Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes

• Published in: Circulation (New York, N.Y.) N.Y.), 2018-08, Vol.138 (9), p.874-885
• Main Authors: Dukkipati, Srinivas R, Kar, Saibal, Holmes, David R, Doshi, Shephal K, Swarup, Vijendra, Gibson, Douglas N, Maini, Brijeshwar, Gordon, Nicole T, Main, Michael L, Reddy, Vivek Y
• Format: Article
• Language: English
• Subjects: 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
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/CIRCULATIONAHA.118.035090

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