Douglas J. Lang

Implantable cardioverter defibrillator lead technology : improved performance and lower defibrillation thresholds

The performance of an ICD system depends, in part, on the effectiveness with which the lead system functions. Engineering trade‐offs are made during the design of a lead to optimize one or more performance characteristics: e.g., lead handling, fatigue life, size, and optimized therapy delivery. To assure low defibrillation thresholds, careful attention must be taken during the design process to prevent these trade‐offs from hampering the leads therapy effectiveness. Four basic design rules are described that capture many of the engineering concepts that will enhance a leads efficacy: (1) minimize electrode pullback, (2) deliver current to the apex, (3) minimize energy loss in the lead, and (4) use large, efficient electrodes. These rules speak to optimizing delivery of current to the heart and efficiency of the lead and electrode interface. When the lead performs its function well, the complete ICD system of the heart, lead, and implantable pulse generator will provide optimal safety margins for device implant and an increased number of patients that can be implanted with a single‐lead system.

A New Defibrillator Discrimination Algorithm Utilizing Electrogram Morphology Analysis

Inappropriate therapies delivered by implantable cardioverter defibrillators (ICDs) for supraventricular arrhythmias remain a common problem, particularly in the event of rapidly conducted atrial fibrillation or marked sinus tachycardia. The ability to differentiate between ventricular tachycardia and supraventricular arrhythmias is the major goal of discrimination algorithms. Therefore, we developed a new algorithm, SimDis, utilizing morphological features of the shocking electrograms. This algorithm was developed from electrogram data obtained from 36 patients undergoing ICD implantation. An independent test set was evaluated in 25 patients. Recordings were made in sinus rhythm, sinus tachycardia, and following the induction of ventricular tachycardia and atrial fibrillation. The arrhythmia complex is defined as wide if the duration is at least 30% greater than the template in sinus rhythm. For narrow complexes, four maximum and minimum values were measured to form a 4‐element feature vector, which was compared with a representative feature vector during normal sinus rhythm. For each rhythm, any wide complex was classified as ventricular tachycardia. For narrow complexes, the second step of the algorithm compared the electrogram with the template, computing similarity and dissimilarity values. These values were then mapped to determine if they fell within a previously established discrimination boundary. On the independent test set, the SimDis algorithm correctly classified 100% of ventricular tachycardias (27/27), 98% of sinus tachycardias (54/55), and 100% of episodes of atrial fibrillation (37/37). We conclude that the SimDis algorithm yields high sensitivity (100%) and specificity (99%) for arrhythmia discrimination, using the computational capabilities of an ICD system.

Effect of Shock Timing on Defibrillation Success

The goal of this study was to determine whether delivering transvenous defibrillation shocks, coordinated with the up/down‐slope VF waveform patterns in the shocking lead, would improve the probability of successful defibrillation. Anesthetized swine (32–38 kg, n = 8) were implanted with an RV → SVC + SQArray transvenous system to measure VF waveform patterns and to deliver shocks. The shocks were generated by a Cardiac Pacemakers Inc. biphasic waveform generator. Energy required for 50% success probability (E50) was determined using the multishock up‐down protocol. VF was repeatedly induced and defibrillation shocks at E50 were given after 10 seconds. The defibrillation outcome, delivered energy (Ed), peak voltage (V), peak current (I), system impedance (Z) and VF waveform pattern at the time of shock were recorded and measured. Out of a total of 685 shocks, 324 (47%) succeeded and 361 (53%) failed. The Ed, V, I, and Z were similar for the two defibrillation outcome groups (success or failure). VF patterns were classified as high or low amplitude at the time of the shock based on the peak‐to‐peak amplitude of signals recorded between shocking electrodes. Shocks that coincided with high amplitude VF patterns were further divided into shocks that occurred on the up‐slope or on the down‐slope. The probability of success when the E50 shocks were coincident with high or low amplitude fibrillation did not differ significantly (Students t‐test: 46% vs 48%, P = NS). However, during high amplitude fibrillation, shocks delivered on the up‐slope were significantly more successful than those delivered on the down‐slope (Chi‐square: 67% vs 39%; P < 0.001). These results suggest that delivering defibrillation shocks during the up‐slope of the high amplitude signal in the shocking lead may improve the probability of successful defibrillation of ICDs.

Comparison of Impedance Minute Ventilation and Direct Measured Minute Ventilation in a Rate Adaptive Pacemaker

Respiration rate (RR) and minute ventilation (MV) provide important clinical information on the state of the patient. This study evaluated the accuracy of determining these using a pacemaker impedance sensor. In 20 patients who were previously implanted with a Guidant PULSAR MAX group of pacemakers, the telemetered impedance sensor waveform was recorded simultaneously with direct volume respiration waveforms as measured by a pneumatometer. Patients underwent 30 minutes of breathing tests while supine and standing, and a 10‐minute ergonometer bicycle exercise test at a workload of 50 W. Breathing tests included regular and rapid‐shallow breathing sequences. RR was determined by a computerized algorithm, from impedance and respiration signals. The mean RR by impedance was 21.3 ± 7.7 breaths/min, by direct volume was 21.1 ± 7.6 breaths/min, range 7–66, the mean difference of RR measured by the impedance sensor, as compared with the true measurement, being 0.2 ± 2.1 breaths/min. During the entire exercise, the mean correlation coefficient between impedance (iMV) and direct measured MV was 0.96 ± 0.03, slope 0.13 ± 0.05 L/Ω and range 0.07–0.26 L/Ω. Bland‐Altman limits of agreement were ± 4.6 L/min for MV versus iMV with each patient calibrated separately. The correlation coefficient for iMV versus MV over the entire 10 minutes of exercise, including the initial 4 minutes of exercise, was 0.99. The transthoracic impedance sensor of an implanted pacemaker can accurately detect respiration parameters. There was a large variation between subjects in the iMV versus MV slope during a bicycle exercise test, whereas for each subject, the slope was stable during submaximal bicycle exercise. (PACE 2003; 26:2127–2133)

A preview of implantable cardioverter defibrillator systems in the next millennium: an integrative cardiac rhythm management approach

The implantable cardioverter defibrillator (ICD), a primary therapeutic option for preventing sudden cardiac death, has rapidly evolved since being introduced clinically in 1980. Technologic advances in several key areas have enabled ICDs to provide more sophisticated rhythm management. Recent emphasis has been placed on dual-chamber ICDs possessing adaptive-rate pacing capabilities. Adoption of dual-chamber ICD systems has been rapid. The capabilities of future ICD systems will be governed by an integrative strategy that brings together sets of features specifically targeted at multifaceted rhythm disorders. The addition of atrial therapy will require more sophisticated rhythm discrimination algorithms. ICD technology will improve on several fronts including leads, integrated circuits, batteries, and capacitors. Additionally, state-of-the-art pacemaker technology will continue to be incorporated into ICDs. As these new ICD systems become increasingly sophisticated from an engineering viewpoint, tremendous emphasis will be placed on decreasing the complexity of programming, device interrogation, and patient monitoring during routine patient follow-up. Vast improvements in ICD programming systems may ultimately permit the 1-minute follow-up.

Large Capacitor Defibrillation Waveform Reduces Peak Voltages Without Increasing Energies

This study tested the hypothesis that increasing capacitance would allow a reduction in ICD size without reducing the deliverable energy. For example, the volume of a single 450 μF capacitor (390 V peak) is 1/3 less than that of two 250 μF capacitors (780 V), but it can store equivalent amounts of energy.Methods: Endocardial defibrillation electrodes (3.4 cm) were positioned in the RV apex and at the RA/ SVC junction in six mixed‐breed, isoflurane anesthetized pigs (41 ± 3 kg). Three 17‐cm ribbon wires were positioned subcutaneously on the left lateral chest (SQArray). Two CPI VENTAK ECDs were equipped to deliver 60/40 biphasic waveforms using either 125 μF (STD) or 500 μF (LD) of capacitance. A 15 shock up/down protocol was used to determine the 50% probability of success levels for each waveform in each animal. Shocks were delivered from RV(‐)→SVC + SQArray(+) in random order. Results were compared using paired Studentsf‐tests and are reported as mean ± SE. Results: The 500 μF long duration waveform reduced peak voltage 41% (374 ± 18 V [STD] vs 219 ± 14 V (LD], P < 0.001) and reduced peak current 38% (11.0 ± 1.1 A [STD] vs 6.8 ± 0.6 A [LD], P < 0.001) but did not significantly change the delivered energy(12.4 ± 1.3 J [STD] vs 13.4 ± 1.0 J [LD]). Durations increased from 10.0 ± 0.2 to 17.6 ± 0.5 msec (P < 0.001).Conclusions: Defibrillation with a 500 μF, long duration biphasic defibrillation waveform received similar amounts of energy but significantly reduced peak voltage and current compared to a waveform produced from 125 μF. A single large capacitor could be used to reduce the physical size of an ICD compared to the standard two capacitor system.

Future of bradyarrhythmia therapy systems: automaticity.

Since the first fixed-rate ventricular pacemaker was introduced in the late 1950s, pacing systems have evolved rapidly. Current developments focus on making devices more sophisticated and less complex--a challenging combination. Automaticity features such as beat-by-beat capture verification, sensitivity threshold adaptation, and algorithms to govern dynamically the maximum sensor rate have either recently been introduced or are likely to be introduced in the near future. Technologic advances are likely to allow meaningful improvements in current drain, battery performance, memory capacity, signal processing, telemetry, and programmer interface. Bradyarrhythmia therapy devices of the future promise to go beyond the pacemaker. Ultimately, pacing systems will become part of integrated cardiac rhythm management systems.

Shock timing lowers transvenous defibrillation energy requirement

Previous studies suggested that time periods exist during ventricular fibrillation when defibrillation shocks are more effective. However, there is no agreement on the amount of energy that can be saved or whether an implantable defibrillator can time shocks to these time periods. We conducted a study having two parts to investigate if there was any advantage to synchronizing internal defibrillation shocks to morphological patterns in ventricular fibrillation (VF). VF electrograms were recorded from the same three-electrode lead system used for internal defibrillation. In Part 1, we found no difference in the probability of successful defibrillation between shocks that were delivered into coarse and fine VF (48% vs 46%). However, shocks that were delivered to the upslope of coarse VF electrograms were more efficacious than those to the downslope of the waveform (67% vs 39%, P < .001). In the second study, we developed a real time computer system to prospectively deliver shocks on the upslope feature we identified in the first study. We found that the energy requirements at E50 and E80 were significantly lower for shocks delivered on the upslope of coarse VF than those delivered randomly at the end of 10 sec. We estimated a probability of success (POS) defibrillation curve using a maximum likelihood method for the timed and random shocks. The POS curve width was significantly narrower for shocks that were delivered to the upslope feature than the control treatment (7.1 +/- 0.9 vs. 10.8 +/- 1.7 J, P < 0.01). If these findings extend to clinical defibrillation, they may allow programming of internal defibrillators at lower energies. This could reduce potential postshock cardiac dysfunction, allow production of smaller devices, and improve battery life.

Strength-duration relationship for biphasic defibrillation in dogs

The relationship between biphasic shock duration and defibrillation efficacy was measured in dogs with a catheter/patch lead system to better define defibrillation mechanisms with this waveform. The defibrillation energy, voltage, and current at 50% defibrillation success were measured for short (6 ms) and long (12 ms) biphasic shocks with similar fixed tilts and pulsewidth ratios (60:40). The short biphasic waveform had comparable energy requirements, but higher voltage (42%) and currents (39%) than the long biphasic shock (p<0.01). For these pulse widths, biphasic defibrillation in the dog follows a strength-duration relationship, with constant defibrillation energy requirements.<<ETX>>

A comparison of standard vs up/down methods for determining the deftbrillation probability curve

Computer simulations showed that the combination of a sequential up/down test protocol and maximum likelihood curve fitting produced better estimates of defibrillation probability curves than a batch method. Specifically, for equal numbers of test shocks the up/down method gave 22% better estimates of p50 than the standard 5 bin method. Alternatively. the up/down method required only half the number of shocks for similar accuracy.