Device can detect PH missed by other testing methods: Case series
Corvista System useful whether or not patients show signs of condition
Corvista Health’s point-of-care device can detect cases of pulmonary hypertension (PH) that other noninvasive diagnostic tools miss, according to a recent case series.
“By enabling physicians to identify pulmonary hypertension within minutes, non-invasively, and even when traditional tests fail, we are offering a new standard of care that has the potential to save lives and preserve quality of life for countless patients worldwide,” Charles R. Bridges, MD, executive vice president and chief scientific officer of Corvista, said in a company press release.
The four presented cases demonstrate how Corvista’s point-of-care device, the Corvista System, can be useful in different clinical scenarios, including in patients showing clear signs of PH in standard tests and those not showing obvious signs of the disease.
The study, “Facilitating Earlier Diagnosis of Pulmonary Hypertension Using a Novel Noninvasive Diagnostic,” was published in JACC: Case Reports. Three of the authors are Corvista employees.
Device aimed at reducing delays in PH diagnosis
PH occurs when high pressure is present in the pulmonary arteries, the blood vessels that carry blood from the heart to the lungs. The most common type of PH, group 2, is caused by left-sided heart disease, which makes it harder for the heart to pump blood. Other kinds of PH have different features, but shortness of breath, fatigue, and chest pain are common symptoms across classifications.
Diagnosing PH can be difficult because its symptoms may overlap with those of other diseases. Right heart catheterization (RHC), which measures pulmonary artery pressure, is the gold standard diagnostic test for PH, but it is invasive.
People living with undiagnosed PH are being asked to endure years of uncertainty, undergoing repeated echocardiograms and visiting multiple specialists before receiving an accurate diagnosis.
Transthoracic echocardiograms (TTEs), which noninvasively assess heart structure and function, can be a preliminary diagnostic step. However, this method can be challenging in measuring tricuspid regurgitant velocity (TRV), a key metric for estimating pulmonary artery pressure. Up to 41% of TTEs may fail to capture TRV, complicating diagnosis and leading to delays, according to Corvista.
“People living with undiagnosed PH are being asked to endure years of uncertainty, undergoing repeated echocardiograms and visiting multiple specialists before receiving an accurate diagnosis,” Bridges said. “For those with a rare and particularly deadly type of PH which primarily affects young women, Pulmonary Arterial Hypertension (PAH), the delay has severe consequences. They wait, on average, up to three years for a correct diagnosis — time during which the disease silently progresses, often with irreversible heart failure.”
With its point-of-care technology, Corvista aims to reduce these delays. After a noninvasive heart monitoring procedure lasting less than five minutes, the tool’s machine learning algorithms can assist in diagnosing PH with high accuracy. The U.S. Food and Drug Administration approved this tool last year.
Study details four real-world cases
The present report describes four real-world cases in which the Corvista System successfully identified PH. The researchers highlighted one case involving a 75-year-old woman experiencing worsening shortness of breath and fatigue.
Over the course of six years, she underwent three TTEs, none of which identified signs of PH. Clinicians ruled out several types of lung disease. They suspected the woman had obstructive coronary artery disease, a heart condition that might explain her symptoms.
To investigate this possibility, the clinical team scheduled a left heart catheterization (LHC), which can help diagnose coronary artery disease. However, before this, they used the Corvista point-of-care device to assess the probability of PH. The results suggested possible PH, so the team added an RHC to the LHC procedure.
Although the LHC didn’t show signs of coronary artery disease, the RHC confirmed the diagnosis of group 2 PH. A specialist prescribed empagliflozin (sold as Jardiance and others) to treat the woman’s underlying left heart disease. She has done well on this medication thus far, with no unscheduled office visits or hospitalizations.
According to Corvista, this case illustrates a potential real-world application of the point-of-care device. The system “has the potential to contribute to the PH diagnostic pathway by raising the suspicion in patients where TTE was negative, inconclusive, or absent,” the researchers wrote.
The team also presented three supporting cases in which the point-of-care device, a TTE, and RHC all pointed toward PH. Two of these individuals, similar to the woman in the first case, had group 2 PH. The other, a 69-year-old woman, had possible PAH.
“In all 3 cases, [the point-of-care device] resulted in further diagnostics, followed by meaningful alterations in clinical management strategy,” the team noted.
While the first case occurred in the U.S., the other three were in Hong Kong, suggesting the device may be useful across broadly different regions and healthcare systems, according to the researchers.
Future applications of the device could include PH screening in groups at high risk of having the disease, which may help address the existing delays in PH diagnosis.
“This case series illustrates that the [the point-of-care] test may add meaningfully to the standard of care by identifying patients with PH earlier in their clinical course, when transthoracic and transesophageal echocardiography often fail to provide evidence of PH,” the researchers wrote.
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