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Biomedical subjects

A E Epstein

Publications and source records attributed to A E Epstein.

At least 19 recordsLinked to original sources
PubMed1996

Classification of death in antiarrhythmia trials.

OBJECTIVES: We sought to develop and apply a new scheme for the classification of death to be used in trials of antiarrhythmia 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.

Arrhythmias, Cardiac↗
PubMed1995

The risk of atrial fibrillation following radiofrequency catheter ablation of atrial flutter.

BACKGROUND: Although radiofrequency catheter ablation of atrial flutter is associated with a high rate of initial success, several clinical issues regarding this therapy remain to be defined. For example, the risks of recurrent atrial flutter and of developing atrial fibrillation after flutter ablation are unknown. In addition, it is not known whether elimination of atrial flutter will modify the natural history of atrial fibrillation in patients who experience both of these arrhythmias. The purpose of the present study was to determine the actuarial freedom from recurrent or new atrial arrhythmias in patients with atrial flutter undergoing catheter ablation. METHODS AND RESULTS: The study population consisted of 59 consecutive patients (mean age, 61.9 +/- 12.6 years) with typical atrial flutter who underwent catheter ablation of the reentrant circuit. Catheter ablation was not advised for patients in whom paroxysmal atrial fibrillation had been a major clinical problem. The inducibility of atrial fibrillation and atrial flutter was assessed after successful atrial flutter ablation with programmed atrial stimulation and rapid atrial pacing to a cycle length of 180 ms or 2:1 atrial capture. Atrial flutter was successfully ablated and rendered noninducible in 53 of 59 patients (90%). Over a mean follow-up period of 13.2 +/- 6.6 months, atrial flutter recurred in 5 patients (9.4%). Atrial fibrillation occurred in 14 of 53 patients after successful ablation (26.4%). Four clinical variables were associated by univariate analysis with the late occurrence of atrial fibrillation: (1) the presence of structural heart disease, (2) a history of atrial fibrillation before ablation of atrial flutter, (3) inducible sustained atrial fibrillation after ablation, and (4) a greater number of failed antiarrhythmic drugs. By multivariate analysis, only the persistent inducibility of sustained atrial fibrillation predicted the later development of atrial fibrillation. CONCLUSIONS: Although atrial flutter ablation is highly effective and associated with a low risk of recurrent atrial flutter, atrial fibrillation continues to be a long-term risk for individuals undergoing this procedure. The risk of later atrial fibrillation is especially high for patients in whom sustained atrial fibrillation remains inducible after ablation of atrial flutter.

Aged↗
PubMed1995

Antiarrhythmics Versus Implantable Defibrillators (AVID)--rationale, design, and methods.

The Antiarrhythmics Versus Implantable Defibrillators (AVID) study compares a strategy of initial treatment with an implantable cardioverter-defibrillator (ICD) to a strategy of initial treatment with an antiarrhythmic drug to prevent death in patients with a history of ventricular fibrillation or hemodynamically compromising ventricular tachycardia, or both. Neither arrhythmia can have been due to a transient or correctable cause. The principle exclusions are a contraindication to amiodarone therapy and inability to undergo ICD implantation. Antiarrhythmic drug therapy includes empiric amiodarone and guided sotalol. The ICDs allowed are advanced generation devices, and most are implanted transvenously. The primary end point of the study is total mortality. Secondary end points are cost and quality of life. The study was designed in 2 phases. The pilot phase enrolled 200 patients between June 1993 and June 1994. Data collected during the pilot phase confirmed that the trial is feasible. An additional 1,000 patients will be enrolled between June 1994 and March 1997. It is anticipated that all 1,200 patients will be followed until September 1998, and will be included in the intention-to-treat analysis.

Amiodarone↗
PubMed1995

Association between ease of suppression of ventricular arrhythmia and survival.

BACKGROUND: We tested the hypothesis that patients whose ventricular arrhythmias are easy to suppress have a lower rate of arrhythmic death, defined as arrhythmic death and nonfatal cardiac arrest, the primary end point in the Cardiac Arrhythmia Suppression Trials (CAST-I and CAST-II), than patients whose ventricular arrhythmias are hard to suppress. In addition, we evaluated the association between ease of suppression of ventricular arrhythmias and mortality of all causes. METHODS AND RESULTS: CAST-I investigated the effect on arrhythmic death of ventricular premature depolarization (VPD) suppression achieved by three drugs, encainide, flecainide, and moricizine, at two different dose levels; CAST-II investigated the same effect, using moricizine alone at three dose levels. If suppression was achieved, patients were randomized to the effective active drug or corresponding placebo. To examine the independence of easily suppressed ventricular arrhythmias as a predictor of arrhythmic death, we adjusted statistically for other variables that were related both to ease of suppression and arrhythmic death. Patients with ventricular arrhythmias (n = 1778) that were easy to suppress had fewer arrhythmic deaths during follow-up than those with ventricular arrhythmias that were hard to suppress (n = 1173) (relative risk, .59; P = .003). Patients whose VPDs were easily suppressed were older and had a lower frequency of prior history of heart failure and myocardial infarction. They also had a higher incidence of anterior myocardial infarction, VPD frequency, and average ejection fraction. After adjusting for these variables, we found that easily suppressed ventricular arrhythmias were still significant predictors of arrhythmic death (relative risk, .66; P = .013). CONCLUSIONS: This study shows that the ease of VPD suppression identifies a subgroup of postmyocardial infarction patients who have low risk of arrhythmic death.

Aged↗
PubMed1995

Clinical investigation of antiarrhythmic devices. A statement for healthcare professionals from a joint task force of the North American Society of Pacing and Electrophysiology, the American College of Cardiology, the American Heart Association, and the Working Groups on Arrhythmias and Cardiac Pacing of the European Society of Cardiology.

The goal of radiofrequency catheter ablation and the criterion for efficacy is the elimination of arrhythmogenic myocardium. The application of radiofrequency current in the heart clearly results in lower morbidity and mortality rates than thoracic and cardiac surgical procedures in general, and comparisons of therapy with radiofrequency catheter ablation and therapy with thoracic and cardiac surgical procedures in randomized clinical trials is unwarranted. Trials of radiofrequency catheter ablation versus medical or implantable cardioverter-defibrillator therapy may be indicated in certain conditions, such as ventricular tachycardia associated with coronary artery disease. Randomized trials are recommended for new and radical departures in technology that aim to accomplish the same goals as radiofrequency catheter ablation. Surveillance using registries and/or databases is necessary in the assessment of long-term safety and efficacy.

American Heart Association↗
PubMed1995

NASPE/ACC/AHA/ESC medical/scientific statement special report--clinical investigation of antiarrhythmic devices: a statement for healthcare professionals from a Joint Task Force of the North American Society of Pacing and Electrophysiology, the American College of Cardiology, the American Heart Association, and the Working Groups on Arrhythmias and Cardiac Pacing of the European Society of Cardiology.

The goal of radiofrequency catheter ablation and the criterion for efficacy is the elimination of arrhythmogenic myocardium. The application of radiofrequency current in the heart clearly results in lower morbidity and mortality rates than thoracic and cardiac surgical procedures in general, and comparisons of therapy with radiofrequency catheter ablation and therapy with thoracic and cardiac surgical procedures in randomized clinical trials are unwarranted. Trials of radiofrequency catheter ablation versus medical or implantable cardioverter defibrillator therapy may be indicated in certain conditions, such as ventricular tachycardia associated with coronary artery disease. Randomized trials are recommended for new and radical departures in technology that aim to accomplish the same goals as radiofrequency catheter ablation. Surveillance using registries and/or databases is necessary in the assessment of long-term safety and efficacy.

Arrhythmias, Cardiac↗
PubMed1995

Drugs versus devices: contemporary practice in light of contemporary trials.

In years past, the secondary prevention of life-threatening ventricular arrhythmias was limited to empiric drug therapy. In close temporal proximity to the birth of electrophysiologic study-guided treatment strategies to manage these arrhythmias, devices to convert arrhythmias were envisioned and designed. Now, advanced generation implantable defibrillators provide synchronized, low-energy cardioversion, antitachycardia pacing, and pacing support for bradycardia. Over the past decade and half, this technology that was once applied as a therapy of last resort has evolved and emerged as a therapy of first choice. Recently, however, enthusiasm for drug treatment strategies has also increased, especially the use of amiodarone. Most experts now agree that drug therapy chosen by electrophysiologic study guidance provides superior survival compared to the empiric use of Class I drugs, as long as a drug that suppresses arrhythmia inducibility is found. The empiric use of amiodarone and beta blockers may also improve outcome. This review examines some of the recent clinical trials utilizing pharmacologic and nonpharmacologic methods. The importance of ongoing and future clinical trials is emphasized.

Anti-Arrhythmia Agents↗
PubMed1995

Elevated defibrillation threshold when right-sided venous access is used for nonthoracotomy implantable defibrillator lead implantation. The Endotak Investigators.

INTRODUCTION: Although myriad factors influence the defibrillation threshold, the relation between the site of transvenous lead entry into the vascular system and the defibrillation threshold has not been reported. This study examines the influence that venous entry site has on defibrillation success for a transvenous implantable cardioverter defibrillator lead with two defibrillating coils. METHODS AND RESULTS: The study population comprised 345 patients. Their mean age was 61 +/- 13 years and, left ventricular ejection fraction was 0.33 +/- 0.13. A left-sided approach was used in 324 (93.9%) of the patients, and a right-sided approach was used in the remaining 21 (6.1%) patients. There was no difference in the gender, age, left ventricular ejection fraction, or underlying cardiac disease in the two groups. For all patients, with a transvenous lead used either alone or with a submuscular or subcutaneous patch, the biphasic defibrillation threshold was 9.9 +/- 4.8 J when a left-sided approach was used, and 14.0 +/- 7.3 J when a right-sided approach was used (P = 0.02). When a transvenous lead was used with a submuscular or subcutaneous patch (115 patients), the biphasic defibrillation threshold was 9.5 +/- 4.3 J when a left-sided approach was used, and 12.0 +/- 10.0 J when a right-sided approach was used (P = 0.98). When a transvenous lead was used without a submuscular or subcutaneous patch (230 patients), the biphasic defibrillation threshold was 10.1 +/- 5.0 J when a left-sided approach was used, and 14.6 +/- 6.6 J when a right-sided approach was used (P < 0.01). For the entire group of patients and for each specific lead arrangement, there was no significant difference in the defibrillating lead system impedance when right-sided versus left-sided approaches were compared. CONCLUSION: Left-sided approaches to implant transvenous leads with two coils for defibrillation result in lower biphasic defibrillation thresholds than when right-sided approaches are used.

Defibrillators, Implantable↗
PubMed1994

Predictors of recurrent atrioventricular nodal reentry after selective slow pathway ablation.

Although radiofrequency catheter ablation of the slow atrioventricular (AV) nodal pathway is highly effective for the management of AV nodal reentrant tachycardia (AVNRT), this arrhythmia may recur in some patients after an ablation procedure that initially renders AVNRT noninducible. A retrospective study examined the factors that are associated with the recurrence of AVNRT after selective radiofrequency catheter ablation of the slow pathway. Patients were included in the study if they had initially inducible, typical slow-fast AVNRT that was noninducible at the end of the ablation session. Selective ablation of the slow pathway was performed using radiofrequency energy applied along the tricuspid annulus near the coronary sinus ostium. AVNRT recurred after initially successful slow pathway ablation in 10 of 136 patients (7.4%) over a mean follow-up period of 20.1 +/- 5.0 months; the time to recurrence ranged from 1 to 411 days. Despite the absence of inducible AVNRT, dual anterograde AV nodal conduction properties persisted after slow pathway ablation in 10 patients. AVNRT recurred in 4 of 10 patients who had evidence of residual slow pathway conduction compared with only 6 of 126 who had no residual slow pathway conduction (p = 0.003). All patients with persistent slow pathway conduction and recurrent AVNRT also had residual AV nodal echo beats. AVNRT recurred in 3 of 6 patients without accelerated junctional tachycardia during radiofrequency application compared with only 7 of 109 with accelerated junctional tachycardia (p = 0.003). Thus, AVNRT infrequently recurs after successful selective radiofrequency ablation of the slow pathway.(ABSTRACT TRUNCATED AT 250 WORDS)

Atrioventricular Node↗
PubMed1994

Implantable cardioverter-defibrillator therapy in 300 patients with coronary artery disease presenting exclusively with ventricular fibrillation.

To determine outcomes of implantable cardioverter-defibrillator (ICD) therapy in a uniform population of survivors of sudden cardiac death, we used epicardial defibrillation lead systems to study 300 patients with coronary artery disease (CAD) presenting exclusively with ventricular fibrillation (VF) unassociated with acute myocardial infarction. Operative (30-day) mortality, 2.7% overall, was lower (0.6%) in patients with ejection fractions (EF) > or = 0.30. Over a median follow-up of 1.9 years, cumulative actuarial shock incidence was similar in patients who underwent concomitant coronary artery bypass graft (CABG) surgery (38%) and in those who did not. The 2-year cumulative actuarial incidences of any or appropriate shocks were 65% and 38%, respectively. Sudden death survival at 2 years was 92.5% and 99.3% for patients with EFs < or = 0.30 and > 0.30, respectively. The total mortality rate was similar in shocked and in unshocked patients. Multivariate analysis identified EF and female gender as significant predictors of any and appropriate shock occurrence (all p values < or = 0.05) and EF as a significant predictor of sudden, cardiac, and total mortality (all p values < 0.03). We conclude that in CAD patients presenting exclusively with VF unassociated with acute myocardial infarction and treated with thoracotomy-requiring ICD therapy: (1) operative (30-day) mortality is minimal for patients with an EF > or = 0.30; (2) device use is high and sudden death rates low regardless of concomitant CABG; (3) low EF is a significant predictor of cumulative shock occurrence and mortality (sudden, cardiac, and total); (4) female gender may be a predictor of shock occurrence; and (5) similar mortalities and low sudden-death rates in shocked and nonshocked ICD patients imply that ICD therapy improves survival in shocked patients to a level observed in comparable patients in whom ventricular tachyarrhythmia does not recur.

Actuarial Analysis↗
PubMed1994

New insights into the definition and meaning of proarrhythmia during initiation of antiarrhythmic drug therapy from the Cardiac Arrhythmia Suppression Trial and its pilot study. The CAST and CAPS Investigators.

OBJECTIVES: This study was undertaken to determine the characteristics of worsening ventricular arrhythmia during antiarrhythmic drug titration. BACKGROUND: Proarrhythmia is an evolving concept in cardiology. Its definition, incidence and clinical significance in various patient settings require refinement. METHODS: The impact of early proarrhythmia was analyzed in 3,840 patients in the Cardiac Arrhythmia Suppression Trial (CAST). RESULTS: Drug therapy did not affect the incidence of new, sustained but nonfatal ventricular tachycardia (placebo 0.5%, active drug 0.4%). Nevertheless, there was a threefold increase in arrhythmic death (placebo 0.5% vs. active drug 1.6%). The incidence of increased ventricular premature depolarizations was equivalent (3% to 5%) for the three study drugs and indistinguishable from that seen with placebo. Patients with increased ventricular premature depolarizations on the first drug tested had fewer at baseline (65 +/- 94 vs. 137 +/- 260 per hour; mean +/- SD) (p < 0.01). When increased ventricular premature depolarizations occurred with the first drug, they were much more likely also to be present with the second drug (for example, 42% vs. 5%, p < 0.001). Increased ventricular premature depolarizations during initiation of therapy independently predicted increased risk of subsequent arrhythmic death (independent relative risk 2.34, p = 0.0053) in the absence of continued antiarrhythmic drug therapy. CONCLUSIONS: The overall incidence of early worsening of arrhythmia in the present study was low. In the absence of placebo control, the incidence of proarrhythmia will be overestimated. Increased ventricular premature depolarizations had characteristics that suggest they often represent spontaneous variability rather than proarrhythmia. The main finding is that markedly increased ventricular premature depolarizations during drug titration predict long-term increased risk of arrhythmic death in this patient population despite absence of long-term antiarrhythmic drug therapy.

Aged↗
PubMed1993

Mortality following ventricular arrhythmia suppression by encainide, flecainide, and moricizine after myocardial infarction. The original design concept of the Cardiac Arrhythmia Suppression Trial (CAST).

OBJECTIVE: To test the hypothesis that in survivors of myocardial infarction, the suppression of ventricular premature depolarizations improves survival free of cardiac arrest and arrhythmic death. DESIGN: International, prospective, multicenter, randomized, placebo-controlled trial. SETTING: University and community hospitals. PATIENTS: A total of 3549 patients with myocardial infarction and left ventricular dysfunction. INTERVENTION: Administration of encainide, flecainide, moricizine, or placebo to suppress ventricular premature depolarizations. MAIN OUTCOME MEASURES: Overall survival and survival free of cardiac arrest or arrhythmic death were compared in patients randomized to long-term, active antiarrhythmic drug therapy vs corresponding placebo, using the stratified log rank statistic. RESULTS: At 1 year from the time of randomization to blinded therapy, 95% of placebo-treated patients vs 90% of active drug-treated patients remained alive (P = .0006). Similarly, at 1 year, 96% of placebo-treated patients vs 93% of active drug-treated patients remained free of cardiac arrest or arrhythmic death (P = .003). CONCLUSIONS: The suppression of asymptomatic or mildly symptomatic ventricular arrhythmias after myocardial infarction does not improve survival and can increase mortality. Treatment strategies designed solely to suppress these arrhythmias should no longer be followed.

Aged↗
PubMed1993

Outcome with implantable cardioverter-defibrillator therapy for survivors of ventricular fibrillation secondary to idiopathic dilated cardiomyopathy or coronary artery disease without myocardial infarction.

Patients with idiopathic dilated cardiomyopathy (IDC) constitute a minority among implantable cardioverter-defibrillator (ICD) recipients; how these patients fare versus those with coronary artery disease (CAD) is not well defined, nor is the mechanism of cardiac arrest recurrence, which may involve a more significant role of bradyarrhythmias. A retrospective multicenter study regarding outcome of ICD therapy was conducted in 224 patients with either IDC (n = 69; 31%) or CAD (n = 155; 69%) presenting exclusively with ventricular fibrillation (VF) unassociated with acute myocardial infarction. Patients with IDC were significantly younger (mean age 57 vs 61 years in patients with CAD, p < 0.04) and less male predominant (64 vs 79% in patients with CAD, p < 0.02). There was no significant difference in mean left ventricular ejection fraction (0.27 in IDC patients vs 0.29 in CAD patients), but sustained ventricular tachycardia was induced less often in patients with IDC (21 vs 58% in CAD patients, p < 0.001). Bradycardia pacing, either by an ICD with bradycardia pacing ability or a separate bradycardia pacemaker, was available in only 15% of ICD implantees. During a median follow-up duration of 1.7 years for patients with IDC and 1.9 years for patients with CAD, estimated cumulative event rates were similar for any type shock (2-year incidence of 74% in IDC patients, 69% in CAD patients) as well as for appropriate shock (2-year incidence of 46% in IDC patients, 40% in CAD patients).(ABSTRACT TRUNCATED AT 250 WORDS)

Cardiomyopathy, Dilated↗
PubMed1993

Radiofrequency ablation for treatment of primary atrial tachycardias.

OBJECTIVES: The purpose of this study was to determine the safety and efficacy of radiofrequency ablation as definitive therapy for primary atrial tachycardias. BACKGROUND: Primary atrial tachycardias are often difficult to control with antiarrhythmic medications and frequently require nonpharmacologic interventions for definitive therapy. Despite isolated reports of successful treatment of primary atrial tachycardias with radiofrequency ablation, the safety and efficacy of this technique have not been established in a larger series with long-term follow-up. METHODS: The immediate procedural success rate, associated complications and follow-up data of radiofrequency ablation were evaluated in 15 consecutive patients (11 adults and 4 children) with primary atrial arrhythmias that were refractory to medical management. RESULTS: The clinical arrhythmia was ectopic atrial tachycardia in 11 patients and sinus node reentry in 4. The site of origin of the tachycardia was in the right atrium in 14 patients and in the left atrium in 1 patient (with two distinct foci) where the local atrial electrogram preceded the onset of the P wave by 10 to 30 ms. Radiofrequency energy successfully terminated the primary atrial tachycardia in each of the patients, and all were discharged from the electrophysiology laboratory in sinus rhythm without inducible atrial tachycardia. A mean of 10.8 +/- 9.9 radiofrequency applications were delivered using 30 W of power for 30 s. The local intracardiac activation time (relative to the P wave in the surface electrocardiogram) was a mean of -21 +/- 5 ms at the successful ablation site and -15 +/- 6 ms at unsuccessful sites (p < 0.001). No complications were observed, although one patient with incessant ectopic atrial tachycardia had sinus pauses after ablation. During a mean follow-up period of 277 +/- 133 days, the clinical arrhythmia recurred in three patients (20%, 95% confidence intervals 3% to 37%) including two patients with ectopic atrial tachycardia and one patient with sinus node reentry. One of these patients was successfully treated in a second ablation session. CONCLUSIONS: Thus, radiofrequency catheter ablation appears to be a safe and effective technique for the treatment of primary atrial arrhythmias that are refractory to antiarrhythmic medications.

Adolescent↗