Christopher Labos MD, MSc in his case against “cholesterol denialism.”

Preventive Cardiology

America’s CKM Syndrome Problem

A new JAMA study revealed that a shocking 90% of US adults are at risk of developing cardiovascular-kidney-metabolic (CKM) syndrome, underscoring the need for preventative action before we face a wave of CKM-related heart disease.

• Officially published by the AHA six months ago, CKM syndrome defines the connections and risks associated with obesity, type 2 diabetes, chronic kidney disease, and cardiovascular disease.

The researchers analyzed 2011-2020 NHANES survey results and laboratory measurements from 10,762 nationally representative US adults (47.3yr avg. age, 51.8% women, 64.4% White) to assess their CKM stages, finding the following breakdown:

• Stage 0 (no risk factors) – 10.6%
• Stage 1 (overweight, prediabetes) – 25.9%
• Stage 2 (metabolic risk factors like hypertension, diabetes, CKD) – 49%
• Stage 3 (kidney disease or high cardiovascular risks) – 5.4%
• Stage 4 (heart disease, with or without kidney disease) – 9.2%

In other words, half of US adults have moderate CKM syndrome risks (Stage 2), and nearly a sixth of adult Americans already have advanced CKM syndrome (Stages 3 & 4). Yikes.

These rates stayed relatively stable throughout the study period, while certain groups were far more likely to have advanced stage CKM syndrome including those older than 65 (55.3% vs. 10.7% in 45-64yrs), men (16.9% vs. 12.4% in Women), and Black people (18.9% vs. 13.8% in Whites).

The Takeaway

Many Cardiac Wire readers shouldn’t be surprised by these numbers, noting the mounting evidence that diabetes, obesity, and hypertension rates are skyrocketing. However, the fact that 90% of US adults have high CKM syndrome risks is still shocking, and underscores the urgent need to improve CKM prevention and care.

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.

Advance Your Cardiac MR Visualization

Ready to advance your CMRI assessments? See how you could leverage TeraRecon’s Intuition Cardiac MR package for a range of cardiac anatomy and physiology evaluations, and how your peers are already benefiting from it.

The Wire

• New HCM Guidelines: The ACC and AHA’s updated hypertrophic cardiomyopathy guidelines feature a new recommendation for the use of myosin inhibitors (e.g. BMS’ Camzyos/mavacamten) in patients with symptomatic obstructive HCM who aren’t properly treated with first-line therapies. The updated guidelines also support moderate- to high-intensity recreational exercise, recommend assessing patients for their risk of sudden cardiac death (especially pediatric patients), and reiterate the importance of collaborative decision-making.

• Pediatric Hypertension Wake-Up Call: A retrospective population-based study in Canada (1996-2021) underscores the importance of routine screening for pediatric hypertension. The study followed 25k children with hypertension (aged 3-18 years) and 128k matched children without hypertension. Over 12.9 years, hypertension was associated with twice the risk of MACE and two to three times higher risk for stroke, hospitalization for MI or unstable angina, or congestive heart failure.

• Imaging AI Funding Down: Signify Research reports that imaging AI startups’ VC funding fell 19% to $627M in 2023 from just 35 deals, down significantly from 2022 ($771M, 50 deals) and 2021 ($1.1B, 63 deals). Cardiovascular imaging AI companies were among 2023’s fundraising leaders (namely HeartFlow’s $215M and Elucid’s $80M), while eight of the 15 most-funded imaging AI companies since 2015 place a heavy focus on cardiovascular and stroke imaging.

• inHEART Series A: Speaking of cardiovascular imaging AI funding, inHEART raised a $11M Series A round to drive the commercial expansion of its “digital twin” solution for cardiac ablation planning and support new product development. The funding comes just a few months after the FDA clearance of its ablation planning solution, which automates the segmentation of preprocedural CT and MR images to create 3D cardiac models. inHEART is also developing new solutions that guide heart failure treatment and predict sudden cardiac death and cardio-embolic stroke.

• Anteris DurAVR’s Strong Start: The Anteris DurAVR transcatheter valve is showing promise as a potential next-gen treatment for severe aortic stenosis. In late-breaking research presented at SCAI, DurAVR was successfully implanted in all 28 cases with excellent post-procedural hemodynamics, despite a small mean annulus size (effective orifice area of 2.17 cm² and a mean pressure gradient of 8.34 mmHg). The first-in-class biomimetic valve features single-piece leaflet geometry for optimal hemodynamics, ADAPT anti-calcification, and a balloon-expandable platform with open-cell geometry for coronary access.

• EHR + Echo AI for HF: EHR + Echo AI for HF: A new study out of Scotland showed that EHR data analytics and echocardiography AI could identify and classify patients with heart failure. The researchers used keyword searches combined with EHR filtering, and then applied Us2.ai’s echo AI solution to analyze historical echo images, before integrating analysis of routinely stored plasma samples. Out of 578 patients (236 w/ HFpEF,  156 w/ HFrEF, 186 controls), the HF patients had far more risk factors and AI-identified echo abnormalities, and unsurprisingly had worse outcomes over a three-year follow up.

• Refractory Angina Gene Therapy: Final Phase II data from the EXACT study suggests that XyloCor Therapeutics’ VEGF gene therapy XC001 (encoberminogene rezmadenovec) might be a promising treatment for patients with “no option” refractory angina. After 12 months, the study’s 32 patients showed an increase in exercise duration (+88.3 to 477.6 seconds), a decline in total myocardial perfusion (-10.2%), and less frequent angina (-8.8 episodes), while none reported severe adverse events.

• Evolut TAVR’s Age & Annulus Advantage: Medtronic added to its Evolut TAVR’s small annulus advantage at SCAI 2024, where new SMART trial analysis showed that the Evolut self-expanding valves’ 12-month advantages versus Edwards’ SAPIEN 3 balloon-expandable valves are consistent among patients both over and under 80 years old. The SMART trial was originally presented at ACC24, where it showed that the Evolut had much lower bioprosthetic-valve dysfunction and hemodynamic structural valve dysfunction in patients with small aortic annuli.

• Panera Pulls Charged Drinks: Panera announced plans to discontinue its caffeinated Charged Lemonade and Charged Sips drinks, following two cardiovascular-related wrongful-death lawsuits and one case alleging that the drinks caused a 28-year-old woman to develop AFib. The cancellation comes about two years after the Charged drinks launched, and ahead of the breadmaker’s IPO later this year. At 390 mg, a large Charged Lemonade has more caffeine than 3.5 cans of Red Bull.

• Anthos Factor XI Cost-Effective: A study presented at the ISPOR meeting found that Anthos Therapeutics’ investigational Factor XI-inhibiting anticoagulant, abelacimab, could reduce both care costs and bleeding. Using AZALEA-TIMI 71 study data, researchers calculated that abelacimab would save $50k and add 1.5 quality-adjusted life years per person compared to the DOAC rivaroxaban (J&J’s Xarelto). Based on reported bleeding rates, the economic study deemed abelacimab cost-effective, even when priced up to 20 times higher than rivaroxaban. 

• PCI Safe Before, During, and After TAVR: Using data from over 49k patients, researchers showed that PCI for stable CAD can be safely performed within 90 days before or after TAVR, or concomitantly during TAVR procedures. All-cause mortality was similar between the three groups at 3-year follow-up (34.8%-36.6%); however, event rates were markedly lower in those who underwent PCI before TAVR compared to simultaneous procedures.

Us2.ai’s Next Gen AI

Us2.ai recently scored FDA clearance for Us2.v2, the newest version of its flagship software featuring 45 automated echocardiography parameters, including strain analysis. See how the new version automates echo exams and improves cardiovascular disease detection.

Personalized Cardiac Care Through Science-Based Plaque Analysis

Check out Cleerly’s latest Cardiac Beat video, where National Jewish Health’s cardiovascular prevention and wellness leader, Dr. Andrew Freeman, and Cleerly founder and CEO, Dr. James Min, discuss addressing the root cause of heart disease and personalizing care through science-based plaque analysis.

The Resource Wire

• Automatic, Precise Analysis – From the First Beat: Monebo’s Kinetic ECG Algorithm leads with its versatility, precision, and efficiency, enabling a long list of use cases. See how it might impact your ECG monitoring clients here.

• Experience the future of learning: Medtronic Academy 2.0 is here! Unlock your ultimate destination for structural heart medical education with the newly redesigned Medtronic Academy 2.0. Gain access to expert-led courses, webinars, and a wealth of resources to stay ahead in cardiovascular care. Visit now!

• 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.

• HeartFlow FFRCT’s Real World Impact: See how HeartFlow FFRCT Analysis significantly improved NHS England’s patient outcomes and clinical efficiency in a massive real world implementation across 90k patients in this presentation by Newcastle University’s Professor Vijay Kunadian. 

• Better Cardiovascular Care, With a Better Bottom Line: Twenty million chest CTs are acquired in the U.S. each year, but CAC is typically unreported. See how you can leverage Bunkerhill Health’s Incidental CAC algorithm to screen for incidental coronary calcium on routine chest CTs in real-time, improving care and your bottom line.