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CHAMPION-AF Debate, IVUS trials, and Research Partnerships
April 6, 2026
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Together with
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“In Bayesian terms, the prior evidence for LAAC is extremely pessimistic. If CHAMPION AF was to change practice, it would have had to been an utter grand slam… when you look at the actual data, and the way it should have been analyzed, it also was a negative trial.”
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John Mandrola, MD, breaking down the results of CHAMPION-AF.
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Winning a KLAS award is more than just bragging rights in the cardiology world, it’s a sign that your company is changing the way physicians practice for the better. In the latest episode of The Cardiac Wire Show, we sat down with David Smarro, CEO of Infinitt North America, and Monique Rasband from KLAS Research to find out more about what led to Infinitt’s Cardiology Suite Best in KLAS win.
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ACC.26 saw an overall drop in research fervor, but one long-awaited study, CHAMPION-AF, spurred a new discussion around the field of left atrial appendage closure and the data we’ve used to justify the procedure.
- Left atrial appendage closure (LAAC) uses an implantable device (like Boston Scientific’s Watchman) to close off a pocket of tissue on the left atrium of the heart.
- This potentially helps patients living with atrial fibrillation to minimize the risk of stroke-causing blood clots that form in the left atrial appendage.
The latest in a long line of LAAC noninferiority trials, CHAMPION-AF set out to answer the question: is the Watchman FLX LAAC device an alternative to oral anticoagulation for stroke prevention?
Researchers randomized 3k patients with a low-bleeding risk and high stroke risk (calculated via CHADSVASC and HAS-BLED) to receive either direct acting OAC or LAAC and followed them for three years.
- The composite primary end-point of stroke, systemic embolism, and CV death occurred in 5.7% of the Watchman group and 4.8% of the OAC group.
- Non-procedure-related bleeding was much lower for LAAC than OAC (10.9% vs. 19.0%).
At first glance, these results seem like a win, and the study’s conclusion asserts that LAAC met the non-inferiority cutoff, but there’s much more to the story.
- Adding CV death to the composite endpoint doesn’t help clarify things, since neither LAAC or OAC affect CV death directly.
- The statistical definition of noninferiority was also more lenient in CHAMPION-AF than the earlier CLOSURE-AF trial, which determined LAAC was not noninferior to OAC.
Speaking of CLOSURE-AF, that trial was funded and designed by the German Center for Cardiovascular Research (a government project), while BSCI directly funded CHAMPION-AF.
Taking it all into consideration, CHAMPION-AF has divided people’s opinions on whether or not an LAAC device is equal to taking medications orally.
- Some physicians hope these results don’t make the procedure more popular while others say it empowers patients to decide for themselves.
- That said, investors saw right through the framing of CHAMPION-AF’s results and BSCI’s stock dropped 10% in the week following the late-breaking publication.
The Takeaway
The average patient doesn’t have the statistical education necessary to interpret the results of CHAMPION-AF, but the average cardiologist does and keeping a critical eye on what is a permanent structural procedure versus a daily pill is key. We still can’t say LAAC is better than OAC, just maybe more convenient.
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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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cvi42’s Real World Results
Consistency of measurements over time is of utmost importance for clinical interpretation and follow-up. Read about how cardiac imagers are using Circle Cardiovascular Imaging’s cvi42 platform to dramatically reduce manual segmentation by up to 60%.
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Your Cardiology Data is Valuable. Put it To Work.
See how one major Midwest health system’s decision to implement Merge Cardio transformed physician and staff workflows, improved data entry speed and accuracy, and increased cost savings.
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- IVUS and Complex PCI: Three major intravascular ultrasound trials – DKCRUSH VIII, OPTIMAL, and IVUS-CHIP – presented conflicting data at ACC.26 on the necessity of IVUS for guiding complex PCI. DKCRUSH VIII demonstrated that IVUS guidance reduced target-vessel failure by 60% in complex bifurcation lesions, while OPTIMAL and IVUS-CHIP yielded neutral primary results for left main and high-risk procedures. Experts suggest these discrepancies may stem from “operator bias,” where the high IVUS expertise of participating surgeons likely improved their angiography-only techniques.
- Olezarsen Lacks Plaque Impact: The Essence-TIMI 73b trial found that while Ionis’ olezarsen significantly reduced triglycerides (-63.9%) and remnant cholesterol (-71.9%) via APOC3 inhibition, it did not change noncalcified coronary plaque volume at 12 months. Despite effective lipid lowering, researchers noted that the short study duration and the “well-treated” baseline of participants (most were already on statins) likely limited the observable impact on plaque.
- SirPAD’s Sirolimus Success: Another ACC late-breaker, the SirPAD trial found that Concept Medical’s MagicTouch sirolimus drug-coated balloon (DCB) significantly outperforms uncoated balloons in treating peripheral artery disease. At one year, the DCB reduced major adverse limb events from 15% to 8.8% across an all-comer population (1.3k, randomized 1:1), including those with chronic limb-threatening ischemia. As the largest RCT of its kind, these results position sirolimus DCBs to potentially redefine standard care for complex vascular interventions.
- PCI Deferral Safety: The PRO-TAVI trial demonstrated that deferring PCI in patients with concomitant CAD and AS scheduled for TAVI is a safe and noninferior strategy. Among 466 patients, deferral significantly reduced major bleeding (6% vs 15%) compared to pre-TAVI PCI, with only 11% of patients eventually requiring revascularization within one year. Investigators concluded that for older populations, prioritizing the valve and intervening on coronaries only when clinically necessary is safer and reduces procedural burden, which challenges the current “PCI-first” paradigm.
- Food-as-Medicine at ACC.26: Two new studies, GoFreshRx and THRIVE, demonstrated that integrating DASH-aligned grocery deliveries with dietician counseling significantly improves blood pressure control in Black adults. In GoFreshRx, participants receiving home-delivered groceries saw a 7-mmHg systolic reduction (which was partially sustained months after the intervention ended). Similarly, THRIVE’s tailored produce prescriptions led to a 6.8-mmHg systolic drop.
- EHR Alerts for Valve Disease: A joint effort by Medtronic and Tempus, the ALERT trial demonstrated that automated EHR notifications significantly improve the timely management of aortic stenosis and mitral regurgitation. Using Tempus’ AI-enabled platform to flag unreferred patients, the system increased 90-day heart team evaluations or interventions to 24.3%, compared to 19.9% in usual care. The strategy effectively mitigated referral delays and undertreatment and provided clinicians with the data needed to meet critical 90-day quality metrics for valvular heart disease.
- USHV & Iterative Health Research Alliance: US Heart & Vascular (USHV) and Iterative Health collaborated to expand community-based cardiovascular research by integrating USHV’s clinical sites into Iterative Health’s global network. The partnership marks Iterative Health’s expansion into cardiology, providing USHV physicians a way to decentralize their trials from traditional academic centers. This approach could also offer biopharma sponsors a high-performing infrastructure for future cardiovascular trial success.
- AI-Powered PH Detection: Anumana received FDA 510(k) clearance for the first AI-enabled algorithm designed to detect early signs of pulmonary hypertension using standard 12-lead ECGs. By identifying subtle patterns invisible to the human eye, the software helps clinicians bypass the non-specific symptoms and frequent two-year diagnostic delays associated with the progressive disease. Validated on 250k Mayo Clinic records, the tool demonstrated 73% sensitivity in dyspneic patients and identified over 85% of PAH cases before formal diagnosis.
- A Transseptal Ultrasound Solution: Exactice Medical and ImSonic partnered to develop the AIM device, the first platform to integrate 2D/3D intracardiac echocardiography with a steerable transseptal needle guide in a single solution. Currently a prototype, the device eliminates the complex coordination of separate imaging and puncture tools by keeping the guide needle and ultrasound sensor aligned which reduces off-target risks and streamlines workflows.
- PET vs. SPECT for Downstream Cardiac Procedures: Cardiac PET may be more expensive than SPECT myocardial perfusion imaging, but PET resulted in fewer downstream procedures in a paper presented at ACC 2026. Among 942k patients, PET produced fewer referrals to invasive coronary angiography (6% vs. 6.8%) and had higher yield for PCI (0.9% vs. 0.4%). Men got more angiography referrals and underwent more PCI procedures than women for PET (7.2% vs. 5.4%) and SPECT (7.1% vs. 5.6%).
- Kerendia Shows Ischemia Resilience: Ischemic heart disease contributes to approximately 60% of heart failure cases, often complicating outcomes and pharmaceutical efficacy. To see if that trend is true for finerenone, researchers conducted a subanalysis from the FINEARTS trial, finding that the benefits of the drug are not impacted by ischemia in patients with HFpEF/HFmrEF. This was seen in both ischemic and non-ischemic patients in FINEARTS who ultimately saw the similar benefit from taking finerenone (ischemia’s RR: 0.86 vs. 0.81 for non-ischemia).
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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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Making the Leap to Outsource Post-Processing
Interested in how to outsource cardiac image post-processing, but not sure where to start? PIA walks you through how to assess and compare vendors, understand pricing models and payment options, and outline your requirements to identify vendors who meet your clinical needs.
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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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- 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.
- 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 report from Us2.ai.
- Why Competitors Benchmark Against Monebo’s ECG Algorithm: In the world of cardiac monitoring, it’s a big deal when your competitors use your technology as their benchmark for success. Learn why Monebo Technologies’ ECG analysis algorithm has been the “predicate device” of at least 13 other companies FDA 510(k) clearance regulatory filings and what this means for providers and their patients.
- Changes in Heart Failure Management: Heart failure is a complex condition with high heart failure hospitalization and cardiovascular mortality rates, especially among patients with HFpEF and HFmrEF, for whom treatment options have been limited. Read how Bayer’s Dr. Alanna Morris-Simon discusses the changing treatment landscape and strategies for improving patient outcomes.
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