Nonthoracotomy Lead Research Articles

Experience with a New Implantable Pacer‐, Cardioverter‐Defibrillator for the Therapy of Recurrent Sustained Ventricular Tachyarrhythmias: A Step Toward a Universal Ventricular Tachyarrhythmia Control Device

Ten consecutive patients (mean age 57.9 +/- 7.6 years) were treated with an investigational tachyarrhythmia control device, the implantable Medtronic Pacer-, Cardioverter-, Defibrillator model 7216A or 7217B. All patients had coronary artery disease with old myocardial infarctions and presented hemodynamically significant sustained ventricular tachyarrhythmias not suppressed by antiarrhythmic drug therapy and unrelated to acute myocardial infarction. In two patients a nonthoracotomy lead system was implanted. Lowest effective defibrillation energy ranged from 5 to 18 joules (mean 12.2 +/- 4 joules) for the epicardial bielectrode systems and were 15 and 18 joules for the nonthoracotomy lead system implants. The postoperative periods were unremarkable. Follow-up ranged from 7 to 19 months (mean 13.8 +/- 4.5 months). Spontaneous tachyarrhythmia episodes were detected and treated by the device in six patients, five of them received staged therapies. No deaths occurred and no hospital admissions were necessary for device related or ventricular tachyarrhythmia related complications. In conclusion, this integrated device represents a major step toward the development of a universal ventricular arrhythmia control device.

Electrode system influence on biphasic waveform defibrillation efficacy in humans.

Several clinical studies have demonstrated a general superiority of biphasic waveform defibrillation compared with monophasic waveform defibrillation using epicardial lead systems. To test the breadth of utility of biphasic waveforms in humans, a prospective, randomized evaluation of defibrillation efficacy of monophasic and single capacitor biphasic waveform pulses was performed for two distinct nonthoracotomy lead systems as well as for an epicardial electrode system in 51 cardiac arrest survivors undergoing automatic defibrillator implantation. The configurations tested consisted of a right ventricular-left ventricular (RV-LV) epicardial patch-patch system, an RV catheter-chest patch (CP) nonthoracotomy system, and a coronary sinus (CS) catheter-RV catheter nonthoracotomy system. For each configuration, the defibrillation current and voltage waveforms were recorded via a digital oscilloscope to measure defibrillation threshold voltage, current, resistance, and stored energy. Biphasic waveform defibrillation proved more efficient than monophasic waveform defibrillation for the epicardial RV-LV system (4.8 +/- 4.1 versus 6.7 +/- 4.9 J, p = 0.047) and the nonthoracotomy RV-CP system (23.4 +/- 11.1 versus 34.3 +/- 10.4 J, p = 0.0042). Biphasic waveform defibrillation thresholds were not significantly lower than monophasic waveform defibrillation thresholds for the CS-RV nonthoracotomy system (15.6 +/- 7.2 versus 20.0 +/- 11.5 J, p = 0.11). Biphasic waveform defibrillation proved more efficacious than monophasic waveform defibrillation in 13 of 20 patients (65%) with RV-LV epicardial patches, 10 of 15 patients (67%) with an RV-CP nonthoracotomy system, and nine of 16 patients (56%) with an RV-CS nonthoracotomy system. Biphasic pulsing was useful with nonthoracotomy lead systems as well as with epicardial lead systems. However, the degree of biphasic waveform defibrillation superiority appeared to be electrode system dependent. Furthermore, for a few individuals, biphasic waveform defibrillation proved less efficient than monophasic waveform defibrillation, regardless of the lead system used.

Substantial reduction in defibrillation thresholds in dogs using a one capacitor dual biphasic waveform and multielectrode nonthoracotomy lead configurations

Substantial reduction in defibrillation thresholds in dogs using a one capacitor dual biphasic waveform and multielectrode nonthoracotomy lead configurations

Comparison of the internal defibrillation thresholds for monophasic and double and single capacitor biphasic waveforms

Implantable cardiac defibrillators are now an accepted form of therapy for patients with life-threatening ventricular arrhythmias that cannot be controlled by antiarrhythmic drugs. These devices could be made even more acceptable if they were smaller, had increased longevity and the surgical procedure for implantation was less invasive. Reducing the energy requirements for internal defibrillation with use of a nonthoracotomy lead system would make all of these goals achievable.Monophasic and double and single capacitor biphasic waveforms were compared in 14 anesthetized dogs (25.5 ± 2.2 kg) with use of a nonthoracotomy lead system that has previously been shown to distribute the delivered voltage throughout the heart more equally. Cathodal catheter electrodes were placed in the right ventricular apex and outflow tract. The anodal electrode was a large cutaneous R2 patch placed over the left side of the chest. The mean energy requirement for defibrillation when a single capacitor biphasic waveform was used was significantly less (6.4 ± 2.6 J) than that for either the double capacitor biphasic or the monophasic waveform (18.0 ± 8.0 and 17.4 ± 8.0 J, respectively) of the same duration. Unexpectedly, the leading edge voltage for the phase I of the single capacitor biphasic waveform was significantly less (266 ± 51 V) than that for either the double capacitor biphasic or the monophasic waveform (336 ± 76 and 427 ± 117 V, respectively). In conclusion, in large dogs, defibrillation is possible at low energy levels with a single capacitor biphasic waveform.

Strength‐Duration Curves of Fixed Pulse Width Variable Tilt Truncated Exponential Waveforms for Nonthoracomy Internal Defibrillation in Dogs

Six anesthetized dogs (wgt 19.6 + 1.1 kg) underwent defibrillation trials using truncated monophasic pulses of 2.5-20 msec in duration. The current pathway consisted of a 4 cm2 RV catheter electrode (cathode) and a 13.9 cm2 subcutaneous chest wall patch (anode). Fibrillation was induced by alternating current and defibrillation attempted 10 seconds later. Only one test shock was assessed for each fibrillation episode. The various durations were tested randomly, and the minimum peak voltage and energy resulting in defibrillation was determined for each. Shorter pulse durations were associated with lower energies with pulses of 2.5-15 msec having significantly lower energy thresholds than shocks of 20 msec (P less than 0.05). The relationship between duration and voltage threshold is hyperbolic with minimum voltage between 7.5 and 12.5 msec while the shortest and longest pulses were associated with the highest voltage thresholds. Shocks of 5 to 15 msec were associated with significantly lower voltage threshold than 2.5 msec pulses (P less than 0.05). The threshold average current (Iav) reached a nadir at 10 msec. Shocks in the midrange of those tested resulted in the best combination of low average current and energy requirements for defibrillation using this nonthoracotomy lead system.