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PubMed1997

Initial clinical experience with an implantable human atrial defibrillator.

Low energy biatrial shock is an effective means of restoring sinus rhythm in patients with atrial fibrillation (AF). Ventricular proarrhythmia is avoided provided that shocks are well synchronized to R waves that are not at closely coupled intervals or preceded by long-short cycles. Based on these principles, an implantable atrial defibrillator has been developed and was implanted in three patients with drug refractory paroxysmal AF. The device detects AF via an actively fixed right atrial and a self-retaining coronary sinus defibrillating leads, and delivers 3/3 ms biphasic shocks up to 300 V synchronized to the R wave. The mean implant threshold (ED50) was 195 V (1.8 J). and minimum voltage at conversion during follow-up assessments at 1, 3, and 6 months were 260 V, 2.5 J. 250 V, 2.3 J, and 300 V, 3.0 J respectively. Detection of AF was 100% specific and shocks were 100% synchronized, although only a proportion of synchronized R waves were considered suitable for shock delivery primarily because of closely coupled cycles. Three patients had 9 spontaneous AF episodes, 8/9 (89%) successfully defibrillated by shocks of 260-300 V. Sedation was not used in 4 out of 9 (45%) episodes. Backup ventricular pacing was initiated by the device in 6 out of (67%) episodes. One patient had more frequent AF after lead placement, which subsided after a change of medication. There was no ventricular proarrhythmia. It is concluded that an implantable atrial defibrillator is a viable therapy for selected patients with paroxysmal AF. The device is capable of accurate AF detection, R wave synchronization and ventricular support pacing after successful defibrillation of AF.

Adult↗
PubMed1998

Several unsuccessful internal and external defibrillations during active can ICD implantation in a patient with pneumothorax.

During implantable cardioverter defibrillator (ICD) implantation of an active can ICD several defibrillations with 20 J and 34 J as well as 360 J externally were ineffective. The implant criteria were finally met with a second defibrillation lead and reversed polarity. A left-sided pneumothorax due to subclavian vein puncture was detected soon after ICD implantation. It is assumed that especially in the active can alignment the developing pneumothorax made defibrillation current flow more difficult. In case of several unsuccessful defibrillations during active can ICD implantation in which the subclavian vein was punctured, the possibility of a pneumothorax should be considered.

Defibrillators, Implantable↗
PubMed1998

Transvenous single lead atrial defibrillation: efficacy and risk of ventricular fibrillation in an ischemic canine model.

Transvenous atrial defibrillation with multiple atrial lead systems has been shown to be effective in models without the potential for ventricular arrhythmias. The specific aim of this study was to evaluate the efficacy and safety of transvenous single lead atrial defibrillation in a canine model of ischemic cardiomyopathy. Ten dogs had ischemic cardiomyopathy induced by repeated intracoronary microsphere injections. The mean LV ejection fraction decreased from 71% +/- 9% to 38% +/- 14% (P = 0.003). Spontaneous atrial fibrillation (AF) developed in four dogs, and in six AF was induced electrically. Atrial defibrillation thresholds (ADFTs) were determined with synchronous low energy shocks using a transvenous tripolar lead with two defibrillation coils (right ventricle, superior vena cava) and an integrated sensing lead (RV coil vs electrode tip). The ADFTs derived by logistic regression were compared at 50% and 90% probability of success (ED50, ED90): ED50 was 2.4 +/- 1.7 J and 2.9 +/- 2.1 J, respectively, for 5- and 10-ms monophasic shocks, and 1.8 +/- 0.9 J, respectively, for 5- and 10-ms biphasic shocks. Immediately after 3 of 2,179 (0.1%) synchronized shocks, ventricular fibrillation (VF) developed. VF was induced in 3 of 1,062 (0.3%) shocks with integrated sensing (RV coil vs electrode tip) compared to 0 of 1,117 shocks when a separate bipolar RV sensing electrode was used for synchronization. In our canine model of ischemic cardiomyopathy, low energy atrial defibrillation via a transvenous single lead system was highly effective. However, there was a small but definite risk of VF induction, which seemed to be greater when an integrated as opposed to a true bipolar RV sensing was used.

Animals↗
PubMed1998

The effect of inducing ventricular fibrillation with 50-Hz pacing versus T wave stimulation on the ability to defibrillate.

When testing an ICD, there are at least two techniques for inducing ventricular fibrillation: (1) high frequency (approximately equal to 50 Hz) pacing; and (2) a single T wave stimulus. It is generally assumed that these two methods yield similar results. This study directly tested this assumption. In six dogs, one defibrillation electrode was placed in the right ventricular (RV) apex and the second was placed cutaneously on the left thorax. All defibrillation and T wave stimuli were biphasic between these two electrodes. Pacing was monophasic from the tip of the RV catheter to the cutaneous patch. The voltage which defibrillates 50% of the time (DF50) was measured using a 10-step Bayesian up-down method. Observations for two DF50 measurements were randomly interleaved. For one DF50 measurement, fibrillation was induced with 99 pacing stimuli at a 20-ms pacing interval (50-Hz pacing). For the second DF50 measurement, fibrillation was induced with a single defibrillation shock of approximately 1/2 J delivered at a time corresponding to the peak of the T wave in the lead II electrogram (T wave stimuli). The average DF50 when measured after fibrillation induced with 50-Hz pacing was 379 +/- 54.6 V, as compared to 382 +/- 50.3 V when fibrillation was induced with T wave stimuli. The difference of 3 V was not statistically significant. If these results are confirmed in humans, it is reasonable to assume that the efficacy of a defibrillation shock is the same whether T wave stimuli or 50-Hz pacing are used to induce fibrillation.

Animals↗
PubMed1999

Impact of transvenous lead position on active-can ICD defibrillation: a computer simulation study.

Optimizing lead placement in transvenous defibrillation remains central to the clinical aspects of the defibrillation procedure. Studies involving superior vena cava (SVC) return electrodes have found that left ventricular (LV) leads or septal positioning of the right ventricular (RV) lead minimizes the voltage defibrillation threshold (VDFT) in endocardial lead-->SVC defibrillation systems. However, similar studies have not been conducted for active-can configurations. The goal of this study was to determine the optimal lead position to minimize the VDFT for systems incorporating an active can. This study used a high resolution finite element model of a human torso that includes the fiber architecture of the ventricular myocardium to find the role of lead positioning in a transvenous LEAD-->can defibrillation electrode system. It was found that, among single lead systems, posterior positioning of leads in the right ventricle lowers VDFTs appreciably. Furthermore, a septal location of leads resulted in lower VDFTs than free-wall positioning. Increasing the number of leads, and thus the effective lead surface area in the right ventricle also resulted in lower VDFTs. However, the lead configuration that resulted in the lowest VDFTs is a combination of mid-cavity right ventricle lead and a mid-cavity left ventricle lead. The addition of a left ventricular lead resulted in a reduction in the size of the low gradient regions and a change of its location from the left ventricular free wall to the septal wall.

Catheterization, Central Venous↗
PubMed1999

Prehospital discharge defibrillation testing in ICD recipients: a prospective study based on cost analysis.

Prehospital discharge defibrillation testing is often performed to verify the function of newly implanted cardioverter defibrillators (ICDs). To determine whether elimination of predischarge testing could reduce costs without placing patients at additional risk, 31 patients were randomized in this prospective clinical evaluation to either receive or not receive a predischarge ICD defibrillation test. Expenses associated with postimplant care was the primary endpoint. All patients underwent induction of ventricular fibrillation after 6 months to evaluate ICD function. The groups were well matched in terms of patient characteristics, initial lead implant parameters, and defibrillation thresholds. Elimination of prehospital discharge testing resulted in a savings of $1,800/patient after 6 months, with no difference between groups in terms of ICD complication rates or unanticipated hospital admissions. Further studies are needed to better define the most appropriate time to assess defibrillation thresholds in the first year after implantation.

Aged↗
PubMed1999

Double pulse transthoracic defibrillation in the calf using percent fibrillation cycle length as spacing determinate.

Recent studies have found that when multiple pulses of energy are used for defibrillation with implantable electrodes, the spacing between these pulses is better determined as a percentage of the fibrillation cycle length (CL), rather than as a fixed function of time. Here, this concept is further tested in the transthoracic defibrillation of calves, which are approximately the size of heavy humans. Eleven 90-110 kg calves (101 +/- 6 kg) were used in evaluating the effectiveness in achieving transthoracic ventricular defibrillation of ten double pulse waveforms (two 50 A 4-ms rectangular monopulses) having leading edge-to-edge spacings of 4 ms (a 50 A 8-ms rectangular monopulse) and 50, 60, 70, 80, 90, 100, 110, 120, 130 percent fibrillation CL, respectively. In each of these waveforms, the total time when 50 A current was flowing (on time) was 8 ms. Our results show an unequivocal adverse interaction between the pulses, when the spacing is around 60%-70% fibrillation CL; but that the two pulses combined to defibrillate as effectively as a single 8-ms pulse when the spacing is around 110%-130% fibrillation CL. Electrocardiographic analysis suggests that the adverse interaction is due to a refibrillation phenomenon. This study confirms that double pulses can interact and have a negative effect on defibrillation efficacy. Our data suggests that the mechanism of this interaction involves the second pulse reinitiating fibrillation when the pulse separation is in a critical range of values. Our results are also compatible with the hypothesis that the spacing of multiple pulses is better determined as a percentage of the fibrillation CL than as absolute time, although more study is necessary to fully test this hypothesis.

Animals↗
PubMed1999

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.

Animals↗
PubMed2006

Influence of drive cycle length on initiation of ventricular fibrillation during implantable cardioverter defibrillator threshold testing.

BACKGROUND: Programmed electrical stimulation of the heart as a method to induce tachyarrhythmias has been described since the 1960s. To date, no study has examined optimal drive cycle length in the induction of ventricular fibrillation (VF) during defibrillation threshold testing after implantable cardioverter-defibrillator placement. We hypothesized that longer drive cycle length, by means of the longer action potential duration, would promote intramyocardial phase 2 reentry and facilitate induction of VF. METHODS: Fifty consecutive implants were randomized in a prospective crossover format for this study. The group consisted of 40 men and 10 women, with each patient receiving either a 400 or 600 ms initial drive train prior to 1.2 J internal shock on the T wave with a goal to induce ventricular fibrillation. The timing of the T wave shock was determined by measuring the interval from the beginning of the QRS to the apex of the T wave in lead II. Successful inductions were defibrillated via the cardioverter defibrillator. Patients were then crossed over and the protocol repeated. RESULTS: Twenty of 23 (87%) patients were successfully induced into VF in the initial 400 ms drive train arm whereas 22 of 27 (81%) were successfully induced in the 600 ms arm. Thus, a total of 44 (88%) patients were successfully induced at 400 ms, 41 (82%) patients were successfully induced at 600 ms, and 2 (4%) patients were not inducible at either cycle length, but were inducible with 50 Hz ventricular stimulation. However, no significant difference was noted between the two groups. CONCLUSION: No investigation to date has questioned whether a relationship exists between drive cycle length and initiation of ventricular fibrillation. Our study addresses this question, though negative for difference between 400 and 600 ms drive trains. Further research into optimal strategies for inducing ventricular fibrillation will minimize patient sedation time and discomfort while undergoing defibrillator threshold testing.

Aged↗
PubMed1996

Transvenous defibrillation lead systems.

The use of the implantable cardioverter defibrillator has grown dramatically over the past 10 years. One of the major advances in defibrillation technology is the development of transvenous lead systems. Compared with traditional epicardial lead systems, transvenous defibrillation leads reduce perioperative mortality, hospitalization, and costs. Transvenous lead systems provide reliable sensing of ventricular tachyarrhythmias, although redetection of ventricular fibrillation can be prolonged, especially with integrated lead systems. Both ramp and burst adaptive pacing are equally effective for the termination of ventricular tachycardia and are successful in up to 90% of spontaneous events. Defibrillation thresholds are higher with transvenous leads than with epicardial patches. These thresholds are reduced with the use of multiple transvenous leads, subcutaneous patches, or with reversing shock polarity. However, the development of biphasic waveforms has made the largest impact on the efficacy of these lead systems, allowing dual coil transvenous systems to be effective in about 90% of patients. Defibrillation efficacy is further enhanced and implantation simplified by the incorporation of an active pulse generator located in the left pectoral region. Active pectoral pulse generators with biphasic waveforms will be the primary lead system for new implants.

Defibrillators, Implantable↗
PubMed1998

Virtual electrode effects in transvenous defibrillation-modulation by structure and interface: evidence from bidomain simulations and optical mapping.

INTRODUCTION: Our goal in this combined modeling and experimental study was to gain insight into the transmembrane potential changes in defibrillation conditions, namely, when shocks are delivered by an implantable cardioverter defibrillator (ICD). Two hypotheses concerning the presence and characteristics of virtual electrode effects (VEE) during an ICD shock were tested numerically and experimentally: (H1) anisotropy-dependent VEE are induced over a considerable portion of the "bulk" myocardium; and (H2) surface (epicardial and endocardial) VEE are generated under special tissue bath conditions and are not fully anisotropy determined. METHODS AND RESULTS: Optical mapping was performed on Langendorff-perfused rabbit hearts (n = 4) stained with di-4-ANEPPS. Monophasic shocks were applied during the plateau phase of an action potential through a 9-mm long distal electrode in the right or left ventricle and a 6-cm proximal electrode positioned 3 cm posteriorly to the heart. We modeled the experiment using an ellipsoidal bidomain heart with transmural fiber rotation, placed in a perfusing bath, and subjected to defibrillation shocks delivered by an electrode configuration as described. Our numerical simulations demonstrated VEE occupying a significant portion of the myocardium in the conditions of unequal anisotropy ratios for the intra- and extracellular domains. Statistically significant differences in epicardial polarization patterns were predicted numerically and confirmed experimentally when the interface conditions varied. CONCLUSION: The present study concludes that VEE are present in transvenous defibrillation. They are shaped by the combined effect of cardiac tissue characteristics and interface conditions. Because of their size, VEE might contribute significantly to defibrillation outcome.

Animals↗
PubMed1998

Optimization of shocking lead configuration for transvenous atrial defibrillation.

INTRODUCTION: High atrial defibrillation energy requirements (ADER) in patients with chronic atrial fibrillation (AF) may limit the acceptance of transvenous atrial defibrillation. We evaluated an optimized defibrillation electrode configuration that could help to reduce the ADER in patients with AF. METHODS AND RESULTS: We tested ten different configurations in nine dogs with AF (3.33+/-2.92 days) induced by rapid atrial pacing. The configurations were: right atrial (RA) appendage as anode and coronary sinus (CS) as cathode; RA and innominate vein (I) as anode to CS (cathode); RA-CS (anode) to I (cathode); I-CS (anode) to RA (cathode); RA and left lateral subcutaneous patch (P) as anode to CS (cathode); RA-CS (anode) to P (cathode); P-CS (anode) to RA (cathode); superior vena cava (SVC) and CS (anode) to RA (cathode); RA-CS (anode) to SVC (cathode); and RA-SVC (anode) to CS (cathode). ADER was defined as the voltage needed to defibrillate the atria in 10% to 90% of 20 consecutive shocks. Three lead systems had ADER lower than the RA (anode) to CS (cathode) configuration, which required a mean of 143+/-58 volts. These three were: RA-SVC (anode) to CS (cathode) 103+/-29 V; I-CS (anode) to RA (cathode) 129+/-39 V; and P-CS (anode) to RA (cathode) 130+/-38 V. The remaining configurations had ADER higher than the RA (anode) to CS (cathode) configuration. CONCLUSION: Adding an additional shocking electrode may reduce ADER when compared with the RA (anode) to CS (cathode) configuration. This concept could be incorporated into future implantable atrial defibrillators or used for refractory patients undergoing temporary transvenous cardioversion.

Animals↗
PubMed1998

Temporal stability of defibrillation thresholds with an active pectoral lead system.

INTRODUCTION: Monophasic defibrillation thresholds rise over time with a variety of lead systems. These chronic changes are attenuated or eliminated by biphasic waveforms, although the effect appears dependent upon the lead system. With the downsizing of pulse generator size to allow for routine pectoral implantation, active can lead systems have now become standard. However, the temporal stability of such lead systems has not been evaluated previously. METHODS AND RESULTS: This study was a prospective assessment of the changes of active pectoral defibrillation thresholds over time. Thresholds were measured at implant, predischarge, and at a mean follow-up of 50 days in 46 patients with a uniform testing protocol and shock polarity. The lead system was a dual-coil Endotak DSP lead with an active pectoral pulse generator. Defibrillation thresholds were 9.9+/-5.5 J at implantation, 8.5+/-6.0 J predischarge, and 7.6+/-5.5 J at follow-up (ANOVA, P = 0.007). Moreover, only two patients developed an increased threshold > 5 J, and no patient had an inadequate safety margin at follow-up. CONCLUSION: These results indicate that active pectoral defibrillation thresholds are stable over the first 2 months postimplantation and question the need for routine serial defibrillation threshold testing.

Aged↗
PubMed1998

Effect of shock waveform on relationship between upper limit of vulnerability and defibrillation threshold.

INTRODUCTION: The upper limit of vulnerability (ULV) correlates with the defibrillation threshold (DFT). The ULV can be determined with a single episode of ventricular fibrillation and is more reproducible than the single-point DFT. The critical-point hypothesis of defibrillation predicts that the relation between the ULV and the DFT is independent of shock waveform. The principal goal of this study was to test this prediction. METHODS AND RESULTS: We studied 45 patients at implants of pectoral cardioverter defibrillators. In the monophasic-biphasic group (n = 15), DFT and ULV were determined for monophasic and biphasic pulses from a 120-microF capacitor. In the 60- to 110-microF group (n = 30), DFT and ULV were compared for a clinically used 110-microF waveform and a novel 60-microF waveform with 70% phase 1 tilt and 7-msec phase 2 duration. In the monophasic-biphasic group, all measures of ULV and DFT were greater for monophasic than biphasic waveforms (P < 0.0001). In the 60- to 110-microF group, the current and voltage at the ULV and DFT were higher for the 60-microF waveform (P < 0.0001), but stored energy was lower (ULV 17%, P < 0.0001; DFT 19%, P = 0.03). There was a close correlation between ULV and DFT for both the monophasic-biphasic group (monophasic r2 = 0.75, P < 0.001; biphasic r2 = 0.82, P < 0.001) and the 60- to 110-microF group (60 microF r2 = 0.81 P < 0.001; 110 microF r2 = 0.75, P < 0.001). The ratio of ULV to DFT was not significantly different for monophasic versus biphasic pulses (1.17 +/- 0.12 vs 1.14 +/- 0.19, P = 0.19) or 60-microF versus 110-microF pulses (1.15 +/- 0.16 vs 1.11 +/- 0.14, P = 0.82). The slopes of the ULV versus DFT regression lines also were not significantly different (monophasic vs biphasic pulses, P = 0.46; 60-microF vs 110-microF pulses, P = 0.99). The sample sizes required to detect the observed differences between experimental conditions (P < 0.05) were 4 for ULV versus 6 for DFT in the monophasic-biphasic group (95% power) and 11 for ULV versus 31 for DFT in the 60- to 110-microF group (75% power). CONCLUSION: The relation between ULV and DFT is independent of shock waveform. Fewer patients are required to detect a moderate difference in efficacy of defibrillation waveforms by ULV than by DFT. A small-capacitor biphasic waveform with a long second phase defibrillates with lower stored energy than a clinically used waveform.

Aged↗
PubMed2000

Optimization of transvenous coil position for active can defibrillation thresholds.

INTRODUCTION: Lead systems that include an active pectoral pulse generator are now standard for initial defibrillator implantations. However, the optimal transvenous lead system and coil location for such active can configurations are unknown. The purpose of this study was to evaluate the benefit and optimal position of a superior vena cava (SVC) coil on defibrillation thresholds with an active left pectoral pulse generator and right ventricular coil. METHODS AND RESULTS: This prospective, randomized study was performed on 27 patients. Each subject was evaluated with three lead configurations, with the order of testing randomized. Biphasic shocks were delivered between the right ventricular coil and an active can alone (unipolar), or an active can in common with the proximal coil positioned either at the right atrial/SVC junction (low SVC) or in the left subclavian vein (high SVC). Stored energies at defibrillation threshold were higher for the single-coil, unipolar configuration (11.2 +/- 6.6 J) than for the high (8.9 +/- 4.2 J) or low (8.5 +/- 4.2 J) SVC configurations (P < 0.01). Moreover, 96% of subjects had low (< or = 15 J) thresholds with the SVC coil in either position compared with 81% for the single-coil configuration. Shock impedance (P < 0.001) was increased with the unipolar configuration, whereas peak current was reduced (P < 0.001). CONCLUSION: The addition of a proximal transvenous coil to an active can unipolar lead configuration reduces defibrillation energy requirements. The position of this coil has no significant effect on defibrillation thresholds.

Aged↗
PubMed2006

Intraoperative testing of the implantable cardioverter-defibrillator: how much is enough?

INTRODUCTION: Defibrillation testing of the implantable cardioverter-defibrillator (ICD) is considered a standard and required practice at the time of implantation. How much testing, if any in some cases, should be performed, however, remains unknown. METHODS AND RESULTS: Included in this retrospective analysis were 835 patients (77% men; age 65 +/- 13 years) who received transvenous ICDs between January 1996 and December 2003. One hundred twenty-nine (15.5%) had intraoperative defibrillation threshold (DFT) testing, 503 (60.2%) had limited defibrillation safety margin testing, and 203 (24.3%) had no defibrillation testing. We compared the outcome (success of ICD therapies against spontaneous VT/VF events and survival) of the three groups of patients, who in some respects had important clinical differences. The success of the first delivered shocks against VT/VF was similar for DFT (91%), safety margin testing (91%), and no-testing (92%) groups; and the second shocks terminated the remaining episodes in all three groups. Sudden-death-free survival rates were similar in the three groups, however, the overall long-term survival rate was significantly lower in the no-testing group (58%) than in the DFT (74%) and safety margin testing (69%) groups (P < 0.0005). Multivariate analysis found no strong predictors of sudden death, but there were several independent predictors of overall mortality including lack of ICD testing (HR: 2.031, CI: 1.253-3.290, P = 0.004). CONCLUSION: In this select patient cohort, success of ICD therapies and sudden-death-free survival were similar in patients who had DFT, safety margin testing, and no testing, but overall survival was significantly lower in the no-testing group. Thus in the absence of prospective mortality data, a minimum of safety margin ICD testing should remain standard practice.

Aged↗
PubMed1995

Infections after cardioverter-defibrillator implantation: observations in 335 patients over 10 years.

OBJECTIVE: To determine the incidence of infection after implantation of a cardioverter-defibrillator and the management of this complication. SUBJECTS: 335 consecutive patients who had a cardioverter-defibrillator implanted between January 1984 and December 1993. MAIN OUTCOME MEASURES: Incidence of infection within the first month after implantation (early infection) and after the first month (late infection). RESULTS: Infections associated with cardioverter-defibrillator devices occurred in 13 patients (3.9%) during a mean follow up of 22 (11) months. All patients had general signs of inflammation, fever (> 37.5 degrees C), and leucocytosis (> 10,000/ml) with or without purulent drainage. Five patients (38%) had infections during the first implantation, whereas eight patients (62%) had infections after replacement of the pulse generator. Early infection was observed in four patients (31%) and late infection in nine (69%). Incidence of infection was higher in patients who underwent epicardial cardioverter-defibrillator implantation (12/207 patients, 5.8%) than in those who received nonthoracotomy lead systems (1/125 patients, 0.8%) (P < 0.05). Infections were caused by staphyloccocus in 10 patients, pseudomonas in two patients, and streptococcus in one patient. The whole device had to be removed in all patients. During a mean follow up of 39 (29) months seven patients died: six of congestive heart failure and one of myocardial reinfarction. CONCLUSIONS: Infection, one of the most serious complications after cardioverter-defibrillator implantation, is associated with increased morbidity and mortality. When infection occurs the system must be removed to avoid a fatal outcome.

Adolescent↗
PubMed2000

Effect of second-phase duration on the strength-duration relation for human transvenous defibrillation.

BACKGROUND: The mechanism by which biphasic waveforms improve defibrillation efficacy is unclear. In addition, the optimal shape of the biphasic waveforms remains controversial. Animal experiments suggest that prolonging the duration of the second phase longer than the first worsens defibrillation thresholds (DFT). The purpose of this study was to determine the strength-duration relation for the second phase of a biphasic defibrillation waveform in humans. METHODS AND RESULTS: This was a prospective, randomized study of biphasic DFT in 36 patients; a uniform dual-coil transvenous lead system was used. In each patient, 3 DFTs were determined with the pulse duration for the second phase of the defibrillation waveform varying between 1 and 18 ms. The duration of the first phase was fixed at 6 ms and the capacitance was 150 microF. There was a significant increase in the leading edge voltage at DFT only when the second-phase pulse duration was decreased to 1 ms. There was no increase in DFT voltage even when the second-phase pulse duration was increased from 2 to 18 ms. Similar relations were observed for stored energy, leading edge current, or phase 2 energy. The normalized average current delivered during phase 2 decreased monotonically with increasing phase 2 duration. CONCLUSIONS: In humans, the biphasic DFT voltage or energy is increased only when the second phase of the waveform is <2 ms. The DFT voltage is insensitive to increasing the second phase of the defibrillator waveform to as long as 18 ms, or 3 times the duration of the first phase of the waveform.

Coronary Disease↗