Head-To-Head Comparison of Arrhythmia Discrimination Performance of Subcutaneous and Transvenous ICD Arrhythmia Detection Algorithms: The START Study

Authors


  • This study was supported by Cameron Health Inc.

  • Clinical Trial Registration: NCT01161589.

  • Dr. Gold receives consulting fees from Boston Scientific, Medtronic, St. Jude, and Sorin; research grants from Boston Scientific, Medtronic, St. Jude, Sorin, and Cameron Health; and honoraria from Biotronik. Dr. Theuns receives consulting fees from Cameron Health and research grants from Biotronik, Boston Scientific, and St. Jude Medical. Dr. Knight receives consulting fees from Cameron Health and Boston Scientific; honoraria from Boston Scientific and Medtronic; and research grants from Boston Scientific, Cameron Health, Medtronic, and St. Jude. Dr. Sturdivant receives honoraria from Boston Scientific and Medtronic; and a research grant from Boston Scientific. Mr. Sanghera is an employee of Cameron Health. Dr. Ellenbogen receives consulting fees from Biosense Webster, Boston Scientific, Medtronic, Sorin, and St. Jude Medical; honoraria from Biosense Webster, Boston Scientific, Medtronic, St. Jude Medical, and Sanofi-Aventis; and research grants from Biotronik, Boston Scientific, Cameron Health, Cryocath, Medtronic, St. Jude Medical, Sorin, and Spectranetics. Dr. Wood receives honoraria from Boston Scientific, Medtronic, and St. Jude Medical; and research grants from Boston Scientific, Medtronic, and St. Jude Medical. Dr. Burke receives consulting fees from AJ Medical Devices and Cameron Health; honoraria from Medtronic and Spectranetics; research grants from AJ Medical Devices, Boston Scientific, and Cameron Health; and serves on an advisory board for Boston Scientific and Medtronic.

Address for correspondence: Michael R. Gold, M.D., Ph.D., Division of Cardiology, Medical University of South Carolina, 25 Courtenay Drive, ART 7031, Charleston, SC 29425, USA. Fax: 843-876-4990; E-mail: goldmr@musc.edu

Abstract

Arrhythmia Detection with S-ICD Versus Transvenous ICDs.

Background: The development of a totally subcutaneous implantable defibrillator (S-ICD) system requires a new approach for arrhythmia detection. To evaluate arrhythmia discrimination of one such system, the Subcutaneous versus Transvenous Arrhythmia Recognition Testing (START) study was designed as a prospective, multicenter trial comparing simulated sensing performances of the S-ICD system with single- (SC-TV) and dual-chamber transvenous (DC-TV) implantable cardioverter-defibrillator (ICD) systems.

Methods: At ICD implantation, induced ventricular and atrial arrhythmias were recorded simultaneously in transvenous (right ventricular [RV]→superior vena cava [SVC]+ Coil) and cutaneous electrode configurations. Recorded signals of ventricular (n = 46) and atrial arrhythmias (n = 50) with ventricular rates >170 bpm from 64 patients were used to compare detection performance of the S-ICD system with TV-ICD systems from 3 manufacturers. Appropriate detection of ventricular tachyarrhythmias was assessed with devices programmed in single-zone (rate ≥170 bpm) and dual-zone configurations (ventricular fibrillation ≥240 bpm; ventricular tachycardia ≥170 bpm). S-ICD specificity performance for supraventricular arrhythmias was compared to single- and dual-chamber devices in a dual-zone configuration.

Results: Appropriate detection of ventricular tachyarrhythmias for subcutaneous and TV devices in single- and dual-zone configurations was 100% and >99%, respectively. Specificity for supraventricular arrhythmias was significantly better for the S-ICD system compared to 2 of 3 TV systems, as well as the composite of TV devices (98.0%[S-ICD] vs 76.7%[SC-TV range: 64.0–92.0%] vs 68.0%[DC-TV range: 32.7–89.8%; P < 0.001]).

Conclusion: Appropriate ventricular arrhythmia detection is excellent for all ICD systems evaluated; however, specificity of supraventricular arrhythmia discrimination by the S-ICD system is better than discrimination by 2 of 3 TV systems.

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