title: Systematic CT Methodology for the Evaluation of Subclinical Leaflet Thrombosis.
abstract: Subclinical leaflet thrombosis was recently described in a randomized trial of transcatheter aortic valve replacement. It was subsequently demonstrated in a series of registries that this was a commonly observed imaging finding seen in all transcatheter and surgical bioprostheses. The phenomenon has aroused considerable interest due to the as-yet-undefined risk for later clinical events and the possibility of pharmacological intervention with anticoagulation. Subclinical leaflet thrombosis is easily detected noninvasively by technically suitable computed tomography (CT) with a high degree of concordance to transesophageal echocardiography findings. The CT hallmarks were noted to be hypoattenuated leaflet thickening (HALT) associated with reduced leaflet motion (RELM). The combination of HALT and RELM signified hypoattenuation affecting motion, the standardized imaging endpoint used. This paper describes the systematic CT evaluation methodology that was devised during the Portico trial investigation and U.S. Food and Drug Administration submission; it also highlights the need for an ongoing discussion among experts to enable, with the help of the Valve Academic Research Consortium, standardization of reporting of this imaging finding to cater to the present and future needs of clinical trials.
authors.affiliation: Heart Valve Center, New York University Langone Medical Center, New York, New York. Electronic address: hasanjilaihawi@gmail.com.
authors.forename: Hasan
authors.initials: H
authors.lastname: Jilaihawi
authors.affiliation: MedStar Cardiovascular Research Network at Washington Hospital Center, Washington DC.
authors.forename: Federico M
authors.initials: FM
authors.lastname: Asch
authors.affiliation: St. Jude Medical, Minnepolis, Minnesota.
authors.forename: Eric
authors.initials: E
authors.lastname: Manasse
authors.affiliation: Hackensack University Medical Center, Hackensack, New Jersey.
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Ruiz
authors.affiliation: Hackensack University Medical Center, Hackensack, New Jersey.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Jelnin
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Kashif
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kawamori
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Maeno
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Kazuno
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Takahashi
authors.affiliation: St. Jude Medical, Minnepolis, Minnesota.
authors.forename: Richard
authors.initials: R
authors.lastname: Olson
authors.affiliation: St. Jude Medical, Minnepolis, Minnesota.
authors.forename: Joe
authors.initials: J
authors.lastname: Alkhatib
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Daniel
authors.initials: D
authors.lastname: Berman
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: John
authors.initials: J
authors.lastname: Friedman
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Norman
authors.initials: N
authors.lastname: Gellada
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Tarun
authors.initials: T
authors.lastname: Chakravarty
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
mesh_terms: D001021:Aortic Valve / Q000000981:diagnostic imaging* / Q000503:physiopathology / Q000601:surgery*; D058070:Asymptomatic Diseases; D001705:Bioprosthesis; D017548:Echocardiography, Transesophageal; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation; D006801:Humans; D011237:Predictive Value of Tests; D012307:Risk Factors; D012720:Severity of Illness Index; D013927:Thrombosis / Q000000981:diagnostic imaging* / Q000209:etiology / Q000628:therapy; D014057:Tomography, X-Ray Computed; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation; D016896:Treatment Outcome
keywords: TAVI; TAVR; aortic stenosis; aortic valve replacement; leaflet thrombosis; transcatheter aortic valve implantation; transcatheter aortic valve replacement