AccurKardia COO Mohamed Sadeq Ali, on why AI adoption will become imperative for healthcare providers.

In the latest Cardiac Wire Q&A, we sat down with AccurKardia CEO Juan C Jimenez and COO Mohamed Sadeq Ali to discuss ECG automation’s massive potential to improve clinical efficiency and care outcomes. Check out our discussion here.

Surgeries & Interventions

Medtronic and J&J’s LAA Expansions

The left atrial appendage device space became far more competitive last week, following the launch of Medtronic’s Penditure LAA exclusion system and Johnson & Johnson MedTech’s acquisition of LAAX device company Laminar.

Medtronic made waves across the LAA closure segment, announcing the FDA approval and limited commercial launch of its Penditure LAA exclusion system.

• The Penditure system features a curved implantable clip that comes pre-loaded on a single-use delivery system
• It’s deployed during concomitant cardiac surgery procedures (vs. dedicated LAA interventions), and has the unique ability to be recaptured, repositioned, and redeployed

We usually have far earlier warning before Medtronic enters a completely new cardiac device segment, but that’s because it just acquired the Penditure system from medical device incubator Syntheon in August 2023.

Johnson & Johnson MedTech further expanded into the LAA space with its acquisition of left atrial appendage elimination (LAAX) device company Laminar for $400M, plus potential milestone payments. 

• Laminar will become part of J&J’s Biosense Webster business, which already has a strong presence in EP ablation and intracardiac echo
• The Laminar LAAX device recently scored an FDA approval for its U.S. pivotal study, which will begin enrollment in early 2024
• Although not mentioned in the announcement, J&J also acquired Coherex Medical’s LAA system in 2015, which is reportedly still in development

If approved, J&J’s investigational Laminar LAAX device would hit the market long after the current LAA device players, although J&J seems to be optimistic about the Laminar system’s unique use of rotational motion to eliminate the LAA (vs. using plugs to occlude the LAA). 

Medtronic and J&J would enter a competitive LAA closure segment that’s led by Boston Scientific, and also includes Abbott and AtriClip. It’s also likely large enough (estimated $1.4B to $2.2B) and growing fast enough (BSCI predicts 4x growth through 2030) to support more competitors.

• That said, AtriCure’s stock dipped 20% last week following Medtronic’s Penditure launch, in part because the two devices are both deployed during other cardiac procedures.

The Takeaway

Given that 38 million people worldwide are living with AFib, and roughly 40% of them can’t take blood thinners over long periods, there’s plenty of room for innovative new LAA devices. 
Although the Penditure and Laminar systems are still largely unproven, the fact that they are both offered by medtech powerhouses and come equipped with unique new capabilities could make them well positioned among the next phase of LAA systems.

Start Measuring What Matters

Looking to optimize your cardiovascular imaging services, but don’t know what to measure? Check out this Change Healthcare report for insights on how to track and evaluate your cardiovascular imaging performance, assess quality, and enhance operational efficiency. Read the full article now and start measuring what matters!

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.

The Wire

• New AFib Guidelines: The new ACC/AHA AFib guidelines, co-published in JACC and Circulation, emphasize prevention for at-risk people and modifying lifestyle factors for people with the disease (e.g. weight loss, physical activity, and alcohol moderation). The new guidelines also give a Class 1 indication for catheter ablation as a first-line therapy in AFib patients with HFrEF, and upgrade the recommendation for left atrial appendage occlusion devices to Class 2a for patients who can’t take anticoagulants.

• Twin Study Shows Vegan CV Benefits: A Stanford Medicine-led identical twin trial provided solid evidence that a vegan diet improves overall cardiovascular health. The researchers randomized 22 pairs of identical twins to follow vegan or a healthy omnivorous diet for eight weeks (1 twin per diet), finding that the vegan group had far greater average decreases in LDL-C (−13.9 mg/dL), fasting insulin level (−2.9 μIU/mL), and body weight (−1.9 kg) compared to the omnivore twins.

• Avidity & BMS’ CV Alliance: Avidity Biosciences announced a global licensing and research collaboration with Bristol Myers Squibb, covering up to five cardiovascular targets using Avidity’s AOC platform technology. The deal gives Avidity $100M up front, plus up to $2.2B in milestone payments and low double-digit royalties. Antibody Oligonucleotide Conjugates (AOCs) are a new class of RNA therapeutics that are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to target the root cause of diseases. 

• Appendage Closure = Milder Strokes: A retrospective JACC study found that ischemic strokes were less severe among AFib patients who underwent left atrial appendage closure versus those taking direct oral anticoagulants. In the study of 447 patients, strokes were less frequently disabling or fatal among LAAC patients at the time of hospital discharge (38.3% vs. 70.3%) and three months later (33.3% vs 56.2%).

• High LDL-C and Mortality: A study of a large and ethnically diverse US cohort treated from 2010–2020 added more evidence of severe hypercholesterolemia’s link to higher all-cause mortality. Among 18.7k patients with LDL-C ≥190 mg/dL, a 20–mg/dL increase in LDL-C and triglyceride levels was associated with increased nine-year all-cause mortality risk (adjusted HRs: 1.08 & 1.04). Mortality risks among severe hypercholesterolemia patients were far higher if they also had high BMI, hypertension, or diabetes.

• Cardiology @ RSNA23: Last week’s RSNA 2023 conference welcomed ~34k imaging professionals to the Windy City, revealing a number of cardiovascular-targeted trends within this very radiologist-targeted conference. Although informatics players have been expanding into cardiology for years, RSNA brought significantly more focus on cardiology thanks to Visage Imaging and Terarecon. Meanwhile, the major CT scanner companies arguably placed more focus on cardiac CT than any other exams, and the AI companies continued to expand their cardiac imaging AI portfolios.

• Neuroses and AFib Risks: Analysis of UK Biobank data concluded that mental health population screening could help identify people with greater AFib risks. In the study of almost 395k people, those with higher neuroticism scores were more likely to develop AFib within 10 years (HR: 1.05). Although linking these conditions has historically been controversial, the study found that the relationship between neuroticism and AF is both “longitudinal and causal.” 

• Intravascular Imaging’s PCI Advantage: A new meta-analysis found that intravascular imaging-guided PCI brings better outcomes than the current standard, angiography. In the study of 32 randomized controlled trials and 22,684 patients, intravascular imaging-guided PCI was associated with significantly reduced risks for MACE (-28%, the primary endpoint), as well as CV death (-44%), stent thrombosis (-52%), and target lesion revascularization (-25%) compared to angiography. Functionally-guided PCI (e.g., FFR and iFR), also outperformed angiography, with 19% lower MACE risk.

• Arineta DLIR Gets FDA Nod: Cardiac CT developer Arineta Cardio Imaging received FDA 510(k) clearance for a new deep learning imaging reconstruction (DLIR) protocol for its SpotLight family of in-office cardiac CT scanners. Arineta’s DLIR solution uses deep learning to process images, improving image quality and reducing noise. 

• Text Restores CIED Connections: Remote monitoring of cardiac implantable electronic devices is convenient, but they sometimes lose their connection to CIED manufacturers’ centralized servers. When that happens, it appears that text messages are more effective than standard-of-care phone calls for contacting patients and getting their implants back online. In a Cardiovascular Digital Health Journal study of 6,085 patients at 20 medical centers, the reconnection time with SMS messages (via the Implicity platform) was 43% lower than with phone calls (11 vs. 6.3 days).

• Waning Trust in Science: A Pew Research survey of 8,842 American adults found that 27% have little to no confidence in scientists to act in the public’s best interests, a wild spike compared to the 12% who said the same in 2020. Some other disheartening stats from the survey include the fact that only 57% of Americans believe science has had a mostly positive effect on society, down 16% from pre-COVID responses. Despite the waning confidence, trust in scientists still outranks business leaders and elected officials.

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 Benefits of Outsourced Post-Processing

Using an outsourced cardiac image post-processing solution doesn’t have to mean sacrificing control of the results. Discover how PIA’s customizable post-processing workflow can help you get the most out of your images.

The Resource Wire

• 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!

• From CPACS to CVIS: Cardiovascular imaging has come a long way from CPACS. Explore the evolution of cardiology image and data management in this Merge by Merative executive brief, and see what makes CVIS such a significant advancement.

• HeartFlow’s FFRCT’s Nationwide Improvements: What happens when HeartFlow’s FFRCT Analysis is adopted nationwide? See how the NHS’ nationwide implementation of HeartFlow’s FFRCT solution led to significant reductions in cardiovascular and all-cause mortality, plus solid efficiency gains. 

• How to Identify and Treat More CVD Patients: Do you know how many patients with high CVD risks are in your chest CT archive? See how the Stanford Health Care System used Bunkerhill Health’s Incidental CAC algorithm to screen its previous non-gated chest CTs, identify patients with coronary calcium, and get them on statins.

• Accurately Measuring Heart Rate Variability: Heart rate variability measurement and analysis involves two critical elements – the ability to accurately discern the R wave in noisy environments, and using the correct analysis method for a given application. Check out how Monebo’s Kinetic HRV ECG Algorithm excels at both of these essential tasks.