Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes
BACKGROUND:In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predicto...
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Published in | Circulation (New York, N.Y.) Vol. 138; no. 9; pp. 874 - 885 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
by the American College of Cardiology Foundation and the American Heart Association, Inc
28.08.2018
|
Subjects | |
Online Access | Get full text |
ISSN | 0009-7322 1524-4539 1524-4539 |
DOI | 10.1161/CIRCULATIONAHA.118.035090 |
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Abstract | BACKGROUND:In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors, and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation.
METHODS:We studied the device arms of 4 prospective Food and Drug Administration trialsPROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (n=463); PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) (n=269); CAP (Continued Access to PROTECT AF registry) (n=566); and CAP2 (Continued Access to PREVAIL registry) (n=578). Surveillance transesophageal echocardiographs were performed at 45 days and 12 months in all patients, and also at 6 months in the randomized control trials. We assessed both the incidence of DRT during these transesophageal echocardiographs (and other unscheduled transesophageal echocardiographs), and clinical outcomes of postprocedure stroke or systemic embolism (SSE) and adjusted for CHA2DS2-VASC and HAS-BLED scores.
RESULTS:Of 1739 patients who received an implant (7159 patient-years follow-up; CHA2DS2-VASc=4.0), DRT was seen in 65 patients (3.74%). The rates of SSE with and without DRT were 7.46 and 1.78 per 100 patient-years (adjusted rate ratio, 3.55; 95% confidence interval [CI], 2.18–5.79; P<0.001), and ischemic SSE rates were 6.28 and 1.65 per 100 patient-years (adjusted rate ratio, 3.22; 95% CI, 1.90–5.45, P<0.001). On multivariable modeling analysis, the predictors of DRT were as followshistory of transient ischemic attack or stroke (odds ratio [OR], 2.31; 95% CI, 1.26–4.25; P=0.007), permanent atrial fibrillation (OR, 2.24; 95% CI, 1.19–4.20; P=0.012); vascular disease (OR, 2.06; 95% CI, 1.08–3.91; P=0.028); left atrial appendage diameter (OR, 1.06 per mm increase; 95% CI, 1.01–1.12; P=0.019); left ventricular ejection fraction (OR, 0.96 per 1% increase; 95% CI, 0.94–0.99; P=0.009). DRT and SSE both occurred in 17 of 65 patients (26.2%). Of the 19 SSE events in these patients with DRT, 9 of 19 (47.4%) and 12 of 19 (63.2%) occurred within 1 and 6 months of DRT detection. Conversely, after left atrial appendage closure, most SSEs (123/142, 86.62%) occurred in patients without DRT.
CONCLUSIONS:After left atrial appendage closure with Watchman, DRT (≈3.7%) is not frequent but, when present, is associated with a higher rate of stroke and systemic embolism. |
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AbstractList | In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors, and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation.
We studied the device arms of 4 prospective Food and Drug Administration trials: PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (n=463); PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) (n=269); CAP (Continued Access to PROTECT AF registry) (n=566); and CAP2 (Continued Access to PREVAIL registry) (n=578). Surveillance transesophageal echocardiographs were performed at 45 days and 12 months in all patients, and also at 6 months in the randomized control trials. We assessed both the incidence of DRT during these transesophageal echocardiographs (and other unscheduled transesophageal echocardiographs), and clinical outcomes of postprocedure stroke or systemic embolism (SSE) and adjusted for CHA
DS
-VASC and HAS-BLED scores.
Of 1739 patients who received an implant (7159 patient-years follow-up; CHA
DS
-VASc=4.0), DRT was seen in 65 patients (3.74%). The rates of SSE with and without DRT were 7.46 and 1.78 per 100 patient-years (adjusted rate ratio, 3.55; 95% confidence interval [CI], 2.18-5.79; P<0.001), and ischemic SSE rates were 6.28 and 1.65 per 100 patient-years (adjusted rate ratio, 3.22; 95% CI, 1.90-5.45, P<0.001). On multivariable modeling analysis, the predictors of DRT were as follows: history of transient ischemic attack or stroke (odds ratio [OR], 2.31; 95% CI, 1.26-4.25; P=0.007), permanent atrial fibrillation (OR, 2.24; 95% CI, 1.19-4.20; P=0.012); vascular disease (OR, 2.06; 95% CI, 1.08-3.91; P=0.028); left atrial appendage diameter (OR, 1.06 per mm increase; 95% CI, 1.01-1.12; P=0.019); left ventricular ejection fraction (OR, 0.96 per 1% increase; 95% CI, 0.94-0.99; P=0.009). DRT and SSE both occurred in 17 of 65 patients (26.2%). Of the 19 SSE events in these patients with DRT, 9 of 19 (47.4%) and 12 of 19 (63.2%) occurred within 1 and 6 months of DRT detection. Conversely, after left atrial appendage closure, most SSEs (123/142, 86.62%) occurred in patients without DRT.
After left atrial appendage closure with Watchman, DRT (≈3.7%) is not frequent but, when present, is associated with a higher rate of stroke and systemic embolism. BACKGROUND:In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors, and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation. METHODS:We studied the device arms of 4 prospective Food and Drug Administration trialsPROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (n=463); PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) (n=269); CAP (Continued Access to PROTECT AF registry) (n=566); and CAP2 (Continued Access to PREVAIL registry) (n=578). Surveillance transesophageal echocardiographs were performed at 45 days and 12 months in all patients, and also at 6 months in the randomized control trials. We assessed both the incidence of DRT during these transesophageal echocardiographs (and other unscheduled transesophageal echocardiographs), and clinical outcomes of postprocedure stroke or systemic embolism (SSE) and adjusted for CHA2DS2-VASC and HAS-BLED scores. RESULTS:Of 1739 patients who received an implant (7159 patient-years follow-up; CHA2DS2-VASc=4.0), DRT was seen in 65 patients (3.74%). The rates of SSE with and without DRT were 7.46 and 1.78 per 100 patient-years (adjusted rate ratio, 3.55; 95% confidence interval [CI], 2.18–5.79; P<0.001), and ischemic SSE rates were 6.28 and 1.65 per 100 patient-years (adjusted rate ratio, 3.22; 95% CI, 1.90–5.45, P<0.001). On multivariable modeling analysis, the predictors of DRT were as followshistory of transient ischemic attack or stroke (odds ratio [OR], 2.31; 95% CI, 1.26–4.25; P=0.007), permanent atrial fibrillation (OR, 2.24; 95% CI, 1.19–4.20; P=0.012); vascular disease (OR, 2.06; 95% CI, 1.08–3.91; P=0.028); left atrial appendage diameter (OR, 1.06 per mm increase; 95% CI, 1.01–1.12; P=0.019); left ventricular ejection fraction (OR, 0.96 per 1% increase; 95% CI, 0.94–0.99; P=0.009). DRT and SSE both occurred in 17 of 65 patients (26.2%). Of the 19 SSE events in these patients with DRT, 9 of 19 (47.4%) and 12 of 19 (63.2%) occurred within 1 and 6 months of DRT detection. Conversely, after left atrial appendage closure, most SSEs (123/142, 86.62%) occurred in patients without DRT. CONCLUSIONS:After left atrial appendage closure with Watchman, DRT (≈3.7%) is not frequent but, when present, is associated with a higher rate of stroke and systemic embolism. In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors, and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation.BACKGROUNDIn patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors, and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation.We studied the device arms of 4 prospective Food and Drug Administration trials: PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (n=463); PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) (n=269); CAP (Continued Access to PROTECT AF registry) (n=566); and CAP2 (Continued Access to PREVAIL registry) (n=578). Surveillance transesophageal echocardiographs were performed at 45 days and 12 months in all patients, and also at 6 months in the randomized control trials. We assessed both the incidence of DRT during these transesophageal echocardiographs (and other unscheduled transesophageal echocardiographs), and clinical outcomes of postprocedure stroke or systemic embolism (SSE) and adjusted for CHA2DS2-VASC and HAS-BLED scores.METHODSWe studied the device arms of 4 prospective Food and Drug Administration trials: PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (n=463); PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) (n=269); CAP (Continued Access to PROTECT AF registry) (n=566); and CAP2 (Continued Access to PREVAIL registry) (n=578). Surveillance transesophageal echocardiographs were performed at 45 days and 12 months in all patients, and also at 6 months in the randomized control trials. We assessed both the incidence of DRT during these transesophageal echocardiographs (and other unscheduled transesophageal echocardiographs), and clinical outcomes of postprocedure stroke or systemic embolism (SSE) and adjusted for CHA2DS2-VASC and HAS-BLED scores.Of 1739 patients who received an implant (7159 patient-years follow-up; CHA2DS2-VASc=4.0), DRT was seen in 65 patients (3.74%). The rates of SSE with and without DRT were 7.46 and 1.78 per 100 patient-years (adjusted rate ratio, 3.55; 95% confidence interval [CI], 2.18-5.79; P<0.001), and ischemic SSE rates were 6.28 and 1.65 per 100 patient-years (adjusted rate ratio, 3.22; 95% CI, 1.90-5.45, P<0.001). On multivariable modeling analysis, the predictors of DRT were as follows: history of transient ischemic attack or stroke (odds ratio [OR], 2.31; 95% CI, 1.26-4.25; P=0.007), permanent atrial fibrillation (OR, 2.24; 95% CI, 1.19-4.20; P=0.012); vascular disease (OR, 2.06; 95% CI, 1.08-3.91; P=0.028); left atrial appendage diameter (OR, 1.06 per mm increase; 95% CI, 1.01-1.12; P=0.019); left ventricular ejection fraction (OR, 0.96 per 1% increase; 95% CI, 0.94-0.99; P=0.009). DRT and SSE both occurred in 17 of 65 patients (26.2%). Of the 19 SSE events in these patients with DRT, 9 of 19 (47.4%) and 12 of 19 (63.2%) occurred within 1 and 6 months of DRT detection. Conversely, after left atrial appendage closure, most SSEs (123/142, 86.62%) occurred in patients without DRT.RESULTSOf 1739 patients who received an implant (7159 patient-years follow-up; CHA2DS2-VASc=4.0), DRT was seen in 65 patients (3.74%). The rates of SSE with and without DRT were 7.46 and 1.78 per 100 patient-years (adjusted rate ratio, 3.55; 95% confidence interval [CI], 2.18-5.79; P<0.001), and ischemic SSE rates were 6.28 and 1.65 per 100 patient-years (adjusted rate ratio, 3.22; 95% CI, 1.90-5.45, P<0.001). On multivariable modeling analysis, the predictors of DRT were as follows: history of transient ischemic attack or stroke (odds ratio [OR], 2.31; 95% CI, 1.26-4.25; P=0.007), permanent atrial fibrillation (OR, 2.24; 95% CI, 1.19-4.20; P=0.012); vascular disease (OR, 2.06; 95% CI, 1.08-3.91; P=0.028); left atrial appendage diameter (OR, 1.06 per mm increase; 95% CI, 1.01-1.12; P=0.019); left ventricular ejection fraction (OR, 0.96 per 1% increase; 95% CI, 0.94-0.99; P=0.009). DRT and SSE both occurred in 17 of 65 patients (26.2%). Of the 19 SSE events in these patients with DRT, 9 of 19 (47.4%) and 12 of 19 (63.2%) occurred within 1 and 6 months of DRT detection. Conversely, after left atrial appendage closure, most SSEs (123/142, 86.62%) occurred in patients without DRT.After left atrial appendage closure with Watchman, DRT (≈3.7%) is not frequent but, when present, is associated with a higher rate of stroke and systemic embolism.CONCLUSIONSAfter left atrial appendage closure with Watchman, DRT (≈3.7%) is not frequent but, when present, is associated with a higher rate of stroke and systemic embolism. |
Author | Gordon, Nicole T. Kar, Saibal Dukkipati, Srinivas R. Holmes, David R. Gibson, Douglas N. Reddy, Vivek Y. Swarup, Vijendra Main, Michael L. Doshi, Shephal K. Maini, Brijeshwar |
AuthorAffiliation | Icahn School of Medicine at Mount Sinai, New York, NY (S.R.D., V.Y.R.) Cedars Sinai Medical Center, Los Angeles, CA (S.K.) Mayo Clinic, Rochester, MN (D.R.H.) Pacific Heart Institute, Santa Monica, CA (S.K.D.) Arizona Heart Rhythm Center, Phoenix (V.S.) Scripps Clinic, La Jolla, CA (D.N.G.) Delray Medical, Delray Beach, FL (B.M.) Boston Scientific Corporation, St. Paul, MN (N.T.G.) University of Missouri-Kansas City (M.L.M.) |
AuthorAffiliation_xml | – name: Icahn School of Medicine at Mount Sinai, New York, NY (S.R.D., V.Y.R.) Cedars Sinai Medical Center, Los Angeles, CA (S.K.) Mayo Clinic, Rochester, MN (D.R.H.) Pacific Heart Institute, Santa Monica, CA (S.K.D.) Arizona Heart Rhythm Center, Phoenix (V.S.) Scripps Clinic, La Jolla, CA (D.N.G.) Delray Medical, Delray Beach, FL (B.M.) Boston Scientific Corporation, St. Paul, MN (N.T.G.) University of Missouri-Kansas City (M.L.M.) |
Author_xml | – sequence: 1 givenname: Srinivas surname: Dukkipati middlename: R. fullname: Dukkipati, Srinivas R. organization: Icahn School of Medicine at Mount Sinai, New York, NY (S.R.D., V.Y.R.) Cedars Sinai Medical Center, Los Angeles, CA (S.K.) Mayo Clinic, Rochester, MN (D.R.H.) Pacific Heart Institute, Santa Monica, CA (S.K.D.) Arizona Heart Rhythm Center, Phoenix (V.S.) Scripps Clinic, La Jolla, CA (D.N.G.) Delray Medical, Delray Beach, FL (B.M.) Boston Scientific Corporation, St. Paul, MN (N.T.G.) University of Missouri-Kansas City (M.L.M.) – sequence: 2 givenname: Saibal surname: Kar fullname: Kar, Saibal – sequence: 3 givenname: David surname: Holmes middlename: R. fullname: Holmes, David R. – sequence: 4 givenname: Shephal surname: Doshi middlename: K. fullname: Doshi, Shephal K. – sequence: 5 givenname: Vijendra surname: Swarup fullname: Swarup, Vijendra – sequence: 6 givenname: Douglas surname: Gibson middlename: N. fullname: Gibson, Douglas N. – sequence: 7 givenname: Brijeshwar surname: Maini fullname: Maini, Brijeshwar – sequence: 8 givenname: Nicole surname: Gordon middlename: T. fullname: Gordon, Nicole T. – sequence: 9 givenname: Michael surname: Main middlename: L. fullname: Main, Michael L. – sequence: 10 givenname: Vivek surname: Reddy middlename: Y. fullname: Reddy, Vivek Y. |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29752398$$D View this record in MEDLINE/PubMed |
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Cites_doi | 10.1093/eurheartj/ehr488 10.1001/jama.2014.15192 10.1016/j.jacc.2017.10.021 10.1016/j.hrthm.2017.05.038 10.1016/j.jacc.2018.01.076 10.1160/TH11-05-0364 10.1016/j.jacc.2015.04.025 10.1161/CIRCULATIONAHA.110.976449 10.4244/EIJ-D-17-00672 10.1007/s00380-017-0971-x 10.1016/S0140-6736(09)61343-X 10.4244/EIJ-D-17-00042 10.1161/CIRCINTERVENTIONS.117.005997 10.1002/ccd.26903 10.1016/j.amjcard.2016.01.039 10.1016/j.jacep.2017.05.006 10.1016/j.hrthm.2016.10.020 10.1016/j.jacc.2014.04.029 10.1016/j.jcin.2016.11.029 10.1161/CIRCULATIONAHA.112.114389 |
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Keywords | atrial fibrillation percutaneous coronary intervention thrombosis stroke atrial appendage |
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References | e_1_3_3_6_2 e_1_3_3_5_2 e_1_3_3_8_2 e_1_3_3_7_2 e_1_3_3_17_2 e_1_3_3_9_2 e_1_3_3_16_2 e_1_3_3_19_2 e_1_3_3_18_2 e_1_3_3_13_2 e_1_3_3_12_2 e_1_3_3_15_2 e_1_3_3_14_2 e_1_3_3_2_2 e_1_3_3_20_2 e_1_3_3_4_2 e_1_3_3_11_2 e_1_3_3_22_2 e_1_3_3_3_2 e_1_3_3_10_2 e_1_3_3_21_2 30857396 - Circulation. 2019 Feb 26;139(9):1241-1242 30354457 - Circulation. 2018 Aug 28;138(9):886-888 32011833 - Circulation. 2019 Feb 26;139(9):1240 |
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Snippet | BACKGROUND:In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial... In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however,... |
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SubjectTerms | Aged Aged, 80 and over Atrial Appendage - diagnostic imaging Atrial Appendage - physiopathology Atrial Fibrillation - diagnosis Atrial Fibrillation - epidemiology Atrial Fibrillation - physiopathology Atrial Fibrillation - therapy Atrial Function, Left Cardiac Catheterization - adverse effects Cardiac Catheterization - instrumentation Echocardiography, Transesophageal Female Humans Incidence Intracranial Embolism - diagnostic imaging Intracranial Embolism - epidemiology Male Prosthesis Design Randomized Controlled Trials as Topic Registries Retrospective Studies Risk Assessment Risk Factors Stroke - diagnostic imaging Stroke - epidemiology Thrombosis - diagnostic imaging Thrombosis - epidemiology Time Factors Treatment Outcome |
Title | Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes |
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