21st century medicine takes shape in Orange County.
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BY JUDY COOPER
Get ready for another medical breakthrough. One that you and your family will experience when you go to the doctor for your annual physical in the 21st century. The Thomas Edison of this invention is a Newport Beach physician and medical researcher named Dr. Harvey Eisenberg. "Medicine has always been reactive. We sit and wait for symptoms to develop and then we react to them. The realty is that most of the diseases that will kill you never give you that first symptoms, or by the time you get that first symptoms it is too late for the cure. With heart attacks and strokes, cancer and emphysema, your body is not a great early warning system," says Eisenberg, a medical researcher who has been a professor of medicine at Harvard, UCLA and UC Irvine and now heads HealthView in Newport Beach.
The future that Eisenberg envisions is almost here. As Edison's bulb changed night forever, so a superfast CT body scan has the potential to revolutionize medicine.
Today, a CT scan takes a stop-action picture of what is going on inside your body. But, as in photography where the better the camera and the faster the electron beam and the more sophisticated the software, the better it captures images of a beating heart or breathing lungs.
Imagine a CT scan so fast and so complete that it takes a three-dimensional picture of all your internal organs allowing doctors to discover disease at its earliest stages. A powerful diagnostic tool, indeed.
With its 50-100 millisecond exposure time paired with proprietary software, the scanner at HealthView, Newport Beach, is, according to HealthView director Eisenberg, the fastest electron gun in the West. Working with a team of physics, engineering and computer science people both on the academic and private side, Eisenberg has developed an ultrafast electron beam computed tomography (CT) scanner and its complementary AngioCAT software that he uses to non-invasively detect a number of diseases, including heart disease, osteoporosis, lung and other cancers and emphysema.
Eisenberg says HealthView's electron gun is 10 to 30 times faster than conventional CT scanners, including the new spiral scanners. With it and his especially-developed software, patients can see detailed three-dimensional color images of their organs and skeleton, even viewing calcification in the heart and arteries long before symptoms show up.
While the major CT manufacturers are trying to make faster scanners, he says, his machine still has a five to eight times edge over even the latest technology. "You need that edge because even at the fastest speed we are still working at the threshold of usability. Our exposure time is the bare minimum needed to stop and study the heart," he says. "We're now developing the next generation of this technology that will be literally 100 times faster that what we currently have." His next state project has recently been funded by Congress, which has allocated $8 million in appropriations for FY 98 and FY 99 so far, with more expected.
Eisenberg is a radiologist and academician with a physics background who has spent his career pioneering and developing technology and applications for medicine. He has been a full professor at UCLA and UCI medical schools and as associate professor at Harvard, and at each university was director of its cardiovascular and interventional radiology divisions.
"I have spent the past 30 years either as a medical director or a consultant to a number of major companies developing technology for medicine, including Raytheon, Adac Labs, Phillips and General Electric," says Eisenberg. "We helped to pioneer a number of fields - mammography, digital electronic imaging and the field of Interventional Radiology." While running a division at Harvard's Beth Israel Hospital he also worked as medical director at Raytheon, where he worked to develop the forerunner of what has become HealthView's current AngioCAT. "Back in the mid- 70's we tried to invent CT scanning, but we didn't know it. We called it tomosynthesis. The mathematics were identical, only the specs were much greater than anything built to this day."
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Since Raytheon was a military company, Eisenberg experienced the frequent frustration of putting together a team and project, only to have it put aside for more lucrative military pursuits such as the patriot missile. "Our project was meant to prove the principles of 3D imaging but with four dimensions, including time," says Eisenberg. "We learned a lot, but couldn't get Raytheon to build it." Another company did get funded to build their machine, and it evolved into one called Imatron. Eisenberg and his team worked with Imatron since its inception, then parted on philosophical differences. "Large companies often build machines, then go looking for an application," he says. "We had an idea of what we wanted to achieve an Imatron did not want to pursue it, so we formed our own privately-funded group and began modifying the Imatron technology."
In the early '80's Eisenberg gave up a tenured full professorship at UCLA to take over a private hospital with a research institute. While he continues to work with universities, he found the private sector more freeing and pursues funding that does not have strings attached to it in terms of rushing something to the marketplace. "We wanted to make money," he says, but we also wanted to build something substantial."
In a partnership at a hospital in Brea, which specialized in outpatient surgery and treatment, he and his team worked on technology and quickly recognized that computers would be an important part of medicine. "Since my background is interventional radiology, I was trying to create a tool that could image the whole body very rapidly in four dimensions and allow us to use the imagery to interact with the body to do therapy and minimally invasive advanced surgery techniques," he says.
"As we were creating this capability, I realized the diagnostic capabilities were so strong that we were starting to see diseases at much earlier stages than could have otherwise been picked up." And this capability evolved to the applications for preventative medicine he uses today at HealthView. He and his team tried their electron gun at Mt. Sinai Hospital in Miami in the early '80's and developed the first test screening for heart and coronary artery disease. "At first we didn't think it would work. We were surprised when we started to realize just how powerful a tool it was."
DISEASE BREAKTHROUGH
A New England Journal of Medicine article last December on the value of electron beam computed tomography states that "when image quality is adequate, electron beam CT may be useful to detect or rule out high grade coronary artery stenosis and occlusions." The authors also note that "annually, more than one million coronary artery angiographic procedures are performed in the United States. Replacing even a fraction of these diagnostic procedures with a non-invasive imaging technique would constitute an important advance in the care of patients with known or suspected coronary artery disease".
"In recent years, "says Eisenberg, "there have been articles finally staring to make the public aware of the changing knowledge of coronary artery disease. The way we've approached it and treated it for decades has really been quite wrong. It has been based on the premise that plaques grow progressively until they plug the artery. And that they don't become dangerous until they become large enough to alter blood flow, which is when they register on treadmill studies like EKG's, echocardiograms, SPECT-Thallium scans, Cardiolytes and PET scans - all of the things we've typically used to detect coronary artery disease. We defined it as flow-altering disease and if the blockage wasn't large enough, it wasn't important. If it was large enough, we would go in and fix it with an angioplasty, stent, or bypass and that would take care of the patient".
Eisenberg says the really attack risk predicator is not so much the lesion size but how much of the surface of the arteries is covered with plaque, or what is called "plaque burden". This is because any plaque of size, once it has a complex structure, is capable of rupturing to plug the artery. The second major risk predictor is how fast they are growing and actively metabolizing which increases their likelihood of rupturing and plugging the vessel. Eisenberg works with the Mayo Clinic which images dissected hearts of cadavers to validate the calcium screening test as an accurate predicator of plaque burden. The findings were corroborated by the National Institute of Health.
The fact that small plaques were mostly responsible for heart attacks came from numerous studies at leading institutions who collected data on patients where an angiogram was done both before and after a heart attack. "We were able to see the block, then go back and see what plaque was responsible for it", he says. "Since they don't break off they just clot at the site. You can identify which plaque has caused blockage. Eight-five per cent of the time it's a small plaque. The small plaque suddenly ruptures and forms a blood clot on the surface that rapidly propagates to block the vessel. That's the mechanism of most heart attacks".
Cardiologist Jonathan Tobis agrees. Tobis is professor of medicine and radiology at the UCI Division of Cardiology, Professor of Cardiology at UCLA and was formerly Director of the Catheterization Lab at the UCI Medical Center for fifteen years. "We all know the classic case of the person with no symptoms who goes to the doctor, has blood work, a stress test, is told he is healthy, then goes out two weeks later and drops dead from a heart attack. Why that happens is better understood now than ever before.
"The reason is that plaque develops in the arteries; and when you get an unstable plaque, in other words, a fibrous capsule surrounding a lipid pool, and the capsule fractures, you get a mixture of blood with the liquid and that causes the blood to clot, or thrombosis."
Vulnerable or unstable plaque is the real danger, concurs Fullerton cardiologist Dr. John Zamarra. "The arteries can have soft plaque which won't show up on a ultrafast CT scan. This is not to say that your body has not calcified yet. Also, you can have an artery that is heavily calcified but if the plaque is stable, it may represent not an immediate danger.
"The HealthView scan cannot detect whether or not plaque is unstable, but it can detect calcified plaque and calcium may represent may represent the body's attempt to heal the unstable plaque. Calcium is deposited in plaque to heal the body scar it over, so it may represent a response to injury. It's an inflammatory process. We don't know what excites it totally. But the LDL (or bad cholesterol) that becomes oxidized is a noxious element for the body and when it is deposited in the wall of the artery, the body has a response to it, almost like an infectious agent. There are some doctors who think it may actually be an infectious agent, but most studies are inconclusive."
When unstable plaque ruptures or if there is a shear point at the edge of the cap because of high blood pressure or tension in the artery, Zamarra says, then noxious material is exuded into the blood stream, a clot forms and that's when you have a patient with a problem.
Total cholesterol scores can be misleading, Zamarra says. "If most is HDL, or good cholesterol, you won't have much plaque. Plus, there are different types of bad cholesterol; some stick and some don't. If you have LDL that is small and dense, it has a tendency to get oxidized and will stick. If your LDL is the large type, it does not tend to get oxidized and won't stick, so you can have a high level of cholesterol but still have a low score on the scale. This is not to say that you don't have soft plaque, it's just that your body has not calcified it yet."
Zamarra says people can put themselves at risk if they lead an unhealthy lifestyle, but that he also sees people who are overweight, leading unhealthy lifestyles, whose arteries are clear and who are not at risk because they have good genes.
"The average patient with a heart attack has a cholesterol of 225," Zamarra says, "and the average cholesterol in the U.S. is 220 so there is not much difference. Normal risk factors: smoking, hypertension, diabetes, and being overweight only account for 50 percent of the problem. Fifty percent of the time if someone has a heart attack, or hardening of the arteries, he or she doesn't have the usual risk factors. They have a genetic problem and you will pick up 80 percent with genetic testing. The rest fall into lifestyle and other factors."
Both Dr. Zamarra and Dr. Tobis feel the real benefits of the HealthView ultrafast CT scan are its ability to detect early signs of coronary artery disease in people in their 30's, 40's and 50's, plus its use as a motivational tool for older patients to make lifestyle changes. "When you see some buildup which has become calcified, you know it is just the tip of the iceberg," says Tobis. "Seeing the calcification can make a difference to the patient. That person tends to get religion in a medical sense. If he was not motivated before, this provides the motivation. As a physician it also helps me see how aggressive I would want to be in treating that person."
Dr. Tobis says the ultrafast scan will not replace an angiogram at this point in its development. "In the future it might. It's ideal for early detection, to follow preventative programs and monitor regression," he says. "It has so many other uses that it is unremarkable."
LOOKING AT ALL THE ORGANS
Endocrinologist and nephrologist Dr. Arnold S. Brickman uses the HealthView scan to detect osteoporosis in men and women and to find early stage tumors and other pathology in the endocrine glands including the thyroid, parathyroid and adrenal glands, and most importantly to him, in the pancreas. He also finds it useful in determining disease in the ovaries in females, and the testes in males. A professor of medicine at the UCLA School of Medicine, Brickman, who specializes in metabolic bone disorders such as osteoporosis, was associated with Eisenberg when he was in Brea and now his operations in Newport Center. He says the HealthView technology has improved as well as its potential and is excited about soon being able to obtain information on bone density of the hip with the next generation of the technology. He says that while other bone density tests such as the DEXA (dual energy X-ray absorptiometry) measures anything mineralized or that contains calcium in the path of the x-ray beam, it can include other calcification nearby and make interpretation more difficult, whereas with the CT scan you can focus on a specific part of the body. "You are actually imaging a cube of bone in the core," he says. This provides superior information to the DEXA with a scan in younger people, at least in the spine."
Dr. Brickman says there are only a handful of ultrafast CT scanners in the country. "Dr. Eisenberg set up one at Walter Reed Hospital in Washington, D.C. and he still does work with them there, and he set up one in Dallas, Texas." As it becomes more accepted by the medical community, Brickman thinks the number of these machines will grow with most locating in major academic centers at first, then branching out as the CT scan did in its early stages.
Brickman says the next generation of the technology, which may emerge in about a year to a year and a half, will be able to provide very specific physiologic information on the various tissues and organs imaged. For example, he says, it could supplement a sigmoidoscopy in detecting colon cancer. He sees promise for the next generation becoming a safe and valuable diagnostic tool. "Because a full body scan would be done so rarely, it could be a bargain to be scanned from head to groin to gain a great deal of information," says Brickman.
THE HEALTHVIEW TEST
The HealthView Test takes only 15 minutes. Patients have three EKG electrodes placed on their body, then fully clothed, they lie on a table and are asked to hold their breath a few times as the scanner arch moves slowly over their body, usually from the neck to the pelvis; however, other areas, such as the carotid arteries and the leg vasculature, may be included to determine risk for strokes. The radiation exposure is comparable to a simple fluoroscopy exam, like an upper GI, according to Eisenberg. After the scan the patient takes a tour of his body on a computer screen, viewing each bone and organ three dimensionally in one millimeter slices, as he or another HealthView physician explains what is being seen.
Results are then sent to the patient's own doctor who handles treatment. The cost of the scan, including a 45 minute to one-hour consultation, is $710.00, discounted by $100.00 if payment is made at the time of service. Although HealthView is not contracted with Blue Cross or Blue Shield, they usually pay 50 to 70 percent if there is a medical necessity and a doctor's referral, Eisenberg says.
Eisenberg feels his technology's most important use is a tracking and/or monitoring system for heart plaques and as a means of guiding physician and patient in the treatment process. "There are some new fast scanners whose users claim can monitor coronary artery calcium; however, their exposure times are still far too long to allow the accurate reproducibility essential to tracking coronary artery disease," he says.
Although HealthView's scan was originally developed to detect coronary artery diseases, Eisenberg says it evolved into a detection tool for many more diseases including all cancers in the internal organs, lungs, pancreas, kidneys, adrenals, liver, lymph nodes and spine. "We look for aneurysms which we can see very accurately, and pick up degenerative diseases, such as emphysema. It never ceases to amaze me - people come in who have just had a normal chest x-ray and I find massive destruction of their lungs not subtle, but massive.
"In effect our technology enables virtual endoscopy where we look inside the bronchial tree, whole stomach and duodenum for cancers and ulcers. We find emphysema with this technique long before it will show up with any other form of testing including pulmonary function tests. We are literally seeing he very early stages of cell breakdown. In addition to offering colonoscopy, in the next month or two we will have the ability to detect Alzheimer's disease in advance of symptoms.
Eisenberg says the scan also uncovers back problems before the symptomatic level and finds malignancies in women's breasts and ovaries missed by mammography and ultrasound. "We feel ours is a powerful additional to mammography and other screenings. For women we cover everything she would be worrying about: heart disease, which is the No. 1 killer by a 6-10 margin over breast cancer, lung cancer which is No. 2, then cancers of the breast, ovaries, and colon. As we study, we see men have virtually the same incidence of osteoporosis as women - almost the opposite of what happened with heart disease in women."
For Eisenberg, there is one overriding issue - the way medicine has traditionally been practiced is about to change. "We must take a preventative approach and continue to come up with ways to detect pretty much all the diseases you have to worry about at the asymptomatic stage." OCM
