PET Tracer for Cardiac Amyloidosis Shows Promise

New results were presented this weekend on a PET radiopharmaceutical being developed by Bayer for imaging cardiac amyloidosis. The tracer turned in promising results in a paper presented at ESC 2026 and published simultaneously in JAMA.

Cardiac amyloidosis occurs when abnormal proteins called amyloid fibrils build up in heart tissue, eventually leading to heart failure and death. It was once thought to be untreatable, but new pharmaceutical therapies have become available that slow disease progression and improve patient outcomes. 

  • But first you have to make a diagnosis, and that’s been the hard part. Multiple imaging modalities are often required, and patients with cardiac amyloidosis often experience diagnostic delays of one to two years or more.

Enter Bayer, which earlier this year acquired a pair of radiopharmaceuticals from Attralus, one for PET imaging and the other for SPECT. The PET agent is iodine-124 evuzamitide, a radiolabeled synthetic peptide that binds to the amyloid fibrils that characterize cardiac amyloidosis. 

  • The acquisition was a bit of a departure for Bayer, which until the purchase had focused its imaging business mostly on contrast agents for X-ray, CT, and MRI. 

But the results presented over the weekend from the Phase III REVEAL trial indicate Bayer may have placed a good bet. 

  • Researchers enrolled 170 patients from 18 U.S. centers who got PET/CT scans with iodine-124 evuzamitide. Three physicians with experience in cardiac PET/CT reviewed the results.

The REVEAL investigators discovered…

  • Iodine-124 evuzamitide had 94% sensitivity for cardiac amyloidosis, with 86% specificity. 
  • Positive predictive value was 85%, and negative predictive value was 94%.  
  • The radiotracer showed high diagnostic accuracy for both types of cardiac amyloidosis, light chain (AL) and transthyretin (ATTR) amyloidosis.
  • The radiotracer was well tolerated by patients. 

The findings indicate that iodine-124 evuzamitide has potential “as a reliable first-line test to exclude cardiac amyloidosis,” meaning it could rule out the need for invasive biopsy. 

  • What next for the tracer? Bayer said it would be discussing the REVEAL data as well as regulatory submissions with the FDA and other health authorities.

The Takeaway

New results from REVEAL indicate that Bayer’s iodine-124 evuzamitide PET radiotracer has the potential to fundamentally change the diagnosis of cardiac amyloidosis, historically one of the more challenging heart conditions to detect and manage. 

Opportunistic Screening Takes Big Step Forward

Opportunistic screening took a big step forward this week with new research in Nature Scientific Reports showing how an AI algorithm from Riverain Technologies was able to calculate coronary artery calcium scores from non-contrast CT scans – with performance close to that of radiologists. 

Opportunistic screening gives radiologists the chance to detect clinical conditions other than those for which the original scan was ordered. 

  • Potential use cases include calculating cardiovascular risk from mammograms or undiagnosed osteoporosis from CT exams.

One of the opportunistic applications with the most potential is CAC scoring from CT scans. 

  • CAC scores are a good marker for future cardiovascular risk. But it can be time-consuming to perform separate cardiac CT scans just to acquire CAC data when thousands of abdominal and thoracic CT studies are conducted every day and could serve just as well.

Riverain’s ClearRead CT CAC algorithm uses AI to analyze non-contrast CT exams and produce Agatston scores, the reference standard for CAC analysis. 

  • Previous research found Agatston scores to be predictive for both cardiovascular and all-cause mortality, but generating the scores requires some manual involvement from clinicians. 

In the new study, Mass General Brigham researchers compared ClearRead CT CAC’s performance to ground-truth calculations from radiologists in 491 patients who got non-contrast CT scans at five U.S. hospitals in 2022 and 2023. Researchers found…

  • CAC score agreement between AI and radiologists was high, with a kappa of 0.959 (1.0 is perfect agreement).
  • The association remained strong regardless of sex, age, race, ethnicity, and CT scanner model, with kappa higher than 0.90 for all groups except “other race.” 
  • The AI model’s CAC scores from non-gated CT scans were similar to those from gated cardiac CT exams (kappa = 0.906), which are generally considered the gold standard for cardiac CT but are more complex to perform.
  • The model’s kappa for gated CT exams compared favorably to recent research conducted with other commercially available algorithms.

The results are a boost for opportunistic screening but in particular for Riverain, which got FDA clearance for ClearRead CT CAC in December 2024 and offers the solution as part of its ClearRead CT suite.

The Takeaway

The new results show that opportunistic screening is moving beyond the research phase and that the opportunity could be now for real-world clinical use. 

CAC Research Leads Imaging at AHA 2025

The 2025 American Heart Association annual conference wraps up today, and cardiac imaging has been a major focus in New Orleans. In particular, research has highlighted imaging’s power to predict future cardiac events – and guide treatment to prevent them. 

Coronary artery calcium scoring with CT is a great example, as CAC scores can predict not only cardiovascular but also all-cause mortality. 

  • Another common theme at AHA 2025 has been opportunistic screening, in which data from imaging exams acquired for other clinical indications can be used to detect osteoporosis, cardiovascular disease, and other issues. 

Check out the items below for some of the hottest imaging topics at AHA 2025, and for a deeper dive into non-imaging news from New Orleans, be sure to visit our Cardiac Wire sister site

News from the show’s first three days include…

  • A massive study of 40k people found that those with CT-derived CAC scores greater than 0 were 2X-3X more likely to die from any cause than people without any CAC – and more died of causes other than cardiovascular disease. Also, 8.5% of patients had other significant findings. 
  • Community health personnel on a Native American reservation were trained to perform point-of-care screening echocardiography assisted by Us2.ai’s AI algorithms. 
  • Us2.ai’s algorithm was also used with transthoracic echo in the SCAN-MP study to detect transthyretin amyloid cardiomyopathy, a cause of heart failure. 
  • Treadmill stress tests fell short compared to CCTA in screening older master’s athletes for ischemia that could lead to sudden cardiac death.
  • A program in Brazil that used echocardiography to screen schoolchildren for latent rheumatic heart disease led to lower prevalence rates after 10 years (2.5% vs. 4.5%). 
  • Patients with hypertrophic cardiomyopathy who had higher levels of myocardial fibrosis on cardiac MRI were almost 6X more likely to have adverse events over eight years.
  • HeartLung Technologies’ AI tool predicted CAC presence on CT scans in 2.1k participants in the MESA study with higher AUC than other tools (AUC = 0.73 vs. 0.68).
  • Another study used HeartLung’s AI to analyze CAC scans to detect myosteatosis – a sign of systemic metabolic dysfunction – which predicted atrial fibrillation and heart failure. 
  • A program promoting CAC scoring to an urban population brought in people for screening who might have been missed through physician referral. 

The Takeaway

This week’s news from AHA 2025 shows medical imaging’s contribution to early detection of cardiovascular disease – the leading cause of death worldwide. CT-based CAC scoring has especially promising potential, not only for heart disease but also other conditions through opportunistic screening.

Cardiac CT’s Long-Term PROMISE

Coronary CT angiography works just as well as traditional stress testing over the long haul for patients with stable symptoms of coronary artery disease. That’s according to the latest follow-up data from the PROMISE study in JAMA Cardiology, which found no difference in mortality between either strategy. 

PROMISE was a randomized controlled trial that compared patient work-up with anatomical CCTA scans to functional stress testing (exercise ECG, stress echo, or stress nuclear) in 10k patients from 2010 to 2014. 

  • The first PROMISE results found that in patients with CAD symptoms who were followed up for just over two years, there was little difference between anatomical CCTA and functional stress testing for endpoints like death, myocardial infarction, or other complications.

But what about over a longer follow-up period? The new results extend PROMISE’s follow-up to a median of 10.6 years, finding… 

  • Mortality rates were largely the same whether patients got CCTA or stress testing (14.3% vs. 14.5%, p = 0.56). 
  • Cardiovascular mortality rates were also similar (4.0% vs. 4.3%, p = 0.77).
  • As were noncardiovascular death rates (10.7% for both).

There were some differences in the predictive power of each modality based on patient characteristics…

  • With CCTA, any abnormal finding increased a patient’s mortality risk compared to normal findings for severe, moderate, and mild disease (HR = 3.44, 3.38, and 1.99, respectively).
  • With stress testing, only patients with severely abnormal disease had higher mortality risk (HR = 1.45).

The new PROMISE data also tracks well with recent 10-year findings from SCOT-HEART, another major study that demonstrated CCTA’s value.

  • Combining results from PROMISE and SCOT-HEART shows 89% survival of patients with stable angina at 12 years, demonstrating good effectiveness regardless of workup strategy.

The Takeaway

PROMISE findings have gone a long way toward showing that CCTA is every bit as effective as stress testing, and the new results reinforce this message. The findings are also good news for radiology, which has a stronger hold over anatomical imaging with CT than it does over the predominant stress modalities, which are largely controlled by cardiology.

CT Guides Heart Health

People who got evidence of their cardiovascular health from coronary CT angiography scans led healthier lifestyles compared to those who got conventional cardiac risk scoring. That’s according to a new study in JAMA Cardiology that has intriguing ramifications not only for managing heart disease but also for the imaging-based wellness industry. 

Cardiovascular disease is the number one killer globally, accounting for one in seven deaths.

  • The risk of heart disease can be managed through lifestyle changes like better diet and exercise, but getting patients to follow their doctors’ advice can be a challenge.

So researchers in the new study investigated whether data from a patient’s own coronary CT angiography exam would be a better motivational tool compared to simply calculating a risk score based on demographic factors like weight, BMI, and daily step count.

  • They drew 400 participants from the SCOT-HEART 2 study of CT-based cardiovascular screening in Scotland. 

Cardiovascular risk scores were calculated for one group using the ASSIGN criteria for 10-year cardiac event risk, while another group got CCTA scans and were shown their results. 

  • Interventions were recommended for patients in either group based on cardiac risk as calculated by either ASSIGN criteria or CCTA scans, ranging from no interventions to low-level statin therapy to high-intensity statin and enzyme inhibitor treatment.

At six months of follow up, researchers calculated how many participants met the U.K.’s NICE recommendations for diet, body mass index, smoking, and physical exercise, finding …

  • Nearly three times more CCTA patients complied with NICE healthy lifestyle guidelines (17% vs. 6%).
  • Fewer CCTA patients were told to start preventive therapy due to their risk (51% vs. 75%).
  • And of these, CCTA patients were more likely to have followed advice to begin a therapeutic program (77% vs. 46%). 
  • There was no difference in behavior between CCTA patients who saw their own images and those who were told verbally of their results.

In one important fact, the researchers noted that the study was only designed to measure compliance. 

  • It did not assess any change in coronary events over time – these will be addressed in the larger SCOT-HEART 2 study. 

The Takeaway

The new study offers powerful evidence that getting their own medical imaging results can drive patients to adopt lifestyle changes that lower their disease risk. In addition to informing cardiovascular disease management, it’s also possible to see these findings employed as part of the wellness screening programs that are becoming increasingly prevalent. 

Opportunistic Calcium Scoring Shifts to Abdomen

Most of the recent research on calcium scoring has focused on calcium in the coronary arteries and its link to cardiovascular disease. But a new study in American Heart Journal used abdominal CT scans with AI analysis for opportunistic measurement of abdominal aortic calcium to predict cardiac events – possibly earlier than CAC scores.

CT-derived CAC scores have become a powerful tool for predicting cardiovascular disease, helping physicians determine when to begin preventive therapy with treatments like statins.

  • CAC scores can be generated from dedicated cardiac CT scans, or even lung screening exams as part of a two-for-one test

Abdominal CT represents another promising area for calculating calcium. 

  • Previous research has found that atherosclerosis in the abdominal aorta may occur before its development in the coronary arteries, creating the opportunity to detect calcium earlier. 

Researchers from NYU Langone did just that in the new study, performing abdominal and cardiac CT scans in 3.6k patients and using an AI algorithm they developed in partnership with Visage Imaging to calculate AAC. They found that over an average three-year follow-up period … 

  • AI analysis of AAC severity was positively associated with CAC.
  • AAC could be used to rule out the presence of CAC relative to two versions of the PREVENT score (AUC=0.701 and 0.7802). 
  • The presence of AAC was associated with a higher adjusted risk of major adverse cardiovascular events (HR=2.18).
  • A doubling of the AAC score was linked to 11% higher risk of MACE.

The Takeaway

The new results are an exciting demonstration of opportunistic screening’s value, especially given the volume of abdominal CT scans performed annually. AI analysis of routinely acquired abdominal CT could give radiologists a tool for detecting heart disease risk even earlier than what’s possible with CAC scoring.

CAC Scoring Shines at ACC 2025

The American College of Cardiology’s annual meeting is wrapping up today in Chicago, and new research into coronary artery calcium scoring has been one of cardiac imaging’s top trends at McCormick Place.

CAC scoring has been around for ages as a way to detect and quantify calcium buildup in the coronary arteries based on data from non-contrast CT scans. 

  • But it’s only been in recent years that CAC scoring has come into its own as a tool for predicting risk of mortality and major cardiac events – in some cases years before they happen. 

Clinicians are learning that they can use CT-generated CAC scores to estimate future risk and guide interventions to reduce it, such by prescribing statins or behavior modifications. 

Research presented at ACC 2025 underscored CAC scoring’s potential

  • In the CLARIFY CAC screening program, researchers found a 6.2% rate of thoracic aneurysm, indicating a need for screening and prevention.
  • CAC scores of 0 were more common in women than men (49% vs. 23%), but there was no statistically significant difference in non-calcified plaque rates between genders.
  • Researchers found moderate accuracy (AUC range=0.60-0.73) for a method of generating CAC scores from 12-lead ECG data rather than non-contrast CT scans.
  • Bunkerhill Health’s I-CAC algorithm was used to generate automated CAC scores for 200 patients. After six months, patients with scores >400 had a 17% rate of cardiac events and 11% all-cause mortality. 
  • A commonly used measure for low-value care based on administrative claims classified too many CAC tests as inappropriate, with a positive predictive value of only 43%.
  • A case study focused on the paradox of a 59-year-old healthy triathlete with a CAC score of 780, possibly due to chronic coronary stress from high-endurance exercise. Invasive testing was deferred in favor of medical therapy due to his low cardiac risk.
  • On the other hand, a literature review of 19.4k people found no statistically significant difference in CAC scores between endurance athletes and healthy controls.
  • Non-calcified plaque in patients with CAC scores of 0 was common (26%) in residents of rural Appalachia, indicating high risk of rupture and suggesting the limitation of relying on CAC scores. 
  • A Sunday debate discussed whether CAC scoring should be added to mammography and colon cancer screening, or reserved as a decision aid. 

The Takeaway

The studies from ACC 2025 show that CAC scoring has a bright future – bright enough that it’s generating heightened interest from cardiology. New CAC scoring tools arriving on the market should improve its predictive value even more. 

AI Enables Single-Click Cardiac MRI

Cardiac MRI is one of the most powerful imaging tools for assessing heart function, but it’s difficult and time-consuming to perform. Could automated AI planning offer a solution? A new research paper shows how AI-based software can speed up cardiac MRI workflow

Cardiac MRI has a variety of useful clinical applications, generating high-resolution images for tissue characterization and functional assessment without the ionizing radiation of angiography or CT.

  • But cardiac MR also requires highly trained MR technologists to perform complex tasks like finding reference cardiac planes, adjusting parameters for every sequence, and interacting with patients – all challenges in today’s era of workforce shortages. 

Cardiac MRI’s complexity also increases the number of clicks required by technologists to plan exams. 

  • This can introduce scan errors and produces inter-operator variability between exams. 

Fortunately, vendors are developing AI-based software that automates cardiac MR planning – in this case, Siemens Healthineers’ myExam Cardiac Assist and AI Cardiac Scan Companion. 

  • The solution enables single-click cardiac MR planning with a pre-defined protocol that includes auto-positioning to identify the center of the heart and shift the scanner table to isocenter, as well as positioning localizers to perform auto-align without manual intervention. 

How well does it work in the real world? Researchers tested the AI software against conventional manual cardiac MR exam planning in 82 patients from August 2023 to February 2024, finding that automated protocols had … 

  • A lower mean rate of procedure errors (0.45 vs. 1.13).
  • A higher rate of error-free exams (71% vs. 45%).
  • Shorter duration of free-breathing studies (30 vs. 37 minutes).
  • But similar duration of breath-hold exams (42 vs. 44 minutes, p=0.42).
  • While reducing the error gap between more and less experienced technologists. 

In their discussion of the study’s significance, the researchers note that most of the recent literature on AI in medical imaging has focused on its use for image reconstruction, analysis, and reporting.

  • Meanwhile, there’s been relatively little attention paid to one of radiology’s biggest pain points – exam preparation and planning. 

The Takeaway

The new study’s results are exciting in that they offer not only a method for performing cardiac MR more easily (potentially expanding patient access), but also address the persistent shortage of technologists. What’s not to like?

FFR-CT Reduces Invasive Angiography Rates

Performing automated CT-derived fractional flow reserve with Shukun Technology’s software reduced referrals to invasive coronary angiography by 19% in a new study in Radiology. The findings suggest that software-based FFR-CT can serve a gatekeeper role in managing workup of patients with suspected coronary artery disease. 

Cardiac CT has been a revolutionary tool for assessing people with heart problems, evolving rapidly into a first-line modality that’s eclipsed other more traditional imaging technologies. 

  • But CCTA’s prowess also has a downside – more referrals to invasive coronary angiography, in some cases for patients without obstructive disease.

Rising to this challenge is FFR-CT, which uses automated software to calculate maximum blood flow in the coronary arteries and detect dangerous coronary lesions that could be early signs of a cardiac event. 

  • The segment to date has been dominated by Heartflow, thanks to its early start in the field: its FFRCT software got FDA clearance in 2014 and the company has used its dominance to build a massive cash position.

In the new China CT-FFR Study 3, researchers in China used another FFR-CT application, Shukun’s skCT-FFR, and compared angio referral rates for 5.3k patients with suspected coronary artery disease who were scanned with either CCTA alone or CCTA and FFR-CT. They found …

  • Referral rates were lower for those who got FFR-CT (10% vs. 12.4%), a 19% relative difference.
  • Fewer cardiac events occurred in the FFR-CT group at one year (0.5% vs. 1.1%).
  • There was no statistically significant difference in major adverse cardiac event rates at 90 days (0.5% vs. 0.8%, p=0.12) and one year (2.9% vs. 2.8%, p=0.9).

Shukun is not as well known in the West as other developers of FFR-CT software like Heartflow, but the company has raised over $250M to date – enough to land it in the top echelon of AI developers. 

  • One advantage of Shukun that was evident with the new study is that image processing was performed on-site, rather than being shipped off-site as is the case with other applications. 

The Takeaway

The study shows that FFR-CT can make cardiac CT more precise while tamping down on referrals to invasive angiography that have come from growing CT use. The results should also help put Shukun on the radar of many industry observers in a segment that so far has been dominated by HeartFlow.

Imaging News from ESC 2024

The European Society of Cardiology annual meeting concluded on September 2 in London, with around 32k clinicians from 171 countries attending some 4.4k presentations. Organizers reported that attendance finally rebounded to pre-COVID numbers. 

While much of ESC 2024 focused on treatments for cardiovascular disease, diagnosis with medical imaging still played a prominent role. 

  • Cardiac CT dominated many ESC sessions, and AI showed it is nearly as hot in cardiology as it is in radiology. 

Major imaging-related ESC presentations included…

  • A track on cardiac CT that underscored CT’s prognostic value:
    • Myocardial revascularization patients who got FFR-CT had lower hazard ratios for MACE and all-cause mortality (HR=0.73 and 0.48).
    • Incidental coronary artery anomalies appeared on 1.45% of CCTA scans for patients with suspected coronary artery disease.
  • AI flexed its muscles in a machine learning track:
    • AI of low-dose CT scans had an AUC of 0.95 for predicting pulmonary congestion, a sign of acute heart failure. 
    • Echocardiography AI identified HFpEF with higher AUC than clinical models (0.75 vs. 0.69).
    • AI of transthoracic echo detected hypertrophic cardiomyopathy with AUC=0.85.

Another ESC hot topic was CT for calculating coronary artery calcium (CAC) scores, a possible predictor of heart disease. Sessions found … 

  • AI-generated volumetry of cardiac chambers based on CAC scans better predicted cardiovascular events than Agatston scores over 15 years of follow-up in an analysis of 5.8k patients from the MESA study. 
  • AI-CAC with CT was comparable to cardiac MRI read by humans for predicting atrial fibrillation (0.802 vs. 0.798) and stroke (0.762 vs. 0.751) over 15 years, which could give an edge to AI-CAC given its automated nature.
  • An AI algorithm enabled opportunistic screening of CAC quantification from non-gated chest CT scans of 631 patients, finding high CAC scores in 13%. Many got statins, while 22 got additional imaging and 2 intervention.
  • AI-generated CAC scores were also highlighted in a Polish study, detecting CAC on contrast CT at a rate comparable to humans on non-contrast CT (77% vs. 79%), possibly eliminating the need for additional non-contrast CT.  

The Takeaway

This week’s ESC 2024 sessions demonstrate the vital role of imaging in diagnosing and treating cardiovascular disease. While radiologists may not control the patients, they can always apply knowledge of advances in other disciplines to their work.

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