Cedars-Sinai cardiologist Dr. Martha Gulati following Wegovy’s expanded FDA approval for cardiovascular event risk reduction.

Obesity Care

Wegovy Gains Expanded Approval for CVD Risk Reduction

The hottest drug class in the world just got even hotter after the FDA approved Novo Nordisk’s weight-loss drug Wegovy for cardiovascular event risk reduction, opening new cardiology-focused routes for GLP-1 care and coverage.

• Wegovy’s expanded FDA approval now supports its use for the reduction of major adverse cardiovascular events in obese or overweight adults with established CVD.
• Semeglutide was already approved for diabetes (via Ozempic) and weight loss (via Wegovy), although payors have largely resisted covering non-diabetic patients.

The expanded approval could have a major cardiology impact, making cardiologists a key driver of Wegovy prescriptions, while making CVD risk reduction a primary way to increase coverage of the GLP-1 (vs. out-of-pocket or on/off-label diabetes care).  

More importantly, it could lead to significantly better cardiovascular outcomes for these patients. The SELECT trial, which served as the basis for this expanded CVD approval, showed that Wegovy slashed patients’ major cardiac event risks by 20% over five years, while cutting non-fatal heart attacks by 28% and reducing cardiovascular mortality by 15%.

• The SELECT trial included the types of patients who are most likely to be impacted by Wegovy’s expanded approval: non-diabetics with obesity and established CVD.

Considering that the overwhelming demand for GLP-1s gives Novo Nordisk little reason to reduce Wegovy’s $1,350 monthly price, the expanded coverage should further increase healthcare’s overall GLP-1 costs. 

• However, this expansion could serve as a case study for whether GLP-1s’ ability to reduce future cardiovascular events makes both clinical and financial sense over the long term.

Wegovy’s CVD approval might also pave the way for similar expansions for Lilly’s tirzepatide (Mounjaro and Zepbound), which has shown even stronger weight loss results than semeglutide, and is now being evaluated for its cardiovascular benefits in clinical trials. 

The Takeaway

To many people, Wegovy’s expanded FDA approval is an accessibility and affordability story, giving millions of patents a new route for GLP-1 care and coverage. However, this is also very much a cardiology story, as it could reduce those same millions of patients’ major cardiac events by 20%, while giving cardiologists a central role in managing a drug class that’s poised to dominate the next decade.

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.

Where to Go for Cardio AI?

TeraRecon’s Cardio Suite is a collection of hand-selected, vendor-neutral Cardiology AI algorithms that aid in the analysis and interpretation of echocardiograms and chest CTs. Learn about TeraRecon’s AI offering and how they improve efficiency and accuracy here.

The Wire

• Painting Away Future Blockages: UVA Health researchers just landed $2.8M in NIH funding to support the development of their fascinating epiNanopaint technology, which would theoretically be “painted” into transplanted veins to prevent future blockages and avoid revascularization procedures. The researchers will initially focus on studying whether the DOT1L enzyme can be targeted with “painted” drugs to safely and effectively prevent vessels from narrowing following vascular reconstruction surgeries.

• ACC HFrEF Consensus Statement: The ACC’s updated HFrEF consensus statement emphasized the importance of treatment with four key medications: sacubitril/valsartan (Entresto), SGLT2 inhibitors, beta-blockers, and mineralocorticoid antagonists. Clinicians were specifically encouraged to initiate treatment with Entresto and strive for comprehensive coverage across all four classes. The guidelines also emphasized the integration of telehealth and the use of multidisciplinary teams as potential strategies to streamline patient management.

• Dangers of Ultra-Processed Food: A new umbrella meta-analysis review added more evidence of ultra-processed food’s association with poor health outcomes. The review of 45 pooled analyses with a total of 9.9M people suggests that people who consume ultra-processed foods have a 1.5-times higher risk of CVD-related mortality and 1.13-times higher risk of diabetes. UPF consumers also had 1.5-times higher odds of experiencing a range of common mental health disorders.

• Bodyport’s HF Event Advantage: Bodyport’s remote heart failure monitoring system, which features a unique cardiac scale that measures weight and hemodynamic biomarkers, identifies twice as many heart failure events as conventional weight-based approaches. That’s the takeaway from the new SCALE-HF1 study, where Bodyport demonstrated 70% accuracy in predicting HF events, surpassing the weight-based standard of care (35%), while generating fewer alerts (2.58 versus 4.18 alerts per patient-year).

• Abbott’s HeartMate Monitoring Recall: Abbott recalled its HeartMate Touch Communication System (version 1.0.32), receiving a Class I recall designation from the FDA, which means that the issue has the potential for serious injuries or death. The HeartMate Touch Communication System is designed for use with a controller to monitor patients on the company’s HeartMate 3 LVAD system, but there have been a small number of reports of unintentional pump starts and stops. Abbott plans to release corrected Touch software soon. 

• STRONG-HF Supports Quick Up-Titration: A new analysis of the STRONG-HF study shows that rapid up-titration of heart failure medications to optimal guideline-directed levels benefits patients regardless of their baseline health. In the study of 1,072 acute HF patients, the benefits of high-intensity treatment were reported broadly, regardless of baseline quality of life scores, age, degree of LVEF, NT-proBNP levels, and systolic blood pressure.

• BioCardia & StemCardia Alliance: BioCardia and StemCardia announced a long-term partnership leveraging BioCardia’s biotherapeutic delivery system for the minimally invasive transplantation of StemCardia’s investigational stem cell heart failure treatment. BioCardia will be StemCardia’s exclusive biotherapeutic delivery partner through studies that are expected to result in FDA approval of an investigational new drug application, and the following Phase I/II clinical trials.

• Incidental CAC AI: South Korean researchers showed that AI can accurately assess coronary artery calcium scores using CT scans performed for lung cancer screening. The researchers analyzed 1k low-dose chests CTs using AI solutions from Coreline Soft and Siemens Healthineers, comparing them to radiologists’ CAC assessments. The two algorithms showed substantial agreement with the radiologists for CAC presence and severity (kappa=0.793 & 0.671), while AI was more likely to identify CAC in scans (57% & 60% vs. 53%).

• Who Excels at MV Repair? A registry study suggests that medical centers with higher volumes of surgical mitral valve repair (MVr) logically achieve better long-term TEER outcomes. Among about 42k patients at 500 sites, adjusted risk at centers with higher MVr volumes was significantly lower for one-year TEER mortality and one-year HF readmissions. However, rates of TEER success and 30-day TEER mortality were similar regardless of center volume. 

• Docs Negative View on PE: A new JAMA survey came to a not-so-shocking conclusion: physicians have a largely negative opinion of private equity investment in healthcare. Researchers surveyed 525 US doctors, finding that 61% viewed PE negatively, 29% were neutral, and 11% had a favorable opinion. Doctors saw PE negatively with respect to physician well-being (58%), healthcare costs (57%), and health equity (51%). Interestingly, only 5.5% of respondents worked for a PE-owned healthcare entity.

• FTC to Probe PE in Healthcare: In related news, the US Federal Trade Commission said last week that it was launching a probe into private equity’s growing role in healthcare. The agency is looking for details on PE transactions that could increase consolidation and generate profits while harming patient health, worker safety, and quality and affordability of care.

AI-Powered Home Ultrasound

The recently published CUMIN study shows the technical feasibility of AI-POCUS in the hands of novice nurses and opens new possibilities for redefining how we approach cardiac care. Learn more on this page from Us2.ai.

Can AI Improve How We Prevent Heart Disease Progression?

Tune in to Cleerly’s upcoming webinar (March 19, 2pm ET) where study leaders will discuss how the landmark TRANSFORM randomized controlled trial will test whether an AI-personalized care strategy can outperform traditional risk factor management and prevent cardiovascular events.

The Resource Wire

• Nothing Is More Expensive Than a Missed Opportunity: The emergence of AI CAC detection and new CVD treatments could transform preventative CVD care. Check out this Johns Hopkins editorial in JACC detailing how solutions like Bunkerhill Health’s Incidental CAC algorithm can create opportunities for more effective preventative CVD care, but only if providers seize that opportunity.

• Ready for More Precise ECG Monitoring? Monebo designs, develops, and licenses complex ECG algorithms for use in a wide variety of monitoring applications. If you’re a medical device developer, monitoring center, or system integrator see why Monebo might be right for you.

• 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.