Prosthetic Heart Valve (PHV) endocarditis is complicated by peri-annular extension (abscesses/mycotic aneurysms) in up to 50% of patients and has an in-hospital mortality of approximately 30%. However, with current standard imaging tools such as…
ID
Bron
Verkorte titel
Aandoening
PET-CT, CTA, prosthetic heart valve, endocarditis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Qualification Visual Score for Hypermetabolism (QVSH)<br>
- Standardized Uptake Value (SUV) ratio (quantitative measurement)
Achtergrond van het onderzoek
Rationale:
Prosthetic Heart Valve (PHV) endocarditis is complicated by peri-annular extension (abscesses/mycotic aneurysms) in up to 50% of patients and has an in-hospital mortality of approximately 30%. However, with current standard imaging tools such as Echocardiography and Computed Tomography Angiography (CTA), it remains difficult to detect peri-annular extension, which is an indication for urgent surgery in order to reduce mortality. Furthermore, if peri-annular abnormalities are found with imaging, differentiation between active and non-active inflammatory tissue is impossible, because of the lack of metabolic information. Hybrid imaging with combined anatomical information by CTA and metabolic information by FDG-PET may provide this additional information. However, normal baseline FDG uptake at different time points after aortic PHV implantation is unknown and obligatory for correct interpretation of CTA/PET scans in PHV patients.
Objective: To determine normal FDG-uptake around PHV’s in aortic position.
Study design: Prospective multi-centre cross-sectional study
Methods: 18-Fluorine FDG-PET is performed to assess uptake around the PHV after fusion with the CTA. FDG uptake is scored by: 1. Qualification Visual Score for Hypermetabolism (QVSH) which can be: none, mild, moderate or severe. 2. Standardized Uptake Value (SUV) ratio’s, defined as the maximum SUV value around the PHV divided by the mean SUV value in the mediastinum.
Study population: The total group consists of patients (≥ 50 years) after uncomplicated PHV implantation in aortic position (n=75). The FDG-PET/CTA imaging is performed in the early and late and chronic postoperative episode (group 1, 2 and 3 respectively):
• Early postoperative (group 1, n=25): 5 (± 1) weeks after PHV implantation .
• Late postoperative (group 2, n=25): 12 (± 2) weeks after PHV implantation .
• Chronic postoperative (group 3, n=25): 12 (± 2) months after PHV implantation.
We will only include patients in group 3 in case FDG uptake around the PHV in group 2 results in moderate or severe FDG uptake according to the QVSH score in 1 or more patients.
Of note: patients cannot be included in two groups.
Main study parameters: 18F-FDG/PET baseline uptake measured by the QVSH value and the SUV ratio’s around the PHV in early, late and possibly also in the chronic postoperative phase: 5 (± 1) weeks, 12 (± 2) weeks and 12 (± 2) months respectively.
Doel van het onderzoek
Prosthetic Heart Valve (PHV) endocarditis is complicated by peri-annular extension (abscesses/mycotic aneurysms) in up to 50% of patients and has an in-hospital mortality of approximately 30%. However, with current standard imaging tools such as Echocardiography and Computed Tomography Angiography (CTA), it remains difficult to detect peri-annular extension, which is an indication for urgent surgery in order to reduce mortality. Furthermore, if peri-annular abnormalities are found with imaging, differentiation between active and non-active inflammatory tissue is impossible, because of the lack of metabolic information. Hybrid imaging with combined anatomical information by CTA and metabolic information by FDG-PET may provide this additional information. However, normal baseline FDG uptake at different time points after aortic PHV implantation is unknown and obligatory for correct interpretation of CTA/PET scans in PHV patients.
Onderzoeksopzet
cross-sectional
Onderzoeksproduct en/of interventie
PET-CT and CTA
Publiek
P.O. Box 85500, E01.132
A.M. Harder, den
Utrecht 3508 GA
The Netherlands
A.M.denHarder-4@umcutrecht.nl
Wetenschappelijk
P.O. Box 85500, E01.132
A.M. Harder, den
Utrecht 3508 GA
The Netherlands
A.M.denHarder-4@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Age ≥ 50 years
Patients after uncomplicated PHV implantation in aortic position (mechanical and biological PHVs).
Normal routine follow up TTE (standardly performed 5 days after operation). With no signs of obstruction, endocarditis or significant paravalvular leakages.
Group 1: 5 (± 1) weeks after PHV implantation (n=25).
Group 2: 12 (± 2) weeks after PHV implantation (n=25).
Group 3 : 12 (± 2) months after PHV implantation (n=25). Inclusion in group 3: only in case of ≥ 1 patients with post-operative moderate/severe uptake (QVSH score) in group 2.
Weight < 110 kg
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Known contrast allergy
Known renal impairment (GFR<60)
Diabetes Mellitus
Mild contractile dysfunction of the left and/or right ventrical (Eyeballing, Ejection fraction <45 %, TAPSE <14 mm)
Active cardiac decompensation
Uncontrolled cardiac arrhythmias
Suspicion on active endocarditis
Previous participation in scientific studies using radiation.
(Possible) pregnancy in pre-menopausal women above 50 years not on reliable birth control therapy. Other contraindications for contrast use according the standard daily clinical routine according to the protocol “Protocol preventie contrastreactie en contrastnefropathie” by the department of radiology UMCU or EMC
Use of pericardial patches and re-operation of aortic PHV in past medical history
Contraindication for Computed Tomography Angiography according the standard daily clinical routine
Refusal to be informed about potential additional CTA or FDG-PET findings
If already included in group 1 (early post operative phase), patients cannot be included in group 2 or 3 (late post operative phase).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5478 |
NTR-old | NTR5895 |
Ander register | NL42743.041.12 : 12-633 |