Gabe Wilson, MD after tirzepatide kept 99% of obese prediabetic patients from developing diabetes.

Pharmaceuticals

Tirzepatide’s Prediabetes Triumph

Eli Lilly’s GLP-1 tirzepatide has triumphed yet again, as the full SURMOUNT-1 trial showed that the drug kept nearly 99% of prediabetic patients diabetes-free over 3 years, while improving cardiometabolic metrics.

• Tirzepatide (Mounjaro / Zepbound) is used to promote weight loss and treat Type 2 diabetes through the GIP and GLP-1 receptor pathways.
• Like Novo Nordisk’s semaglutide, evidence of tirzepatide’s cardiometabolic and cardiovascular benefits continue to mount.

In the final results from the three-year SURMOUNT-1 trial, tirzepatide lowered the risk of progression to Type 2 diabetes by 94% versus placebo in adult prediabetic patients who were obese or overweight.

• At the treatment endpoint of 176 weeks, 99% of prediabetic patients were still diabetes-free.
• 17 weeks after treatment ended, only 2.4% of patients who took tirzepatide were diagnosed with Type 2 diabetes versus 13.7% in the study’s placebo group.

Unsurprisingly, dosage impacted patients’ weight loss, with higher doses leading to greater losses.

• The 5 mg group saw 15.4% average body weight reduction, while 10 mg resulted in 19.9% reduction, and 15 mg caused a substantial 22.9% body weight loss. 
• That’s far greater than the control group, which only saw a 2.1% reduction.
• These weight loss levels are also greater than we’ve seen in semaglutide studies.

Tirzepatide also improved glycemic control and cardiometabolic risk factors like fasting insulin and blood pressure, adding to its resume across a range of diseases.

• In tirzepatide’s late-stage SUMMIT trial, the drug cut the risk of adverse HF outcomes by 38% compared to placebo, while improving symptoms.

• Lilly’s SYNERGY-NASH trial showed that >50% of patients on tirzepatide experienced fibrosis improvement without their MASH worsening compared to 29.7% in the placebo group.

The Takeaway

SURMOUNT-1 represents another huge advancement for Eli Lilly in the GLP-1 race and could expand tirzepatide to millions of prediabetic patients, allowing them to avoid diabetes and the cardiovascular risks that come with it.

Innovating AFib Care

The first manifestation of AFib is often stroke, but many hospitals aren’t set up to coordinate these patients’ post-stroke care. See how UCSD is leveraging Viz.ai’s Viz Connect solution to simplify neuro and EP collaboration in this HRX 2024 interview.

Making the Leap to Outsource Post-Processing

Interested in how to outsource cardiac image post-processing, but not sure where to start? PIA walks you through how to assess and compare vendors, understand pricing models and payment options, and outline your requirements to identify vendors who meet your clinical needs. 

Transforming Ischemia Detection

CCTA AI is poised to transform ischemia detection, leading to far greater diagnostic efficiencies and far fewer unnecessary invasive procedures. See how ischemia’s AI transformation is unfolding in this Cardiac Wire Show interview with Cleerly’s chief medical officer James Earls, MD.

The Wire

• Cardiawave Hits Valvosoft Endpoints: Cardiawave’s Valvosoft ultrasound therapy met its pivotal study endpoint for the treatment of severe symptomatic calcific aortic stenosis, improving HF symptoms for 80.5% of patients, while substantially improving hemodynamics and quality of life six months after treatment. Valvosoft non-invasively restores leaflet mobility in stenotic valves by using high-intensity ultrasound waves to micro-fracture calcifications without damaging tissue. The results should give Valvosoft a boost in its upcoming U.S. and EU regulatory bids.

• SmartCardia’s 7-Lead Clearance: Further expanding its remote monitoring portfolio, SmartCardia received FDA clearance for its 7-lead live ECG monitoring patch and cloud platform for mobile outpatient cardiac telemetry. SmartCardia claims that the 7L patch is easy-to-wear, cable-free, waterproof and can continuously monitor patients for up to 14 days, while transmitting all ECG events live. This approval comes on the heels of the FDA clearance of SmartCardia’s Extended Holter, Event and Holter monitoring solution. 

• Lp(a) Reduces Statin Benefits: A Circulation study found that patients with high lipoprotein(a) levels are at a greater risk of CVD even if they’re taking statins. The meta-analysis of six different statin trials uncovered that the relative risk of CVD associated with elevated Lp(a) ranged from 38% higher in statin-taking patients with the lowest LDL-C levels to 90% greater in statin-taking patients with the highest LDL-C levels.

• Balloon vs. Self-Expanding TAVR: Five-year analysis comparing self-expanding (Medtronic’s Evolut R) and balloon-expandable (Edwards’ SAPIEN 3) transcatheter aortic valves revealed similar overall outcomes, but very different stroke rates. The SOLVE-TAVI trial showed similar combined rates of mortality, stroke, paravalvular leak, and permanent pacemaker implantation (67.7% SEV  vs. 63.4% BEV). However, the two valves differed notably in five-year stroke rates (2.2% vs. 9.6%), largely due to SEVs’ advantage among patients with small aortic annuli (echoing the SMART trial). 

• Avidity’s Cardio Pivot: Shifting gears from its muscular dystrophy focused pipelines, Avidity Biosciences announced two new development candidates for rare genetic cardiomyopathies. The company is developing antibody oligonucleotide conjugates 1086 and 1072 to treat phospholamban cardiomyopathy and PRKAG2 syndrome, respectively. Preclinical data for both drugs demonstrated robust delivery to the heart with “potent” ~80% reductions to cardiac phospholamban mRNA and PRKAG2 mRNA without affecting safety.

• Eko SENSORA CPT’s Code: Eko Health announced that the AMA issued a Category III CPT code that covers its SENSORA platform of FDA-cleared AI algorithms (or other qualifying products) for identifying structural heart murmurs, low ejection fraction, and arrhythmias. The newly issued CPT code will be effective on July 1, 2025, paving the way for reimbursement and expanded clinical use of AI-enabled heart disease detection by integrating detection software with a smart stethoscope.

• Discontinuing GLP-1s: New estimates suggest that 50% to 75% of patients stop GLP-1 treatment within a year, leading to rebounds in body weight and potential worsening of cardiometabolic health. Researchers speculate that patients could be quitting their GLP-1s due to high out-of-pocket costs and side effects, as well as a lack of appropriate framing of these medications as chronic therapies. 

• Fourth Frontier’s Monitoring Clearance: Fourth Frontier achieved FDA 510(k) clearance for its Frontier X Plus single-lead, chest-worn, continuous ECG monitor that relays user data to remote dashboards. The device uses a range of algorithms to identify and classify arrhythmias, even during intense exercise. With this clearance now complete, Fourth Frontier aims to enter the U.S. market as a prescription-based, class II medical device and will partner with independent diagnostic testing centers and cardiac rehabilitation centers for at-home monitoring.

• Societies Press for T-TEER Payments: In a 13-page letter, six cardiovascular societies called on CMS to approve payments for tricuspid transcatheter edge-to-edge repair (T-TEER) for tricuspid valve regurgitation. The request follows the FDA’s clearance of Abbott’s TriClip, and Abbott’s formal request for a T-TEER national coverage determination. CMS will release a decision memo by April 2025.

• Tabia Adds AHA CarePlans: In an upgrade to its cardiac offerings, Tabia Health integrated AHA’s CarePlans into its AI-powered healthcare orchestration platform to improve plan utilization and patient adherence. As part of the initiative, Tabia will leverage its technology to make it easier and more cost-effective for patients, providers, and payors to stay on track with wellness pathways like AHA’s “Life’s Essential 8,” which encourages people to improve their heart health through lifestyle changes.

• The Best U.S. Stroke Hospitals: Healthgrades’ recently published its 2025 Specialty Excellence Awards, recognizing the top 99 U.S. hospitals for stroke care and treatment. The top three spots went to AdventHealth Orlando (Florida), Advocate Christ Medical Center, and Advocate Good Shepherd Hospital (both Illinois). Awards were based on Medicare provider analysis and were given to hospitals with a transfer-out rate of less than 10%. Curiously, major institutions like Mayo Clinic and NYU didn’t make the top 10.

Transform CVIS Workflows

See why Merge Cardio is a 2024 Best in KLAS cardiology solution, and how it can help improve your cardiology workflows, simplify data collection, and automate cardiology reporting.

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!

AI-Driven Novice Heart Failure Screening

We hear a lot about AI’s potential to expand echocardiography to far more users and clinical settings, and a study using Us2.ai’s AI-automated echo analysis and reporting solution showed that echo AI might make novice-led heart failure screening possible.

The Resource Wire

• Explore the Potential of Cardio AI: Explore the potential of AI-powered cardiology solutions in this on-demand TeraRecon webinar, detailing how its Cardio Suite solutions help expedite disease diagnosis, care coordination, and provide the data to support cardiac treatment decisions.

• 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.

• Structural Heart + Enterprise Imaging: Has your structural heart reporting evolved at the same pace as your structural heart procedures? See how Optum’s enterprise imaging gives interventional cardiologists the imaging tools they need as structural heart procedures become more common and more complex. 

• An All-in-One Coronary Care Solution: See how HeartFlow ONE is transforming precision heart care as the first all-in-one CCTA pathway, combining FFRCT, stenosis, and plaque analysis in a single workflow.

• Cardiology AI: From Research to Clinical Practice: Explore how AI algorithms are reshaping cardiology with insights from Tempus’ recent webinar, featuring Dr. David Ouyang of UCLA and Cedars-Sinai, alongside Tempus’ Dr. John Pfeifer and Dr. Brandon Fornwalt. This expert panel dives into how AI can bridge diagnostic gaps, enhance patient outcomes, and streamline workflows for conditions like AFib and pulmonary hypertension. Read the full recap to glimpse the future of AI-driven cardiology.

• 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.

• Addressing Coronary Artery Disease: Learn how the AGENT™ Drug-Coated Balloon provides a new treatment option for in-stent restenosis in the U.S. Rx Only. (Sponsored by Boston Scientific)

• The All in One Cardiac Imaging Solution: Ready for an all-in-one solution that supports all of your MR and CT needs? See how Circle Cardiovascular Imaging’s cvi42 can streamline your core reading and reporting workflows within a single, customizable platform.

The Industry Wire

1. Providence CEO: ‘Old-school M&A is dead.’
2. NYC Health + Hospitals cuts $150M after adding 3k RNs.
3. Employers taking payors to court over exorbitant costs.
4. Gartner nails it with 2025 Strategic Technology Trends.
5. Where does Medicare Advantage go from here?
6. CarePoint Health Systems files for Chapter 11.
7. Rebuilding the primary care workforce with pharmacists.
8. Amazon faces major data leak of 3 million employee records.
9. Trump administration might help the future of telehealth.
10. The GenAI Glossary: 48 AI terms that everyone should know.