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CLINICAL RESEARCH: HEART RHYTHM DISORDER

Strategic Programming of Detection and Therapy Parameters in Implantable Cardioverter-Defibrillators Reduces Shocks in Primary Prevention Patients

Results From the PREPARE (Primary Prevention Parameters Evaluation) Study

Bruce L. Wilkoff, MD, FACC^_*,_*, Brian D. Williamson, MD, FACC, Richard S. Stern, MD, FACC, Stephen L. Moore, DO, FACC, Fei Lu, MD, FACC^||, Sung W. Lee, MD, FACC^¶, Ulrika M. Birgersdotter-Green, MD^#, Mark S. Wathen, MD^_**, Isabelle C. Van Gelder, MD, Brooke M. Heubner, MS, Mark L. Brown, PhD, Keith K. Holloman, BA for the PREPARE Study Investigators

^_* The Cleveland Clinic Foundation, Cleveland, Ohio
William Beaumont Hospital, Troy, Michigan
Doctors Medical Clinic, San Pablo, California
EMH Regional Medical Center, Elyria, Ohio
^|| Fairview Regional Medical Center, Minneapolis, Minnesota
^¶ Washington Adventist Hospital, Takoma Park, Maryland
^# University of California-San Diego, San Diego, California
^_** Vanderbilt University Medical Center, Nashville, Tennessee
University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
Medtronic, Inc., Minneapolis, Minnesota.

Manuscript received September 25, 2007; revised manuscript received April 18, 2008, accepted May 2, 2008.

^_* Reprint requests and correspondence: Dr. Bruce L. Wilkoff, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Director of Cardiac Pacing and Tachyarrhythmia Devices, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Desk F-15, Cleveland, Ohio 44195. (Email: wilkofb{at}ccf.org).

Objectives: Our purpose was to demonstrate that strategically chosen implantable cardioverter-defibrillator (ICD) ventricular tachycardia (VT) or ventricular fibrillation (VF) detection and therapy parameters can reduce the combined incidence of device-delivered shocks, arrhythmic syncope, and untreated sustained symptomatic VT/VF (morbidity index).

Background: Strategically chosen ICD VT/VF detection and therapy parameters have been shown in previous studies to reduce the number of shocked episodes. In the PREPARE (Primary Prevention Parameters Evaluation) study, these prior strategies were combined with additional strategies specific to primary prevention patients.

Methods: The PREPARE study was a prospective, cohort-controlled study that analyzed 700 patients (biventricular [Bi-V] ICD and non–Bi-V ICD) with primary prevention indications for an ICD from 38 centers followed for 1 year. VT/VF was detected for rates 182 beats/min that were maintained for at least 30 of 40 beats. Antitachycardia pacing was programmed as the first therapy for regular rhythms with rates of 182 to 250 beats/min, and supraventricular tachycardia discriminators were used for rhythms 200 beats/min. The control cohort consisted of 689 primary prevention patients from the EMPIRIC (Comparison of Empiric to Physician-Tailored Programming of Implantable Cardioverter Defibrillators Trial) (non–Bi-V ICD, physician arm only) and MIRACLE ICD (Multicenter InSync Implantable Cardioversion Defibrillation Randomized Clinical Evaluation) (Bi-V ICD) trials for whom VT/VF detection and therapy programming were not controlled.

Results: The PREPARE programming significantly reduced the morbidity index incidence density (0.26 events/patient-year for PREPARE study patients vs. 0.69 control cohort, p = 0.003). The PREPARE study patients were less likely to receive a shock in the first year compared with control patients (9% vs. 17%, p < 0.01). The incidence of untreated VT and arrhythmic syncope was similar between the PREPARE study patients and the control cohort.

Conclusions: Strategically chosen VT/VF detection and therapy parameters can safely reduce shocks and other morbidities associated with ICD therapy in patients receiving an ICD for primary prevention indications. (PREPARE-Primary Prevention Parameters Evaluation; NCT00279279)

Key Words: defibrillators • implantable • tachyarrhythmias • defibrillation • cardioversion

Abbreviations and Acronyms   ATP = antitachycardia pacing   Bi-V = biventricular   CI = confidence interval   HR = hazard ratio   ICD = implantable cardioverter-defibrillator   LVEF = left ventricular ejection fraction   SVT = supraventricular tachycardia   VF = ventricular fibrillation   VT = ventricular tachycardia

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