Srihari S. Naidu, MD

We’ve got a surge of research from ESC 2026, which convened this weekend in Munich, Germany. This issue and the next will be packed with news from Europe’s biggest cardiology conference, starting with the full results of the pivotal ACACIA-HCM trial.

Cheers,

Vik

Cardiology Pharmaceuticals

The Full Picture Clarifies Aficamten’s Impact on nHCM

We are inching closer to a treatment for nonobstructive hypertrophic cardiomyopathy after Cytokinetics presented the full results from the ACACIA-HCM trial, showing that its cardiac myosin inhibitor, MYQORZO (aficamten), meaningfully improves how nHCM patients feel and function.

• Unlike obstructive HCM, nHCM has no approved treatment.
• This means about half the HCM population has no targeted therapeutic options.
• Bristol Myers Squibb’s cardiac myosin inhibitor, mavacamten, showed no clinical benefit in the ODYSSEY-HCM trial.

ACACIA-HCM’s design focused on two parallel primary endpoints that measured both symptom burden and exercise capacity at 36 weeks in 517 randomized adults (KCCQ score and peak VO2) each with a miniscule p-value of 0.025 or less.

As we already know from the topline results in May of 2026, both primary endpoints were met.

• Patients’ KCCQ scores improved 11.4 points with aficamten versus 8.4 with placebo.
• Peak VO2 rose 0.64 ml/kg/min with aficamten while staying unchanged on placebo.

But the full picture reveals only some of the secondary endpoints reinforced aficamten’s benefits.

• Aficamten significantly improved NYHA functional class (41.9% vs. 27.8%), composite CPET z-scores, and NT-proBNP.
• However, it missed statistical significance for improving left atrial volume index and showed no benefit for time-to-first-cardiovascular-event.

We also can’t talk about cardiac myosin inhibitors without talking about safety, and aficamten’s full profile seemed pretty safe, with some common side effects apparent.

• Reversible LVEF reductions (sub 50%) occurred more with aficamten (10.5% vs. 0.8%).
• Serious adverse events were more common with aficamten (20.2% vs 14.7%). 
• HF events occurred mostly during aficamten dose titration or before week 12.

Because the individual endpoint differences are modest, investigators also published a global efficacy analysis in Circulation looking at exercise capacity, cardiac structure, biomarkers, diastolic function, and symptoms.

• In that analysis, 53% of aficamten patients showed a clinical response across three or more outcome measures, compared to just 13% on placebo.

These results couldn’t have come at a better time, as Cytokinetics now plans to use the data to submit a supplemental New Drug Application to the FDA in Q4 2026.

• That submission plan comes alongside a Cytokinetics’ lawsuit against BMS over a patent it obtained containing the active ingredient in aficamten.

The Takeaway

The full picture of ACACIA-HCM confirms that aficamten has more than a puncher’s chance of becoming the first approved drug for nHCM. Bearing that in mind, the secondary endpoints suggest it’ll be a symptom management approach rather than a cure.

The Benefits of Outsourced Post-Processing

Using an outsourced cardiac image post-processing solution doesn’t have to mean sacrificing control of the results. Discover how PIA’s customizable post-processing workflow can help you get the most out of your images.

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.

The Benefits of Cardiovascular Structured Reporting

Cardiovascular imaging’s growing demand means providers need structured reporting to manage their clinical workflows. Discover why Optum’s structured reports allow for more automated EHR and modality data while helping standardize clinical workflows.

The Wire

• Mounjaro’s New MACE Indication: The FDA approved Eli Lilly’s Mounjaro (tirzepatide) for lowering MACE risk in high-risk adults with T2D, making it the first GIP/GLP-1 with this indication. The approval rests on SURPASS-CVOT, the first head-to-head cardiovascular outcomes trial of two incretin medicines, where Mounjaro showed non-inferiority to Trulicity with an 8% lower rate of CV death, heart attack, or stroke (HR: 0.92) across more than 13,000 participants. Lilly’s Mounjaro now joins Novo Nordisk’s Wegovy, marking the second time a weight loss drug gained a CV indication.

• A Cardiac Amyloidosis Radiotracer: The cardiology community has taken some big strides toward better diagnosing cardiac amyloidosis, and we may now even have a dedicated PET/CT radiotracer on the way. Presented at ESC 2026, results from Bayer’s REVEAL trial suggest that its iodine-124 evuzamitide PET/CT radio tracer had 94% sensitivity for cardiac amyloidosis, with 86% specificity. It also showed a PPV of 85%, and NPV of 94% with high diagnostic accuracy for both light chain and transthyretin amyloidosis. Bayer acquired the compound from Attralus earlier this year. 

• Philips and Imricor’s Interventional MRI Launch: Philips and Imricor partnered to launch a new solution for MRI-guided interventional cardiology procedures. The package combines a Philips 1.5T MRI scanner and Cardiac MR Suite software with Imricor’s NorthStar interventional MR mapping and guidance system and electrophysiology recorder/stimulator and catheters. The combination will enable clinicians to better visualize cardiac anatomy and arrhythmia substrate while tracking catheters, evaluating treatment response, and performing other interventional tasks in the MRI suite.

• Alcohol’s Association with SCD: Alcohol is a well-known adversary to heart health given its associations with hypertension, but an EJPC study has shown its effects can be deadly. Among 10.1k participants who had rates of alcohol consumption categorized as none (0 units/week), low (1–7), moderate (8–14), high (15–21), or very high (>21), very high intake yielded a 40% higher risk of sudden cardiac death than moderate intake. Higher intake was most common in men and those who smoked, highlighting a potential group for targeted interventions.

• FFR_CT Reduces Invasive Angiography: Dutch researchers presented data from the FUSION trial at ESC 2026 in which Heartflow’s FFR_CT Analysis AI solution reduced unnecessary invasive cath lab procedures by 44%. In 528 patients with chest pain from 12 hospitals, FFR_CT was added to standard coronary CT angiography scans to quantify coronary artery blood flow, reducing the percentage of patients referred for invasive coronary angiography (22% vs. 39%) while maintaining overall revascularization rates (20% for both). 

• CCTA and Chest Pain: In more CT news from ESC, Coronary CT angiography fell short in determining which patients with chest pain but no heart attack might be at risk for future cardiac events. Per the TARGET-CTCA trial, 3.2k who presented to the ER with chest pain were studied, with half getting CCTA. At the end of three years, there was no statistically significant difference in myocardial infarction or cardiac-caused death between those who got CCTA and those who received the usual care (7.1% vs. 7.3%, p = 0.71). 

• Could Pomegranates Treat HFpEF? Sort of – pomegranates (and some berries) cause the body to produce a small compound called urolithin A, which is what really initiates the cardioprotective cascade. Researchers from King’s College London found that animal models treated with urolithin A saw a massive improvement of up to 80% in heart function compared to those which weren’t. Much of the effect appears to be driven by the activation of the PKGIɑ protein, which improves cardiac muscle relaxation and subsequently prevents fibrosis.

• Ironing Out Anaemia Pre-Surgery: Blood transfusions are associated with increased hospital stays and mortality, and yet up to 50% of cardiac surgery patients receive them. Now, a new BMJ study suggests IV iron could help reduce its prevalence. Among 955 anaemic adults undergoing heart surgery, administering iron intravenously before the procedure resulted in a 10% lower risk of blood transfusion. Patients treated with iron also had a small one-day improvement in time spent alive and at home within 90 days after surgery.

• GE Adds to Cardiac Ultrasound Line: GE HealthCare used ESC 2026 as a stage to unveil the next generation of its Vivid line of cardiovascular ultrasound scanners. The new scanners include Vivid Explorer, targeted at high-volume echo labs and routine interventional procedures; Vivid Advanced, for midsized hospitals and cardiology practices; and Vivid Focus, for everyday cardiac imaging. The new systems broaden GE’s echocardiography line beyond the ultra-premium Vivid Pioneer. 

• Proteins Linking Social Factors to Heart Failure: Researchers analyzed nearly 5,000 plasma proteins across 9.8k patients to probe how adverse social determinants of health (SDOH) tie to heart failure risk. Deriving SDOH factors from patients’ income, education, and area deprivation, the study found there were proteins associated with both SDOH burden and incident heart failure, with several showing mediation effects. Among the proteins that stood out the most was C1QTNF1 which could have a potentially causal role in heart failure.

• Are Younger TEER Patients In the Clear? Not all adults aged ≤65 years with mitral valve regurgitation are healthy enough to undergo surgery, but transcatheter edge‐to‐edge repair is a common alternative. A new JAHA study clarifies long-term outcomes for younger patients, showing they achieve a lower 3-year mortality rate than older adults (18.5% versus 30.3%). That wasn’t the case for all younger patients though, as those who didn’t have procedural success had no survival advantage over their elders, emphasizing the importance of timely follow-up.

Merge & Us2.ai for Accessible Cardiac AI

AI isn’t the future anymore, it’s an irreplaceable feature for cardiac imaging. Dive deeper into how Merge & Us2.ai are integrating FDA-cleared algorithms with advanced imaging systems to help clinicians focus on what matters most – their patients.

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.

Merge Cardio 12.5 is Officially Available!

From AI-generated echo measurements to upgraded UI and reports, Merge Cardio 12.5 brings a long list of new innovations to the table. Find out more about how Merge Cardio’s latest version streamlines workflows to make your cardiovascular service line more cost-effective and patient-centered.

The Resource Wire

• How AI Expands the Role of CMR Experts: If you’re an MRI technologist, AI could be the best thing that ever happened to your career. Read here to learn about the benefits of AI for CMR experts and how it can accelerate both your training and career.

• 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%.

• 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.

• Telemedicine Isn’t About Technology. It’s About People. With temporary telehealth rules expiring, millions of Medicare patients may lose their ability to see their doctors remotely. Read why Monebo and the Alliance for Connected Care are urging Congress to make telemedicine a permanent part of the healthcare system.

The Industry Wire

1. CMS cracks down on $1.6B in lab fraud payments. 
2. FDA approves four new COVID-19 vaccines for 2026-2027. 
3. FDA approves heart/stroke indications for Lilly’s Mounjaro. 
4. Study tracks on-again, off-again Wegovy use.
5. AstraZeneca releases autopsy on failed heart disease drug.
6. Sanford acquisition of Memorial health clears state hurdle. 
7. High costs push Americans abroad for fertility treatments.
8. Former CDC staffers detail how to fix agency. 
9. Florida AG sues PBMs for alleged drug price fixing.
10. Physician specialists push back on No Surprises study.