Salim S. Virani, MD, PhD, on the US’ slow LDL-C improvements.

Population Health

America’s Cholesterol Awareness Problem

The prevalence of US adults with high LDL cholesterol levels, and the prevalence of adults who are unaware of their high LDL-C are both declining. However, these improvements aren’t happening nearly fast enough – especially given our expanding cholesterol treatment options.

That’s the takeaway from a new JAMA Cardiology Research Letter analyzing National Health and Nutrition Examination Survey data from 23,667 US adults from the National Health and Nutrition Examination Survey between 1999 and 2020.

Overall, 1851 (7.8%) of the participants had LDL-C levels of 160-189 mg/dL, while 669 (2.8%) had LDL-C levels of 190 mg/dL or greater. Those overall numbers reflect significant age-adjusted declines between the 1999-2000 and 2017-2020 study periods:

• The prevalence of participants with 160-189 mg/dL LDL-C levels fell from 12.4% to 6.1%, representing a decline from 21.5M to 14M US adults
• The prevalence of participants with 190 mg/dL or greater LDL-C levels fell from 3.8% to 2.1%, representing a decline from 6.6M to 4.8 US adults

That period also drove notable declines in Americans who were unaware of their high cholesterol and not receiving treatment.

• The prevalence of unaware/untreated participants with 160-189 mg/dL LDL-C levels fell from 52.1% to 42.7%, representing a decline from 11.9M to 6.1M US adults
• The prevalence of unaware/untreated participants with 190 mg/dL or greater LDL-C levels fell from 40.8% to 26.8%, representing a decline from 3M to 1.4M US adults

At first glance, these cholesterol declines and awareness improvements seem like a public health success story, however the authors were more focused on the 7.5M million Americans with high cholesterol who remain unaware and untreated

These cholesterol awareness and treatment gaps are (unsurprisingly) deepest among Black, Hispanic, and socioeconomically disadvantaged people, as well as among younger people who would benefit most from early treatment. 

• These disparities are likely due to challenges with access to primary care, low rates of screening in primary care, lack of consensus on screening recommendations, insufficient emphasis on LDL-C as a quality measure, and hesitance to treat asymptomatic individuals. 

The Takeaway

Cholesterol awareness and treatment rates might be improving, but they’re still “suboptimal,” and they highlight America’s continued challenges with LDL-C education, screening, and action.

ECG Data You Can Trust

Noise and artifacts can make automated ECG analysis less reliable than what’s required for the exacting standards of cardiac safety trials. Monebo’s Kinetic Intervals ECG Algorithm provides precise interval measurements between any two points on the ECG waveform, allowing clinicians to utilize data they can trust.

PRECISE Trial Rewrites the Patient Pathway

HeartFlow’s landmark PRECISE trial found that their precision approach for evaluating people with stable chest pain avoided unnecessary testing and improved care without putting patients at risk of a missed heart disease diagnosis.

The Wire

• Pascal On Par with MitraClip: The Clasp IID trial showed similar performance for two mitral TEER devices: Edwards Lifesciences’ Pascal and Abbott’s MitraClip. In the noninferiority study of 300 patients with significant symptomatic DMR, the rate of major adverse events at 30 days was 4.6% for Pascal and 5.4% for MitraClip. The two TEER devices also had similar one year rates of survival, freedom from HF hospitalization, major adverse events, and degree of MR. 

• Second Pig Heart Recipient Dies: Lawrence Faucette, the 58-year-old recipient of the second-ever genetically modified pig heart transplant has died six weeks after surgery. Faucette was in good shape a few weeks ago, but his body began to reject the xenotransplant in recent days. This is the second attempted pig heart transplant, both of which resulted in deaths within two months, although scientists view each as important steps towards future successful xenotransplants.

• Viability Test Unhelpful PCI Guide: A new analysis of the REVIVED-BCIS2 trial highlighted imaging-based myocardium viability testing’s inability to identify patients with ischemic cardiomyopathy who would benefit from PCI. However, the extent of nonviable myocardium was associated with event-free survival and improved left ventricular function, regardless of treatment group (PCI or optimal medical therapy).

• Inari Medical Acquires LimFlow: Chronic limb-threatening ischemia (CLTI) treatment startup LimFlow SA will be acquired by major venous thromboembolism treatment company Inari Medical for $250M and up to $165M in milestone payments. The acquisition comes less than two months after the LimFlow System landed FDA clearance, with support of a trial showing that it achieved a 99% technical success rate and 76% limb salvage rate. Inari was already a LimFlow minority investor and board member, and now plans to drive the LimFlow System’s commercialization.

• FoCUS+AI Measures LVEF at Bedside: Researchers in Canada combined EchoNous’s Kosmos handheld ultrasound scanner with AI to measure LVEF at 424 patients’ bedside, finding that novice clinicians could use this combination in settings where cart-based echo isn’t available. AI-assisted focused cardiac ultrasound (FoCUS) matched up well against a cart-based TTE scanner for detecting abnormal LVEF (<50%), with an AUC of 0.98, sensitivity of 93%, and specificity of 92%.

• Women Get Equal Pulsed Field Benefits: A post-approval study of MANIFEST-PF registry data shows that women with AFib get the same pulsed field ablation benefits as men (Boston Scientific’s Farapulse). In the study of 1,568 patients, females fared as well as males on 1-year freedom from atrial arrhythmia (76.3% and 79%), with similar rates of acute major adverse events (2.5% and 1.5%). The results are reassuring, as patient sex has been known to affect the success and safety of AF ablation.

• CMS Cuts MPFS Rates, Cardiology Stays Flat: CMS released its final 2024 Medicare Physician Fee Schedule (MPFS), and the agency is once again driving down physician payments. Final 2024 payment amounts will be reduced by 1.25% overall compared to calendar 2023, and the finalized conversion factor for 2024 is down 3.4% to $32.74. While the ACC estimates that reimbursements for cardiovascular services will remain largely even with 2023, the SCAI spoke out against the new schedule.

• Toku’s Retinal AI Breakthrough Designation: The FDA granted Breakthrough Device Designation to Toku’’s CLAiR AI technology platform, an AI-based system designed to deliver real-time cardiovascular disease risk assessments through routine eye exams. Toku announced an $8M funding round earlier this year with support from two of the most influential players in the optical industry, and will now leverage the new FDA Breakthrough Designation to expedite its path to market.

• Troponin Could Guide NSTEMI Patients: A new study found that high cardiac troponin levels independently predict all-cause mortality in NSTEMI patients and could help identify those who need urgent revascularization. In the study of 544 NSTEMI patients seen in a tertiary care ICCU, those with the highest hs-cTnI levels (≥2878 ng/L) at admission had more than twice as high a mortality risk (HR=2.6, aHR=2.06) after three years.

• COVID Clinician Exodus? The number of physicians planning to reduce their clinical hours doubled during the COVID-19 pandemic compared to previous years. In Mayo Clinic Proceedings, 40% of 1.3k physicians surveyed in 2021 said they would “likely” or “definitely” reduce clinical hours in the next 12 months, compared to 16% in 2011 and 20% in 2014. These numbers underscore the pandemic’s impact on physician job satisfaction and could hint at continued workforce shortages.

• Intrepid TMVR Early Outcomes: New analysis from an early feasibility study showed that Abbott’s Intrepid TMVR system was successful in 31 of 33 patients (93.9%) with mitral regurgitation, recording no deaths or strokes 30 days post-procedure. Major vascular complications were reported in eight patients (24.2%), but they didn’t require surgery, and four cases of VTE (12%) were successfully treated. One year post-op, the patients had a 6.7% all-cause mortality rate and MR was almost completely eliminated.

Register now: Durability & TAVR: Critical Appraisal of the evidence after TCT.

Join Medtronic’s expert faculty for a live, case-based discussion on November 14 at 7:00 p.m. ET. Over the course of 90 minutes, they will discuss durability and TAVR and evidence review designed to expand your TAVR expertise. Register now!

Incidental CAC Predicts Long-Term Risks

What if you could identify which of your asymptomatic patients have high risks of future cardiac events? Stanford-led researchers used Bunkerhill Health’s Incidental CAC algorithm to do just that, finding that patients with ≥100 incidental CAC scores had a 24% 10-year risk of developing ASCVD and far higher risks of major adverse events.

The Resource Wire

• Ready to enhance your cardiovascular CT services with automated CT-FFR integration? Tune-in to Keya Medical and Precision Image Analysis’s SCCT webinar and learn from industry experts how to solve the challenges of scaling CT-FFR services and overcome the complexity of CT-FFR implementation.

• How can AI help physicians “see” beyond conventional lipid profiles? Tune in to this on-demand webinar showcasing how Cleerly’s AI-QCT solution complements conventional approaches to evaluating heart disease risk factors, and improves coronary artery disease diagnosis and heart attack risk assessments.

• Us2.ai published what might be the most comprehensive paper we’ve seen on AI echo, detailing the benefits of AI-automated echocardiography, the global need for more scalable and flexible CVD assessments, and how its technology is fit for the future. If you’re focused on the echo, echo AI, or echo accessibility and efficiency, this paper is worth checking out.

• Ready to realize the benefits of cardiovascular imaging structured reporting? Check out these quick and powerful Change Healthcare videos detailing the efficiency gains provided by structured reporting and what it takes to drive adoption.