University of Galway’s professor Bill McEvoy on the ESC’s new, more-aggressive hypertension guidelines.

Pharmaceuticals

Alylam’s Vutrisiran Shines in HELIOS-B Trial

Alylam’s vutrisiran dominated early ESC 2024 headlines and conversations, after full results from the Phase 3 HELIOS-B trial highlighted its significant impact on transthyretin amyloidosis with cardiomyopathy (ATTR-CM). 

• ATTR-CM is a rare, progressive heart disease caused by the buildup of amyloid protein in the heart, and is currently only treated with Pfizer’s ATTR-CM “stabilizer” tafamidis.
• Analym’s vutrisiran (aka Amvuttra) “silences” the TTR gene via RNA interference, limiting amyloid buildup and slowing disease progression.
• Vutrisiran already has FDA approval for hATTR-PN amyloidosis, and is looking to become the first ATTR-CM silencer.

The HELIOS-B study gave 655 ATTR-CM patients either vutrisiran or a placebo for 36 months, finding that the vutrisiran group achieved significant reductions in the primary endpoint by 42 month follow-up (a composite of all-cause mortality and CV events). 

• Those improvements spanned both the overall patient population (-28%) and monotherapy patients who weren’t taking Pfizer’s tafamidis (-33%). 

Vutrisiran also nailed all secondary endpoints, including…

• All cause mortality at 42 months (-35%)
• 6-minute walk test declines at 30 months (-7.5 vs. -31 meters)
• KCCQ-OS score declines at 30 months (-1.30 vs. -6.25 points)

Meanwhile, adverse events were similar across the vutrisiran and placebo groups, both overall (99% vs. 98%) and for serious adverse events (62% vs. 67%).

These results suggest that vutrisiran could be headed towards FDA approval for ATTR-CM, joining Pfizer’s tafamidis (Vyndaqel and Vyndamax) and potentially BridgeBio’s investigational ATTR-CM stabilizer acoramidis.

The mortality and CV event reductions in the vutrisiran plus tafamidis group also raises questions about combining an ATTR-CM silencer with a stabilizer, or regarding which ATTR-CM drug is more effective.

• This trial wasn’t powered to prove vutrisiran’s impact as an add-on to tafamidis (another forthcoming Phase 3 trial will evaluate that), although these results are promising.
• When HELIOS-B’s monotherapy results are compared to the major tafamidis and acoramidis trials, vutrisiran shows some mortality and CV event advantages (but we all know we can’t compare separate trials).

Either way, trust in vutrisiran’s monotherapy and add-on effectiveness (and economics) will be keys to adoption if it is approved.

The Takeaway

Although there’s still unanswered questions about vutrisiran’s monotherapy advantages versus tafamidis or potential as an add-on, it appears to be on the way to becoming the first ATTR-CM silencer. That’s good news for ATTR-CM patients, who’ve had limited options before now, and could be part of a new wave of treatments and awareness.

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.

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.

TeraRecon’s Mitral Valve Workflow

Are your mitral valve planning workflows ready for higher procedure volumes? Take this step-by-step tour of TeraRecon’s Mitral Valve Workflow to see how it gives imagers the tools to evaluate the mitral valve and support TMVR treatment planning.

The Wire

• 2024 ESC Hypertension Guidelines: The ESC’s new hypertension guidelines adopt an ambitious systolic BP target of 120-129 mmHg for most patients, representing a “paradigm shift” from the previous two step approach (<140/90 mmHg, then <130/80 mmHg). The guidelines also add a policy to pursue BP that’s “as low as reasonably achievable” if patients are frail or can’t reach 120-129 mmHg, while adding a new “Elevated BP” category (120-139/70-89 mmHg) to treat more at-risk individuals earlier, and for the first time recommended renal denervation to treat resistant hypertension.

• DynamX’s Real World Advantages: Elixir Medical added real-world evidence that its DynamX Coronary Bioadaptor is a strong competitor to Medtronic’s Resolute Onyx stent. In the 2,400-patient INFINITY-SWEDEHEART trial, DynamX’s target lesion failure rate was non-inferior to the Resolute Onyx after 12 months (2.35% vs. 2.77%, the primary endpoint), while achieving lower or similar rates of target vessel MI (1.27% vs. 1.52%), ischemia-driven target lesion revascularization (1.27% vs. 2.11%), cardiovascular death (0.59% vs. 0.50%), and target vessel failure (3.03% vs. 3.52%).

• GLP-1 Complements SGLT2 in HFpEF: A retrospective study suggests that GLP-1s may have additive benefits when combined with SGLT2is in patients with HFpEF, type 2 diabetes, and excess weight/obesity. Among 14k patients, GLP-1/SGLT2is were associated with significantly lower risk for a range of events over 12 months compared to SGLT2is alone, including heart failure exacerbations (-38%), ER visits/hospitalizations (-26%), new onset atrial arrhythmias (-19%), and pulmonary hypertension (-20%). 

• Music to My Lp(a): With its LP(a) treatment zerlasiran headed towards Phase 3 trials, and amid persistent gaps in LP(a) awareness and testing, Silence Therapeutics launched its Music to My Lp(a) marketing campaign. Set to “low,” “elevated,” and “high” tempo/volume music, the campaign focuses on educating the public about LP(a)’s genetic origins, its role as a cardiovascular risk factor, and the need for testing.

• PFA vs. CBA for PVI: Pulsed-field ablation (PFA) is known for its safety and speed advantages, but it might have better PVI effectiveness than cryoballoon ablation (CBA). Among 550 patients, 12% of both the PFA and CBA groups needed a repeat procedure, while pulmonary vein reconduction occurred in a similar proportion of patients (73% & 75%). Roof lines (linear lesions created in the roof of the atria) were more frequently set after PFA (36% vs. 11%). 

• Mapping the Way for AL Amyloid: Cardiovascular MRI with extracellular volume (ECV) mapping could bring a new era in AL amyloidosis assessments. That’s from a JAMA analysis of 560 patients that found CMRI ECV mapping was the only independent predictor of prognosis, while showing that a rapid and deep hematological response to therapy is key, especially for those with ECV greater than 0.40%. The authors suggest ECV mapping may reshape AL amyloidosis treatment by emphasizing the need for an early, deep therapy response to improve outcomes.

• The AI Evidence Gap: Do AI approvals lack data supporting their safety and effectiveness? A Nature Medicine study questions the FDA’s AI approval process, claiming that 43% of over 521 AI-based regulatory authorizations lacked clinical validation data. Researchers also criticized the FDA’s practice of letting vendors use retrospective rather than prospective data for regulatory submissions, while raising questions about AI safety.

• CV Blood Test: A blood test could have a huge impact on long-term cardiovascular outcomes. Researchers measured high-sensitivity CRP, LDL-C, and LP(a) in 27,939 healthy U.S. women (avg. age: 54.7yrs) and analyzed their 30-year outcomes. Women with the highest quintile CRP, LDL-C, and LP(a) levels were far more likely to experience major cardiovascular events than those in the lowest quintile (Hazard ratios: 1.70, 1.36, 1.33). Women in the highest quintile of all three biomarkers had the greatest CV event risk (HR: 3.71).

• No Aspirin in Afib + ACS: The safest option for antithrombotic therapy in patients with Afib and concurrent ACS or PCI treatment may be apixaban plus a P2Y12 inhibitor — without aspirin. Analysis of the AUGUSTUS trial showed 21.9% of those on dual therapy experienced the composite endpoint of death, bleeding, or cardiovascular hospitalization. That’s in contrast to 27.3%-33.3% with other regimens, including triple therapy with aspirin or vitamin K antagonist-based therapies, such as warfarin.

• Hospital Gains, Home Strains for HF Patients: A study of 1.2 million Medicare patients hospitalized with heart failure between 2008 to 2018 showed a 26% drop in in-hospital mortality, but virtually no improvement in post-discharge mortality. Short term and long term risk adjusted mortality ratios were 1.02 and 0.96, respectively, suggesting that while in-hospital care has advanced, better long-term outpatient strategies are needed to reduce HF mortality post-discharge.

• BP Activity Intervention Disappoints: In the RESET-BP study, a three-month intervention for reducing sedentary behavior among desk workers (increasing standing and steps) failed to significantly reduce their blood pressure. In the study of 271 adults with high systolic BP 120-159 or diastolic BP 80-90 mm Hg, the intervention cohort saw their SBP and DBP drop by just -0.22 and -0.13 mm Hg, with no significant changes in ambulatory BP or pulse wave velocity.

Relieving The Burden of Post-Processing

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.

AI Algorithms in Cardiology: Navigating the Path from Research to Practice

Join Tempus on Tuesday, September 24 for an in-depth webinar exploring the transformative power of cardiology AI algorithms. Learn from leading experts, including Cedars Sinai’s Dr. David Ouyang and Tempus’ senior cardiology team Dr. Brandon Fornwalt and Dr. John Pfeifer, about how cardiology AI algorithms are unlocking new possibilities for diagnosis, treatment, and patient outcomes. Secure your spot now to be part of this pivotal discussion.

AI-Powered Home Ultrasound

The recently published CUMIN study shows the technical feasibility of AI-POCUS in the hands of novice nurses and opens new possibilities for redefining how we approach cardiac care. Learn more on this page from Us2.ai.

The Resource Wire

• The Behavioral Science Behind Optum’s Hemo System: When Optum set out to design its next-generation Cardiology Hemodynamics monitoring system, it put behavior science at the heart of its product strategy. See how Optum’s UX designers applied its behavioral science team’s findings to improve its Hemodynamics solution to help make physicians and technicians even more efficient and user-centric.

• An All-in-One Coronary Care Solution: See how HeartFlow ONE is transforming precision heart care as the first all-in-one CCTA pathway, combining FFRCT, stenosis, and plaque analysis in a single workflow.

• Streamlining Cath Lab Hemodynamic Workflows: Is your hemodynamic solution keeping your cath lab efficient? Merge Hemo is a cath lab hemodynamic monitoring solution, providing a Best in KLAS user experience, while enhancing clinical workflows, automating data collection, and streamlining inventory management.

• Meet Your EP Decision Support Digital Assistant: Time is of the essence when it comes to managing Afib, and there’s ways to be more efficient. Tune in to this GE HealthCare Cardiology Coffee Break (September 18 at 12:00pm EDT) exploring how clinical decision support with CardioVisio can help you make faster decisions and accelerate the diagnostic process.

• 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!

• Tracking Your Post-Treatment Plaque: Tune-in to this on-demand Cleerly webinar where preventative cardiologist John Osborne, MD, PhD, FACC, FNLA explores how to use CTA to track plaque progression and identify residual risk post-treatment.

• The Post-Acute Stroke Game Changer: See how Viz Connect solution can optimize your post-acute stroke pathway. The Viz.ai solution allows the cardiology team to promptly receive Neurology referrals to evaluate patients with suspected AFib for cardiac monitoring and reduce their risk of secondary stroke.

• 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.

The Industry Wire

1. Oregon’s hospital price cap cut patient costs, increased utilization.
2. U.S. govt warns hospitals of Iran-based ransomware attacks.
3. Minnesota’s CentraCare launches $230M outpatient expansions.
4. AI remains the most exciting emerging healthcare tech.
5. San Diego’s Sharp HealthCare and Palomar Health launch partnership.
6. Cedars-Sinai raises $1B for research, clinical care, and academic leadership.
7. HCA completes acquisition of Valesco physician practice management firm.
8. TennCare intentionally kept patients from care.
9. HHS cancels appeal on hospital web tracker decision.
10. How McLaren Port Huron Hospital used paper records after cyberattack.