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Objectives The Atrial Dynamic Overdrive Pacing Trial (ADOPT) was a single blind, randomized, controlled study to evaluate the efficacy and safety of the atrial fibrillation (AF) Suppression Algorithm (St. Jude Medical Cardiac Rhythm Management Division, Sylmar, California) in patients with sick sinus syndrome and AF. Background This algorithm increases the pacing rate when the native rhythm emerges and periodically reduces the rate to search for intrinsic atrial activity. Methods Symptomatic AF burden (percentage of days during which symptomatic AF occurred) was the primary end point. Patients underwent pacemaker implantation, were randomized to DDDR with the algorithm on (treatment) or off (control), and were followed for six months. Results Baseline characteristics and antiarrhythmic drugs used were similar in both groups. The percentage of atrial pacing was higher in the treatment group (92.9% vs. 67.9%, p Conclusions The ADOPT demonstrated that overdrive atrial pacing with the AF Suppression Algorithm decreased symptomatic AF burden significantly in patients with sick sinus syndrome and AF. The decrease in relative AF burden was substantial (25%), although the absolute difference was small (2.50% control vs. 1.87% treatment).

Objectives This study compared a biphasic waveform with a conventional monophasic waveform for cardioversion of atrial fibrillation (AF). Background Biphasic shock waveforms have been demonstrated to be superior to monophasic shocks for termination of ventricular fibrillation, but data regarding biphasic shocks for conversion of AF are still emerging. Methods In an international, multicenter, randomized, double-blind clinical trial, we compared the effectiveness of damped sine wave monophasic versus impedance-compensated truncated exponential biphasic shocks for the cardioversion of AF. Patients received up to five shocks, as necessary for conversion: 100 J, 150 J, 200 J, a fourth shock at maximum output for the initial waveform (200 J biphasic, 360 J monophasic) and a final cross-over shock at maximum output of the alternate waveform. Results Analysis included 107 monophasic and 96 biphasic patients. The success rate was higher for biphasic than for monophasic shocks at each of the three shared energy levels (100 J: 60% vs. 22%, p Conclusions For the cardioversion of AF, a biphasic shock waveform has greater efficacy, requires fewer shocks and lower delivered energy, and results in less dermal injury than a monophasic shock waveform.

OBJECTIVES The goal of this study was to identify subgroups of arrhythmia patients who do not benefit from use of the implantable cardiac defibrillator (ICD). BACKGROUND Treatment of serious ventricular arrhythmias has evolved toward more common use of the ICD. Since estimates of the cost per year of life saved by ICD therapy vary from $25,000 to perhaps $125,000, it is important to identify patient subgroups that do not benefit from the ICD. METHODS Data for 491 ICD patients enrolled in the Antiarrhythmics Versus Implantable Defibrillators Study were used to create a hazards model relating baseline factors to time to first recurrent arrhythmia. The model was used to predict the hazard for recurrent arrhythmia among all trial patients. A priori cut points provided lower and higher recurrent arrhythmia risk strata. For each stratum the incremental years of life due to ICD versus antiarrhythmic drug therapy were calculated. RESULTS Factors that predicted recurrent arrhythmia were: ventricular tachycardia as the index arrhythmia, history of cerebrovascular disease, lower left ventricular ejection fraction, a history of any tachyarrhythmia before the index event and the absence of revascularization after the index event. Survival times (over a follow-up of three years) were identical in each arm of the lowest risk sextile (survival advantage 0.03 ± 0.12 [se] years), while the survival advantage for patients above the first sextile was 0.27 ± 0.07 (se) years (two-sided p = 0.05). CONCLUSIONS Patients presenting with an isolated episode of ventricular fibrillation in the absence of cerebrovascular disease or history of prior arrhythmia who have undergone revascularization or who have moderately preserved left ventricular function (left ventricular ejection fraction > 0.27) are not likely to benefit from ICD therapy compared with amiodarone therapy.

Objective.The goal of this study was to establish guidelines for the prognostic use of the time domain signal-averaged electrocardiogram (ECG) after myocardial infarction.Background.Previous studies of the prognostic use of the signal-averaged ECG in postinfarction patients had one or more of the following limitations: a small study group, empiric definition of an abnormal recording and possible bias in the selection of high risk groups or classification of arrhythmic events, or both. To correct for these limitations, a substudy was conducted in conjunction with the Cardiac Arrhythmia Suppression Trial (CAST).Methods.Ten centers recruited 1,211 patients with acute myocardial infarction without application of the ejection fraction or Holter criteria restrictions of the main CAST protocol. Several clinical variables, ventricular arrhythmias on the Holter recording, ejection fraction and six signal-averaged ECG variables were analyzed. Patients with bundle branch block were exluded from the analysis, and the remaining 1,158 were followed for up to 1 year after infarction. The classification of arrhythmic events was reviewed independently by the CAST Events Committee.Results.During an average (±SD) follow-up of 10.3 ± 3.2 months, 45 patients had a serious arrhythmic event (nonfatal ventricular tachycardia or sudden cardiac arrhythmic death). A Cox regression analysis with only the six signal-averaged ECG variables indicated that the filtered QRS duration at 40 Hz ≥120 ms (QRSD-40 Hz) at a cutpoint ≥120 ms was the most predictive criterion of arrhythmic events. In a regression analysis that included all clinical, Holter and ejection fraction variables, a QRSD-40 Hz ≥120 ms was the most significant predictor (p < 0.0001). The positive, negative and total predictive accuracy and odds ratio for QRSD-40 Hz ≥120 ms were 17%, 98%, 88% and 8.4, respectively, and improved to 32%, 97% 94% and 16.7, respectively, after combination with ejection fraction ≤40% and complex ventricular arrhythmias on the Holter recording.Conclusions.The signal-averaged ECG predicts serious arrhythmic events in the first year after infarction better than do clinical, ejection fraction and ventricular arrhythmia variables, and QRSD-40 Hz ≥120 ms provides the best predictive criterion in this clinical setting.

Objectives. The purpose of this study was to determine whether the induction at electrophysiologic study of sustained monomorphic ventricular tachycardias with multiple QRS complex configurations predicted failure of subsequent serial electrophysiologic study guided antiarrhythmic drug testing. Background. Ventricular tachycardias with multiple QRS complex configurations are associated with failure of surgical therapy for ventricular tachycardia. As such, the presence of multiple monomorphic QRS complex ventricular tachycardias during electrophysiologic testing may predict failure of subsequent medical therapy. Methods. Fifty-one consecutive patients with coronary artery disease had reproducible induction of monomorphic ventricular tachycardia during a baseline electrophysiologic study. Each patient then underwent a mean of 1.5 antiarrhythmic drug trials. An antiarrhythmic drug regimen that suppressed induction of ventricular tachycardia was identified in 13 (26%) of the 51 patients. Results. Patients with only one inducible monomorphic QRS complex ventricular tachycardia at baseline study were more likely to have an antiarrhythmic drug regimen identified that suppressed inducible ventricular tachycardia than were patients with multiple monomorphic QRS complex ventricular tachycardias (12 [36%] of 33 patients vs. 1 [6%] of 18, p = 0.04). In seven patients with only one induced configuration of ventricular tachycardia, a second monomorphic ventricular tachycardia with a different QRS complex configuration occurred during attempts at pacing termination of the induced ventricular tachycardia. None of these seven patients then had successful drug suppression of inducible ventricular tachycardia. Thus, 12 (46%) of 26 patients with a single monomorphic QRS complex ventricular tachycardia observed at baseline study had successful serial drug testing compared with 1 (4%) of 25 patients with multiple QRS complex ventricular tachycardia configurations (p = 0.002). Conclusions. The induction or observation of multiple monomorphic QRS complex ventricular tachycardias at baseline electrophysiologic study predicted failure of subsequent serial electrophysiologic study-guided antiarrhythmic drug therapy.

The Atrial Dynamic Overdrive Pacing Trial (ADOPT) was a single blind, randomized, controlled study to evaluate the efficacy and safety of the atrial fibrillation (AF) Suppression Algorithm (St. Jude Medical Cardiac Rhythm Management Division, Sylmar, California) in patients with sick sinus syndrome and AF.This algorithm increases the pacing rate when the native rhythm emerges and periodically reduces the rate to search for intrinsic atrial activity.Symptomatic AF burden (percentage of days during which symptomatic AF occurred) was the primary end point. Patients underwent pacemaker implantation, were randomized to DDDR with the algorithm on (treatment) or off (control), and were followed for six months.Baseline characteristics and antiarrhythmic drugs used were similar in both groups. The percentage of atrial pacing was higher in the treatment group (92.9% vs. 67.9%, p0.0001). The AF Suppression Algorithm reduced symptomatic AF burden by 25% (2.50% control vs. 1.87% treatment). Atrial fibrillation burden decreased progressively in both groups but was lower in the treatment group at each follow-up visit (one, three, and six months) (p = 0.005). Quality of life scores improved in both groups. The mean number of AF episodes (4.3 +/- 11.5 control vs. 3.2 +/- 8.6 treatment); total hospitalizations (17 control vs. 15 treatment); and incidence of complications, adverse events, and deaths were not statistically different between groups.The ADOPT demonstrated that overdrive atrial pacing with the AF Suppression Algorithm decreased symptomatic AF burden significantly in patients with sick sinus syndrome and AF. The decrease in relative AF burden was substantial (25%), although the absolute difference was small (2.50% control vs. 1.87% treatment).

OBJECTIVES To evaluate whether use of beta-adrenergic blocking agents, alone or in combination with specific antiarrhythmic therapy, is associated with improved survival in persons with ventricular fibrillation (VF) or symptomatic ventricular tachycardia (VT). BACKGROUND The ability of beta-blockers to alter the mortality of patients with VF or VT receiving contemporary medical management is not well defined. METHODS Survival of 1,016 randomized and 2,101 eligible, nonrandomized patients with VF or symptomatic VT followed in the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial through December 31, 1996 was assessed using Cox proportional hazards analysis. RESULTS The 817 (28%) patients discharged from hospital receiving beta-blockers had less ventricular dysfunction, fewer symptoms of heart failure and a different pattern of medication use compared with patients not receiving beta-blockers. Before adjustment for important prognostic variables, beta-blockade was not significantly associated with survival in randomized or in eligible, nonrandomized patients treated with specific antiarrhythmic therapy. After adjustment, beta-blockade remained unrelated to survival in randomized or in eligible, nonrandomized patients treated with amiodarone alone (n = 1142; adjusted relative risk [RR] = 0.96; 95% confidence interval [CI] 0.64-1.45; p = 0.85) or a defibrillator alone (n = 1347; adjusted RR = 0.88; 95% CI 0.55 to 1.40; p = 0.58). In contrast, beta-blockade was independently associated with improved survival in eligible, nonrandomized patients who were not treated with specific antiarrhythmic therapy (n = 412; adjusted RR = 0.47; 95% CI 0.25 to 0.88; p = 0.018). CONCLUSIONS Beta-blocker use was independently associated with improved survival in patients with VF or symptomatic VT who were not treated with specific antiarrhythmic therapy, but a protective effect was not prominent in patients already receiving amiodarone or a defibrillator.

The determinants of atrioventricular (AV) nodal “slow pathway” conduction remain controversial. We hypothesized that anterograde “slow pathway” conduction time depends on the length (rather than functional properties) of the pathway. Therefore, we studied 19 patients (4 men and 15 women, mean age 51 ± 4 years) with typical AV nodal reentrant tachycardia (AVNRT) who underwent successful radiofrequency ablation (RFA) of the “slow pathway”. As a measure of the pathway length we determined two distances in both RAO and LAO projections: I) coronary sinus (CS) os to the His bundle and 2) mapping catheter tip at the successful ablation site to the His bundle. These distances were correlated with the conduction time of the “slow pathway” (AH interval) during programmed atrial stimulation following coupling intervals longer than the functional “slow pathway” refractory period and during AVNRT. RFA was initially attempted in the posteroseptal area of the right atrium close to the CS os and was delivered at progressively superior and anterior locations (closer to the compact AV node) only when inferior RFA applications were unsuccessful. Results There was a significant correlation between the anterograde “slow pathway” conduction time (AH) and the distance between the mapping catheter tip (MAP) and the His bundle (HIS) in both LAO (Fig.) and RAO projections (p l 0.001). This was true when slow pathway conduction time was measured either during programmed atrial stimulation or during AVNRT. Download : Download high-res image (43KB) Download : Download full-size image “Slow pathway” conduction time did not correlate with tle distance between the CS os and the His bundle. Conclusion In this study, AV nodal “slow pathway” conduction time was related to the distance between the “slow pathway” atrial insertion site and the His Bundle. This supports the hypothesis that “slow pathway” conduction time is in part due to pathway length and may not be due to functional properties.

Objectives. We sought to develop and apply a new scheme for the classification of death to be used in trials of antiarryhythmia treatments. Background. Because presently accepted classifications of death do not fully describe or tabulate all significant aspects of terminal events, nor do they consider unique aspects of arrhythmia investigations, a new classification scheme that addresses these issues is desirable. Methods. A classification scheme of deaths that occur in antiarrhythmia trials was developed using the following categories: 1) primary organ cause (cardiac [arrhythmic, nonarrhythmic or unknown], noncardiac or unknown); 2) temporal course (sudden, nonsudden or unknown); 3) documentation (witnessed, monitored [yes, no or unknown]); 4) operative relation (preoperative, perioperative or postoperative); and 5) system relation (procedure related, pulse generator related and lead related [yes, no or unknown]). Results. The classification scheme was used in a clinical trial of a new implantable cardioverter-defibrillator (1,250 patients, of whom 79 died) and used in an application for device market approval. Application of the classification to data reported using an older classification scheme is demonstrated. Conclusions. We propose a descriptive classification scheme that 1) fully describes and tabulates all significant aspects of terminal events; 2) incorporates previously used categorizations of death and new categorizations that address unique aspects of arrhythmia investigations; and 3) tabulates sufficient data to allow comparison with other studies. Events in a clinical trial of implantable defibrillator therapy were classified using the new classification scheme.

Objectives. We hypothesized that if the Electrophysiology Study Versus Electrocardiographic Monitoring (ESVEM) trial programmed stimulation protocol misclassified some drug trials as effective, then the misclassification rate would be proportionally greater for drugs other than sotalol. Background. In the ESVEM trial, patients treated with sotalol had fewer arrhythmic recurrences than those treated with other antiarrhythmic drugs despite similar efficacy predictions during electrophysiologic testing. Methods. We retrospectively compared the standard programmed stimulation protocol used at Case Western Reserve University, which used three extrastimuli during all follow-up studies, with the ESVEM protocol in 176 antiarrhythmic drug trials: sotalol (n = 54), procainamide (n = 73) and quinidine/mexiletine (n = 49). Results. Predictions of efficacy were higher in the sotalol trials (14 of 54 standard, 20 of 54 ESVEM) than in procainamide trials (7 of 73 standard, 14 of 73 ESVEM) or quinidine/mexiletine trials (1 of 49 standard, 7 of 49 ESVEM). Thus, the two protocols classified 19 of 176 trials differently: not effective by the standard protocol but effective by the ESVEM trial. Discordant predictions of drug efficacy constituted a smaller proportion of ESVEM protocol efficacy predictions for sotalol (6 [30%] of 20) than for the other drugs (13 [62%] of 21, p ⩽ 0.05). Conclusions. In the present study, the ESVEM programmed stimulation protocol predicted efficacy more often than the standard protocol. Discordant predictions represented a smaller portion of efficacy predictions for sotalol than for the other drugs. Thus, in the ESVEM trial, the superior long-term follow-up observed in patients assigned to sotalol may have been an artifact of the stimulation protocol utilized by the ESVEM investigators.

Objectives. This study attempted to determine whether cine magnetic resonance imaging (MRI), because of its unique ability to image the right ventricle, detects abnormalities in patients with right ventricular outflow tract ventricular tachycardia.Background. Right ventricular outflow tract ventricular tachycardia occurs in the absence of apparent structural heart disease.Methods. We compared cine MRI scans in 22 patients with right ventricular outflow tract ventricular tachycardia, 16 subjects without structural heart disease and 44 patients with other cardiovascular diseases. Echocardiography was performed in 21 patients with ventricular tachycardia.Results. All 22 patients with ventricular tachycardia had normal left ventricular function and no evidence of coronary artery disease. Cine MRI revealed right ventricular structural and wall motion abnormalities more often in patients with ventricular tachycardia (21 [95%] of 22) than in normal subjects (2 [12.5%] of 16, p < 0.0001) or patients without arrhythmia (17[39%] of 44, p < 0.0001). The abnormalities in patients with ventricular tachycardia (fixed focal wall thinning, excavation, decreased systolic thickening) were located in the right ventricular outflow tract, whereas those in patients without arrhythmia were confined to the free wall. Cine MRI demonstrated abnormalities in patients with ventricular tachycardia more often than did echocardiography (21 [95%] of 22 vs. 2 [9%] of 21, respectively, p < 0.0001). Conclusions. Right ventricular outflow tract ventricular tachycardia was associated with focal structural and wall motion abnormalities of the right ventricular outflow tract that were detected more often by cine MRI than by other imaging modalities and were not present in patients without arrhythmia or in normal subjects.

OBJECTIVES This study evaluated the prognosis of patients resuscitated from ventricular tachycardia (VT) or ventricular fibrillation (VF) with a transient or correctable cause suspected as the cause of the VT/VF. BACKGROUND Patients resuscitated from VT/VF in whom a transient or correctable cause has been identified are thought to be at low risk for recurrence and often receive no primary treatment for their arrhythmias. METHODS In the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial, patients with a potentially transient or correctable cause of VT/VF were not eligible for randomization. The mortality of these patients was compared with the mortality of patients with a known high risk of recurrence of VT/VF in the AVID registry. RESULTS Compared with patients having high risk VT/VF, those with a transient or correctable cause for their presenting VT/VF were younger and had a higher left ventricular ejection fraction. These patients were more often treated with revascularization as the primary therapy, more commonly received a beta-blocker, less often required therapy for congestive heart failure and less commonly received either an antiarrhythmic drug or an implantable cardioverter defibrillator. Nevertheless, subsequent mortality of patients with a transient or correctable cause of VT/VF was no different or perhaps even worse than that of the primary VT/VF population. CONCLUSIONS Patients identified with a transient or correctable cause for their VT/VF remain at high risk for death. Further research is needed to define truly reversible causes of VT/VF. Meanwhile, these patients may require more aggressive evaluation, treatment and follow-up than is currently practiced.

To assess the electrophysiologic effects of acute hemodynamic improvement in patients with left ventricular systolic dysfunction, 12 patients with a left ventricular ejection fraction