1. (pnoninferiority < 0.0001)
SIMPLE
Trial design: Patients receiving an ICD implantation were randomized to routine defibrillation threshold (DFT) testing or no testing. They were followed for 3.1 years.
Results
(pnoninferiority < )
(psuperiority = 0.30)
Primary outcome: Failed appropriate shock or arrhythmic death for no testing vs. routine DFT testing: 7.2% vs. 8.3%; pnoninferiority <
Post-procedure: Chest compressions: 0% vs. 0.4%, p = 0.06; intubation: 0.1% vs. 0.6%, p = 0.03
CHF admission: 11.2% vs. 10.7%, p = 0.72 %
Conclusions
No DFT testing was noninferior to routine DFT testing at the time of ICD implantation for sub-sequent failed appropriate shocks/arrhythmic death
Important finding; has the potential to simplify ICD implantation and lower costs
Primary endpoint
No DFT testing
(n = 1,247)
Routine DFT testing
(n = 1,253)
Healey JS, et al. Lancet 2015;Feb 22:[Epub]