title: Clinical Bioprosthetic Heart Valve Thrombosis After Transcatheter Aortic Valve Replacement: Incidence, Characteristics, and Treatment Outcomes.
abstract: The aim of this study was to determine the incidence, characteristics, and treatment outcomes of patients diagnosed with clinical transcatheter heart valve thrombosis.
  
  
  
  Limited data exists on clinical or manifest transcatheter heart valve thrombosis. Prior studies have focused on subclinical thrombosis.
  
  
  
  A retrospective analysis was conducted of prospectively collected data from a single-center registry that included 642 consecutive patients who underwent transcatheter aortic valve replacement between 2007 and 2015 (305 patients had self-expanding valves; balloon-expandable, n = 281; mechanically expanding, n = 56). Long-term oral anticoagulation (OAC) was indicated in 261 patients, while 377 patients received dual-antiplatelet therapy post-procedure. All patients underwent scheduled clinical and echocardiographic follow-up.
  
  
  
  The overall incidence of clinical valve thrombosis was 2.8% (n = 18). No patient on OAC developed thrombosis. Of the detected thrombosis cases, 13 patients had balloon-expandable, 3 had self-expanding, and 2 had mechanically expanding valves. Thrombosis occurred significantly more often with balloon-expandable valves (odds ratio: 3.45; 95% confidence interval: 1.22 to 9.81; p = 0.01) and following valve-in-valve procedures (odds ratio: 5.93; 95% confidence interval: 2.01 to 17.51; p = 0.005). Median time to diagnosis of valve thrombosis was 181 days. The median N-terminal pro-brain natriuretic peptide level was 1,318 pg/ml (interquartile range: 606 to 1,676 pg/ml). The mean transvalvular gradient and valve area were 34 ± 14 mm Hg and 1.0 ± 0.46 cm2, respectively. Computed tomography showed hypoattenuating areas with reduced leaflet motion. Initiation of OAC resulted in significant reduction of transvalvular gradient and clinical improvement. No deaths were related to valve thrombosis.
  
  
  
  Clinical transcatheter heart valve thrombosis is more common than previously considered, characterized by imaging abnormalities and increased gradients and N-terminal pro-brain natriuretic peptide levels. It occurred more commonly after balloon-expandable transcatheter aortic valve replacement and valve-in-valve procedures. OAC appeared to be effective in the prevention and treatment of valve thrombosis. Randomized control trials are needed to define optimal antithrombotic therapy after transcatheter aortic valve replacement.
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany; Christian Medical College Hospital, Vellore, Tamil Nadu, India.
authors.forename: John
authors.initials: J
authors.lastname: Jose
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Dmitriy S
authors.initials: DS
authors.lastname: Sulimov
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Mohamed
authors.initials: M
authors.lastname: El-Mawardy
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany; Tachikawa General Hospital, Nagaoka, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Sato
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Abdelhakim
authors.initials: A
authors.lastname: Allali
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Erik W
authors.initials: EW
authors.lastname: Holy
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Björn
authors.initials: B
authors.lastname: Becker
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Landt
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Kebernik
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Bettina
authors.initials: B
authors.lastname: Schwarz
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany.
authors.forename: Gert
authors.initials: G
authors.lastname: Richardt
authors.affiliation: Heart Center, Segeberger Kliniken (Academic Teaching Hospital of the Universities of Kiel, Lübeck, and Hamburg), Bad Segeberg, Germany. Electronic address: mohamed.abdel-wahab@segebergerkliniken.de.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Wahab
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D063126:Balloon Valvuloplasty; D015415:Biomarkers / Q000097:blood; D001705:Bioprosthesis; D000072226:Computed Tomography Angiography; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D017548:Echocardiography, Transesophageal; D005260:Female; D005858:Germany / Q000453:epidemiology; D006349:Heart Valve Diseases / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000453:epidemiology*; D006350:Heart Valve Prosthesis; D006801:Humans; D015994:Incidence; D008297:Male; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010446:Peptide Fragments / Q000097:blood; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011474:Prosthesis Design; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D013927:Thrombosis / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000453:epidemiology*; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000295:instrumentation*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D015415:Biomarkers; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain
keywords: aortic stenosis; balloon-expandable; clinical thrombosis; oral anticoagulation; self-expanding; transcatheter aortic valve replacement; transcatheter heart valve thrombosis