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First patient enrolled in Stroke Feasibility Study

First patient enrolled in Stroke Feasibility Study

AtriCure has announced the enrolment of the first patient in a feasibility study using the AtriClip left atrial appendage exclusion system for stroke reduction in atrial fibrillation patients unable to take anticoagulation. Marc Gerdisch, chief of cardiovascular and thoracic surgery at Franciscan St. Francis Health in Indianapolis, Indiana, USA, performed the first procedure via a minimally invasive surgical approach.

“We have used the AtriClip device for our at-risk patients undergoing open heart surgery since 2008, and it has performed exceptionally well,” says Gerdisch. “With enrolment of this first stroke study patient, we have begun the process of providing atrial fibrillation patients at highest risk, the opportunity to eliminate the most common source of atrial fibrillation-related strokes.”

Patients with atrial fibrillation are five times more likely to suffer a stroke compared with patients who have a normal heart rhythm. The higher risk of atrial fibrillation-related stroke is believed to be related to the pooling of blood in a small muscular pouch within the left atria called the left atrial appendage (LAA). In atrial fibrillation patients, the left atrial appendage has been shown to be the source of more than 90% of stroke-causing blood clots. During atrial fibrillation, blood flow out of the left atrial appendage is reduced, increasing the likelihood of clot formation. In some cases these clots travel from the heart to the brain blocking the blood supply. Atrial fibrillation-related strokes are typically much more severe and disabling than non-atrial fibrillation strokes due to the size and location of clots.

Anticoagulant medications reduce the risk of stroke significantly although they carry a risk of severe bleeding. Other patients may be unable to maintain a therapeutic level of anticoagulation in their systems. This study will enrol atrial fibrillation patients contraindicated to anticoagulation medication and as a result do not have a reasonable alternative available. No left atrial appendage closure devices have been approved for stroke prophylaxis in the United States to-date.

“Atrial fibrillation patients who are unable to take anticoagulation present a conundrum for cardiologists,” according to J D Graham, the referring cardiologist for this case. “We need a reliable method to address their embolic risk, and the answer will come from controlled trials like this.”

The Stroke Feasibility Study is being conducted under an Investigational Device Exemption (IDE). The US Food & Drug Administration (FDA) previously cleared the AtriClip left atrial appendage exclusion system for the occlusion of the left atrial appendage, under direct visualisation, in conjunction with other open cardiac surgical procedures.