PMID- 19925609
OWN - NLM
STAT- MEDLINE
DCOM- 20100908
LR  - 20191210
IS  - 1540-8167 (Electronic)
IS  - 1045-3873 (Linking)
VI  - 21
IP  - 5
DP  - 2010 May
TI  - Clinical performance of the St. Jude Medical Riata defibrillation lead in a large 
      patient population.
PG  - 551-6
LID - 10.1111/j.1540-8167.2009.01651.x [doi]
AB  - 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.
FAU - Porterfield, James G
AU  - Porterfield JG
AD  - Methodist University Hospital, and University of Tennessee Health Science Center, 
      1211 Union Ave., Suite 475, Memphis, TN 38104, USA. jgporterfield@gmail.com
FAU - Porterfield, Linda M
AU  - Porterfield LM
FAU - Kuck, Karl H
AU  - Kuck KH
FAU - Corbisiero, Raffaele
AU  - Corbisiero R
FAU - Greenberg, Steven M
AU  - Greenberg SM
FAU - Hindricks, Gerhard
AU  - Hindricks G
FAU - Wazni, Oussama
AU  - Wazni O
FAU - Beau, Scott L
AU  - Beau SL
FAU - Herre, John M
AU  - Herre JM
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20091117
PL  - United States
TA  - J Cardiovasc Electrophysiol
JT  - Journal of cardiovascular electrophysiology
JID - 9010756
SB  - IM
MH  - Aged
MH  - Arrhythmias, Cardiac/mortality/*therapy
MH  - *Defibrillators, Implantable/adverse effects
MH  - Equipment Design
MH  - Equipment Failure
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Injuries/epidemiology/etiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Monitoring, Physiologic
MH  - Prosthesis Implantation
MH  - Reoperation
MH  - Retrospective Studies
MH  - Time Factors
EDAT- 2009/11/21 06:00
MHDA- 2010/09/09 06:00
CRDT- 2009/11/21 06:00
PHST- 2009/11/21 06:00 [entrez]
PHST- 2009/11/21 06:00 [pubmed]
PHST- 2010/09/09 06:00 [medline]
AID - JCE1651 [pii]
AID - 10.1111/j.1540-8167.2009.01651.x [doi]
PST - ppublish
SO  - J Cardiovasc Electrophysiol. 2010 May;21(5):551-6. doi: 
      10.1111/j.1540-8167.2009.01651.x. Epub 2009 Nov 17.