title: 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.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: The Atrial Fibrillation Institute, St. Vincent's Medical Center, Jacksonville, Florida.
authors.forename: Saumil R
authors.initials: SR
authors.lastname: Oza
authors.affiliation: Outcomes Research, S2 Statistical Solutions, Inc, Cincinnati, Ohio.
authors.forename: Tina D
authors.initials: TD
authors.lastname: Hunter
authors.affiliation: New York Presbyterian Hospital, Columbia University Medical Center, New York, New York.
authors.forename: Angelo B
authors.initials: AB
authors.lastname: Biviano
authors.affiliation: Geisinger Heart Institute, Geisinger Wyoming Valley Medical Center, Wilkes Barre, Pennsylvania.
authors.forename: Gopi
authors.initials: G
authors.lastname: Dandamudi
authors.affiliation: Cardiovascular Sciences, Tampa General Hospital and University of South Florida Morsani College of Medicine, Tampa, Florida.
authors.forename: Bengt
authors.initials: B
authors.lastname: Herweg
authors.affiliation: St. Joseph's Hospital of Atlanta/Emory University, Atlanta, Georgia.
authors.forename: Anshul M
authors.initials: AM
authors.lastname: Patel
authors.affiliation: Arrhythmia and Ablation Center, Florida Hospital, Orlando, Florida.
authors.forename: Scott J
authors.initials: SJ
authors.lastname: Pollak
authors.affiliation: Florida Hospital Memorial Medical Center, Daytona Beach, Florida.
authors.forename: Huijian
authors.initials: H
authors.lastname: Wang
authors.affiliation: Florida Electrophysiology Associates, West Palm Beach, Florida, USA.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Fishel
mesh_terms: D000368:Aged; D001281:Atrial Fibrillation / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D062906:Cardiac Catheters; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D012042:Registries; D012307:Risk Factors; D007507:Therapeutic Irrigation / Q000009:adverse effects / Q000295:instrumentation*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
keywords: acute safety; atrial fibrillation; catheter ablation; complications; thermocool SF catheter