BOSTON—Closing the left atrial appendage (LAA) in high-risk atrial fibrillation patients who have an intolerance to warfarin proved safe and effective in a single-center observational trial presented at a late-breaking clinical session May 11 at the 33rd annual scientific sessions of the Heart Rhythm Society.
“A severe consequence of atrial fibrillation is an embolic event,” said the study’s lead author, Randall Lee, MD, of the University of California, San Francisco.
Previous study data have shown that “if you eliminate the left atrial appendage you may be able to reduce the risk of stroke.” To better understand this notion, Lee et al evaluated the use of a percutaneous procedure to close the LAA using image guidewires, magnet guidewires, endocath occlusion balloons and suture delivery.
The non-randomized, single-center, observational trial assessed the safety and efficacy of an LAA closure. One-hundred and nineteen patients were included in the study and all had AF, a CHADS score of 1 and were ineligible to receive warfarin therapy. Patients with a history of cardiac surgery and pericarditis, among other factors, were excluded.
Of the 119 patients, 16 patients were excluded because they had an LAA width greater than 40 mm. Eleven patients were excluded for LAA thrombus, leaving the patient-to-treat population at 89 patients. Lee reported that the researchers failed to treat four patients due to various reasons, including pericardial adhesions.
LAA closure was achieved in 96 percent of patients (85 of 89 patients). The authors defined acute LAA closure success as any width less than 1 mm. Three percent of patients had closure that was equal to or less than 2 mm and one patient had a closure that was between 3 mm and 5mm.
Lee said that while there were no device complications reported during the study, two patients had pericardial access complications. Additionally, he said that the main peri-procedural event seen was chest pain that was due to a placed pig tail catheter. This occurred in 25 percent of patients. When the catheter was removed, chest pain symptoms decreased.
Lee reported that two non-embolic stokes occurred during the study along with two deaths; however, the patient deaths were not procedural related, he said.
“I’ve introduced a new procedure in terms of the percutaneous LA Lariat, but what can we actually take from this?” he asked.
“It’s feasible, it’s effective at closing the left atrial appendage and at least in this single center study, it had acceptable low access complications and periprocedural events,” he added.
“This can be considered a potential option for high-risk patients with atrial fibrillation who are at risk for embolic events who really do have contraindications or intolerance to anticoagulation therapy,” he summed.
Lee called the fact that this was a single center, observational trial a limitation. He said that a prospective, multicenter study looking at LAA closure is in the works.