Centauri is an open-platform PFA solution designed for focal contact force catheter workflows. It uses a custom monopolar waveform to create transmural lesions while avoiding microbubbles and muscle stimulation, aiming to improve procedural efficiency, safety, and outcomes in cardiac ablation—particularly for paroxysmal atrial fibrillation.

Dr. Andreas Hecker, President CRM/EP at Biotronik, highlighted the collaboration as part of their commitment to advancing electrophysiology innovation and supporting physicians.

CardioFocus CEO Steve Ogilvie praised Biotronik’s expertise and global reach, emphasizing their role in driving Centauri’s growth across Europe.

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Analyzing nearly 380,000 TAVR cases from 2016 to 2021, researchers found stroke rates of 2.31% in women versus 1.69% in men. Disabling strokes occurred in 1.61% of women and 1.02% of men. Women in the study were slightly older on average and more often had obesity, while men showed more histories of coronary artery disease and related conditions.

The authors emphasized the need for clinicians to counsel female patients on their elevated stroke risk and suggested that tailored procedural strategies—such as embolic protection devices—may help mitigate this risk.

Further research is needed to understand the anatomical and procedural factors behind this sex disparity and to develop targeted prevention approaches.

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Analyzing over 100,000 Medicare patients from 2017 to 2022, researchers found that 50% underwent SAVR alongside another procedure—most commonly coronary artery bypass grafting (CABG), thoracic aorta replacement, or mitral/tricuspid valve interventions.

Key findings include:

• 30-day mortality: 2.3% for isolated SAVR, rising to 11.7% for SAVR with CABG and mitral valve intervention.
• Five-year mortality: 19.1% for isolated SAVR versus 49.1% for SAVR plus CABG and mitral valve repair.
• An exception was SAVR with tricuspid intervention, which showed slightly better five-year survival (18.1%) than isolated SAVR.

This real-world data contrasts with the PARTNER 3 trial’s findings in low-risk patients, underscoring higher risks in older, more complex cases.

The authors stress the need for more focused research and registries to optimize treatment for elderly patients requiring multivalve and coronary interventions, especially as transcatheter therapies evolve.

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The FDA-approved CAP enables ongoing clinical use of the device while collecting one-year follow-up data in preparation for a premarket approval (PMA) submission. The protocol closely mirrors the original investigational device exemption (IDE) study and will remain active until FDA completes the PMA review or enrollment is complete.

CEO Christoffer Rosenblad emphasized the study as a key step toward expanding access to life-saving technology and supporting clinicians in advanced heart care.

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CEO John Erb emphasized confidence in ultrafiltration’s role but noted hospital-based outpatient settings offer stronger opportunities for patients and business growth. The trial shutdown is expected to save about $4 million over 2.5 years.

The company clarified the termination is unrelated to device safety or performance. Its FDA-cleared Aquadex SmartFlow ultrafiltration system remains available for adults and pediatric patients unresponsive to diuretics, with increasing demand in outpatient heart failure programs and pediatric critical care.

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Lead author William B. Grant, PhD, noted that RCTs, designed primarily for drugs with narrow dose-response curves, may not fully capture the benefits of nutrients like vitamin D, which have broader, threshold-based effects. The team reviewed over 40 years of observational and ecological studies linking vitamin D to significant improvements in CVD mortality.

Vitamin D’s cardiovascular benefits include lowering blood pressure and reducing inflammation. The authors recommend vitamin D as part of an integrated strategy alongside other supplements, a heart-healthy diet, and medications to manage and prevent CVD.

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The landmark trial uses JenaValve’s Trilogy TAVR system, with the initial procedure completed at Cedars-Sinai in Los Angeles. Unlike TAVR’s established use for aortic stenosis, its role in AR remains limited — ARTIST aims to generate pivotal evidence for broader use in lower-risk AR patients.

Analysts anticipate FDA approval for the Trilogy valve in AR by late 2025, expanding options for this underserved patient group. JenaValve was acquired by Edwards Lifesciences in 2024 as part of a $1.2 billion deal to boost Edwards’ TAVR leadership.

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“This is the first noninvasive method to differentiate types of heart rejection,” said co-author Dr. Sounok Sen. The team is now expanding research to 100 patients to validate these findings.

This breakthrough could transform transplant monitoring by reducing risks and discomfort associated with repeated biopsies.

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The Siegel system features an 8 Fr delivery sheath enabling less invasive procedures and wider patient access, especially for women. It is the only nickel-free TAVR device, benefiting patients with nickel allergies. Designed with Rhenium alloys, Siegel offers high strength, fatigue resistance, and no foreshortening during implantation, enhancing precise delivery.

“This TAVR’s unique design should reduce pacemaker and vascular complications,” said lead investigator Dr. Pradeep Yadav.

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The authors cite Foldax’s polymer Tria mitral valve—approved in India with positive one-year data—as a rare recent surgical innovation. They note that surgical valve technology is now mature, with strong outcomes expected, reducing urgency for new developments.

Conservatism within the cardiac surgery community and a focus on comparing existing procedures may also hamper research and investment. The surgeons highlighted numerous trials pitting transcatheter aortic valve replacement (TAVR) against surgical aortic valve replacement (SAVR), with TAVR favored by patients despite surgery’s durability, especially in younger individuals.

Borger and Marin-Cuartas call for improved data organization, new randomized trials, and increased research investment to highlight surgery’s long-term benefits.

“If transcatheter trials confirm surgical advantages in lower-risk patients, industry may reconsider its relationship with cardiac surgery,” they wrote. Renewed innovation would benefit patients and the specialty alike.

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