• John D Day, Rahul N Doshi, Peter Belott, Ulrika Birgersdotter-Green, Mahnaz Behboodikhah, Peter Ott, Kathryn A Glatter, Serge Tobias, Howard Frumin, Byron K Lee, John Merillat, Isaac Wiener, Samuel Wang, Harlan Grogin, Sung Chun, Rob Patrawalla, Brian Crandall, Jeffrey S Osborn, J Peter Weiss, Donald L Lappe, and Stacey Neuman.
• Utah Heart Clinic Arrhythmia Service, LDS Hospital, 324 10th Ave, #206, Salt Lake City, UT 84103, USA. john.day@cv-research.org
• Circulation. 2007 May 8;115(18):2382-9.

BackgroundImplantable 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 ResultsA 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 < or = 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 > or = 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.ConclusionsAlthough 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.

35 keywords...

hide…