Prevention of thromboembolic events in atrial fibrillation patients with persistent leaks following the watchman implantation

Abstract Introduction Peri-device leak is not uncommon after percutaneous occlusion of left atrial appendage using the Watchman device. Prior studies have reported the clinical relevance of small leaks (<5mm) as they were associated with a significant increase in ischemic events. Purpose We evaluated the prevalence of stroke in patients with post-watchman leaks on half-dose non-vitamin K oral anticoagulants (HD-NOAC) vs antiplatelet therapy (APT). Methods This consecutive series included post-watchman cases that had a residual leak of ≤5 mm at the 45-day echocardiogram and were unwilling to undergo any leak-closure procedure. Based on their subsequent antithrombotic therapy, they were classified into group 1: HD-NOAC and group 2: dual-APT for 6 months followed by Aspirin only. Patients were closely monitored for thromboembolic (TE) events via telemedicine. Stroke/transient ischemic attacks that occurred while the patients were in full compliance with the anti-thrombotic therapy, were counted as the reportable TE events. Results A total of 141 (age: 66.89± 8.76 years, male: 88 (62.4%), CHA2DS2-VASc score: 3.41 ± 1.56, HAS-BLED: 3.72 ± 1.01) and 154 (age: 72.45 ±7.05 years, male: 99 (64.3%), CHA2DS2-VASc score: 3.75 ± 1.61, HAS-BLED: 3.89 ± 1.05) patients were included in group 1 and 2 respectively. All leaks were between 3-5 mm. TE events were reported in 2 (2/141, 2.12%) patients in group 1 and 9 (9/154, 5.8%) in group 2 while being on antithrombotic therapy (p=04). No residual neurological deficits were detected in the 2 patients from group 1 contrary to the 9 subjects in group 2 that had neurological deficits persistent at follow-up. Of note, 8 (5.6%) patients in group 1 experienced stroke after discontinuing the drug for other medical procedures or due to poor compliance. Conclusion Under full compliance, HD-NOAC is associated with significantly lower TE rate compared to the APT therapy in post-watchman cases with persistent leaks of ≤5 mm. However, discontinuation of the HD-NOAC increases the stroke-risk to a comparable level.