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Dual-coil vs single-coil active pectoral implantable defibrillator lead systems: defibrillation energy requirements and probability of defibrillation success at multiples of the defibrillation energy requirements.

AIMS: The aim of the study was to compare the defibrillation energy requirements and the probability of successful defibrillation at multiples of the minimum defibrillation energy requirements in active pectoral implantable defibrillators with single- and dual-coil lead systems. METHODS AND RESULTS: Eighty-three consecutive patients undergoing implantation of an active pectoral cardioverter-defibrillator were randomized to receive a dual- or single-coil lead system. Defibrillators of two manufacturers with a fixed tilt biphasic defibrillation waveform were used. Defibrillation energy requirements were determined using a step-down defibrillation testing protocol. According to the randomization protocol, the patients were assigned to three additional consecutive defibrillation attempts during device implantation and during pre-discharge testing of either 1.0, 1.5 or 2.0 times the determined defibrillation energy requirement. Patients presenting defibrillation energy requirements > 15 J were excluded from analysis. Eighty of 83 patients (96%) completed the study protocol. Three patients were excluded due to elevated defibrillation energy requirements. The defibrillation energy requirements in the dual- and single-coil patient groups were 8.0 +/- 3.6 J and 8.4 +/- 3.7 J (ns), respectively. A comparable percentage of study patients showed defibrillation energy requirements <10 J (dual-coil: 88% vs single-coil: 83%). Defibrillation impedance was significantly different (dual-coil: 50 +/- 5.8 Ohm; single-coil: 39.8 +/- 4.2 Ohm). Regarding the probabilities of successful defibrillation, there were no significant differences between the two patient groups. The probabilities of defibrillation at the three multiples of the defibrillation energy requirement using a dual- and single-coil lead system were 82, 89.7 and 93.6 and 77.8, 94.1 and 95.8%, respectively (P=0.88, P=0.42, P=0.62, respectively). CONCLUSIONS: Dual- and single-coil active pectoral defibrillator systems show no difference in defibrillation energy requirements and no difference in the probability of successful defibrillation at multiples of the minimum defibrillation energy requirement. The use of more simplified defibrillator lead systems may contribute to a future lead design focusing on improvement in lead durability.

Aged↗

Probability of successful defibrillation at multiples of the defibrillation energy requirement in patients with an implantable defibrillator.

BACKGROUND: The probability of successful defibrillation has been determined in normal animals but not in patients undergoing defibrillator implantation. Therefore, the purpose of this prospective study was to determine the probability of successful defibrillation in humans on the basis of a step-down defibrillation energy requirement. METHODS AND RESULTS: Fifty-three consecutive patients underwent five separate inductions of ventricular fibrillation after the defibrillation energy requirement was determined with the use of small decrements and a step-down protocol (20, 15, 12, 10, 8, 6, 5, 4, 3, 2, 1, and 0.8 J). The first shock energy for defibrillation was either 1.0, 1.3, 1.5, 1.7, or 2.0 times the defibrillation energy requirement, and the likelihoods of successful defibrillation were 70+/-27%, 84+/-12%, 86+/-25%, 80+/-29%, and 88+/-32%, respectively (P=.03). The frequencies of uniformly successful defibrillation (5 of 5 defibrillation attempts) were 30%, 27%, 60%, 64%, and 73%, respectively (P=.01). Seven patients in whom the defibrillation energy requirement was <4 J had an overall rate of successful defibrillation of 54+/-20% compared with 86+/-20% in the remaining 47 patients (P=.002). The likelihood of successful defibrillation at twice the defibrillation energy requirement was 98% in the 46 patients with a defibrillation energy requirement of >4 J and 67% in the 7 patients with a defibrillation energy requirement of <4 J (P=.17). An absolute safety margin of 7 J was associated with a 96% probability of successful defibrillation. CONCLUSIONS: The probability of successful defibrillation is 70% at the defibrillation energy requirement. The probability plateaus at 88%, at twice the defibrillation energy requirement. A 96% probability of successful defibrillation is achieved at an absolute safety margin of 7 J, and a 98% success rate is achieved at energies that are twice the defibrillation energy requirement if the defibrillation energy requirement is >4 J. If the defibrillation energy requirement is <4 J, larger multiples of the defibrillation energy requirement are needed to achieve a high probability of successful defibrillation.

Arrhythmias, Cardiac↗

[Cardioverter-defibrillator implantations without thoracotomy: clinical experience with various electrode configurations and defibrillation wave forms of an endocardial/subcutaneous defibrillator system].

Twenty-seven consecutive patients with refractory ventricular arrhythmias were investigated for implantation of an nonthoracotomy cardioverter-defibrillator lead system. Supply with a nonthoracotomy lead system could be achieved in 25 of 27 patients (92.5%), while implantation proved impossible in two patients due to elevated defibrillation thresholds. After implantation of an endocardial defibrillation electrode no differences were found compared to the implantation of an endocardial defibrillation electrode with a subcutaneous chest wall defibrillation patch with regard to the defibrillation thresholds obtained for monophasic defibrillation waveform. Supply with an endocardial defibrillation lead system was successful in 18 of 25 patients (72%). Ten consecutive patients with implantation of an endocardial defibrillation lead system alone were compared for defibrillation efficacy following monophasic and biphasic defibrillation waveforms. Defibrillation with biphasic waveforms led to a decrease in the necessary defibrillation energy from 19 J (4.6 J) to 10 J (4.0 J). There was occurrence of refractory ventricular fibrillation that could not be controlled by endocardial and transthoracic defibrillation in two patients during the intraoperative testing of defibrillation thresholds. In both cases these arrhythmias could be terminated by the described method of endocardial/extrathoracic defibrillation (200 J). Further perioperative complications were not observed. Over a mean follow-up of 6.8 (1-17) months all patients demonstrated regular functioning of the cardioverter-defibrillator. Dislocation of defibrillation electrodes did not occur. Implantation of a cardioverter-defibrillator can be performed without thoracotomy in the majority of cases. The use of defibrillator systems with biphasic waveform widens the scope for implantation of nonthoracotomy defibrillating lead systems.

Adult↗

The implanted defibrillator: relation of defibrillating lead configuration and clinical variables to defibrillation threshold.

Forty-two defibrillating lead systems for the automatic implantable defibrillator were implanted and tested in 41 patients. Two basic lead configurations were used: 1) spring-patch, consisting of a transvenous superior vena cava spring electrode as the anode and an apical or left lateral ventricular patch electrode (either small [13.9 cm2] or large [27.9 cm2]) as the cathode; and 2) patch-patch, consisting of an anterior right ventricular patch as the anode and a posterior left ventricular patch as the cathode. Of the 42 lead systems, 10 were spring-patch and 32 were patch-patch combinations. The defibrillation threshold for the patch-patch combinations (9.8 +/- 6.5 J, mean +/- standard deviation) was significantly (p less than 0.01) lower than that for the spring-patch combinations (19.1 +/- 10.3 J). Subgroup analysis revealed the lowest defibrillation thresholds for patch-patch combinations with at least one large patch. Total surface area of defibrillating leads was strongly negatively correlated with the defibrillation threshold (p less than 0.005). Analysis of the relation of clinical variables to defibrillation threshold revealed that only amiodarone therapy was independently associated with a significantly (p less than 0.05) higher defibrillation threshold. Thus, surface area of the defibrillating leads is a critical determinant of the defibrillation threshold for the implanted defibrillator. Patch-patch lead systems with at least one large patch may provide an increased safety margin for defibrillation. Conversely, amiodarone therapy is associated with higher defibrillation thresholds and may decrease the margin of safety.

Adolescent↗

Predictors of defibrillation efficacy in patients undergoing epicardial defibrillator implantation. The Multicenter Pacemaker-Cardioverter-Defibrillator (PCD) Investigators Group.

OBJECTIVES: The objective of this study was to identify predictors of defibrillation threshold in patients undergoing epicardial defibrillator implantation. BACKGROUND: Factors that predict epicardial defibrillation efficacy are poorly defined. METHODS: The data from 375 consecutive adult patients were reviewed. After exclusion of 137 patients in whom defibrillation threshold was not obtained, 238 patients (32 women and 206 men) with a mean age of 58.9 +/- 13.3 years formed the study group. Coronary heart disease was present in 175 patients and the mean left ventricular ejection fraction was 35.8 +/- 15.4%. At device implantation, three epicardial patch sizes were available and shocks could be delivered over one current pathway (two patches) or over two current pathways (three patches with simultaneous or sequential shocks). Defibrillation threshold was defined as the lowest programmed energy that successfully defibrillated the heart, provided there had been an unsuccessful shock at a lower energy level or successful defibrillation at < or = 5 J. RESULTS: The mean defibrillation threshold was 8.6 +/- 5.3 J. With univariate analysis, female gender, sequential shocks with three patches, higher left ventricular ejection fraction and lower New York Heart Association functional class predicted a lower defibrillation threshold. In the multivariate analysis, female gender (coefficient -3.9; 95% confidence interval [CI] -1.9 to -5.0 J), ejection fraction (coefficient -0.6; CI -0.1 to -1.0 J/decile) and sequential shocks (coefficient -2.5; CI -1.0 to -4.0 J) were independently associated with a lower defibrillation threshold. Total epicardial patch conductive surface area normalized to body surface area reached borderline significance (coefficient 0.004; CI 0 to 0.01; p = 0.10). Antiarrhythmic drug use, including amiodarone, did not predict defibrillation threshold. CONCLUSIONS: Female gender, high left ventricular ejection fraction and the use of sequential pulse shocks were important determinants of improved defibrillation efficacy.

Aged↗

Effects of oral propafenone on defibrillation and pacing thresholds in patients receiving implantable cardioverter-defibrillators. Propafenone Defibrillation Threshold Investigators.

OBJECTIVES: The effects of propafenone, a predominantly class IC antiarrhythmic drug, on defibrillation and pacing thresholds were evaluated in patients undergoing cardioverter-defibrillator implantation. BACKGROUND: Previous studies have shown that the class IC agents encainide and flecainide may increase the energy requirements for pacing and defibrillation. Animal studies with propafenone have shown inconsistent results regarding its effect on defibrillation energy requirements. This report investigated the effects of propafenone on defibrillation and pacing thresholds in humans. METHODS: After cardioverter-defibrillator implantation, 47 patients were enrolled in a double-blind, three-way parallel, randomized trial of 450 mg/day (Group 1) or 675 mg/day (Group 2) of oral propafenone or placebo (Group 3) for 3 to 7 days. Predischarge defibrillation and pacing thresholds after treatment were compared with baseline thresholds obtained at implantation. RESULTS: There was no statistically significant difference between implantation and predischarge defibrillation thresholds in the three groups (Group 1: [mean +/- SE] 11.0 +/- 1.3 vs. 12.1 +/- 1.5 J; Group 2: 11.5 +/- 1.1 vs. 13.6 +/- 1.3 J; Group 3: 12.5 +/- 1.2 vs. 13.3 +/- 1.6 J), and no significant difference between treatment groups was found with a 0.86 power to detect a 5-J difference between groups. Paired pulse width pacing thresholds at 2.8 V were compared in 14 patients. A small increase of 0.02 ms was noted at predischarge testing in patients treated with propafenone and placebo. CONCLUSIONS: Short-term oral propafenone (450 and 675 mg/day) does not significantly affect defibrillation or pacing thresholds. Concomitant use of propafenone in patients with implantable cardioverter-defibrillators with recurrent ventricular or atrial tachyarrhythmias should not interfere with proper device function.

Administration, Oral↗

[Reproducibility of the effectiveness of defibrillation for terminating induced ventricular fibrillation using intraoperatively measured defibrillation threshold energy in patients with implanted cardioverter-defibrillator].

The aim of the present study was to assess the long-term reproducibility of the defibrillation efficacy of energies set at the intraoperatively measured defibrillation threshold using a modified testing protocol. Between December 1993 and January 1996, 83 patients receiving an implantable cardioverter-defibrillator (ICD) in combination with a non-thoracotomy lead system and having an intraoperatively measured defibrillation threshold (DFT) < or = 15 J were enrolled in a substudy of a prospective, randomized multicenter trial ("Low Energy Endotak Trial" (LEET)). Step-down DFT testing was performed intraoperatively (15, 10, 8, 5 J). It was mandatory to reproduce a successful conversion of ventricular fibrillation at the DFT energy during implantation (DFT+). At the end of implantation, at predischarge, and after one year, assessment of the defibrillation efficacy of DFT+ energy was repeated (first shock: DFT+, second shock: 2 x DFT+). Mean DFT+ at implant was 9.6 + 3.3 J. Immediately after implantation, successful conversion of induced ventricular fibrillation was achieved in 70/79 (89%) patients using DFT+ energies. In 7/8 (89%) patients only the second shock set at 2 x DFT+ and in one patient only the third shock set at maximum energy (34 J) was successful. At predischarge, defibrillation efficacy of DFT+ was reproducible in 61/77 (79%) patients. The remaining 16 patients were successfully converted using a second shock set at 2 x DFT+. One year after implantation, conversion of ventricular fibrillation was achieved at energies set at DFT+ in 52/62 (84%) patients and in the remaining 10 patients at energies set at 2 x DFT+. A total of 183/218 (84%) episodes of induced ventricular fibrillation were terminated successfully using DFT+ energies. There was no correlation between the intraoperatively determined DFT+ or the underlying cardiac disease and the defibrillation efficacy. These results demonstrate that the defibrillation efficacy for termination of induced ventricular fibrillation using DFT+ energies is reproducible at implantation, at predischarge, and one year after ICD insertion. Energies set at twice DFT+ seems to allow for reliable defibrillation within the first year after ICD implantation.

Adult↗

Relation of the intraoperative defibrillation threshold to successful postoperative defibrillation with an automatic implantable cardioverter defibrillator.

To determine the relation between the intraoperative defibrillation threshold and successful postoperative termination of induced ventricular fibrillation (VF) with the automatic implantable cardioverter defibrillator (AICD), 33 patients who underwent AICD implantation were studied. The defibrillation threshold, determined after at least 10 seconds of VF, was 5 J in 2, 10 J in 6, 15 J in 10, 20 J in 10 and 25 J in 5 patients. The AICD energy rating on the first discharge was 28 +/- 1.8 J. Defibrillation of induced VF was demonstrated postoperatively in 29 of 33 (88%) patients. The AICD terminated VF postoperatively in all 18 patients with a defibrillation threshold less than or equal to 15 J. Only 11 of the 15 (73%) patients with a defibrillation threshold greater than or equal to 20 J (p less than 0.04) had VF terminated postoperatively. In all 4 patients in whom the AICD failed to terminate induced VF, the energy difference between the AICD rating and the defibrillation threshold was less than or equal to 10 J. Among the 14 patients with a difference of less than or equal to 10 J between the AICD energy rating and the defibrillation threshold, there were no significant differences between the 4 patients with and the 10 without successful VF termination with respect to the duration of VF induced postoperatively or the AICD lead system. In summary, failure to terminate VF with the AICD is not uncommon (27%) when the defibrillation threshold approaches the energy delivering capacity of the AICD.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Defibrillation efficacy comparing a subcutaneous array electrode versus an "active can" implantable cardioverter defibrillator and a subcutaneous array electrode in addition to an "active can" implantable cardioverter defibrillator: results from active can versus array trials I and II.

INTRODUCTION: Placement of implantable cardioverter defibrillators (ICDs) has been simplified by using the shell of a pectorally implanted ICD as a defibrillation electrode in combination with an endocardial right ventricular defibrillation lead. However, a sufficiently low defibrillation threshold (DFT) cannot be obtained in a few patients. Therefore, alternative approaches were systematically tested in the Active Can versus Array Trial (ACAT). METHODS AND RESULTS: In the first of two prospective randomized studies, the DFT of a subcutaneous left dorsolateral array anode introduced from a pectoral incision was compared to that of a standard active can anode in 68 patients. Intraoperatively, the DFT was determined twice in each patient using either the active can or, in patients with a subcutaneous array lead, once with all three fingers and once omitting the middle finger of the array. The second prospective randomized study included 40 patients. DFT also was determined twice in each patient using an active can in a left pectoral position as anode alone and combined with a left dorsolateral array electrode with two fingers. In ACAT I, stored energy at DFT decreased from 13.1+/-7.7 J (active can) to 9.6+/-6.1 J (three-finger array lead) (P = 0.04), impedance decreased from 53+/-8 ohms to 40+/-6 ohms (P < 0.0001). Omitting the middle finger of the array lead, stored energy at DFT increased by 0.9 J (P = 0.47) and impedance by 2 ohm (P < 0.0001). In ACAT II, DFT and impedance using an active can device were significantly lower when a two-finger array lead was added that decreased stored energy at DFT from 10.1+/-5.2 J to 6.9+/-3.9 J (P = 0.001) and impedance from 56+/-5 1 to 42+/-5 l (P < 0.0001). CONCLUSION: In combination with a right ventricular defibrillation electrode, a left pectoral subcutaneous array lead improves defibrillation efficacy if used instead of, or in addition to, a left pectoral active can ICD device. Implantation of the array lead can be simplified by using two instead of three fingers, without a significant loss of defibrillation efficacy.

Adult↗

Leakage of energy to the body surface during defibrillation shock by an implantable cardioverter-defibrillator (ICD) system--experimental evaluation during defibrillation shocks through the right ventricular lead and the subcutaneous active-can in canines.

The leakage of electrical current to the body surface during defibrillation shock delivery by an implantable cardioverter-defibrillator (ICD) device (the Medtronic Jewel Plus PCD system) was evaluated in 5 dogs. The defibrillation shocks were delivered between the active-can implanted in the left subclavicular region and the endocardial lead placed in the right ventricle at the energy levels of 1, 2, 8, 12, 24 and 34 J. During each delivery, the electrical current leakage from the body surface was measured by electrodes connected to a circuit at 4 recording positions: (A) parallel-subcutaneous (the electrodes were fixed in the subcutaneous tissue of the left shoulder and the right lower chest, and the direction of the electrode vector was parallel to the direction of the defibrillation energy flow); (B) cross-subcutaneous (the electrodes were fixed in the subcutaneous tissue of the right shoulder and the left lower chest, and the vector of the electrodes was roughly perpendicular to the direction of the energy flow); (C) parallel-surface (the electrodes were fixed with ECG paste on the shaved skin surface at the left shoulder and the right lower chest); and (D) surface grounded (the electrodes were fixed on the shaved skin surface at the left shoulder and the left foot, which was grounded). The circuit resistance was set at a variable level (100-5,000 ohms) in accordance with the resistance measured through each canine body. Leakage energies were measured in 750 defibrillation shocks with each circuit resistance in 5 dogs. The leakage energy increased in accordance with the increase of the delivered energy and the decrease of the circuit resistance in all 4 recording positions. When the circuit resistance was set at 1,000 ohms, the leakage energy during shock delivery at 34 J was 32+/-17 mJ at position A, 5+/-9 mJ at B, 10+/-9 mJ at C, and 4+/-3 mJ at D (p=0.042). The peak current was highest at position A and was 87+/-22 mA with a circuit resistance of 1,000 ohms. The power of the leakage energy depended on the delivered energy and the impedance between the electrodes. The angle between the alignment of the recording electrodes and the direction of the energy flow was another important factor in determining the leakage energy. Although the peak current of the leakage energy reached the level of macro shock, the highest leakage energy from the body surface was considerably less because of the short duration of the shock delivery.

Animals↗

Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs Implantable Defibrillator study. Cardiac Arrest Study Hamburg . Canadian Implantable Defibrillator Study.

AIMS: Three randomized trials of implantable cardioverter defibrillator (ICD) therapy vs medical treatment for the prevention of death in survivors of ventricular fibrillation or sustained ventricular tachycardia have been reported with what might appear to be different results. The present analysis was performed to obtain the most precise estimate of the efficacy of the ICD, compared to amiodarone, for prolonging survival in patients with malignant ventricular arrhythmia. METHODS AND RESULTS: Individual patient data from the Antiarrhythmics vs Implantable Defibrillator (AVID) study, the Cardiac Arrest Study Hamburg (CASH) and the Canadian Implantable Defibrillator Study (CIDS) were merged into a master database according to a pre-specified protocol. Proportional hazard modelling of individual patient data was used to estimate hazard ratios and to investigate subgroup interactions. Fixed effect meta-analysis techniques were also used to evaluate treatment effects and to assess heterogeneity across studies. The classic fixed effects meta-analysis showed that the estimates of ICD benefit from the three studies were consistent with each other (P heterogeneity=0.306). It also showed a significant reduction in death from any cause with the ICD; with a summary hazard ratio (ICD:amiodarone) of 0.72 (95% confidence interval 0.60, 0.87;P=0.0006). For the outcome of arrhythmic death, the hazard ratio was 0.50 (95% confidence interval 0.37, 0.67;P<0.0001). Survival was extended by a mean of 4.4 months by the ICD over a follow-up period of 6 years. Patients with left ventricular ejection fraction < or = 35% derived significantly more benefit from ICD therapy than those with better preserved left ventricular function. Patients treated before the availability of non-thoracotomy ICD implants derived significantly less benefit from ICD therapy than those treated in the non-thoracotomy era. CONCLUSION: Results from the three trials of the ICD vs amiodarone are consistent with each other. There is a 28% reduction in the relative risk of death with the ICD that is due almost entirely to a 50% reduction in arrhythmic death.

Amiodarone↗

Do baseline characteristics accurately discriminate between patients likely versus unlikely to benefit from implantable defibrillator therapy? Evaluation of the Canadian implantable defibrillator study implantable cardioverter defibrillatory efficacy score in the antiarrhythmics versus implantable defibrillators trial.

OBJECTIVE: Our purpose was to evaluate whether baseline characteristics predictive of implantable cardioverter defibrillator (ICD) efficacy in the Canadian Implantable Defibrillator Study (CIDS) are predictive in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. BACKGROUND: ICD therapy is superior to antiarrhythmic drug use in patients with life-threatening arrhythmias. However, identification of subgroups most likely to benefit from ICD therapy may be useful. Data from CIDS suggest that 3 characteristics (age > or =70 years, ejection fraction [EF] < or =0.35, and New York Heart Association class >II) can be combined to reliably categorize patients as likely (> or =2 characteristics) versus unlikely to benefit (<2 characteristics) from ICD therapy. METHODS: The utility of the CIDS categorization of ICD efficacy was assessed by Kaplan-Meier analysis and Cox hazards modeling. The accuracy of the CIDS score was formally tested by evaluating for interaction between categorization of benefit and treatment in a Cox model. RESULTS: ICD therapy was associated with a significantly lower risk of death in the 320 patients categorized as likely to benefit (relative risk [RR] 0.57, 95% confidence interval [CI] 0.37-0.88, P =.01) and a trend toward a lower risk of death in the 689 patients categorized as unlikely to benefit (RR 0.70, 95% CI 0.48-1.03, P =.07). Categorization of benefit was imperfect, as evidenced by a lack of statistical interaction (P =.5). Although 32 of the 42 deaths prevented by ICD therapy in AVID were in patients categorized as likely to benefit, all 42 of these patients had EF values < or =0.35. Neither advanced age nor poorer functional class predicted ICD efficacy in AVID. CONCLUSION: Of the 3 characteristics identified to predict ICD efficacy in CIDS, only depressed EF predicted ICD efficacy in AVID. Thus physicians faced with limited resources might elect to consider ICD therapy over antiarrhythmic drug use in patients with severely depressed EF values.

Aged↗

Application of models of defibrillation to human defibrillation data: implications for optimizing implantable defibrillator capacitance.

BACKGROUND: Theoretical models predict that optimal capacitance for implantable cardioverter-defibrillators (ICDs) is proportional to the time-dependent parameter of the strength-duration relationship. The hyperbolic model gives this relationship for average current in terms of the chronaxie (t(c)). The exponential model gives the relationship for leading-edge current in terms of the membrane time constant (tau(m)). We hypothesized that these models predict results of clinical studies of ICD capacitance if human time constants are used. METHODS AND RESULTS: We studied 12 patients with epicardial ICDs and 15 patients with transvenous ICDs. Defibrillation threshold (DFT) was determined for 120-microF monophasic capacitive-discharge pulses at pulse widths of 1.5, 3.0, 7.5, and 15 ms. To compare the predictions of the average-current versus leading-edge-current methods, we derived a new exponential average-current model. We then calculated individual patient time parameters for each model. Model predictions were validated by retrospective comparison with clinical crossover studies of small-capacitor and standard-capacitor waveforms. All three models provided a good fit to the data (r2=.88 to .97, P<.001). Time constants were lower for transvenous pathways (53+/-7 omega) than epicardial pathways (36+/-6 omega) (t(c), P<.001; average-current tau(m), P=.002; leading-edge-current tau(m), P<.06). For epicardial pathways, optimal capacitance was greater for either average-current model than for the leading-edge-current model (P<.001). For transvenous pathways, optimal capacitance differed for all three models (P<.001). All models provided a good correlation with the effect of capacitance on DFT in previous clinical studies: r2=.75 to .84, P<.003. For 90-microF, 120-microF, and 150-microF capacitors, predicted stored-energy DFTs were 3% to 8%, 8% to 16%, and 14% to 26% above that for the optimal capacitance. CONCLUSIONS: Model predictions based on measured human cardiac-muscle time parameter have a good correlation with clinical studies of ICD capacitance. Most of the predicted reduction in DFT can be achieved with approximately 90-microF capacitors.

Defibrillators, Implantable↗

Automatic external defibrillators for public access defibrillation: recommendations for specifying and reporting arrhythmia analysis algorithm performance, incorporating new waveforms, and enhancing safety. A statement for health professionals from the American Heart Association Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy.

These recommendations are presented to enhance the safety and efficacy of AEDs intended for public access. The task force recommends that manufacturers present developmental and validation data on their own devices, emphasizing high sensitivity for shockable rhythms and high specificity for nonshockable rhythms. Alternative defibrillation waveforms may reduce energy requirements, reducing the size and weight of the device. The highest levels of safety for public access defibrillation are needed. Safe and effective use of AEDs that are widely available and easily handled by nonmedical personnel has the potential to dramatically increase survival from cardiac arrest.

Algorithms↗

Automatic external defibrillators for public access defibrillation: recommendations for specifying and reporting arrhythmia analysis algorithm performance, incorporating new waveforms, and enhancing safety. A statement for health professionals from the American Heart Association Task Force on Automatic External Defibrillation, Subcommittee on AED and Efficacy.

These recommendations are presented to enhance the safety and efficacy of AEDs intended for public access. The task force recommends that manufacturers present developmental and validation data on their own devices, emphasizing high sensitivity for shockable rhythms and high specificity for nonshockable rhythms. Alternative defibrillation waveforms may reduce energy requirements, reducing the size and weight of the device. The highest levels of safety for public access defibrillation are needed. Safe and effective use of AEDs that are widely available and easily handled by non-medical personnel has the potential to dramatically increase survival from cardiac arrest.

Algorithms↗

The defibrillation success rate versus energy relationship: Part I--Curve fitting and the most efficient defibrillation energy.

The effect of applying an energy pulse to the heart during ventricular fibrillation is described by the probability of successful defibrillation or success rate. Seven to ten (8.60 +/- 0.84: mean +/- standard deviation) defibrillation trials per energy were randomly attempted at energies which span the defibrillation success rate versus energy curve. We obtained 70.0 +/- 8.4 episodes per dog. We fit the defibrillation success rate versus energy relationship from ten dogs (20.5 +/- 1.5 kg) to four types of curves: linear, exponential, probit transformed linear, and logit transformed linear. The correlation coefficients for each fit are 0.917 +/- 0.057, 0.944 +/- 0.014, 0.926 +/- 0.51, and 0.889 +/- 0.098, respectively. We therefore conclude that the exponential curve best describes the DSRE relationship. This suggests the existence of an energy below which defibrillation does not occur. At higher energies, the exponential curve asymptotically approaches a 100% success rate, which indicates that increasing the energy produces a diminishing benefit to defibrillation success rate. The estimated energies with a 0% defibrillation success rate are surprisingly consistent among dogs, with 2.072 +/- 0.553 J. The estimated energy with an 80% defibrillation success rate is 5.217 +/- 1.091 J. The estimated defibrillation success rate corresponding to the defibrillation threshold of 3.59 +/- 1.06 J is consistent with 0.516 +/- 0.144. The estimated energies with a 0% success rate correlate well with the defibrillation thresholds with R = 0.772; P = 0.0088. Since implantable defibrillators have a limited energy supply, we determined energy efficiency by dividing defibrillation success rate by the applied energy and energy consumption by dividing the applied energy by the defibrillation success rate. The most efficient defibrillation energy occurs at the maximum energy efficiency and the minimum energy consumption. The most efficient defibrillation energy of 4.34 +/- 0.97 J determined from the exponential fit has a success rate of 0.70 +/- 0.06. The most efficient defibrillation energy can be predicted from the defibrillation threshold. Clinically, a 70% success rate may not be adequate. We, therefore, compared the energy efficiency and consumption of energies with 90% and 95% success rates to the most efficient defibrillation energy. About a 50% increase in energy from the most efficient defibrillation energy is necessary for a 90% success rate which results in about a 13% loss in energy efficiency and about a 16% increase in energy consumption. About an 84% energy increase is necessary for a 95% success rate which results in about a 24% loss in energy efficiency and about a 33% increase in energy consumption.(ABSTRACT TRUNCATED AT 400 WORDS)

Animals↗

Combination biphasic waveform plus sequential pulse defibrillation improves defibrillation efficacy of a nonthoracotomy lead system.

OBJECTIVES: We hypothesized that combining biphasic waveform and sequential pulse defibrillation techniques would lower the defibrillation threshold of a nonthoracotomy lead system in humans below that obtained with biphasic or sequential pulse defibrillation alone. BACKGROUND: Previous studies have shown that sequential pulse monophasic shocks and biphasic waveform shocks are more effective than single monophasic shocks for ventricular defibrillation. METHODS: Thirteen patients aged 48 to 71 years undergoing nonthoracotomy defibrillation lead testing participated in the study. Transvenous electrodes were positioned in the right ventricular apex, superior vena cava and coronary sinus. A cutaneous patch electrode was placed on the left chest wall. All electrodes were connected to an external defibrillator. In random order, defibrillation threshold measurements were made for biphasic defibrillation alone, sequential defibrillation alone and combined biphasic plus sequential defibrillation. RESULTS: The mean defibrillation threshold-delivered energy was 18.0 +/- 11.9 J for biphasic defibrillation and 16.3 +/- 9.0 J for sequential defibrillation. Biphasic plus sequential defibrillation significantly reduced the threshold energy to 10.2 +/- 5.3 J (p < 0.001). Threshold peak voltage and current values showed corresponding reductions. The combined waveform resulted in a greater reduction in defibrillation threshold in patients with threshold energies > 18 J versus those with threshold values < or = 18 J for sequential (p = 0.001) or biphasic (p < 0.01) waveform alone. The nonthoracotomy lead implantation rate was improved from 62% with each of the single techniques (biphasic waveform or sequential pulse defibrillation) to 85% with the combined waveform. CONCLUSIONS: Adding biphasic waveform to sequential pulse defibrillation significantly reduced the defibrillation threshold compared with either technique alone, and nonthoracotomy lead system implantation can be enhanced by this combined technique.

Aged↗