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. 

Video-assisted Epicardial Ablation and Left Atrial Appendage Exclusion for Atrial Fibrillation: Extended Follow-up.

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.


Minimally Invasive Pulmonary Vein Isolation and Partial Autonomic Denervation for Surgical Treatment of Atrial Fibrillation

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.


Preliminary Results of a Limited Thoracotomy: New Approach to Treat Atrial Fibrillation

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.


The Effect of Ablation Technology on Surgical Outcomes after the Cox-Maze Procedure: A Propensity Analysis

Published in the Journal of Thoracic and Cardiovascular Surgery, February 2007

This single center study at Barnes-Jewish Hospital consisted of 242 total patients. Of these patients, 154 were treated with the Cox-Maze III procedure, while 88 were treated with the Cox-Maze IV procedure (Using AtriCure ablation clamps).

The study focused on clinical outcomes comparing the “cut-and sew” Cox-Maze III procedure to the Cox-Maze IV procedure (using alternative energy sources to create ablation lines) using propensity analysis. Out of the 242 total patients, 116 patients matched closely enough to create this side-by side study (58 Cox-Maze III patients, 58 Cox-Maze IV patients).

Any episode of atrial fibrillation after three months was considered a failure.

Follow up was presented with six-month and twelve month data. At six months, freedom from atrial fibrillation was reported at 98% for both groups. At 12 months, freedom from atrial fibrillation was reported at 96% for Cox-Maze III patients and 93% for Cox-Maze IV patients. The study concludes that that the Cox Maze IV procedure produces similar surgical outcomes to the Cox-Maze III procedure at 1 year follow-up.

Intraoperative Epicardial Electrophysiologic Mapping and Isolation of Autonomic Ganglionic Plexi

Published in the Annals of Thoracic Surgery, February 2007

This single center study at The University of Cincinnati consisted of 41 total patients. Of these patients, 26 are six months or more beyond their operation. Follow-up information is available for 15 of these patients.

The study focused on performing ganglionic plexi (GP) testing and ablation on the 41 total patients in a minimally invasive procedure using the AtriCure Isolator® clamps and the Isolator Transpolar™ pen. Active ganglionic plexi sites were found on all 41 patients, with an average of 5.0 GPs on the right atria and 2.7 on the left. All sites were inactive after ablation.

Any episode of atrial fibrillation after six months was considered a failure.

Follow up results were reported with six-month data. At six months, freedom from atrial fibrillation was reported at 93% (14 out of 15).  The authors plan to submit a follow up article when the remaining patients are eligible for six-month data.

Medical City Dallas Single Center Experience

Presented at the AHA Scientific Sessions; November, 2006

The single center study at Medical City Dallas consisted of 312 total patients. Of these patients, 79 were treated with the minimally invasive surgical (MIS) approach. Results from all 79 MIS patients were presented at the November 2006 American Heart Association Scientific Sessions. In addition, a follow-up peer-reviewed journal article was published in Circulation reporting on 49 of the original 79 patients.

The study focused on clinical outcomes for the minimally invasive procedure. The centers all performed pulmonary vein isolation and ganglionic plexi ablation, procedures were verified for conduction block using the Transpolar pen, and exclusion of the left atrial appendage was performed.

Success was defined as no episodes of atrial fibrillation of 3 seconds or greater. A single episode of AF lasting longer than 3 seconds was considered a failure. In addition, patients were monitored by both ECG monitoring as well as long term monitoring (Cardiac Event Monitor). If the surgery was deemed a success, and only after consulting with patients and their cardiologists, antiarrhythmic drugs could be discontinued 3 months after surgery.

One death occurred in surgery while excising left atrial appendage. The death was attributed by independent physician reviewers to a non-AtriCure stapler that was used to excise the appendage.

Follow up was presented with six-month data. Out of the 47 patients in the Circulation article, 55.3% of patients completed the follow up criteria in its entirety. With ECG monitoring, success was presented at 100% freedom from AF in paroxysmal patients and 71.4% freedom from AF in permanent patients.

With long term monitoring data, success was presented at 93.3% freedom from AF in paroxysmal patients and 66.7% freedom from AF in permanent patients.

 

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