Afshine Emrani, MD, FACC

A lot of people talk about AI’s potential, but few physicians out there are as involved in its day to day use as Ilya Karagodin, MD. That’s why it was very rewarding to talk to him about how his practice integrated Us2.ai’s AI-echo platform. You can give it a watch here.

Oh, also we have an oral PCSK9 inhibitor now for those with trypanophobia.

Cheers,

Vik

Cardiology Pharmaceuticals

An Oral PCSK9i and What it Means for Merck

PCSK9 inhibitors are some of the most effective LDL-lowering drugs out there, but they’ve all required injection, and some even refrigeration. That just changed, however, with the FDA’s approval of Merck’s Lipfendra (enlicitide), the first ever oral PCSK9i.

• Despite their overall efficacy, PCSK9is have struggled to gain widespread adoption, in some cases due to cost, and in others, payor logistics and convenience.
• Lipfendra comes as a once daily 20mg tablet, making it a convenient alternative to injectables that need dosing every 2-4 weeks or every three months by a professional.
• The approval comes with indications for adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).

Budding from the CORALreef trial series, including the Lipids and HeFH readouts, Lipfendra’s approval rests on a solid body of data that shows its robust LDL-C reduction ability.

• In CORALreef Lipids, LDL-C fell 57.1% in patients on Lipfendra versus a 3.0% increase with placebo at 24 weeks.
• That’s an adjusted between-group difference of 55.8%.
• Meanwhile, In CORALreef HeFH, the between-group LDL reduction was 59.4%.
• Both studies supported Lipfendra’s safety, though the HeFH group did face numerically higher but non-significant rates of diarrhea (7% vs. 2%) and dizziness (9% vs. 4%).

But a key piece of evidence is still missing. The trials to date establish Lipfendra’s LDL-lowering abilities, not cardiovascular event reduction.

• We still have to wait for the CORALreef Outcomes trial, to know whether Lipfendra actually reduces heart attacks and strokes.

That distinction is important, because it’s what’s actually going to move the needle for Merck as being seen as the go-to for most patients rather than an oral alternative.

• For example, the GLP-1 race taught us that while oral GLP-1s are more convenient, in many cases, some patients prefer the weekly injectables due to better results.
• That said, one study found that people are ambivalent about injections versus pills for their drug regimen.

And of course, pricing, insurance coverage, and payor opinions will factor heavily into whether or not a daily-oral formulation overtakes injectables.

The Takeaway

Being the first to an oral formulation can be its own way to win, and Merck achieved just that with Lipfendra’s approval. Now we just need the data from CORALreef Outcomes to know if it’s as good as its injectable peers.

Telemedicine Isn’t About Technology. It’s About People.

With temporary telehealth rules expiring, millions of Medicare patients may lose their ability to see their doctors remotely. Read why Monebo and the Alliance for Connected Care are urging Congress to make telemedicine a permanent part of the healthcare system.

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.

CA Diagnosis Using Echo AI

Diagnosing cardiac amyloidosis using echo can be challenging due to the imaging overlap between CA and more prevalent causes of cardiomyopathy. Read more about how Us2.ai’s echocardiographic score and fully automated deep-learning model overcome this challenge to enable better diagnosis.

The Wire

• Kerendia and the BP Question: A new FINEARTS-HF substudy published in JAMA clarifies an important question. Does Bayer’s HFpEF/HFmrEF drug, Kerendia, work well across the BP spectrum? The answer is yes, with researchers finding that Kerendia consistently reduced cardiovascular death and total HF events versus placebo, regardless of baseline systolic and diastolic BP. You can read our in-depth coverage here.

• First Single-Port MVR: Corewell Health performed the world’s first single-port robotic mitral valve repair, further streamlining a fix that once required open heart surgery. These days, surgeons almost always opt for the five-port method to address leaky mitral valves. It’s extremely safe and highly successful, but takes a while and can leave patients in pain. By using just one port and a tiny access incision, Corewell claims it has limited those downsides. 

• YEARS Shines In RCT: A new JAMA randomized controlled trial questions current guidelines for ruling out pulmonary embolism in cancer patients. Past research suggests the YEARS algorithm struggles to exclude PE in this group, but these latest results show a lower diagnostic failure rate than CT pulmonary angiography alone (1.8% vs. 5.5%) after 90 days. The findings were based on 698 patients, with a roughly even split between YEARS and just CTPA.

• Bunkerhill Lands $25M: Bunkerhill’s ascent continues with a $25M Series B, bringing its lifetime funding to $55M. The raise will help grow the company’s Carebricks agentic AI platform, which has already amassed an impressive client list with names like Cleveland Clinic and Intermountain Health. In March, the FDA cleared two of Bunkerhill’s AI solutions for calculating coronary and aortic valve calcium using contrast CT, bringing the number of risk detection and diagnostic algorithms embedded into Carebricks to nine.

• Synthetic CBD Soothes Pericarditis: A small JAHA study demonstrated pharmaceutically manufactured cannabidiol may have the potential to reduce pericarditis pain and recurrence. Phase 2 trial data from 27 patients showed a 3.7 point average pain reduction relative to an 11-point scale after eight weeks on the medication. Patients then continued taking CBD while stopping their baseline medications, and 71% of participants remained pericarditis free over an 18-week period. Phase 3 is ongoing and could have preliminary results by the end of 2026.  

• Emboline Triumphs Over AorticLab: A German court ruled that AorticLab’s embolic protection device did indeed infringe upon Emboline’s IP. The ruling goes against a January patent court verdict, which stated the AorticLab’s FLOWer didn’t violate the U.S. company’s European patent. Now, AorticLab must stop sales and recall FLOWer products throughout Germany, though the devices will remain available across Italy and France.

• LightningWire’s Not-So-Shocking Clearance: ElectroWire Medical’s LightningWire system received FDA clearance for its use in transseptal puncture and cardiac catheterization. Though the model boasts more stiffness than the market-leading 0.035-inch wire, it’s only the width of a grain of sand, enabling compatibility with many devices. Plus, LightningWire’s activation cable lowers infection risks by allowing control of radiofrequency from within the sterile field. Now, all that’s left is for LightningWire to strike the market with its initial limited release.

• A Reason to Skip Conferences? New data out of Australia suggests that acute MI patients hospitalized during a major cardiology conference may face a higher risk of death. Researchers compared roughly 25k acute MI patients admitted during the CSANZ annual meeting against patients admitted on identical weekdays up to four weeks before or after. The 30-day mortality rate was 11.3% for conference-period admissions versus 9.7% otherwise, though six-month mortality was comparable. The authors stress the data can’t prove causation, but speculate that staff absences may delay critical treatments.

• Cardiologist’s UPMC Suit Ends: The lawsuit that interventional cardiologist Hemal Gada filed against the University of Pittsburgh Medical Center (UPMC) following his 2025 termination has been dismissed with prejudice by mutual agreement. Gada had alleged he was fired not for performance but rather raising concerns with UPMC’s ethics office about the CEO’s close relationship with Edwards Lifesciences. UPMC countered that he was terminated over how he treated coworkers. Under the resolution, both sides agreed to bear their own costs.

• Bayer & Henry Ford: Bayer and Henry Ford Health announced a clinical trials partnership, making Henry Ford one of only four U.S. academic health systems selected for Bayer’s research network. Bayer will combine its drug development process with Henry Ford’s clinical research program and community reach, aiming to streamline trial enrollment while also using EHR data for better insights. The partnership’s initial focus areas include cardiovascular and renal disease. The deal follows Bayer’s first such alliance, announced in July with UC Anschutz and its partners.

• IHD Death Progress is Stalling: A new Global Burden of Disease analysis found that while U.S. deaths from ischemic heart disease have fallen for over three decades, that progress is now slowing, especially in younger demographics. Although national IHD mortality dropped roughly 58-61% over the full study period, the decline in deaths has slowed sharply to about 19-25% since 2013. The researchers estimate that 89% of U.S. IHD deaths are attributable to modifiable risk factors, led by elevated systolic BP, diet, and high LDL-C.

Heart Failure Places Enormous Strain on our Healthcare Systems and Patients

There are 3.7 million US patients with HFpEF or HFmrEF, with prevalence only expected to rise. To learn more about the heart failure landscape and Bayer’s commitment to addressing patient unmet need, watch the video here.

Fujifilm’s Ultrasound for every Cardiovascular Ultrasound Environment

From academia to clinical diagnostics, versatility in cardiac ultrasound is essential. Discover why clinicians are choosing Fujifilm’s LISENDO 880 for exceptional image quality, comprehensive strain analysis, stress imaging, and innovative Virtual Contrast technology — all while delivering outstanding value.

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.

The Resource Wire

• State-of-the-Art Cardiac Monitoring at Scale: Cleared for 13 different heart rhythm interpretations, AccurKardia’s AccurECG 2.0 shortens the time from an arrhythmia incident to clinical intervention. Watch here to find out how AccurKardia and Specialized Medical are teaming up to bring the AccurECG 2.0 technology to clinicians across the U.S. 

• Circle CVI’s CAD-RADS Rundown: Ever wondered how CAD-RADS enhance the communication of coronary artery disease findings from imaging studies? Check out this guide from Circle Cardiovascular Imaging about the evolution of CAD-RADS and how to incorporate them into your practice.

• The Power of AI in Cardiovascular Imaging: Cardiac labs are under more pressure than ever to deliver more with greater speed and precision. Hear from ACUSON Origin customer, Tony Gallagher about how Siemens Healthineers’ cardiovascular ultrasound system is improving exam efficiency and showing positive impact on ROI.

• How Automated MRI Software Transformed Radiology Regional: Radiology Regional recently integrated automated MRI scanning software into their imaging practice imaging. Hear from their team how automating CMR scans transformed their practice and enhanced patient care.

• Merge Hemo Expands to Puerto Rico: Merge partnered with Alpha Biomedical to bring Merge Hemo to Puerto Rico, marking the software’s first expansion outside the 50 U.S. states. Read more about the work Merge is doing to expand access to its award winning solutions beyond the United States.

The Industry Wire

1. Biopharma firms ride high into Q2 earnings season. 
2. UnitedHealthcare beats expectations with Q2 financials. 
3. Are payors backing away from pledges to reform prior authorization? 
4. U.S. Senate votes to save WISeR prior auth pilot project.
5. Hospitals look for help to automate RCM processes. 
6. FDA officials retreat from policy guidelines from previous officials. 
7. Is data on ultrasound-directed gene therapy “too good to be true?”
8. Deaths from coronary artery disease fall in U.S. 
9. Editors at diabetes journal rebel after claiming censorship. 
10. California farm linked to cyclosporiasis outbreak preps wider recall.