Joseph Marine, MD.

The cardiac CT space is booming with new software that quantifies and characterizes plaque, but only one uncovers plaque morphology based on ground-truth histology. Watch this episode of The Cardiac Wire Show to learn from Dr. Robert Pelberg, MD and Dr. Mark Berlacher, MD about Elucid’s non-invasive plaque analysis.

Cardiology Pharmaceuticals

AstraZeneca’s Anselamimab Comes Up Short in Phase 3 Trial

In a setback to one of its rarer disease pipelines, AstraZeneca’s amyloidosis antibody, anselamimab, failed to significantly reduce all-cause mortality and CV hospitalizations in the CARES Phase 3 trial’s overall patient population.

• AL amyloidosis is a rare disease (only about 70k people worldwide) where misfolded light chain proteins form toxic amyloid deposits in the heart and kidneys.
• These deposits cause progressive organ damage and dysfunction, often leading to death from cardiac failure.
• Current treatments focus on plasma cell dyscrasia but don’t address existing amyloid deposits that damage organs.

 The CARES clinical program was the largest prospective cardiac AL amyloidosis investigation to date, enrolling 406 patients to test whether anselamimab could reduce all-cause mortality and cardiovascular hospitalizations when added to standard background therapy.

• All patients had Mayo disease stages IIIa (281 patients) and IIIb (125 patients), which are considered the most advanced.
• Treatment with anselamimab was administered weekly for 4 weeks, then every 2 weeks for 18 months but led to no significant improvements in mortality or hospitalization rates.

However, despite the overall trial not reaching statistical significance, researchers identified meaningful clinical benefits in a “prespecified patient subgroup” that experienced extended survival and fewer cardiovascular hospitalizations compared to placebo.

• The subgroup analysis was planned before the trial began, lending credibility to the findings.
• That said, AstraZeneca has not released any description or data regarding this patient subgroup.

So what do these mixed results mean for AstraZeneca? 

• While anselamimab didn’t achieve broad efficacy across all patients, the meaningful benefits seen in a defined subgroup suggest it could still fill a critical treatment gap.
• AstraZeneca didn’t reveal its plans for anselamimab, but will still share this data with global health authorities and present it at a coming medical meeting.

The Takeaway

It’s never easy when a drug fails to meet expectations in later stage trials and while we don’t have the full data yet, AstraZeneca’s update makes it seem like anselamimab’s scope could be even more limited than intended. Hopefully we’ll learn more about the patient subgroup that significantly benefitted from the drug in case AZ pivots its efforts to them.

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.

Streamline Your Cardiology Imaging Workflows

See how cardiologists and their teams can streamline imaging workflows to make their cardiovascular service line more efficient, cost-effective, and patient-centered, using Merge’s cardiology solutions.

Discover The Monebo Advantage

Need complex ECG monitoring algorithms for use in a variety of applications? Here are just a few reasons why companies across the healthcare spectrum rely on Monebo to power their ECG monitoring and analysis.

The Wire

• GDMT Improves HF LEF: A JACC study of 28k patients with HFrEF suggests GDMT helped almost a third of patients reach an improved ejection fraction (HFimpEF) within 12 months, with some exceptions. Despite these improvements, HFimpEF patients had worsening HF rates of 17.4 per 100 person-years and death rates of 5.7 per 100 person-years, but this was still lower than persistent HFrEF patients. The study also found that GDMT use decreased after HFimpEF diagnosis, suggesting need for continued treatment optimization.

• Vektor vMap Hits 2k Procedures: Vektor Medical announced that its FDA-cleared vMap system reached 2,000 procedures in the United States, demonstrating increasing adoption by electrophysiologists for uncovering AFib across the heart. The AI-powered system localizes arrhythmias in all four heart chambers within one minute, helping reduce procedure times and improve patient outcomes. Clinical studies show vMap can decrease fluoroscopy time and potentially reduce repeat interventions.

• Roche Cuts CT-173 Development: Roche discontinued CT-173, an obesity drug from its $2.7B Carmot acquisition, despite previously touting its potential to avoid the usual GLP-1 weight loss plateaus. The company cited lack of competitiveness and developability and also axed four unrelated phase 1 programs including three solid tumor assets and an eye disease candidate. The cuts are part of portfolio reprioritization towards high-value areas like other obesity solutions and Alzheimer’s.

• USPSTF On the Chopping Block? HHS Secretary Robert F. Kennedy, Jr. is reportedly mulling changes to the USPSTF that could include firing all 16 members of the advisory panel and replacing them with his own picks. USPSTF consists of clinicians who volunteer for the panel to provide guidance on preventive care issues like screening, and payors must cover USPSTF-recommended exams without requiring patient co-pays. Medical groups like the AMA have gone on record opposing any change to the current USPSTF panel.

• Stereotaxis’ FDA Clearance: Stereotaxis received FDA 510(k) clearance for its Magic Sweep navigation device, touted as the world’s first robotically navigated high-density EP mapping catheter. The 20-electrode device enables rapid, detailed heart chamber mapping for cardiac ablation procedures and integrates with Stereotaxis’ robotic systems for precise navigation. This marks Stereotaxis’s first FDA clearance for an interventional catheter in nearly 20 years, and comes shortly after the company raised $12.5M through institutional investors and an industry partner.

• Dapagliflozin + Spironolactone = Better HF: Combining dapagliflozin and spironolactone for treating HF could be more effective than dapagliflozin alone, but not without side effects. A randomized crossover trial of 108 HF patients compared a dapagliflozin/spironolactone combination to dapagliflozin alone and found the combo reduced NT-proBNP levels by 11% more while lowering SBP (-5.2 mmHg) and urinary albumin over 12-weeks. However, the combo decreased kidney function (eGFR: -6.4 mL/min/1.73m²) and increased potassium levels.

• Rocket Begins Layoffs, Pivots to CV Pipeline: Rocket Pharmaceuticals will lay off 30% of its workforce and narrow its focus to cardiovascular programs after a patient death in its Danon disease gene therapy trial prompted an FDA hold. Now the company plans to prioritize its AAV platform and cardiovascular assets while deprioritizing hematology programs. Rocket believes the restructuring will extend its cash runway into Q2 2027, while delaying FDA approval timelines for other drugs.

• AHA Ventures Backs Auxira: Partnering with the AHA’s venture arm, Auxira Health plans to expand cardiology practices’ access to its white-label telehealth staffing solution. The startup virtually embeds clinical support teams (APPs, nurses, medical assistants) into existing workflows, handling lower-acuity tasks to help cardiologists focus on complex care. Auxira’s current results include 37% increased capacity, 14% improved patient satisfaction, and 35% reduced after-hours work.

• Get Those Steps In: New research published in The Lancet Public Health seems to support RFK’s mission of strapping wearables to everyone’s wrist. The systematic review of 57 studies found that 7,000 daily steps is the magic number for health outcomes, with participants that reached that threshold seeing a significantly lower risk of all-cause mortality (-47%), dementia (-38%), cardiovascular disease (-25%), and type 2 diabetes (-14%).

• USG Cracks Down on Ultra-Processing: The HHS, FDA, and USDA launched an initiative to reduce American consumption of ultra-processed foods, which research links to cardiovascular disease, type 2 diabetes, obesity, and other health conditions. The first phase of the initiative involves creating a uniform definition to guide researchers and policymakers and considers ultra-processed foods anything from packaged snacks, to sugary drinks, cereals, and frozen dinners that undergo industrial processing.

• The Best Cardiology Hospitals: NYU Langone claimed the No. 1 spot for cardiology, heart surgery, and vascular surgery in U.S. News & World Report’s Best Hospitals rankings, ending Cleveland Clinic’s five-year reign. Mount Sinai Hospital ranked No. 2, with Cleveland Clinic dropping to No. 3. The rankings analyzed data from nearly 4,500 facilities and are weighted based on patient outcomes (45%), hospital structure (35%), expert opinion surveys (12%), patient experience (5%), and transparency initiatives (3%).

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.

Redefining Percutaneous Coronary Intervention

Learn about the AGENT™ Drug-Coated Balloon from Boston Scientific and how this technology is expanding the treatment options for patients with in-stent restenosis in the U.S. Rx only. (Sponsored by Boston Scientific)

The Resource Wire

• 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.

• 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 workflows.

• Patient Attitudes Towards Us2.ai’s AI-Echo: The medical imaging field is rapidly accepting AI, but how are patients feeling about the shift? Get the scoop on patients’ positive opinions toward Us2.ai’s software that supports task shifting from conventional echo to AI-echo.

• Personalized Plaque Analysis Now With Medicare Coverage: 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.

• A Single Cardiac Service Line Platform: Transitioning across multiple imaging platforms is a daily reality for many cardiologists, but it doesn’t have to be. See how three leading cardiac imagers are leveraging Circle CVI’s unified multi-modal software across their diverse caseloads, without switching to other platforms.

• 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. 

• Automate Your Echo Reporting: It’s a good feeling when your echo report is already 83% complete before you even sit down to work on it. See how Centricity Cardio Enterprise’s echo automation features make this “good feeling” an everyday occurrence in this quick GE HealthCare demo video.

The Industry Wire

1. Humana raises outlook as it navigates high medical costs.
2. Tariffs on European medicines could cost drugmakers billions.
3. Elevance names former Cencora CEO to board.
4. White House, CMS launch initiative to spur use of digital health.
5. US Senate confirms Susan Monarez as CDC director.
6. FDA’s top vaccine official, Vinay Prasad, out after 3 months.
7. Medicare Part D premiums likely to increase next year.
8. Astrana Health CEO on value-based care letdowns.
9. UVM Health lays off dozens.
10. How hospital ‘harm events’ slip through the cracks.