A prospective randomized trial of single- or dual-chamber implantable cardioverter-defibrillators to minimize inappropriate shock risk in primary sudden cardiac death prevention

Paul Andrew Friedman, David John Bradley, Celeste Koestler, Joshua Slusser, David Hodge, Kent R Bailey, Fred Kusumoto, Thomas M. Munger, Arie Militanu, Michael Glikson

Research output: Contribution to journalArticle

22 Citations (Scopus)

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.

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Implantable Defibrillators
Sudden Cardiac Death
Shock
Primary Prevention
Cardiac Arrhythmias
Quality of Life
Stroke
Costs and Cost Analysis
Equipment and Supplies

Keywords

  • Implantable defibrillator
  • Quality of life
  • Shock prevention
  • Single vs. dual chamber

ASJC Scopus subject areas

  • Medicine(all)

Cite this

@article{55ab0c34996242abba459c96552e9a84,
title = "A prospective randomized trial of single- or dual-chamber implantable cardioverter-defibrillators to minimize inappropriate shock risk in primary sudden cardiac death prevention",
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.",
keywords = "Implantable defibrillator, Quality of life, Shock prevention, Single vs. dual chamber",
author = "Friedman, {Paul Andrew} and Bradley, {David John} and Celeste Koestler and Joshua Slusser and David Hodge and Bailey, {Kent R} and Fred Kusumoto and Munger, {Thomas M.} and Arie Militanu and Michael Glikson",
year = "2014",
month = "10",
day = "1",
doi = "10.1093/europace/euu022",
language = "English (US)",
volume = "16",
pages = "1460--1468",
journal = "Europace",
issn = "1099-5129",
publisher = "Oxford University Press",
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TY - JOUR

T1 - A prospective randomized trial of single- or dual-chamber implantable cardioverter-defibrillators to minimize inappropriate shock risk in primary sudden cardiac death prevention

AU - Friedman, Paul Andrew

AU - Bradley, David John

AU - Koestler, Celeste

AU - Slusser, Joshua

AU - Hodge, David

AU - Bailey, Kent R

AU - Kusumoto, Fred

AU - Munger, Thomas M.

AU - Militanu, Arie

AU - Glikson, Michael

PY - 2014/10/1

Y1 - 2014/10/1

N2 - 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.

AB - 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.

KW - Implantable defibrillator

KW - Quality of life

KW - Shock prevention

KW - Single vs. dual chamber

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U2 - 10.1093/europace/euu022

DO - 10.1093/europace/euu022

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SN - 1099-5129

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