Incidence of Premature Lead Failure in 2088 TendrilTM Pacing Leads: A Single Centre Experience

Abstract

Recent reports describe a high rate of premature lead failure in the St Jude/Abbott TendrilTM 2088 (St. Jude Medical Inc., St. Paul, MN, USA) pacing lead principally manifested by electrical noise. This finding awaits confirmation. We performed a retrospective analysis of 2088 TendrilTM leads among 362 patients implanted from 2010 to 2018. Eligible leads were those with device interrogations beyond one month from lead implantation. Review of serial device interrogations was conducted for each lead, particularly focussing on electrical noise as a marker of premature lead dysfunction. Four hundred and eight (408) leads among 337 patients were included in this study, with an average patient age of 81±11 years at the time of lead implantation. Mean follow-up was 2.5±1.8 years. There were eight leads with electrical noise indicating premature lead failure. This reflects an overall 1.7% rate of lead dysfunction; the failure rate was 6.2% at 4 years. The majority of cases were detected during routine checks without adverse clinical consequences. Four (4) cases required device reprogramming to avoid interference or inhibition due to noise. The rate of Tendril TM 2088 premature lead failure appears to be similar to recent local and international studies. This study reports a significantly higher rate of lead dysfunction at 4 years (6.2%) than the published Abbott product performance reports.