Introduction:
The objective of this retrospective multicenter study is to report the initial long-term performance results after percutaneous exclusion of the LAA with the endo-epicardial Lariat device to prevent AF-related thromboembolic events.
Methods and results:
Patients with successful LAA ligation and at least 1-year follow-up were analyzed (N=355). At 1 year, TEE follow-up was present in 172 patients. A leak was defined as presence of flow into the LAA as assessed by TEE.
At 6 months, 19 (11%) patients had a leak; 2 strokes occurred: 1 in a patient without a leak and 1 associated with mesenteric ischemia in a patient without a known acute leak, who died before repeat TEE could be performed.
At 12 months, 34 (20%) patients had a leak; 6 patients developed a neurological event (5 strokes and 1 TIA), 4 in patients with a leak, 2 in patients without a leak.
3% were followed-up for more than one 1 year (with a mean of 21±9 months). 1 additional thromboembolic event (TIA) occurred 14 months post-implant in a patient without anticoagulation and with a partially excluded LAA (stump), although no leak or thrombus were detected on standard TEE. Among patients with a leak (36% of those with long-term follow-up), 75% were on long-term anticoagulation and no additional TE events were detected.
Out of 355 patients, 9 (2.5%) patients had a neurological event: 4 with a leak, 4 without a leak and 1 in a patient where TEE was not repeated. Considering those with known LAA status, thromboembolic events were more common in patients with a leak (4/34 vs 4/136; RR 4, 95% CI 1.1-15.4).
Conclusion:
In this multicenter experience with the Lariat device, the rate of leaks was high (20% of those with TEE follow-up at 1 year). Thromboembolic events were not rare (overall, 2.5%), and occurred more frequently in patients with a leak (RR 4).