Detection of high-frequency artifact as a function of pulse generator algorithms and outer-insulation material.

ABSTRACT

BACKGROUND: A high rate of malfunction, predominantly intermittent high-frequency artifacts (HFAs), has been recently reported in Abbott Medical Tendril pacing leads. OBJECTIVE: To investigate the factors associated with the occurrence of HFAs on Tendril leads using a commonly used comparator lead for a control. METHODS: We reviewed institutional data for Medtronic CapSureFix 5076 and Abbott Medical Tendril pace-sense leads retrospectively. Recordings deemed to be due to electromagnetic interference and far-field oversensing were not included in the classification of HFAs. RESULTS: A total of 7673 leads were analyzed 1628 Optim-insulated Tendril leads, 825 non-Optim Tendril leads, and 5220 CapSureFix 5076. HFAs were seen in 212 leads and were more frequently observed in Tendril compared to CapSureFix leads during a mean follow-up of 4.1 ± 3.6 years. Lower age at implant, defibrillator systems, atrial position, and connection to an Abbott Medical generator were associated with increased HFA. In multivariable analysis, only connection to Abbott Medical generators (odds ratio 7.686, P < .001) and age (odds ratio 0.988 per year, P = .016) were independently associated with HFAs on pace-sense leads. In an Abbott-generator-only analysis, Optim-insulated Tendril leads were more likely to display HFAs than non-Optim Tendril leads but not Medtronic CapSureFix 5076 leads. CONCLUSION: Abbott Medical pulse generators independently predict HFA in Tendril and CapSureFix 5076 leads, likely the result of displaying short or low-amplitude noise episodes that other devices do not record. When restricted to Abbott generators only, Optim-insulated Tendril leads show an increased incidence of HFAs when compared to non-Optim Tendril leads but not CapSureFix 5076 leads.