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Kerendia comes to HF, PREVENT underperforms, and Women’s Hypertension
July 17, 2025
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Together with
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“We have mammograms & colonoscopies, but no equivalent screening for the most common cause of death: heart disease. Heart failure, valve disease, and PH are often diagnosed late.
Echo is the gold standard, but is expensive, limiting use… We need a scalable screen.
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Pierre Elias, MD
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The demand for cardiac imaging has never been higher, which means cardiologists, radiologists, and imaging teams are facing heavier workloads than ever before. Watch this episode of the Cardiac Wire Show to learn about how Dr. Lee Mitsumori partnered with PIA Medical for his cardiac image post-processing and saved hours of his team’s time.
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Cardiology Pharmaceuticals
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One of the hardest-to-treat cardiac conditions just got a little more hopeful as the FDA approved Bayer’s KERENDIA (finerenone) for treating heart failure patients with left ventricular ejection fraction ≥40%, marking the first new pharmaceutical option for HF in years.
- KERENDIA is a non-steroidal mineralocorticoid receptor antagonist that blocks receptor overactivation in the heart and kidneys
- The drug has been approved since July 2021 for chronic kidney disease associated with type 2 diabetes, with several studies examining its HF impacts since.
While not originally intended for HF, KERENDIA’s approval stems from the 6k patient Phase III FINEARTS-HF trial during which the drug demonstrated a 16% relative risk reduction in cardiovascular death and total HF events.
Follow-up sub-analyses also found that…
- KERENDIA lowered the risk of CV events most in patients enrolled within one week (RR: 0.74) or three months of WHF (RR: 0.79).
- The drug also significantly improved KCCQ from baseline by an average of 1.62 points at 12 months.
- It also appears effective regardless of baseline bodyweight and reduces CV death and HF events across all BMI groups.
That’s exciting stuff from a drug that treats a disease it wasn’t designed for, but it still has some side effects worth noting when compared to placebo.
- Main adverse reactions included hyperkalemia (9.7% vs 4.2% placebo), hypotension (7.6% vs 4.7%), hyponatremia (1.9% vs 0.9%), and worsening renal function events (18% vs 12%).
- Nearly a quarter of finerenone patients experienced a ≥15% decline in eGFR compared to 13.4% on placebo.
- Notably, eGFR decline was associated with higher risk of CV death and HF events in patients on placebo but not in those on finerenone (aRR: 1.07 vs. 1.50).
The Takeaway
Bayer’s KERENDIA approval represents the first new treatment option specifically approved for an HF population that includes up to 3.7M people in the U.S. alone, and could become a core part of the comprehensive care these patients need.
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Cracking the Code of ECG Analysis with Monebo’s AI Genetic Algorithm
How do you teach a computer to recognize the complex patterns in an ECG signal? Discover how Monebo found the answer by blending human expertise and a little evolutionary magic in this article that breaks down the advantages of genetic algorithms in ECG analysis.
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CMR Access Is Broken — Here’s How to Fix It
Cardiac MRI is one of the most powerful tools for diagnosing heart disease, yet it’s still out of reach for many patients. Download Vista AI’s new infographic to see what’s holding CMR adoption back—and how AI and automation can help make gold-standard imaging more accessible than ever.
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- Cardio Diagnostics + AGEPHA: Cardio Diagnostics partnered with AGEPHA Pharma to conduct a clinical study exploring precision-guided treatment for inflammation-driven coronary heart disease (CHD). AGEPHA will supply LODOCO (low-dose colchicine) for the research, which will use Cardio Diagnostics’ PrecisionCHD AI-powered genetic-epigenetic blood test to identify patients with inflammation-driven CHD and assess their response to anti-inflammatory treatment. The study represents a precision medicine approach where both diagnosis and treatment are guided by patients’ unique molecular insights.
- BP Pill Before Bed? Adding to the bedtime BP pill debate, a recent RCT suggests taking hypertension meds before bed could be the better way to go. The study compared morning versus bedtime dosing of antihypertensive medication (olmesartan + amlodipine) in 720 patients and found the bedtime dosing group achieved significantly better nighttime blood pressure control and improved circadian rhythm compared to morning dosing. Nighttime dosing also led to a 3.0 mmHg greater reduction in nighttime systolic blood pressure with no increased risk of nocturnal hypotension.
- Cardio AI Clearance Boom: A new FDA report showed that when it comes to clearances for medical AI, cardiology is second only to radiology. To date, the FDA has cleared approximately 1,250 clinical AI algorithms for direct patient care in the United States, with over 1,000 focused on medical imaging. Cardiology makes up 116 of these AI algorithms (184 if you include cardiac-specific imaging AI). It also looks like the momentum isn’t slowing down, with the approval rate now reaching 30 per month in recent months compared to 13.5 in 2022 and 7 in 2019 (May 2025 saw a record 39 new AI clearances).
- A New CA-Echo AI: Researchers developed a new AI screening algorithm that uses transthoracic echocardiography to differentiate cardiac amyloidosis (CA) from similar phenotypes. The algorithm was trained on apical four-chamber video clips and validated across 18 global sites with 597 CA cases and 2,122 controls. It achieved strong detection performance with 93% AUC, 85% sensitivity, and 93% specificity, outperforming existing clinical scoring systems while maintaining accuracy across all CA subtypes and patient demographics.
- CorWave’s First Patient: A heart team in Australia has completed the world’s first implantation of CorWave’s new left ventricular assist device (LVAD. The device uses advanced wave membrane technology that works in harmony with the patient’s heart, adjusting blood flow as needed and preserving natural pulse. The procedure was performed at St. Vincent’s Hospital in Sydney on an advanced heart failure patient who has since been discharged and is recovering at home with improved quality of life.
- BP Remains a Burden: An updated JACC forecasting study using Global Burden of Disease 2021 data gives the cardiac care community some unsurprising insights. According to the report, high systolic BP will remain the leading contributor to disability-adjusted life years (DALYs) in 2050, followed by high cholesterol, BMI, tobacco use, and glucose. Researchers also predict age-standardized DALY rates will decline across all risk factors, while crude DALYs will rise due to population growth and aging.
- AMA FIghts Scope Creep: The AMA recently reported that it has achieved 180 scope of practice victories nationwide, opposing the inappropriate expansion of medical practice rights to non-physicians with sub-optimal training. Per the report, the AMA is continuing to fight state and local bills that would allow nurse practitioners, physician assistants, optometrists, pharmacists, psychologists, and naturopaths to perform procedures or prescribe medications traditionally requiring physician oversight. Despite successes, the AMA faces growing resistance, with record numbers of scope expansion bills in 2023 and 2024.
- Geneticure’s New Patent: Geneticure was granted a U.S. Patent (No. 12,351,873) for its genetic-based weighted algorithm model that predicts patient response to renal denervation, a minimally invasive hypertension treatment. The patent will help protect Geneticure’s method of using genetic profiles to identify patients most likely to benefit from the procedure, addressing the different blood pressure responses seen across patient groups. Geneticure believes the patent will support its mission to eliminate trial-and-error approaches in hypertension treatment.
- PREVENT Potentially Underperforms: Casting doubt on the AHA’s new PREVENT equations, a recent study suggests they might not be as effective as thought at predicting future CVD risk. Published in JACC, the study analyzed data from 270k patients and found that applying the PREVENT equations led to moderate discrimination (C-index 0.69-0.74) but showed mixed calibration across systems, generally underestimating actual cardiovascular events. While PREVENT showed some improvements over other predictive equations, its accuracy was inconsistent across different healthcare settings and patient demographics.
- FDA Clears TAVI Guidance Software: The FDA cleared software from French medical device developer Caranx Medical for intraoperative guidance of transcatheter heart valve implantation. Caranx’s TAVIPILOT Soft targets the $8B market for TAVI procedures and aims to make the procedure available to additional patients and interventional cardiology centers. The AI solution enables real-time intraoperative guidance using medical images and anatomical and instrument landmarks. Caranx is also developing an autonomous robot designed to assist with TAVI procedures.
- China Woes Force Imaging OEMs to Shift Strategies: Big medical imaging OEMs are shifting their manufacturing strategies due to lower sales in China, but they still see the country as an important market. That’s according to an article in Medical Buyer that profiles activities of GE HealthCare, Siemens Healthineers, and Philips. Each saw double-digit declines in China revenues and are concerned about the impact of tariffs, but are stepping up efforts to streamline supply chains and cut costs due to the country’s long-term growth potential.
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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.
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How to Improve Cardiology Workflows and Get More Patient Time
Complex processes and reporting requirements can mean cardiologists spend more time with clinical systems than they do with their patients. See how Merge Hemo and Merge Cardio work together to help you streamline and scale your clinical and data management workflows, so you can have more time in front of your patients.
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LVAD therapy receives 1A Recommendation for inotrope-dependent patients
The U.S. joint societies of the AHA/ACC/HFSA have given LVAD therapy a 1A Recommendation for heart failure patients dependent on intravenous inotropes or who cannot be weaned from temporary mechanical circulatory support. As both the strongest class of recommendation and highest level of evidence, a 1A Recommendation indicates LVAD therapy is supported by strong data and the benefits far outweigh the risks.
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- PIA Medical Processes It All: Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.
- A Universal View of Your Patient: Think you’re getting the most out of your viewer? See how GE HealthCare’s Centricity Cardio Enterprise Universal Viewer allows you to quickly review exams, access and compare prior studies, and perform measurements in this 60-second video.
- 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.
- Discover Innovation in Intervention: Explore how the AGENT™ Drug-Coated Balloon from Boston Scientific is advancing U.S.-based treatment options for patients with coronary artery disease. Rx Only. (Sponsored by Boston Scientific)
- 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.
- 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.
- Us2.ai’s Echo Automation Impact: Improving clinician efficiency and quality is the goal for most AI solutions, but we rarely see AI achieve both. See how the AI-ECHO RCT used Us2.ai to achieve both of those goals, while reducing sonographer fatigue in the process.
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