The Use of the Hemobag

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The Use of the Hemobagto Improve
Clinical Outcomes in any Blood Management Program

• Keith A. Samolyk CCP, LCP
• Global Blood Resources LLC
• WWW.MYBLOODFIRST.COM

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Roadmap

• Factors affecting transfusion decisions
• Blood conservation techniques
• Ways to reverse hemodilution
• Ultrafiltration / Hemoconcentration
• The Hemobag how it works
• Clinical trial of the Hemobag
• Flagship cases

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What drives transfusion decisions?
LVEDP, EF, LM stenosis, diseased vessels,
lowest Hct on CPB vs. adverse outcomes

• 6,980 CABG patients
• Significant association
• Hctlowest death
• IABP return to CPB
• No association
• Hctlowest and stroke

Disease Variables (9)
Surgeon (56)
Age, sex, BSA, comorbidity score
Patient Variables (35)
NNECDSG 1998
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Lowest Hct on CPB vs Adverse Outcomes6,980 CABG
patients

• Significant association
• Hctlowest death
• IABP return to CPB
• No association
• Hctlowest stroke

Adjusted Mortality
Lowest Hct on CPB
NNECDSG(Defoe 2000)
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Managing anemia with transfusion after CPB
increases mortality10,178 CABG patients

• If Hct lt 22 raised with transfusion...
• Mortality directly influenced by transfusion

NNECDSG
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Minimum Accepted Hematocrit Levels

• During ECC
• 18- 21 normal risk patients
• 21- 25 high-risk patients during bypass
• Post-Operatively
• Adequate oxygen delivery decreases morbidity
  mortality
• 22-25 normal risk patients
• 25-30 high-risk patients
• Jehovah's Witness patients
• Remarkable tolerance of severe acute normovolemic
  anemia
• Tight adherence to specific guideline
• Most cases can be performed without using
  allogeneic blood and a HCT above min.

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Typical Blood Conservation Techniques Used Today

• Acute Normovolemic Hemodilution (ANH)
• Hemodilution with crystalloid solutions
• Intraoperative Autologous Donation (IAD)
• Cell Saver for Shed Blood and Conservation
• Apheresis / Platelet Gel / PRP
• Ultrafiltration (Hemoconcentration), Hemobag
• Autotransfusion of unprocessed Shed Blood
• from chest tube collection drains

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Blood Conservation Techniques for ECC

• Minimize circuit prime by
• Condensing circuit to accommodate priming volume
  of 1100 mL 1400 mL
• Smaller volume increases risk of micro-air, poor
  air handling qualities, and less reaction time
• Retrograde Autologous Prime (RAP)
• Displace crystalloid prime with patients own
  whole blood
• slow controlled exsanguination (1000 mL or more)
• team support of Anesthesia
• short acting vasoconstrictors like Neosynepherine
  
• Can be done for free and is very cost effective
• Closed Biocompatible/Heparin Coated Systems/SMC
• Reduce surface activation of blood
• Air is foreign surface

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Anesthesia may give 1-4 L perioperatively For
every 1L of crystalloid given only 250 mL remain
intravascular

• Total Body Water Increase leads to
• Tissue edema cellular/organ dysfunction
• Prolonged ventilatory support
• Pulmonary hypertension
• Decreased lung compliance
• Coagulopathy

Its not just ECC that contributes to hemodilution
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Average Circuit Volume is 12001600mL

• Retrograde Auto Priming for free can
• reduce circuit prime volume to 500800 mL or
  less
• while maintaining a safe and trusted circuit
• helping to eliminate hemodilution
• How else can we reverse Hemodilution ?

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Answer Hemoconcentraters
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Positive Effects of Ultrafiltration/Hemoconcentrat
ion

• Removes noncellular H20
• Decreases total body H20
• ? concentrating WB
• Increases
• Hct
• platelets clotting factors
• albumin plasma proteins
• Removes cytokines anaphylatoxins
• C3a, C5a
• IL6, IL8, TNF-A
• ET-1, bradykinins
• adhesion molecules
• sE-Selectin

• Improves organ fcn
• myocardial fcn
• cerebral oxygenation
• pulmonary compliance
• Reduces post-op blood loss
• ? reduces transfusions
• Reduces perioperative morbidity

Naik, 1991, Hospital for the Sick, Great Ormond
St. UK
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Benefits of MUFMUF increases

• Post CPB Hct
• Systolic and diastolic pressure
• Cardiac Index
• Myocardial contractility
• Red cell mass

• Pulmonary compliance
• Arterial oxygenation
• Cerebral oxygenation
• Left ventricular function
• Diastolic compliance
• Plasma proteins

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Ultrafiltration combats Hemodilution MUF decreases

• Heart rate PVR
• Myocardial wall thickness
• Pulmonary hypertension
• Incidence of effusions
• Intrapulmonary shunt fraction

• 24 hr blood loss
• Inotrope requirement
• Blood product usage
• TBW content
• Hospital stay

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How does it happen?
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Capillary "Type"
Permeability varies with type of
capillary Capillary type varies with organ
function 1. Tight (brain) 2. Continuous
(skeletal muscle, skin) 3. Fenestrated
(secretory glands, kidney, gut) 4. Discontinuous
(liver, spleen, bone marrow)
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Edema Most common clinical manifestation of an
imbalance of forces at the capillary wall

• Excess accumulation of fluid in the interstitial
  space that has not been readsorbed into
  capillaries or taken up by the lymphatics
• Causes include
• Obstruction
• Permeability or change in reflection coefficient
• Increased protein permeability results in an
  imbalance
• Occurs in trauma, thermal injury, inflammation
• Life threatening manifestations - endotoxic
  shock, ARDS
• Plasma Protein
• Reduction in circulating plasma proteins,
  especially albumin
• Liver dysfunction, malnutrition, or acute
  alteration of fluid status
• Albumin attenuates extravasation of fluid out of
  intravascular space to interstitial space
• Capillary pressure

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How can we get these positive effects of
HEMOCONCENTRATION?

• Removes noncellular H20
• Decreases total body H20
• ? concentrating WB
• Increases
• Hct
• Platelets clotting factors
• Albumin plasma proteins
• Removes cytokines anaphylatoxins

• Improves organ fcn
• myocardial fcn
• cerebral oxygenation
• pulmonary compliance
• Reduces post-op blood loss ? reduces transfusions
  
• Reduces perioperative morbidity

Naik, 1991, Hospital for the Sick, Great Ormond
St. UK
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A New Technology for Blood Management is the
HEMOBAG

• A Universal Blood Reservoir for
• Salvaging Autologous Whole Blood
• from ECCs
• Specially designed for quickly
• Filling
• Hemoconcentrating
• Transfusing
• All in the same Hemobag
• Doubles use of any Hemoconcentrator

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TS3 Tubing Set doubles the use of any
Hemoconcentrator
For use both during the case
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And at the end of the case forWhole Blood
Salvaging of the ECC Circuit
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HEMOBAG SUMMARY
HEMOBAG SUMMARY
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Your Body Your Choice pg. 26, S.Farmer and D.
Webb
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The Big Picture
Choices/ Alternatives Publication Vol 4 Issue 2,
Center for Bloodless Medicine and Surgery,
University of Miami / Jackson Med Ctr.
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Salvaged Blood with a Cell Saver
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Blood Salvaged with the Hemobag
Everything thats Autologous is Concentrated and
given back for stability and Homeostasis
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Data from 40 Patients ECCs chased with 2.0 L of
crystalloid filling the Hemobag

• Average time to
• Fill the Hemobag 60 sec /- 20 sec
• Hemoconcentrate contents of the Hemobag (2L?1L)
• 10.5 min /- 1 min (total 11.5 min /- 80 sec)

Average change in blood parameters
Pre-Hemobag Post-Hemobag HCT
21.4 53.1 Total
Protein 2.6 g/dL 8.2 g/dL
Fibrinogen 92 mg/dL 305.8
mg/dL Platelet Conc. 186 K/uL 266
K/uL
Salem Hospital, Salem Oregon
Ave. volume returned 820 mL
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FLAGSHIP CASE 1Over 80y/o female, AVR case,
post-op bleeding 300mL, left ICU post-op Day
1, no blood products given

• Reinfused 900 mL Conc. Autologous Whole Blood
  from CPB circuit with
• Hct 57
• Platelets 364 K
• Fibrinogen 740 mg
• Albumin 6.6 g/dL
• Total protein 11.7 g/dL
• Time 12 minutes
• Extracorporeal circuit kept viable ready to go
  back emergently

Results represent what is possible with the
Hemobag
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FLAGSHIP CASE 260 yr old CABG x 3, post-op
bleeding was 290 mL, left ICU on Post-op Day 1,
no blood products given

• Reinfused 1150 mL Conc. Autologous Whole Blood
  from CPB circuit with
• Hct 56
• Platelets 430 K
• Fibrinogen 972 mg
• Albumin 5.7 g/dL
• Total protein 13.6 g/dL
• 300 increase in FVII
• 73 activity to 223
• Time 10 minutes
• Extracorporeal circuit kept viable ready to go
  back

Illustrates capabilities of the Hemobag when
used for Whole Blood Salvaging in CV Surgery
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Both the Hemobag and TS3 tubing set come 5 to a
box and are sold together
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Sterile Peel Pouches
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Easy to Understand Directions
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Benefits Overview
CELL SAVER
HEMOBAG
VS
If you were the patient wouldnt you want all
your own AUTOLOGOUS CELLS back first?
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Conclusion about the Hemobag

• The Hemobag system effectively
• Concentrates Extracorporeal Circuit contents
• Produces Autologous Whole Blood
• high in RBCs and plasma proteins
• Offers advantages over current technology
• quick, easy, enhanced end product
• The Hemobag is the Missing Piece
• in the Big Picture of
• Blood Salvaging and Conservation

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Bottom Line

• Life is related to blood and anything you can do
  to save more of a patients Own Whole Blood is
  better than anything else Period !
• Patients transfused with allogeneic blood
  products are exposed to a host of new potential
  complications
• No one is exempt from resultant immunosuppression
• The least of these is a mild form of TRALI which
  leads to
• longer and delayed time to extubation discharge
  from the ICU
• increased risk of Morbidity and Mortality
• Autologous whole blood is jugular for perfect
  natural homeostasis
• We should be doing everything we can to conserve
  more of this precious substance
• Its in the Patients Best Interest - Its the
  Right of all Patients

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Thank You for listening !Global Blood Resources
LLC
WWW.MYBLOODFIRST.COM WWW.HEMOBAG.COM