Philips HEARTSTART XLT M3500B Manuale Utente

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Clinical Performance Summary - Cardioversion
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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