Hemostatic Agents in the OR: Are You Providing Safe Care?

1. Hemostatic Agents in the OR: Are You Providing Safe Care? Peggy Camp, RN, BSN, MSN September 13, 2012

2. Hemostatic Agents in the OR: Are You Providing Safe Care? • Today’s presentation will provide a review and update on: • The types and properties of topical haemostatic sealants commonly used in the Peri-operative setting. • Common surgical applications • FDA approved Products/applications • Clinical Facts for the Peri-operative Nurse • Potential Complications • “Take-aways” for Clinicians

3. Hemostatic Agents in the OR: Are You Providing Safe Care? Historical Overview Major Factors affecting today’s surgical environment Cost Containment Growing Aging Population Impact on today’s care delivery systems Growth in less invasive procedures Emergence of new products to control bleeding, enhance clinical outcomes

4. Hemostatic Agents in the OR: Are You Providing Safe Care? What has changed in the past 5 years in health care delivery? • Emphasis on controlling costs • Increase in minimally invasive procedures in the OR and other clinical areas (IR, Cath Lab) • Expectation of improved clinical outcomes • High level of oversight on clinical interventions and outcomes • Surgical Complications including SSI, readmissions • Blood Transfusions • Implants • Advanced Haemostatic Agents

5. Hemostatic Agents in the OR: Are You Providing Safe Care? • Haemostatic Agent Characteristics

6. Hemostatic Agents in the OR: Are You Providing Safe Care? • Current products -MECHANICAL

7. Hemostatic Agents in the OR: Are You Providing Safe Care? Current products -ACTIVES

8. Hemostatic Agents in the OR: Are You Providing Safe Care? Current Products -FLOWABLES

9. Hemostatic Agents in the OR: Are You Providing Safe Care? Current Products –Fibrin Sealants

10. Hemostatic Agents in the OR: Are You Providing Safe Care? Current Products –Peg Polymers ,Cyanoacrylates, Glutaraldehydes

11. Hemostatic Agents in the OR: Are You Providing Safe Care? • Common Surgical Applications* General Surgery - Hernia Mesh Fixation, Fundoplication, Bariatric Surgery, Colostomy Closure, Burns Cardiac Surgery - Effective agent for active bleeding sites ; some agents help to prevent adhesions Head & Neck Surgery – thyroidectomies, septoplasties - good agent for controlling active bleeding Neurosurgery - Control active bleeding in intra-cerebral hemorrhage, effective in sealing CSF Leakage Orthopedic Surgery - Limited applications include Achilles Tendon Repairs; should not be used with methylmethacrylates OB-GYN Surgery - Laparoscopic Ovarian Cystectomies, Abdominal Myomectomy, Laparoscopic Ovarian Cystectomies

12. Hemostatic Agents in the OR: Are You Providing Safe Care? • Common Surgical Applications Ophthalmologic Surgery – Eyelid procedures to seal suture lines/tissues; limited applications for treatment of corneal perforations or glaucoma bleb leaks Thoracic Surgery – seal air leaks in Lung Resections Urologic Surgery - Laparoscopic Nephrectomy Vascular Surgery – Broad applications for active bleeding – Aortic Aneurysms, Peripheral Vascular Procedures, i.e. Carotid Endarterectomy, Av Access Procedures *Note – there are a number of outcome studies in all specialties that indicate less intra/post bleeding and new applications are emerging on a daily basis.

13. Haemostatic Agents in the OR: Are You Providing Safe Care? FDA Approved Products FDA FDA Approved Hemostats

14. Hemostatic Agents in the OR: Are You Providing Safe Care? • FACTS TO CONSIDER • What is the origin of the product being used & what are the patient implications? • What clinical studies are there to support the application being considered • How easy is the product to use? • What benefits are there for this product? • What limitations are there for this product? • What does the product cost & does clinical outcomes justify this expense? • What safety mechanisms are in place to insure optimal patient outcomes ---what needs to be considered?

15. Hemostatic Agents in the OR: Are You Providing Safe Care? • IMMUNE-MEDIATED COAGULOPATHY (IMC) • Iatrogenic medical condition resulting from exposure to non-human coagulation proteins (porcine and bovine) thrombin • Has been noted in all surgical specialties (Trauma) • True incidence unknown due largely to under reporting (2000) • Delayed onset – most often following surgical procedures where Bovine Thrombin used • Increased Morbidity and Mortality • Difficult to Diagnose and Manage • Is an AVOIDABLE complication

16. Hemostatic Agents in the OR: Are You Providing Safe Care? • IMMUNE-MEDIATED COAGULOPATHY (IMC) • Strategies to improve patient outcomes • Patient Assessment • Identification of high risk/at risk patients • Education of Surgical Team (including Physicians) • Using the right product for the right reason • Timely intervention

17. Hemostatic Agents in the OR: Are You Providing Safe Care? “Take-aways” for the Peri-operative Nurse • Understand the Risks and Benefits and Cost of Haemostatic Agents • Read the labels on the packaging including Black Box Warnings • Assessment is key for ALL patients – never assume that there have been no previous exposures • Educate yourself, your peers and your surgeons – stay current on published studies • When in doubt, STOP and ask questions

18. Hemostatic Agents in the OR: Are You Providing Safe Care?

19. References • Achneck, H., Bantayehu,S., Jamiolkowski, R., Alba, D., Shapiro, M., Lawson, J. A comprehensive Review of Topical Hemostatic Agents. Annals of Surgery. 2010; 251: 217-228. • Ness,P., Creer,M., Rodgers,G., Naoum, J., Renkens,K., Voils, S., Alexander, W., (RETACC Panel). Building an immune-mediated coagulopathy consensus: early recognition and evaluation to enhance post-surgical patient safety. Patient Safety in Surgery. 2009: 10.1186-/1754-9493-3-8. • Rodgers, G. Immune-mediated Coagulopathy Associated With Bovine Thrombin: Review of the Pediatric Literature. Journal of Pediatric Hematology/Oncology. 33: 2 86-88 • Spahn, R & Rossaint, R . Coagulopathy and blood component transfusion in trauma. British Journal of Anesthesia.2005: 95(2). 130-139. • Spotnitz, W and Burks, S. State-of-the-Art Review: Hemostats, Sealants,and Adhesives II: Update as Well as How and When to Use the Components of the Surgical Toolbox. Clinical and Applied Thrombosis/Hemostasis. 2010:16:497 – 513.