ZOLL AutoPulse ® Non-invasive Cardiac Support Pump

ZOLL AutoPulse® ZOLL AutoPulse®

Non-invasive Cardiac Support Pump Non-invasive Cardiac Support Pump


ZOLL’s History ZOLL’s History

1952 Dr Paul Zoll first to successfully pace human

1956 Dr Paul Zoll first to successful externally defibrillate

patient

1988 PD 1200 Pacemaker/Defibrillator/Monitor brought to

market

1995 M Series Introduced – First fully integrated Shockable

Rhythm Interpretation (Advisory)

Pacemaker/Defibrillator/Monitor

1997 RescueNet – first integrated data system for EMS

developed

2002 First CPR Guidance System developed with the AED Plus

2004 Revivant Corporation acquired – adding the AutoPulse

Manual CPR device to the product offering

• Automatic

• Portable

• Non-invasive

• Battery Operated


30% - 40% of normal flow

10% - 20% of normal flow Kern KB Bailliere’s Clinical Anaesthesiology. 2000;14(3):591-609.

Manual CPRManual CPR

Conventional CPR provides less than optimal blood flow to the heart and brain

• A well perfused myocardium is more likely to experience ROSC• Paradis et al found that a minimum of 15 mmHg was required to achieve ROSC• Manual CPR, on average achieves 12.5 mmHg• Levels of ROSC increase with CPP in prolonged cardiac arrest.•AutoPulse provides upwards of 25 mmHg of CPP •At >25 mmHg of CPP, ROSC rates are at 79%

Solution: The AutoPulse The Solution – AutoPulse The Solution – AutoPulse

ZOLL AutoPulse®ZOLL AutoPulse®

• Uninterrupted compressions

• Consistent rate & depth

• User friendly

• Suitable for emergency department

• Superior Coronary Perfusion Pressure (CPP) compared with conventional CPR during resuscitation

Operating RationalOperating Rational

Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR


Circumferential

AutoPulse

CPR

Uni-Directional

Manual

CPR

Presenting Cardiac RhythmsPresenting Cardiac Rhythms

Studies show that VF or VT is the initial rhythm less than 50% of the time

25%41%

75%59%

0%

20%

40%

60%

80%

100%

120%

Hospital Pre-Hospital

% o

f C

ard

iac

Arr

es

ts

VF/VT PEA/Asystole

Peberdy MA, Kaye W et al. Resuscitation 2003; 58:297-308.Kaye W et al. Journal of the American College of Cardiology. 2002:39(5), Suppl A.Cobb L et al. JAMA. 2002; 288(23):3008-3013.

Presenting Cardiac RhythmsPresenting Cardiac Rhythms

• Defibrillation is only required in less than 50% of cases.

• Quality CPR is required in 100% of cases!

• Does not adequately perfuse the brain or heart


• Does not adequately perfuse the brain or heart

Manual CPR delivers• Inconsistent compressions• Fatigue• Pausing to rotate staff• Pausing to move the patient• OH&S Issues


Manual CPR v AutoPulseManual CPR v AutoPulse

Manual CPR

AutoPulse CPR

AutoPulse - Consistent CompressionsAutoPulse - Consistent Compressions

Clinical Evidence Summary…Clinical Evidence Summary…

Clinical Evidence – Manual CPRClinical Evidence – Manual CPR

• Manual CPR is variable at best, even when performed by trained professionals – Abella et al, Wik et al

• Effective CPR, with minimal interruptions, improves probability of successful defibrillation – Sato et al, Ikeno et al

• Effective CPR is more important than the timing of defibrillation in achieving ROSC – Ristagno, et al

Clinical Evidence - CPPClinical Evidence - CPP

• CPP is the best predictor of ROSC in prolonged cardiac arrests

• ROSC does not occur in patients where CPP is below 15mmHg

• Manual CPR achieves 12.5mm Hg on average – Paradis et al

• CPP is improved with AutoPulse over manual CPR. – Timmerman et al

AutoPulse Manual CPR

CPP drops quickly when

AutoPulse compressions

stop

CPP returns after several


AutoPulse

Timerman S et al. Resuscitation. 2004;61:273-280


Clinical Evidence - ROSCClinical Evidence - ROSC

• AutoPulse provides pre arrest blood flow levels to heart and brain - Halperin

et al • AutoPulse provides superior levels of

ROSC and survival when compared to manual CPR – Ong et al

• AutoPulse provides superior levels of ROSC and survival when compared to piston driven automated CPR – Ikeno et al

Clinical Evidence - ROSCClinical Evidence - ROSC

• AutoPulse provides superior levels of neurological function when compared to both manual and piston driven CPR – Ong et al, Ikeno et al

Clinical ReviewClinical Review

Abella et al JAMA. 2005;293:305-310Abella et al JAMA. 2005;293:305-310

• University of Chicago Hospital• 67 Patients• Evaluated Quality of manual CPR in

first 5 mins of code• Found that even in highly trained

professionals CPR was:– too shallow, – too slow – ventilation occurred too frequently.

Wik et al JAMA. 2005;293:305-310Wik et al JAMA. 2005;293:305-310

• Multi-location Emergency Services human study (Stockholm, London, Akershus)

• Evaluated Quality of manual CPR in first 5 mins of arrest of 176 patients

• 49% of time of code, patients did not receive CPR

• With adjustment for defibrillation analysis, 42% time of code, patients did not receive CPR

Wik et al JAMA. 2005;293:305-310Wik et al JAMA. 2005;293:305-310

• 59% of compressions were too shallow

• Found high compression rates– Decreased cardiac output – Not enough time for proper venous

return to heart

• CPR performed by people is significantly different to guidelines

• Rodent study of 25 subjects put into VF• 4 minutes later defibrillation

commenced• animals were grouped into 0, 10, 20, 30

and 40 s delays in between defibrillation and cessation of CPR

• No animals that received more than 10 s delay in defibrillation survived more than 24 hours.

• Resuscitation and survival rates lessened as delay increased

Sato et al. Critical Care Medicine. 1997;25:733-736

Sato et al. Critical Care Medicine. 1997;25:733-736

• Porcine study of 24 subjects put into VF• 5 minutes later treatment commenced• 4 randomized groups

– Optimal CPR with early defibrillation– Optimal CPR with 3 minutes of CPR first– Conventional CPR* with early defibrillation– Conventional CPR* with 3 minutes of CPR

first

* Simulated by 25% that compression required to give 15 mm Hg CPP.

Ristagno et al. Chest. 2007;132:70-75Ristagno et al. Chest. 2007;132:70-75

• All 12 subjects that were given optimal CPR achieved ROSC

• Only 2 of the 12 subjects (16.6%) that were given conventional CPR achieved ROSC and those were shocked first

• All surviving animals achieved full neurological recovery

Ristagno et al. Chest. 2007;132:70-75Ristagno et al. Chest. 2007;132:70-75

Paradis NA et al. JAMA. 1990;263:1106-1113

Paradis NA et al. JAMA. 1990;263:1106-1113

• Coronary Perfusion Pressure < 15 mmHg does not achieve Return of Spontaneous Circulation

46%

0%

79%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

<15 15-25 >25

CPP (mm Hg)

% o

f pat

ien

ts w

/ RO

SC

Conventional CPRmean CPP = 12.5 mmHg

• 16 terminal patients • In-hospital cardiac arrest• 10 minutes of failed advanced care life

support• Catheters were placed in the thoracic aorta

and right atrium to measure CPP and peak aortic pressure

• AutoPulse and Manual Compressions were alternated for 90 seconds each

• Average time between arrest and the start of experiment was 30 (+/-5) minutes



AutoPulse Manual CPR

CPP drops quickly when


stop

CPP returns after several


AutoPulse





15

20

0

5

10

15

20

25

Co

ron

ary

Pe

rfu

sio

n P

res

su

re (

CP

P)

mm

Hg

Manual CPR AutoPulse

Results: AutoPulse-generated Coronary Perfusion Pressure (CPP) was 33% better than manual CPR

Halperin et al. JAMA. 2006;295:2629-2637


• Porcine Study of 20 subjects @ John Hopkins

• VF induced for 1 minute• Treated with conventional CPR (“The

Thumper”) or the AutoPulse• Two arms of study

– “BLS” scenario – no epinephrine– “ALS” scenario – with epinephrine



29% 31%

127% 129%

0%

20%

40%

60%

80%

100%

120%

140%

Heart (Myocardium*) Brain (Cerebrum**)

% o

f P

re-a

rres

t B

loo

d F

low

Conventional CPR AutoPulse

Results: AutoPulse produced pre-arrest levels of blood flow to the heart and brain (ACLS protocol – with epinephrine)

Ong et al. JAMA. 2006;295:2629-2637Ong et al. JAMA. 2006;295:2629-2637

• Study conducted by Richmond Fire Department of almost 800 patients

• Overall improvement of ROSC (70.8%), survival to hospital admission (88%) and survival to discharge (234%).

Ong et al. JAMA. 2006;295:2629-2637Ong et al. JAMA. 2006;295:2629-2637

• Improvement occurred regardless of initial cardiac rhythm– VF/VT– Asystole*– PEA*

• Particularly where VF was initial rhythm or where the patient had a witnessed arrest or received bystander CPR until the AutoPulse was applied.

* Small sample sizes

Ikeno et al. Resuscitation. 2006;68:109-118


• Porcine Study with 56 subjects• 22 in AutoPulse, 22 using “the thumper” at

20% compression, 12 at 30% compression• VF induced for 4 minutes before treatment• All subjects that achieved ROSC, survived

for 72 hours• Of the thumper subjects, none survived

20% compression (simulating manual CPR), even with adrenaline administered



• Of the 30% compression group, 4 of 12 (33%) achieved ROSC. 50% required adrenaline

• 2 of these 4 survivors at 72 hours had good neurological function. 2 were severely impaired

• 8/12 (67%) subjects suffered rib fracture and 4/12 (33%) suffered lung injury



• Of the AutoPulse group, 16 of 22 (73%) achieved ROSC. 50% required adrenaline

• All 16 survivors achieved good neurological outcomes after 72 hours

• No subjects in this group received rib fracture of lung injury

Mechanical Chest Compression During Resuscitation Academic Medical Centre, Amsterdam


• 2 patients being treated with the AutoPulse• Primary Percutaneous Coronary Intervention. • Adequately displayed the coronary system

through the AutoPulse in order to complete the procedures.

• Conventional CPR - Intra-arterial blood pressures of up to 60mmHg

• AutoPulse - Intra-arterial blood pressures of up to 120mmHg

Mechanical chest compression during resuscitation: Experience in hospital and use in pre-hospital care.Cardiac Monitoring Department -Academic Medical Centre, Amsterdam



• 2 patients being treated with the AutoPulse• Primary Percutaneous Coronary Intervention. • Adequately displayed the coronary system

through the AutoPulse in order to complete the procedures.

• Conventional CPR - Intra-arterial blood pressures of up to 60mmHg

• AutoPulse - Intra-arterial blood pressures of up to 120mmHg

Mechanical chest compression during resuscitation: Experience in hospital and use in pre-hospital care.Cardiac Monitoring Department -Academic Medical Centre, Amsterdam

Documents

ZOLL AutoPulse ® Non-invasive Cardiac Support Pump