Electric Shock Hazards In Cardiac Catheterization By Daniel I. Weinberg, M.S.E.E., John L Art ley, D. Eng., Robert E. Whalen, M.D., and Henry D. Mclntosh, M.D. • It has long been recognized that the heart may be fibrillated as well as defibrillated by electric shock. Burchell1 recently emphasized the potential hazard of ventricular fibrillation from electric shock if a pacemaker and an electrocardiograph were connected so that a current existed between them. It seemed possible that many of the techniques used in a cardiac catheter laboratory, especially those involving electrode catheters, may pose a similar threat to patients. The present study was designed to determine the minimum current and voltage that, when delivered directly to the heart via intracardiac catheters, would cause fibrillation in dogs. It was found that a very small current or voltage could produce ventricular fibrillation. Therefore, a detailed analysis of the equipment in a routine catheter laboratory was undertaken to determine usually unrecognized sources of such currents. As a result of these analyses, recommendations are made indicating how this potential hazard can be minimized. Methods ANIMAL STUDIES Five mongrel dogs ranging from 10 to 17 Kg. in weight were nnesthetized with pentobarbital sodium (30 mg./Kg. body weight) administered intravenously. After endotracheal intubation, respiration was maintained with n. positive pressure respirator. Either no. 7 platinum-tipped electrode From tho Cardiovnscular Laboratory, Department of Medicine, and the Department of Electrical Engineoring, Duke University, Durham, North Carolina. Supported in part by Grants H-4807, HTS 5369, and H-6960 from the National Heart Institute of tho National Institutes of Health, U. S. Public Health Service, and grants-in-aid from the Life 1 Insurance Medical Research Fund and the American and North Carolina Heart Associations. This paper is based on a thesis submitted by Mr. Weinberg, in partial fulfillment of the requirements for the degree of Master of Science in Electrical Engineering. Received for publication July 9, 1962. 1004 catheters or no. 7 Lehninn catheters* were introduced into the femoral artery and/or vein and passed under fluoroscopic control into the aorta, right atrium, or either ventricle. These catheters were used as electrodes and to monitor intravaseular pressures. The no. 7 Lehman catheter was filled with either 0.85 per cent or 5 per cent sodium chloride. Pressures were recorded by coupling Statham strain gauge pressure transducers to a photographic recorder-)- which wns also used for continuous recording of the electrocardiogram. In most cases, the current path existed between one intrncardiac catheter nnd a 15-cm.2 metnl plate pressed firmly against the shaven left chest wall over the point of maximal apical impulse. Conducting paste was used to insure good electrical conductivity between the electrode and the skin. In some studies, the current path existed between two intracardiac platinum-tipped electrode catheters. The circuit diagram (fig. 1) shows the circuit used. The transformer, T, isolates the system from the power line ground. The variable output transformer, e, was adjusted to supply the desired voltage. The magnitude of the electric current was calculated (using Ohm's law) after measuring the voltage drop across the resistor, R,, with the vacuum tube voltmeter, Y1. The voltage applied across the catheter and the dog was measured with an A.C. vacuum tube voltmeter, V2. The commercial power line frequency of 60 cycles per second was used for these experiments because: (1) its general availability in the United States makes it the probable frequency used in most catheter laboratories, and (2) it is in the range of frequencies at which tho heart is most sensitive.2 In each study, the current magnitude was gradually increased until ventricular fibrillation developed. This phenomenon was preceded by tho appearance of premature ventricular contractions. When these appeared, the current was increased more slowly. The heart was readily defibrillated by a countershoek of 150 to 450 volts applied across the closed chest. The position of the catheter and the number of studies carried out for each position are listed in table 1. PATIENT STUDIES During normal catheterization procedures in •U. S. Catheter Corporation, Glens Falls, New York. (Electronics for Medicine, Tnc, ^Vhite Plains, New York. Circulation Research, Volume XI, December 106S 1005 ELECTRIC HAZARDS IN CATHETERIZATION this laboratory, the patient lies on a cotton sheet which covers an inflated vinyl air mattress on top of n 1-inch thick foam rubber pad which is placed on the plastic top of a fluoroscopy table. This combination presumably isolates the patient from the grounded table frame. The resistance to ground was measured in 27 pntients by connecting a standard ohmmeter between an arm electrode on the patient and the grounded table frame. This resistance was measured both beforo and after catheterization, both with and without a connection between the patient and the electrocardiograph. The capacitance betweon a patient on the catheter table and the table was measured with a capncitance bridge. Results ANIMAL STUDIES The results of these studies are presented in table 1. The ventricles are clearly more sensitive to the fibrillating effects of an electric current than is the right atrium. Ventricular fibrillation developed on the average with a current of 170 microamperes, a voltage of 0.2 volt, and an impedance magnitude of the current path of 920 ohms. This voltage and impedance were measured with platinumtipped electrode catheters in the heart. The impedance magnitude was calculated from simultaneous voltage and current measurements. The minimum current which produced ventricular fibrillation was 35 microamperes and was recorded when the current existed between two catheters, one in each ventricle. The minimum voltage which produced ventricular fibrillation was 0.06 volt (between the platinum-tipped electrode catheter in the right ventricle and the chest electrode). PATIENT STUDIES The resistance of patients to ground before eatheterization, without electrocardiographic electrodes attached to the patient, was greater than 3 megohms. In 4 of the 27 patients, the resistance dropped from over 3 megohms before the catheterization to an average of 37,000 ohms after the catheterization. These measurements (both before and after catheterization) were made when the electrocardiographic leads were not connected and when there were no catheters in the patient. The patient was not in direct contact with the table. The reduction in resistance after cathCiroulation Reaearch, Volume XI, Deoembsr 106t Electrode Catheter Chest Electrode Figure I. Equipment for applying and measuring voltage and current. riGURE 1 Equipment for applying and measuring voltage and current. (T) isolation transformer, (e) variable voltage transformer, (B{) ammeter shunt, (Vj) voltmeter used to measure current, and (V,) voltmeter used to measure applied voltage. eterization was probably caused by the introduction of a liquid, such as perspiration, saline, or blood, which served as a path between the patient and the table. It is apparent that the events occurring during a catheterization procedure can markedly reduce the resistance of the patient to ground. In the other 23 eases, the resistance remained above 3 megohms. The connection of the electrocardiographic leads provides a relatively low resistance (6,000 ohms) path to ground through the recorder used to trace the electrocardiogram. The catheterization procedure did not appreciably affect this resistance. The capacitance measured between the patient and the table was 700 picofarads (700 X 10"1- farads). Discussion That such small currents can produce electric shock in animals came as something of a surprise. One wonders why ventricular fibrillation caused by electric shock is not more common in cardiac catheter laboratories. The incidence of such catastrophes is unknown, for one learns of such accidents only by "word of mouth." The incidence is probably small, however. Over 2,000 humans with intracardiac catheters connected to electronic recording equipment have been studied in this Cardiovascular Laboratory. There have been four episodes of established ventricular fibrillation. In two of these studies, the catheter 1006 WEINBERG, ABTLEY, WHALEN, McINTOSH TABLE 1 Summary of Results (l) Current path [. Kight vent, to chest TI. Left vent, to cliest III. Kight atrium to chost IV. Right vent, to left vont. Y. Left vent, to chest VI. Left vent, to cheat (2) Electrode typo (3) Number of Dogs Fibr. (4) Fibr. current (microamperes) Mesn S.D. Mln. (6) Fibr. voltage (volts) Min. Mean S.D. (6) Resistance (ohms) Mean S.D. Pt 0 20 60 205 158 0.06 0.18 0.1 920 860 Pt 3 16 40 162 30 0.10 0.21 0.12 910 312 Pt O 7 7,000 •. 7,300 548 1.2 2 27 0.29 439 33 Pt 2 7 35 149 97 0.25 0.33 0.04 1,420 120 5% NaCl 1 O 140 140 0.85% NuCl 1 6 75 110 was in the root of the aorta at the time of arrhythmia. At the time, none of these arrhythmias was thought to have been produced by electric shock since other well-recognized precipitating causes for ventricular fibrillation were present in each case. However, these studies suggest that electric shock could possibly have caused or contributed to the two episodes of arrhythmia that developed with the catheter in the ventricle. The possibility of such an accident occurring requires that cardiac physiologists use the utmost care in laboratory equipment and study design. The type of catheter used in these studies as an electrode did not appear to alter the fibrillating current appreciably. The current magnitude resulting in ventricular fibrillation using the saline-filled catheter is approximately the same as that observed with the platinum-tipped electrode catheter (table 1). The voltage requirements, however, were considerably higher for the saline-filled catheters because of their relatively high resistance. The resistance of the platinum-tipped electrode catheter was measured at 5 ohms; that of the no. 7 Lehman catheter filled with 5 per cent saline solution was 57,000 ohms, while the catheter filled with 0.85 per cent saline had a resistance of 350,000 ohms. There was considerable variation in the current magnitude required to produce ven- 86 12.0 13.0 1.0 93,000 7,000 24.0 30.0 14.0 276,000 31,600 tricular fibrillation in the same and in different dogs. This variation may be due in part to instant-to-instant changes in the metabolic state of the heart. More likely it was caused by variation in the current density in the heart muscle. For a given current, the current density in the muscle will tend to be higher if the two electrodes: (1) are closer together rather than far apart, (2) are small rather than large, (3) are in intimate contact with the muscle rather than having an intermediate volume of blood, and (4) have sharp projections rather than smooth faces. For example, it was possible to induce ventricular fibrillation with an otherwise subfibrillatory current if the electrode catheter was pressed against the heart wall. When no current was in the catheter, manipulation of the electrode against the endocardium might produce extrasystoles but not ventricular fibrillation. The assumption that current density is critical for inducing ventricular fibrillation is consistent with earlier observations by Hooker.3 Although the present studies did not establish that ventricular fibrillation was induced when the electrode was not touching the endocardium, it appears that contact merely facilitates this phenomenon. ANALYSIS OF ELECTRIC SHOCK HAZARDS This study demonstrated that a current as low as 35 microamperes can cause ventricular Circulation Retearch, Volume XI, December l>6t 1007 ELECTRIC HAZARDS IN CATHETERIZATION fibrillation in dogs. A voltage from catheter tip to chest electrode as low as 0.06 volt can produce the same catastrophe. If a safety factor of 10 is introduced to account for unusually sensitive conditions, a current equal to or greater than 3.5 microamperes is a potentially dangerous current. By the same reasoning, it might be assumed that a voltage of 6 millivolts between the catheter tip and the chest electrode is potentially dangerous. In figure 2 is a diagram of a current path which can exist with a possible connection of equipment in normal operating conditions. The essential features of the power supply transformer and the input stage of the amplifier are shown. The intracardiac catheter is connected to the grid of the first stage of the amplifier through a coupling capacitor, Cg. The 1-megohm grid resistor, Rg, is connected to the chassis of the amplifier, as is the center tap of the secondary of the power supply transformer. The case and chassis of the amplifier and power supply in this example are not grounded. RL and CL represent, respectively, the resistance and capacitance of the patient to ground. RL will vary over a wide range depending on whether an electrocardiograph is connected to the patient or whether connection to ground is established during catheterization through liquids spilled on and around the patient. For this analysis, values for RL and CL are assumed to be 10,000 ohms and 700 picofarads, respectively. Therefore, the impedance from patient to ground at 60 cycles per second is essentially 10,000 ohms. The circuit diagram (fig. 2) shows the 60-cycle power supply to the amplifier to be grounded and the switch, S, open between ground and the primary of the supply transformer. The capacitance Ct represents the electrostatic coupling between the primary and secondary windings of the power supply transformer. The capacitance is about 350 picofarads. Rt represents leakage resistance from primary to secondary windings and may be assumed in this example to be 10° ohms. An equivalent circuit of the current pathCirculatioii Research, Volumo XI. December 196t Electrode Catheter Patient Figure 2. Current Pathways. Patient C Figure 3. Equivalent Circuit. /^Chassis Connection -|f Capacitor > Transformer ©Power Ground -"*- Resistor Source -•''-Switch i --HEIectron Tube FIGURES 2 and 3 Current pathtvays. (e) voltage source, (S) power line mvitch, (C,) electrostatic coupling between primary and secondary windings of transformer, (Rt) leakage resistance between transfonner windings, (Cg) input coupling capacitor of amplifier, (RB) grid-leak resistor, (RL) leakage resistance between patient and ground, and (CL) capacitance between patient and ground. Equivalent circuit. Symbols are the same as in figure 2. way described in figure 2 is indicated in figure 3. With the impedances corresponding to the values given in the previous paragraph (ignoring those impedances which have negligible effect) and assuming an applied line voltage of 120 volts, the current in the "heart" is 15.7 microamperes, which is potentially dangerous. Occasionally, in medical electronic equipment, the power supply transformer is shielded to eliminate appreciable capacitive coupling between the primary and secondary windings. If, however (fig. 3), a leakage resistance, Rt, from the primary to secondary 1008 is of the order of 40 megohms, a potentially dangerous current still exists. If a capacitor of 0.01 microfarad (0.01 X 10"6 farads) is placed from the primary winding to the chassis (as is often done to reduce 60 cycle noise),4 approximately 110 microamperes would be delivered to the heart. PRECAUTIONS AGAINST ELECTRIC SHOCK Extrapolating results obtained from experiments on animals to man should always be done with caution. However, if there is a difference in the ventricular fibrillation threshold level in man, the safety precautions to be recommended are still valid. If the actual values are larger, no harm is done by taking these precautions, while if they are smaller, the precautions become even more necessary. Bach cardiac catheter laboratory has its own characteristics. It is, therefore, important that safety practices be established under the supervision of a qualified engineer. The safety program should cover the three phases of operation: (1) design and construction of equipment, (2) operating procedure, and (3) preventive maintenance. The materials and components used in medical equipment should be of the highest quality to minimize the danger of breakdown and electric shock. Where possible, hermetically sealed components and devices should be used to prevent the introduction of moisture and foreign matter which can speed deterioration of insulation and electrical characteristics. Proper grounding of electrical equipment not only reduces the danger to patient and personnel, but also reduces the electrical noise level.5 Properly connected three-prong plugs and receptacles should be used. Such connections cause the ground side of the line to remain the same with respect to the position of ground on the equipment. There should be a common and single ground lead to which all connections are made. This should be large enough to carry ground currents without appreciable voltage drops and should be connected to ground at a point near the entrance of the power system ground into the building. To this common ground should be connected: WEINBEEO, ABTLEY, WHALEN, McINTOSH (1) all chassis and cases of amplifiers, (2) the shield between primary and secondary power supply transformer, (3) one side of amplifier signal input (balanced amplifiers should be grounded by case and chassis), (4) all conductors within reach of patients. The ungrounded side of all circuits should be fused at a level which permits just the proper current required for the instrument. AVhere it is necessary to reclose circuits quickly after a fault, for example, x-ray fluoroscopic equipment, defibrillator, etc., quickly reset circuit breakers rather than fuses should be used. The preventive maintenance program can be divided into two parts: (1) the testing and inspection of the instruments and (2) inspection of the building utilities. The instruments must be inspected and tested for adequate insulation resistance, good insulation condition, proper fusing, and proper ground connections. The building utilities must be tested and inspected for proper ground connections. Insulation resistance should be tested with a meter made for that purpose, which applies 500 volts to the insulation under test and which is used in accordance with the meter manufacturer's instruction. The resistance should be measured periodically. The results should be plotted on a graph, as a function of time. In this way, a drop in resistance can be detected and the cause corrected before a dangerous condition arises. Ground resistance should be tested with an instrument which applies a current of several amperes. The resistance should be low enough so the voltage drop to the common ground point in the room, under the maximum fault current, will not exceed 0.01 volt. These tests and inspections should be made by conscientious, qualified technicians. Visual inspections should be made daily for proper connections, frayed insulation, etc. The resistance of the insulation and ground connections should be measured upon receipt of equipment, whenever equipment is changed, and monthly until a history of normal values is obtained. After normal values are deterCirculation Reacarah, Volume XI, December 196t 1009 ELECTRIC HAZARDS IN 0ATHETERIZAT1ON mined, measurements every three months should suffice. The building ground should be tested whenever there is a change in the electrical system, as well as every three months. RECOMMENDED LABORATORY PROCEDURE Before an electrode catheter is connected to a patient, but after it is connected to its amplifier, the potential between the catheter and the patient and between the catheter and ground should be measured with a sensitive, high-impedance voltmeter (A.C. and D.C.). If a dangerous potential exists, the catheter should not be connected to the patient until the source of the voltage has been determined and the situation corrected. If, after the catheter has been inserted, additional electrical connections are made to the patient, the potential of the new lead with respect to the patient and with respect to ground should be similarly measured. Summary 1. These studies demonstrate that ventricular fibrillation can be produced in anesthe- tized, mechanically ventilated dogs by a current as low as 35 microamperes and a voltage as low as 0.06 volt. 2. Analysis of circuits of medical electronic equipment which is usually considered safe indicates that such low current levels may exist in the heart during eatheterization. 3. The safety procedures established for our laboratory to minimize the hazard of electric shock are presented. References 1. BUROHELL, H. B.: Hidden hazards of enrdinc pacemakers. Circulation 24: 161, 1961. 2. KOUWENHOVEN, W. B., HOOKER, D. K., AND LOTZ, E. L.: Electric shock effects of fre quency. Electrical Engineering 55: 384, 1936. 3. HOOKER, D. B., KOUWENHOVEN, W. B., AND LANGWORTHY, O. R.: Effect of alternating current on the heart. Am. J. Physiol. 103: 444, 1933. •1. GEIQES, K. S.: Measurement of electric shock hazard in radio equipment. Underwriters Laboratories, Inc. Bull. Res., vol. 33, I!)4i5. 5. National Electrical Code, Standard of the National Board of Fire Underwriters. New York, National Board of Fire Underwriters, 1959. Book Review Physiologie Hnmalne. Oellnlaire et Organique, H. Laborit. Pnris, Masson & Cie, 1961, 585 pages, illustrated. $12.00 soft cover, $13.60 hard cover. Laborit relates the most important data pertaining to human physiology. He emphasizes, "that, in the cell, the life appeal's to us as the ionisation of the molecule of hydrogen carried with the substrates. How this molecule is transported into the cell, by what procedures it is ionised, how hydrogen ion is used and then expelled from the organism ore the questions which we try to answer in every page. It is the key concept which guides the whole book." The author is perfectly aware of cybernetics, Circulation Research, Volume XI, December 196t and this science provides concepts and schemes useful in illustrating the reactions of equilibrium and autoregulation mechanisms of the orgonism. This book is written primarily for physicians. The general principles of physics and chemistry necessary for the understanding of physiology are concisely explained. Then, every function is described according to widely accepted facts. At the end of every chapter, the author communicates his own ideas and comments, creating a lively synthesis of physiology. He knows how to stimulate the interest and the critical attitudes of the reader, and it is this which makes the reading of this book fascinating for everyone interested in physiology.