176-52: Durata Lead Performance: Results from a Prospective, Multicenter Study

Introduction: The Cardiac Lead Assessment study is a prospective, multicenter study investigating externalized conductors (EC) and electrical dysfunction (ED) in certain St. Jude Medical leads. This analysis was limited specifically to OptimTM-insulated DurataTM ICD leads.

Methods: Patients previously implanted with Durata ICD leads from 2008 to 2010 were enrolled. Fluoroscopy is performed in three views (AP, LAO, RAO) at enrollment and annually thereafter. All fluoroscopic images are adjudicated for the presence of EC by a panel of experienced electrophysiologists. Leads are classified as exhibiting EC if either a conductor cable does not fit within the shock electrode shadow width or if the radius of curvature of the suspected EC region is significantly different from the remainder of the lead body. Upon occurrence of a lead revision, electrical performance data are adjudicated by another physician panel to determine the presence of ED based on predefined criteria. Patients will continue follow-up for a period of 3 years.

Results: A total of 880 patients implanted with Durata leads have completed fluoroscopic evaluation at enrollment. None of these 880 leads at enrollment exhibited EC. A total of 578 patients have completed 1 year follow-up with fluoroscopic evaluation, and one of these leads was adjudicated to have EC. Based on the images of this lead, the externalization appears to be extravascular, under the clavicle, and is likely due to clavicular crush. Through 2 years of follow-up the electrical function of this lead has been normal. A total of 113 patients have completed 2 years of follow-up with fluoroscopic evaluation, with no new ECs. Over a follow-up of 21.7 ± 5.1 months from enrollment, in patients that have been implanted for 4.4 ± 0.9 years, there have been 8 cases of ED, none of which exhibited EC.

Conclusions: In 880 Durata leads systematically imaged at enrollment, none have exhibited EC. One Durata lead after 1 year of follow-up was adjudicated to have EC, likely due to clavicular crush. Eight leads (0.9%) monitored through 21.7± 5.1 months post-enrollment have exhibited electrical dysfunction, none of which exhibited EC.