Small leaks after LAA closure could lead to neurological events

BOSTON — More than one-fifth of patients participating in a registry of the Lariat left atrial appendage ligation device had various degrees of left atrial appendage leak after ligation, and some of those leaks were associated with neurological events, according to data presented at the Heart Rhythm Society Annual Scientific Sessions.

Researchers evaluated the frequency and clinical implications of left atrial appendage (LAA) leaks after endo-epicardial ligation with a device used for LAA closure (Lariat, SentreHeart). The retrospective study included 99 consecutive patients with atrial fibrillation at four centers who underwent LAA ligation with the Lariat device for stroke prevention. The Lariat received clearance from the FDA in 2006 for suture placement, but is sometimes used off-label for LAA closure.

Leaks were detected by 2-D or 3-D transesophageal echocardiography (TEE). Leaks were classified as small if they were 5 mm or smaller in diameter.

“Leaks are common (more than one-fifth in our cohort) and they can occur de novo even after 6 months from the Lariat implant,” Carola Gianni, MD, from Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas, told Cardiology Today. “Small leaks are not benign and they can be undetected by standard 2-D TEE.”

Gianni and colleagues reported no periprocedural deaths or strokes. The rate of major bleeding was 9.3%.

At implant, 93 patients had no acute leak, five patients had a small leak detected, and one patient could not be implanted because of unfavorable anatomy, according to the researchers.

At 6 months, among the five patients with a small leak at implant, three showed no residual leak and two had a stable leak, and among the 93 patients with no leak at implant, 81 had no re-opening and 12 had a leak (small in eight patients; > 5 mm in four patients).

At 12 months, six late re-openings were detected (small in five patients; > 5 mm in one patient). In total, 23.5% of patients had various degrees of LAA leak after ligation with the Lariat device.

Gianni and colleagues found that three patients with a small late re-opening developed a neurological event; there were two strokes and one transient ischemic attack. In three patients, 2-D TEE did not detect small leaks.

“3-D TEE appears more sensitive in detecting small re-openings and should be used for standard screening,” Gianni and colleagues wrote in an abstract. “Small leaks (≤ 5 mm), that are considered safe in patients implanted with the Watchman device, can lead to neurological events in the Lariat population.” – by Erik Swain

Reference:

Gianni C, et al. Abstract PO01-80. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015; Boston.

Disclosure: Gianni reports no relevant financial disclosures.