Characterization of RadiOlabeled Tracer Uptake Pattern in Noninfected Transcatheter Aortic Valves. (COUNT)

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Status

Active, not recruiting

Conditions

Infective Endocarditis

Treatments

Radiation: 18F-FDG PET/CT

Study type

Observational

Funder types

Other

Identifiers

NCT03683355

COUNT

Details and patient eligibility

About

Therefore, the objective of the study is to characterize the pattern of radiolabeled tracer (18F-FDG) uptake in noninfected transcatheter heart valves in early follow-up after transcatheter aortic valve replacement (TAVR).

Full description

Diagnostic accuracy of Infective endocarditis (IE) is commonly challenging. Current clinical guidelines recommend the use of the modified Duke criteria, based on clinical, echocardiographic and biological findings, as well as the results of blood cultures and serologies. Advances in imaging techniques have resulted in an improvement in the identification of endocardial involvements and extracardiac complications of IE. Thus, recent works have demonstrated that 18F-FDG PET/CT and radiolabeled leucocyte SPECT/CT may improve the detection of silent endocardial lesions. The sites of radiotracer accumulation show regions of a high metabolic activity due to an inflammation or infection process. It is well known that, in surgical prosthetic valves, a mild radiotracer uptake in the perivalvular area may occur in the absence of infection and could therefore be considered as a normal pattern, particularly early after valve replacement. However, evidence of this phenomenon is lacking regarding transcatheter heart valves and the factors used to distinguish between normal and abnormal patterns of radiolabeled tracer are not standardized. The hypothesis is that patients undergoing transcatheter aortic valve replacement (TAVR) show a radiolabeled tracer (18F-FDG) uptake around the prosthesis despite the absence of IE. Moreover, the uptake pattern might vary between different platforms.

Therefore, the objective of the study is to characterize the pattern of radiolabeled tracer uptake in noninfected transcatheter heart valves in early follow-up after TAVR.

This will be a pilot study including 30 patients after TAVR procedure.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients >18-year-old undergoing TAVR procedure with Edwards Sapien 3 and Core Valve Evolut R devices.
Informed written consent

Exclusion criteria

Inability to provide signed informed consent.
Patients with definitive or possible IE according to modified Duke criteria and current clinical guidelines for the management of IE.
Any contraindication for 18F-FDG PET/CT.
Any condition making it unlikely the patient will be able to complete the protocol procedures and follow-up visits.