University of New Mexico interventional cardiologist, James Blankenship, MD, after voting in favor of the Abbott TriClip TEER device, in part because of its quality of life benefits.

Surgeries & Interventions

FDA Panel Strongly Supports Abbott TriClip TEER

The FDA expert advisory panel votes are in, and they’re pointing in an overwhelmingly positive direction for Abbott’s TriClip tricuspid edge-to-edge repair (TEER) treatment.

• The TriClip G4 is intended to treat tricuspid regurgitation by clipping together a portion of a patient’s tricuspid valve leaflets to keep blood from leaking from the right ventricle into the atrium.

The FDA’s Circulatory System Devices expert panel analyzed available TriClip data, voting 13-1 that the device’s benefits outweigh its risks for patients with severe tricuspid regurgitation, including a 12-2 vote supporting its effectiveness and a 14-0 vote for its safety.

Those results might have caught some interventionalists and FDA-watchers off guard, noting that their previously-released source documents seemed to highlight the fact that that TriClip’s pivotal TRILUMINATE study only showed clear benefits for patients’ quality of life, but no benefits for HF hospitalization or mortality, and it was open-label (so prone to placebo effect).

• Those concerns were echoed online after the FDA panel votes became public, with criticisms largely aligning with the concerns in the panel documents (only QoL, placebo effect) and suggesting that the data doesn’t justify a 13-1 vote.

Regardless, the FDA panelists largely supported quality of life as an important TR metric and were impressed with the TriClip’s safety profile, with one panelist explaining that “if we can help symptoms at a low cost in terms of risk, it makes a lot of sense.” 

• The fact that the TriClip has already been approved in over 50 countries and has been used in over 10k patients probably helps too.

The TriClip’s strong panel vote continues a recent hot streak for trancatheter-based TR treatments, coming just a week after the FDA approved Edwards’ EVOQUE transcatheter tricuspid valve replacement system, potentially giving interventionalists the options to repair or replace the tricuspid valve if/when the TriClip is approved.

• That streak started much earlier in Europe, where the TriClip has been approved since 2020, and Edwards already markets its Pascal and Cardioband TR valve repair systems.
• TR’s hot streak could also continue, as the Pascal system is approaching the end of its CLASP II TR pivotal trial, and a range of other TR systems are in development.

The Takeaway

One week ago, the US had no transcatheter TR therapies, and now it appears that we are on the way to having two. Regardless of how you view the panel’s decision making process, this is a big deal for TR treatments, and could lead to big changes for TR patients and their care teams.

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)

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!

Incidental CAC Predicts Long-Term Risks

What if you could identify which of your asymptomatic patients have high risks of future cardiac events? Stanford-led researchers used Bunkerhill Health’s Incidental CAC algorithm to do just that, finding that patients with ≥100 incidental CAC scores had a 24% 10-year risk of developing ASCVD and far higher risks of major adverse events.

The Wire

• CSL’s ApoA-I Misses Phase 3 Mark: In another sign that artificially raising HDL doesn’t reduce major cardiac events, CSL Behring announced that its massive Phase 3 trial evaluating its CSL112 (apolipoprotein A-I) cholesterol efflux enhancer failed to hit its primary endpoint. The AEGIS-II trial gave 18,200 heart attack patients in 49 countries either CSL112 or a placebo, finding that the drug didn’t reduce MACE within 90 days. CSL Behring nixed any short-term plans to seek regulatory filings as it apparently refocuses on its plasma products.

• Us2.ai Slashes Echo Workflows: Researchers using Us2.ai’s automated echo AI software achieved a 70% workflow reduction in a new study published in Journal of Echocardiography. In 23 patients, Japanese researchers significantly reduced average echo measurement (159 vs. 325 seconds) and report creation times (71 vs. 429 seconds) compared to manual methods. The research team said that the echo AI software enhanced clinical workflow by providing “rapid, zero-click” reports, without compromising accuracy.

• Smartphone-Based BP Dose Personalization: In the PERSONAL‐CovidBP trial, a novel smartphone-enabled approach to amlodipine dosing effectively reduced 205 participants’ average BP from 142/87 to 131/81 mmHg. Using Closed Loop Medicine’s dose-personalizing smartphone app, almost 85% of patients achieved BP control on novel doses (1 – 10mg, excluding 5 and 10mg), while adherence to BP monitoring and medication reached 84% and 94%, respectively.

• Canary’s First Cardiac Monitors: Smart orthopedic implant startup Canary Medical took a major step in its expansion to cardiology, completing the first-in-human trial of its Cardiac Auscultation monitoring sensor. Canary’s new cardiac sensor measures acoustic signals to help patients and providers better manage their congestive heart failure, and the two-patient trial successfully demonstrated that the sensor was indeed able to detect mitral regurgitation sound signals.

• PRESERVing Functional Capacity in HFpEF: A post-hoc analysis of the PRESERVE-HR trial found that HFpEF patients who underwent short-term β-blocker treatment withdrawal peaked their heart rates by 30 bpm after 2 weeks. Notably, participants with smaller left ventricular volumes saw a short-term uptick in maximal functional capacity. The results are a step in the right direction for HFpEF treatment, with further studies needed to assess whether increases in heart rates can be a therapeutic measure for HFpEF, chronotropic incompetence, and small LV dimensions.

• CAC Predicts Non-Cardiac Aging: The presence of coronary artery calcium on cardiac CT scans can be used as a broad-based marker for healthy aging that goes beyond just heart health. That’s from a new paper in Atherosclerosis, where researchers studied 2.3k people aged over 75, finding that those with CAC scores ≥1000 had higher rates of non-cardiac pathology compared to those with zero CAC scores, such as dementia (8% vs. 2%), hearing impairment (67% vs. 46%), and composite abnormal aging score (3.7 vs. 2.6).

• AorticLab’s FLOWer CE Mark: AorticLab announced the European CE Mark approval of its FLOWer embolic protection device, which is intended to improve the safety of TAVI/TAVR procedures by protecting patients from cerebral and peripheral embolic injuries. The FLOWer filter is positioned in the aortic arch during TAVR procedures, covering all three branches, and capturing emboli up to 60μm before they can travel to other parts of the body. With its CE Mark complete, AorticLab will now begin its US regulatory process.

• AI Cuts CCTA Radiation Dose: Thanks to AI reconstruction, wide 16cm detectors, and a fast 0.25-second gantry rotation time, researchers from China conducted coronary CT angiography scans of patients with irregular heart rhythms at the same radiation dose as patients with regular heart rhythms. In a paper in Heliyon, the researchers described scanning 427 patients who underwent CCTA with ECG triggering, finding no statistically significant difference in radiation dose between patients (2.7 vs. 2.9 mSv) and similar image quality. 

• Eplontersen Fast Tracked for ATTR-CM: The FDA granted Fast Track designation to Ionis Pharmaceuticals and AstraZeneca’s eplontersen for adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), a progressive and fatal condition that affects hundreds of thousands of people worldwide. Eplontersen recently gained approval for polyneuropathy of hereditary transthyretin-mediated amyloidosis (aka hATTR-PN or ATTRv-PN) that the companies are commercializing as WAINUA, and the new Fast Track designation will facilitate eplontersen’s development and FDA review for ATTR-CM patients.

• BP Variability Predicts CV Outcomes: A new analysis of ASCOT study patients revealed a potential need to monitor visit-to-visit systolic blood pressure variability (BPV). In the study of hospital and mortality records for 8,580 participants with up to 21 years follow-up, visit-to-visit systolic BPV was a strong independent predictor of CV events (HR per 5 mmHg = 1.22), even stronger than mean SBP (HR per 10 mmHg = 1.14).

• Using CoDE(-ACS) to Rule Out Codes: Researchers leveraged a machine learning tool to pinpoint patients with low probability for MI, beating guideline-recommended MI triage pathways. In a Circulation study, the CoDE-ACS clinical decision-making tool identified 56% of patients as low probability, achieving a negative predictive value of 99.7% and sensitivity of 99.0%. The model performed irrespective of the timing of troponin measurement and could potentially reduce unnecessary testing and hospital admissions.

Precision QRS Detection

QRS detection is essential for any ECG algorithm, and Monebo’s Kinetic QRS ECG Algorithm sets the standard for accuracy. Kinetic QRS accurately detects the QRS complex, no matter the amplitude, waveform, or noise levels.

Advancing CAD Risk Assessments

When HeartFlow used its Plaque Analysis solution to analyze more than 11,000 CCTAs in the DECODE Study, the solution achieved 95% agreement with IVUS and led to changes in two out of every three patients’ treatment plans. See how HeartFlow Plaque Analysis can help you accurately assess your patients’ CAD risks and personalize their treatment

The Resource Wire

• Leveraging a Proven Echo AI Platform: Us2.ai has developed a promising new pathway for bringing custom echo AI applications into widespread clinical and commercial use – historically a challenge for algorithms produced by health systems and academic institutions. Find out how it worked in a Ugandan RHD program.

• Overcoming Cardiovascular Data Challenges: Aggregating multisource cardiology data is a worthy mission, but it’s often thwarted by confusion and complexity. This Change Healthcare article with Dr. Jennifer Hall, chief of data science at the American Heart Association, outlines best practices to help you overcome your cardiology data challenges and start leveraging deeper insights.

• The Holy Grail of Prevention: For years, world-renowned prevention expert Dr. Arthur Agatston, author of The South Beach Diet and developer of the “Agatston Score,” had been looking for technology that could accurately identify all types of plaque in the heart. Then, he was introduced to Cleerly. Hear from Dr. Agatston on why he believes “Cleerly really is the holy grail of prevention.”

• Optimizing Your Post-Processing Workflow: The growth of cardiac CT and CMRI volumes and continued shortages in the imaging technologist workforce can mean big challenges for imaging organizations. Join this Cardiac Wire Show starring Precision Image Analysis’ Jim Canfield and Cleveland Clinic’s Scott D. Flamm, MD, MBA to see how outsourcing cardiac image post-processing can solve this problem, while improving efficiency, accuracy, and standardization.

• Where to Go for Cardio AI? TeraRecon’s Cardio Suite is a collection of hand-selected, vendor-neutral Cardiology AI algorithms that aid in the analysis and interpretation of echocardiograms and chest CTs. Learn about TeraRecon’s AI offering and how they improve efficiency and accuracy here.