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Inflammation in HF, AZ’s HTN Win, and BSCI’s TAVR Return
May 21, 2026
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“One of my key takeaways from watching the FDA over the past 6 years is that the term “safe and effective” is a legalism that is turned into a marketing slogan but has little meaning for clinical care.”

Joseph Marine, MD

Back in October, I was pretty stoked to read about the adipokine hypothesis for HF and inflammation-driven pathophysiology. Now it’s interesting to see more research exploring the prevalence of inflammation in HF patients.

Hope you enjoy and thanks for reading.

Vik

Heart Failure

Inflammation’s Prevalence and Role in Heart Failure

Heart failure inflammation might actually be an underrecognized therapeutic target, after analysis of the POSEIDON registry found that systemic inflammation is present in nearly half of heart failure patients, regardless of ejection fraction.

  • High inflammatory risk is defined as hsCRP levels ≥2 mg/L.
  • Researchers already knew that inflammation contributes to heart failure pathophysiology, but its prevalence and relevance were unknown until now.

To explore inflammation prevalence, the POSEIDON registry analyzed 11.8k heart failure patients with available hsCRP readings and found that their inflammatory burden proved remarkably uniform.

  • Elevated hsCRP levels were consistent across HF sub-types, coming in at: 38.8% in HFpEF, 38.1% in HFmrEF, and 38.2% in HFrEF
  • Within each HF subtype, patients who showed high hsCRP were more likely to be females and have CKD, obesity, worse NYHA class, and higher NT-proBNP levels.
  • However, body mass index proved to be the exception, showing stronger association with hsCRP in HFpEF versus other subtypes.

These results parallel the adipokine-adiposity framework that was proposed last October in JACC, which hypothesizes that visceral fat increases cause secretion of an altered adipokine profile that leads to systemic inflammation alongside cardiac hypertrophy and fibrosis.

  • That hypothesis consisted of three “domains” of adipokines (I,II,III) and more specifically, it suggested that Domain III played a major role in HFpEF development.
  • Domain III adipokines are heightened by high body fat and drive the inflammation, hypertrophy, and fibrosis effects directly causing HFpEF.

So what does this mean for POSEIDON’s results? The key distinction here is the consistent high inflammation phenotype that 4 out of 10 HF patients exhibit (regardless of HF subtype).

  • When taken in the context of the adipokine hypothesis, it means that there could be distinct pathophysiologies across and within each HF subtype.

That’s significant because it suggests the potential for inflammation specific therapeutic targets that are unique to about 40% of the HF patient spectrum.

The Takeaway

There’s a growing macro-trend within cardiology that is raising understanding and awareness of inflammation’s role as a CV risk factor. These results fit into that trend and are especially important to our understanding of inflammation’s impact on heart failure’s varying pathophysiologies.

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Earlier Detection, Better Outcomes

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Staying ALERT with Tempus

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The Wire

  • Baxdrostat’s Big Approval: AstraZeneca took a big step into the antihypertensive segment, announcing the FDA approval of Baxfendy (baxdrostat) as an add-on therapy for adults with hard-to-control hypertension. Brought on through AstraZeneca’s $1.3B acquisition of CinCor, Baxdrostat inhibits the production of aldosterone, a hormone that raises blood pressure. This novel mechanism has proven to be safe and effective so far, including in the BaxHTN Phase 3 trial, which cut SBP by 15.7 mmHg (9.8 mmHg placebo-adjusted) at 12 weeks.
  • Boston Scientific’s MiRus Investment: Boston Scientific returned to the TAVR arena, acquiring a 34% stake in MiRus for $1.5B, and giving BSCI exclusive rights to acquire the startup for another $3B. MIRus’ SIEGEL system is the first nickel-free, balloon-expandable TAVR valve intended to restore function and normal blood flow of severely narrowed aortic valves. The investment gives BSCI a path back into the TAVR market, following the discontinuation of its Acurate platform last year. It also continues the recent TAVR startup investment spree by the cardiotech leaders.
  • BSCI’s IVL Evidence: We might have another IVL competitor coming, after Boston Scientific’s SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter nailed its IDE. In the FRACTURE IDE trial, the SEISMIQ 4CE reached all primary safety and effectiveness endpoints, including a 93.3% freedom from MACE rate at 30 days and a 93.7% procedural success rate (beating its 86.2% and 85.8% goals). BSCI acquired the SEISMIQ through its purchase of Bold Medical, placing it among J&J, Abbott, and Stryker in the IVL race.
  • A Rare Genetic CM IND: China-based Chengdu Origen Biotechnology and Vanotech received FDA clearance to proceed with an IND application for KHN921, an AAV9-based gene therapy for hypertrophic cardiomyopathy associated with MYBPC3 mutations. The multi-center, open-label Phase I/II trial will evaluate safety and efficacy of KHN921’s single intracoronary administration in adults with MYBPC3-HCM. KHN921 works by delivering a functional MYBPC3 gene to restore normal myosin-binding protein C expression in cardiomyocytes.
  • DynamX Bioadaptor’s 4-Year Advantage: Four-year results from the BIOADAPTOR trial once again showed that Elixir Medical’s DynamX Bioadaptor offers solid safety and efficacy advantages versus Medtronic’s Resolute Onyx Drug-Eluting Stent. The Elixir DynamX system produced a 66% reduction in target lesion failure rate (2.8% vs. 7.8%), and a 88% lower rate of cardiovascular death (0.5% versus 3.7%), with numerically lower rates of target vessel MI (0.9% vs. 1.8%) and target lesion revascularization (1.4% vs. 2.8%). The DynamX posted similarly strong 1-3-year results.
  • A New Cholesterol Drug: Cyclarity Therapeutics presented clinical trial data showing that its UDP-003 cyclodextrin-based therapy safely removed 7-ketocholesterol (7KC) from humans for the first time. The Phase 1 trial demonstrated that UP-003 led to dose-dependent urinary excretion of 7KC, a key driver of atherosclerotic plaque, with no serious adverse events. The approach differs from statins by directly binding and removing 7KC rather than systemically altering cholesterol regulation.
  • Inflammation-Guided PCI: New research out of EuroPCR 2026 suggests that inflammation measurements could help identify high-risk PCI patients. Researchers from China analysed 2,075 CAD patients who underwent PCI and pre-procedural coronary CT angiography, finding that patients with higher local coronary inflammation had 3-times greater MACE risks within three years (HR: 3.20). Risks were even greater among patients with both local and systemic inflammation (HR: 4.18), although local inflammation was the primary risk factor.
  • BioCardia’s FDA Pathways: BioCardia announced that the FDA identified two pathways for the clearance of its Helix Transendocardial Delivery Catheter System. The FDA reportedly raised no safety or compatibility concerns with the Helix and prefers simultaneous approval with the company’s CardiAMP cell therapy system for heart failure. The FDA also suggested a follow-on pre-submission could enable Helix’s approval via the DeNovo pathway. The Helix catheter enables minimally invasive targeted delivery of therapeutics into the heart muscle while CardiAMP uses bone marrow cells to address microvascular dysfunction.
  • AHA Backs PAD AI: An AHA science advisory reviewed AI apps across the peripheral artery disease continuum, finding that AI shows promise for improved care delivery. Per the advisory, AI models demonstrated strong performance in automating PAD detection from EHRs, while predicting MACE and limb events, and enhancing diagnostic accuracy through advanced imaging analysis. The advisory also outlines strategies for addressing adoption barriers including bias mitigation and frameworks for responsible AI deployment.
  • Philips Updates Angio Dose Reduction: Philips this week introduced SmartIQ, a new coronary imaging technology for use with its Azurion angiography system. SmartIQ can help interventionalists manage the tradeoff between radiation dose reduction and image quality, with a focus on producing contrast-rich images with reduced background noise. It also includes a new ultra-low-dose protocol for coronary interventions that reduces dose by 50% compared to ClarityIQ, the company’s previous technology. 
  • Tracking Plaque with Serial CCTA Scans: Coronary CT angiography is an ideal way to measure coronary plaque, but what’s the best way to follow it over time? In a new European Radiology paper, researchers presented a novel technique using AI to analyze serial CCTA scans reviewed side-by-side to quantify and track plaque changes. In a proof-of-concept study with 30 patients, they found high scan reproducibility for quantifying plaque burden and volume, suggesting the technique could track the effectiveness of plaque-reduction interventions. 

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The Power of AI in Cardiovascular Imaging

Cardiac labs are under more pressure than ever to deliver more with greater speed and precision. Hear from Tony Gallagher, Director of Noninvasive Cardiology at Baptist Health Lexington about how Siemens Healthineers’ ACUSON Origin is reshaping daily practice and transforming the future of echocardiography.

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The Resource Wire

  • How Us2.ai Improves CA Screening: Cardiac amyloidosis may not be as rare as previously thought, with early and accurate detection becoming increasingly critical for treatment. Read about how the AI-SCREEN-CA study implemented Us2.ai’s automated CA reporting and AI-based pattern recognition analysis, leading to better disease screening at scale.
  • Heart Failure Hospitalization Doubles Risk of Cardiovascular Death: 21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or cardiovascular death, and 25% of those who experience hospitalization are readmitted due to heart failure within one year of discharge. Watch Bayer’s Dr. Alanna Morris-Simon discuss heart failure hospitalizations and when to assess care plans.
  • PIA’s Post-Processing Solution: Advanced cardiac imaging often calls for a time-consuming post-processing step, requiring costly software, hardware, and training. See how PIA provides this post-processing at lower cost, improved consistency, and greater efficiency. 
  • The Nature of Raw ECG Signals: Raw ECG recordings are inherently affected by noise, motion artifacts, and variability in signal acquisition. Read more about how Monebo has focused on transforming raw cardiac signals into reliable, clinically meaningful insight for over two decades.

The Industry Wire

  1. KFF: ACA plan enrollment plummets.
  2. Twenty-nine large health org and CMS target simplifying prior auth.
  3. Sutter Health and Santa Clara University to build AI-focused med school.
  4. GHO Capital and CBC Group form $21B healthcare investment firm.
  5. NYC H+H breach exposes 1.8M patients’ data, including fingerprints.
  6. Hospital wastewater shows drug-resistant fungus months before patients.
  7. States sue to expand student loans for nursing and other healthcare degrees.
  8. 71% of US adults use health-related apps, and 64% use health devices.
  9. How Aetna is using AI for patient engagement.
  10. TrumpRx site adds 600 more generics.