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- Title
Worldwide Clinical Experience with a New Dual-Chamber Implantable Cardioverter Defibrillator System.
- Authors
Schoels, Wolfgang; Swerdlow, Charles D.; Jung, Werner; Stein, Kenneth M.; Seidl, Karlheinz; Haffajee, Charles J.
- Abstract
Introduction: Management of atrial tachyarrhythmias represents a significant challenge in patients with implantable cardioverter defibrillators (ICDs). Drug therapy of these arrhythmias is limited by moderate efficacy, ventricular proarrhythmia, and drug-device interactions. This study tested the safety and efficacy of a new dual-chamber ICD to detect and treat atrial as well as ventricular tachyarrhythmias. Methods and Results: A dual-chamber ICD (Medtronic 7250 Jewel AF) was implanted in 293 of 303 patients at 49 centers in Europe, Canada, and North America. Specific data were collected at implant and during a mean follow-up period of 7.9 ± 4.7 months. There were no clinically evident failures to detect and treat ventricular arrhythmias. In patients with at least one of the dual-chamber detection criteria activated, 1,056 of 1,192 episodes of ventricular tachycardia or fibrillation detected were judged to be appropriate (89% positive predictive accuracy). Therapy efficacy was 100% in the ventricular fibrillation zone and 98% in the ventricular tachycardia zone. Positive predictive accuracy for detection of atrial episodes was 95% (1,052/1,107). For episodes classified as atrial tachycardia by the device, the efficacy of atrial antitachycardia pacing and high-frequency (50-Hz) burst pacing was 55% and 17%, respectively. High-frequency burst pacing terminated 16.8% of episodes classified as atrial fibrillation, and atrial defibrillation had an estimated efficacy of 76%. The actuarial estimates of 6-month complication-free survival and total survival were 88% and 94%, respectively. Conclusion: This novel dual-chamber ICD is capable of safely and effectively discriminating atrial from ventricular tachyarrhythmias and of treating atrial tachyarrhythmias without compromising detection and treatment of ventricular tachyarrhythmias.
- Subjects
ATRIAL fibrillation; ATRIAL arrhythmias; IMPLANTABLE cardioverter-defibrillators; IMPLANTED cardiovascular instruments; HEART diseases; MEDICAL equipment
- Publication
Journal of Cardiovascular Electrophysiology, 2001, Vol 12, Issue 5, p521
- ISSN
1045-3873
- Publication type
Article
- DOI
10.1046/j.1540-8167.2001.00521.x