Jessica Golbus, MD discussing the results of the SEISMIC-HF trial.

Cardiac imaging is evolving fast, making it essential that providers have the right imaging workflows to allow them to succeed today and make sure they’re ready for the future.

Check out this Cardiac Wire Show interview with Christopher D. Maroules, MD, FSCCT to learn the technologies that he and his teams are using to keep up with the cardiac imaging evolution.

Cholesterol Reduction

Muvalaplin Aces Phase 2 Lp(a) Test

Impressive results from the Phase 2 KRAKEN trial presented at the AHA 2024 Scientific Sessions showed that Eli Lilly’s muvalaplin greatly reduces Lp(a) blood levels, adding an attractive oral option to its Lp(a) pipeline.

• High Lp(a) is an inherited CVD risk factor that impacts one out of every five people and currently has no approved drug therapies. 
• Muvalaplin stops the formation of Lp(a) by blocking the initial bond between its two components, apolipoprotein(a) and apolipoproteinB.
• Lilly is already working on an injectable Lp(a) drug called lepodisiran, but muvalaplin’s oral route could be a game-changer.

By the study’s 12-week endpoint, patients experienced significant reductions in blood Lp(a) when taking oral muvalaplin across three different doses, compared to a placebo.

• Patients who received the 10 mg dose saw a 47.6% reduction in Lp(a).
• Those who received 60 mg saw an 81.7% reduction.
• The largest 240 mg dose led to an 85.8% reduction, suggesting a tapering off effect at higher doses.

Muvalaplin also aced the secondary endpoints for Lp(a) thresholds, while the higher doses significantly reduced apoB levels. 

• The percentage of patients with Lp(a) levels below 125 nmol/L was 64.2% at 10 mg, 95.9% with 60 mg, and 96.7% with 240 mg, compared to 6.0% in the placebo group.
• ApoB levels also declined at all doses, with placebo-adjusted reductions of 8.9% (10 mg), 13.1% (60 mg) and 16.1% (240 mg).

Treatment-related adverse events were similar in the muvalaplin and placebo groups, occurring in 14.9% of the placebo group, 5.9% of the 10 mg group, 14.3% of the 60 mg group, and 14.7% of the 240 mg group. 

The results add to an increasingly competitive Lp(a) drug landscape, which includes promising candidates from a field of major pharma players…

• Amgen’s front-runner injectable siRNA olpasiran (Phase 3).
• Silence Therapeutics’ injectable siRNA zerlasiran (Phase 3).
• AstraZeneca’s oral Lp(a) disruptor YS2302018 (preclinical).
• Novartis/ Ionis’ injectable oligonucleotide pelacarsen (Phase 2).
• Lilly’s own injectable siRNA lepodisiran (Phase 2)

The Takeaway

Though only a Phase 2 trial that didn’t record outcomes, the success of Lilly’s muvalaplin in lowering blood Lp(a) signals a strong start for oral prevention, and could give the drugmaker a differentiated option among a rapidly growing field of injectable Lp(a) reducers.

New Horizons in Structural Heart

TAVR and TMVR rates are rising rapidly, placing more pressure on interventional planning. Tune into this Circle CVI and Radcliffe Cardiology breakout detailing how to leverage modern CT workflows to produce efficient and accurate pre-procedural plans.

Configure Your PCI Study

See for yourself how cardiac imagers use GE HealthCare’s Centricity Cardio Enterprise Universal Viewer to do their PCI studies, including configurable viewport setup and side-by-side comparisons.

Echo Automation’s Big Impact

Improving clinician efficiency and quality is the goal for most AI solutions, but we rarely see AI achieve both. See how Juntendo University’s Dr. Nobuyuki Kagiyama achieved both of those goals, while reducing sonographer fatigue in the process.

The Wire

• BridgeBio Lands ATTR-CM Approval: America’s ATTR-CM patients have a new treatment option – beyond Pfizer’s tafamidis – following the FDA approval of BridgeBio Pharma’s Attruby (acoramidis). Attruby is an orally-administered near-complete (≥90%) transthyretin stabilizer, labeled to reduce cardiovascular death and cardiovascular hospitalization risks in adults with ATTR-CM. Attruby should be a welcomed new option for ATTR-CM patients, given that it halts disease progression, and slashed mortality and CV hospitalization in its pivotal trial (-42% & 50%).

• BridgeBio Adds Acoramidis Evidence: Just days before its FDA approval, BridgeBio released new data further supporting acoramidis’ potential to compete with Pfizer’s tafamidis as America’s go-to ATTR-CM treatment. The open-label extension of the Phase 3 ATTRibute-CM trial showed that BridgeBio’s acoramidis reduced all-cause mortality in ATTR-CM patients by 36% (36 month follow-up) and 34% (42 months) compared to placebo, while cutting a composite of mortality and hospitalization by 46% (36 months) and 48% (42 months).

• Whistleblower Cardiologist Fired: A whistleblower cardiologist claims he was fired from Trinity Health Muskegon for reporting a colleague for allegedly performing unnecessary heart procedures. The former chief of cardiology was originally suspended for “behavior.” Following his suspension, the doctor and other cardiologists submitted a letter outlining their accused colleague’s pattern of misreading results in order to justify unnecessary ICD implantations. After filing the letter, the whistleblower was fired and has since filed a lawsuit making the same unnecessary procedure allegations.

• NewAmsterdam’s LDL-C Combo Data: NewAmsterdam announced topline data from its Phase 3 TANDEM trial that showed the promise of its obicetrapib-ezetimibe combination LDL-C therapy. Compared to placebo, the combo resulted in a 52.2% mean reduction in LDL-C blood levels after 84 days of treatment, beating obicetrapib (-35.5%) and ezetimibe (-23.3%) when taken on their own. NewAmsterdam hopes to use the results to support regulatory filings for the fixed-dose combination to treat heterozygous familial hypercholesterolemia and ASCVD.

• Medtronic & Tempus’ AS Alliance: Medtronic and Tempus commenced the ALERT study to assess the undertreatment of aortic stenosis and mitral regurgitation, as well as associated disparities with guideline recommended treatments like TAVR. The study will use the Tempus Next platform’s automated patient identification software to catch AS or mitral regurgitation patients who meet therapy criteria, but do not have a treatment plan in place. The study will also evaluate the impact of Tempus’ EHR notifications on clinical treatments.

• Cardiosense’s Wearable HF Results: Results from Cardiosense’s SEISMIC-HF I study showed that its wearable CardioTag device might be just as good as traditional implantable pulmonary artery pressure sensors when it comes to predicting the onset of heart failure. The study found that CardioTag and its machine learning algorithm produced an error of only 1.04 mmHg in estimating PCWP when compared against implantable pulmonary artery pressure sensors. 

• No Glory in GLORIOUS Trial: According to the GLORIOUS study, neither GLP-1s nor restrictive oxygenation improved clinical outcomes after cardiopulmonary bypass-assisted coronary artery surgery and/or valve replacement surgery. After a median follow-up of 5.9 years, neither strategy reduced the risk of mortality or morbidity from renal failure, stroke, or heart failure. Despite the neutral results, the study’s lead investigator claimed it helps inform clinical practice. It’s also the first GLP-1 trial in quite a while that didn’t show hugely positive results.

• Ultromics’ Amyloidosis Clearance: The FDA cleared Ultromics’ EchoGo Amyloidosis software for detecting cardiac amyloidosis from echo AI scans, joining the company’s EchoGo platform and complementing its EchoGo Heart Failure solution. EchoGo Amyloidosis was developed through a partnership between Ultromics and J&J’s Janssen division (which makes an AL amyloidosis drug), and is the first of 15 breakthrough cardiac devices in the FDA’s Total Product Lifecycle Advisory Program to gain marketing authorization. 

• RFM Improves Long-Term AFib: One of the major hurdles for long-term AFib ablation is the gradual worsening of CVD risk factors like age and weight gain. To help solve this problem, the ARREST-AF cohort study examined how putting ablation patients on CV risk factor management therapy would impact outcomes, finding that it improved AFib ablation’s long-term success. Compared to the control, RFM reduced AFib burden while improving both single-procedure and multiple-procedure arrhythmia-free survival by 16% and 42%, respectively.

• HeartBeam’s ECG Evidence: HeartBeam announced results from two studies evaluating its vector-based ECG technology for arrhythmia and heart attack detection. The first study found excellent agreement when physicians diagnosed various arrhythmias utilizing the HeartBeam-synthesized 12-lead ECG (captured with a 3-lead device) compared to a standard 12-lead ECG (Sensitivity: 94%, Specificity: 100%). The second study found HeartBeam’s algorithm accurately detected ACS and matched the assessment of expert ED physicians who typically rely on standard 12-lead ECGs for ACS assessment. 

• Cook Medical’s Cooked IVC Results: A new analysis uncovered a range of problems with Cook Medical’s Celect inferior vena cava (IVC) research and reporting. The device’s clinical study protocol didn’t follow FDA testing guidance, while unsealed court documents revealed that the study’s IVC perforation outcome definitions had lower sensitivity for detecting adverse events than the recommended guidelines. A further comparison of legal and public records showed that adverse events and deaths were misreported to FDA reviewers, publications, and on the device label. 

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.

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.

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

• Connecting the ECG Monitoring Ecosystem: There’s so much that goes into building the solutions that providers use each week, and that’s definitely true for ECG monitoring. In this Cardiac Wire Show interview with Flipside Media’s president Brad Ummer, we get an insider’s view of what it takes to develop an ECG monitoring solution, including Flipside’s partnership with Monebo Technologies.

• 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.

• TeraRecon’s Mitral Valve Workflow: Are your mitral valve planning workflows ready for higher procedure volumes? Take this step-by-step tour of TeraRecon’s Mitral Valve Workflow to see how it gives imagers the tools to evaluate the mitral valve and support TMVR treatment planning.

• Redefining Percutaneous Coronary Intervention: Learn about the AGENT™ Drug-Coated Balloon from Boston Scientific and how this technology is expanding the treatment options for patients with in-stent restenosis in the U.S. Rx only. (Sponsored by Boston Scientific)

• Salem’s Single CVIS Platform: Selecting a new CVIS platform is a difficult task, but it’s easy to know when you choose the right one. See why Salem Health adopted Optum’s cardiovascular solution, and the impact it had on report turnaround times, standard echo times and standard coronary cases, and structured reporting in this case study.

• Streamlining Cath Lab Hemodynamic Workflows: Is your hemodynamic solution keeping your cath lab efficient? Merge Hemo is a cath lab hemodynamic monitoring solution, providing a Best in KLAS user experience, while enhancing clinical workflows, automating data collection, and streamlining inventory management.

• 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.

• Advancing CAD Risk Assessments: When HeartFlow used its Plaque Analysis solution to analyze more than 11,000 CCTAs in the DECODE Study, the solution achieved 95% agreement with IVUS and led to changes in two out of every three patients’ treatment plans. See how HeartFlow Plaque Analysis can help you accurately assess your patients’ CAD risks and personalize their treatment.

The Industry Wire

1. Chronic pain affects 24.3% of U.S. adults.
2. Eli Lilly follows J&J with federal 340B rebate lawsuit
3. 4M people would lose coverage if ACA subsidies expire.
4. RFK Jr. may seek to rescind AMA’s ability to create billing codes.
5. Geisinger performs shoulder replacement with a lifetime guarantee.
6. Indiana residents and feds fight monopolizing hospital merger.
7. CommonSpirit taps into University of Utah Health providers.
8. WHO’s primary care digital transformation handbook.
9. Steward bankruptcy leads to CareMax bankruptcy.
10. RFK Jr. weighs changes on Medicare payments.