Clinical Performance Summary
13-20 Specifications & Safety
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Conclusion
The 150J SMART Biphasic waveform defibrillated at higher rates than 200-
360J 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 cate-
gory) (p=0.04).
Biphasic Patients
Number/(Percent)
Monophasic Patients
Number/(Percent)
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
Return of Spontaneous
Circulation
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