Ryan P. Daly, MD in response to California nurse practitioners’ lawsuit that seeks to allow them to use the term ‘doctor.’

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Digital Health

Astellas Expands into Heart Failure Digital Therapeutics

Astellas Pharma and Eko Health announced an alliance that will combine Eko’s digital stethoscope and CVD detection software with Welldoc’s chronic care management capabilities as the core components of Astellas’ new Z1608 digital therapeutic for heart failure.

The home-based and patient-operated digital therapeutic solution looks to put heart failure patients “at the center of their care,” combining:

• Eko Health’s new CORE 500 smart stethoscope, which provides audio enhancement, AI-based heart disease detection, and 3-lead ECG arrhythmia assessments
• Welldoc’s Chronic Care Management digital therapeutic platform, which analyzes patient data and provides real-time digital coaching
• American Heart Association-provided educational content focused on helping heart failure patients and caregivers develop lifestyle plans

Astellas will next research whether Z1608-based monitoring and coaching improves home HF management and reduces acute decompensation events, using those outcomes to support its FDA clearance and future commercialization efforts.

Some might be surprised by Astellas’ expansion into heart failure DTx given its history as a traditional pharma company and relatively limited role in cardiology (it also produces the Lexiscan SPECT MPI stress agent). 

• However, Astellas is among a growing group of large pharma companies looking to expand into digital health (also: Bayer, Roche, Pfizer, Novartis, BMS) and is positioning what it calls its “Rx+ BUSINESS” as a core part of its corporate strategy.

Expanding to patient homes through virtual care programs is also a logical part of Eko Health’s strategy, in addition expanding its smart stethoscopes and software across traditional healthcare locations and provider roles.

The Takeaway

Astellas and Eko Health’s DTx announcement didn’t generate much press coverage or social media buzz amid yet another busy week in the cardiology and digital health arenas. 

However, the Z1608 might have deserved more attention given that it sits at the epicenter of some of the biggest trends in medicine (home-based care, personalized monitoring, DTx for chronic care, digital pharma) and will be distributed by a $11B healthcare company with thousands of U.S. employees.

Accurate and Efficient Remote Cardiac Patient Monitoring

The expansion of remote cardiac patient monitoring is creating more care opportunities, but also new operational challenges for cardiology teams. Check out this Cardiac Wire Show, where ARTELLA Solutions’ Jacinta Fitzsimons shares how the right combination of technology and service can help physicians get the most out of their cardiac RPM programs – today and into the future.

Creating A Novice Heart Failure Screening Pathway

We hear a lot about AI’s potential to expand echocardiography to far more users and clinical settings, and a study using Us2.ai’s AI-automated echo analysis and reporting solution showed that echo’s AI-driven expansion might go far beyond what many of us had in mind.

The Wire

• Heart Drugs Dominate Medicare Costs: Seven of the top ten prescription drugs in terms of 2021 Medicare Part D costs were either directly or adjacently associated with cardiovascular conditions. Two blood thinners – BMS’s Eliquis (apixaban) and Janssen’s Xarelto (rivaroxaban) – produced the first and third-highest Part D spending ($12.6B & $5.2B), while five diabetes drugs accounted for nearly $18B. Two of those diabetes drugs have particularly close links to CV health, as Ozempic is also marketed as Novo Nordisk’s Wegovy weight loss drug (and is sometimes used off-label) and Jardiance was approved for heart failure late in 2021.

• Farapulse PFA’s AFib Impact: Early data from the EU-PORIA registry highlighted the safety and efficacy of Boston Scientific’s Farapulse PFA ablation system. Among 1,233 AF patients treated at seven high volume centers, 74% were arrhythmia-free after one year, while 3.6% experienced adverse events (45 total, 21 major). The median procedure PFA time was 58 minutes, which the authors described as “short,” and compares well to thermal ablation times.

• Renibus Adds Funding, Advances Towards Phase 3 Trial: Cardio-renal disease biopharma company Renibus Therapeutics completed a $47M Series B round that it will use to advance its drug candidate RBT-1 through a pivotal Phase 3 trial evaluating its ability to improve postoperative outcomes in cardiac surgery patients. RBT-1 (stannic protoporfin/iron sucrose) induces anti-inflammatory, antioxidant, and iron scavenging pathways that act as cytoprotective preconditioning agents. The new funding and upcoming Phase 3 trial follow positive Phase 2 results released earlier this year.

• Opportunistic AI Diabetes Detection: An AI algorithm that analyzes chest X-rays and EHR data may make it possible to “opportunistically” identify patients with undiagnosed type 2 diabetes. Researchers developed the deep learning model using data from 160k patients and then applied it to a test cohort of almost 10k patients (16% w/ T2D), finding that it flagged suspicious type 2 diabetes cases with an 0.84 AUC.

• Cleerly & Cenegenics’s Precision Plaque Alliance: Cardiac CT AI leader Cleerly announced an interesting new alliance with “performance health age management” company, Cenegenics. Through the partnership, Cenegenics will offer its wellness- and longevity-focused clientele access to Cleerly’s CCTA AI analysis, allowing its members and their physicians to identify plaque buildup and create personalized treatment plans. Cleerly services will be available in all 21 Cenegenics Centers within the U.S.

• New Polygenic Risk Score Improves CAD Prediction: A groundbreaking polygenic risk score named GPSMult was able to predict CAD with a new level of accuracy. GPSMult was trained on genomic data from over 269k CAD patients and 1.2M controls, then outperformed all available CAD risk scores across a diverse external validation dataset with over 190k patients. The GPSMult score also identified healthy individuals who are at-risk of future CAD events as accurately as those with existing CAD.

• Medtronic Recalls 350k Defibrillators: After 28 incidents and 22 nonfatal injuries, Medtronic issued a FDA Class I recall (the most serious recall level) for a range of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) distributed since October 2017 – impacting over 348k units. The affected ICDs and CRT-Ds with glassed feedthrough may deliver low or no energy output when high voltage therapy is needed due to inappropriate activation of the Short Circuit Protection feature, which could lead to serious injury or death.

• CVAUSA Acquires in Kissimmee: Cardiovascular Associates of America (CVAUSA) kept its cardiology practice acquisition spree going, partnering with Kissimmee, Florida-area practice Cardiovascular Associates (9 physicians, 4 NPs, 5 locations). The partnership comes less than a month after CVAUSA acquired Tampa-based practice Bay Area Cardiology and Vascular Associates, and gives CVAUSA six practices in the sunshine state. It also marks CVAUSA’s eighth practice acquisition in 2023 (15th since 2021).

• Omega-3 May Lower AFib Risk: Some omega-3 fatty acids were linked to a lower risk for atrial fibrillation in a new global study, further supporting current guidelines recommending fish/omega-3 fatty acid consumption. Researchers looked at circulating and tissue fatty acid levels in 17 prospective studies involving almost 55k people in 21 countries, including 7,720 people with AFib. Samples with higher levels of EPA were neutral for Afib, but people with higher levels of DHA, DPA, and EPA+DHA had 7-11% lower chances of developing AF.

• Google Reveals Med-PaLM Results: Google pulled back the curtain on the accuracy of its Med-PaLM large language model with new results published in Nature, finding that 92.6% of Med-PaLM answers “aligned with medical consensus” – matching human clinicians. The paper goes into a ton of detail on model development and performance evaluation for the hardcore AI enthusiasts, but also includes a great discussion on both the potential of responsible AI and the challenges of building it for healthcare.

• SGLT2is Help Diabetics After MI: A South Korean real-world study showed that patients with type 2 diabetes benefit from early use of SGL2 inhibitors after heart attacks. In the analysis of 938 patients who received SGLT2i treatment within two weeks of an MI and 1,876 patients who didn’t, the SGLT2i group had lower risk for dying or heart failure hospitalization (9.8% vs. 13.9%) and lower rates of major adverse cardiac events (9.1% vs. 11.6%) through 2.1 years.

Imaging AI + Calcium Scoring for Heart Attack Prevention

See how CCTA AI combines with CAC scoring to transform preventive heart care in this on-demand webinar featuring world-renowned prevention expert Dr. Arthur Agatston (author of the South Beach Diet, creator of the Agatston score), Cleerly founder Dr. James Min, and CMO Dr. James P. Earls.

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. 

The Resource Wire

• 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!

• Check out this Change Healthcare report detailing the benefits of cardiovascular structured reporting, and how to drive structured reporting adoption in your own organization.

• HeartFlow’s landmark PRECISE trial found that their precision approach for evaluating people with stable chest pain avoided unnecessary testing and improved care without putting patients at risk of a missed heart disease diagnosis.