CCTA AI Predicts Ischemia and MBF

A Cedars-Sinai and Amsterdam UMC-led team developed a machine learning system that analyzes quantitative plaque in coronary CTA exams to identify patients with ischemia and impaired myocardial blood flow (MBF), potentially creating an alternative to current methods.

The researchers trained the ML model using invasive FFR data from 254 patients (484 FFR vessels) to predict ischemia and impaired MBF by analyzing plaque data in CCTA exams. 

They then tested it with CCTAs from 208 patients (581 vessels) who also underwent invasive FFR and H2O PET exams, finding that the CCTA ML scores:

  • Predicted FFR-defined ischemia far more accurately than standard CCTA stenosis evaluations, while rivaling FFRCT assessments (AUCs: 0.92 vs. 0.84 & 0.93)
  • Predicted PET-based impaired MBF more accurately than standard CCTA stenosis evaluations and FFRCT assessments (AUCs: 0.80 vs. 0.74 & 0.77)

Because the ML scoring system operates locally, the authors highlighted its potential to quickly assess high-risk patients before invasive coronary angiography (avoiding off-site processing delays) or to assess low-risk patients at earlier stages, helping to improve ICA efficiency and accuracy.

The researchers plan to continue to develop their CCTA plaque AI solution, including adding more plaque features and CCTA metrics, and potentially seeking regulatory approval depending on the results of future validation studies.

The Takeaway

CCTA plaque AI is already one of the hottest segments on the commercial side of imaging AI, and this study highlights similar advances in academic centers, while showing that CCTA plaque AI can quickly and accurately predict both ischemia and lower MBF.

Plaque AI’s First Reimbursement

The small list of cardiac imaging AI solutions to earn Medicare reimbursements just got bigger, following CMS’ move to add an OPPS code for AI-based coronary plaque assessments. That represents a major milestone for Cleerly, who filed for this code and leads the plaque AI segment, and it marks another sign of progress for the business of imaging AI.

With CMS’ October 1st OPPS update, Cleerly and other approved plaque AI solutions now qualify for $900 to $1,000 reimbursements when used with Medicare patients scanned in hospital outpatient settings. 

  • That achievement sets the stage for plaque AI’s next major reimbursement hurdle: gaining coverage from local Medicare Administrative Contractors (MACs) and major commercial payers.

Cleerly and its qualifying plaque AI competitors join a growing list of Medicare-reimbursed imaging AI solutions, headlined by HeartFlow’s FFRCT solution ($930-$950) and Perspectum’s LiverMultiScan MRI software ($850-$1,150), both of which have since expanded their reimbursements across MAC regions and major commercial payers. 

  • The last few years also brought temporary NTAP reimbursements for Viz.ai (LVO detection / coordination), Caption Health (echo AI guidance), and Optellum (lung cancer risk assessments), plus a growing number of imaging AI CPT III codes that might lead to future reimbursements.

The new reimbursement should also drive advancements within the CCTA plaque AI segment, giving providers more incentive to adopt this technology, and providing emerging plaque AI vendors (e.g. Elucid, Artrya) a clearer path towards commercialization and VC funding.

The Takeaway

CMS’ new plaque AI OPPS code marks a major milestone for Cleerly’s commercial and clinical expansion, and a solid step for the plaque AI segment. 

The reimbursement also adds momentum for the overall imaging AI industry, which finally seems to be gaining support from CMS. That’s good news for AI vendors, since it’s pretty much proven that reimbursements drive AI adoption and are often necessary to show ROI.

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