Acquired cardiovascular disease
Exclusion of the left atrial appendage with a novel device: Early results of a multicenter trial

Read at the 91st Annual Meeting of The American Association for Thoracic Surgery, Philadelphia, Pennsylvania, May 7-11, 2011.
https://doi.org/10.1016/j.jtcvs.2011.07.052Get rights and content
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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.

CTSNet classification

18
19
24
40.1

Abbreviations and Acronyms

AF
atrial fibrillation
AE
adverse event
AVR
aortic valve replacement
CABG
coronary artery bypass grafting
CHADS
Congestive Heart Failure, Hypertension, Age > 75 years, Diabetes Mellitus, Stroke
CTA
computed tomography angiography
EXCLUDE
Exclusion of Left Atrial Appendage with AtriClip Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery
FDA
Food and Drug Administration
LAA
left atrial appendage
TEE
transesophageal echocardiography

Cited by (0)

Funding provided by Atricure Inc, West Chester, Ohio. ClinicalTrials.gov number NCT00779857.

Disclosures: Authors have nothing to disclose with regard to commercial support.