TAVR pioneer Alain Cribier, MD, FACC, who passed away last week at the age of 79.

Heart Failure

Reprieve Cardiovascular Looks to Transform ADHF Decongestion Management

Reprieve Cardiovascular emerged this week, announcing a hefty $42M Series A round and an even bigger mission to “transform the standard of care” for patients with acute decompensated heart failure.

Founded in 2020 and operating in stealth before now, Reprieve Cardiovascular is developing an intelligent automated diuretic and fluid management system for ADHF treatment. 

The Reprieve System is designed to monitor ADHF patients and deliver personalized diuretic dosing and fluid replacement, while giving physicians real-time insights to help them optimize patient care. More specifically, The Reprieve System is meant to allow care teams to…

• Find the Right Dose, Fast – by measuring and analyzing urine output, and optimizing patients’ diuretic dose in the first hour.
• Maintain The Right Dosing – by recommending when to escalate/end therapy. 
• Keep the Kidney Happy and Control Diuretic Resistance – by continuously titrating saline replacement (when needed) to maximize urine output and maintain renal function.

That approach could get HF care teams’ attention, given that even after 60 years of clinical use, diuretic optimization can still be a challenge without real-time visibility into patient information. Plus, fluid volume overload still causes 25% of discharged HF patients to be readmitted within 30 days.

To meet this clinical need and prove its capabilities, Reprieve Cardiovascular is targeting its new funding towards its clinical and development programs, including the ongoing FASTR pilot trial (compares Reprieve vs. standard diuretic therapy) and its upcoming pivotal trial.

The Takeaway

We don’t see many diuretic and fluid management startups emerging these days, but given acute ADHF patients’ lengthy hospital stays and significant readmission risks, there’s certainly room for innovation in this space. Reprieve Cardiovascular still has lots to prove, but its combination of automated monitoring, dosing, and fluid replacement could end up being the innovation that ADHF patients and their providers have been looking for.

A Milestone Study for Cardiac Strain Analysis

Us2.ai’s deep learning algorithm was able to interpret echo AI left ventricular strain images with similar accuracy as conventional measurements. Read all about this milestone study and its implications for echo strain access in EHJ-Digital Health.

Cleerly Revealed What Other CAD Tests Couldn’t

“I could have had a heart attack.” Florida-based registered nurse, Sharon Bruno BSN, RN, had a zero CAC Score and no known heart disease symptoms, but she learned through Cleerly’s AI-enabled CCTA analysis that she actually had moderate plaque burden. See how Sharon’s proactive detection allowed her to make lifestyle changes early enough to reduce her CVD risks.

PIA Medical Processes It All

Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.

The Wire

• Lp(a)’s Independent CVD Risks: High lipoprotein(a) is widely known as a ASCVD risk factor, but it’s been debated whether Lp(a) exclusively increases cardiovascular risks in patients who also happen to have inflammation. A new MGB study helped clarify that debate. Using three large primary prevention and secondary prevention datasets, patients with high Lp(a) levels had 2% to 5% increased MACE risks per 50-nmol/L higher Lp(a), and risk levels were similar across participants with both high and low levels of hs-CRP (an inflammation biomarker).

• Impulse Dynamics’s HF Funding: Impulse Dynamics landed a whopping $136M in Series F financing (total now $543M) to support its commercialization efforts, future product development, and clinical trials. Impulse Dynamics’ CCM therapy uses an implantable pulse generator to support heart contraction and improve key heart failure quality of life symptoms. The company is also planning to enter the implantable cardioverter defibrillator market, and has completed trial enrollment for its CCM-D system, which is intended to both serve as a defibrillator and improve HF symptoms.

• Post-TAVR Anticoagulant Tradeoffs: A study comparing blood thinners post-TAVR found that at 5 years, vitamin-K antagonists (VKAs), such as Coumadin, were linked to a 25% increase in all-cause mortality but a 36% reduction in disabling stroke compared to DOACs like Eliquis or Xarelto. Despite aligning with previous studies, the findings emphasize the need to balance survival benefit, stroke risk, and patient preference when choosing anticoagulants after TAVR.

• Scot’s New Heart: Scot Pollard, the former Kansas basketball star and NBA champ, is now recovering from what appears to be a successful heart transplant. Pollard and his care team originally struggled to find a donor heart large enough to support his 6-foot-11 body, but his new heart proved to be “a perfect fit,” and Pollard is now walking and already preparing to leave the ICU floor.

• CMR-ECGI for HCM Detection: A new study highlighted cardiovascular MR-guided electrocardiographic imaging’s (CMR-ECGI) potential to detect biomarkers of subclinical hypertrophic cardiomyopathy (HCM), paving the way for earlier treatment. In the study of 211 people, subclinical HCM gene mutation carriers showed abnormal electrophysiology in their CMR-ECGI exams that was not evident with their 12-lead ECG exams, while those with overt HCM had more severe CMR-ECGI abnormalities. This is the latest in several studies highlighting CMR-ECGI’s potential.

• BiVACOR’s Artificial Heart Funding: Artificial heart developer BiVACOR landed a $13M grant from the Australian government to address the treatment gap for patients with severe biventricular heart failure. More specifically, the funding will support clinical work on the BiVACOR Total Artificial Heart, begin development on the device’s wireless power sources, and support its upcoming early feasibility study.

• PVF Status Improves MV-TEER Outcomes: An analysis of patients who underwent mitral valve transcatheter edge-to-edge repair (MV-TEER) showed how a convenient Pulse-wave Doppler exam of pulmonary vein flow (PVF) provides information that could help improve procedure outcomes. In the study of 265 patients post-MV-TEER, those with abnormal PVF (72.5%) were more likely to have AFib (70% vs. 42%), >moderate residual mitral regurgitation (16% vs. 3%), and mortality (HR = 1.70).

• iCardio.ai’s AS Detection Designation: Echo AI startup iCardio.ai announced that its aortic stenosis detection solution landed FDA Breakthrough Device Designation, potentially streamlining its path towards approval and reimbursement. The designation notably covers iCardio.ai’s AS solution for screening outside of the echo lab, such as in primary care settings, which could have a big impact on early AS detection and treatment. That would be a significant change from current AS detection pathways, but the solution has performed fully-automated AS detection with high accuracy in previous studies.

• The Niacin Paradox: While niacin (vitamin B3) is common in our food and has been shown to reduce LDL cholesterol, a study published in Nature Medicine revealed a ‘niacin paradox’ that suggests excess niacin breakdown products might actually increase CVD risks. Two niacin metabolites, 2PY and 4PY, were associated with 64% and 89% increases in 3-year MACE among US-based adults, while 4PY was associated with increased vascular inflammation in mice.

• Cagent’s PAD Catheter Funding: Cagent Vascular closed a $30M Series C round (total raised now $51.9M) that it will use to increase its commercial activities in the US and expand its serration angioplasty technology product portfolio. Cagent’s Serranator PTA Serration Balloon Catheters are already relatively well established for peripheral artery disease treatment (over 10k used so far), using three embedded serrated elements designed to modify plaque, aid arterial expansion, and restore blood flow by creating linear, interrupted scoring along the endoluminal surface.

• Photon-Counting CT Improves Stenosis Imaging: Ultra-high-resolution photon-counting CT with a minimum 0.2mm slice thickness produces more accurate images of coronary stenosis compared to conventional CT, thanks to its reduced image artifacts from calcium and stents. That’s from a Germany-based study that used a Siemens Healthineers Naeotom Alpha photon-counting CT to scan 114 patients with suspected coronary artery disease, leading to stenosis severity downgrades in 54% of patients.

Explore the Potential of Cardio AI

Explore the potential of AI-powered cardiology solutions in this on-demand TeraRecon webinar, detailing how its Cardio Suite solutions help expedite disease diagnosis, care coordination, and provide the data to support cardiac treatment decisions.

Cardiovascular Structured Reporting Adoption Benefits

Check out this Change Healthcare report detailing the benefits of cardiovascular structured reporting, and how to drive structured reporting adoption in your own organization.

The Resource Wire

• Merge Cardiology is Best in KLAS: Merge Cardio and Merge Hemo continued their KLAS hot streak, ranking Best in KLAS 2024 for Cardiology and Hemodynamics for the 9th and 12th years. The Merge by Merative cardiology solutions further expanded their KLAS score leads this year, with Merge Cardio scoring 82.8 (up from 82.7 last year) and Merge Hemo surging to 91.5 (from 85.7 in 2023).

• HeartFlow FFRCT Catches Missed Blockages: Karen Moore had always been diligent about her heart health, which is why she was concerned when she began showing symptoms of heart disease but all of her tests came back negative. See how Karen and her physician used HeartFlow FFRCT to catch a 90% blockage and place a stent in the right location, before it was too late.

• Better Cardiovascular Care, With a Better Bottom Line: Twenty million chest CTs are acquired in the U.S. each year, but CAC is typically unreported. See how you can leverage Bunkerhill Health’s Incidental CAC algorithm to screen for incidental coronary calcium on routine chest CTs in real-time, improving care and your bottom line.

• 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!