Prospective randomized comparison of 50%/50% versus 65%/65% tilt biphasic waveform on defibrillation in humans

It is unknown if there is a single optimal biphasic waveform for defibrillation. Biphasic waveform tilt may be an important determinant of defibrillation efficacy. The purpose of this study was to compare acute defibrillation success with a three-electrode configuration in humans using 50%/50% versus 65%/65% tilt truncated exponential, biphasic waveforms delivered through a 110-microF capacitor. Acute DFTs for biphasic waveforms with 50%/50% versus 65%/65% tilt were measured in random order in 60 patients using a binary search method. The electrode configuration consisted of a RV coil as the cathode, and a SVC coil plus a pectoral active can emulator (CAN) as the anode. The waveforms were derived from an external voltage source with 110-microF capacitance, and the leading edge voltage of phase 2 was equal to the trailing edge voltage of phase 1. Stored energy DFT (9.2 +/- 5.7 [50%/50%] vs 10.8 +/- 6.4 [65%/65%] J, P = 0.007), current DFT (10.9 +/- 4.0 [50%/50%] vs 12.0 +/- 4.4 [65%/65%] A, P = 0.002) and voltage DFT (391 +/- 118 [50%/50%] vs 424 +/- 128 [65%/65%] V, P = 0.004) were significantly lower for the 50%/50% tilt waveform versus the 65%/65% tilt waveform using this three-electrode configuration and a 110-microF capacitor. For an RV(-)/SVC plus CAN(+) electrode configuration and a 110-microF capacitor, a 50%/50% tilt biphasic waveform results in a 15% reduction in energy DFT, 9% reduction in current DFT, and 8% reduction in voltage DFT versus a 65%/65% tilt biphasic waveform.     

Defibrillation with a minimally invasive direct cardiac massage device

OBJECTIVE: This study examined (1) the defibrillation efficacy of using a minimally invasive direct cardiac massage (MID-CM) device as one electrode of the defibrillation electrical circuit and (2) the effect on external defibrillation of defibrillating when the MID-CM device is in place and a pneumothorax is present. METHODS: Part 1: in seven pigs, defibrillation thresholds (DFTs) were determined with a truncated exponential biphasic waveform. DFTs were determined for five electrode configurations: standard transthoracic defibrillation with electrodes on the left and right chest walls (1), with the MID-CM as one of the defibrillation electrodes pressed gently (2) or firmly (3) against the heart with the right chest wall patch as the second electrode, the same as (1) with the MID-CM device in place and the lungs at end-inspiration (4) or at end-expiration (5). Part 2: in six pigs, DFTs were determined with a monophasic damped sinusoidal waveform with external defibrillation electrodes (1) and with the device as one defibrillation electrode and the other electrode on either the anterior (2), lateral (3), or posterior right chest wall (4). RESULTS: Part 1: the DFTs for (2) or (3) were not different (18.7+/-12.4 vs. 17.0+/-8.3 J), but both DFTs were lower than that for (1) (155+/-45 J). The DFT was elevated for (4) (205+/-69 J) compared with (1). For (5) only one animal could be defibrillated with shocks up to 360 J. Part 2: the DFTs for (2), (3) or (4) were not different (19.5+/-11.0, 25.4+/-9.4, 27.4+/-9.0 J), but all three were lower than the DFT for (1) (198+/-70 J). CONCLUSIONS: Using the MID-CM device as one electrode of the defibrillation circuit markedly lowers the DFT compared with that for standard transthoracic defibrillation for both a monophasic and biphasic waveform. Defibrillation with the device in place and the chest opened elevates the DFT for external defibrillation much more during end-expiration than during end-inspiration.     

Biphasic Defibrillation Using a Single Capacitor with Large Capacitance: Reduction of Peak Voltages and ICD Device Size

The volume of current implantable cardioverter defibrillators (ICD) is not convenient for pectoral implantation. One way to reduce the size of the pulse generator is to find a more effective defibrillation pulse waveform generated from smaller volume capacitors. In a prospective randomized crossover study we compared the step-down defibrillation threshold (DFT) of a standard biphasic waveform (STD), delivered by two 250-μF capacitors connected in series with an 80% tilt, to an experimental biphasic waveform delivered by a single 450μF capacitor with a 60% tilt. The experimental waveform delivered the same energy with a lower peak voltage and a longer duration (LVLDj. Intraopera-tively, in 25 patients receiving endocardial (n = 12) or endocardial-subcutaneous array (n = 13) defibrillation leads, the DFT was determined for both waveforms. Energy requirements did not differ at DFT for the STD and LVLD waveforms with the low impedance (32 ± 4Ω) endocardial-subcutaneous array defibrillation lead system (6.4 ± 4.4 J and 5.9 ± 4.2 J, respectively) or increased slightly (P - 0.06) with the higher impedance (42 ± 4 Ω) endocardial lead system (10.4 ± 4.6 J and 12.7 ± 5.7 /. respectively), However, the voltage needed at DFT was one-third lower with the LVLD waveform than with the STD waveform for both lead systems (256 ± 85 V vs 154 ± 53 V and 348 ± 76 V vs 232 ± 54 V, respectively). Thus, a single capacitor with a large capacitance can generate a defibrillation pulse with a substantial lower peak voltage requirement without significantly increasing the energy requirements. The volume reduction in using a single capacitor can decrease ICD device size.     

Right pectoral implantable cardioverter defibrillators: role of the proximal (SVC) coil

Introduction: Increased defibrillation thresholds (DFTs) with right active pectoral implantable cardioverter defibrillators (ICDs) and/or right proximal coils (SVC) are attributed to poorer vector. However, SVC affects impedance, current flow, and shock waveform phase duration (PD), which exert independent DFT effects.
Objective: Compare DFTs and shock characteristics in SVC On with SVC Off in right ICDs.
Methods and Results : DFT+ testing (n = 42, 62% males, 62 ±15 years, left ventricular ejection fraction (LVEF) 26 ± 11%, ischemic cardiomyopathy 65%, amiodarone 26%) revealed >20% incidence of high DFT (>20J) . Dilated cardiomyopathy and amiodarone increased DFT. Individual impedance variability (25–74 Ω) generated a wide PD range (2.6–8.7 ms). Overall, SVC On reduced impedance by 33% (from 54 ± 10 to 35 ± 5Ω, P< 0.0001), and shortened PD (from 5.45 ± 1.20 to 3.67 ± 0.74 ms, P< 0.01). SVC On affected DFTs in 19/42 (45%) patients. SVC On was beneficial in 12/19. PD shortened but current flow remained unaltered. (In these, SVC Off impedance was >45Ω and PD >5 ms.) SVC On was detrimental in 7/19 despite increasing current flow. In these, PD shortened excessively (median 2.9 ms) because impedance was low (31 ± 4Ω). In 3/6 cases with DFTs >20 J in both SVC On and Off , PD optimization reduced DFT. Overall, selection of best SVC configuration or deliberate PD programming yielded DFTs ≤20 J in >90% patients, reducing need for system modification to <7%.
Conclusions : Right pectoral active ICDs have high DFTs. The SVC coil may be detrimental when pulse waveform excessively shortens. Noninvasive maneuvers, for example, SVC and waveform optimization, may improve DFT.     

"Tuned" Defibrillation Waveforms Outperform 50/50% Tilt Defibrillation Waveforms: A Randomized Multi-Center Study

Introduction: A superior performance of a tuned waveform based on duration using an assumed cardiac membrane time constant of 3.5 ms and of a 50/50% tilt waveform over a standard 65/65% tilt waveform has been documented before. However, there has been no direct comparison of the tuned versus the 50/50% tilt waveforms.
Methods: In 34 patients, defibrillation thresholds (DFTs) for tuned versus 50/50% tilt waveforms in a random order were measured by using the optimized binary search method. High voltage lead impedance was measured and used to select the pulse widths for tuned and 50/50% tilt defibrillation waveforms.
Results: Delivered energy (7.3 ± 4.6 J vs 8.7 ± 5.3 J, P = 0.01), stored energy (8.2 ± 5.1 J vs 9.7 ± 5.6 J, P = 0.01), and delivered voltage (405.9 ± 121.7 V vs 445.0 ± 122.6 V, P = 0.008) were significantly lower for the tuned than for the 50/50% tilt waveform. In four patients with DFT ≥15 J, the tuned waveform lowered the mean energy DFT by 2.8 J and mean voltage DFT by 45 V. For all patients, the mean peak delivered energy DFT was reduced from 29 J to 22 J (24% decrease). Multiple regression analysis showed that a left ventricular ejection fraction <20% is a significant predictor of this advantage.
Conclusion: Energy and voltage DFTs are lowered with an implantable cardioverter defibrillator that uses a tuned waveform compared to a standard 50% tilt biphasic waveform.     

Defibrillation with Low Voltage using a Left Ventricular Catheter and Four Cutaneous Patch Electrodes in Dogs

The purpose of this study was to determine a lower limit of defibrillation thresholds (DFTs) that could be used to evaluate nonthoracotomy lead configurations for implantable defibrillators. A lead configuration that consisted of a left ventricular catheter and four circumferential cutaneous patches was tested because it was hypothesized to create a relatively uniform electric field for defibrillation. In eight anesthetized dogs, three 8F defibrillating catheters with 6 cm platinum clad titanium tips were inserted into the right ventricle (R), right ventricular outflow tract (O), and left ventricle (L). Four cutaneous patch electrodes (4P), each with a surface area of 42 cm2, were placed on the left lateral, right lateral, anterior and posterior thorax. DFTs for ten lead configurations, consisting of different combinations of these electrodes, were evaluated. DFTs were determined by using a modified Purdue technique and applying a single capacitor biphasic shock with both phases 6 ms in duration after 15 sec of electrically induced fibrillation. The L(-)----4P+ configuration produced a lower DFT than R(-)----4P+ (3.2 +/- 1.6 J vs 8.0 +/- 4.2 J, P less than 0.001) with reduced current (2.6 +/- 0.7 A vs 4.1 +/- 1.2 A, P less than 0.001). Lowering the impedance by a mean of 40%, configurations that used four patches produced lower DFTs than those that used a single left lateral patch. The use of an O catheter produced lower DFTs only when used in conjunction with an R catheter.(ABSTRACT TRUNCATED AT 250 WORDS)     

Comparison of Defibrillation Efficacy Using Biphasic Waveforms Delivered from Various Capacitances/Pulse Widths

The efficacy of the biphasic waveform shock for the defibrillation of the ventricular myocardium has been reported by researchers and physicians. Although many authors have suggested that biphasic waveforms delivered from lower capacitances and shorter pulse widths could result in the reduction of the energy required for sucessful defibrillation, no report has described the smallest capacitance and pulse width yielding the lowest DFT. In the study, we compared efficacies of the biphasic waveform shocks and DFT safety margins among five different capacitances (175 μf, 125 μf, 100 μf, 75 μf, and 50 μf) combined with 1–3 pulse widths. These experiments perfomed in six dogs used an endocardial lead/subcutaneous patch defibrillation electrode system. The average DFTs at E50 for 175 μf (6.5/3.5 ms), 125 μf (6.5/3.5 ms), 100 μf (6.0/3.0 ms), 75 μf (4.0/2.0) ms, and 50 μf (3.0/2.0 ms) were 8.5, 10.0, 11.0, 14.0, and 16.5 J, respectively. These results indicate that a biphasic waveform delivered from a larger capacitance with a proper pulse width could achieve a higher defibrillation efficacy. All DFTs at E50 for all waveforms were compared to their deliverable energies and maximum stored energies. This comparison indicated a narrow DFT safety margin with capacitances below 100 μf. Therefore, it is concluded that higher energy and higher leading edge voltage are required for a biphasic waveform delivered from a smaller capacitance with a shorter pulse width. Since the current capacitor technology provides a maximum voltage of 750 V using two capacitors in series, with the electrode impedance system used in this study, smaller capacitors appear to have a decreased probability of defibrillation success at a given energy.     

Transthoracic impedance does not decrease with rapidly repeated countershocks in a swine cardiac arrest model

STUDY PURPOSE: Successful defibrillation is dependent upon the delivery of adequate electrical current to the myocardium. One of the major determinant of current flow is transthoracic impedance. Prior work has suggested that impedance falls with repeated shocks during sinus rhythm. The purpose of this study was to evaluate changes in transthoracic impedance with repeated defibrillation shocks in an animal model of cardiac arrest due to ventricular fibrillation (VF). METHODS: VF was electrically induced in anesthetized swine. After 5 min of untreated VF, monophasic or biphasic waveform defibrillation was attempted using a standard sequence of 'stacked shocks' (200, 300, then 360 J, if necessary) administered via adhesive electrodes. If one of the first three shocks failed to convert VF, conventional CPR was initiated and defibrillation (360 J) attempted 1 min later. Strength-duration curves for delivered voltage and current were measured during each shock and transthoracic impedance calculated. Animals requiring a minimum of four shocks were selected for study inclusion. Impedance data from sequential shocks were analyzed using mixed linear models to account for the repeated-measures design and the variability of the initial impedance of individual animals. RESULTS: Thirteen animals (monophasic waveform, n=7, biphasic waveform, n=6) required at least four shocks to terminate VF (range 4-6). Transthoracic impedance did not change from the first shock in the 13 animals (46+/-8 Omega) to the fourth shock (46+/-9 Omega). In animals receiving more than four shocks, transthoracic impedance likewise did not change significantly from the first to the last shock, which terminated VF. The lack of a significant change in impedance was also observed when animals were analyzed according to defibrillation waveform. CONCLUSION: Transthoracic impedance does not change significantly with repeated shocks in a VF cardiac arrest model. This is likely due to the lack of reactive skin and soft tissue hyperemia and edema observed in non-arrest models.     

Bidirectional Defibrillation Using Implantable Defibrillators: A Prospective Randomized Comparison Between Pectoral and Abdominal Active Generators

SANDSTEDT, B., et al. : Bidirectional Defibrillation Using Implantable Defibrillators: A Prospective Randomized Comparison Between Pectoral and Abdominal Active Generators. The objective of this study was to compare the effects of active abdominal and pectoral generator positions on DFTs in a bidirectional tripolar ICD system. Twenty-five consecutive patients had ICD systems implanted under general anesthesia. A transvenous single lead bipolar defibrillation system and an active 57-cc test emulator in the abdominal and pectoral positions were used in the same patient. A randomized, alternating stepdown protocol was used starting at 15 J with 3-J decrements until failure. The mean implantation time was  114 ± 23 minutes  , the mean arrhythmia duration was  14.5 ± 1.5 seconds  , and the mean recovery time was  5.4 ± 1.1 minutes  . The mean DFTs in the abdominal and pectoral positions were  10.9 ± 5.1  and  9.7 ± 5.2 J  , respectively (NS), the mean intraindividual DFT difference (abdominal minus pectoral) was  −0.89 ± 4.15 J  (  range −9.5 to + 5.8 J  ). The 95% confidence interval showed a  −2.60 to + 0.82 J  mean difference (NS). The DFT was < 15 J in 72% and 88% of the patients and the defibrillation impedance was  41 ± 3  and  44 ± 3 Ω  , abdominal versus pectoral positions. There was no difference in DFT between active abdominal and pectoral generator bidirectional tripolar defibrillation. The pectoral position may be considered the primary option, but in cases of high DFTs the abdominal site should be considered an alternative to adding a subcutaneous patch. In some patients, the anatomy may favor an abdominal position. Possible differences in the long-term functionality on the leads are not yet well known and need to be further evaluated.     

Efficacy of Tuned Waveforms Based on Different Membrane Time Constants on Defibrillation Thresholds: Primary Results from the POWER Trial

Background: The efficacy of tuned defibrillation waveforms versus the nominal fixed‐tilt waveform has been previously studied. However, the optimal membrane time constant for tuning was not known. The POWER (Pulsewidth Optimized Waveform Evaluation tRial) trial was designed to determine the optimal membrane time constant for programming “tuned” biphasic waveforms. Methods: This acute, multicenter study included 121 implantable cardioverter‐defibrillator/cardiac resynchronization therapy defibrillator patients who were randomized at implant to any two of the three membrane time constant waveforms (2.5, 3.5, and 4.5 ms). Fixed pulse widths were programmed using the measured high voltage shock impedance. The defibrillation threshold (DFT) estimates were obtained using a hybrid protocol starting with an upper limit of vulnerability estimate followed by a step‐up/step‐down ventricular fibrillation induction process. Results: DFT voltage was significantly lower using 3.5‐ and 4.5‐ms waveforms as compared to the 2.5‐ms waveform (P = 0.004 and 0.035, respectively). DFT voltage with both 3.5‐ and 4.5‐ms waveforms was ≤ that obtained with the 2.5‐ms waveform in 78.5% of the cases. The mean difference in DFT voltage using the 3.5‐ms waveform and the 4.5‐ms waveform was not significant (P = 0.4). However, the 3.5‐ms waveform gave a lower DFT than the 4.5‐ms waveform in 19 patients although the reverse was true in only nine (P = 0.02 not significant for multiple comparisons). Conclusions: The use of a 3.5‐ or 4.5‐ms time constant‐based waveforms had lower DFTs when compared to the 2.5‐ms waveform. This study suggests that the first defibrillation attempt at implantation should be with 3.5‐ or 4.5‐ms time constant‐based waveforms. The 3.5‐ms‐based waveform trended toward the best choice. (PACE 2012; 35:1253–1261)     

Porcine defibrillation thresholds with chopped biphasic truncated exponential waveforms

PURPOSE: Conventional biphasic truncated exponential (BTE) waveforms have been studied extensively but less is known about "chopping modulated" BTE shocks. Previous studies comparing chopped and unchopped waveforms have found conflicting results. This study compared the defibrillation thresholds (DFTs) of a variety of chopped and unchopped BTE waveforms. METHODS: Six anesthetized pigs were defibrillated after 15s of electrically induced ventricular fibrillation (VF). Three waveform types were studied: unchopped BTE, "short" duration chopped, and "long" duration chopped waveforms. Each type included waveforms generated with 50, 100, and 200 microF capacitances, giving 9 total waveforms. Shocks were delivered in a standard up-down protocol and the order of the waveforms was randomized. Defibrillation thresholds were calculated using a Bayesian logistic regression model. RESULTS: DFTs of the 50, 100, and 200 microF unchopped waveforms were 122+/-22, 124+/-22, and 126+/-22 J. Short chopped DFTs were at least 75+/-23 J higher than unchopped DFTs. Long chopped DFTs averaged 66+/-20 J more than short chopped DFTs. There is a 99.5% probability that the best of the chopped waveforms has a higher DFT than the worst of the unchopped waveforms, and a 95% probability that the difference is at least 37 J. DFT differences between capacitor values were less than 7 J for all waveform types. CONCLUSIONS: When treating swine with short-duration VF, chopped waveforms require more energy to defibrillate than unchopped waveforms. More study is required to assess the performance of chopped waveforms when treating cardiac arrest patients.     

Adjustable atrial and ventricular temporary electrode for low-energy termination of tachyarrhythmias early after cardiac surgery

Supraventricular and ventricular tachycardias are common and serious postoperative complications early after cardiac surgery. We introduce a completely removable temporary adjustable defibrillation electrode (TADE) for low energy cardioversion/defibrillation of postoperative atrial and ventricular tachyarrhythmias. The electrode consists of three loops of steel wires connected to one steel wire, which are movable within an isolation sheet for adjusting the active surface to the individual size of the heart chambers. Evaluation of the electrode was performed in 10 open-chest beagles with a mean weight of 25.5 kg. The electrodes were first positioned on the left and right atrium. Atrial fibrillation (AF) was induced via a bipolar temporary heart wire. Atrial defibrillation thresholds (DFTs) were measured according to a step-down shock protocol (5-0.4 J). Thereafter, the electrodes were adjusted and positioned on the right and left ventricle. Ventricular fibrillation (VF) was induced and DFTs were recorded the same way. Aortic flow and pressure and left ventricular pressure were continuously monitored throughout the experiment. For termination of AF, mean DFTs were 0.4 +/- 0 J (lowest possible shock level) with a mean shock impedance of 70 +/- 7.6 ohms. VF was terminated with a mean DFT of 3 +/- 1.1 J with a mean impedance 56.1 +/- 7.9 ohms. Complete transcutaneous removal of the electrodes was possible in all animals without any complications. In conclusion, successful low energy termination of AF and VF is possible with the tested temporary adjustable electrode. A clinical study is planned for further evaluation.     

A comparison of biventricular and conventional transvenous defibrillation: a computational study using patient derived models

Conventional transvenous defibrillation is performed with an ICD using a dual current pathway. The defibrillation energy is delivered from the RV electrode to the superior vena cava (SVC) electrode and the metallic case (CAN) of the ICD. Biventricular defibrillation uses an additional electrode placed in the LV free wall with sequential shocks to create an additional current vector. Clinical studies of biventricular defibrillation have reported a 45% reduction in mean defibrillation threshold (DFT) energy. The aim of the study was to use computational methods to examine the biventricular defibrillation fields together with their corresponding DFTs in a variety of patient derived models and to compare them to simulations of conventional defibrillation. A library of thoracic models derived from nine patients was used to solve for electric field distributions. The defibrillation waveform consisted of a LV --> SVC + CAN monophasic shock followed by a biphasic shock delivered via the RV --> SVC + CAN electrodes. When the initial voltage of the two shocks is the same, the simulations show that the biventricular configuration reduces the mean DFT by 46% (3.5 +/- 1.3 vs 5.5 +/- 2.7 J, P = 0.005). When the leading edge of the biphasic shock is equal to the trailing edge of the monophasic shock, there is no statistically significant difference in the mean DFT (4.9 +/- 1.9 vs 5.5 +/- 2.7 J, P > 0.05) with the DFT decreasing in some patients and increasing in others. These results suggest that patient-specific computational models may be able to identify those patients who would most benefit from a biventricular configuration.     

A Patch in the Pectoral Position Lowers Defibrillation Threshold

Implantable pacemaker cardioverter defibrillators are now available with biphasic waveforms, which have been shown to markedly improve defibrillation thresholds (DFTs). However, in a number of patients the DFT remains high. Also, DFT may increase after implantation, especially if antiarrhythmic drugs are added. We report on the use of a subcutaneous patch in the pectoral position in 15 patients receiving a transvenous defibrillator as a method of easily reducing the DFT. A 660-mm² patch electrode was placed beneath the generator in a pocket created on the pectoral fascia. The energy required for defibrillation was lowered by 56% on average, and the system impedance was lowered by a mean of 25%. This maneuver allowed all patients to undergo a successful implant with adequate safety margin.     

The Effect of Electrode Size on Transvenous Defibrillation Energy Requirements: A Prospective Evaluation

Recent technological advances have resulted in high success rates for implantation of nonthoracotomy defibrillation lead systems. Further decreases in defibrillator size, facilitating pectoral placement, will depend in part on lowering defibrillation energy requirements. The purpose of this study was to determine if endocardial defibrillation energy requirements are influenced by electrode size. Thirteen adult mongrel dogs were studied under general anesthesia. A9 Fr integrated bipolar pace/sense/defibrillation electrode (cathode) was positioned transvenously at the RV apex. The second defibrillation electrode (anode) was positioned at the junction of the RA and SVC. Two diameters of the proximal electrode, 7 Fr and 11 Fr, were sequentially tested in random order in each animal. The DFT for each electrode was determined using a 50-V up-down method. Energy, leading edge voltage, and current, current distribution, and total resistance were measured. The mean defibrillation voltage threshold with the 11 Fr proximal electrode was significantly less than with the 7 Fr proximal electrode (551.1 ± 76.5 V vs 588.5 ± 54.6 V, P < 0.01). Similarly, the mean DFT with the 11 Fr electrode was less than with the 7 Fr electrode (20.7 ±5.7J vs 23.3 ± 4.4 J.P < 0.01). Lower DFTs were found using the larger electrode in 11 of the 13 animals studied. However, there was no difference in defibrillation lead impedance between the two electrode systems. Endocardial defibrillation energy requirements may be lowered with a larger diameter proximal electrode. The mechanism by which this occurs may be due to a more even distribation of current gradients with the larger electrode. Determination of the optimal electrode size requires evaluation in humans, as this may allow further reduction in defibrillation energy requirements and defibrillator size.     

Short Biphasic Pulses from 90 Microfarad Capacitors Lower Defibrillation Threshold

For defibrillation between right ventricular and retropectoral patch electrodes using truncated exponential pulses, the stored energy defibrillation threshold (DFT) is lower for short pulses from small 60-μF capacitors than for conventional pulses from 120-μF capacitors, but 60-μF pulses frequently require higher voltages than are currently used. The goal of this study was to determine if DFT could be reduced by intermediate size 90-μF capacitors. This study compared biphasic waveform DFTs for 120μF-65% tilt pulses, 90μF-65% tilt pulses, and 90 μF-50% tilt pulses in 20 patients at defibrillator implantation. The 90μF-50% tilt pulses were selected because their duration is half that of 120μF-65% tilt pulses. The stored energy DFT for 90 μF-50% tilt pulses (9.1 ± 4.3 J) was less than both the DFT for 120 μF-65% tilt pulses (12.0 ± 5.5 J, P < 0.005) and the DFT for 90μF-65% tilt pulses (11.6 ± 5.8 J, P < 0.005). There was no significant difference between the latter two values. The voltage DFTs for 90 μF-50% pulses (436 ± 113 V) and 120 μF-65% tilt pulses (436 ± 104 V) were not statistically different; the voltage DFT for 90 μF-65% tilt pulses was higher than for either of the other two pulses (490 ± 131, P < 0.005). The DFT was 20 } or greater in three patients for both 120 μF-65% tilt pulses and 90 μF-65% tilt pulses, but it was 16 J or less in all patients for 90 μF-50% tilt pulses. When pathways were dichotomized by the median resistance of 71 Ω, 90 μF-50% tilt pulses significantly reduced DFTs compared to 120 μF-65% tilt pulses for higher resistance pathways (9.2 ± 4.0 J vs 13.0 ± 6.2 J, P = 0.002), but not lower resistance pathways (9.0 ± 4.8 J vs 10.9 ± 4.6 J, P = NS). For the electrode configuration tested, biphasic 90 μF-50% tilt pulses reduce stored energy DFT in comparison with 120 μF-65% tilt pulses without increasing voltage DFT. However, 90 μF-65% tilt pulses provide no benefit.     

Optimized Pulse Durations Minimize the Effect of Polarity Reversal on Defibrillation Efficacy with Biphasic Shocks

There are conflicting results on the effect of polarity change on the defibrillation efficacy of biphasic shocks possibly caused by different shock durations. The goal of the present study was to investigate the influence of polarity reversal on defibrillation efficacy for different biphasic shock durations in a porcine animal model. In eight anesthesized pigs using a transvenous/submuscular lead system DFTs for 4 phase 1 durations were determined: 8.1 ms, 6 ms, 3.8 ms and 1.7 ms. The phase 1/phase 2 ratio was constant at 60%/40%. For cathodal shocks, the defibrillation coil in the right ventricular apex was the cathode during phase 1 and for anodal shocks it was the anode. For both polarities, the strength-duration curve revealed a DFT minimum at 3.8 ms (cathodal shocks: 21.3 +/- 6.4 J, P < 0.001; anodal shocks: 21.9 +/- 8 J, P = 0.05). For anodal shocks and phase 1 durations of 1.7, 3.8, and 6 ms there was no significant difference of the stored energy at the DFT compared to cathodal shocks. In contrast, significantly lower DFTs were observed for anodal shocks with a phase 1 duration of 8.1 ms (28.8 +/- 6.4 J compared to 33.1 +/- 5.9 J for cathodal shocks, P = 0.006). The effect of lower defibrillation energy requirements with polarity reversal depends on the total biphasic shock duration; for the pulse duration with the lowest DFT, polarity reversal does not increase defibrillation efficacy of biphasic shocks.     

A Prospective, Randomized, Comparison in Patients Between a Pectoral Unipolar Defibrillation System and That Using an Additional Inferior Vena Cava Electrode

The decrease of defibrillation energy requirement would render the currently available transvenous defibrillator more effective and favor the device miniaturization process and the increase of longevity. The unipolar defibrillation systems using a single RV electrode and the pectoral pulse generator titanium shell (CAN) proved to be very efficient. The addition of a third defibrillating electrode in the coronary sinus did not prove to offer advantages and in the superior vena cava showed only a slight reduction of the defibrillation threshold (DFT). The purpose of this study was to determine whether the defibrillation efficacy of the single lead unipolar transvenous system could be improved by adding an electrode in the inferior vena cava (IVC). In 17 patients, we prospectively and randomly compared the DFT obtained with a single lead unipolar system with the DFT obtained using an additional of an IVC lead. The RV electrode, Medtronic 6936, was used as anode (first phase of biphasic) in both configurations. A 108 cm2 surface CAN, Medtronic 7219/7220 C, was inserted in a left submuscular infraclavicular pocket and used as cathode, alone or in combination with IVC, Medtronic 6933. The superior edge of the IVC coil was positioned 2-3 cm below the right atrium-IVC junction. Thus, using biphasic 65% tilt pulses generated by a 120 microF external defibrillator, Medtronic D.I.S.D. 5358 CL, the RV-CAN DFT was compared with that obtained with the RV-CAN plus IVC configuration. Mean energy DFTs were 7.8 +/- 3.6 and 4.8 +/- 1.7 J (P < 0.0001) and mean impedance 65.8 +/- 13 O and 43.1 +/- 5.5 O (P < 0.0001) with the RV-CAN and the IVC configuration, respectively. The addition of IVC significantly reduces the DFT of a single lead active CAN pectoral pulse generator. The clinical use of this biphasic and dual pathway configuration may be considered in patients not meeting implant criteria with the single lead or the dual lead RV-superior vena cava systems. This configuration may also prove helpful in the use of very small, low output ICDs, where the clinical impact of ICD generator size, longevity, and related cost may offset the problems of dual lead systems.     

Prospective Randomized Comparison of Biphasic Waveform Tilt Using a Unipolar Defibrillation System

Background: A unipolar defihrillation system using a single right ventricular (RV) electrode and the active shell or container of an implantable cardioverter defibrillator situated in a left infraclavicular pocket has been shown to be as efficient in defibrillation as an epicardial lead system. Additional improvements in this system would have favorable practice implications and could derive from alterations in pulse waveform shape. The specific purpose of this study is to determine whether defibrillation efficacy can be improved further in humans by lowering biphasic waveform tilt. Methods: We prospectively and randomly compared the defibrillation efficacy of a 50% and a 65% tilt asymmetric biphasic waveform using the unipolar defibrillation system in 15 consecutive cardiac arrest survivors prior to implantation of a presently available standard transvenous defibrillation system. The RV defibrillation electrode has a 5-cm coil located on a 10.5 French lead and was used as the anode. The system cathode was the active 108 cm² surface area shell (or “CAN”) of a prototype titanium alloy pulse generator placed in the left infraclavicular pocket. The defibrillation pulse derived from a 120-μF capacitor and was delivered from RV ± CAN, with RV positive with respect to the CAN during the initial portion of the cycle. Defibrillation threshold (DFT) stored energy, delivered energy, leading edge voltage and current, pulse resistance, and pulse width were measured for both tilts examined. Results: The unipolar single lead system, RV ± CAN, using a 65% tilt biphasic pulse resulted in a stored energy DFT of 8.7 ± 5.7 J and a delivered energy DFT of 7.6 ± 5.0 J. In ail 15 patients, stored and delivered energy DFTs were < 20 J. The 50% tilt biphasic pulse resulted in a stored energy DFT of 8.2 ± 5.4 J and a delivered energy DFT of 6.1 ± 4.0 J;P = 0.69 and 0.17, respectively. As with the 65% tilt pulse, all 15 patients had stored and delivered energy DFTs < 20 J. Conclusion: The unipolar single lead transvenous defibrillation system provides defibrillation at energy levels comparable to that reported with epicardial lead systems. This system is not improved by use of a 50% tilt biphasic waveform instead of a standard 65% tilt biphasic pulse. (PACE 1995; 18:1369–1373)     

The strength-duration relationship of monophasic waveforms with varying capacitance sizes in external defibrillation

The shape of the shock waveform influences defibrillation efficacy. However, the optimal combination between capacitance size and truncation/tilt which can determine monophasic waveform's shape, has not been determined for external defibrillation. The purpose of this study was to assess the effects of varying capacitance and tilt on external defibrillation using exponential monophasic waveforms. In a pig model of external defibrillation (n = 10, 30 +/- 6 kg), nine exponential monophasic waveforms combining three capacitance values (30 microF, 60 microF, and 120 microF) and three tilt values (55%, 75%, and 95%) were tested randomly. The energy and leading edge voltage at 50% defibrillation success (E50 and V50) were used to evaluate defibrillation efficacy. E50 and V50 were determined by the Bayesian technique. The lowest stored E50 for the 30microF, 60 microF, and 120 microF waveforms were 90 +/- 12 J (95% tilt), 106 +/- 45 J (55% tilt), and 107 +/- 52 J (75% tilt), respectively. The lowest V50 for the 30 microF, 60 microF, and 120 microF waveforms were 2,439 +/- 166 V (95% tilt), 1,849 +/- 375 V (55% tilt), and 1,301 +/- 322 V (75% tilt), respectively. The average current at external defibrillation threshold demonstrated a strength versus pulse duration relationship similar to that seen with pacing. Reducing capacitance has the same effect as truncating the waveform. The E50 is more sensitive to tilt values changes in larger capacitance waveforms. This study suggests that the optimal combination between capacitance and tilt may be 120 microF and 55%-75% for external defibrillation.