title: Assessment of Device-Related Thrombus and Associated Clinical Outcomes With the WATCHMAN Left Atrial Appendage Closure Device for Embolic Protection in Patients With Atrial Fibrillation (from the PROTECT-AF Trial).
abstract: Left atrial appendage closure with the WATCHMAN device is an alternative to anticoagulation for stroke prevention in selected patients with atrial fibrillation (AF). LA device-related thrombus (DRT) is poorly defined and understood. We aimed to (1) develop consensus echocardiographic diagnostic criteria for DRT; (2) estimate the incidence of DRT; and (3) determine clinical event rates in patients with DRT. In phase 1 (training), a training manual was developed and reviewed by 3 echocardiographers with left atrial appendage closure device experience. All available transesophageal (TEE) studies in the WATCHMAN left atrial appendage system for embolic protection in patients with atrial fibrillation (PROTECT-AF) trial patients with suspected DRT were reviewed in 2 subsequent phases. In phase 2 (primary blind read), each reviewer independently scored each study for DRT, and final echo criteria were developed. Unanimously scored studies were considered adjudicated, whereas all others were reevaluated by all reviewers in phase 3 (group adjudication read). DRT was suspected in 35 of 485 patients by the site investigator, the echocardiography core laboratory, or both; 93 of the individual TEE studies were available for review. In phase 2, 3 readers agreed on 67 (72%) of time points. Based on phases 1 and 2, 5 DRT criteria were developed. In phase 3, studies without agreement in phase 2 were adjudicated using these criteria. Overall, at least 1 TEE was DRT positive in 27 (5.7%) PROTECT-AF patients. Stroke, peripheral embolism, or cardiac/unexplained death occurred in subjects with DRT at a rate of 3.4 per 100 patient-years follow-up. In conclusion, DRT were identified on at least 1 TEE in 27 PROTECT-AF patients, indicating a DRT incidence of 5.7%. Primary efficacy events in patients with DRT occurred at a rate of 3.4 per 100 patient-years follow-up, intermediate in frequency between event rates previously reported for the overall device and warfarin arms in PROTECT-AF.
authors.affiliation: Saint Luke's Mid America Heart Institute, Kansas City, Missouri. Electronic address: mmain@saint-lukes.org.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Main
authors.affiliation: University of California Davis Medical Center, Sacramento, California.
authors.forename: Dali
authors.initials: D
authors.lastname: Fan
authors.affiliation: Mount Sinai School of Medicine, New York, New York.
authors.forename: Vivek Y
authors.initials: VY
authors.lastname: Reddy
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
authors.affiliation: Boston Scientific Corporation, St. Paul, Minnesota.
authors.forename: Nicole T
authors.initials: NT
authors.lastname: Gordon
authors.affiliation: Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
authors.forename: Tina R
authors.initials: TR
authors.lastname: Coggins
authors.affiliation: Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
authors.forename: John A
authors.initials: JA
authors.lastname: House
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Liao
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Dawn
authors.initials: D
authors.lastname: Rabineau
authors.affiliation: Boston Scientific Corporation, St. Paul, Minnesota.
authors.forename: George G
authors.initials: GG
authors.lastname: Latus
authors.affiliation: Saint Luke's Mid America Heart Institute, Kansas City, Missouri.
authors.forename: Kenneth C
authors.initials: KC
authors.lastname: Huber
authors.affiliation: Cardiovascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: Pacific Heart Institute and Providence, St. John's Health Center, Santa Monica, California.
authors.forename: Richard F
authors.initials: RF
authors.lastname: Wright
authors.affiliation: Pacific Heart Institute and Providence, St. John's Health Center, Santa Monica, California.
authors.forename: Shephal K
authors.initials: SK
authors.lastname: Doshi
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D020517:Atrial Appendage / Q000601:surgery*; D001281:Atrial Fibrillation / Q000150:complications / Q000601:surgery*; D003328:Coronary Thrombosis / Q000175:diagnosis* / Q000453:epidemiology*; D057505:Embolic Protection Devices / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome; D014859:Warfarin / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D014859:Warfarin