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Experience with a dual chamber implantable defibrillator.
Volker Kühlkamp1, Bruce L Wilkoff, Amy B Brown
1Department of Cardiology, Universitätsklinikum Tübingen, Germany. volker.kuehlkamp@med.uni-tuebingen.de
Pacing and Clinical Electrophysiology : PACE
|August 8, 2002
Summary
This study shows that the Gem DR dual chamber implantable defibrillator effectively detects ventricular arrhythmias with 100% accuracy. It also reduces inappropriate detections of supraventricular arrhythmias by 72%, proving safe and effective.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Devices
Background:
- Dual chamber pacing in implantable defibrillators offers potential benefits for arrhythmia detection and management.
- Distinguishing supraventricular from ventricular arrhythmias is crucial for appropriate defibrillator therapy.
Purpose of the Study:
- To evaluate the safety and performance of a dual chamber implantable cardioverter defibrillator (ICD) with an algorithm for discriminating supraventricular from ventricular arrhythmias.
- To assess the efficacy of the Gem DR device in detecting and treating tachyarrhythmias.
Main Methods:
- A study involving 300 patients implanted with the Gem DR ICD for various indications including ventricular tachycardia and sudden cardiac death survivorship.
- Analysis of 1,092 documented arrhythmia episodes (796 ventricular tachyarrhythmias, 296 supraventricular episodes) during a mean follow-up of 1.7 months.
- Comparison of dual chamber detection algorithm performance against single chamber, rate-only detection.
Main Results:
- The device achieved 100% detection of sustained ventricular tachyarrhythmias.
- Inappropriate detection of supraventricular tachyarrhythmias was reduced by 72% compared to single chamber devices.
- Positive predictive value for ventricular tachyarrhythmia detection was 90.5% for episodes exceeding the detection rate.
- Adverse events occurred in a minority of patients, with incisional pain being most common (22%). No deaths were attributed to device failure.
Conclusions:
- The Gem DR dual chamber ICD is safe and effective for detecting and treating ventricular tachyarrhythmias.
- The dual chamber detection algorithm successfully differentiates supraventricular tachycardias from ventricular tachycardias, improving therapeutic accuracy.
- The device demonstrates high sensitivity and specificity for critical arrhythmia detection in a clinical setting.