Writer, Ruxandra Teslo on how difficult FDA regulations can be.

There was an indie-folk band called “The Head and The Heart” that was pretty popular a few years back. Maybe they were onto something with their name since today’s top story explores a CVD link between the two.

Cheers and thanks for stopping by,

Vik

Cardiovascular Disease

Low Blood Pressure’s Alzheimer’s Link

Hypertension has long been tied to cognitive decline, but new research in JAHA suggests it’s actually hypotension that carries the strongest association with Alzheimer’s disease.

• Traditionally, hypertension negatively impacts cognition by damaging cerebral blood vessels, accelerating brain atrophy, and triggering neuroinflammation.
• However, hypotension can also lead to similar brain impacts by reducing how much blood is delivered to the brain.

To map the relationship between CVD subtypes and Alzheimer’s risk, researchers analyzed EHR data across a UK Biobank and All of Us cohort to examine a wide range of cardiovascular diagnoses and their association with Alzheimer’s using ICD-10 codes.

• Hypotension showed the strongest association with Alzheimer’s in both UK Biobank and All of Us (OR: 2.74 and 1.97, respectively).
• Hypertension ranked second in the UK Biobank (OR: 1.57), followed by cardiac arrhythmias (1.52) and cerebral infarction (1.49).
• In the All of Us cohort, cerebral infarction had the second strongest association (1.85), with hypertension close behind (1.65).

Race and ethnicity also modified the associations in a meaningful way, suggesting the dominant pathway may differ by population.

• Hypotension was most strongly linked to Alzheimer’s in white individuals, while hypertension held the strongest association in Black and Hispanic individuals.
• The researchers attribute this partly to higher rates of uncontrolled hypertension in Black and Hispanic populations.

A genetic proximity analysis added another layer, identifying shared genomic locations between Alzheimer’s disease and CVD-related traits.

• These locations were most prominently near the APOE, MAPT, SPI1, and WNT3 genes.
• APOE stands out given its established roles in lipid metabolism, blood-brain barrier integrity, and both cardiovascular and neurodegenerative disease.

All that said, this hypotension finding warrants careful interpretation. For example, low blood pressure can reflect frailty, heart failure, or prior hypertension treatment, any of which independently elevates dementia risk.

• The study’s cross-sectional design and reliance on ICD-10 coding for hypotension also limit causality conclusions.

The Takeaway

It’s becoming clearer and clearer that heart and brain health are inseparably linked. Although which exact CVD risk factors cause which neurological effects is still being explored, this study makes a strong case for keeping an eye on hypotension.

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.

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.

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

• No Longer the “Forgotten Valve”: The FDA cleared the Edwards Lifesciences Triformis Resilia, making it the first surgical tricuspid valve replacement designed for tricuspid valve disease. The device includes a flat-profile “sewing ring” that mimics the tricuspid annulus and commissure, as well as septal markers to help with positioning. Triformis also comes with Edwards’ anti-calcification Resilia bovine pericardial tissue. Notably, the FDA cleared it without a pivotal trial, instead relying on a retrospective analysis of 204 patients who received off-label tricuspid replacements from 2016 to 2024.

• SCOTUS Backs the Skinny Label: The U.S. Supreme Court unanimously sided with Hikma Pharmaceuticals in a closely watched patent fight with Amarin Pharma over Hikma’s generic version of icosapent ethyl, the active ingredient in Amarin’s Vascepa. At issue was Hikma’s “skinny label,” which carved its generic down to the older severe hypertriglyceridemia indication while omitting Vascepa’s still-patented cardiovascular-risk-reduction use. The ruling clears Hikma to sell its version in the U.S., reinforcing the skinny-label pathway for launching generics against drugs with other indications under patent.

• The Heart-Mind Comorbidity: A new Nature analysis examined why anxiety and mood disorders (AMD) often occur alongside CVD, finding that the two have shared risk mechanisms. Per the study, the comorbidity link is largely mediated by genetic and environmental effects that span biological, behavioral, psychological, and social causes. The study also claims AMD impacts CVD risk, while CVD has no impact on a person’s AMD risk. If further studies support this link, patients with both conditions could benefit from a collaborative care approach.

• Next Gen Heart Rate Tracking: Google just unveiled a new way for people to better understand their heart health using the cameras they already have in their pocket. The Nature paper introduced a PHRM system that passively tracks HR and resting-HR using front-facing smartphone cameras to capture video of the user’s face in the seconds after face unlock events. PHRM applies deep learning to estimate HR with a mean absolute percentage error <10% compared to ECGs, then integrates the HR measurements into an RHR estimate with a mean absolute error of less than 5 beats per minute (comparable to most wearables). 

• FDA Clears Clarius Ejection Fraction AI: Clarius Mobile Health received FDA clearance for its Ejection Fraction AI, a cardiac ultrasound tool that automatically calculates LVEF in real time within the Clarius App. Available on the company’s PA, PAL, and C3 HD3 wireless scanners, the software provides an objective measure of cardiac function from standard cardiac views, reducing reliance on visual estimation and supporting faster point-of-care decision-making in primary care, emergency medicine, and underserved settings.

• CT Shows Air Pollution’s Effect on Cardiac Function: Cardiac CT scans demonstrated air pollution’s negative effects on heart function in a new Radiology study. Researchers tracked 11.1k people in Ontario, Canada who got cardiac CT scans and correlated metrics like coronary artery calcium and plaque burden to atmospheric particulate exposure. People with greater pollution exposure had 11% higher rates of CAC and 13% higher rates of total plaque burden, and women had 81% higher odds of obstructive CAD – a relationship that was not statistically significant in men.

• Study Supports BAC’s Predictive Power: Breast arterial calcification can predict future heart problems in women, even in those with no history of MACE. As part of a recent study, researchers derived BAC levels from digital mammograms of 4.3k women without MACE histories, finding a BAC prevalence of 8.04% – compared to 13%-17% in recent studies that included patients with MACE. BAC presence could be the first sign that women without symptoms should be referred for additional cardiovascular workup.

• Going After the Leadless Leaders: Biotronik announced the first U.S. implant of its LivIQ leadless pacemaker as part of its BIO-LivIQ global pivotal trial. The next-generation, single-device system is designed to deliver atrioventricular (AV) synchrony through advanced electrical atrial far-field sensing, paired with a maneuverable catheter for placement. Biotronik says it would be the world’s first intracardiac pacemaker to enable AV-synchronous pacing both at rest and during exercise from a single implantable device.

• Star Trek Star Verdict: A New Mexico jury awarded the family of actor Nichelle Nichols, who played Lt. Uhura on the original Star Trek, a $13M verdict in their medical malpractice case against Gila Regional Medical Center. The family alleged that when the 89-year-old sought treatment at the hospital in 2022, doctors failed to diagnose her congestive heart failure and discharged her to an assisted living center where she died three hours later. Though the jury awarded $13M, New Mexico law caps awards against hospitals owned by governmental agencies, like Gila, at $400k.

• Funding the Runway to Approval: BioCardia raised capital through the sale of 3.5M shares for a total of $4.4M to bring its cellular heart failure therapeutics to market. The company says the net proceeds, combined with outstanding warrants from prior financing, should extend its cash runway well beyond an anticipated first market approval in 2027 and through initial commercial sales. BioCardia plans to file its Japanese market submission for CardiAMP HF with the PMDA for final review by Q4 2026.

• A PET Scan for Stubborn Hypertension: Pentixapharm received FDA clearance of its IND application for Ga-PentixaFor, a CXCR4-targeted PET/CT imaging agent aimed at identifying primary aldosteronism in patients with treatment-resistant hypertension. The clearance authorizes the company to launch its U.S.-focused, multi-center Phase 3 PANDA study, with the design shaped by prior FDA feedback from a Type B pre-IND meeting.

Heart Failure Hospitalization Doubles Risk of Cardiovascular Death

21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or cardiovascular death, and 25% of those who experience hospitalization are readmitted due to heart failure within one year of discharge. Watch Bayer’s Dr. Alanna Morris-Simon discuss heart failure hospitalizations and when to assess care plans.

Staying ALERT with Tempus

Undertreatment and time to treatment of valvular heart disease are among the biggest challenges health systems face today, but Tempus’ AI-driven EHR notifications can change that. Read the results of Medtronic and Tempus’ ALERT trial which found that delivering data directly to providers resulted in a 40% relative increase in life-saving valve procedures.

From Fetal to Adult Cardiovascular Ultrasound

Continuity of care is critical when it comes to a patient’s cardiovascular health. That’s why cardiologists across America are picking Fujifilm’s Lisendo 880 cardiovascular ultrasound for its versatility and precise imaging starting at a patient’s fetal development to adulthood.

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.

• Beyond the Calcium Score with Circle CVI: The coronary artery calcium score has been the non-invasive gold standard for a quick look at heart disease risk, but it only tells part of the story. Learn more about how Circle Cardiovascular Imaging is using AI-enabled coronary plaque analysis to redefine heart risk beyond what a CAC score can tell us.

• 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 AI Expands the Role of CMR Experts: If you’re an MRI technologist, AI could be the best thing that ever happened to your career. Read here to learn about the benefits of AI for CMR experts and how it can accelerate both your training and career.

• Merge Cardio 12.5 is Officially Available! From AI-generated echo measurements to upgraded UI and reports, Merge Cardio 12.5 brings a long list of new innovations to the table.Find out more about how Merge Cardio’s latest version streamlines workflows to make your cardiovascular service line more cost-effective and patient-centered.

The Industry Wire

1. AMA swears in new president.
2. Don’t call physicians “providers”.
3. AMA urges exemptions in Medicaid work requirements.
4. House moves toward blocking Medicare AI prior authorizations.
5. Nearly 600 confirmed Ebola cases in Congo.
6. Three ways GLP-1s are getting better.
7. OB-GYN group recommends vaccines for the first time.
8. Debate over drinking study spirals into politics.
9. UPMC eliminates 500 positions.
10. Planned Parenthood clinics close amid funding restrictions.