Hemostatic Agents in the OR: Are You Providing Safe Care? Peggy Camp, RN, BSN, MSN September 13, 2012 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 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 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 Hemostatic Agents in the OR: Are You Providing Safe Care? Haemostatic Agent Characteristics CATEGOR Y SAFETY EFFICACY EASE OF USE COST Mechanical Relatively Safe Swelling Minimal Bleeding Easy to prepare/use Inexpensive Active Potential for: Antibody Formation, Disease Transmission: Viral, Prion Recombinant Effective for localized & diffuse bleeding Relatively easy to prepare/use Moderately priced Flowable Disease Transmission: Viral, Prion Localized Bleeding Relatively easy to prepare/use More expensive than active Fibrin Sealant Disease Transmission: Viral, Prion Antibody formation/swelling Coagulation profile important to know Localized and Diffuse Bleeding More difficult to prepare/use Most expensive Hemostatic Agents in the OR: Are You Providing Safe Care? Current products -MECHANICAL CATEGORY ACTION COMPOSITION/ORIGIN CLINICAL CONSIDERATIONS COMMERCIAL NAME Mechanical Minimal Bleeding Porcine Gelatin Swelling (do not use in confined areas); do not use in infected cases; may cause foreign body reaction if not removed Gelfoam Powder /Sponge Surgifoam Powder /Sponge Bovine Collagen Swelling (do not use in confined areas); do not use in infected cases; may cause foreign body reaction if not removed; adhesion formation Avitene sponge & flour; Helistat and Helitene; Instat Oxidized Regenerated Cellulose Swelling (do not use in confined areas); do not use in infected cases; may cause foreign body reaction if not removed; adhesion formation Surgicel, Surgicel Fibrillar, and Nu-Knit Polysaccharide Spheres Swelling (do not use in confined areas); no demonstrated safety studies in neurologic, urologic and ophthalmic surgery; should not be injected Arista Hemostatic Agents in the OR: Are You Providing Safe Care? Current products -ACTIVES CATEGORY ACTION COMPOSITION/ORIGIN CLINICAL CONSIDERATIONS COMMERCIAL NAME Actives Localized and Diffuse Bleeding Bovine Thrombin Should not be used for patients with bovine allergies; can stimulate Antigen formation and interrupt clotting cascade ; potential for infection transmission; has Black Box Warning Thrombin Pooled Human Thrombin Swelling risk; Do not use in patients with allergies to Human blood products; unknown potential for infection transmission and interruption of clotting cascade Evithrom Commercially manufactured; to date clinical studies have not demonstrated this product has produced antigens or impacted clotting cascade Recothrom Recombinant Thrombin Hemostatic Agents in the OR: Are You Providing Safe Care? Current Products -FLOWABLES CATEGORY ACTION COMPOSITION/ORIGIN CLINICAL CONSIDERATIONS COMMERCIAL NAME Flowables Localized bleeding Bovine Gelatin and Human Thrombin Should not be used for patients with bovine allergies; swelling risk – approved for use in all specialties EXCEPT Ophthalmology; absorption 68 weeks; not to be used with blood Salvage devices or Cardio-pulmonary Bypass circuits; potential for infection transmission Floseal Porcine Gelatin with/without Thrombin Swelling risk; absorption in 4-6 weeks. Do not use in patients with Porcine allergies; not to be used with blood Salvage devices or Cardio-pulmonary Bypass circuits; potential for infection transmission * Can be used in combination with Recothrom Surgiflo Hemostatic Agents in the OR: Are You Providing Safe Care? Current Products –Fibrin Sealants CATEGORY ACTION COMPOSITION/ ORIGIN CLINICAL CONSIDERATIONS COMMERCIAL NAME Fibrin Sealants Localized and Diffuse Bleeding Human PlasmaDerived Fibrin Sealant 2 component hemostat & sealant –contains pooled human plasma fibrinogen and & thrombin – doesn’t need active bleeding or blood –derived fibrinogen for activation - do not to use with Blood Salvage devices or CPBypass circuits; potential concerns infection transmission, air embolus, tissue rupture and gas entrapment. Systems differ in terms of storage and application. Potential concerns –do not use in patients with Bovine allergies, infection/ foreign body reaction/swelling/tissue compression ; immunologic and coagulation complications. Tisseal Evicel Crosseal Patient ‘s Own Plasma with Bovine Collagen/Throm bin Patient ‘s Own Plasma to create Fibrinogen and thrombin Requires trained technician for processing; not be used in patients with acquired or hereditary hematologic or coagulation disorders; not be used with patients on active heparin or Coumadin therapy or non-steroidal antiflammatory agent use (48 hrs); adjunct for liver resection surgery; studies indicate clot stability and Fibrinogen less effective than commercially prepared products Vitagel Cryoseal Hemostatic Agents in the OR: Are You Providing Safe Care? Current Products –Peg Polymers ,Cyanoacrylates, Glutaraldehydes CATEGORY ACTION COMPOSITION /ORIGIN CLINICAL CONSIDERATIONS COMMERCIAL NAME Peg Polymers Two synthetic polymers that mix and cross link at the wound site Polyethylene glycol hydrogels Can prevent pericardial adhesions; good agent for vascular reconstructions; does not cause inflammation; infection risks minimal; should not be used in closed spaces because of swelling risk Coseal Cyanoacrylates Monomers form polymers in presence of water and serves to glue surfaces together Achieves 65% binding power in 20 sec; full strength in 2 min regardless of temperature /air /water Liquid monomers Used as a replacement for sutures primarily on facial, extremity and torso wounds; attains strength of healed tissue after 7 days Dermabond Indermil Glutaraldehyde cross linked with bovine albumin Commonly used in vascular procedures for sealing holes around staple lines; good agent for arterial bleeds; hyper-sensitivity a concern; inert substance that is NEVER absorbed Bioglue Glutaraldehydes 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 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. Haemostatic Agents in the OR: Are You Providing Safe Care? FDA Approved Products CATEGORY MECHANICAL CLASS Bovine Collagen Oxidized Regenerated Cellulose Polysaccharide Spheres Gelfoam/Surgifoam Powder and Sponge Avitene, Helistat, Instat, Ultrafoam Surgical, Surgicel Fibrillar, Nu-Knit Arista, Hemostase, Vitasure ACTIVE Bovine Thrombin Pooled Human Thrombin Recombinant Thrombin Thrombin – JMI Evithrom FDA Approved Hemostats Recothrom FLOWABLE Bovine Gelatin & Pooled Human Thrombin Porcine Gelatin (+/- Thrombin) Floseal. Pooled human Plasma Individual Human Plasma W Bovine Collagen & Bovine Thrombin Individual Human Plasma Tisseal, Evicel Vitagel FIBRIN SEALANT Porcine Gelatin PRODUCT FDA Surgiflo Cryoseal 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? 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 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 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 Hemostatic Agents in the OR: Are You Providing Safe Care? 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.