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Performance of the St. Jude Medical Riata leads

Andrew E Epstein1, James H Baker, Scott L Beau

  • 1Division of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama 35294-0006, USA. aepstein@uab.edu

Heart Rhythm
|December 24, 2008
PubMed

Insights

The incidence of adverse events for St. Jude Medical Riata implantable cardioverter-defibrillator (ICD) leads is rare. This study found low rates of conductor fracture, insulation damage, dislodgement, and perforation in over 7,000 patients.

Area of Science:

  • Cardiology
  • Biomedical Engineering
  • Medical Device Performance

Background:

  • High-voltage implantable cardioverter-defibrillator (ICD) lead performance is under scrutiny.
  • Lead-related adverse events stem from various factors like patient traits, therapies, implantation methods, access site, and lead design.
  • Limited studies possess the patient numbers and follow-up duration to accurately assess ICD lead performance and adverse event incidence.

Purpose of the Study:

  • To determine the incidence of lead-related adverse events for St. Jude Medical Riata ICD leads.
  • Specifically investigate conductor fracture, insulation damage, perforation, and dislodgement.

Main Methods:

  • Analysis of data from four prospective registries and clinical trials: Advancements in ICD Therapy, OPTIMUM, RHYTHM, and PAS.
  • Inclusion of 7,497 patients implanted with Riata leads.
  • Median follow-up of 22 months, recording adverse events requiring lead revision, extraction, or replacement.

Main Results:

  • Conductor fracture incidence: 0.09%.
  • Insulation damage incidence: 0.13%.
  • Lead dislodgement incidence: 0.88%.
  • Perforation incidence: 0.31%.

Conclusions:

  • The incidence of lead-related adverse events (conductor fracture, insulation damage, dislodgement, perforation) requiring intervention for St. Jude Medical Riata ICD leads is rare.
  • Findings based on over 7,000 leads and a median follow-up exceeding 22 months across multiple prospective studies.
Abstract

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