Increased Risk of Left Atrial Appendage Leak with Lariat Ligation Device

A study of left atrial appendage ligations in patients with atrial fibrillation (AF) found that leaks are common when doctors perform the surgery with a device called the Lariat and that those leaks can lead to neurological events.

Researchers evaluated outcomes for 99 consecutive AF patients whose surgeons used a Lariat device to close the left atrial appendage (LAA) during endo-epicardial ligation.

Physicians used 2-D or 3-D trans-esophageal echocardiography (TEE) to detect leaks immediately after surgery and, again, after 6 and 12 months. The study team then looked for evidence of adverse events associated with those leaks.

The first round of scans found 5 small leaks (≤ 5mm) in 5 patients and no leaks in the remaining 93. “Unfavorable anatomy” rendered 1 patient ineligible for the surgery. The second round of scans found ongoing leaks in 2 of the 5 patients with initial leakage — the other 3 patients showed no signs of residual leaks — and 12 new leaks (8 small and 4 large) among the other 93 patients. The third round of scans found another 5 new leaks (4 small and 1 large).

Among the 22 patients who exhibited some degree of LAA leakage at some point after surgery, there was 1 stroke and 1 transient ischemic attack in patients with small leaks during the follow-up period.

“Small leaks (≤ 5 mm), that are considered safe in patients implanted with the Watchman device, can lead to neurological events in the Lariat population,” wrote the authors of the study, which was presented at the 2015 scientific sessions of the Heart Rhythm Society’s annual meeting.

The study authors also noted that 2-D TEE failed to catch small leaks in 3 patients.

“3-D TEE appears more sensitive in detecting small re-openings and should be used for standard screening,” they wrote.

The Lariat Suture Delivery System works much like a lasso. Physicians use it as part of minimally invasive surgery by slipping a loop of suture over the LAA and tightening until it seals stroke-causing clots away from the rest of the heart and body.

Previous trials have found the Lariat to be an effective tool for safely shutting off the LAA. A 2013 paper in the Journal of the American College of Cardiology reported that 85 of 89 (96%) patients were successfully treated with the procedure and that 81 of the 85 patients had complete closure immediately. The other 4 of 85 patients were found to have a ≤3-mm residual LAA leak by TEE color Doppler evaluation. There were no complications due to the device (though 3 minor access-related complications). Of the patients undergoing 1-year TEE (n = 65), there was 98% complete LAA closure, including the patients with previous leaks.

Such data have convinced many medical centers around the country to begin using the Lariat for LAA closures, even though the device is not specifically approved for such a procedure. The US Food and Drug Association approved it in 2006 for the placement of sutures.

Long-term trials are underway to determine effective the Lariat is in preventing stroke and other adverse events after LAA closure.