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.
RCT Entities:
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.
Authors: Vivienne A Ezzat; Victor Lee; Syed Ahsan; Anthony W Chow; Oliver Segal; Edward Rowland; Martin D Lowe; Pier D Lambiase Journal: Open Heart Date: 2015-02-17