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PubMed2005

Improved defibrillation efficacy with an ascending ramp waveform in humans.

OBJECTIVES: The purpose of this study was to compare an ascending ramp waveform (RAMP) with a standard, clinically available biphasic truncated exponential waveform (BTE) for defibrillation in humans. BACKGROUND: In animal studies, RAMP had a lower defibrillation threshold (DFT) than BTE. METHODS: We studied 63 patients at implantable cardioverter-defibrillator placement using a dual-coil lead and left pectoral active can. The subjects were divided into two groups, one with a 12-ms ascending first phase and one with a 7-ms ascending first phase. Phase 2 of RAMP for both groups was a truncated exponential decay with 65% tilt and reversed polarity. The BTE had a 50% tilt in each phase. DFT and upper limit of vulnerability (ULV) were measured for both waveforms using a binary search protocol. RESULTS: The patient population was 77% male, with a mean age of 63 +/- 10 years and ejection fraction of 33 +/- 13%. Delivered energy at DFT was lower with the 7-ms RAMP vs BTE (5.4 +/- 2.6 J vs 6.5 +/- 3.4 J; P < .01) but unchanged with the 12-ms RAMP (7.4 +/- 4.5 J vs 7.1 +/- 4.9 J). Maximal voltage at DFT was significantly lower with either RAMP compared to BTE (P < .01). There was a strong correlation between ULV and DFT for both RAMP and BTE (P < .01). CONCLUSIONS: The 7-ms ascending ramp waveform significantly reduced delivered energy (18%) and voltage (24%) at DFT, whereas the 12-ms RAMP reduced only DFT voltage. This is the first report of a waveform that is superior to a BTE for defibrillation in humans. ULV correlates with DFT for RAMP, supporting the use of ULV testing for implantation of devices.

Algorithms↗
PubMed2005

Predictive value of ventricular arrhythmia inducibility for subsequent ventricular tachycardia or ventricular fibrillation in Multicenter Automatic Defibrillator Implantation Trial (MADIT) II patients.

UNLABELLED: In the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II, implantable cardioverter-defibrillator (ICD)-randomized patients underwent electrophysiologic testing. Both inducible and noninducible patients received an ICD. We correlated inducibility with the occurrence of subsequent ventricular tachycardia (VT) or ventricular fibrillation (VF). Intracardiac ICD electrograms for subsequent events were analyzed to categorize the spontaneous arrhythmia as VT or VF. The two-year Kaplan-Meier event rate for VT in inducible patients was 29.0% versus 19.3% in noninducible patients. However, ICD therapy for spontaneous VF was less common at two years in inducible patients (3.2%) than in noninducible patients (8.6%). In the MADIT II study, inducibility predicted an increased likelihood of VT but decreased VF. OBJECTIVES: We correlated electrophysiologic inducibility with spontaneous ventricular tachycardia (VT) or ventricular fibrillation (VF) in the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II. BACKGROUND: In the MADIT II study, 593 (82%) of 720 implantable cardioverter-defibrillator (ICD) randomized patients underwent electrophysiologic testing. Patients received an ICD whether they were inducible or not. METHODS: A "standard" inducibility definition included sustained monomorphic or polymorphic VT induced with three or fewer extrastimuli or VF induced with two or fewer extrastimuli. We compared a narrow inducibility definition (only monomorphic VT) and a broad definition (standard definition plus VF with three extrastimuli). We used ICD-stored electrograms to categorize spontaneous VT or VF. RESULTS: Inducible patients (standard definition) had a greater likelihood of experiencing ICD therapy for VT than noninducible patients (p = 0.023). Unexpectedly, ICD therapy for spontaneous VF was less common (p = 0.021) in inducible patients than in noninducible patients. The two-year Kaplan-Meier event rate for VT or VF was 29.4% for inducible patients and 25.5% for noninducible patients. Standard inducibility did not predict the combined end point of VT or VF (p = 0.280, by log-rank analysis). The narrow inducibility definition outperformed the standard definition, whereas the broad definition appeared inferior to the standard definition. CONCLUSIONS: In the MADIT II study patients, inducibility was associated with an increased likelihood of VT. Noninducible MADIT II study subjects using this electrophysiologic protocol had a considerable VT event rate and a higher VF event rate than inducible patients. Induction of polymorphic VT or VF, even with double extrastimuli, appears less relevant than induction of monomorphic VT.

Aged↗
PubMed2006

The frequency and incremental cost of major complications among medicare beneficiaries receiving implantable cardioverter-defibrillators.

OBJECTIVES: We aimed to quantify the frequency and nature of early complications after implantable cardioverter-defibrillator (ICD) implantation in general practice, and estimate the incremental costs of those complications to the health care system. BACKGROUND: Cardioverter-defibrillator implantation rates are rising quickly. Little has been published regarding the outcomes and costs of these procedures in unselected populations. METHODS: Using Medicare Provider Analysis and Review (MedPAR) files, we identified 30,984 admissions containing procedure codes for new ICD or cardiac resynchronization therapy defibrillator implantation in fiscal year 2003. The frequencies of eight complicating diagnoses during these admissions were determined. Length of stay (LOS) and total hospital costs, derived using whole-hospital cost to charge ratios, were calculated for each admission. The incremental effects of any and each complication on LOS and hospital cost were estimated in multivariable models, adjusting for demographic factors and comorbid conditions. RESULTS: The mean cost for all admissions was 42,184 dollars (median 37,902 dollars) with mean LOS of 4.7 days (median 2.0 days). One or more complications were coded in 10.8% of admissions, most commonly "mechanical complication of the ICD" and hemorrhage/hematoma. The occurrence of any complication increased adjusted LOS by 3.4 days and costs by 7,251 dollars. Each of the individual complications was associated with highly significant increases in both LOS (1 to 10 days) and hospital cost (5,000 dollars to 20,000 dollars). CONCLUSIONS: In fiscal 2003, 10.8% of Medicare patients undergoing cardioverter-defibrillator implantation experienced one or more early complications, associated with significant increases in LOS and costs. Efforts to reduce these complications could have significant clinical and financial benefits.

Aged↗
PubMed2006

Cost-effectiveness of a microvolt T-wave alternans screening strategy for implantable cardioverter-defibrillator placement in the MADIT-II-eligible population.

OBJECTIVES: This study was designed to compare the cost-effectiveness of implantable cardioverter-defibrillator (ICD) placement with and without risk stratification with microvolt T-wave alternans (MTWA) testing in the MADIT-II (Second Multicenter Automatic Defibrillator Implantation Trial) eligible population. BACKGROUND: Implantable cardioverter-defibrillators have been shown to prevent mortality in the MADIT-II population. Microvolt T-wave alternans testing has been shown to be effective in risk stratifying MADIT-II-eligible patients. METHODS: On the basis of published data, cost-effectiveness of three therapeutic strategies in MADIT-II-eligible patients was assessed using a Markov model: 1) ICD placement in all; 2) ICD placement in patients testing MTWA non-negative;, and 3) medical management. Outcomes of expected cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness were determined for patient lifetime. RESULTS: Under base-case assumptions, providing ICDs only to those who test MTWA non-negative produced a gain of 1.14 QALYs at an incremental cost of 55,700 dollars when compared to medical therapy, resulting in an incremental cost-effectiveness ratio (ICER) of 48,700 dollars/QALY. When compared with a MTWA risk-stratification strategy, placing ICDs in all patients resulted in an ICER of 88,700 dollars/QALY. Most (83%) of the potential benefit was achieved by implanting ICDs in the 67% of patients who tested MTWA non-negative. Results were most sensitive to the effectiveness of MTWA as a risk-stratification tool, MTWA negative screen rate, cost and efficacy of ICD therapy, and patient risk for arrhythmic death. CONCLUSIONS: Risk stratification with MTWA testing in MADIT-II-eligible patients improves the cost-effectiveness of ICDs. Implanting defibrillators in all MADIT-II-eligible patients, however, is not cost-effective, with one-third of patients deriving little additional benefit at great expense.

Aged↗
PubMed2003

Transvenous cardioversion--a novel asymmetric rectangular biphasic waveform from a radiofrequency defibrillator compared with conventional waveforms in atrial fibrillation.

BACKGROUND: We investigated a novel device that delivered biphasic and monophasic shocks without tilt, in transvenous cardioversion of atrial fibrillation (AF). The device contains a radiofrequency (RF) transmitting primary, a 15mm air gap and a passive secondary unit that produces the required direct current waveform. METHODS: The device was assessed in 10 anaesthetised and ventilated sheep (65 +/- SD 12kg). Defibrillation leads were positioned in the distal coronary sinus and the lateral right atrium. The novel RF defibrillator was assessed using rectangular monophasic or biphasic pulses and compared to conventional (C) tilted waveforms (Ventritex HVS-02). During AF placebo shocks were delivered to a 50 Omega dummy load. Sustained AF was induced by rapid atrial pacing and 5 attempts at cardioversion were made for each waveform. Success was defined as reversion to sinus rhythm within 5 beats of shock delivery. RESULTS: No arrhythmic complications were observed for the 400 shocks delivered. CONCLUSION: A reduction in phase 2 voltage does not affect the efficacy of rectangular waveforms but does facilitate energy reduction. Asymmetric rectangular biphasic waveforms with phase 2 voltage at 50% of phase 1 are more efficacious than equivalent voltage conventional waveforms for transvenous cardioversion of AF. The novel defibrillator is safe and effective. Design modifications will enable this device to be used as an implantable defibrillator with an external RF power source.

Animals↗
PubMed2005

Defibrillation and biphasic shocks: Implications for perianesthesia nursing.

Cardiac arrests, the majority of which are due to ventricular fibrillation (VF), are a significant threat to survival. The definitive therapy for cardiac arrests due to VF is rapid, early defibrillation. There have been several advances made to modern defibrillators to electively or emergently terminate lethal and nonlethal arrhythmias through external defibrillation. The most recent improvement is in the efficacy of the delivered shock. Biphasic shock waveforms have been shown to be superior to monophasic shocks and are recognized in the current Advanced Cardiac Life Support guidelines by the American Heart Association. Because hospitals are increasingly replacing older models of monophasic capability defibrillators with the newer biphasic capability models, it will be essential for perianesthesia nurses to understand the principles of biphasic technology.

Defibrillators↗
PubMed2004

CPR courses and semi-automatic defibrillators--life saving in cardiac arrest?

OBJECTIVES: The aim was to assess the knowledge of life-supporting first-aid in both cardiac arrest survivors and relatives, and their willingness to have a semi-automatic external defibrillator in their homes and use it in an emergency. MATERIAL AND METHODS: Cardiac arrest survivors, their families, friends, neighbours and co-workers were interviewed by medical students using prepared questionnaires. Their knowledge and self-assessment of life-supporting first-aid, their willingness to have a semi-automatic defibrillator in their homes and their willingness to use it in an emergency before and after a course in cardiopulmonary resuscitation (CPR) with a semi-automatic external defibrillator was evaluated. Courses were taught by medical students who had received special training in basic and advanced life support. RESULTS: Both patients and relatives, after a course of 2-3 h, were no longer afraid of making mistakes by providing life-supporting first-aid. The automated external defibrillator (AED) was generally accepted and considered easy to handle. CONCLUSION: We consider equipping high-risk patients and their families with AEDs as a viable method of increasing their survival in case of a recurring cardiac arrest. This, of course, should be corroborated by further studies.

Cardiopulmonary Resuscitation↗
PubMed2005

Layperson positioning of defibrillation electrodes guided by pictorial instructions.

BACKGROUND: Correct positioning of defibrillation electrodes is essential to achieve sufficient transmyocardial current to depolarize a critical mass of myocardium, and thus terminate ventricular fibrillation (VF). AIM: To evaluate the pictures on the self-adhesive defibrillation electrodes in guiding laypersons to place the electrodes in the recommended position. METHODS: Defibrillation electrodes from five manufactures (Access Cardio Systems, Schiller, Medtronic, Cardiac Science and Philips) were included in the study and compared with electrodes with a lateral view picture, designed for the study, showing the placement of the apical electrode. A total of 150 laypersons without any experience or training in use of a defibrillator participated in the study. The participants placed randomly selected electrodes on the chest of a resuscitation manikin without any guidance apart from the pictures on the electrodes. The distances of the electrodes from the recommended positions were measured. RESULTS: The proportion of participants who placed both electrodes within 5 cm from recommended position varied from 8% to 36% with the different electrodes. Usually, the apical electrode was placed too anteriorly. Electrodes placed with help of the lateral instruction picture, (designed for the study), showing the placement of the apical electrode were placed significantly more often within 5 cm than any of the others (64%, 95% confidence interval 44-80, P < 0.05). CONCLUSIONS: The current practice in designing pictures on the electrodes does not seem to be optimal in showing the recommended position of the apical electrode as recommended by Guidelines 2000. It is suggested that by showing a lateral view in the instructions, success in placing the apical electrodes correctly can be improved.

Adolescent↗
PubMed2006

Reconfirmation algorithms should be the standard of care in automated external defibrillators.

Non-sustained and self-terminating arrhythmias pose a significant challenge during resuscitation. Delivery of a defibrillation shock to a non-shockable rhythm has a poorly understood effect on the heart. The importance of assessing rhythm right up until the delivery of a shock is of increased importance when "blind" shocks are being delivered by automatic defibrillators or minimally trained rescuers. Reconfirmation algorithms are common in current-generation implantable defibrillators but this investigation of current-generation AEDs shows that only 71% of devices presently available have reconfirmation algorithms. A case of spontaneous reversion of a non-sustained arrhythmia is presented. The implications of delivering a defibrillator shock to a non-shockable rhythm are discussed.

Algorithms↗
PubMed2006

A public access defibrillation programme in non-inpatient hospital areas.

INTRODUCTION: Automatic external defibrillators (AED) have proven to be valuable and life saving for out of hospital cardiac arrests. Their use in hospital arrests is less well documented, but they offer the opportunity to improve survival in the hospital setting also. METHODS: The implementation of a public access defibrillation (PAD) programme at a tertiary care hospital is described, with reference specifically to targeting areas where time from arrest to arrival of defibrillation would be greater than 3 min. RESULTS: Nine AEDs were placed in areas of the hospital distant from inpatient or outpatient floors. The locations of the AEDs were chosen based on a 3 min walk from currently available defibrillators to all areas of the hospital, including parking garages and walkways from building to building. In this programme AED use in non-inpatient hospital locations resulted in the resuscitation of a patient in ventricular fibrillation. CONCLUSION: PAD in non-inpatient hospital settings can be life saving and similar programmes should be considered for other hospitals.

Boston↗
PubMed1996

Implantable cardioverter defibrillator: use in patients with no symptoms and at high risk.

Twenty-seven patients with asymptomatic, nonsustained ventricular tachycardia whose evaluation suggested they were at high risk for sustained ventricular arrhythmias were treated with implantable cardioverter defibrillators. The option of conventional therapy (including the option of no therapy) was presented to each patient and rejected in favor of defibrillator implantation on an experimental basis. Eighteen patients had coronary artery disease and inducible sustained ventricular tachycardia, 8 had idiopathic dilated cardiomyopathy, and 1 had hypertrophic cardiomyopathy and a strong family history of sudden cardiac death. The mean ejection fraction was 27% +/- 10%. Operative morbidity (3%) and mortality (3%) were low. Mean overall survival was 92% and 88% at 1 and 2 years, respectively. Sixteen (59%) of the 27 patients had appropriate defibrillator discharges during a mean follow-up of 35 +/- 15 months. The mean time to first appropriate discharge was 18 +/- 17 months, and mean follow-up after first discharge was 17 +/- 20 months. In conclusion, implantable cardioverter defibrillator placement in high-risk patients without symptoms is a feasible approach that may have resulted in benefit in selected patients. Large-scale randomized trials currently under way will determine the risk/benefit ratio of this management approach.

Actuarial Analysis↗
PubMed2000

Optimal method to achieve consistently low defibrillation energy requirements.

Reduction of the defibrillation energy requirement offers the opportunity to decrease implantable cardioverter defibrillator (ICD) size and to increase device longevity. Therefore, the purpose of this prospective study was to obtain confirmed defibrillation thresholds (DFTs) of < or = 15 J in each patient with an endocardial dual-coil lead system incorporating an active pectoral pulse generator (TRIAD lead system: RV- --> SVC+ + CAN+). According to our previous clinical and experimental studies, we tried to lower DFTs that were > 15 J by repositioning the distal coil of the endocardial lead system in the right ventricle. A total of 190 consecutive patients requiring ICDs for ventricular fibrillation and/or recurrent ventricular tachycardia were investigated at the time of ICD implantation (42 women, 148 men; mean age 61.9 +/- 12.0 years; mean left ventricular ejection fraction 42.7 +/- 16.6%). Coronary artery disease was present in 139 patients; nonischemic dilated cardiomyopathy in 34 patients; and other etiologies in 17 patients; 47 patients had undergone previous cardiac surgery. Regardless of optimal pacing and sensing parameters, for patients having DFTs > 15, we repositioned the distal coil of the endocardial lead system toward the intraventricular septum to include this part of both ventricles within the electrical defibrillating field. In 177 of 190 patients, induced ventricular fibrillation was successfully terminated with < or = 15 J (group I) using the initial lead position. Repositioning of the endocardial lead was necessary in 13 patients whose DFT(plus) (DFT(plus) = second additional success at lowest energy level) were > 15 J (group II). In all patients, repositioning was successful within a 15 J energy level (100% success). The mean DFT(plus) was 7.3 +/- 3.5 J (group I) and 11.0 +/- 4.5 J (group II; p<0.005). The mean DFT(plus) of all patients enrolled in the study was 7.6 +/- 3.7 J (range: 2 to 15 J). In 87% of all patients, DFT(plus) of < or = 10 J was achieved. Repositioning of the endocardial lead in the right ventricle is a simple and effective method to reduce intraoperative high DFTs. As a result of this procedure, ICDs with a 20 J output should be sufficient for the vast majority (87%) of our patients. Furthermore, we were able to avoid additional subcutaneous or epicardial electrodes in all patients.

Aged↗
PubMed1996

Chronic rise in defibrillation threshold with a hybrid lead system.

Nonthoracotomy leads have become standard for implantable cardioverter-defibrillators (ICD) because of low perioperative morbidity, mortality, and expense. Reported increases in defibrillation thresholds (DFTs) with these lead systems, however, have raised the possibility of an eventual loss of defibrillation efficacy. The mechanism of this increase is unknown. In contrast, defibrillation efficacy of traditional epicardial lead systems has been demonstrated to remain relatively stable. In the present study, we examined the implantation and chronic DFTs in 45 patients with a hybrid system (a high right atrial coil and an extrapericardial patch) that combines elements from both the thoracotomy and nonthoracotomy approach. The mean threshold increased from 11.7 +/- 3.0 to 15.8 +/- 10.0 J (p < 0.001) and mean impedance increased from 37.0 +/- 7.7 to 48.8 +/- 9.0 ohms (p < 0.0001). There was a marked (> or = 10 J) increase in DFT in 11 patients (24%) including 4 who required reoperation to obtain an adequate safety margin. The increase in DFT was unrelated to any of the analyzed variables. We conclude that the presence of an extrapericardial patch does not prevent the increase in DFT reported with nonthoracotomy lead systems. This increase is unpredictable and occurs in almost 25% of patients.

Aged↗
PubMed1996

Indications for dual-chamber (DDD) pacing in implantable cardioverter-defibrillator patients.

New technologic development of implantable cardioverter-defibrillators (ICDs) keeps up with the exponential increase of their use for primary and secondary prevention of sudden cardiac death. The first-generation ICD with limited shock capability alone could be considered adequate in most cardiac arrest victims, but it was not suitable for sudden death prevention in all high-risk patients with cardiac disease. The second-generation ICD was comprised of hybrid pacemaker-defibrillator systems that provided on-demand ventricular antibradycardia pacing. The third-generation devices include additional functions, such as antitachycardia pacing for ventricular tachycardia (VT) reversion and low-energy ventricular cardioversion, in addition to ventricular defibrillation and single-chamber ventricular demand pacing. In the near future, advanced dual-chamber atrioventricular (AV) pacing and defibrillating systems will also be available. The dual chamber ICD will allow atrial inhibited/dual-chamber (AAI/DDD) rate-responsive pacing, simultaneous atrial and ventricular sensing to optimize the arrhythmia identification, and ICD shock delivery in the proper arrhythmia-related chamber. Clinical benefits of these devices compared with their cost and complexity will require careful evaluation.

Cardiac Pacing, Artificial↗
PubMed1996

Comparison of long-term outcomes of patients treated with nonthoracotomy and thoracotomy implantable defibrillators.

In 193 consecutive patients treated with implantable defibrillators at our institution, thoracotomy approaches were used in 87 patients and nonthoracotomy approaches in 106 patients. Long-term outcomes of the 2 groups were compared by the intention-to-treat analysis. Surgical mortality (30-day mortality) rates were 5.7% in the thoracotomy group and 0% in the nonthoracotomy group. Six of 106 patients who underwent nonthoracotomy implantation had a high defibrillation threshold and did not receive nonthoracotomy defibrillators. The duration of follow-up was 52 +/- 31 months in the thoracotomy group, and 23 +/- 15 months in nonthoracotomy group. Actuarial survival rates at 6 and 24 months were, respectively, 90% and 81% in nonthoracotomy patients and 89% and 80% in thoracotomy patients (p = NS). In patients with left ventricular ejection fraction <30%, surgical mortality was 0% by the nonthoracotomy and 10% by the thoracotomy approach. Despite the 10% difference in 30-day mortality, survival rates at 6 months were 85% in nonthoracotomy patients and 81% in thoracotomy patients. At 24 months they were 73% in nonthoracotomy patients and 74% in thoracotomy patients. Thus, this nonrandomized study suggests that while short-term survival is better in nonthoracotomy patients than thoracotomy patients, the difference in survival diminishes quickly during the first few months and disappears by 6 months. The results were similar in patients with severe ventricular dysfunction. Several important implantable-cardioverter defibrillator (ICD) trials initially utilized thoracotomy ICDs. Although questions may be raised with regard to applicability of such a trial in the era of nonthoracotomy ICDs, this study suggests that the results of such ICD trials will be largely applicable to patients treated with nonthoracotomy ICDs.

Aged↗
PubMed1997

Clinical and socioeconomic profile of patients with malignant ventricular arrhythmias in 1993 to 1995. AVID investigators. Antiarrhythmics Versus Implantable Defibrillator.

This report summarizes the clinical and socioeconomic characteristics of the first 542 patients entered into the Antiarrhythmics Versus Implantable Defibrillator (AVID) trial. AVID is a multicenter trial comparing a strategy of initial implantable cardioverter-defibrillator placement to initial antiarrhythmic drug therapy in preventing death in patients resuscitated from cardiac arrest who were not taking amiodarone and who did not have an implantable cardioverter-defibrillator in place at the time of the index event. These patients were randomly assigned to immediate defibrillator placement or to "best" medical therapy. Clinical and socioeconomic histories were collected by interview using standard terms developed for the study. Patients without (group 1) and with (group 2) a history of prior cardiac arrest were compared. The mean age of the 542 patients was 65 +/- 10 years, most were men, white, had coronary disease, and were highly functional despite the fact that only a minority were employed. Almost all had some form of health insurance. At the time of the index event, few were taking any therapy to prevent cardiac arrest, even in the group of patients with a history of previous cardiac arrest. Thus, the clinical and socioeconomic profile of patients resuscitated from sudden cardiac death entered into the AVID study is generally as expected. There is a striking absence of any attempt at chronic therapy to prevent cardiac arrest in most patients with a prior ventricular tachycardia or ventricular fibrillation.

Aged↗
PubMed1997

What can we expect from prophylactic implantable defibrillators?

Death due to ventricular tachyarrhythmia (VT) remains an important public health problem; patients with prior myocardial infarction (MI) constitute the largest identifiable population for prophylactic interventions. Targeting of progressively higher-risk subgroups of post-MI survivors carries inevitable tradeoffs with respect to the global impact of interventions on overall mortality. Therapy with aspirin, beta blockers, and angiotensin-converting enzyme (ACE) inhibitors comprise the benchmark against which all additional interventions, including implantable defibrillators, must be measured. Initial enthusiasm for empiric amiodarone therapy has been tempered by the limited benefit demonstrated in recent randomized trials. Trials of other class III antiarrhythmic drugs, including both d,l-sotalol and d-sotalol, have also failed to demonstrate survival benefit. The Multicenter Automatic Defibrillator Implantation Trial (MADIT) demonstrated significantly improved survival associated with defibrillators in a small subgroup of post-MI survivors with a high short-term risk of death. The ultimate number and optimal criteria for selection of patients who may benefit from prophylactic defibrillator therapy after MI will undergo continued evolution as new data from current and ongoing trials become available.

Amiodarone↗
PubMed1996

Compatibility of a nonthoracotomy lead system with a biphasic implantable cardioverter-defibrillator. Cadence-Endotak 60-Series IDE investigators.

This prospective multicenter study was conducted under the Food and Drug Administration Investigational Device Exemption to evaluate the safety and efficacy of the combination of the Cadence implantable defibrillator (Ventritex, Inc.) and 60-series Endotak C leads (Cardiac Pacemakers, Inc.). Implantation was attempted in 148 patients with hemodynamically compromising ventricular tachycardia or fibrillation (VF), or with pace-terminable ventricular tachycardia. The system was successfully implanted in 97% of patients, with 96% of implants in a transvenous-lead-alone configuration. At implantation, the defibrillation threshold was 455 +/- 94 V (14 +/- 6 J) for lead-alone patients and 532 +/- 40 V (19 +/- 3 J) for those requiring a subcutaneous patch. VF conversion efficacy was reconfirmed in patients who underwent a 3-month chronic induction study. The system successfully detected all 763 induced arrhythmias and terminated 99.5% of them; after system modification, successful conversion was demonstrated in the 2 patients who initially had induced episodes requiring external defibrillation (1 lead revision; 1 reprogramming). All spontaneous episodes were terminated with an implantable-cardioverter defibrillator. Postshock VF redetection times were significantly shorter than initial detection times (4.5 +/- 1.8 seconds detection, 2.1 +/- 0.7 seconds redetection; p<0.0001). During an 8-month mean follow-up (range 1 to 31 months), 2 unwitnessed deaths were classified as sudden cardiac deaths, and 11 patients experienced a total of 12 complications, none of which was associated with the Cadence-Endotak combination.

Adult↗