Emory’s Chandanreddy Devireddy, MD in response to the latest study supporting RDN’s hypertension benefits.

Cardiovascular Disease

FOURIER-OLE Shows Benefits of Reducing LDL-C Levels

How low can you go? The lower the better, at least when it comes to low-density lipoprotein cholesterol (LDL-C). That’s according to new findings from the FOURIER-OLE study, which found the lowest rates of cardiovascular disease among individuals with the lowest LDL-C levels.

High LDL-C is a well-known cardiovascular disease risk factor, but cholesterol-lowering drugs like statins have been remarkably successful in helping people reduce their lipid levels. Currently, optimal LDL-C is considered to be under 100 mg/dL.

In FOURIER-OLE, researchers examined how reducing LDL-C to different levels below the optimal threshold impacted cardiovascular disease incidence. They examined a subset of 6,635 participants from the FOURIER study, which itself had 27,564 individuals who received either a placebo or Amgen’s cholesterol-lowering drug Repatha (evolocumab).

FOURIER-OLE researchers followed this subset of individuals for an additional five years to determine the relationship between LDL-C levels and major cardiovascular events, finding that:

• The rates of cardiovascular events tended to be lowest for those with the lowest LDL-C levels (<20 mg/dL).
• There was no statistically significant association between lower LDL-C levels and increased risk of safety outcomes from use of Repatha – which had been an issue in a recent reanalysis of FOURIER study data. 
• Despite lowering cardiovascular events, Repatha use had no statistically significant impact on all-cause mortality.

The study and related Cardiology Twitter chatter raise a number of questions: 

• Should established clinical guidelines for LDL-C be lowered even further to spread the benefits of lipid-lowering drugs to more individuals?
• If so, what would be the cost of such an expansion? 
• How concerning is FOURIER-OLE’s lack of an impact on all-cause mortality? 

The same chatter also revealed some lingering misconceptions about Repatha’s cost, which most seem to believe is still $14,000 annually. However, Repatha was reduced by 60% to $6,600 in 2018, bringing it in line with the standard of care.

The Takeaway

In addition to reinforcing the benefits of lipid-lowering drugs, the new FOURIER-OLE findings revive the debate over the cost-effectiveness of population-based cardiovascular interventions. Sure, lower is better – but at what cost?

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The Wire

• Ultrasound Renal Denervation Win: Results from the RADIANCE II trial showed that ReCor-based ultrasound renal denervation (RDN) reduced blood pressure out to 2 months compared to a sham procedure, even without help from antihypertensive medications. In the randomized study (n = 224) daytime ambulatory systolic BP was reduced to a greater extent in the RDN group than the sham procedure group (-7.9 mmHg vs. -1.8 mmHg), and there were no adverse events. RDN also significantly improved six out of seven secondary BP outcomes.

• SpectraWAVE’s FDA: SpectraWAVE’s flagship HyperVue Intravascular Imaging System scored its long-awaited FDA 510(k) clearance, marking a key milestone in the innovative startup’s path towards commercialization. The HyperVue system combines SpectraWAVE’s DeepOCT and NIRS spectroscopy technology within a no-flush catheter, supporting both image acquisition and AI-based image review to help physicians optimize coronary stent placement in the cath lab.

• Novice RHD Echo Screening: A new JASE study showed how echocardiography-based rheumatic heart disease (RHD) screening could expand to healthcare settings that don’t staff sonographers. The researchers had novice practitioners perform handheld echo exams on 3,329 at-risk participants (4% w/ borderline or definite RHD), finding that relying on non-experts to perform the echos and offsite experts to review the exams achieved slightly higher sensitivity (88.4% vs. 86.5%) and much higher specificity (77.1% vs. 61.4%) than relying on non-experts for both steps.

• Puzzle Medical Adds $25M: Percutaneous heart pump startup Puzzle Medical completed its $25M Series A round to complete the company’s human feasibility study evaluating its novel pump’s safety and efficacy in patients with advanced heart failure. Puzzle will also use some funding to expand R&D and grow its team. The Puzzle Medical ModulHeart is a minimally invasive long-term hemodynamic transcatheter pump that could help avoid open-heart surgery, and reduce blood trauma and long-term complications.

• Baseline Cardiac Damage Affects AVR Outcomes: The extent of damage to the heart before undergoing aortic valve replacement (AVR) has a big impact on a patient’s quality of life after the procedure. Among nearly 2,000 patients who underwent AVR, those with more severe damage to the heart before the procedure had lower quality of life scores both pre- and post-procedure. In a multivariable model, each one-stage increase in baseline cardiac damage was associated with a 24% increase in the odds of a poor outcome at one year (death, KCCQ-OS <60, or a decrease in KCCQ-OS of ≥10 points).

• Novartis Partners With Dawn Health: Novartis entered a partnership with Dawn Health to develop new chronic condition management tools. The collaboration will see Dawn and Novartis build a virtual care platform (patient mobile apps, symptom monitoring, CDS services, clinical offerings) geared toward conditions with an unmet need around disease progression such as hypertension, cardiovascular disease, multiple sclerosis, and breast cancer.

• Patient Education Gap: A Wolters Kluwer Health survey found that 94% of patients want more patient education, yet 32% never receive educational materials from their providers. Among 1k healthcare consumers, 66% reported having lingering questions after their provider encounters and 19% frequently have new questions, causing many patients to turn to social media and other unvetted sources for answers.

• Teleflex’s PCI Catheter Milestones: Teleflex announced the FDA clearance of its Triumph Catheter and the first clinical use of its GuideLiner Coast Catheter. Both catheters are intended for use in complex PCIs. The Triumph Catheter features six wire exit ports to improve wire navigation and allow clear visualization, while the GuideLiner Coast Catheter adds a hydrophilic option to Teleflex’s guide extension portfolio.

• Tele-ECG Risk Stratification: Tele-cardiology tools could expand primary care’s role for cardiology risk assessments, especially in low-resource regions. Researchers had primary care clinicians perform electrocardiography exams on 675 patients, before recording the ECG measurements with dedicated software and routing the data to offsite cardiologists for diagnosis. A comparison of the patients’ ECG and echo screening results revealed that patients with abnormal ECGs had a 2.2-times higher chance of major heart disease in their echo exams.

• Us2.ai’s Platform Expansion: Us2.ai continued its AI platform expansion, making its AI-based automated echo reporting and measurement solution available on the Nuance Precision Imaging Network and TeraRecon’s Eureka Clinical AI platform. The new partnerships further expand Us2.ai’s AI platform channel, following similar alliances with Blackford, Aidoc, and Viz.ai.

• Advancing Cell Therapy for HF: The largest clinical trial of cell therapy in HFrEF to date provided novel insights into how cardiac cell therapy using MPCs may benefit HFrEF. Although the therapy did not hit the primary and secondary endpoints (reduction in recurrent nonfatal hospitalization or urgent care events), MPC therapy did decrease the risk of MI or stroke by 58% and the risk of 3-point MACE by 28%. Among a subset of patients with high baseline inflammation, MPCs decreased risks to an even greater degree (75% & 38%).

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.

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.

Democratizing Echocardiography with AI

We talk a lot about AI’s potential to expand echo access, and this Imaging Wire Show reveals that ultrasound’s AI-driven expansion might go far beyond what many of us had in mind. Check out our discussion with Duke Health’s Madhav Swaminathan, MBBS, MD and Us2.ai’s Carolyn Lam MBBS, PhD and James Hare, to see how AI is democratizing echo exams.