Cardiovascular Diseases — Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM)
Citation(s)
Anderson J Implantable defibrillators are preferable to pharmacologic therapy for patients with ventricular tachyarrhythmias: an antagonist's viewpoint. Prog Cardiovasc Dis. 1996 Mar-Apr;38(5):393-400. Review.
Anderson KP, Bigger JT Jr, Freedman RA Electrocardiographic predictors in the ESVEM trial: unsustained ventricular tachycardia, heart period variability, and the signal-averaged electrocardiogram. Prog Cardiovasc Dis. 1996 May-Jun;38(6):463-88. Review.
Anderson KP, Walker R, Dustman T, Fuller M, Mori M Spontaneous sustained ventricular tachycardia in the Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) Trial. J Am Coll Cardiol. 1995 Aug;26(2):489-96.
Biblo LA, Carlson MD, Waldo AL Insights into the Electrophysiology Study Versus Electrocardiographic Monitoring Trial: its programmed stimulation protocol may introduce bias when assessing long-term antiarrhythmic drug therapy. J Am Coll Cardiol. 1995 Jun;25(7):1601-4.
Bigger JT Jr, Fleiss JL, Rolnitzky LM, Steinman RC Stability over time of heart period variability in patients with previous myocardial infarction and ventricular arrhythmias. The CAPS and ESVEM investigators. Am J Cardiol. 1992 Mar 15;69(8):718-23.
Campbell RW Interpretation of the results of the Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) study: impact on algorithm for drug selection. Coron Artery Dis. 1994 Aug;5(8):682-5. Review.
Cannom DS, Ruggio J Specialty care at the crossroads: electrophysiology practice in the managed-care era. Prog Cardiovasc Dis. 1996 Mar-Apr;38(5):401-6.
Caruso AC, Marcus FI, Hahn EA, Hartz VL, Mason JW Predictors of arrhythmic death and cardiac arrest in the ESVEM trial. Electrophysiologic Study Versus Electromagnetic Monitoring. Circulation. 1997 Sep 16;96(6):1888-92.
d'Avila A, Fenelon G, Nellens P, Brugada P Interpretation of the results of the Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) study: electrocardiographic monitoring advocates' view. Coron Artery Dis. 1994 Aug;5(8):677-81. Review.
Freedman RA, Steinberg JS Selective prolongation of QRS late potentials by sodium channel blocking antiarrhythmic drugs: relation to slowing of ventricular tachycardia. Electrophysiologic Study Versus Electrocardiographic Monitoring Trial (ESVEM) Investigators. J Am Coll Cardiol. 1991 Apr;17(5):1017-25.
Garan H A perspective on the ESVEM trial and current knowledge: catheter ablation for ventricular tachyarrhythmias. Prog Cardiovasc Dis. 1996 May-Jun;38(6):457-62.
Garan H A perspective on the ESVEM trial current knowledge: sotalol should not be the first-line agent in the management of ventricular arrhythmias. Prog Cardiovasc Dis. 1996 May-Jun;38(6):455-6.
Gettes LS ESVEM and the hazards of clinical trials. Circulation. 1995 Apr 1;91(7):1908-9.
Hlatky MA Cost and efficacy analysis in the ESVEM trial: implications for diagnosis and therapy for ventricular tachyarrhythmias. Prog Cardiovasc Dis. 1996 Mar-Apr;38(5):371-6.
Karagounis LA, Stein KM, Bair T, Albright D, Anderson JL Fractal dimension predicts arrhythmia recurrence in patients being treated for life-threatening ventricular arrhythmias. ESVEM Investigators. J Electrocardiol. 1995;28 Suppl:71-3.
Klein RC Comparative efficacy of sotalol and class I antiarrhythmic agents in patients with ventricular tachycardia or fibrillation: results of the Electrophysiology Study Versus Electrocardiographic Monitoring (ESVEM) Trial. Eur Heart J. 1993 Nov;14 Suppl H:78-84.
Lazzara R Results of Holter ECG guided therapy for ventricular arrhythmias: the ESVEM trial. Pacing Clin Electrophysiol. 1994 Mar;17(3 Pt 2):473-7.
Mann DE, Hartz V, Hahn EA, Reiter MJ Effect of reproducibility of baseline arrhythmia induction on drug efficacy predictions and outcome in the Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) trial. Am J Cardiol. 1997 Dec 1;80(11):1448-52.
Mason JW A comparison of electrophysiologic testing with Holter monitoring to predict antiarrhythmic-drug efficacy for ventricular tachyarrhythmias. Electrophysiologic Study versus Electrocardiographic Monitoring Investigators. N Engl J Med. 1993 Aug 12;329(7):445-51.
Mason JW A comparison of seven antiarrhythmic drugs in patients with ventricular tachyarrhythmias. Electrophysiologic Study versus Electrocardiographic Monitoring Investigators. N Engl J Med. 1993 Aug 12;329(7):452-8.
Mason JW Implications of the ESVEM trial for use of antiarrhythmic drugs that prolong cardiac repolarization. Am J Cardiol. 1993 Nov 26;72(16):59F-61F. Review.
Mitchell LB, Duff HJ, Gillis AM, Ramadan D, Wyse DG A randomized clinical trial of the noninvasive and invasive approaches to drug therapy for ventricular tachycardia: long-term follow-up of the Calgary trial. Prog Cardiovasc Dis. 1996 Mar-Apr;38(5):377-84.
Mitchell LB, Wyse DG Interpretation of the results of the Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) study: programmed ventricular stimulation advocates view. Coron Artery Dis. 1994 Aug;5(8):671-6. Review.
Monograph on Lessons Learned from ESVEM I Mason JW, Guest Editor. Publications in the monograph are the results of a meeting in August 1995 of the ESVEM investigators and a number of non-ESVEM investigators prominent in the field of electrophysiology. The purpose of the meeting was to discuss the impact of ESVEM and developments in the field.
Olshansky B, Hahn EA, Hartz VL, Prater SP, Mason JW Clinical significance of syncope in the electrophysiologic study versus electrocardiographic monitoring (ESVEM) trial. The ESVEM Investigators. Am Heart J. 1999 May;137(5):878-86.
Olshansky B, Hartz V, Hahn E, Mason J, Weaver MD; ESVEM Investigators Location of death (in-hospital or out-of-hospital) and type of death (arrhythmic, nonarrhythmic, noncardiac) after inducible sustained ventricular tachyarrhythmias after syncope, sustained ventricular tachycardia, or nonfatal cardiac arrest (the ESVEM trial). Am J Cardiol. 2000 Oct 15;86(8):846-51.
Prystowsky EN Electrophysiologic Study versus Electrocardiographic Monitoring (ESVEM): a critical appraisal. Control Clin Trials. 1996 Jun;17(3 Suppl):28S-36S.
Reiffel JA, Hahn E, Hartz V, Reiter MJ Sotalol for ventricular tachyarrhythmias: beta-blocking and class III contributions, and relative efficacy versus class I drugs after prior drug failure. ESVEM Investigators. Electrophysiologic Study Versus Electrocardiographic Monitoring. Am J Cardiol. 1997 Apr 15;79(8):1048-53.
Reiffel JA Implications of the Electrophysiologic Study versus Electrocardiographic Monitoring trial for controlling ventricular tachycardia and fibrillation. Am J Cardiol. 1996 Aug 29;78(4A):34-40.
Reiter MJ, Karagounis LA, Mann DE, Reiffel JA, Hahn E, Hartz V Reproducibility of drug efficacy predictions by Holter monitoring in the electrophysiologic study versus electrocardiographic monitoring (ESVEM) trial. ESVEM Investigators. Am J Cardiol. 1997 Feb 1;79(3):315-22.
Reiter MJ, Mann DE, Reiffel JE, Hahn E, Hartz V Significance and incidence of concordance of drug efficacy predictions by Holter monitoring and electrophysiological study in the ESVEM Trial. Electrophysiologic Study Versus Electrocardiographic Monitoring. Circulation. 1995 Apr 1;91(7):1988-95.
Saksena S, Madan N, Lewis C Implanted cardioverter-defibrillators are preferable to drugs as primary therapy in sustained ventricular tachyarrhythmias. Prog Cardiovasc Dis. 1996 May-Jun;38(6):445-54. Review.
Steinbeck G, Greene HL Management of patients with life-threatening sustained ventricular tachyarrhythmias--the role of guided antiarrhythmic drug therapy. Prog Cardiovasc Dis. 1996 May-Jun;38(6):419-28.
The ESVEM trial Electrophysiologic Study Versus Electrocardiographic Monitoring for selection of antiarrhythmic therapy of ventricular tachyarrhythmias. The ESVEM Investigators. Circulation. 1989 Jun;79(6):1354-60.
Winters SL, Curwin JH Sotalol and the management of ventricular arrhythmias: implications of ESVEM. Pacing Clin Electrophysiol. 1995 Mar;18(3 Pt 1):377-8.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
