Delays in diagnostic tests used to identify transthyretin amyloid cardiomyopathy (ATTR-CM) in the EU4 + UK
Authors: Deemer J , Melinis N , Brown S , Chung W Y 
Published: October 2021

Background

Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed, progressive disease characterised by amyloid protein deposits building in the left ventricle. The symptoms of ATTR-CM are like those associated with heart failure, and specialised tests are needed to identify ATTR-CM.

Purpose

This paper examines the tests used to identify ATTR-CM in France, Germany, Italy, Spain and United Kingdom and the time between these tests.

Methods

Ipsos' ATTR-CM Therapy Monitor was fielded between November 2020 and December 2020, with 210 (FR: 46, DE: 40, IT: 43, ES: 42, UK: 39) treating doctors providing data on 320 (FR: 71, DE: 63, IT: 64, ES: 63, UK: 59) patients diagnosed with ATTR-CM. Ipsos analysed information provided on the diagnostic tests ordered for the 320 patients to understand how ATTR-CM is diagnosed across the five markets, and also tracked the order in which the tests were conducted, across four batteries, to understand the flow of the diagnostic procedures.

Results

Overall, the patients in our study went through 6 diagnostic tests on average before receiving a confirmed ATTR-CM diagnosis via Echocardiogram (ECHO) with strain imaging (83%), Cardiac Magnetic Resonance Imaging MRI (75%), Genetic tests (69%), Laboratory tests (59%), Scintigraphy tests (52%), and Biopsy tests (51%) as the top tests ordered. Overall, 15% of the reported patients had an unknown order of tests. Patients in Germany, France and Italy received the most tests on average (FR: 6, DE: 7, IT: 6, ES: 5 and UK: 5). Patients in Germany also experienced the shortest delays between batteries of tests (3.2 wks. between 1st and 2nd batteries; 3.9 wks. between 2nd and 3rd batteries) and were most likely to receive a Genetic test (84%) or Biopsy test (68%) to confirm diagnosis. In comparison, patients in Spain experienced the longest testing delays (7.3 wks. between 1st and 2nd batteries; 5.8 wks. between 2nd and 3rd batteries) and went through only 5 diagnostic tests before receiving a confirmed diagnosis.

Across the markets, 59% of doctors experienced a decline in ability to diagnose patients with ATTR-CM due to COVID-19, with the degree of impact differing drastically by region (FR: 43%, DE: 20%, IT: 79%, ES: 88% and UK: 64%). With doctors indicating that 16% of their patients were untreated due to late diagnosis with advanced disease (FR: 15%, DE: 10%, IT: 16%, ES: 20% and UK: 21%), identifying suspected ATTR-CM and running the necessary tests to diagnose ATTR-CM early are essential.

Conclusion

Overall, the patients reported on in this study received upwards of 6 diagnostic tests before confirmation of ATTR-CM, with 4.5 weeks between each battery of tests. In addition to regional nuances in regard to test choice, we see evidence that there are country level differences between how quickly patients receive diagnostic tests. Further research is needed to identify ways of increasing the speed of testing and subsequent diagnosis.

Funding Acknowledgement

Type of funding sources: None. Diagnostic Procedures by Region