Josh Farkas, MD on the nature of late-breakers at cardiology conferences.

Ladies and gentlemen, I’m thrilled to announce the launch of The Bio Wire, which published its monumental first issue today. The newsletter will be written by the immensely talented Jack Troy and he’ll be covering outcomes, breakthroughs, and industry trends in the world of bioscience.

We also have a webinar on the best practices in cardiac CT coming up on Friday 09/25 at 2:00 pm ET where we’ll be hearing from Dr. Alberto Morales, Kimberly Hatch, and Karthick Nalladevan on the key things to consider when working with cardiac CT.

Thanks for reading, 

Vik

Surgeries & Interventions

A Tale of Two Studies and the Importance of Patient Selection

Two recent studies are forcing an important conversation in cardiology – some of the field’s most common procedures may not be as clearly beneficial as open-label data originally suggests.

• First, an eight-trial meta-analysis found that left atrial appendage closure (LAAC) was no better than oral anticoagulation for preventing stroke overall.
• Then, PVI-SHAM-AF found catheter ablation for AFib didn’t significantly beat a sham procedure for improving AFib-related quality of life at six months.

Let’s start with PVI-SHAM-AF, since it’s more contested. Researchers randomized 262 patients to either the clinician’s choice of ablation (RF, Cryo, or PFA) or a “sham” procedure where patients were sedated and given IV sheaths but not catheterized, finding that…

• Quality of life AFEQT scores (a scale 0-100)  improved 19.8 points with ablation versus 15.7 with sham without statistical significance.
• Yet, ablation clearly led to freedom from AFib (73% vs. 52% for sham).
• That means the observed effect of a procedure isn’t the same as its specific effect. Much of what patients felt, they felt after a sham too.

But EPs are pushing back on PVI-SHAM-AF’s results with online comments clarifying:

• Two earlier sham-controlled trials already showed clear benefit, making PVI-SHAM-AF the possible outlier, not the verdict.
• Selection bias matters too, with roughly 80% of PVI-SHAM-AF’s invited patients declining to participate, leading to a less-symptomatic study population and more placebo effect.

The LAAC meta-analysis points the same way from a different angle. To determine LAAC’s real-world efficacy, researchers examined 7.4k patients who either received LAAC or oral anticoagulation with a focus on their long-term stroke and major bleeding rates.

• LAAC’s overall stroke (IRR: 1.08) and major bleeding impact (IRR: 0.96) were similar to anticoagulation.
• However, LAAC was associated with higher ischemic stroke rates (IRR: 1.34) but lower non-procedural bleeding (IRR: 0.73).
• Thus, the study’s authors say the data doesn’t support LAAC as routine first-line stroke prevention.

Do these two studies mean that these cardiac interventions are in trouble? Not exactly.

• Rather these two trials keep shrinking the obviousness of positive effects that looked meaningful in open-label data.
• As a result, defending a procedure on the basis that it “improves symptoms” or “successfully closes the appendage” may not be enough to justify it.

The Takeaway

The evidentiary bar is rising for some cardiac procedures, and the exact benefits of a procedure like ablation or LAAC still need exploration. For the cardiac medtech industry that means proving a device’s value against rigorous study design and patient selection. For clinicians it means more questions to consider.

Canon’s 30 Years of Caring

For over 30 years, Canon has helped advance pediatric interventional cardiology through innovation and a commitment to better care. Learn more about how and why modern pediatric cardiac angiography came to be from one of its founding members, Dr. John P. Cheatham.

The VASCADE MVP XL

Sometimes EP procedures call for a venous vascular closure system that is simply bigger. Haemonetics’ VASCADE MVP XL closure system comes with 58% more collagen and a 9% larger disc compared to the VASCADE MVP system as well as an expanded indication for utilizing 10-14F inner diameter sheaths.

Circle CVI’s cvi42 v6.5 is Now Live!

Cardiovascular imaging plays a critical role in helping care teams with everything from prevention to procedural planning. That’s why Circle Cardiovascular Imaging released v6.5 of its cvi42 software with features like automated phase offset correction, editable plaque segmentation, and quantitative perfusion to support every aspect of CV imaging workflows.

The Wire

• Tricuspid Repair’s HF Benefits: Highlighting the importance of treating the “forgotten valve” the TRIC-I-HF trial confirmed a slew of benefits for TTVR. Researchers randomized 360 patients (mean age 80) with symptomatic severe tricuspid regurgitation to TTVR plus medical therapy or medical therapy alone. The repair arm won decisively in the composite outcome of death, HF hospitalization, and QoL improvement at one year (win ratio: 2.42). Three years post intervention, freedom from death or HF hospitalization was 52.4% with repair versus 21.0% for medical therapy alone (HR: 0.40).

• Statins Cut Heart Events in Healthy Seniors: As if the most widely prescribed heart drugs needed another win, new ESC data shows that statins are even good for healthy seniors. The STAREE trial randomized nearly 10k adults aged 70+ with no CVD, diabetes, or dementia to atorvastatin or placebo, finding that atorvastatin cut MACE (10.9 vs. 15.5 events per 1,000 person-years, HR: 0.70) over a 5.9 year follow-up. However, atorvastatin didn’t impact the composite outcome of death, dementia, or persistent physical disability (HR: 0.94).

• AccurKardia’s AI-ECG Tackles Two Cardiac Problems: Two studies presented at ESC showcased how Accurkardia’s AI-ECG applications are turning ECG into a broad biomarker. The first study validated the company’s hyperkalemia detecting AK+ Guard algorithm in three U.S. health systems, finding that it achieved 80.5% sensitivity and an AUROC of 0.87 across 425k CKD patients. Separately, the second study showed that AccurKardia’s AK-AVS score independently predicted post-TAVR paravalvular leak in 1.4k patients, with each 0.10 increase raising leak odds (OR: 1.10), suggesting it could be valuable for risk stratification and valve selection.

• Tailored Antibiotics for Infective Endocarditis: Shorter antibiotic courses help to prevent bacterial resistance and expensive care. That’s why POET II’s results at ESC are crucial for patients with infective endocarditis. Among 508 patients randomized to response-tailored or standard-duration treatment for left-sided IE, the tailored approach led to a median treatment length nearly 14 days shorter than standard protocol. The groups had similar safety outcomes, though relapse rates were slightly higher for the intervention group (5.1% vs 1.6%).

• Community Care to Control Hypertension: Another big study at ESC showed that community-based hypertension interventions lead to long-lasting population health. The study randomized 34k participants to either usual BP care or treatment from nonphysician clinicians trained to provide antihypertensive medications. After seven years, the percentage of participants with BP below 130/80 mmHg was 33.9% for the intervention group and 10.5%, for standard care. Importantly, the intervention group faced a lower CVD (3.4% vs 4.2%) and dementia risk (8.9% vs 10.6%).

• Default Antiplatelets for ACS: Half a decade ago, the 2020 ISAR-REACT 5 trial hinted at prasugrel’s superiority over ticagrelor for stopping clotting around PCI stents for acute coronary syndrome. Now research from ESC 2026 suggests there may not be much difference in post-PCI outcomes between the two antiplatelets. Of the study’s 17k ACS patients, 9.4k received ticagrelor post-PCI while 7.6k received prasugrel, leading to extremely similar composite rates of death, MI, or stroke (11.8% for ticagrelor vs. 11.1% for prasugrel).

• Initiating PCSK9is Pre-PCI: Results from the AMUNDSEN trial suggest starting heart attack patients on PCSK9is before PCI could significantly lower LDL-C levels. To uncover a LDL management strategy for high-risk post MI patients, the study randomized 2.1k patients to either Amgen’s Repatha (evolocumab) and standard care or standard care alone for one year. Over 80% of the Repatha group reached the study’s combined endpoint of LDL-C <55 mg/dL and a ≥50% drop from baseline compared to 40% in the control arm. Curiously, this didn’t change hospitalization or mortality rates between the groups at one year.

• Conflict-of-Interest at the ESC: Amid the research news, the European Society of Cardiology judged its former president Kim Fox guilty of severe misconduct during his presidency. The judgment follows a Danish documentary that revealed Fox and his wife received more than £50M through their contract research organization while he chaired a 2006 ESC guideline recommending the Servier heart drug ivabradine. The case serves as a stark reminder that even the highest of medical organizations are not immune to corruption.

• Elucid Raises $55M: Cardiac AI developer Elucid raised a $55M Series D funding round that brings its total funding to $185M. The funds are intended for the commercialization of its BioIntegrated FFR-CT solution, currently under FDA 510(k) review, as well as its already-cleared Plaque-IQ plaque analysis application for CCTA exams. Elucid plans to offer both solutions as part of a comprehensive clinical platform that helps physicians stratify and manage patients at risk of cardiovascular disease.

• Us2.ai’s Corbotics Collaboration: Us2.ai and Corbotics joined forces to create an automated workflow for transthoracic echocardiography exams by pairing Us2.ai’s AI echo analysis algorithms with Corbotics’ Bed Based Echo (BBE) autonomous robotic image acquisition technology. The FDA granted BBE Breakthrough Device Designation in June, and when cleared the solution could enable bedside acquisition of echo exams that can then be analyzed with Us2.ai software, giving more patients in resource-challenged areas access to high-quality imaging.

• Silencers and Stabilizers in ATTR-CM: Although studies are now pointing to stabilizers’ superiority to silencers for ATTR-CM, a meta-analysis of two Phase 3 trials suggests nuance. Researchers examined 2k patients from the HELIOS-B and CARDIO-TTRansform trials finding that transthyretin gene-silencing therapies reduced the composite of death and recurrent cardiovascular events by 20% in ATTR-CM. Above all, silencers’ benefits were only significant in patients not on stabilizers, not in those already receiving them.

Redefining Cardiac Analytics

More data doesn’t equal deeper insight. There’s a fundamental difference 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.

How Automated MRI Software Transformed Radiology Regional

Radiology Regional recently integrated automated MRI scanning software into their imaging practice imaging. Hear from their team how automating CMR scans streamlined their practice and enhanced patient care.

The Resource Wire

• State-of-the-Art Cardiac Monitoring at Scale: Cleared for 13 different heart rhythm interpretations, AccurKardia’s AccurECG 2.0 shortens the time from an arrhythmia incident to clinical intervention. Watch here to find out how AccurKardia and Specialized Medical are teaming up to bring the AccurECG 2.0 technology to clinicians across the U.S. 

• 9 Merge Cardio Features to Change Your Cardiology Workflows: Having the right tools is essential for efficient cardiology imaging workflows and delivering exceptional patient care. Read this article on how Merge Cardio can make the biggest difference to your imaging workflows, care team user experiences, and patient care delivery.

• Outsourced Post-Processing with PIA: Behind each study is a patient whose care is a top priority. That’s why each PIA out-sourced imaging client is assigned a lead technologist responsible for ensuring study customization while allowing cases to be received 24/7 in a secure and scalable way. 

• Change Healthcare and Optum Unite: Change Healthcare and Optum merged five years ago to advance a more modern, information and technology-enabled health care platform. Read more about how, and why, Change Healthcare became Optum.

• AHA Scientific Sessions Discussion: Heart Failure Treatment Developments and Impact on Women: Women with heart failure with preserved and mildly reduced ejection fraction (HFpEF and HFmrEF, respectively) often present with different symptoms than men, leading to underrecognition. Moreover, the incidence of HFpEF in women is increasing more than in men. Watch Dr. Martha Gulati discuss prevalence and changing treatment options.

• 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.

• Earlier Detection, Better Outcomes: When it comes to heart disease, early detection is crucial to a patient’s long-term health. Learn more about how Fujifilm helps clinicians achieve that with the Lisendo 880 cardiovascular ultrasound system’s unique solutions that detect early abnormalities seen in heart failure, while offering insight into cardiac functions and groundbreaking hemodynamic analysis.

The Industry Wire

1. Medical groups support flu and Covid shots amid confusion.
2. Congo Ebola outbreak deaths pass 3k, no slowdown in sight.
3. UnitedHealthcare cuts prior authorization from 1,700 codes.
4. HCA cuts corporate and support roles following earnings hit.
5. Scan.com raises $220M for U.S. medical imaging network.
6. Self-pay hospital visits spike as coverage losses mount.
7. Employers begin cutting GLP-1 weight-loss coverage.
8. DaVita agrees to $15M settlement for data breach claims.
9. McKesson confirms data theft from third-party app cyberattack.
10. Florida sues PBMs over alleged price fixing.