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Ancora Heart’s TLVR Milestone | Cardiology’s Mainstream Week March 27, 2023
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Together with
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“That’s exactly what Big Coffee wants you to think.”
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One Twitter conspiracy theorist after a NEJM study found that people who drink caffeinated coffee don’t experience more premature atrial contractions.
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Surgeries & Interventions
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New data presented at THT 2023 and published in JCF suggests that Ancora Heart’s investigational AccuCinch Transcatheter Left Ventricular Restoration (TLVR) system improves heart failure patients’ cardiac structure, quality of life, and function.
Ancora Heart’s AccuCinch TLVR is the first completely percutaneous device that reduces the size of the left ventricle, addressing a fundamental issue in systolic heart failure progression. The AccuCinch would be used in patients with severe HF that can no longer be managed by medications and pacemakers, and would otherwise require LVADs or heart transplants.
Twelve month analysis of the study’s 51 HFrEF subjects (LVEF 20-40%, MR ≤2+, 86% male, 56.3yrs avg) who were treated with optimal medical therapy and subsequently underwent AccuCinch TLVR, revealed significant improvements to:
- End-diastolic volume (-33.6 ml), the primary outcome
- LV free wall radius (-29.6% to 9.2 mm)
- Quality of life scores (KCCQ-OS 16.4 pts)
- Six-minute walk test distances (45.9 m)
- NYHA classifications (65% improved ≥ 1, 94% improved or unchanged)
- Ejection fraction (3.1)
Although there were no periprocedural deaths, during the follow-up period one subject died (day 280) and one subject received an LVAD (day 13).
These study results got their share of praise, and should make AccuCinch’s current CORCINCH-HF pivotal RCT trial even higher-stakes, which has the same key inclusion criteria, and would be used to support the TLVR device’s FDA Premarket Approval application.
Takeaway
After 20 years of R&D, this data reinforces TLVR’s potential to expand and improve the treatment options available to heart failure patients. There’s still plenty more work to be done, but Ancora Heart’s catheter-based left ventricle therapy seems to be on the right track.
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HeartFlow Analysis Streamlines Care
Faced with cath lab inefficiencies and an increased reliance on stress testing, Cone Health pursued a more advanced solution. See how the HeartFlow FFRct Analysis allowed Cone Health to improve the patient journey through streamlined CAD testing.
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Monebo’s AF ECG Algorithm
Atrial fibrillation is often difficult to characterize with an automated algorithm due to the changing waveform morphology, system, or muscle noise. This is especially true given the size constraints of ambulatory devices to detect AFib. See how Monebo’s Kinetic AF ECG Algorithm overcomes these size limitations without sacrificing accuracy.
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Revolutionizing Heart Attack Prevention
Cleerly founder and CEO Dr. James Min talks with preventive cardiologist Dr. Erica Jones about Cleerly’s groundbreaking new pathway for heart attack prevention. Watch their conversation to learn about Cleerly’s impact on cardiac health outcomes.
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- Statin Disparities: A JAMA Cardiology study made mainstream news last week for highlighting significant statin disparities among Black and Hispanic US adults. Analysis of 3,417 participants representing 39.4M US adults (2013-2020) found that Blacks and Hispanics were far less likely to use statins than Whites, both overall (20% & 15.4% vs. 27.9%) and among patients with the highest 10-year ASCVD risks (23.8% & 23.9% vs. 37.6%).
- Coffee’s OK: Cardiology’s mainstream news streak continued after an NEJM study found that drinking caffeinated coffee does not produce significantly more premature atrial contractions. The randomized trial monitored 100 adults (38yrs avg age, 51% women) for two weeks, instructing them daily to drink or avoid caffeinated coffee. The participants’ caffeine and caffeine-free days had similar premature atrial contractions (58 vs. 53) and serum glucose levels (95 vs. 86 mg/dL), but caffeine did produce more premature ventricular contractions (154 vs. 102).
- Less isn’t More with AF Ablation: Data from the AWARE trial suggests that double wide-area circumferential ablation (WACA) for patients with paroxysmal atrial fibrillation doesn’t come close to doubling the benefits. The researchers performed single and double WACA on 195 and 203 randomized paroxysmal AF patients, finding similar levels of recurrent atrial arrhythmias at 1 year (26.7% & 24.6%), repeated catheter ablations (10.3% & 7.4%), and serious adverse events (6.7% & 6.9%).
- Predicting ‘Broken Heart’ Effects: A predictive score generated from cardiac MRI could identify which patients with takotsubo syndrome (aka “broken heart syndrome”) will experience major adverse cardiovascular events. German researchers tested a score they called PE2RT in 79 patients, finding that higher scores predicted greater MACE likelihood. The score could offer an easier way to predict the downstream effects of takotsubo syndrome, a form of left ventricular dysfunction occurring in some patients during periods of emotional distress.
- Physician Salaries Down, Cardiologists Up: The latest news on physician salaries is out, and although it’s not pretty overall, cardiology was still near the top and growing. A new Doximity survey (n = 31k docs) found that average physician pay declined by 2.4% in 2022, after increasing by 3.8% in 2021, noting that the overall declines were exacerbated by inflation and poor job satisfaction. Cardiologists were the 8th-highest paid speciality at $544k in 2022, up from $537k in 2021 when it maintained the same number 8 ranking.
- The CAC Debate: The hottest debate on Cardiology Twitter once again focused on CAC Scoring last week, with CAC’s many critics pointing out its lack of RCT evidence and the too-common occurrence of higher-risk patients with zero CAC not getting preventative care (or CAC changing over time). Although the conversation started with a similar focus on increased LDL-C testing, the CAC debaters seemed more focused on what is wrong or right with CAC scoring than the merits of LDL-C screening.
- Cleveland Clinic’s IBM Quantum System One: IBM deployed its Quantum System One at Cleveland Clinic, the first quantum computer dedicated exclusively to healthcare research. The installation is the fruit of a 10-year partnership between Cleveland Clinic and IBM centered around developing quantum computing pipelines to screen drugs targeted at specific proteins, improving prediction models for cardiovascular risk, and searching genome sequencing findings for more effective Alzheimer’s drugs. It looks as futuristic as it sounds.
- Regeneron Evkeeza Extended to 5-11yrs: The FDA approved Regeneron Pharmaceuticals’ Evkeeza (evinacumab-dgnb) for children aged 5 to 11-years with homozygous familial hypercholesterolemia (HoFH), a rare inherited condition characterized by extremely high LDL-C that affects just 1,300 people in the US. Evkeeza was first approved for individuals with HoFH aged 12 and above in February 2021, and both approvals position Evkeeza as an adjunct to other lipid-lowering therapies.
- Patients Want Rapid Test Access: Patients want access to test results quickly, even if it’s before their healthcare provider. In a JAMA Network Open study, researchers from Beth Israel Deaconess Medical Center found that of 8,139 patients who got their results through online portals, 95.7% preferred the portal and only 7.5% were anxious after getting abnormal test results before their provider.
- Could Cath Labs Ditch the Aprons? A new JSCAI study suggests that Image Diagnostics’ novel Protego radiation shielding system could allow cardiac cath lab personnel to ditch lead aprons. In a study of 50 procedures, Protego offered more radiation protection than standard lead aprons and met state rules on radiation protection. Lead aprons can cause musculoskeletal problems over the long term, and have increasingly been retired from regular use in diagnostic suites.
- DOJ Changes Tune on Change Deal: The U.S. Department of Justice dropped its opposition to Change Healthcare’s acquisition by UnitedHealthcare Group and its Optum subsidiary. The DOJ and the states of Minnesota and New York had opposed the deal, but last week they filed a court brief that effectively ends their opposition. Having already completed the acquisition, Change and Optum are now free to continue their integration.
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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.
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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.
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Reducing Variability in Echo Analysis
What if AI could produce echo measurements that are comparable to expert physicians, but with less variability? That’s precisely what this Nature study revealed about Us2.ai’s solution, finding that its measurements had fewer and smaller differences compared to three human experts than when the experts were compared with each other.
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