A group of physician-entrepreneurs at Sheba Medical Center have developed a product that harnesses the power of artificial intelligence (AI) to diagnose a patient’s cardiac problem on the spot.
All it takes is a physician with a handheld ultrasound probe and a digital tablet to catch a problem, whose immediate detection could in some cases mean the difference between life and death.
Because AI drives the diagnosis, all doctors — not only cardiologists — can use the product, called AISAP, successfully.
Ultrasound is commonly used to diagnose heart issues, and portable ultrasound machines, known as point-of-care ultrasound (POCUS), have become common in recent years. Portable ultrasound machines make it possible for patients to be scanned at the hospital or home bedside, in an ambulance, or even at a clinic in the remote countryside.
But this doesn’t necessarily mean that a patient receives a timely, lifesaving diagnosis. Even if POCUS is available, not every patient can be prioritized for a scan, and not enough expert physicians may be available to quickly interpret them. This is the challenge that AISAP surmounts.
“There are a lot of scenarios today where a non-cardiologist is managing a cardiac patient. It could be on the internal medicine floor, in the emergency department, in the intensive care unit, or an outpatient setting. These physicians need rapid answers,” said Prof. Robert Klempfner, co-founder and chief medical officer of AISAP.
This is an urgent challenge when according to the World Health Organization, cardiovascular diseases are the leading cause of death globally, ending an estimated 17.9 million lives annually. According to the Centers for Disease Control and Prevention, there are 6.2 million American adults currently living with heart failure.
Those behind AISAP, working as part of Sheba’s ARC digital innovation infrastructure, believe that this situation can be prevented at least in part by their invention. It can be used by any physician to close the loop from clinical question through imaging to diagnosis within minutes, thus catching and managing cardiac problems in time. AISAP changes POCUS into POCAD (point-of-care assisted diagnosis).
The ultimate goal is to tailor AISAP for the diagnosis of disease in several organs, however, the focus is on the heart for now.
“We’re not trying to replace the full echo study. That’s a 60-minute study done by an expert technician and interpreted by a cardiologist, but we did want to find a way to answer key clinical questions and provide the core information that’s needed in a five to seven-minute exam,” explained Klempfner, who is also director the Israeli Center for Cardiovascular Research and director of the Cardiac Rehabilitation Institute at Sheba Medical Centre.
To achieve this, Klempfner and his colleagues developed a platform that can be used without any specialized equipment. All that is needed is a handheld scanning device and a digital tablet. AISAP is agnostic about the brand and manufacturer of both.
“The handheld scanner probe — whether it is manufactured by GE, Siemens, Philips, Butterfly, or the like — costs $2,500 to $6,000, a fraction of the cost of a full echo-cardiology machine,” Klempfner noted.
Arriving at a diagnosis involves the acquisition and interpretation of data. The clinician doing the scanning needs to know how to get the right images, and how to understand what they mean. AISAP is designed to do the heavy lifting and eliminate variability by evaluating the quality of the images of just two required scan points and interpreting information about eight critical heart functions.
AISAP looks at left heart function, right heart function, all the major valvular pathology, fluid around the heart, and the diameter of the inferior vena cava vein. Inferior vena cava measurements are related to conditions such as fluid underload indicating shock or dehydration, and fluid overload, which is connected to heart failure — the most expensive condition in adults over the age of 60 in the US today, according to Klempfner.
“These eight data points are the must-haves that we came up with after doing several rather large surveys among physicians in Israel, Europe, and the US,” he said.
As the clinician scans the two necessary spots on a patient’s chest, AISAP gives real-time feedback on the quality of the images. If they are not good enough for interpretation, the platform tells the clinician to try again to optimize the image. AISAP is purposely designed not to interpret images that are not sufficiently clear.
After the quick scan is performed, the images are sent to the secure AISAP cloud-based platform, which is on and accessible from anywhere at all times. The images are analyzed using AI, which compares them to an enormous database of existing scans. The analysis is sent back to the tablet almost immediately. The images and report are sent to the healthcare organization’s digital infrastructure for future reference. They can also be shared securely anywhere in the world with a click of a button.
“The AISAP cloud contains the collective intelligence of hundreds of millions of frames that it has seen. We train the system on the entire database of imaging that we have at our disposal from Sheba. These are images that are already fully annotated and diagnosed by expert cardiologists,” Kempfner explained.
“So AISAP has a lot of experience — probably more than any living cardiologist.”
It would follow that AISAP is more experienced than any non-cardiologist, and therefore helps him or her know whether a patient has a heart problem, how severe it is, and whether a cardiologist consult is called for.
“In my department, we only have two echocardiogram lab slots a day — and that’s on a good day. But we have five or six patients who need to be imaged. That means we end up either keeping them in the hospital longer or sending them home with referrals for an echo in the community or back at the hospital a week or two later,” said Sheba internal medicine resident Dr. Kobi Faierstein.
“AISAP has revolutionized our care of patients. We perform the bedside AISAP examination and received the report within seconds, and if I need to I can share the report with a cardiologist for immediate feedback. I feel much more secure about discharging patients,” he said.
Klempfner said it takes just a handful of hours to train a physician how to use AISAP. There is a learning curve, and it can take doing between 30-50 scans to get the full hang of it.
“AISAP measures everything you are doing and provides you with an organized report in real-time. We can work on the places where you’re less strong, and if need be, send a technician to work with you at the bedside to improve,” Klempfner said.
Faierstein reported that the immediate feedback that the system gives letting him know that he needs to improve the view is extremely helpful.
“At first it took me around 15 minutes to do a scan, and now I am down to just five. I’ve learned how to adjust the placement of the probe for larger patients, or for intubated ones, for example,” he said.
A prospective clinical trial with 1,000 patients in seven departments has been conducted at Sheba. According to Klempfner, 50 percent of the patients scanned with ASIAP who otherwise would not have been prioritized for a full echocardiogram (because of more minor, vague symptoms) showed findings, and half of those patients required a change in management.
“By giving physicians insights that would not come from listening with a stethoscope, AISAP impacted the management of 250 patients,” Klempfner said.
Klempfner and his team will be presenting these and other results of their AISAP trial in two papers at the European Society of Cardiology Congress in Amsterdam in August.
AISAP has gained approval from the Health Ministry’s Pharmaceutical Division and has already been sold to Sheba. The company is in negotiation for sales to four other Israeli hospitals.
In a bid to gain FDA approval and hopefully, thereafter go to market in the US by 2024, AISAP is wrapping up a larger prospective clinical trial with Jefferson Health in Pennsylvania and New Jersey, Inova Health System in Virginia, and Padeh Poriyah Hospital in Tiberias.
The aim is to demonstrate that non-expert physicians obtain and interpret images better using AISAP than they do without it. The doctors’ results will be compared to those of expert cardiologists from Mass General Brigham, which is running the study.