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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

To address important issues in clinical trial design for new CPR devices 2.Several Goals 1. To provide a clinical summary of the history of CPR and devices to assist with #1 2 .

Chain of Survival ‡ Rapid Access ‡ Cardiopulmonary resuscitation ‡ Early Defibrillation ‡ Advanced cardiopulmonary life support 3 .

Kouwenhoven described chest compression ‡ These two techniques form the critical steps of modern CPR 4 . Safar et al and Elam et al ³rediscovered´ mouth to mouth ‡ In 1960.The Beginnings of CPR ‡ Resuscitation of arrest patients has been attempted for over a century ‡ In the 1950¶s.

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 5 .

02 P=NS IAC S-CPR Hosp D/C Intact Neuro 6 .007 50 40 % occurrence 30 20 10 0 ROSC P=0.Interposed Abdominal Counterpulsation14 60 P=0.

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 7 .

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 8 .No Long Term Benefit ‡ High dose epinephrine ± Short term improvement (ROSC.18. hospital admission) 17 ± No long term improvement (hospital discharge and neurologic function) 17.

23 ‡ Another study24 comparing ACD-CPR to S-CPR found improvement in several endpoints 45 40 35 30 25 20 15 10 5 0 P=0.03 ROSC 24 Hr Intact Neuro Fx 9 .Active-Compression Decompression ‡ Several studies found no improvement22.0004 P=0.002 % occurrence ACD-CPR S-CPR P=0.

63 ACD-CPR + ITD S-CPR 10 .41 P=0.033 P=0.Combination devices ‡ Inspiratory impedance threshold devices combined with ACD-CPR26.02 % occurrence 15 10 5 0 24 Hr Hosp 24 Hr Hosp D/C D/C P=0.27 40 35 30 25 20 P=0.

29 60 50 40 30 % occurrence 20 10 0 Hosp D/C Intact Neuro Fx all arrest VF arrest 11 .Automatic External Defibrillators28.

03 10 5 0 AED + CPR S-CPR 12 .Public Access Defibrillation30 25 20 15 Survival to Hosp D/C P=0.

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 longterm outcomes ‡ Fostering an environment to enhance clinical research in this field will be important 13 .