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 Article

Industry Collaboration

cited authors

  • Oza, Saumil R., Hunter, Tina D., Biviano, Angelo B., Dandamudi, Gopi, Herweg, Bengt, Patel, Anshul M., Pollak, Scott J., Wang, Huijian, Fishel, Robert S.

funding text

  • This study was funded by Biosense Webster, Inc.

abstract

  • Acute Safety from 2 AF Ablation Registries. 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).

authors

Publication Date

  • August 1, 2014

webpage

published in

category

start page

  • 852

end page

  • 858

volume

  • 25

issue

  • 8

WoS Citations

  • 11

WoS References

  • 17