Divaka Perera, MD, of King’s College London, on the REVIVED trial findings.

Surgeries & Interventions

PCI Fizzles in REVIVED Study

The highly anticipated REVIVED trial found that percutaneous coronary intervention (PCI) does not reduce all-cause mortality or heart failure hospitalization in patients with severe ventricular dysfunction. 

The researchers thought that PCI would improve outcomes in these patients, all of whom had myocardial viability, extensive and stable coronary artery disease, and severe ischaemic left ventricular dysfunction (ejection fraction ≤ 35%). In fact, the researchers selected this patient population because they were the most likely cohort to experience PCI benefits. The authors wanted to “stack the deck” in favor of intervention. 

But when the investigators randomized 700 patients into either PCI or medical therapy groups, and then followed up between 2 and 8.5 years later, they found no clear PCI advantage.  

• By a median of 3.4 years, 38% of the medical therapy group had either died or experienced heart failure hospitalization.
  
• Surprisingly, the percentage was exactly the same in the PCI group (hazard ratio: 0.99).
  
• There was also no difference in left ventricular ejection fraction at six and 12 months.
  
• By 2 years, quality-of-life scores were not significantly different.

The Takeaway

The authors found no long-term benefit to the more invasive option for patients with stable coronary artery disease and impaired LV systolic function. That’s consistent with other studies showing PCI isn’t always safer or better than medication therapy for people with CAD, although it is the first to demonstrate these findings in this patient population. It might also prompt cardiologists to think twice before offering PCI to patients with ischemic cardiomyopathy.

Detecting CAC and Undiagnosed CAD

Do you know how many patients in your health system are at risk for coronary artery disease but are undiagnosed? This article details how Nanox AI’s CAC solution can help clinicians identify those who often go undetected. 

When Your Company Saves Your Life

We’re happy to share a special interview detailing how Cleerly’s CCTA AI solution allowed one of its own team members to catch and treat his asymptomatic, life-threatening atherosclerosis.

The Wire

• Rheumatic AFib: The largest trial in patients with rheumatic atrial fibrillation has found that rivararoxaban increases major CV event risk and mortality, compared to vitamin K antagonists (VKAs). 4.6k patients (138 sites, 24 countries) took either rivaroxaban 20mg daily or adjusted dose VKA. Over a three year follow-up, rivaroxaban increased the risk of stroke, systemic embolism, MI, or death by 25% when compared with VKA therapy. 

• Hello Heart’s Cholesterol App: Fresh off the heels of its $70M Series D raise, Hello Heart is leaning in on cholesterol tracking in an effort to become the first digital therapeutic to tackle all key cardiovascular disease factors – blood pressure, cholesterol, and diabetes. With Hello Heart’s new My Cholesterol feature, users can import their cholesterol lab results to visualize trends over time and receive AI-powered coaching specific to their lifestyles, as well as personalized explanations of lipid panels that can be difficult to interpret without support.

• Detecting “Hot” Arteries: Researchers successfully used a novel PET-CT technique to predict which heart attack patients were most likely to experience a recurrent event. The researchers leveraged an inflammation-binding PET tracer (18F-NaF) to highlight “hot” coronary arterial plaque in 704 patients with recent MI and multivessel disease. Compared with those with “cold” arteries (inactive disease), those with hot arteries were almost 2.5 times more likely to die of any cause, and 82% more likely to experience coronary heart disease death or another heart attack.

• Fitbit’s AFib Debut: Fitbit unveiled its smartwatch model Sense 2, which can detect signs of AFib through its ECG app and PPG algorithm (both FDA cleared & CE marked). When the watch detects heart-rate irregularities it automatically notifies the wearer, who can then share the readings with a healthcare provider. The new version includes other previously-integrated features, including breathing rate, skin temperature, and oxygen saturation.

• The Smartphone Screening Advantage: Smartphone screening more than doubled AFib detection and treatment rates in older people compared to routine screening. Researchers randomized 5.5k high-risk older adults to either smartphone or conventional screening groups. The smartphone screeners used the Preventicus Heartbeats app to perform heart rate/rhythm recordings twice a day for 14 days, and then twice a week, with follow-up from a local physician not involved in the study if the reading was abnormal. Over six months, AFib was significantly more likely to be detected and treated in the smartphone group (odds ratio: 2.12). 

• Statins and Muscle Symptoms: An expansive meta-analysis found that a majority of muscle-related side effects associated with statin therapy are actually not due to the treatment. Across 19 randomized double-blind trials (124k patients), over one-quarter of patients taking a statin reported muscle pain/weakness, but so did patients taking a placebo (27.1% vs. 26.6%). After the first year, the authors found no excess risk of muscle pain or weakness with statins (rate ratio: 0.99). 

• Cardiology’s Digital Health Roadmap: The World Heart Federation published a Roadmap for Digital Health in Cardiology, a reference document for policymakers, healthcare professionals, and patient advocates. The report identified at least 17 “roadblocks” to implementing digital health technologies for CVD (e.g. lack of monitoring and evaluation standards) and proposed corresponding solutions (e.g. continually monitoring software performance and safety when using rapidly changing algorithms). 

• ScionHealth’s HF RPM: Louisville-based ScionHealth is teaming up with Cadence to implement a chronic condition RPM platform starting with 18 of the health system’s community hospitals. The intervention-as-needed platform is designed to improve care for heart failure and diabetes patients by collecting daily vitals (blood pressure, heart rate, blood oxygen, glucose levels, weight) and transmitting the data to their care teams. The groups plan to expand the program to ScionHealth’s full 79 hospital network in the near future. 

• Myocarditis After COVID vs. Vaccine: A meta-analysis of 43M people revealed that COVID patients were 11 times more likely to develop myocarditis as a result of their infection, compared to after the vaccine. The risk of COVID-related myocarditis also appeared to be half as much among patients who had received at least one dose of a vaccine prior to infection. 

• AstraZeneca’s SGLT2 Inhibitor Victory: AstraZeneca’s SGLT2 inhibitor Farxiga (dapagliflozin) is the first heart failure drug to reduce the risk of death in all patients, regardless of their left ventricular ejection fraction range. In this NEJM-published study, researchers randomly assigned six thousand individuals with HF and a left ventricular ejection fraction greater than 40% to receive dapagliflozin (10mg once daily) or a matching placebo. Over a 2.3-year median follow-up, dapagliflozin was tied to an 18% reduction in worsening heart failure or CV death.

• Medtronic’s Stent Launch: Medtronic recently announced the launch of its Onyx Frontier drug-eluting stent (FDA approved & CE marked). Onyx Frontier inherits the same clinical data and indications as Medtronic’s previous Resolute Onyx stent, while adding improvements to its flexibility and “crossing profile” (It can more easily cross through narrow stenoses). 

Us2.ai Brings Clarity to Cardiac Imaging

Learn about how Us2.ai is bringing simplicity and clarity to the world of cardiac ultrasound, on the latest episode of The Bleeding Edge of Digital Health featuring Us2.ai’s founders, James Hare and Dr. Carolyn Lam.

User Experience and Cardiovascular Imaging Transformation

Check out this Change Healthcare video discussing the importance of user experience in the adoption of structured reporting, and how it can lead to improvements in imaging speed, quality, and cardiologist workflow.