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Specifications
A-28
www.zoll.com
9650-001355-01 Rev. M
Results
: The study population of 165 patients had a mean age of 66±12 years with 116 male
patients.
The total efficacy of consecutive rectilinear biphasic shocks was significantly greater than that
of monophasic shocks. The following table displays the Kaplan-Meier (product-limit)
“survival” curves for each of the two waveforms. As all patients begin in the failure mode, the
estimated life-table probabilities refer to the chance of still being in failure after the k
th
shock
(k=1,2,3,4):
As can be seen from the table, the Biphasic experience is superior over the entire course of
shocks delivered. The one degree of freedom chi-square statistic for the Mantel-Haenszel test is
30.39 (p<0.0001). Similarly, the log-rank test, also a one degree of freedom chi-square statistic,
is 30.38 (p<0.0001). The residual number of patients not successfully treated after four shocks
is 5.7% for biphasic compared to 20.8% for monophasic.
There was a significant difference between the first shock efficacy of biphasic shocks at 70J of
68% and that of monophasic shocks at 100J of 21% (p=0.0001, 95% confidence interval of the
difference of 34.1% to 60.7%).
Successful cardioversion with rectilinear biphasic shocks was achieved with 48% less delivered
current than with monophasic shocks (11±1 vs. 21±4 A, p<0.0001).
One half of the patients who failed cardioversion after four consecutive escalating monophasic
shocks were subsequently successfully cardioverted using a biphasic shock at 170J. No patient
was successfully cardioverted using a 360J monophasic shock after the patient had failed
cardioversion with biphasic shocks.
Conclusion
: The data demonstrate the superior efficacy of low energy rectilinear biphasic
shocks compared to high energy monophasic shocks for transthoracic cardioversion of atrial
fibrillation. There were no unsafe outcomes or adverse events due to the use of Rectilinear
Biphasic Waveform.
Table A-3. Kaplan-Meier Estimate for the Probability of Shock Failure
Shock #
Biphasic
Monophasic
0
1.000
1.000
1
0.318
0.792
2
0.147
0.558
3
0.091
0.324
4
0.057
0.208
Summary of Contents for X Series
Page 1: ...Includes Real CPR Help and See Thru CPR X Series Operator s Guide 9650 001355 01 Rev M...
Page 64: ...Chapter 2 Product Overview 2 24 www zoll com 9650 001355 01 Rev M...
Page 74: ...Chapter 3 Monitoring Overview 3 10 www zoll com 9650 001355 01 Rev M...
Page 80: ...Chapter 4 Trends 4 6 www zoll com 9650 001355 01 Rev M...
Page 90: ...Chapter 5 Alarms 5 10 www zoll com 9650 001355 01 Rev M...
Page 110: ...Chapter 7 Monitoring Respiration Resp and Heart Rate HR 7 10 www zoll com 9650 001355 01 Rev M...
Page 126: ...Chapter 8 Monitoring Non Invasive Blood Pressure NIBP 8 16 www zoll com 9650 001355 01 Rev M...
Page 156: ...Chapter 10 Pulse CO Oximetry SpO2 10 18 www zoll com 9650 001355 01 Rev M...
Page 166: ...Chapter 11 Monitoring Invasive Pressures IBP 11 10 www zoll com 9650 001355 01 Rev M...
Page 198: ...Chapter 14 12 Lead ECG Interpretive Analysis 14 16 www zoll com 9650 001355 01 Rev M...
Page 218: ...Chapter 16 Advisory Defibrillation 16 6 www zoll com 9650 001355 01 Rev M...
Page 224: ...Chapter 17 Analysis CPR Protocol Defibrillation 17 6 www zoll com 9650 001355 01 Rev M...
Page 234: ...Chapter 18 External Pacing 18 10 www zoll com 9650 001355 01 Rev M...
Page 242: ...Chapter 19 Real CPR Help 19 8 www zoll com 9650 001355 01 Rev M...
Page 254: ...Chapter 21 Patient Data 21 6 www zoll com 9650 001355 01 Rev M...
Page 338: ...Specifications A 38 www zoll com 9650 001355 01 Rev M...