Clinical Efficacy and Safety of the New Cardioverter Defibrillator Systems

Clinical efficacy and safety of two new third-generation implantable cardioverter defibrillators (ICD) were studied in 38 patients with ventricular tachycardia (VT) or fibrillation (VF). There were 31 patients with coronary disease, three patients with right ventricular dysplasia, one patient with dilated cardiomyopathy, and three patients with valvular disease. Twenty-four patients (group I) received an ICD with monophasic (Ventak PRx 1700, CPI) and 14 patients (group II) with biphasic shocks (Cadence V 100, Ventritex). Intraoperatively, the mean defibrillation threshold was significantly lower in group II than in group I, both in patients with induced VT (group I 11.0 ± 6.3 joules: group N 5.8 ± 1.3 joules) (P < O.01) and induced VF (group I 17.5 ± 4.6 joules; group II 9.6 ± 5.2 joules) (P < O.O1). During the mean follow-up of 12 ± 7 months four patients (11%) died. 865 arrhythmia events (AE) occurred and were terminated by ATP (671 VTs, 78%). Acceleration of VTs was observed in 28 AE (3%) and ATP was unable to interrupt 58 AE (7%). ICD shocks were delivered as a first therapy in 108 AE (13%).     

A Second Defibrillator Chest Patch Electrode Will Increase Implantation Rates for Nonthoracotomy Defibrillators

Nonthoracotomy defibrillator systems can be implanted with a lower morbidity and mortality, compared to epicardial systems. However, implantation may be unsuccessful in up to 15% of patients, using a monophasic waveform. It was the purpose of this study to prospectively examine the efficacy of a second chest patch electrode in a nonthoracotomy defibrillator system. Fourteen patients (mean age 62 ± 11 years, ejection fraction = 0.29 ± 0.12) with elevated defibrillation thresholds, defined as ≥ 24 J, were studied. The initial lead system consisted of a right ventricular electrode (cathode), a left innominate vein, and subscapular chest patch electrode (anodes). If the initial defibrillation threshold was ≥ 24 J, a second chest patch electrode was added. This was placed subcutaneously in the anterior chest (8 cases), or submuscularly in the subscapular space (6 cases). This resulted in a decrease in the system impedance at the defibrillation threshold, from 72.3 ± 13.3 Ω to 52.2 ± 8.6 Ω. Additionally, the defibrillation threshold decreased from ≥ 24 J, with a single patch, to 16.6 ± 2.8 J with two patches. These changes were associated with successful implantation of a nonthoracotomy defibrillator system in all cases. In conclusion, the addition of a second chest patch electrode (using a subscapular approach) will result in lower defibrillation thresholds in patients with high defibrillation thresholds, and will subsequently increase implantation rates for nonthoracotomy defibrillators.     

Experience with Two Different Nonthoracotomy Systems for Implantable Defibrillator in 170 Patients

Implantation of a nonthoracotomy system (Medtronic PCD or CPI Endotak) was attempted in 170 patients with ventricular tachycardia (VT) or ventricular fibrillation (VF) not requiring concomitant cardiac surgery. A nonthoracotomy system could be successfully implanted in 95 of the 115 patients with the PCD system and 49 of 55 patients receiving the Endotak lead system. In 26 patients with failed nontboracotomy system because of defibrillation threshold (DFT) > 25 joules (J), an epicardial system was implanted at the same setting. Patients receiving the two lead systems were comparable with regard to age, sex, and ejection fraction. However, since tbe PCD system offers tiered therapy multiprogrammable options, all attempts were made to implant tbis lead system in patients with VT that could be pace terminated. Mean DFT(15 ± 4.7 vs 17 ± 4.6 J;P = 0.03) and implant time (2.5 ± 0.6 vs 3.3 ± 0.7 hours; P = 0.02) were less with the Endotak lead system. There was no perioperative mortality. During a mean follow-up of 20 ± 4 months, there were eight instances of lead dislodgment in patients receiving the PCD system. Tbere were four nonsudden cardiac deaths and one sudden death in the Endotak group and three nonsudden deaths in the PCD group. Sudden cardiac death and total survival using the intention-to-treat analysis during this follow-up period were 99% and 95%, respectively. In conclusion, successful implantation, perioperative mortality, and survival rate are comparable with both lead systems; however, incorporating two defibrillating electrodes in one lead minimizes lead dislodgment and reduces implant time.     

A Direct Comparison of Epicardial and Nonthoracotomy Defibrillation Using Monophasic and Biphasic Shocks

Defibrillation using epicardial patches may be associated with lower energy requirements than nonthoracotomy defibrillation although a direct comparison using various waveforms has not been reported. To directly compare defibrillation efficacy using these two configurations, nine mongrel dogs (20.9 ± 2.3 kg) first underwent nonthoracotomy defibrillation testing followed by a thoracotomy and implantation of epicardial patch electrodes and redetermination of defibrillation efficacy. Each dog served as its own control. Nonthoracotomy electrode configuration consisted of a right ventricular catheter (cathode) and a chest wall subcutaneous patch (anode). The epicardial configuration consisted of two 13.9 cm² epicardial patches. Alternating current induced ventricular fibrillation was allowed to persist for 10 seconds, followed by either a monophasic or a single capacitor biphasic shock of 10-msec total duration. Four trials of five leading edge voltages were performed for monophasic and biphasic pulses and stepwise logistic regression analysis was used to determine 80% probability of successful defibrillation (E80). For epicardial defibrillation E80s were: monophasic 19.2 ± 4.2 J and biphasic 12.6 ± 4.0 J; nonthoracotomy defibrillation E80s were: monophasic 24.2± 4.4 J and biphasic 17.8 ± 4.1 J. Epicardial patch defibrillation required less energy than nonthoracotomy electrode configuration. However, using biphasic pulses nonthoracotomy defibrillation could achieve lower defibrillation energy requirements than epicardial defibrillation with monophasic pulses.     

Initial Experience with a New Transvenous Defibrillation System

The clinical efficacy and safely of a new bidirectional transvenous defibrillation endocardial lead system (ELS) was studied in 39 patients with ventricular tachycardia (VT) or fibrillation (VF). There were 28 patients with coronary disease and 11 patients with nonischemic VT/VF. Fourteen patients received the ELS combined with antitachycardia pacing devices (Ventak PRx 1700, CPI) and 25 patients with the Ventak P or P2 (CPI). Implantation of the ELS was attempted in 47 patients. Intraoperatively, the mean defibrillation threshold (DFT) was > 25 joules in five patients and no reliable ELS position was found in three other patients. These eight patients underwent thoracotomy and epicardial leads implantation. The mean DFT was ≤ 20 jouJes in all 39 patients and the mean DFT was 18 joules. During the mean follow-up of 8 ± 2 months two patients (5%) died suddenly. Complications occurred in two patients (5%).     

Comparison of Biphasic and Monophasic Pulses: Does the Advantage of Biphasic Shocks Depend on the Waveshape?

With present implantable defibrillators, the ability to vary the defibrillation technique has been shown to increase the number of patients suitable for transvenous system. As newer waveforms become available, the need for a flexible device may change. In addition, although it has been shown that the option of biphasic waveform may increase the defibrillation efficacy, this may depend upon the shape of the biphasic waveform used. Thirty patients undergoing transvenous defibrillator implant were included in the study. In 20 patients (group I), defibrillation efficacy of simultaneous monophasic, sequential monophasic, and biphasic waveform with 50% tilt was determined randomly. Similarly, in ten patients (group II) testing of simultaneous monophasic shocks and biphasic waveforms with 65% and 80% tilt was performed in random order. The electrode system used consisted of two transvenous leads and a subcutaneous patch in all 30 patients. In group I, 50% tilt biphasic waveform consistently provided similar or better defibrillation efficacy compared to monophasic waveforms (biphasic 7.5 ±5.1 joules vs simultaneous 17 ± 7.8 joules, P < 0.01; and vs sequential 17 ± 8.4 joules, P <0.01). In group II, 65% tilt biphasic pulse required less energy for defibrillation as compared with simultaneous monophasic shocks (9.6 ± 4.5 joulesvs 15.6 ± 5.1 joules, P = 0.04). No significant difference was observed in terms of defibrillation threshold between 80% tilt biphasic shocks and simultaneous monophasic pulses (11.8 ± 6 joules vs 15.6 ±5.1 joules, P = NS). Biphasic shocks with smaller tilt delivered using a triple lead system more uniformly improved defibrillation threshold over standard monophasic waveforms.     

Implantation of an Automatic Defibrillator Using a New Nonthoracotomy Approach

Most current nonthoracotomy systems for defibrillator implantation use monophasic devices. To determine the safety and efficacy of a new nonthoracotomy lead configuration when used in conjunction with a device that used biphasic waveforms, 38 consecutive patients were taken to the operating room for implantation of a Cadence tiered therapy defibrillator system. The lead system consisted of a transvenous coil electrode positioned at the right atrial-superior vena caval junction, a bipolar endocardial right ventricular lead, and a large patch placed subcutaneously near the cardiac apex. Of the 38 nontboracotomy defibrillator implantations attempted, 36 (95%) were completed with adequate defibriliation thresholds. The mean defibriliation threshold in these 36 patients was ± 563 ± 10 V (± 20 ± 1 J). There was no perioperative mortality. Complications included coil lead migration (5). sensing lead migration (1), infection (3), pneumothorax (2), arterial embolism (1), and folding of the subcutaneous patch with an increase in defibriliation threshold (1). No patient died during a median follow-up period of 22 weeks. Fourteen patients (39%) had spontaneous sustained ventricular tachyarrhythmias, which were all successfully terminated by the implanted device. Shocks for nonsustained arrhythmias were aborted in eight patients (22%). Spurious discharges for sinus tachycardia or atrial fibrillation occurred in six patients (17%) and were readily diagnosed by examination of the stored electrograms. Thus, implantation of a biphasic tiered therapy defibrillator system using this nonthoracotomy approach is feasible in the majority of patients. The major complication associated with this procedure is lead dislodgment. The clinical course of these patients compares favorably with that of patients who have undergone defibrillator implantation via an epicardial approach.     

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.     

Early Postoperative Increase in Defibrillation Threshold with Nonthoracotomy System in Humans

The stability of the defibrillation threshold (DFT) early after implantation of an implantable cardioverter defibrillator was evaluated in 15 patients. All but one patient had a three lead nonthoracotomy system using a subcutaneous patch, a right ventricular endocardial lead, and a lead in coronary sinus (n = 5) or superior vena cava (n = 9). Shocks were delivered using simultaneous in nine, sequential in three, and single pathway (coronary sinus not used) in one patient. DFTs were measured at implant (n = 15), 2–8 days postoperation (postop, n = 15), and 4–6 weeks later (n = 8). The DFT was defined as the lowest energy shock that resulted in successful defibrillation. The DFT was assessed with output beginning at 18 joules or 2–4 joules above the implant DFT. All shocks were delivered in 2- to 4-joule increments or decrements. DFTs were significantly higher postoperatively than DFTs at implant (22.7 ± 7.0 J vs 16.9 ± 3.9 J; P < 0.05), Eight of 15 patients had DFT determined at all three study periods. In these patients, DFT increased at postop (22.8 ± 8.3 J vs 16.4 ± 3.9 J at implant: P < 0.05) and returned to baseline at 4–6 weeks (16 ± 7.1) vs 16.4 ± 3.9 J at implant; P = N.S.). Thus, in patients with a multilead nonthoracotomy system, a DFT rise was observed early after implant. The DFT appears to return to baseline in 4–6 weeks. These results have important implications for programming energy output after implantable cardioverter defibrillator implantation.     

Bipolar Transvenous Defibrillation: Efficacy of Two Different Positions of the Anode

For most nonthoracotomy defibrillotion lead systems, the transvenous anode can be positioned independently of the right ventricular (RV) cathode. Usually a vertical position in the superior vena cava (SVC) is chosen. However, it is unknown if this position yields the optimal defibrillation threshold (DFT). There-fort, in 15 patients undergoing defibrillator implantation the SVC position was compared in a crossover study design with a horizontal position in the left brachiocephalic vein (BCV). Mean DFT was not different for SVC and BCV (19.2 ± 9.6) vs 18.5 ± 9.1 J) but DFT of individual patients differed by up to 12 joules. A positive correlation between impedance and DFT in the BCV position (r = 0.6; P ≤ 0.05) indicated that the improved geometry of the defibrillation field with the BCV position is opposed by a higher impedance found for this position (63 ± 15 Ω vs 52 ± 7 Ω). Thus, defibrillation is not improved in general although individual patients might benefit.     

Influence of Anodal Electrode Position on Transvenous Defibrillation Efficacy in Humans: A Prospective Randomized Comparison

Nonthoracotomy lead systems for implantable cardioverter defibrillators (ICDs) have reduced operative mortality and morbidity as compared to epicardial lead systems but are usually associated with higher defibrillation thresholds (DFTs). The purpose of this prospective randomized trial was to investigate if the second defibrillation electrode in the left subclavian vein can increase defibrillation efficacy and decrease DFT as compared to the superior vena cava (SVC) position in nonthoracotomy lead systems for ICDs. Seventeen patients (mean age; 49.9 ± 11.3 years, mean ejection fraction; 46.1%± 15.8%) were implanted with an investigational unipolar electrode (Medtronic 13001) used as the defibrillation anode. DFT testing was started in the SVC (n = 10, group A) or the left subclavian vein (n = 7, group B), and repeated in the alternative position starting at the DFT of the initial position. Fifteen patients were eligible for analysis (group A: n = 9, group B: n = 6). With the electrode in the SVC, ventricular fibrillation could be successfully terminated in 9 out of 15 patients (60%). In the left subclavian vein the success rate was 100% (P < 0.01). Mean DFT in the SVC was 13.0 ± 5.2 J and in the left subclavian vein 10.2 ± 4.9 J. DFTs in the left subclavian vein were either lower (group A: n = 5/9, group B: n = 5/6) or equal to the results in the SVC position (P < 0.001). Thus, the left subclavian vein appears to be a superior alternative for positioning of the defibrillation anode as compared to the SVC for nonthoracotomy lead systems using two separate leads.     

Incidence of Lead System Malfunction Detected During Implantable Defibrillator Generator Replacement

Implantable cardioverter-defibrillator (ICD) generator replacement due to a depleted battery is a frequently performed procedure. The frequency with which sensing and defibrillation system failures are identified during device replacement procedures has not been previously described. Therefore, the purpose of this study was to prospectively determine the frequency of lead system malfunction detected at the time of device replacement in 55 consecutive patients undergoing ICD generator replacement. The mean age of the patients was 63 ± 10 years and 40 of them were men. Forty-nine patients had an epicardial lead system, and six patients had a nonthoracotomy lead system. Four (7%) of these 55 patients were noted to have previously undetected lead system failure, either sensing (n = 3) or defibrillation (n = 1), necessitating system revision. The lead systems that failed were 40 ± 6 months old (33–49 months). In summary, during ICD generator replacement, previously undetected problems with sensing or defibrillation may be identified in approximately 10% of patients. Therefore, a comprehensive evaluation of the sensing and the defibrillation functions should be an essential component of the ICD generator replacement procedure.     

Clinical Experience with a New Cardioverter Defibrillator Capable of Biphasic Waveform Pulse and Enhanced Data Storage: Results of a Prospective Multicenter Study

A recently introduced cardioverter defibrillator was implanted in 162 patients with refractory ventricular tachyarrhythmias and/or aborted sudden cardiac death. The new device is capable of delivering monophasic and biphasic defibrillation waveform pulses, arrhythmia detection, and therapy in two independently programmable zones, antibradycardia and postshock pacing. Additionally, the device provides enhanced data logs by storing intracardiac “far-field” electrograms of spontaneous arrhythmic episodes. One hundred sixty-two patients (mean age 55.5 years; mean left ventricular ejection fraction 36%) were enrolled in this multicenter investigation; coronary artery disease was the primary cardiac disease in 63.6% of the patients, idiopathic cardiomyopathy in 23.8%. Ventricular fibrillation was present in 49.7% of the patients; 29.3% of the patients experienced ventricular fibrillation and ventricular tachycardia; monomorphic ventricuiar tachycardia alone was present in 19.1% of the patients. In 26 patients the device was implanted with standard epicardial defibrillation leads (mean defibrillation threshold 11.5±3.7J). One hundred thirty-nine patients underwent testing for implantation of a nonthoracotomy system and in 136 (98%), a nonthoracotomy system could be implanted. Defibrillation thresholds with a biphasic waveform (mean 10.2 ± 4.3 J) were lower than with a monophasic waveform (mean 17.4 ± 5.7 J). Two patients (1.2%) died perioperatively (< 30 days). During study time period follow-up, there were 338 device discharges in 49 patients. Analysis of stored electrograms classified 25% of discharges as inappropriate and due to supraventricular tachyarrhythmias. At a mean follow-up of 10.8 months, cumulative survival from sudden cardiac death was 98.8%, and survival from all-cause mortality was 96.3%. This study demonstates the effectiveness of a new implantable cardioverter defibrillator in preventing arrhythmic death and the superior defibrillation efficacy of biphasic waveform pulses, which results in a higher implantation rate of nonthoracotomy systems, as well as the accurate arrhythmia classification made possible by the stored electrograms.     

Effects of Antiarrhythmic Drugs on Epicardial Defibrillation Energy Requirements and the Rate of Defibrillator Discharges

Antiarrhythmic drugs are commonly used with the implantable cardioverter/defibrillator to treat recurrent ventricular tachyarrhythmias. Since various antiarrhythmic drugs have been reported to alter defibrillation threshold, an important question is whether the device will provide adequate energy for defibrillation during long-term follow-up and to what extent antiarrhythmic drug treatment will affect defibrillation energy requirements. To answer these questions, the defibrillation thresholds were determined in 20 patients using an epicardial patch-patch lead configuration at the time of implantation and at the time of pulse generator replacement. During a mean follow-up period of 24 ± 6 months, the defibrillation threshold increased significantly from 14.2 ± 3.7 joules to 18.3 ± 5.5 joules in the entire group (P < 0.05). This increase in defibrillation threshold was due to a marked elevation of defibrillation energy requirements in the subgroup of patients taking amiodarone compared with patients receiving mexiletine. Based on these results it is mandatory to retest defibrillation threshold at any time of pulse generator replacement to guarantee continued effectiveness. In particular, if amiodarone treatment is initiated after implantation of a defibrillator, it is recommended to reevaluate defibrillation threshold to ensure an adequate margin of safety.     

Defibrillation Thresholds and Perioperative Mortality Associated with Endocardial and Epicardial Defihrillation Lead Systems

Defibrillation thresholds (DFT) and perioperative mortality were evaluated in 123 patients who had endocardial defibrillation leads implanted in conjunction with the Medtronic model 7216A/7217 (Medtronic, Inc.) cardioverter-defibrillator (ICD). Clinical variables, implant DFTs, and 30-day perioperative mortality were compared with 266 patients who had the ICD implanted with epicardial defibrillation leads. The two groups were comparable in age, gender, and incidence of coronary artery disease. New York Heart Association Class I and II were more frequent in patients with endocardial leads (87.7%) as compared to those with epicardial leads (78.8%; P < 0.001). Mean left ventricular ejection fraction was significantly higher in patients with the endocardial lead system (37% vs 33%; P < 0.05). A significant proportion of patients with epicardial lead systems underwent another cardiac surgical procedure at the time of ICD implantation (13.9%) as compared to none in those who had endocardial leads implanted (P < 0.001). All patients with endocardial leads had implantation of triple lead systems as compared to 53.4% with epicardial leads (P < 0.001). The mean DFT at implant was lower in epicardial lead recipients (8.9 J) as compared to endocardial lead recipients (13.3 J; P < 0.001). Perioperative mortality had a significant trend to lower risk for endocardial lead systems (0.8%) as compared to epicardial systems (4.2%; P = 0.07). We conclude that this endocardial lead system has additional electrode and higher defibrillation energy requirements than the epicardial lead systems used with the Medtronic pacemaker ICD. However, the use of endocardial nonthoracotomy defibrillation leads is associated with a markedly reduced perioperative risk of ICD implantation. This could be due to patient characteristics, a less invasive implant procedure, and absence of concomitant cardiac surgery.     

Rise in Chronic Defibrillation Energy Requirements Necessitating Implantable Defibrillator Lead System Revision

The chronic defibrillation energy requirement (DER) is believed to remain clinically stable in patients with defibrillators. Six patients (two with an epicardial and four with a nonthoracotomy system) were identified with a rise in their chronic DER, which eliminated a 10-J safety margin, thus necessitating a defibrillator lead system revision. The mean increase in DER was 14.7 ± 4 J and was discovered at a mean of 16.0 ± 18 months (range 2-41) following implantation. Management included placement of a defibrillator with a biphasic waveform, placement of an additional defibrillation electrode, or both. At 2 months following revision of the defibrillation system, a 10-J DER safety margin was present in each patient. In some patients, there is a progressive increase in the chronic DER with elimination of a 10-J safety margin necessitating revision of the defibrillation system. Routine reevaluation of the chronic DER, therefore, is necessary to identify these patients.     

Nonthoracotomy Implantation of Cardioverter Defibrillators: Preliminary Experience with a Defibrillation Lead Placed at the Right Ventricular Outflow Tract

Although morbidity and mortality associated with defibrillator implantation using a nonthoracotomy approach have decreased as compared with a thoracotomy approach, dfifihrillation thresholds have been higher and fewer patients satisfied implan t criteria. It may be possible to improve on the success of nonthoracotomy defibrillator implantation by the placement of a right ventricular (HV) outflow defibrillation lead. Implnntable car-dioverter defibrillator implantation data of 30 consecutive patients with clinical VT or VF were reviewed. Three defibrillation leads were routinely used. When either pacing threshold at the RV apex ivas inadequate (n - 2) or 18-J shocks were not successful in terminating VF in 3 of 4 trials (n = 8). the RV apex lead was positioned to the HV outflow tract attaching to the septum. Defibrillation testing was first performed with the RV apex lead in combination with CS, SVC. and/or subcutaneous leads. Twenty patients satisfied implant criteria with a defibrillation threshold of 13.5 ± 3.6 J. In 7 of the 10 patients, whose RV lead was repositioned to the RV outflow tract, this lead in combination with SVC, CS, or subcutaneous leads produced successful defibrillation at < 18 J or in 3 of 4 trials. This approach improved the overall success of nonthoracotomy implantation of defibrillators from 69% to 90%, After a follow-up of 27 ± 6 months, there was no dislodgment of the HV outflow tract defibrillation leads. Conclusions: This article reports the preliminary observation that placement of defibrillation leads to the RV outflow tract in humans was possible and without dislodgment. RV outflow tract offers an alternative for placement of defibrillation leads, which may improve on the success of nonthoracotomy defibrillator implantation.     

A Prospective, Randomized Evaluation of a Nonthoracotomy Implantable Cardioverter Defibrillator Lead System

Nonthoracotomy lead systems for ICDs have been developed that obviate the need for a thoracotomy and reduce the morbidity and mortality associated with implantation. However, an adequate DFT cannot be achieved in some patients using transvenous electrodes alone. Thus, a new subcutaneous "array" electrode was designed and tested in a prospective, randomized trial that compared the DFT obtained using monophasic shock waveforms with a single transvenous lead alone that has two defibrillating electrodes, the transvenous lead linked to a subcutaneous/submuscular patch electrode, and the transvenous lead linked to the investigational array electrode. There were 267 patients randomized to one of the three nonthoracotomy ICD lead systems. All had DFTs that met the implantation criterion of ≤ 25 J. The resultant study population was 82% male and 18% female, mean age of 63 ± 11 years. The indication for ICD implantation was monomorphic VT in 70%, VF in 19%, monomorphic VT/VF in 6%, and polymorphic VT in 4% of the patients, respectively. The mean LVEF was 0.33 ± 0.13. The mean DFT obtained with the transvenous lead alone was 17.5 ± 4.9 J as compared to 16.9 ± 5.5 J with the lead linked to a patch electrode (P = NS), and 14.9 ± 5.6 with the lead linked to the array electrode (array versus lead alone, P = 0.0001; array versus lead/patch, P = 0.007). The results of this investigation suggest that the subcutaneous array may be superior to the standard patch as a subcutaneous electrode to lower the DFT and increase the margin of safety for successful nonthoracotomy defibrillation.     

Effect of Biphasic Waveform Pulse on Endocardial Defibrillation Efficacy in Humans

Several clinical studies have proved increased defibrillation efficacy for implantable cardioverter defibrillators with biphasic pulse waveforms compared to monophasic pulse waveforms. This difference in defibrillation efficacy depends on the type of defibrillation lead system used. The influence of biphasic defibrillation pulse waveforms on the defibrillation efficacy of purely endocardial defibrillation lead systems has not yet been sufficiently examined, we, therefore studied 30 consecutive patients with drug refractory ventricular tachyarrhythmias during the implantation of a cardioverter defibrillator. After implanting an endocardial "integrated" sensing/defibrillation lead we performed a prospective randomized comparison of the defibrillation efficacy of monophasic and biphasic defibrillation waveform pulses. For endocardial defibrillation with the biphasic waveform the mean defibrillation threshold was 12.5 ± 4.9 joules and for the monophasic waveform 22.2 ± 5.6 joules (P < 0.0001). There was a decrease in the required defibrillation energy of biphasic defibrillation in 29/30 patients. Thus considering purely endocardial defibrillation a statistically significant and clinically relevant increase in defibrillation efficacy can be demonstrated for biphasic defibrillation waveform pulses.     

Long Runs of Non-Sustained Ventricular Tachycardia on 24-Hour Ambulatory Electrocardiogram Predict Major Arrhythmic Events in Patients with Idiopathic Dilated Cardiomyopathy

This study examined the prognostic significance of the rate and length of non-sustained (NS) ventricular tachycardia (VT) on 24-hour ambulatory electrocardiograms (ECG) recorded in 343 patients with idiopathic dilated cardiomyopathy (IDC) in the prospective Marburg Cardiomyopathy study. NSVT was defined as ≥3 consecutive ventricular premature beats at >120 bpm. During 52 ± 21 months of follow-up, major arrhythmic events defined as sustained VT, VF, or sudden cardiac death occurred in 46 of 343 patients (13%). Patients with 3–4 beat runs of NSVT had a similar arrhythmia-free survival as patients without NSVT on baseline 24-hour ambulatory ECG. The incidence of major arrhythmic events during follow-up increased significantly from 2% per year in patients without NSVT, to 5% per year in patients with 5–9 beat runs of NSVT, to 10% per year in patients with ≥10 beat runs of NSVT (P < 0.05). Unlike the length, the rate of NSVT was similar in patients with versus without subsequent major arrhythmic events (163 ± 23 vs 160 ± 24 bpm). Thus, the length but not the rate of NSVT on 24-hour ambulatory ECG was a predictor of major arrhythmic events in patients with IDC. The presence of NSVT with ≥10 beat runs on ambulatory ECG was associated with a particularly high risk of major arrhythmic events.