Europace Advance Access published online on October 2, 2007
Europace, doi:10.1093/europace/eum126
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The quick-implantable-defibrillator trial
1 Department of Cardiology, St. Georg's Hospital, Hamburg, Germany; 2 Heart Centre, University Clinic, Leipzig, Germany; 3 Department of Cardiology, J-W-Goethe University, Frankfurt, Germany; 4 Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany; 5 Department of Cardiology and Angiology, Westfaelische Wilhelms-University, Muenster, Germany
Aims 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.
Methods and 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)
Conclusion 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.
Key Words: Implantable cardioverter defibrillator, Programmed ventricular stimulation, Defibrillation threshold testing, DFT, ICD
* Corresponding author. Tel: +49 40 2890 2305/4488; fax: +49 40 2890 4435. E-mail address: dietmarbaensch{at}alice-dsl.de
Manuscript submitted 26 April 2007. Accepted after revision 7 June 2007.