Incidence, predictors and outcomes of device-related thrombus after left atrial appendage closure with the WATCHMAN device-Insights from the EWOLUTION real world registry.

ABSTRACT

BACKGROUND: In this analysis of the EWOLUTION registry, we evaluated the incidence, relevance and predictors of device-related thrombus in a large multi-center real-world cohort undergoing LAAc with the WATCHMAN device. METHODS AND RESULTS: We analyzed the 835 patients who underwent percutaneous LAA closure with the WATCHMAN device in the EWOLUTION registry in whom at least one TEE follow up was performed. Patients were 74 ± 9 y/o and were at high risk for stroke and bleeding (CHA2DS2-VASC-Score 4.3 ± 1.7; HAS-BLED-Score 2.3 ± 1.2). Device-related thrombus was detected in 4.1% (34/835) after a median of 54 days (IQR 42-111 days) with 91.2% (31/34) being detected within 3 months after the procedure or at the time of first TEE. Hereby DRT occurred irrespective of postprocedural anticoagulation. Patients with DRT more frequently had long-standing, non-paroxysmal atrial fibrillation (82.4 vs. 64.9%, p < .01), evidence of dense spontaneous echo contrast (26.5 vs. 11.9%, p = .03) and larger LAA diameters at the ostium (22.8 ± 3.5 vs. 21.1 ± 3.5 mm, p < .01) compared to patients without DRT. Left ventricular ejection fraction, device compression ratio and the incidence of renal dysfunction did not differ between the two groups. In a multivariate analysis, only non-paroxysmal atrial fibrillation identified as an independent predictor of developing DRT. Specific treatment of DRT was initiated in 62% (21/34) of patients whereas resolution was confirmed in 86% (18/21) of cases. Overall, no significant differences in annual rates of stroke/TIA or systemic embolism were observed in patients with or without DRT (DRT 1.7 vs. No-DRT 2.2%/year, p = .8). CONCLUSIONS: In real-world patients undergoing LAAc with the WATCHMAN device, DRT is rare. DRT was most frequently detected within the first 3 months after LAAc regardless of post-procedural regimen and was not associated with an increased risk of stroke or SE. While long-standing atrial fibrillation was the only independent factor associated with DRT, medical treatment of DRT resulted in a resolution of thrombi in most cases.