CMS Just Increased the Consequences of CIED Infections!

Need a Solution?

Patient Environment Challenges:

The increase in admissions for cardiovascular implantable electronic device (CIED) infection is 5-fold the increase in CIED implantations:^1,2

• Increased rate of infection likely due to more patient comorbidities, longer procedures, and more resistant S aureus and coagulase-negative Staphylococcus species (eg, S epidermidis)

Patients suffering from surgical site infections following CIED implantation procedures:³

• Spend an average of 2 extra weeks in the hospital
• Undergo repeat surgical procedures to treat the infection
• Cost the facility an average of $72,485
• Experience significant increases in morbidity and mortality, with 1-year mortality rates of 26.5% to 35.1%, depending on device type

Governmental, Facility, & Societal Environment Challenges:

In an effort to control health care costs and improve patient outcomes, CMS will stop paying for infections following pacemaker and defibrillator implants effective October 1, 2012:⁴

• The Inpatient Prospective Payment System (IPPS) final rule for FY 13 adds surgical site infections, following CIED implantation, as a condition subject to the Hospital Acquired Condition payment provision, aka “Never Pay.”
• CMS considers these infections to be reasonably preventable and has classified them as complicating conditions that would otherwise result in a higher payment to the hospital. Under the new policy, CMS will pay for the original surgery, but will not reimburse hospitals at a higher rate for treating the infection.

CMS CIED SSI “Never Pay” decision will significantly impact hospital practices:^5,6

• A survey polled 100 hospital CEOs and CFOs at academic health centers and community hospitals across the U.S. to determine how hospital practices are likely to change as the result of the new CMS rule.
• Findings included:
  • Over 90% of CFOs and CEOs consider the financial impact of the “Never Pay” decision to be “very important” to their hospitals.
  • The majority of CFOs and CEOs support the adoption of new technologies including the The AIGISRx® Antibacterial Envelope to help reduce the risk of CIED infections.

A Solution to Your Challenges!

The AIGISRx® Antibacterial Envelope is designed to help prevent CIED infections.

• Designed to:
  • Securely hold a pacemaker or ICD, creating a stable environment surrounding the device and leads after surgical placement⁷
  • Elute antibiotic agents rifampin and minocycline over a 7 to 10 day period⁷
• Results show:
  • The AIGISRx® had 0% infections vs matched controls in 848 patient Vanderbilt University study⁸
  • COMMAND Study showed that The AIGISRx® can reduce infections by up to 70%^9,10
• Help prevent CIED infection with the AIGISRx® Antibacterial Envelope.

More Protection. Less Risk.

For more information, visit www.tyrx.com.

References:

1. Voigt A, Shalaby A, Saba S. Continued rise in rates of cardiovascular implantable electronic device infections in the United States: temporal trends and causative insights. Pacing Clin Electrophysiol. 2010;33(4):414-419.
2. Voigt A, Shalaby A, Saba S. Rising rates of cardiac rhythm management device infections in the United States: 1996 through 2003. J Amer Coll Cardiol. 2006;48(3):590-591.
3. Greenspon AJ, Patel JD, Lau E, et al. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011:58(10):1001-1006.
4. Centers for Medicare & Medicaid Services, Inpatient Prospective Payment Systems (IPPS), Fiscal Year 2013.
5. TYRX CEO Survey, 2012.
6. TYRX CFO Survey, 2012.
7. The AIGISRx® IFU.
8. Kolek, Driesen, Ellis. Vanderbilt University ACC Abstract Presentation, 2012.
9. Bloom HL, Constantin L, Dan D, et al. Implantation success and infection in cardiovascular implantable electronic device procedures utilizing an antibacterial envelope. Pacing Clin Electrophysiol. 2011;34(2):133-142.
10. Gould PA, Krahn AD; for the Canadian Heart Rhythm Society Working Group on Device Advisories. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA. 2006;295(16):1907-1911.