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The Amazing
ADAPTIV
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• Biphasic defibrillation
• The differences
• Update the studies
• The damage
• The AHA guidelines
• Predictions
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Biphasic Defibrillation
• Current flows in two phases, first in one
direction from one electrode, and then current
flows the other way from the other electrode
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Biphasic Defibrillation
• How does it work?
We really don’t know (it’s magic!)
• Is it really better?
– It has been in the hospital
• EP Lab
• AF patients
– OOH
• No more survivors with biphasic (yet)
• Better at certain endpoints (5 sec. post shock, ROSC)
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Defibrillation
Electrical Current Stops VF
•Must overcome resistance (impedance) to flow
Shock
VF
Defibrillation
NSR
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Defibrillation
Impedance
60
Current variance due
to impedance, energy
held constant
Peak Current (amps)
50
40
30
20
10
0
25
50
75
100
125
150
Patient Impedance (ohms)
The current a heart receives from a 200J
shock depends on the patient’s impedance
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Defibrillation
Electricity and the Heart
• Defibrillators use energy to deliver
the shock
– Energy is expressed in joules
Energy = Current x Voltage x Time
Joules =
Amps x Volts x Seconds
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The Differences
Histogram of patient impedances
Percentage of Patients
16
14
12
10
8
6
4
2
0
30
40
50
60
70
80
90
100
110
120
130
140
Impedance (ohms)
Source: Medtronic Physio-Control: Impedance data on 723 SCA patients.
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150
More
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Biphasic Waveforms
40
Monophasic Peak Current
Current (amps)
30
Biphasic Peak Current
20
10
0
-10
-20
0
5
10
15
20
Time (msec)
Biphasic waveforms have a lower peak current
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Biphasic Current Duration
Duration adjusted biphasic waveforms
Low Impedance Shock
Medium High
50 ohms
75 ohms
Current (amps)
125 ohms
Time (msec)
Biphasic waveforms duration can
adjust for impedance
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Voltage Compensation
2000
Voltage Waveforms
for 200 J Shocks
1500
50 ohms
75 ohms
100 ohms
125 ohms
150 ohms
Voltage (V)
1000
500
0
0
5
10
15
20
-500
-1000
Time (ms)
-1500
• Voltage (pressure) can adjust for impedance
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Medtronic ADAPTIV BTE Waveform
40
50 ohms (369J)
75 ohms (356J)
125 ohms (320J)
35
30
Current (amps)
25
20
15
10
5
0
-5
-10
-15
-20
-2
0
2
4
6
8
10
12
14
16
Time (msec)
Source: Medtronic Physio-Control; Shocks delivered from commercial device into resistors.
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18
20
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Heartstream Basic Claims
• Gives just the right amount to the patient
• Low energy--doesn’t damage the heart
• Proven technology—most published studies
• Only one with AHA rating
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First shock setting (AED mode), 75 ohms
35
MDS - 208 J delivered
30
Heartstream - 152 J delivered
Current (A)
25
Physio - 203 J delivered
20
Zoll - 143 J delivered
15
10
5
0
-5
-10
-15
-2
0
2
4
6
8
10
12
14
Time (ms)
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16
18
20
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CL6815-00
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Heartstream--The Studies
• There are lots of them! What were the results?
– Worst success in EP lab (86% versus MPC 100% at 200J
biphasic)
– Worst results of all manufacturers for AF (Page, et al, CL
6864-00)
– 78% at 150J
– 90% at 200J versus 97% for MPC
• OOH
• Never have shown an increase in survival….. but showed better
success at other endpoints
• Defined shock success at 5 seconds post shock
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Out-of-Hospital Cardiac Arrest Studies
Defining outcomes for pre-hospital defibrillation
Failed shock: VF present 5 seconds after the shock
VF
Successful shock: asystole or organized rhythm for 5 seconds after the
shock
organized
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Out-of-Hospital Cardiac Arrest Studies
Defining outcomes for pre-hospital defibrillation – the controversy
Success?
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Heartstream--The Studies
• OOH study (ORCA or Schneider study) was
instrumental in getting Class IIa rating in
international guidelines
– Compared 150J BTE to escalating MTE
• MTE believed to be an inferior waveform
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A Comparison of Clinically Used Biphasic
Waveforms for External Defibrillation
• Publication:
RG Walker, Academic Emergency Medicine
2001;8(5):432-3 (CL6873-00)
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Methods
• Short duration (30 sec), electrically-induced
VF
• Used each manufacturer’s recommended
/default 3-shock protocol for automated
defibrillation
• 8 pigs; 16 trials for each waveform
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Compared Efficacy of Four Biphasic Defibs:
Low Impedance Episodes
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
 3 Shocks
 2 Shocks
1 Shock
HS
PC
SL
Comparison in 8 pigs, 256 VF episodes
Impedance 40 +/- 7 ohms
Walker RG, et al. Acad Emerg Med. 2001;8(5):432-433.
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ZL
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Typical distribution of patient impedances for OOH
Ttransthoracic Defibrillation
Percentage of
Patients
Pigs = ~40 ohms
Average human = ~ 80 - 85 ohms
16%
14%
12%
10%
8%
6%
4%
2%
0%
30 40 50 60 70 80 90 100 110 120 130 140 150 More
Impedance (ohms)
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Compared Efficacy of Four Biphasic Defibs:
Medium Impedance Episodes
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
 2 Shocks
1 Shock
HS
PC
 3 Shocks
SL
ZL
Comparison in 8 pigs, 256 VF episodes Impedance 92 +/- 7 ohms (50 ohms added)
Walker RG, et al. Acad Emerg Med. 2001;8(5):432-433.
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ZOLL—Main Claims
• Has low peak current which causes less damage
• Can achieve what MPC does but with less energy
(ZOLL’s energy fluctuates a lot)
• Lots of published studies support low energy
– 2 published studies, one EP and one AF study
• Very weak OOH abstract just presented at a conference
• Often give Heartstream studies to customers
• New, potentially damaging study just presented in May, 2002
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First shock setting (AED mode), 75 ohms
35
MDS - 208 J delivered
30
Heartstream - 152 J delivered
Current (A)
25
Physio - 203 J delivered
20
Zoll - 143 J delivered
15
10
5
0
-5
-10
-15
-2
0
2
4
6
8
10
12
14
Time (ms)
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16
18
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High Impedance
18
LIFEPAK 12 biphasic device (360J)
FirstSave (high)
M Series (200J)
ForeRunner (150J)
16
14
12
Current (amps)
10
8
6
4
2
0
-2
-4
-6
-8
-10
-12
-2
0
2
4
6
8
10
12
14
16
Time (msec)
Maximum shock into 125 ohms
Source: Medtronic Physio-Control; Shocks delivered from commercial device into resistors.
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18
20
22
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Current Duration
25
20
Shock comparison at maximum energy level
High impedance condition (125 ohms)
Medtronic Physio-Control
(360J)
Current (amps)
15
Company B (200J)
10
Increased Duration for
Increased Impedance
5
0
0
2
4
6
8
10
12
14
16
18
20
All waveforms
generated using
actual devices
-5
-10
-15
Time (msec)
High impedance patients receive more energy with the
Medtronic Physio-Control waveform
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ZOLL Waveform Delivers More Energy and
Higher Peak Current at 100J than MPC
100 J setting, 100 ohms
100 J setting, 75 ohms
15
5
0
-5
5
0
-5
-10
-10
-15
-15
-2
0
2
4
6
8
10
12
14
16
18
20
Physio - 102 J delivered
Zoll - 119 J delivered
10
Current (A)
10
Current (A)
15
Physio - 102 J delivered
Zoll - 120 J delivered
-2
0
2
4
6
8
10
Time (ms)
Time (ms)
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12
14
16
18
20
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ZOLL Waveform Delivers More Energy and More
Current at 200J than MPC
200 J setting, 75 ohms
25
25
Physio - 203 J delivered
Zoll - 224 J delivered
20
15
15
10
10
5
0
-5
5
0
-5
-10
-10
-15
-15
-20
-20
-2
0
2
4
6
8
10
12
14
16
18
20
Physio - 205 J delivered
Zoll - 220 J delivered
20
Current (A)
Current (A)
200 J setting, 100 ohms
-2
0
2
4
Time (ms)
6
8
10
Time (ms)
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12
14
16
18
20
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Damage
• Clinically significant damage has not been
proven with monophasic shocks at
traditional energy levels
• Our ADAPTIV biphasic shocks give 40%
less peak current than monophasic shocks
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Damage:
None at Levels up to 360J Monophasic
Cardiac troponin I levels after monophasic shocks13
Not Elevated
Minimally elevated
(0.8–1.5 ng/ml)*
* Permanent cardiac injury occurs
at levels greater than 7.7ng/ml
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1st Shock Comparison, Average Impedance
25
LIFEPAK 12 biphasic device (200J)
FirstSave (low)
M Series (120J)
ForeRunner (150J)
20
Current (amps)
15
10
5
0
-5
-10
-15
-2
0
2
4
6
8
10
Time (msec)
First shock into 75 ohms
Source: Medtronic Physio-Control; Shocks delivered from commercial device into resistors.
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12
14
16
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The Illusion of Damage
18
LIFEPAK 12 biphasic device (360J)
FirstSave (high)
M Series (200J)
ForeRunner (150J)
16
14
12
Current (amps)
10
8
6
4
2
0
-2
-4
-6
-8
-10
-12
-2
0
2
4
6
8
10
12
14
16
Time (msec)
Maximum shock into 125 ohms
Source: Medtronic Physio-Control; Shocks delivered from commercial device into resistors.
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18
20
22
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Summary: Damage
• Peak current, not energy causes damage
• No documented clinically significant
damage with monophasic waveforms
• ADAPTIV biphasic waveform at 360J
offers peak current levels similar to
monophasic at 100J
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Summary: Heartstream
• Heartstream
– Extends waveform duration
– Energy remains fixed at 150 J
• Gives most current to low impedance patients
• Gives least current to high impedance patients
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Summary: ZOLL
• ZOLL
– Does good job of delivering higher level of current to
high impedance patients
– Does not ever extend duration
– Must go to BTE waveform at 200J and above 85 ohms
• But does not extend duration
– Tries to pass off Heartstream’s studies as their own
– U. Mass AF study will be discussed Thursday at lunch
time session
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The Guidelines
• ILCOR
– What is their position?
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International Guidelines 2000 Regarding
1
Biphasic Defibrillation
“Current research confirms that biphasic shock
energies of  200J are safe and effective.” (Class
IIa) P I-90
“Research has not yet determined the optimal
biphasic waveform.” P I-90
American Heart Association/International Liaison
Committee on Resuscitation, pp I-90–I-91.
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The Guidelines on
Biphasic Energy Levels
“We cannot make a definitive recommendation for
the energy for first and subsequent nonescalating
biphasic defibrillation attempts.” P I-91
• “Even though both escalating or nonescalating
biphasic defibrillators are available, there was
insufficient data to recommend one over the
other.”
Source: Guidelines 2000 for Cardiovascular Resuscitation and Emergency
Cardiovascular Care.Circulation. 2000;102(suppl I) 8. August 22, 2000
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Biphasic
350
300
250
200
Monophasic
150
Biphasic
100
50
0
Spontaneous VF
Electrically Induced
Spontaneous VF
Electrically Induced VF
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Author’s Conclusions
“These results suggest that clinical studies that involve
defibrillating spontaneous arrhythmias in either a prehospital or
intensive care unit setting are necessary to determine optimal
defibrillation energy levels for defibrillation using BTE
waveforms and should include shock strengths to 360 J.”
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Biphasic Defibrillation-MDT 1st OOH
Results—46 VF patients
• MDS in LIFEPAK 12
– 28 VF patients
– Collapse to shock =
13.03 minutes
– First shock success
19/28 (68%)
– ROSC 15/28 (54%)
– Survival 5/28 (18%)
• BTE in LIFEPAK 12
– 18 VF patients
– Collapse to shock =
12.25 minutes
– First shock success
15/18 (83%)
– ROSC 15/18 (83%)
– Survival 8/18 (44%)
Doets, vanAlem, Koster presentation at the World Congress in Australia, May 2002
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Reality
• LIFEPAKs have
– Current Duration
– Voltage Compensation
PLUS
– Optional energy settings
• Lower risk of refibrillation
• Higher second shock success
• Wider range of therapy
• Trend toward more survivors
– Goal: to save more lives
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Predictions
• More studies will show biphasic is better
in OOH setting
• Customers will become more interested
(and confused) in biphasic defibrillation
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Predictions
• More manufacturers will try to build devices
capable of >200J
• The Guidelines will remain open to
interpretation
• More lives will be saved
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