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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
Death with an implantable cardioverter-defibrillator: a MADIT-II substudy
Fernando Chernomordik1,2,3, Christian Jons4, Helmut U Klein4
1Leviev Heart Center, Sheba Medical Center, Ramat Gan, Israel.
Sudden cardiac death classification is inaccurate for implantable cardioverter-defibrillator patients. Device data and clinical factors like heart failure hospitalizations identify ventricular tachyarrhythmic mortality risk.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Trials
Background:
- Limited data exist on factors predicting ventricular tachyarrhythmic (VTA) or non-arrhythmic (NA) mortality in implantable cardioverter-defibrillator (ICD) patients.
- Current sudden cardiac death (SCD) vs. non-sudden cardiac death (NSCD) classification may lack accuracy.
Purpose of the Study:
- To correlate clinical adjudication of mortality events with device interrogation data in MADIT-II.
- To identify risk factors for VTA mortality in ICD recipients.
Main Methods:
- Analysis of 746 ICD patients from the MADIT-II trial with available interrogation data at death.
- Categorization of deaths into VTA or NA based on device interrogation, validating clinical adjudication.
- Multivariate analysis to identify independent risk factors for VTA mortality.
Main Results:
- Clinical adjudication of SCD/NSCD was inaccurate; 50% of adjudicated SCD and 25% of adjudicated NSCD events were misclassified regarding VTA.
- Factors independently associated with VTA mortality included prior VT/VF, heart failure hospitalization, and hypertension.
- Hazard ratios for VTA mortality were 8.0 for prior VT/VF, 6.7 for heart failure hospitalization, and 4.0 for hypertension.
Conclusions:
- The current SCD vs. NSCD classification is insufficient for accurately identifying VTA events in ICD recipients.
- Simple clinical parameters can identify ICD patients at increased risk for VTA mortality.
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