FYI: "pocket infections "


To All,

Many of us have had a problem with PM/ICD site implant
infection....the following addresses this issue & a possible
solution....just thought someone might be interested. Karen

AIGISRxTM Anti-bacterial Envelope
Surgical Site Infections “pocket infections” associated with implanted pacemakers and cardioverter defibrillators are estimated to cost over $1 billion annually. Approximately 500,000 pacemakers and defibrillators are implanted annually in the United States with estimates as high as 7% being explanted due to infection. Not only are the pacemakers and defibrillators removed, the entire system is normally removed, including leads (wires connecting the device to the heart). “Pocket infections” are not only costly but are debilitating to patients and are causes of pain and loss of productivity. A recent article appearing in the Heart Rhythm Journal, April 2008, states, “indications (for extractions) were infection (60.3%), mechanical lead failure (29.3%) and upgrade of device system (8.8%)”. “Pocket infections” may occur days, weeks and months after the device has been implanted. Although antibiotics are administered in conjunction with these implant procedures - “pocket infections” can occur.
In January 2008, the FDA cleared the AIGISRxTM Anti-bacterial Envelope for United States market release. AIGISRxTM has been shown to reduce infection by 100% in an in-vivo (animal model) bacterial challenge associated with implanted pacemakers and cardioverter defibrillators. AIGISRxTM is a polypropylene mesh (similar to a hernia mesh) coated with a fully resorbable polymer which carries two antibiotics – minocycline and rifampin. At time of implant the physician inserts the pacemaker or defibrillator into the AIGISRxTM mesh and then places both the device and AIGISRxTM into the surgically created pocket of the patient. The antibiotics provide localized antimicrobial activity within the surgically created pocket.

AIGISRxTM has been implanted by some of the top teaching hospitals in the United States.

Before your next pacemaker or defibrillator implant, you may want to ask your doctor about the possibility of infection and if the AIGISRxTM mesh envelope is an option for you.
To learn more, visit www.TYRX.com


7 Comments

Definitely Worthwhile!

by bobad - 2008-11-02 01:11:15

The envelope would stop infection introduced during surgery, which has tremendous value.

However, I think some infections have more or less external sources, and can come much later. Mine came 3 months after surgery.

The source of the bacteria are hair follicles and sebaceous glands in the pectoral and preaxillary areas. The skin is so thin that I believe the infectious organism penetrate it, and colonize the pacer.

Good point,bobad..hmmmm?

by pacepal - 2008-11-02 09:11:19

First...I apologize if this appears as a double post...I have no clue as to where the first post went!

Just thinking...an organism introduced to the outer layer of skin(ectodermal)...penetrating through to the inner layer(mesodermal)...down through the subcutaneous fat layer...should meet with positive resistance and become neutralized as it attempts o penetrate the antibiotic-coated-mesh-envelope.

Questions to my vascular surgeon would be:..(1) would he first do intradermal skin test of the tetracycline & the rifampin(an antituberclar) to determine & rule out the possibility of patient-drug-sensitivity..(2)..have studies with documented results been submitted in regard to the resorbtion factor of the two antibiotics...(rifampin) holds contraindication factors for many of the meds that "heart" patients are maintained on.....UGH! so-o many variables!

Life would be so much easier if we were all born with the same blueprint.

Someone let me know how off-track I am.

Karen

Anitbiotic Effects Time Limited

by bobad - 2008-11-02 10:11:53


It's my understanding (reading the literature) that the antibiotic effects of the envelope only lasts about 3 weeks. This may vary with brand.

Any bacteria penetrating or migrating after the first few weeks would not be killed.

Don't get me wrong, I think the envelope could prevent early infecton, which is by far the worst kind.

Thanks

by ElectricFrank - 2008-11-02 12:11:05

Thanks for the info. It sounds like this is another one of those things we need to insist on. I had no infection problems with my implant, but who knows on the next one. Hospitals are becoming a pool of nasty bugs.

frank

Good point,bobad

by pacepal - 2008-11-02 12:11:51

I agree with you re prevention of early infection:

also,allergic reaction(sulfa-based with the Minocycline) could ?.. be controlled with steroids & antihistamines: interaction effects of Rifampin to Ace's..BB's..
..Warfarin..Digoxin..to list just a few.. could ?.. be controlled through temporary dose adjustment.

...so!..similar in principal to the drug-eluting stent(used with vascular surgery) ?

My vascular surgeon's primary concern is scar tissue...he doesn't like scar tissue! I guess that could get messy come time for generator replacement.

Life with a PM/ICD is a life with adaptation...trade-off...adjustment...acceptance...appreciation / graitude.

Works for me....lifeis good.,,,,,,Karen

Delayed Infection

by ElectricFrank - 2008-11-03 12:11:13

Some of the more recent resistant infections may be capable of laying dormant for a period of time and then appearing. An infection could also be encapsulated in scar tissue in the incision and later be released.

I agree that it is a good idea to test for sensitivity to the antibiotic used in the envelope.

It's a complex world out there.

frank

When I had my pacer moved under the muscle

by kathykat11 - 2011-09-22 01:09:55

I asked about the antibacterial envelope and my doctor said he doesn't like them for the scaring they encourage and the fact that out body grows through the mesh making it a bear to get out later. He said that I always works on the assumption that he will eventually be doing the replacement and he wouldn't want to be taking the envelope and all of the extra tissue that has to be removed because of it meshing into skin or muscle tissue is not worth the additiomal antibiotic coverage since he alays gives iv antibiotics pre and post surgery as well as oral med for 10 days.
Kathykat11

You know you're wired when...

You need to be re-booted each morning.

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