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LV Thresholds Matter, Inotropes vs. LVAD, and Medtronic’s PFA
January 26, 2026
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“When medications are over-the-counter, they have a real price. When they are behind the pharmacy counter, the price is a shell game.”

FDA Commissioner Dr. Marty Makary, MD MPH.

It’s well known that inotropes can stabilize HF patients, but they don’t change disease trajectory and in some cases they can be just as dangerous as what they’re meant to treat. In the latest Cardiac Wire exclusive, Sanjeev Gulati, MD explains how Abbott’s HeartMate 3 LVAD offers a new and potentially better treatment strategy for eligible advanced HF patients.

Cardiology Policy

Women Need Lower LV Thresholds for AV Surgery

New multicenter data published in JAMA suggests that surgery for aortic regurgitation may need to be done earlier than current guidelines recommend, with lower LV size thresholds and possibly different cutoffs for men and women.

  • LVESDi and LVESVi (Left Ventricular End-Systolic Diameter/Volume Index) are echocardiographic measurements that assess heart function and predict HF risk.
  • Current guidelines recommend aortic valve surgery using uniform LVESDi thresholds (25 mm/m²) regardless of patient sex with a single 45 mL/m² LVESVi threshold.
  • Although LV enlargement is a common sign of aortic regurgitation, it’s uncertain whether diameter or volume is more important, and if sex-specific thresholds help.

Studying several cohorts, researchers followed 808 patients with symptomatic AR and preserved LVEF with a median 7-year follow-up examining mortality rates after medication and valve surgery, revealing some critical differences between men and women.

  • Average baseline LVESDi was identical between sexes (both 20 mm/m²), whereas men had larger average LVESVi (39 vs 31 mL/m²).
  • During medical management, 74 patients died with the survival rate significantly lower in women (80% vs 89%), due to too high of a threshold for surgery.
  • Meanwhile, a threshold of LVESDi ≥20 mm/m² for both sexes led to much higher mortality risk than expected (guidelines recommend surgery at 25 mm/m²).
  • After surgery, survival rates were similar between the sexes (85% women vs 89% men), suggesting timely surgery eliminates the medication survival gap.

So what to do with all this data? Well, it might be time to reconsider current guidelines, since they might actually disadvantage women by applying sex-neutral criteria that don’t account for their different cardiac remodeling patterns, a problem that we’ve also seen in HF management for women.

  • On the bright side, European guidelines recently incorporated LVESVi with a 45 mL/m² threshold, but this analysis demonstrates women need a lower 40 mL/m² cutoff.

The Takeaway

Although complex, this study suggests that lower LV enlargement thresholds and sex-specific volume cutoffs may allow earlier identification of high-risk patients, particularly women. That’s important considering they face higher mortality with medical management, which appears to be driven by delayed surgery rather than differences in survival following the operation.

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The Wire

  • Inotropes are Temporary, LVADs Improve the Long-Term: Advanced heart failure is rising globally, driving major morbidity, recurrent hospitalizations, and steep costs. While we already know that inotropes can stabilize HF patients, they don’t change disease trajectory and their long-term use carries its own risks. Read the latest Cardiac Wire exclusive to learn why Abbott’s HeartMate 3 LVAD is a better option for advanced HF patients, leading to real-world survival rates of ~85.7% at 1 year and ~59.7% at 5 years, alongside improved quality of life and fewer adverse events.
  • New Calcium Score Predicts Adverse Events: Researchers have developed a new scoring system to predict major adverse cardiovascular events, based on CT-derived calcium measurements. In a study of 313 patients, their New Total Calcium score – which included calcium data from other areas of the heart besides the coronary arteries – predicted MACE in patients getting aortic valve replacement with good AUC values at various time points: one year (0.91), two years (0.80), and three years (0.81). NTC could help identify high-risk patients getting valve repair.
  • CBD for Lowering LDL-C: Bringing us closer to medical cannabis in cardiology, CannaLean Biotechs completed a first-in-human feasibility study of its compound, CLC-01, an oral cannabidiol-chitosan formulation for dyslipidemia in adults with elevated LDL-C. The company reported the drug was well tolerated with no serious adverse events and only mild, transient events, alongside a continued LDL-C decrease over 12 weeks and follow-up, with mean LDL down ~28% by study end versus control. CannaLean plans larger controlled trials to further explore the benefits of lowering LDL-C using CBD.
  • CVD Mortality Post-COVID: The AHA’s latest statistical update suggests that U.S. cardiovascular death rates are returning to pre-pandemic levels, with CVD remaining the number one cause of death. The update saw age-adjusted CVD mortality dip to 218.3 per 100,000 in 2023 (down from 224.3 in 2022). Coronary heart disease and stroke deaths declined slightly, and stroke now ranks #4 among leading causes of death as COVID falls out of the top five.
  • Birth BP Predicts Childhood Hypertension: BP monitoring at birth might be worthwhile for keeping an eye on a child’s health. In the ENVIRONAGE study of 500 Belgian children, BP was measured at birth, ages 4–6, and ages 9–11. Higher early-life BP led to a greater risk of hypertension later in childhood. Each standard deviation increase in initial mean arterial pressure was associated with an increased risk of elevated BP (HR: 2.84) and hypertension (HR: 3.75), supporting earlier BP monitoring starting at birth.
  • LXR Inverse Agonist For Lowering Triglycerides: Researchers developed TLC-2716, an oral LXR inverse agonist that acts on the gut and liver to avoid side effects while reducing triglyceride-rich lipoproteins. The team tested TLC-2716 in human liver models replicating steatohepatitis, and found that the compound reduced lipid accumulation and suppressed inflammatory and fibrotic gene expression. After 14 days of treatment in a Phase 1 trial, the compound was well tolerated and produced placebo-adjusted reductions up to 38.5% in plasma triglycerides and 61% in postprandial remnant cholesterol.
  • FillPoint Expands US Heart & Vascular Partnership: FillPoint Health announced an expanded strategic partnership with US Heart & Vascular to increase its specialty cardiovascular therapy offerings, with a focus on advanced heart failure, edema-related conditions, and rare cardiomyopathies. The collaboration will combine FillPoint’s specialty pharmacy services and MSO infrastructure with USHV’s national clinic network to provide better therapy access, monitoring, and delivery for complex patients.
  • Kardium’s PULSAR Trial for Paroxysmal AFib: Continuing the success story of its unique spherical PFA catheter, Kardium published strong results from its PULSAR trial in JACC. The study found that Kardium’s Globe Pulsed Field System achieved consistent pulmonary vein isolation in 95% of veins with a single application and reported a 0% device-related primary safety event rate. At the study’s 12 month follow-up, 78% of patients were free from atrial arrhythmias at 12 months, falling in line with the current 78%-88% average seen in other PFA studies.
  • Bayer and Vanderbilt’s Drug Collaboration: Bayer and Vanderbilt University Medical Center signed a five-year agreement to advance new therapies from target identification through IND filing, initially focusing on cardiovascular and kidney diseases. The partnership will pair Bayer’s drug discovery and translational capabilities with VUMC’s BioVU DNA, plasma resources, and clinical data to accelerate development across Bayer’s broader pharma pipeline. The focus on CVD and kidney disease comes naturally for Bayer following the success of their Kerendia (finerenone) pipeline for HF and CKD.
  • Medtronic’s Affera Sphere-360 Hits Two Milestones: Adding a PFA player in Europe, Medtronic announced CE Mark approval alongside the first U.S. cases for its Affera Sphere-360 navigation, mapping, and single-shot PFA catheter. The 34 mm catheter works as a shape-changing lattice that can access circumferential pulmonary vein lesions without catheter rotation, aiming to simplify workflow and improve consistency across different anatomies. Sphere-360 is now commercial in Europe and investigational in the U.S.
  • Operator Volume Matters for TAVR: A fresh look at STS/ACC TVT registry data suggests that the more TAVRs a hospital performs, the better the outcomes, despite maturation of the field. Per the registry, low-volume TAVR operators had higher risks of in-hospital complications and higher 30-day mortality than high-volume operators, alongside more sedation, longer cases, more contrast, higher residual gradients, and paravalvular leak. For M-TEER, 30-day mortality didn’t differ by volume, but in-hospital complications were worse with low-volume operators.

Tempus Receives FDA 510(k) Clearance for Tempus ECG-Low EF

Tempus announces the expansion of its Tempus ECG-AI portfolio with Tempus ECG-Low EF, software intended for use to analyze 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%) in patients 40 years of age or older at risk of heart failure. It is not intended as a stand-alone diagnostic and positive results may suggest the need for further clinical evaluation. For Full Indications for Use, visit here.

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Circle CVI’s CAD-RADS Rundown

Ever wondered how CAD-RADS enhances the communication of coronary artery disease findings from imaging studies? Check out this guide from Circle Cardiovascular Imaging about the evolution of CAD-RADS and how to incorporate it into your practice.

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The Resource Wire

  • What Every Cardiologist Needs to Watch for in Heart Failure: Patients with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF) face a high risk of hospitalization for heart failure and cardiovascular death, even with guideline-directed medical treatment. Hear from Bayer’s Dr. Alanna Morris-Simon as she shares common heart failure signs to look out for.
  • 9 Merge Cardio Features to Change Your Cardiology Workflows: Having the right tools is essential for efficient cardiology imaging workflows and delivering exceptional patient care. Read this article on how Merge Cardio can make the biggest difference to your imaging workflows, care team user experiences, and patient care delivery.
  • How Us2.ai Improves CA Screening: Cardiac amyloidosis may not be as rare as previously thought, with early and accurate detection becoming increasingly critical for treatment. Read about how the AI-SCREEN-CA study implemented Us2.ai’s automated CA reporting and AI-based pattern recognition analysis, leading to better disease screening at scale.
  • Personalized Plaque Analysis Now With Medicare Coverage: Heartflow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.
  • Explore Vitrea Advanced Visualization: Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow.

The Industry Wire

  1. House passes healthcare package, Senate votes this week.
  2. Insurance CEOs’ no good, very bad day on the Hill.
  3. Epic fights back against Texas AG lawsuit.
  4. Number of new drug shortages in U.S. hits lowest level in 20 years.
  5. Health systems in limbo over H-1B visa uncertainty.
  6. Three big questions about Trump’s healthcare policy plan.
  7. Nvidia CEO to Lilly CEO: You were running around the forest.
  8. How North Carolina erased medical debt for 2.5M people.
  9. Walmart plans clinical research sites at former healthcare centers.
  10. Ten hospitals with the shortest ED visit times.