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.

Percutaneous Left Atrial Appendage Closure With a Novel LAA Occluder for Stroke Prevention in Atrial Fibrillation

“…Another possible reason that there was no DRT in this study is that the proportion of long-standing AF, an independent factor associated with DRT, was low after AF ablation. 23 The immediate success rate of occlusion was 100% (PDL ≤3 mm), but there were 3 patients with 1-stop LAA closure and ablation who had residual flow >3 mm during follow-up. This may be caused by regression of tissue edema caused by ablation.…”

“…In fact, DRT was most frequently detected within the first 3 months after LAA closure. 23 However, Dukkipati et al 24 reported that late DRT was detected in 27 of 1,504 patients (1.8%) at 12 months. Because the decision in this study on whether to perform subsequent TEE was based on the 3-month follow-up results, the incidence of late DRT may have been underestimated.…”

Left Atrial Appendage Closure Yields Favorable Cardio- and Cerebrovascular Outcomes in Patients With Non-valvular Atrial Fibrillation and Prior Stroke

“…In a multivariable regression analysis, a history of previous stroke was identified as an independent predictor of DRT ( 30 ). However, in the WOLUTION registry, which contains a high proportion of patients with prior stroke/TIA (30.5%) and a positive detection rate of DRT (4.1%), no data was provided on the impact of history of prior stroke/TIA on occurrence of DRT and the correlation between DRT and future thromboembolic risk ( 32 ). In our cohort, the incidence rate of DRT was in accordance with those of aforementioned studies and did not differ between patients with and without prior stroke.…”

Impact and predictors of device-related thrombus after percutaneous left atrial appendage closure

“…Søndergaard et al 30 compared two different drug regimens [antiplatelet therapy (APT) vs. oral anticoagulant (OAC)] in the overall population of PROTECT AF and PREVAIL trials, CAP, CAP2, ASAP and EWOLUTION registries and observed a higher DRT rates in the group of patients on the APT regimen compared with those on OAC, but it did not translate into a significant difference in terms of neurological events between the two groups. The 2-year follow-up data of the EWOLUTION registry in 1020 patients showed a lack of significant differences in the annual incidence of thromboembolic events in patients with or without DRT (respectively 1.7% vs. 2.2%, P = 0.805) for the WM device 31,32 …”