Cleerly’s Udo Hoffmann, MD, MPH on why we need to elevate cardiovascular screening to the level of cancer screening.

There’s been plenty of studies evaluating healthcare AI accuracy, but does AI improve patient care? Check out the latest Cardiac Wire show with Udo Hoffmann, MD, MPH and learn how Cleerly’s new TRANSFORM trial could prove that AI-guided cardiovascular care reduces heart attacks.

Surgeries & Interventions

Medtronic’s Symplicity Spyral RDN System Lands FDA Approval

The brand new US renal denervation arena gained its second major competitor on Friday, with the FDA approval and immediate commercial launch of Medtronic’s Symplicity Spyral RDN system.

• Renal denervation (RDN) is intended for hypertension that can’t be controlled by conventional therapies, either due to ineffectiveness, side effects, or adherence issues
• RDN is a minimally invasive procedure that lowers blood pressure by denervating the sympathetic nerves surrounding renal arteries, reducing overactivity that can lead to hypertension
• Medtronic’s Symplicity Spyral RDN system has been in development for 14 years, and is already approved in over 70 countries globally

The Symplicity Spyral’s approval comes just 10 days after Recor Medical’s Paradise system became the first RDN system to land FDA approval, suddenly introducing two RDN systems to US clinicians and patients who were limited to pharma and lifestyle interventions before now.

The approval also represents somewhat of a comeback story, after an FDA expert panel voted against the Symplicity Spyral in August, finding that its benefits didn’t outweigh its risks (6-7 vote).

• Recor’s RDN system on the other hand, came away with a panel endorsement through a far stronger 10-to-2 vote

It’s possible that the Symplicity Spyral’s approval was helped by an updated FDA indication, positioning it as an “adjunctive treatment (aka additional treatment) in patients with hypertension in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.”

• That’s the same FDA indication as the Recor Paradise system, but represents a change from Medtronic’s PMA application which didn’t limit the Symplicity Spyral to patients also taking antihypertensives (not just for adjunctive use).

With the Symplicity Spyral’s approval now complete, eyes will be on Medtronic’s powerful commercial organization to see how they can bring RDN into clinical practice, noting the many hurdles that completely new interventions usually face when targeting a disease that’s historically been treated with medications.

Takeaway

Although media coverage might focus on the Spyral Symplicity’s negative panel vote, that will only matter if it doesn’t prove effective in the clinic or for Medtronic’s business.

What might not get enough coverage is how much of a monumental feat this is for the Medtronic RDN team, and what the sudden availability of two different renal denervation systems might mean for hypertension treatment in the US. 

If renal denervation ends up achieving what Medtronic and Recor believe it’s capable of, we just entered a completely new era in hypertension treatment.

The First Step to Coronary Artery Disease Diagnosis

HeartFlow’s new RoadMap Analysis solution allows CT readers to accurately, efficiently, and consistently identify stenoses in the coronary arteries. See how RoadMap Analysis’ visual and quantitative insights into the narrowing of all major coronary arteries helps readers evaluate coronary CT angiograms before determining the need for an FFRCT.

Reducing ECG Background Noise

Monebo’s Kinitec Rhythms ECG Algorithm separates true ECG signals from background noise, leading to more accurate diagnoses and improved operator efficiency. See for yourself how the algorithm measured up to a gold standard.

The Wire

• Cardiology AI, The Claims Leader: A new analysis in NEJM AI showed that cardio AI products have been submitted in far more CPT reimbursement claims than AI products from any other healthcare specialty, even including non-cardiac radiology solutions. The authors analyzed a database of over 11B CPT claims filed between January 2018 and June 2023, finding that cardiology solutions recorded the first (Heartflow for FFR-CT, 67,306 claims), third (Cleerly for ASCVD, 4,459 claims), seventh (Anumana for ECG cardiac dysfunction, 435 claims), and eighth (CADScor for cardiac acoustic waveform, 331 claims) most claims across healthcare AI.

• Lp(a) Plummets With Lilly’s Lepodisiran: In a small Phase I study, a single dose of Eli Lilly’s siRNA therapy lepodisiran caused lipoprotein(a) to plummet. Analysis of six lepodisiran doses and a placebo given to 48 patients with Lp(a) of ≥75 nmol/L, the three highest doses (96 mg, 304 mg and 608 mg) reduced Lp(a) by more than 90%, with effects lasting almost a year. Side effects included injection site pain, brief elevation of creatine kinase, and stuffy nose. 

• Ninerafaxstat’s nHCM Evidence: Imbria Pharmaceuticals’ investigational cardiac mitotrope, ninerafaxstat, met all primary safety and tolerability endpoints in its phase 2 study of 67 randomized patients with non-obstructive hypertrophic cardiomyopathy (nHCM). The ninerafaxstat group also showed significant functional cardiopulmonary exercise test improvements at 12 weeks. As many as one in 200 people have nHCM, and no treatments are approved for the disease.

• Heart Failure Unawareness: An alarming number of people with documented heart failure aren’t aware of their diagnosis. That’s the takeaway from a 2013-2016 Minnesota survey of 787 people with heart failure, finding that 293 of them (37%) didn’t even know or remember that they had it. Patients with diabetes were less likely to be aware of their HF diagnosis, while being female and having HFrEF were linked to greater HF awareness.

• Jana Care Series B: Jana Care closed a $6M Series B round to expand the development of its quantitative home blood testing platform, used to monitor chronic kidney disease and heart failure patients. Jana’s platform allows patients to perform self-administered blood tests from their homes, while clinicians can remotely review test results as needed, potentially helping to overcome key distance, technological, and socioeconomic barriers to HF and CKD monitoring. 

• CAC and Asymptomatic MI Risks: CT measurements of coronary artery calcium (CAC) could identify more people who are at risk of a heart attack but who don’t have symptoms or risk factors. In an AHA 2023 study, researchers looked at risk factors and CT-derived CAC scores in 429 patients who experienced myocardial infarctions (heart attacks), finding that the MI patients without previous risk factors still had high CAC scores (82% had CAC ≥50), and 77% met criteria for preventive therapy like statins or aspirin.

• Hello Heart Performs Across SDOH Factors: New research published in Circulation highlighted the potential for Hello Heart’s digital therapeutic for cardiovascular risk self-management to bridge inequity gaps in prevention. Out of 27,553 participants, 80.5% of those with baseline stage 2 hypertension reduced their systolic BP (-16.6 mmHg avg.) at 6 month follow-up, and 82.9% of those with high cholesterol (≥240 mg/dL) saw improvements. These changes came regardless of social determinants of health such as language, income, and urban/rural geography.

• Food is Medicine: The “food is medicine” concept picked up steam last week when the Bipartisan Policy Center released policy recommendations in support of prescribing medically tailored meals to address chronic diseases like diabetes and heart disease. The recommendations include calls for Congress to boost Medicare coverage for specialized nutrition therapy, CMS to bolster data collection efforts for food-based reimbursement testing, and the creation of new medschool accreditation groups establishing “nutrition-specific competencies.”

• PFA Safety Holds Up: A survey of 24 European centers highlighted the real-world safety of pulsed-field ablation (Boston Scientific’s Farawave). Across more than 17k patients treated with PFA, the rate of major adverse events was 1.01%, including pericardial tamponade (0.34%) and vascular AEs (0.31%). No esophageal AEs, PV stenosis or persistent phrenic palsy were reported, while stroke and death rates were 0.13% and 0.03%. The survey did flag unexpected risks for coronary spasm (0.16%) and acute renal failure due to hemolysis (0.03%).

• Ozempic’s Weight Loss Bans: It’s no secret that weight loss-focused patients have been clamoring for GLP-1s, driving shortages that are only expected to increase following the FDA approval of Eli Lilly’s Zepbound and Novo Nordisk’s finding that Wegovy cuts cardiovascular events by 20%. Concerns that shortages could be keeping GLP-1s out of the hands of diabetics has prompted Belgium to temporarily ban the use of Ozempic for weight loss, while doctors and prescribers in Britain have been ordered to stop prescribing Ozempic to non-diabetics.

• Postnatal BP Self-Monitoring: A study presented at AHA 2023 shows that following pregnancies with hypertension complications, patients could benefit from self-monitoring their blood pressure and transmitting results electronically to physicians. In a single-center randomized study with 220 participants, those who self-monitored and had meds adjusted as needed with physician guidance had a 6.5-mm Hg lower diastolic BP and 6.5-mm Hg lower systolic BP than the control group nine months postpartum.

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.

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!

The Resource Wire

• Cleerly Transforms Personalized CVD Care: Cleerly is launching perhaps the first large-scale randomized imaging AI trial, as it seeks to prove that AI-guided cardiovascular care reduces heart attacks. The five year TRANSFORM trial will investigate whether CVD patients who receive treatments based on results from Cleerly’s investigational AI-based plaque staging system have better outcomes.

• 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.

• Protecting Your Cardiovascular Imaging Data: Are you sure about your cardiovascular imaging data security? Tune-in to this Change Healthcare webinar discussing how hospital systems and healthcare providers can strategically improve their data security.

• AI Echo Copilot – The Future of Echocardiography: New technology from Us2.ai called Us2.connect allows you to add AI automation to any echo device. Any echo machine can now have 100% automated reporting with disease detection and editable measurements – all generated in realtime as you scan.