Paul A Friedman1, David Bradley2, Celeste Koestler2, Joshua Slusser3, David Hodge3, Kent Bailey3, Fred Kusumoto4, Thomas M Munger2, Arie Militanu5, Michael Glikson6. 1. Division of Cardiovascular Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA pfriedman@mayo.edu. 2. Division of Cardiovascular Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. 3. Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA. 4. Division of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL, USA. 5. Division of Biomedical Statistics and Informatics, Electrophysiology and Pacing, Carmel Medical Center, Haifa, Israel. 6. Division of Biomedical Statistics and Informatics, Electrophysiology and Pacing, Heart Institute, Sheba Medical Center, Ramat Gan, Israel.
Abstract
AIMS: Dual-chamber implantable cardioverter-defibrillators (ICDs) may improve specificity and reduce the risk of inappropriate shocks, and enhance atrial arrhythmia (AT/AF) detection to permit stroke prevention compared with single-chamber ICDs, but at additional expense and risk. METHODS AND RESULTS: Patients (n = 100) receiving primary prevention ICDs at two USA and two Israeli centres were randomized to dual-chamber or single-chamber devices between December 2008 and December 2010 and were followed for 1 year. Programming in both groups included: delayed detection to avoid therapy for non-sustained episodes; high detection cut-off rates to avoid treating slower, better tolerated arrhythmias; minimized right ventricular pacing; and routine use of supraventricular-ventricular tahcycardia discriminators and antitachycardia pacing. The primary outcome was the proportion of patients with inappropriate shocks. One patient in each group (2%) received inappropriate shocks (P = 1.00). Death occurred in two patients in the single-chamber arm, and in none of the patients in the dual-chamber arm (P = 0.15). New AT/AF was detected in 12 patients (24%) in the dual-chamber group, vs. no patients in the single-chamber group (P < 0.001). Among US participants, the mean cost of dual- vs. single-chamber ICD implantation was $16 579 vs. $14 249, respectively (P < 0.001); there was no difference in the quality of life (EQ-5D index difference 0.013, P = 0.769; EQ VAS difference 3.3, P = 0.49). CONCLUSION: When optimal programming is utilized, inappropriate shocks are rare in primary prevention patients with both single- and dual-chamber ICDs. The routine use of dual-chamber ICDs increases the expense without reducing inappropriate shocks or improving the quality of life at 1 year. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00787800. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Dual-chamber implantable cardioverter-defibrillators (ICDs) may improve specificity and reduce the risk of inappropriate shocks, and enhance atrial arrhythmia (AT/AF) detection to permit stroke prevention compared with single-chamber ICDs, but at additional expense and risk. METHODS AND RESULTS:Patients (n = 100) receiving primary prevention ICDs at two USA and two Israeli centres were randomized to dual-chamber or single-chamber devices between December 2008 and December 2010 and were followed for 1 year. Programming in both groups included: delayed detection to avoid therapy for non-sustained episodes; high detection cut-off rates to avoid treating slower, better tolerated arrhythmias; minimized right ventricular pacing; and routine use of supraventricular-ventricular tahcycardia discriminators and antitachycardia pacing. The primary outcome was the proportion of patients with inappropriate shocks. One patient in each group (2%) received inappropriate shocks (P = 1.00). Death occurred in two patients in the single-chamber arm, and in none of the patients in the dual-chamber arm (P = 0.15). New AT/AF was detected in 12 patients (24%) in the dual-chamber group, vs. no patients in the single-chamber group (P < 0.001). Among US participants, the mean cost of dual- vs. single-chamber ICD implantation was $16 579 vs. $14 249, respectively (P < 0.001); there was no difference in the quality of life (EQ-5D index difference 0.013, P = 0.769; EQ VAS difference 3.3, P = 0.49). CONCLUSION: When optimal programming is utilized, inappropriate shocks are rare in primary prevention patients with both single- and dual-chamber ICDs. The routine use of dual-chamber ICDs increases the expense without reducing inappropriate shocks or improving the quality of life at 1 year. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00787800. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Emily P Zeitler; Gillian D Sanders; Kavisha Singh; Ruth Ann Greenfield; Anne M Gillis; Bruce L Wilkoff; Jonathan P Piccini; Sana M Al-Khatib Journal: Europace Date: 2018-10-01 Impact factor: 5.214
Authors: Emily P Zeitler; Sana M Al-Khatib; Daniel J Friedman; Joo Yoon Han; Jeanne E Poole; Gust H Bardy; J Thomas Bigger; Alfred E Buxton; Arthur J Moss; Kerry L Lee; Paul Dorian; Riccardo Cappato; Alan H Kadish; Peter J Kudenchuk; Daniel B Mark; Lurdes Y T Inoue; Gillian D Sanders Journal: J Cardiovasc Electrophysiol Date: 2017-08-23
Authors: Tariel A Atabekov; Roman E Batalov; Svetlana I Sazonova; Sergey N Krivolapov; Mikhail S Khlynin; Anna I Mishkina; Konstantin V Zavadovsky; Antonio Curnis; Sergey V Popov Journal: Int J Cardiovasc Imaging Date: 2021-06-07 Impact factor: 2.357
Authors: Pamela N Peterson; Robert T Greenlee; Alan S Go; David J Magid; Andrea Cassidy-Bushrow; Romel Garcia-Montilla; Karen A Glenn; Jerry H Gurwitz; Stephen C Hammill; John Hayes; Alan Kadish; Kristi Reynolds; Param Sharma; David H Smith; Paul D Varosy; Humberto Vidaillet; Chan X Zeng; Sharon-Lise T Normand; Frederick A Masoudi Journal: J Am Heart Assoc Date: 2017-11-09 Impact factor: 5.501