Quality of life in the Canadian Implantable Defibrillator Study (CIDS)

Irvine, Jane; Dorian, Paul; Baker, Brian; O’Brien, Bernie J.; Roberts, Robin S.; Gent, Michael; Newman, David W.; Connolly, Stuart J.

doi:10.1067/mhj.2002.124049

Cited by 296 publications

(143 citation statements)

References 28 publications

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“…A substudy of the CIDS trial 87 reported the effects of ICDs and AADs on three domains of the Mental Health Inventory (MHI) and seven domains of the Nottingham Health Profile (NHP), with an additional assessment of the consequences of ICD shocks on these measures (see Table 26). At 12 months' follow-up the ICD group had shown a significantly greater improvement than the AAD group on the MHI domains of 'total index' (p = 0.001), 'psychological distress' (p = 0.001) and 'psychological well-being' (p = 0.03) and the NHP domains of 'energy level' (p = 0.0001), 'physical mobility' (p = 0.002), 'emotional reactions' (p = 0.002), 'sleep disturbance' (p = 0.02) and 'lifestyle impairment' (p = 0.005).…”

Section: Quality Of Lifementioning

confidence: 99%

“…A total of 16 patients had their ICD explanted permanently or temporarily because of infection, heart transplantation or patient preference; 52/331 (15.7%) patients randomised to amiodarone received an ICD. For QoL, 87 of the original 400 participants, 317 spoke English; participation rate was 79%. Of the 317 recruited, 287 (90.5%) were alive at the 12-month assessment; 22/287 (7.7%) were missing the baseline QoL assessment (11 from each group) and 127/287 (44%) were missing data at one of the follow-up assessments (63 amiodarone, 64 ICD).…”

Section: Reference Listsmentioning

confidence: 99%

“…The effects of ICD shocks on QoL were assessed in the CIDS trial 87 on the different domains of the MHI and the NHP through univariate comparisons between groups in terms of the numbers of shocks (i.e. ICD no shocks, ICD one to four shocks, ICD five or more shocks and AAD group without an ICD) (see Table 26).…”

Section: Quality Of Lifementioning

confidence: 99%

“…Crossover rates of 5% per year for both treatment groups were anticipated. QoL study 87 was conducted with the original 400 patients only because of cost. Of these, 317 spoke English; participation rate was 79%.…”

Section: Reference Listsmentioning

confidence: 99%

“…External safety and efficacy monitoring committee reviewed the unblinded study data every 6 months for safety and did three formal interim analyses of efficacy with the intention of stopping the study early in favour of ICD if one-sided p ≤ 0.001. For QoL study, 87 analysis of variance with repeated measures used. Significant time changes and group effects followed up by means of post-hoc tests (Tukey honestly significant difference test).…”

Section: Reference Listsmentioning

confidence: 99%

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Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Colquitt¹,

Mendes²,

Clegg³

et al. 2014

Health Technology Assessment

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BackgroundThis assessment updates and expands on two previous technology assessments that evaluated implantable cardioverter defibrillators (ICDs) for arrhythmias and cardiac resynchronisation therapy (CRT) for heart failure (HF).ObjectivesTo assess the clinical effectiveness and cost-effectiveness of ICDs in addition to optimal pharmacological therapy (OPT) for people at increased risk of sudden cardiac death (SCD) as a result of ventricular arrhythmias despite receiving OPT; to assess CRT with or without a defibrillator (CRT-D or CRT-P) in addition to OPT for people with HF as a result of left ventricular systolic dysfunction (LVSD) and cardiac dyssynchrony despite receiving OPT; and to assess CRT-D in addition to OPT for people with both conditions.Data sourcesElectronic resources including MEDLINE, EMBASE and The Cochrane Library were searched from inception to November 2012. Additional studies were sought from reference lists, clinical experts and manufacturers’ submissions to the National Institute for Health and Care Excellence.Review methodsInclusion criteria were applied by two reviewers independently. Data extraction and quality assessment were undertaken by one reviewer and checked by a second. Data were synthesised through narrative review and meta-analyses. For the three populations above, randomised controlled trials (RCTs) comparing (1) ICD with standard therapy, (2) CRT-P or CRT-D with each other or with OPT and (3) CRT-D with OPT, CRT-P or ICD were eligible. Outcomes included mortality, adverse events and quality of life. A previously developed Markov model was adapted to estimate the cost-effectiveness of OPT, ICDs, CRT-P and CRT-D in the three populations by simulating disease progression calculated at 4-weekly cycles over a lifetime horizon.ResultsA total of 4556 references were identified, of which 26 RCTs were included in the review: 13 compared ICD with medical therapy, four compared CRT-P/CRT-D with OPT and nine compared CRT-D with ICD. ICDs reduced all-cause mortality in people at increased risk of SCD, defined in trials as those with previous ventricular arrhythmias/cardiac arrest, myocardial infarction (MI) > 3 weeks previously, non-ischaemic cardiomyopathy (depending on data included) or ischaemic/non-ischaemic HF and left ventricular ejection fraction ≤ 35%. There was no benefit in people scheduled for coronary artery bypass graft. A reduction in SCD but not all-cause mortality was found in people with recent MI. Incremental cost-effectiveness ratios (ICERs) ranged from £14,231 per quality-adjusted life-year (QALY) to £29,756 per QALY for the scenarios modelled. CRT-P and CRT-D reduced mortality and HF hospitalisations, and improved other outcomes, in people with HF as a result of LVSD and cardiac dyssynchrony when compared with OPT. The rate of SCD was lower with CRT-D than with CRT-P but other outcomes were similar. CRT-P and CRT-D compared with OPT produced ICERs of £27,584 per QALY and £27,899 per QALY respectively. The ICER for CRT-D compared with CRT-P was £28,420 per QALY. In people with both conditions, CRT-D reduced the risk of all-cause mortality and HF hospitalisation, and improved other outcomes, compared with ICDs. Complications were more common with CRT-D. Initial management with OPT alone was most cost-effective (ICER £2824 per QALY compared with ICD) when health-related quality of life was kept constant over time. Costs and QALYs for CRT-D and CRT-P were similar. The ICER for CRT-D compared with ICD was £27,195 per QALY and that for CRT-D compared with OPT was £35,193 per QALY.LimitationsLimitations of the model include the structural assumptions made about disease progression and treatment provision, the extrapolation of trial survival estimates over time and the assumptions made around parameter values when evidence was not available for specific patient groups.ConclusionsIn people at risk of SCD as a result of ventricular arrhythmias and in those with HF as a result of LVSD and cardiac dyssynchrony, the interventions modelled produced ICERs of < £30,000 per QALY gained. In people with both conditions, the ICER for CRT-D compared with ICD, but not CRT-D compared with OPT, was < £30,000 per QALY, and the costs and QALYs for CRT-D and CRT-P were similar. A RCT comparing CRT-D and CRT-P in people with HF as a result of LVSD and cardiac dyssynchrony is required, for both those with and those without an ICD indication. A RCT is also needed into the benefits of ICD in non-ischaemic cardiomyopathy in the absence of dyssynchrony.Study registrationThis study is registered as PROSPERO number CRD42012002062.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Quality Of Lifementioning

confidence: 99%

Section: Reference Listsmentioning

confidence: 99%

Section: Quality Of Lifementioning

confidence: 99%

Section: Reference Listsmentioning

confidence: 99%

Section: Reference Listsmentioning

confidence: 99%

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Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Colquitt¹,

Mendes²,

Clegg³

et al. 2014

Health Technology Assessment

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Implantable Cardioverter Defibrillators and Quality of Life<subtitle>Results From the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation Study</subtitle>

Subačius²,

et al. 2007

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Background: The Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study demonstrated that implantable cardioverter defibrillators (ICDs) significantly reduce the risk of sudden cardiac death in patients with nonischemic cardiomyopathy and an ejection fraction of 35% or less, with no statistically significant decrease in overall mortality. The impact of ICD placement and shock on health-related quality of life (HRQL) in this population is unknown. Methods: The 12-Item Medical Outcomes Short-Form Health Survey and the Minnesota Living with Heart Failure Questionnaire were administered to 458 patients with nonischemic cardiomyopathy, an ejection fraction of 35% or less, and either nonsustained ventricular tachycardia or 10 or more premature ventricular depolarizations per hour atbaseline,1monthafterrandomization,andevery3months thereafter throughout the trial. The subjects were randomized to an ICD or standard medical therapy. Outcomes were compared using hierarchical linear regression. Results: Overall, there were no significant differences in HRQL throughout the trial between patients randomized to an ICD or standard medical therapy. However, in patients with 1 or more ICD shocks, HRQL declined 0.5±0.2 (mean±SD) points per shock on the emotional scale of the Minnesota Living with Heart Failure Questionnaire (P=.04) and 1.0±0.5 points per shock on the mental component score of the 12-Item Medical Outcomes Short-Form Health Survey (P =.04). Conclusions: Overall, HRQL was not affected by ICD implantation in patients in the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation study. Implantable cardioverter defibrillator shock was associated with a reduction in some measures of HRQL, but the effects were unlikely to result in a clinically observable alteration until 5 or more shocks were experienced.

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Comparison of β-Blockers, Amiodarone Plus β-Blockers, or Sotalol for Prevention of Shocks From Implantable Cardioverter Defibrillators<SUBTITLE>The OPTIC Study: A Randomized Trial</SUBTITLE>

Connolly

Dorian²,

Roberts³

et al. 2006

JAMA

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388

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Quality of life in the Canadian Implantable Defibrillator Study (CIDS)

Cited by 296 publications

References 28 publications

Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Implantable Cardioverter Defibrillators and Quality of Life<subtitle>Results From the Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation Study</subtitle>

Comparison of β-Blockers, Amiodarone Plus β-Blockers, or Sotalol for Prevention of Shocks From Implantable Cardioverter Defibrillators<SUBTITLE>The OPTIC Study: A Randomized Trial</SUBTITLE>

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