A Comparison of Empiric to Physician-Tailored Programming of Implantable Cardioverter-Defibrillators
Results From the Prospective Randomized Multicenter EMPIRIC Trial
Bruce L. Wilkoff, MD, FACC*,*,
Kevin T. Ousdigian, MS ,
Laurence D. Sterns, MD, FACC ,
Zengri J. Wang, PhD,
Ryan D. Wilson, MBA,
John M. Morgan, MD, FACC for the EMPIRIC Trial Investigators
* The Cleveland Clinic Foundation, Cleveland, Ohio
Medtronic, Inc., Minneapolis, Minnesota
Victoria Cardiac Arrhythmia Trials, Victoria, British Columbia, Canada
Wessex Cardiology, Southampton, England
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Figure 1 Programmed implantable cardioverter-defibrillator (ICD) therapies versus heart rate. (A) Percentage of all patients programmed to antitachycardia pacing (ATP) and/or shock therapy (number of patients with ATP or shock therapy on at each heart rate/total number of patients in the arm). The dotted line illustrates that nearly all EMPIRIC arm patients had their ICD enabled to treat tachycardias >150 beats/min. In marked contrast, tailored programming was enabled to treat slower tachycardias in a much smaller proportion of patients. (B) Percent of treated patients programmed to ATP on (number of patients with ATP on at each heart rate/number of patients with ATP or shock therapy on at each heart rate). The dotted line illustrates that nearly all EMPIRIC arm patients had ATP on up to 250 beats/min. In marked contrast, a small proportion of tailored arm patients had ATP on at faster heart rates.
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Figure 2 Number of episodes by arm. (A) True ventricular tachycardia/ventricular fibrillation (VT/VF) episodes. (B) True supraventricular tachycardia or other non-VT/VF event (SVT) episodes. Solid bars = shocked; ruled bars = not shocked. GEE = general estimating equation adjustment for multiple recurrences per patient.
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Figure 3 Percentage of episodes shocked—primary end point in the trial. The upper bound for the percentage difference is 1-sided 95% upper confidence bound. SVT = supraventricular tachycardia; other abbreviations as in Figure 2.
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Figure 4 Time to first shock. (A) All-cause; (B) true VT/VF; (C) true SVT. CI = confidence interval; HR = hazard ratio; other abbreviations as in Figures 2 and 3.
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Figure 5 Safety and health-care utilization end points. ER = emergency room; other abbreviations as in Figures 2 and 4.
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Figure 6 Subgroup analysis on time to first all-cause shock. AF = atrial fibrillation; AFL = atrial flutter; AT = atrial tachycardia; CAD = coronary artery disease; EF = ejection fraction; EPS = electrophysiologic study; MVT = monomorphic ventricular tachycardia; other abbreviations as in Figures 1 and 4.
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