Key result
In 15,387 patients with St. Jude Medical Riata RV leads, the incidence of adverse events was <1% for each type, including perforation (0.38%), dislodgement (0.93%), and conductor fracture (0.18%).
Population
15,387 patients implanted from 6-1-2001 to 11-27-2007 with the St. Jude Medical Riata family of RV leads at…
Design
Cohort
Follow-up
mean 18.0 months
Authors
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Low adverse event rates support short-term Riata lead acceptability; extends observational data but leaves open longer-term durability.
Cohort (n=15,387)
Yes
The St. Jude Medical Riata defibrillation lead demonstrated a low incidence of adverse events (<1% for each type) over a mean follow-up of 18 months in a large multicenter cohort.
Porterfield et al. (2009) conducted a cohort in Patients requiring an implantable cardioverter defibrillator (ICD) (n=15,387). St. Jude Medical Riata family of RV leads was evaluated on Chronic lead-related adverse events (perforation, dislodgment, conductor fracture, and insulation damage) requiring revision, extraction, or replacement. In 15,387 patients with St. Jude Medical Riata RV leads, the incidence of adverse events was <1% for each type, including perforation (0.38%), dislodgement (0.93%), and conductor fracture (0.18%).
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