CoMFFort-Q in CIEDs - clinical outcomes study

  • Research type

    Research Study

  • Full title

    Co-morbidity, frailty, functional status and quality of life in cardiac implantable electronic devices – a clinical outcomes study.

  • IRAS ID

    167170

  • Contact name

    John M Morgan

  • Contact email

    jmm@hrclinic.org

  • Sponsor organisation

    University Hospitals Southampton NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 11 months, 28 days

  • Research summary

    Research Summary:
    This is a study to examine functional status quality of life and key co-morbidity in patients with cardiac implantable electronic devices (CIEDs).

    Device related infection is a growing problem in individuals with CIEDs. This is partly thought to be due to the increasing age and frailty of people who receive these treatments. Once this type of infection develops, the best treatment is to remove the device. This involves an operation which can be risky. Measuring baseline (at the time of new implant or replacement battery) quality of life, frailty and co-morbidity can help prove the association between quality of life, frailty and co-morbidity and CIED related infection. Knowing this may in turn help prevent the problem from getting worse.

    A proportion of patients who receive a CIED have a particular type of device that is capable of treating life threatening heart rhythms. These are known as defibrillators (ICDs and CRT-Ds)

    As people age, the quality of life and the individual's ability to perform normal daily activities required to meet basic needs (functional status) changes. The risk of dying from an abnormal heart rhythm increases as does the risk of dying from lots of other causes.

    At present, doctors have to use their judgement to decide whether somebody is likely to live long enough to benefit from their ICD / CRT-D or not. Guidelines say that ICDs /CRT-Ds should only be implanted in patients whose estimated life expectancy is at least one year with a good functional status.

    We would like to measure quality of life, frailty and co-morbidity in patients with ICDs / CRT-D to help doctors make more informed decisions as to who may benefit from ICD / CRT-D therapy.

    Summary of Results:
    Little research has been undertaken to determine which patients benefit the least from ICD therapy. As patients age and accumulate comorbidities, the risk of death increases and the benefit of ICDs diminishes. We sought to evaluate the impact of comorbidity, frailty, functional status on death prior to ICD therapy.
    Methods
    A prospective, multicentre, observational study involving 15 English hospitals was undertaken. Patients were eligible for inclusion for the study if they were scheduled to have a de novo, upgrade to or replacement of transvenous or subcutaneous ICD or CRT-D. Baseline characteristics were collected and participants were asked to complete a frailty assessment (Fried score and a functional status questionnaire (EQ-5D-5L). The Charlson Comorbidity Score was calculated. Patients were prospectively followed up for 2.5 years. The primary outcome was death with no-prior appropriate therapy.
    Results
    In total, 662 patients were enrolled, mean age 65.6 (IQR 65-75) years. A total of 63 patients (9.5%) died across this period, of these, 54 died without receiving appropriate therapy. Frailty was present in 83/662 (12.5%) and severe comorbidity was present in 69/662 (10.4%).
    Multivariate predictors of death with no appropriate therapy were identified and a risk score comprising frailty, severe comorbidity, age >70 years, eGFR <60 ml/min/1.73 m2 EQ5D5L <0.6 was developed.
    Conclusion:
    Comorbidities, frailty and the EQ-5D-5L score are powerful, independent predictors of death with no appropriate in ICD/CRT-D recipients.

  • REC name

    Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

  • REC reference

    14/YH/1315

  • Date of REC Opinion

    23 Dec 2014

  • REC opinion

    Favourable Opinion