ORIGINAL RESEARCH article
Front. Cardiovasc. Med.
Sec. Heart Failure and Transplantation
Volume 12 - 2025 | doi: 10.3389/fcvm.2025.1638380
This article is part of the Research TopicTransforming Care in Heart Failure and Cardiomyopathies: Emerging Insights and TreatmentsView all 7 articles
Trends in Diagnostic Testing in Medicare Patients With Wild-Type Transthyretin Amyloid Cardiomyopathy
Provisionally accepted
Ronald M. Witteles1*Haechung Chung2Feng Dai2Cynthia Gutierrez3
Andrew Rava3
Swarup Sameer4Abbas Ebrahim2Cindi Pankratova2
Donna McGuire5- 1Stanford University Division of Cardiovascular Medicine, Stanford, United States
- 2Pfizer Inc, New York, United States
- 3Genesis Research Group, Hoboken, NJ, United States
- 4Clarify Health Solutions, New York, United States
- 5Envision Pharma, Inc., Fairfield, United States
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Background: Most patients with wild-type transthyretin amyloid cardiomyopathy (ATTRwt-CM) are diagnosed noninvasively, using nuclear imaging and monoclonal protein testing. However, concerns have been raised that some may receive an ATTRwt-CM diagnosis based on incomplete evaluations (not based on current consensus recommendations). Using a cohort of US Medicare Fee-for-Service patients, we aimed to examine the frequency and cadence of diagnostic testing for ATTRwt-CM. Methods: In this retrospective observational cross-sectional study, administrative de-identified claims data from 2018 to 2022 were derived from patients aged ≥65 years who had at least one claim for ATTRwt-CM and heart failure or cardiomyopathy, and ≥2 years of continuous Medicare enrollment before the first ATTRwt-CM diagnosis. Patients with claims for any other form of amyloidosis, multiple myeloma, or plasma cell dyscrasias were excluded. Results: Among 2,050 patients with ATTRwt-CM, mean (SD) age was 80.0 (6.9) years, and 75.5% were men. Annual new ATTRwt-CM diagnoses nearly tripled over the study period (2018, n=198; 2022, n=578). Technetium-99m pyrophosphate (PYP) scintigraphy use was performed in approximately half of diagnosed patients by the end of the study period (2018, 30%; 2022, 49%). Cardiac biopsy use declined from 14% in patients diagnosed in 2018 to 5% in those diagnosed in 2022. A small minority (14%) of patients underwent the recommended noninvasive diagnostic testing comprised of PYP scintigraphy and complete monoclonal protein testing. Conclusions: Based on Medicare claims data, most patients diagnosed with ATTRwt-CM have not been diagnosed following consensus-recommended pathways.
Keywords: Amyloidosis, cardiomyopathy, diagnosis, Heart Failure, IDENTIFICATION, transthyretin
Received: 30 May 2025; Accepted: 25 Aug 2025.
Copyright: © 2025 Witteles, Chung, Dai, Gutierrez, Rava, Sameer, Ebrahim, Pankratova and McGuire. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Ronald M. Witteles, Stanford University Division of Cardiovascular Medicine, Stanford, United States
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