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Implantable cardioverter-defibrillators for secondary prevention: is it worth it in the elderly?

Aging is associated with structural alterations in the heart that predispose the elderly to life-threatening ventricular arrhythmias. The majority of sudden cardiac deaths occur in people aged 65 and older. As the proportion of elderly in our population continues to grow, a greater number of elderly patients with malignant ventricular arrhythmias will require appropriate medical management. Clinical outcome trials have demonstrated that implantable cardioverter-defibrillators (ICDs) improve overall survival compared with pharmacologic therapy when used for the secondary prevention of cardiac arrest. Despite proven efficacy, physicians may be reluctant to implant a defibrillator in an older patient. This review summarizes the data pertaining to the use of defibrillators for secondary prevention in the elderly. ICD use for secondary prevention reduces all-cause mortality and appears to be economically advantageous in an older patient population. Currently, there is no convincing data to suggest that ICD therapy should be withheld from a patient based on age alone.

Age Factors↗

Chagas' disease and the use of implantable cardioverter-defibrillators in Brazil.

The authors discuss the epidemiology and pathogenesis of Chagas' disease in Brazil, including the use of treatment with a cardioverter-defibrillator in patients with low ejection fraction. Select patients may benefit from resynchronization therapy associated with cardioverter-defibrillator treatment. Electrophysiologic study is indicated in the assessment of the potential utility of an implantable cardioverter-defibrillator.

Brazil↗

Initial experience with transvenous implantable cardioverter defibrillator lead systems: operative morbidity and mortality.

Introduction of non-thoracotomy lead systems (Medtronic, Inc.) for the implantable cardioverter defibrillator (ICD) has expanded the indications for use of this mode of therapy. Patients previously considered "too ill" to undergo a thoracotomy as well as patients who are at a high risk for developing sudden death but without previous cardiac arrest, are now considered candidates. The initial experience with the non-thoracotomy lead system at our institution was analyzed for morbidity and mortality. Thirty-four patients underwent attempted intravascular lead implantation, with 30 having initial successful implantation (88.2%). There were 23 males; average ejection fraction (EF) was 38.6%. Three patients developed pulmonary edema and low output immediately after the procedure. Three patients developed electromechanical dissociation during defibrillation threshold testing. A prolonged testing time for the non-thoracotomy lead system was noted when compared to the thoracotomy system (57.39 vs 32.30 min; P < 0.0000). There were more intraoperative morbidities with the non-thoracotomy leads than with the thoracotomy system. There were no perioperative deaths. The potential consequences of prolonged anesthesia time and extensive defibrillation threshold testing should be considered when choosing the route of ICD implant, the type of anesthesia, and the intraoperative testing protocol for each patient.

Defibrillators, Implantable↗

Automatic implantable cardioverter defibrillator: cost effectiveness.

Unexpected out-of-hospital cardiac arrest is in most cases due to ventricular fibrillation or rapid ventricular tachycardia. The usual therapeutic strategy in survivors starts with drug treatment, in case of failure followed by nonpharmacological therapy, which may include catheter ablation, ablative surgery, and finally defibrillator implantation. In most cases, this strategy is long lasting and very expensive. Implantation of a defibrillator as a first choice therapy may be cost effective, especially if the probability of successful drug treatment is low. However, cost-effective aspects have been studied only retrospectively and in models. In 1989 we started a prospective cost-effectiveness analysis of implantation of the automatic implantable cardioverter defibrillator (AICD) as first choice therapy ("early" AICD implantation) in successfully resuscitated postinfarct patients. Evaluation is being done in a randomized way with one group having early AICD implantation and the other group following the usual conventional therapeutic strategy. We compare medical, economic, and quality-of-life aspects. As of June 1992, 46 patients have entered the study. Totally 60 patients will be included. Results are expected in 1993 and will be expressed as cost effectiveness ratios in both study arms.

Cost-Benefit Analysis↗

A pilot study: defibrillation thresholds in dogs are similar with isoflurane, halothane, and pentobarbital.

The objective of this pilot study was to determine if three common anesthetic drugs have differing effects on the measurement of defibrillation thresholds (DFT) in dogs. The drugs compared were pentobarbital, isoflurane, and halothane. We used six dogs, which were surgically instrumented, in a chronic study design. Each dog had two internal defibrillation patches placed on its heart, which were used to deliver the defibrillation energy. DFT was determined while each dog was anesthetized under each of the listed drugs in a crossover design. This pilot study suggests that differences in DFT due to the anesthetic drugs is not significant in studies with low numbers of animals (halothane 14.5 +/- 1.0, isoflurane 14.2 +/- 1.0, pentobarbital 12.8 +/- 1.0; P = NS; mean +/- SE). The variation in DFT between individual animals is much larger than the difference in DFT due to the drugs.

Anesthesia, Inhalation↗

Evaluation of outpatients experiencing implantable cardioverter defibrillator shocks associated with minimal symptoms.

Patients receiving minimally symptomatic shocks from their implantable cardioverter defibrillators were studied prospectively using transtelephonic ECG loop monitoring. The time course to the first subsequent shock was evaluated. Twenty-nine consecutive patients who received a shock preceded by mild palpitations or no symptoms were given a transtelephonic ECG loop monitor and instructed to activate the monitor if a subsequent shock occurred. Kaplan-Meier analysis was used to quantitate the time to first shock during the study period. The point estimate +/- standard error of patients receiving a shock during the study period was 31% +/- 9% at 30 days, 41% +/- 9% at 60 days, and 60% +/- 9% at 120 days. The ECG was successfully transmitted in 7 of 13 patients who had shocks in the 60-day monitoring period, and demonstrated inappropriate shocks in 6 of 7. Determination of the cause of shock led to a change in subsequent management in all 7 patients. We conclude that the incidence of inappropriate shocks may be higher than estimated previously in patients with minimal symptoms prior to the shock. There are thousands of patients with implantable cardioverter defibrillators that have no storage function for treated tachycardias; transtelephonic ECG loop monitoring can determine the cause of implantable cardioverter defibrillator discharge in these patients, and the diagnosis is invaluable in their management.

Adolescent↗

Impact of pulse characteristics on atrial defibrillation energy requirements.

In summary, many issues pertaining to pulse characteristics and atrial defibrillation remain unsolved. Perhaps the most burning questions are whether a further reduction in atrial defibrillation energy requirements can be achieved by the combination of biphasic waveforms with dual pathway sequential shocks to produce a more homogenous distribution of charge, whether right and left atrial polarity of the first phase of asymmetrical biphasic shocks can reduce energy requirements in individual patients and whether the delivery of very long biphasic shocks (possibly > 20 msec) can reduce the discomfort of shorter shocks by decreasing the peak current density. Only then will the wide-spread acceptance of the implantable atrial defibrillator become closer to reality.

Animals↗

The probability of defibrillation success and the incidence of postshock arrhythmia as a function of shock strength.

The effects of high voltage defibrillation shocks given to six swine were studied to determine if there is a limit to the advantage gained from increasing the shock strength. An endocardial electrode was placed in the right ventricle, and a 114-cm2 cutaneous patch was placed on the left lateral thorax. Monophasic (10 msec) and single capacitor biphasic (5/5 msec) shocks with leading edge voltages of 200, 400, 600, 800, and 990 volts (approximately 2.3-59 J) were tested. For monophasic shocks, the probability of successful defibrillation ranged from 0% at 200 V to 90% at 990 V. The incidence of postshock arrhythmia increased from 0% for successful shocks at 600 V to 67% for successful shocks at 990 V. For biphasic shocks, the probability of success peaked at 97% for the 600-, 800-, and 990-V shocks. The incidence of postshock arrhythmia increased from 8% at 400 V to 55% at 990 V. Although more postshock arrhythmias occurred at lower strengths for biphasic than for monophasic shocks, an efficacy criterion, quantifying the probability of defibrillation success and the probability that a postshock arrhythmia will not occur, was always higher for biphasic shocks. The probability of success never reached 100% for either waveform while the incidence of postshock arrhythmia increased as the shock strength increased. In conclusion, for the catheter-patch electrode configuration, increasing the shock strength does not always improve the probability of success and may increase the incidence of postshock arrhythmia.

Animals↗

Inappropriate discharge by an implantable cardioverter defibrillator: recognition of myopotential sensing using telemetered intracardiac electrograms.

Inappropriate therapy from implantable anti-tachyarrhythmia devices is a common problem with a variety of etiologies. The verification of arrhythmias or other sensed events that precipitate defibrillating shocks is difficult with first- and second-generation devices due to the absence of sufficient data storage and the inability to examine stored and real-time intracardiac electrograms. In addition, the absence of premonitory symptoms is an unreliable marker for the appropriateness of defibrillator shocks. The incorporation of improved data storage and the ability to inspect intracardiac electrograms in newer devices have greatly increased the ability to diagnose abnormal device behavior as shown in the following case report. Inappropriate implantable cardioverter defibrillator discharge due to myopotential sensing is described. The diagnosis was facilitated by telemetered intracardiac electrograms.

Action Potentials↗

Initial clinical experience with a dual lead endocardial defibrillation system with atrial pace/sense capability. United States and Canada Enguard Investigations.

Ninety-three patients underwent implants of the Telectronics Model 4211 ICD attached to the Enguard PFX endocardial defibrillation lead system. Eighty-one males and 12 females ranging in age from 25-85 years (mean = 64). Coronary disease was the substrate in the majority (88%); mean left ventricular ejection fraction was 30%. VT was present in 66%, VF in 22%, and both in 7%. Three lead configurations were used in the study: ventriculo-atrial (U1, 86%); bidirectional (B2, 12%); and ventricular to patch (U2, 2%). Mean RV pacing thresholds were 0.46 V pre- and 0.54 V posttesting, with no significant differences between the two. Mean R wave voltage was 11.05 mV pre- and 11.72 mV posttesting, also not significantly different. A subgroup of 13 patients had mean atrial pacing thresholds of 0.59 V at 0.5 msec pulse width, with mean P waves of 4.01 mV. Mean defibrillation threshold for the entire group was 10.6 J using biphasic waveforms. Defibrillation thresholds by configuration were: 399 V (U1); 475 V (U2); and 350 V (B2). All patients but one had thresholds < 550 V in at least one configuration. The 4211/Enguard system was implanted without (86%) or with (14%) a subcutaneous patch electrode. Early postoperative findings related to the ICD system include: one device circuit failure, one early lead dislodgement, and one pacing exist block.(ABSTRACT TRUNCATED AT 250 WORDS)

Defibrillators, Implantable↗

A long thin electrode is equivalent to a short thick electrode for defibrillation in the right ventricle.

We hypothesized that a long thin right ventricular (RV) electrode would have equivalent defibrillation threshold (DFT) performance to a short thick electrode with approximately the same surface area. This could lead to thinner transvenous lead systems, which would be easier to implant. A thin (5.1 French) lead was compared to a standard control (10.7 French). The thin lead had an 8-cm RV electrode length with a surface area of 4.26 cm2. The standard lead had a RV electrode length of 3.7 cm and a surface area of 4.12 cm2. A 140-mu French capacitor 65%/65% tilt biphasic defibrillation shock was delivered between the RV electrode and a 14-cm2 subcutaneous patch. DFTs were determined following 10 seconds of fibrillation in 11 dogs by a triple determination averaging technique. The thin lead had a lower resistance (77.1 +/- 27.4 omega vs 88.9 +/- 30.3 omega, P < 0.001) than did the thick lead. There was no significant difference in stored energy DFTs (9.9 +/- 2.5 vs 10.3 +/- 2.7, P = 0.098 2-sided, P = 0.049 1- sided). This was in spite of the fact that the long thin lead had a portion of its RV coil extending above the tricuspid valve and, thus, not contributing efficiently to the ventricular gradients in the small dog heart. We conclude that a long thin right ventricular electrode and a standard short thick electrode had equivalent defibrillation performance. This preliminary result should be confirmed in clinical studies as it could lead to significantly thinner transvenous lead systems.

Animals↗

Atrial fibrillation after implantable cardioverter defibrillator implantation.

Atrial fibrillation is a reported complication of automatic defibrillator implantation. Its incidence, risk factors, time-course, and complications have not been well-defined. Accordingly, data from 117 patients who underwent defibrillator implantation via a thoracotomy (n = 71) or nonthoracotomy (n = 46) approach were reviewed. To identify risk factors, 15 variables of potential predictive value were chosen and analyzed. Atrial fibrillation developed in 26/117 patients (22%) during the early postoperative period and all but one of these 26 patients had undergone thoracotomy (P < 0.001). Patients who developed atrial fibrillation tended to be older than those who did not (63 +/- 2 vs 58 +/- 2 years, P = 0.04) and more frequently had a prior history of paroxysmal atrial fibrillation (31% vs 10%, P = 0.02). They were also less likely to be taking Class I or III antiarrhythmic drugs (1/26 vs 24/91, P = 0.01). By multivariate analysis, operative approach (P < 0.001), the absence of antiarrhythmic drug therapy (P = 0.006), and a prior history of atrial fibrillation (P = 0.003) were significant independent variables. Digoxin neither prevented the occurrence of atrial fibrillation nor slowed the maximal ventricular response. The mortality and complication rates did not differ between the two groups. The major adverse effect of postimplant atrial fibrillation was automatic defibrillator discharge; six patients received between 1 and 11 discharges for atrial fibrillation with rapid ventricular rates.

Adolescent↗

Changes in the amplitude of endocardial electrograms following defibrillator discharge: comparison of two lead systems.

Changes in the amplitude of endocardial electrograms after an unsuccessful shock attempt have been demonstrated to cause failure of redetection of ventricular fibrillation in patients using an integrated sense-pace defibrillating lead system. Thus, the objective of this study was to compare the effects of defibrillator shocks on the amplitude of endocardial electrograms in 26 patients using two different nonthoracotomy systems, a previous lead (model 0062) or a redesigned version (model 0072). At implant, bipolar endocardial electrograms were obtained before each shock application, during initial detection and redetection of ventricular fibrillation in case the applied shock was unsuccessful, and during intervals of 5, 10, 20, 30, 60, and 120 seconds after each shock delivery. No significant difference was noted in endocardial amplitudes between the lead models 0062 and 0072 during baseline sinus rhythm (12.2 +/- 4.6 mV vs 11.4 +/- 3.8 mV), and during initial ventricular fibrillation (7.0 +/- 2.4 mV vs 7.6 +/- 2.3 mV). During redetection of ventricular fibrillation, however, there was a significant difference (P = 0.0006) in endocardial amplitudes (3.4 +/- 1.9 mV vs 6.6 +/- 2.3 mV) between both leads tested. Comparing lead models 0062 and 0072, marked differences were found in endocardial amplitudes during sinus rhythm 5, 10, and 20 seconds after successful arrhythmia termination: 2.8 +/- 1.9 mV vs 8.6 +/- 2.9 mV (P < 0.0001), 4.6 +/- 2.9 mV vs 9.2 +/- 3.2 mV (P = 0.0007), and 6.4 +/- 4.0 mV vs 10.5 +/- 3.6 mV (P = 0.01). At predischarge testing, failure of redetection of ventricular fibrillation was documented in two patients with the lead model 0062 requiring external defibrillation to restore sinus rhythm. These findings demonstrate a significant less postshock attenuation of the endocardial electrogram amplitudes during persistent ventricular fibrillation after an unsuccessful shock attempt as well as during sinus rhythm immediately following an effective shock delivery using the redesigned lead system model 0072 compared to the electrogram amplitudes obtained in patients using the previous lead model 0062.

Adult↗

The subcutaneous array: a new lead adjunct for the transvenous ICD to lower defibrillation thresholds.

Despite the benefits of transvenous implantable cardioverter defibrillators (ICDs), concern exists that patients with high defibrillation thresholds (DFTs) have an inadequate safety margin between the DFT and the maximum defibrillator energy. A new transvenous ICD lead adjunct, a subcutaneous lead array (SQ Array), was developed to increase safety margins by lowering DFTs. Composed of three lead elements joined in a common yoke, the SQ Array is tunneled subcutaneously in the left lateral chest. Serving as their own controls, 20 patients were studied intraoperatively comparing transvenous lead-alone DFTs with lead-SQ Array DFTs. Seventeen males and three females were randomized to receive the SQ Array through the CPI Ventak PRx/Endotak 70 series protocol. Mean patient age was 63.7 +/- 2.5 years and mean ejection fraction 0.34 +/- 0.04. DFTs were determine using a precise protocol of step-down/step-up testing commencing at 20 joules. Lead-alone DFTs were tested using the proximal coil as the anode (+). For the lead-SQ Array, the proximal coil and the array were linked as a common anode. The lead-SQ Array resulted in a statistically significant reduction in mean monophasic DFT from 23.3 +/- 2.3 joules (lead-alone) to 13.5 +/- 1.9 joules (lead-SQ Array) (P < 0.001). Six patients had lead-alone DFTs > 25 joules but did not require thoracotomy because of adequate DFT reduction with the SQ Array. We conclude that the SQ Array adjunct to the transvenous ICD lead lowers monophasic DFTs an average of 9.8 joules (40.6%) obviating the need for a thoracotomy in selected patients.

Adult↗

Defibrillator twiddler's syndrome causing device failure in a subpectoral transvenous system.

Twiddler's syndrome is well described as a complication of cardiac pacing. Defibrillator twiddler's syndrome has been recently reported with abdominal implantations of epicardial and transvenous defibrillator systems. We report a case of a patient with a transvenous defibrillator system implanted with the pulse generator placed in the subpectoral plane. The patient developed twiddler's syndrome, which resulted in retraction of both leads. This caused inappropriate shocks due to sensing both the atrial and ventricular electrograms. While the subpectoral position leaves the generator deeper and more difficult for the patient to access, it may not lessen the chance of twiddler's syndrome. It is possible that the subpectoral position may actually predispose the patient to this malady.

Aged↗

Treatment of refractory ventricular fibrillation by combined internal (epicardial) and external (transthoracic) defibrillation.

This report describes a modified defibrillation technique used successfully in a patient with an implanted epicardial cardioverter defibrillator who developed refractory ventricular fibrillation. During operative testing at the time of generator replacement, two episodes of intractable ventricular fibrillation were terminated by using a combined internal (epicardial)-external (transthoracic) defibrillation system that delivered a 360-J shock between the anterior epicardial patch and a large posterior skin electrode.

Defibrillators, Implantable↗

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-microF capacitors than for conventional pulses from 120-microF capacitors, but 60-microF 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-microF capacitors. This study compared biphasic waveform DFTs for 120 microF-65% tilt pulses, 90 microF-65% tilt pulses, and 90 microF-50% tilt pulses in 20 patients at defibrillator implantation. The 90 microF-50% tilt pulses were selected because their duration is half that of 120 microF-65% tilt pulses. The stored energy DFT for 90 microF-50% tilt pulses (9.1 +/- 4.3 J) was less than both the DFT for 120 microF-65% tilt pulses (12.0 +/- 5.5 J, P < 0.005) and the DFT for 90 microF-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 microF-50% pulses (436 +/- 113 V) and 120 microF-65% tilt pulses (436 +/- 104 V) were not statistically different; the voltage DFT for 90 microF-65% tilt pulses was higher than for either of the other two pulses (490 +/- 131, P < 0.005). The DFT was 20 J or greater in three patients for both 120 microF-65% tilt pulses and 90 microF-65% tilt pulses, but it was 16 J or less in all patients for 90 microF-50% tilt pulses. When pathways were dichotomized by the median resistance of 71 omega, 90 microF-50% tilt pulses significantly reduced DFTs compared to 120 microF-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 microF-50% tilt pulses reduce stored energy DFT in comparison with 120 microF-65% tilt pulses without increasing voltage DFT. However, 90 microF-65% tilt pulses provide no benefit.

Defibrillators, Implantable↗

Comparison of single-biphasic versus sequential-biphasic shocks on defibrillation threshold in pigs.

Current generation implantable cardioverter defibrillators use monophasic, biphasic, or sequential pulse shocks, most of which truncate after a given time, dumping the remaining charge on the capacitor through an internal resistor. We hypothesized that having an additional current pathway, and delivering the majority of the remaining charge on a single capacitor to the two pathways using additional shock phases, would improve defibrillation efficacy. This hypothesis was tested by comparing DFTs using a simulated single capacitor, single-biphasic shock (two 5-ms pulses separated by 0.2 ms), delivered to coupled pairs of electrodes, to those using a sequential-biphasic shock (four 5-ms pulses separated by 0.2 ms) delivered to separate opposing electrodes, delivered from the same electrodes for both waveforms. In eight open-chest anesthetized pigs, four mesh electrodes (Medtronic TX-7, 6.5 cm2), were sutured on the epicardium of the anterior and posterior surfaces of each ventricle. Shocks were delivered from a 200-microF capacitor bank. Triplicate DFTs were obtained using each waveform in a randomized crossover design. Initial leading edge voltage (mean +/- SEM: 420 +/- 33 V vs 497 +/- 34 V; P < 0.05), initial peak current (4.8 +/- 0.4 A vs 13 +/- 1.1 A; P < 0.001), and delivered energy (16.9 +/- 2.6 J vs 30.4 +/- 5.3 J; P < 0.05) at the DFT were all significantly lower using sequential-biphasic shocks than those using single-biphasic shocks, respectively. We conclude that for direct heart defibrillation, it is worthwhile to combine sequential capability to biphasic shocks and deliver the remaining charge on the capacitor to the two different pathways.

Animals↗