CINCINNATI, Ohio (Ivanhoe Newswire) - Do you ever struggle just to walk up a flight of stairs? Extreme weakness can be a signal that something is seriously wrong with your heart. Now, a new device is help people regain their energy and save lives.
Lugging heavy groceries used to be exhausting for John Brinker.
"It would have worn me out to do this," John Brinker, heart patient, told Ivanhoe.
John's energy level had crashed.
An angiogram revealed a dangerous blockage in his coronary artery, severely reducing blood flow to his heart.
Doctor Dean Kereiakes with The Christ Hospital in Cincinnati used a new mesh scaffold to prop open John's clogged artery.
"It will open the blood vessel," Dean J. Kereiakes, MD, FACC, Medical Director at The Christ Hospital Heart and Vascular Center, told Ivanhoe.
It releases medication into the blood vessel. Then, unlike a metal stent, it disappears after the artery heals.
"It slowly dissolves like a lollipop in your mouth and goes away, leaving behind a normal appearing and normal functioning artery," Dr. Kereiakes said.
John is one of the first patients in the U.S. to receive a dissolving stent. No metal left behind means a lower risk of clotting and stent fractures.
"I'm back as good as ever, maybe better," Brinker explained.
Today John's heart is healthy. He's full of energy and even enjoys a trip to the grocery store.
The dissolving stent, called "Absorb," is already approved for use in Europe and parts of Asia and Latin America. It's being tested right now in the U.S. Click here for study information: http://www.lindnerresearch.com/pages/absorb/.
BACKGROUND: Affecting more than 13 million Americans, coronary heart disease is the number one killer in America. Heart disease happens when plaque buildup in the coronary arteries, a condition called atherosclerosis, which leads to blockages. The arteries start out smooth and elastic, then they become narrow and rigid, restricting blood flow to the heart. Plaque can start to deposit in the blood vessel walls at a young age. As you grow older, the plaque builds up as well, increasing the risk of heart attacks and blood clots. Plaque releases chemicals that promote the process of healing, but make the inner walls of the blood vessel sticky. Substances like lipoproteins and calcium that travel in the bloodstream will stick to the inside of the vessel walls. The narrowed coronary artery can eventually develop new blood vessels that can escape the blockage. During times of increased stress, the new arteries may not be able to supply a sufficient amount of oxygen-infused blood to the heart. (Source:www.webmd.com)
SIGNS: The most common symptom of coronary artery disease is angina, or chest pain. It can be described as pressure, heaviness, aching, numbness, fullness, pressure, painful feeling, or squeezing. Angina is sometimes mistaken for heartburn. Other symptoms can include: dizziness, weakness, shortness of breath, palpitations, nausea, sweating, and a faster heartbeat. (Source: www.webmd.com)
TREATMENT: Treatment for coronary artery disease involves making lifestyle changes, taking medications, and sometimes undergoing invasive surgery. Common procedures can include balloon angioplasty (PTCA), stent placement, and coronary artery bypass surgery. All of these will increase blood supply to the heart, but they do not cure coronary heart disease. New innovative ways doctors are exploring are angiogenesis and EECP (Enhanced External Counterpulsation). Angiogenesis involves giving substances, like stem cells, through the vein or directly into the damaged heart tissue. Patients who have bad angina, but do not get relieve through medications or who do not qualify for surgeries, may use EECP. It is an outpatient procedure that uses treatment cuffs placed on the legs that inflate and deflate, increasing the blood supply that feeds coronary arteries. (Source: www.webmd.com)
NEW TECHNOLOGY: One of the newest advances for blocked arteries is a device called Absorb. After opening blocked arteries, it dissolves. Absorb is the first drug-eluting, bioresorbable vascular scaffold (BVS) for the treatment of coronary artery disease. The device is made by a health care company called Abbott. It is a tiny mesh tubular scaffold made of polylactide, a biocompatible material used in medical implants like dissolvable sutures. Absorb will provide support to the heart vessel until normal functioning is restored and dissolves naturally. Absorb is in stage III clinical trials. Approximately 2,250 patients are enrolled so far. The trial will compare Absorb BVS to traditional drug-eluting stents. The device is not approved for sale in the United States, but in Europe, Asia, and Latin America there are more than 3,000 patients with this device in clinical trials and commercial use. Researchers believe that this new device has the potential to help with blockages without leaving a permanent metallic stent behind. The blood vessels have an opportunity to return to a natural state, resulting in a reduced risk for some patients who require future interventions. (Source: www.thechristhospital.com)
Dean Kereiakes, MD, Medical Director for The Christ Hospital Heart and Vascular Center and for The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati, talks about a new absorbable stent.
What is the Absorb scaffold and what is new about it?
Dr. Kereiakes: The Absorb scaffold is a revolutionary technology for treating obstructive coronary disease, or atherosclerotic blockages in the coronary arteries. The novel aspect of Absorb is that although it's a stent, which holds the artery open physically for at least three to six months, which is the requisite duration of mechanical scaffolding required, it also medicates the surface of the artery to prevent recurrent blockage and finally slowly dissolves like a lollipop in your mouth. It goes away, leaving behind a normal appearing, normal functioning artery at eighteen to twenty-four months following placement.
Why is it a good idea for the stent or the scaffold to dissolve?
Dr. Kereiakes: The history of coronary stenting began in about 1990 with bare metal stents as investigational devices here in the U.S. In about 2000, drug coated stents (DES) began to be used as investigational devices and were subsequently FDA approved in 2003. We now understand late outcomes beyond one year and even five to ten years after DES placement. There is persistence of a chronic metal prosthesis with polymer on it. The polymer impregnated with medicine which leaches out over thirty to ninety days. However, polymers are gums or paints placed on top of a metal scaffold that is a permanent prosthesis inside of your coronary artery. Over time the body may not embrace this device and in fact, it can cause various levels of inflammatory response reaction from the body. Metal ions can leach out of the metal platform and illicit inflammation or hypersensitivity reactions, and these can lead to adverse outcomes. Also, the heart is dynamic and doesn't stand still. It not only contracts, it rotates with each beat and stents are being subjected to bending or movement forces. If you bend a coat hanger enough times it breaks. Stent metal struts are only thirty two thousandths of an inch thick. If they are stressed repetitively, particularly in bend segments of the artery where there's torsion, this may lead to stent fracture, which can present as restenosis or a recurrent blockage that requires yet another procedure. Stent struts can't fracture if they are not present due to resorption. The brilliance of this concept is that there's no possible allergic reaction, hypersensitivity reaction, stent fracture, late stent thrombosis, clotting, or what we now call neoatherosclerosis which is the development of new atherosclerosis on the surface of the stented segment. These aren't going to be a problem when the stent is gone.
So you said there could be a problem with another blockage around the stent in time?
Dr. Kereiakes: Well, we know that both drug eluting stents, particularly the first generation drug eluting stents, and bare metal stents develop neoatherosclerosis, which is the development of yellow plaque or atherosclerosis on the surface of the stent. In fact, this may reflect some irritant effect of the prosthesis. Foreign devices that are left inside the artery may accelerate atherosclerosis to some extent and increase the likelihood of getting another blockage. The other real advantage of a stent that "goes away" is that it is flexible and doesn't distort the normal coronary anatomy. Coronary arteries are not straight tubes; they have curves and bends, and when you put a metal platform into them, you straighten them out which turns out not to be a good thing. Nothing remains to distort the anatomy if the device is gone at the end of the day.
Who is a good candidate for this new type of stent?
Dr. Kereiakes: The application of the technology right now is limited by the complexity of coronary anatomy. That means heavily calcified blockages in tortuous or curvy arteries are not optimal candidates for this device at the present time. The Absorb stent struts are relatively thick and they may have the propensity to suffer trauma because they are composed of polylactic acid which slowly dissolves over time. Absorb will not be a work horse device for all blockages, but rather applied more selectively in blockages that are easier to get at, and I think that's going to be very important. That means proximal segments of the vessels where tortuosity is not too great and where they're not densely calcified. Where this device is already approved for use and CE marked in Europe, European operators are teaching us how it can be used. They're learning that it can be placed in more complex coronary anatomy. They are performing complex procedures without being confined by the rigor of an FDA sanctioned protocol for proof of principle. We are testing the relative safety and efficacy of this device compared to the best in class metal platform drug eluting stent in the ABSORB trial.
What are you doing here with the trial?
Dr. Kereiakes: Well, ABSORB has several segments. ABSORB has fifty "roll in" patients that will be done in about ten centers and which is limited to one device size: three millimeter in diameter and eighteen millimeter length. So it's very challenging to find patients that have only one isolated blockage in a vessel that fits that demand. In addition, two hundred patients will be treated open label with the Absorb device, and then subjected to serial imaging studies by intravascular ultrasound, angiography, or optical coherence tomography at one or two years, to look and see what's left behind, if anything. Finally, two thousand patients will be randomly assigned on a 2 to 1 basis to either the BVS absorbable platform or the XIENCE V Everolimus eluting stent, which has a metal platform stent and has been widely hailed as "best in class" among metal platform drug eluting stents. At the end of one year we'll determine whether the primary end point of target lesion failure, which is a composite of three different events, is similar following BVS or XIENCE V. We should be able to tell that in two thousand patients.
You mentioned that this might be a good idea for people who are active. Can you explain why?
Dr. Kereiakes: The BVS Absorb should preserve autoregulation. I've had the experience in my career of stenting literally tens of thousands of arteries. When a young person wants to perform a high level of physical activity, it may not be practical after metal platform stents. The permanent metal platform continues to limit the coronary artery's normal capacity to expand in response to an increased need of the working heart muscle for oxygen. The BVS Absorb dissolves and thus, doesn't continue to place a limit on the artery.
How many of these have been used so far in the United States?
Dr. Kereiakes: There have been nine placed in the United States at this point in time and four of them here in our center. There are three active centers and we're trying to get ten centers up as quickly as possible.
When was the first one done here?
Dr. Kereiakes: Actually, we did our first one here in January this year, 2013.
What are concerns of doctors who are not using this procedure? Why aren't they?
Dr. Kereiakes: They don't have access to it. This is not a FDA approved device; this is an investigational device. It can only be administered under the auspice of this tightly run clinical research trial.
What are the disadvantages?
Dr. Kereiakes: It's a little larger; less sleek if you will. It's more like a Ford than a Ferrari, but we're struck by how relatively easy it is to use and for the types of blockages that we are allowed to treat in the trial it works very well.
Who is funding this study?
Dr. Kereiakes: Abbott Vascular.
Are you directly or indirectly compensated by the manufacturer for your involvement?
Dr. Kereiakes: No, I am not personally compensated for the conduct of the trial. I am a consultant to four or five catheter companies whom I've helped to design devices, utilize them in animals before they go into humans, and then test the devices for approval in the U.S. I've helped in the design and development of catheters similar to BVS. I've been involved with BVS for almost a decade to be honest with you. I have been paid as a consultant. The corporate sponsors pay for the research function, which means the research nurses that have to track the patients, and for the investigational devices which are provided by the study. The cost of a trial like this can be a hundred million dollars for a company; it's huge.
Will your hospital organization benefit financially by this product?
Dr. Kereiakes: Not other than the fact that we have access to a ground breaking, leading edge technology that others don't.
Would you use this procedure, product, or drug if you were not compensated in the way that was as described?
Dr. Kereiakes: Absolutely. In fact, the first one we did the hospital didn't get reimbursed from CMS or Medicare. It took doing the procedure and informing Medicare. Medicare administrators have to become knowledgeable about these things and they have to be informed of the protocol. They are usually supportive, but there is often a time lag. These technologies are not going to cost them more than the usual approved technology that would be used as an alternative. We wouldn't use this novel technology if we didn't believe it was at least as safe and effective as the standard technology. So that allows us really to comfortably and ethically randomly assign patients to one treatment or the other.
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