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A comparison of empiric to physician-tailored programming of implantable cardioverter-defibrillators: results from the prospective randomized multicenter EMPIRIC trial

Wilkoff, Bruce L., Ousdigian, Kevin T., Sterns, Laurence D., Wang, Zengri J., Wilson, Ryan D., Morgan, John M. and EMPIRIC Trial Investigators, None (2006) A comparison of empiric to physician-tailored programming of implantable cardioverter-defibrillators: results from the prospective randomized multicenter EMPIRIC trial Journal of the American College of Cardiology, 48, (2), pp. 330-339. (doi:10.1016/j.jacc.2006.03.037).

Record type: Article

Abstract

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.

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Published date: 18 July 2006

Identifiers

Local EPrints ID: 61609
URI: http://eprints.soton.ac.uk/id/eprint/61609
ISSN: 0735-1097
PURE UUID: 603bd109-60e6-40ec-9c36-355a0910fafd

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Date deposited: 06 Oct 2008
Last modified: 17 Jul 2017 14:21

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Contributors

Author: Bruce L. Wilkoff
Author: Kevin T. Ousdigian
Author: Laurence D. Sterns
Author: Zengri J. Wang
Author: Ryan D. Wilson
Author: John M. Morgan
Author: None EMPIRIC Trial Investigators

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