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Clinical Studies

AJC Article Summary

• The HeartSine® SAMARITAN® SCOPE™ escalating Biphasic waveform (100 J - 150 J - 200 J) had significantly better performance in removing Ventricular Fibrillation than the Heartstream non-escalating biphasic waveform (150 J - 150 J - 150 J ).
  
  
  
  • The data shows that the first shock efficacy for the HeartSine 100 Joule (J) vs. the Heartstream 150 J was statistically equivalent.
    
    
  • The second shock data shows the HeartSine® 150 J vs. the Heartstream 150 J was statistically equivalent (if not slightly better -SAMARITAN® SCOPE = 82% vs. Phillips = 78% [p=NS]).
    
    
  • "However, by the third shock, the SAMARITAN® device (using a 100 - 150 -200 J protocol) showed significantly better performance for discontinuation of VF" (SAMARITAN® SCOPE = 92% vs. Phillips = 83% [p=0.029 - meaning these results were statistically significant]
  
  
• The data presented in this paper is from a "Real World" resuscitation environment and not a closely controlled Cath Lab clinical study (where the patient is put into VF for 15 seconds and shocked out of VF. which is not indicative of a "Real World Resuscitation" or Real World down times). The paper represents data from 78 consecutive patients in cardiac arrest which occurred in the out-of-hospital physician-led ambulance or in-hospital Cardiac Arrest Team events, where down times exceed several minutes (hence a "Real World" environment).
  
  
• The SAMARITAN® SCOPE escalating Biphasic waveform was able to produce significantly better performance even though we had to treat twice as many patients who had a downtime of 9 minutes. The mean response time for in-hospital patients was 1.4 minutes vs. 9 minutes for out-of-hospital patients. When analyzing the data for the Phillips Biphasic unit, they only treated 33% of the out-of-hospital cardiac arrest patients (leaving 67% of the cardiac arrest patients the Phillips device; treated were the "easy to treat "in-hospital patients who had a response time of 1.4 minutes.) Conversely, the HeartSine® SAMARITAN® SCOPE biphasic units treated 68%of the cardiac arrest patients from the out-of-hospital group.

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