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PubMed2002

Recent advances in implantable cardioverter defibrillator systems.

The usefulness of the implantable cardioverter defibrillator (ICD) for the prevention of sudden cardiac death caused by ventricular tachyarrhythmias has been proven by several international randomized multi-center clinical trials. Recent advances in medical technologies, such as size reduction and the functional improvements of the device, have resulted in relatively easy implantation. As a result, the number of ICD recipients has been rapidly increasing and the indications for ICD implantation have been expanding. Dual chamber ICDs offer improved tachyarrhythmia detection algorithms such as discrimination of supraventricular arrhythmias. In Europe and the United States, biventricular ICDs are now available for the treatment of congestive heart failure associated with ventricular tachyarrhythmias. Although the incidence of inappropriate shock by ICDs is decreasing, inappropriate discharges of ICDs and a declining quality of life are still problems.

Clinical Trials as Topic↗
PubMed2001

Algorithms for better arrhythmia discrimination in implantable cardioverter defibrillators.

The discrimination of concomitant atrial tachyarrhythmias and sinus tachycardias in patients with malignant ventricular tachyarrhythmias is a major challenge for new defibrillator devices. Different algorithms have now been established to distinguish between atrial and ventricular tachyarrhythmias. Furthermore, new dual-chamber implantable defibrillators are capable of tiered atrial therapies for both regular and irregular atrial and ventricular tachyarrhythmias. The increasingly complex and subtle dual-chamber detection algorithms have proven to be safe and effective for the detection of ventricular tachycardia, and also in terms of an increase in specificity and a reduction in inappropriate ventricular therapies for supraventricular tachyarrhythmias. Stable electrode position, and a continuous and correct atrial signal quality, are prerequisites for atrial therapies and algorithms for arrhythmia discrimination.

Algorithms↗
PubMedDate not supplied

Do positive health expectations and optimism relate to quality-of-life outcomes for the patient with an implantable cardioverter defibrillator?

PURPOSE: Clinical trials with the implantable cardioverter defibrillator (ICD) have demonstrated desirable outcomes in terms of mortality and morbidity among patients with potentially lethal arrhythmias. This study examined the "resilience factors" of positive health expectations and global optimism prospectively using the general quality-of-life (QOL) scores of newly implanted ICD patients. METHODS: The study enrolled 88 newly implanted ICD patients (mean age, 65.3 +/- 13.2 years; 83% male; 92% white) assessed 8 and 14 months after ICD implantation. A series of 2 x 2 factorial multivariate analyses of covariance were performed to examine the differences between baseline low versus high positive health expectations and baseline low versus high optimism in short- and long-term general QOL scores. RESULTS: After control was used for ejection fraction (mean, 31%), the patients with baseline high positive health expectations reported better general health at a long-term follow-up assessment (P = .002). The patients with high optimism reported better mental health and social functioning at a short-term follow-up assessment (P =. 056), and this finding approached significance at a long-term follow-up assessment (P = .061). CONCLUSIONS: Positive health expectations and optimism are differentially related to various components of QOL. Collectively, these two resilience factors may be targeted in future studies of interventions to improve QOL for ICD patients.

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PubMed1994

Safety of pacemaker implantation in patients with transvenous (nonthoracotomy) implantable cardioverter defibrillators.

While several reports have documented the safety of implantation of transvenous pacemakers in patients with epicardial patch-based implantable cardioverter defibrillators (ICDs), the implantation of transvenous pacemakers in patients with transvenous (nonthoracotomy) ICDs has not been well-described. We present three patients with transvenous ICDs who subsequently underwent implantation of transvenous pacemakers without complication. Technical considerations and a testing, protocol for detection of pacemaker-ICD interactions are discussed.

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PubMed1992

Different ways of application of the implantable cardioverter defibrillator (ICD)--which is the current approach?

The implantable cardioverter defibrillator (ICD) has proved to be effective in patients at risk of sudden cardiac death (SCD). Because of the development of more effective lead- and defibrillator systems the surgical implantation modes have changed from extensive operative interventions (sternotomy, lateral thoracotomy) to less traumatical (subxiphoidal/subcostal approach) and less invasive (transvenous) techniques. Procedures with less operative damage may be offered to patients with reduced cardiac function. However, the kind of operative procedure to be performed must be decided individually. The different system configurations, their advantages and disadvantages as well as their complications are surveyed and discussed in the light of our patient population, 102 cases between 1984 and 1991, and the literature. Even when the "non thoracotomy" implantations will become the favoured method, the standard incisions by thoracotomy will still be of importance. Considering that major complications occur also in transvenous implant procedures and that cardiac operations have to be performed in 20-30% of the patients simultaneously, we suggest--following the recommendations of the North American Society of Pacing and Electrophysiology (NASPE)--that the devices be implanted exclusively in units for cardiac surgery in cooperation with rhythmologically well-trained cardiologists.

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PubMed1992

Role of ventricular tachycardia surgery and catheter ablation as complements or alternatives to the implantable cardioverter defibrillator in the 1990s.

Although the implantable cardioverter defibrillator is used increasingly, other nonpharmacological approaches have their indications and merits. Furthermore, as the natural history of ventricular tachyarrhythmias or their underlying structural cardiac abnormality, i.e., coronary artery disease, dilated cardiomyopathy, arrhythmogenic right ventricular disease, etc. change, the mode of therapy may be modified accordingly. Because of the disappointing results of the CAST study in previously asymptomatic patients after myocardial infarction and the evidence that failure of one or two antiarrhythmic drugs tested by programmed ventricular stimulation in patients with documented sustained ventricular tachycardia or fibrillation predicts further drug failure, there will be a significant increase in the use of implantable cardioverters defibrillators in the 1990s. However, care should be taken to avoid inappropriate use of these devices.

Adult↗
PubMed1997

Delivery of noncommitted shocks for nonsustained ventricular arrhythmias by a new implantable cardioverter defibrillator with abortive shock capability.

INTRODUCTION: To describe the delivery of noncommitted implantable cardioverter defibrillator (ICD) shocks despite self-termination of ventricular arrhythmias. Abortive shock capability should eliminate the delivery of shocks for self-terminating ventricular arrhythmias. The delivery of noncommitted shocks despite abortive shock capability is, therefore, unexpected and previously unreported. METHODS AND RESULTS: Among 118 patients who received the Transvene nonthoracotomy lead system and the Jewel ICD (model 7219D), three patients (1.7%) experienced supurious, noncommitted shocks for self-terminating arrhythmias. Only one detection zone (i.e., ventricular fibrillation) had been programmed in the defibrillator in each patient. In all three patients, the ventricular arrhythmias self-terminated during the charging period. One patient received seven shocks during periods of asystole, and the other two patients received one shock each. Two different mechanisms for shock delivery in this setting were identified: one occurring in the absence of electrical activity at the end of the bradycardia escape interval (i.e., associated with bradyarrhythmias), and the other when two sensed electrical events (i.e., escape beats) occurred during the so-called "synchronization" window of the defibrillator. CONCLUSIONS: In rare patients with the Jewel defibrillator, shocks may be delivered for self-terminating arrhythmias despite abortive shock capability. Patients who are dependent upon pacing from their implanted defibrillator are at particular risk for shock in the aftermath of self-terminating ventricular arrhythmias. Defibrillator programming strategies aimed at eliminating or diminishing the incidence of this problem are discussed.

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PubMed2002

Effectiveness and cost-effectiveness of implantable cardioverter defibrillators in the treatment of ventricular arrhythmias among medicare beneficiaries.

PURPOSE: The implantable cardioverter defibrillator has been assessed in randomized trials, but the generalizability of trial results to broader clinical settings is unclear. Our purpose was to evaluate the outcomes and costs of defibrillator use in an unselected population. SUBJECTS AND METHODS: We identified 125,892 Medicare patients who were discharged between 1987 and 1995 after hospitalization with a primary diagnosis of ventricular tachycardia or ventricular fibrillation, 7789 of whom (6.2%) received a defibrillator. We used a multivariable propensity score that included patient and hospital characteristics to match pairs of patients, in which one patient received a defibrillator and the other did not. We compared mortality and costs in these 7612 matched pairs during 8 years of follow-up. RESULTS: Patients who received a defibrillator were more likely to be younger, white, male, and urban dwelling, and to have ischemic heart disease, heart failure, or a history of ventricular fibrillation. In the matched-pairs analysis, those who received a defibrillator had significantly lower mortality: 11% versus 19% at 1 year (odds ratio [OR] = 0.57; 95% confidence interval [CI]: 0.51 to 0.63), 20% versus 30% at 2 years (OR = 0.66; 95% CI: 0.60 to 0.72), and 28% versus 39% at 3 years (OR = 0.70; 95% CI: 0.63 to 0.77). These patients also had lower mortality at 8 years (P = 0.0001), although this advantage over patients who received medical treatment only decreased over time. Expenditures among defibrillator recipients were consistently higher, with a cost-effectiveness ratio of $78,400 per life-year gained. CONCLUSION: The use of implantable defibrillators was associated with significantly lower mortality and higher costs, whereas the cost-effectiveness was higher than many, but not all, generally accepted therapies.

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PubMed1999

Examining the psychosocial impact of implantable cardioverter defibrillators: a literature review.

BACKGROUND: The implantable cardioverter defibrillator (ICD) has proven to be superior to medications in treating potentially life-threatening ventricular arrhythmias, resulting in reduced mortality rates. Despite the number of patients receiving this therapy, its psychosocial impact is not well understood. HYPOTHESIS: The purposes of this paper are (1) to review the available literature documenting the psychosocial impact of the ICD on patients, (2) to hypothesize possible mechanisms for this psychosocial impact, and (3) to suggest clinical risk profiles and indications for psychological consultation. METHODS: Electronic and library searches (e.g., MEDLINE, PsychLit) were used to gather studies examining the psychosocial impact of the ICD. Only studies investigating psychosocial outcomes (e.g., psychological distress, quality of life, social and role functioning), either prospectively or cross-sectionally, were admitted into the review. No literature reviews or secondary sources were included. RESULTS AND CONCLUSIONS: Current research suggests that ICD-specific fears and symptoms of anxiety (e.g., excessive worry, physiological arousal) are the most common psychological symptoms experienced by ICD recipients, with approximately 13-38% of recipients experiencing diagnosable levels of anxiety. Depressive symptoms are reported at rates that are generally consistent with other cardiac populations. Although the incidence of psychological disorders appears to be similar to that found in general cardiac populations, specific ICD-related concerns such as fear of shock, fear of device malfunction, fear of death, and fear of embarrassment have been identified. Selected psychological theories such as classical conditioning, learned helplessness, and a cognitive appraisal model help to explain the occurrence of psychological symptoms post implantation. Psychosocial adjustment risk profiles indicate that young ICD recipients and those with high discharge rates may experience the most adjustment difficulties.

Adaptation, Psychological↗
PubMed1994

One-incision approach for insertion of implantable cardioverter defibrillators.

The placement of a transvenous implantable cardioverter defibrillator (ICD) system through a single infraclavicular skin incision has been a surgical goal for years. The development of a new investigational model of ICD with substantially reduced dimensions (volume, 83 cm3; mass, 132 g) has made the one-incision approach a clinical reality. Between March and September 1993, 4 female and 19 male patients (mean age, 60 +/- 9.6 years; range, 46 to 73 years) underwent implantation of this device for the treatment of ventricular fibrillation (n = 14) or ventricular tachycardia (n = 9). One transvenous lead was placed in the right ventricular apex and another in the left subclavian vein. A subpectoral pocket was formed in the infraclavicular area from the same incision to house the ICD generator and, if necessary, the subcutaneous patch. The mean operation time (81.5 +/- 32.7 minutes; range, 54 to 195 minutes) was significantly shorter than that noted for a previous series made up of patients undergoing traditional transvenous ICD implantations. In 20 patients (87%), endovenous defibrillation without a subcutaneous patch successfully caused externally induced ventricular fibrillation to revert with a mean minimum energy output of 21.9 +/- 3.5 J (range, 12 to 24 J). Endovenous defibrillation was more successful when biphasic (n = 16/17 [94%]) shocks rather than monophasic shocks (n = 4/6 [67%]) were used. No mortality, morbidity, or surgical complications were observed. These results indicate that the one-incision approach and the small size of the ICD generator can substantially facilitate ICD implantation and result in a reduction in the surgical trauma, the operation time, and the amount of material implanted.

Aged↗
PubMed1994

[The effect of the impulse form of the defibrillation shock on its effectiveness and device technology of the implantable cardiac defibrillator].

Efforts have been focussed on the development of implantable cardioverter-defibrillator systems that reduce the size of the devices, simplify the methods of electrode implantation, and increase device longevity. The size of implantable units is predominantly determined by the capacitors and batteries, and this is dependent on the output energy requirements. The energy required for defibrillation and therefore the size of the devices can be reduced by utilizing optimal lead systems and waveforms. This report describes our experience with various shock waveforms in 86 consecutive patients undergoing implantation of a cardioverter-defibrillator with a nonthoracotomy approach. Table 1 provides information on the demographic characteristics of the study population, the various shock waveforms and lead configurations tested. In 20 patients, a bidirectional lead configuration was tested using simultaneous and sequential monophasic waveforms. In 18 patients, simultaneous monophasic and biphasic waveforms with a fixed pulse duration of 6.3 ms were employed utilizing a bidirectional lead system. In 31 patients, a undirectional lead configuration was used, and simultaneous monophasic and biphasic shocks with a constant tilt were delivered. In 17 patients, the defibrillation efficacy of biphasic and triphasic shock waveforms with a fixed pulse duration of 10 ms was evaluated. The study design was an open, randomized and prospective evaluation in all patients. Defibrillation threshold was determined in a randomized sequence using a step down protocol. The defibrillation threshold was defined as the lowest energy required for effective defibrillation on two occasions. In the 20 patients using a bidirectional lead configuration, there was no significant difference in defibrillation energy requirements between simultaneous and sequential monophasic shock waveforms.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1998

Influence of anaesthesia on defibrillation threshold.

Internal cardioverter-defibrillator implantation can be performed under local or general anaesthesia. Whether the technique of general anaesthesia influences the defibrillation threshold remains a matter of debate. We therefore compared, in a prospective, randomised clinical study, the effect of intravenous anaesthesia using propofol with inhalational anaesthesia using isoflurane on the defibrillation threshold in 68 patients scheduled for transvenous single-lead internal cardioverter-defibrillator implantation. Defibrillation threshold was measured at implantation and at device testing 1 week and 1 month after implantation. Patients acted as their own controls. Neither the anaesthetic technique nor the duration of anaesthesia was associated with significant changes in the defibrillation threshold. We conclude that in this group of high-risk patients, both types of anaesthesia are acceptable techniques for internal cardioverter-defibrillator implantation and testing.

Anesthesia, General↗
PubMedDate not supplied

Implantable cardioverter defibrillator therapy in children with long QT syndrome.

We report our experience with implantable cardioverter defibrillator (ICD) implantation and follow-up in high-risk patients with congenital long QT syndrome (LQTS). Congenital LQTS is associated with significant risk of malignant ventricular arrhythmias and sudden cardiac death (SCD). ICD implant is recommended for prevention of SCD in this patient population, but there are few published data regarding the efficacy and side effects of such therapy. We report our experience with 12 patients who underwent ICD implant for high-risk LQTS at our center in the past 5 years with respect to implant complications, appropriate and inappropriate therapies, device follow-up, and the impact on lifestyle. During a follow-up of 34.7+/-16.6 months, appropriate therapies were noted in 5, inappropriate therapies in 4, and no therapies in 3 patients. Clusters of appropriate therapies were seen in 3 patients, 1 of whom subsequently died. Female sex and congenital deafness appear to be associated with a higher risk of appropriate therapies. One patient experienced two complications at implant that were successfully treated. ICD implantation in LQTS patients presenting with SCD or recurrent syncope despite beta-blocker therapy appears to be justified in preventing SCD risk. In asymptomatic siblings of SCD patients, the benefits of ICD implant are not clear from our data.

Adolescent↗
PubMed1999

Mechanisms of death in the CABG Patch trial: a randomized trial of implantable cardiac defibrillator prophylaxis in patients at high risk of death after coronary artery bypass graft surgery.

BACKGROUND: The CABG Patch trial compared prophylactic implantable cardiac-defibrillator (ICD) implantation with no antiarrhythmic therapy in coronary bypass surgery patients who had a left ventricular ejection fraction <0.36 and an abnormal signal-averaged ECG. There were 102 deaths among the 446 ICD group patients and 96 deaths among the 454 control group patients, a hazard ratio of 1.07 (P=0.63). The mechanisms of death were classified, and hypotheses were tested about the effects of ICD therapy on arrhythmic and nonarrhythmic cardiac deaths in the CABG Patch Trial and the Multicenter Automatic Defibrillator Implantation Trial (MADIT). METHODS AND RESULTS: The 198 deaths in the trial were reviewed by an independent Events Committee and classified by the method of Hinkle and Thaler. Only 54 deaths (27%) occurred out of hospital; 145 deaths (73%) were witnessed. Seventy-nine (82%) of the 96 deaths in the control group and 76 (75%) of the 102 deaths in the ICD group were due to cardiac causes. Cumulative arrhythmic mortality at 42 months was 6.9% in the control group and 4.0% in the ICD group (P=0. 057). Cumulative nonarrhythmic cardiac mortality at 42 months was 12. 4% in the control group and 13.0% in the ICD group (P=0.275). Death due to pump failure was significantly associated with death >1 hour from the onset of symptoms, dyspnea within 7 days of death, and overt heart failure within 7 days of death. CONCLUSIONS: In the CABG Patch Trial, ICD therapy reduced arrhythmic death 45% without significant effect on nonarrhythmic deaths. Because 71% of the deaths were nonarrhythmic, total mortality was not significantly reduced.

Anti-Arrhythmia Agents↗
PubMedDate not supplied

Effects of myocardial infarction on catheter defibrillation threshold.

Because the automatic implantable defibrillator may be used in patients having ischemic heart disease, it is important to know whether myocardial ischemia changes the threshold for ventricular defibrillation under experimental conditions simulating automatic internal defibrillation. We determined changes in ventricular defibrillation threshold following coronary occlusion, using an electrode catheter designed for use with an automatic implantable defibrillator. Acute myocardial ischemia was produced without thoracotomy in 10 dogs (experimental group) by embolization with a plastic bead injected via a catheter into the left coronary artery. A control group of 4 dogs had only saline injected into the artery. Defibrillation threshold was measured at 15-min intervals from 1 hour before embolization to 2 hours after embolization. In the control group, voltage, current, energy, and impedance were unchanged after injection of saline into the coronary artery, and india ink perfusion revealed no ischemic areas. In the experimental group postembolization threshold current and energy were significantly higher than preembolization values: 0.47 vs 0.40 A/kg and 1.01 vs 0.80 J/kg, respectively (p less than 0.01). The magnitude of the peak change in threshold current after embolization was positively correlated (r = 0.79) with the size of the ischemic zone, determined by weighing unstained areas after india ink perfusion. Defibrillation threshold for a catheter electrode configuration increases for at least 2 hours following onset of acute myocardial ischemia. This finding must be accounted for in the design and use of an automatic implantable defibrillator.

Animals↗
PubMed1999

[Implantable ventricular defibrillator. Systematic induction of ventricular arrhythmia is not useful except for implantation].

Checking the efficacy of a defibrillator after its implantation is current practice. This control usually entails induction of ventricular fibrillation (VF). The aim of this study was to assess the utility of this practice in patients with an endovascular system of electrodes. Implantation was acquired when a margin of security of 10 days or more had been obtained. During the postoperative test, the choice of energy was that which reduced VF at implantation. Of the 84 patients included in this study, 59 were implanted with an endovascular electrode system alone and the other 25 patients had endovascular electrodes associated with a subcutaneous patch electrode. The average time from implantation to the postoperative test was 31 +/- 12 days. Arrhythmia sensing was normal and reduction by the defibrillator was observed in all patients. The average energy of the electric shocks was not significantly different to that observed at implantation (18.6 +/- 3.6 J and 19.3 +/- 4.7 J). Fifty patients had antiarrhythmic drugs (amiodarone = 43) at implantation, and 32 at the time of the postoperative test (amiodarone = 17). This study showed that the postoperative test with induction of VF was normal in all patients. Therefore, the authors propose that follow-up should consist of consultation including interrogation of the defibrillator and a chest X-ray to check the position of the electrodes. If one of these tests is abnormal or if the perioperative threshold of defibrillation does not provide an adequate margin of safety, induction of a ventricular arrhythmia is necessary to check the function of the system.

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