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(Circulation. 2007;115:2382-2389.)
© 2007 American Heart Association, Inc.

Arrhythmia/Electrophysiology

Inductionless or Limited Shock Testing Is Possible in Most Patients With Implantable Cardioverter- Defibrillators/Cardiac Resynchronization Therapy Defibrillators

Results of the Multicenter ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations)

John D. Day, MD; Rahul N. Doshi, MD; Peter Belott, MD; Ulrika Birgersdotter-Green, MD; Mahnaz Behboodikhah, MD; Peter Ott, MD; Kathryn A. Glatter, MD; Serge Tobias, MD; Howard Frumin, MD; Byron K. Lee, MD; John Merillat, MD; Isaac Wiener, MD; Samuel Wang, MD; Harlan Grogin, MD; Sung Chun, MD; Rob Patrawalla, MD; Brian Crandall, MD; Jeffrey S. Osborn, MD; J. Peter Weiss, MD; Donald L. Lappe, MD; Stacey Neuman, PhD

From Utah Heart Clinic Arrhythmia Service (J.D.D., B.C., J.S.O., J.P.W., D.L.L.), LDS Hospital, Salt Lake City, Utah; Fullerton Cardiovascular Medical Group (R.N.D.), Fullerton, Calif; Grossmont Hospital (P.B.), La Mesa, Calif; UC San Diego Medical Center (U.B.-G.), San Diego, Calif; Hoag Hospital (M.B.), Newport Beach, Calif; Arizona Health Sciences Center (P.O.), Tucson, Ariz; University of California, Davis (K.A.G.), Sacramento, Calif; Long Beach Memorial (S.T.), Long Beach, Calif, South Orange County Cardiology (H.F.), Laguna Hills, Calif; University of California, San Francisco (B.K.L.), San Francisco, Calif; Valley Heart Association (J.M.), Modesto, Calif; Arrhythmia Services (I.W.), Los Angeles, Calif; Berkeley Cardiovascular Medical Group (S.W.), San Francisco, Calif; Central Coast Cardiovascular Research (H.G.), Salinas, Calif; Palo Alto Medical & Research Foundation (S.C.), Stanford, Calif; Cardiovascular Medicine and Cardiovascular Arrhythmias (R.P.), Redwood City, Calif; and Boston Scientific Cardiac Rhythm Management (S.N.), St. Paul, Minn.

Correspondence to John D. Day, MD, Utah Heart Clinic, LDS Hospital, 324 10th Ave, #206, Salt Lake City, UT 84103. E-mail john.day{at}cv-research.org

Received September 5, 2006; accepted February 20, 2007.

Background— Implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators have relied on multiple ventricular fibrillation (VF) induction/defibrillation tests at implantation to ensure that the device can reliably sense, detect, and convert VF. The ASSURE Study (Arrhythmia Single Shock Defibrillation Threshold Testing Versus Upper Limit of Vulnerability: Risk Reduction Evaluation With Implantable Cardioverter-Defibrillator Implantations) is the first large, multicenter, prospective trial comparing vulnerability safety margin testing versus defibrillation safety margin testing with a single VF induction/defibrillation.

Methods and Results— A total of 426 patients receiving an implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator underwent vulnerability safety margin or defibrillation safety margin screening at 14 J in a randomized order. After this, patients underwent confirmatory testing, which required 2 VF conversions without failure at 21 J. Patients who passed their first 14-J and confirmatory tests, irrespective of the results of their second 14-J test, had their devices programmed to a 21-J shock for ventricular tachycardia (VT) or VF 200 bpm and were followed up for 1 year. Of 420 patients who underwent 14-J vulnerability safety margin screening, 322 (76.7%) passed. Of these, 317 (98.4%) also passed 21-J confirmatory tests. Of 416 patients who underwent 14-J defibrillation safety margin screening, 343 (82.5%) passed, and 338 (98.5%) also passed 21-J confirmatory tests. Most clinical VT/VF episodes (32 of 37, or 86%) were terminated by the first shock, with no difference in first shock success. In all observed cases in which the first shock was unsuccessful, subsequent shocks terminated VT/VF without complication.

Conclusions— Although spontaneous episodes of fast VT/VF were limited, there was no difference in the odds of first shock efficacy between groups. Screening with vulnerability safety margin or defibrillation safety margin may allow for inductionless or limited shock testing in most patients.

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CLINICAL PERSPECTIVE

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