Clinical Performance Summary - Cardioversion

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

Monophasic Patients

P Value

 

 

 

Number (Percent)

Number (Percent)

 

 

 

 

 

 

 

 

 

 

 

Cumulative

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cardioversion Efficacy

 

 

 

 

 

 

 

Single shock only

58/96

(60%)

24/107

(22%)

<0.0001

 

13

<2 shocks

74/96

(77%)

47/107

(44%)

<0.0001

 

<3 shocks

86/96

(90%)

57/107

(53%)

<0.0001

 

 

<4 shocks

87/96

(91%)

91/107

(85%)

.29

 

 

 

 

 

 

 

 

 

 

Skin “burn”

 

 

 

 

0.0001

 

 

None

25/90

(28%)

15/105

(14%)

 

 

 

Mild

50/90

(56%)

47/105

(45%)

 

 

 

Moderate

15/90

(17%)

41/105

(39%)

 

 

 

Severe

0/90

(0%)

2/105

(2%)

 

 

 

 

 

 

 

 

 

Number of shocks

1.7 + 1.0

2.8 + 1.2

<0.0001

 

 

 

 

 

 

 

 

Cumulative delivered

217 + 176J

548 + 331J

<0.0001

 

 

energy

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

Mild - erythema, no tenderness

 

 

 

 

 

 

Moderate - erythema, tenderness

 

 

 

 

 

 

Severe - blistering or necrosis, tenderness

 

 

 

 

 

 

 

 

 

 

 

 

 

M3500B HeartStart XLT Defibrillator/Monitor

13-17

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Image 163
Philips M3500B manual Biphasic Patients Monophasic Patients Value Number Percent