title: The clinical impact of incomplete left atrial appendage closure with the Watchman Device in patients with atrial fibrillation: a PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) substudy.
abstract: OBJECTIVE
  The purpose of this study was to investigate the frequency and clinical impact of incomplete left atrial appendage (LAA) sealing and consequent peri-device residual blood flow in patients undergoing percutaneous LAA closure with the Watchman device (Atritech, Inc., Plymouth, Minnesota).
  
  
  BACKGROUND
  During percutaneous LAA closure for stroke prophylaxis, the geometric variability of the LAA ostium may result in an incomplete seal of the LAA. On the one hand, this could enhance thrombus formation and embolization of thrombi around the device into the circulation; on the other hand, the relatively small size of these leaks may preclude clinically relevant embolizations.
  
  
  METHODS
  Patients randomly assigned to device implantation in the PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial were analyzed. Transesophageal echocardiography was performed at 45 days, 6 months, and 12 months. Per the study protocol, patients discontinued warfarin therapy if the 45-day Transesophageal echocardiogram revealed either minimal or no peri-device flow (jet ≤5 mm width). The impact of peri-device flow severity, defined as minor, moderate, or major (<1 mm, 1 mm to 3 mm, >3 mm, respectively) on the composite primary efficacy endpoint (stroke, systemic embolism, and cardiovascular death) is expressed as hazard ratio (HR) with 95% confidence interval (CI).
  
  
  RESULTS
  Transesophageal echocardiography follow-up revealed that 32.0% of implanted patients had at least some degree of peri-device flow at 12 months. The HR of the primary efficacy endpoint per 1 mm larger per-device flow was 0.84 (95% CI: 0.62 to 1.14; p = 0.256). Compared to patients with no peri-device flow, the HRs were 0.85 (95% CI: 0.11 to 6.40), 0.83 (95% CI: 0.33 to 2.09), and 0.48 (95% CI: 0.11 to 2.09) for minor, moderate, and major peri-device flow, respectively (p = 0.798). Compared to patients with no peri-device flow who discontinued warfarin, the HR for patients with any peri-device flow and continuing warfarin was 0.63 (95% CI: 0.14 to 2.71; p = 0.530).
  
  
  CONCLUSIONS
  These data indicate that residual peri-device flow into the LAA after percutaneous closure with the Watchman device was common, and is not associated with an increased risk of thromboembolism. This finding should be interpreted with caution as the low event rate decreases the confidence of this conclusion.
authors.affiliation: Mount Sinai School of Medicine, New York City, New York, USA.
authors.forename: Juan F
authors.initials: JF
authors.lastname: Viles-Gonzalez
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.forename: Pamela
authors.initials: P
authors.lastname: Douglas
authors.forename: Srinivas
authors.initials: S
authors.lastname: Dukkipati
authors.forename: Ted
authors.initials: T
authors.lastname: Feldman
authors.forename: Rodney
authors.initials: R
authors.lastname: Horton
authors.forename: David
authors.initials: D
authors.lastname: Holmes
authors.forename: Vivek Y
authors.initials: VY
authors.lastname: Reddy
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage / Q000627:therapeutic use; D020517:Atrial Appendage / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D001281:Atrial Fibrillation / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000379:methods*; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D004562:Electrocardiography; D004617:Embolism / Q000150:complications / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D011446:Prospective Studies; D019736:Prostheses and Implants; D011474:Prosthesis Design; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014859:Warfarin / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D014859:Warfarin