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Meds-to-Beds for PCSK9is, CELEBRATE results, and Cigna Covers Plaque AI
September 25, 2025
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Together with
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“Metformin is for those who want science, a gazillion positive RCTs, and regulatory oversight; berberine is for those who want vibes and influencers.”
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Michael Albert, MD
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This year Philips unveiled the Transcend Plus release for EPIQ CVx and Affiniti CVx, delivering breakthrough image quality and FDA-cleared AI enhancements in cardiovascular ultrasound at ESC 2025. Learn more about what makes the new release so special in this episode of the Cardiac Wire Show with one of Philips’ Applications Specialist, Stephanie Ribeiro.
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PCSK9 inhibitors might finally reach their clinical potential in the patients who need them most, after the ELL-ASCVD study demonstrated that a Meds-to-Beds program delivering these medications before hospital discharge significantly improved patient uptake.
- PCSK9is are guideline-recommended for ASCVD patients but face significant access barriers including physician inertia, insurance denials (31% rejection rate), and complex prior authorization processes despite 60% price reductions.
- High-risk post-revascularization patients are an ideal population for aggressive LDL lowering, yet many fail to achieve target LDL levels due to these barriers.
The ELL-ASCVD program enrolled 72 patients immediately following their revascularization procedures, with 69% post-PCI, 18% post-CABG, and 13% post-peripheral interventions, finding that the Meds-to-Beds approach led to significant improvement in patient outcomes.
- LDL goal achievement (< 70 mg/dL) reached 92% at 6 months with the M2B program versus 40% in historical controls.
- Better yet, 79% of patients achieved the < 55 mg/dL target versus 25% with standard care.
- Median LDL reduction was 66% with PCSK9is versus 25% in controls.
- The program successfully navigated insurance coverage for most patients despite a diverse payor mix (33% Medicare, 36% Medicaid, and 21% private insurance).
Even with demonstrated clinical benefits and price reductions, physician inertia could continue to prevent appropriate PCSK9i adoption. Real-world implementation challenges included…
- Twelve patients whose prescriptions were withdrawn by outpatient providers, reflecting “disagreement with GDMT or preference for alternative approaches.”
- Eight patients who couldn’t obtain insurance approval.
- Four patients who faced prohibitive out-of-pocket costs, illustrating persistent barriers despite manufacturer price cuts.
The Takeaway
The ELL-ASCVD study demonstrates that access barriers, not medication efficacy, represent the primary obstacle to optimal PCSK9 inhibitor use in high-risk patients. Whatever those barriers may be, it’s important to remember that they can be removed with the right effort.
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GLS Analysis of Us2.ai’s Fully-Automated Software
Ten years after the first head-to-head comparison of 2D echocardiography, the latest review suggests Us2.ai is among the easiest to use and integrate. Read the study to learn about how Us2.ai’s software requires zero operator input, operates without human intervention, and leads to high agreement with traditional semi-automated speckle- tracking software solutions.
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Heartflow Plaque Analysis: Accurate CAD Assessment Now Covered Across the US
HeartFlow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.
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- A New STEMI Intervention: CeleCor Therapeutics announced positive Phase 3 results for Disaggpro (zalunfiban), an investigational heart-attack drug. The CELEBRATE study enrolled 2,467 STEMI patients across 45 international sites and showed positive primary efficacy and safety outcomes, though CeleCor will present the full results at AHA 2025. Disaggpro is designed for pre-hospital treatment via subcutaneous auto-injector, reaching maximum effect within 15 minutes. Currently, only aspirin is routinely used pre-hospital in the U.S.
- Heartflow Gets New Plaque Analysis 510(k): Heartflow received 510(k) clearance for the latest version of its Heartflow Plaque Analysis AI algorithm, which calculates coronary artery disease from CCTA scans. The new version features an updated algorithm and includes 3D color-coded visual representation of plaque type, volume, and distribution.
- AI Industry Payments: A new study in JAMA tracks the medical AI industry’s payments to healthcare providers and hospitals, finding that such payments totaled $120M from 2017 to 2023. Cardiologists got the most money ($59M) with radiologists second at $40M, even though the FDA has authorized far more AI-enabled devices for radiology than cardiology (77% of total authorizations as of the last count). The payments raise the issue of physician conflict of interest as well as whether payments are being adequately disclosed.
- CV Risk Prediction Using Mammo: Researchers developed a deep learning algorithm to predict cardiovascular risk in women using routine mammography images. The algorithm was developed from 49k women using only mammographic features and age and achieved a concordance index of 0.72, performing comparably to standard cardiovascular risk prediction tools like PREDICT and PREVENT. The authors suggest this type of modeling could improve cardiovascular screening opportunities for women during routine mammography visits.
- Multimodal R-AAOCA Exams: A new JAMA study suggests that combining CCTA and functional nuclear imaging might be a better option for assessing right anomalous aortic origin of a coronary artery (R-AAOCA); a relatively rare congenital heart condition that’s currently assessed with invasive FFR exams. In the 55-patients study, CCTA achieved 100% sensitivity and 57% specificity, ruling out 42% of R-AAOCA cases. Functional nuclear imaging then filled in the gaps, achieving 100% specificity and 27% sensitivity, thus reducing the number of patients who need invasive testing.
- Heavy Metal is Bad for Pregnancy: A study out of Japan suggests heavy metal exposure could have an unexpected negative impact on hypertensive disorders of pregnancy (HDP). Researchers examined over 88k pregnant women and found that despite relatively low metal exposure levels, 3.1% of women developed HDP. Higher blood concentrations of lead, cadmium, and mercury led to respective odds ratios of 1.58, 1.30, and 1.15 for HDP. The findings suggest even low-dose heavy metal exposure is an underrecognized risk factor for HDP.
- Type 2 MI’s Long Term Risks: A recent Medicare study of over 1.8M beneficiaries who experienced MI found that type 2 MI’s share of all heart attacks increased from 19.4% to 26.8% between 2018-2021. The study revealed that type 2 MI showed lower short-term mortality and cardiovascular events than type 1 MI, but higher long-term mortality and stroke risk. Type 2 MI patients had persistently lower recurrent MI and heart failure hospitalization rates.
- Cigna Covers AI Plaque Analysis: Cigna will now cover plaque analysis technologies like those from Heartflow, Elucid, and Cleerly starting October 1, 2025. With 16M covered individuals, Cigna joins UnitedHealthcare and EviCore in providing coverage for this AI-based plaque analysis technology and combined with Medicare coverage and other insurers, the technology is now covered for over 61M Americans. More specifically, coverage applies to patients with acute/stable chest pain meeting specific clinical criteria.
- Ncardia Launches a New iPSC: Ncardia launched its Ncyte NHP-C vCardiomyocytes, the first commercially available ventricular-like cardiomyocytes derived from cynomolgus monkey induced pluripotent stem cells. This innovation provides a scalable and ethical alternative to live animal testing for cardiac safety research, closely mimicking human cardiac electrophysiology. The cells enable cross-species mechanistic studies, improve cardiotoxicity prediction, and support FDA guidance on reducing non-human primate use in preclinical testing.
- FlyteHealth + Heartbeat: FlyteHealth and Heartbeat Health partnered to create a bundled virtual cardiometabolic and cardiology care program. The integrated solution addresses conditions from pre-diabetes and hypertension to cardiovascular disease through one entry point for employers and payors. Features include AI-driven care plans, multidisciplinary teams, remote monitoring, and mobile apps. The partnership also aims to eliminate care gaps and provide measurable ROI through coordinated virtual care delivery.
- Bunkerhill’s ECG-EF Clearance: Bunkerhill Health received FDA clearance for ECG-EF, an AI algorithm that detects reduced left ventricular ejection fraction from routine 12-lead ECGs to identify heart failure risk. Developed by Carelog and integrated into Bunkerhill’s Carebricks platform, the technology enables early detection of heart conditions using accessible ECG tests rather than specialized echocardiography equipment. The algorithm can flag high-risk patients earlier and at scale, potentially improving outcomes for millions with undiagnosed LEF by enabling intervention before symptoms develop.
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Explore Vitrea Advanced Visualization
Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow
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PIA’s Post-Processing Solution
Advanced cardiac imaging often calls for a time-consuming post-processing step, requiring costly software, hardware, and training. See how PIA provides this post-processing at lower cost, improved consistency, and greater efficiency.
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A Solution for Your Entire Cardiology Service Line
The pace of change in healthcare can be dizzying, creating new and more complex challenges for cardiology departments to overcome. See how Merge Cardio and Merge Hemo can turn those challenges into opportunities for greater workflow efficiency and improved care.
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- The Hidden Costs of Delaying Cardiac MRI Adoption: Despite being the gold standard for functional cardiac imaging, many hospitals remain slow to adopt it. From missed revenue to lost patients, the impact goes far beyond the scan. Read about the real clinical and financial risks of falling behind.
- Siemens Healthineers ACUSON Origin Ultrasound System is Redefining CVUS: ACUSON Origin meets the demands of today’s cardiovascular care with AI-powered efficiency across adult and pediatric echo, vascular, structural heart, and EP. Streamlined workflows, intuitive walk-up usability, and advanced ergonomics empower clinicians to deliver confident, high-quality care—supporting a wide range of complex cases and clinical applications.
- The Monebo Difference in Comprehensive Cardiac Mapping: Monitoring the heart 24/7 means being in tune with the body’s natural cycles. Read about how Monebo’s approach to cardiac monitoring provides visual representations of a patient’s heart rate, cardiac muscle relaxation, and electrical excitation throughout the day.
- Identify and Treat Cardiovascular Disease: Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.
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