Experience with a dual chamber implantable defibrillator.
An implantable defibrillator with dual chamber pacing may have advantages for pacing, sensing, and detection of brady- and tachyarrhythmias. This study evaluates the safety and performance of a dual chamber implantable cardioverter defibrillator that incorporates an algorithm to discriminate supraventricular from ventricular arrhythmias. The 300 patients in this study had the device implanted for the following indications: ventricular tachycardia (47%), sudden cardiac death survivorship (51%), and prophylactic implants (2%). Patients received dual chamber pacing for accepted bradyarrhythmic (51.7%) or investigational indications. During a mean follow-up period of 1.7 months a total of 1,092 arrhythmia episodes in 96 patients were fully documented in the device memory: 66 patients experienced a total of 796 ventricular tachyarrhythmia episodes and 42 experienced a total of 296 supraventricular episodes. The device appropriately detected 100% of sustained ventricular tachyarrhythmias while reducing the inappropriate detection of supraventricular tachyarrhythmias by 72% compared to single chamber rate only detection. The positive predictive value was 90.5% for ventricular tachyarrhythmia detection in episodes that exceeded the tachycardia detection rate. Adverse events observed in at least 2% of the patients were incisional pain (22%), inappropriate ventricular detection (7%), atrial lead dislodgement (4%), atrial oversensing/undersensing (3%), hematoma (3%), incessant ventricular tachyarrhythmia (2%), and pneumothorax (2%). There were 13 deaths, none of which were attributed to device failure. The Gem DR is safe and effective for the detection and treatment of ventricular tachyarrhythmias. The dual chamber detection algorithm appropriately recognized supraventricular tachycardia with rapid ventricular rates 72% of the time while maintaining 100% detection of sustained ventricular tachyarrhythmias.
Kühlkamp
Volker
V
Department of Cardiology, Universitätsklinikum Tübingen, Germany. volker.kuehlkamp@med.uni-tuebingen.de
Wilkoff
Bruce L
BL
Brown
Amy B
AB
Volosin
Kent J
KJ
Hügl
B J
BJ
Stafford
Wayne
W
Cameron
Douglas A
DA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D001145:Arrhythmias, Cardiac / Q000175:diagnosis* / Q000628:therapy*; D016001:Confidence Intervals; D017147:Defibrillators, Implantable; D003937:Diagnosis, Differential; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D016019:Survival Analysis; D016896:Treatment Outcome