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TTVR Results, Cardiac Tech Clearances, and POAF Risks
April 20, 2026
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Together with
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“The first few decades of GLP-1 research were driven by basic science observations in the lab, later verified in the clinic. Now, unexpected patient observations with GLP-1 medicines provide novel insights, and scientists then head back to the lab to figure out the mechanisms.”
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Discoverer of the GLP-1 mechanism, Daniel J. Drucker, MD, on the state of GLP-1 research.
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Surgeries & Interventions
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We’re finally starting to get some real-world data on treating tricuspid regurgitation with transcatheter tricuspid valve replacement (TTVR) and a new TVT registry study suggests TTVR outcomes are even better than previously thought.
- Most transcatheter therapies focus on the aortic and mitral valves, but that changed in 2024 when Edwards Lifesciences secured the first and only approval for a TTVR valve.
- However, Edwards’ EVOQUE device is only indicated for improving health status, (i.e. QoL and NYHA class) not for reducing mortality or heart failure hospitalizations.
The TVT Registry analysis followed the 30 day outcomes of 1,034 patients with symptomatic, severe TR who were treated with Edwards’ EVOQUE valve. But it differed in one key way from the TRISCEND II pivotal trial that earned the valve’s approval – patient baseline health.
- The registry’s patients faced several comorbidities like AFib (83.8%), NYHA class III/IV symptoms (~75%), T2D (>33%), and recent HF hospitalization (~50%).
What surprised investigators was that this registry actually showed better results in two key TTVR complications – severe bleeding and pacemaker / CIED rates.
- Severe bleeding rates came in at 7.9%, considerably less than the 10.4% in TRISCEND II.
- In patients without a prior CIED, 15.9% of patients treated with EVOQUE ended up needing one at 30 days, which was also lower than TRISCEND II’s 24.7%.
Meanwhile, the registry’s in-hospital mortality and stroke rates were 2.3% and 0.2%, respectively, and mortality inched up to 3.1% at 30 days post procedure. Although tough to compare, TRISCEND II had a 12.5% mortality rate at one year.
These bleeding and CIED rate reductions are encouraging, but don’t mean EVOQUE is a slam-dunk yet.
- For example, registry studies are observational, they’re not placebo controlled, and they don’t have a comparison group.
- This registry also only uses 30-day data, and patients go on to live years with these devices, so we still have to see what EVOQUE’s real durability looks like.
The Takeaway
The EVOQUE technology has faced push back on its indication and effectiveness, but at least these results reassure that complication rates for bleeding and pacemaker implantation could be lower than expected. We’ll still need to wait and see how this device fares in the long run.
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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.
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Tempus Receives FDA 510(k) Clearance for Tempus ECG-Low EF
Tempus announces the expansion of its Tempus ECG-AI portfolio with Tempus ECG-Low EF, software intended for use to analyze 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%) in patients 40 years of age or older at risk of heart failure. It is not intended as a stand-alone diagnostic and positive results may suggest the need for further clinical evaluation. For Full Indications for Use, visit here.
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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.
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- Protaryx Medical Gains FDA Clearance: In what could help further simplify interventional cardiac procedures, Protaryx Medical secured FDA clearance for its next-generation transseptal puncture device that makes complex left-heart access easier during minimally invasive procedures. The device’s delivery system is zero-exchange (meaning there’s no need to change catheter sheaths during the procedure) and features an atraumatic design. Protaryx’s device has already demonstrated short crossing times and reduced fluoroscopic exposure with no device-related adverse events from its FIH study.
- Updating “Fitness to Fly” Guidelines: A statement published in BMJ called for the British Cardiovascular Society (BCS) to revise its 15-year-old report on airline passenger “fitness to fly” to reflect modern clinical standards. The statement argues that the previous 2010 guidance came before the shift to primary PCI as the default STEMI reperfusion strategy and experts note that the older guidelines also lack direction on TAVR, complex PCI, and CCTA. The statement’s authors urge the BCS to address patient multimorbidity and eliminate inconsistent decision-making within challenging airliner cabin environments by releasing new guidelines.
- Endospan NEXUS’ FDA Approval: Endospan received FDA approval for its NEXUS Aortic Arch Stent Graft, a bimodular system for high-risk surgical patients. Supported by one-year TRIOMPHE IDE study data, the device treats complex ascending and arch anatomy using a low-profile 20F delivery system to minimize vessel manipulation. This transcatheter solution addresses a clinical gap for 120k annual patients, providing a minimally invasive option for life-threatening aortic dissections and arch disease previously ineligible for traditional repair.
- POAF’s Long-Term Impact: Highlighting one of the most common heart surgery complications, the VISION Cardiac Surgery study revealed that 31.8% of patients developed new-onset postoperative atrial fibrillation (POAF) within 30 days of surgery. Despite POAF’s prevalence, its management seemed inconsistent, with only 15.6% of patients receiving anticoagulation alone at discharge. At one year, POAF was tied to an 11-fold increase in clinical AFib and a higher risk of all-cause death (3.0% vs. 1.7%), emphasizing its CV burden post-discharge.
- GDMT Lowers Arrhythmia Risk: Data from Biotronik’s BIO-LIBRA registry revealed that combining ARNI and SGLT2 inhibitors significantly reduces the risk of ventricular tachyarrhythmias (VT/VF) and death in patients with non-ischemic cardiomyopathy, regardless of if they have a pacing device. Among 1,000 examined patients, SGLT2 inhibitors were associated with a 53% lower risk of arrhythmias, while ARNI therapy improved survival. The combined effect of both drug classes resulted in a 61% lower adjusted risk, making it clear how important it is to optimize medical therapy alongside pacing devices.
- Corify ACORYS FDA Clearance: Corify Care received FDA clearance for ACORYS, a non-invasive, imageless mapping platform that provides a real-time, four-chamber view of cardiac electrical activity. Validated in over 2.5k patients, the system delivers single-beat global mapping to identify ablation targets without requiring pre-procedural CT/MRI or the induction of unstable arrhythmias. Corify’s 4D technology already has CE mark approval in the EU and has shown it can streamline EP workflows for complex cases, including ventricular tachycardia and atrial tachyarrhythmias.
- Supira Medical Cleared for Pivotal pVAD Trial: Supira Medical gained FDA approval for its SUPPORT II trial, a randomized study evaluating a next-generation percutaneous ventricular assist device (pVAD) for high-risk PCI patients. Enrolling up to 385 participants at 40 U.S. sites, the pivotal trial will provide the primary data for a future PMA submission. The system aims to enhance efficiency and deliverability, while demonstrating potential for patient ambulation in cardiogenic shock. This approval comes at a time when studies and public opinion are questioning J&J’s Impella LVAD device.
- TEXTMEDS Highlights Post-ACS Gender Disparities: A secondary analysis of the TEXTMEDS study revealed significant gaps in medication adherence and risk-factor control between men and women 12 months after acute coronary syndrome. Men achieved higher adherence (53.9% vs. 46.1%) and superior LDL targets, while women were more likely to maintain a healthy BMI but be less active. Socioeconomic factors largely explained the adherence gap, though women remained significantly less likely to adhere to statins, suggesting a need for targeted interventions to improve long-term outcomes.
- PET Preferred Over SPECT for MPI: A new ASNC position statement recommends that cardiac PET should be used instead of SPECT for myocardial perfusion imaging to assess coronary artery disease. In updating its 2016 guidelines, ASNC said that a growing body of evidence supports PET for CAD diagnosis due to the “unique capabilities” of PET MPI and the use of dynamic PET acquisitions to quantify myocardial blood flow. The new statement was lauded by PET radiotracer suppliers like Bracco, which called it a “defining moment in cardiovascular imaging.”
- Bunkerhill Gets Calcium Clearances: Bunkerhill Health received FDA clearance for two new solutions for calculating coronary and aortic valve calcium from contrast CT scans. Bunkerhill Contrast CAC and Bunkerhill Contrast AVC use AI to detect and quantify CAC and AVC on contrast-enhanced non-gated chest CT scans, and complement the company’s existing clearances for non-contrast CT. The company also noted the new CMS reimbursement pathway that began April 1 for AI analysis of CAC and AVC.
- Stereotaxis Acquires Robocath: In a move that will further expand its endovascular portfolio, Stereotaxis entered into a definitive agreement to acquire French robotic firm Robocath for up to $45M in cash and milestones. The deal merges Stereotaxis’ magnetic navigation tech with Robocath’s mechanical R-One+ system, forming an integrated platform for electrophysiology, coronary, and neurovascular interventions. Stereotaxis plans to seek U.S. and European clearance for a next-generation multi-device system within two years while expanding its global robotic footprint.
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How Vista AI Helps Solve the Technologist Shortage
Fewer than 2% of MRI scanners are routinely used for cardiac imaging—mainly due to a shortage of trained technologists amid rising demand. Vista AI addresses this challenge by automating CMR scanning, empowering technologists of all experience levels to deliver high-quality cardiac exams consistently and efficiently.
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Book a Time with AccurKardia at HRS 26
The AccurKardia team is heading to Chicago from April 23-26, and will be exhibiting their FDA-cleared AccurECG 2.0 platform. Book a time here to find out about AccurECG’s device-agnostic, vendor neutral, and enterprise-volume ready design.
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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.
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- 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.
- 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 ACUSON Origin customer, Tony Gallagher about how Siemens Healthineers’ cardiovascular ultrasound system is improving exam efficiency and showing positive impact on ROI.
- Beyond the Calcium Score with Circle CVI: The coronary artery calcium score has been the non-invasive gold standard for a quick look at heart disease risk, but it only tells part of the story. Learn more about how Circle Cardiovascular Imaging is using AI-enabled coronary plaque analysis to redefine heart risk beyond what a CAC score can tell us.
- CA Diagnosis Using Echo AI: Diagnosing cardiac amyloidosis using echo can be challenging due to the imaging overlap between CA and more prevalent causes of cardiomyopathy. Read more about how Us2.ai’s echocardiographic score and fully automated deep-learning model overcome this challenge to enable better diagnosis.
- 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.
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