Consistent compressions' No interruptions'

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Consistent compressions.No interruptions.

• Improved blood flow is within reach.

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Contents

• Coronary Perfusion and Return of Spontaneous
  Circulation (ROSC)
• Clinical Background and The Problems
• The Solution AutoPulse
• AutoPulse Clinical Studies

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Coronary Perfusion andReturn of Spontaneous
Circulation(ROSC)
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Coronary Perfusion
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Coronary Perfusion Pressure
Aortic Pressure (AP)
Right Atrial Pressure (RAP)
CPP AP minus RAP
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Myocardial Perfusion and ROSC
A well perfused myocardium is more likely to
experience return of spontaneous circulation
(ROSC)
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Clinical Background andThe Problems
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AHA Guidelines 2005 CPR

• Simply put push hard, push fast, allow full
  chest recoil, minimize interruptions in
  compressions

Circulation. 2005112IV-206.
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AHA Guidelines 2005 AutoPulse

• LDB-CPR may be considered for use by properly
  trained personnel as an adjunct to CPR for
  patients with cardiac arrest in the
  out-of-hospital or in-hospital setting (Class
  IIb).
• Load-distributing band.

Circulation. 2005112IV-59.
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Summary of the Problems

• Too many people are dying from sudden cardiac
  arrest (SCA)
• Circulation is inadequate during SCA
• The presenting rhythm in SCA is shockable lt 50
  of the time in both the Hospital and EMS
  environments
• There are significant opportunities for
  improvement with manual CPR
• Defibrillation is most effective during the first
  few minutes after cardiac arrest

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Presenting Cardiac Rhythms
Conclusion Recent studies show that VF or VT is
the initial rhythm less than 50 of the time
Peberdy MA et al. Resuscitation
200358297-308. Kaye W et al. Journal of the
American College of Cardiology. 200239(5),Suppl
A. Cobb L et al. JAMA. 2002288(23)3008-3013.
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Conventional CPR and Blood Flow
Conventional CPR provides less than optimal blood
flow to the heart and brain
30 - 40 of normal flow
10 - 20 of normal flow
Kern KB Baillieres Clinical Anaesthesiology.
200014(3)591-609.
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Limitations of Manual CPR
Cardiac Pump
Thoracic Pump
Compresses only the heart
Compresses the entire chest
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Limitations of Manual CPR

• Even when done properly, manual CPR does not
  adequately perfuse the brain or heart
• Additional limitations of manual CPR
• Inconsistent compressions
• Fatigue
• Pausing to rotate rescuers or to move the patient

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CPP and ROSC

• Victims with CPP lt 15 mmHg do not achieve ROSC
• With conventional CPR, the overall mean CPP 12.5

Paradis NA et al. JAMA. 19902631106-1113.
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Consequences of Pausing

• Decreased VF quality
• Decreased CPP
• Decreased ROSC
• Decreased 24-hour survival

Eftestol T et al. Circulation. 2002105(19)2270-2
273. Sato Y et al. Crit Care Med.
199725(5)733-736. Anouk P et al. Annuls of
Emergency Medicine. 2003.
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Quality of Manual CPR JAMA Articles

• In-hospital (Abella et al.)
• the quality of multiple parameters of CPR was
  inconsistent and often did not meet published
  guideline recommendations, even when performed by
  well-trained hospital staff.
• Out-of-hospital (Wik et al.)
• chest compressions were not delivered half of
  the time, and most compressions were too
  shallow

Abella BS et al. JAMA. 2005293(1)305-310. Wik L
et al. JAMA. 2005293(1)299-304.
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Effectiveness of Defibrillation
Defibrillation is most effective during the first
few minutes after cardiac arrest
Defibrillation most effective
Circulation enhances outcome

• Engdahl J et al. Resuscitation.
  200252(3)235-245.
• Guidelines for CPR and ECC. Circulation.
  2000102(suppl I)I-23.

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The Solution AutoPulse
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AutoPulse

• What is the AutoPulse?
• A revolutionary non-invasive cardiac support pump
• What does the AutoPulse do?
• Chest compressions that humans cant possibly do
• What does the AutoPulse do for the SCA patient?
• Moves more blood, more effectively, to the heart
  and brain
• Offers the promise of better outcomes

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Overriding Benefits
Consistent compressions. No interruptions. Improv
ed blood flow is within reach.
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Summary of Benefits / Solutions

• Improved blood flow
• Functions as an additional person
• Fast, easy and intuitive to start-up and use
• Clinician safety
• No risk of being injured while attempting to do
  manual compressions in the back of a moving
  ambulance or gurney

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Improved Blood Flow

• Consistent, uninterrupted compressions
• Thoracic compression, in conjunction with cardiac
  compression (best of both)

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AutoPulse Offers Best of Both
Cardiac Pump
Thoracic Pump
Compresses only the heart
Compresses the entire chest
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Functions as an Additional Person

• Clinician is free to perform other critical tasks
• Eliminates clinician fatigue

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Fast, Easy and Intuitiveto Start-up and Use

• Extremely simple user interface
• Automatically sizes the patient, calculating
• Size
• Shape
• Compliance/resistance
• No need to enter patient information or make
  manual adjustments

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Clinician Safety

• No risk of being injured while attempting to do
  manual compressions in the back of a moving
  ambulance or on a gurney

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Clinical Studies
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Human Long-term Survival Study(Ornato et al.)

• Conducted by Ornato et al. in Richmond, VA
• Compared survival rates in 783 patients
• 499 patients treated with manual CPR
• 284 patients treated with the AutoPulse
• 235 improvement in survival to discharge
• 88 improvement in survival to hospital admission
• 71 improvement in field ROSC

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Human Long-term Survival Study(Ornato et al.)
Results AutoPulse improved survival to hospital
discharge by 235
p0.0001
Ornato J et al. American Heart Association Annual
Meeting. 2005.
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ASPIRE

• AutoPulse Pre-hospital International
  Resuscitation
• Randomized (cluster randomization)
• Multi-center
• Vancouver, BC
• Calgary, Alberta
• Seattle, WA
• Columbus, OH
• Pittsburgh, PA

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ASPIRE

• 1,071 patients enrolled, however 767 used for
  primary comparison due to cardiac cause
• 373 patients treated with manual CPR
• 394 patients treated with the AutoPulse
• Primary endpoint 4 hour survival (representing
  hospital admission)
• Secondary endpoint survival to discharge
• Terminated based on statistically insignificant
  secondary endpoint data

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ZOLLs View of ASPIRE

• We are disappointed by ASPIREs problems
• Inconclusive results
• Early termination prior to achievement of
  statistical significance
• Problems appear to be related to study issues and
  not the AutoPulse
• Implementation issues
• Very late use of the AutoPulse (average of 12
  minutes after 911 dispatch)
• Inconsistent training and monitoring
• Study design
• Allowed for multiple protocols
• One site that changed protocols had a
  disproportionate impact on the combined data from
  all five sites

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ZOLLs View of ASPIRE

• We are planning a major new study involving
  leading resuscitation experts in the US and
  Europe
• This new study will build on the lessons learned
  from ASPIRE
• The favorable conclusions of the other two new
  studies presented at AHA, plus the four previous
  studies, add to a strong body of evidence
  favoring the AutoPulse

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Human Short-term Survival Study(Swanson et al.)

• Conducted by Swanson et al. in Volusia County, FL
• Compared the rate of delivery of 523 patients in
  ROSC sustained to the ED
• 405 patients treated with manual CPR
• 118 patients treated with the AutoPulse
• Increased sustained ROSC rate was most pronounced
  when the initial presenting rhythm was asystole
  or PEA

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Human Short-term Survival Study(Swanson et al.)
Results AutoPulse improved the rate of delivery
of patients in ROSC sustained to the ED by 53
p0.02
Swanson M et al. Circulation. 2005112(17)II-106.
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Human Short-term Survival Study(Casner et al.)

• Conducted by Casner et al. in San Francisco, CA
• Compared the rate of delivery of 162 patients in
  ROSC sustained to the ED
• 93 patients treated with manual CPR
• 69 patients treated with the AutoPulse
• Increased sustained ROSC rate was most pronounced
  when the initial presenting rhythm was asystole
  or PEA

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Human Short-term Survival Study(Casner et al.)
Results AutoPulse improved the rate of delivery
of patients in ROSC sustained to the ED by 35
p0.003
Casner M et al. Prehospital Emergency Care.
20059(1)61-67.
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Human Hemodynamics Study (Timerman et al.)

• Conducted by Timerman et al. in Sao Paolo, Brazil
• 16 terminally ill subjects who experienced
  in-hospital cardiac arrest
• Study initiated after at least 10 minutes of
  failed ACLS support
• AutoPulse and manual compressions were alternated
  for 90 seconds each
• Catheters were placed in the thoracic aorta and
  right atrium to measure CPP and peak aortic
  pressure
• Average time between arrest and the start of
  experiment was 30 (/-5) minutes

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Human Hemodynamics Study (Timerman et al.)
Results AutoPulse-generated Coronary Perfusion
Pressure (CPP) was 33 better than manual CPR
p0.015
Timerman S et al. Resuscitation. 200461273-280.
Timerman S et al. Prehospital Emergency Care.
20037(1)162.
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Human Hemodynamics Study - Example
CPP drops quickly when AutoPulse compressions stop
CPP returns after several AutoPulse compressions
Manual CPR
AutoPulse
AutoPulse
Timerman S et al. Resuscitation. 200461273-280.
Timerman S et al. Prehospital Emergency Care.
20037(1)162.
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Animal Survival Study(Ikeno et al.)

• Conducted by Ikeno et al. _at_ Stanford
• Objective was to evaluate the ability of
  AutoPulses improved hemodynamics to affect
  survival
• Used a clinically relevant cardiac arrest model
• 8 min down 4 min BLS 4 min ALS
• End-points were ROSC, 24-hour survival and
  neurologic status at 24-hours
• CPR treatment was randomized to AutoPulse or
  conventional CPR (The Thumper)

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Animal Survival Study(Ikeno et al.)
Results

• 73 of subjects supported with the AutoPulse
  returned to normal blood flow and survived
• - 88 of the survivors were neurologically
  normal
• 0 of the subjects supported with only
  conventional CPR survived

0
plt0.01
Ikeno F et al. Resuscitation. 200668109-118.
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Animal Hemodynamics Study(Halperin et al.)

• Conducted by Halperin et al. _at_ Johns Hopkins
• 20 16-kg pigs induced with VF for one minute
• Treated with conventional CPR (The Thumper) or
  the AutoPulse
• Two arms of study
• BLS scenario no epinephrine
• ALS scenario with epinephrine
• Regional flow measured with neutron-activated
  microspheres

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Animal Hemodynamics Study(Halperin et al.)
Results AutoPulse produced pre-arrest levels
of blood flow to the heart and brain (ACLS
protocol with epinephrine)
plt0.02 plt0.003
Halperin HR et al. JACC. 200444(11)2214-20.
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Credible Research, Incredible Results

• A growing body of third-party clinical studies
  support the unprecedented benefits of the
  AutoPulse
• Human study (Ornato et al.) shows improved short
  and long-term survival
• 2 human studies (Swanson et al. and Casner et
  al.) show improved short-term survival
• Human study (Timerman et al.) shows improved
  blood pressure
• Animal study (Ikeno et al.) shows blood pressure
  equivalent to normal and neurologically intact
  survival
• Animal study (Halperin et al.) shows blood
  pressure equivalent to pre-arrest levels