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PubMed1995

Cardiac release of histamine after ventricular fibrillation and defibrillation during insertion of implantable cardioverter defibrillators (ICD).

Histamine has inotropic, chronotropic, arrhythmogenic, and vasoactive effects, and is released from the heart in ischaemia-reperfusion injury. The effect of ventricular fibrillation (VF) and defibrillation (DEF) on histamine release was investigated in 9 anaesthetized patients undergoing transvenous implantation of ICD. Concomitant arterial and coronary sinus (CS) blood samples were drawn before induction of VF (duration 20 seconds), immediately after, and 2 and 5 min after DEF (18-24 Joules). Basal arterial histamine was 2.5 +/- 6 nmol/l, and did not increase after VF. The histamine level in CS was 1.1 +/- 0.2 nmol/l before VF (p < 0.008 compared to arterial), and increased to 2.5 +/- 0.6 nmol/l immediately after (p < 0.045 compared to basal), to 3 +/- 1.1 nmol/l 2 min after (p < 0.45), and to 2.4 +/- 0.8 nmol/l 5 min after VF. In the basal state there was an uptake of histamine across the coronary circulation. After VF/DEF the level of histamine increased in coronary venous blood, suggesting cardiac release of histamine.

Aged↗
PubMed2006

Implantable defibrillator early after primary percutaneous intervention for ST-elevation myocardial infarction: rationale and design of the Defibrillator After Primary Angioplasty (DAPA) trial.

BACKGROUND: It has been shown that an implantable cardioverter defibrillator (ICD) may be beneficial when added to optimal drug treatment in patients with reduced left ventricular function who survive a myocardial infarction (MI). However, it is not known whether patients with increased risk of death after primary percutaneous coronary intervention (PCI) for ST-elevation MI also have benefit of prophylactic ICD therapy to reduce sudden cardiac death. METHODS AND STUDY DESIGN: The DAPA trial is designed to evaluate the efficacy and safety of ICD in high-risk patients after primary PCI for ST-elevation MI. In this randomized multicenter controlled study, a total of 700 patients will be included. Enrolment started in October 2004. Inclusion criteria are thrombolysis in myocardial infarction flow less than 3 after primary PCI or left ventricular ejection fraction lower than 30% as measured short after admission for the index MI. Patients will be randomized between 30 and 60 days after their MI. The primary end point will be total death during the follow-up period of at least 3 years for each patient. CONCLUSIONS: This multicenter trial of patients at high risk of death after primary angioplasty for ST-elevation MI will evaluate prophylactic ICD therapy in addition to the current standard of care.

Adult↗
PubMed2005

The Department of Health National Defibrillator Programme: analysis of downloads from 250 deployments of public access defibrillators.

From April 2000 to November 2002, the Department of Health (England) placed 681 automated external defibrillators (AEDs) in 110 public places for use by volunteer lay first responders. An audit has been undertaken of the first 250 deployments, of which 182 were for confirmed cardiac arrest. Of these, 177 were witnessed whilst 5 occurred in situations that were remote or initially inaccessible to the responders. The response interval between collapse and the initiation of CPR or AED placement was estimated to be 3-5 min in most cases. Ventricular fibrillation or rapid ventricular tachycardia (one case) was the first recorded rhythm in 146 cases (82%). In all, 44 of the 177 witnessed cases are known to have survived to hospital discharge (25%). Complete downloads are available for 173 witnessed cases and of these 140 were shocked: first-shock success, defined as termination of the fibrillatory waveform for 5 s or more, was achieved in 132 of them. When data quality permitted, the downloads were analysed with special reference to the numbers of compressions given and also to interruptions in compression sequences for ventilations, for rhythm analysis by the AED, for clinical checks, and for unexplained operator delays. The average rate of compressions during sequences was 120 min(-1), but because of interruptions, the actual number administered over a full minute from the first CPR prompt was a median of only 38. The speed of response by the lay first responders in relation to AED use was similar to that reported for healthcare professionals.

Cardiopulmonary Resuscitation↗
PubMed2000

Prophylactic implantable cardioverter defibrillator trials: MUSTT, MADIT, and beyond. Multicenter Unsustained Tachycardia Trial. Multicenter Automatic Defibrillator Implantation Trial.

MUSTT and MADIT have clearly shown the survival benefit of an implantable cardioverter defibrillator (ICD) in patients with previous myocardial infarction, left ventricular ejection fraction < or = 0.40, and nonsustained ventricular tachycardia (VT), and who have had sustained VT induced at electrophysiology study. Progress in primary prevention of sudden cardiac death (SCD) depends on a concerted effort by clinicians to identify and appropriately treat MUSTT/MADIT-type patients; further research to more precisely define patient subgroups at risk for SCD and the willingness of industry to develop a lower priced ICD for prophylactic use are needed.

Clinical Trials as Topic↗
PubMed1996

Impact of the implantable defibrillator on mortality: the axiom of overall implantable cardioverter-defibrillator survival.

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.

Arrhythmias, Cardiac↗
PubMed1999

A stepwise testing protocol for modern implantable cardioverter-defibrillator systems to prevent pacemaker-implantable cardioverter-defibrillator interactions.

Current use of newer implantable cardioverter-defibrillators (ICDs) has changed the spectrum of pacemaker-ICD interactions and provided new tools for testing and understanding those interactions. Testing for pacemaker-ICD interactions was performed in 31 procedures involving 22 patients. The protocol included: (1) evaluation of pacemaker stimulus artifact amplitude and its ratio to that of the evoked ventricular electrogram, (2) testing for inhibition of ventricular fibrillation (VF) detection by the ICD during asynchronous pacing at maximum output, (3) evaluation by pacemaker event marker recordings of pacemaker sensing behavior while programmed to nonasynchronous mode during ventricular tachycardia (VT) or VF, and (4) evaluation of postshock interactions. Inhibition of detection of VT/VF was found in 6 of 22 patients (27.2%). Large stimulus artifact amplitude (>2 mV) or stimulus artifact:evoked QRS ratio > 1/3 had a positive predictive accuracy of 18% and 14.4%, respectively, and a negative predictive accuracy of 100% and 92.3%, respectively, for clinically significant interaction. Asynchronous pacing occurred in 16 of 31 procedures (51.6%), and was due to underdetection by the pacemaker in 4 of 16 (25%) and noise reversion in 12 of 16 (75%). Postshock phenomena occurred in 6 cases, 3 of which were clinically significant. Overall, 11 of 22 patients (50%) had clinically significant interactions discovered by this protocol, which led to system revisions in 6 and to pacemaker output reprogramming in 5. Thus, pacemaker-ICD interactions are frequently detected using a thorough and systematic protocol. Most cases can be managed by system revision or pacemaker reprogramming.

Artifacts↗
PubMed1998

High failure rate for an epicardial implantable cardioverter-defibrillator lead: implications for long-term follow-up of patients with an implantable cardioverter-defibrillator.

OBJECTIVES: The purpose of this study was to determine the risk of epicardial lead failure during long-term follow-up and its mode of presentation. BACKGROUND: Despite the high prevalence of epicardial lead-based implantable cardioverter-defibrillators, their long-term performance is unknown, and appropriate follow-up has not been established. METHODS: The study group comprised all patients in whom an epicardial lead system was implanted at the Mayo Clinic between October 31, 1984 and November 3, 1994. The number of lead fractures and leads with fluid within the insulation and the mode of presentation were determined retrospectively by review of patient visits, radiographs of lead systems and data derived from formal lead testing. RESULTS: At 4 years, the survival rate free of lead malfunction, using formal lead testing, for 160 Medtronic epicardial patches (models 6897 and 6921) was 72% compared with 92.5% for the 179 Cardiac Pacemaker, Inc. (CPI) patches (models 0040 and 0041) (p = 0.01). In addition, five Medtronic patches in three patients had fluid within the lead insulation but no obvious fracture. No CPI patches had fluid identified within the leads. Of 330 Medtronic epicardial pace/sense leads (model 6917), the 4-year survival rate free of lead malfunction as assessed by lead testing was 96%. In all, 19 presentations of lead malfunction were found in 17 patients (2 patients had more than one lead fracture at different times). In 11 (58%) of these presentations, the patients were asymptomatic despite the presence of obvious lead fracture. CONCLUSIONS: Epicardial lead malfunction is common on long-term follow-up, and some leads have a failure rate of 28% at 4 years. Many patients with fractured leads remain asymptomatic, despite involvement of multiple leads in some cases. Therefore, consideration should be given to regular periodic lead testing in addition to routine X-ray examination, as asymptomatic lead malfunction can present with normal chest X-ray findings.

Aged↗
PubMed2001

Indications for dual-chamber cardioverter defibrillators at implant and at 1 year follow-up: a retrospective analysis in the single-chamber defibrillator era.

AIM: This retrospective four-centre study assessed the current indications for dual-chamber implantable cardioverter defibrillators (ICDs) at implant and during a medium-term follow-up period in a group of patients treated by single-chamber ICD in the pre dual-chamber ICD era. METHODS AND RESULTS: The study population consisted of 153 consecutive patients (127 males, mean age 58 +/- 6 years) treated by single-chamber ICD for ventricular tachycardia and/or ventricular fibrillation. Definite indications for having a dual-chamber ICD included the presence of sinus node dysfunction and of second- or third-degree atrioventricular (AV) block, while possible indications were represented by paroxysmal atrial fibrillation or flutter and first-degree AV block. At implant, dual-chamber ICD would appear definitely indicated in 10.5% of cases, and possibly indicated in an additional 17.5% of cases. During 12 +/- 10 months follow-up, such percentages remained stable (11 and 19.5%, respectively). Inappropriate ICD intervention was documented in five of 13 patients (38%), with episodes of paroxysmal atrial fibrillation or flutter. CONCLUSION: In this non-selected study population, a dual-chamber ICD would have potentially benefited approximately 30% of the patients. During medium-term follow-up, there was no progression towards increasing dual-chamber ICD indications. The 15% cumulative incidence of paroxysmal atrial tachyarrhythmias justifies the activation of dedicated detection algorithms.

Adult↗
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↗
PubMed1995

Awareness during anaesthesia for implantable cardioverter defibrillator implantation. Recall of defibrillation shocks.

Implantable cardioverter defibrillator implantation is performed under general anaesthesia. This report describes awareness or recall in two of 33 patients scheduled for implantation. After induction, anaesthesia was maintained using continuous infusions of propofol and atracurium and intermittent boluses of alfentanil. Propofol was given in the same arm as the implantation side. In these two patients propofol flowed out of the bleeding central venous access. To minimise the possibility of awareness, we advise that continuous infusions should be administered intravenously on the contralateral side to the implantation and that neuromuscular blocking agent be given by intermittent bolus injections.

Anesthesia, General↗
PubMed1995

Implantable cardioverter defibrillator lead technology: improved performance and lower defibrillation thresholds.

The performance of an ICD system depends, in part, on the effectiveness with which the lead system functions. Engineering trade-offs are made during the design of a lead to optimize one or more performance characteristics: e.g., lead handling, fatigue life, size, and optimized therapy delivery. To assure low defibrillation thresholds, careful attention must be taken during the design process to prevent these trade-offs from hampering the lead's therapy effectiveness. Four basic design rules are described that capture many of the engineering concepts that will enhance a lead's efficacy: (1) minimize electrode pullback, (2) deliver current to the apex, (3) minimize energy loss in the lead, and (4) use large, efficient electrodes. These rules speak to optimizing delivery of current to the heart and efficiency of the lead and electrode interface. When the lead performs its function well, the complete ICD system of the heart, lead, and implantable pulse generator will provide optimal safety margins for device implant and an increased number of patients that can be implanted with a single-lead system.

Animals↗
PubMed1997

The effect of polarity of the initial phase of a biphasic shock waveform on the defibrillation threshold of pectorally implanted defibrillators.

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.

Aged↗
PubMed1998

Oversensing in a cardioverter defibrillator system caused by interaction between two endocardial defibrillation leads in the right ventricle.

A 53-year-old male patient underwent implantable cardioverter defibrillator (ICD) implantation with a single lead (Endotak) transvenous system due to recurrent episodes of drug refractory ventricular tachycardia. After pulse generator replacement, inappropriate ICD shocks were observed due to muscle potential sensing. Intraoperatively, the old Endotak lead could not be extracted; therefore, it was transsected and capped. A new lead was inserted and tested without any problems. At the predischarge test, VF was induced and was followed by ICD shocks during sinus rhythm. In another surgical procedure, the old Endotak lead was explanted using a special instrument. The present report demonstrates that two endocardial Endotak leads should be avoided, because the leads may disturb each other and be followed by inappropriate ICD discharges.

Defibrillators, Implantable↗
PubMed2004

Microvolt T-wave alternans distinguishes between patients likely and patients not likely to benefit from implanted cardiac defibrillator therapy: a solution to the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II conundrum.

BACKGROUND: In 2003, the Centers for Medicaid and Medicare Services recommended QRS duration as a means to identify MADIT II-like patients suitable for implanted cardiac defibrillator (ICD) therapy. We compared the ability of microvolt T-wave alternans and QRS duration to identify groups at high and low risk of dying among heart failure patients who met MADIT II criteria for ICD prophylaxis. METHODS AND RESULTS: Patients with MADIT II characteristics and sinus rhythm had a microvolt T-wave alternans exercise test and a 12-lead ECG. Our primary end point was 2-year all-cause mortality. Of 177 MADIT II-like patients, 32% had a QRS duration >120 ms, and 68% had an abnormal (positive or indeterminate) microvolt T-wave alternans test. During an average follow-up of 20+/-6 months, 20 patients died. We compared patients with an abnormal microvolt T-wave alternans test to those with a normal (negative) test, and patients with a QRS >120 ms with those with a QRS < or =120 ms; the hazard ratios for 2-year mortality were 4.8 (P=0.020) and 1.5 (P=0.367), respectively. The actuarial mortality rate was substantially lower among patients with a normal microvolt T-wave alternans test (3.8%; 95% confidence interval: 0, 9.0) than the mortality rate in patients with a narrow QRS (12.0%; 95% confidence interval: 5.6, 18.5). The corresponding false-negative rates are 3.5% and 10.2%, respectively. CONCLUSIONS: Among MADIT II-like patients, a microvolt T-wave alternans test is better than QRS duration at identifying a high-risk group and also better at identifying a low-risk group unlikely to benefit from ICD therapy.

Aged↗
PubMed2000

Canadian implantable defibrillator study (CIDS) : a randomized trial of the implantable cardioverter defibrillator against amiodarone.

BACKGROUND: Patients surviving ventricular fibrillation (VF) or sustained ventricular tachycardia (VT) are at a high risk of death due to a recurrence of arrhythmia. The implantable cardioverter defibrillator (ICD) terminates VT or VF, but it is not known whether this device prolongs life in these patients compared with medical therapy with amiodarone. METHODS AND RESULTS: A total of 659 patients with resuscitated VF or VT or with unmonitored syncope were randomly assigned to treatment with the ICD or with amiodarone. The primary outcome measure was all-cause mortality, and the secondary outcome was arrhythmic death. A total of 328 patients were randomized to receive an ICD. A thoracotomy was done in 33, no ICD was implanted in 18, and the rest had a nonthoracotomy ICD. All 331 patients randomized to amiodarone received it initially. At 5 years, 85.4% of patients assigned to amiodarone were still receiving it at a mean dose of 255 mg/day, 28.1% of ICD patients were also receiving amiodarone, and 21.4% of amiodarone patients had received an ICD. A nonsignificant reduction in the risk of death was observed with the ICD, from 10.2% per year to 8.3% per year (19.7% relative risk reduction; 95% confidence interval, -7.7% to 40%; P=0.142). A nonsignificant reduction in the risk of arrhythmic death was observed, from 4.5% per year to 3.0% per year (32.8% relative risk reduction; 95% confidence interval, -7.2% to 57.8%; P=0.094). CONCLUSIONS: A 20% relative risk reduction occurred in all-cause mortality and a 33% reduction occurred in arrhythmic mortality with ICD therapy compared with amiodarone; this reduction did not reach statistical significance.

Aged↗
PubMed1994

Rise in chronic defibrillation thresholds in nonthoracotomy implantable defibrillator.

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.

Aged↗