PMID- 24602038
OWN - NLM
STAT- MEDLINE
DCOM- 20150423
LR  - 20220321
IS  - 1540-8167 (Electronic)
IS  - 1045-3873 (Print)
IS  - 1045-3873 (Linking)
VI  - 25
IP  - 8
DP  - 2014 Aug
TI  - Acute safety of an open-irrigated ablation catheter with 56-hole porous tip for 
      radiofrequency ablation of paroxysmal atrial fibrillation: analysis from 2 
      observational registry studies.
PG  - 852-858
LID - 10.1111/jce.12403 [doi]
AB  - INTRODUCTION: This report presents safety data on the use of a new 
      open-irrigation radiofrequency ablation (RFA) catheter with a 56-hole porous tip 
      in 742 patients enrolled in 2 US prospective, multicenter observational registry 
      studies representing real-world use of the catheter. METHODS: This analysis is 
      comprised of patients who underwent RFA of drug-refractory recurrent symptomatic 
      paroxysmal atrial fibrillation (AF). Acute adverse events (AEs) were collected 
      and categorized by seriousness, timing, and relatedness, with 7 days of follow-up 
      data in one study and at least 120 days of data from a 1-year follow-up in the 
      other. Acute serious adverse events (SAEs) that were identified as potentially 
      related to the device and/or procedure were adjudicated by an independent safety 
      committee. RESULTS: A total of 30 patients (4.0%) in the combined studies 
      experienced an acute SAE related to the device and/or procedure, which was 
      similar in the subset of patients age 65 and over (4.2%). These SAEs included 
      1.2% cardiac tamponade/perforation, 0.7% pericarditis, 0.5% pulmonary events, and 
      0.8% vascular access complications. No myocardial infarction, stroke, transient 
      ischemic attack, or atrioesophageal fistulas within 7 days postprocedure were 
      reported. In the study with extended follow-up, 1 pulmonary vein stenosis and 1 
      esophageal injury were seen beyond 7 days postprocedure (0.2% each). There were 
      no device or procedure related deaths. CONCLUSION: Results from 2 large 
      observational studies demonstrated that a new porous tip RFA catheter was safe 
      for the treatment of drug refractory, recurrent, symptomatic paroxysmal AF, 
      including treatment of older patients (>/=65 years).
CI  - (c) 2014 The Authors Journal of Cardiovascular Electrophysiology Published by Wiley 
      Periodicals, Inc.
FAU - Oza, Saumil R
AU  - Oza SR
AD  - The Atrial Fibrillation Institute, St. Vincent's Medical Center, Jacksonville, 
      Florida.
FAU - Hunter, Tina D
AU  - Hunter TD
AD  - Outcomes Research, S2 Statistical Solutions, Inc, Cincinnati, Ohio.
FAU - Biviano, Angelo B
AU  - Biviano AB
AD  - New York Presbyterian Hospital, Columbia University Medical Center, New York, New 
      York.
FAU - Dandamudi, Gopi
AU  - Dandamudi G
AD  - Geisinger Heart Institute, Geisinger Wyoming Valley Medical Center, Wilkes Barre, 
      Pennsylvania.
FAU - Herweg, Bengt
AU  - Herweg B
AD  - Cardiovascular Sciences, Tampa General Hospital and University of South Florida 
      Morsani College of Medicine, Tampa, Florida.
FAU - Patel, Anshul M
AU  - Patel AM
AD  - St. Joseph's Hospital of Atlanta/Emory University, Atlanta, Georgia.
FAU - Pollak, Scott J
AU  - Pollak SJ
AD  - Arrhythmia and Ablation Center, Florida Hospital, Orlando, Florida.
FAU - Wang, Huijian
AU  - Wang H
AD  - Florida Hospital Memorial Medical Center, Daytona Beach, Florida.
FAU - Fishel, Robert S
AU  - Fishel RS
AD  - Florida Electrophysiology Associates, West Palm Beach, Florida, USA.
LA  - eng
GR  - K23 HL105893/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140409
PL  - United States
TA  - J Cardiovasc Electrophysiol
JT  - Journal of cardiovascular electrophysiology
JID - 9010756
SB  - IM
MH  - Aged
MH  - Atrial Fibrillation/complications/diagnosis/physiopathology/*surgery
MH  - *Cardiac Catheters
MH  - Catheter Ablation/adverse effects/*instrumentation
MH  - Equipment Design
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Recurrence
MH  - Registries
MH  - Risk Factors
MH  - Therapeutic Irrigation/adverse effects/*instrumentation
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
PMC - PMC4282391
OTO - NOTNLM
OT  - acute safety
OT  - atrial fibrillation
OT  - catheter ablation
OT  - complications
OT  - thermocool SF catheter
EDAT- 2014/03/08 06:00
MHDA- 2015/04/24 06:00
CRDT- 2014/03/08 06:00
PHST- 2013/12/13 00:00 [received]
PHST- 2014/02/13 00:00 [revised]
PHST- 2014/02/27 00:00 [accepted]
PHST- 2014/03/08 06:00 [entrez]
PHST- 2014/03/08 06:00 [pubmed]
PHST- 2015/04/24 06:00 [medline]
AID - 10.1111/jce.12403 [doi]
PST - ppublish
SO  - J Cardiovasc Electrophysiol. 2014 Aug;25(8):852-858. doi: 10.1111/jce.12403. Epub 
      2014 Apr 9.