PMID- 26990515
OWN - NLM
STAT- MEDLINE
DCOM- 20171107
LR  - 20180228
IS  - 1540-8167 (Electronic)
IS  - 1045-3873 (Linking)
VI  - 27
IP  - 6
DP  - 2016 Jun
TI  - Long-Term Evaluation of Biotronik Linox and Linox(smart) Implantable Cardioverter 
      Defibrillator Leads.
PG  - 735-42
LID - 10.1111/jce.12971 [doi]
AB  - INTRODUCTION: Expert consensus holds that post-market, systematic surveillance of 
      ICD leads is essential to ensure confirmation of adequate lead performance. 
      GALAXY (NCT00836589) and CELESTIAL (NCT00810264) are ongoing multicenter, 
      prospective, non-randomized registries conducted to confirm the long-term safety 
      and reliability of Biotronik leads. METHODS AND RESULTS: ICD and CRT-D patients 
      are followed for Linox and Linox(smart) ICD lead performance and safety for 5 
      years post-implant. All procedural and system-related adverse events (AEs) were 
      assessed at each follow-up, along with lead electrical parameters. An independent 
      CEC of EPs adjudicated AEs to determine AE category and lead relatedness. The 
      analysis used categories of lead observations per ISO 5841-2 (Third edition). A 
      total of 3,933 leads were implanted in 3,840 patients (73.0% male, mean age 67.0 
      +/- 12.2 years) at 146 US centers. The estimated cumulative survival probability 
      was 96.3% at 5 years after implant for Linox leads and 96.6% at 4 years after 
      implant for Linox(smart) leads. A comparison of the Linox and Linox(smart) 
      survival functions did not find evidence of a difference (P = 0.2155). The most 
      common AEs were oversensing (23, 0.58%), conductor fracture (14, 0.36%), failure 
      to capture (13, 0.33%), lead dislodgement (12, 0.31%), insulation breach (10, 
      0.25%), and abnormal pacing impedance (8, 0.20%). CONCLUSIONS: Linox and 
      Linox(smart) ICD leads are safe, reliable and infrequently associated with 
      lead-related AEs. Additionally, estimated cumulative survival probability is 
      clinically acceptable and well within industry standards. Ongoing data collection 
      will confirm the longer-term safety and performance of the Linox family of ICD 
      leads.
CI  - (c) 2016 Wiley Periodicals, Inc.
FAU - Good, Eric D
AU  - Good ED
AD  - University of Michigan, Ann Arbor, Michigan, USA.
FAU - Cakulev, Ivan
AU  - Cakulev I
AD  - University Hospitals of Cleveland, Cleveland, Ohio, USA.
FAU - Orlov, Michael V
AU  - Orlov MV
AD  - Steward St. Elizabeth's Medical Center, Brighton, MA, USA.
FAU - Hirsh, David
AU  - Hirsh D
AD  - Emory University, Atlanta, Georgia, USA.
FAU - Simeles, John
AU  - Simeles J
AD  - Biotronik, Lake Oswego, Oregon, USA.
FAU - Mohr, Kelly
AU  - Mohr K
AD  - Biotronik, Lake Oswego, Oregon, USA.
FAU - Moll, Phil
AU  - Moll P
AD  - Biotronik, Lake Oswego, Oregon, USA.
FAU - Bloom, Heather
AU  - Bloom H
AD  - Emory University and Atlanta VA Medical Center, Atlanta, Georgia, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00836589
SI  - ClinicalTrials.gov/NCT00810264
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20160503
PL  - United States
TA  - J Cardiovasc Electrophysiol
JT  - Journal of cardiovascular electrophysiology
JID - 9010756
SB  - IM
MH  - Aged
MH  - Arrhythmias, Cardiac/diagnosis/physiopathology/*therapy
MH  - *Defibrillators, Implantable
MH  - Electric Countershock/adverse effects/*instrumentation
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Prosthesis Failure
MH  - Registries
MH  - Stroke Volume
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
MH  - Ventricular Function, Left
OTO - NOTNLM
OT  - Biotronik
OT  - Linox lead
OT  - Performance
OT  - adverse event
OT  - cardiac resynchronization therapy
OT  - implantable cardioverter defibrillator
OT  - lead
OT  - reliability
OT  - survival
EDAT- 2016/03/19 06:00
MHDA- 2017/11/08 06:00
CRDT- 2016/03/19 06:00
PHST- 2015/11/23 00:00 [received]
PHST- 2016/02/22 00:00 [revised]
PHST- 2016/03/01 00:00 [accepted]
PHST- 2016/03/19 06:00 [entrez]
PHST- 2016/03/19 06:00 [pubmed]
PHST- 2017/11/08 06:00 [medline]
AID - 10.1111/jce.12971 [doi]
PST - ppublish
SO  - J Cardiovasc Electrophysiol. 2016 Jun;27(6):735-42. doi: 10.1111/jce.12971. Epub 
      2016 May 3.