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(Circulation. 1997;96:1888-1892.)
© 1997 American Heart Association, Inc.

Articles

Predictors of Arrhythmic Death and Cardiac Arrest in the ESVEM Trial

Anthony C. Caruso, MD; Frank I. Marcus, MD; Elizabeth A. Hahn; Vernon L. Hartz; Jay W. Mason, MD,; ; and the ESVEM Investigators¹

From the Department of Medicine, University of Arizona Health Sciences Center, Tucson, Ariz, and the Division of Cardiology, University of Utah Medical Center, Salt Lake City.

Correspondence to Frank I. Marcus, MD, Cardiology Section, University of Arizona Health Sciences Center, 1501 N Campbell Ave, PO Box 24-5037, Tucson, AZ 85724.

	Abstract

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Background The purpose of this study was to determine if the presenting ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation/cardiac arrest) predicted the type of arrhythmia recurrence in patients treated with antiarrhythmic drugs.

Methods and Results In the previously reported Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) trial, there were 486 patients who were randomized to antiarrhythmic drug testing guided by electrophysiological study or by ambulatory ECG monitoring. Use of a defibrillator (implantable cardioverter-defibrillator, ICD) without stored electrograms among 81 patients precluded determination of the type of arrhythmia recurrence; thus these patients were censored at the time of ICD implantation. Of the 486 patients, 381 presented with ventricular tachycardia and 105 with cardiac arrest. Over a 6-year follow-up period, 285 of the 486 patients had an arrhythmia recurrence; of these, 97 had an arrhythmic death or cardiac arrest as a first recurrence. In the current analysis, all 129 arrhythmic deaths/cardiac arrests that occurred any time during follow-up were evaluated as end points.

Conclusions Although univariate analysis suggested that there was an association between the presenting arrhythmia and outcome, multivariate analysis failed to substantiate the predictive value of the presenting arrhythmia. Left ventricular ejection fraction was the single most important predictor of arrhythmic death or cardiac arrest. This information may be an important factor in deciding whether to advise ICD therapy.

Key Words: arrhythmia • antiarrhythmia agents • defibrillation

	Introduction

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The Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) trial was a multicenter study designed to determine if electrophysiological study (EPS) or ambulatory ECG monitoring provided a more accurate prediction of antiarrhythmic drug efficacy in patients with sustained ventricular tachyarrhythmias.^{1 2} It was found that there was no difference in recurrence of ventricular arrhythmias in the 296 patients receiving drugs predicted to be effective by either EPS or ambulatory ECG monitoring and exercise testing.³ The purpose of the current analysis was to determine which clinical characteristics were predictive of arrhythmic death or cardiac arrest. Patients who present with cardiac arrest are managed differently because of a perceived greater risk of recurrent cardiac arrest.^{4 5} These patients receive implantable cardioverter-defibrillators (ICDs) more frequently than patients who present with ventricular tachyarrhythmias without cardiac arrest.⁴ Therefore, we were especially interested in determining if the type of presenting arrhythmia (ventricular tachycardia or ventricular fibrillation/cardiac arrest) predicted the type of arrhythmia recurrence.

	Methods

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The design and primary results of the ESVEM trial have been described previously.^{1 2 3 6} A total of 486 patients were randomized to antiarrhythmic drug testing guided by EPS or by ambulatory ECG monitoring (Holter monitoring). Their clinical presentation was ventricular tachycardia (n=356), syncope (n=25), and ventricular fibrillation or cardiac arrest (n=105). The patients with syncope had ventricular tachycardia inducible at electrophysiological testing. Hereafter, the 381 patients with ventricular tachycardia or syncope will be called the ventricular tachycardia group and the 105 patients will be called the cardiac arrest group. Patients then received up to six antiarrhythmic drugs in random order until one was predicted to be effective by the method to which they were randomized. The drugs were imipramine, mexiletine, pirmenol, procainamide, propafenone, quinidine, and sotalol. Patients also underwent exercise testing before hospital discharge. Each drug was tested at a specified dose. If this dose could not be achieved because of intolerance, a lower dose was then used as long as it exceeded a specified minimum dose. Testing was performed for each drug until one drug was determined to be effective or all eligible drugs failed. The 486 patients all had EPS with the same protocol for induction, and the arrhythmias had to be induced twice at baseline. Follow-up among all 486 randomized was nearly complete. At 1 year, only 4 (1%) of the patients who had received a prediction of efficacy and 6 patients (3%) who had not were lost to follow-up. An additional 9 and 11 patients (3% and 6%, respectively) were lost to follow-up after 1 year.

The primary end point in the ESVEM trial was the recurrence of arrhythmia in patients who were receiving a drug predicted to be effective by serial testing. Intention-to-treat analyses were also performed for all randomized patients. Recurrence of arrhythmia was defined as any one of the following: documented ventricular tachyarrhythmias >15 beats in duration, ventricular fibrillation, death caused by arrhythmia, cardiac arrest, ICD discharge, torsade de pointes, and unmonitored syncope with no explanation other than arrhythmia. Of the recurrences of ventricular tachycardia, 85% were sustained (>15 seconds). Although ICD discharges were considered to represent an arrhythmic event, it was not possible to further classify these events with accuracy. A committee reviewed all deaths and classified them according to the criteria of Hinkle and Thaler.⁷ For the purpose of this analysis, only cardiac death and arrhythmic death were considered end points.

Because the aim of the present study was to evaluate whether the type of presenting arrhythmia predicted the type of arrhythmia recurrence, this analysis was made with the patients who were randomized to the ESVEM study whether or not an antiarrhythmic drug was identified that was predicted to be effective. Of the 486 patients randomized, 81 had a defibrillator implanted after withdrawal from the study. Because it was not possible to be certain of the type of arrhythmia recurrence that may have caused the defibrillator to discharge (because the devices did not have electrogram storage), these patients were censored at the time of the ICD implantation. Nine of the 81 patients who had ICD implantation had cardiac arrest before device implantation, so these patients were not censored. The clinical characteristics of these 81 patients were not different from the other 405 patients. In particular, 26% of each patient group had a left ventricular ejection fraction (LVEF) 40%.

Ten variables were assessed for prediction of arrhythmic death or cardiac arrest. These were (1) method of assessment (either serial invasive EPS or ambulatory ECG monitoring), (2) enrolling institution, (3) presenting arrhythmia, (4) cycle length of the induced arrhythmia (ventricular tachycardia of cycle length <235 ms [>255 bpm] or ventricular fibrillation versus sustained ventricular tachycardia of <255 bpm), (5) mean premature ventricular beat (PVB) frequency per hour as determined by baseline ambulatory ECG monitoring, (6) presence of coronary artery disease, (7) congestive heart failure categorized by the symptom-activity scale (SAS) class,⁸ (8) age, (9) sex, and (10) LVEF determined by echocardiography, radionuclide ventriculography, or ventriculography at the time of cardiac catheterization. The univariate effect of presenting arrhythmia on outcome was assessed with both actuarial methods and a comparison of the proportions with different categories of outcomes. A multivariate Cox proportional hazards model was constructed with the use of a step-down approach starting with those variables that were significant univariately at P<.25. In addition to the randomized assessment method and the five stratification variables (enrolling institution, presenting arrhythmia, mean PVB frequency per hour, presence of coronary artery disease, and SAS class⁸ ), the final model included only those variables that were significant at P<.05. Comparisons of means and proportions were made with standard statistical tests for continuous and categorical data. SAS software was used for all analyses.⁹

	Results

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Clinical Characteristics of the 486 Patients
Table 1 shows the characteristics of the 381 patients in the ventricular tachycardia group and the 105 patients in the cardiac arrest group. The mean age was 65 years. Eighty-four percent of the patients had coronary artery disease. The mean LVEF was 32%. Seventy-three percent of the patients were categorized as having congestive heart failure of SAS class II, III, or IV; 30% had SAS class III or IV.⁸ The cardiac arrest group had a lower LVEF and fewer patients with at least 30 PVB per hour compared with the ventricular tachycardia group. The two patient groups were similar in age, sex, disease origin, and functional classification.

View this table: [in this window] [in a new window]   Table 1. Clinical Characteristics of 486 Patients Randomized by Presenting Arrhythmia

Arrhythmia Recurrence
Over a 6-year follow-up period, 285 of the 486 patients had an arrhythmia recurrence; 129 patients had arrhythmic death or cardiac arrest as a first recurrent event or subsequent event. The first recurrent arrhythmia was arrhythmic death or cardiac arrest in 97 (Table 2). Patients in the cardiac arrest group were more likely to experience arrhythmic death or cardiac arrest (29%) as their first recurrent arrhythmia compared with patients in the ventricular tachycardia group (18%), whereas the reverse pattern was seen for the end point of all other arrhythmias (32% versus 40%, P=.038) (Table 2). Initial univariate analysis of the patients who had arrhythmic death or cardiac arrest as a first or subsequent event suggested that there was an association between presenting arrhythmia and outcome (Table 3). However, multivariate analysis did not support the predictive value of the presenting arrhythmia identified by univariate analysis (Table 4 and Fig 1). Of the variables tested, ejection fraction and SAS class III or IV were the most significant independent predictors of arrhythmic death or cardiac arrest. Fig 2 illustrates that as the LVEF decreased, the risk of cardiac arrest or arrhythmic death increased. For each decrease of 5% in LVEF, the risk of cardiac arrest or arrhythmic death increased by 15%. When the same univariate and multivariate analyses were done including only the 296 patients who had an efficacy prediction, the results were virtually identical with the exception that SAS class III and IV was no longer a significant independent predictor (P=.094).

View this table: [in this window] [in a new window]   Table 2. Relationship of the Presenting Arrhythmia to Type of First Recurrent Arrhythmia

View this table: [in this window] [in a new window]   Table 3. Univariate Analyses for Arrhythmic Death/Cardiac Arrest (Censored at ICD Implantation) Any Time During Follow-up

View this table: [in this window] [in a new window]   Table 4. Multivariate Model for Arrhythmic Death/Cardiac Arrest (Censored at ICD Implantation) Any Time During Follow-up (n=432)

View larger version (15K): [in this window] [in a new window]   Figure 1. Cumulative probability of arrhythmic death or cardiac arrest by presenting arrhythmia. The probability value shown is adjusted for covariates (see Table 4). VT indicates ventricular tachycardia; CA, cardiac arrest.

View larger version (16K): [in this window] [in a new window]   Figure 2. Estimated relative risk of arrhythmic death or cardiac arrest for different values of left ventricular ejection fraction (LVEF) compared with the risk for a patient with LVEF of 30%

Only 1 of the 19 patients whose presenting arrhythmia was cardiac arrest and who had an LVEF 40% had cardiac arrest as a first recurrence, whereas 14 of these patients had no arrhythmia recurrence. Of the 8 patients with cardiac arrest as the presenting arrhythmia and who had an ICD discharge, none had LVEF 40% (Table 2).

	Discussion

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Of the 10 clinical variables evaluated, LVEF was a more important determinant of the type of recurrent ventricular arrhythmia than the initial clinical presentation of the arrhythmia (ventricular tachycardia versus cardiac arrest). The higher the LVEF, the lower the risk that a recurrent ventricular arrhythmia would be arrhythmic death or cardiac arrest. Previous studies have reported that LVEF, usually dichotomized at 0.30, is a determinant of arrhythmia recurrence,^{10 11 12 13 14} sudden death or cardiac arrest,^{11 15 16 17 18 19 20 21 22} as well as cardiac or total mortality^{11 12 20 23 24 25 26 27}

The present study establishes the importance of left ventricular function assessed by measurement of LVEF or by SAS class as a determinant of arrhythmic death or cardiac arrest in a large group of patients who had sustained ventricular arrhythmias and were followed prospectively for 6 years after their index arrhythmia.

The relation between left ventricular function and type of arrhythmia recurrence also has been observed in patients treated with amiodarone.^{28 29 30} In a group of 122 patients with ventricular tachycardia/ventricular fibrillation who had failed conventional antiarrhythmic drug therapy and were treated with amiodarone, 29% of 84 patients with LVEF <40% died suddenly compared with 1 of 35 with LVEF 40%. The mean follow-up period was 19.5 months. Among the 49 patients with LVEF <40%, neither inducibility of tolerated ventricular tachycardia nor inability to induce ventricular tachycardia after amiodarone predicted a low risk of sudden death.³⁰ A multivariate analysis of 427 patients who had sustained ventricular tachycardia or cardiac arrest and who were treated with oral amiodarone showed that advanced age, low ejection fraction, and a history of cardiac arrest were independent risk factors for sudden death during amiodarone therapy.²⁹ The incidence of sudden cardiac death differed significantly when patients with LVEF >40% were compared with those who had LVEF <40%. By multivariate analysis, a 10% decrease in ejection fraction was associated with a 50% increase in sudden death. Left ventricular function had a greater impact on predicting sudden death than did the presenting arrhythmia.²⁹ DiCarlo et al²⁸ also reported that LVEF <40% was associated with a high risk of cardiac arrest during treatment with amiodarone for sustained ventricular tachycardia or ventricular fibrillation. McGovern et al³¹ found that LVEF was more important than the rate and duration of induced ventricular tachycardia as a determinant of recurrent ventricular tachycardia as well as sudden cardiac death in patients who were still inducible to ventricular tachycardia 2 weeks after treatment with amiodarone.

Although 141 of the patients received amiodarone after withdrawal from the present study, it is not likely that amiodarone is a determinant of the results. There was no difference in the presenting arrhythmia among patients who did or did not receive amiodarone after they were withdrawn from the protocol (P=.564). Also there was no difference in the percent of patients who received an ICD and were treated with amiodarone (49%) and those who did not receive an ICD and were treated with this drug (45%, P=.597).

It should also be noted that the results of this analysis were virtually identical when restricted to the 296 patients with efficacy prediction, none of whom received amiodarone.

The observation that the initial presenting arrhythmia of ventricular fibrillation or cardiac arrest was not the most important determinant of the type of recurrence could be explained by the confounding effect of the antiarrhythmic drug on the rate of the recurrent ventricular arrhythmia. If the rate of the recurrent arrhythmia is considerably slower, the arrhythmia may be better tolerated hemodynamically. It has been reported that "partial" drug responders, defined as drug-induced slowing of the ventricular tachycardia rate <150 bpm with systolic blood pressure >90 mm Hg, predicted a low 2-year mortality rate.³² However, results of electrophysiologically guided drug testing did not predict prognosis in cardiac arrest survivors.

The results of our analysis highlighting the importance of decreased LVEF as a prognostic determinant of arrhythmic death as well as cardiac arrest may apply to patients with ventricular tachycardia/cardiac arrest who are not predicted to be responders to antiarrhythmic drugs or to a larger less-selected population treated empirically with a type III antiarrhythmic drug such as amiodarone.

The major clinical question in treating a patient who has had sustained ventricular tachycardia or cardiac arrest is whether to select antiarrhythmic drug therapy with a drug such as sotalol or amiodarone or to implant a defibrillator. Our study suggests that the clinical presentation or the initial arrhythmia is not the most important criteria for predicting the type of recurrent arrhythmia. This information may be a factor in determining whether or not to advise ICD therapy in patients presenting with cardiac arrest compared with sustained ventricular tachycardia without arrest and may be of use in formulating designs for clinical trials related to this question.

Summary
LVEF is the single most important prognostic factor for predicting whether an arrhythmia recurrence is likely to be ventricular tachycardia or cardiac arrest in patients with life-threatening ventricular arrhythmias who are treated with antiarrhythmic drugs.

	Footnotes

 
¹ A complete list of investigators appears in the "Appendix."

	Appendix 1

Top Abstract Introduction Methods Results Discussion Appendix 1 References

 
The enrollment centers and study investigators participating in the ESVEM trial are listed below. For each center, the first person listed was the principal investigator.

University of Arizona, Tucson: F.I. Marcus, A. Caruso, H.L. Faitelson, T.E. Raya, Z. Garcia, K. Gear, and M.K. Pierce; Baylor College of Medicine, Houston, Tex: C.M. Pratt, A. Boahene, A. Pacifico, C. Wyndham, and M. Francis; University of British Columbia, Vancouver: C.R. Kerr, J.A. Yeung, and S. Vorderbrugge; University of California, San Francisco: J.C. Griffin, M. Lesh, M.M. Scheinman, and M. Wong; University of Colorado, Denver: M. J. Reiter, D. Mann, T. Heyborne, and C. Kenny; Columbia University, New York, NY: J.T. Bigger, Jr, J. Coromilas, F.D. Livelli, Jr, J. Reiffel, J.S. Steinberg, J. Campoin, and A.M. Squatrito; University of Massachusetts, Worcester: S.K. Huang, R. Mittleman, P. Collett-Willey, and K. Rofino; Newark Beth Israel Medical Center, Newark, NJ: S. Saksena, R.B. Krol, and L. Duque; University of New Mexico, Albuquerque: R.C. Klein, C. Machell, L.Widman, C. Acosta-Miller, and G. Lomeli; Northwestern University, Chicago, Ill: R. Kehoe, T.A. Zheutlin, T. Mattioni, and C. Dunnington; University of Oklahoma, Oklahoma City: R. Lazara, K. Beckman, K. Friday, W.M. Jackman, T. Deaton, K. Drennan, J. Foster, and S. Harris; Oregon Health Sciences University, Portland: J.H. McAnulty, J. Kron, B.D. Halperin, K. Sinner, and K. Martin; University of Pennsylvania-Presbyterian Medical Center, Philadelphia: L.N. Horowitz, C.D. Gottlieb, and C. Vrabel; University of Utah, Salt Lake City: J.W. Mason, J.L. Andersons, K.P. Anderson, R.A. Freedman, L. Karagounis, D.A. Rawling, M. Hutson, D. Mannis, and M. Roskelley.

Principal Investigator: J.W. Mason, University of Utah.

Trial Coordinating Center: University of Utah.

Data Coordinating Center (University of Arizona): T. Moon, E. Hahn, V. Hartz, A. Rico, and N. Jenrow.

Safety Monitoring Committee: R. Bressler (chair), H.L. Greene, M. Lebowitz, T. Moon, and E. Morkin.

End Points Committee: W.D. Weaver (chair), T. Bump, F. Morady, and B. Olshansky.

Received January 9, 1997; revision received May 5, 1997; accepted May 12, 1997.

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