New Highlights in Central Line- Associated Bloodstream Infection and Surgical-Site Infection Prevention

1. New Highlights in Central Line-Associated Bloodstream Infectionand Surgical-Site Infection Prevention Rabih O. Darouiche, MD VA Distinguished Service Professor Director, Center of Prostheses Infectionat Baylor College of Medicine Safe Practices Webinar February 18, 2010

2. Disclosure Statement • Co-invented antimicrobial-coated catheters that are licensed by Baylor College of Medicine to Cook Inc • Received educational and research grants from CareFusion • Do not plan to discuss off-label and investigational use of devices or drugs

3. Address similarities and differences between CLABSI and SSI Assess the impact of these two infections Analyze potentially protective approaches Overview of Presentation

4. Similarities Between CLABSI and SSI Both infections result primarily from breaking skin integrity Both infections are caused mostly by skin organisms Both infections occur at unacceptably high rates, can be difficult to manage, may require future intervention(s), and are expensive to treat

5. Differences Between CLABSI and SSI CLABSI manifests while the catheter is still in place, whereas SSI can manifest at any time after surgery, usually by 30 days post-op Microbiologic cause of CLABSI is almost always identified, whereas the microbiologic cause of SSI is unknown in many patients Occurrence of CLABSI can be attributed to various healthcare providers, whereas SSI is typically linked to the surgeon

6. Clinical Manifestations of infected CVC Exit site infection Tunnel infection Thrombophlebitis BSI

7. Impact of CLABSI Incidence: of the 6 million CVC inserted annually in the U.S., 250,000 result in BSI Management: cure often requires removal of the infected catheter and long antibiotic therapy Medical sequelae: attributable mortality 5%-25% Economic burden: cost of treatment is $10K-$56K; annual cost in U.S., $3 billion–$16.8 billion

8. Annual Death Rates in the U.S. for Selected Infectious Diseases

9. Nosocomial Infections in the ICU 95% Urinary Catheters 86% Mechanical Ventilation 87% central lines < 55 = 33% 55 – 70 = 32% >70 = 35% N= 14,177 National Nosocomial Infections Surveillance (NNIS) (97 hospitals)

10. Gram-Positive Bacteremia in Cancer Patients: Role of the CVC 80% 70% 70% 56% 60% 50% 44% % of Bacteremia with CVC as the source 40% 30% 30% 20% 10% 0% Non-CRBSI CRBSI Non-CRBSI CRBSI Solid Tumor Malignancy Hematologic Malignancy

11. Difference between Surveillance Definition (by National Healthcare Safety Network: NHSN) and Clinical/Microbiologic Definition of CLABSI Surveillance definition:includes all cases of BSI in patients with CVC in whom other sites of infection are excluded (catheter-associated BSI varies from from 1.3/1000 cath-days in medical surgical wards to 5.6/1000 cath-days in burn ICU) Clinical/microbiologic definition: includes only cases of BSI in patients with CVC in whom other sites of infection are excluded and microbiologic relationship of catheter to BSI exists (catheter-related BSI)

12. Relationship between Catheter Colonization and Bloodstream Infection Principle: catheter colonization is a prelude to catheter-related bloodstream infection Objective: to prevent infection by inhibiting catheter colonization

13. IA Recommendations in Upcoming CDC Guidelines for Prevention of CLABSI Staff education and training Insert CVC in subclavian catheters Place hemodialysis catheters in jugular or femoral veins Promptly remove CVC when no longer essential Hand wash with soap/water or alcohol-based hand rubs Utilize 2% chlorhexidine-based preparation for skin cleansing before inserting CVC, during dressing changes, and wiping access ports of needleless catheter systems Use sterile gauze or transparent semi-permeable dressings Use antimicrobial-impregnated CVC if expected duration of placement >5 days and CLABSI remains higher than goal set by institutions despite comprehensive strategy Guidelines for the Prevention of Intravascular Catheter-related Infections. Atlanta (GA): Centers for Disease Control and Prevention; 2010. [draft]

14. Before insertion: Educate healthcare personnel involved in the insertion, care, and maintenance of central venous catheters (CVCs). At insertion: Use a catheter checklist at the time of CVC insertion. Perform hand hygiene prior to catheter insertion or manipulation. Avoid using the femoral vein for central venous access in adult patients. Use a catheter cart or kit with components for aseptic catheter insertion. Use maximal sterile barrier precautions. Use chlorhexidine gluconate 2% and isopropyl alcohol solution as skin antiseptic preparation in patients over two months of age and allow appropriate drying time per product guidelines. After insertion: Use a standardized protocol to disinfect catheter hubs, needleless connectors, and injection ports before accessing the ports. Remove nonessential catheters. Use a standardized protocol for non-tunneled CVCs in adults and adolescents for dressing care. Perform surveillance for CLABSI and report the data on a regular basis. NQF CLABSI Prevention Safe Practice Specifications: 2010 Update

15. Comprehensive Protective StrategyInfection Control Bundle Hand washing Maximal barrier precautions 2% chlorhexidine-based skin antisepsis Avoiding femoral site if possible Removing unnecessary catheters

16. Although very essential, they: Are not easily enforceable Are not very durable Do not completely prevent infection Save some, but not enough, lives Potential Limitations of Traditional Infection Control Measures

17. Reasons to Optimize Prevention of SSI Unacceptably high incidence: the 30 million annual surgical procedures in the U.S. result in 300,000-500,000 cases of SSI Difficult management: may require repeated surgical interventions Serious medical consequences: tremendous morbidity and occasional mortality Soaring economic burden: annual cost of treatment in the U.S. is >$7 billion

18. Perioperative Approaches for Preventing SSI Non-antimicrobial approaches Normothermia Adequate oxygenation Tight glucose control Antimicrobial approaches Systemic antibiotic prophylaxis Nasal application of mupirocin Skin antisepsis

19. Impact of Timing of Systemic Antibiotic Prophylaxis on SSI

20. A Prospective Randomized Trial of Nasal Mupirocin Plus Chlorhexidine Wash • Rapid identification of nasal carriage by S. aureus followed by a 5-day course of nasal mupirocin plus chlorhexidine wash: • Reduces S. aureus infection (3.4% vs. 7.7%) • Decreases S. aureus SSI by almost 60% • Bode, et al. N Engl J Med 2010;362:9-17

21. Importance of the Skin Largest bodily organ Protective barrier Skin flora most common cause of SSI (and CLABSI) 80% of bacteria reside in epidermis

22. Factors that Support the Need for Optimal Skin Antisepsis Most pathogens that cause SSI are skin flora At least 2/3 of cases of SSI are incisional Most SSI are considered preventable Other preventive measures reduce but do not eliminate SSI

23. Commonly used Preoperative Antiseptics Povidone-iodine (Iodophor) Chlorhexidine gluconate Alcohol Combination products: >2 active agents

24. Comparison of Antimicrobial Activity of Antiseptic Preparations Chlorhexidine-based preparations are better than alcohol or iodine-based products in: Reducing colonization of vascular catheters Preventing contamination of blood cultures Decreasing contamination of surgical tissues

25. Pressing Need to Compare Clinical Efficacy of Antiseptic Preparations in Preventing SSI CDC guidelines for prevention of infections related to vascular catheters recommend antiseptic cleansing of the skin with 2% chlorhexidine-containing products O’Grady, et al. Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep 2002;51(RR-10):1-29 CDC has not previously issued a preference as to type of preoperative skin antiseptics

26. Prospective, Randomized, 6-Center Clinical Trial of 849 Patients Population: adult patients scheduled for abdominal or non-abdominal clean-contaminated surgery Randomization: hospital-stratified Intervention: preoperative skin cleansing with: ChloraPrep® (2% chlorhexidine gluconate-70% isopropyl alcohol = CA) 26-ml applicators; OR 10% povidone-iodine (PI) scrub and paint Evaluation: SSI was assessed by blinded evaluators Darouiche, et al. N Engl J Med 2010;362:18-26

28. Kaplan-Meier Curves for Freedom from Surgical-Site Infection (Intention-to-Treat Population)

30. Chlorhexidine-Alcohol (CA) vs. Povidone-Iodine (PI) for Prevention of SSI CA significantly reduces SSI Number of patients needed to receive CA instead of PI to prevent one case of SSI: 17 Delays onset of SSI CA and PI have similar rates of adverse events (including events related to study medication in 0.7% in each group) and serious adverse events

31. New CMS Regulations (effective 10/08) Changes to Inpatient Prospective Payment System 10 non-reimbursable conditions met these criteria: High cost High volume Triggers a high-paying MS-DRG May be considered reasonably preventable through application of evidence-based guidelines Federal Register, Volume 73, No. 161; 08/19/08

32. Non-reimbursable Infectious Conditions Catheter-associated urinary tract infection Vascular catheter-associated infection Surgical-site infection-mediastinitis after CABG Surgery on various joints, including shoulder, elbow, and spine

33. Perspective Optimal prevention of CLABSI and SSI can: Improve patient care Incur cost-savings Enhance infection control measures