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TAVR Reinterventions, Wearable Ultrasound, and Danaher Acquires Masimo
February 19, 2026
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Together with
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Renin-angiotensin-aldosterone system inhibitor therapy is a cornerstone of heart failure management, yet concerns about hyperkalemia can limit its use. Read this Cardiac Wire exclusive by Dr. Ravi Dhingra, MD, MPH to learn more about why managing hyperkalemia may help support continuation of guideline-recommended therapy in patients with heart failure.
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Surgeries & Interventions
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We might need to reconsider the concept of a TAVR-first strategy for low-risk aortic stenosis patients, after extended results from the Evolut Low Risk trial showed that reintervention rates at seven years were considerably higher in TAVR recipients compared to surgical replacement.
- The Evolut Low Risk trial previously established Medtronic’s Evolut TAVR valve as an alternative to surgery in low-risk severe AS patients through its 2-year outcomes.
- However, true long-term durability questions are still being answered as the trial follow-up entered its seventh out of ten years.
As has been the case for each yearly follow-up, the trial examined 1.4k patients (730 TAVR, 684 surgery) who underwent valve replacement from 2016-2019 and revealed similar mortality outcomes with a growing gap in reintervention rate…
- The study’s composite endpoint of all-cause mortality or stroke showed no significant difference at six years (23.3% TAVR vs. 20.4% surgery).
- Despite this, the reintervention rate was significantly higher for TAVR, with a hazard ratio of 1.66 compared to SAVR at six years and far greater than the five year data.
- This prompted researchers to look at the extended seven year data, uncovering that reintervention rates reached 9.8% for TAVR versus 6.0% for surgery.
But what drove this increase in TAVR reinterventions? Researchers found two main causes, aortic regurgitation and valve stenosis, one of which impacted TAVR far more than SAVR.
- Aortic regurgitation requiring reintervention occurred in 5.6% of TAVR versus 1.6% of surgery patients (sHR: 3.39), representing a 3-fold higher risk.
- That said, stenosis-driven reintervention rates were the same between the two (3.6% TAVR v. 3.5% surgery).
These results also play into a bigger story about when it’s appropriate to give a patient a TAVR valve, as Edwards’ EARLY TAVR trial also raised eyebrows when it came to implanting younger, lower risk AS patients with a valve.
- That study found that earlier intervention with a TAVR valve was better than watchful waiting in asymptomatic patients over a 3.8 year follow-up.
- While it was enough to convince the FDA, many researchers and practicing cardiologists advised caution since TAVR’s long-term durability is still unknown.
The Takeaway
The Evolut Low Risk trial’s extended follow-up reveals a troubling durability trend, one which is likely only going to look worse by the study’s tenth year. While that doesn’t invalidate TAVR in low-risk patients, it’s a reminder that these devices aren’t a “one and done” cure and need long term management.
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Harnessing the Power of AI to Improve Patient Care
Endeavor Health is one of the first healthcare providers in the Midwest to use AI in the echocardiography lab. Learn how they are harnessing echo AI’s tremendous potential to improve diagnoses in this page from Us2.ai.
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Merge Hemo Ranks 2026 Best in KLAS
Merge Hemo ranked 2026 Best in KLAS for cardiology hemodynamics, marking the 14th year it’s been named a category leader. Find out more about why Merge’s strategy of a modular, unified imaging solutions portfolio continues to dominate the KLAS rankings, year in, year out.
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- Rethinking HK Care in Patients With HF: Renin-angiotensin-aldosterone system inhibitor therapy is a cornerstone of heart failure management, yet concerns about hyperkalemia can limit its use. In this article for Cardiac Wire by Dr. Ravi Dhingra, MD, MPH, learn more about how potassium binders may be considered as part of an approach to managing hyperkalemia.
- SMART’s Wearable Ultrasound: The Singapore-MIT Alliance for Research and Technology launched the Wearable Imaging for Transforming Elderly Care project to develop the world’s first wearable ultrasound system for continuous 48-hour cardiovascular monitoring. Utilizing sub-micrometer 3D printing and AI-enhanced diagnostics, the technology enables real-time tracking of chronic conditions like heart failure outside hospital settings. The project aims to shift cardiac care from episodic snapshots to proactive home-based management with the goal of improving patient outcomes while reducing burden on the healthcare system.
- Danaher Acquires Masimo: Biotech development giant, Danaher, entered into a definitive agreement to acquire Masimo for $9.9B. The acquisition will establish Masimo as an autonomous brand within Danaher’s Diagnostics segment while taking the company’s remote health monitoring technologies global and enhancing its acute care offerings. You may know Masimo from its lawsuit with Apple after the tech titan infringed on the company’s blood-oxygen monitoring technology and had to fork over $634M in a settlement.
- AI of Cardiac MRI Predicts MACE: Researchers from China developed a machine learning model to predict which patients with ST-segment elevation myocardial infarction would go on to have other major adverse cardiovascular events. In a paper in Radiology with 1.1k patients, their algorithm performed better than clinical models in predicting MACE at a median of 40 months (AUC = 0.91 vs. 0.62-0.86). AI models could make it easier to use cardiac MRI, such as by embedding algorithms in post-processing for use as decision support.
- Affinia’s AFTX-201 Earns Orphan Status: The European Medicines Agency granted orphan drug status to Affinia Therapeutics for AFTX-201, a gene therapy targeting BAG3-associated dilated cardiomyopathy. The treatment uses a viral shell protein to deliver the BAG3 gene at doses significantly lower than conventional pharma and gene therapies. Preclinical data so far has shown that this one-time intravenous therapy can actually restore heart function by addressing the underlying genetic deficiency, which is urgent since nearly 25% of BAG3-DCM patients currently need heart transplants.
- Real-World Opportunistic Screening: A Michigan health system launched a real-world opportunistic screening program to detect cardiovascular disease using AI solutions from Bunkerhill Health. McLaren Heart & Vascular Institute is using Bunkerhill’s iCAC and iAVC algorithms to analyze CT scans acquired for other clinical indications to detect incidental calcium in the coronary arteries and aortic valves. McLaren has begun scanning routine chest CT studies acquired in the past 12 months, and reports good results.
- Don’t Touch the Doc’s Money: A coalition of 38 healthcare organizations, including the ACC and the STS Surgeons, signed a letter backing the Efficiency Adjustment Delay Act (HR 7520). The bill aims to postpone a 2.5% Medicare pay cut which was triggered by a CMS “efficiency adjustment” until 2030. CMS implemented the reduction based on the belief that technologies like AI simplify procedures; however, lawmakers and medical groups argue the cut ignores clinician burnout and lacks data regarding actual procedure times.
- Elumn8’s Series C: Simpson Interventions closed its Series C financing (amount undisclosed) and rebranded to become Elumn8 as part of its mission to advance image-enabled technologies for complex coronary interventions. The fresh funding will support the Acolyte Image-Guided Crossing and Re-Entry Catheter System which is currently in a pre-market trial for coronary chronic total occlusions. Elumn8’s system uses optical coherence tomography to provide real-time visualization and improve precision. The device already has FDA Breakthrough status and is enrolling up to 103 patients to evaluate its safety and performance in treating CCTOs.
- Vektor Medical’s vMap-Guided VT Ablation: A peer-reviewed study in EP Europace demonstrated that using Vektor Medical’s vMap to guide ablation significantly improves outcomes for patients with hemodynamically unstable ventricular tachycardia. By using AI to localize arrhythmia sources from a 12-lead ECG, the vMap group achieved 80% arrhythmia-free survival at one year, compared to 43% for conventional strategies. Notably, these results included a 37% acute VT termination rate without increasing procedure time, fluoroscopy, or complications.
- Retia Medical’s FDA Clearance: Retia Medical received FDA 510(k) clearance for its Argos Infinity software platform, designed for high-risk surgical and critical care settings. The platform utilizes the Multi-Beat Analysis algorithm to transform existing physiologic data into cardiovascular insights, identifying potential surgical instability before the patient’s vital signs deteriorate. This earlier recognition is vital for preventing complications like acute kidney injury, which is a key CMS reimbursement as of this year.
- Aortic Stenosis Referral Gaps: A recent Canadian study revealed that passive automated prompts in medical records fail to improve referral rates for aortic stenosis. Among the study’s 343 participants, only 60% of severe and 20% of moderate patients were referred for specialized assessment while unreferred patients faced a drastically higher mortality rate of 19.6% versus 2.3%. Researchers clarified that automatic referral processes need to ensure that high-risk individuals are directed to life-saving valve interventions immediately rather than flagging them as potential patients.
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Vista AI Grows CMR Volume
Are your patients waiting weeks or months for cardiac MRIs? See Brigham and Women’s Hospital’s real-world results showing how Vista AI’s software for automated MRI scanning led to 50% more scan slots, without adding more scanners or staff.
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The Largest Registry on Plaque Analysis in CAD
What if 50% of your CCTA patients could benefit from an adjustment to their treatment plan? Read more about Heartflow’s DECIDE registry that demonstrates how Heartflow Plaque Analysis using its Plaque Staging software empowers physicians with clinical insights that lead to real-world impact.
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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 Efficiency of the Kinetic Rhythms ECG Algorithm: See how you can interpret up to twenty-nine distinct rhythms by embedding the Kinetic Rhythms ECG Algorithm on your device or software suite. Ensure precise ECG interpretations regardless of whether they’re taken at the bedside or in an ambulatory setting.
- Heart failure places enormous strain on our healthcare systems and patients: There are 3.7 million US patients with HFpEF or HFmrEF, with prevalence only expected to rise. To learn more about the heart failure landscape and Bayer’s commitment to addressing patient unmet need, watch the video here.
- A Cardiovascular Ultrasound Platform You Can Trust: Being able to provide premium diagnostic information for your pediatric patients every day, all day, is vital. Find out why cardiac imagers trust Fujifilm’s Lisendo 880, and how its premium imaging quality, efficiency tools, and reliability you can trust, have helped change workflows for clinicians and technologists alike.
- 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.
- 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.
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