OBJECTIVES: To develop a computer model to test shock reduction strategies such as antitachycardia pacing and shock withholding for supraventricular rhythms, oversensing, and nonsustained ventricular tachycardia. BACKGROUND: While the implantable cardioverter defibrillator (ICD) can reduce mortality, inappropriate ICD shocks remain a limitation. Randomized trials provide evidence of efficacy, but they are not always practical. Computer models provide an alternative approach, and are particularly useful when evaluating multiple interventions. METHODS: A computer model was developed using clinical data and validated in a large ICD data set (EMPIRIC). After validation, the model was applied to 736 adjudicated clinical episodes from the ICD arm of Sudden Cardiac Death Heart Failure Trial (SCD-HeFT). RESULTS: The shock reduction strategies hypothetically reduced the number of VT/VF shocked episodes in SCD-HeFT by an estimated 59% (from 952 observed to 395 modeled shocks, probability of >0.999) at detection duration settings (18 of 24 intervals). The percentage of patients experiencing inappropriate shocks over 5 years was decreased by 15% (23.5-8.4%), and the number of shocks for non-VT/VF episodes was decreased from 423 to 77 (82% reduction). The percentage of patients receiving shocks for VT/VF was reduced from 30.7% (SCD-HeFT) to 26.1% with the addition of ATP. Extended detection (24 of 32 or 30 of 40 intervals) showed modest additional improvement compared to 18 of 24 intervals. CONCLUSION: Computer modeling is able to predict the results of a known clinical trial and demonstrate that shock reduction strategies have the potential to significantly reduce inappropriate and unnecessary ICD shocks versus the mandated programming used in SCD-HeFT.
OBJECTIVES: To develop a computer model to test shock reduction strategies such as antitachycardia pacing and shock withholding for supraventricular rhythms, oversensing, and nonsustained ventricular tachycardia. BACKGROUND: While the implantable cardioverter defibrillator (ICD) can reduce mortality, inappropriate ICD shocks remain a limitation. Randomized trials provide evidence of efficacy, but they are not always practical. Computer models provide an alternative approach, and are particularly useful when evaluating multiple interventions. METHODS: A computer model was developed using clinical data and validated in a large ICD data set (EMPIRIC). After validation, the model was applied to 736 adjudicated clinical episodes from the ICD arm of Sudden Cardiac Death Heart Failure Trial (SCD-HeFT). RESULTS: The shock reduction strategies hypothetically reduced the number of VT/VF shocked episodes in SCD-HeFT by an estimated 59% (from 952 observed to 395 modeled shocks, probability of >0.999) at detection duration settings (18 of 24 intervals). The percentage of patients experiencing inappropriate shocks over 5 years was decreased by 15% (23.5-8.4%), and the number of shocks for non-VT/VF episodes was decreased from 423 to 77 (82% reduction). The percentage of patients receiving shocks for VT/VF was reduced from 30.7% (SCD-HeFT) to 26.1% with the addition of ATP. Extended detection (24 of 32 or 30 of 40 intervals) showed modest additional improvement compared to 18 of 24 intervals. CONCLUSION: Computer modeling is able to predict the results of a known clinical trial and demonstrate that shock reduction strategies have the potential to significantly reduce inappropriate and unnecessary ICD shocks versus the mandated programming used in SCD-HeFT.
Authors: S González-Enríquez; F Rodríguez-Entem; V Expósito; C Castrillo-Bustamante; A Canteli; A Solloso; I Madrazo; J J Olalla Journal: J Interv Card Electrophysiol Date: 2012-10-19 Impact factor: 1.900
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