Rick Pescatore, DO

Drug-coated balloons have been a go-to option for in-stent restenosis for over a decade, but U.S. patients and physicians have historically been limited to other, often inferior, treatments. That changed with the FDA approval of Boston Scientific’s AGENT™ Drug-Coated Balloon. Learn more about the AGENT™ Drug-Coated Balloon’s significance, acceptance, and potential impact in this Cardiac Wire Show interview with Kathleen Kearney, MD.

Structural Heart

There’s No Clear King of TAVR Valves

Cardiologists have a wide selection of TAVR valves to choose from, and a new study pitting the top three second generation devices against each other suggests there’s not much difference in the long run.

• Second generation TAVR valves improve on first gen valves by featuring better deliverability, reduced paravalvular leakage, and easier repositioning or retrieval.
• So far, we haven’t known the long-term clinical outcomes of second-generation devices for TAVR beyond five years after implantation.

In a search for the king of TAVR valves, researchers compared seven year outcomes of Edward’s Sapien 3, Medtronic’s Evolut R/PRO, and Boston Scientific’s Acurate Neo, finding that all three had similar composite mortality, stroke, and HF re-hospitalization rates.

• Of the study’s 383 TAVR patients, 131 received the Sapien 3, 134 received the Evolut R/PRO, and 118 got the Acurate Neo.
• By the seven year follow up, the composite mortality, stroke and HF re-hospitalization rates were similar for all three (60.2% for Sapien 3, 51.6% for Evolut R/PRO, and 62.1% for Acurate Neo).

When it came to valve-related clinical efficacy, again all three valves were similar in their VARC-3 definitions (2.2% for Sapien 3, 1.2% for Evolut R/PRO, and 4.2% for Acurate Neo).

• Even in the case of valve durability, researchers found that all three contenders had similarly low rates of valve degeneration.

Before you get disappointed with the three way tie, there are a couple of serious caveats to mention about this study.

• First, the patient population is small relative to the number of people receiving these valves every year, so the sample isn’t the most representative.
• Second, the study only included patients who did not have a CT before TAVR, which excludes a good chunk of patients as well.

The Takeaway

While this study is framed like a head-to-head comparison, we’ll certainly need more powerful clinical studies before we can crown a king of the TAVR hill. That said, there’s some comfort in knowing that, at least in the first seven years after implantation, the most common valves all perform similarly well.

Explore Vitrea Advanced Visualization

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The Wire

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• VAD Implantation in Pediatric CHD: New research suggests that children with CHD are more likely to suffer from complications following VAD implantation. Researchers collected data on 966 pediatric VAD recipients and found that those with CHD (36%) were more likely to need mechanical ventilation (67.0% vs 44.1%), parenteral nutrition (63.6% vs 45.1%), and extracorporeal membrane oxygenation before implantation (33.2% vs 20.5%). CHD patients were also more likely to experience MACE and had worse survival rates (HR: 2.05).

• PALBI Predicts TAVR Mortality: Predicting TAVR’s mortality risk isn’t easy, but a patient’s platelet-albumin-bilirubin (PALBI) score could give some clues about post-TAVR outcomes. One study followed 812 patients with AS and/or aortic regurgitation who underwent TAVR and found that higher PALBI scores led to higher all-cause mortality (HR = 2.68) and higher cardiovascular mortality (HR = 2.79). ROC curve analysis of PALBI scores for all-cause mortality led to an AUC of 0.63, suggesting that they could be used for insights into post procedural patient health.

• Google Introduces AI Co-Scientist: Google introduced its new AI co-scientist, a multi-agent generative AI system that can help scientists generate novel hypotheses and research proposals. AI co-scientist is designed to “mirror the reasoning process underpinning the scientific method” and is purpose-built for collaboration. It not only performs standard literature review and summarization, but can reportedly formulate demonstrably novel hypotheses by building upon prior evidence and tailoring it to specific research objectives.

• Ataciguat for AV Calcification: Although pharmacological treatments for fibrocalcific aortic valve stenosis (FCAVS) have been elusive for over 50 years, a recent Circulation roundup study suggests ataciguat (Sanofi) could be a potential treatment. Researchers first tested the drug on human tissue and uncovered that ataciguat increased sGC signaling and reduced bone morphogenetic protein 2 signaling in aortic valve interstitial cells. Phase 1 and 2 studies later confirmed this in human patients and found ataciguat slowed the progression of aortic valve calcification in patients with moderate FCAVS. 

• Arrowhead’s Preclinical Results: Arrowhead Pharmaceuticals announced impressive preclinical results on its RNAi drug, ARO-ALK7, for treating obesity. ARO-ALK7 directly targets the ACVR1C gene expressed in adipose tissue and demonstrated an 80-91% knockdown of gene activity depending on dose (0.3-1.5mg/kg), with 75% knockdown still observed after 12 weeks. These gene activity reductions halved the fat mass of mice and were attributed to lipolysis and increased energy expenditure.

• AI Boosts SPECT Myocardial Perfusion: Researchers applied a deep learning algorithm to conventional quantitative SPECT myocardial perfusion data, finding that the combination boosted diagnostic accuracy for detecting obstructive CAD. In a paper in JNM, researchers fed the algorithm data from 555 patients undergoing stress SPECT-MPI to produce total perfusion deficit-deep learning scores, which had higher AUC than AI prediction alone or traditional stress total perfusion deficit (0.84 vs. 0.80 and 0.74).

• CV Phone Home: According to new research in JACC, teleprehabilitation (say that 10x fast) could help reduce MACE before elective cardiac surgery. Among 394 patients, half received an online personalized teleprehabilitation program before surgery, with modules including exercise training, psychological support, nutritional support, and smoking cessation. MACE occurred in 16.8% of the teleprehabilitation group (vs. 25.5% of the control), and the modules also reduced the number of active smokers, pulmonary risk, and depression scores.

• Surgical MV Repair Data: A recent JACC study suggests that surgical mitral valve repair leads to low mortality and excellent long-term outcomes, shedding light on a procedure with little long term data. The retrospective study examined 3.3k patients who underwent surgical mitral repair for degenerative MR and found that in-hospital mortality was 0.48% for all cases and 0.21% for isolated mitral valve repair, while the procedure’s 10-year survival was 89.65%. 

• An SGLTi for MACE? As evidence mounts regarding SGLTis CV benefits, it appears sotagliflozin in particular could significantly reduce MACE risk in patients with T2D, CKD, and other CV risk factors. One study tracked data from over 10k patients who were randomized to receive either sotagliflozin or placebo, discovering that sotagliflozin led to a 23% reduction in MACE risk over , a far more significant reduction than other SGLT inhibitors.

• Apple Health Study: Apple kicked off a new study in partnership with Brigham and Women’s Hospital to glean insights into the “relationships between various areas of health, such as mental health’s impact on heart rate, or how sleep can influence exercise” using data from its devices. The Apple Health Study will enroll participants through the Research app, allowing users to control how much data they share. The research follows a trio of studies launched in 2019 on hearing, women’s health, and movement, which went on to shape new features in several Apple products.

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See how one major Midwest health system’s decision to implement Merge Cardio transformed physician and staff workflows, improved data entry speed and accuracy, and increased cost savings.

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!

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The Resource Wire

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• Circle CVI’s Cardiac CT Expansion: Watch this Cardiac Wire interview with Circle Cardiovascular Imaging’s Chief Product Officer, Scott Galbari as he sheds light on Circle CVI’s history with cardiac MRI and how the company is tackling the coming demand for cardiac CT.

• 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.

• Physician Perspectives on HeartFlow: Physicians worldwide are using the HeartFlow Analysis to help diagnose suspected coronary artery disease. Explore their perspectives on adopting HeartFlow’s technologies today.

• 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.

• Tracking Your Post-Treatment Plaque: Tune-in to this on-demand Cleerly webinar where preventative cardiologist John Osborne, MD, PhD, FACC, FNLA explores how to use CTA to track plaque progression and identify residual risk post-treatment.

• 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.

• Discover Innovation in Intervention: Explore how the AGENT™ Drug-Coated Balloon from Boston Scientific is advancing U.S.-based treatment options for patients with coronary artery disease. Rx Only. (Sponsored by Boston Scientific)

• Making Cardiovascular Data Work for You: Today, cloud-native analytics can automate data acquisition and synthesize complex data. Discover what Optum’s technology can do to facilitate future advancements in cardiovascular data and analytics.

The Industry Wire

1. Thousands of UC healthcare employees go on strike.
2. House budget blueprint could bring Medicaid cuts.
3. State healthcare for noncitizens cost Illinois $1.6B.
4. HIPAA warns of malicious DICOM installers.
5. Trump signs healthcare price transparency order.
6. Mystery illness in DRC kills more than 50 people.
7. Child becomes first measles death in 10 years.
8. FDA declares semaglutide shortage over. 
9. Utah bans fluoride from its tap water. 
10. Walgreens ducks $1B COVID test settlement.