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Cardioverter-defibrillators were implanted in children aged 4 to 16 years over a 5-year period with no mortality and eventual clinically appropriate shocks in 6 of 11 patients. Both transvenous and epicardial implantable cardioverter-defibrillators were safe and effective in children resuscitated from sudden death or at high risk for sudden death.
BACKGROUND: We wished to determine the incidence, reasons, costs, and predictors of cardiac-related hospital readmission in patients with tiered-therapy implantable defibrillators. Hospital readmission in patients with defibrillators reduces their quality of life and increases the cost associated with such therapy. METHODS AND RESULTS: We retrospectively studied 65 consecutive local patients (median age, 67 years; median ejection fraction, 0.34) who underwent tiered-therapy defibrillator implantation at this institution. Patients were followed for a median of 19 months (interquartile range, 10 to 27 months). The cause, duration, costs, and predictors of cardiac-related rehospitalizations were analyzed. There were 76 cardiac admissions for 34 patients. The rate of cardiac-related hospital readmission was 0.72 per patient-year of follow-up. Arrhythmia-related admissions accounted for 43 of such admissions in 24 patients. Actuarial freedom from cardiac-related admissions was 0.57 and 0.40 at 1 and 2 years, respectively. The median length of stay for hospital readmissions was 5 days (interquartile range, 3 to 8 days). The median cost per admission was $5842 (interquartile range, $3549 to $12 170). The time to first readmission and the total rehospitalization time per year of follow-up were associated with a poor preimplant New York Heart Association functional class. Readmission for cardiac arrhythmias was not predicted by clinical parameters. CONCLUSIONS: Rehospitalization for cardiac reasons is common in patients receiving implantable defibrillators and is responsible for substantial resource consumption. The need for readmission for arrhythmia-related reasons cannot be predicted by clinical parameters at the time of device implantation.
BACKGROUND: To establish the chronic stability of defibrillation thresholds (DFTs) in a transvenous cardioverter/defibrillator (TCD) system, we studied 37 consecutive patients with TCD systems implanted for > 6 months. METHODS AND RESULTS: DFT was measured by a step-down method at implant and 2 and 6 months later. The mean ejection fraction was 34.5 +/- 14.3%. Coronary artery disease with previous myocardial infarction was present in 31 patients. The mean DFT rose from 13.3 +/- 4.3 J at implant to 16.5 +/- 4.7 J at 2 months (P < .001) and 17.6 +/- 5.4 J at 6 months (P < .0001). ANOVA revealed a statistically significant rise in DFT over time (P < .0005). At 2 months, 25 patients had a rise in DFT, and 14 had a rise > or = 5 J. The observed rise at 2 months persisted in 19 patients. A chronic rise, defined as > or = 5 J rise at 6 months, occurred in 17 patients. Univariate analysis of clinical as well as implant variables revealed no predictors of a rise in DFT in this group. CONCLUSIONS: We conclude that there is a significant rise in DFT at 2 and 6 months in this TCD system. Although the chronic threshold remained well within the available energy range of the pulse generator, this observation has important implications for implantation guidelines, programming, and future pulse generator development for TCD patients.
Replacing one defibrillation electrode lead by the defibrillator can may simplify implantation of the ICD. In this multicenter study, 304 patients were randomized to receive either the biphasic active can (AC) (model 7219C system, Medtronic, Inc.) or the passive can (PC) (model 7219D system). The AC and PC systems were compared with respect to their ability to meet the implant defibrillation criterion and to defibrillate VF, and to DFTs, implant time, patient adverse events, and survival rates. A higher percentage fulfilled the implant defibrillation criterion on the first configuration with the AC (86.3% vs 75.9% for PC; P = 0.023), and the first shock success for terminating induced VF was 94% for AC compared to 89% for PC (P = 0.026). DFTs were significantly lower (10.9 vs 12.7 J; P = 0.031), and implant time was significantly shorter for the AC patients (99.2 vs 112.0 min; P = 0.002). The two groups showed no significant differences in 3-month adverse event rates, 3-month survival, and hospital stay.
We unexpectedly anesthetized a 31-year-old male with mild myotonic dystrophy (MD) that had not been diagnosed preoperatively, for implantable cardioverter defibrillator (ICD) implantation. Although MD is an uncommon disorder, cardiac conduction abnormalities and dilated cardiomyopathy are seen commonly in these patients. Therefore, chances of ICD implantation may increase in MD patients. But, the patients are often unaware of this disease and it is common for them to conceal their symptoms, and the diagnosis may not be made before the operation. We emphasize that preoperative assessment is important and that it is necessary to consider MD in patients for ICD implantation.
As soon as it was established that the implantable cardioverter-defibrillator (ICD) effectively prevents sudden death, it became axiomatic that whether the ICD will prolong overall survival depends entirely on the population of patients to which it is applied. This axiom of overall ICD survival immediately reveals the only vital question that remains regarding usage of the ICD; namely, How does one select those patients in whom prevention of sudden death by the ICD will also prolong life? This axiom also reveals the essential futility of randomized trials now being conducted for the purpose of discerning the true efficacy of the ICD. Claims to the scientific high ground notwithstanding, if a study asks the wrong question from the beginning, then the design of that study (including whether the study is randomized or nonrandomized), is completely irrelevant. Ideally, funds now being spent on these randomized trials should be diverted to the design and initiation of more appropriate trials, trials that will teach us to select patients for the ICD more effectively. At the very least, however, we should recognize the problems inherent in the ongoing trials, so that when their results are finally published (and are loudly touted by whichever faction feels vindicated by them), we will not be carried away into inappropriate clinical behavior.
The effect of initial phase polarity on the DFT of two pectorally implanted biphasic ICDs was tested in a randomized, prospective manner at the time of implantation. Twenty-two consecutive patients with VT-VF who received either the Medtronic PCD 7219C Jewel device (10 patients) or PCD 7219D Jewel device (12 patients) were studied. DFT testing was performed in a standard step-down manner. Both initial phase polarities--initial defibrillation current flowing from active can/SVC coil +/- subcutaneous patch) to the RV coil (RV coil to active can/SVC (RV+)--were tested in random order. The mean DFT achieved with RV+ compared with RV-was lower for the 7219C patient group (6.6 +/- 3.1 vs 10.8 +/- 5.5 J; P = 0.007). A similar trend was observed for the 7219D group, though the difference did not reach statistical significance (12.0 +/ 4.0 vs 16.3 +/- 7.3 J; P = 0.07). Seven of the 10 patients in the 7219C group had a lower DFT with RV+, while the initial phase polarity made no difference in 3. In the 7219D group, 7 patients had a lower DFT using RV+, 2 patients had a lower DFT using RV-, and the initial phase polarity made no difference in 3. In conclusion, this study demonstrates that changing the polarity of the initial phase of a biphasic shock waveform can have a significant impact on the DFT achieved at the time of ICD implantation.
We describe a 23-year-old patient with idiopathic dilated cardiomyopathy in whom an implantable cardioverter defibrillator was implanted via the right external iliac vein. Addition of a subcutaneous patch was required to obtain an adequate safety margin for defibrillation.
Infarct size as determined by perfusion imaging is an independent predictor of mortality after implantable cardioverter defibrillator (ICD) implantation in patients with coronary artery disease (CAD) and life-threatening ventricular arrhythmias (VA). However, its value as a predictor of VA recurrence and hospitalisation after ICD implantation is unknown. Therefore, the objective of this study was to evaluate whether infarct size as determined by perfusion imaging can help to identify patients who are at high risk for recurrence of VA and hospitalisation after ICD implantation. We studied 56 patients with CAD and life-threatening VA. Before ICD implantation, all patients underwent a uniform study protocol including a thallium-201 stress-redistribution perfusion study. A defect score as a measurement of infarct size was calculated using a 17-segment 5-point scoring system. Study endpoints during follow-up were documented episodes of appropriate anti-tachycardia pacing and/or shocks for VA and cardiac hospitalisation for electrical storm (defined as three or more appropriate ICD interventions within 24 h), heart failure or angina. After a mean follow-up of 470+/-308 days, 22 patients (39%) had recurrences of VA. In univariate analysis, predictors for recurrence were: (a) ventricular tachycardia (VT) as the initial presenting arrhythmia (86% vs 59% for patients without ICD therapy, P=0.04), (b) treatment with beta-blockers (36% vs 68%, P=0.03) and (c) a defect score (DS) > or = 20 (64% vs 32%, P=0.03). In multivariate analysis, VT as the presenting arrhythmia (chi2=5.51, P=0.02) and a DS > or = 20 (chi2=4.22, P=0.04) remained independent predictors. Cardiac hospitalisation was more frequent in patients with a DS > or = 20 (44% vs 13% for patients with DS < 20, P=0.015) and this was particularly due to more frequent hospitalisations for electrical storm (24% vs 3% for patients with DS < 20, P=0.037). The extent of scarring determined by perfusion imaging can separate patients with CAD into high- and low-risk groups for recurrence of VA and cardiac hospitalisation after ICD implantation.
Implantable cardioverter-defibrillator (ICD) generator replacement due to a depleted battery is a frequently performed procedure. The frequency with which sensing and defibrillation system failures are identified during device replacement procedures has not been previously described. Therefore, the purpose of this study was to prospectively determine the frequency of lead system malfunction detected at the time of device replacement in 55 consecutive patients undergoing ICD generator replacement. The mean age of the patients was 63 +/- 10 years and 40 of them were men. Forty-nine patients had an epicardial lead system, and six patients had a nonthoracotomy lead system. Four [7%] of these 55 patients were noted to have previously undetected lead system failure, either sensing (n = 3) or defibrillation (n = 1), necessitating system revision. The lead systems that failed were 40 +/- 6 months old (33-49 months). In summary, during ICD generator replacement, previously undetected problems with sensing or defibrillation may be identified in approximately 10% of patients. Therefore, a comprehensive evaluation of the sensing and the defibrillation functions should be an essential component of the ICD generator replacement procedure.
OBJECTIVES: The purpose of this study was to examine the circadian variation of ventricular arrhythmias detected by an implantable cardioverter defibrillator in patients with and without ischemic heart disease. BACKGROUND: Previous studies have shown a circadian variation of ventricular arrhythmias, sudden death and myocardial infarction with a peak occurrence in the morning hours. The circadian pattern, which is similar for both arrhythmic and ischemic events, suggests that ischemia may play a critical role in the genesis of ventricular arrhythmias and sudden death. We hypothesized that, if ischemia plays an important role in the triggering of ventricular arrhythmias, the circadian pattern should be different in patients with ischemic heart disease compared with patients with nonischemic heart disease. METHODS: The circadian variation of ventricular arrhythmias recorded by an implantable cardioverter defibrillator was studied in 310 patients during a mean follow-up of 181 +/- 163 days. Two hundred four patients had a history of ischemic heart disease and 106 patients had nonischemic heart disease. The times of the episodes of ventricular arrhythmias were retrieved from the data log of each device during follow-up, and the circadian pattern was compared between the two groups. RESULTS: During follow-up, 1,061 episodes of ventricular arrhythmias were recorded by the device in the 310 patients. Six hundred eighty-two episodes occurred in the group of patients with ischemic heart disease and 379 occurred in the nonischemic heart disease group. The circadian variation of the episodes showed a typical pattern with a morning and afternoon peak in both groups of patients with ischemic and nonischemic heart disease, but there was no significant difference between the two groups. CONCLUSIONS: The circadian rhythm of ventricular arrhythmias in patients with ischemic heart disease is similar to patients with nonischemic heart disease, suggesting that the trigger mechanisms of the initiation of ventricular tachyarrhythmias may be similar, irrespective of the underlying heart disease.
The present generation implantable defibrillator introduced on-line event markers that can be used to evaluate tachycardia detection in the electrophysiological testing mode. These markers were used to assess the appropriateness of programming the morphology criterion for detection of ventricular tachycardia. Twenty-one consecutive patients (19 men, 2 women) performed 29 bicycle exercise tests with real-time recording of the electrocardiogram and the event markers on a multichannel recorder. Mean ejection fraction was 29% (range 15%-69%). Seven patients were taking antiarrhythmic agents. Twelve patients satisfied the morphology criterion at rest (n = 1) or during exercise (group I), and nine patients did not (group II). One patient was excluded from analysis because of continuous ventricular pacing. Mean peak heart rate was 130 beats/min in group I and 125 beats/min in group II. No statistical differences existed between the groups in relation to cycle length of ventricular tachycardia and mode of induction of arrhythmia, QRS duration on the electrocardiogram, during native rhythm, amplitude and duration of defibrillation patch R wave, calculated duty cycle at peak heart rate, and number of discharges of the automatic implantable cardioverter defibrillator at 2 to 14 months of follow-up time. It is concluded that clinical, electrocardiographic, and implantation data are unreliable in predicting satisfaction of the morphology criterion during high heart rates in native rhythm. Formal exercise testing in the electrophysiological mode enables a rational decision to be made about the appropriateness of the use of probability density function in each patient.
BACKGROUND: The probability of successful defibrillation has been determined in normal animals but not in patients undergoing defibrillator implantation. Therefore, the purpose of this prospective study was to determine the probability of successful defibrillation in humans on the basis of a step-down defibrillation energy requirement. METHODS AND RESULTS: Fifty-three consecutive patients underwent five separate inductions of ventricular fibrillation after the defibrillation energy requirement was determined with the use of small decrements and a step-down protocol (20, 15, 12, 10, 8, 6, 5, 4, 3, 2, 1, and 0.8 J). The first shock energy for defibrillation was either 1.0, 1.3, 1.5, 1.7, or 2.0 times the defibrillation energy requirement, and the likelihoods of successful defibrillation were 70+/-27%, 84+/-12%, 86+/-25%, 80+/-29%, and 88+/-32%, respectively (P=.03). The frequencies of uniformly successful defibrillation (5 of 5 defibrillation attempts) were 30%, 27%, 60%, 64%, and 73%, respectively (P=.01). Seven patients in whom the defibrillation energy requirement was <4 J had an overall rate of successful defibrillation of 54+/-20% compared with 86+/-20% in the remaining 47 patients (P=.002). The likelihood of successful defibrillation at twice the defibrillation energy requirement was 98% in the 46 patients with a defibrillation energy requirement of >4 J and 67% in the 7 patients with a defibrillation energy requirement of <4 J (P=.17). An absolute safety margin of 7 J was associated with a 96% probability of successful defibrillation. CONCLUSIONS: The probability of successful defibrillation is 70% at the defibrillation energy requirement. The probability plateaus at 88%, at twice the defibrillation energy requirement. A 96% probability of successful defibrillation is achieved at an absolute safety margin of 7 J, and a 98% success rate is achieved at energies that are twice the defibrillation energy requirement if the defibrillation energy requirement is >4 J. If the defibrillation energy requirement is <4 J, larger multiples of the defibrillation energy requirement are needed to achieve a high probability of successful defibrillation.
OBJECTIVES: This study aimed to determine whether increased QT interval variability is associated with an increased risk for ventricular tachycardia (VT) or ventricular fibrillation (VF), documented by interrogation of the implantable cardioverter-defibrillator (ICD), in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II. BACKGROUND: Unstable repolarization has been proposed as a risk factor for re-entrant arrhythmias, but confirmatory data from clinical trials are lacking. METHODS: The QT variability was assessed in 10-min, resting high-resolution electrocardiogram recordings at study entry using a semiautomated algorithm that measured beat-to-beat QT duration in 817 MADIT II patients. The incidence of VT/VF requiring device therapy was determined by ICD interrogation. RESULTS: Median normalized QT variability (QTVN) was 0.179 and 0.125, respectively, in patients with VT/VF versus those without VT/VF (p = 0.001); QTVI (QTVN adjusted for heart rate variance) also was significantly (p < 0.05) higher in VT/VF patients than in those without VT/VF. Either QTVN or QTVI was linked with a significantly higher probability of VT/VF: two-year risk of VT/VF from Kaplan-Meier curves was 40% in highest quartile versus 21% in lower quartiles for QTVN, and 37% versus 22% for QTVI (p < 0.05 for each). In multivariate Cox regression models adjusting for clinical covariates (race, New York Heart Association functional class, time after myocardial infarction), top-quartile QTVI and QTVN were independently associated with VT/VF (hazard ratio for QTVN 2.18, 95%confidence interval [CI] 1.34 to 3.55, p = 0.002; hazard ratio for QTVI 1.80, 95% CI 1.09 to 2.95, p = 0.021). CONCLUSIONS: In postinfarction patients with severe left ventricular dysfunction, increased QT variability, a marker of repolarization lability, is associated with an increased risk for VT/VF.
BACKGROUND: Theoretical models predict that optimal capacitance for implantable cardioverter-defibrillators (ICDs) is proportional to the time-dependent parameter of the strength-duration relationship. The hyperbolic model gives this relationship for average current in terms of the chronaxie (t(c)). The exponential model gives the relationship for leading-edge current in terms of the membrane time constant (tau(m)). We hypothesized that these models predict results of clinical studies of ICD capacitance if human time constants are used. METHODS AND RESULTS: We studied 12 patients with epicardial ICDs and 15 patients with transvenous ICDs. Defibrillation threshold (DFT) was determined for 120-microF monophasic capacitive-discharge pulses at pulse widths of 1.5, 3.0, 7.5, and 15 ms. To compare the predictions of the average-current versus leading-edge-current methods, we derived a new exponential average-current model. We then calculated individual patient time parameters for each model. Model predictions were validated by retrospective comparison with clinical crossover studies of small-capacitor and standard-capacitor waveforms. All three models provided a good fit to the data (r2=.88 to .97, P<.001). Time constants were lower for transvenous pathways (53+/-7 omega) than epicardial pathways (36+/-6 omega) (t(c), P<.001; average-current tau(m), P=.002; leading-edge-current tau(m), P<.06). For epicardial pathways, optimal capacitance was greater for either average-current model than for the leading-edge-current model (P<.001). For transvenous pathways, optimal capacitance differed for all three models (P<.001). All models provided a good correlation with the effect of capacitance on DFT in previous clinical studies: r2=.75 to .84, P<.003. For 90-microF, 120-microF, and 150-microF capacitors, predicted stored-energy DFTs were 3% to 8%, 8% to 16%, and 14% to 26% above that for the optimal capacitance. CONCLUSIONS: Model predictions based on measured human cardiac-muscle time parameter have a good correlation with clinical studies of ICD capacitance. Most of the predicted reduction in DFT can be achieved with approximately 90-microF capacitors.
The authors report their experience of implantable defibrillators over a 5 year period. Between February 1988 and July 1992, 36 patients (25 men, 11 women, average age 51 +/- 11 years, range 18 +/- 71 years) underwent implantation of an automatic defibrillator with epicardial (n = 13, Group I) or endocardial leads (n = 23, Group II) without patch electrodes (n = 7), with subcutaneous patch electrodes (n = 12) or epicardial patch electrodes (n = 4). Three serious early complications were observed: 2 cardiogenic shocks in Group I, one of which died on Day 1 and one case of infection which required explanation of the defibrillator on Day 23 in Group II. Late complications in Group I included one case of disactivation of the defibrillator, 2 losses of output, one of which required replacement of the defibrillator and 2 increases of threshold treated by implantation of an endocardial lead. In Group II, 2 patients had inappropriate shocks due to overdetection (n = 1) and double counting (n = 1). During an average follow-up period of 28.5 +/- 9 months in group I and 13 +/- 6 months in Group II, 4 patients died, 2 from sudden death. Ninety seven shocks were delivered in 19 patients (56%), 5.1 shocks per patient. In the 17 patients with an antitachycardia function, 14 (82%) developed 947 episodes of VT treated successfully by antitachycardia pacing in 917 cases. This retrospective study confirms the efficacy of implantable defibrillators in the treatment of malignant ventricular arrhythmias. The efficacy of endocardial and epicardial leads seems to be the same but there seems to be a lower immediate mortality and morbidity with the endocardial system.
UNLABELLED: The automatic implantable defibrillator (AID) is the treatment of choice for primary and secondary prevention of sudden death. At the Instituto Nacional de Cardiología, since October 1996 until January 2002, 25 patients were implanted with 26 AID. There were 23 men (92%) and the mean age of the whole group, was 51.4 years. Twenty-three patients (92%) presented structural heart disease, the most common was ischemic heart disease in 13 patients (52%), with a mean ejection fraction of 37.8%. One patient without structural heart disease had Brugada Syndrome. The most frequent clinical arrhythmia was ventricular tachycardia in 14 patients (56%). The mean follow-up was of 29.3 months during which a total of 30 events of ventricular arrhythmia were treated through AID; six of them were inappropriate due to paroxismal atrial fibrillation; 10 AID patients (34%) have not applied for therapy. Three patients (12%) of the group died due to congestive heart failure refractory to pharmacologic treatment. CONCLUSION: The implant of the AID is a safe and effective measure for primary and secondary prevention of sudden death. World-wide experience evidences, that this kind of device has not modified the mortality rate due to heart failure in these patients, but it has diminished sudden arrhythmic death.
From March 1992 to April 1996 a pectoral biphasic transvenous implantable cardioverter defibrillator without subcutaneous leads was implanted in 35 patients with life threatening ventricular tachyarrhythmias. Mean age was 58 +/- 9 years; 23 patients had coronary artery disease, 10 non ischemic dilated cardiomyopathy and 2 arrhythmogenic right ventricular dysplasia. All were in NYHA functional class I and II and 4 in class III: mean ejection fraction was 35 +/- 12%. The mean duration of the implantation procedure was 85 +/- 35 min. The mean defibrillation threshold, measured in 23 active-CAN devices was 8.8 +/- 5 J. There were no operative complications except in one case of transient ischemic electromechanical dissociation. The mean hospital stay from the time of implant to predischarge evaluation was 6.2 +/- 2 days. The average follow-up period was 18.5 +/- 11 months. Two patients had non sudden and non arrhythmic cardiac death in the third and sixth month, respectively. In 19 patients 171 implantable cardioverter defibrillator interventions were reported: in 5 patients five inappropriate interventions were reported and in the remaining 14 were reported: 35 ventricular fibrillation and 131 ventricular tachycardia. The short duration of the procedure, brief hospitalization with very low perioperative morbidity, high efficacy and low mid-term complications give a new image to this therapeutic option.