Clinical Performance Summary - Cardioversion 21 Specifications and Safety
295
Table 83 Clinical Summary - Cardioversion
Conclusion
The SMART Biphasic waveform cardioverted at higher rates than the monophasic damped sine
waveform at each step of the protocol, although the cumulative biphasic rate after 4 shocks was not
significantly different from the monophasic rate. Tissue damage was more pronounced in the
monophasic population.
Biphasic Patients
Number (%)
Monophasic Patients
Number (%)
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%)
56/107 (53%)
91/107 (85%)
<0.0001
<0.0001
<0.0001
0.29
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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