Mount Sinai’s Jeffrey Bander, MD on what it will take for cardiology departments to adopt AI solutions.

Cardiovascular AI solutions are still far more commonly found in cardiology journal papers than in actual clinical workflows, but that’s changing fast and there’s a lot to learn from cardiology AI’s early adopters. Tune into the latest Cardiac Wire Show with Mount Sinai’s Jeffrey Bander, MD and Us2.ai’s Seth Koeppel to see how they launched and expanded their echo AI partnership, and learn how to “adopt echo AI the right way.”

Hypertension

Merck’s Sotatercept Lands PAH Approval

Patients with pulmonary arterial hypertension (PAH) suddenly have a new and potentially powerful treatment option available to them, following the FDA approval of Merck’s sotatercept-csrk, which will be marketed as Winrevair in the US.

• PAH is a rare (40k patients in the US) and usually fatal disease caused by the overproduction of activin proteins.
• Although evolving treatments have helped improve PAH symptoms, available medications haven’t made much of an impact on mortality rates.

Sotatercept emerges as the first activin signaling inhibitor PAH treatment, directly targeting and trapping the proteins that are overproduced in PAH patients, and potentially reversing the blood vessel narrowing and right ventricle damage that it’s known to create.

• Sotatercept is an add-on to standard-of-care PAH therapies, available in 45 mg and 60 mg injections that are administered every 3 weeks.

The approval relied on sotatercept’s STELLAR trial, which found that patients taking sotatercept had far greater improvements to 6-minute walk distances over 24 weeks (+41 vs. +1 meters) compared to patients taking standard therapies and a placebo, with lower rates of all-cause death or nonfatal clinical PAH worsening (5% vs. 26%).

• Sotatercept was also well tolerated, although it still does increase hemoglobin and can carry bleeding risks.

Sotatercept is widely viewed as a strategic win for Merck, which acquired Acceleron for rights to sotatercept for $11.5B in 2021, hoping to bulk up its portfolio before its blockbuster cancer drug Keytruda goes off patent in 2028.

• Some analysts are forecasting that sotatercept will generate $2B to $5B annually by 2030, with 20% of sotatercept revenue going in royalties to Bristol Myers Squibb.

If you’re wondering how a drug with 40k potential patients can bring in $5B, Merck plans to charge a wholesale price of $14k per vial of sotatercept, which will add up to around $243k per patient annually.

• That’s way more than what some would view as fair, noting that the Institute for Clinical and Economic Review estimated sotatercept’s clinical value at roughly $35k per year.
• However, Merck appears well set up to execute its Winrevair strategy, noting that it has marketed its existing PAH drug Adempas for over a decade.

The Takeaway

PAH diagnoses have long been viewed as fatal, and although sotatercept still has lots to prove, it appears that this new drug is on a path to becoming a key part of a redefined PAH standard-of-care, while giving these patients better and potentially longer lives.

A Milestone Study for Cardiac Strain Analysis

Us2.ai’s deep learning algorithm was able to interpret echo AI left ventricular strain images with similar accuracy as conventional measurements. Read all about this milestone study and its implications for echo strain access in EHJ-Digital Health.

Can AI Prevent Heart Disease Progression?

Tune in to Cleerly’s on-demand webinar 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 Wire

• Bempedoic Acid Label Expansion: And just like that, bempedoic acid is FDA-approved for primary cardiovascular event prevention, with or without statins, expanding Esperion’s Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) to 70M US patients… assuming support by ACC/AHA guidelines and insurers comes next. The FDA expansion is based on the strong results from the CLEAR Outcomes trial, which found that bempedoic acid reduced LDL-C (-20%), achieved a lower MACE rate (11.7% vs. 13.3% w/ placebo), and reduced risk of MI and revascularization (-20% & -19%) without safety issues.. but also without impacting mortality.

• SGLT2i Lighten the Load for ACHD Patients: A study from four European centers showed that SGLT2 inhibitors also help adults with congenital heart disease (ACHD). In 174 ACHD patients treated from 2016 to 2023, SGLT2i had a threefold reduction in 6-month heart failure hospitalization rates following treatment initiation. While 10.3% of patients reported side effects, only 6.9% discontinued treatment, marking a step forward in addressing HF-related complications in ACHD patients.

• Evolut FX+ Approved: A new Medtronic Evolut TAVR generation is now upon us, following the FDA approval of the Evolut FX+ TAVR system for the treatment of symptomatic severe aortic stenosis across all risk categories. The Evolut FX+ TAVR system inherits the performance benefits of previous generations, while launching with four-times larger coronary access windows through a modified diamond-shaped frame design, and increased space for catheter maneuverability. The Evolut FX+ TAVR system will see an early launch in Spring 2024 and full launch in Summer 2024.

• ATTR-CA Biomarkers: A study in JACC examined data from 2,275 patients with transthyretin cardiac amyloidosis (ATTR-CA) and found that increases in N-terminal pro–B-type natriuretic peptide (NT-proBNP) and outpatient diuretic intensification (ODI) were closely linked to higher mortality rates. With all the buzz surrounding biomarkers for diagnosing cardiac conditions, the findings offer a method for more objectively monitoring ATTR-CA disease progression.

• UPMC Implant Investigation: UPMC’s cardiology department is at the center of a U.S. House investigation due to its alleged practice of implanting “experimental” pediatric heart valves without patient consent or FDA authority. UPMC surgeons reportedly implanted at least 90 MASA valves in pediatric patients with congenital valve defects between 2008 and 2014, and some patients’ families say that they weren’t informed that the procedure was experimental. 

• Early Data for Auxilius’ Once-Daily Nicorandil: Boston-based Auxilius Pharma announced topline Phase 1a data for its AUX–001 drug for the treatment of chronic stable angina pectoris. The oral once-daily extended-release formulation (40 mg) of the angina drug nicorandil was tested in 16 healthy volunteers, finding that AUX-001 far surpassed the halflife of nicorandil (>9hrs vs.  49 minutes) and it was safe and well-tolerated. Auxilius is now seeking a mid-to-large size partner to take development forward.

• Novo Nordisk Acquires Cardior: Novo Nordisk bolstered its cardiovascular drug pipeline, acquiring Cardior Pharmaceuticals for up to $1.11B, giving it access to Cardior’s RNA-targeted drugs intended to prevent, repair, and reverse heart diseases. The acquisition is highlighted by Cardior’s lead compound, CDR132L, which is currently in Phase 2 clinical development and has shown promising safety and efficacy results as a heart failure treatment. Novo Nordisk’s cardiology portfolio has been one of the beneficiaries of its GLP-1 windfall, previously acquiring KBP Biosciences for $1.3B.

• Apixaban Wins in Anticoagulant Duel: In a head-to-head between edoxaban (Lixiana) and apixaban (Eliquis) for anticoagulation therapy in patients with non-valvular Afib, both drugs were effective in preventing thromboembolism and ischemic stroke, but edoxaban had a 42% higher risk of major bleeding. Although this study predominantly involved an elderly population, numerous other cohort studies support the comparable effectiveness of the anticoagulants, with apixaban consistently linked to lower rates of major bleeding.

• J&J’s Shockwave Bid: Johnson & Johnson is reportedly once again in talks to acquire intravascular lithotripsy leader Shockwave, coming nearly a year after J&J, Medtronic, and Boston Scientific all allegedly explored acquiring the company. Reports suggest that the acquisition could be finalized within the coming weeks, although another bidder might emerge. While terms of the  deal aren’t known, Shockwave had $489.7M in 2023 revenue and its market cap jumped 11% to $11B following the acquisition reports.

• First Percutaneous LAOO Removal: A Texas-based cardiology team detailed their experience performing the first percutaneous removals of unstable LAAO devices using ŌNŌCOR Vascular’s ŌNŌ retrieval device. Reporting in JACC: Clinical Electrophysiology, the researchers demonstrated the new retrieval system’s performance in three different elderly patients with unstable Watchman FLX devices. The ŌNŌ product was cleared by the FDA in May 2022 and has been previously used to remove a range of other devices and large balloon fragments.

• OPSYNVI’s Combo FDA Approval: Patients with pulmonary arterial hypertension now have a macitentan/tadalafil combination pill to choose from, following the FDA approval of Johnson & Johnson’s OPSYNVI. The first and only once-daily single-tablet combo therapy for PAH addresses these patients’ common medication compliance challenges associated with taking separate ERA and PDE5 inhibitor pills.

The Evolution and Adoption of FFRCT

FFRCT has quickly become one of the most-used AI applications across healthcare, making a major impact on stenosis diagnosis and angiography caseloads. Still, many cardiologists are just now mapping out their own FFRCT adoption. See how one cardiologist made the move to FFRCT and how it impacted his practice in this Cardiac Wire show interview with Corazon Imaging’s John A Rumberger, PhD, MD, FACC, MSCCT.

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 Resource Wire

• From CPACS to CVIS: Cardiovascular imaging has come a long way from CPACS. Explore the evolution of cardiology image and data management in this Merge by Merative executive brief, and see what makes CVIS such a significant advancement.

• HeartFlow’s FFRCT’s Nationwide Improvements: What happens when HeartFlow’s FFRCT Analysis is adopted nationwide? See how the NHS’ nationwide implementation of HeartFlow’s FFRCT solution led to significant reductions in cardiovascular and all-cause mortality, plus solid efficiency gains.

• 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.

• 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!