Dr. John Rumberger why he decided to use FFRCT for stenosis assessments, rather than sending patients directly to the cath lab.

Over the last five years FFRCT has quickly become one of the most-used AI applications across healthcare, making a major impact on stenosis diagnosis and angiography caseloads. Still many cardiologists are just now mapping out their own FFRCT adoption.

See how one cardiologist made the move to FFRCT and how it impacted his practice in this Cardiac Wire show interview with Corazon Imaging’s John A Rumberger, PhD, MD, FACC, MSCCT.

Surgeries & Interventions

Boston Scientific AGENT Drug-Coated Balloon Lands Long-Awaited FDA Approval

The United States has been way behind other nations in using drug-coated balloons (DCB) to treat coronary in-stent restenosis (ISR), but that’s about to change thanks to the FDA approval of Boston Scientific’s AGENT Drug-Coated Balloon. 

• Boston Scientific’s AGENT DCB is a paclitaxel-coated balloon catheter, designed to re-open ISR vessels and then transfer the drug to the vessel wall to help prevent ISR reoccurrence (which happens w/ 10% of PCIs).
• AGENT DCB already has regulatory approval in Europe, Latin America, and Asia, already treating 100k global patients before its US launch in the coming months.
• The AGENT DCB is widely supported for its ability to address an unmet need for US cardiologists and patients, who have been limited to less-effective ISR treatments like repeat balloon angioplasty or additional stent layers.

Boston Scientific’s AGENT DCB FDA approval stands on the shoulders of its stellar AGENT IDE Trial results, which were met with applause at TCT 2023 after showing perhaps the strongest evidence yet that DCBs are safe, effective, and superior to balloon angioplasty. 

The study included 480 patients with ISR, finding that after one year the AGENT DCB was far superior to balloon angioplasty for…

• Target lesion failure (17.9% vs. 28.7%, the primary endpoint)
• Target lesion revascularization (12.4% vs. 24.0%) 
• Target vessel myocardial infarction (6.4% vs 12.3%)
• Stent thrombosis (0.0% vs. 3.9%)

This data and the AGENT DCB’s long-awaited FDA approval earned praise from interventional cardiologists and the investment community (not to mention Boston Scientific), with most believing that the DCB could gain much quicker and stronger adoption than many new therapies.

• It also turned attention to AGENT DCB’s potential to expand beyond ISR treatment, including bifurcation lesions, ACS, diffuse LAD disease, and small vessels.

The Takeaway
Except for the fact that the AGENT DCB’s FDA approval came 10 whole years after its EU CE Mark, it launches in the US in an ideal situation, noting that it should see strong clinical demand (again, ISR happens in 10% of all PCIs) and it’s supported by solid research and clinical evidence.

Automatic, Precise Analysis – From the First Beat

Monebo’s Kinetic ECG Algorithm leads with its versatility, precision, and efficiency, enabling a long list of use cases. See how it might impact your ECG monitoring clients here.

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

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)

The Wire

• Pot Smoking’s CV Risks: Survey results from 434k US adults warned of cannabis smoking’s cardiovascular risks, while suggesting that patients should be screened for cannabis use. Overall, daily cannabis use put people at higher risk for CHD (+16%), MI (+25%), stroke (+42%), and a composite of these conditions (+28%). Risks were even more pronounced in respondents who had never smoked tobacco, as their daily cannabis use came with far higher risks for MI (+49%), stroke (+116%), and the CV composite (+77%). 

• Biosense Webster’s PFA CE Mark: Biosense Webster’s high-priority Varipulse pulsed field ablation system landed European CE Mark approval last week for the treatment of symptomatic drug refractory recurrent paroxysmal AFib. Varipulse’s EU CE Mark comes two months after its approval in Japan, and is supported by Biosense Webster’s recent inspIRE study, in which 75.6% of patients saw no atrial arrhythmia recurrence after 12 months. Long viewed as a future ablation technology, PFA is now gaining momentum, including recent FDA approvals from Medtronic and Boston Scientific.

• ECGs for Low-Risk Folks: A Korean health study supports the use of ECGs to identify potentially deadly abnormalities in people who otherwise have low cardiovascular risks. Among 660k low-risk people who had annual check-ups, the rates of all-cause mortality and CV mortality were 1.1% and 0.18% over 8.8 years. However, people with major ECG abnormalities had far higher rates of all-cause mortality (+11%) and CV mortality (+92%) compared to those with no ECG abnormalities.

• Machine Learning’s HF Predictions: Using medical records from 2,488 people hospitalized for heart failure, an Iranian team was able to create 10 machine learning models that predicted HF outcomes with different levels of accuracy. The best ML algorithm still had relatively modest performance for hospital readmission, one month mortality, and one year mortality (AUCs: 0.74, 0.61, 0.88), while the most important predictive factors were hospital length of stay, hemoglobin level, and family history. 

• Aidoc & ACC’s CAC Alliance: Aidoc and the American College of Cardiology announced a partnership focused on Aidoc’s incidental coronary artery calcification solution, which analyzes unrelated CTs (e.g. following an accident) to identify patients with high CAC scores and coordinate follow-up care. The partnership will focus on: 1) Refining Aidoc’s CAC solution to ensure coordination with clinical teams, 2) Integration of ACC guidelines, which will serve as the foundation for developing upstream workflows, 3) Promoting health equity by expanding CAC scoring to patients who are unlikely to be screened.

• SELECTing More Patients for GLP-1s: A study from the Western Denmark Heart Registry found that one in three patients who experienced a first-time heart attack met criteria similar to patients in the SELECT trial, which demonstrated that the GLP-1 semaglutide reduced MACE rates by 20%. Based on the Danish registry’s 10.7% MACE risk over five years, semaglutide might have prevented one major cardiac event for every 49 people in the registry.

• CW’s ViVE 2024 Takeaways: Cardiac Wire made a visit to ViVE 2024 last week, finding that the event had plenty of cardiology-related conversations, but few dedicated cardiovascular companies or solutions. The exhibit hall featured a handful of imaging companies with a solid cardiology focus (Aidoc, GE, Canon), and a pair of pure digital health companies focused on remote patient monitoring and chronic care management (Rimidi) and preventive cardiovascular management (HelloHeart). That said, broader innovations presented at ViVE may prove to have a massive impact on all specialties, including cardiology. 

• ECG AI Predict SCD: A new AI-driven ECG model outshined traditional methods for identifying individuals at high risk of sudden cardiac death (SCD). When tested against an external ECG dataset, the model surpassed conventional ECG risk scores (AUCs: 0.820 vs. 0.743), potentially making it the first AI model to outperform traditional methods of predicting out-of-hospital SCD at the community level. 

• Helping ADHF Patients Out of the ReD: A new JACC study detailed how a wearable vest that quantifies lung fluid helped guide heart failure decongestion strategies, and significantly reduced 30-day HF readmissions. In a proof-of-concept trial, a mere 2% of patients wearing the remote dielectric sensing (ReDS) system experienced post-discharge HF complications (unplanned visits, hospitalization, or death) compared to 20% of patients who received routine care.

• Powerful ECG AI Funding: Slovakia-based ECG AI startup, Powerful Medical, scored a €2.5M grant and a €5M follow-on investment from the European Innovation Council (EIC) to support its clinical validation and commercialization efforts. Powerful Medical’s flagship ECG interpretation platform, PMcardi, uses AI and 12-lead ECG data to detect acute heart attack and 38 other cardiac abnormalities “at the first point of contact.” 

• Bad Hearts Fail Kidneys: New data shows that HF patients experience significantly greater declines in eGFR rates—a marker used to assess kidney function—compared to the general population. Tracking 2,672 HF patients over 15 years, eGFR rates fell by -1.70 mL/min/1.73 m² per year, surpassing the normal age-related decline of -1 mL/min/1.73 m². Factors like age, diabetes, and hospitalizations influenced the drop, correlating with heightened all-cause and cardiovascular mortality.

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!

Better Cardiovascular Care, With a Better Bottom Line

Twenty million chest CTs are acquired in the U.S. each year, but CAC is typically unreported. See how you can leverage Bunkerhill Health’s Incidental CAC algorithm to screen for incidental coronary calcium on routine chest CTs in real-time, improving care and your bottom line.

The Resource Wire

• PIA’s Post-Processing Solution: Advanced cardiac imaging often calls for a time-consuming post-processing step, requiring costly software, hardware, and training. See how PIA provides this post-processing at lower cost, improved consistency, and greater efficiency. 

• Explore the Potential of Cardio AI: Explore the potential of AI-powered cardiology solutions in this on-demand TeraRecon webinar, detailing how its Cardio Suite solutions help expedite disease diagnosis, care coordination, and provide the data to support cardiac treatment decisions.

• 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 here.

• 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!

• Can AI Improve How We Prevent Heart Disease Progression? Tune in to Cleerly’s upcoming webinar (March 19, 2pm ET) where study leaders will discuss how the landmark TRANSFORM randomized controlled trial will test whether an AI-personalized care strategy can outperform traditional risk factor management and prevent cardiovascular events.