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Hemostatic Agents in the OR_ Are You Providing Safe Care_ - DAORN

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					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?

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

          Historical Overview
   Major Factors affecting today’s surgical
                environment
             qCost Containment
          qGrowing Aging Population

   Impact on today’s care delivery systems
     qGrowth in less invasive procedures
 qEmergence 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?
     v Emphasis on controlling costs
     v Increase in minimally invasive procedures in the OR and
       other clinical areas (IR, Cath Lab)
     v Expectation of improved clinical outcomes
     v High level of oversight on clinical interventions and
       outcomes
       ü Surgical Complications including SSI, readmissions
       ü Blood Transfusions
       ü Implants
       ü Advanced Haemostatic Agents
        Hemostatic Agents in the OR: Are You Providing
                          Safe Care?
— Haemostatic Agent Characteristics

    CATEGOR          SAFETY                  EFFICACY              EASE OF USE          COST
    Y
    Mechanical       Relatively Safe         Minimal Bleeding      Easy to              Inexpensive
                     Swelling                                      prepare/use

    Active           Potential for:          Effective for         Relatively easy to   Moderately priced
                     Antibody Formation,     localized & diffuse   prepare/use
                     Disease Transmission:   bleeding
                     Viral, Prion
                     Recombinant


    Flowable         Disease Transmission:   Localized Bleeding    Relatively easy to   More expensive
                     Viral, Prion                                  prepare/use          than active

    Fibrin Sealant   Disease Transmission:   Localized and         More difficult to    Most expensive
                     Viral, Prion            Diffuse Bleeding      prepare/use
                     Antibody
                     formation/swelling
                     Coagulation profile
                     important to know
         Hemostatic Agents in the OR: Are You Providing
                           Safe Care?

 — Current products -MECHANICAL
CATEGORY     ACTION     COMPOSITION/ORIGIN     CLINICAL CONSIDERATIONS                    COMMERCIAL NAME


Mechanical   Minimal    Porcine Gelatin        Swelling (do not use in confined areas);   Gelfoam Powder
             Bleeding                          do not use in infected cases; may cause    /Sponge
                                               foreign body reaction if not removed       Surgifoam Powder /Sponge




                        Bovine Collagen        Swelling (do not use in confined areas);   Avitene sponge & flour;
                                               do not use in infected cases; may cause    Helistat and Helitene; Instat
                                               foreign body reaction if not removed;
                                               adhesion formation


                        Oxidized Regenerated   Swelling (do not use in confined areas);   Surgicel, Surgicel Fibrillar,
                        Cellulose              do not use in infected cases; may cause    and Nu-Knit
                                               foreign body reaction if not removed;
                                               adhesion formation


                        Polysaccharide         Swelling (do not use in confined areas);   Arista
                        Spheres                no demonstrated safety studies in
                                               neurologic, urologic and ophthalmic
                                               surgery; should not be injected
            Hemostatic Agents in the OR: Are You
                      Providing Safe Care?
Current products -ACTIVES
CATEGORY   ACTION      COMPOSITION/ORIGIN     CLINICAL CONSIDERATIONS                      COMMERCIAL NAME




Actives    Localized   Bovine Thrombin        Should not be used for patients with         Thrombin
           and                                bovine allergies; can stimulate Antigen
           Diffuse                            formation and interrupt clotting cascade ;
           Bleeding                           potential for infection transmission; has
                                              Black Box Warning

                       Pooled Human           Swelling risk; Do not use in patients with   Evithrom
                       Thrombin               allergies to Human blood products;
                                              unknown potential for infection
                                              transmission and interruption of clotting
                                              cascade

                                              Commercially manufactured; to date           Recothrom
                       Recombinant Thrombin   clinical studies have not demonstrated
                                              this product has produced antigens or
                                              impacted clotting cascade
      Hemostatic Agents in the OR: Are You
          Providing Safe Care?

      Current Products -FLOWABLES
CATEGORY    ACTION      COMPOSITION/ORIGIN         CLINICAL CONSIDERATIONS                    COMMERCIAL
                                                                                              NAME

Flowables   Localized   Bovine Gelatin and Human   Should not be used for patients with       Floseal
            bleeding    Thrombin                   bovine allergies; swelling risk –
                                                   approved for use in all specialties
                                                   EXCEPT Ophthalmology; absorption 6-
                                                   8 weeks; not to be used with blood
                                                   Salvage devices or Cardio-pulmonary
                                                   Bypass circuits; potential for infection
                                                   transmission

                        Porcine Gelatin            Swelling risk; absorption in 4-6 weeks.    Surgiflo
                        with/without Thrombin      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
     Hemostatic Agents in the OR: Are You Providing Safe Care?

Current Products –Fibrin Sealants
      CATEGORY   ACTION      COMPOSITION/       CLINICAL CONSIDERATIONS                           COMMERCIAL
                             ORIGIN                                                               NAME


      Fibrin     Localized   Human Plasma-      2 component hemostat & sealant –contains          Tisseal
      Sealants   and         Derived Fibrin     pooled human plasma fibrinogen and &              Evicel
                 Diffuse     Sealant            thrombin – doesn’t need active bleeding or        Crosseal
                 Bleeding                       blood –derived fibrinogen for activation - do
                                                not to use with Blood Salvage devices or CP-
                                                Bypass circuits; potential concerns infection
                             Patient ‘s Own     transmission, air embolus, tissue rupture and
                             Plasma with        gas entrapment.                                   Vitagel
                             Bovine             Systems differ in terms of storage and
                             Collagen/Throm     application. Potential concerns –do not use in
                             bin                patients with Bovine allergies, infection/
                                                foreign body reaction/swelling/tissue
                             Patient ‘s Own     compression ; immunologic and coagulation
                             Plasma to create   complications.                                    Cryoseal
                             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 anti-
                                                flammatory agent use (48 hrs); adjunct for
                                                liver resection surgery; studies indicate clot
                                                stability and Fibrinogen less effective than
                                                commercially prepared products
           Hemostatic Agents in the OR: Are You Providing Safe Care?

           Current Products –Peg Polymers ,Cyanoacrylates,
                          Glutaraldehydes
CATEGORY          ACTION            COMPOSITION      CLINICAL CONSIDERATIONS                 COMMERCIAL NAME
                                    /ORIGIN
Peg Polymers      Two synthetic     Polyethylene     Can prevent pericardial adhesions;      Coseal
                  polymers that     glycol           good agent for vascular
                  mix and cross     hydrogels        reconstructions; does not cause
                  link at the                        inflammation; infection risks
                  wound site                         minimal; should not be used in closed
                                                     spaces because of swelling risk

Cyanoacrylates    Monomers form     Liquid           Used as a replacement for sutures       Dermabond
                  polymers in       monomers         primarily on facial, extremity and      Indermil
                  presence of                        torso wounds; attains strength of
                  water and                          healed tissue after 7 days
                  serves to glue
                  surfaces
                  together
Glutaraldehydes   Achieves 65%      Glutaraldehyde   Commonly used in vascular               Bioglue
                  binding power     cross linked     procedures for sealing holes around
                  in 20 sec; full   with bovine      staple lines; good agent for arterial
                  strength in 2     albumin          bleeds; hyper-sensitivity a concern;
                  min regardless                     inert substance that is NEVER
                  of temperature                     absorbed
                  /air /water
            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

      CATEGO
     RY                            CLASS                        PRODUCT
MECHANICAL       Porcine Gelatin                  Gelfoam/Surgifoam Powder and
                                                  Sponge
                 Bovine Collagen                  Avitene, Helistat, Instat, Ultrafoam
                 Oxidized Regenerated Cellulose   Surgical, Surgicel Fibrillar, Nu-Knit

ACTIVE
                 Polysaccharide Spheres
                 Bovine Thrombin
                                                                        FDA
                                                  Arista, Hemostase, Vitasure
                                                  Thrombin – JMI
                 Pooled Human Thrombin                 FDA
                                                  Evithrom Approved Hemostats
                 Recombinant Thrombin             Recothrom
FLOWABLE         Bovine Gelatin & Pooled Human    Floseal.
                 Thrombin
                 Porcine Gelatin (+/- Thrombin)   Surgiflo
FIBRIN SEALANT   Pooled human Plasma              Tisseal, Evicel
                 Individual Human Plasma W        Vitagel
                 Bovine Collagen & Bovine
                 Thrombin                         Cryoseal
                 Individual Human Plasma
       Hemostatic Agents in the OR: Are You
              Providing Safe Care?

— FACTS TO CONSIDER

ü What is the origin of the product being used & what are the patient implications?

ü What clinical studies are there to support the application being considered

ü How easy is the product to use?

ü What benefits are there for this product?

ü What limitations are there for this product?

ü What does the product cost & does clinical outcomes justify this expense?

ü 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)



ü Iatrogenic medical condition resulting from exposure to non-human coagulation proteins
  (porcine and bovine) thrombin

ü Has been noted in all surgical specialties (Trauma)

ü True incidence unknown due largely to under reporting (2000)

ü Delayed onset – most often following surgical procedures where Bovine Thrombin used

ü Increased Morbidity and Mortality

ü Difficult to Diagnose and Manage

ü Is an AVOIDABLE complication
      Hemostatic Agents in the OR: Are You
             Providing Safe Care?

— IMMUNE-MEDIATED COAGULOPATHY (IMC)

ü 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
    Ø Understand the Risks and Benefits and Cost of Haemostatic
      Agents
    Ø Read the labels on the packaging including Black Box
      Warnings
    Ø Assessment is key for ALL patients – never assume that
      there have been no previous exposures
    Ø Educate yourself, your peers and your surgeons – stay
      current on published studies
    Ø 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.

				
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