Muthiah Vaduganathan, MD, MPH on semaglutide’s continued hot streak.

Pharmaceuticals

Semaglutide Adds to Cardiovascular Resume

Semaglutide continued to add to its cardiovascular resume, with two new studies highlighting its ability to improve heart failure symptoms and cardiorenal outcomes. 

Already a smash hit for its weight loss and obesity benefits, semaglutide’s cardiovascular potential has been gaining attention over the last few months following previous studies finding that the GLP-1 reduces major cardiac event risks by 20% and improves key heart failure quality of life metrics. 

The first of the two latest studies further supported semaglutide’s heart failure impact, showing that it led to a range of improvements among patients with HFpEF and obesity, regardless of LVEF level. In the secondary analysis of the STEP-HFpEF trial (263 semaglutide, 266 placebo; 52 weeks)…

• Semaglutide takers showed improvements to HFpEF symptoms, physical limitations, exercise function, and inflammation, and weight, with no safety concerns 
• Improvements and safety were similar across patient LVEF levels, which is notable given that this isn’t the case with other common HF drugs

The second study doesn’t even include data yet, but is more significant. Novo Nordisk announced that it will stop semaglutide’s FLOW kidney outcomes trial early after finding sufficient evidence supporting its efficacy for CKD. 

• Starting in 2019, the FLOW trial (n = 3,534 patients w/ T2D & CKD) compared 1mg of semaglutide and a placebo’s ability to slow renal impairment progression and reduce the risk of renal and cardiovascular mortality.

Novo Nordisk will now power down the FLOW trial, and will remain blinded to study data until its conclusion, before releasing results in H1 2024. 

• However, observers are already viewing this as a major step towards semaglutide’s potential expansion to treating four interrelated conditions (obesity, diabetes, CVD, and CKD).
• This would also further expand CKD patients’ available treatment options, potentially alongside SGLT2i drugs, which are already used for diabetes and heart failure, and are making progress towards also becoming CKD treatments. 

Takeaway

It’s hard to overstate semaglutide’s impact, given that the GLP-1 has made Novo Nordisk Europe’s most valuable company with a market cap larger than Denmark’s GDP. The fact that semaglutide could soon expand to CVD and CKD might make it one of the most clinically and financially significant drugs we’ve ever seen.

Optimizing Your Post-Processing Workflow

The growth of cardiac CT and CMRI volumes and continued shortages in the imaging technologist workforce can mean big challenges for imaging organizations. Join this Cardiac Wire Show starring Precision Image Analysis’ Jim Canfield and Cleveland Clinic’s Scott D. Flamm, MD, MBA to see how outsourcing cardiac image post-processing can solve this problem, while improving efficiency, accuracy, and standardization.

Cleery’s Best AI Award

Cleery came out on top at HLTH 2023’s Digital Health Awards, where it was named winner of the Best Use of AI in Health Tech category. That’s quite an accomplishment given that there were over 450 competing AI companies, and a testament to how it’s using AI to “revolutionize the identification and prevention of heart disease.”

The Wire

• Patisiran’s ATTR Cardiomyopathy Denial: The FDA denied Alnylam Pharmaceuticals’ supplemental new drug application for using patisiran (marketed as Onpattro) to treat ATTR cardiomyopathy. Although some disagree with this decision, the FDA found insufficient evidence of patisiran’s clinical effectiveness. The drug remains approved for treating adult polyneuropathy of hereditary ATTR amyloidosis, but Alnylam will no longer pursue expanding patisiran’s indications in the US. Moving forward, Alnylam will focus on its other ATTR amyloidosis candidates: vutrisiran and ALN-TTRsc04.

• CW’s HLTH 2023 Takeaways: Cardiac Wire made a visit to HLTH 2023 this week, finding that it’s far from a typical cardiology conference, but did have a surprising amount of cardiovascular-focused content and exhibitors. The exhibit hall featured a number of remote CV monitoring players (e.g. Acorai, AliveCor, Bodyport, Casana, QT Medical), AI companies focused on detecting CVD in imaging and ECG exams (Accurkardia, Aidoc, Caption, Cleerly) and point-of-care device innovators (Eko, Exo). That said, broader AI and workflow innovations presented at the conference may prove to have a massive impact on all specialties, including cardiology. 

• Cardiovascular-Kidney-Metabolic Syndrome: The connection between obesity, type 2 diabetes, chronic kidney disease, and cardiovascular disease has become abundantly clear, leading the American Heart Association to officially define this clinical overlap as cardiovascular-kidney-metabolic syndrome (CKM syndrome). In its official statements, the AHA defined CKM syndrome’s severity stages (0-4), detailed how different healthcare specialties should collaborate for shared CKM patients, and encouraged adding CKM factors to risk calculators.

• Modifiable CVD Risk Factors’ Major Toll: In somewhat related news, a large pooled NEJM analysis of 112 studies in 34 countries charted the effects of five modifiable CV risk factors: BMI, systolic BP, LDL-C, smoking, and diabetes. Data from over 1.5M people show that these five factors may be at the root of over half of CVD cases in both women and men (57.2% & 52.6%) and roughly one fifth of all-cause deaths (22.2% & 19.1%).

• Welldoc Weight Management: And in more somewhat related news, Welldoc is adding weight management to its chronic condition management platform, joining existing offerings for diabetes, hypertension, and mental wellbeing. The platform works with health plans, health systems, and employers to provide personalized digital coaching while connecting people to their health data to show progress toward their goals. Unlike other companies entering the obesity care space with a sharp focus on GLP-1s, Welldoc is positioning its service as a “holistic” approach to weight management.

• Donation After Circulatory Death: A large single-center study supports the use of hearts donated after circulatory death (DCD), potentially broadening the pool of available organs beyond donation after brain death (DBD). In the observational study of 385 heart transplant patients (one-third DCD), outcomes were statistically similar on a range of endpoints for DCD and DBD, including one-year survival (94% vs. 92%), incidence of primary graft dysfunction (6% for both), and treated rejection during the first year (13% vs. 18%).

• CPAP Adherence: Patients with obstructive sleep apnea who adhere to their CPAP treatment plans have far lower risks of future major adverse cardiac or cerebrovascular events (MACCEs). That’s the takeaway from a new JAMA meta-analysis of three RTCs with 4,186 patients that found that CPAP treatment adherence (≥4 hours/day) is associated with an over 30% reduced risk of MACCEs (hazard ratio of 0.69) compared to patients who used CPAP less than four hours daily.

• NuraLogix’s Video AI Launch: NuraLogix announced the availability of its unique Anura telehealth platform, allowing physicians to monitor a wide range of patient vitals during video calls using analysis of patients’ faces. The platform analyzes facial blood flow data and then applies AI to estimate over 100 health parameters (e.g. pulse, respiration, blood pressure, cardiac workload) and make risk assessments (e.g. T2D, CVD, heart attack, stroke, hypertension).

• Mobile Cardiac PET Kickbacks: A mobile cardiac PET scan provider has agreed to an $85M settlement to resolve charges that it paid kickbacks to cardiologists for patient referrals. Cardiac Imaging of Oakbrook Terrace, Illinois will pay $75M and its founder Sam Kancherlapalli will pay $10M to US authorities to settle allegations that they paid cardiologists fees of $500 or more to supervise PET scans for patients they referred to Cardiac Imaging between 2014 and 2023. 

• Haemonetics Acquires OpSens: Global medtech company Haemonetics Corporation announced an agreement to acquire interventional cardiology company OpSens for $253M. The acquisition gives Haemonetics access to OpSens’ fiber optic sensor technology and product line, which the company notes has “significant commercial synergies” with its existing Vascular Closure portfolio and global sales infrastructure. OpSens’ core products, SavvyWire and OptoWire, are guidewires used in TAVR and PCI procedures.

• Declining US Life Expectancy: The Washington Post put out an amazing article on why US life expectancy has been undergoing a swift decline since 2014. Although firearms and opioids play a role, chronic conditions account for twice the deaths as all homicides, suicides, overdoses, and car accidents combined. The piece explores a long list of reasons behind the trend, concluding that social factors are the true “causes of the causes,” as seen in the fact that the life expectancy gap between the wealthy and poor has grown 15 times faster than the income gap since 1980.

Us2.ai’s Heart Failure Screening Impact

See how Us2.ai’s echo AI solution improved heart failure screening in the NHS, reducing echo waiting times from 12 months to under 6 weeks.

The Behavioral Science Behind Change Cardiology Hemo

When Change Healthcare set out to design its next-generation Cardiology Hemo monitoring system, they put behavior science at the heart of its product strategy. See how Change’s UX designers applied its behavioral science team’s findings to improve its Hemodynamics solution to help make physicians and technicians even more efficient.

The Resource Wire

• The expansion of remote cardiac patient monitoring is creating more care opportunities, but also new operational challenges for cardiology teams. Check out this Cardiac Wire Show, where ARTELLA Solutions’ Jacinta Fitzsimons shares how the right combination of technology and service can help physicians get the most out of their cardiac RPM programs – today and into the future.

• 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. 

• Gain in-depth knowledge of fluoroscopic anatomy and cutting-edge imaging techniques with renowned expert, Dr. Nicolo Piazza. This five-session master class is happening now through November. Register now!

• 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.