Nir Uriel, MD MSc on the surge of new heart failure innovations and the shortage of heart failure specialists to deliver them.

Heart Failure

Endotronix Cordella Shows HF Impact in PROACTIVE-HF Trial

Endotronix took a big step toward its vision for pulmonary artery pressure-based heart failure medication optimization, releasing positive results from its Cordella Sensor’s PROACTIVE-HF pivotal trial.

The Cordella Solution sits at the intersection of medtech and digital health, combining an implanted PA sensor to measure congestion, a handheld PA pressure reader, a range of vital sign measurements (BP, pulse, weight, O2 sensor), and a digital health platform that provides patients and clinicians with key HF data.

The multi-center, prospective PROACTIVE-HF trial implanted the Cordella sensor in 528 NYHA class III HF patients (at 75 U.S. and European sites) and provided them and their clinicians with the Cordella platform. At six months, the trial met all primary safety and efficacy endpoints, and achieved key secondary endpoints:

• 99.2% freedom from device or system-related complications
• 99.8% freedom from PA sensor failure
• 0.15 HF hospitalization/all-cause mortality rate (well below 0.43 goal)
• 5-point improvement in KCCQ scores
• 23 meter improvement in 6-minute walk test
• 2.4 mmHg decrease in seated mean PA pressure 
• 5.9 mmHg decrease in-office systolic blood pressure
• 2.2 lb decrease in at-home weight 

These results were consistent across all patient sub-groups, and aligned with the Cordella Sensor’s 12-month data in the previous SIRONA 2 trial.

With these positive results on the books, Endotronix now awaits the FDA’s response to its PMA application, continues enrollment for its randomized and blinded PROACTIVE-HF 2 trial (the current trial was single-blinded and not randomized), and is preparing for its commercial launch later this year.

Once Endotronix commercially launches, it will have the benefits of an already-established market for PA pressure monitoring, noting that Abbott’s competing CardioMEMS system has been approved for a decade. 

• In order to show differentiation once it does hit the market, Endotronix will rely on its unique abilities to involve patients with their HF data, measure a broad range of metrics, and to perform measurements while patients are seated (vs. lying down).

The Takeaway

Even if PA pressure-guided HF medication management is already well established, healthcare’s continued challenges with GDMT optimization suggest that there’s certainly room for new or improved solutions. Endotronix’s early messaging and trial results indicate that combining PA pressure with modern digital health approaches for “smart medication titration” might prove to be one of the GDMT-optimizing solutions we’ve been waiting for.

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The Wire

• Cleerly’s CAD Breakthrough: Cleerly’s high-priority Coronary Artery Disease Staging System landed FDA Breakthrough Device Designation and was accepted into FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot. The Cleerly CAD Staging System analyzes atherosclerosis, stenosis, and ischemia in CT scans, with the goal of providing physicians with more accurate and personalized risk assessments. The CAD Staging System is also the focus of Cleerly’s ambitious new TRANSFORM trial, investigating whether patients who receive cardiovascular treatments based on Cleerly results have better outcomes.

• Over a Billion Now Have Obesity: Global obesity rates have more than tripled over the past three decades, translating to over a billion people worldwide. A new Lancet study found that 1 in 8 people now have obesity, dramatically raising the risk of conditions like high blood pressure and diabetes. Between 1990 and 2022, the global rate of obesity doubled among women (8.8% to 18.5%), nearly tripled in men (4.8% to 14.0%), and quadrupled in adolescents (6.9% in girls and 9.3% in boys). 

• Another Zilebesiran Milestone: Alnylam and Roche’s long-lasting antihypertensive Zilebesiran reached another positive milestone, after topline results of its Kardia-2 study showed that injections of the SiRNA drove significant 30-day blood pressure reductions when combined with standard of care BP meds, while showing an encouraging safety and tolerability profile. The results come about five months after Alnylam’s successful Kardia-1 trial, and will lead to the KARDIA-3 trial evaluating Zilebesiran among patients who have high cardiovascular risks. 

• CardioOne’s PE Acquisition: Cardiology practice management platform company CardioOne was acquired by healthcare-focused private equity firm WindRose Health Investors, which will provide up to $100M in additional capital to support CardioOne’s business and portfolio expansion. Despite its new PE ownership, CardioOne exists to help cardiology practices thrive while staying independent, providing them a platform that combines technology, talent, and administrative support to reduce operational burdens and streamline their expansion into value-based care. 

• Mavacamten and Comorbid Hypertension: A post-hoc analysis of the EXPLORER-HCM study found that the cardiac myosin inhibitor mavacamten (BMS’ Camzyos) is effective for the treatment of LVOT obstruction in patients with hypertrophic cardiomyopathy who also have hypertension. In the placebo-controlled study of 251 patients (47.4% w/ hypertension), mavacamten-treated participants had similar improvements on all endpoints, regardless of comorbid hypertension and mean SBP. Based on this data, patients with grade 1 hypertension should be able to safely take mavacamten.

• CAC’s Predictive Power: The DISCHARGE Trial Group released another study highlighting the power of cardiac CT, this time showing that CAC scores are extremely effective for predicting outcomes, and likely guiding care. The researchers performed CAC exams on 1.7k patients across 16 European countries, finding that patients with zero CAC scores had far better 3.5-year outcomes than those with scores of 1-399 and ≥400 for MACE (0.5% vs. 1.9% & 6.8%), obstructive coronary artery disease (4.1% vs. 29.7% & 76%), and revascularization (0=1.7% vs. ≥400=46.2%).

• BridgeBio & Bayer’s ATTR-CM Alliance: BridgeBio Pharma will make its transthyretin amyloid cardiomyopathy (ATTR-CM) drug acoramidis exclusively available through Bayer in Europe. The licensing deal gives BridgeBio $310M in upfront and near-term milestone payments, tiered royalties that start in the low-thirties percent, plus additional undisclosed milestone payments. Acoramidis performed well in its recent Phase 3 trial, and appears to be on a path towards approval in both Europe and the US.

• RE-ACCESSing Coronaries After TAVR: The importance of valvular design was highlighted by the RE-ACCESS 2 study (N=127), which had a 5.5% case failure rate in coronary cannulation (aka re-access) when utilizing self-expanding TAVR valves. Six out of the study’s seven unsuccessful post-TAVR cannulations occurred with the Evolut system, suggesting that the ACURATE valve’s open-cell design holds potential for improved coronary access. Regardless of the valve type, ensuring commissural alignment was most important for successful coronary cannulation.

• Laplace’s First In-Human TTVR: Laplace Interventional announced the first first-in-human procedure using its Transcatheter Tricuspid Valve Replacement (TTVR), which allows tricuspid regurgitation treatments without open-heart surgery. The successful procedure took place at Tucson Medical Center and was conducted as an FDA Early Feasibility Study. Laplace’s first TTVR procedure continues a recent hot streak for TR treatments, coming within a month of the FDA clearance of Edwards’ EVOQUE TTVR system and a very positive FDA panel vote for Abbott’s TriClip tricuspid edge-to-edge repair system.

• The RIGHT Anticoagulation Post PCI: Results from the RIGHT trial challenge the routine use of postprocedural anticoagulation (PPA) after PCI for STEMI patients. While PPA was safe, it failed to reduce 30-day ischemic events (2.5% in both PPA and placebo groups). However, due to variations in anticoagulants across participating centers, the study couldn’t make conclusive determinations regarding the efficacy of all anticoagulants in reducing 30-day ischemic events.

• Haemonetics Acquires Attune: Haemonetics acquired AFib ablation safety company Attune Medical for at least $160M, bolstering Haemonetics’ presence in the electrophysiology market, and representing a 7-times premium over Attune’s $22M annual revenue. Attune’s ensoETM device uses temperature regulation to reduce esophageal injuries during RF ablation procedures, and is the only FDA-approved device with this capability. Haemonetics appears to be on a cardiology acquisition spree, as it acquired interventional cardiology company OpSens for $253M in October.

Can AI Improve How We Prevent Heart Disease Progression?

Tune in to Cleerly’s upcoming webinar (March 19, 2pm ET) where study leaders will discuss how the landmark TRANSFORM randomized controlled trial will test whether an AI-personalized care strategy can outperform traditional risk factor management and prevent cardiovascular events.

PIA Medical Processes It All

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The Resource Wire

• Automatic, Precise Analysis – From the First Beat: Monebo’s Kinetic ECG Algorithm leads with its versatility, precision, and efficiency, enabling a long list of use cases. See how it might impact your ECG monitoring clients here.

• Experience the future of learning: Medtronic Academy 2.0 is here! Unlock your ultimate destination for structural heart medical education with the newly redesigned Medtronic Academy 2.0. Gain access to expert-led courses, webinars, and a wealth of resources to stay ahead in cardiovascular care. Visit now!

• 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.

• HeartFlow’s FFRCT’s Nationwide Improvements: What happens when HeartFlow’s FFRCT Analysis is adopted nationwide? See how the NHS’ nationwide implementation of HeartFlow’s FFRCT solution led to significant reductions in cardiovascular and all-cause mortality, plus solid efficiency gains.

• How to Identify and Treat More CVD Patients: Do you know how many patients with high CVD risks are in your chest CT archive? See how the Stanford Health Care System used Bunkerhill Health’s Incidental CAC algorithm to screen its previous non-gated chest CTs, identify patients with coronary calcium, and get them on statins.