James Januzzi, MD on whether MI is overdiagnosed.

Cardiology Testing

The MI Overdiagnosis Problem

Over 750k people are diagnosed with myocardial infarction in the United States every year, and a new JAMA paper suggests that far more of those patients are incorrectly diagnosed than many might expect.

Because of the clinical and medicolegal consequences of incorrectly discharging an MI patient, medical practices and clinical research have largely focused on addressing MI underdiagnosis. However, evidence continues to mount that MI overdiagnosis could actually be more common:

• A review of patients with clinically diagnosed MI found that 9% of those events would have been reclassified as myocardial injury after expert review.
• Another review of clinical trials with central adjudication committees identified 15% to 20% fewer MIs than site investigators originally reported.
• A CMRI study revealed that only half of patients with clinically diagnosed MI had an infarction pattern on their cardiac MRI exams, leading to alternative diagnoses (e.g. myocarditis) for one-fifth of the participants.

So what’s causing this trend towards MI overdiagnosis? The authors believe that the current MI diagnosis criteria (symptoms of coronary ischemia + abnormal troponin levels) isn’t sufficient, and the liberal use of troponin testing (particularly in the US) has compounded this problem.

• One study revealed that a quarter of all ED visitors underwent a troponin test, even though less than half of them had chest pain.
• Another study showed that roughly one in seven ED patients had elevated troponin, even though they weren’t experiencing an MI, in part because troponin can be a sign of other non-coronary diseases.
• Current troponin thresholds are based on cohorts of young or middle-aged adults, and many patients who receive troponin tests are older.

In other words, we’re giving more low-probability patients highly sensitive troponin tests, and there’s “a complete lack of understanding” about troponin-based MI diagnosis, leading to a surge in false-positive MI cases.

In order to reduce MI overdiagnosis, the authors suggest…

• Enacting laws limiting malpractice payments (and limiting defensive medicine)
• Limiting troponin testing to higher-probability patients
• Considering new age-specific troponin thresholds
• Adopting new AI-based MI detection solutions
• Developing new biomarkers for MI detection
• Using cardiac imaging for ambiguous cases
• Better adherence to the MI guidelines

The Takeaway

MI overdiagnosis might not get the headlines, but there’s a strong chance that it’s now more common than MI underdiagnosis, leading to a cascade of unnecessary testing, treatments, costs, and stress. We need more research to confirm this theory, and we’d need some big changes if it proves to be true.

Us2.ai’s Next Gen AI

Us2.ai recently scored FDA clearance for Us2.v2, the newest version of its flagship software featuring 45 automated echocardiography parameters, including strain analysis. See how the new version automates echo exams and improves cardiovascular disease detection.

Personalized Care Pathway for Heart Attack Prevention

More than 50% of patients who suffer a heart attack are considered “low risk” based on symptoms, but in fact do have plaque build up. Cleerly tackles the matter head-on in their 5-step care pathway for early diagnosis, informed decision making, and personalized treatment.

The Wire

• Wegovy’s Medicare Accessibility: KFF estimates that recent moves from the FDA and CMS to support semaglutide (Novo Nordisk’s Wegovy) for CVD event risk reduction will expand coverage to 3.6M more Medicare beneficiaries (7% of all beneficiaries). Because Medicare doesn’t support weight loss-only medications, this expansion will have a major impact on beneficiaries’ GLP-1 accessibility… and costs. If 10% of that population uses Wegovy for a full year, it would add up to $2.8B in new Medicare Part D spending.

• HF Mortality Rising: A JAMA Cardiology study revealed that heart failure-related mortality is on the rise in the US, reversing declines seen between 1999 and 2005. The annual HF mortality rate declined by 1.62% from 1999-2005 and fell by 3.3% from 2005-2009. However, HF mortality increased by 1.92% between 2012-2019, and jumped by 7.06% in 2020-2021. This shift represented a 103.2% overall reversal in mortality rates, with the greatest reversal seen in people younger than 45 (906.3%).

• Us2.ai’s PCWP Evidence: A new study out of Northwestern showed that Us2.ai’s automated echo measurements matched human expert estimates of invasively measured pulmonary capillary wedge pressure (PCWP), representing another example of how echo AI could aid in HF detection. Among 626 patients with HFpEF and HFmrEF, Us2.ai’s echo AI measurements of LA pressure performed as well as core lab measurements, while reservoir strain had the highest AUROCs for predicting elevated PCWP with both the core lab and Us2.ai measurements (0.69 & 0.66).

• Banning Non-Competes: In a move that’s reverberating throughout the business and healthcare world, the FTC this week banned non-compete agreements. The ban drew praise from physicians and nurses, who’s ability to switch employers has been hindered by non-competes, while the American Hospital Association (predictably) issued a statement panning the decision. Noting that up to 45% of physicians are involved in non-competes, the FTC estimates that this ban could reduce healthcare costs by up to $194B over the next 10 years based on the theory that non-competes drive consolidation.

• PFA + SERF Ablation: Thermedical announced the successful completion of a feasibility study assessing the treatment of ventricular tachycardia using Pulsed Field Ablation therapy combined with the company’s SERF Ablation System. Thermedical’s SERF System has already been shown to eliminate VT in the majority of study participants, and they believe that the PFA + SERF combo might “offer a more complete approach to VT ablation.”

• Medtronic’s Avalus Ultra Launch: Medtronic announced the commercial launch of its Avalus Ultra surgical aortic tissue valve, which is built upon the decade-plus foundation of the previous Avalus valve. The Avalus Ultra is designed to facilitate ease of use during implantation and support lifetime patient management, including future valve-in-valve procedures. 

• When to Use Clopidogrel Post-PCI: A real-world JACC study provided new insights into which post-PCI patients might have better or worse outcomes with clopidogrel. In the study of 4,335 patients, major atherothrombotic event (MAE) rates within one year post-PCI were similar with clopidogrel and the alternatives (prasugrel or ticagrelor). However, the alternative therapies had around 50% lower MAE rates in patients who had ABCD-GENE scores <10 or in patients with ≥10 ABCD-GENE scores who didn’t have CYP2C19 loss-of-function.

• Lexeo’s FA-CM Fast Track: The FDA granted Fast Track designation to Lexeo Therapeutics’ LX2006 for the treatment of Friedreich’s ataxia cardiomyopathy (FM-CA). LX2006 is a gene therapy that’s designed to promote frataxin protein expression and restore mitochondrial function in myocardial cells. The Fast Track designation combines with LX2006’s Rare Pediatric Disease and Orphan Drug designations to potentially speed up its development and regulatory processes.

• Flecainide’s INSTANT AFIB Conversions: The INSTANT trial showed that InCarda Therapeutics’ FlecIH, an inhaled flecainide acetate solution, was effective in converting recent-onset symptomatic AFib to sinus rhythm. FlecIH achieved a 42.6% conversion rate within a median time of 14.6 minutes, which rose to 46.9% among patients without prior flecainide exposure. With only two cases of AFib recurrence by day five, FlecIH presents a potential first-line option for acute AFib cardioversion.

• Exo’s AI Expansion: Handheld ultrasound startup Exo further expanded its AI portfolio, launching new FDA-cleared cardiac and lung solutions for use with its Exo Iris POCUS device. The new Exo cardiac AI solution specifically targets heart failure detection, providing LVEF and stroke volume measurements in “a few heartbeats,” while the lung AI focuses on pulmonary edema detection. The new AI solutions join a growing portfolio of Exo AI solutions (also: bladder, hip, and thyroid), due in part to its earlier acquisition of echo AI developer Medo AI.

• Games, Cash Motivate Physical Activity: The BE-ACTIVE study (n= 1,062) showed that home-based gamification tools and/or “loss-framed” financial incentives can motivate people with high cardiovascular risks to be more active. An intervention combining points-based gamification plus cash (+868 steps) drove the greatest activity increases versus basic text reminders, followed by gamification alone (+538), and financial incentives alone (+492). Improvement in the gamification + cash arm lasted another six months without further intervention.

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.

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.

The Resource Wire

• HeartFlow Analysis Streamlines Care: Faced with cath lab inefficiencies and an increased reliance on stress testing, Cone Health pursued a more advanced solution. See how the HeartFlow FFRct Analysis allowed Cone Health to improve the patient journey through streamlined CAD testing. 

• 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.

• 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.

• 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!

• Streamline Your Cardiology Imaging Workflows: See how cardiologists and their teams can streamline imaging workflows to make their cardiovascular service line more efficient, cost-effective, and patient-centered, using Merge’s cardiology solutions.