Heather Farley, MD on addressing physician burnout.

Pharmaceuticals

Vascepa’s ACS Advantage

Amarin’s fish oil-based Vascepa (icosapent ethyl, aka IPE) made its mark in 2018’s REDUCE-IT trial after achieving a 25% MACE reduction among high-risk statin users, and new post hoc analysis of the same data suggests that IPE might have an even greater benefit among patients who recently had acute coronary syndrome (ACS).

Researchers analyzed 840 REDUCE-IT participants (10.3% of total trial) who experienced ACS within 12 months of trial randomization, finding that most patients who received IPE treatments had better five-year outcomes than those who received a placebo, including:

• 36% reduced incidence of the composite primary endpoint (CV death, non-fatal MI, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina)
  • That’s far higher than the 25% improvement in the original REDUCE-IT trial
• 44% fewer urgent or emergent revascularizations
• 36% reduced incidence of the composite secondary outcomes (CV death, non-fatal MI, or non-fatal stroke)

Patients in the IPE group also enjoyed a 9.3% absolute risk reduction for experiencing a first composite primary event (18.7% vs. 28%) and had a “number needed to treat” to avoid a primary event of 11 patients. 

• That appears to suggest that IPE treatment timing is crucial with ACS. IPE had a far lower absolute risk reduction and much higher number needed to treat (4.7% & 21) among 3,651 patients in the original REDUCE-IT trial who experienced ACS 12 months or more before randomization.

IPE treatments also showed a positive safety profile with recent ACS patients, matching the placebo group for patients with at least one treatment-emergent adverse event (78.8% vs. 76.7%), total bleeding (6.9% vs. 8.1%), and bleeding-related serious adverse events (1.6% vs. 3.2%), even among patients who received DAPT.

• IPE’s bleeding risk advantages are notable given that ACS patients generally receive intensive antithrombotic therapy. However, like the original REDUCE-IT trial, IPE had higher treatment-related rates of AFib or flutter (7.4% vs. 2.9%).

The Takeaway

With two FDA clearances and 20 million prescriptions so far, IPE has achieved quite a bit, but it hasn’t yet reached what some viewed as its early potential — and even the REDUCE-IT trial has faced its share of criticism. This study might not drastically alleviate IPE’s headwinds, but it does provide solid evidence supporting initiating IPE “as soon as possible after ACS.”

TeraRecon’s Structural Heart Enhancements

Detecting and addressing mitral valve and LAA conditions can be challenging. Check out TeraRecon’s Structural Heart white paper and discover how improving workflow and pretreatment planning can streamline these processes and potentially improve patient outcomes.

Protecting Your Cardiovascular Imaging Data

Are you sure about your cardiovascular imaging data security? Tune-in to this Change Healthcare webinar discussing how hospital systems and healthcare providers can strategically improve their data security.

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.

The Wire

• Survival Edge For CRT-Ds in HFrEF: In a 14-year follow-up analysis of 1,050 HFrEF patients from the RAFT trial, individuals with cardiac-resynchronization therapy defibrillators (CRT-D) exhibited notably lower mortality rates compared to those with traditional ICDs (71.2% vs. 76.4%). The CRT-D patients also experienced fewer secondary outcomes (75.4% vs. 77.7%; composite of all-cause death, heart transplantation, or VAD implantation), supporting the growing optimism for CRT even amidst shifts in heart failure pharmacotherapy.

• Pi-Cardia’s TAVR Leaflet Breakthrough: The FDA granted Breakthrough Device Designation to Pi-Cardia’s ShortCut leaflet splitting device, which facilitates valve-in-valve TAVR procedures before implantation of a second valve. The designation is another positive milestone for Pi-Cardia, coming about four months after completing enrollment for its ShortCut pivotal study.

• Stopping the Bleed: Scientists have engineered a next-gen hemostat, capable of achieving hemostasis within 9 minutes at radial artery puncture sites for 100% of patients under high-dose heparin. Fashioned from shellfish-extracted chitosan with a spherical microporous design, the hemostat can quickly absorb blood and concentrate clotting components, challenging the dogma that chitosan does not affect the physiological clotting process.

• Intelerad Launches Cardiac MRI Software: At last weekend’s SCMR meeting in London, Intelerad launched Precession, a new solution for viewing, analyzing, and reporting cardiac MRI scans via a standard web browser. Intelerad focused on improving productivity in developing Precession, with the company claiming it can reduce to five minutes tasks that previously took 30 minutes. Precession includes collaboration and structured reporting features, and can manage all the functions of cardiac CT, cardiac MR, and echocardiography programs.

• How to Detect Primary Aldosteronism: A University of Michigan study showed how an EHR best-practice advisory (BPA) can help improve the detection of primary aldosteronism (PA) in patients with hypertension, while minimally interrupting workflows. The “noninterruptive” BPA flagged 14,603 PA screening candidates within 15 months (displayed EHR alert, but didn’t require an action), leading to 2,040 PA screening referrals, 1,439 completed screenings, and 250 positive diagnoses. In typical practice, only 2%-4% of those at risk for PA get screened.

• Is Physician Burnout Easing? That’s the suggestion of a new Medscape report indicating that while doctor burnout levels are still high, they ticked down in 2024 compared to the previous year. Overall, fewer physicians reported burnout (49% vs. 53%) and depression (20% vs. 23%), although cardiologist burnout rates increased to 47% (vs. 43% in 2023) making it the 12th most burned out out of 25 specialties.

• Tracking Arrhythmic Risks Before CABG: Patients undergoing CABG could benefit from preoperative assessments using speckle tracking echocardiography (STE). A recent study in Circulation: Cardiovascular Imaging found that patients with global PALS values <28% had a 3.6-fold higher risk of post-op AFib. Identifying PALS preoperatively may help in predicting patients with higher arrhythmic risk and allow for closer monitoring after surgery.

• Selfie-Based RPM: Patient smartphones generally play major role in remote patient monitoring, but Blue Spark Technologies’ new VitalTraq platform took it to a new level, using a 30 to 60-second selfie scan to capture a range of vital sign measurements, many of which are cardiac-related (heart rate, heart rate variability, blood pressure, and respiratory rate). VitalTraq’s contactless monitoring capabilities rely on remote photoplethysmography (rPPG) technology, which captures blood flow patterns in patient faces and translates them into biometrics that usually require several devices to collect.

• Balancing Risks and Costs with LAAO Combinations: Combining LAAO with other procedures showed similar MACEs and hospital stays as LAAO-only procedures. That’s from a JACC study that also found that costs were higher with combined procedures ($44,723 vs $32,364) but lower than LAAO with sequential procedures ($51,552 vs $63,170). Different LAAO combinations had varied outcomes, notably increased risks of heart block with concomitant AFib ablation (OR=2.16) and stroke or vascular injury with concomitant TAVR (OR=2.12 and 2.23).

• CroíValve’s TANDEM II Trial: CroíValve announced the FDA approval and launch of its TANDEM II early feasibility study evaluating its DUO Tricuspid Coaptation Valve System in patients with severe or greater symptomatic tricuspid regurgitation. The DUO system features a coaptation valve that works in tandem with the native tricuspid valve to restore valve function. The previous TANDEM I trial showed strong symptomatic improvement in TR patients across all key measures.

• Another Study on Statin Underuse: A new NHANES study found that only one in three people with severe dyslipidemia gets treated. Out of 24,722 people surveyed between 2011 and 2020, 5.4% had severely high cholesterol ( ≥190 mg/dL), and in this subset statin use remained stagnant for the study period, ranging from 34.7% to 33.4%. Awareness of high LDL was relatively high though stagnant (48.1%-51.9%), and researchers say the problem lies partly in non-adherence to treatment.

Cleerly Transforms Personalized CVD Care

Cleerly is launching perhaps the first large-scale randomized imaging AI trial, as it seeks to prove that AI-guided cardiovascular care reduces heart attacks. The five year TRANSFORM trial will investigate whether CVD patients who receive treatments based on results from Cleerly’s investigational AI-based plaque staging system have better outcomes.

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 Resource Wire

• 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.

• 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!

• How to Improve Cardiology Workflows and Get More Patient Time: Complex processes and reporting requirements can mean cardiologists spend more time with clinical systems than they do with their patients. See how Merge Hemo and Merge Cardio work together to help you streamline and scale your clinical and data management workflows, so you can have more time in front of your patients.

• HeartFlow FFRCT Catches Missed Blockages: Karen Moore had always been diligent about her heart health, which is why she was concerned when she began showing symptoms of heart disease but all of her tests came back negative. See how Karen and her physician used HeartFlow FFRCT to catch a 90% blockage and place a stent in the right location, before it was too late.

• 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.