October 04, 2013
John C. Lincoln North Mountain Hospital Implants Valley's First Infection-Fighting, Self-Dissolving Safety Solution for Replacement Pacemakers
The AIGISRx R dissolving antibacterial mesh pouch for pacemakers and other implanted cardiac devices.
A new solution to the problems of infection and other complications associated with replacement pacemakers and implanted defibrillators is now available at John C. Lincoln North Mountain Hospital.
The new solution, cleared just a couple of months ago by the FDA, is the AIGISRx R, a fully bioresorbable antibacterial mesh envelope that holds a replacement cardiac device. More than 3 million patients in the U.S. currently have implanted cardiac devices that, sooner or later, will need to be replaced.
The AIGISRx R, from drug/device manufacturer TYRX, Inc., combines the traditional technologies of dissolving stitches and drug eluting stents, the mesh tubes that hold arteries open and release antibiotics over time to fight infection. AIGISRx R contains two antimicrobial agents that are released into adjacent tissue.
"This is important, because scar tissue from previous procedures doesn't easily allow the body to deliver administered antibiotics or the body's own immune cells to scarred sites," said Mark Seifert, MD, a cardiologist and electrophysiologist, who implanted the Valley's first dissolving mesh envelope in the North Mountain Hospital cardiac catheterization lab.
"Infection rates for repeat pacemaker procedures are much higher than first implants," Dr. Seifert explained. "It's harder to fight infections that lodge in scar tissue in patients who are at higher risk of infection, like those having repeat pacemaker procedures at the same site."
National statistics show that patients with surgical site infections following cardiac implant procedures spend an average of two extra weeks in the hospital, undergo repeat surgical procedures to treat the infection, and cost an average of $72,485. Additionally, somewhere between 1 out of 3 to 1 out of 4 such patients die – while others experience significant increases in sickness and disability. Up to half of those who get severe infections die within three years.
"Having the antibiotic time-release mesh adjacent to the scar tissue helps prevent infection," Dr. Seifert said.
Another key concern that the AIGISRx R addresses is that surgical mesh left in the body may bond with tissue and be difficult to remove when surgeons have to do a future pacemaker procedure. Dissolving mesh, like dissolving stitches, eliminates that problem. The AIGISRx R dissolves in approximately 9 weeks.
A retired history teacher made history at John C. Lincoln North Mountain Hospital by becoming first in the Valley to get the new antibiotic-coated dissolving mesh envelope for his new pacemaker implant.
"I feel really good," said Phoenix resident Dan Koestner. "It’s pretty cool to be the first one to get this new device."
Dr. Seifert pointed out that the AIGISRx R is really valuable for patients at higher risk of infection, especially those who have had multiple procedures, or who are older, or those who have chronic diseases like diabetes or who are immunocompromised.
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