Michael R Gold1, Raul Weiss2, Dominic A M J Theuns3, Warren Smith4, Angel Leon5, Bradley P Knight6, Nathan Carter7, Michael Husby7, Martin C Burke8. 1. Medical University of South Carolina, Charleston, South Carolina. Electronic address: goldmr@musc.edu. 2. Ohio State University, Columbus, Ohio. 3. Erasmus Medical Center, Rotterdam, The Netherlands. 4. Auckland City Hospital, Auckland, New Zealand. 5. Emory University School of Medicine, Atlanta, Georgia. 6. Northwestern University, Chicago, Illinois. 7. Boston Scientific Corporation, Natick, Massachusetts. 8. University of Chicago, Chicago, Illinois.
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.
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.
Authors: Vincent C Thomas; Mark Peterson; Martin McDaniel; Humberto Restrepo; Abraham Rothman; Amit Jain Journal: Pediatr Cardiol Date: 2017-05-22 Impact factor: 1.655
Authors: Pier D Lambiase; Dominic A Theuns; Francis Murgatroyd; Craig Barr; Lars Eckardt; Petr Neuzil; Marcoen Scholten; Margaret Hood; Jȕrgen Kuschyk; Amy J Brisben; Nathan Carter; Timothy M Stivland; Reinoud Knops; Lucas V A Boersma Journal: Eur Heart J Date: 2022-06-01 Impact factor: 35.855
Authors: Bruce L Wilkoff; Laurent Fauchier; Martin K Stiles; Carlos A Morillo; Sana M Al-Khatib; Jesœs Almendral; Luis Aguinaga; Ronald D Berger; Alejandro Cuesta; James P Daubert; Sergio Dubner; Kenneth A Ellenbogen; N A Mark Estes; Guilherme Fenelon; Fermin C Garcia; Maurizio Gasparini; David E Haines; Jeff S Healey; Jodie L Hurtwitz; Roberto Keegan; Christof Kolb; Karl-Heinz Kuck; Germanas Marinskis; Martino Martinelli; Mark McGuire; Luis G Molina; Ken Okumura; Alessandro Proclemer; Andrea M Russo; Jagmeet P Singh; Charles D Swerdlow; Wee Siong Teo; William Uribe; Sami Viskin; Chun-Chieh Wang; Shu Zhang Journal: J Arrhythm Date: 2016-02-01