The quick-implantable-defibrillator trial.
OBJECTIVE
Earlier ICD therapy included an electrophysiological study (EPS), an extensive defibrillation threshold test (DFT), and a pre-discharge test. Now that ICD-therapy is widely accepted, an EPS is no longer performed in most patients, extensive DFT-tests have been reduced to a minimum of two effective shocks and discharge tests have been discarded in most centres. However, it has never been demonstrated prospectively that this simplification is safe.


RESULTS
The Quick-Implantable-Defibrillator (Quick-ICD) Trial was a prospective multi-centre trial, which randomized patients, who had survived a cardiac arrest (SCD) or an unstable ventricular tachycardia (VT), to two different clinical strategies: (a) The extensive strategy included an EPS, an extensive DFT-test, and a pre-discharge test; (b) In the simplified approach (quick strategy) the ICD was implanted without an EPS and a pre-discharge test. Two effective shocks during implantation at 21 J were sufficient. The primary endpoint of this trial was a cluster of adverse events related to the diagnostic approach and to ICD-therapy. One hundred and ninety patients were included, 97 randomized to the extensive-, 93 to the quick strategy. Mean follow-up was 12 +/- 7 months. Twenty-seven patients reached the endpoint in the quick group and 32 in the extensive group. During follow-up, the event-free survival was equal in the two study arms (test for equivalence, P = 0.0044). The initial hospital stay was significantly shorter in the quick population (8.4 +/- 4.7 vs. 11.2 +/- 7.4 days, P = 0.004)


CONCLUSIONS
It is safe and cost-effective to implant an ICD without an EPS, an extensive DFT-, and a pre-discharge test in carefully selected patients after survived SCD or unstable VTs.
Bänsch
Dietmar
D
Department of Cardiology, St. Georg's Hospital, Hamburg, Germany. dietmarbaensch@alice-dsl.de
Kottkamp
Hans
H
Grönefeld
Gerian
G
Vogt
Jürgen
J
Israel
Carsten
C
Böcker
Dirk
D
Hindricks
Gerd
G
Kuck
Karl-Heinz
KH
D000368:Aged; D003362:Cost-Benefit Analysis; D017147:Defibrillators, Implantable / Q000009:adverse effects; D004554:Electric Countershock / Q000191:economics / Q000379:methods; D022062:Electrophysiologic Techniques, Cardiac / Q000191:economics / Q000379:methods; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D006323:Heart Arrest / Q000517:prevention & control / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D017180:Tachycardia, Ventricular / Q000517:prevention & control / Q000628:therapy*