All concepts, explanations, trials, and studies have been
re-written in plain English and may contain errors. I am
not a doctor
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The DEFINITE Trial:
Defibrillators in Non-ischemic Cardiomyopathy Treatment
Evaluation

Ischemia : Lack of blood flow to the heart, usually because of
           blocked coronary arteries, chronic fast heart rate,
           etc. Non-ischemic CHF is heart failure from any other
           cause - DCM, viral, chemo-induced, etc.

May, 2003 - About 35% of all CHF is from a non-ischemic cause.
Patients with non-ischemic CHF are at increased risk for sudden
cardiac death (SCD). While both beta-blockers and ACE
inhibitors reduce risk of sudden death, SCD is still a real
risk. The DEFINITE trial studied implanting ICDs to prevent
sudden death in patients with non-ischemic CHF.
	458 patients with EFs under 36% and non-ischemic DCM got
either standard meds (229 patients) or standard meds plus ICD
implant (229).
	Standard meds were beta-blockers, ACE inhibitors,
digoxin, and diuretics as needed. The ICDs used were single-
chamber ICDs programmed VVI 40 bpm, VF Zone only; 180 bpm.

See: www.chfpatients.com/glossary_2.htm#nbg_code for VVI info.

The study's primary end point was total mortality. The
secondary end point was death from heart arrhythmia. Patients
all had non-ischemic cardiomyopathy, CHF symptoms, documented
nonsustained ventricular tachycardia (VT) or an average of 10
PVCs per hour on Holter monitor. None were class 4.

Characteristic		Standard Therapy (229)	ICD (229)
(usually an average)

Age in years		58			58
Male			70 %			72 %
White race		68 %			68 %
Diabetes		23 %			23 %
A-fib			26 %			23 %
Years had CHF		3.3			2.4
Class one to 2		79 %			79 %
Class 3			21 %			21 %
LBBB			20 %			20 %
QRS			116 ms			115 ms
NSVT only		23 %			22 %
PVCs only		10 %			9 %
NSVT and PVCs		68 %			69 %
LV EF			22 %			21 %
6 minute walk distance	328 meters		311 m
On ACE inhibitor	87 %			84 %
On beta-blocker		84 %			86 %
On diuretic		86 %			87 %
On ARB			9 %			16 %
On amiodarone		7 %			4 %
On digoxin		42 %			42 %

Patients were followed an average of 26 months. Fifty-six deaths
occurred - 33 in the meds-only group and 23 in the ICD group. In
the meds group, arrhythmia caused 33% of deaths and 13% of
deaths in the ICD group.
	At 2 years, all-cause mortality was 14% in the meds
group versus 8% in the ICD group. ICD use gave a 34% "relative"
risk reduction for all-cause death. The absolute mortality
benefit at 2 years was almost 6%.
	ICD use significantly lowered risk of arrhythmic death.
There were 11 arrhythmic deaths in the meds group and only 3 in
the ICD group. ICD use gave a 74% reduction in relative risk of
arrhythmic death.
	Results were analyzed for relative risk of mortality in
patients based on sex, EF, QRS duration, heart class, and
history of a-fib. Males with EF less than 20%, heart class 3,
with QRS more than 120ms were most likely to benefit from an ICD.

CONCLUSIONS

1)  Patients with non-ischemic cardiomyopathy, serious left heart
    weakness, and arrhythmia have an annual mortality of 6 to 7%
    when taking ACE inhibitors and beta-blockers.
2)  On meds, SCD causes 1/3 of all deaths, less than expected.
3)  Despite this, ICD implant reduced arrhythmic death in these
    patients.
4)  ICD implant reduced all-cause mortality. Absolute reduction
    in risk of death was almost 6% at 2 years. Relative risk
    reduction was 34%.