD, MPH, said.

In an interview with MD Magazine®, Tarakji, an electrophysiologist in the Department of Cardiovascular Medicine at the Cleveland Clinic, explained the issues which drove the WRAP-IT trial, and what its findings can mean for his peers.

MD Mag: What is the burden of infection in cardiac devices?

Tarakji: So, we implanted a lot of these devices—I’m talking about pacemakers and defibrillators, which we refer to as cardiac implantable electronic devices (CIED). It's estimated about 1.5 million patients receive a device implantation procedure in the world every year. And these devices, they've extended the lives and improve the quality of lives of thousands and thousands of patients. But despite the advancement in technology, we still encounter complications.

Probably one of the major complications is device infection. The rate of device infection in the literature is estimated at 1% to 4% of all these procedures. Why is it a serious complication? It’s because of the consequences. When a patient develops device infection and diagnosis is confirmed, the management of device infection involves removing the device and leads. So, all the hardware needs to be out of the body and for that you need to perform a procedure called lead extraction.

That by itself could lead to complications that could be fatal. So, the consequences could be catastrophic for patients, in addition to long, extended antibiotic therapy and prolonged hospital stay. And obviously, that's a major healthcare expenditure as well. But most importantly, even when you go through all the right steps in the management of device infection, the mortality is still high. The 30-day mortality rate is about 4% to 5% in all comers, and the 1 year mortality is 8% to 15%.

So, it is a complication that as electrophysiologists, we really need to get this as close to zero as possible.

How close can we get to zero?

Of course, that's a wishful number. Again, because we know the consequences of device infection, the cornerstone of dealing with this issue is prevention. And in addition to strict sterile surgical techniques, the only proven intervention so far that we have to show effectiveness and reduced infection has been the use of 1 dose of preoperative antibiotic at the time of procedure.

Other than this we don't have any evidence of any other intervention that will lead to decrease in the risk of infection.

Can you explain the function of the envelope?

The antibiotic envelope is constructed of a multi-filament mesh that's fully absorbable, and it also has absorbable polymers that are mixed with 2 antibiotics: rifampin and minocycline. The envelope will literally wrap the pacemaker or defibrillator before you implant in the pocket, and then you close the incision. And then, those antibiotics get eluded in the pocket over a course of 7 days.

The envelope itself is fully absorbed within 9 weeks. So, the aim of the WRAP-IT study was to see if this antibiotic envelope is effective at reducing the risk of major device infection over a course of 12 months. We also looked at safety of using the envelope, as far as the complication rate in the same cohort of patients.

What’s the best benefit we can derive from current advances in cardiovascular care?

When it comes to infection rate, the reason we need to get this as close to zero as possible is the fact that we're implanting a lot of these devices, and the risk for the patient is not with the initial implant ,but throughout their whole lifetime. They go through multiple procedures to replace the battery, or to get an upgrade from their pacemaker to defibrillator. So it's not a one-time risk that they encounter, but it's a recurrent one over the course of a lifetime.

We're implanting these devices to improve the quality of life or extend the life of so many—and sometimes, as a procedure that's done in a primary prevention effort to avoid the risk of sudden death. So you really need to get the complication rate with this new technology, amazing technology. But at the same time, you need to work hard at minimizing the potential of any complication that can come along with these technologies.

The study, "The World-Wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) to Reduce Cardiac Implantable Electronic Device Infection," was presented at ACC 2019.