Consequences of Implantable Cardiac Device Infection on Patients and the Healthcare System
Despite efforts to take pacemaker precautions and reduce pacemaker risks, infection after cardiac implantable electronic defibrillators (CIEDs) implantation is a real possibility. When pacemaker infection does occur, the risk to the patient and the costs to the healthcare system are substantial.1-3
Infections typically cost the facility an average of about €36,7224 and 26-30 bed days to treat one infection. 4-5
CIED INFECTION AND MORTALITY
Mortality significantly increased following CIED infections. Studies show a ~50% mortality rate at three years in patients who had a CIED infection.1
CIED Infections Are Costly
Infections typically cost the facility an average of about €36,7224 and 26-30 bed days to treat one infection. 4-5
BENEFITS OF TYRX ANTIBACTERIAL ENVELOPES
The TYRX™ Absorbable Antibacterial Envelope may help reduce infection; studies show a 70% to 100% reduction of infection in high-risk patients. 6-11
Economic Impact of CIED Infection
1
Mittal S et al. Heart Rhythm. 2014;11(4):595-601.
2
Henrikson CA et al. JACC EP.2017;3(10):1158-1167.
3
Sohail MR et al. Arch Intern Med. 2011;171(20):1821-1828.
4
Ahsan SY et al. Europace 2014;16: 1482-1489
5
Ludwig S et al, 2017. Incidence and costs of cardiac device infections: retrospective analysis using German health claims data. J. Comp. Eff. Res. 10.2217/cer-2017-0080 (Epub ahead of print)
6
Bloom HL et al.Pacing Clin Electrophysiol.2011;(2):133-142
7
Mittal S et al. Heart Rhythm. 2014;11(4):595-601
8
Kolek MJ et al. J Cardio Electrophysiol. 2015;26(10):1111-1116
9
Shariff N et al. J Cardio Electrophysiol. 2015;26(7):783-789
10
Henrikson CA, et al. JACC EP. 2017;3(10):1158-1167
11
Kolek MJ et al. Pacing Clin Electrophysiol.2013;36(3):354-361
TYRX™ Cardiac Absorbable Antibacterial Envelope
*
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScanTM device, see the MRI SureScanTM technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu
The envelope is intended to hold the following CIED securely to create a stable environment when implanted in the body at the following locations: Implantable Pulse Generator (IPG), Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Devices (CRT-P and CRT-D); implant locations are pectoral, abdominal, or flank (lateral to the body midline and superior to the gluteal) regions.
The envelope contains the ancillary medicinal substance ansamycin, which has been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the device.
The envelope is contraindicated for use in patients with allergy or history of allergy to tetracyclines, ansamycin, or absorbable sutures; in patients with systemic lupus erythematosus (SLE) because minocycline has been reported to aggravate this condition; in contaminated or infected wounds.