TY - JOUR
T1 - Incidence, predictors and outcomes of device-related thrombus after left atrial appendage closure with the WATCHMAN device—Insights from the EWOLUTION real world registry
AU - Sedaghat, Alexander
AU - Nickenig, Georg
AU - Schrickel, Jan Wilko
AU - Ince, H. seyin
AU - Schmidt, Boris
AU - Protopopov, Alexey V.
AU - Betts, Timothy R.
AU - Gori, Tommaso
AU - Sievert, Horst
AU - Mazzone, Patrizio
AU - Grygier, Marek
AU - Wald, Christof
AU - Vireca, Elisa
AU - Allocco, Dominic
AU - the EWOLUTION study group
AU - Boersma, Lucas V. A.
N1 - Funding Information:
Dr Sedaghat has received travel grants from BSC. Dr Schmidt has received personal fees from BSC. Prof. Sievert has received personal fees from BSC. Prof. Boersma has received personal fees from BSC. Dr Betts has received personal fees from BSC. Dr Grygier is an Advisory Board Member and proctor for BSC. Dr Grygier has also received honoraria for lectures from BSC. Dr Mazzone is a proctor for BSC. Prof. Gori has no conflicts to declare. Dr Wald has no conflicts to declare. Dr Protopopov has no conflicts to declare. Prof. Nickenig has no conflicts to declare. Prof. Schrickel has no conflicts to declare. Dominic Allocco and Elisa Vireca are employees and shareholders at BSC. Prof. Ince is a proctor for BSC and has received personal fees from BSC.
Publisher Copyright:
© 2021 Wiley Periodicals LLC.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/6/1
Y1 - 2021/6/1
N2 - 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.
AB - 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.
KW - WATCHMAN
KW - device-related thrombus
KW - left atrial appendage
UR - https://www.scopus.com/pages/publications/85099211494
U2 - 10.1002/ccd.29458
DO - 10.1002/ccd.29458
M3 - Article
C2 - 33417282
SN - 1522-1946
VL - 97
SP - E1019-E1024
JO - Catheterization and cardiovascular interventions
JF - Catheterization and cardiovascular interventions
IS - 7
ER -
SDG 3 Good Health and Well-being