Abstract
Background The subcutaneous implantable cardioverter-defibrillator system (S-ICD) uses a novel detection algorithm previously shown to discriminate induced tachyarrhythmias (ventricular vs supraventricular) effectively. Objective The purpose of this study was to evaluate the role of the S-ICD discrimination algorithm in reducing the incidence of spontaneous inappropriate shocks. Methods A total of 314 subjects underwent implantation with an S-ICD system as part of the S-ICD Clinical Investigation (IDE Trial). Subjects were grouped according to programming at discharge to either a single shock zone or 2 shock zones, with a discrimination algorithm in the lower rate zone. Results This cohort had 226 subjects (72%) with dual zone programming and 88 subjects (28%) with single zone programming. Over a mean follow-up period of 661 ± 174 days, inappropriate shocks occurred in 23 subjects from the dual zone subgroup (10.2%) and 23 subjects from the single zone subgroup (26.1%, P <.001), with 2-year inappropriate shock-free rates of 89.7% vs 73.6%;,respectively (hazard ratio 0.38, P =.001). Freedom from appropriate shocks did not differ between subgroups (92.2% vs 90.3%, hazard ratio 0.82, P =.64). Moreover, mean time to appropriate therapy did not differ between subgroups, and there was only 1 episode of arrhythmic syncope in the cohort. Conclusion The addition of a second shock zone with an active discrimination algorithm was strongly associated with a reduction in inappropriate shocks with the S-ICD system and did not result in prolongation of detection times or increased syncope. These data support the use of dual zone programming as a standard setting for S-ICD patients.
Original language | English (US) |
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Pages (from-to) | 1352-1358 |
Number of pages | 7 |
Journal | Heart rhythm |
Volume | 11 |
Issue number | 8 |
DOIs | |
State | Published - Aug 2014 |
Funding
Dr. Gold reports consulting fees and research grants from Boston Scientific, Medtronic, St. Jude’s Medical, and Sorin, as well as speaking fees with Sorin Group and Biotronik. Dr. Weiss reports consulting fees, speaking fees, and research grants from Biosense Webster, Biotronik, Boston Scientific, Medtronic, and St. Jude’s Medical. Dr. Burke reports research grants, speaking fees, and consulting fees from Boston Scientific, Medtronic, and St. Jude’s Medical. Drs. Smith and Knight report receiving consulting fees, speaking fees, and research support from Boston Scientific. Dr. Theuns reports receiving institutional grant support and a consulting fee from Boston Scientific. Dr. Leon reports receiving research grants from Boston Scientific. Mr. Carter and Mr. Husby are employees of Boston Scientific. The S-ICD System Investigational Device Exemption Clinical Study was sponsored in its entirety by Cameron Health, Inc., a subsidiary of Boston Scientific Corporation. Clinical Trial Unique identifier: NCT01064076.
Keywords
- Inappropriate shock
- Inappropriate therapy
- Oversensing
- Rhythm discrimination
- Subcutaneous implantable-defibrillator
- Supraventricular tachyarrhythmia
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
- Physiology (medical)