AtriCure to Evaluate Stroke Prevention in Atrial Fibrillation

AtriCure Inc. is set to conduct a study of its AtriClip device to determine whether it effectively can prevent stroke in patients with atrial fibrillation (Afib).

The company has received U.S. Food and Drug Administration (FDA) approval to enroll patients in a clinical study of its AtriClip Left Atrial Appendage Exclusion System. The feasibility study will enroll Afib patients at seven medical centers throughout the nation and will focus particularly on subjects with significantly high stroke risks as well as substantial bleeding risks that contraindicate them for anticoagulation therapy. Research indicates that up to 40 percent of patients cannot take oral anticoagulants due to excessive bleeding risks.¹

Patients with Afib have a 500 percent increased risk of stroke compared with the general public.² Afib-related strokes are associated with higher morbidity and mortality than non-Afib related strokes.³ Since the left atrial appendage (LAA), a muscular pouch attached to the heart, has been found to be the source of approximately 90 percent of thrombi in Afib patients evaluated after a confirmed stroke, AtriCure’s study will focus on complete and permanent mechanical closure of the LAA.<sup>4

“Managing high risk Afib patients requires balancing the risk of stroke against the risk of major bleeding,” said Basel Ramlawi, M.D., a cardiothoracic surgeon at Houston Methodist DeBakey Heart Center and the study’s principal investigator. “This study is a major step toward developing the clinical evidence necessary to establish a viable, safe and attractive alternative to life-long anticoagulation in Afib patients that currently have very limited options.”</sup>

During the feasibility study, patients will undergo a minimally invasive surgical procedure. Utilizing small incisions in the chest wall, surgeons will place the AtriClip device directly onto the base of the LAA while the heart is still beating. Complete exclusion of the LAA is confirmed during the procedure using echo graphic imaging. Three months following the procedure, a computerized tomography scan will be performed to re-confirm complete and permanent LAA exclusion on all patients.

The AtriClip LAA Exclusion System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. AtriCure received FDA 510(k) clearance for the AtriClip device in June 2010 based upon the results of the EXCLUDE trial, where clinicians achieved complete and permanent exclusion of the LAA in 98.4 percent of patients without complications. Since its launch, more than 25,000 AtriClips have been implanted worldwide, the company claims.

“The Stroke Feasibility IDE study is significant because it is the first to focus entirely on a group of untreated and undertreated Afib patients that may benefit the most from total and permanent exclusion of their left atrial appendage,” AtriCure President/CEO Michael Carrel said.

Headquartered in West Chester, Ohio, AtriCure is a developer and provider of atrial fibrillation treatment devices.

References:
¹ Sudlow M, Thomson R, Thwaites B, Rodgers H, Kenny RA. Prevalence of atrial fibrillation and eligibility of anticoagulation in the community. The Lancet. 1998 Oct 10;352(9135):1167-71.
² Benjamin EJ, Chen PS, Bild DE, et al. Prevention of atrial fibrillation: report from a national heart, lung, and blood institute workshop. Circulation. 2009 Feb 3; 119(4):606-18.
³ Marini C, De Santis F, Sacco S, et al. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005 Jun;36(6):1115-9.
⁴ Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Annals of Thoracic Surgery. 1996 Feb:61(2);755-9.