Consistency of T-Amylo diagnostic performance across patient subgroups: the PROVALTA study
C Goena-Vives, X Arana-Achaga, I Toranzo-Nieto, M Sutil-Vega, P Menendez-Suarez, D Mialdea-Salmeron, I Fiteni-Mera, L Bernal, M Pajares, I Francisco-RecueroAbstract
Background
Transthyretin cardiac amyloidosis (ATTR-CM) is characterized by heterogeneous clinical presentation across different patient profiles, including variations in age, sex, and overall clinical risk. Ensuring that diagnostic prediction tools maintain consistent performance across these diverse subgroups is essential for their broad clinical applicability. The aim of the study was to assess the consistency of diagnostic performance of the T-Amylo prediction model and simplified score across predefined subgroups according to sex, age, and number of clinical red flags in a prospective multicentre study.
Methods
PROVALTA is a prospective, multicentre observational study including patients ≥65 years with septal hypertrophy (≥12 mm) and at least one clinical red flag suggestive of ATTR-CM. The T-Amylo prediction model and simplified score were applied a priori. Diagnostic performance was assessed using sensitivity, specificity, positive and negative predictive values, receiver-operating characteristic curves, and the area under the curve (AUC) across predefined subgroups.
Results
The study included 367 patients aged ≥65 years with septal hypertrophy (≥12 mm) and at least one clinical red flag suggestive of ATTR-CM. Mean age was approximately 80 years, with a slight predominance of women (52%), and more than half of the cohort had a prior diagnosis of heart failure (54.5%). ATTR-CM was confirmed in 32 patients (8.7%). Diagnostic performance of the T-Amylo prediction model was consistent across sex, with identical discrimination in men and women (AUC 0.84 for both). Performance remained consistent across age groups (<80 vs ≥80 years), with AUC values of 0.89 and 0.80, respectively, and across increasing numbers of clinical red flags (1–3 vs 4–7), with AUC values of 0.85 and 0.76, respectively, with high negative predictive values in all subgroups. Similarly, the simplified demonstrated robust performance, maintaining high specificity and negative predictive value across sex, age, and clinical risk profiles, with no clinically relevant loss of diagnostic accuracy in any subgroup. A detailed summary of diagnostic metrics is provided in Table 1.
Conclusions
This prospective multicentre study demonstrates that the diagnostic accuracy of both the T-Amylo prediction model and the simplified score is preserved across sex, age, and varying clinical risk profiles. These findings confirm the robustness of T-Amylo and support its applicability across a broad spectrum of patients with suspected ATTR-CM.For image description, please refer to the figure legend and surrounding text.