Sprint Fidelis implantable cardioverter-defibrillators lead patient management and survival: Single center study

Cardiol J. 2017;24(3):259-265. doi: 10.5603/CJ.a2016.0110. Epub 2016 Dec 2.

Abstract

Background: Over the last several years significant rises in the use of implanted cardioverter-defibrillators (ICD) have also resulted in a number of associated complications. This number includes lead failure. Sprint Fidelis (SF) ICD lead is regarded as a lead with elevated failure risk. Every center acting in accordance with the guidelines should observe patients more thoroughly especially with recalled leads and run a registry of their follow-up. The aim of this research was to present follow-up of the patients with SF leads (types 6948, 6949) from a single implantation center.

Methods: There were 36 SF leads implanted in 36 patients. Mean follow-up period was 76 months (IQR 40.3-86.8). Patients were subjected to regular check-ups in 3 to 6 month intervals.

Results: Patients were implanted at a median age of 66.5 years and majority of them had ischemic cardiomyopathy (72%). A majority of the studied population were men (72.2%). Predominantly dual-chamber ICD (ICD-DR) were implanted (50% ICD-DR vs. 47.2% ICD-VR). The guidelines for management of patients implanted with SF were fully implemented. During the follow-up 14 (38.9%) patients died. No deaths were noted that could be attributed to lead failure. In 5 cases lead failure was identified and of these 4 leads were replaced. Median time from implantation to the detection of lead dysfunction was 52 months (IQR 49; 83). The symptoms of failure consisted of: inappropriate shocks, alternating ventricular lead signal, or loss of ventricular stimulation.

Conclusions: The follow-up of patients with recalled SF leads in a single center supports that implementation SF management guidelines could be effective in clinical practice.

Keywords: Sprint Fidelis; defibrillators; implantable (E07.305.250.159.175) lead failure; lead extraction; lead survival.

MeSH terms

  • Aged
  • Cardiomyopathies / diagnosis
  • Cardiomyopathies / physiopathology
  • Cardiomyopathies / therapy*
  • Defibrillators, Implantable / adverse effects*
  • Device Removal / methods*
  • Disease Management*
  • Equipment Design
  • Equipment Failure
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Postoperative Complications / diagnosis
  • Postoperative Complications / epidemiology
  • Postoperative Complications / surgery*
  • Practice Guidelines as Topic*
  • Prognosis
  • Registries*
  • Retrospective Studies
  • Stroke Volume / physiology
  • Time Factors