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A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
Is there benefit in implanting defibrillators in patients with severe heart failure?
Tushar V Salukhe1, Natalia I Briceno, Emily A Ferenczi
1International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, 59-61 North Wharf Road, London, UK. salukhe@aol.com
Insights
Severe heart failure patients may benefit from implantable cardioverter defibrillators (ICDs). Current practice withholds ICDs, but this study found no evidence that severe heart failure reduces their effectiveness in preventing sudden cardiac death.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Trials
Background:
- Current practice often excludes patients with severe heart failure from receiving implantable cardioverter defibrillators (ICDs).
- This exclusion is based on the assumption that their deaths are non-sudden and thus not preventable by ICDs.
- This assumption suggests that the benefits of ICDs should decrease in subgroups with more severe heart failure.
Purpose of the Study:
- To investigate whether patients with severe heart failure benefit less from implantable cardioverter defibrillators (ICDs).
- To challenge the prevailing assumption that severe heart failure limits the effectiveness of ICD therapy.
Main Methods:
- Analysis of data from six randomized controlled trials involving 7873 patients, with 2734 assigned to ICDs.
- Subgroup analysis based on New York Heart Association (NYHA) class and left ventricular ejection fraction (LVEF).
- Evaluation of mortality reduction and z-scores across different severity subgroups.
Main Results:
- No significant difference in z-scores was observed between mild-to-moderate and severe heart failure patients when categorized by NYHA class (p=0.922).
- Subgrouping by LVEF also showed no significant difference in z-scores (p=0.170).
- These findings indicate that the benefit of ICD implantation is not attenuated in patients with higher NYHA class or lower LVEF.
Conclusions:
- Existing trial data do not support the notion that the relative risk reduction from ICDs is smaller in patients with severe heart failure.
- The assumption that severe heart failure patients benefit less from ICD therapy requires re-evaluation.
- Further consideration of ICD implantation in severe heart failure populations is warranted.
Background:
It is current practice to withhold implantable cardioverter defibrillators (ICD) from patients with severe heart failure because their deaths are judged as non-sudden and therefore assumed not to be preventable by ICD. If this was true, there should be a trend towards reduced preventability of deaths in the severe heart failure subgroups within existing randomised control ICD trials. We tested the prevailing assumption that patients with most severe heart failure would not benefit from ICD implantation. METHODS Six trials were identified enrolling 7873 patients, with 2734 patients randomly assigned to receive an ICD. Reduction in mortality in the ICD arm varied between 5.6% and 31%. All six trials provided data separated into higher and lower ejection fraction subgroups. Five trials provided data separated into higher and lower New York Heart Association (NYHA) class patient subgroups.
Results:
For patients subcategorised by NYHA class, there was a non-significant difference in z-score (p=0.922) between patients with mild to moderate and severe heart failure. Similarly, subgrouping by left ventricular ejection fraction (LVEF) revealed no significant difference between z-scores (p=0.170). Both observations suggest no attenuation of benefit of ICD implantation in patients with higher NYHA class or lower LVEF.
Conclusion:
There is no evidence within the existing trial populations of a tendency for the relative risk reduction to be smaller in patients with severe heart failure. The prevailing assumption that severe heart failure patients are less likely to benefit from ICD therapy must be questioned.
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