Agilent Technologies Heartstream FR2, User Manual

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F-2
Clinical Summary
The 150 J SMART Biphasic waveform defibrillated 98% of VF patients in the first
series of three shocks or fewer compared with 69% of patients treated with
monophasic waveform shocks. Outcomes are summarized as follows:
Conclusions
The 150 J SMART Biphasic waveform defibrillated at higher rates than the 200-360 J
monophasic waveforms, resulting in more patients achieving return of spontaneous
circulation (ROSC) (p=0.01). EMS system outcomes of survival discharge were not
significantly different statistically. However, patients resuscitated with the
lower-energy SMART Biphasic waveform were more likely to have good cerebral
performance (CPC, cerebral performance category) (p=0.04).
SMART Biphasic Patients
Number (%)
Monophasic Patients
Number (%)
P Value
(chi square)
Defibrillation Efficacy
Single shock only
</= 2 shocks
</= 3 shocks
52/54 (96%)
52/54 (96%)
53/54 (98%) 36/61 (59%)
39/61 (64%)
42/61 (69%) <0.0001
<0.0001
<0.001
Patients Defibrillated
54/54 (100%) 49/58 (84%) 0.003
ROSC
41/54 (76%) 33/61 (54%) 0.01
Survival to Hospital Admission 33/54 (61%) 31/61 (51%) 0.27
Survival to Hospital Discharge 15/54 (28%) 19/61 (31%) 0.69
CPC = 1 (Good)
13/15 (87%) 10/19 (53%) 0.04