PowerPoint Presentation (PDF) - Perfusion.com

Complete Surface
Modification:
Why bother and is it possible?
Kevin McCusker PhD, CCP
Assistant Professor
New York Medical College
Serdar Gunaydin MD, PhD
Professor
University of Kirikkale

Modified Extracorporeal
Circuits to Attenuate SIRS:
Everything is possible?
Kevin McCusker PhD, CCP
Assistant Professor
New York Medical College
Serdar Gunaydin MD, PhD
Professor
University of Kirikkale

NO Sour Faces!

177 cm, 60 Kg
Marathon Runner
Healthy lifestyle promoter
Died MI, age 52 (while running)
Father died MI age 43
172 cm, 122 Kg
Slothful
Legendary gluttony
Smoker
Died age 90

Are We Evolving ?

Factor XII
Kinin
Generation
Angiotensin
System
Complement
System
Inflammatory Response
Factor XIIa
HMW-Kininogen
Bradykinin
Prorenin
Renin
C 1
Prekallikrein
Kallikrein
_
C 1
Plasminogen
Factor XII
Factor XIIa
Factor XI
Factor XIa
Plasmin
Coagulation
System
Fibrinolytic
System

BACKGROUND
• The continuous interaction of blood with artificial contact
surfaces used in CPB leads to substantial damage of cells
and plasma proteins, the release of various inflammatory
cytokines and activation of coagulation and fibrinolytic
systems
• To diminish the negative side-effects of the contact of
blood to foreign surfaces, coating techniques have been
developed
• Hemo-biocompatibility, cellular and protein conservation
are among the most important issues in recent research

BACKGROUND-2
• New Advancements: polymer strain
developed for use in CPB by polymerizing
the monomer
• Backbone is hydrophobic and pendant
groups having mild hydrophilicity with no
chemical functioning groups.
• Outer side of the molecule is inactive
chemically, its surface would have little
tendency to react with blood components

BACKGROUND-3
• Biocompatible and high performance of coated
circuits with clear advantages were demonstrated
by in vitro and ex vivo experiments, applying very
unique technology :
- blocks initiation of platelet adhesion and clot
activating factors
- reduces adsorption and degeneration of proteins
- minimizes attachment of cells in the oxygenator,
tubing and filters
- Low toxicity and leaching

Biological Response to
Implanted Materials in Blood
Red blood
cell
Protein
adsorption
Platelet
adhesion
Fibrin and
thrombus
formation
Material
surface
Platelet
Fibrin

COATING TECHNOLOGY
• 1250 A.D. „De Proprietatibus Rerum‟
(Properties of Things: Surface preparations for metal-metal
bonding)
• 18th Century: Dobereiner, Faraday
(Surface-induced catalysis)
• 1922: J Loeb
(Proteins and Theory of Colloidal Behaviour)
• 1946: Langmuir
(Molecular Films, The Cyclotron & the New Biology)
• 1963: Gott
(Heparin Surface Coating)

Recent advances in
biocompatible surface-modifying
additives for cardiopulmonary
bypass
K. McCusker PhD, CCP
V. Vijay M.D
S. Gunaydin MD, PhD
Perfusion 2003

How does PMEA
work?
Water in blood
collects at
coating’s
hydrophilic
interface
Blood exposed to
“friendlier” surface,
not the raw plastics
or metals

How does PMEA work?
Proteins are not
denatured
Platelet
adhesion on
surface is
minimized

Heparin-Immobilized
Surfaces
• Biocompatible
• Non-leaching
• Bi-polymer Coating with Heparin
• FDA Clearance

CURRENT COATING TECHNOLOGIES
HEPARIN
POLYMER
POLYMER BASED HEPARIN BONDED

Trillium Biopassive Surface

HEPARIN COATING
• Heparin-coated circuits have improved
biocompatibility
• Decreased inflammatory response to CPB
BUT…..
• Thrombogenesis is not reduced
• Complete systemic heparinization should be
maintained to avoid complications secondary to the
activation of coagulation
• Cost-effective ?

HYALURONAN
• About 1-10% of the cartilage
glycosaminoglycans is hyaluronan
• It is widely distributed in other
tissues, e.g. skin, eye, and in most, if
not all, body liquids
• The term hyaluronan has lately
substituted the terms hyaluronic
acid and hyaluronate
• Its structure is the simplest of all
glycosaminoglycans
• Hyaluronan is used in medical
applications for its unique
physical/chemical properties. It is
very hydrophilic; its viscous
solutions have most unusual
rheological properties and are
exceedingly lubricious

GBS TM (GISH Biocompatibile Surfaces) Coating
• GBS TM coating is
a heparin based,
covalently bond,
biocompatibile
coating.
• Hyaluronan
exhibits both
hydrophilic and
hydrophobic
properties
Sorin
Hyaluranon groups
Heparin groups

Rheological Properties
In solution , the very large linear polymer chains takes on the form of
expanded random coils and these chains entangle with each other at very
low concentrations which may contribute to the unusual rheological
properties (pseudoplastic)
Lubricity
There is evidence that hyaluronan separates most tissue surfaces that slide
along each other. Solutions of hyaluronan are extremely lubricious and
have been shown to reduce postoperative adhesion formation following
surgery
Hydrophilicity
HYALURONAN
The polymer takes up a stiffened helical configuration attributed to
hydrogen bonding between the hydroxyl groups along the chain, forming a
coil structure that traps water approximately 1000 times its weight in water

Clinical Performance and
Biocompatibility of Novel
Hyaluronan-Based Extracorporeal
Circuits
S Gunaydin MD, PhD
K McCusker PhD, CCP
V.Vijay MD
Journal Extra-Corporeal Technology
2005 Sept.37 (3): 290 – 295.

SOFTLINE
WHERE DID SOFTLINE COME FROM?
– Based on Glycerol-Polyethylenglycol-
Rizinoleat (GPR)
– GPR is used as an excipient in the
pharmaceutical industries for many years
– GPR is pharmacological absolute harmless
(expert testimony from 3rd party)

SOFTLINE
HOW DOES IT WORK?
– Adhesion to surface via intra-molecule interaction of
the lipophilic part (van-der-Waals-Forces)
– Hydrophilic part directed to the blood
– GPR is watersoluble
– No active interaction with physiological processes
(biologically inert)
– Physicochemical modification of surface properties
(improved hydrophilicity)
– Reduced protein adsorption and protein denaturation
– Reduced cell adsorption and cell activation

SOFTLINE
WHAT ARE THE EFFECTS OF COATING?
– Immobilization of water from the contacting aqueous
fluids
– Adsorbed water in addition with the coating substance
acts as a steric hindering*
– Original surface of the device is not reachable for blood
components
– The “Soft”, hydrated surface reduces protein
denaturation and cell activation.
(*) A steric hindrance occurs when the sizes of groups
within a molecule prevents chemical reactions observed
in related smaller molecules.

SOFTLINE ATTRIBUTES
– Hydrophilic
– Full synthetic
– Heparin FREE
– No use of human or animal derived substances in the
coating
– Waterbased coating process

METHODS
In a six-month period, 100 patients (EuroScore 6+ ) were prospectively
randomized to one of the two perfusion protocols (N=50)
‣ Group 1: Glycerol-polyethylenglycol-rizinoleat (GPR) coating
(Softline, Quadrox-i®, Maquet, Germany)
‣ Group 2: Control
(VKMO 4200, Maquet, Germany)
The primary endpoints of this study were to evaluate the qualified
comfort and safety level of ECC in high risk CABG cases
Secondary endpoints were to document any differences in contact
activation- inflammatory response, hemolysis, hemodilution,
myocardial protection and clinical outcome

EuroSCORE
Age (years)
PARAMETERS
SCORE
Female sex 1
Chronic pulmonary disease 1
Extracardiac arteriopathy
(carotid occlusion >50%, claudication)
Neurologic dysfunction 2
Previous cardiac surgery 3
Serum creatinine >200 µmol/L 2
Critical preoperative state b 3
Unstable angina 2
Left ventricular dysfunction
EF 30-50%
EF

THE MAST SYSTEM
A NEW CONDENSED BYPASS CIRCUIT FOR
ADULT CARDIAC SURGERY
McCusker K PhD. CCP, Vijay V M.D
DeBois W CCP, Sisto D M.D
Perfusion 2001; 16: 447-452
*United States Patent Issued
www.USPTO.GOV

Clinical Outcomes of
Complete X-Coating Circuit
in
MAST Condensed Bypass Setting
McCusker, Vijay, Gunaydin, DeBois, Helm, Sisto
Journal of Extra-corporeal Technology. 2002: 34

QUEST for ULTIMATE BYPASS

“PINNACLE” SYSTEM
Our novel condensed design
is aimed to provide a perfusion
circuit that minimizes priming
volume and to prevent air from
being pumped through the
circuit in the event of cannulae
or tubing kinks
It also provides a combined
perfusion and cardioplegia
circuit which no priming liquid
is circulated
The way the hard shell
reservoir is included in the
present set-up enables easy
switching from a closed system
with augmented venous
drainage to an open system.

“PINNACLE” SYSTEM
The International Journal of Artificial Organs
Artificial Heart and Cardiac Assist Devices
Vol. 32/ no. 11, 2010/pp 212-221

COMPARISON OF OPEN AND CLOSED
EXTRACORPOREAL CIRCUITS IN
HIGH RISK CORONARY
REVASCULARIZATION
Impact on air handling, inflammation,
hemodilution & myocardial function
Serdar Gunaydin MD, PhD
University of K.Kale
Ankara, Turkey
Kevin McCusker CCP, PhD
New York Medical College
Portsmouth Regional Hospital

Air Handling
The Emboli Detection and Classification
(EDAC®) QUANTIFIER employs
ultrasound technology to detect individual
gaseous microemboli in blood flowing
through an extracorporeal circuit
The unit has demonstrated count rates
exceeding 1000 emboli/sec, with
diameters from 10 microns to the
connector diameter, and with flow rates
between 2.0 L/minute and 6.0 L/minute
Three sensors were placed
- venous inlet
- in between bubble trap and oxygenator
- on arterial line after arterial filter
Statistical evaluation was done on overall
data obtained at T3 (on-CPB) and T4 (off-
CPB)

Perioperative Regional Cerebral
Oxygen Saturation (rSO2)
Near infrared monitoring utilized the INVOS 4100 cerebral oximeter
(Somanetics Corp, Troy, MI, USA)
This measure is a weighted average of both mixed arterial and venous
oxygen saturations in the cerebral cortex
rSO 2 values were automatically collected every 30 sec on an internal
clock and stored as a Microsoft Excel file
Data were then retrospectively collected, averaged, and synchronized
with pump and EDAC records

BIOMATERIAL EVALUATION
Hollow fiber specimens were collected by a specific saw
(Proxxon, Germany) under sterile conditions for
further laboratory research- microscopic & analytic
techniques
• Blood cells adsorption analysis
• Adhesion & aggregation of blood cells
• Total protein, albumin & fibrinogen adhesion tests
• Blood protein adsorption analysis by Spectrophotometry
• Evaluation of fiber contents under Scanning & Tunneling
Electron Microscopy (STM)

PMEA, Fiber, 2000X

Hyaluronan, Fiber, 2000X

Softline, Fiber, 2000X

SEM
SOFTLINE
CONTROL

RESULTS-Microscopy-Platelet /
Uncoated

RESULTS: Microscopy-Platelet / Coated

Polypropylene exposed to flowing human blood
(2 hours @ 2ml/min)
Control PP
Coated PP

Polycarbonate exposed to flowing human blood
(2 hours @ 2ml/min)
Control PC
Coated PC

Scanning Electron Micrographs of
Extracorporeal Circuits after 4 h without
Heparinization
Control circuit
Softline circuit
Both circuit segments are from the entry point into the centrifugal pump.

RESULTS- SCANNING AND
TUNNELING ELECTRON
MICROSCOPY
• No protein structures could be
observed in coated fiber surfaces
• Albumin was demonstrated in
uncoated fibers, confirming
biochemical data

RESULTS- SCANNING AND
TUNNELING ELECTRON
MICROSCOPY
a) X-ray model of albumin b) STM image of albumin
c) STM image of albumin (uncoated oxygenator)

Fiber Comparison after 6 hours
of Extracorporeal Circulation
Coated Oxygenator
Uncoated Oxygenator
ACT = 180 seconds
Porcine Model

RESULTS-BIOMATERIAL
PLATELET ADHESION
COATED UNCOATED
Platelet adhesion & aggregation were significantly lower
in coated based group with respect to control

RESULTS-BIOMATERIAL
Scanning Electron Microscopy /Circuits
COATED
UNCOATED
Coated group demonstrated better surface preservation
with respect to control

RESULTS-BIOMATERIAL
Scanning Electron Microscopy /Fibers X150
COATED
UNCOATED

RESULTS-BIOMATERIAL
Scanning Electron Microscopy /Fibers x600
COATED
UNCOATED

PERIOPERATIVE EVALUATION
PARAMETERS
•Hemodynamic parameters
HR, MAP, CVP, PAP, CO, CI
•Biochemical Analysis
• Standard blood biochemistry (total protein & albumin)
• Arterial blood gases
• Serum interleukin (IL)-2 levels
•Biocompatibility & Hematologic Assesment
ACT, CBC, PT, fibrinogen, enzyme-linked C3a levels
•CPB Performance
O 2 transfer rate & pressure drop at different flow rates
•Thromboelastography (TEG)

PERIOPERATIVE EVALUATION
• T1: Following induction of anaesthesia (before
administration of heparin)
• T2: 15 min. following initiation of CPB
• T3: Before cessation of CPB
• T4: 15 min. following reversal with protamine
• T5: Postoperative first day (ICU)

PERIOPERATIVE EVALUATION
• Duration of CPB (t-CPB), x-clamp (t-x-clamp) and time
until extubation (t-intubation)
• Hemorrhage (mL)
• Use of blood & blood products (unit)
• Arrhythmia
• CO and CI
• Inotropic support
• ICU stay
• Incidence of complication & infection
• NYHA Class
• EF by Doppler echocardiography
• Hospital stay
• Mortality rate

WBC COUNT (/mm3)
RESULTS- Hematologic Data: WBC
18000
16000
14000
12000
10000
8000
6000
4000
2000
0
* *
BASELINE ON-CPB OFF-CPB PROTAMINE ICU
COATED
UNCOATED

PLATELET COUNT (/MM3)
RESULTS- Hematologic Data:
Platelet Count (1000/mm 3 )
350
300
250
200
150
COATED
UNCOATED
100
50
* * *
0
BASELINE ON-CPB OFF-CPB PROTAMINE ICU

FIBRINOGEN LEVELS (mg/dl)
RESULTS- Hematologic Data:
Fibrinogen
3
2,5
2
1,5
1
0,5
*
*
COATED
UNCOATED
0
BASELINE
ON-CPB
OFF-CPB
PROTAMINE
ICU

C4-d Levels (ng/ml)
RESULTS: C4d-LEVELS
0,6
0,5
0,4
0,3
0,2
0,1
0
* *
Baseline On-CPB Off-CPB Protamine ICU
COATED
UNCOATED

SERUM IL-6 LEVELS (pg/ml)
RESULTS: Serum Interleukin-6 levels
Bender Medsystems, CV10%, Sensitivity1.4
pg/ml)
250
200
150
100
*
50
0
-50
BASELINE ON-CPB OFF-CPB PROTAMINE ICU
COATED
UNCOATED

C3a LEVELS (ng/ml)
RESULTS-C3a LEVELS
5
4
3
2
1
0
*
Baseline On-CPB Off-CPB Protamine ICU
*
COATED
UNCOATED

CONCLUSION
‣Comfort and safety level of novel GPR
coated circuits were satisfactory in high
risk CABG cases vs. conventional
controls
‣Novel GPR coated circuits provided a
better perioperative outcome versus
controls via attenuated inflammatory
response, reduced platelet adhesionaggregation
and protein adsorption in
patients undergoing high-risk CABG

NO Production: Endothelial Cells
Blood Vessel
Interior
Red Blood Cell
Vascular
Endothelial Cell
Smooth
Muscle Cell
Platelet
N O S
L - A r g i n i n e
+
O 2 / N A D P H
N O S
G T P
F e
G C
NO
C i t r u l l i n e
+
N A D P +
N O c G M P
P P i
[ C a 2 + ] d e c r .
surface flux:
1 x 10 -10 mol/cm 2 min
NOS : Nitric Oxide Synthase

Nitric Oxide Releasing/Generating Polymers:
Preparation, Characterization and
Biomedical Applications
NO
NO
NO
Red blood cell
Polymer
NO
NO
Platelet

Nitric Oxide Release Polymer Coatings for
Extracorporeal Circuits
pump
oxygenator
Applications:
•Extracorporeal Oxygenation
•Cardiopulmonary Bypass
•Hemodialysis
•Liver Support Systems

BIG “BANG”
OPCAB
MICAB
MIVR
Minimized ECC
Percutaneous Interventions
Robotics
Physiological CPB

1. McCusker K, Gunaydin S, Sari T, Vijay V, Aydin H, Farsak B, Yorgancioglu C, Sargon M, Kirazli S,
Kocakulak M, Akcelik O, Ozisik K, Tezcaner T, Zorlutuna Y. Clinical evaluation of strategic
leukofiltration with surface modification: Enhanced preservation or fantasy. Filtration 2005, 1(1):47-58
2. McCusker K, Gunaydin S, Vijay V. Strategic leukofiltration in cardiac surgery-Review. Curr Med Chem-
Cardiovascular&Hematologic Agents 2005,3:323-331
3. Gunaydin S, McCusker K, Vijay V, Sari T, Sargon MF, Onur MA, Kocakulak M, Gurpinar A, Tezcaner T,
Zorlutuna Y. Clinical Significance of Strategic Leukocyte filtration in different Risk Cohorts Undergoing
Cardiac Surgery. Filtration 2005, 1(2):95-106
4. Gunaydin S, McCusker K, Vijay V, Isbir S, Sari T, Onur MA, Gurpinar A, Sezgin A, Sargon MF,
Tezcaner T, Zorlutuna Y. Comparison of polymethoxyethylacrylate coated circuits with leukocyte filtration
and reduced heparinization protocol on heparin bonded circuits in different risk cohorts. Perfusion 2006;
21(6):329-342
5. K McCusker, S Gunaydin, V Vijay, T Sari, MF Sargon, MA Onur , A Gurpinar, A Sezgin, T Tezcaner, Y
Zorlutuna. Comparison of continuous and strategic leukofiltration in different risk cohorts undergoing
coronary revascularization. Filtration 2007 (in press)
6. S Gunaydin, K Ayrancioglu, E Dikmen, K Mccusker, V Vijay, T Sari, T Tezcaner, Y Zorlutuna. Clinical
effects of leukofiltration and surface modification on post-cardiopulmonary bypass atrial fibrillation in
different risk cohorts. Perfusion 2007 (in press)
7. T Gourlay, K McCusker, AH O-Yurvati, S Gunaydin. STS Blood Conservation Guidelines - The role of
leukocyte filtration. Ann Thorac Surg (in press)
8. Gunaydin S, Farsak B, Sari T, McCusker K, Vijay V, Yorgancioglu C, Tezcaner T, Zorlutuna Y.,
“Improved outcome in strategic leukofiltration with polymethoxyethylacrylate-coated extracorporeal
circuits”, 16th Annual Meeting of the Mediterranean Association of Caridology and Cardiac Surgery,
Bodrum, Turkey, Carden Jennings, B37, 2004
9. McCusker K, Gunaydin S, Vijay V, Isbir S, Sari T, Onur MA, Gurpinar A, Sezgin A, Sargon MF,
Tezcaner T, Zorlutuna Y. Comparison of novel therapeutic strategies for reducing complications of
cardiopulmonary bypass in different risk cohorts. American Academy of Cardiovascular Perfusion, Reno
(U.S.A.), 2006
10. K McCusker, S Gunaydin, K Ayrancioglu, E Dikmen, V Vijay, T Sari, T Tezcaner, Y Zorlutuna. Clinical
effects of leukofiltration and surface modification on post-cardiopulmonary bypass atrial fibrillation in
different risk cohorts. American Academy of Cardiovascular Perfusion, San Diego, Ca (U.S.A.), 2007
11. S Gunaydin, K McCusker, V Vijay, U Yildiz, T Tezcaner, Y Zorlutuna. Clinical evaluation of surface
coated extracorporeal circuits with leukocyte filtration, aprotinin and combined therapy as an adjunct to
cardiopulmonary bypass in high risk patients. Society of Thoracic Surgeons, San Diego, Ca (U.S.A.), 2007
12. Serdar Gunaydin, Kamil Ayrancioglu,Kevin Mccusker, Venkataramana Vijay, Tamer Sari,. Clinical
Outcome And Biocompatibility Of Leukocyte Filtration On Hyaluronan Based Heparin Bonded Circuits In
High Risk Patients. American Society of Extracoporeal Technology, Atlanta, 2007

DISCUSSION
Studies with similar objectives and
methods have often yielded
contradictory results which
suggest that the specific response
mechanisms of CPB may vary
between patients
The high standard of current CPB
systems has made it increasingly
difficult to test technical
improvements in clinical studies
involving relatively small patient
groups
In most cases, the statistical power
of such studies will not suffice to
show a significant clinical benefit
associated with changes in the
CPB circuit
The use of closed circuits may not have
their benefit revealed when applied to
patients without comorbidities, classified
in low-risk category
As with technological advances,
patients who benefit most will be those
who are in most need
Costs for incorporating technology are
reduced to the point that it becomes
standard of care for the conduct of CPB

Isolated Extra-Corporeal Perfusion
Circuit for Use During Off-Pump
Coronary Artery Bypass Grafting
McCusker K PhD, Gunaydin S MD PhD, Vijay V MD
Journal of ExtraCorporeal Technology.
2000: 32 -38

Porcine Retinal Angiography
Pre and Post Bypass using Control Circuit
Pre Bypass
Post Bypass

Porcine Retinal Angiography
Pre and Post Bypass using Condensed Circuit
Pre Bypass
Post Bypass

Blood: An Emotional Topic
―…the sweeping story of a
substance that has been feared,
revered, mythologized, and used
in magic and medicine from
earliest times—a substance that
has become the center of a huge,
secretive, and often dangerous
worldwide commerce.‖
—From the publisher’s description of the book
Starr D. Blood: An Epic History of Medicine and Commerce. New York, NY: HarperCollins
Publishers; 2000.

Blood Collection and Utilization
in the US*
~15 million units of whole blood and RBCs donated
29 million units of blood components transfused
Mean age of whole-blood–derived platelet units:
o 3.16 days at transfusion
o 3.08 days for an apheresis platelet unit
Average cost of RBC units increased by 30.8%
from 2002
135 hospitals canceled elective surgery on ≥1 days because of
blood inventory shortages
*2004 statistics
US Dept of Health and Human Services. The 2005 Nationwide Blood Collection and
Utilization Survey Report. Available at: http://portal.aabb.org/apps/docs/05nbcusrpt.pdf.
Accessed April 23, 2007.

We’re just starting….

QUESTIONS
Platelet Function ?
Decreased albumin?
- Albumin particles was demonstrated
in 80X80 nm area in 2 µl volume in
hollow fibers
- The contribution of Albumin
detached within the fibers for
biocompatibility ?
Hemodilution?
Protein denaturation ?
Heparin-coated circuits ?
Tip-to-tip coated circuits ?
Condensed circuits ?
Near-infrared Spectroscopy ?
Physiologic CPB?

Kevin McCusker PhD, CCP
Serdar Gunaydin M.D., PhD
kmccusker2@comcast.net

½, 3/8 or 9/16?

DESIGN OF THE IDEAL
EXTRACORPOREAL CIRCUIT
• Should not activate the
complement system
• Promote the reversible
adsorption of plasma
proteins to prevent platelet
adhesion (surface tension
˜25 erg.cm 2 )
• Bind albumin reversibly
• Prevent the adsorption of
fibrinogen, factor XII &
high molecular weight
kininogen
• Supress the activation of C3
• Decrease hemolysis

Comparison of polymethoxyethylacrylatecoated
circuits with leukocyte filtration and
reduced heparinization protocol on heparinbonded
circuits in different risk cohorts
Serdar Gunaydin MD, PhD
Kevin McCusker PhD, CCP
V Vijay MD
Perfusion 2006; 21: 1-14

Can Such Pumps be "Real"
Heart-Lung Machines ?
Cardiothoracic Surgery, Klinikum Braunschweig, Germany

Challenges for Modern Mini-Circuits
Provide circulatory support for
a wide range of cardiac surgery
Provide safe and effective deairing
+
Maintain advantages of MPC
(low foreign surface area and less hemodilution)

Minimized Perfusion Circuit
Air Removal
AutoVent
Arterial Filter
Air Bubble
Detector
Centrifugal Pump
Control Unit
Bubble Trap
Electronic Venous
Line Occluder
Auxilliary
Roller Pump
Centrifugal Pump

STEPS FORWARD

STEP BACK or
“STEPS BACK”

PERFUSION DATA
ON-CPB HCT
• HCT > 30 % 68 %
• HCT > 25 % 94 %
• HCT > 23 % 100 %

TRANSFUSION DATA
BLOOD PRODUCT USAGE THROUGHOUT LENGTH OF STAY
Intra Op
Post Op
Packed Cells 0.2 1.1
FFP 0.0 0.3
Platelets 0.03 0.4
CRYO Precipate 0.0 0.0

1 2
ICU LOS
100%
94%
90%
80%
78%
76%
70%
60%
50%
46%
Group I
Group II
40%
30%
20%
10%
0%
< 24 hours < 48 hours

HOSPITAL LOS
100%
90%
7 Days
80%
70%
60%
7 Days
50%
40%
89%
30%
60%
20%
10%
0%
Group I
Group II

Demographic Data
Group 1
(Closed)
Group 2
(Control)
p
Age (y) 64.4 ± 2.2 62.2 ±2.5 NS
Male sex 12 14 NS
BSA (m 2 ) 1.61 ± 0.05 1.64 ± 0.06 NS
NYHA class 3.2 ± 0.15 3.1 ± 0.16 NS
Ejection fraction 0.37 ± 0.08 0.39 ± 0.09 NS
LVEDP (mm Hg) 17.8 ±1.6 18.2 ±1.6
NS

pg.mL-1
RESULTS
300
IL-6
*
250
200
*
150
Closed
Control
100
50
0
T1 T3 T4 T5 T6

ng.mL-1
0.8
0.7
0.6
0.5
*
C3a
*
*
0.4
0.3
Closed
Control
0.2
0.1
0
T1 T3 T4 T5 T6

ng.mL-1
RESULTS
14
12
CKMB
*
10
8
6
Closed
Control
4
2
0
Pre-CPB
Post CPB

RFI % Change
RESULTS
25
20
Neutrophil CD11b/CD18
*
*
15
10
Closed
Control
5
0
T1 T3 T4 T5 T6
-5

μmol.L-1
RESULTS
12
FHb
10
8
6
Closed
Control
4
2
0
T1 T3 T4 T5 T6

Perioperative Outcome
GROUP 1
(Closed)
GROUP 2
(Control)
P
Duration of CPB (min) 98.7±4.2 94.5±3.7 NS
Duration of x-clamp (min) 76.8±3 74.5±3.2 NS
t-intub (h) 12.5±0.6 16.8±1.5 0.001
Postop hemorrhage (mL) 653±23 757±30 0.03
Arrhythmia (n) AF:5 AF:11 0.025
Blood transfusion (Unit) 2.4±0.22 2.7±0.26 NS
Blood products (Unit) 2.2±0.35 2.9±0.3 NS
Inotropic support (n) 11 15 NS
Postop NYHA Class 2.8±0.1 2.9±0.1 NS
IABP (n) 2 5 NS
ICU stay (day) 2.8±0.24 4.1±0.27 0.051
Postoperative EF (%) 43±1.5 39.4±1.4 NS
Hospital stay (day) 7.8±0.5 10.6±1.1 0.054
Mortality rate (%) 3.3(N=1) 6(N=2) NS

Results-Air Handling
GME (emboli.sec -1 ) Group 1
(Closed)
Group 2
(Control)
p
T3 T4 T3 T4
Venous (inlet) 32.8±5.3 94.2±8.7 40.4±4.7 107.3±11 NS
Bubble trap-oxygenator 22.3±4.1 44.3±6 29.3±4.7 51.4±7.1 NS
Arterial (outlet) 12.6±3.6 18.3±4.6 17.5±4 22.7±4.5 NS

Results-rSO2
74
Cerebral Oxygen Saturation
(rSO2)
72
70
68
66
64
62
70.5
68.9
65.4
62.4
67.5
63.5
66.4
62.3
69.2
64.1
Closed
Control
60
58
56
54
T1 T3 T4 T5 T6

Microalbumin (mg.dL-1)
Biomaterial Evaluation
2.5
2
Desorbed protein on oxygenator fibers
*
1.5
1
0.5
0
Closed
Control

CONCLUSION
Dual Configuration Open/Closed ECC
“PINNACLE SYSTEM” provided a
comfort and safety level similar to
conventional control via satisfactory air
handling, attenuated inflammatory
response and hemodilution with a better
clinical outcome in patients undergoing
high risk CABG