Cleveland Clinic’s Pasquale Santangeli, MD, PhD after the ADVENT trial found PFA ablation noninferior (but not particularly superior) to conventional thermal ablation.

===========

First time reading Cardiac Wire? Sign up here!

Electrophysiology

Most Subclinical AF Patients Better Off Without Anticoagulants

The growing number of people walking around with cardiac monitoring devices will undoubtedly lead to far more subclinical AFib detections, but the NOAH-AFNET 6 trial provided some much needed reassurance that many of these patients would be better off without anticoagulants.

NOAH-AFNET 6 specifically evaluated patients with implantable device-detected atrial high-rate episodes (AHREs), who often don’t even notice these episodes, and can be treated with anticoagulants that were historically reserved for patients with ECG-diagnosed AFib.

The researchers randomized 2,536 older patients who had experienced AHREs (all ≥65yrs; 65% ≥75yrs) to take either edoxaban or a placebo, measuring the  anticoagulant’s efficacy (composite of: CV death, stroke, or systemic embolism) and safety (all cause mortality or major bleeding).

• The edoxaban group had fewer efficacy events: 83 vs. 101 (3.2% vs. 4% per patient year)
• But also significantly more safety outcomes: 149 vs. 114 (5.9% vs. 4.5% patient year)
• And the two groups had similar rates of stroke: 0.9% vs. 1.0%

The trial was terminated early at a median 21 months (vs. goal of 220 primary events) after safety monitors noted the high rate of bleeding in the edoxaban group, and edoxaban’s apparent “futility” as an AHRE treatment.

This bad news for edoxaban supporters was celebrated as good news for patient care, including by two cardiologists with the largest platforms around:

• Venk Murthy, MD expressed appreciation that this trial was done, but a lack of surprise about the result, given AHRE patients’ relatively low risks and considering that “anticoagulants are among the most dangerous of the widely prescribed meds.” Murthy also warned of how the trend towards Apple watch-based AFib monitoring will detect far more low-risk AFib patients who could be similarly harmed by unnecessary anticoagulant use.

• John Mandrola, MD praised NOAH AFNET 6’s scientific fundamentals: it was well-conducted, addressed a common problem, delivered actional clinical results, and advanced our overall knowledge of AF. Although other forthcoming research will confirm whether this is truly “practice changing,” the study effectively shifted Mandrola’s approach towards holding off on anticoagulants with most of these patients.

The Takeaway

The growing number of patients who have been identified with AHRE or subclinical AF has placed new pressures on cardiologists who have to decide whether to solve for stroke risks (with anticoagulants) or bleeding risks (by withholding anticoagulants). The NOAH-AFNET trial added much needed data to support these decisions, clarifying that many of these patients are better off without anticoagulants.

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. 

Upcoming master class: Multimodality imaging for cardiac interventions

Join Dr. Nicolo Piazza for a five-session master class delving into chamber views, projection curves, and advanced imaging. The first session kicks off on September 18 at 7:30 p.m. ET. Don’t miss it!

The Wire

• Qiliqiangxin’s HF Impact: The QUEST trial arguably raised the most eyebrows at ESC 2023, finding that the traditional Chinese Medicine qiliqiangxin significantly improved HFrEF patient outcomes. The study randomized 3,110 HFreF patients in China to either take qiliqiangxin plus three heart failure drugs or only take the HF drugs, finding that after 18.3 months the qiliqiangxin+meds group had a 22% lower rate of HF hospitalization or cardiovascular death (25% vs. 30%, P <0.001). The qiliqiangxin group also had greater three-month reductions in serum NT-proBNP levels (-444 vs. -363), matching a 2013 study.

• Siemens Launches Echo Scanner: ESC 2023 brought the launch of Siemens Healthineers’ Acuson Origin cardiovascular ultrasound scanner. The Acuson Origin includes a number of AI-powered features to improve consistency, reproducibility, and efficiency, such as auto-tracking on contrast images and 2D and 4D HeartAI tools that provide automated contouring and quantification of all four heart chambers. 

• Olpasiran’s Long-Lasting Lp(a) Reductions: The latest data from Amgen’s Ocean(a)-DOSE trial showed that olpasiran has a long-lasting impact on Lp(a) levels, well after patients’ last dose. Amgen made waves at AHA 2022, when the Ocean(a)-DOSE trial showed that patients who took at least 75 mg of olpasiran saw an over 95% Lp(a) reduction at week 36. That wave reformed at ESC 2023 where follow-up data revealed that patients who hadn’t taken olpasiran for nearly a year still had 40% to 50% Lp(a) reductions.

• HeartFlow’s FFRCT’s National Improvements: Two-year results from the NHS’ nationwide implementation of HeartFlow’s FFRCT Analysis solution revealed significant improvements in patient outcomes and clinical efficiency. The deliciously-named FISH&CHIPS study of 90k patients showed that the NHS’ FFRCT adoption led to significant reductions in cardiovascular and all-cause mortality (-14% & -8%). Those mortality improvements complement solid efficiency gains, driven by reductions in invasive cardiac angiography and additional non-invasive heart testing after CCTA, and an increase in PCI procedures (-5% & -14% & +8%).

• Withings Body Scan Clearance: Withings announced the FDA clearance of its Body Scan Connected Health Station, making it the first smart scale to gain approval for the detection of atrial fibrillation through a 6-Lead ECG. Outside of the AFib detection and the obvious weight measurement features, Body Scan also carries a range of other sensors to pick up unique biomarkers, such as basal metabolic rate (the number of calories the body burns at rest) and overall body composition (whole-body fat, water percentage, visceral fat, plus muscle / bone mass).

• PFA’s Noninferior Ablation Results: Results presented at ESC 2023 showed that Boston Scientific’s FARAPULSE PFA System achieved noninferior safety and efficacy versus conventional thermal ablation for the treatment of paroxysmal AFib. ADVENT trial researchers randomized 607 patients to undergo PFA or conventional ablation (RF & cryo), finding that after one year the groups had similar clinical success rates (73.3% vs. 71.3%) and rates of serious adverse events (2.1% vs. 1.5%). PFA also showed efficiency advantages, and potentially less myocardial tissue damage, although some commenters focused on PFA’s lacking superiority evidence.

• US2.ai Cuts Glasgow and Clyde HF Times: Results from the OPERA Study presented at ESC 2023 showed how US2.ai’s echo AI solution improved the NHS Greater Glasgow and Clyde’s heart failure screening pathway. The real world study of 900 patients with suspected HF scanned between January and August 2021 found that the US2.ai-enabled screening pathway reduced echo waiting times from 12 months to under 6 weeks. Those improvements would have allowed 9x more suspected HF patients to be screened each year, while giving physicians more time for diagnosis and patient care.

• Europe’s CVD Costs: Cardiovascular disease cost the EU an estimated €282 billion in 2021, equaling 2% of Europe’s GDP and surpassing the EU’s €186.6B total 2023 spending budget. Health and long-term care accounted for the majority of the EU’s CVD costs (55%), followed by informal care costs and productivity losses (28% & 17%). The authors urged the EU to better combat cardiovascular risks, particularly calling for preventative cardiovascular health regulations and investing in research.

• Blackford Adds Ligence Echo AI: Blackford Analysis announced the addition of Ligence Medical AI Solutions’ Ligence Heart echo algorithm to its multi-vendor AI platform, joining Us2.ai as its second echo AI solution. Ligence Heart, which has a CE Mark and is pending FDA clearance, mimics the steps taken by cardiologists and sonographers, enabling clinicians to analyze echo images moments after they are acquired. 

• OCT-Guided PCI’s Mixed Results: Key trials presented at ESC 2023 arguably fell short of showing that OCT-guided PCI is significantly better than angiography-guided PCI. The highly anticipated ILUMIEN IV trial (n=2.5k) found that OCT-guided and angiography-guided PCI had similar two-year rates of target-vessel failure (7.4% vs 8.2%), although OCT-guided PCI had less stent thrombosis, better stent placement, fewer procedural complications. OCT did better in the OCTOBER trial (n=1.2k), finding that OCT-guided PCI in patients with complex coronary-artery bifurcation lesions was associated with a lower incidence of MACE after two years versus angiography-guided PCI (10.1% vs. 14.1%).

• Leqvio’s Long-Term Data: Results from the ORION-8 trial highlighted Novartis Leqvio’s (inclisiran) long-term LDL-C reduction efficacy and safety when combined with statin therapy. Among the 2,446 patients who took inclisiran twice-yearly for three years along with statin therapy, six-year follow-up data revealed that 78.4% reached their prespecified LDL-C targets, with a 49.4% average LDL-C reduction. 

Overcoming Cardiovascular Data Challenges

Aggregating multisource cardiology data is a worthy mission, but it’s often thwarted by confusion and complexity. This Change Healthcare article with Dr. Jennifer Hall, chief of data science at the American Heart Association, outlines best practices to help you overcome your cardiology data challenges and start leveraging deeper insights.

PRECISE Trial Rewrites the Patient Pathway

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.

The Resource Wire

• Noise and artifacts can make automated ECG analysis less reliable than what’s required for the exacting standards of cardiac safety trials. Monebo’s Kinetic Intervals ECG Algorithm provides precise interval measurements between any two points on the ECG waveform, allowing clinicians to utilize data they can trust.

• We talk a lot about AI’s potential to expand echo access, and this Imaging Wire Show reveals that ultrasound’s AI-driven expansion might go far beyond what many of us had in mind. Check out our discussion with Duke Health’s Madhav Swaminathan, MBBS, MD and Us2.ai’s Carolyn Lam MBBS, PhD and James Hare, to see how AI is democratizing echo exams.

• How can AI help physicians “see” beyond conventional lipid profiles? Tune in to this upcoming webinar, examining how Cleerly’s AI-QCT solution complements conventional approaches to evaluating heart disease risk factors, and improve coronary artery disease diagnosis and heart attack risk assessments. Reserve your spot today in order to join live on September 21st.