Systematic CT Methodology for the Evaluation of Subclinical Leaflet Thrombosis. [Review]
Systematic CT Methodology for the Evaluation of Subclinical Leaflet Thrombosis. [Review]
- 2017
Copyright � 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. 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.
English
1876-7591
*Aortic Valve/dg [Diagnostic Imaging]
*Aortic Valve/su [Surgery]
*Heart Valve Prosthesis Implantation/ae [Adverse Effects]
*Thrombosis/dg [Diagnostic Imaging]
*Tomography, X-Ray Computed
Aortic Valve/pp [Physiopathology]
Asymptomatic Diseases
Bioprosthesis
Echocardiography, Transesophageal
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation/is [Instrumentation]
Humans
Predictive Value of Tests
Risk Factors
Severity of Illness Index
Thrombosis/et [Etiology]
Thrombosis/th [Therapy]
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
Transcatheter Aortic Valve Replacement/is [Instrumentation]
Treatment Outcome
MedStar Heart & Vascular Institute
Journal Article
Review
Copyright � 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. 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.
English
1876-7591
*Aortic Valve/dg [Diagnostic Imaging]
*Aortic Valve/su [Surgery]
*Heart Valve Prosthesis Implantation/ae [Adverse Effects]
*Thrombosis/dg [Diagnostic Imaging]
*Tomography, X-Ray Computed
Aortic Valve/pp [Physiopathology]
Asymptomatic Diseases
Bioprosthesis
Echocardiography, Transesophageal
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation/is [Instrumentation]
Humans
Predictive Value of Tests
Risk Factors
Severity of Illness Index
Thrombosis/et [Etiology]
Thrombosis/th [Therapy]
Transcatheter Aortic Valve Replacement/ae [Adverse Effects]
Transcatheter Aortic Valve Replacement/is [Instrumentation]
Treatment Outcome
MedStar Heart & Vascular Institute
Journal Article
Review