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SAPIEN M3 for MAC, HF in Young Adults, and Siemens CVUS Moves
By Viktor Zarev, Virginia Hunt
October 15, 2026
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Together with
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“The next frontier for TMVR in MAC may, therefore, shift toward identifying patients where valvular replacement would translate into a more meaningful benefit.”
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Safi et al. on the results of the ENCIRCLE MAC Registry
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Ol’ Blue Eyes is Back… is the name of my favorite Frank Sinatra album. My eyes are green anyway, but they’re back too – and on the lookout for the best cardiology news every week!
A huge thank you to Virginia for holding down the fort while I was out and thanks for reading,
Viktor (Vik) Zarev, Senior Editor
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Giving hope to one of the toughest mitral valve patient groups, one-year results from the ENCIRCLE MAC Registry suggest that TMVR with Edwards Lifesciences’ SAPIEN M3 system could help reduce valve dysfunction in select patients with mitral annular calcification (MAC).
- MAC is among the most complex structural heart diseases because the valve is often too calcified for surgery and too anatomically difficult for transcatheter edge-to-edge repair.
- It’s also common, with MAC affecting roughly 23% of older adults and makes mitral valve dysfunction far more likely.
- Enter Edwards’ SAPIEN M3 TMVR system, which gained FDA approval in December of 2025 with both an MR and MAC indication.
Until now, most data on the SAPIEN M3 system stemmed from the ENCRICLE trial which focused on mitral regurgitation rather than calcification.
So to further validate the valve replacement system, Edwards launched the ENCIRCLE MAC Registry, which followed 93 patients with MAC-related mitral disease for one year after they received the SAPIEN M3, finding that…
- Mitral regurgitation grade was reduced to ≤1+ (trace, trivial, or mild) in 98.5% of patients at one year.
- By the one year mark, 87.7% of patients were NYHA class I/II compared to only 26.9% at baseline.
- Patient KCCQ scores also rose 18.5 points, and 6-minute walk distance improved.
Those are real benefits, but there’s also a reality check – while the trial showed a lower composite rate of death or HF hospitalization rate than predicted (33.6% vs. 45%), that’s still a third of all recipients experiencing negative outcomes.
And that’s because this is a very technically demanding procedure that comes with its own cardiac complications…
- One-year all-cause mortality was 21.1% and mitral valve reintervention came in 11.4% (mostly for paravalvular leak closure).
- Structural complications also occurred in 9% of patients, mostly due to intraprocedural injuries during the technically difficult “encircling” step of the intervention.
In reality, this study is a lesson in patient selection and its limitations.
- For example, more than 70% of screened patients were excluded from treatment.
- About half of those exclusions were due to anatomical reasons.
- This high screen-failure rate is not necessarily a weakness; rather, it’s a reflection of the population’s complexity.
The Takeaway
When it comes to MAC-related mitral valve dysfunction, the situation is already dire for most patients. These fresh results from the ENCIRCLE MAC Registry suggest that some of those patients could still benefit from the SAPIEN M3 valve, at least, for one year post-implant.
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- HF Ascends in Young Adults: Nearly one in four U.S. adults will develop HF, but new data shows that cases are increasingly developing earlier in life. A JCF analysis found that HF mortality rates more than doubled in patients aged 25-44 (+121%) between 2001 and 2020. During that window, mortality rates rose 96% for those aged 45-64 years, greatly exceeding the 22% increase in older adults. While some of the trend may be related to improved diagnostics, the authors note that early development of obesity is likely a larger driver.
- Siemens Specializes in CV: Siemens Healthineers is going all in on cardiovascular imaging as it announced plans to end sales of general ultrasound devices. Popular models of the Acuson general ultrasound system were moved off-market on Monday, the same day the company disclosed plans to home in on intracardiac echocardiography and AI solutions for procedural CV therapies. The decision is also part of a larger Siemens trend that has seen the company increasingly go after the cardiac imaging market with its major cardiac CT ultrasound AI software innovations.
- Handheld Cardiac Implant Reader: BridgeSource Medical received FDA de novo clearance for its SmartRead handheld device that helps quickly identify a patient’s pacemaker or defibrillator brand in the ER. The approval fills an interesting time-saving niche since many ER patients don’t know how to or can’t communicate their device brand which often leads to X-rays and care delays. SmartRead identifies the patient’s implant within 20 seconds by mimicking the communication pings of major manufacturers. The device’s development stems from NIH small business grants.
- Score Triages Heart Transplants: One in five U.S. heart-transplant candidates will die or be delisted before undergoing transplant, but the new U.S. Candidate Risk Score could better prioritize sicker patients. Among 8.2k transplant candidates, the US-CRS showed better discrimination than the current system in predicting six-week mortality (AUC 0.807 vs 0.693, respectively). US-CRS-based rankings also increased the likelihood that the candidate at the top of the list would die within six weeks without the transplant by four percentage points.
- Biomarkers for Acoramidis Response: BridgeBio published a post-hoc analysis of their ATTRibute-CM trial that combined two biomarkers to evaluate the efficacy of their ATTR-CM drug, Acoramidis. Researchers paired an early marker of transthyretin stabilization (serum TTR at day 28) with a later myocardial stress marker (NT-proBNP at month 12) and found that each +0.1 increase in the serum TTR to NT-proBNP ratio led to a 63% lower adjusted risk of death or cardiovascular hospitalization. However, these findings are only exploratory and need validation.
- JenaValve Catheter Recall: More than 360 units of the 23-mm, 25-mm, and 27-mm JenaValve Trilogy delivery catheter have been recalled due to sleeve liner separations that could stunt deployment. Though the FDA’s Class 2 designation warns of only temporary or reversible injury, organizations have been instructed to separate affected devices until a JenaValve representative retrieves them. This recall comes just months after the Trilogy system became the first TAVR device to receive FDA approval for treating aortic regurgitation.
- Gut Microbe Eases Atherosclerosis: A new Nature paper links pentadecanoic acid, a molecule produced by gut bacteria, to lower cholesterol and smaller plaques. The compound appears to alleviate atherosclerosis by inhibiting HMG-CoA reductase, the same enzyme blocked by statins to limit cholesterol production. Mice given pentadecanoic acid saw vastly improved plaque burdens and lipid profiles, suggesting therapeutic potential. Statins may dominate the cholesterol drug market, but they’re not always effective or well tolerated, leaving room for alternatives.
- Sutureless Valve Durability: Corcym presented positive mid-term data from a MANTRA trial sub-analysis of its Perceval Plus sutureless aortic valve, marking the valve’s longest follow-up to date. Specifically, the valve’s FREE anti-calcification tissue and designs were evaluated in 708 patients, and showed a 99.7% freedom from structural valve deterioration three to seven years post-implant. Perceval patients also saw 96.6% freedom from reoperation, and a 3.7% pacemaker rate at 30 days, alongside quality-of-life gains.
- Societies Support TAVR for Regurgitation: The ACC, SCAI, and STS sent a joint letter to CMS saying that they “strongly support” Medicare coverage for TAVR in patients with symptomatic, severe native aortic regurgitation. The move follows JenaValve’s Trilogy system becoming the first TAVR device FDA-approved for AR, with the societies urging a “coverage-with-evidence-development framework” given limited data (only ~1,500 AR cases versus nearly 1M for stenosis). The letter also champions in-person heart team evaluation, and continued quality oversight. CMS expects to share a proposal by March 2027.
- Stent Graft for Complex Aortic Repair: The FDA expanded the approved indications for Gore’s Viabahn VBX balloon-expandable endoprosthesis, making it the first device cleared for both fenestrated and branched endovascular aortic repair (FEVAR and BEVAR). In these procedures, the stent graft bridges the aortic endograft to renal or mesenteric arteries to maintain vessel perfusion. The approval draws on three-year EMBRACE registry data showing high primary patency (97.5% for FEVAR, 94.0% for BEVAR). The device was first FDA-approved for iliac arteries in 2017.
- Apple Owes Masimo Another $184M: A U.S. district court ordered Apple to pay Masimo $184.2M in prejudgment interest on top of the $634M a jury awarded last year, after the Apple Watch was found to infringe a Masimo pulse oximetry patent. The ruling brings Apple’s total to more than $818M. The judge sided with Masimo on owing interest but set the rate based on Masimo’s borrowing costs rather than the steeper 7% it sought.
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Most Health Systems Have Deployed AI. Few Have Scaled It.
75% of health systems have deployed GenAI, yet only 4% report scaled implementation with measurable outcomes (Becker’s 2026). Cardiology shows the difference: HCM diagnosis in about three months versus 2 to 5 years, and pre discharge ILR placements up from 3 to 51. Join Viz.ai CMO Tim Showalter, MD on October 22 to hear what it takes. Register now.
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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.
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