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Cardiovascular Collapsed AHA
Cardiovascular Collapsed AHA
Background—The national standard for safe 60-Hz intracardiac leakage current under a single-fault condition is 50 mA.
This standard is intended to protect patients from alternating current (AC) at levels below the threshold for sensation,
but the minimum unsafe level for AC in closed-chest humans is not known. To determine this value, we studied 40
patients at testing of implantable cardioverter-defibrillators using a programmable source of 60-Hz AC.
Methods and Results—We applied AC for 5-second test periods in increasing strengths until ventricular fibrillation (VF)
was induced or 1 mA was reached. Two current paths were tested: bipolar, between tip and ring electrodes of a right
ventricular pacing catheter, and unipolar, from tip to a remote electrode. We observed a characteristic sequence of 3
responses as AC was increased: (1) intermittent ventricular capture with QRS morphology identical to pacing through
the electrodes (minimum value, 20 mA); (2) continuous capture at cycle length 282688 ms (minimum value, 32 mA);
and (3) VF persisting after AC termination (minimum value, 49 mA). Continuous capture caused loss of pulsatile arterial
pressure and cardiovascular collapse (mean arterial pressure, 3268 mm Hg) for the duration of AC with no ECG
evidence of AC stimulation. Thus, the clinical picture was that of hypotensive ventricular tachycardia (VT). The
continuous-capture threshold was #50 mA in 9 patients (22%) for bipolar AC and in 5 (12%) for unipolar AC. All
patients showed continuous capture over a wide range for both bipolar AC (68618 to 2166238 mA) and unipolar AC
(84627 to 2786226 mA).
Conclusions—Leakage current causes cardiovascular collapse at levels below the VF threshold. Stimulation by silent AC
that is neither felt nor visible on the ECG presents as hypotensive VT. In patients with intracardiac electrodes, leakage
current less than or equal to the present standard of 50 mA may cause VT or VF. The safety standard for leakage current
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lasting $5 seconds should be #20 mA. This standard should be based on the continuous-capture threshold. (Circulation.
1999;99:2559-2564.)
Key Words: electrical stimulation n fibrillation n tachyarrhythmias
Received October 26, 1998; revision received February 8, 1999; accepted February 12, 1999.
From the Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, Calif (C.D.S., D.M.G.); Medtronic Inc, Minneapolis, Minn (W.H.O.,
M.E.O.); the Joint Department of Biomedical Engineering at The University of Memphis and the University of Tennessee-Memphis, Memphis, Tenn
(R.A.M.); and the Division of Cardiology, Harbor-UCLA Medical Center, Torrance, Calif (M.L.).
Correspondence to Charles D. Swerdlow, MD, 8635 W Third St, Suite 1190 W, Los Angeles, CA 90048. E-mail swerdlow@ucla.edu
© 1999 American Heart Association, Inc.
Circulation is available at http://www.circulationaha.org
2559
2560 Safe Value for 60-Hz Current
Methods
Figure 1. One patient’s responses to increasing AC. Baseline
Patients rhythm is DDD pacing with varying degrees of ventricular fusion.
We studied 40 patients under propofol anesthesia at postoperative ECG leads I, II, and right ventricular apical electrogram (RVA)
testing of transvenous implantable defibrillators. All patients gave are shown for 5-second applications of bipolar AC at 20, 40,
written informed consent according to a protocol approved by the and 120 mA and unipolar AC at 500 mA. On the RVA electro-
gram, amplitude modulation of the 60-Hz signal is artifact
Human Subjects Committee of Cedars–Sinai Medical Center. Table
caused by the electrophysiological recording system. At 20 mA
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1 shows clinical characteristics of the study patients. At the time of (top), intermittent capture results in predominantly negative QRS
study, all antiarrhythmic drugs had been discontinued for 5 half- complexes in lead II. At 40 mA (second panel), continuous cap-
lives, except for digoxin (3 patients) and b-blockers (7 patients). The ture occurs during AC, resulting in ventricular cycle length of
3 patients in whom atrial fibrillation was the indication for a 200 ms. At 120 mA (third panel), continuous capture degener-
dual-chamber implantable defibrillator had neither spontaneous nor ates to VF. Bottom, Unipolar AC at 999 mA results in continuous
inducible VT or VF. capture at cycle length of 275 ms. Note that even at this level,
AC artifact cannot be detected on surface ECG. In this patient,
Study Procedure the range of continuous capture for bipolar AC is 40 to 110 mA
versus 70 to .999 mA for unipolar AC.
Radial arterial pressure was recorded continuously. We gave AC
through a standard 6F temporary pacing catheter with a distal
electrode area of 15 mm2 and ring-electrode area of 7 mm2 (Explorer, responses occurred as AC was increased (Figure 1): (1) intermittent
Boston Scientific). It was inserted via the right femoral vein and ventricular capture with QRS morphology identical to pacing
positioned with its tip near the right ventricular apex. AC was through the electrodes; (2) continuous ventricular capture with the
delivered from a battery-operated, custom-built, constant-current same QRS morphology; and (3) initial continuous capture progress-
source (Medtronic model 2917 60-Hz fibrillator, IDE No. G970011) ing to sustained VT or VF that persisted after termination of AC. We
that permitted us to program the duration and strength of AC. We defined continuous capture as a consecutive series of stimulated QRS
measured the root-mean-square value of delivered AC using a digital complexes without intervening spontaneous QRS complexes for the
ammeter (model 87 True RMS Multimeter, Fluke Inc). Fixed- duration of AC.
duration AC was applied in increasing strengths until sustained VT AC was increased if intermittent capture was not stimulated by a
or VF was induced or the maximum output of 999 mA was reached. level of 40 mA. If intermittent capture was stimulated, this threshold
Sustained VT was defined as VT requiring termination by cardio- procedure was performed: AC was decreased by 2 levels and was
version or pacing. Sustained VF was defined as VF requiring applied up to 5 times at this and the next-higher level unless
defibrillation. We recorded the 12-lead ECG and right ventricular intermittent capture was induced. This process was iterated until 5
electrogram on optical disk using a multichannel, electrophysiology consecutive AC applications at a given level did not result in
data–acquisition system (Cardiolab 3.1 or 4.0, Prucka, Inc). We also intermittent capture. The weakest AC strength that stimulated any
recorded single-channel ECGs on a monitor designed for intraoper- QRS complexes was defined as the intermittent capture threshold.
ative or intensive care unit use (model M1094A or M1094B, Hewlett We then repeated the threshold process until we determined the
Packard) and on the monitor of an external defibrillator (model continuous-capture threshold and the VF threshold or until we
PD1200, Zoll Medical). The latter 2 monitors meet American Heart reached the maximum output of the fibrillator. If AC induced
Association guidelines for 60-Hz notch filters4 on ECG equipment; sustained VT, the sustained-VT threshold was accepted as an end
the former does not. point, and the VF threshold was not determined. We defined the
sustained-VT/VF threshold as the weakest current that induced either
Threshold Measurement sustained VT or VF. No threshold procedure required .1 decrease
The initial programmed strength of AC was 40 mA. We increased it (step down) in AC. There was a 15-second rest period after each
by 10-mA increments up to 200 mA, by 50 mA between 250 and 600 application of AC that produced continuous capture and a 4-minute
mA, and by 100 mA thereafter. A characteristic sequence of 3 rest after each episode of sustained VT or VF.
Swerdlow et al May 18, 1999 2561
Statistical Analysis
We compared bipolar and unipolar thresholds for intermittent cap-
ture, continuous capture, and sustained VT/VF using paired t tests.
We analyzed possible correlations between selected clinical vari-
ables and threshold values. We analyzed prior myocardial infarction,
left ventricular ejection fraction, and heart failure class to test the
hypothesis that thresholds are lower for patients who have more
advanced heart disease. We performed correlations between thresh-
olds and the clinical variables of body-surface area, age, and sex to
test the null hypothesis.
To analyze reproducibility, we used the Lin concordance coeffi-
cient16 between first and second determinations of each threshold Figure 3. Percentile plot of thresholds for continuous capture
value in the first 20 patients. We used a previously described17 t test and VF (or sustained VT). Cumulative percent of patients is
based on absolute differences normalized by median value to shown on abscissa and root-mean-square AC current (in mA) on
determine whether continuous-capture threshold or VF threshold was ordinate. Squares denote unipolar data; circles, bipolar data.
more reproducible. Solid symbols identify data from patients in whom the only clini-
cal arrhythmia was atrial fibrillation (AF). Top, Thresholds for
continuous capture. Current strength of 50 mA caused continu-
Results ous capture in 5 patients (12%) with unipolar AC and in 9 (22%)
Table 2 shows that group mean values for intermittent- with bipolar AC (P50.49). Bottom, Thresholds for sustained
VT/VF. These plots do not reach 100% because sustained-
capture, continuous-capture, and sustained-VT/VF thresholds VT/VF thresholds exceeded maximum output of stimulator in 6
were lower for bipolar AC than for unipolar AC (P#0.001). patients (15%) with bipolar AC and 8 (20%) with unipolar AC.
2562 Safe Value for 60-Hz Current
patients with intracardiac electrodes. power-line surge, intermediate for current induced by elec-
tromagnetic interference from nearby equipment, or long for
Cardiovascular Collapse Caused by a broken ground wire.
Continuous Capture
Prior Studies Limitations
Green et al5 first described a sequence of 3 responses to We determined the minimum unsafe value of AC, not the
increasing AC that corresponds to the sequence of intermit- maximum safe value. We studied patients under propofol
tent capture, continuous capture, and electrically induced VF anesthesia; thresholds might differ in conscious patients.
observed in the present study. They and other early investi- Most patients in this study had ventricular arrhythmias and
gators were unable to record the ECG during AC because of structural heart disease. However, patients with cardiac dis-
inadequate filtering. They recognized continuous capture by ease are most likely to undergo invasive cardiac procedures
its hemodynamic consequences.5,6,8,9 Subsequent investiga- and thus to be exposed to intracardiac AC.
tors who used filtered ECGs described continuous capture as
“rapid, ineffectual VT”6 and “runs of ectopic beats.”18 In Clinical Implications
canines, continuous capture for 3 to 5 minutes always resulted The principal clinical implication of our study is that AC
in death.8 causes cardiovascular collapse in closed-chest humans at
levels substantially below the VF threshold.
Mechanism A second implication is that the physician cannot rely on
The continuous-capture threshold for AC is substantially the ECG to distinguish continuous capture by AC from
below the capture threshold for a single pacing stimulus. This
spontaneous VT. American Heart Association guidelines
observation suggests that continuous capture at low levels of
require 60-Hz notch filters on ECG equipment to suppress
AC requires a cumulative or summation effect of subthresh-
AC interference,4 and our data show that intracardiac AC at
old stimuli.19 –21
50 mA causes no such interference. Thus, the clinical presen-
Significance tation of continuous capture by AC #50 mA is electrocar-
As a basis for safety standards, the continuous-capture thresh- diographically silent and indistinguishable from hypotensive
old is superior to the VF threshold for the following reasons: VT. Transient continuous capture may be misdiagnosed as
(1) it defines the minimum unsafe level of AC lasting $5 nonsustained VT. This spurious diagnosis may lead to unnec-
seconds; (2) continuous capture results in cardiovascular essary diagnostic procedures, including costly and invasive
collapse over a wide range of AC below the VF threshold; (3) electrophysiological studies. Sustained flow of intracardiac
the continuous capture threshold can be determined without leakage current could present as VT refractory to cardiover-
2564 Safe Value for 60-Hz Current
sion. In this situation, the patient’s survival depends on rapid 5. Green HL, Raftery EB, Gregory IC. Ventricular fibrillation threshold of
interruption of the leakage-current circuit. However, a re- healthy dogs to 50 Hz current in relation to earth leakage currents of
electromedical equipment. Biomed Eng. 1972;7:408 – 414.
sponsible physician would probably treat the patient unsuc- 6. Raftery E, Green H, Gregory I. Disturbances of heart rhythm produced by
cessfully with the sequence of electrical cardioversions and 50 Hz leakage currents in dogs. Cardiovasc Res. 1975;9:256 –262.
antiarrhythmic drugs recommended for VT. In a patient with 7. Raftery EB, Green HL, Yacoub MH. Disturbances of heart rhythm
an intracardiac catheter, leakage current should be considered produced by 50 Hz leakage currents in human subjects. Cardiovasc Res.
1975;9:263–265.
a new mechanism in the differential diagnosis of VT. 8. Roy OZ, Scott JR, Park GC. 60 Hz ventricular fibrillation and pump
A third implication is that under certain circumstances, failure thresholds versus electrode area. IEEE Trans Biomed Eng. 1976;
routine methods would fail to detect leakage-current–induced BME-23:45– 48.
VF, resulting in sudden cardiac death.14 AC at 50 mA is 9. Graystone P, Ledsome J. Microshock hazards in hospital: fibrillation
thresholds: the wrong parameter. In: Digest of the 10th International
below the threshold of cutaneous sensation25 and could thus Conference on Medical and Biologic Engineering. Dresden, Germany,
be conducted through an unsuspecting device operator to an 1973:159.
unsuspecting patient. 10. Weinberg DI, Artley JL, Whalen RE, McIntosh HD. Electric shock
hazards in cardiac catheterization. Circ Res. 1962;11:1004 –1009.
A fourth implication is that safety standards may consider
11. Whalen RE, Starmer CF, McIntosh HD. Electrical hazards associated
the duration of AC and, by implication, its cause. Under with cardiac pacemaking. Ann N Y Acad Sci. 1964;111:922–931.
transient conditions #1 second, such as power-line surges, 12. Bruner J, Leonard PF. Codes and standards: who makes the rules? In:
the 50-mA standard may be safe. Electricity, Safety, and the Patient. Chicago, Ill: Year Book; 1989:
240 –279.
A final implication is that the 50-mA standard is insuffi- 13. Laks M, Arzbaecher RC, Bailey J, Berson A, Briller S, Geselowitz D.
cient to protect patients with intracardiac electrodes from VT Will relaxing safe current limits for electromedical equipment increase
or VF caused by leakage current lasting $5 seconds. Our hazards to patients? Circulation. 1994;89:909 –910.
results indicate that the safety standard for AC lasting $5 14. Laks MM, Arzbaecher RC, Bailey JJ, Geselowitz DB, Berson AS. Rec-
ommendations for safe current limits for electrocardiographs: a statement
seconds must be based on the continuous-capture threshold. for healthcare professionals from the Committee of Electrocardiography,
In the present study, the maximum value that did not cause American Heart Association. Circulation. 1996;93:837– 839.
cardiovascular collapse in any patient was 20 mA. 15. Laks MM, Arzbaecher RC, Bailey JJ, Geselowitz DB, Berson AS.
Comments on “Special report: recommendations for safe current limits
for electrocardiographs.” Circulation. 1997;95:277–278. Letter.
Acknowledgment 16. Lin L. A concordance correlation coefficient to evaluate reproducibility.
This work was done during the tenure of a national Grant-in-Aid Biometrics. 1989;45:255–268.
from the American Heart Association and the Council on Clinical 17. Swerdlow C, Ahern T, Chen P-S. Comparative reproducibility of defi-
Cardiology to Dr Swerdlow. brillation threshold and upper limit of vulnerability. Pacing Clin Electro-
physiol. 1996;19:2103–2111.
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