ZOLL AutoPulse ® Non-invasive Cardiac Support Pump

ZOLL AutoPulse ®

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 ZOLL AutoPulse ®

30% - 40% of normal flow10% - 20% of normal flow Kern KB Bailliere’s Clinical Anaesthesiology. 2000;14(3): Manual 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

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 Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Operating Rational Circumferential AutoPulse CPR Uni-Directional Manual CPR

Presenting Cardiac Rhythms Studies show that VF or VT is the initial rhythm less than 50% of the time Peberdy MA, Kaye W et al. Resuscitation 2003; 58: Kaye W et al. Journal of the American College of Cardiology. 2002:39(5), Suppl A. Cobb L et al. JAMA. 2002; 288(23):

Presenting 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 Manual CPR

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

Manual CPR v AutoPulse Manual CPR AutoPulse CPR

AutoPulse - Consistent Compressions

Clinical Evidence Summary…

Clinical 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 - 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

AutoPulseManual CPR CPP drops quickly when AutoPulse compressions stop CPP returns after several AutoPulse compressions AutoPulse Timerman S et al. Resuscitation. 2004;61:

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

Clinical Review

Abella et al JAMA. 2005;293: 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: 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: % 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:

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;132:70-75

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;132:70-75

Paradis NA et al. JAMA. 1990;263: Coronary Perfusion Pressure < 15 mmHg does not achieve Return of Spontaneous Circulation Conventional CPR mean 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 Timerman S et al. Resuscitation. 2004;61:

AutoPulseManual CPR CPP drops quickly when AutoPulse compressions stop CPP returns after several AutoPulse compressions AutoPulse Timerman S et al. Resuscitation. 2004;61:

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

Halperin et al. JAMA. 2006;295: Porcine Study of 20 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

Halperin et al. JAMA. 2006;295: Results: AutoPulse produced pre-arrest levels of blood flow to the heart and brain (ACLS protocol – with epinephrine)

Ong et al. JAMA. 2006;295: 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: 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: 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

Ikeno et al. Resuscitation. 2006;68: 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

Ikeno et al. Resuscitation. 2006;68: 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

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