Device-related thrombus after left atrial appendage closure: Incidence, predictors, and outcomes

Srinivas R. Dukkipati, Saibal Kar, David Holmes, Shephal K. Doshi, Vijendra Swarup, Douglas N. Gibson, Brijeshwar Maini, Nicole T. Gordon, Michael L. Main, Vivek Y. Reddy

Research output: Contribution to journalArticle

53 Citations (Scopus)

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 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. 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 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. 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.

Original languageEnglish (US)
Pages (from-to)874-885
Number of pages12
JournalCirculation
Volume138
Issue number9
DOIs
StatePublished - Jan 1 2018

Fingerprint

Atrial Appendage
Thrombosis
Equipment and Supplies
Incidence
Embolism
Confidence Intervals
Odds Ratio
Atrial Fibrillation
Stroke
Registries
Thromboembolism
Transient Ischemic Attack
Warfarin
United States Food and Drug Administration
Vascular Diseases
Stroke Volume

Keywords

  • Atrial appendage
  • Atrial fibrillation
  • Percutaneous coronary intervention
  • Stroke
  • Thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Dukkipati, S. R., Kar, S., Holmes, D., Doshi, S. K., Swarup, V., Gibson, D. N., ... Reddy, V. Y. (2018). Device-related thrombus after left atrial appendage closure: Incidence, predictors, and outcomes. Circulation, 138(9), 874-885. https://doi.org/10.1161/CIRCULATIONAHA.118.035090

Device-related thrombus after left atrial appendage closure : Incidence, predictors, and outcomes. / Dukkipati, Srinivas R.; Kar, Saibal; Holmes, David; Doshi, Shephal K.; Swarup, Vijendra; Gibson, Douglas N.; Maini, Brijeshwar; Gordon, Nicole T.; Main, Michael L.; Reddy, Vivek Y.

In: Circulation, Vol. 138, No. 9, 01.01.2018, p. 874-885.

Research output: Contribution to journalArticle

Dukkipati, SR, Kar, S, Holmes, D, Doshi, SK, Swarup, V, Gibson, DN, Maini, B, Gordon, NT, Main, ML & Reddy, VY 2018, 'Device-related thrombus after left atrial appendage closure: Incidence, predictors, and outcomes', Circulation, vol. 138, no. 9, pp. 874-885. https://doi.org/10.1161/CIRCULATIONAHA.118.035090
Dukkipati, Srinivas R. ; Kar, Saibal ; Holmes, David ; Doshi, Shephal K. ; Swarup, Vijendra ; Gibson, Douglas N. ; Maini, Brijeshwar ; Gordon, Nicole T. ; Main, Michael L. ; Reddy, Vivek Y. / Device-related thrombus after left atrial appendage closure : Incidence, predictors, and outcomes. In: Circulation. 2018 ; Vol. 138, No. 9. pp. 874-885.
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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 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. 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 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. 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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TY - JOUR

T1 - Device-related thrombus after left atrial appendage closure

T2 - Incidence, predictors, and outcomes

AU - Dukkipati, Srinivas R.

AU - Kar, Saibal

AU - Holmes, David

AU - Doshi, Shephal K.

AU - Swarup, Vijendra

AU - Gibson, Douglas N.

AU - Maini, Brijeshwar

AU - Gordon, Nicole T.

AU - Main, Michael L.

AU - Reddy, Vivek Y.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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 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. 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 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. 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.

AB - 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 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. 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 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. 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.

KW - Atrial appendage

KW - Atrial fibrillation

KW - Percutaneous coronary intervention

KW - Stroke

KW - Thrombosis

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