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Risk Equations Struggle, OCEANIC-STROKE, and A DoD Canon Contract
December 1, 2025
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Together with
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“This study underscores the inadequacy of ASCVD risk- and symptom-based screening in identifying patients at risk for their first MI. Missing almost half of the at-risk population has serious public health implications…”
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Mueller et al.
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It can be difficult to handle cardiac MRI demand with backlogs and technologist shortages reaching all-time highs. Watch the latest episode of The Cardiac Wire Show to find out how Dr. Ned Danehy and his team at Radiology Regional are using Vista AI’s Automated MRI Scanning Software to reduce their backlogs while improving accuracy and workflows.
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Prevention guidelines might be failing younger patients, after a new JACC Advances analysis of first-MI patients under 65 revealed that over half would not have qualified for statins just two days before their cardiac event based on their ASCVD Risk Estimator Plus and PREVENT equations scores.
- Traditional cardiovascular risk assessment relies on population-level calculators that use biomarkers like LDL-C and BP to estimate 10-year ASCVD risk and statin therapy needs.
- Current ACC/AHA guidelines recommend intensive treatment only for patients classified as intermediate or high risk, leaving low-risk patients without preventive interventions.
Assessing these equations’ applicability to younger people, researchers examined 465 patients (81% male) aged ≤65 presenting with first MI at two large hospitals and simulated how current guideline-directed tools would have classified them just 48 hours before their cardiac event…
- Using ASCVD Risk Estimator Plus, 45% of MI patients would not have been recommended statins or imaging based on low 10-year risk scores, with one-third classified as low risk.
- The newer PREVENT equations performed even worse, missing 61% of MI patients who would have been classified as too low-risk for preventive interventions.
Beyond the equations, symptom-based screening also failed…
- 60% of patients had no chest pain or dyspnea until within 48 hours of MI presentation, with 54% experiencing chest pain for the first time only 24 hours before their event.
- None of these low-to-intermediate risk patients would have received statin recommendations under 2018’s ACC/AHA cholesterol management guidelines.
Despite guideline-directed risk assessment tools working well on the population level, they’re not the most capable at gauging a patient’s individual risk.
- Clinical events still occur in patients deemed low risk by current calculators, so we know risk-score approaches are limited.
- Low LDL-C also doesn’t provide any guarantees that a patient is free from ASCVD, since it’s not a form of direct disease detection.
The Takeaway
While we’ve seen many studies validate population-level risk equations in the past, this study is a reminder that patients are individuals, and more importantly, looking for disease using only biomarkers is like judging how good something tastes just by how it smells – it’s never the full picture.
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GLS Analysis of Us2.ai’s Fully-Automated Software
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9 Merge Cardio Features to Change Your Cardiology Workflows
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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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- Asundexian OCEANIC-STROKE Results: Bringing factor XIa inhibitors back into the spotlight, Bayer’s Phase III OCEANIC-STROKE study showed that asundexian significantly reduced ischemic stroke risk versus placebo when combined with antiplatelet therapy, without increasing major bleeding rates. This marks the first successful Phase III trial of a factor XIa inhibitor, and with ~12M annual strokes worldwide, asundexian could become a potential breakthrough in secondary stroke prevention. Bayer plans to pursue global marketing authorization following the study.
- BMS, J&J Call it Quits on Librexia ACS: In less positive factor XIa news, Bristol Myers Squibb and Johnson & Johnson discontinued their Phase 3 Librexia ACS trial that was evaluating milvexian for acute coronary syndrome after interim analysis showed it would unlikely meet primary efficacy endpoints. No new safety concerns emerged and the companies remain confident in milvexian’s potential while planning to continue its two other Phase 3 trials: Librexia AF (atrial fibrillation) and Librexia STROKE (secondary stroke prevention).
- CureMetrix Partners with Therapixel: CureMetrix signed a partnership with Therapixel that integrates each company’s mammography AI technologies. CureMetrix’s cmAngio software for calculating breast arterial calcification from mammograms will be available through Therapixel’s MammoScreen breast cancer AI software, giving users a two-for-one test to detect both breast cancer and cardiovascular disease in women.
- Canon Medical HIT’s DoD Contract: The Department of Defense awarded Canon Medical Informatics a contract to deploy its Vitrea Advanced Visualization imaging platform across DoD medical facilities. The system will consolidate multiple vendor softwares, supporting thousands of weekly imaging studies in radiology, cardiology, vascular, and oncology. The initiative aims to enhance interoperability, diagnostic consistency, and operational efficiency while reducing costs through automated workflows and unified data access across the Defense Health Agency network.
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- A New Guidewire Clearance: Transmural Systems received FDA 510(k) clearance for its TELLTALE electrosurgical guidewire system that prevents coronary obstruction during TAVR procedures. Using radiofrequency energy for precise leaflet modification, TELLTALE simplifies the NIH-pioneered BASILICA procedure for patients with native aortic stenosis or bioprosthetic valve failure. The device initially earned Breakthrough Device designation following a pivotal study that demonstrated safety while offering predictable outcomes for previously inoperable high-risk patients.
- AZ’s Next U.S. Investment: AstraZeneca announced it will invest $2B to expand its Maryland manufacturing facility, including doubling its biologics capacity at its Frederick facility and building a new Gaithersburg clinical supply site. The investment supports 2,600 jobs, strengthens the U.S. medicine supply chain, and enables domestic production of rare disease treatments. This marks AstraZeneca’s fourth major 2025 U.S. announcement under its $50B commitment.
- Integra Enters Cardiac Surgery: Integra LifeSciences received FDA 510(k) clearance for its CUSA Clarity Ultrasonic Surgical Aspirator System for cardiac surgeries, including valve replacement and repair procedures requiring tissue debridement. The CUSA device fragments, emulsifies, and aspirates soft and hard tissue across multiple types of surgical procedures with this clearance expanding the system’s indications to the cardiac space.
- JenaValve Notches a Win for Trilogy: JenaValve’s Trilogy valve could lead to substantial improvements in valve function, cardiac remodeling, and quality of life through two years. The ALIGN-AR study evaluated TAVR using the dedicated Trilogy valve in 700 high-surgical-risk patients with symptomatic moderate-to-severe aortic regurgitation and found that the device met both coprimary endpoints: 30-day safety composite (24.0%) and 1-year mortality (7.7%). Technical success reached 95%, with low rates of death (1.6%), stroke (1.7%), and residual regurgitation.
- Transplants are Safe After LVAD Infections: Results from a recent Duke University study suggest heart transplantation is safe for carefully selected patients with HM3 LVAD-associated infections, without increased short-term morbidity or mortality post-transplant. Researchers reviewed 115 HeartMate 3 LVAD (Abbott) patients who underwent heart transplantation between 2014-2024. Despite 51% having pre-transplant LVAD-specific infections, no significant differences emerged in one-year survival, hospital length of stay, acute rejection, or primary graft dysfunction compared to uninfected patients.
- Blood Culture Matters for Complications: A meta-analysis of 35 studies (17k patients) suggests blood culture status doesn’t affect survival but influences complication patterns and clinical presentation. Researchers compared blood culture-negative infective endocarditis (BCNIE) with blood culture-positive infective endocarditis (BCPIE) and found that short-term mortality showed no significant difference between groups (RR=0.95). However, BCNIE patients experienced higher rates of heart failure (RR=1.33) but fewer embolic events (RR=0.81) compared to BCPIE.
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What Every Cardiologist Needs to Watch for in Heart Failure
Patients with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF) face a high risk of hospitalization for heart failure and cardiovascular death, even with guideline-directed medical treatment. Hear from Bayer’s Dr. Alanna Morris-Simon as she shares common heart failure signs to look out for.
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Relieving The Burden of Post-Processing
With the advent of advanced imaging technologies like CCTA come added burdens to technologists and diagnostic imaging centers. See how PIA can relieve the burden of post-processing, saving you time while helping your bottom line.
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The Largest Registry on Plaque Analysis in CAD
What if 50% of your CCTA patients could benefit from an adjustment to their treatment plan? Read more about Heartflow’s DECIDE registry that demonstrates how Heartflow Plaque Analysis using its Plaque Staging software empowers physicians with clinical insights that lead to real-world impact.
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- Tempus Receives FDA 510(k) Clearance for Tempus ECG-Low EF: Tempus announces the expansion of its Tempus ECG-AI portfolio with Tempus ECG-Low EF, software intended for use to analyze 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%) in patients 40 years of age or older at risk of heart failure. It is not intended as a stand-alone diagnostic and positive results may suggest the need for further clinical evaluation. For Full Indications for Use, visit here.
- Why Competitors Benchmark Against Monebo’s ECG Algorithm: In the world of cardiac monitoring, it’s a big deal when your competitors use your technology as their benchmark for success. Learn why Monebo Technologies’ ECG analysis algorithm has been the “predicate device” of at least 13 other companies FDA 510(k) clearance regulatory filings and what this means for providers and their patients.
- The All in One Cardiac Imaging Solution: Ready for an all-in-one solution that supports all of your MR and CT needs? See how Circle Cardiovascular Imaging’s cvi42 can streamline your core reading and reporting workflows within a single, customizable platform.
- 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.
- Vista AI Grows CMR Volume: Are your patients waiting weeks or months for cardiac MRIs? See Brigham and Women’s Hospital’s real-world results showing how Vista AI’s software for automated MRI scanning led to 50% more scan slots, without adding more scanners or staff.
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