The implantable cardioverter-defibrillator

Ventricular arrhythmias remain a major cause of cardiovascular mortality. Therapy for serious ventricular arrhythmias has evolved over the past decade, from treatment primarily with antiarrhythmic drugs to implanted devices. The implantable cardioverter-defibrillator (ICD) is the best therapy for patients who have experienced an episode of ventricular fibrillation not accompanied by an acute myocardial infarction or other transient or reversible cause. It is also superior therapy in patients with sustained ventricular tachycardia (VT) causing syncope or hemodynamic compromise. Controlled clinical trials have confirmed the utility of these devices. As primary prevention, the ICD is superior to conventional antiarrhythmic drug therapy in patients who have survived a myocardial infarction and who have spontaneous, nonsustained ventricular tachycardia, a low ejection fraction, inducible VT at electrophysiologic study, and whose VT is not suppressed by procainamide. The effect of the ICD on survival of other patient populations remains to be proven. The device is costly, but its price is generally accepted to be reasonable. The ICD has been a major advance in the treatment of ventricular arrhythmias.     

Primary prevention of sudden cardiac death: indications for cardioverter-defibrillator implantation.

Sudden cardiac death accounts for 400,000 to 450,000 deaths annually in Europe and in the United States. In patients with previous life-threatening arrhythmia, several perspective, randomized, controlled studies have demonstrated that implantable cardioverter-defibrillator (ICD) therapy is superior to the best antiarrhythmic therapy in prolonging survival. Furthermore, in a stratified-risk population with coronary artery disease, left ventricular ejection fraction < or = 35%, non-sustained ventricular arrhythmias, and inducible ventricular tachycardia, the ICD supports the class I level of recommendation by the guidelines published in 1998. The American College of Cardiology, American Heart Association, and North American Society of Pacing and Electrophysiology have updated the 1998 guidelines on the implantation of arrhythmia devices including in a class IIa level of recommendation also patients with a previous Q wave myocardial infarction and left ventricular ejection fraction < or = 30%, independently of their arrhythmic risk profile. In the recent years several randomized studies assessed the role of ICD treatment for primary prevention of sudden cardiac death and total mortality reduction in high-risk groups of patients with ischemic and non-ischemic dilated cardiomyopathy, with special reference to those with heart failure and ventricular dysfunction. This article reviews those trials that have resulted in defining indications for ICD, and that will expand its use in the future.     

Catheter ablation of ventricular tachycardia in ischaemic and non-ischaemic cardiomyopathy: where are we today? A clinical review

According to the current guidelines, patients with ischaemic cardiomyopathy (ICM) or non-ischaemic cardiomyopathy (NICM) at risk for sudden cardiac death should undergo implantation of an implantable cardioverter-defibrillator (ICD). Although ICDs effectively terminate ventricular arrhythmias, the arrhythmogenic substrate remains unchanged or may progress over time, resulting in recurrent ICD shocks. Defibrillator shocks increase mortality and worsen quality of life. Evidence from two prospective randomized trials on outcome in patients with ischaemic heart disease undergoing catheter ablation for ventricular tachycardia (VT) suggests that ablation prevents recurrence of VT and decreases the number of ICD shocks. This review will highlight the recent progress made in the ablative treatment of VT in patients with ICM and NICM.     

Improved survival in patients with nonischemic advanced heart failure and syncope treated with an implantable cardioverter-defibrillator

The purpose of this study was to assess whether in patients with syncope and heart failure due to nonischemic cardiomyopathy, treatment with an implantable cardioverter-defibrillator (ICD) compared with conventional medical therapy is associated with a reduction in sudden death and total mortality. Patients with advanced heart failure who have syncope have been shown to be at high risk for sudden death. Further risk stratification has been difficult in patients with nonischemic cardiomyopathy in whom inducibility on electrophysiologic study is not predictive of future risk. Of 639 consecutive patients with nonischemic cardiomyopathy referred for heart transplantation, 147 patients with history of syncope and no prior history of sustained ventricular tachycardia or cardiac arrest were identified. Outcomes were compared for the 25 patients managed with an ICD and 122 patients managed with conventional medical therapy. There were no differences in the baseline variables in the 2 groups of patients, including age, ejection fraction, and medical treatments for heart failure, but patients receiving an ICD were more likely to have had nonsustained ventricular tachycardia (56% vs. 15%, p = 0.001). During a mean follow-up of 22 months, there were 31 deaths, 18 sudden, in patients treated with conventional therapy, whereas there were 2 deaths, none sudden, in patients treated with an ICD. An appropriate shock occurred in 40% of the ICD patients. Actuarial survival at 2 years was 84.9% with ICD therapy and 66.9% with conventional therapy (p = 0.04). Thus, in patients with nonischemic cardiomyopathy and syncope, therapy with an ICD is associated with a reduction in sudden death and an improvement in overall survival.     

Implantable cardioverter-defibrillators in children

BACKGROUND: Implantable cardioverter-defibrillators (ICD) have been increasingly used in adult patients for the prevention of sudden cardiac death (SCD). The usefulness and feasibility of ICD implantation in children have been less well established. AIM: To analyse indications, results and safety of ICD therapy in children. METHODS: ICDs were implanted in seven children, aged from 6 to 17 years. All patients underwent cardiological evaluation which included analysis of medical history, physical examination, chest X-ray, standard ECG, 24-hour Holter ECG monitoring and echocardiography. RESULTS: In five children devices were implanted due to aborted sudden death (ventricular fibrillation) whereas in the remaining two - as a primary prevention of SCD. Three children had hypertrophic cardiomyopathy, one - dilated cardiomyopathy, one - mitral valve prolapse and QT prolongation, one - congenital long QT syndrome and the remaining patient - idiopathic ventricular tachycardia. Single-chamber devices were implanted in six children, and dual-chamber system - in one patient. In all patients endocardial leads were implanted and ICD pocket was formed under the greater pectoral muscle. During follow-up ranging between four months to 5.4 years, four children developed ventricular fibrillation or ventricular tachycardia which were terminated by appropriate ICD discharges. CONCLUSIONS: 1. ICD implantation in children is effective in the prevention of SCD. 2. In our population, the most frequent indications for device implantation were life-threatening ventricular arrhythmias occurring in patients with cardiomyopathy. 3. Cardiac arrest due to ventricular fibrillation may occur in children without a history of aborted SCD. 4. ICD implantation in children is feasible and safe.     

Is primary antiarrhythmic drug therapy for ventricular arrhythmias obsolete?

Sudden cardiac death (SCD) remains a major public health threat. Patients with aborted SCD have a high incidence of recurrent life-threatening ventricular arrhythmias. Antiarrhythmic drug approaches dominated early attempts to prevent SCD; however, several trials with sotalol and amiodarone revealed an unacceptably high rate of recurrent arrhythmic events. With the advent of the implantable cardioverter defibrillator (ICD), the primary role of antiarrhythmic drug therapy for the secondary prevention of SCD has been called into question. Two recently completed trials, the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial and the Canadian Implantable Defibrillator Study (CIDS), confirm the superiority of the ICD over the best medical therapy for saving lives.     

Prophylactic implantation of cardioverter-defibrillator in patients with severe cardiac amyloidosis and high risk for sudden cardiac death

BACKGROUND: Cardiac light-chain amyloidosis carries a high risk for death predominantly from progressive cardiomyopathy or sudden death (SCD). Independent risk factors for SCD are syncope and complex nonsustained ventricular arrhythmias. OBJECTIVE: The purpose of this study was to test whether prophylactic placement of an implantable cardioverter-defibrillator (ICD) reduces SCD in patients with cardiac amyloidosis. METHODS: Nineteen patients with histologically proven cardiac amyloidosis and a history of syncope and/or ventricular extra beats (Lown grade IVa or higher) received an ICD. RESULTS: During a mean follow-up of 811 +/- 151 days, two patients with sustained ventricular tachyarrhythmias were successfully treated by the ICD. Two patients underwent heart transplantation, and seven patients died due to electromechanical dissociation (n = 6) or glioblastoma (n = 1). Nonsurvivors more often showed progression of left ventricular wall thickness, low-voltage pattern, ventricular arrhythmias (Lown grade IVa or higher), and higher N-terminal pro-brain natriuretic peptide levels than did survivors. Bradycardias requiring ventricular pacing (VVI 40/min <1%, DDD 60/min 6% +/- 1%) occurred only rarely. CONCLUSION: Patients with cardiac amyloidosis predominantly die as a result of electromechanical dissociation and other diagnoses not amenable to ICD therapy. Selected patients with cardiac amyloidosis may benefit from ICD placement. Better predictors of arrhythmia-associated SCD and randomized trials are required to elucidate the impact of ICD placement in high-risk patients with cardiac amyloidosis.     

Roles and indications for use of implantable defibrillator and resynchronization therapy in the prevention of sudden cardiac death in heart failure

Implantable devices are indicated in the primary and secondary prevention of potentially life-threatening ventricular tachyarrhythmias in patients with heart failure. Early studies, including the landmark MADIT trials, showed that implantable cardioverter–defibrillator (ICD) and cardiac resynchronization therapy (CRT) devices can play a significant role in aborting and preventing ventricular arrhythmias, respectively, that can cause sudden cardiac death. To this day, there have been a number of randomized controlled trials, with respective substudy analyses, that have attempted to better understand the indications for these interventions in patient care. Here, we summarize the major results of these studies, and we discuss the role of ICD therapy for both ischemic and non-ischemic cardiomyopathy, emerging evidence in support of wearable defibrillators, and the impact of modified ICD programming strategies on patient outcomes. Regarding CRT therapy, the phenomenon of ventricular reverse remodeling is an important prognostic indicator in preventing future ventricular tachyarrhythmia episodes. In summation, we provide an overview of the possible selection criteria that can be used in identifying appropriate patients for ICD and/or CRT therapy, as supported by the data.     

A critical appraisal of indications for the implantable cardioverter defibrillator (ICD).

The implantable cardioverter defibrillator (ICD) is a remarkably effective therapy for reducing sudden cardiac death in patients with malignant ventricular arrhythmias. The indications for implantation of the ICD were approved in 1985 by the United States Food and Drug Administration; it could be implanted in patients who have experienced cardiac arrest or in those with recurrent ventricular arrhythmias which are not suppressed by anti-arrhythmic drugs in the electrophysiology laboratory. These established indications have not changed in the last seven years. In the near future, the release of third-generation ICDs (with antitachycardia pacing) will likely further expand indications for the device. Many patients with stable ventricular tachycardia who have not had syncope or cardiac arrest will receive a third-generation defibrillator. Also, three clinical trials now in progress--CABG-PATCH, Multicenter Automatic Defibrillator Implantation Trial (MADIT) and Multicenter Unsustained Tachycardia Trial (MUSTT)--are studying "pre-event" patients with low ejection fraction and electrical instability; some of the patients in each trial are being prospectively randomized to the ICD. Within the next five years we will have a better understanding of the role of ICD therapy in such patients. Until these studies are completed, it is important that the indications for the ICD not be expanded.     

The Timing of Implantable Cardioverter-Defibrillator Implantation in Patients with Heart Failure

Patients who survive a myocardial infarction (MI) are at increased risk of sudden death due to fatal ventricular arrhythmias. Implantable cardioverter-defibrillators (ICDs) reduce mortality in appropriately selected patients with heart failure and left ventricular dysfunction, regardless of etiology. Post hoc analyses from landmark trials have evaluated the effect of time (both since MI and duration of nonischemic cardiomyopathy) before ICD implantation on the efficacy of ICD therapy. Time remains a clinically important variable in the decision of if and when to implant an ICD. Future trials should focus on invasive and/or noninvasive risk stratification of patients with ischemic and nonischemic cardiomyopathy for better identification of those who would benefit from early ICD implantation, and those in whom a watch and wait approach is appropriate.     

Arrhythmogenic Right Ventricular Cardiomyopathy: Risk Stratification and Indications for Defibrillator Therapy

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a genetically determined disease which predisposes to life-threatening ventricular arrhythmias. The main goal of ARVC therapy is prevention of sudden cardiac death (SCD). Implantable cardioverter defibrillator (ICD) is the most effective therapy for interruption of potentially lethal ventricular tachyarrhythmias. Despite its life-saving potential, ICD implantation is associated with a high rate of complications and significant impact on quality of life. Accurate risk stratification is needed to identify individuals who most benefit from the therapy. While there is general agreement that patients with a history of cardiac arrest or hemodynamically unstable ventricular tachycardia are at high risk of SCD and needs an ICD, indications for primary prevention remain a matter of debate. The article reviews the available scientific evidence and guidelines that may help to stratify the arrhythmic risk of ARVC patients and guide ICD implantation. Other therapeutic strategies, either alternative or additional to ICD, will be also addressed.     

Use of traditional and biventricular implantable cardiac devices for primary and secondary prevention of sudden death

Sudden cardiac death is the leading cause of cardiac mortality, particularly among high-risk populations with known left ventricular systolic dysfunction. Multiple randomized clinical trials demonstrated a significant mortality benefit of the implantable cardioverter defibrillator (ICD) compared with antiarrhythmic drug therapy or standard medical care. Initial ICD trials showed a mortality improvement for patients who previously had experienced aborted sudden cardiac death or sustained ventricular tachycardia (secondary prevention). Primary prevention trials in selected high-risk patients who had both ischemic and nonischemic cardiomyopathy also demonstrated a mortality benefit associated with ICD treatment. More recently, cardiac resynchronization therapy with or without defibrillator capability has been shown to reduce morbidity and mortality among advanced heart failure patients with a prolonged QRS duration.     

Amiodarone: clinical trials

Amiodarone is an antiarrhythmic agent commonly used in the treatment of supraventricular and ventricular tachyarrhythmias. This article reviews the results and clinical implications of primary and secondary prevention trials in which amiodarone was used in one of the treatment arms. Key post-myocardial infarction primary prevention trials include the European Myocardial Infarct Amiodarone Trial (EMIAT) and the Canadian Amiodarone Myocardial Infarction Trial (CAMIAT), both of which demonstrated that amiodarone reduced arrhythmic but not overall mortality. In congestive heart failure patients, amiodarone was studied as a primary prevention strategy in two pivotal trials: Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiac en Argentina (GESICA) and Amiodarone in Patients With Congestive Heart Failure and Asymptomatic Ventricular Arrhythmia (CHF-STAT). Amiodarone was associated with a neutral overall survival and a trend toward improved survival in nonischemic cardiomyopathy patients in CHF/STAT and improved survival in GESICA. In post-myocardial infarction patients with nonsustained ventricular tachycardia and a depressed ejection fraction, the Multicenter Automatic Defibrillator Implantation Trial (MADIT) demonstrated that implantable cardioverter-defibrillators (ICD) statistically improved survival compared to the antiarrhythmic drug arm, most of whose patients were taking amiodarone. In patients with histories of sustained ventricular tachycardia or ventricular fibrillation, the Cardiac Arrest Study in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) trial demonstrated that empiric amiodarone lowered arrhythmic recurrence rates compared to other drugs guided by serial Holter or electrophysiologic studies. However, arrhythmic death rates were high in both treatment arms of the study. Several secondary prevention trials, including the Antiarrhythmics Versus Implantable Defibrillators Study (AVID), the Canadian Implantable Defibrillator Study (CIDS), and the Cardiac Arrest Study Hamburg (CASH), have demonstrated the superiority of ICD therapy compared to empiric amiodarone in improving overall survival. Based on the above findings, amiodarone is safe to use in post-myocardial infarction and congestive heart failure patients that need antiarrhythmic therapy. Although amiodarone is effective in treating malignant arrhythmias, high-risk patients should be considered for an ICD as frontline therapy.     

A comprehensive approach to management of ventricular arrhythmias

This review presents five cases that highlight the complexity of taking care of patients with ventricular arrhythmias. Three of the cases discuss management of patients with nonsustained ventricular tachycardia in the setting of structural heart disease: dilated cardiomyopathy, hypertrophic cardiomyopathy, and after myocardial infarction. A fourth case asks whether data from implantable cardioverter defibrillator (ICD) trials can be extrapolated to older patients, and the fifth case discusses management of recurrent ventricular arrhythmias in a patient with an ICD.     

AVID and Beyond: Lessons Learned

The implantable cardioverter defibrillator (ICD) has been approved by the Food and Drug Administration (FDA) since 1985 and is widely used in practice. Until recently, however, the efficacy of the ICD has depended on a large published series of retrospective studies analyzing ventricular tachycardia and fibrillation patients. The recently published Antiarrhythmics Versus Implantable Defibrillator (AVID) trial is the first prospective randomized trial to show clearly that the ICD is more effective than drug therapy (amiodarone or sotalol) in patients who have survived an out-of-hospital cardiac arrest or have syncopal or hemodynamically significant ventricular tachycardia. The survival advantages probably hold true only for patients with an ejection fraction under 35% who have either coronary disease or other forms of cardiomyopathy. The survival advantage in this trial—which was halted prematurely because of the results noted—was short-lived (2.8 months) and expensive. The results of this trial will clearly define the role of the ICD in everyday clinical practice and will be of invaluable benefit to patients, physicians, and insurers alike. The results of the AVID trial, as well as other postevent and pre-event trials, are summarized in this article. A number of sub studies have already resulted from the AVID study and are also presented.     

Third- and fourth-generation implantable cardioverter defibrillators: current status and future development

Implantable cardioverter defibrillator (ICD) therapy has become the mainstay of therapy for patients with a history of sudden cardiac death or life-threatening ventricular arrhythmias. The current generation of ICDs used for secondary prevention combines features for tachycardia reversion with demand ventricular pacing, antitachycardia pacing, programmable shock therapy, and tachycardia events memory. Although demand pacing and defibrillation is indicated for primary prevention usage of ICDs, the application of antitachycardia pacing modes is more controversial. High energy cardioversion and defibrillation shocks remaining the mainstay of sudden death prevention will be redefined as more effective defibrillation shock modes and lead systems are developed. Fourth-generation ICD systems accomplished a significant reduction of device size and almost universal success using an endocardial lead configuration and pectoral implant. A variety of new directions of ICD therapy in clinical practice such as primary prevention applications and the adjunctive role of antiarrhythmic drug therapy are currently being examined in clinical trials. The concepts underlying initiation of tachyarrhythmias are being studied to develop new approaches to tachycardia prevention. These include rate support, subthreshold stimulation, and multiple site pacing. The current developments of ICD therapy promise continued growth of this technology.     

Advances in implantable cardioverter defibrillators.

Implantable cardioverter defibrillators (ICDs) have become an important therapeutic modality for patients who have had a cardiac arrest or are at risk for life-threatening ventricular arrhythmias. Clinical trials have confirmed the role of the ICD for patients with sustained ventricular arrhythmias and have expanded the indications to include patients with coronary artery disease, left ventricular dysfunction, nonsustained ventricular tachycardia, and inducible ventricular tachycardia. Numerous technologic advances in ICDs have resulted in decreased size, greater ease of placement, and increased functionality. Important advancements have been made in the effectiveness of arrhythmia classification and electrogram storage. Dual-chamber ICDs have become increasingly sophisticated with rate-adaptive sensors. Biventricular pacing is being combined with ICD function in patients with heart failure, systolic dysfunction, and QRS widening. Future advances in devices will likely lead to improved arrhythmia classification, more advanced automated features, and additional features including more sophisticated sensors and biventricular pacing systems.     

Arrhythmias in Patients with Heart Failure

Opinion statement Both atrial and ventricular arrhythmias are very common in patients with congestive heart failure, and their presence is associated with symptoms, significant morbidity, and mortality. Studies have attempted to determine the prognostic significance of atrial and ventricular arrhythmias in patients with heart failure. Whether atrial fibrillation is an independent risk factor of mortality remains controversial. The presence of ventricular arrhythmias in patients with ischemic cardiomyopathy identifies patients at high risk for sudden death. However, in patients with nonischemic cardiomyopathy there is not a strong correlation between ventricular arrhythmias and increased risk for sudden death. Multiple trials using antiarrhythmic drugs, pharmacologic therapy, and implantable cardioverter defibrillators have been performed in an attempt to improve survival in patients 1) post-myocardial infarction; 2) with congestive heart failure, with and without nonsustained ventricular tachycardia; and 3) with sustained ventricular tachycardia and those who have survived an out-of-hospital cardiac arrest. The purpose of this article is to present an overview of arrhythmias in patients with heart failure and discuss the prevalence, prognostic significance, complications, mechanisms, and trials that have formed the current therapies presently used.     

Prognostic significance of 24 hour ambulatory electrocardiographic monitoring in patients with hypertrophic cardiomyopathy: A prospective study

The prevalence and prognostic significance of ventricular arrhythmias identified on 24 hour ambulatory electrocardiographic monitoring was prospectlvely assessed in 99 patients with hypertrophie cardiomyopathy. In the absence of antlarrhythmic therapy, high grade ventricular arrhythmias (grade 3 and above) were common; that is, they were identified in 66 percent of the patients, including 19 percent with episodes of asymptomatic ventricular tachycardia.Clinical outcome was assessed 3 years after the initial 24 hour ambulatory electrocardiogram. Of the 84 patients who did not undergo ventricular septal myotomy-myectomy, 6 died suddenly or experienced cardiac arrest, 1 died of progressive congestive heart failure and the other 77 have survived without a cardiac catastrophe. The prevalence rate of sudden death or cardiac arrest during the follow-up period was the same (3 percent) in patients with high grade arrhythmias other than ventricular tachycardia (1 of 37) as in those with no or low grade arrhythmias (1 of 29). However, the occurrence of a sudden cardiac catastrophe was significantly more common in patients with asymptomatic ventricular tachycardia of brief duration on 24 hour electrocardiography (4 [24 percent] of 17) than in patients without ventricular tachycardia (2 [3 percent] of 66) (p <0.02).In summary, (1) high grade ventricular arrhythmias are commonly found on continuous 24 hour electrocardiographic monitoring in patients with hypertrophic cardiomyopathy; and (2) although sudden death is relatively uncommon in patients with high grade ventricular arrhythmias other than ventricular tachycardia (annual mortality rate 1 percent), the finding of ventricular tachycardia on 24 hour electrocardlography identifies a subgroup of patients at high risk for sudden death (annual mortality rate 8.6 percent). Although no conclusions can be drawn regarding the impact of therapy, our findings suggest that 24 hour electrocardiographic monitoring should be performed in patients with hypertrophic cardiomyopathy and that it may be reasonable to initiate antlarrhythmic therapy if ventricular tachycardia is identified.     

Predictors of appropriate implantable defibrillator therapies in patients with arrhythmogenic right ventricular dysplasia

BACKGROUND: Arrhythmogenic right ventricular dysplasia (ARVD) is an inherited cardiomyopathy characterized by ventricular arrhythmias and sudden cardiac death. The risk factors for sudden death and indications for implantable cardioverter-defibrillator (ICD) placement in patients with ARVD are not well defined. OBJECTIVES: The purpose of this study was to determine which clinical and electrophysiologic variables best predict appropriate ICD therapies in patients with ARVD. Particular attention focused on whether the ICD was implanted for primary or second prevention. METHODS: We enrolled 67 patients (mean age 36 +/- 14 years) with definite or probable ARVD who had undergone ICD placement. Appropriate ICD therapies were recorded, and Kaplan-Meier analysis was used to compare the event-free survival time between patients based upon the indication for ICD placement (primary vs secondary prevention), results of electrophysiologic testing, and whether the patient had probable or definite ARVD. RESULTS: Over a mean follow-up of 4.4 +/- 2.9 years, 40 (73%) of 55 patients who met task force criteria for ARVD and 4 (33%) of 12 patients with probable ARVD had appropriate ICD therapies for ventricular tachycardia/ventricular fibrillation (VT/VF; P = .027). Mean time to ICD therapy was 1.1 +/- 1.4 years. Eleven of 28 patients who received an ICD for primary prevention (39%) and 33 of 35 patients who received an ICD for secondary prevention (85%) experienced appropriate ICD therapies (P = .001). Electrophysiologic testing did not predict appropriate ICD interventions in patients who received an ICD for primary prevention. Fourteen patients (21%) received ICD therapy for life-threatening (VT/VF >240 bpm) arrhythmias. There was no difference in the incidence of life-threatening arrhythmias in the primary and secondary prevention groups (P = .29). CONCLUSION: Patients who meet task force criteria for ARVD are at high risk for sudden cardiac death and should undergo ICD placement for primary and secondary prevention, regardless of electrophysiologic testing results. Further research is needed to confirm that a low-risk subset of patients who may not require ICD placement can be identified.