January 28, 2019EP Europace
The impact of implantable cardioverter-defibrillator implantation on health-related quality of life in the DANISH trial
Key result
ICD implantation does not alter quality of life versus usual care in non-ischaemic systolic heart failure.
- P=0.13
- n=1,116
Why the study?
The DANISH trial found no overall effect on all-cause mortality, and the effect of ICD implantation on HRQoL remained to be established due to conflicting results from previous trials.
Does implantable cardioverter-defibrillator implantation improve health-related quality of life in patients with non-ischaemic systolic heart failure?
Population
1116 patients with non-ischaemic systolic HF
Comparison
ICD implantation vs usual clinical care
Design
Prespecified secondary endpoint analysis of a 1:1 randomized controlled trial
Follow-up
8 months
Authors
Discussion
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Implication
No HRQoL benefit from ICD in non-ischaemic systolic HF; extends evidence that any advantage is confined to mortality reduction.
Study Design
Type
RCT (n=1,116)
Randomization
1:1
Structured PICO
Does implantable cardioverter-defibrillator implantation improve health-related quality of life in patients with non-ischaemic systolic heart failure?
P
Population
1,116 patients with non-ischaemic systolic heart failure followed for 8 months to assess changes in health-related quality of life.
I
Intervention
Implantable cardioverter-defibrillator (ICD) implantation
C
Comparator
Usual clinical care
O
Outcome
Change in health-related quality of life (HRQoL) assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ) 8 months after randomizationpatient reported
Main Result
Absolute Event Rate: -7% vs -4.2%
p-value: p=0.13
ICD implantation does not significantly alter health-related quality of life compared to usual care in patients with non-ischaemic systolic heart failure.
Cite This Study
Bundgaard et al. (2019) conducted an RCT in non-ischaemic systolic heart failure (n=1,116). Implantable cardioverter-defibrillator implantation vs. usual clinical care was evaluated on Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score at 8 months (p=0.13). ICD implantation in non-ischaemic systolic heart failure did not significantly alter health-related quality of life compared with usual care (LS mean change -7.0 vs -4.2; P=0.13).