Michael Albert, MD after SURMOUNT-4 trial analysis revealed that patients on Eli Lilly’s tirzepatide regained roughly half the weight they lost a year after ending the treatment.

Welcome to the last Cardiac Wire of 2023, as we’ll be taking a break for the holidays! Thank you to all of our readers and sponsors who make this newsletter possible, and keep an eye out for our next issue on January 4th.

Electrophysiology

Medtronic’s PulseSelect Becomes First FDA-Approved PFA System

The AFib pulsed field ablation treatment era officially began in the US last week, following the FDA approval of Medtronic’s PulseSelect Pulsed Field Ablation System for the treatment of both paroxysmal and persistent atrial fibrillation. 

• PFA systems use electroporation (short electrical pulses) to achieve pulmonary vein isolation.
• PFA is seen as safer and faster than current thermal ablation techniques, reducing damage to surrounding tissues and improving procedural efficiency.
• The PulseSelect gained CE Mark approval in November, and will launch commercially in early 2024.

Medtronic was understandably celebratory in its PulseSelect lunch announcement, highlighting how it sets “a new standard in safety for AF ablation with excellent efficacy and efficiency.”

• To back those statements up, Medtronic reminded us that the PulseSelect had a 0.7% safety event rate and 80% clinical success rate in the PULSED AF study.
• At 1 year, the PulseSelect PFA was also clinically effective among 66.2% of patients with paroxysmal AF and 55.1% of patients with persistent AF (both above the 50% target).

Medtronic also emphasized the PulseSelect’s role in the company’s overall AFib ablation lineup, which includes its current cryoablation portfolio, and its PulseSelect-compatible Affera mapping system (currently CE Marked).

The PulseSelect might be the US’ first PFA system, but more are likely on the way, including later-stage systems from Boston Scientific (CE Marked, FDA expected in 2024) and ablation giant Biosense Webster. Abbott meanwhile has an earlier-stage system, but is taking a “wait-and-see” approach to the PFA segment.

The Takeaway
The pulsed field ablation era is now upon us, and although not everyone is convinced it will be a game-changer, many believe it could have a major impact on how AFib ablations are performed. If that proves true, it would also have a major impact on the $7B-$9B AFib ablation segment, while likely benefiting the PFA first-movers like Medtronic.

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.

Unify Your Cardiovascular Data

In this era of interoperability, it’s time to focus on cardiology. See how Change Healthcare’s enterprise cardiology platform provides a single database for CPACS, Hemo, CVIS, and ECGM — helping to improve data access and integrity while simplifying your IT configuration.

The Wire

• Cholesterol Vaccine: University of New Mexico researchers published study results for a cholesterol-lowering PCSK9 vaccine that they say could be administered once a year for less than $100 a dose. The virus-like particle bivalent vaccine displays two PCSK9-derived peptides that stimulate the immune response against PCSK9, reducing cholesterol levels by up to 30% in mice and monkeys. The UNM researchers are now seeking funding for human trials. 

• Esperion Label Expansions: The FDA had an early Christmas gift for Esperion, expanding label indications for Esperion’s LDL-lowering drugs Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe). The agency added primary hyperlipidemia as a Nexletol/Nexlizet qualifier for existing approved populations and removed the requirement that patients already had to be on the maximum tolerated statins. The FDA also removed the statement clarifying that Nexletol/Nexlizet’s effect “on cardiovascular morbidity and mortality has not been determined.”

• AI-ECG for STEMI Detection: An AI-ECG model outperformed conventional STEMI criteria for spotting patients who need immediate revascularization due to occluded coronary arteries. Dubbed ‘Queen of Hearts,’ the AI-ECG scored an AUC of 0.938, surpassing STEMI criteria’s 0.651 AUC, and aligning closely with expert ECG readers’ performance in an analysis of 3,254 ECGs. The model, accessible via a smartphone app, can potentially revolutionize ACS triage and expedite revascularization efforts for those in need.

• Holiday Heart Attacks: The AHA urged the public to be aware of “holiday heart attacks,” citing multiple studies that have shown that more people die from heart attacks during the last week of December than at any other time of the year (especially on December 25th). We don’t know exactly what triggers holiday heart attacks, although experts believe it’s due to a combination of factors, including winter weather restricting blood flow, added stress, and holiday party overindulgences.

• Improving NSTE-ACS Triage: A BMJ study found that assigning preHEART risk scores to patients with suspected NSTE-ACS, and directing them to PCI as quickly as needed, is both effective and economical. In the study of 1,069 patients, triaged patients had shorter times from first medical contact to final diagnostics or revascularization (20 vs. 42 hours) and shorter hospital stays (2 vs. 3 days) compared to standard care. Their ICA and revascularization costs were also lower (€4,899 vs. €5,599).

• Top 8 Hospital-at-Home Programs: Becker’s published a behind-the-scenes look at the country’s top eight hospital-at-home programs by average daily patient volume. The program administrators at each system share quick samples of their secret sauce, as well as lessons learned while spinning up their home care units. The largest operations currently range from NC-based Atrium Health with 45 patients/day, to MO-based Saint Luke’s with 10 patients/day.

• Early Ablation for Early AFib: Earlier ablation might mean better cardiovascular outcomes in patients with early onset AFib. That’s from a Chinese registry study of 1,694 under-45yr patients with AFib, that found longer diagnosis-to ablation (DAT) times were associated with more cardiovascular events (DAT ≤ 1 year: 6.1/100 person-years; DAT ≤ 3 years: 7.9/100 person-years). The risk for CV events was 36% lower for those with DATs of less than one year compared with over six years.

• HHS AI Transparency Rule: AI transparency is once again in the headlines with HHS’ publication of a final rule that among other issues sets transparency requirements for predictive AI algorithms used in healthcare. The rule aims to make it possible for clinicians to access a consistent, baseline set of information about AI algorithms. The final rule also includes provisions on data interoperability and information blocking requirements. 

• Post-Tirzepatide Weight Gains: Data from the SURMOUNT-4 trial revealed that patients on Eli Lilly’s Zepbound (tirzepatide) regained roughly half the weight they had lost a year after ending the treatment. Over the 88-week study period, patients who stopped Zepbound after 36 weeks regained 14.8% of the weight they had initially lost but still ended with 9.9% less weight overall. Despite the perceived setback, some suggest that these findings underscore the need to view obesity as a chronic disease. 

• Predicting AF with Single-Lead ECG AI: Scripps Research scientists developed a deep learning model for predicting AF risk based on non-AF ECG signals. Analyzing almost 460k single-lead ECG recordings, the model achieved an AUC of 0.80 for AF prediction over a two-week period, significantly improving discrimination compared to using demographic metrics alone (AUC=0.67). The findings suggest that this could be a promising digital approach for identifying individuals with paroxysmal AF.

• US Health Spending Growth Eases: Is the US getting a handle on healthcare spending? In new CMS data, US national health expenditures grew 4.1% in 2022 to $4.5T. That’s a lot of money, but it’s down slightly compared to the 4.4% growth rate from 2016-2019, and it brings down healthcare’s share of US GDP versus 2021 (17.3% vs. 18.2%). Despite the slowed growth, US health spending is expected to grow 5.4% annually from 2022-2031.

Making the Leap to Outsource Post-Processing

Interested in how to outsource cardiac image post-processing, but not sure where to start? PIA walks you through how to assess and compare vendors, understand pricing models and payment options, and outline your requirements to identify vendors who meet your clinical needs. 

Clearly Transforming Cardiovascular Event Prevention

There’s been plenty of studies evaluating healthcare AI accuracy, but does AI improve patient care? Check out this Cardiac Wire show with Udo Hoffmann, MD, MPH and learn how Cleerly’s new TRANSFORM trial could prove that AI-guided cardiovascular care reduces heart attacks.

The Resource Wire

• AHA Honors Stanford & Bunkerhill’s Incidental CAC Paper: Stanford University’s paper exploring how Bunkerhill’s incidental CAC algorithm increased statin use won the American Heart Association’s 2023 Willerson Award for the best clinical paper published in Circulation this year. See how Bunkerhill’s incidental CAC impacted patient care here.

• ECG Data You Can Trust: Noise and artifacts can make automated ECG analysis less reliable than what’s required for the exacting standards of cardiac safety trials. Monebo’s Kinetic Intervals ECG Algorithm provides precise interval measurements between any two points on the ECG waveform, allowing clinicians to utilize data they can trust.

• 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!

• A Solution for Your Entire Cardiology Service Line: The pace of change in healthcare can be dizzying, creating new and more complex challenges for cardiology departments to overcome. See how Merge Cardio and Merge Hemo can turn those challenges into opportunities for greater workflow efficiency and improved care.

• The First Step to Coronary Artery Disease Diagnosis: HeartFlow’s new RoadMap Analysis solution allows CT readers to accurately, efficiently, and consistently identify stenoses in the coronary arteries. See how RoadMap Analysis’ visual and quantitative insights into the narrowing of all major coronary arteries helps readers evaluate coronary CT angiograms before determining the need for an FFRCT.