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Published on: June 12, 2021
Individual patient data network meta-analysis of mortality effects of implantable cardiac devices
B Woods1, N Hawkins2, S Mealing3
1Centre for Health Economics, University of York, York, UK Department of Health Economics, ICON Clinical Research, Oxford, UK.
Insights
Cardiac resynchronisation therapy-defibrillators (CRT-D) offer the greatest mortality reduction in heart failure patients. Benefits vary by patient characteristics like QRS duration, LBBB, age, and gender, informing personalized treatment decisions.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Trials
Background:
- Heart failure with reduced ejection fraction (HFrEF) is a significant cause of mortality.
- Implantable cardioverter defibrillators (ICD), cardiac resynchronisation therapy pacemakers (CRT-P), and combination therapy (CRT-D) are used to manage HFrEF.
- Previous studies suggest these devices reduce all-cause mortality compared to medical therapy alone.
Purpose of the Study:
- To synthesize data from major randomized controlled trials on device therapy for HFrEF.
- To estimate the comparative mortality effects of ICD, CRT-P, and CRT-D.
- To investigate how device benefits vary according to patient characteristics.
Main Methods:
- Network meta-analysis of individual patient data from 13 randomized trials.
- Inclusion of 12,638 patients with HFrEF.
- Adjustment for patient characteristics as predictors of mortality benefit.
Main Results:
- Unadjusted analyses showed CRT-D (42% mortality reduction) was most effective, followed by ICD (29%) and CRT-P (28%) versus medical therapy.
- CRT-D demonstrated greater mortality reduction than CRT-P (19%) and ICD (18%).
- QRS duration (≥150 ms), LBBB morphology, female gender, and younger age (<60) were significant predictors of differential device benefit.
Conclusions:
- Device therapy offers significant mortality benefits in HFrEF patients.
- Patient characteristics, including QRS duration, LBBB, age, and gender, modify these benefits.
- These findings support personalized treatment decisions and shared decision-making in clinical practice.
Objective:
Implantable cardioverter defibrillators (ICD), cardiac resynchronisation therapy pacemakers (CRT-P) and the combination therapy (CRT-D) have been shown to reduce all-cause mortality compared with medical therapy alone in patients with heart failure and reduced EF. Our aim was to synthesise data from major randomised controlled trials to estimate the comparative mortality effects of these devices and how these vary according to patients' characteristics.
Methods:
Data from 13 randomised trials (12 638 patients) were provided by medical technology companies. Individual patient data were synthesised using network meta-analysis.
Results:
Unadjusted analyses found CRT-D to be the most effective treatment (reduction in rate of death vs medical therapy: 42% (95% credible interval: 32-50%), followed by ICD (29% (20-37%)) and CRT-P (28% (15-40%)). CRT-D reduced mortality compared with CRT-P (19% (1-33%)) and ICD (18% (7-28%)). QRS duration, left bundle branch block (LBBB) morphology, age and gender were included as predictors of benefit in the final adjusted model. In this model, CRT-D reduced mortality in all subgroups (range: 53% (34-66%) to 28% (-1% to 49%)). Patients with QRS duration ≥150 ms, LBBB morphology and female gender benefited more from CRT-P and CRT-D. Men and those <60 years benefited more from ICD.
Conclusions:
These data provide estimates for the mortality benefits of device therapy conditional upon multiple patient characteristics. They can be used to estimate an individual patient's expected relative benefit and thus inform shared decision making. Clinical guidelines should discuss age and gender as predictors of device benefits.
