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Vyndaqel 61mg is indicated for the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SmPC for how to report adverse reactions.
Nuclear scintigraphy with [99mTc-PYP*/99mTc-DPD/99mTc-HMDP] provides a unique myocardial uptake pattern in amyloid and may identify ATTR deposits early in the course of disease3
Planar and SPECT images should be evaluated to confirm diffuse radiotracer uptake in the myocardium3
If myocardial tracer uptake is visually present on SPECT, proceed to step 2, semiquantitative grading3
If no myocardial tracer uptake is present on SPECT, the visual grade is 03
Examine both planar and SPECT images for tracer uptake in the myocardium relative to ribs and grade using the following scale3,4
Strongly suggestive of ATTR-CM3:
Visual scores of ≥2 on planar and SPECT images with concurrent testing to rule out AL
Not suggestive or equivocal of ATTR-CM3:
Visual scrores of <2
Diagnosis of ATTR-CM cannot be made solely based on heart-to-contralateral lung (H/CL) ratio. H/CL ratio is not recommended if there is absence of myocardial uptake on SPECT imaging.3
H/CL ratio is typically concordant with visual grade3
An H/CL ratio is calculated as the fraction of heart ROI mean counts to contralateral lung ROI mean counts3
Quantification of cardiac 99mTc-PYP* uptake using H/CL ratio4
Biopsy-proven ATTR cardiac amyloidosis with H/CL=2.084
If clinical suspicion for cardiac amyloidosis remains high despite a negative or inconclusive scintigraphy scan, consider EMB3
Congo red positive staining of myocardial tissue on light microscopy and apple-green birefringence on polarized light microscopy images1
Congo red positive staining for amyloid myocardial biopsy
To determine amyloid type, immunohistochemistry (IHC) tests and/or mass spectrometry should be performed.1
Apple-green birefringence myocardial biopsy
Risk of complications and the need for specialized centers and expertise may contribute to a diagnostic delay.1,6
Used to determine if the disease is hereditary due to a mutation in the TTR gene or if it is wild type7
Genetic counseling and gene sequencing are recommended following confirmation of hATTR-CM7
|Nuclear scintigraphy, endomyocardial biopsy and genetic testing can support an early ATTR-CM diagnosis|
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PP-UNP-IRL-0176. January 2023