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
