title: Initial Experience With High-Risk Patients Excluded From Clinical Trials: Safety of Short-Term Anticoagulation After Left Atrial Appendage Closure Device.
abstract: The implantation of left atrial appendage closure device (WATCHMAN, Boston Scientific, Natick, MA) is an alternative option to oral anticoagulation (OAC) for stroke prevention in atrial fibrillation. Patients require short-term OAC after implantation to avoid device thrombosis. The 2 clinical trials that assessed this device excluded patients thought not to be candidates for OAC. As such, little is known about the safety of this strategy in patients with previous major bleeding events.
  
  
  
  All 20 consecutive patients with history of spontaneous major bleeding while on OAC who had subsequently undergone WATCHMAN device implantation at our institution were included. A newly conceived multidisciplinary Atrial Fibrillation Stroke Prevention Center evaluated patients for candidacy for device implantation and subsequent antithrombotic therapy. The primary outcome was spontaneous major bleeding while receiving short-term postprocedural OAC. Median CHA2DS2-VASc and HAS-BLED scores were 5 (quartiles 5-6) and 5 (quartiles 4-5), respectively. Previous major bleeding events were major gastrointestinal bleeding, intracranial bleeding, spontaneous hemopericardium with cardiac tamponade, and hemarthrosis in 11, 7, 1, and 1 patients, respectively. None of the patients had spontaneous major bleeding during the course of OAC after device implantation. In 1 patient, OAC was discontinued after 40 days because of mechanical fall with head trauma resulting in subdural hematoma with no associated neurological deficits; this was managed conservatively.
  
  
  
  With careful multidisciplinary evaluation, a short course of OAC after WATCHMAN device implantation in patients with previous spontaneous major bleeding events is associated with low risk of recurrent spontaneous major bleeding.
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Amr F
authors.initials: AF
authors.lastname: Barakat
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Ayman A
authors.initials: AA
authors.lastname: Hussein
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Walid I
authors.initials: WI
authors.lastname: Saliba
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Bassiouny
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Khaldoun
authors.initials: K
authors.lastname: Tarakji
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Kanj
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Wael
authors.initials: W
authors.lastname: Jaber
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: L Leonardo
authors.initials: LL
authors.lastname: Rodriguez
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Richard
authors.initials: R
authors.lastname: Grimm
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: M Shazam
authors.initials: MS
authors.lastname: Hussain
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Andrew
authors.initials: A
authors.lastname: Russman
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Ken
authors.initials: K
authors.lastname: Uchino
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Dolora
authors.initials: D
authors.lastname: Wisco
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Peter
authors.initials: P
authors.lastname: Rasmussen
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Mark
authors.initials: M
authors.lastname: Bain
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: John
authors.initials: J
authors.lastname: Vargo
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Gregory
authors.initials: G
authors.lastname: Zuccaro
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: David
authors.initials: D
authors.lastname: Gottesman
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH.
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Lindsay
authors.affiliation: From the Department of Medicine (A.F.B.), Heart and Vascular Institute (A.A.H., W.I.S., M.B., K.T., M.K., W.J., L.L.R., R.G., B.D.L., O.M.W.), Cerebrovascular Center (M.S.H., A.R., K.U., D.W., P.R., M.B.), and Digestive Disease Institute (J.V., G.Z., D.G.), Cleveland Clinic Foundation, Cleveland, OH. waznio@ccf.org.
authors.forename: Oussama M
authors.initials: OM
authors.lastname: Wazni
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000000981:diagnostic imaging / Q000601:surgery*; D017548:Echocardiography, Transesophageal; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D055989:Septal Occluder Device; D020521:Stroke / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants
keywords: anticoagulants; atrial appendage; atrial fibrillation; standard of care; stroke; thromboembolism