title: Incidence and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure With the Amplatzer Cardiac Plug.
abstract: Routine device surveillance after successful left atrial appendage closure is recommended to evaluate for intermediate to late complications. The aim of this study was to assess the incidence and clinical impact of these complications on cardiovascular events.
  
  
  
  Centers participating in the Amplatzer Cardiac Plug multicenter study were requested to submit their post-procedural transesophageal echocardiograms for independent adjudication. Thirteen of 22 centers contributed all their post-procedural echocardiograms, which included 344 from 605 consecutive patients. These images were submitted to a core laboratory and reviewed by 2 independent experts for peri-device leak, device-associated thrombus, device embolization, device migration, left atrial appendage thrombus, and left atrial thrombus. Clinical events were prospectively collected by each center.
  
  
  
  Of the 344 transesophageal echocardiograms, 339 were deemed analyzable. Patients' mean age was 74.4 ± 7.5 years, and 67.3% were men. The mean CHADS2score was 2.7 ± 1.3, the mean CHA2DS2-VASc score was 4.3 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.2. Amplatzer Cardiac Plug implantation was successful in all patients. Periprocedural major adverse events occurred in 2.4%. Median clinical follow-up duration was 355 days (range 179 to 622 days). Follow-up transesophageal echocardiography was performed after a median of 134 days (range 88 to 227 days). Device-associated thrombus was observed in 3.2% and peri-device leak in 12.5% (5.5% minimal, 5.8% mild, 0.6% moderate, 0.6% severe). Neither device-associated thrombus nor peri-device leak was associated with an increased risk for cardiovascular events. Independent predictors of device-associated thrombus were smoking (odds ratio: 5.79; p = 0.017) and female sex (odds ratio: 4.22; p = 0.027).
  
  
  
  Following successful left atrial appendage closure with the Amplatzer Cardiac Plug, the presence of peri-device leak was relatively low, and device-associated thrombus was infrequent. Neither was associated with increased risk for thromboembolism.
authors.affiliation: Vancouver General Hospital, Vancouver, British Columbia, Canada. Electronic address: jsaw@mail.ubc.ca.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Saw
authors.affiliation: AHEPA University Hospital, Thessaloniki, Greece; Interbalkan European Medical Center, Thessaloniki, Greece.
authors.forename: Apostolos
authors.initials: A
authors.lastname: Tzikas
authors.affiliation: University Hospital of Bern, Bern, Switzerland.
authors.forename: Samera
authors.initials: S
authors.lastname: Shakir
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Sameer
authors.initials: S
authors.lastname: Gafoor
authors.affiliation: University Hospital of Bonn, Bonn, Germany.
authors.forename: Heyder
authors.initials: H
authors.lastname: Omran
authors.affiliation: Aarhus University Hospital, Skejby, Denmark.
authors.forename: Jens Erik
authors.initials: JE
authors.lastname: Nielsen-Kudsk
authors.affiliation: St-Luc University Hospital, Brussels, Belgium.
authors.forename: Joelle
authors.initials: J
authors.lastname: Kefer
authors.affiliation: Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.
authors.forename: Adel
authors.initials: A
authors.lastname: Aminian
authors.affiliation: Fondazione Toscana Gabriele Monasterio, Massa, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Berti
authors.affiliation: Ospedale Careggi di Firenze, Florence, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Santoro
authors.affiliation: University Hospital of Zurich, Zurich, Switzerland.
authors.forename: Fabian
authors.initials: F
authors.lastname: Nietlispach
authors.affiliation: University Hospital of Bern, Bern, Switzerland.
authors.forename: Aris
authors.initials: A
authors.lastname: Moschovitis
authors.affiliation: University Hospital of Salamanca, Salamanca, Spain.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Cruz-Gonzalez
authors.affiliation: AZ Delta Hospital, Roeselare, Belgium.
authors.forename: Francis
authors.initials: F
authors.lastname: Stammen
authors.affiliation: Universitätsmedizin Göttingen, Göttingen, Germany.
authors.forename: Tobias
authors.initials: T
authors.lastname: Tichelbäcker
authors.affiliation: Hospital Clinic of University of Barcelona, Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Freixa
authors.affiliation: Montreal Heart Institute, Montreal, Quebec, Canada.
authors.forename: Reda
authors.initials: R
authors.lastname: Ibrahim
authors.affiliation: Universitätsmedizin Göttingen, Göttingen, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schillinger
authors.affiliation: University Hospital of Bern, Bern, Switzerland.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: University Hospital of Bern, Bern, Switzerland.
authors.forename: Steffen
authors.initials: S
authors.lastname: Gloekler
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020517:Atrial Appendage / Q000503:physiopathology; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D002170:Canada; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D016009:Chi-Square Distribution; D016208:Databases, Factual; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D004868:Equipment Failure; D005060:Europe; D005260:Female; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013927:Thrombosis / Q000000981:diagnostic imaging / Q000453:epidemiology*; D013997:Time Factors; D016896:Treatment Outcome
keywords: Amplatzer Cardiac Plug (ACP); device-associated thrombus; left atrial appendage (LAA); peri-device leak