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Transcript
The Use of the Hemobag®
to Improve Clinical Outcomes in
any Blood Management Program
Keith A. Samolyk CCP, LCP
Global Blood Resources LLC
WWW.MYBLOODFIRST.COM
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
2
What drives transfusion decisions?
6,980 CABG patients
Significant
association:
LVEDP, EF, LM stenosis, #
diseased vessels, lowest Hct
on CPB vs. adverse outcomes
Disease Variables (9%)
Surgeon (56%)
Hctlowest & death
IABP & return to CPB
No association:
Age, sex, BSA,
comorbidity score
Hctlowest and stroke
Patient Variables (35%) NNECDSG31998
Lowest Hct on CPB vs Adverse Outcomes
6,980 CABG patients
5
Adjusted Mortality
Significant association
Hctlowest & death
IABP & return to CPB
No association
Hctlowest & stroke
4
3
2
1
0
<19
19-20
21-22
23-24
>25
Lowest Hct on CPB
NNECDSG(Defoe 42000)
Managing anemia with transfusion
after CPB increases mortality
10,178 CABG patients
If Hct < 22% & raised with
transfusion...
Mortality directly
influenced by
transfusion
8
7
6
5
<21
>21
4
3
2
1
0
<22
22-24 24-26
>26
5
NNECDSG
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.
6
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
7
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
8
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
It’s not just ECC that contributes to hemodilution
9
Average Circuit Volume is ~ 1200–1600mL
Retrograde Auto Priming for free can
reduce circuit prime volume to ~ 500–800 mL or less
while maintaining a safe and trusted circuit
helping to eliminate hemodilution
How else can we reverse Hemodilution ?
10
Answer: Hemoconcentraters
11
Positive Effects of Ultrafiltration/Hemoconcentration
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.12UK
Benefits of MUF
MUF 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
13
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
14
How does it happen?
15
16
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)
17
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
18
19
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
20
Naik, 1991, Hospital for the Sick, Great Ormond St. UK
A New Technology for
Blood Management is the
HEMOBAG®
A Universal Blood Reservoir for
Salvaging Autologous Whole Blood
from ECC’s
Specially designed for quickly
Filling
Hemoconcentrating
Transfusing
All in the same Hemobag®
Doubles use of any Hemoconcentrator
TS3 Tubing Set doubles the use of
any Hemoconcentrator
For use both during the case
22
And at the end of the case for
Whole Blood Salvaging of the ECC Circuit
23
HEMOBAG®® SUMMARY
HEMOBAG SUMMARY
24
“Your Body Your Choice” pg. 26, S.Farmer and D. Webb
25
The Big Picture
Choices/ Alternatives Publication Vol 4 Issue 2, Center for Bloodless Medicine and Surgery, University of Miami / Jackson Med Ctr.26
Salvaged Blood with a Cell Saver
27
Blood Salvaged with the Hemobag®
Everything that’s Autologous is
Concentrated and given back
for stability and Homeostasis
28
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)
Pre- and Post- Hemobag Blood Components
Average change in blood parameters:
Pre-Hemobag
HCT
21.4%
Total Protein
2.6 g/dL
Fibrinogen
92 mg/dL
Platelet Conc. 186 K/uL
Post-Hemobag
53.1%
8.2 g/dL
305.8 mg/dL
266 K/uL
Pre-Hemobag
305.8
Post-Hemobag
266
186
53.1
21.4
Hct 1%
2.6
8.2
92
Total Protein2 g/dl Fibrinogen mg/dl
3
Platelet Count4 K/ul
Salem Hospital, Salem Oregon
29
Ave. volume returned = 820 mL
FLAGSHIP CASE #1:Over 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
Change in Blood Parameters
Patient
740
800
700
600
500
400
300
200
100
0
364
221
155
57
23
Plt. Ct. k/cumm
Time: 12 minutes
Extracorporeal circuit kept
viable & ready to go back
emergently
Results represent what is
possible with the
Hemobag®
Hemobag
Fibrinogen mg/dl
HCT %
Change in Protein Levels
15
10
5
0
Albumin gm/dl
Total Protein gm/dl
Patient
2.3
4
Hemobag
6.6
11.7
30
FLAGSHIP CASE #2:60 yr old CABG x 3, post-op bleeding was
290 mL, left ICU on Post-op Day #1, no blood products given
Change in Blood Parameters
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%
Patient
972
1000
800
600
430
400
292
241
200
26
56
0
Plt. Ct. k/cumm Fibrinogen mg/dl
HCT %
Change in Protein Levels
15
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
Hemobag
10
5
0
Albumin gm/dl
Total Protein gm/dl
Patient
2.1
4.1
Hemobag
5.7
13.6
31
Both the Hemobag® and TS3 tubing set come
5 to a box and are sold together
32
Sterile Peel Pouches
33
Easy to Understand Directions
34
Benefits Overview
CELL SAVER
VS
HEMOBAG®
If you were the patient wouldn’t you want all your own
AUTOLOGOUS CELLS back first?
35
Conclusion about the Hemobag®
The Hemobag® system effectively
Concentrates Extracorporeal Circuit contents
Produces Autologous Whole Blood
high in RBC’s 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”
36
Bottom Line
Life is related to blood and anything you can do to save more of a
patient’s 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
It’s in the Patient’s Best Interest - It’s the Right of all Patients
37
Thank You for listening !
Global Blood Resources LLC
WWW.MYBLOODFIRST.COM
WWW.HEMOBAG.COM
38