Philips HEARTSTART XLT M3500B User Manual

Page 163

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Clinical Performance Summary - Cardioversion

M3500B HeartStart XLT Defibrillator/Monitor

13-17

13

The 150J SMART Biphasic waveform successfully converted far more
patients with an initial 100J shock (60% compared with 22% for the
monophasic waveform), and successfully converted patients at least as well
with a maximum energy of 200J as the monophasic did with its maximum
energy of 360J (91% compared to 85% for the monophasic waveform). Over-
all, the biphasic waveform required fewer shocks (1.7, compared to 2.8 for the
monophasic waveform) and lower delivered energy (217J, compared to 548J
for the monophasic waveform). Outcomes are summarized in , Table 13-4.

Table 13-4 Clinical Summary - Cardioversion

Biphasic Patients

Number (Percent)

Monophasic Patients

Number (Percent)

P Value

Cumulative
Cardioversion Efficacy

Single shock only
<2 shocks
<3 shocks
<4 shocks

58/96 (60%)
74/96 (77%)
86/96 (90%)
87/96 (91%)

24/107 (22%)
47/107 (44%)
57/107 (53%)
91/107 (85%)

<0.0001
<0.0001
<0.0001

.29

Skin “burn”

None
Mild
Moderate
Severe

25/90 (28%)
50/90 (56%)
15/90 (17%)

0/90 (0%)

15/105 (14%)
47/105 (45%)
41/105 (39%)

2/105 (2%)

0.0001

Number of shocks

1.7 + 1.0

2.8 + 1.2

<0.0001

Cumulative delivered
energy

217 + 176J

548 + 331J

<0.0001

Skin reaction definitions: (Evaluated 24 - 48 hours after procedure)

Mild - erythema, no tenderness
Moderate - erythema, tenderness
Severe - blistering or necrosis, tenderness

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