A now-viral tweet by X/Twitter CEO Elon Musk after Bronny James, the son of basketball legend LeBron James, suffered cardiac arrest while practicing this week.

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Cardiology Pharmaceuticals

Alnylam and Roche’s Long-Lasting Antihypertensive Alliance

Just days after Alnylam Pharmaceuticals showed that a single injection of zilebesiran can control blood pressure for up to six months, the biotech has joined forces with Roche to usher the mid-stage medication through its clinical trials into clinical use.

Zilebesiran is an investigational RNA interference therapeutic agent that inhibits hepatic angiotensinogen synthesis, which plays a key role in hypertension development. 

• Perhaps more notably, zilebesiran’s ability to control blood pressure over long periods could address the daily medication adherence challenges that often undermine hypertension care.

Roche seems to agree about the value that a long-lasting hypertensive might generate, committing to pay $310M upfront followed by milestone-based payments worth up to $2.8B for Alnylam… And that’s not including Alnylam’s share of post-commercialization sales.

The alliance combines Alnylam’s RNAi therapeutics expertise with Roche’s massive funding and extensive track record with drug development and commercialization. More specifically:

• Alnylam will lead the joint clinical development for zilebesiran’s hypertension indication, splitting development costs with Roche 40% / 60%
• Roche will lead future clinical development for other indications
• Alnylam and Roche will co-commercialize zilebesiran in the U.S., where the companies will split an equal share of profits
• Roche will exclusively commercialize zilebesiran outside the U.S., giving Alnylam  low double digit royalties on net foreign sales  

In the near term, Alnylam and Roche will primarily focus on clinical development, including one Phase 2 trial evaluating zilebesiran as a monotherapy and another Phase 2 combining zilebesiran with existing BP meds (including Pfizer’s Norvasc).

The Takeaway

We’ll have to wait to see whether zilebesiran will become the long-lasting antihypertensive that many in cardiology have been waiting for. But there are reasons to be optimistic, given Alnylam’s track record with previous RNAi drugs (5 FDA-approved drugs since 2018, including a cholesterol med that’s now Novartis’ Leqvio) and Roche’s R&D and global commercialization horsepower.

Transformation Through Structured Reporting

Ready to realize the benefits of cardiovascular imaging structured reporting? Check out these quick and powerful Change Healthcare videos detailing the efficiency gains provided by structured reporting and what it takes to drive adoption.

ACC/AHA Chest Pain Guidelines Highlight FFRct

Coronary CTA + FFRct is now a front-line pathway in the ACC/AHA’s 2021 Chest Pain Guidelines. Check out the clinical data supporting FFRct’s positioning as a “dominant strategy” and how HeartFlowFFRct Analysis impacts patients, physicians, and administrators.

The Wire

• Bronny James Cardiac Arrest: Bronny James, the son of basketball legend LeBron James, suffered cardiac arrest while practicing this week, bringing concerns about athletic sudden cardiac arrest and vaccine conspiracy theories back into the spotlight. Bronny is recovering after a brief stay in the ICU. However, allegations that his cardiac arrest was caused by a previous COVID vaccination quickly shifted news coverage from recoveries to conspiracies, which were amplified by a viral Elon Musk tweet.

• Bridgebio’s Acoramidis Proves Promising for ATTR-CM: Big news for the transthyretin amyloid cardiomyopathy, or ATTR-CM, community: Phase 3 data reveal that Bridgebio’s acoramidis improves mortality, morbidity, and quality-of-life outcomes in a population with few existing treatment options. In the study, 421 ATTR-CM patients received 800 mg acoramidis twice daily and 211 patients received placebo twice daily. At 30 months, the acoramidis group saw improvements in all-cause mortality, rates of CV hospitalization, NT-proBNP levels, and 6-minute walk distance. Both groups showed similar rates of adverse events and discontinuation.

• Biosense Webster’s OPTRELL Mapping Catheter: Biosense Webster further expanded its diagnostic catheter portfolio, announcing the FDA clearance and commercial launch of its OPTRELL Mapping Catheter. The high-density catheter is intended for use in complex EP ablation cases, leveraging its fixed array of electrodes and integration with Biosense Webster’s CARTO 3 mapping system to quickly and effectively identify ablation targets.

• The AHA on VB Payments: The American Heart Association’s new policy statement on value-based payments for clinicians treating CVD advises a shift away from fee-for-service towards value-based reimbursement, with the primary focus on healthcare quality and cost. The policy outlines four key themes for successful value-based payment models, including 1) adequate focus on quality of care, 2) the use of payment as a tool to improve equity, 3) moving towards more flexible funding, and 4) tapping into clinicians’ intrinsic motivations.

• Outpatient Vascular Care: Good, Bad or Ugly? The New York Times and ProPublica have both recently detailed what appeared to be big problems with outpatient peripheral arterial disease treatments, suggesting that these procedures largely prioritize profit over patient care. However, an editorial by cardiologist Anish Koka, MD suggests that this coverage ignored “the real issues” with outpatient atherectomies, potentially at the expense of one well-respected physician’s reputation and many patients’ trust.

• FDA Clears Bunkerhill Health’s CAC AI: The FDA cleared Bunkerhill Health’s iCAC algorithm for detecting incidental coronary artery calcium (CAC) on routine non-gated chest CT scans. The iCAC algorithm was developed by Stanford University’s Bhavik Patel, MD, and is being commercialized by Bunkerhill Health, an innovative healthcare AI startup that brings AI algorithms developed by researchers to commercialization and clinical use (without the researchers spinning out a separate company or losing ownership of the algorithm IP). 

• Coronary Reactivity Testing Is Cost-Effective: Although coronary reactivity testing (CRT) can be complex and expensive, the long-term economic benefits appear to be worth it. That’s from a new Mayo Clinic study that compared the outcomes of 207 ANOCA patients who underwent CRT to 207 ANOCA patients with similar presentations who underwent coronary angiography without CRT. Over a 2-year follow-up, the CRT group had fewer repeat angiograms and lower yearly costs (total: $37.8k vs. $13.7k).

• Laplace Targets TR with $12.9M Series B: Tricuspid regurgitation treatment startup Laplace Interventional closed a $12.9M Series B round to fuel the next phase of trials supporting its transcatheter tricuspid valve technology, including the novel tech’s First-in-Human and clinical feasibility studies. Laplace is developing a prosthetic valve that would be delivered through tricuspid regurgitation patients’ vasculature, avoiding open-heart surgery and associated complications.

• Telehealth Less Effective with CVD: New research out of the University of Texas added to the growing body of evidence that telehealth’s promise of lower costs and reduced utilization isn’t as straightforward as it appears. Analysis of patient visits across all hospital-based outpatient clinics in Maryland from 2012 to 2021 revealed that virtual visits reduced 30-day follow-ups by 13.6% and cut costs by $239 per patient. However, conditions with “low virtualization potential” – such as “circulatory” conditions – saw nearly zero benefit from virtual care.

• Post-TAVR PPI Problems: A study published in JACC showed that patients who undergo self-expanding TAVR procedures and subsequently require new permanent pacemaker implantation (PPI) face greater mortality risks. Among 3,211 patients who underwent TAVR with SEV, 362 required new PPIs within 30 days (11.3%). Those new PPI patients had far higher all-cause mortality rates over one-year (16.9% vs 10.8%; adjusted HR: 1.66), while PPI patients with baseline EF <40% were associated with even worse outcomes (P = 0.049).

• Hospital M&A Up in Q2: Kaufman Hall’s Q2 Mergers & Acquisitions Report recorded 20 health system M&A moves during the second quarter, the largest total since the start of the pandemic. A major driver of recent transactions was to combine and optimize organizational capabilities, a trend that was evident in Q2’s largest transactions: 1) the combination of Froedtert Health and ThedaCare in Wisconsin; 2) Kaiser Hospital Foundation’s creating VBC entity Risant Health through the acquisition of its first member, Geisinger Health.

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.

Reducing Variability in Echo Analysis

What if AI could produce echo measurements that are comparable to expert physicians, but with less variability? That’s precisely what this Nature study revealed about Us2.ai’s solution, finding that its measurements had fewer and smaller differences compared to three human experts than when the experts were compared with each other.

The Resource Wire

• For years, world-renowned prevention expert Dr. Arthur Agatston, author of The South Beach Diet and developer of the “Agatston Score,” had been looking for technology that could accurately identify all types of plaque in the heart. Then, he was introduced to Cleerly. Hear from Dr. Agatston on why he believes “Cleerly really is the holy grail of prevention.”

• With the advent of advanced imaging technologies like CCTA come added burdens to technologists and diagnostic imaging centers. See how PIA can relieve the burden of post-processing, saving you time while helping your bottom line.

• 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!