title: Initial Experience With Novel Oral Anticoagulants During the First 45 Days After Left Atrial Appendage Closure With the Watchman Device.
abstract: BACKGROUND
  The use of oral anticoagulation or dual antiplatelet therapy (DAPT) is recommended within the first 45 days after left atrial appendage (LAA) closure using the Watchman device because of incomplete device endothelialization. This study reports for the first time the feasibility of novel oral anticoagulants (NOAC) in these patients.
  
  
  OBJECTIVE
  NOAC therapy is safe and effective after LAA closure.
  
  
  METHODS
  Interventional LAA closure was performed successfully in 45 patients. Of these, 18 patients received NOAC during the first 45 days after implantation and 27 patients received DAPT. Transesophageal echocardiography was conducted 45 days after implantation. The primary study endpoint was abnormal thrombus apposition 45 days after implantation. Secondary study endpoints were death from any cause, major adverse cardiac and cerebrovascular events (MACCE), and major bleedings.
  
  
  RESULTS
  After 45 days, transesophageal echocardiography revealed no abnormal thrombus apposition. During a follow-up of 417 ± 323 days, 7 patients died. No stroke or transient ischemic attack occurred. Nonfatal myocardial infarction occurred in 1 patient. There was a nonsignificant trend for lower all-cause mortality (P = 0.159) and occurrence of MACCE (P = 0.096) in the NOAC group compared with the DAPT group. Overall, 6 patients suffered from a major bleeding (NOAC, n = 3; DAPT, n = 3). In NOAC group, major bleedings (at day 205, 688, and 736) occurred long after termination of NOAC therapy. There was no significant difference in the frequency of major bleedings in different groups.
  
  
  CONCLUSIONS
  Our pilot study suggests that NOAC therapy within the first 45 days after interventional LAA closure is safe and effective.
authors.affiliation: Department of Cardiology and Angiology, Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.
authors.forename: Leif I
authors.initials: LI
authors.lastname: Bösche
authors.affiliation: Department of Cardiology and Angiology, Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.
authors.forename: Faegheh
authors.initials: F
authors.lastname: Afshari
authors.affiliation: Department of Cardiology and Angiology, Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.
authors.forename: Dominik
authors.initials: D
authors.lastname: Schöne
authors.affiliation: Department of Cardiology and Angiology, Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.
authors.forename: Aydan
authors.initials: A
authors.lastname: Ewers
authors.affiliation: Department of Cardiology and Angiology, Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Mügge
authors.affiliation: Department of Cardiology and Angiology, Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Gotzmann
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D020517:Atrial Appendage / Q000187:drug effects* / Q000601:surgery; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000379:methods; D000069604:Dabigatran / Q000009:adverse effects / Q000627:therapeutic use; D017548:Echocardiography, Transesophageal; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012189:Retrospective Studies; D000069552:Rivaroxaban / Q000009:adverse effects / Q000627:therapeutic use; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D015996:Survival Rate; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000069552:Rivaroxaban; D000069604:Dabigatran