A tweet from Jonathan Reiner, MD, an interventional cardiologist at George Washington University School of Medicine.

Cardiovascular Disease Solutions

GRACE 3.0: Correcting the Default Male Risk

A Lancet-published study highlighted the limitations of the GRACE 2.0 heart attack mortality risk score – namely, the systematic underestimation of mortality risk in female patients – and offered a solution.

The internationally used Global Registry of Acute Coronary Events (GRACE) 2.0 system was developed and validated using a predominantly male patient population. And yet it “is used in both sexes alike,” without accounting for sex-specific disease characteristics.

In the new Lancet study, researchers from the UK and Switzerland reviewed GRACE 2.0’s performance in 421k patients with non-ST-elevation acute coronary syndromes, and found it to be less accurate in women: 

• GRACE 2.0 accurately predicted in-hospital death for male patients but was notably less accurate with female patients (AUCs: 0.86 vs. 0.82). 
  
• GRACE 2.0 was prone to incorrectly classify women as low-to-intermediate risk, keeping at-risk women from receiving early invasive treatment. 

The authors didn’t stop there. They developed their own AI-powered algorithm that accounted for sex-specific disease differences. Their risk prediction model, dubbed GRACE 3.0, was trained on 310k patients, validated in 78k patients, and externally validated in 21k patients. GRACE 3.0 performed better for both women and men: 

• Grace 3.0’s prediction accuracy exceeded GRACE 2.0 in both validation cohorts, irrespective of sex. 

• On the external dataset, the model showed superior discrimination for both male and female patients (AUCs 0.91 & 0.87).

• GRACE 3.0 decreased the proportion of women (-5.3%) and increased the proportion of men (+2.2%) considered low-to-intermediate risk.

The Takeaway

This study and the new GRACE 3.0 system take on an issue that has long plagued cardiology: male-biased data. The authors revealed clinically relevant limitations of the GRACE 2.0 score, which favors the under-treatment of female patients, and demonstrated GRACE 3.0’s advantages for males and females alike.

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The Wire

• Biosense Webster’s OCTARAY: Biosense Webster announced the market debut of its OCTARAY mapping catheter, designed to map cardiac arrhythmias. The catheter has eight splines to improve signal quality, which in turn allows electrophysiologists to quickly capture a chamber’s anatomy and conduction properties. The new device comes with TRUEref technology – a novel mapping reference electrode – powered by the Carto 3 version 7 system.

• CMR and PET Comparable in CAD: In a head-to-head comparison, two noninvasive imaging methods for assessing coronary artery disease – cardiac MRI (CMR) and PET with rubidium (RbPET) – identified CAD to nearly identical degrees. With fractional flow reserve assessment via invasive coronary angiography as the reference, CMR and RbPET showed no significant differences in sensitivity (59% vs. 64%), specificity (84% vs. 89%), and positive and negative predictive values among 372 patients with suspected stenosis.

• EchoNous’s Kosmos AS Achievement: A paper published in JASE found that EchoNous’s commercially available Kosmos handheld ultrasound device, which has CW Doppler (CWD) capabilities, could reliably detect and grade aortic stenosis (AS). Of 118 patients with known or suspected AS, Kosmos with CWD achieved “excellent” agreement with a high-end cart-based echo system (intraclass correlation: 0.97). The handheld device detected at least moderate AS with 93% sensitivity, 98% specificity, and 96% total diagnostic accuracy. 

• JenaValve’s $100M Series C: TAVR manufacturer JenaValve announced the close of its $100M Series C funding round. JenaValve will use the fresh financing to complete its Trilogy Heart Valve System’s premarket approval study, bolster its European data development initiatives, and expand manufacturing capabilities worldwide. 

• Monkeypox & Acute Myocarditis: A case study published in JACC: Case Reports highlights the possibility of cardiac manifestations in patients with monkeypox infection. The study detailed a 31-year-old man who developed myocarditis three days after testing positive for monkeypox. The patient recovered quickly and was discharged one week later. The authors speculate that the monkeypox virus may have an affinity for myocardium tissue or cause immune-mediated injury to the heart. 

• Postpartum Hypertension RPM: Clinical management platform Rimidi and Boston Medical Center released findings from their ongoing RPM program for postpartum hypertension, which monitors new moms for six weeks using cellular-connected blood pressure cuffs and alerts clinicians of abnormal readings. In a six-month period, 505 patients recorded 9k BP readings, leading to 1.1k abnormal BP alerts and 700 care team messages. Following the strong engagement from the hypertension program, BMC is now expanding the program to include gestational hypertension (using smart BP cuffs) and gestational diabetes (using FreeStyle Libre CGMs).

• CuriMeta Debut: Data analytics firm CuriMeta locked in $6M in seed funding last week, courtesy of its founding collaborators BJC Healthcare and WashU Medicine. The funding will help the startup provide curated data sets and analyze clinical data provided by BJC and WashU to advance precision therapies. CuriMeta is recruiting data contributors from provider organizations and academic medical centers, particularly those focused on cardiology, oncology, and neurology.

• The Home Advantage: Kaiser Permanente researchers revealed that high-risk CVD patients who received home-based cardiac rehabilitation were 21% less likely to be hospitalized within twelve months than those who received center-based rehab. The two study arms (N = 2.5k) fared similarly when it came to medication adherence, blood pressure control, LDL cholesterol, and hemoglobin A_1c at twelve months. The analysis was uniquely comprehensive; the authors included a medically complex and racially diverse population. 

• Viz.ai’s RV/LV FDA Clearance: Viz.ai announced the FDA clearance of its automated RV/LV ratio analysis algorithm, a new risk stratification feature the company has added to its pulmonary embolism AI module Viz PE. The added right heart strain analysis will allow the Viz PE system to help care teams make clinical decisions with added insights into patients’ right heart strain. This addition might also improve clinicians’ experience with Viz PE, noting the risk of developing AI “alert fatigue” when all severity levels are treated the same.

• FFR vs. IVUS PCI Guidance: A NEJM-published study found FFR guidance for percutaneous coronary intervention did not result in worse patient outcomes than intravascular ultrasonography (IVUS). Researchers randomized 1.7k patients with intermediate stenosis (based on visual estimation) to undergo either an FFR- or IVUS-guided procedure. At two years post-procedure, both groups had a similar rate of composite death, heart attack, and revascularization (8.1% vs. 8.5%), as well as similar self-reported chest pain symptoms.

• Cardiologists Favor Home Dialysis: The American Heart Association published a 19-page statement supporting the use of home dialysis over in-center dialysis for patients with kidney and cardiovascular disease. The authors underscore that it is important for cardiologists to be comfortable with kidney failure treatment options, as end-stage kidney disease and cardiovascular disease frequently co-exist. Thrice-weekly in-center hemodialysis is currently the most common therapy worldwide, despite an estimated 15% annual mortality rate in the US. Home dialysis therapies, the authors assert, should improve outcomes. 

Pivoting to Population Health AI

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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.