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PubMed2005

The growing mismatch between patient longevity and the service life of implantable cardioverter-defibrillators.

Implantable cardioverter-defibrillators (ICDs) are lifesaving devices. Over 100,000 patients received ICDs in 2004 at a cost of $2 billion for the pulse generators alone. Because of expanded indications and coverage by Medicare, the number of ICD implantations and replacements is expected to increase dramatically during the next decade. The average ICD patient at our institution now lives nearly 10 years after the procedure. However, the service life of pulse generators has decreased from 4.7 +/- 1 year for single-chamber units to 4.0 +/- 1 year for dual-chamber devices. This mismatch between patient longevity and the service life of ICDs poses a significant clinical and economic burden that must be addressed. One near-term solution is for manufacturers to provide devices with larger batteries so that most patients can have an ICD pulse generator that lasts a lifetime. For the long-term, more robust or renewable energy sources are needed.

Cost-Benefit Analysis↗
PubMed1999

Managing atrial tachyarrhythmias in patients with implantable cardioverter defibrillators.

The implantable cardioverter defibrillator (ICD) is accepted as the therapy of choice in preventing sudden cardiac death. Multiple studies, such as Antiarrhythmics Versus Implantable Defibrillators (AVID), the Canadian Implantable Defibrillator Study (CIDS), the Cardiac Arrest Study Hamburg (CASH), and the Multicenter Automatic Defibrillator Implantation Trial (MADIT), have shown a substantial benefit in survival rates for patients treated with ICDs compared with antiarrhythmic drug treatment. The detection of spontaneous ventricular tachycardias (VT) is based primarily on the programmed heart rate for intervention of the device. Supraventricular tachycardias (SVTs) cause unnecessary therapy delivery in about 10-20% of patients with ICDs. ICD therapy needs to be improved to become more specific for VT detection, by implementing algorithms that discriminate between VTs and SVTs. The enhanced detection criteria in currently available ICD devices are able to decrease the rate of unnecessary therapy to < 5% of patients. Atrial tachyarrhythmias can be managed with programmable features of the device, antiarrhythmic drug treatment, and in rare cases, ablation procedures. Dual-chamber ICDs, requiring an additional atrial lead, are indicated in specific situations of slow VT and concurrent, continuous SVTs at very similar heart rates. Using all these options, SVTs can be managed to achieve an acceptably low incidence of unnecessary therapy delivery in < 5% of ICD patients.

Death, Sudden, Cardiac↗
PubMed1999

Use of the prophylactic implantable cardioverter defibrillator for patients with normal hearts.

About 10-20% of patients dying suddenly and unexpectedly do not have structural heart disease. The major causes of sudden death in this population are acute ischemia, the syndrome of right bundle branch block, and ST-elevation from V1 to V3, the long QT-syndrome, and the Wolff-Parkinson-While syndrome. In some patients, none of these syndromes can be recognized and ventricular fibrillation is classified as idiopathic. There are good preventive and therapeutic methods against acute ischemia and there are also curative treatments for the Wolff-Parkinson-White syndrome. Patients with idiopathic ventricular fibrillation cannot be recognized beforehand. However, there are electrocardiographic and genetic markers for the Brugada syndrome and the long QT syndrome. It is, therefore, justified to discuss the possible role of the prophylactic defibrillator to prevent sudden death in these 2 syndromes for which no effective treatment exists. Patients with Brugada syndrome have a high incidence of sudden death, and prophylactic defibrillators are indicated in patients with inducible arrhythmias at electrophysiologic study, irrespective of symptoms. On the contrary, the incidence of sudden death in the long QT syndrome is very low, making prophylactic defibrillator implantation not cost-effective.

Bundle-Branch Block↗
PubMed2004

Biventricular implantable cardiac defibrillator in dextrocardia with situs viscerum inversus.

A case of dextrocardia in situs viscerum inversus, prior myocardial infarction, dilated cardiomyopathy with severe left ventricular systolic dysfunction, ventricular tachyarrhythmias and recurrent episodes of heart failure is described. Coronary artery bypass grafting for multivessel coronary artery disease had been previously performed; coronary and graft anatomy evaluation excluded the possibility of any further revascularization procedure. Electrocardiography showed left bundle branch block and echocardiography revealed significant interventricular mechanical dyssynchrony. After a complete vascular and cardiac anatomy evaluation, the patient was submitted to biventricular cardiac defibrillator implantation via a right approach and using conventional fluoroscopic equipment.

Aged↗
PubMed2004

Alleviation of central sleep apnea by ventricular pacing in a patient with an implanted cardioverter defibrillator.

A 75-year-old man with a single chamber cardioverter defibrillator implanted for the management of sustained ventricular tachycardia developing after a healed myocardial infarction was admitted for evaluation of a sleep disorder. Polysomnography confirmed the presence of severe predominant central sleep apnea syndrome. The apnea-hypopnea index score decreased from 43.3 during spontaneous cardiac rhythm to 24.6 during VVI pacing at a rate of 70 beats/min. Ventricular pacing reduced the number of episodes of central sleep apnea/hypopnea without reducing the total sleep time, though it had no effect on episodes of obstructive sleep apnea/hypopnea.

Aged↗
PubMed2003

Implantation of pacemakers and implantable cardioverter defibrillators in orally anticoagulated patients.

The safety of pacemaker and defibrillator implantations in orally anticoagulated patients using standard techniques has not been thoroughly evaluated. This article describes a prospectively collected experience in such patients. Patients presenting for device implantation who were treated with warfarin were allowed to continue therapy provided that the INR was < 3.5. Implantations involved cannulation of the left axillary vein. Except for defibrillator leads, 7 Fr introducers were used, and all were leads actively fixated. The study included 47 patients who underwent implantation of permanent pacemakers (n = 39), defibrillators (n = 5), or biventricular pacemakers (n = 3). The mean INR was 2.3. The primary indication for anticoagulation was a mechanical cardiac prosthesis in 11 (24%) patients. Atrial fibrillation was present in 33 patients. There were no instances of major bleeding or hematomas requiring evacuation. One patient had a small soft hematoma, which resolved spontaneously. At 6 weeks, all patients had well-healed scars with satisfactory pacing and sensing thresholds. In experienced centers, patients requiring treatment with warfarin may undergo implantation of pacemakers or defibrillators with minimal risk despite continuation of anticoagulation.

Administration, Oral↗
PubMed2005

Comparison of efficacy of implanted cardioverter-defibrillator in patients with versus without diabetes mellitus.

In the second Multicenter Automatic Defibrillator Implantation Trial, patients with a previous myocardial infarction and left ventricular ejection fraction < or =0.30 benefited significantly from prophylactic implantable cardioverter-defibrillator (ICD) placement. Diabetic patients who had a myocardial infarction had a worse prognosis compared with nondiabetics. The present study used data from the second Multicenter Automatic Defibrillator Implantation Trial to assess the efficacy of ICD placement on survival in diabetic patients. Of the 1,232 patients in the second Multicenter Automatic Defibrillator Implantation Trial, 489 were characterized as diabetic. They were more likely to be New York Heart Association class II to IV, be hypertensive, have renal dysfunction, have an increased body mass index, and to take diuretic drugs. Diabetic patients had a 24% greater adjusted risk of death than nondiabetic patients. The hazard ratio (HR) for the risk of death in patients treated with the ICD compared with conventional therapy was similar in diabetics (HR 0.61; 95% confidence interval [CI] 0.38 to 0.98) and nondiabetics (HR 0.71; 95% CI 0.49 to 1.05), with no evidence of interaction. Thus, diabetic patients derive a similar benefit from ICD therapy despite being sicker and having a higher mortality rate overall.

Aged↗
PubMed1999

Using missing data techniques to explore the lack of survival effect: illustration with the CABG patch trial.

The Multicenter Automatic Defibrillator Implantation Trial (MADIT) showed a conclusive 54 per cent reduction in mortality in patients with inducible sustained monomorphic ventricular tachycardia (VT) and impaired left ventricular function who received an implantable defibrillator compared with those who did not. The Coronary Artery Bypass Graft (CABG) Patch Trial, which studied a patient population with a similar extent of left ventricular dysfunction and overall cardiovascular risk, demonstrated no mortality benefit from placement of an implantable defibrillator. All patients in the MADIT trial were 'VT inducible', while this criterion was neither required nor evaluated for entry into the CABG Patch Trial. A statistical approach to estimating with good accuracy the fraction of CABG Patch patients who were inducible at the time of their randomization from the prevalence of VT inducibility in the surviving CABG Patch Trial control population during follow-up is presented. This more generally applicable approach estimates the mixing percentage using missing data techniques. We present the mathematical and physiological basis of the assumptions underpinning the mixture model and its estimation procedure. The mixture model forms the basis for the electrophysiological substudy to the CABG Patch Trial, which directly tests the hypothesis that the difference in the frequency of inducible VT between the MADIT and CABG Patch patients populations is sufficient to account for the difference in effect on mortality.

Algorithms↗
PubMed1996

Thoracoscopic approach to implantable cardioverter defibrillator patch electrode implantation.

Even if transvenous lead system for automatic implantable cardioverter defibrillators (ICDs) has been one of the main surgical advances in the recent past, its major limitation is the high defibrillation thresholds in some cases. Thus, an additional patch may be required and implanted either in a subcutaneous position or in an epicardial position. We describe another possibility: the implantation of extrapericardial patch under video-thoracoscopic control. This new technique allows a deep implantation of the whole material without thoracotomy. Seven patients were included in our preliminary experience. During defibrillation threshold evaluation, two patients required 34 J with the single transvenous lead system, and five patients were not defibrillated with the single lead system; therefore, they required a 300-J external rescue shock. We decided to implant an additional patch in those seven patients with high defibrillation thresholds. This patch was inserted into the pleural cavity through a left subcostal incision. Under video thoracoscopy, it was positioned and stitched onto the pericardium. The defibrillation generator was then implanted through the left subcostal incision in a subdiaphragmatic space. As a result, preoperative defibrillation thresholds were significantly reduced (14.29 +/- 3.45 J, mean +/- SD) and remained stable during follow-up controls (eighth day and second month). Long-term follow-up (14 +/- 4.5 months) was uneventful, with an excellent tolerance for the patients. In conclusion, extrapericardial implantation of defibrillation patches under video thoracoscopy is an easy technique that allows low defibrillation thresholds.

Adult↗
PubMed1999

Multicenter evaluation of implantable cardioverter defibrillator testing after implant: the Post Implant Testing Study (PITS).

To reassess the function of the implantable cardioverter defibrillator (ICD) many electrophysiology centers perform a second test after the initial test at implant. A prospective multicenter study evaluated the necessity and yield of routine postimplant defibrillator testing. The results of 843 postimplant defibrillator tests were collected from 31 centers. The 764 routine tests in which ventricular fibrillation was successfully induced were analyzed. Variables examined included patient age, presenting arrhythmia, underlying heart disease, left ventricular ejection fraction, defibrillator age, make and model of ICD, electrode system, defibrillation threshold, polarity, and waveform. The overall failure rate was 3.1% (24/764). Units tested later than 365 days after implant tended to have a higher failure rate than those tested within the first month or the next eleven months (6.5%, 3.0%, 2.3%, respectively, P = 0.374). The failure rate was higher in patients with left ventricular ejection fraction < 40% than those with higher ejection fractions (3.8% vs 2.0%, P = 0.167). These trends did not reach statistical significance. No other baseline characteristic was associated with higher failure rates. Routine testing of ICDs reveals an overall failure rate of 3.1%. While the rate was low, defibrillator failure places the patient at high risk for sudden cardiac death. As any failure in this population is associated with a high risk of sudden cardiac death, routine defibrillator testing may be justified.

Adolescent↗
PubMed1997

[A rare cause of inappropriate shocks of an implantable automatic defibrillator. Twiddler syndrome].

The authors report the case of a patient with an automatic defibrillator implanted by an endocavitary approach. The device emitted a series of inappropriate shocks. They were triggered by the detection of myopotentials resulting from lesions of the lead due to Twiddler's syndrome. This was reproduced by telemetry in real time and confirmed by chest and abdominal X-ray and the peroperative findings. Treatment consisted of ablation of all implanted material which was replaced by a new retropectoral model.

Electrocardiography, Ambulatory↗
PubMed2000

Identification of patients most likely to benefit from implantable cardioverter-defibrillator therapy: the Canadian Implantable Defibrillator Study.

BACKGROUND: Patients with resuscitated ventricular tachyarrhythmias (ventricular tachycardia/ventricular fibrillation) benefit from implantable cardioverter-defibrillators (ICDs) compared with medical therapy. We hypothesized that the patients who benefit most from an ICD are those at greatest risk of death. METHODS AND RESULTS: In the Canadian Implantable Defibrillator Study (CIDS), 659 patients with resuscitated ventricular tachyarrhythmias were randomly assigned to receive an ICD or amiodarone and were then followed for a mean of 3 years. There were 98 and 83 deaths in the amiodarone and ICD groups, respectively. We used multivariate Cox analysis to assess the impact of baseline parameters on the mortality in the amiodarone group. Reduced left ventricular ejection fraction, advanced age, and poor NYHA status identified high-risk patients (P=0.0001 to 0.0009). Quartiles of risk were constructed, and the mortality reduction associated with ICD treatment in each quartile was assessed. There was a significant interaction between risk quartile and the ICD treatment effect (P=0.011). In the highest risk quartile, there was a 50% relative risk reduction (95% CI 21% to 68%) of death in the ICD group, whereas in the 3 lower quartiles, there was no benefit. Patients who are most likely to benefit from an ICD can be identified with a simple risk score (>/=2 of the following factors: age >/=70 years, left ventricular ejection fraction </=35%, and NYHA class III or IV). Thirteen of 15 deaths that were prevented by the ICD occurred in patients with >/=2 risk factors. CONCLUSIONS: In CIDS, patients at highest risk of death benefited most from ICD therapy. These can be identified easily on the basis of age, poor ventricular function, and poor functional status.

Aged↗
PubMed2004

Long-term comparison of the implantable cardioverter defibrillator versus amiodarone: eleven-year follow-up of a subset of patients in the Canadian Implantable Defibrillator Study (CIDS).

BACKGROUND: The implantable cardioverter defibrillator (ICD) is superior to amiodarone for secondary prophylaxis of sudden cardiac death. However, the magnitude of this benefit over long-term follow-up is not known. Thus, our objective was to evaluate the long-term consequences of using amiodarone versus an ICD as first-line monotherapy in patients with a prior history of sustained ventricular tachycardia/ventricular fibrillation or cardiac arrest. METHODS AND RESULTS: A total of 120 patients were enrolled at St Michael's Hospital in the Canadian Implantable Defibrillator Study (CIDS) and were randomly assigned to receive either amiodarone (n=60) or an ICD (n=60). The treatment strategy was not altered after the end of CIDS unless the initial assigned therapy was not effective or was associated with serious side effects. After a mean follow-up of 5.6+/-2.6 years, there were 28 deaths (47%) in the amiodarone group, compared with 16 deaths (27%) in the ICD group (P=0.0213). Total mortality was 5.5% per year in the amiodarone group versus 2.8% per year in the ICD group (hazard ratio of amiodarone: ICD, 2.011; 95% confidence interval, 1.087 to 3.721; P=0.0261). In the amiodarone group, 49 patients (82% of all patients) had side effects related to amiodarone, of which 30 patients (50% of all patients) required discontinuation or dose reduction; 19 patients crossed over to ICD because of amiodarone failure (n=7) or side effects (n=12). CONCLUSIONS: In a subset of CIDS, the benefit of the ICD over amiodarone increases with time; most amiodarone-treated patients eventually develop side effects, have arrhythmia recurrences, or die.

Aged↗
PubMed2002

Cardiovascular responses to repetitive defibrillation during implantable cardioverter-defibrillator testing.

OBJECTIVE: To study the effects of electrical applications and subsequent postshock hypotension on myocardial performance and vascular tone during implantable cardioverter-defibrillator (ICD) placement. DESIGN: Prospective, blinded, observational investigation. SETTING: Single, university-affiliated institution. PARTICIPANTS: Twenty patients undergoing elective ICD placement and testing under general anesthesia. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Serial measurements were made of hemodynamic variables, left ventricular end-systolic (ESA) and end-diastolic (EDA) areas, fractional-area-of-contraction (FAC), time of hypoperfusion (when mean arterial pressure < or =50 mmHg postshock), and applied conversion energy. Multiple linear regression was performed to determine correlations among collected variables, and repeated measures analysis of variance was used to compare mean values. Minimal changes were detected in mean values of arterial, pulmonary, and central venous pressures; cardiac output; heart rate; and mixed venous saturation during repeated testing. Percentage changes in cardiac index (CI) rose and systemic vascular resistance index (SVRI) fell, however, as the number of shocks increased, reaching significance at the seventh and eighth shocks (v baseline; both p = 0.015). The percentage change in CI was linearly related to hypoperfusion time and accumulated energy (%deltaCI = 1.553 + [0.068 x sigma hypoperfusion time [sec]], r = 0.92, p < 0.001; %deltaCI = 0.326 + [0.125 x sigma Energy [J]], r = 0.94, p < 0.001). The percentage change in SVRI was inversely related to hypoperfusion time and accumulated energy (%deltaSVRI = 2.195 - [0.122 x sigma energy [J]], r = 0.79, p = 0.004; %deltaSVRI = 0.542 - [0.0634 - sigma hypoperfusion time [sec]], r = 0.73, p = 0.01). Echocardiographic EDA, ESA, and FAC were not significantly changed but showed substantial variability. CONCLUSION: Hemodynamic stability was generally well maintained during ICD placement and testing. Increases in CI were associated with concurrent reductions in systemic afterload, rather than enhanced FAC. Increasing postshock hypotension and applied energy were associated with decreases in CI and systemic afterload. Insignificant, but highly variable, changes were noted echocardiographically.

Adult↗
PubMed2006

Quality of life and psychological status of patients with implantable cardioverter defibrillators.

BACKGROUND: Implantable cardioverter defibrillators reduce mortality in patients at high risk for sudden cardiac death and in patients with heart failure. Patients with defibrillators often experience psychological distress and poor quality of life, which can potentiate pathological processes that increase the risk for sudden cardiac death. To achieve the full benefits of the defibrillators, patients must maintain their psychological status and quality of life. OBJECTIVES: To review the research on psychological status and quality of life of patients with implantable cardioverter defibrillators and suggest nursing interventions to improve the patients' health. METHOD: Searches of PubMed were used to find articles on depression, anxiety, and quality of life in patients with implantable cardioverter defibrillators. RESULTS: Poor quality of life is associated with anxiety and depression in patients with implantable cardioverter defibrillators. Discharges of the devices have adverse consequences for patients' psychological status and quality of life. Younger patients are at highest risk for psychological distress and poor quality of life after implantation. Longitudinal research would facilitate determining the course of the changes in psychological status and quality of life during the time patients have the defibrillators. More intensive intervention may be necessary for the most vulnerable recipients: patients who are young, have experienced shocks, and are in psychological distress. CONCLUSIONS: Poor quality of life and depression are common in patients with implantable cardioverter defibrillators. Nursing interventions to reduce psychological distress and improve quality of life may reduce morbidity and mortality in these patients. Additional research is needed to determine effective interventions.

Age Factors↗
PubMed1992

Automatic implantable cardioverter defibrillator: surgical approaches for implantation.

Surgical approaches for implantation of the automatic cardioverter defibrillator are sternotomy, left thoracotomy, subxiphoid, and subcostal. Although any one of these may be combined with insertion of one or more of the electrodes transvenously, surgical entry into the chest is required for every noninvestigational defibrillator implantation operation. The approaches differ in exposure provided for selecting electrode sites and for handling untoward events, in amount and location of tissue that must be divided or dissected, and in average time required. The operation is an electrical one. Its purpose is to obtain reliable rhythm sensing so that defibrillation or cardioversion shocks will occur only when necessary, and to obtain low enough defibrillation thresholds for shocks of 30 joules or less to have a 10-joule defibrillation safety margin. Many of the patients have had previous cardiac operations. They usually have low or very low ejection fractions. Intraoperative electrophysiological testing with often multiple defibrillation episodes is required. The choice of approach varies with the state of the patient, the institutional experience, and the surgeon. This article describes technique, and the advantages and disadvantages of the four approaches as used by four surgeons in four different institutions.

Defibrillators, Implantable↗