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Clinical Performance of the St. Jude Medical Riata Defibrillation Lead in a Large Patient Population
Author(s) -
PORTERFIELD JAMES G.,
PORTERFIELD LINDA M.,
KUCK KARL H.,
CORBISIERO RAFFAELE,
GREENBERG STEVEN M.,
HINDRICKS GERHARD,
WAZNI OUSSAMA,
BEAU SCOTT L.,
HERRE JOHN M.
Publication year - 2010
Publication title -
journal of cardiovascular electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.193
H-Index - 138
eISSN - 1540-8167
pISSN - 1045-3873
DOI - 10.1111/j.1540-8167.2009.01651.x
Subject(s) - medicine , implantable cardioverter defibrillator , defibrillation , perforation , incidence (geometry) , lead (geology) , surgery , defibrillation threshold , population , materials science , physics , geomorphology , optics , punching , metallurgy , geology , environmental health
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. (J Cardiovasc Electrophysiol, Vol. 21, pp. 551‐556, May 2010)