December 31, 2013
Dissolving, antibiotic-infused mesh envelope for pacemakers prevents infection
Electrophysiologist Mark Seifert, MD, holds pacemakers in the recently approved AIGISRx R mesh envelope.
Never again. Walter Narkiewicz never again wants to experience an infection when a new pacemaker is implanted.
"It was hard to deal with," the East Valley retiree said. "It hurt. I felt as if I had the flu . . . really tired and queasy."
Thanks to elegant new technology first available in Arizona at John C. Lincoln North Mountain Hospital, Walter won't have to go through that experience again.
His problems started in October, when his pacemaker was replaced at another hospital. For a week or more, things seemed fine. Then his incision became infected and split open.
Did You Know?
What can cause arrhythmias?
- A pacemaker is about the size of 50-cent piece.
- Arrhythmias – abnormal heart rhythms – are the most common reasons for implanting a pacemaker under the skin near your heart.
- Normal aging of the heart.
- Heart muscle damage resulting from a heart attack.
- Genetic conditions.
Walter's cardiologist treated the infection for a few days, but recognized the need for an expert. He referred Walter to John C. Lincoln electrophysiologist Mark Seifert, MD, who admitted Walter to North Mountain Hospital for intensive treatment.
When the infection was under control, Dr. Seifert removed the offending pacemaker. Three days later, he implanted a new pacemaker tucked inside a mesh envelope called the AIGISRx R.
Approved just a couple of months ago by the Food and Drug Administration, the antibiotic-infused, bioresorbable mesh can hold a pacemaker or an implantable defibrillator. To understand it, think about dissolving stitches. Then think about drug-eluting stents, mesh tubes that hold arteries open and release drugs over time.
AIGISRx R, from drug/device manufacturer TYRX, Inc., combines both technologies.
"Infection rates for repeat pacemaker procedures are much higher than first implants," said Dr. Seifert, who implanted the Valley's first AIGISRx R in fall 2013. "It's harder to fight infections lodged in scar tissue." The mesh contains two time-release antimicrobials to fight infection at the site.
The mesh holding the pacemaker contains two time-release antimicrobials to fight and also prevent infection at the site. The body breaks down and absorbs the mesh in eight to 12 weeks.
Surgical mesh left in the body may bond with tissue and be difficult to remove when surgeons need to install a replacement pacemaker. The AIGISRx R mesh eliminates that problem by dissolving within a couple of months.
Additional care for patients with surgical site infections costs an average of $72,485. Up to one-third of such patients die. Others experience more illness and disability.
These qualities make the mesh envelope a desirable option for more than three million American patients with implanted cardiac devices that, sooner or later, will need to be replaced.
"The antibiotic time-release mesh adjacent to the scar tissue not only fights infection, but also helps prevent infection," Dr. Seifert said. AIGISRx R is really valuable for high-risk patients who have had multiple procedures, are older, have chronic diseases or are immunocompromised.
"I believe we should use the envelope prophylactically to prevent infection in these patients," Dr. Seifert said. "The slight increase in cost is more than offset by the money we save by preventing rehospitalizations, not to mention the pain and suffering we're preventing for our patients."
"It's life changing," said Narkiewicz, who returned home less than a day after his new pacemaker in an envelope was implanted.
For more information, see JCL.com/Cardiac.
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