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David L Hayes

Publications and source records attributed to David L Hayes.

39 records · Page 3Linked to original sources

Long-term structural failure of coaxial polyurethane implantable cardioverter defibrillator leads.

Transvene models 6936/6966, a coaxial polyurethane ICD lead, may be prone to structural failure. These models comprise 54% of ICD lead failures in the authors' Multicenter Registry database. Because ICD leads perform a vital function, the clinical features, causes, and probability of Transvene 6936/6966 lead failure were determined. The Registry and United States Food and Drug Administration databases were queried for the clinical features and structural causes of the Transvene 6936/6966 lead failure, and a five-center substudy estimated the survival probability for 521 Transvene 6936/6966 implants. The mean time to failure was 4.8 +/- 2.1 years, and the estimated survival at 60 and 84 months after implant were 92% and 84%, respectively. Oversensing was the most common sign of failure (76%), and 24 patients experienced inappropriate shocks. The manufacturer's reports indicated that high voltage coil fracture and 80A polyurethane defects were the predominant causes of lead failure. Transvene models 6936 and 6966 coaxial polyurethane ICD leads are prone to failure over time. Patients who have these leads should be evaluated frequently. Additional studies are needed to identify safe management strategies.

Death, Sudden, Cardiac↗

Impaired detection of ventricular tachyarrhythmias by a rate-smoothing algorithm in dual-chamber implantable defibrillators: intradevice interactions.

INTRODUCTION: Rate smoothing is an algorithm initially designed to prevent rapid changes in pacemaker rates. In this study, we sought to determine the potential of the rate-smoothing mechanism in preventing detection of ventricular tachyarrhythmias. METHODS AND RESULTS: Clinical testing of rate smoothing was performed at the time of defibrillator arrhythmia induction in 16 patients with implantable defibrillators during 65 episodes of ventricular tachyarrhythmias. We also performed simulator-based testing to assess detection of ventricular tachycardia between 170 and 220 beats/min with systematic sequential change of rate-smoothing percent, AV delay, and maximal rate. During clinical testing of 54 ventricular fibrillation/polymorphic ventricular tachyarrhythmia episodes, there were no cases of nondetection and 3 episodes (5%) of minimally delayed detection. Of 10 monomorphic ventricular tachyarrhythmias, 6 had either delayed (2 cases) or absent (4 cases) detection. During simulator testing, complex interrelationships were demonstrated in AV delay, upper rate, and rate-smoothing percent in determining the severity of the effect on detection. Generally, long AV delay, higher upper rate, and smaller (more aggressive) rate smoothing were associated with increased risk of ventricular tachyarrhythmia underdetection. Importantly, use of parameters that impaired detection was always accompanied by a programmer warning message. CONCLUSION: Rate smoothing may result in delay or failure of ventricular tachycardia detection. It is important to consider warning messages when programming rate smoothing and to test for appropriate detection when rate smoothing is used despite warning messages.

Algorithms↗