Absolute risk reduction in total mortality with implantable cardioverter defibrillators: analysis of primary and secondary prevention trial data to aid risk/benefit analysis

Betts, Timothy R.; Sadarmin, Praveen P.; Tomlinson, David R.; Rajappan, Kim; Wong, Kevin; Bono, Joseph de; Bashir, Yaver

doi:10.1093/europace/eus427

Cited by 38 publications

(26 citation statements)

References 41 publications

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“…However, closely reviewing the 3-year mortality rates observed in primary and secondary prevention trials demonstrates a comparable trend. 17 After 8 years, we observed a mortality of 52% in primary prevention CRT-D recipients. Yet, only 12% of the REVERSE population had died after 5 years; however, this trial included only patients with mild heart failure.…”

Section: Mortality In Icd and Crt-d Recipientsmentioning

confidence: 88%

The clinical course of patients with implantable cardioverter-defibrillators: Extended experience on clinical outcome, device replacements, and device-related complications

et al. 2015

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Section: Mortality In Icd and Crt-d Recipientsmentioning

confidence: 88%

The clinical course of patients with implantable cardioverter-defibrillators: Extended experience on clinical outcome, device replacements, and device-related complications

et al. 2015

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“…3,4) Current indications for an ICD include not only a near-fatal arrhythmic event 5) and ischemic cardiomyopathy but also severe nonischemic cardiomyopathy with a low left ventricular ejection fraction (LVEF).…”

Section: Mplantable Cardioverter-defibrillators (Icds) Have Beenmentioning

confidence: 99%

Assessment of Efficacy and Necessity of Routine Defibrillation Threshold Testing in Patients Undergoing Implantable Cardioverter-Defibrillator (ICD) Implantation

et al. 2015

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SummaryDefibrillation threshold (DFT) testing is performed routinely in patients undergoing implantable cardioverter-defibrillator (ICD) implantation to verify the ability of the ICD to terminate ventricular fibrillation (VF). However, neither the efficacy nor the safety of DFT testing has been proven; thus, the necessity of such testing is controversial. We conducted a retrospective study of the efficacy of DFT testing, particularly with respect to long-term outcomes of ICD implantation.The study included 150 patients (125 men, 25 women, aged 59.0 ± 17.6 years) who underwent ICD or cardiac resynchronization therapy defibrillator implantation, with (n = 73) or without (n = 77) intraoperative DFT testing, between June 1996 and September 2007. VF was induced by delivery of a T-wave shock, and a 20-25-J shock was then delivered. If the 20-25-J shock failed to terminate VF, 30 J was delivered. We assessed whether undersensed VF events occurred during DFT testing and/or during patient follow-up and checked for any association between undersensing and delayed shock delivery. During DFT testing, fine VF was sensed, and shocks were delivered in a timely manner. Nevertheless, 2 patients in the DFT testing group died from VF within 3 years after device implantation.DFT testing, in comparison to non-DFT testing, appeared to have no influence on the long-term outcomes of our patients, suggesting that DFT testing at the time of ICD implantation is limited. (Int Heart J 2015; 56: 618-621) Key words: Ventricular arrhythmia, Mortality I mplantable cardioverter-defibrillators (ICDs) have been shown to reduce mortality resulting from both ischemic 1,2) and non-ischemic cardiomyopathies 2) and to terminate potentially fatal ventricular arrhythmias.3,4) Current indications for an ICD include not only a near-fatal arrhythmic event 5) and ischemic cardiomyopathy but also severe nonischemic cardiomyopathy with a low left ventricular ejection fraction (LVEF).Defibrillation threshold (DFT) testing during ICD implantation has been considered necessary for appropriate shock delivery, 6) and a DFT safety margin of 10 J is the standard recommendation.6,7) However, neither the efficacy nor benefit of DFT testing has been proven. [8][9][10][11] Induction of ventricular fibrillation (VF) during DFT can cause hemodynamic compromise, clinical deterioration, and life-threatening cerebrovascular accidents.12-15) Thus, we conducted a retrospective study to assess the effect of DFT testing on long-term outcomes in patients with an ICD or cardiac resynchronization therapy defibrillator (CRT-D). MethodsStudy patients: The study included 150 patients (125 men, 25 women) who received an ICD (n = 85) or CRT-D (n = 65) at our hospital between June 1996 and September 2007. Hospital records were obtained, from which we extracted the patient clinical characteristics, follow-up times, ICD intracardiac recordings, and clinical outcomes. The ICDs and CRT-Ds were implanted in a standard transvenous manner. We divided the patients into 2 groups, those in whom DFT...

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“…Implantable cardiac defibrillators (ICD) are established as preventing death in patients with left ventricular dysfunction and ischaemic heart disease (IHD) 1 . In patients without IHD, however, ICDs are already considered controversial, 2 and recent trial data have been interpreted as indicating that they are not beneficial 3 …”

Section: Introductionmentioning

confidence: 99%

Implantable cardioverter defibrillators for primary prevention of death in left ventricular dysfunction with and without ischaemic heart disease: a meta-analysis of 8567 patients in the 11 trials

Shun-Shin

Zheng

Cole

et al. 2017

European Heart Journal

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AimsPrimary prevention implantable cardioverter defibrillators (ICDs) are established therapy for reducing mortality in patients with left ventricular systolic dysfunction and ischaemic heart disease (IHD). However, their efficacy in patients without IHD has been controversial. We undertook a meta-analysis of the totality of the evidence.Methods and resultsWe systematically identified all RCTs comparing ICD vs. no ICD in primary prevention. Eligible RCTs were those that recruited patients with left ventricular dysfunction, reported all-cause mortality, and presented their results stratified by the presence of IHD (or recruited only those with or without). Our primary endpoint was all-cause mortality. We identified 11 studies enrolling 8567 participants with left ventricular dysfunction, including 3128 patients without IHD and 5439 patients with IHD. In patients without IHD, ICD therapy reduced mortality by 24% (HR 0.76, 95% CI 0.64 to 0.90, P = 0.001). In patients with IHD, ICD implantation (at a dedicated procedure), also reduced mortality by 24% (HR 0.76, 95% CI 0.60 to 0.96, P = 0.02).ConclusionsUntil now, it has never been explicitly stated that the patients without IHD in COMPANION showed significant survival benefit from adding ICD therapy (to a background of CRT). Even before DANISH, meta-analysis of patients without ischaemic heart disease already showed reduced mortality. DANISH is consistent with these data. With a significant 24% mortality reduction in both aetiologies, it may no longer be necessary to distinguish between them when deciding on primary prevention ICD implantation.

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Absolute risk reduction in total mortality with implantable cardioverter defibrillators: analysis of primary and secondary prevention trial data to aid risk/benefit analysis

Cited by 38 publications

References 41 publications

The clinical course of patients with implantable cardioverter-defibrillators: Extended experience on clinical outcome, device replacements, and device-related complications

The clinical course of patients with implantable cardioverter-defibrillators: Extended experience on clinical outcome, device replacements, and device-related complications

Assessment of Efficacy and Necessity of Routine Defibrillation Threshold Testing in Patients Undergoing Implantable Cardioverter-Defibrillator (ICD) Implantation

Implantable cardioverter defibrillators for primary prevention of death in left ventricular dysfunction with and without ischaemic heart disease: a meta-analysis of 8567 patients in the 11 trials

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