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Update on Cardiopulmonary Resuscitation. Randall Brockman M.D. Cardiologist/Electrophysiologist Medical Officer for FDA. Circ System Devices Advisory Panel Sept 2004. Several Goals. To address important issues in clinical trial design for new CPR devices

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Update on Cardiopulmonary Resuscitation

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Update on cardiopulmonary resuscitation l.jpg

Update on Cardiopulmonary Resuscitation

Randall Brockman M.D.

Cardiologist/Electrophysiologist

Medical Officer for FDA

Circ System Devices Advisory Panel

Sept 2004


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Several Goals

  • To address important issues in clinical trial design for new CPR devices

  • To provide a clinical summary of the history of CPR and devices to assist with #1


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Chain of Survival

  • Rapid Access

  • Cardiopulmonary resuscitation

  • Early Defibrillation

  • Advanced cardiopulmonary life support


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The Beginnings of CPR

  • Resuscitation of arrest patients has been attempted for over a century

  • In the 1950’s, Safar et al and Elam et al “rediscovered” mouth to mouth

  • In 1960, Kouwenhoven described chest compression

  • These two techniques form the critical steps of modern CPR


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In-hospital Cardiac Arrest

  • Essentially unchanged over the last three to four decades

  • Return of spontaneous circulation (ROSC) in about 30% of patients

  • Approximately 15% of patients are discharged neurologically intact


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Interposed Abdominal Counterpulsation14

P=0.007

% occurrence

P=0.02

P=NS


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Out-of-hospital Arrest

  • Hospital admission rates of 8-22%

  • Survival to discharge with intact neurologic function 1-8%

  • Largely unchanged despite multiple additions to the basic components of CPR


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No Long Term Benefit

  • High dose epinephrine

    • Short term improvement (ROSC, hospital admission) 17

    • No long term improvement (hospital discharge and neurologic function) 17,18,19

  • Vest CPR20

    • Trend towards increased rate of ROSC and 24 hour survival but no difference in rate of hospital discharge

  • Transcutaneous pacing21

    • No improvement in rates of hospital admission or discharge


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Active-Compression Decompression

  • Several studies found no improvement22,23

  • Another study24 comparing ACD-CPR to S-CPR found improvement in several endpoints

P=0.0004

P=0.002

% occurrence

P=0.03


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Combination devices

  • Inspiratory impedance threshold devices combined with ACD-CPR26,27

P=0.033

P=0.02

P=0.41

% occurrence

P=0.63


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Automatic External Defibrillators28,29

% occurrence


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Public Access Defibrillation30

P=0.03


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Summary

  • Survival rates with intact neurologic function have changed little over the past 30-40 years

  • Choosing appropriate endpoints for clinical trials will be important to determine which devices will facilitate improvement in long-term outcomes

  • Fostering an environment to enhance clinical research in this field will be important


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