Prospective evaluation of the effect of biphasic waveform defibrillation on ventricular pacing thresholds.

INTRODUCTION: Significant increases in ventricular pacing threshold have been observed following monophasic waveform ventricular defibrillation shocks. High-output pacing is recommended to ensure consistent capture, particularly in pacemaker-dependent patients who are likely to be defibrillated. Whether biphasic waveform defibrillation compounds this problem is not known. The purpose of this prospective study was to examine serial changes in ventricular pacing thresholds following single, multiple, low- and high-energy biphasic defibrillation shocks from an implanted defibrillator. METHODS AND RESULTS: Bipolar pacing thresholds before and after defibrillation, and the adequacy of pacing capture at three times preshock threshold in the immediate aftermath of ventricular defibrillation, were prospectively evaluated in 67 consecutively tested recipients of a biphasic implanted cardioverter defibrillator. Overall, serial pacing thresholds following successful defibrillation were completely unchanged after 141 of 177 (80%) ventricular fibrillation inductions. In no case did the threshold pulse width increment > 0.06 msec from its baseline value after shock, nor did pacing at a pulse width of three times preshock threshold from dedicated bipolar pacing electrodes fail to result in successful ventricular capture. Changes in threshold were not related to when measured from the time of shock, defibrillation energy, number of shocks, electrode system, chronicity of leads, shock orientation, or to clinical factors. CONCLUSIONS: No clinically important changes in pacing threshold were observed after biphasic waveform defibrillation. Bradycardia pacing at conventional pacemaker outputs of three times baseline pulse width threshold from bipolar electrodes dedicated exclusively to pacing or sensing (but not defibrillation) consistently allowed for an adequate safety margin following defibrillation.

Malignant sustained ventricular tachyarrhythmias in women: characteristics and outcome of treatment with an implantable cardioverter defibrillator.

Clinical rhythm, heart disease, ejection fraction, defibrillation threshold, recurrent arrhythmias, and mortality were compared in 268 consecutive recipients (213 men and 55 women) of their first implantable cardioverter defibrillator for life-threatening ventricular tachycardia or fibrillation. Women were younger than men, less likely to have structural heart disease, and more likely to have clinical ventricular fibrillation, a higher ejection fraction, and a lower defibrillation threshold. Complications of defibrillator placement were similar in both sexes. Unadjusted survival tended to be higher in women than in men (97% vs 90%, respectively, at 2 years, P = 0.08), largely due to fewer deaths from noncardiac causes or cardiac causes other than arrhythmia (P = 0.04). Women also tended to be at lower, albeit still substantial, risk for recurrent arrhythmias during follow-up (37% vs 52% in men at 2 years, P = 0.11). After adjustment for baseline differences, overall survival, arrhythmia death-free survival, nonarrhythmia death-free survival, and frequency of recurrent arrhythmias were not found to be gender related. Despite their apparent "lower risk" status on initial presentation, women remained at substantial risk for recurrent arrhythmias. This underscores the need to avoid being unduly biased by the "appearance" of health in managing women with malignant arrhythmias. That survival and other clinical endpoints were all ultimately independent of gender emphasizes the importance of other clinical variables in assessing risk from ventricular tachyarrhythmias.

Management of ventricular fibrillation with transvenous defibrillators without baseline electrophysiologic testing or antiarrhythmic drugs.

INTRODUCTION: Baseline electrophysiologic study (EPS) is routinely performed in patients resuscitated from ventricular fibrillation (VF) to risk stratify and select patients for chronic antiarrhythmic drug therapy. The role of EP testing prior to insertion of a multiprogrammable implantable cardioverter defibrillator (ICD), however, is unclear. METHODS AND RESULTS: This study was a retrospective review of outcome in 66 survivors of an initial episode of out-of-hospital VF not associated with a Q wave myocardial infarction or reversible causes, treated with transvenous ICDs as first-line therapy. Patients were excluded from the study if they had a previous history of monomorphic ventricular tachycardia (VT), a clinical history suggestive of supraventricular tachycardia, or had undergone preoperative EP testing. Fifty-two of the patients (79%) were male with an average age of 58 +/- 11 years. Coronary artery disease was present in 43 patients (66%), cardiomyopathy in 15 patients (23%), and valvular heart disease in 1 patient (1.5%). Seven patients (11%) had no detectable structural heart disease. The mean left ventricular ejection fraction was 0.40 +/- 0.16. With an average follow-up of 25 +/- 12 months, survival free of death from any cause was 100%. Twenty-three patients (35%) experienced 48 episodes of recurrent rapid VT or VF (average cycle length: 236 +/- 47 msec) treated by their device. The mean time to first therapy was 223 +/- 200 days. Only one of these patients also received antitachycardia pacing for two episodes of VT. One patient (1.5%) temporarily received amiodarone after removal of an infected device that was subsequently replaced. No other patient received antiarrhythmic drug therapy. CONCLUSION: After a cardiac arrest due to primary VF, select patients treated with multiprogrammable ICDs can be managed successfully without baseline EPS or antiarrhythmic drug therapy.

Mechanical complications after implantation of multiple-lead nonthoracotomy defibrillator systems: implications for management and future system design.

Nonthoracotomy lead system (NTL) implantable cardioverter defibrillators (ICDs) provide excellent protection against sudden death from ventricular tachyarrhythmias. However, these devices have unique mechanical complications and management issues. We reviewed the major complications occurring in 159 patients who underwent attempted implantation of a multilead NTL system. Successful implantation was obtained in 98% of patients. Two-year, all-cause actuarial survival on an intention-to-treat basis was 94%. Major complications occurred in 28 (17.6%) patients over a follow-up period of 21 +/- 10 months. Complications included 11 (6.9%) lead dislodgements, 10 (5.7%) lead fractures in 9 patients, 2 (1.3%) pocket infections, 1 frozen shoulder, 1 right ventricular perforation, 1 pneumothorax, 1 bleed requiring transfusion, 1 thromboembolism, and 1 "twiddle"-induced torsion of leads. Most of the lead dislodgements and fractures were identified by routine x-ray surveillance. Single-lead systems may significantly reduce complication rates in the future and maintain excellent survival rates.

Truncated biphasic pulses for transthoracic defibrillation.

BACKGROUND: Early defibrillation is the single most important factor for improving out-of-hospital ventricular fibrillation resuscitation rates. To achieve the earlier response times required for survival, typically < 6 minutes from time of collapse, it will be necessary to equip a far wider network of first responders (firefighters, police, and other individuals with responsibility for public safety) with small, lightweight, and inexpensive automatic external defibrillators (AEDs). An important step in reducing the size and cost of AEDs will be to improve defibrillation efficacy. Because biphasic waveform defibrillation has had a favorable impact on implantable cardioverter-defibrillators (ICDs), there are reasons to believe that biphasic waveforms would also improve transthoracic defibrillators. Our purpose, therefore, was to examine the efficacy of two different low-energy biphasic truncated waveforms referenced to a standard damped sine waveform for transthoracic defibrillation in humans. METHODS AND RESULTS: We prospectively and randomly compared the transthoracic defibrillation efficacy of two different truncated biphasic waveforms, 115 J (70 microF) and 130 J (105 microF), with that of a standard 200-J (36-microF, 28-mH) damped sine wave pulse using right anterior and left lateral thoracic pads (R2 Medical Systems) in 30 cardiac arrest survivors during transvenous ICD surgery. The right anterior patch electrode was used as the cathode and the left lateral thoracic pad as the anode. Transthoracic ventricular defibrillation rescue shocks were tested after a failed transvenous defibrillation shock delivered in the course of ICD testing. Each of the three different rescue shocks was tested in random order in each patient. All shocks were delivered at end expiration. The investigators responsible for determining transthoracic shock efficacy were blinded throughout the study to the transthoracic rescue waveform used. A total of 33 patients were considered for study, but three patients failed to satisfy all entry criteria or did not have a sufficient number of ventricular fibrillation inductions to allow for testing of all three waveforms. Percent efficacy for the three waveforms was then compared in the 30 patients who satisfied entry criteria and completed the protocol. The study population had a mean age of 61 +/- 11 years, with 22 (73%) being men. The mean left ventricular ejection fraction was 0.39 +/- 0.14. Coronary artery disease was present in 22 (73%). The 115-J (70-microF) biphasic pulse, the 130-J (105-microF) biphasic pulse, and the 200-J (36-microF, 28-mH) damped sine wave pulse were equally effective, resulting in a 97% first-shock ventricular defibrillation efficacy rate. Each waveform failed to defibrillate once, with each waveform failing in a different patient. CONCLUSIONS: The results of this study suggest that biphasic truncated transthoracic shocks of low energy (115 and 130 J) are as effective as 200-J damped sine wave shocks used in standard transthoracic defibrillators. This finding may contribute significantly to the miniaturization and cost reduction of transthoracic defibrillators, which could enable the development of a new generation of AEDs appropriate for an expanded group of out-of-hospital first responders and, eventually, layperson use.

A prospective randomized comparison of defibrillation efficacy of truncated pulses and damped sine wave pulses in humans.

INTRODUCTION: Damped sine wave pulses have been used for nearly 50 years in transthoracic defibrillation systems. The purpose of this study was to determine whether damped sine wave pulses have a role in implantable defibrillators. METHODS AND RESULTS: In 21 survivors of cardiac arrest, we prospectively compared defibrillation efficacy of a standard truncated capacitor (RC) monophasic pulse with a damped sine wave inductor-capacitor (LRC) pulse using a right ventricular-left ventricular epicardial patch-patch electrode system. The RC pulse was a standard 65% tilt monophasic waveform generated from a 120 mu F capacitor. The LRC pulse was designed to simulate the waveform currently used in transthoracic defibrillators and was generated by passing the charge stored on a 40 mu F capacitor through a 37-mH inductor. Capacitor voltage, peak delivered voltage, peak delivered current, discharge pathway resistance, delivered energy, and stored energy were compared for the two waveforms at the defibrillation threshold. There was no difference in defibrillation efficacy for the two waveforms. Peak delivered voltage was similar at the defibrillation threshold: 313 +/- 101 V for the RC pulse and 342 +/- 119 V for the LRC pulse (P = 0.16). Similarly, no differences were found in defibrillation threshold peak delivered current: 8.6 +/- 2.5 (RC) versus 9.3 +/- 2.7 (LRC) amperes (A) (P = 0.20); discharge pathway resistance: 37 +/- 11 (RC) versus 38 +/- 13 (LRC) omega (P = 0.71); delivered energy: 7.0 +/- 4.5 (RC) versus 7.0 +/- 4.0 (LRC) joules (J) (P = 0.88); and stored energy: 8.7 +/- 5.7 (RC) versus 9.8 +/- 5.4 (LRC) J (P = 0.35). Although both waveforms performed the same, it was necessary to use substantially higher stored voltages with the damped sine wave delivery system than with the truncated waveform delivery system: 356 +/- 110 V for the RC pulse and 675 +/- 192 V for the LRC pulse (P < 0.0001). CONCLUSION: This study demonstrates that RC monophasic pulses provide equally effective epicardial defibrillation as LRC pulses with respect to delivered voltage and current and stored and delivered energy. However, in order for LRC pulses to provide comparable delivered voltage, current, and energy to that of RC pulses, nearly twice the voltage must be stored on the capacitor to accomplish the same task. These findings suggest that despite the nearly 50-year experience with damped sine wave pulses with transthoracic defibrillators, there is no need to begin using damped sine wave pulses for implantable defibrillators. Moreover, these data raise a question regarding the need for inductors in transthoracic defibrillators.

Clinical experience with a tiered-therapy, multiprogrammable antiarrhythmia device.

BACKGROUND: The purpose of this report is to describe our initial experience with a tiered-therapy, variable detection criteria, multiprogrammable antiarrhythmia device capable of antitachycardia pacing, cardioversion, and defibrillation in 50 cardiac arrest survivors. METHODS AND RESULTS: An epicardial lead system was used in 35 patients. A transvenous lead system was used in 15 patients. The index arrhythmia leading to device implantation was ventricular fibrillation (VF) in 23 patients, ventricular tachycardia (VT) in 21 patients, and both VT and VF in six patients. Postoperatively, all 50 patients benefited from the additional functions available in the new device compared with a device capable only of high-energy termination of arrhythmias using a simple rate detection algorithm. Total patient survival over a mean follow-up period of 15 +/- 5 months was 96%, with no patient succumbing to sudden arrhythmic death, cardiac death, or surgical death. Nine patients (18%) avoided the need for a bradycardia pacemaker because of the device's backup bradycardia pacing function. A programmable tachycardia cycle length stability algorithm prevented inappropriate device intervention into atrial fibrillation in 11 patients (22%). Detection schema flexibility, antitachycardia pacing capabilities, and low-energy cardioversion options allowed the elimination or avoidance of antiarrhythmic drugs in 41 patients (82%). Device data storage facilitated troubleshooting and reprogramming of detection algorithms and therapeutic schema in all 50 patients. Finally, the ability to perform noninvasive programmed electrical stimulation obviated the need for invasive cardiac catheterization in 35 of 35 patients who required electrophysiological testing after device implantation. CONCLUSIONS: These findings indicate that a multiprogrammable antiarrhythmia device can provide a substantial advance in the treatment of patients with disabling or life-threatening ventricular arrhythmias by minimizing the use of painful shocks, reducing the need for antiarrhythmic drugs, lowering the incidence of inappropriate shocks, facilitating electrophysiological evaluation, and obviating the need for dual-device therapy.

Electrode system influence on biphasic waveform defibrillation efficacy in humans.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.