Adam Cifu, MD

Today’s top story takes a look at the five year data from EARLY-TAVR and while some questions have been answered, it seems others have emerged.

As always, thanks for reading,

Vik

Structural Heart

EARLY TAVR 5-Year Data Answer Some Questions, Raise Others

Whether or not to intervene early in asymptomatic aortic stenosis was answered by EARLY TAVR in 2024, and new 5-year data presented at NYV 2026 now suggests that the benefit of early intervention is driven by reductions in death and stroke rather than just heart failure.

• EARLY TAVR reshaped the AS field when first published in 2024, leading the FDA to approve TAVR for asymptomatic patients with severe AS in 2025.
• The trial enrolled patients aged 65 or older deemed suitable for transfemoral TAVR, so the findings may not generalize to populations outside those criteria.

To assess durability of the early-intervention strategy, investigators extended follow-up to a median of 5 years, capturing outcomes for patients randomized to either early TAVR or clinical surveillance.

• The composite endpoint of death, stroke, or heart failure hospitalization was significantly lower with early TAVR (15.2% vs 24.2%).
• NEARLY-TAVR Returns, WISeR’s Funding Cuts, and IL-6 Biomarkerotably, a death-or-stroke reduction emerged specifically after the study’s 2-year mark (HR: 0.61).

The shape of the benefit also changed over time, which is the most clinically interesting part of this update.

• In the first two years, early intervention prevented roughly 70% of HF events because patients never became symptomatic (3.5% vs 10.3%).
• Beyond two years, the HF benefit faded as nearly three-quarters of surveillance patients crossed over to TAVR, while death and stroke became dominant.
• Most importantly, early intervention carried no penalty since death and stroke rates were identical between arms in the first two years.

However, the individual endpoints tell a more nuanced story when separated out.

• All-cause mortality showed no significant difference at 5 years (10.3% vs 12.3%).
• Stroke, uncoupled from death, was numerically lower with early TAVR but didn’t reach significance (4.8% vs 7.6%).
• This means the composite benefit is real but should be interpreted as directional.

The mechanism behind the death and stroke reduction also remains an open question. 

• While the heart failure benefit is well understood, investigators are still working out why waiting appears to cost patients.
• Theories include: valve degeneration, new-onset AFib, and acute valve syndrome accumulating during surveillance.

The Takeaway

When you look at the composite results, EARLY TAVR’s 5-year readout still supports the FDA’s decision to approve TAVR in asymptomatic AS patients. That said, a closer look at the divided data points tells us that there’s still some questions left unanswered.

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The Wire

• A Biomarker for Lp(a)-Associated CAD: A cohort study in JAMA Cardiology suggests that levels of inflammatory biomarker IL-6 could alter Lp(a)-associated risk for new onset CAD. Across 43.5k patients in the U.K., those in the top category for IL-6 concentrations had a 34% higher risk of Lp(a)-associated CAD. The results matter due to the lack of effective medications or lifestyle changes for reducing Lp(a) levels, while showing that IL-6 could be a useful biomarker for CAD and AS.

• WISeR Under Fire: Leading cardiology groups cheered a House committee vote to bar federal spending on WISeR, a CMS pilot that brings AI-powered prior authorization to Medicare. HHS launched the initiative last year to root out fraud, waste, and abuse. WISeR has attracted plenty of critics, though, for causing care delays and a deluge of denials. ASNC has raised concerns that advanced diagnostic imaging could become a target of WISeR, while ASE previously cautioned the model might import issues with Medicare Advantage to traditional Medicare. 

• Nicorandil Guards the Kidneys in PCI: Oral nicorandil, an angina drug, could lower the risk of contrast-associated acute kidney injury (CA-AKI) in patients with kidney dysfunction undergoing PCI. Researchers in Circulation randomized more than 600 patients to high-dose nicorandil (30mg daily), conventional-dose (15mg daily), or no nicorandil, finding that CA-AKI rates were lowest in the high-dose group (8.7% vs. 10.9% vs.19.8%). This translated to a 61% relative risk reduction with high-dose nicorandil.

• TAVR Durability Matches Surgery: Adding fuel to the TAVR vs. SAVR fire, a recent JAMA study found that both procedures show similar durability after seven years. Follow-up data from 537 patients showed that deteriorating artificial valve leaks and narrowing were very similar for TAVR and surgery respectively (7.3% vs. 7.6%). The methods also had similar outcomes for bioprosthetic valve failure and valve reintervention.

• J&J Upgrades Ablation Catheter: Johnson & Johnson released a new cardiac ablation catheter that allows physicians to move between heat-based and electrical pulse methods in one tool with 87% effectiveness. This added flexibility may allow clinicians to pursue more personalized care while maintaining their familiarity with features like contact-force sensation from the previous model. The device will first launch across Europe and is awaiting FDA approval in the U.S.

• Funding an Adaptive Fix for TR: Ireland’s CroíValve closed a $27M expansion funding, combining $20M in Series B financing with $7M in EIC and DTIF grants, bringing its Series B total to $36M ($43M including grants). The proceeds will fund the enlarged TANDEM II study for evaluating the DUO Adapt System in patients with severe symptomatic tricuspid regurgitation. CroiValve’s transcatheter device preserves native anatomy, working in “tandem” with the tricuspid valve by placing a valve between the leaflets, while avoiding contact with critical right-heart structures.

• An AI Read on SCD: AI may have helped uncover a waveform biomarker that could suggest sudden cardiac death is unrelated to LVEF. A Nature study applied deep learning to a Swedish dataset linking ECGs to death certificates and isolated a high-risk group of patients who had a 7.0% annual rate of sudden cardiac death. Furthermore, 86.1% of these patients went unflagged by LVEF scans and those with implanted defibrillators had a 54.4% lower risk of death.

• An Early Alert on Impella Sheaths: The FDA issued an early alert warning of possible unexpected bleeding risks with J&J’s Impella heart pump introducer sheaths tied to manufacturing defects. The company reported eight cases of major bleeding and three patient deaths possibly related to introducer leakage. The problem involves potential leakage in 14F and 23F introducers which the FDA warns could cause access-site bleeding requiring intervention like device exchange, manual compression, or transfusion, and in some anticoagulated patients, life-threatening hemorrhage.

• The Right Time for PE Thrombectomy: Imperative Care announced a post-hoc analysis of its SYMPHONY-PE trial that suggests earlier mechanical thrombectomy may speed cardiac recovery in intermediate-risk pulmonary embolism. Among 109 trial patients, those treated within 12 hours of diagnosis saw greater drops in mean pulmonary artery pressure (8.6 vs. 5.8) and RV/LV ratio (0.52 vs. 0.37) than those treated later. Mechanical thrombectomy’s benefit was most pronounced in higher-risk patients with no meaningful difference in safety between groups.

• Reproductive History as a Heart Risk Clue: New data from the VIRGO and NHANES databases suggest that a woman’s detailed reproductive history could sharpen CVD risk assessment and flag candidates for early prevention. Comparing 1.5k women who had an acute MI against matched controls, researchers found higher odds of early-onset MI tied to early menarche (OR: 2.07), menopause (OR: 1.82), gestational diabetes (OR: 1.65), birth control pill use for 1-5 years (OR: 1.67), and past female hormone use (OR: 1.99).

• Keeping It Brief with DAPT: A JAMA Cardiology meta-analysis found that for patients at high bleeding risk, a shorter dual antiplatelet therapy (DAPT) regimen after PCI is safer and just as effective as the standard duration. Across 11.4k randomized patients, shorter DAPT was linked to a 29% risk reduction for significant bleeding without compromising protection from MACE. It seems like it’s not quite time to totally ditch the full course of DAPT in these cases, but a one-size-fits-all approach may no longer cut it.

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CathWorks is now part of Medtronic.

The CathWorks FFRangio™ system is the new standard in coronary physiology. Learn more.
Source: Fearon WF, Jeremias A, Witberg G, et al. Angiography-Derived Fractional Flow Reserve to Guide PCI. NEJM 2026. doi: 10.1056/NEJMoa2600949

The Resource Wire

• Fujifilm’s Ultrasound for every Cardiovascular Ultrasound Environment: From academia to clinical diagnostics, versatility in cardiac ultrasound is essential. Discover why clinicians are choosing Fujifilm’s LISENDO 880 for exceptional image quality, comprehensive strain analysis, stress imaging, and innovative Virtual Contrast technology — all while delivering outstanding value.

• Redefining Cardiac Analytics: More data doesn’t equal deeper insight. There’s a fundamental distinction between measuring the timing of heart beats and understanding how the heart recovers electrically after each beat. Monebo is using that distinction to define the next frontier of cardiac analytics.

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• Identify and Treat Cardiovascular Disease: Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.

• The Economics of AI-Assisted HF Diagnosis: As sonographer shortages become more common, so too are diagnostic delays and missed opportunities for early heart failure treatment. Find out how task-shifting LVEF assessment to novice operators using AI-assisted ultrasound is both clinically viable and cost-saving.

• 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 Industry Wire

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7. Project erases $170M in medical debt for 140k Mass. residents. 
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10. Illinois neurosurgeons accused of leaving patients under anesthesia.