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PubMed2003

Utilization of implantable defibrillators in Africa.

Sub-Saharan Africa is dominated by diseases of poverty. HIV/AIDS affects 28.5 out of a total of 600 million in the region. South Africa is the only country in sub-Saharan Africa in which implantable cardiovertor defibrillators (ICDs) are implanted (0.8/million in 2001). Only 3 of the 35 new ICDs were implanted in state-funded public hospitals. The pacemaker implantation rate for South Africa was 41/million in 2001. Approximately 20% of the population consume 56% of the health care expenditure, mainly funded by Medical Insurance. A tax-funded state health care system serves the rest of the population, but is concentrated on improving sanitation and primary health care. Diversion of funds from academic tertiary hospitals has reduced specialised services, particularly cardiology and cardiac surgery, and has resulted in an exodus of skilled personnel to the private sector. In the rest of sub-Saharan Africa, tertiary health care is mainly privately funded. Cardiology and cardiac surgery is not widely available. Many countries are crippled by debt and chronic local conflicts. Only one state hospital (Groote Schuur, Cape Town) provides an electrophysiology (EP) service including catheter ablation and ICD implantation, and training in EP, by two electrophysiologists. EP services are available privately in 3 centres. No EP service exists in the rest of sub-Saharan Africa.

Africa↗

PubMed2000

Patients' attitudes toward implanted defibrillator shocks.

In addition to its beneficial effect on patient survival, the implanted cardioverter defibrillator (ICD) changes a patient's life physically, socially, and psychologically. For improved patient management, it is important to understand the quality-of-life changes that accompany this mode of treatment. To this end, 119 patients were surveyed retrospectively and interviewed concurrently regarding their emotional, physical, and behavioral responses to ICD shocks and to the device itself. Most (55%) correctly estimated the total number of shocks they had received within a 10% margin. They found the shocks severe, 79% assigning a score between 3 and 5 on a scale of 1-5. Common descriptions of the shock sensation were a blow to the body or a spasm causing the entire body to jump. Most patients tolerated the shocks as lifesaving, but 23% dreaded shocks and 5% even said they would rather be without the ICD and take their chances. After a shock, 50% of patients called their physician and 42% continued their daily routine. Thirty percent went to a hospital emergency room or called a rescue service. Sixty-five percent had no preshock prodromes. Fifty-four percent were interested in the programmable option of a warning signal prior to a shock, while 31% preferred no warning. Of the 74% who were advised not to drive after implantation, 29% drove anyway. Five patients were shocked while driving with no resulting accidents. We conclude that most patients find ICD shocks moderately uncomfortable, but they tolerate them because of the lifesaving protection provided by the device.

Adult↗

PubMed2002

Prognostic value of baseline electrophysiology studies in patients with sustained ventricular tachyarrhythmia: the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial.

OBJECTIVES: We sought to determine the value of electrophysiology (EP) testing in patients with ventricular fibrillation (VF), ventricular tachycardia (VT) with syncope, or sustained VT in the setting of left ventricular dysfunction. BACKGROUND: Traditionally, EP testing is part of the workup of patients with sustained VT or VF. Recently, some have suggested that EP testing is unnecessary in these patients, many of whom are likely to receive an implantable cardioverter-defibrillator (ICD). METHODS: Within a multicenter trial (Antiarrhythmics Versus Implantable Defibrillators) designed to evaluate whether drugs or ICD resulted in a better outcome, data were analyzed regarding EP testing. Although this testing was not required, it was performed in >50% of patients. Information regarding the results of EP testing was correlated to baseline clinical characteristics and outcome. RESULTS: Of 572 patients subjected to an EP test, 384 (67%) had inducible sustained VT or VF. Inducible patients were more likely to have coronary artery disease, previous infarction, and VT as their index arrhythmic event. Inducibility of VT or VF did not predict death or recurrent VT or VF. CONCLUSIONS: Information derived from EP testing in this patient population, particularly those with VF, is of limited value and may not be worth the risks and costs of the procedure, particularly in those patients likely to receive an ICD.

Aged↗

PubMed2006

Withdrawing implantable defibrillator shock therapy in terminally ill patients.

PURPOSE: The purpose of this study is to review a multidisciplinary strategy used to identify patients with terminal illnesses and initiate withdrawal of implantable cardioverter defibrillator (ICD) shock therapy as part of a comprehensive comfort care approach. With indications for ICDs increasing, more patients are receiving devices. Once protected from an arrhythmic death, these patients may develop other terminal diseases such as cancer or congestive heart failure. It is appropriate to withdraw defibrillator shock therapy when such patients desire only comfort care. METHODS: The charts of ICD patients who had died were reviewed. Two groups emerged: Group 1 (20) included patients whose defibrillator was turned off through the comprehensive comfort care approach. Group 2 (43) included patients whose clinical course was so rapid that the defibrillator was not turned off. Pacing therapy was not withdrawn in either group. RESULTS: Defibrillator discharges, cause of death, and time from ICD discharge to death were compared. Group 2 patients died more acutely than Group 1. Group 1 experienced fewer shocks prior to death when compared to Group 2. Comparing pacemaker dependent and non-dependent patients, there was no difference in the time between therapy discontinuation and death. CONCLUSION: This is the largest study to date to review the characteristics of patients with ICDs and terminal illness. Only one-third of terminally ill patients with ICDs were able to have shock therapy withdrawn as part of a comfort care strategy. These patients experienced fewer shocks in the final days of their illness.

Aged↗

PubMed1996

Comparison of d,l-sotalol and implantable defibrillators for treatment of sustained ventricular tachycardia or fibrillation in patients with coronary artery disease.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) and d,l-sotalol are widely used to treat ventricular tachyarrhythmia and ventricular fibrillation (VT/VF). The purpose of this study was to compare the long-term efficacy of d,l-sotalol and ICDs in patients with coronary artery disease. METHODS AND RESULTS: In a case-control study, 50 patients treated with oral d,l-sotalol were matched to 50 patients treated with ICDs. Both groups were matched for sex (82 men), age (58 +/- 10 years), ejection fraction (40 +/- 12%), extent of coronary artery disease, presenting arrhythmia, and year that treatment began. In all patients in the sotalol group, VT/VF was inducible in the drug-free electrophysiological study. Induction of sustained VT/VF was suppressed by d,l-sotalol (438 +/- 95 mg/d). In the ICD group, either VT/VF was not inducible (n = 5) or inducible sustained VT/VF was refractory to antiarrhythmic drug treatment (n = 45). Sotalol treatment led to a marked reduction in arrhythmic events. Whereas 83% of the patients in the sotalol group were free of sudden death and nonfatal VT at 3 years, only 33% of the ICD patients did not receive appropriate ICD therapies (P < .005). Actuarial rates for absence of sudden death at 3 years were 85% in the sotalol group and 100% in the ICD group (P < .005). Actuarial rates for overall survival at 3 years were 75% in the sotalol group and 85% in the ICD group (P = .02). CONCLUSIONS: In this case-control study, ICD therapy was more effective tha electrophysiologically guided antiar-rhythmic treatment with d,l-sotalol in prevention of sudden death and reduction of total morality in patients with coronary artery disease. Prospective studies are needed to confirm these results.

Administration, Oral↗

PubMed2003

Clinical trials of prophylactic implantable defibrillator therapy in patients with nonischemic cardiomyopathy: what have we learned and what can we expect from future trials?

Several randomized clinical trials have been designed to evaluate the usefulness of prophylactic implantable cardioverter defibrillator (ICD) therapy in patients with nonischemic cardiomyopathy. In 2 trials, CAT and AMIOVIRT, no survival benefit was reported for patients with dilated cardiomyopathy and prophylactic ICD therapy. The major limitation of both trials is the small sample size of 104 patients in CAT and 103 patients in AMIOVIRT. Another limitation of both trials is the lack of a run-in phase on optimized medical therapy. Since LV function may improve considerably on optimized medical therapy, LV function should be reevaluated 3 to 4 months after initiation of ACE inhibitors, ss-blockers and aldosterone antagonists before prophylactic ICD therapy is considered. Two additional trials, DEFINITE and SCD-HEFT, are still ongoing. Particularly SCD-HEFT will follow a sufficient number of patients with nonischemic cardiomyopathy to give a more definitive answer with regard to the clinical usefulness of prophylactic ICDs in patients with nonischemic cardiomyopathy. Recently, the Marburg Cardiomyopathy study (MACAS) was finished. The results of MACAS strongly suggest that reduced LV ejection fraction is the most important arrhythmia risk predictor in idiopathic dilated cardiomyopathy, whereas signal-averaged ECG, baroreflex sensitivity, heart rate variability and T wave alternans do not appear to be helpful for arrhythmia risk stratification. In addition, MACAS showed that total mortality in patients with idiopathic dilated cardiomyopathy and an ejection fraction <30% is only about 5% per year on optimized medical therapy after exclusion of patients with end stage heart failure and after exclusion of patients with sustained ventricular arrhythmias. Thus, any future study designed to demonstrate a mortality benefit by prophylactic ICD therapy with an 80% power in this patient population needs to enroll more than 1000 patients.

Adrenergic beta-Antagonists↗

PubMed1999

Correlation waveform analysis to discriminate monomorphic ventricular tachycardia from sinus rhythm using stored electrograms from implantable defibrillators.

In order to examine whether a template-matching program utilizing correlation waveform analysis (CWA) might be used to discriminate monomorphic ventricular tachycardia (MMVT) from sinus rhythm (SR) in patients with implantable cardioverter defibrillators (ICDs), we studied stored episodes of induced MMVT in 25 patients and compared them to corresponding stored SR electrograms. We calculated mean correlation coefficients for SR beats against an SR template chosen within each sinus episode, induced MMVT beats against an induced MMVT template within each ventricular tachycardia episode, and induced MMVT beats against the original SR template. For each patient, the 99.5% lower confidence limit for the mean correlation coefficient of SR beats versus an SR template (patient-specific method) or the empirical correlation coefficient value 0.9 were selected as threshold values to discriminate induced MMVT from SR. The mean correlation coefficient for induced MMVT beats versus the original SR template for each patient was subtracted from both threshold values. A positive value is defined as accurate discrimination of induced MMVT from SR. Using 0.9 for a threshold cut off, 21 of 25 episodes of induced MMVT were accurately labeled with a sensitivity of 84%. Using the patient-specific method, we were able to correctly distinguish 23 of 25 episodes of induced MMVT from SR with a sensitivity of 92%. There was no statistically significant difference between the patient-specific or empirical methods in detecting MMVT (P 50.4). This is the first demonstration using stored intracardiac electrograms from ICDs that CWA is able to discriminate MMVT from SR with high sensitivity. Such a template-matching system may be used for off-line analysis or real-time rhythm discrimination.

Aged↗

PubMed2001

Discrepancy between inducibility of ventricular tachycardia and activity of cardiac sarcoidosis. Requirement of defibrillator implantation for the inactive stage of cardiac sarcoidosis.

Monomorphic ventricular tachycardia (VT) developed in two patients with cardiac sarcoidosis. Before treatment with prednisolone, technetium or gallium scintigram revealed abnormal accumulation in the heart and bilateral hilar lymph nodes, but programmed electrical stimulation failed to induce VT in either case. Prednisolone was administered and the abnormal accumulation of the scintigra ms disappeared. However, VT became reproducibly inducible, and in one of the patients, transient entrainment was demonstrated in clinical VT morphology. Defibrillators were implanted in both patients. Some VTs associated with cardiac sarcoidosis are due to reentry, and inducibility of VT is not associated with the activity of cardiac sarcoidosis. Even though steroid therapy suppresses the activity of cardiac sarcoidosis, defibrillator implantation is necessary to prevent a possible arrhythmic event during the follow-up.

Adult↗

PubMed1994

Three-year outcome of a nonthoracotomy approach to cardioverter-defibrillator implantation in 189 consecutive patients.

To date, no long-term clinical data have been published in patients undergoing a nonthoracotomy approach to cardioverter-defibrillator system implantation. In the present report, 189 consecutive patients prospectively underwent a standardized approach to cardioverter-defibrillator system implantation in which the nonthoracotomy configurations were tested first. If satisfactory defibrillation thresholds were not obtained, thoracotomy was performed during the same intraoperative session. A nonthoracotomy system was successfully implanted in 149 of 189 patients (79%), with a higher success rate (90%) observed in patients who had more recent implantations. The overall rate of complications associated with these systems was low (11%). Over a mean follow-up of 12.5 +/- 9.3 months, 17 patients (9%) died. Three-year total, cardiac, and sudden death-free actuarial survival for all patients was 83 +/- 11%, 88 +/- 7%, and 94 +/- 2%, respectively. Three-year sudden death-free actuarial survival was higher in the nonthoracotomy than in the thoracotomy patients (97 +/- 2% vs 87 +/- 6%, p = 0.047), although total survival was similar (77 +/- 11% vs 83 +/- 7%, p = 0.77). These data suggest that a majority of patients (> 80%) requiring a cardioverter-defibrillator system can undergo implantation using a nonthoracotomy approach. Patients receiving nonthoracotomy systems have 3-year outcomes comparable to those implanted via thoracotomy. If these results are maintained, a nonthoracotomy approach will supplant thoracotomy-implanted systems as the preferred method because of the simpler implant procedure and lower overall cost involved.

Actuarial Analysis↗

PubMed1994

[Pericardial constriction caused by epicardial patches of automatic implantable defibrillators. Apropos of 3 cases].

The authors report three cases of pericardial constriction secondary to implantation of an automatic defibrillator. In one case, the pericardial constriction occurred 1 year after implantation and was associated with ascending infection of the patch electrodes from the stimulator; the patient died when the patch electrodes were removed, the infection having eroded the left ventricular wall. In the other two cases, signs of constriction appeared 2 years after implantation. In one of these patients, surgery showed a fibrous pericardial reaction deforming the patch electrodes with a favourable outcome when the electrodes were removed. The other patient refused surgery. In the three cases, the diagnosis was confirmed by right heart catheterisation and ventriculography which showed signs of adiastole and severe deformation of the ventricular contours. Pericardial constriction due to patch electrodes is a potentially serious complication of implantable automatic defibrillators, the prevalence of which may be underestimated. The use of endocavitary or extra-pericardial electrodes should avoid this complication.

Defibrillators, Implantable↗

PubMed1997

Interaction between electronic article surveillance systems and implantable defibrillators: insights from a fourth generation ICD.

We present a case report of an inappropriate discharge from a fourth generation implantable cardioverter defibrillator (ICD) as a result of exposure to electromagnetic interference. A 60-year-old man implanted with a Medtronic 7219D defibrillator experienced shocks without preceding symptoms while walking through an electronic surveillance system in a store. Though this has been reported, the mechanism of the interaction remains unexplained. The electrogram storage capabilities of this particular device enabled us to establish that this resulted from inappropriate sensing of the electromagnetic interference.

Defibrillators, Implantable↗

PubMed2003

Do arrhythmia patients improve survival by participating in randomized clinical trials? Observations from the Cardiac Arrhythmia Suppression Trial (CAST)and the Antiarrhythmics Versus Implantable Defibrillators Trial (AVID).

It is debatable whether patients benefit directly from participation in a randomized clinical trial. We attempt to address this question for participants in the Cardiac Arrhythmia Suppression Trial (CAST) and the Antiarrhythmics Versus Implantable Defibrillators (AVID) studies. Survival rates were compared between eligible patients who enrolled in the trials and eligible patients who did not enroll, adjusting for baseline covariates. In CAST, despite that the active therapy was found to confer an almost threefold increased risk of death, survival was similar between the 3163 enrolled and the 1363 nonenrolled eligible patients. However, when patients were under study management, their risk of death was approximately 20% lower than when they left study management. In AVID, overall survival was similar between the 1016 enrolled and the 1246 nonenrolled eligible patients. However, mortality was substantially higher among patients not enrolled because the referring physician mandated the type of therapy. Overall these observational analyses suggest a net improvement in survival for the participants in these two trials.

Arrhythmias, Cardiac↗

PubMed2003

[Use of an implantable defibrillator for the prevention of sudden death in hypertrophic cardiomyopathy].

Hypertrophic cardiomyopathy is an inherited muscle disorder disease. Sudden death is the most dreaded complication, risk stratification is of critical importance and patients with high risk should receive an implantable cardioverter defibrillator (ICD). We report the case of 26 years old man affected by a severe form of hypertrophic cardiomyopathy. Our patient falls into a high risk category because of his young age, massive left ventricular hypertrophy and family history of premature death due to hypertrophic cardiomyopathy. Considering his risk of dying sufficiently high, we proceed to percutaneous ICD under local anesthesia. Evolution was favorable after 3 months follow up.

Adult↗

PubMed1997

Permanent pacing from the coronary sinus in a patient with an implantable defibrillator.

A woman with an ICD underwent permanent pacemaker implantation for bradycardia-tachycardia syndrome. Despite multiple right atrial positions, oversensing secondary to "double counting" was always noted. A coronary sinus pacing catheter was inserted and left atrial pacing was accomplished with acceptable pacing and sensing characteristics. The patient has since done well without further shocks.

Bradycardia↗

PubMed2000

Analysis of the pattern of initiation of sustained ventricular arrhythmias in patients with implantable defibrillators.

INTRODUCTION: The purpose of this study was to analyze the pattern of initiation of sustained ventricular arrhythmias in patients with varying types of underlying structural heart disease. METHODS AND RESULTS: The study group consisted of 90 patients with an implantable cardioverter defibrillator. Cardiovascular diagnoses included coronary artery disease in 64 patients (71%). The patients were divided into four groups based on the type and severity of structural heart disease. Two hundred sixty episodes of sustained ventricular arrhythmias were analyzed. The mean coupling interval of the initiating beat of all ventricular arrhythmias was 523 +/- 171 msec. The coupling interval of the initiating beat was longer in patients with impaired ventricular function, particularly those with nonischemic dilated cardiomyopathy. The prematurity index was similar regardless of the type of underlying structural heart disease. However, the prematurity index was shorter in patients with polymorphic ventricular tachycardia (VT) compared to those with monomorphic VT. A pause was observed more commonly before the onset of polymorphic VT/ventricular fibrillation than sustained monomorphic VT. Two hundred twenty-two (85%) of the arrhythmia episodes were initiated by a late-coupled premature beat, 33 (13%) were initiated by an early-coupled premature beat, and 5 episodes (2%) were initiated with a short-long-short sequence. The pattern of initiation of the ventricular arrhythmias was similar in all patient groups and for both monomorphic and polymorphic tachycardias. CONCLUSION: These findings demonstrate that sustained ventricular arrhythmias typically are initiated by late-coupled ventricular premature depolarizations, regardless of the type or severity of underlying structural heart disease or resultant arrhythmia.

Adult↗

PubMed1999

Safety and efficacy of implantable defibrillator therapy with programmed shock energy at twice the augmented step-down defibrillation threshold: results of the prospective, randomized, multicenter Low-Energy Endotak Trial.

Whether the safety and efficacy of implantable cardioverter defibrillator (ICD) therapy can be assured with lower output devices is an important question. The purpose of this study was to evaluate whether programming the device output at twice the augmented defibrillation threshold was as safe and effective as using the maximum energy. Patients indicated for ICD therapy, but without slow monomorphic ventricular tachycardia (MVT), who achieved an augmented defibrillation threshold (DFT plus) < or = 15 joules (J) with a single endocardial lead system and a biphasic defibrillator were included in the study. Prior to ICD implantation, patients were randomized into 2 groups. The shock energies in test group patient were set as follows: first shock at twice DFT plus, the second to fifth shocks at maximum output (34 J). In control group patients, all shocks were programmed at 34 J. The study population consisted of 166 consecutive patients (mean age 57.4 +/- 12.1 years, mean left ventricular ejection fraction 36.8 +/- 13.8%). Mean DFT plus was 9.6 +/- 3.2 J in test group patients and 10.1 +/- 3.5 J in control group patients (p = 0.36). During a mean follow-up of 24.2 +/- 9.6 months, 736 arrhythmia episodes were analyzed. The first shock efficacy was 98.3% in the test group patients versus 97.4% in the control group (p = 0.45). Total mortality was 6%, equally distributed in both study groups. The results of this study prove that the method of doubling the defibrillation energy at the DFT plus level provides an adequate safety margin in defibrillator therapy.

Adult↗

PubMed1986

[Implantable defibrillators. Clinical experience].

The clinical experience with the Automatic Implantable Cardioverter-Defibrillator (AICD) now extends to over 800 patients suffering from malignant ventricular arrhythmias, most of them survivors of sudden cardiac death. This device monitors cardiac rhythm for long periods of time, identifies ventricular fibrillation and life-threatening ventricular tachycardias, and then restores normal heart action with effective electrical discharges. The AICD practically eliminates the need for trained personnel and the time constraints associated with conventional out-of-hospital resuscitation, significantly decreasing the arrhythmic and total mortality rates of the implantees. Through August, 1985, 130 consecutive patients underwent implantation of the AICD at The Johns Hopkins Hospital in Baltimore; the one-year mortality due to arrhythmias was 1.7%. These results are similar to those reported by other centers. Thus, the growing clinical experience with the automatic implantable cardioverter-defibrillator has demonstrated a marked reduction of the mortality rate of the implantees.

Adolescent↗

PubMed1985

Implantable defibrillator electrode systems: a brief review.

Since the first report of a defibrillation attempt with an intracardiac catheter electrode nearly 30 years ago, investigators have developed implantable electrode systems consisting of metal disks, endocardial catheters, and epicardial patches. These early efforts demonstrated the feasibility of low-energy reversion of ventricular tachyarrhythmias, and also provided some insight into the mechanisms of fibrillation and defibrillation. This review describes the evolution of implantable defibrillator electrode systems. Early investigators attempted defibrillation with submuscularly implanted metal disks or a disk electrode paired with an endocardial catheter electrode. Electrode design emphasis turned to transvenous catheter systems with electrodes placed in the right ventricle and right atrium. A more successful configuration placed the proximal electrode in the superior vena cava. In an effort to ensure proper placement of the distal electrode in humans, the catheter was replaced with an epicardial patch. More recently, a combination of electrodes and multiple pulses has substantially reduced the energy required to defibrillate. Effective electrode systems that can convert lethal arrhythmias with a minimum of energy will aid in making implantable cardioverters and defibrillators the therapy of choice in patients at high risk of sudden coronary death.

Arrhythmias, Cardiac↗