Multicenter automatic defibrillator trial

The Multicenter Automatic Defibrillator Trial (MADIT) randomized 196 patients with prior MI, class I—III congestive HF, a LVEF <35%, NSVT, and inducible VT on EP study that was not suppressible with procainamide, to an ICD or conventional therapy (16). Most patients in the conventional therapy arm received amiodarone. The trial was stopped early as it demonstrated a statistically significant, and impressive, 54% reduction in total mortality in the ICD arm at 27 months (16% and 39% in the ICD and conventional therapy groups, respectively). MADIT is notable in that it only enrolled a small number of patients and did not have a control group. In addition, more patients in the ICD group received beta-blockers. 

Steinberg JS, Fischer A, Wang P, Schuger C, Daubert J, McNitt S, Andrews M, Brown M, Hall WJ, Zareba W, Moss AJ. The clinical implications of cumulative right ventricular pacing in the multicenter automatic defibrillator trial II. J Cardiovasc Electrophysiol. 2005 16 359-365. 

The Multicenter Automatic Defibrillator Implantation Trial (MADIT) randomized 196 patients with ischemic cardiomyopathy, EF < 35%, a documented episode of nonsustained VT (NSVT), and inducible VT on electrophysiology study (EPS) to ICD versus conventional medical therapy [9]. After a mean follow-up of 27 months, the RR reduction for allcause mortality in the ICD arm was 59% [p = 0.009]. 

MADIT = Multicenter Automatic Defibrillator Implantation Trial. 

Moss AJ, Hall WJ, Cannom DS, et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter automatic defibrillator implantation trial investigators. N EnglJ Med.Dec 26 1996 335(26) 1933-1940. 

Bloomfield DM, Steinman RC, Namerow PB, et al. Microvolt T-wave alternans distinguishes between patients likely and patients not likely to benefit from implanted cardiac defibrillator therapy a solution to the multicenter automatic defibrillator implantation trial (MADIT) II conundrum. Circulation. Oct 5 2004 110(14) 1885-1889. 

Higgins SL. Impact of the multicenter automatic defibrillator implantation trial on implantable cardioverter defibrillator indication trends. Am J Cardiol. Mar 11 1999 83(5B) 79D-82D. 

A serious deleterious outcome associated to date primarily with myoblasts (and with thawed BM in chemotherapy patients) (50) is the incidence of cardiac electrical instability for a presumed transient period after cell delivery. These early reports of electrical instability in patients after the receipt of autologous skeletal myoblasts have led to doubts about the safety of these cells as a treatment in the injured heart. Patients who received myoblasts in the earliest clinical studies (33,38) were extremely ill patients with an expected high potential for negative electrical events. In fact, many of the patients who were included in the early trials met the Multicenter Automatic Defibrillator Implantation Trial MADIT-II criteria, which were presented after those trials began, and suggested that all patients who met those criteria be treated with AlCDs. As a result, in more recent clinical studies, many investigators have only enrolled patients who receive AlCDs... 

Moss AJ, Zareba W, Hall JW, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. Multicenter Automatic Defibrillator Implantation Trial II Investigators. N Engl J Med 2002 346(12) 877-83. 

Moss AJ, Brown MW, Cannom DS, Daubert JP, Estes M, Poster E, Greenberg HM, Hall WJ, Higgins SL, Klein H, Pfeffer M, Wilber D, Zareba W. Multicenter automatic defibrillator implantation trial-cardiac resynchronization therapy (MADIT-CRT) design and clinical protocol. Ann Noninvasive Electtocardiol 2005 10 34-43. 

MADIT (Multicenter Automatic Defibrillator Implantation Trial, 1996)... 

Zwanziger, J., et al., The cost effectiveness of implantable cardioverter-defibrillators results from the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II. J Am Coll Cardiol, 2006. 47(11) p. 2310-8. 

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