In addition to the AtriCure® sponsored studies, independent institutions have the ability to create their own clinical trial or study for publication in medical journals or presentations at medical conferences. Several institutions have chosen the AtriCure procedure as a subject for their study.
By holding a study, each individual center or centers determines their own goals, criteria for success, and follow-up procedures. In addition, centers may or may not receive research grants from AtriCure.
Below is a summary of studies from the past six months that have been presented at major medical meetings or published in medical journals in the United States. Additional studies will be added to this list once they are published or presented.
Published in The Annals of Thoracic Surgery, January 2008
This was a retrospective study that examined the extended follow-up of 22 patients who underwent the video-assisted epicardial ablation and left atrial appendage exclusion procedure. The 22 patients were diagnosed with symptomatic, intermittent AF and underwent the above-described procedure from April 2004 through July 2005. The follow-up period for each patient was an average range of 12 to 27 months. Holter monitoring was performed more than six months after the discontinued use of antiarrhythmics.
At the end of the follow-up period, 20 of 22 (91%) patients were free of AF symptoms without the use of antiarrhythmics. The same percentage of patients (91%) was also free from taking warfarin.
The retrospective study concludes that video-assisted epicardial ablation and left atrial appendage exclusion has favorable single-procedure results.
Published in the Journal of Interventional Cardiac Electrophysiology, December 2007
This study consisted of 83 patients undergoing minimally invasive surgical ablation of atrial fibrillation involving pulmonary vein isolation and partial autonomic denervation. Of the 83 patients, 62 had follow-up of 6 months or more. Of those 62, 57 had long-term rhythm monitoring at 6 months.
The objective of the study was to determine the success of a minimally invasive surgical approach to the treatment of atrial fibrillation that combines pulmonary vein antral isolation with targeted partial autonomic denervation.
Success in this study was defined as no AF episodes greater than 15 seconds on long-term monitoring at 6 months follow-up. 56 of 61 (91.8%) patients were free of AF with ECG monitoring at 6 months. 42 of 57 (73.7%) patients were free of AF with long-term monitoring at 6 months. Success rates by classification of AF were 82.1% for paroxysmal and 55.6% for persistent and long-standing persistent combined.
Based on early data, the study concluded that pulmonary vein isolation combined with targeted partial autonomic denervation is a safe and effective treatment approach for paroxysmal AF.
Published in the Journal of Cardiovascular Electrophysiology, December 2007
This study at the Oregon Heart and Vascular Institute and Oregon Cardiology consisted of 21 patients. Of the 21 patients, one was excluded from analysis; the remaining 20 patients were followed for one year.
The study focused on outcomes of a new procedure combining epicardial bipolar radiofrequency (RF), pulmonary vein (PV) antrum isolation, and ganglionated plexus (GP) ablation for the treatment of atrial fibrillation. All study participants had recordable PV potentials and GP activity prior to ablation.
Success in this study was defined as freedom from AF and Class I and Class III antiarrhythmics during one year of follow-up. Follow-up included evaluation by prolonged continuous monitoring capable of detecting asymptomatic arrhythmias.
Epicardial bipolar RF eliminated PV potentials in 18 lf 20 (90%) right and 14 of 20 (70%) left antra. This also eliminated 79% of active GP sites (125 of 159 active sites); almost all remaining active GPs could be eliminated using epicardial bipolar RF forceps.
14 of 16 (87.5%) paroxysmal and persistent patients had a successful procedure. Overall success among patients with all types of AF (paroxysmal, persistent, long-standing persistent) was 75% (15 of 20). The study concludes that combining epicardial bipolar RF, PV antrum isolation, and GP ablation is an effective means of treating atrial fibrillation and should be considered in paroxysmal and persistent patients.
Published in the Journal of Thoracic and Cardiovascular Surgery, February 2007
Published in the Annals of Thoracic Surgery, February 2007
Presented at the AHA Scientific Sessions; November, 2006
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