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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Research Study Shows Cardiac Ultrasound AI May Be Superior to Anatomic Pathologists at Predicting COVID-19 Death Risk

WASE-COVID Study also found that use of artificial intelligence technology minimized variability among echocardiogram scan results

Many physicians—including anatomic pathologists—are watching the development of artificial intelligence (AI)-powered diagnostic tools that are intended to analyze images and analyze the data with accuracy comparable to trained doctors. Now comes news of a recent study that demonstrated the ability of an AI tool to analyze echocardiograph images and deliver analyses equal to or better than trained physicians.

Conducted by researchers from the World Alliance Societies of Echocardiography and presented at the latest annual sessions of the American College of Cardiology (ACC), the WASE-COVID Study involved assessing the ability of the AI platform to analyze digital echocardiograph images with the goal of predicting mortality in patients with severe cases of COVID-19.

The findings could have widespread implications for the adoption of AI solutions that assist doctors in analyzing the full range of digital images used by radiologists, pathologists, and other specialist physicians. The researchers published their study in the Journal of the American Society of Echocardiography (JASE), titled, “Echocardiographic Correlates of In-Hospital Death in Patients with Acute COVID-19 Infection: The World Alliance Societies of Echocardiography (WASE-COVID) Study.”

To complete their research, the WASE-COVID Study scientists examined 870 patients with acute COVID-19 infection from 13 medical centers in nine countries throughout Asia, Europe, United States, and Latin America.

Human versus Artificial Intelligence Analysis

Echocardiograms were analyzed with automated, machine learning-derived algorithms to calculate various data points and identify echocardiographic parameters that would be prognostic of clinical outcomes in hospitalized patients. The results were then compared to human analysis.

All patients in the study had previously tested positive for COVID-19 infection using a polymerase chain reaction (PCR) or rapid antigen test (RAT) and received a clinically-indicated echocardiogram upon admission. For those patients ultimately discharged from the hospital, a follow-up echocardiogram was performed after three months.

“What we learned was that the manual tracings were not able to predict mortality,” Federico Asch, MD, FACC, FASE, Director of the Echocardiography Core Lab at MedStar Health Research Institute in Washington, DC, told US Cardiology Review in a video interview describing the WASE-COVID Study findings.

Asch is also Associate Professor of Medicine (Cardiology) at Georgetown University. He added, “But on the same echoes, if the analysis was done by machine—Ultromics EchoGo Core, a software that is commercially available—when we used the measurements obtained through this platform, we were able to predict in-hospital and out-of-hospital mortality both with ejection fraction and left ventricular longitudinal strain.”

Federico Asch, MD

“When compared to the manual reads, the AI algorithms had a much higher predictive value for mortality,” Federico Asch, MD (above), told US Cardiology Review. “Indeed, they were predictive where the manual ones were not.” These findings may have implications in the development and adoption of artificial intelligence driven clinical laboratory diagnostics and for predicting risk of COVID-19 deaths in hospitalized heart patients. Click here to review the entire video interview. (Photo copyright: US Cardiology Review.)

Nearly half of the 870 hospitalized patients were admitted to intensive care units, 27% were placed on ventilators, 188 patients died in the hospital, and 50 additional patients died within three to six months after being released from the hospital.

According to an Ultromics news release:

  • 10 of 13 medical centers performed limited cardiac exams as their primary COVID in-patient practice and three out of the 13 centers performed comprehensive exams.
  • In-hospital mortality rates ranged from 11% in Asia, 19% in Europe, 26% in the US, to 27% in Latin America.
  • Left ventricular longitudinal strain (LVLS), right ventricle free wall strain (RVFWS), as well as a patient’s age, lactic dehydrogenase levels and history of lung disease, were independently associated with mortality. Left ventricle ejection fraction (LVEF) was not.
  • Fully automated quantification of LVEF and LVLS using AI minimized variability.
  • AI-based left ventricular analyses, but not manual, were significant predictors of in-hospital and follow-up mortality.

The WASE-COVID Study also revealed the varying international use of cardiac ultrasound (echocardiography) on COVID-19 patients.

“By using machines, we reduce variability. By reducing variability, we have a better capacity to compare our results with other outcomes, whether that outcome in this case is mortality or it could be changes over time,” Asch stated in the US Cardiology Review video. “What this really means is that we may be able to show associations and comparisons by using AI that we cannot do with manual [readings] because manual has more variation and is less reliable.”

He said the next steps will be to see if the findings hold true when AI is used in other populations of cardiac patients.

COVID-19 Pandemic Increased Need for Swift Analyses

An earlier WASE Study in 2016 set out to answer whether normal left ventricular heart chamber quantifications vary across countries, geographical regions, and cultures. However, the data produced by that study took years to review. Asch said the COVID-19 pandemic created a need for such analysis to be done more quickly.

“When the pandemic began, we knew that the clinical urgency to learn as much as possible about the cardiovascular connection to COVID-19 was incredibly high, and that we had to find a better way of securely and consistently reviewing all of this information in a timely manner,” he said in the Ultromics new release.

Coronary artery disease (CAD) is the most common form of heart disease and affects more than 16.5 million people over the age of 20. By 2035, the economic burden of CAD will reach an estimated $749 billion in the US alone, according to the Ultromics website.

“COVID-19 has placed an even greater pressure on cardiac care and looks likely to have lasting implications in terms of its impact on the heart,” said Ross Upton, PhD, Founder and CEO of Oxford, UK-based Ultromics, in a news release announcing the US Food and Drug Administration’s 510(k) clearance for the EchoGo Pro, which supports clinicians’ diagnosing of CAD. “The healthcare industry needs to quickly pivot towards AI-powered automation to reduce the time to diagnosis and improve patient care.”

Use of AI to analyze digital pathology images is expected to be a fast-growing element in the anatomic pathology profession, particularly in the diagnosis of cancer. As Dark Daily outlined in this free white Paper, “Anatomic Pathology at the Tipping Point? The Economic Case for Adopting Digital Technology and AI Applications Now,” anatomic pathology laboratories can expect adoption of AI and digital technology to gain in popularity among pathologists in coming years.

—Andrea Downing Peck

Related Information:

Echocardiographic Correlates of In-Hospital Death in Patients with Acute COVID-19 Infection: The World Alliance Societies of Echocardiography (WASE-COVID) Study

ACC 2021: Findings from the WASE COVID Study

Artificial Intelligence Predictors of Death from COVID-19

Left Ventricular Diastolic Function in Healthy Adult Individuals: Results of the World Alliance Societies of Echocardiography Normal Values Study

Echocardiographic Correlates of In-Hospital Death in Patients with Acute COVID-19 Infection: The World Alliance Societies of Echocardiography (WASE-COVID) Study

Human vs AI-Based Echocardiography Analysis as Predictor of Mortality in Acute COVID-19 Patients: WASE-COVID Study

Ultromics Receives FDA Clearance for EchoGo Pro; a First-of-Kind Solution to Diagnose CAD

Anatomic Pathology at the Tipping Point: The Economic Case for Adopting Digital Technology and AI Applications Now

Where Are the Patients? Hospitals and Clinical Laboratories Wonder When Routine Surgeries, Procedures, and Testing Can Be Restarted Once the COVID-19 Outbreak Eases

Even as some states lift stay-at-home orders, clinical laboratories and pathology groups face uncertainty about how quickly routine daily test referrals will return to normal, pre-pandemic levels

Although strokes and heart attacks do not take vacations, a large and growing number of patients with serious health issues who—in normal times—would require immediate attention are not contacting providers to get needed care. Instead, they are avoiding hospital emergency rooms and clinical laboratories for fear they’ll contract the COVID-19 coronavirus.

Starting in early March, hospitals nationwide suspended elective surgeries and procedures and reduced non-COVID-19 inpatient care to make beds available for the predicted on-rush of COVID-19 patients. However, in parts of the country, the predicted high demand for hospital beds and ventilators failed to materialize. Additionally, due to shelter-in-place orders, patients in many states postponed routine office visits with their primary care physicians.

The collective collapse in the number of elective services provided by hospitals, and the fall-off in patients visiting their doctors, is crushing the financial stability of the nation’s clinical laboratory industry.

In, “From Mid-March, Labs Saw Big Drop in Revenue,” Dark Daily’s sister publication, The Dark Report (TDR) reported on the revenue challenges facing clinical pathology groups and clinical laboratories. Kyle Fetter, Executive Vice President and General Manager of Diagnostic Services at XIFIN, a revenue cycle management company, told TDR that starting in the third week of March, labs suffered a steep decline in routine testing. By the end of March, that fall-off in revenue ranged from 44% for some AP specimens to 70% to 80% for some specialty AP work. During these same weeks, XIFIN’s data showed clinical labs experienced a drop in routine testing volume of 58%, hospital outreach testing declined by 61%, and molecular lab volume went down by 52%.

Using data from multiple sources, The Dark Report estimates that—compared to pre-pandemic levels—the clinical laboratory profession lost almost $900 million in revenue each week—or about $5.2 billion as of April 26. (See Dark Daily, “COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling US $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse,” May 4, 2020.)

Can Clinical Laboratories Hang on Financially Until COVID-19 Goes Away?

Though most states have not met the nonbinding criteria recommended by the Trump administration for reopening, nearly 40 governors in early May began loosening stay-at-home orders, reported CNN, including allowing elective medical procedures to resume.

Patients may make up for lost time by returning to doctors’ offices for medical laboratory tests and other COVID-19-delayed procedures, and as this happens, clinical laboratories may experience a surge in routine test orders from doctors’ offices and hospital admissions once stay-at-home orders are lifted and fear of COVID-19 has passed.

According to an article published on Axios, a survey of 163 physicians conducted by SVB Leerink—an investment firm that specializes in healthcare and life sciences—found that “roughly three out of four doctors believe patient appointments will resume to normal, pre-coronavirus levels, no earlier than July, and 45% expect a rebound to occur sometime between July and September.” If so, the financial squeeze facing clinical laboratories, pathology groups, and other medical and dental professionals may continue to loosen.

Christopher Freer, DO, an emergency physician at St. Barnabas Hospital in the Bronx and Director of Emergency Medicine at RWJ Barnabas Health
Christopher Freer, DO (above), an emergency physician at St. Barnabas Hospital in the Bronx and Director of Emergency Medicine at RWJBarnabas Health, told CNBC that emergency departments are seeing patients with severe issues, such as stroke and appendicitis, but that those with milder symptoms appear to be staying away. “Even with coronavirus, we still have healthy people who get an illness and need to go to the emergency room,” he said. “Heart attacks don’t stop.” (Photo copyright: USA Today.)

Hospital Finances Are Being Particularly Stressed by Loss of Patients

The impact of stay-at-home orders on hospital systems, in particular, has been dramatic. CNBC reported that RWJBarnabas Health, an 1l-hospital 22-laboratory health system in New Jersey that has 11 emergency departments, totaled just 180 emergency room visits per day during a mid-April weekend, a sharp decline from their 280-per-day-average.

A recent Washington Post article paints an even bleaker picture. Clinicians in the United States, Spain, United Kingdom, and China anecdotally report a “silent sub-epidemic of people who need care at hospitals but dare not come in,” the article states, noting people with symptoms of appendicitis, heart attacks, stroke, infected gall bladders, and bowel obstructions are avoiding hospital emergency rooms.

“Everybody is frightened to come to the ER,” Mount Sinai Health System cardiovascular surgeon John Puskas, MD, told the Post. Though his 60-bed cardiac unit had been repurposed to care for COVID-19 patients, Puskas said the New York hospital system was seeing “dramatically fewer” cardiac patients. 

Concerned that patients may be ignoring signs of heart attack or stroke rather than go to a hospital, the American College of Cardiology launched the “CardioSmart” campaign, which urges anyone experiencing heart symptoms to get prompt treatment and to continue routine appointments, using telehealth technology when available.

“Hospitals have safety measures to protect you from infection,” the CardioSmart website states. “Getting care quickly is critical. You’ll get better faster, and you’ll limit damage to your health.”

However, David Brown, MD, Chief of Emergency Medicine at Massachusetts General Hospital in Boston, argues the number of people having heart-related issues is unlikely to have dropped during the pandemic.

“Strokes and heart attacks don’t take a vacation just because there’s a pandemic,” Brown told The Boston Globe. “They’re still happening. They just aren’t happening as much inside the hospital, which is a major concern to me.”

Many healthcare professionals are worried about the long-term effect from pandemic-delayed preventative and elective procedures.

“The big question is are we going to see a lot more people that have bad outcomes from heart disease, from stroke, from cancer because they’ve put off what they should have had done, but were too afraid to come to the hospital?” Providence St. Joseph Health CEO Rod Hochman, MD, told CNBC.

Hochman, who is Chair-elect of the American Hospital Association (AHA), maintains the aftereffects of people putting off elective surgeries and screening procedures like colonoscopies and mammograms may be felt for years to come.

“We’re possibly going to see a blip in other disease entities as a consequence of doubling down on COVID-19,” he told CNBC.

In clinical laboratories, COVID-19 testing may have somewhat helped offset the drop in routine testing volume. However, the pandemic’s overall financial costs to labs and pathology groups will likely be felt for months to years, as patients slowly return to healthcare providers’ offices and hospitals.

—Andrea Downing Peck

Related Information:

From Mid-March, Labs Saw Big Drop in Revenue

Opening Up America Again

Doctors Worry the Coronavirus Is Keeping Patients Away from U.S. Hospitals as ER Visits Drop: ‘Heart Attacks Don’t Stop.’

When Doctors Think Patient Visits Will Rebound

Coronavirus and Your Heart: Don’t Ignore Heart Symptoms

‘Strokes and Heart Attacks Don’t Take a Vacation.’ So Why Have Emergency Department Visits Sharply Declined?

This is Where All 50 States Stand on Reopening

COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling US $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse

Registry-based Clinical Trials Can Dramatically Slash Both Time and Cost to Complete Studies Involving New Therapeutic Drugs and Medical Laboratory Tests

New approach to clinical trials promises to make it faster and cheaper to do meaningful clinical studies, thus benefiting pharma firms and in vitro diagnostics manufacturers

There’s a new approach to clinical trials that helps shorten the time required to gain regulatory approval of new therapeutic drugs and in vitro diagnostic tests, while slashing the costs of a clinical trial by as much as 90%. This could end up being an important trend for clinical laboratories and pathology groups to perform medical laboratory testing.

Whatever it is—including clinical trials, everyone wants it faster, better, cheaper. That contemporary notion seems to apply to registry-based randomized clinical trials. This is one approach that can be used when both pharmaceutical and laboratory test companies seek efficient ways to demonstrate functional and clinical value of their products to the FDA, Medicare, and private payers. (more…)