A Strategy of Lead Abandonment in a Large Cohort of Patients With Sprint Fidelis Leads

JACC Clin Electrophysiol. 2019 Sep;5(9):1059-1067. doi: 10.1016/j.jacep.2019.07.006. Epub 2019 Aug 28.

Abstract

Objectives: This study sought to examine outcomes of our approach to managing a large cohort of patients with Sprint Fidelis (Medtronic, Minneapolis, Minnesota) leads.

Background: The optimal management approach for patients with leads under advisory is unknown. Concerns regarding the risk of device infection and complications associated with delaying lead extraction have recently been suggested to argue against abandoning leads under advisory.

Methods: All patients with a Sprint Fidelis lead implanted at our institute were included. Lead management options were discussed with patients who presented for device surgery at the time of device upgrade, lead fracture, or elective replacement indicator. Implantation of a new lead with abandonment of the Sprint Fidelis lead was the recommended strategy. Patients were subsequently followed at the device clinic at 6-month intervals and were enrolled prospectively in a longitudinal registry.

Results: A total of 520 patients had Sprint Fidelis leads implanted between December 2003 and October 2007 at the study center; 217 patients underwent lead replacement (213 underwent a lead abandonment strategy and 4 underwent a lead extraction strategy). Mean follow-up after lead replacement was 55 ± 33 months. In patients undergoing lead abandonment, 10 of 213 (4.7%) had a procedural complication and 3 of 213 (1.4%) developed subsequent device infection requiring system extraction.

Conclusions: In patients with a Sprint Fidelis lead, implanting a new lead without prophylactic extraction may be a feasible and safe strategy but requires longer follow-up.

Keywords: Sprint Fidelis leads; lead abandonment; lead extraction; leads under advisory; pulse generator replacement.

MeSH terms

  • Aged
  • Defibrillators, Implantable* / adverse effects
  • Defibrillators, Implantable* / standards
  • Defibrillators, Implantable* / statistics & numerical data
  • Device Removal* / instrumentation
  • Device Removal* / methods
  • Device Removal* / statistics & numerical data
  • Female
  • Humans
  • Male
  • Medical Device Recalls
  • Middle Aged
  • Prospective Studies
  • Reoperation / statistics & numerical data