Michael J. Kallok

Internal cardiac defibrillation in man: pronounced improvement with sequential pulse delivery to two different lead orientations.

Wider applicability of an implantable automatic defibrillator depends on achieving internal cardiac defibrillation consistently with the lowest possible energy. In animal studies, we have found that the cardiac defibrillation threshold could be reduced when sequential shocks separated in time and spacially arranged were delivered to the heart. We compared internal cardiac defibrillation using a single pulse shock delivered through an intravascular catheter with this new method for internal cardiac defibrillation in patients undergoing cardiac surgery for the correction of arrhythmias. For the single pulse shock and the first pulse of the sequential pulse shock, current was passed through an intravascular catheter with the catheter cathode at the apex of the right ventricle and the anode at the superior vena cava-atrial junction region. The second pulse of the sequential pulse countershock was delivered between the catheter cathode in the right ventricular apex and an oval plaque electrode secured on the laterobasal left ventricular epicardium as anode. With the single pulse alone for shock delivery, 12 patients could be defibrillated with an average of 20.1 +/- 16.8 J, with a corresponding leading-edge peak voltage and current of 836 +/- 319 V and 9.4 +/- 4.5 A, respectively. However, two of the patients could not be defibrillated with energies below 50 J. With the sequential pulse shock delivery, a significant reduction in all values were recorded. Mean total energy for defibrillation averaged 7.7 +/- 6.0 J. Leading-edge peak voltage and current from the catheter averaged 430 +/- 148 V and 5.0 +/- 2.8 A, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Double and triple sequential shocks reduce ventricular defibrillation threshold in dogs with and without myocardial infarction

The role of optimal placement of electrodes and mode of shock delivery from a defibrillator was examined in dogs with and without myocardial infarction. Single, double and triple truncated exponential shocks separated by 1 ms were delivered through various electrode combinations and cardiac vectors after electrical induction of ventricular fibrillation. A single shock through a pathway not incorporating the interventricular septum (catheter electrodes or epicardial patches between anterior and posterior left ventricle) required the highest total energy (22.6 and greater than 26.4 J, respectively) and peak voltage (1,004 and greater than 1,094 V, respectively) to terminate ventricular fibrillation. A single shock through a pathway including the interventricular septum required lower total energy and peak voltage to defibrillate. Combinations of two sequential shocks between an intracardiac catheter electrode and anterior left ventricular epicardial patch, between the catheter electrode and subcutaneous extrathoracic plate and between three ventricular epicardial patches all significantly reduced total energy (7.7, 8.7 and 7.8 J, respectively) and peak voltage (424, 436 and 424 V, respectively) needed to defibrillate. Three sequential shocks exerted no significant additional reduction in total energy of the defibrillation threshold than did two sequential shocks. Infarcted canine heart required less peak voltage but not total energy to terminate ventricular fibrillation than did noninfarcted heart. Therefore, two sequential shocks over different pathways reduce both total energy and peak voltage required to terminate ventricular fibrillation.

Improved internal defibrillation with twin pulse sequential energy delivery to different lead orientations in pigs

Internal cardiac defibrillation with an intravascular catheter was compared with a new method for internal cardiac defibrillation using 2 pulses delivered in sequence directly to the myocardium. For the sequential pulses, the first pulse was passed through an intravascular catheter (Medtronic 6880), between the anode in the superior vena cava-atrial junction region and the cathode in the apex of the right ventricle. The second pulse was delivered between the catheter tip in the right ventricular apex as cathode and an oval plaque electrode (Medtronic TX-7) secured on the epicardium of the left ventricular free wall as anode. Defibrillation pulses were of truncated, trapezoidal waveform (65% tilt), separated by 1, 10 and 100 ms. Using the catheter alone, 36 normal pig hearts could be defibrillated by 44 J. However, 22 pig hearts (60%) could not be defibrillated with energies below 35 J. Defibrillation threshold was improved with sequential twin pulses, the improvement being dependent on pulse separation (42, 34 and 19 J, at 100-, 10- and 1-ms separation, respectively; F = 14.6, df = 2.29, p less than 0.01). In conclusion, sequential twin pulse defibrillation provides a considerable reduction in energy necessary for defibrillation in comparison to single pulses using the catheter alone. In this study, the optimal separation was 1 ms.

Low energy counterchock using an intravascular catheter in an acute cardiac care setting

We examined the feasibility, effectiveness, and safety of using an intravascular catheter positioned in the right ventricular apex for countershock in a coronary care unit setting in 8 patients who had recurrent ventricular tachyarrhythmia. Countershock using 2.5 to 40 J stored energy (damped sinusoidal wave form) was attempted 115 times to terminate 100 episodes of ventricular tachyarrhythmia (ventricular tachycardia, 91; ventricular flutter, 3; ventricular fibrillation, 6). Eighty-six (87%) of 99 countershock attempts for ventricular tachycardia, 3 (60%) of 5 for ventricular flutter, and 4 (36%) of 11 for ventricular fibrillation were successful using this technique. The catheters remained in stable position for 1 to 16 days without dislodgment. A majority of the countershocks were delivered by the regular nursing staff in the coronary unit. We conclude that low energy countershock through an intravascular catheter system is feasible, safe, and effective in a coronary care unit setting. Such a system should be beneficial in the acute management of patients who have recurrent ventricular tachycardia or fibrillation. The catheter lead may also prove useful in managing ventricular tachyarrhythmias that occur during electrophysiologic studies.

Feasibility of an implantable arrhythmia monitor.

Conventional Holter monitoring is of limited benefit in patients with infrequent symptoms suspected to be related to arrhythmia. A small recorder implanted subcutaneously might obviate many limitations of conventional monitoring. To determine the feasibility of obtaining adequate electrocardiographic signals from such a device, a prototype was temporarily implanted in 17 patients undergoing pacemaker implantation. The prototype contained four disc‐shaped titanium electrodes, 0.21 inches in diameter embedded in epoxy. The four electrodes were in a square configuration spaced 0.72 inches center to center and were placed face down in a subcutaneous pocket in the left pectoral region. Bipolar recordings were made from a horizontal pair, a vertical pair, and both diagonal pairs of electrodes (interelectrode distance 1.02 inches) and recorded on electromagnetic tape after filtering at 0.5‐250 Hz. The mean peak‐to‐peak amplitude in each configuration was determined over a five‐beat interval. Clear recordings were obtained from all 17 patients with recognizable P, QRS, and T waves. The amplitude of the signals obtained from the diagonal pairs of electrodes (175 ± 51 and 170 ± 54 μV) were greater than obtained from either the vertical pair (142 ± 62 μV, P = 0.08 compared to diagonal electrodes] or the horizontal pair of electrodes (105 ± 54 μV, P < 0.01). The maximum amplitude recorded from any configuration was 189 ± 54 μV. In six patients the device was also tested with the electrodes face up in the subcutaneous pocket. In this position, there was a slight decrease in signal amplitude (maximum amplitude electrodes face up 136 ± 49 μV compared to 144 ± 49 μV face down, P = NS), but baseline stability was greatly improved during pectoral muscle contraction. These results demonstrate that a device with an interelectrode distance of 1 inch is able to record adequate electrocardiographic signals when placed subcutaneousiy in the left pectoral region. A fully implantable device of similar size, with continuous loop memory and telemetry, might be useful in patients with recurrent unexplained syncope.

Prediction of defibrillation success from a single defibrillation threshold measurement with sequential pulses and two current pathways in humans.

The ultimate aim of defibrillation testing is to predict consistent defibrillation. This study tested the hypothesis that defibrillation success could be predicted from a single measurement of defibrillation threshold. We measured defibrillation threshold by using three patch electrodes and a standard protocol intraoperatively in 49 patients undergoing arrhythmia surgery. Each patient was then assigned to one of five energy subgroups (0.5, 1.0, 1.5, 2.0, or 2.5 times defibrillation threshold) for a single shock (followed by a rescue shock if necessary) for a subsequent ventricular fibrillation episode. A curve relating percent success to energy was then constructed for the group. Defibrillation threshold averaged 4.7 +/- 2.98 J for the group (mean +/- SD). There was a curvilinear relation between the energy of the defibrillation threshold ratio test shock and percent success: 33.3%, 58.3%, 81.8%, 91.7%, and 100% at mean defibrillation threshold ratios of 0.56 +/- 0.14, 1.02 +/- 0.07, 1.53 +/- 0.14, 1.88 +/- 0.09, and 2.60 +/- 0.14, respectively. We conclude that consistent defibrillation is predictable from a single measurement of defibrillation threshold. Furthermore, for an individual patient, a safety margin of 2.6 times defibrillation threshold should approximate 100% successful defibrillation for a single test shock.

A Model to Evaluate Alternative Methods of Defibrillation Threshold Determination

The voltage (or, equivalently, energy) at which defibrillation occurs for a specific episode of fibrillation can be represented by specifying or estimating the probability of successful defibrillation for each voltage or energy. This relation of voltage to probability is the probability function. For a series of attempts, the probability function predicts the frequency with which defibrillation will occur at a given voltage. By defining the defibrillation threshold (DFT) as the voltage at which the probability function takes on a specific value, say 50%, a method of defibrillation threshold determination can be evaluated by how accurately and precisely it estimates the “true” defibrillation threshold. By utilizing estimated probability functions from animals and humans, the relative performance of different methods of defibrillation threshold determination can be evaluated. Three methods were evaluated using published animal data and human clinical data: (1) stepping down to the first voltage that fails; (2) stepping up to the first voltage that succeeds; and (3) doing both 1 and 2 and averaging. In all cases, Method 3 has lower total error. Definitions of defibrillation threshold other than the 50% level can also be evaluated in this fashion.

Increased defibrillation threshold with right-sided active pectoral can.

The aim of this study was to identify the optimal position on the chest wall to place an implant able cardioverter defibrillator in a two-electrode system, consisting of a right ventricular electrode and active can.Methods and Results: Defibrillation thresholds (DFT) were measured in 10 anaesthetised pigs (weight 33–45kg). An Angeflex™ lead was introduced transvenously to the right ventricular apex. The test-can (43cc) was implanted submuscularly in each of four locations: left pectoral (LP), right pectoral (RP), left lateral (LL) and apex (A). The sequence in which the four locations were tested was randomized. Ventricular fibrillation (VF) was induced using 60Hz alternating current. Rectangular biphasic shocks were delivered 10 seconds after VF induction. The DFT was measured using a modified four-reversal binary search. The results of the four configurations were: LP, 14.6± 4.0J; RP, 18.8± 4.2J; LL, 14.7± 4.1J; A, 14.9± 3.1J. Repeated measures analysis of variance showed that the DFT of RP was significantly higher than LP, LL and A (p < 0.05).Conclusions: Implanting an active can in the RP position increases the DFT by 29% compared to LP, LL and A sites. The can position on the left thorax does not appear to have a significant influence on DFT.

Internal Ventricular Defibrillation with Sequential Pulse Countershock in Pigs: Comparison with Single Pulses and Effects of Pulse Separation

We compared single to sequential pulse shocks with different pulse separations on internal cardiac defibrillation by using a catheter and plaque electrodes in open‐chest halothane‐anesthetized pigs. Ten seconds after fibrillation onset, defibrillation was attempted using trapezoidal pulses of 65% tilt, approximately 5 ms duration and fixed outputs from 1.0 to 50 joules (J). With single pulses, minimum defibrillation energy for the catheter alone was 2.4 ± 0.3 J/kg (mean ± standard error) and 2.1 ± 0.2 J/kg for the catheter tip to plaque configuration. With sequential pulse shocks, the first pulse delivered via the catheter and the second pulse from the catheter tip to the plaque electrode, the energy necessary for defibrillation was dependent on the separation time between the two pulses (2.0 ± 0.2, 1.5 ± 0.2, 0.9 ± 0.1, 1.3 ± 0.3, 0.6 ± 0.2, and 1.2 ± 0.2 J/kg at 100, 10, 1, 0.5, 0.2, and 0.1 ms, respectively). Further, at the 0.2 ms separation, 100% of the animals could be defibrillated with less than 2.0 J/kg (35 J total). We conclude that sequential pulse defibrillation provides a significant improvement over single pulse defibrillation. The optimum separation between the sequential pulses in this study was 0.2 ms.

Reduction in Defibrillation Threshold Using an Auxiliary Shock Delivered in the Middle Cardiac Vein

Defibrillation in the middle cardiac vein (MCV) has been shown to reduce ventricular defibrillation thresholds (DFTs). Low amplitude auxiliary shock (AS) from an electrode sutured to the left ventricle at thoracotomy have also been shown to reduce DFT if delivered immediately prior to a biphasic shock (between the ventricular RV and superior vena caval (SVC) electrodes). This study investigates the impact on DFT of an AS shock from a transvenously placed MCV lead system. A standard de‐fibrillation electrode was positioned in the RV in eight anesthetized pigs (35–43 kg). A 50 × 1.8‐mm electrode was inserted in the MCV through an 8 Fr angioplasty guide catheter. A 150‐V (leading edge) monophasic AS was delivered (95 μF capacitor) from the MCV → Can with three different pulse widths (3, 5, 7 ms). A primary biphasic shock (PS) (95 μF capacitor, phasel: 44% tilt, 1.6‐ms extension and phase 2: 2.5‐ms fixed duration) was delivered from the RV → Can ± AS. The four configurations were randomized and DFTs (PS + AS) assessed using a modified binary search. Ventricular fibrillation (VF) was induced with 60 Hz AC followed 10 seconds later by the test shock. The DFTs were compared using repeated measures analysis of variance (ANOVA). All configurations incorporating AS produced significant (P < 0.05) reduction in the DFT compared to no AS (13.8 ± 7.4 J). There was no difference in the efficacy of differing pulse widths (P > 0.05); 3 ms (11.0 ± 5.4 J), 5 ms (11.5 ± 6.0), and 7 ms (10.6 ± 5.3 J). In conclusion, delivering an AS from a transvenous lead system deployed in the MCV reduces the DFT by 23% compared to a conventional RV → Can shock alone.