Key result
A Bayesian mixed treatment comparison model estimated that a new four-pole ICD reduces mortality compared to Class III anti-arrhythmic drugs (RR 0.74), showing negligible differences from existing ICDs.
Why the study?
Early estimates of the effectiveness of new versions of medical devices are needed, but empirical data may be lacking, requiring methods to combine expert opinion with existing trial data.
Does a new four-pole implantable cardioverter defibrillator (ICD) reduce mortality in high risk patients compared to conventional ICDs or drug therapy?
Meta-Analysis (n=9,266)
Does a new four-pole implantable cardioverter defibrillator (ICD) reduce mortality in high risk patients compared to conventional ICDs or drug therapy?
A Bayesian mixed treatment comparison meta-analysis incorporating expert opinion provides early estimates of effectiveness for modified medical devices, showing new four-pole ICDs have similar mortality benefits to existing ICDs compared to drug therapy.
Supports four-pole ICDs over antiarrhythmics for mortality reduction; extends network meta-analysis to iterative device designs.
OBJECTIVES: The aim of this study is to describe and illustrate a method to obtain early estimates of the effectiveness of a new version of a medical device. METHODS: In the absence of empirical data, expert opinion may be elicited on the expected difference between the conventional and modified devices. Bayesian Mixed Treatment Comparison (MTC) meta-analysis can then be used to combine this expert opinion with existing trial data on earlier versions of the device. We illustrate this approach for a new four-pole implantable cardioverter defibrillator (ICD) compared with conventional ICDs, Class III anti-arrhythmic drugs, and conventional drug therapy for the prevention of sudden cardiac death in high risk patients. Existing RCTs were identified from a published systematic review, and we elicited opinion on the difference between four-pole and conventional ICDs from experts recruited at a cardiology conference. RESULTS: Twelve randomized controlled trials were identified. Seven experts provided valid probability distributions for the new ICDs compared with current devices. The MTC model resulted in estimated relative risks of mortality of 0.74 (0.60-0.89) (predictive relative risk [RR] = 0.77 [0.41-1.26]) and 0.83 (0.70-0.97) (predictive RR = 0.84 [0.55-1.22]) with the new ICD therapy compared to Class III anti-arrhythmic drug therapy and conventional drug therapy, respectively. These results showed negligible differences from the preliminary results for the existing ICDs. CONCLUSIONS: The proposed method incorporating expert opinion to adjust for a modification made to an existing device may play a useful role in assisting decision makers to make early informed judgments on the effectiveness of frequently modified healthcare technologies.
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Youn et al. (2012) conducted a meta-analysis in High risk for sudden cardiac death (n=9,266). Four-pole implantable cardioverter defibrillator (ICD) vs. Class III anti-arrhythmic drug therapy was evaluated on Mortality (RR 0.74, 95% CI 0.60-0.89). A Bayesian mixed treatment comparison model estimated that a new four-pole ICD reduces mortality compared to Class III anti-arrhythmic drugs (RR 0.74), showing negligible differences from existing ICDs.
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