Attorney General Matthew J. Platkin after busting another cardiologist for fraud.

Discover how AI is transforming heart valve care in an interview featuring Logan Brigman, VP of Cardiology at Tempus, and Dr. Daniel O’Hair, MD, of Boulder Community Health.

Tune-in to the latest Cardiac Wire show to learn how Tempus’ Next Cardiology platform can help physicians close critical gaps in patient care.

Surgeries & Interventions

LimFlow Limits Limb-Threatening Ischemia

Late-breaking second year results from the PROMISE II trial showed that the LimFlow system achieved strong outcomes for avoiding amputations and promoting limb salvage among “no-option” patients with chronic limb-threatening ischemia (CLTI). 

• The LimFlow system consists of several products designed to optimize blood flow in critically ischemic feet by facilitating revascularization.
• LimFlow gained FDA approval in September 2023, and was soon acquired by Inari Medical for up to $415M.

LimFlow remained effective at two years, with a 65% limb salvage rate that was just 4% below the PROMISE II trial’s one year results.

• The treatment also significantly reduced pain in the affected limb, with a mean pain score of 1.2 (scale of 0-10), and 69% of patients pain free at 2 years.

Rates of wound healing also impressed researchers, as 82% of patients’ wounds were completely healed or healing by the second year, despite all participants starting with non-healing foot ulcers or gangrene.

• Ischemia in the treated limb also decreased significantly, with 65.8% in Rutherford class 4 or below and 54.3% in Rutherford class 0 after two years of treatment.

However, LimFlow wasn’t perfect as 35%-40% of patients needed additional interventions in the first year – most commonly transmetatarsal amputation.

• The researchers stressed that LimFlow therapy is for the sickest CLTI patients and don’t recommend it for those with rest pain due to the increased transmetatarsal risk.
• They also clarified that they don’t fully understand how LimFlow reduces patient pain and symptoms.

The Takeaway

Though CLTI remains relatively rare, LimFlow’s promising results in PROMISE II create hope for the sickest of ischemia patients and may eventually lead to improved preventative therapies for more common causes of amputation like diabetes and peripheral vascular disease.

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!

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)

PIA Medical Processes It All

Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.

The Wire

• J&J’s PFA Play: Officially throwing its hat into the PFA ring, Johnson & Johnson MedTech’s VARIPULSE Platform received FDA approval for treating drug-refractory paroxysmal AFib. By combining PFA with J&J’s CARTO 3 mapping system (a market leader), the combo aims to increase ablation accuracy and safety through precise energy delivery and real-time catheter position visualization. VARIPULSE’s approval is supported by the admIRE study, in which 100% of patients achieved acute procedural success, and follows the FDA approvals of Medtronic and Boston Scientific’s PFA systems.

• A Valve Access CAVEAT: Some transcatheter aortic valves in the CAVEAT study didn’t impair subsequent coronary access, while others faced notable challenges. Edwards’ short-frame Sapien valves achieved the highest rates of coronary cannulation (89%) while tall frame valves like Abbott’s Portico, Boston Scientific’s Acurate Neo, and Medtronic’s Evolut Pro had success rates of just 63%, 62%, and 45%. While the older Evolut Pro valve design led to the lowest coronary access rates, Medtronic’s new Evolut FX series valves address this challenge by adding three large access windows.

• iRhythm Resolves Design Issues: iRhythm Technologies is close to resolving its regulatory and manufacturing issues after the FDA granted 510(k) clearance for design and labeling changes to its Zio AT wearable cardiac monitoring system. The FDA issued a warning to iRhythm in 2023 after inspections revealed that it didn’t seek clearance before making changes to the Zio system and marketing it to high-risk patients. Learning from its mistakes, iRhythm has now delayed its FDA submission for the next-generation Zio MCT device until Q3 2025.

• Shockwave’s PAD Potential: Shockwave Medical made a splash with the first clinical outcomes of its Shockwave Javelin Peripheral IVL Catheter for modifying calcium and crossing narrowed vessels in PAD patients. Despite the complex nature of the calcified lesions, the results met both prespecified safety and effectiveness endpoints, with a major adverse event rate of 1.1% at 30 days and a technical acute procedural success rate of 99%. 

• Fraud Costs Cardiologist License: A New Jersey cardiologist has been stripped of his medical license and is facing up to 10 years in prison after submitting $1.9M worth of false claims between 2017 and 2022. The physician’s scheme included submitting claims to at least six payor programs for office visits that either never happened or were shorter than he claimed. One highlight… he billed for 27.9 hours of office visits in a single day. 

• Verve’s Gene Therapy Progress: Moving on from past setbacks, Verve Therapeutics reported updates on its PCSK9 gene therapy and the first dosing of its ANGPTL3 gene inhibitor. Verve succeeded in dosing seven patients with VERVE-102 in its PCSK9 Heart-2 trial with no serious adverse events or abnormalities, showing promise for a second clinical phase. Meanwhile, the first patient in the Pulse-1 trial received VERVE-201, which permanently turned off their ANGPTL3 gene and will be watched closely for reductions in LDL-C and remnant cholesterol.

• Vantis CrossFAST Clearance: Vantis Vascular announced that it received FDA 510(k) clearance for its CrossFAST Integrated Microcatheter Guide Extension System. The CrossFAST helps physicians perform vascular interventions more smoothly by coupling outer and inner extension catheters together, and provides additional support with challenging anatomies. Thanks to $5M in funding raised earlier this year, the CrossFAST will be available in the U.S. in Q4 via limited market release with full release planned for 2025.

• TTVR Transcends Expectations: Promising results from the TRISCEND trial found transcatheter tricuspid valve replacement (TTVR) with Edwards’ EVOQUE valve paired with optimal medical therapy (OMT) resulted in improvements in symptoms, function, and quality of life for patients with severe tricuspid regurgitation. The benefits were clear 30 days after TTVR, continued to increase through six months, and remained after one year with 64.6% of TTVR+OMT patients alive and well (KCCQ-OS ≥60 points) compared to 31% with OMT alone.

• Cardiology Dominates Breakthrough Designations: FDA Data shows that cardiology dominates the Breakthrough Designation program, making up nearly 21% of all devices. With 218 devices designated since the program went live in 2015, cardiology is ahead of neurology (175), orthopedics (137), GI & urology (99), and general & plastic surgery (69), while all other specialities had between 9 and 41 Breakthrough Designated devices. Only 12% of all Breakthrough products have gone on to secure marketing authorization, so designation doesn’t exactly guarantee commercialization.

• LEF ECG-AI’s Outpatient Code: Notching another expansion for cardiology AI reimbursements, Anumana announced that CMS included low ejection fraction ECG-AI solutions in the 2025 Hospital Outpatient Prospective Payment System (OPPS) final rule under assignment APC 5734. This decision allows outpatient settings to receive reimbursements when they use approved LEF ECG-AI algorithms, reducing financial barriers and expanding the tools for identifying LEF in adults at risk for heart failure.

• PAD Patient Opinions: New registry analysis shows that patients weigh the opinions of their family and friends differently (depending on sex and race/ethnicity) when making decisions about peripheral artery disease. While most people said doctors were important in their PAD care decisions, female patients were less likely to rely on their spouse for opinions. Meanwhile, Hispanic and Asian patients were more likely to rely on their family for PAD decision-making.

Reducing ECG Background Noise

Monebo’s Kinitec Rhythms ECG Algorithm separates true ECG signals from background noise, leading to more accurate diagnoses and improved operator efficiency. See for yourself how the algorithm measured up to a gold standard.

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.

Cloud Transition Success Factors

There are multiple pathways to move your enterprise imaging to the cloud, but certain factors will dictate a successful transition. See how a cloud-native platform enables a range of benefits versus other IT-solution approaches in this Optum white paper.

The Resource Wire

• HeartFlow Uncensored: Dr. Drew’s Health Uncensored did a deep dive on the challenges with traditional heart disease testing and the importance of early diagnoses, while highlighting how HeartFlow’s breakthrough non-invasive tech provides patients clarity and confidence in understanding their heart health.

• Discover Innovation in Intervention: Explore how the AGENT™ Drug-Coated Balloon from Boston Scientific is advancing U.S.-based treatment options for patients with coronary artery disease. Rx Only. (Sponsored by Boston Scientific)

• Configure Your PCI Study: See for yourself how cardiac imagers use GE HealthCare’s Centricity Cardio Enterprise Universal Viewer to do their PCI studies, including configurable viewport setup and side-by-side comparisons.

• Identify and Treat Cardiovascular Disease: Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data. 

• A Single Cardiac Service Line Platform: Transitioning across multiple imaging platforms is a daily reality for many cardiologists, but it doesn’t have to be. See how three leading cardiac imagers are leveraging Circle CVI’s unified multi-modal software across their diverse caseloads, without switching to other platforms.

• Innovating AFib Care: The first manifestation of AFib is often stroke, but many hospitals aren’t set up to coordinate these patients’ post-stroke care. See how UCSD is leveraging Viz.ai’s Viz Connect solution to simplify neuro and EP collaboration in this HRX 2024 interview.

• Harnessing the Power of AI to Improve Patient Care: Endeavor Health is one of the first healthcare providers in the Midwest to use AI in the echocardiography lab. Learn how they are harnessing echo AI’s tremendous potential to improve diagnoses in this report from Us2.ai.

• Cleerly 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 Industry Wire

1. Robert F. Kennedy Jr. looks to close “entire” FDA departments.
2. Ambulance hits cyclist, then bills him $2k for ride to hospital.
3. Physicians make up 16 of the 20 top-paying occupations.
4. NH review supports making PAs’ scope of practice equal to NPs.
5. Astrana acquires $745M in assets from LA-based Prospect Health.
6. CDC: one in five adults experience anxiety or depression.
7. Man gets 2 years in prison for accessing Justice Ginsburg’s EHR.
8. Aetna and Optum settling ‘dummy code’ class-action lawsuit.
9. Ex “Sesame Street” exec to lead St. Jude Children’s fundraising marketing.
10. Medicare-focused payors stocks surge after Trump win.