Incidence, predictors and outcomes of device‐related thrombus after left atrial appendage closure with the WATCHMAN device—Insights from the EWOLUTION real world registry
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 c...
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Veröffentlicht in: | Catheterization and cardiovascular interventions 2021-06, Vol.97 (7), p.E1019-E1024 |
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creator | Sedaghat, Alexander Nickenig, Georg Schrickel, Jan Wilko Ince, Hüseyin Schmidt, Boris Protopopov, Alexey V. Betts, Timothy R. Gori, Tommaso Sievert, Horst Mazzone, Patrizio Grygier, Marek Wald, Christof Vireca, Elisa Allocco, Dominic Boersma, Lucas V.A |
description | 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 |
doi_str_mv | 10.1002/ccd.29458 |
format | Article |
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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.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.29458</identifier><identifier>PMID: 33417282</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley & Sons, Inc</publisher><subject>Blood clots ; Cardiac arrhythmia ; Compression ; device‐related thrombus ; Embolism ; Fibrillation ; Heart ; left atrial appendage ; Medical treatment ; Multivariate analysis ; Patients ; Renal function ; Stroke ; Thrombosis ; Ventricle ; WATCHMAN</subject><ispartof>Catheterization and cardiovascular interventions, 2021-06, Vol.97 (7), p.E1019-E1024</ispartof><rights>2021 Wiley Periodicals LLC.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3538-d9f8d41b927395b5e7a5838ba9afdfc34fd9f6e8d177e0eda5616e1cc12336753</citedby><cites>FETCH-LOGICAL-c3538-d9f8d41b927395b5e7a5838ba9afdfc34fd9f6e8d177e0eda5616e1cc12336753</cites><orcidid>0000-0001-7015-1056</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fccd.29458$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.29458$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1416,27923,27924,45573,45574</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33417282$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sedaghat, Alexander</creatorcontrib><creatorcontrib>Nickenig, Georg</creatorcontrib><creatorcontrib>Schrickel, Jan Wilko</creatorcontrib><creatorcontrib>Ince, Hüseyin</creatorcontrib><creatorcontrib>Schmidt, Boris</creatorcontrib><creatorcontrib>Protopopov, Alexey V.</creatorcontrib><creatorcontrib>Betts, Timothy R.</creatorcontrib><creatorcontrib>Gori, Tommaso</creatorcontrib><creatorcontrib>Sievert, Horst</creatorcontrib><creatorcontrib>Mazzone, Patrizio</creatorcontrib><creatorcontrib>Grygier, Marek</creatorcontrib><creatorcontrib>Wald, Christof</creatorcontrib><creatorcontrib>Vireca, Elisa</creatorcontrib><creatorcontrib>Allocco, Dominic</creatorcontrib><creatorcontrib>Boersma, Lucas V.A</creatorcontrib><creatorcontrib>EWOLUTION study group</creatorcontrib><creatorcontrib>the EWOLUTION study group</creatorcontrib><title>Incidence, predictors and outcomes of device‐related thrombus after left atrial appendage closure with the WATCHMAN device—Insights from the EWOLUTION real world registry</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>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.</description><subject>Blood clots</subject><subject>Cardiac arrhythmia</subject><subject>Compression</subject><subject>device‐related thrombus</subject><subject>Embolism</subject><subject>Fibrillation</subject><subject>Heart</subject><subject>left atrial appendage</subject><subject>Medical treatment</subject><subject>Multivariate analysis</subject><subject>Patients</subject><subject>Renal function</subject><subject>Stroke</subject><subject>Thrombosis</subject><subject>Ventricle</subject><subject>WATCHMAN</subject><issn>1522-1946</issn><issn>1522-726X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp10U1uEzEUwHELgWgbWHABZIkNSKQd2-P5WEahQKTQbFqV3chjPyeuPOOp7SHKrkdgwTk4FCfBJKELJOSF3-Lnvyw9hF6R7JxkGb2QUp3TOufVE3RKOKXTkhZfnx5nUufFCToL4S7Lsrqg9XN0wlhOSlrRU_Rz0UujoJfwHg8elJHR-YBFr7Abo3QdBOw0VvDNSPj18N2DFREUjhvvunZMUkfw2IKOWERvhMViGKBXYg1YWhdGD3hr4ia9AHw7u55__jK7euz9WPTBrDcxYJ16e3N5u1reXC9WV9hDqm2dtyqNaxOi371Az7SwAV4e7wm6-XiZmtPl6tNiPltOJeOsmqpaVyonbU1LVvOWQyl4xapW1EIrLVmukyigUqQsIQMleEEKIFISylhRcjZBbw_dwbv7EUJsOhMkWCt6cGNoaF4WvEiYJfrmH3rnRt-n3zWUs5pl-zNB7w5KeheCB90M3nTC7xqSNX-W2KQlNvslJvv6WBzbDtSj_Lu1BC4OYGss7P5faubzD4fkb72Uqec</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>Sedaghat, Alexander</creator><creator>Nickenig, Georg</creator><creator>Schrickel, Jan Wilko</creator><creator>Ince, Hüseyin</creator><creator>Schmidt, Boris</creator><creator>Protopopov, Alexey V.</creator><creator>Betts, Timothy R.</creator><creator>Gori, Tommaso</creator><creator>Sievert, Horst</creator><creator>Mazzone, Patrizio</creator><creator>Grygier, Marek</creator><creator>Wald, Christof</creator><creator>Vireca, Elisa</creator><creator>Allocco, Dominic</creator><creator>Boersma, Lucas V.A</creator><general>John Wiley & Sons, Inc</general><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-7015-1056</orcidid></search><sort><creationdate>20210601</creationdate><title>Incidence, predictors and outcomes of device‐related thrombus after left atrial appendage closure with the WATCHMAN device—Insights from the EWOLUTION real world registry</title><author>Sedaghat, Alexander ; Nickenig, Georg ; Schrickel, Jan Wilko ; Ince, Hüseyin ; Schmidt, Boris ; Protopopov, Alexey V. ; Betts, Timothy R. ; Gori, Tommaso ; Sievert, Horst ; Mazzone, Patrizio ; Grygier, Marek ; Wald, Christof ; Vireca, Elisa ; Allocco, Dominic ; Boersma, Lucas V.A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3538-d9f8d41b927395b5e7a5838ba9afdfc34fd9f6e8d177e0eda5616e1cc12336753</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Blood clots</topic><topic>Cardiac arrhythmia</topic><topic>Compression</topic><topic>device‐related thrombus</topic><topic>Embolism</topic><topic>Fibrillation</topic><topic>Heart</topic><topic>left atrial appendage</topic><topic>Medical treatment</topic><topic>Multivariate analysis</topic><topic>Patients</topic><topic>Renal function</topic><topic>Stroke</topic><topic>Thrombosis</topic><topic>Ventricle</topic><topic>WATCHMAN</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sedaghat, Alexander</creatorcontrib><creatorcontrib>Nickenig, Georg</creatorcontrib><creatorcontrib>Schrickel, Jan Wilko</creatorcontrib><creatorcontrib>Ince, Hüseyin</creatorcontrib><creatorcontrib>Schmidt, Boris</creatorcontrib><creatorcontrib>Protopopov, Alexey V.</creatorcontrib><creatorcontrib>Betts, Timothy R.</creatorcontrib><creatorcontrib>Gori, Tommaso</creatorcontrib><creatorcontrib>Sievert, Horst</creatorcontrib><creatorcontrib>Mazzone, Patrizio</creatorcontrib><creatorcontrib>Grygier, Marek</creatorcontrib><creatorcontrib>Wald, Christof</creatorcontrib><creatorcontrib>Vireca, Elisa</creatorcontrib><creatorcontrib>Allocco, Dominic</creatorcontrib><creatorcontrib>Boersma, Lucas V.A</creatorcontrib><creatorcontrib>EWOLUTION study group</creatorcontrib><creatorcontrib>the EWOLUTION study group</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Catheterization and cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sedaghat, Alexander</au><au>Nickenig, Georg</au><au>Schrickel, Jan Wilko</au><au>Ince, Hüseyin</au><au>Schmidt, Boris</au><au>Protopopov, Alexey V.</au><au>Betts, Timothy R.</au><au>Gori, Tommaso</au><au>Sievert, Horst</au><au>Mazzone, Patrizio</au><au>Grygier, Marek</au><au>Wald, Christof</au><au>Vireca, Elisa</au><au>Allocco, Dominic</au><au>Boersma, Lucas V.A</au><aucorp>EWOLUTION study group</aucorp><aucorp>the EWOLUTION study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Incidence, predictors and outcomes of device‐related thrombus after left atrial appendage closure with the WATCHMAN device—Insights from the EWOLUTION real world registry</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2021-06-01</date><risdate>2021</risdate><volume>97</volume><issue>7</issue><spage>E1019</spage><epage>E1024</epage><pages>E1019-E1024</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><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.</abstract><cop>Hoboken, USA</cop><pub>John Wiley & Sons, Inc</pub><pmid>33417282</pmid><doi>10.1002/ccd.29458</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0001-7015-1056</orcidid></addata></record> |
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source | Wiley Online Library All Journals |
subjects | Blood clots Cardiac arrhythmia Compression device‐related thrombus Embolism Fibrillation Heart left atrial appendage Medical treatment Multivariate analysis Patients Renal function Stroke Thrombosis Ventricle WATCHMAN |
title | Incidence, predictors and outcomes of device‐related thrombus after left atrial appendage closure with the WATCHMAN device—Insights from the EWOLUTION real world registry |
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