Evaluation of antiarrhythmic drug efficacy in patients with an ICD. Unlimited potential or replete with complexity and problems?

European Heart Journal

Volumn 20, Issue 21, 1999, Pages 1538-1552

  Pratt, C M ⁱ   Camm, A J ^a   Bigger Jr , J T ^b   Breithardt, G ^c   Campbell, R W F ^d   Epstein, A E ^e   Kappenberger, L J ^f   Kuck, K H ^g   Pocock, S ^h   Saksena, S ⁱ   Waldo, A L ⁱ  

^a ST GEORGE'S UNIVERSITY OF LONDON   (United Kingdom)

^b Och Spine at New York Presbyterian Hospitals   (United States)

^c UNIVERSITY OF MÜNSTER   (Germany)

^d FREEMAN HOSPITAL   (United Kingdom)

^e UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^f LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^g DEPARTMENT OF CARDIOLOGY   (Germany)

^h LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

ⁱ NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTIARRHYTHMIC AGENT;

ARTICLE; CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; DEFIBRILLATOR; HEART ARRHYTHMIA; HEART VENTRICLE TACHYCARDIA; HUMAN; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; META ANALYSIS; MORTALITY; PRIMARY PREVENTION; PRIORITY JOURNAL; SECONDARY PREVENTION; SUDDEN DEATH;

ANTI-ARRHYTHMIA AGENTS; ARRHYTHMIA; CAUSE OF DEATH; CLINICAL PROTOCOLS; CLINICAL TRIALS; DEFIBRILLATORS, IMPLANTABLE; EVALUATION STUDIES; HUMANS; PATIENT SELECTION; TACHYCARDIA; TREATMENT OUTCOME;

EID: 0032722665     PISSN: 0195668X     EISSN: None     Source Type: Journal    
DOI: 10.1053/euhj.1999.1850     Document Type: Article

References (70)

1. Siebels J, Cappato R, Ruppel R. Preliminary results of the Cardiac Arrest Study Hamburg (CASH). Am J Cardiol. 72:1993;109F-113F.
2. Siebels J, Kuck KH. Implantable cardioverter defibrillator compared with antiarrhythmic drug treatment in cardiac arrest survivors (the Cardiac Arrest Study Hamburg). Am Heart J. 127:1994;1139-1144.
3. N Engl J Med. 337:1997;1576-1583.
4. Moss AJ, Hall J, Cannom DS. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmias. N Engl J Med. 335:1996;1933-1940.
5. Hohnloser SH, Singh BN. Proarrhythmia with Class III antiarrhythmic drugs: definition, electrophysiologic mechanisms, incidence, predisposing factors, and clinical implications. J Cardiovasc Electrophysiol. 6:1995;920-936.
6. Sagie A, Strasberg B, Kusniec J. Rapid suppression of flecainide induced incessant ventricular tachycardia with high dose intravenous amiodarone. Chest. 93:1988;879-880.
7. Gottlieb CD, Horowitz LN. Potential interactions between antiarrhythmic medication and the automatic implantable cardioverter defibrillator. PACE. 14:1991;898-904.
8. Echt DS, Gremillion ST, Lee JT. Effects of procainamide and lidocaine on defibrillation energy requirements in patients receiving implantable cardioverter defibrillator devices. J Cardiovasc Electrophysiol. 5:1994;752-760.
9. N Engl J Med. 321:1989;406-412.
10. N Engl J Med. 327:1992;227-233.
11. Waldo AL, Camm AJ, de Ruyter H. Effect of d-sotalol on mortality in patients with left ventricular dysfunction after myocardial infarction. Lancet. 348:1996;7-12.
12. Pratt CM, Camm AJ, Cooper W. Mortality in the survival with oral d-sotalol (SWORD) trial. Why did patients die? Am J Cardiol. 81:1998;869-876.
13. Julian DG, Camm AJ, Frangin G. Randomised trial of effect of amiodarone on mortality in patients with left ventricular dysfunction after recent myocardial infarction: EMIAT. Lancet. 349:1997;667-674.
14. Janse MJ, Malik M, Camm AJ. Identification of post acute myocardial infarction patients with potential benefit from prophylactic treatment with amiodarone. A substudy of EMIAT (the European Myocardial Infarct Amiodarone Trial). Eur Heart J. 19:1998;85-95.
15. Clin Cardiol. 20:1997;704-710.
16. J Am Coll Cardiol. 33:1999;132A.
17. Connolly SJ, Gent M, Roberts RS. Canadian Implantable Defibrillator Study (CIDS): study design and organization. Am J Cardiol. 72:1993;103F-8F.
18. Bigger JT. Prophylactic use of implantable cardioverter defibrillators in patients at risk of ventricular arrhythmias after coronary artery bypass graft surgery. Coronary Artery Bypass Graft (CABG) patch trial investigators. N Engl J Med. 337:1997;1569-1575.
19. Buxton AE, Lee KL, DeCarlo L. Nonsustained ventricular tachycardia in coronary artery disease: relation to inducible sustained ventricular tachycardia. MUSTT Investigators. Ann Intern Med. 125:1996;35-39.
20. Bardy GH, Lee KL, Mark DB. The Sudden Cardiac Death in Heart Failure Trial: pilot study (Abstr). PACE. 20:1997;1148.
21. Moss AJ, Connom DS, Dubert JP. Multicenter Automatic Defibrillator Implantation Trial II (MADIT II): design and clinical protocol. Ann Noninvasiv Electrocardiol. 4:1999;83-91.
22. Nisam S, Mower M. ICD trials: an extraordinary means of determining patient risk? PACE. 21:1998;1341-1346.
23. Hinkle LE, Thaler HT. Clinical classification of cardiac deaths. Circulation. 65:1982;457-464.
24. Kim SG, Fogoros RN, Furman S. Standardized reporting of ICD patient outcome: the report of a North American Society of Pacing & Electrophysiology Policy Conference, February 9-10, 1993. Pacing Clin Electrophysiol. 16:1993;1358-1362.
25. Greene HL. The CASCADE Study: randomized antiarrhythmic drug therapy in survivors of cardiac arrest in Seattle. CASCADE Investigators. Am J Cardiol. 72:1993;70F-74F.
26. Dolack GL. Clinical predictors of implantable cardioverter-defibrillator shocks (results of the CASCADE trial). Cardiac Arrest in Seattle, Conventional versus Amiodarone Drug Evaluation. Am J Cardiol. 73:1994;237-241.
27. Am J Cardiol. 72:1993;280-287.
28. Böcker D, Block M, Isbruch F. Comparison of frequency of aggravation of ventricular tachyarrythmias after implantation of automatic defibrillators using epicardial versus nonthoractomy lead systems. Am J Cardiol. 71:1993;1064-1068.
29. Echt DS, Leibson PR, Mitchell B. Mortality and morbidity in patients receiving encainide, flecainide or placebo. N Engl J Med. 324:1991;781-788.
30. Grimm W, Flores BF, Marchilinski FE. Symptoms and electrocardiographically documented rhythm preceding spontaneous shocks in patients with implantable cardioverter defibrillator. Am J Cardiol. 71:1993;1415-1418.
31. Hook BG, Callans DJ, Kleiman RB. Implantable cardioverter defibrillator therapy in the absence of significant symptoms: Rhythm diagnosis and management aided by stored electrogram analysis. Circulation. 87:1993;1897-1906.
32. Kou WH, Calkins H, Lewis RR. Incidence of loss of consciousness during automatic implantable cardioverter-defibrillator shocks. Ann Intern Med. 115:1991;942-945.
33. Bansch D, Brunn J, Castrucci M. Syncope in patients with an implantable cardioverter defibrillator incidence, prediction and implications for driving restrictions. J Am Coll Cardiol. 31:1998;608-615.
34. Wietholt D, Block M, Isbruch F. Clinical experience with antitachycardia pacing and improved detection algorithms in a new implantable cardioverter defibrillator. J Am Coll Cardiol. 21:1993;885-894.
35. Bayes de Luna A, Coumel P, Leclercq JF. Ambulatory sudden cardiac death: mechanisms of production of fatal arrhythmia on the basis of data from 157 cases. Am Heart J. 117:1989;151-159.
36. Exner DV, Gillis AM, Sheldon RS. Telemetry documented, pace terminable ventricular tachycardia in patients with ventricular fibrillation. Am J Cardiol. 81:1998;235-238.
37. Böcker D, Block M, Isbruch F. Do patients with an implantable defibrillator live longer? J Am Coll Cardiol. 21:1993;1638-1644.
38. Böcker D, Bansch D, Henecke A. Potential benefit from implantable cardioverter defibrillator therapy in patients with and without heart failure. Circulation. 98:1998;1636-1643.
39. Stevens SK, Haffajee CI, Naccarelli GV. Effects of oral propafenone on defibrillation and pacing thresholds in patients receiving implantable cardioverter defibrillators. J Am Coll Cardiol. 28:1996;418-422.
40. Jung W, Manz M, Pizzulli L. Effects of chronic amiodarone therapy on defibrillation threshold. Am J Cardiol. 70:1992;1023-1027.
41. Movsowitz C, Marchlinksi FE. Interactions between implantable cardioverter-defibrillators and class III agents. Am J Cardiol. 82:1998;411-481.
42. Tacker WA, Niebauer MJ, Babbs CF. The effect of newer antiarrhythmic drugs on defibrillation threshold. Crit Care Med. 8:1980;177-180.
43. Wang M, Dorian P. dL and d-sotalol decrease defibrillation energy requirements. PACE. 12:1989;1522-1529.
44. Dorian P, Newman D. Effect of sotalol on ventricular fibrillation and defibrillation in humans. Am J Cardiol. 72:1993;72A-9A.
45. Jung W, Manz M, Pizzulli L. Effects of chronic amiodarone therapy on defibrillation threshold. Am J Cardiol. 70:1992;1023-1027.
46. Gilberg JM, Olson WH, Bardy GH. Electrogram width algorithm for discrimination of supraventricular rhythm from ventricular tachycardia (Abstr). PACE. 17:1994;866.
47. Ruetz LL, Bardy GH, Mitchell LB. Clinical evaluation of electrogram width measurements for automatic ventricular tachycardia (Abstr). PACE. 19:1996;582.
48. Osswald S, Cron TA, Sterns L. New ICD technologies: first clinical experience with dual chamber sensing for differentiation of supraventricular arrhythmias. PACE. 21:1998;292-295.
49. Bardy GH, Olson W, Barnes J. Ventricular fibrillation cycle length spectrum: measured values in comparison to sensed values as a function of ICD sensitivity setting (Abstr). PACE. 16:1993;585.
50. Bardy GH, Ivey T, Stewart R. Failure of the automatic implantable cardioverter defibrillator to detect ventricular fibrillation. Am J Cardiol. 58:1986;1107-1108.
51. Cohen TJ, Liem LB. Biosensor applications to antitachycardia devices. PACE. 14:1991;322-328.
52. Prevot E, Vesin JM, Schmidiager H. Analysis of heart rate variability at the onset of spontaneous ventricular tachyarrhythmias as retrieved from a defibrillator. Eur Heart J. 18:1977;592.
53. Vetter R, Celka P, Vesin JM. Subband modeling of the human cardiovascular system: new insights into cardiovascular regulation. Ann Biomed Eng. 26:1998;293-307.
54. Cohen TJ, Liem LB. A hemodynamically responsive antitachycardia system. Development and basis for design in humans. Circulation. 82:1990;394-406.
55. Kaye GC, Astridge P, Perrins J. Tachycardia recognition and diagnosis from changes in right atrial pressure waveform - a feasibility study. PACE. 14:1991;1384-1392.
56. Wood MA, Ellenbogen KA, Kapadia K. Comparison of right ventricular emepdance, pulse pressure and maximal dP/dt for determination of hemodynamic stability of ventricular arrhythmias associated with coronary artery disease. Am J Cardiol. 66:1990;575-582.
57. Krahn AD, Klein GJ, Norris C. The etiology of syncope in patients with negative tilt table and electrophysiological testing. Circulation. 92:1995;1819-1824.
58. Pratt CM, Greenway PS, Schoenfeld MH. An exploration of th precision of classifying sudden cardiac death: Implications for the interpretation of clinical trials. Circulation. 93:1996;519-524.
59. Pocock SJ. Clinical trials with multiple outcomes: a statistical perspective. Con Clin Trials. 18:1997;530-545.
60. Pocock SJ, Geller NL, Tsiatis AA. The analysis of multiple endpoints in clinical trials. Biometrics. 43:1987;487-498.
61. O'Brien PC. Procedures for comparing samples with multiple endpoints. Biometrics. 40:1984;1079-1087.
62. Raviele A, Bongiorni MG, Brignole M. Which strategy is 'best' after myocardial infarction? The Beta-blocker Strategy Plus Implantable Cardioverter Defibrillator Trial: rationale and study design. Am J Cardiol. 83:1999;104D-11D.
63. Wever EFD, Hauer RNW, van Capelle FJI. Randomized study of implantable defibrillator as first-choice therapy versus conventional strategy in post-infarct study death survivors. Circulation. 91:1995;2195-2203.
64. Myerburg RJ, Luceri RM, Thurer R. Time to first shock and clinical outcome in patients receiving an implantable cardioverter-defibrillator. J Am Coll Cardiol. 4:1989;508-514.
65. Huang SKS, Tan de Guzman WLT, Chenarides JG. Effects of long-term amiodarone therapy on the defibrillation threshold and the rate of shocks of the implantable cardioverter-defibrillator. Am Heart J. 122:1991;720-727.
66. Grimm W, Flores BT, Marchlinski FE. Shock occurrence and survival in 241 patients with implantable cardioverter-defibrillator therapy. Circulation. 7:1993;1880-1888.
67. Kelly PA, Cannom DS, Garan H. The automatic implantable cardioverter defibrillator: efficacy, complications and survival in patients with malignant ventricular arrhythmias. J Am Coll Cardiol. 11:1998;1278-1286.
68. Saksena S, Poczobutt-Johanos M, Castle LW. Long-term multicenter experience with a second-generation implantable pacemaker-defibrillator in patients with malignant ventricular tachyarrhythmias. The Guardian Multicenter Investigators Group. J Am Coll Cardiol. 19:1992;490-499.
69. Echt DS, Armstrong K, Schmidt P. Clinical experience, complications, and survival in 70 patients with the automatic implantable cardioverter-defibrillator. Circulation. 71:1985;289-296.
70. Pacifico A, Hohnloser SH, Williams JH. Prevention of implantable-defibrillator shocks by treatment with sotalol. N Eng J Med. 340:1999;1855-1862.