Dr. Santora to host new TV Show on KOCE TV ealth Matters with Dr. Larry Santora will debut this Fall on KOCE TV. The latest information in all aspects of medicine and health related topics will be discussed. The show is sponsored by Chapman University, Orange, California. The debut date will be announced on this web site.
WATCHMAN OFFER
We are currently offering the WATCHMAN left atrial occlusion device on an investigational basis. The primary investigation, which is titled Protect AF Clinical Trial, will be closing on June 30, 2008. It looks like Dr. Tucker is going to be the No. 1 implanter worldwide with about 70 patients enrolled in the clinical trial, exceeding all other sites, including the Mayo Clinic and Harvard and Cleveland Clinic. So, once again, we are very proud to be the most experienced center in the world with this exciting new technology. Going forward as of July 1, patients will still be able to get the WATCHMAN device through a registry, and there will no longer be a randomized clinical trial. That is, all patients interested in the device can simply get the device implanted if they qualify. For more information, contact Dr. Tucker at the Orange County Heart Institute.
Cardiology Research at OCHI
Thursday, September 21, 2006
A step against strokes Local doctor is part of a national study on a heart device that could upgrade care for millions with atrial fibrillation.
By BLYTHE BERNHARD The Orange County Register
A new treatment is available for the more than 2 million Americans who have atrial fibrillation, a disorder that keeps the heart from pumping effectively.
When blood doesn't completely pump out of the heart, clots can form. Strokes can result if a clot travels to an artery in the brain. The disorder is thought to cause about 15 percent of strokes.
Atrial fibrillation is commonly treated with blood-thinning drugs, surgery or pacemakers. Now, an implantable device called the Watchman has been designed to keep clots from traveling to the brain. The device is available through a clinical trial hosted by Western Medical Center in Santa Ana and 40 other hospitals nationwide.
Western Medical cardiologist and principal investigator Dr. Kelly Tucker talks about why he thinks the Watchman is a promising alternative to current therapies.
Q: How does the Watchman work?
A: This device is a cork, if you will or purse of the left. New knowledge has shown us that the blood clots form in a small appendageatrium. It's designed to stick into this appendage and stay there and occlude it. It acts as a barrier so clots cannot form.
Q: What are the results?
A: The device was studied in a pilot trial, beginning in 2001. Of 66 patients, 97% got the device. There were no complications of the procedure. All have come off (blood-thinning drug) Coumadin. There have been no strokes in that group. That's very promising. Based on the trial the FDA approved a larger trial at 40 centers internationally. We're very experienced with the device and we like it. We've done 15 patients. The patients seem to do very well with this strategy and they can stop their Coumadin. The Coumadin is designed to cause your blood to be thin and prevent a blood clot. If you overly thin the blood, the patients can have life-threatening bleeding.
Q: How much does it cost?
A: Probably in the future the actual device will cost a couple of thousand dollars. The federal government has agreed to pay for this. You can bill for this through Medicare. If Medicare covers it, any other insurance will pay as well. Compared to lifelong therapy with this pill, it's extraordinarily inexpensive. Device therapy is almost a perfect therapy. Once you get the device implanted that's the end of it. There's no pill to take, nothing to remember. This particular device never needs to be replaced.
Q: Who is this device for?
A: This is appropriate for patients with atrial fibrillation who are on Coumadin. The FDA is going to require about 600 patients to get the device (before the agency either approves or denies the device for general use). We're about a third of the way there. It should be on the market in two to three years. We've really enjoyed the device. We've found it to be technically easy to implant. In follow-ups it appears to be doing the job.
Q: What is the procedure like?
A: It's an outpatient procedure. There are no stitches or incisions. It's all catheter-based. Patients are up and around immediately and can go home within 23 hours. In the pilot trial, average time for the procedure was 50 minutes. In our hands we're doing them in less than 30 minutes.
Q: What about anesthesia?
A: We do a general anesthetic. We have to put the patients to sleep because we have to image their heart in a special way and we don't want them moving. It's no different than, say, having your appendix out, but there are no stitches or incisions.
Q: Aren't similar devices already out there?
A: It's not as though this is a revolutionary, brand-new idea. We've built on other technologies. We're using them for this specific medical problem. It's very similar to other implantable filters that have been used for many, many years.
Q: How does the clinical trial process work?
A: The FDA of course has to oversee the whole thing. There's a fair amount of regulatory scrutiny involved. The company (Atritech of Plymouth, Minn.) does help support us with a full-time guy; all he does is coordinate the study. There's an enormous amount of paperwork to do a study of this type. They try to help us meet our costs on this sort of thing.
Q: Is there a financial incentive for you to co-host this study?
A: There's a process for us getting paid. These days it's one of the areas of concern for any health care provider. I'm happy to save a life, but my employees want to be paid and I have to pay overhead. Whenever we try to collect for any patient it's a real ordeal. With a study it's a little easier for us in some ways. But we don't support a practice by doing a study of this type. This is almost philanthropic.
Q: Why do you participate in clinical studies?
A: We really are trying to reach out to the community and help people. Coumadin is OK, but this is much, much better. And I know this in my heart. This is the future of medicine. I have a pretty strong heritage of being at the leading edge. When this new technology comes up, if I think it's something that's going to last and help the patients, we get involved with it. I wouldn't even stay in medicine if I couldn't get involved in studies like this. This type of leading-edge medicine is the only thing I'm interested in. To be honest, I don't want to see 800 HMO patients a month. I want to bring in new technologies and change the world.
Monday, November 27, 2006; 11:24 PM
Doctors Test Implants to Block Strokes
By LAURAN NEERGAARD The Associated Press
WASHINGTON -- At least 120,000 Americans a year suffer strokes because of a common irregular heartbeat -- one that's on the rise, hard to treat and can shoot deadly blood clots straight to the brain. Now doctors are experimenting with a new way to prevent those brain attacks: a tiny device that seals off a little section of the jiggling heart where the clots form.
If it works -- and a major study is under way -- the Watchman device might provide long-needed protection for thousands of people with atrial fibrillation, whose main hope now is a problematic blood-thinning drug that too many can't tolerate.
"I don't think I'm biased, but it could potentially revolutionize a-fib, which is a ton of people," says Dr. Steven Almany, vice chief of cardiology at William Beaumont Hospital in Royal Oak, Mich. He has implanted the Watchman into more than a dozen patients so far.
About 2.8 million Americans have atrial fibrillation, the most common type of irregular heartbeat. It is most common among the elderly, and cases are increasing as the population grays.
A-fib occurs when the heart's top chambers, called the atria, get out of sync with the bottom chambers' pumping. The atria speed up, sometimes so fast that they quiver like a bag of worms. Blood pools inside a pocket of the heart, allowing clots to form.
About 20 percent of the nation's strokes are blamed on the condition, and they tend to be particularly severe. About a third of the victims die, and another third are significantly disabled, Almany says.
The blood thinner warfarin, also called Coumadin, lowers the stroke risk dramatically. But it is very difficult to use -- it can't be taken together with dozens of other medicines, and requires dietary restrictions and regular blood testing. In addition, side effects include serious, even life-threatening, bleeding.
By some estimates, almost half the people who should take the drug can't or won't, and "there are lots of people out there on Coumadin who want off," says Dr. William Gray, a cardiologist studying the Watchman at New York's Columbia University Medical Center. "This provides the opportunity, hopefully, to get them off the drug."
In atrial fibrillation, 90 percent of stroke-causing blood clots collect inside a jalapeno pepper-shaped flap of tissue that hangs off the edge of the left atrium. Some call it the heart's belly button, a leftover from fetal development that the body no longer needs.
The Watchman physically seals off that flap, depriving clots of their staging area. The question is whether that really will stop strokes. To find out, doctors are recruiting hundreds of patients around the country to get either the experimental device or the usual Coumadin.
How does the Watchman work?
Doctors thread the mesh-covered metal brace through a leg vein up to the heart, and wedge it into the opening of the troublesome flap. Tiny hooks hold it in place until heart tissue grows over it to form a permanent seal. Forty-five days after implantation, Watchman recipients have a tube put down their throats for a special heart scan to tell if the flap really is closed off. If so, they quit Coumadin.Of the roughly 250 patients enrolled so far, 97 percent of Watchman recipients have quit the drug, Almany says. They still must be tracked for at least two years, to see how many have a stroke.
"I was a little apprehensive at first," Grace Holland of Shelby Township, Mich., says of the experiment.
Holland, 76, didn't mention her heartbeat's "flutter" to doctors for years; she had no idea it could cause a stroke. Finally diagnosed, she took Coumadin for about two years before suddenly suffering internal bleeding that almost killed her, her arms and legs streaked with black as an ambulance sped her to the hospital.
The close call persuaded Holland to try the Watchman, and a year later she's off Coumadin and feeling good. "It's such a relief."
An American Stroke Association spokesman cautioned that it's far too early to know if an implant will prove a better gamble than Coumadin, a proven stroke fighter. "I wouldn't want to raise hopes before the data is in," said Dr. Larry Goldstein, director of Duke University's stroke center.
Nor is the Watchman risk-free. The flap it blocks is very thin, posing a puncture risk as doctors hook the device in place.
"You put a hole in there, you've got a problem," says Almany, who had that happen to one patient -- and had to do emergency surgery to stop massive bleeding and save the man.
Columbia's Gray notes that a similar experimental device, called the PLAATO, did seem to cut stroke risk by two-thirds in a small study several years ago; it hasn't yet moved into large-scale testing.
If the Watchman ultimately works, Almany predicts the procedure could cost $12,000 or so, less than treating a stroke or a bad Coumadin side effect.
SATURDAY, JANUARY 27, 2007
A father's heartfelt crusade
UA Placentia weightlifter and his cardiologist campaign against youth steroid abuse.
Preventing Cardiac Deaths and Disability In Firefighters Using EBCT Heart Scans To Detect Silent Coronary Artery Disease
Lawrence J. Santora, MD; Theresa Norris, RN; Rina Santora, RN; Richard Brandt, Mark Jenkins, Mary Robinson, NP, Nicole Santora <<Download report
CLINICAL STUDY
Coronary Calcification in Body Builders Using Anabolic Steroids
Lawrence J. Santora, MD; Jairo Marin, MD; Jack Vangrow, MD; Craig Minegar, RDCS; Mary Robinson, NP; Janet Mora, RT; Gerald Friede, MS <<Download report
CLINICAL STUDY
New Graduated Pressure Regimen for External Counterpulsation Reduces Mortality and Improves Outcomes in Congestive Heart Failure: A Report From the Cardiomedics External Counterpulsation Patient Registry
Common stress tests can miss problems, cardiologists say.
But not all agree that new technique is ready for wider use.
By VALERIE REITMAN, LA Times Staff Writer
The former president has chest pains. A catheter threaded through his heart finds all three major arteries and a tributary up to 90% blocked. Surgeons buzz through his chest with an electric saw, stop his heart for 73 minutes and use veins from his leg and elsewhere to bypass the blockages.
Bill Clinton is saved. But some cardiologists say the event was far from a medical triumph. As soon as word got out about the extent of previously undetected clogs in Clinton's arteries, some of the nation's top cardiologists began trading barbed e-mails and phone calls, decrying the event as the ultimate failure in preventive medicine, even as "unconscionable."
"The bottom line is, Bill Clinton's walking into the hospital with chest pains is a shocking event in a country where we have plenty of tools to prevent that," says Dr. Morteza Naghavi, a Houston researcher who founded the Assn. for the Eradication of Heart Attack, an influential group of cardiologists that advocates an overhaul of how patients are assessed for heart disease.
As it is now, about 88% of those who have heart attacks would have been labeled low to moderate risk by their doctors on the previous day, according to a recent study published in the Journal of the American College of Cardiology.
Clinton's experience demonstrates that even a former president with access to the best medical care available can have undiagnosed heart disease. Doctors like Naghavi advocate aggressive use of preventive screening, such as blood marker tests and noninvasive scans. In particular, some cardiologists are promoting wider use of a noninvasive diagnostic test known as the coronary calcium scan.
But other physicians say some of these tests have not proved their value, and they cite the expense of widespread screening programs in a time of rising medical costs.
About 1.5 million Americans this year will not be as lucky as Clinton was. They won't get a warning sign — allowing time to get to a hospital — before they suffer a heart attack. About half of those will die.
Clinton appears to have never had the simple $250-to-$400 diagnostic scan that the eradication association and others advocate, although Walter Reed Army Medical Center, near the White House, has been using such tests in middle-aged Army personnel for years, after finding that traditional treadmill stress tests failed to identify many future heart attack victims.
The scan, known as an electron beam computed tomograph, or EBCT, probably would have detected the extensive plaque that lined Clinton's coronary arteries, some cardiologists said. Aggressive interventions, such as stents that open the blockages, could have been taken long before emergency bypass surgery was necessary. Even if the measures couldn't have averted open heart surgery, doctors would have been prepared, rather than surprised, to find such threatening problems.
Some physicians are skeptical of the scans, however. "There's cost and there's radiation, and we don't know how much information it adds beyond traditional indications," says Dr. Lori Mosca, director of preventive cardiology at New York-Presbyterian Hospital.
She notes that the National Institutes of Health are sponsoring national trials ending in 2008 that may show whether the test actually changed the fates of those who were determined to be at high risk.
Many cardiologists have complained that the scan isn't recommended to more Americans now. That is changing slowly as the evidence supporting the benefits of the test becomes more convincing and more medical organizations endorse its use. Earlier this year, three studies published in leading medical journals, including the Journal of the American Medical Assn., found the scans to be of benefit in detecting heart attack risk.
Dr. Scott Grundy, a University of Texas Southwestern researcher who drafted guidelines for the use of statin drugs for the National Cholesterol Education Program, says he believes the scans are as important as cholesterol tests in determing heart attack risk.
Groups such as Naghavi's recommend that men older than 45 and women older than 55 should have the scan, regardless of whether they have risk factors such as diabetes, sedentary lifestyle, obesity, smoking or kidney disease. The American Heart Assn. is considering a less radical proposal, suggesting that cardiologists scan only people in those age groups who have traditional risk factors. About 40% of Americans in that age group have some or all of those risk factors, putting them in what is known as the "intermediate risk" category.
Most insurers do not presently reimburse for the scan because they consider the technology to be "investigational." A spokesman for WellPoint Health Networks, the nation's second-largest health insurer, said the company was considering covering the test. Some cardiologists say insurers should pay for the test because its wider use would save lives. "It's a tragedy because the insurers cover colonoscopy and mammograms, and yet most won't pay for a test for a disease that kills a million men and women a year," says Dr. P.K. Shah, director of cardiology at Cedars-Sinai Medical Center in Los Angeles. More than 45,000 women die of breast cancer each year, for example; heart disease kills 10 times as many women.
EBCT scans, which have been conducted for 20 years, take fast pictures of the heart for 20 seconds inside an open machine. Some critics cite radiation exposure risks, but proponents say it's relatively small — about equivalent to a set of dental X-rays. (Good-quality scanning can also be done with newer CT scanning equipment that many hospitals have, although it produces two to five times the amount of radiation depending on the machine model.)
The medical center run by Dr. Kenneth Cooper, a Texas physician who prescribed an EBCT scan for President Bush, has scanned 10,000 patients who had never had chest pains or other symptoms of heart disease, and it followed them for five years as part of the national trials. Though 60% of those patients were considered to be at intermediate risk, just 278 had heart attacks, and most of them had calcium scores of more than 331 (300 is considered very high). "The correlation was striking," Cooper said.
A high calcium score, Cooper says, does not mean you are certain to suffer a heart attack — as long as you do something about it. When his late mother-in-law, who had already suffered a heart attack, had the test, her score was an extremely high 6,000. But she lived to age 92. "I can assure you if her daughter hadn't been married to me, she would have died 20 years ago," Cooper jokes.
Alan Gehm, 53, was having some chest discomfort and couldn't get an appointment with any cardiologists in the San Diego area, where he lives. So he went to Harbor-UCLA in Torrance, where the scan found a score of 1,000. The next step: another test on the same machine, this time using dye injected into the arm to give a better picture of blood flow. This EBCT angiogram (which insurers do cover) turned up a substantial blockage. The next day doctors put a stent in his artery. "It's a good system," Gehm says. "It saved my life."
The scan has been shown to accurately rule out the 99.5% of those who will not have a heart attack or stroke in the next four to five years, even if they have other risk factors. If the test shows few or no calcium deposits in someone with chest pains — and if no blocks are found on the EBCT angiogram — physicians can generally avoid doing the far more common type of invasive and risky diagnostic angiogram, covered by insurance, that Clinton needed before his bypass.
"I can't tell you the tens of thousands of unnecessary angiograms that are done every year," says Dr. Harvey Hecht, director of preventive cardiology at Beth Israel Hospital in New York. At least 20% of the angiograms performed each year reveal no evidence of obstructions; one study of 9,238 angiograms from five community hospitals reported that 40% showed no obstructions.
In addition to a cholesterol test, the Heart Attack Eradication group advises people to have a C-reactive protein test, which determines inflammation in the blood, and which some scientists believe is also a factor in determining heart attack risk.
Naghavi's group and some other preventive cardiologists also recommend moving away from use of the electrocardiograph -- a still widely used test that monitors the electrical pulses in the heart. Naghavi and others say the test only indicates whether damage has already been done to the heart, rather than predicting its onset.
"We grew up with the EKG; that's the textbook cardiology," says Naghavi. "We think that is old cardiology. It refers to the attitude that you wait and see the disease and treat the disease. That's outdated, and unfortunately it's practiced everywhere."
Treadmill stress tests, which involve attaching an electrocardiograph to the body, typically miss more potential heart attack victims than they identify, giving many people a false sense that they're healthy, some doctors say. This is why major cardiology groups do not suggest doing them on patients without symptoms, though they are widely performed. Clinton had treadmill stress tests done annually.
As for Clinton's case, the former president's spokespeople declined to comment, referring a reporter to transcripts of news conferences and a "Larry King Live" interview given by cardiologists at New York Presbyterian Hospital, where the bypass was performed. Dr. Allan Schwartz, the hospital's chief cardiologist, was asked whether Clinton should have had a coronary scan.
"Whether it would have been useful in detecting things earlier in the president, I can't answer," Schwartz said. "But again, this was detected at the right time…. The key thing here is that his heart had suffered no damage and has suffered no damage."
Some advocates say doctors have been reluctant to embrace the technology because of its association with entrepreneurs who have bought the million-dollar-plus machines and offered the scans at shopping malls. Says Dr. Matthew Budoff, a Harbor-UCLA Medical Center cardiologist and an advocate of the scans, "If they didn't learn it in training or medical school, it's less likely to become part of their practice."
Scan for Heart-Attack Risk To Get a Boost
Major Medical Group Expected To Support Use of EBT Test; Measuring Calcium Build-Up
By RON WINSLOW Staff Reporter of THE WALL STREET JOURNAL
September 21, 2004; Page D1
Heart scans, the popular but controversial tests that link heart-attack risk to an accumulation of calcium in the coronary arteries, are poised to win an endorsement from the American Heart Association, which has long been skeptical of their value.
Within the next few weeks, the influential organization is planning to publish a scientific statement that will say the tests can help doctors predict which patients are at risk of future heart attacks and decide how aggressively to treat those in danger.
The guidelines are expected to apply specifically to patients at "intermediate" risk of a heart attack based on their cholesterol levels, blood pressure, age and health habits. Though it stops well short of supporting widespread screening, the document -- expected to be published in the next few weeks in Circulation: Journal of the American Heart Association -- is likely to spark wider use of the exams and, possibly, improved reimbursement by insurers.
In 2000, the heart association and the American College of Cardiology jointly said there wasn't enough evidence to support wide use of the scans. Since then, a number of new studies have come out suggesting that calcium scores in certain cases can help determine treatment plans for intermediate-risk patients who may be on the borderline for needing aggressive intervention.
"The science has really come a long way," says Mathew Budoff, a preventive cardiologist at Harbor-UCLA Medical Center, Torrance, Calif., and head of the writing committee that is preparing the statement. "And all of them point in the same direction."
Still, there aren't any studies showing that using the test actually leads to better results for patients. "This is a technology that is quite good at what it does -- identify coronary calcium in patients," says Robert Bonow, past president of the AHA and chief of cardiology at Northwestern University Feinberg School of Medicine, Chicago. Though he himself uses the test on some patients, Dr. Bonow adds: "We're still waiting for data that show it will change outcomes."
The tests typically cost $250 to $400 and are available in two different, but similar technologies: electron beam tomography or fast computed tomography scans. They measure the volume of calcium that has built up in a patient's coronary arteries -- a sign of coronary artery disease.
The new statement will say that EBT is the preferred approach, Dr. Budoff says, because it is more accurate and exposes patients to significantly less radiation than the computed tomography, or CT, scans. Like cholesterol and blood-pressure tests, the scans yield a numerical result. But unlike those common measures of heart risk, the scans also provide doctors and patients with a vivid image of the arteries, clearly highlighting any calcium deposits in white.
"It may be the best motivational tool I've seen in getting people to change their lifestyles," says Kevin Graham, a cardiologist at Minneapolis Heart Institute in Minnesota. "When people have objective evidence of coronary disease in graphic form in front of them, they get weak at the knees."
Critics and proponents alike do say the scans have been prone to abuse. At some practices, patients without symptoms but with only slight to modest evidence of calcium have been referred for much more costly and invasive tests to look for artery blockages. "The people who do unnecessary tests are doing medicine for dollars," Dr. Graham says.
Amid aggressive marketing of the scans in some communities, the upcoming heart association statement was provoked in part by questions over which of the two types of scans is better or safer for patients, Dr. Budoff said.
The EBT devices are designed specifically for heart scans and thus have a narrower use. That has prompted some owners of scanning centers to advertise heavily to the public to pay for their investment in the machines. The CT technology is a software upgrade of conventional CT scans, which are used widely in medical evaluations and thus rarely need marketing campaigns to attract patients, says Philip Greenland, chairman of preventive medicine at Northwestern University's Feinberg School of Medicine, Chicago. Estimates are that there are about 100 EBT machines in the U.S. while there are several thousand CT scanners.
Dr. Greenland is the author of one of the recent studies supporting the usefulness of calcium scores. Currently doctors often rely on a global risk score derived from the famous Framingham Heart Study to assess a patient's chances of a heart attack within the next decade. The score is based on factors such as age, gender, total cholesterol, levels of HDL or good cholesterol, blood pressure and whether a person smokes. Some formulas also include blood sugar and family history.
Patients whose score indicates they have a 10% or lower chance of having a heart attack in 10 years are considered at low risk; those with a 20% chance or higher are at high risk, which calls for aggressive treatment to lower cholesterol and adopt healthier living habits. Patients with a 10% to 20% chance are considered at intermediate risk, where treatment is less certain.
Dr. Greenland's study, which involved 1,461 patients and was published last January in the Journal of the American Medical Association, found that in such cases, a high calcium score could push patients into the high-risk category. A low score would indicate a patient is in less danger and that diet and exercise could be sufficient to help avoid heart trouble.
Dr. Graham in Minneapolis cited the case of a healthy 39-year-old woman whose father had suffered a heart attack at age 52 and whose LDL or bad cholesterol was still a relatively high 138 after treatment with a cholesterol-lowering statin drug. The question was whether to get the LDL lower, Dr. Graham says. Her heart scan turned up calcium levels that put her in the 95th percentile for her age -- indicating higher risk. Her drug dose was increased.
Still, some physicians remain skeptical. Steven Nissen, cardiologist at the Cleveland Clinic, argues that a cheaper (as low as $8) blood test for a marker of risk called C-reactive protein, when added to cholesterol and other data, provides plenty of information to treat intermediate-risk patients. Scanning "is an important technique, but there is a lot of hype," he says.
NEWSWEEK:
Published June 16, 2003 A Healthy Heart
Cardiovascular disease is still the No. 1 killer of American men.
New screening tests may help millions avoid the emergency room.
By David Noonan
At 57, Constantine Xinos was in pretty good health. The criminal defense attorney from Oak Brook, Ill., had two classic risk factors for cardiovascular disease -- high blood pressure and a total cholesterol level around 230 -- but he was taking medicine to control both and had never experience chest pain, shortness of breath or any other symptoms of heart trouble. He wasn’t at low risk for a heart attack, but he wasn’t at high risk either. Like millions of other American men, he was what the experts might call an “intermediate-risk individual.” Then one day, after hearing a radio ad, he decided to have his coronary arteries checked in a procedure known as an electron-beam tomography (EBT) scan.
“About three weeks later,” he recalls, “I get a letter that has everything but a black border on it.” The scan showed that one of Xinos’s arteries was seriously blocked by calcium deposits. After consulting a cardiologist, he underwent angioplasty and had two stents emplaced. Five years later Xinos has no doubts about the value of coronary-artery scans. “I’m not saying I would have fallen over,” he says, “but I was walking around 90 percent clogged and didn’t know it. People ignore these things and all of a sudden they go face down in a pan of pizza. Then everybody says ‘Gee, you know, he never had these problems’.”
As it turns out, Xinos’s faith in the technology was not unfounded. Just last month, the largest-ever study of EBT scans found that they are effective in helping doctors predict heart attacks and other cardiac events among patients at intermediate risk, like Xinos. It was the latest in a wave of recent developments that could lead to important changes in the way we diagnose, treat and prevent coronary heart disease (CHD), which remains the single leading cause of death among American men, killing more than 260,000 in the year 2000. Exciting fronts are opening up in the endless was against CHD as researchers look at an array of newer risk factors, from intriguing details about cholesterol (Ever heard of small LDL? How about HDl2B?) to the complicated role vessel inflammation plays. The hope is that this ever more nuanced picture of the disease process will enable doctors to better assess which patients are at risk for heart disease, stop heart attacks before they happen and develop more effective, customized treatment plans.
An understanding of the classic risk factors is still essential, but it seems clear we are entering a new phase in the quest for heart health. And cardiologist Robert Superko is one of those leading the way. Superko, whose new book, “Before the Heart Attacks,” offers a comprehensive guide to the latest ideas in preventing CHD, says the expanding list of risk factors reflects the complexity of cardiovascular disease. He uses the newer risk factors (in addition to the traditional ones) to create what he calls “cardiac fingerprints,” unique clinical profiles of his patients. “I will not treat you as a member of one of these 10,000-person clinical studies,” he says. “I will treat you as an individual.” Dr. George Kondos, who directed the large study of EBT scans, shares Superko’s enthusiasm for the evolving approaches to CHD. For Kondos, a cardiologist at the University of Illinois at Chicago, it’s all about detecting heart disease before the patient develops symptoms. “The traditional risk factors have withstood the test of time, and they are very important,” says Kondos. “But still, up to a third of people with heart disease don’t have those.” For those people, there are some promising new developments in the detection and prevention of CHD that could save thousands of lives.
A high cholesterol level is perhaps the best-known risk factor for heart disease. Everybody knows his cholesterol level, it seems, and almost everybody, it also seems, is taking one of the cholesterol-lowering drugs known as statins, the top-selling drugs in the United States. Twenty years ago total cholesterol was the only number readily available to the typical patient. A few years later, with refinements in testing, one number became three numbers as total cholesterol was joined by good cholesterol (HDL) and bad cholesterol (LDL). Today, thanks to further advances in technology, we know more than ever about what is in fact a maddeningly complex group of molecules.
One of the most lethal forms of cholesterol that can now be tested for is called small LDL. People with a lot of this dense form of LDL are said to the LDL Pattern B and are at a dramatically increased risk of heart disease, says Superko, whose book spells out exactly who should consider being screened for small LDL and other risk factors. Small LDL, an inherited trait, is more common in people who are overweight or diabetic, but it can also show up in those who are fit. One of the nastier details, according to Superko: small LDL speeds the progression of heart disease, so someone with heart disease and small LDL will get worse twice as fast as someone with heart disease but no small LDL. On the upside, and, in some cases, with such drugs as niacin and fibrates.
If small LDL is the kind of cholesterol you definitely don’t want to have, then HDL2B is the kind you definitely do want to have, and the more the better. HDL2B is a superefficient type of HDL, the good cholesterol that helps clear partially blocked arteries. HDL2B, the strongest possible protection against heart disease, is measured as a percentage of total HDL, and Superko likes his patients to be above 35 percent (for postmenopausal women, above 45 percent). Low HDL2B is often found in smokers and overweight, inactive people. It can be raised with improved diet, exercise and weight loss.
As if they needed it, people at risk for heart disease got something new to worry about last November, when The New England Journal of Medicine published a major study about inflammation. The report compared C-Reactive Protein (CRP) -- a blood marker for inflammation – and LDL cholesterol as predictors of heart disease. CRP was found to be a better predictor. The big question, then and now: who needs to get tested for CRP? The answer: hmmm. “It’s not clear exactly yet which patients need CRP screening,” says Dr. Robert Bonow, president of the American Heart Association. The problem is, elevated CRP can be caused by a lot of things, from infections to lack of exercise to physical exertion. If you are already at very low risk for heart disease, Bonow says, and elevated CRP level is not a problem. And if you are already at very high risk, you don’t need a CRP screen to know you’ve got a problem. “Where it could help is in people who have one or two abnormal risk factors but everything else looks OK,” say Bonow. Some doctors treating patients in this intermediate-risk group might be on the fence about how aggressive to be, and an elevated CRP could help them make up their minds, he says. When Superko screens for CRP, he measure it on three separate occasions, three weeks apart, to establish clinical significance in an individual patient.
Like CRP screening, EBT scans of the coronary arteries are unnecessary for those at low risk of heart disease and redundant for those at high risk. “Men about the age of 40 and women above the age of 50 with at lease one traditional risk factor,” says Kondos, describing the population of candidates for the procedure. Kondos, who regularly cites studies showing that half of deaths due to heart disease occur in people with no symptoms, notes that EBT scans do more than simply identify a risk factor. “What you are doing is actually looking at and measuring the disease,” he says. More specifically, the EBT scan measure the buildup of calcium in the arteries that supply the heart muscle with blood. The more calcium, the high the score (more than 400 is abnormal), and the higher the score, the greater the risk of heart attack or some other cardiac event. While Kondos’s study, which appeared in Circulation: Journal of the American Heart Association, supports the efficacy of coronary-artery scans, it may also lend some much needed legitimacy to the scanning industry, which has been criticized in the past for marketing a variety of scans to healthy consumers who don’t really need them.
As for those not-so-healthy consumers who might be confused about all of these new developments in cardiology, well, there’s still the tried and true. “Although we are certainly interested in identifying the importance of some of these newer risk factors, I think we need a little more time and some more science to figure out exactly where they fit in,” says Bonow. “Meanwhile, if we were just to do better in controlling the more standard risk factors -- such as high blood pressure, diabetes, high cholesterol -- in more people, then we could make a major impact in the number of people who are dying each year from heart disease and strokes.” Not to mention all the people who are merely worrying.
Five Tests Worth Paying For
The Wall Street Journal
Health Insurance Usually Won't Cover Them, But These Tests May Very Well Save Your Life
Five promising screening tests could save your life. But if you want one, you'll probably have to pay for it yourself.
In most cases, the tests -- aimed at finding early-stage ovarian cancer, heart disease, lung cancer and aneurysms -- aren't covered by insurance if you are otherwise healthy and at average risk. But the reason the tests aren't covered or even recommended by most doctors has more to do with the complexities of national health policy than what may be best for you as an individual.
Screening tests are expensive, and the government and health insurers need lots of cost-benefit studies proving a particular test will save enough lives to justify the cost.
Other tests simply don't have political support -- breast-cancer groups have raised awareness of mammograms, but when is the last time your doctor mentioned nuclear magnetic-resonance blood tests?
Finally, no screening test is perfect, and a false positive can lead to additional testing and invasive procedures that can do more harm than good. But while false positives are one reason doctors don't recommend these tests for everybody, you, as an individual, may decide that it is worth the risk.
In the end, the decision involves a ca. Here are five screening tlculated risk. Patients who don't get tested are gambling they will be among the majority who stays healthy. Those who do pay for screening may get peace of mind, but they also accept the risk of unnecessary and po. Here are five screening tests you may want to ask for -- and pay for -- yourself. The tests range from in cost from $60 to $500. Some should be done annually; with others the frequency depends on the results.
TRANSVAGINAL ULTRASOUND . . . Cost: about $250
Does it hurt? It is painless, though not exactly comfortable. This test, which is performed annually, uses a wandlike device, inserted into the vagina, to view the ovaries.
Right now, there is no approved screening test for detecting ovarian cancer, which kills 14,300 women a year. It is the deadliest female cancer because it often doesn't produce symptoms until it has reached an advanced stage, when five-year survival is as low as 31%. Early detection boosts five-year survival to 95%.
The best study supporting transvaginal ultrasound comes out of the University of Kentucky, where researchers have screened about 23,000 women over the age of 50 or women over 25 with a family history of the disease.
So far, the screening has picked up about 300 ovarian tumors. Only 29 of those turned out to be cancer, but 76% were caught in the early stage, says Jack van Nagell, director of gynecologic oncology at the University of Kentucky Medical Center. Typically only 25% of ovarian cancers are caught early.
And the five-year survival rate among women in the Kentucky study is 88% -- compared with the national overall ovarian cancer survival rate of 53%.
While all that sounds convincing, skeptics note that nine out of 10 women in the study underwent surgery to remove tumors that weren't cancer. Indeed, women who get the test should know that benign ovarian cysts commonly occur in women of all ages.
"The downside of doing sonos on everybody is the increased cost and increase in additional procedures and surgery that may not be necessary," says Carolyn D. Runowicz, vice chairman of obstetrics and gynecology at St. Luke's-Roosevelt Hospital Center in New York.
Ovarian cancer risk is highest among women in their 70s, and higher among women with a family history of ovarian, breast or colon cancer. Women who have never had children are more likely to develop ovarian cancer than those who have. Tubal ligation and oral contraceptives appear to reduce risk, while fertility drugs and hormone therapy can increase risk.
Does it hurt? It is a blood test -- your basic poke with a needle. The results break down both the good and bad cholesterol into subclasses that can give a better indication of heart-disease risk. Depending on the results, the tests may need to be repeated regularly.
Half the people who have heart attacks have normal cholesterol under traditional testing. Part of the problem is that the typical cholesterol test doesn't directly measure your LDL, or bad cholesterol. It just measures HDL (good cholesterol) and triglycerides, and then uses a formula to come up with an LDL score. But the formula can be unreliable, especially if your triglyceride count is high.
Expanded tests not only provide a direct measurement of LDL, but they also look at the size, type and sometimes number of LDL and HDL particles. A person with a low LDL score could actually have a lot of small LDL particles, putting him or her at higher risk for heart disease. And a person with very high HDL, thought to offer dramatic protection against heart disease, might not be getting as much protection as he thinks, because he can have too much of the wrong kind of HDL.
Insurance plans often will pay for the test if a person has known heart problems or other risk factors such as diabetes. But they usually won't pay for the tests in healthy people -- even though it is estimated that 40 million otherwise healthy people have hidden heart disease. Studies show the expanded tests could have detected 95% of heart-attack patients early.
The best-known expanded test is from Berkeley HeartLab, the Burlingame, Calif., firm that licensed the test from University of California at Berkeley, where it was developed. Another test made by Atherotech of Birmingham, Ala., is known as the VAP test (for vertical auto profile), and uses a high-speed centrifuge process to study particle size. A third test, known as the NMR Lipoprofile (for nuclear magnetic resonance), uses soundwaves to measure the number of particles. It is made by LipoScience of Raleigh, N.C.
You find things you don't find on a regular lipid profile," says Carlos Ayers, head of vascular medicine and preventive cardiology at University of Virginia Medical Center who uses the VAP test. "If you really want to know absolutely whether you have any abnormal lipids or you might have some other findings, the only way to be sure is to get an expanded lipid profile."
The Berkeley test has been used and studied longer. But the Berkeley test costs about $175, compared with $140 for the NMR and $75 to $85 for the VAP.
EBT HEART SCAN . . . Cost: About $500
Does it hurt? A painless, lying-down-type test. You spend 10 minutes in a doughnut-shaped machine, while electron-beam tomography looks for calcium buildup that can signal heart disease. Follow-up scans may be necessary if there is a positive result.
More preventive cardiologists are using the test because current risk-assessment methods miss as many as 75% of patients who go on to develop heart problems. As a result, for 150,000 people a year, the first symptom of heart disease is death.
The biggest-ever study of the scans, published last month in the journal Circulation, found that the tests are useful in predicting heart problems in intermediate-risk patients -- those without symptoms but with at least one traditional risk factor.
Says Harvey Hecht, director of preventive cardiology at Beth Israel Medical Center in New York, EBT "tells you, 'These are your arteries. This is how much plaque you have.' "
Patients with high calcium scores may be prescribed medication or urged to make diet and lifestyle changes. In the case of heavy buildup, a follow-up stress test may be ordered to determine whether there is a blockage that needs to be treated. A positive stress test often leads to an angiogram, which is a riskier and more invasive procedure that uses a catheter and dye is inserted into the artery for a better look.
The test remains controversial. The presence of calcium buildup doesn't always increase your heart-attack risk -- it could be that the deposits found by the scan are stable and harmless, and follow-up tests were unnecessary. At the same time, a person who has a clear scan could actually have undetected and unstable plaque poised to cause a blockage.
"It shouldn't be something you just go out and get, but really you should do it in consultation with a physician," says New York cardiologist Nieca Goldberg. "For some people it would be a false security blanket."
The Society for Atherosclerosis Imaging says the scans are best suited for men over 45 and women over 55 with no risk factors, or 10 years earlier if you have a risk factor like family history or smoking.
SPIRAL CT SCAN . . . Cost: $200 to $450
Does it hurt? No. You glide feet-first into a scanner, stopping at the neck (a few patients might feel a little claustrophobic). This annual test can find lung cancer when it is as small as a grain of rice, compared with conventional X-rays, which often don't spot cancer until it is as big as an orange.
The overall five-year survival rate for lung cancer is just 15%, and studies generally show that survival rates are longer with earlier detection.
Still, not enough is known about whether patients are simply learning about their fatal cancer earlier, or actually living longer. Thus, a debate is raging about whether early detection by spiral CT will make a difference.
While a major national study hopes to answer the question, the early evidence of the scan is promising. Right now, just 15% of lung cancers are found early. But in scanning studies, 80% of the cancers are caught in the early stages.
The biggest problem with the tests is false positives. A Mayo Clinic study found abnormalities on 51% of scans, but only 1% of the study group had cancer. That means half the patients had unnecessary and risky lung biopsies.
"Screening for lung cancer is not a benign and simple test," says Reginald Munden, section chief of thoracic imaging at the University of Texas M.D. Anderson Cancer Center in Houston. "If somebody wants to be screened, I'm not saying we should stop them, it's their money. But people need to know what they're getting into."
The Cornell group, with far more scanning experience, has pushed its false-positive rate down to 15%. It has also learned that the highest risk for a false positive is on the first scan -- after that, doctors can compare results. Anyone with a positive scan should get a second or even third opinion before undergoing surgery. Patients can even request their scans be sent for review to Cornell, Mayo or Moffitt Cancer Center in Tampa, Fla. -- the centers with the most experience reading lung scans.
"To us, CT screening on a yearly basis does save lives," says Claudia I. Henschke, chief of chest imaging at Weill Cornell Medical Center, who has led the CT scanning research. "The only question that still needs some further follow-up is how many it saves."
The scans are suggested for smokers and former smokers 50 and over who have smoked at least 10 "pack years" -- that's a pack a day for 10 years or two packs a day for five years.
ANEURYSM SCAN . . . Cost: $60-$200
Does it hurt? You will just feel a little pressure: a five- to 10-minute ultrasound with a hand-held scanner against the abdomen. The test can spot bulges in the artery wall long before they become life-threatening, and if results are positive, you may be rechecked regularly.
Aneurysm disease is surprisingly common -- it's estimated 7% of men over 60 have it. But few people have even heard of it or realize they might be at risk for abdominal aortic aneurysm, which kills an estimated 30,000 people annually.
Aneurysms caught early can be fixed with surgery. The surgery can be risky, and may require a lengthy recovery, but it nonetheless boosts survival to 96% to 99%. If an aneurysm ruptures, the chance of dying is 80% to 90%.
"We think it's a tremendously useful screening test if you screen the right group of patients," says K. Craig Kent, chief of vascular surgery at New York Presbyterian/Columbia and Cornell.
During a recent quarterly screening in Baton Rouge, La., the nonprofit Aneurysm Outreach (www.alink.org <http://www.alink.org>) found 20 abnormalities in 238 people. "The average person has never heard of an aneurysm or if they have, they think it only occurs in the head," says founder Sheila Arrington, whose father died at 58 from aneurysm.
The best candidates for screening are men above 60 and women above 60 who have a cardiovascular risk factor, such as diabetes, smoking or obesity. Everyone over 50 who has a family history of aneurysm should be screened. A quick screen ultrasound is ideal and costs just $60. But some centers may offer only a lengthier ultrasound that examines the entire abdomen and can cost $200.