Objectives: The purpose of this randomized study was to determine whether a strategically chosen standardized set of programmable settings is at least as effective as physician-tailored choices, as measured by the shock-related morbidity of implantable cardioverter-defibrillator (ICD) therapy.
Background: Programming of ventricular tachyarrhythmia (ventricular tachycardia [VT] or ventricular fibrillation [VF]) detection and therapy for ICDs is complex, requires many choices by highly trained physicians, and directly influences the frequency of shocks and patient morbidity.
Methods: A total of 900 ICD patients were randomly assigned to standardized (EMPIRIC, n = 445) or physician-tailored (TAILORED, n = 455) VT/VF programming and followed for 1 year.
Results: The primary end point was met: the adjusted percentages of both VT/VF (22.3% vs. 28.7%) and supraventricular tachycardia or other non-VT/VF event episodes (11.9% vs. 26.1%) that resulted in a shock were non-inferior and lower in the EMPIRIC arm compared to the TAILORED arm. The time to first all-cause shock was non-inferior in the EMPIRIC arm (hazard ratio = 0.95, 90% confidence interval 0.74 to 1.23, non-inferiority p = 0.0016). The EMPIRIC trial had a significant reduction of patients with 5 or more shocks for all-cause (3.8% vs. 7.0%, p = 0.039) and true VT/VF (0.9% vs. 3.3%, p = 0.018). There were no significant differences in total mortality, syncope, emergency room visits, or unscheduled outpatient visits. Unscheduled hospitalizations occurred significantly less often (p = 0.001) in the EMPIRIC arm.
Conclusions: Standardized empiric ICD programming for VT/VF settings is at least as effective as patient-specific, physician-tailored programming, as measured by many clinical outcomes. Simplified and pre-specified ICD programming is possible without an increase in shock-related morbidity.