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Poorer outcomes associated with more invasive lead management strategies for Abbott Riata leads: a large, multicenter experience.

J Interv Card Electrophysiol

August 2024

Cardiac Electrophysiology Laboratories, Kansas City Heart Rhythm Institute, University of Missouri-Columbia, 5100 W 110Th St., Ste 200, Overland Park, KS, 66211, USA.

Background: Over 100,000 Abbott Riata were implanted in the United States before they were recalled in 2010. There are still a significant number of Abbott Riata leads in use, and it is unclear how these leads should be managed at the time of generator change or lead malfunction. Although data comparing both Sprint Fidelis and Abbott Riata leads in this setting is available, there are no multicenter comparative studies of outcomes for various lead management strategies, including lead extraction (LE), lead abandonment/revision (LA), and generator change (GC) only at the time of device at elective replacement interval (ERI) for Abbott Riata leads.

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Article Synopsis
  • The study analyzed 445 Japanese patients with implantable cardioverter-defibrillator (ICD) leads to investigate the relationship between fracture-prone leads and patient outcomes.
  • During an average follow-up period of 8.6 years, the study found that patients with advisory/Linox leads had a significantly higher risk of lead failure compared to those with non-advisory leads, although overall mortality rates were similar between the two groups.
  • The findings suggest that while fracture-prone ICD leads warrant closer monitoring for failures, they do not negatively impact long-term survival rates in the studied population.
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Background: The Cardiac Lead Assessment Study (CLAS) was a large prospective, multicenter, international postmarket surveillance study conducted at 45 sites.

Objective: The purpose of CLAS was to examine the prevalence and incidence of externalized conductors and electrical dysfunction in subjects with selected St. Jude Medical defibrillator and left ventricular leads.

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Background: St Jude Medical (now Abbott) Optim-insulated implantable cardioverter-defibrillator (ICD) leads were expected to overcome problems with insulation abrasion and externalized conductors in earlier models. Long-term follow-up is essential to the evaluation of lead performance.

Objective: To determine, in a prospective cohort of Optim-insulated ICD leads, the rates of all-cause mechanical failure and its subtypes (conductor fracture, insulation abrasion, externalized conductors, and other mechanical failures) and electrical dysfunction adjudicated as nonmechanical failure.

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Background: Riata implantable cardioverter-defibrillator (ICD) leads are prone to a unique type of mechanical lead failure causing conductor externalization (CE) which may be complicated by a delayed-onset electrical lead failure (ELF).

Case Summary: A 60-year-old male with symptomatic, severe ischaemic cardiomyopathy, and atrial fibrillation following a prior anterior wall myocardial infarction received a dual-chamber ICD with 7F-RiataST ventricular lead as a primary prevention strategy against sudden cardiac death in 2008. In 2017, a pulse generator replacement was performed for elective replacement indicator status.

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