A new, non-invasive technology that uses blood pressure cuffs to help screen people for signs of hardened arteries aims to find heart disease in young people, long before symptoms develop and early enough to do something about it.
That is important because atherosclerosis kills nearly 14 million people globally each year, according to the World Health Organization.
Atherosclerosis is often detected when people are in their 50s and 60s, said Dr. Jeffrey Raines, Harvard University and MIT graduate and retired cardiovascular surgical professor who developed the new system, known as the Soteria Cardiac Platform.
“I would like to see it used at a young age,” explained Raines, noting that previous research has shown that as many as 40 percent of people in their 30s already have signs of hardening arteries. “If you wait too late, it is unclear as to whether or not you can make any change.”
His technology was among the innovations showcased at the FIME Medical Show in Miami Beach August 5-7.
Atherosclerosis occurs when the walls of the arteries harden and expand, narrowing the path through which blood can flow. Over time, plaque builds up and dangerous lipid pools form. The result is limited flow of oxygen-rich blood to the heart and other organs, and eventually, coronary artery disease, heart attack or stroke.
Many people with atherosclerosis have no symptoms. The top risk factors are smoking, hypertension, diabetes, elevated blood lipids (cholesterol), obesity, and lack of exercise. Family history can also play a role.
Technology cleared by the FDA
The test Raines developed, called the Soterogram, costs about $200 for the patient and takes 10 minutes to complete. The cost to a doctor’s office is $50,000 to purchase a platform, or it can be leased at no up-front cost.
The technology was cleared by the US Food and Drug Administration (FDA) in May 2014.
To use it, a patient lies on his or her back and blood pressure cuffs are attached to the calf, thigh and arm, for a series of measurements and mathematical computations that gauge the strength of their artery walls.
The test works by studying arterial compliance, which is measured by the arteries’ change in volume divided by its change in pressure when blood moves through.
An artery with low compliance is stiff, and allows very little change in volume as blood pumps through. The more atherosclerosis an artery has, the more plaque it contains, and the lower its compliance.
“The result is a measurement of generalized arterial elasticity which has a direct correlation with degree of atherosclerosis and cardiovascular risk,” said Raines.
“Current methods do not work”
The patient receives a detailed report of his or her risk of heart disease, stroke or peripheral vascular disease, known as a Soterogram score, which is compared to normal values compiled from clinical studies done by the National Institutes of Health and FDA. It includes whether obstructions are mild, moderate or severe, and identifies precisely where any blockages are located. The Soterogram shows the person’s actual age, their arterial age, and their level of atherosclerosis.
The system is now available in 16 US doctors’ offices, most of them in Florida.
Before receiving FDA clearance, Raines said regulators asked him how his technology would compare to currently available methods for detecting atherosclerosis. Since young, asymptomatic patients are not likely to undergo expensive and invasive cardiac catheterization, Raines surveyed doctors’ offices around the country and found that the most popular techniques were the stress electrocardiogram (ECG) and echocardiogram.
Raines presented the FDA with research on a sample of 177 patients without diagnosed heart disease. An abdominal MRI found artery buildup in 37 patients. By comparison, the stress ECG and echocardiogram combination found none of the previously undiagnosed 37 cases, and the Soterogram found 76 percent of them.
A non-invasive good picture
Dr. Peter Jacobson of Tampa, Florida, said he uses the Soteria Cardiac Platform in his practice because it gives a good picture of a patient’s overall vascular health without exposing them to invasive techniques or the radiation of a CT scan.
“In some of the patients, their vascular age is coming out five to 10 percent higher than their actual chronological age, which is both disturbing to me and the patient,” Jacobson said in an interview.
“So I can see an opportunity for other interventions, through diet, exercise. I am also using it to assist in whether a patient would benefit from additional cardiovascular screening.”
Asked for comment on the Soteria Cardiac Platform, Dr. Suzanne Steinbaum, director of Women’s Heart Health at Lenox Hill Hospital in New York, said she was not familiar enough with the technology to make a detailed assessment, but that she typically offers patients a series of other, well-known tests to gauge their cardiac health.
These include an assessment of lifestyle factors, genetic tests, screening tests like the EndoPat for blood vessel health, the coronary artery calcium score for calcification in the arteries, and the carotid doppler which searches for plaque formation in the arteries of the neck.
Raines, however, said most of these methods are far more costly than the Soterogram, and are mainly used in older people who already have heart disease. The EndoPat, while inexpensive, is delivered at the fingertip and is not the most accurate test for atherosclerosis, he said.
“Current methods do not work in terms of identification of the disease. They just do not work,” Raines said.
“What will work? Early identification of individuals at risk. We need to know early on who is at risk for atherosclerosis. Once those individuals are identified, there has to be aggressive cardiovascular risk control.”