ZOLL AED Plus Rev V User Manual

Page 51

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ZOLL AED PLUS Administrator’s Guide

41

The difference in efficacy between the rectilinear biphasic and the monophasic shocks was greater in

patients with high transthoracic impedance (greater than 90 ohms). The first shock, first induction

efficacy of biphasic shocks was 100% versus 63% for monophasic shocks for patients with high

impedance (p=0.02, 95% confidence interval of the difference of -0.021% to 0.759% and 90%

confidence interval of the difference of 0.037% to 0.706%).

A single patient required a second biphasic shock at 150J to achieve 100% efficacy versus six patients

for whom monophasic shocks of up to 360J were required for 100% total defibrillation efficacy.

Conclusion: The data demonstrate the equivalent efficacy of low energy rectilinear biphasic shocks

compared to standard high energy monophasic shocks for transthoracic defibrillation for all patients

at the 95% confidence level. The data also demonstrate the superior efficacy of low energy rectilinear

biphasic shocks compared to standard high energy monophasic shocks in patients with high

transthoracic impedance at the 90% confidence level. There were no unsafe outcomes or adverse

events due to the use of the rectilinear biphasic waveform.

* Kerber, R., et. al., AHA Scientific Statement, Circulation, 1997; 95: 1677-1682:

“... the task force suggests that to demonstrate superiority of an alternative waveform over standard

waveforms, the upper boundary of the 90% confidence interval of the difference between standard and

alternative waveforms must be < 0% (i.e., alternative is greater than standard).”

Monophasic

Biphasic

1st Shock Efficacy (High

Impedance Patients)

63%

100%

p-value

0.02

95% Confidence Interval

-0.021% to 0.759%

90% Confidence Interval

0.037% to 0.706%

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