Adam Cifu, MD

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Cardiology Pharmaceuticals

At Home Nasal Sprays and PSVT ER Visits

Data analysis from the NODE-301 Phase 3 trial suggests that patients self-adminstering Milestone Pharmaceuticals’ etripamil (CARDAMYST) might be able to avoid ER visits for paroxysmal supraventricular tachycardia (PSVT).

• PSVT includes a range of heart-rhythm disorders and occurs in 1 out of 300 patients, leading to unpredictable elevated heart rates that require medical intervention.
• Etripamil is a fast-acting, self-administered, nasal spray calcium channel blocker currently in development for acutely treating atrioventricular-nodal-dependent PSVT.
• Although promising, etripamil recently faced a setback from the FDA due to nitrosamine impurities and questions around its manufacturing process.

Sniffing around for proof of etripamil’s effectiveness, researchers analyzed data from parts 1 and 2 of the NODE-301 trial and found that patients who self-administered the drug were more likely to treat their PSVT episode at home rather than heading to the ER.

• Nasally administering etripamil stopped the PSVT episode within 30 minutes in 57.8% of patients, compared to 32.1% on placebo.
• Part of why so many placebo patients stopped their PSVT episode could be due to the vagal maneuvers (forced gagging, breath holding, etc.) that patients are instructed to perform.

When it came to going to the ER, 13.6% of etripamil recipients required an ER visit for ongoing PSVT versus 22.4% of placebo, leading to a 39% relative risk reduction.

Although PSVT is rare, these results suggest that etripamil could help relieve volume and cost burdens on ERs.

• One NIH study found that mean expenditures per PSVT patient doubled from $11.7k in the year before diagnosis to $24k in the first postdiagnosis year.

The Takeaway

PSVT is unpredictable, so potentially lessening its impact at home could help alleviate burden on patients and providers alike. However, etripamli is still in the works and hasn’t been FDA approved yet for PSVT, so we’ll have to wait and see till then.

Us2.ai and Fujifilm Automate CVUS

Fujifilm Healthcare Americas and Us2.ai have partnered to equip the LISENDO 880 cardiovascular ultrasound system with an AI-driven clinical workflow solution. Read more about how Us2.ai fully automates the LISENDO 880’s echocardiogram analysis and reporting.

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.

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.

The Wire

• Verve’s Fast Track: The FDA granted Verve Therapeutics Fast Track designation for its VERVE-102 PCSK9 gene inhibitor, only a few weeks after approving its IND application for treating heterozygous familial hypercholesterolemia (HeFH). These back-to-back decisions come amid VERVE-102’s Phase 1b Heart-2 trial for evaluating its safety in adult HeFH patients who require additional lowering of LDL-C. Verve plans to announce demographic and initial safety and efficacy data from the Heart-2 trial in Q2.

• Amulet vs. Watchman, Round 2: Building on results from the AMULET IDE trial, SWISS-APERO’s new data suggests there could be differences in ischemic stroke outcomes between Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman 2.5/Watchman FLX. Focusing on three year results, SWISS-APERO found that the rate of CV death, stroke, TIA, or systemic embolism was 18.2% in Amulet LAAO patients compared to 31.0% for the Watchman 2.5 or Watchman FLX. However, researchers noted the trial was not powered to detect differences in clinical outcomes.

• Volt PFA Hits the Mark: Results from Abbott’s VOLT CE Mark study suggest we could have a new type of pulsed field ablation system on the way. The study examined Abbott’s Volt PFA, which uses a balloon-in-basket system for AFib ablation, finding  that it achieved an acute effectiveness of 99.1%. In the six months following ablation with the Volt PFA, 88.2% of paroxysmal AFib and 76.7% of persistent AFib patients were free from atrial arrhythmias.

• CAD & Dementia’s Risky Relationship: A recent AHA study suggests CAD risk could also increase a patient’s dementia risk in old age. Using the UK Biobank, researchers assessed 365k dementia-free patients for CAD risk and found nearly 9k developed dementia over a 13.9 year follow-up. Genetic and lifestyle risk scores for CAD led to a slightly elevated risk of all-cause dementia (HR: 1.10 for genetic and 1.04 for lifestyle), while people in the highest CAD risk categories were 70% more likely to develop vascular dementia.

• CardioVia’s FDA Clearance: CardioVia gained FDA clearance for its ViaOne technology that helps clinicians reach the surface of the heart without using an exposed needle. The ViaOne device pulls the pericardium away from the heart so a blunt-tip needle can provide access to the pericardial space while sensors track the device’s position. This helps interventional cardiologists and EPs treat arrhythmias with a lower risk of perforation or other complications. 

• A Star In Our Hearts: In a mashup of nature and AI, researchers created a new wearable device that delivers accurate real-time heart monitoring in the shape of a starfish. The five-pointed cardiac monitor records electrocardiogram, seismocardiogram, and gyrocardiogram signals while using AI algorithms to filter movement-related interference and track heart data for signs of complications. Early testing suggests the device accurately identifies warning signs of MI, AFib, and HF ~91% of the time. 

• Pacemaker Mortality Post-TAVR: New data analysis suggests patients who require a permanent pacemaker following TAVR face significantly higher long-term all-cause and CV mortality risks. Researchers explored data from 13k patients in the SwissTAVI registry and found that 15% received a permanent pacemaker within 30 days of undergoing TAVR. After one year, patients who required a permanent pacemaker had higher all-cause and cardiovascular mortality (aHRs: 1.15 & 1.25), and were more likely to experience LVEF decline and/or severe HF symptoms. 

• AtriCure’s New Device: AtriCure announced the first use of its AtriClip PRO-Mini LAA Exclusion System for minimally invasive concomitant procedures. The AtriClip PRO-Mini device received FDA clearance earlier this year and is 60% smaller than the next lowest profile AtriClip device. This significant size reduction provides surgeons better visualization for ensuring precise exclusion of the left atrial appendage during minimally invasive procedures.

• Teladoc Cardiometabolic Health Program: Teladoc rolled out a new Cardiometabolic Health Program aiming to improve population health and prevent the progression of diabetes, hypertension, and obesity. The new program is designed to support the AHA’s Life Essential 8, supported by at-home testing and integration with Teladoc Health’s 24/7 care, devices, and coaching.

• CCTA AI Predicts MACE: A homegrown CCTA AI algorithm developed by South Korean researchers predicted MACE among emergency patients. Researchers tracked MACE over 2.5 years in 408 patients, finding that when combined with clinical risk factors like elevated troponin T scores, patients whose obstructive CAD was detected by AI had an 88X higher risk of MACE. 

• Olmesartan’s Heart Gene Effects: Searching for the genetic components of HF, researchers examined the NIH Cellular Signatures database and found that several angiotensin receptor blockers played a role in slowing HF progression. The most significant was olmesartan (Daiichi Sankyo’s Benicar) which elevated the expression of sarcomeric genes while lowering arrhythmogenic potential. Olmesartan also reduced kinase 1 activation in HF-related cardiomyocytes.

Circle CVI’s Cardiac CT Expansion

Watch this Cardiac Wire interview with Circle Cardiovascular Imaging’s Chief Product Officer, Scott Galbari as he sheds light on Circle CVI’s history with cardiac MRI and how the company is tackling the coming demand for cardiac CT.

Automating and Simplifying CMR Imaging

Watch Vista.ai’s demo on how their intelligent software automates and simplifies image acquisition so all technologists can perform a CMR scan with quality, consistency, and efficiency, increasing throughput and improving patient access.

The Resource Wire

• Explore Vitrea Advanced Visualization: Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow

• A Better Way to Coordinate Post-Stroke Care: Think your EHR messaging system might be holding back your post-stroke care? See how UC San Diego Medical Center streamlined its neuro and EP teams’ post-stroke workflow with Viz Connect, and the impact it had on cardiac monitor placements in inpatient and outpatient settings.

• Cardiology AI: From Research to Clinical Practice: Explore how AI algorithms are reshaping cardiology with insights from Tempus’ recent webinar, featuring Dr. David Ouyang of UCLA and Cedars-Sinai, alongside Tempus’ Dr. John Pfeifer and Dr. Brandon Fornwalt. This expert panel dives into how AI can bridge diagnostic gaps, enhance patient outcomes, and streamline workflows for conditions like AFib and pulmonary hypertension. Read the full recap to glimpse the future of AI-driven cardiology.

• Heartflow Roadmap Analysis For Efficient Care: As Coronary CT scan volumes increase, your entire reading team needs to deliver efficient and consistent reads. Good thing Heartflow’s Roadmap Analysis can help you maintain accuracy and increase CCTA read speeds by up to 25%, with even level 3 readers seeing real efficiency benefits.

• Redefining Percutaneous Coronary Intervention: Learn about the AGENT™ Drug-Coated Balloon from Boston Scientific and how this technology is expanding the treatment options for patients with in-stent restenosis in the U.S. Rx only. (Sponsored by Boston Scientific)

• CVIS and AI in Structural Heart Treatment: Harnessing the power of CVIS and AI to enhance your heart imaging is crucial in today’s fast-paced health care environment. See how Optum’s CVIS can support clinical workflows and meet the needs of EP and structural heart procedures.

• Cut Waste with GE HealthCare’s Inventory Management: Want to make your hospital’s inventory practices more efficient? Tune in to this webinar on how GE HealthCare’s data-driven insights can optimize inventory management and reduce cardiac procedure times by 30-45 minutes.

• Connecting the ECG Monitoring Ecosystem: There’s so much that goes into building the solutions that providers use each week, and that’s definitely true for ECG monitoring. In this Cardiac Wire Show interview with Flipside Media’s president Brad Ummer, we get an insider’s view of what it takes to develop an ECG monitoring solution, including Flipside’s partnership with Monebo Technologies.

The Industry Wire

1. FDA shifts away from animal testing for drug development. 
2. Prospect’s beleaguered Penn. hospitals get last-minute lifeline. 
3. Medicare Advantage contracts squeeze rural hospitals.
4. ‘Chaos and questions’ at U.S. health agencies. 
5. NIH reverses conference attendance ban for scientists. 
6. Healthcare welcomes pause to tariff turmoil. 
7. Novartis to spend $23B on U.S. drug plants.
8. Medicare paid Medicare Advantage $38B for non-Medicare services.
9. Employers are willing to pay for anti-obesity meds.
10. One-third of maternal deaths happen long after delivery.