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Updated: May 29, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Exclusion of the left atrial appendage with a novel device: early results of a multicenter trial
Gorav Ailawadi1, Marc W Gerdisch, Richard L Harvey
1Department of Surgery, University of Virginia, Charlottesville, VA, USA.
Insights
A novel clip safely excluded the left atrial appendage in most cardiac surgery patients, showing high short-term success in preventing stroke-causing clots. Further long-term studies are needed for stroke prevention efficacy.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Innovation
Background:
- Embolic strokes in atrial fibrillation patients often originate from the left atrial appendage (LAA).
- Excluding the LAA during cardiac surgery may reduce stroke risk, particularly in high-risk patients.
- A novel clip device was developed for LAA exclusion.
Purpose of the Study:
- To assess the safety and efficacy of a novel left atrial appendage exclusion clip.
- To report initial results from a multicenter Food and Drug Administration (FDA) trial.
Main Methods:
- 71 patients undergoing elective cardiac surgery with atrial fibrillation or high stroke risk were enrolled.
- The AtriClip device was used for left atrial appendage exclusion.
- Safety assessed at 30 days; efficacy assessed intraoperatively and at 3-month follow-up via imaging.
Main Results:
- 70 patients received the AtriClip device, with 95.7% intraprocedural exclusion success.
- No device-related adverse events or perioperative mortality occurred.
- At 3-month follow-up, 98.4% of imaged patients demonstrated successful LAA exclusion.
Conclusions:
- The AtriClip device enables safe and effective LAA exclusion during open cardiac surgery.
- Short-term imaging shows durable exclusion, with over 95% success rates.
- Long-term studies are necessary to confirm stroke prevention efficacy.
Objective:
Up to 90% of embolic strokes that occur in patients with atrial fibrillation originate from the left atrial appendage. Exclusion of the left atrial appendage during cardiac surgery may decrease the future risk of stroke, especially in patients with atrial fibrillation or at high risk for developing atrial fibrillation. We report the initial results of a multicenter Food and Drug Administration trial to assess the safety and efficacy of a novel left atrial appendage exclusion clip.
Methods:
Patients undergoing elective cardiac surgery via median sternotomy with atrial fibrillation or a Congestive Heart Failure, Hypertension, Age > 75 Years, Diabetes Mellitus, Stroke score greater than 2 were eligible for concomitant AtriClip (Atricure Inc, Westchester, Ohio) device insertion. Device insertion (35, 40, 45, and 50 mm) was performed at any point after sternotomy on or off cardiopulmonary bypass. Safety was assessed at 30 days, and efficacy of left atrial appendage exclusion was assessed at operation (by transesophageal echocardiography) and 3-month follow-up (by computed tomography angiography or transesophageal echocardiography).
Results:
A total of 71 patients (mean age, 73 years) undergoing open cardiac surgery at 7 US centers were enrolled in the study. The left atrial appendage in 1 patient was too small and did not meet eligibility criteria; the remaining 70 patients had successful placement of an AtriClip device. Intraprocedural successful left atrial appendage exclusion was confirmed in 67 of 70 patients (95.7%). Although significant adverse events occurred in 34 of 70 patients (48.6%), there were no adverse events related to the device and no perioperative mortality. At 3-month follow-up, 1 patient died and 65 of 70 patients (92.9%) were available for assessment. Of the patients who underwent imaging, 60 of 61 patients (98.4%) had successful left atrial appendage exclusion by computed tomography angiography or transesophageal echocardiography imaging.
Conclusions:
In this small study, safe and atraumatic exclusion of the left atrial appendage can be performed during open cardiac surgery with the AtriClip device with greater than 95% success and appears to be durable in the short term by imaging. Long-term studies are needed to evaluate the efficacy in the prevention of stroke.
