Related Experiment Video

Updated: May 23, 2026

A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
16:40

A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation

Published on: February 28, 2012

Biventricular defibrillator patients have higher complication rates after revision of recalled leads

Genevieve E Brumberg1, Bahaa Kaseer, Hemal Shah

  • 1University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.

Pacing and Clinical Electrophysiology : PACE
|April 24, 2012
PubMed

Insights

Following updated advisories, Sprint Fidelis® defibrillator lead revisions increased. Biventricular ICD patients experienced higher complication rates, but lead extraction risk was comparable to abandonment.

Area of Science:

  • Cardiology
  • Medical Device Engineering
  • Electrophysiology

Background:

  • The 2009 advisory statement on Sprint Fidelis® Defibrillator Lead failure rates prompted increased lead revisions.
  • Understanding procedural complications and associated patient factors is crucial.

Purpose of the Study:

  • To determine the frequency of major procedural complications after Sprint Fidelis® lead revisions.
  • To identify patient characteristics associated with these complications.

Main Methods:

  • Retrospective review of 621 patients with Fidelis® leads at the University of Pittsburgh Medical Center.
  • Analysis of lead malfunction, revision rates, and procedural complications.

Main Results:

  • Prophylactic lead revisions significantly increased in 2009.
  • 8.5% of patients undergoing revision experienced postoperative complications.
  • Biventricular implantable cardioverter defibrillator (BiVICD) patients had higher complication rates (81.8% vs. 48.7%).

Conclusions:

  • Prophylactic Fidelis® lead revisions and associated complications have risen.
  • BiVICD patients face increased major procedural complication risks.
  • Lead extraction risk is similar to lead abandonment.
Abstract

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