Performance of the St. Jude Medical Riata leads.
BACKGROUND
Recent attention has been focused on the performance of high-voltage implantable cardioverter-defibrillator (ICD) leads. Lead-related adverse events can be caused by several factors, including patient characteristics, concomitant therapies, implantation technique, access site, and lead design. Few studies have included the number of patients and the follow-up duration necessary to characterize accurately the lead performance and the incidence of lead-related adverse events.


OBJECTIVE
This study sought to define the incidence of lead-related adverse events including conductor fracture, insulation damage, perforation, and dislodgement of St. Jude Medical Riata ICD leads.


METHODS
Data from the Advancements in ICD Therapy, OPTIM Lead InsUlation Material (OPTIMUM), Resynchronization HemodYnamic Treatment for Heart Failure Management (RHYTHM), and Post Approval Study (PAS) registries provided data from 7,497 patients with Riata leads. Patients were followed up for a median of 22 months. Adverse events, defined as those that required lead revision, extraction, or replacement, were recorded.


RESULTS
Conductor fracture occurred in 0.09%, insulation damage in 0.13%, dislodgement in 0.88%, and perforation in 0.31% of patients, respectively.


CONCLUSIONS
During more than 22 months of follow-up of over 7,000 Riata leads in 4 prospective registries and clinical trials, the incidence of lead-related adverse events including conductor fracture, insulation damage, dislodgement, and perforation necessitating lead revision, extraction, or replacement is rare.
Epstein
Andrew E
AE
Division of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama 35294-0006, USA. aepstein@uab.edu
Baker
James H
JH
Beau
Scott L
SL
Deering
Thomas F
TF
Greenberg
Steven M
SM
Goldman
Daniel S
DS
D000368:Aged; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004567:Electrodes, Implanted / Q000009:adverse effects*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D004869:Equipment Safety; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008422:Materials Testing; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors