Incomplete occlusion of left atrial appendage (LAA) after ligation with a LARIAT device was common and was associated with thromboembolic events, according to data from a recent study published in JACC: Cardiovascular Interventions.
The LARIAT device (SentreHeart; Redwood, California) is used for percutaneous ligation of LAA by delivering a suture with a combined endocardial and epicardial approach.
Researchers sought to evaluate the incidence and clinical implications of acute incomplete occlusion following LAA with the LARIAT device.
The study included 98 consecutive patients (mean age: 73 ± 8 years; 35% women) who underwent successful LAA ligation with the LARIAT device. Researchers measured leak occurrence, defined as the presence of flow (small if <5 mm; large if ≥5 mm) and determined by transesophageal echocardiography. Transesophageal echocardiography was performed during the LAA ligation procedure, at 6 and 12 months, and after any thromboembolic events.
Leaks were detected in 5% of patients at baseline, 15% of patients at 6 months, and 20% of patients at 12 months. Throughout the follow-up period (16.1 ± 2.5 months), 5 patients developed neurological events, including 4 strokes and 1 transient ischemic attack.
“Leaks can occur de novo even 6 months after the procedure and appear to be associated with an increased risk for thromboembolic events,” the authors wrote. “Although prospective studies are needed to confirm the present findings, this observed association is potentially clinically significant.”
One event was a fatal stroke, in addition to a stroke that had multiple recurrences over the following months. Transesophageal echocardiography was not repeated after these events.
The remaining events occurred after 6 months and were associated with small leaks (<5mm). In 2 out of 3 of these cases, small leaks were missed by standard evaluation with a 2-dimensional transesophageal echocardiography, and were only detected with 3-dimensional imaging.
“In the LARIAT population, long-term surveillance with careful TEE [transesophageal echocardiography] (preferably 3-dimensional) should be considered, and when detected, leaks should be addressed with either resumption of OAC [oral anticoagulation], if possible, or percutaneous closure with endovascular occlusion devices.”
Researchers also noted that there are no standard recommendations for post-procedural oral anticoagulation after the LARIAT procedure, in part because of the difficulty in determining the treatment need and duration. Patients who undergo the LARIAT procedure often do so because they cannot tolerate oral anticoagulants.
However, the study findings suggest that it may not be safe to discontinue treatment after the procedure without proper surveillance—again, preferably with 3-dimensional transesophageal echocardiography, for at least 12 months post-procedure.
Future studies should investigate the efficacy of the LARIAT device compared with long-term oral anticoagulation or other LAA closure techniques.
Gianni C, Biase LD, Trivedi C, et al. Clinical implications of leaks following left atrial appendage ligation with the LARIAT device. J Am Coll Cardiol Intv. 2016;9(10):1051-1057.