Clinical performance of the St. Jude Medical Riata defibrillation lead in a large patient population.
OBJECTIVE
The purpose of this large multicenter study was to evaluate the long-term reliability of an implantable cardioverter defibrillator (ICD) lead to determine the incidence of adverse events (AEs).


BACKGROUND
A recent concern has been the performance of cardiac defibrillator leads. There have been conflicting reports regarding the rate of lead perforation and other AEs.


METHODS
Medical records from patients implanted from 6-1-2001 to 11-27-2007 with the St. Jude Medical Riata family of RV leads at 23 US (N = 12,969) and 5 German (N = 2,418) centers were reviewed for chronic lead-related AEs. These included perforation, dislodgment, conductor fracture and insulation damage. The mean follow-up period was 18.0 months. AEs were defined as those that required Riata lead revision, extraction, or replacement.


RESULTS
The incidence of lead AEs was <1% for each AE type. Perforation occurred in 0.38%, dislodgement in 0.93%, conductor fracture in 0.18%, and insulation damage in 0.21% of patients studied.


CONCLUSIONS
During the follow-up of the 15,387 patients with Riata leads, the incidence of AEs which included perforation, dislodgement, conductor fraction and insulation damage was low and within the range of what is considered clinically acceptable.
Porterfield
James G
JG
Methodist University Hospital, and University of Tennessee Health Science Center, 1211 Union Ave., Suite 475, Memphis, TN 38104, USA. jgporterfield@gmail.com
Porterfield
Linda M
LM
Kuck
Karl H
KH
Corbisiero
Raffaele
R
Greenberg
Steven M
SM
Hindricks
Gerhard
G
Wazni
Oussama
O
Beau
Scott L
SL
Herre
John M
JM
D000368:Aged; D001145:Arrhythmias, Cardiac / Q000401:mortality / Q000628:therapy*; D017147:Defibrillators, Implantable / Q000009:adverse effects; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006335:Heart Injuries / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D019919:Prosthesis Implantation; D012086:Reoperation; D012189:Retrospective Studies; D013997:Time Factors