Retrospective Evaluation of Percutaneous Left Atrial Appendage Closure Ligation and Exclusion (Replace)

Background:

Over the past decade, there have been great interests in eliminating the LAA as a source of emboli through a catheter based approach. A novel epicardial‐deployed percutaneous LAA ligation device called the LARIAT® (SentreHeart, Redwood City, CA) has been recently described in the literature to exclude the LAA. Although the percutaneous left atrial appendage closure and exclusion (PLACE) procedure obviates the need for oral anticoagulation therapy (OAT), there are limited studies that evaluate the occurrence of stroke utilizing the LARIAT suture device. In this retrospective study, we seek to evaluate the clinical status and the occurrence of thromboembolism in patients who have undergone PLACE with the LARIAT device. We retrospectively evaluated the clinical status and risk of thromboembolic events in patients after Percutaneous Left Atrial Appendage Ligation and Exclusion (PLACE) with the LARIAT device.

Methods:

21 patients with atrial fibrillation who underwent PLACE with LARIAT device were retrospectively evaluated for occurrence of systemic embolic events, strokes, transient ischemic attacks, and procedure related complications. Subjects were compared with historical controls.

Results:

Permanent suture was successfully delivered in 20 patients. Mean follow up time was 17.2+‐3.3 months. Only 1 patient developed clinical symptoms of stroke that were thought to be a lacunar infarction from uncontrolled hypertension. One patient had minor perioperative bleeding. One patient developed transient electrocardiographic changes of ischemia during mapping for left atrium ablation following PLACE and underwent coronary artery bypass surgery. Three patient developed transient post‐procedural pericarditis. Three study participants died from non‐PLACE related conditions.

Conclusions:

There was a 32% and 30% reduction in annual risk of stroke when compared to expected CHADS2 and CHA2DS2‐VASc scoring, respectively. If single clinical observation of lacunar stroke is adjudicated to a non‐embolic event then the true rate of embolic stroke is negligible which provides a 100% reduction in the annual risk of stroke in a high risk population.