Lynn Y. Zoiopoulos, DO

Cardiology

Cardiology in H1 2024

The first half of 2024 is now a wrap, and it was another big one in cardiology. Here are some of Cardiac Wire’s top six storylines from the last six months, plus some things to keep in mind as we head into 2024’s second half:

• A Sick World – Over the course of H1 we’ve learned that 90% of US adults are at risk of developing cardiovascular-kidney-metabolic syndrome, artificial sweeteners that we consume every day are associated with increased CVD risks, many patients might have microplastics embedded in their plaque, and the number of Americans with CVD will surge by 60% during the next 25 years. Yikes.

• TR Options – H1 brought the FDA approvals of Edwards’ EVOQUE transcatheter tricuspid valve replacement system and Abbott’s TriClip tricuspid edge-to-edge repair (TEER) system, giving US interventionalists the options to repair or replace the tricuspid valve for the first time. That’s a big change after years of only having surgical TR options, and it appears that more interventional TR devices are on the horizon.

• GLP-1s are for CVD too – So far this year GLP-1s have gone from a weight loss and diabetes drug that “might” have cardiovascular benefits to becoming an FDA-approved and Medicare-covered option for CV event reduction. GLP-1s’ cardiovascular impact is likely to continue to expand, given growing evidence that it also improves HF symptoms.

• Pulsed Field Awakening – Pulsed field ablation was the clear electrophysiology highlight of 2024 so far, after dominating conversations at HRS 2024, producing mounting evidence of its advantages, and scoring its first FDA approval.

• AI Impact – Cardiology might not be the first specialty that comes to mind when discussing healthcare AI, but cardiovascular AI products are seeing major product, reimbursement, and adoption progress this year. We’re also seeing AI play a greater role at cardiovascular conferences, and a steady expansion of cardiovascular AI products beyond imaging and ECG modalities.

• Long-Lasting Treatments – The fact that patients aren’t very good at daily pill adherence drove a big H1 focus on long-lasting and always-on therapies, including the early expansion of renal denervation, more progress with long-term injections, and continued gene editing explorations.

Explore the Potential of Cardio AI

Explore the potential of AI-powered cardiology solutions in this on-demand TeraRecon webinar, detailing how its Cardio Suite solutions help expedite disease diagnosis, care coordination, and provide the data to support cardiac treatment decisions.

Uncover the Brain-Heart Connection

AI might be poised to transform cryptogenic stroke care, but many cardiologists and neurologists still have a lot to learn. Tune-in to this upcoming webinar on July 24th, where Drs. Brett Meyer and Jonathan Hsu will explore how Viz.ai’s post-acute workflow solution, Viz Connect, is being used to accelerate cryptogenic stroke diagnosis and treatment.

Structured Reporting Cuts Late Charges

Structured reporting is often associated with efficiency improvements, but its ability to reduce errors and improve billing accuracy can deliver benefits across a cardiovascular service line. See how Baystate Medical Center’s transition to structured cardiology reporting with Optum helped them reduce unsigned charges by 79%.

The Wire

• Alnylam Amvuttra’s ATTR-CM Impact: Alylam’s vutrisiran (Amvuttra) met all primary and secondary endpoints in the Phase 3 HELIOS-B study evaluating its effect on transthyretin amyloidosis with cardiomyopathy (ATTR-CM), a new indication for the injectible. In 655 patients, the drug demonstrated significant reductions in the composite endpoint of all-cause mortality and CV events – both in the overall (-28%) and monotherapy (-33%) cohorts. Adverse events were similar to placebo. Vutrisiran is FDA-approved for hereditary ATTR, and Alnylam plans to file an sNDA for ATTR-CM this year.

• AliveCor’s 12L & AI Milestone: AliveCor’s clinical capabilities took a giant step forward last week, with the FDA clearance and commercial launch of its KAI 12L AI technology and Kardia 12L ECG System. KAI 12L can detect 35 cardiac determinations (14 arrhythmias and 21 morphologies) including MI and common cardiac ischemia types, using data from reduced leadset ECGs. Meanwhile, the Kardia 12L is the first AI-powered handheld 12-lead ECG system to feature a single cable, potentially simplifying and expanding ECG access.

• Predicting ISR with Lp(a): A new study revealed a link between lipoprotein(a) and in-stent restenosis (ISR) after PCI. In 1,209 PCI patients, those with high Lp(a) (≥50 mg/dL) had a 17% ISR rate compared to 11.6% in those with lower levels. Lp(a) already has an established link to atherosclerosis and MI, and now could be considered for PCI evaluations.

• Endotronix Cordella Lands FDA PMA: Endotronix heads into July 4th with reason to celebrate, following the FDA premarket approval of its Cordella PA Sensor System for the treatment of NYHA Class III heart failure patients. The Cordella System combines an implanted PA sensor to measure congestion, a handheld PA pressure reader, a range of vital sign measurements, and a digital health platform to enable comprehensive home-based HF management. The Cordella system might have a major impact, given the success of its PROACTIVE-HF trial.

• OPTIMIZing PAD Care: An implementation trial of lipid management in PAD patients found that care delivered through vascular teams significantly reduced LDL cholesterol levels. The OPTIMIZE PAD-1 trial showed that patients managed by an interprofessional vascular care team saw an average LDL-C drop of 49.1%, compared to just 5.4% with usual care. The vascular care team patients were over three times more likely to achieve LDL-C <70 mg/dL and eight times more likely to hit LDL-C <55 mg/dL.

• The UK’s Mixed CVD Trends: A study of over 1.6 million people in the UK found that the incidence of heart disease actually decreased by 19% from 2000 to 2019, with the greatest declines among older adults. While coronary heart disease and stroke rates fell by about 30% in total, there were increases in arrhythmias, valve diseases, and thromboembolism. Interestingly, younger age groups saw little improvement, and socioeconomic disparities persisted.

• Tempus’ AFib AI Clearance: Healthcare AI powerhouse Tempus expanded its reach into cardiology, following the FDA clearance of its Tempus ECG-AF solution for the identification of patients with higher AFib risks. The AI solution analyzes resting 12-lead ECGs and is intended to detect signs that a patient might experience AFib within the next 12 months. Tempus is better known in oncology, radiology, and drug discovery, but has been building out its cardiology team for several years and acquired Mpirik in early 2023.

• Aspirin Use Needs ‘Urgent’ Attention: Aspirin use for CVD primary prevention in the US is still too common despite limited benefits and guidelines suggesting against it. In 186k participants surveyed between 2012 and 2021 (excluding 2020), 18.5% of 40-and-over and 29.5% of 60-and-over patients reported taking aspirin for primary prevention. The results show “an urgent need for physicians to inquire about aspirin use, including self-use, and engage in risk-benefit discussions.”

• Butterfly Grows Echo Guidance Garden: Handheld ultrasound maker Butterfly Network added a pair of new cardiology-focused partners to its Butterfly Garden marketplace for AI apps. The latest additions target expanding echo use to non-expert clinicians, adding echo guidance software from HeartFocus and UltraSight. Butterfly historically supported echo guidance through its exclusive partnership with Caption Health, but was likely in need of new echo guidance options following Caption’s acquisition by GE HealthCare last year.

• Prior Authorization Problems: Prior authorization remains a problem for physicians, payers, and regulators alike. MedPAC’s annual report to Congress revealed that 95% of treatments deemed necessary by providers in 2021 were approved, and for those that were denied, appeals were approved in 80% of cases. If you do the math, all the manual labor produced the same outcome in 99% of cases. Meanwhile, an AMA survey showed that the average physician fields 43 PA requests per week that require 12 hours of staff time to resolve.

• Interventional Echo Radiation Risk: A new article in Structural Heart underscores the radiation risks faced by interventional echo personnel. The growing use of fusion imaging – in which echo images are combined with fluoroscopy or CT – means interventional echo specialists are increasingly exposed to ionizing radiation as they provide guidance for structural heart interventions. The article offers recommendations for the use of personal protective gear such as aprons and gloves, as well as lead shielding.

Cleerly at SCCT2024

Cleerly has an action packed SCCT2024 planned. Don’t miss the chance to dive into newly published evidence supporting Cleerly’s personalized AI-enabled CCTA analysis, meet with their executives, or see how their ischemia solutions stack up to traditional methods.

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.

Us2.ai’s Next Gen AI

Us2.ai recently scored FDA clearance for Us2.v2, the newest version of its flagship software featuring 45 automated echocardiography parameters, including strain analysis. See how the new version automates echo exams and improves cardiovascular disease detection.

The Resource Wire

• Enterprise Imaging in Cardiology is Ultimately Human: Imagine having all patient imaging results, at your fingertips. See how GE HealthCare enterprise imaging makes this possible, enabling more precise, personalized, and ultimately human care.

• 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!

• Streamline Your Cardiology Imaging Workflows: See how cardiologists and their teams can streamline imaging workflows to make their cardiovascular service line more efficient, cost-effective, and patient-centered, using Merge’s cardiology solutions. 

• It’s Time to See The Full Picture: See how HeartFlow ONE is transforming precision heart care as the first all-in-one CCTA pathway, combining FFRCT, stenosis, and plaque analysis in a single workflow.

• Taking AI from Idea to the Clinic: There are few areas of healthcare with more innovation than artificial intelligence, but most of those solutions never make it past being published in a medical journal – providing no additional value to medical care or the solutions’ developers. In this Cardiac Wire Show, Bunkerhill Health CEO Nishith Khandwala discusses Bunkerhill’s unique approach to solving this problem and the impact they are having in cardiology and beyond.

• Precision QRS Detection: QRS detection is essential for any ECG algorithm, and Monebo’s Kinetic QRS ECG Algorithm sets the standard for accuracy. Kinetic QRS accurately detects the QRS complex, no matter the amplitude, waveform, or noise levels.