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Circulation. 1997;96:1713-1716

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(Circulation. 1997;96:1713-1716.)
© 1997 American Heart Association, Inc.

Articles

Predicting Arrhythmic Death

A Plea for Standardized Reporting Techniques and Data Based on Continuous Electrocardiographic Monitoring

Francis E. Marchlinski, MD

From the Electrophysiology Section, Allegheny University Hospitals, Allegheny University of the Health Sciences, The Sidney Kimmel Foundation, and The Philadelphia Heart Institute, Philadelphia, Pa.

Correspondence to Francis E. Marchlinski, MD, Electrophysiology Section, Allegheny University Hospitals, Broad and Vine, Mail Stop 471, Philadelphia, PA 19102-1192.


Key Words: Editorials • arrhythmia • mortality • electrophysiology • sudden death


*    Introduction
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 *Introduction
down arrowNeed for Standardized Reporting...
 down arrowClassification Schema for...
 down arrowNeed for Data Based...
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Large, multicenter studies aimed at defining optimum treatment strategies for patients with documented ventricular arrhythmias and for patients at high risk of arrhythmia events have been completed and continue to be established.1 2 3 4 After finding the answer to the proposed study questions, the participating investigators recognize that they have a wealth of data collected prospectively. Wisely, they struggle to analyze the data to address important clinical questions related to their study population.5 6 7 8 9 Frequently, they try to identify clinical variables that might predict an outcome event defined by the study.7 9

In this issue of Circulation, Caruso and colleagues10 perform such an analysis in patients who enrolled in the ESVEM trial. The authors demonstrate that left ventricular ejection fraction was the only independent predictor of arrhythmic death or cardiac arrest in the ESVEM patient population. The authors' data add to a long list of publications that have identified left ventricular ejection fraction as an important predictor of arrhythmia events, arrhythmic death, or cardiac arrest and overall mortality rate in patients who have a history of documented arrhythmia episodes.11 12 13 14 15 16 17 18 19 The authors also suggest that their data may help to identify a patient group with a very low risk for recurrent, life-threatening arrhythmic events. They indicate that only 1 of 19 patients who presented with a cardiac arrest and had a left ventricular ejection fraction >40% developed a life-threatening arrhythmic event during follow-up. They suggest that these data may be important in deciding whether to advise the patient to have implantable defibrillator therapy. A note of caution is advised. Subgroup analyses may result in small patient numbers in the subgroups. Confidence limits on this presumably small defined risk of developing a life-threatening arrhythmia must be large. Furthermore, even a risk of 5% to 10% may be too great in patients with a left ventricular ejection fraction >40% and an excellent long-term survival rate in the absence of a recurrent life-threatening arrhythmic event.20 Although the information on low-risk patient groups provided by Caruso and colleagues serves as a good starting point for additional investigation, it is inconclusive and should not influence clinical decision making.


*    Need for Standardized Reporting Techniques
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 up arrowIntroduction
 *Need for Standardized Reporting...
down arrowClassification Schema for...
 down arrowNeed for Data Based...
 down arrowReferences
 
Caruso and colleagues also indicate in their report10 that clinical presentation does not predict an arrhythmic death or cardiac arrest. At first glance, these results appear to contradict previous reports.21 22 23 24 25 These prior reports suggested that patients presenting with hemodynamically stable ventricular tachycardia (VT) might be at low risk for fatal arrhythmia events. However, the difficulty in comparing study results stems from a critical problem that we face with many reports in the cardiac arrhythmia literature. There is no established standard for classifying patients on the basis of clinical presentation of the arrhythmia. Groups tend to be lumped or split in what frequently seems to be an arbitrary fashion. There is a tendency to create some categories based on ECG diagnosis, some based on hemodynamic tolerance of the arrhythmic event (eg, cardiac arrest and syncope), and some based on clinical symptoms on presentation coupled with the response to programmed ventricular stimulation, eg, syncope with inducible VT. Patients seem to only fall into one unique subgroup, although it is well recognized that the same patient can have multiple different types of arrhythmic presentations and arrhythmic events. A classification schema that facilitates comparison of study results is needed. Our colleagues in heart failure and cardiac transplantation have gone to great effort to establish a cardiovascular functional class system.26 27 28 A report by Braunwald29 simplified the classification of unstable angina. We need a classification system for ventricular arrhythmia presentation that permits uniform and reproducible categorization. The classification schema should couple arrhythmia diagnosis with associated hemodynamic symptoms. This type of classification will facilitate comparison of the study results, aid in decision making regarding therapeutic interventions, and provide a reliable reference for selecting patients who are appropriate for entry into research protocols. Recognized modifiers that may influence the ECG appearance and/or hemodynamic tolerance of the arrhythmia need to be noted. These modifiers need not dilute the subgroup size unless a specific clinical question involving these modifiers is being addressed.


*    Classification Schema for Arrhythmia Presentation
up arrowTop
 up arrowIntroduction
 up arrowNeed for Standardized Reporting...
 *Classification Schema for...
down arrowNeed for Data Based...
 down arrowReferences
 
A suggested classification schema for arrhythmia presentation is provided in the TableDown. This classification moves from right to left in defining the seriousness of the hemodynamic consequences of the arrhythmia. Patients would be classified on the basis of the most serious hemodynamic symptoms and most abnormal ventricular arrhythmia experienced. The strongest argument for the described classification schema comes from published work that tried to incorporate some assessment of hemodynamic tolerance as part of the classification schema for ventricular arrhythmia clinical presentation.21 22 23 24 25 Brugada and Andries21 were among the initial investigators to emphasize the importance of distinguishing VT that produces syncope from VT that is well tolerated. In their report, they indicated that the sudden death risk was >20% in patients with syncopal VT and <5% in patients with VT that was tolerated hemodynamically. Sarter and colleagues22 documented that patients presenting with VT without hemodynamic embarrassment had a 7.3% risk of sudden cardiac death during a mean follow-up of 36 months. Additional work by Saxon and colleagues23 demonstrated that the 4-year survival rate in patients with sustained ventricular arrhythmias and only symptoms of palpitations was much greater than in those patients with a cardiac arrest (64% versus 45%). A classification schema based on more than the ECG diagnosis is warranted.


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  		Table 1. Classification of Ventricular Arrhythmia Presentation

Of note, patients who present with syncope who have inducible arrhythmias are not included in the TableUp. There are very few data available to support including these patients in one of the arrhythmia-presentation groups based on ECG diagnosis or hemodynamic consequences of the arrhythmic event. We30 reported previously that patients with syncope and inducible VT appear to more closely mimic patients with a history of cardiac arrest than those patients with uniform VT with respect to first occurrence of and frequency of implantable defibrillator therapy. Saxon and colleagues23 also noted that the 4-year survival rate was identical for patients presenting with either syncope and inducible ventricular arrhythmias or cardiac arrest (45%) and much lower than for patients presenting with hemodynamically tolerated VT (64%). If these study results are corroborated, then perhaps it would be more appropriate to include patients with syncope and inducible VT with those patients who fall into categories 1A through 2B in the TableUp. For the moment, however, a separate analysis seems appropriate for the patient with syncope and no documented arrhythmia but inducible ventricular arrhythmias at electrophysiological evaluation.

If an arrhythmia presentation occurs only in association with antiarrhythmic drug therapy, it is worth noting. Obviously, patients with clearly identifiable drug-induced arrhythmia syndromes are excluded from the classification process. Although the ability to induce VT and subsequent management strategies do not appear to be significantly influenced by whether the patient is receiving antiarrhythmic drug therapy at the time of arrhythmic presentation, the presence of antiarrhythmic drug therapy can influence the hemodynamic tolerance of the arrhythmia and should be identified with an appropriate subscript.31 32 An indication of the presence or absence of structural heart disease is also appropriate. The long-term prognosis of patients who present with sustained or nonsustained VT in the absence of structural heart disease is uniformly excellent.33 34 The prognosis of patients presenting with a cardiac arrest without structural heart disease may be of more concern.35 Rapid identification and thus the ability to include or exclude such patients in any data analysis may be important. A classification schema can incorporate important information describing modifiers by using additional subscripts (TableUp).29

The suggested classification schema for arrhythmia presentation should aid in (1) the communication about patients with ventricular tachyarrhythmias, (2) the design of study protocols to evaluate new or validate old arrhythmia treatment strategies, and (3) the comparison of study results. Of note, the classification schema will also facilitate recognition by the healthcare provider of the importance of "managing the patient" and not just the ECG when considering both the short-term and long-term treatment strategies for ventricular arrhythmias.


*    Need for Data Based on Continuous ECG Monitoring
up arrowTop
 up arrowIntroduction
 up arrowNeed for Standardized Reporting...
 up arrowClassification Schema for...
 *Need for Data Based...
down arrowReferences
 
Reports based on multicenter studies involving large patient populations that identify clinical predictors of outcome have been helpful in providing information that may be used to assist in developing a prognosis and in patient counseling and in some cases may help identify the usefulness of the most appropriate treatment strategies.1 2 11 Unfortunately, the studies do little to enhance our understanding of arrhythmogenesis. Causal relationships are occasionally implied. However, accurate reporting rarely promotes statements that go beyond simply describing the statistically significant associations. In addition, end points other than total mortality are appropriately subject to criticism36 37 ; implying that a sudden arrhythmic death is synonymous with a ventricular arrhythmia has been demonstrated to be inaccurate, especially in selected patient subgroups.38 Classification of the type of death by committee in the absence of ECG documentation must be considered second best. Holter and in-hospital ECG recordings obtained serendipitously at the time of a fatal event have provided some insight into the mechanism of fatal arrhythmic episodes.39 40 Intracardiac electrogram recordings from patients with implantable defibrillators have furthered the data collection in patients proven to be at high risk for arrhythmic events.41 42 43 Unfortunately, snapshot recordings of events surrounding implantable defibrillator therapy still do not provide insight into the specificity of apparent triggers for arrhythmic events. Multiple surface ECG criteria have also been described as predictors of an increased risk of fatal arrhythmic events.44 45 46 Yet their role as markers of true triggering events has not been determined. With the development of simplified yet sophisticated non–lead-dependent body surface and even implantable ECG recording capabilities coupled with advances in computer technology, we need to take our understanding of arrhythmogenesis to the next step.47 We need to consider, either as part of the next multicenter study designed to assess different treatment strategies or as an independent multicenter effort, a major investment to provide all study patients with the opportunity for continuous ECG monitoring, data collection, and analysis. The details and all of the technical considerations are beyond the scope of this editorial. The technical feasibility of such an effort is, however, without question. This effort will require both industry and government support, for it will be costly. However, the potential for understanding the mechanism of arrhythmogenesis as a result of such an effort provides a much greater opportunity for advancing therapy than another study that compares two effective treatment strategies to define a marginal treatment benefit.


*    Acknowledgments
 
The author thanks Erica Zado, PA, for her efforts in the preparation and review of this manuscript.


*    Footnotes
 
The opinions expressed in this editorial are not necessarily those of the editors or of the American Heart Association.


*    References
up arrowTop
 up arrowIntroduction
 up arrowNeed for Standardized Reporting...
 up arrowClassification Schema for...
 up arrowNeed for Data Based...
 *References
 

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