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Preventing P.A.D.

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DETROIT, Mich. (Ivanhoe Newswire) - When you think of a build-up of plaque in your body, you might think of your heart, but build-ups in other places can be dangerous too. Now, doctors are testing a new tech tool to help them remove the problem without removing limbs.

Similar to a blockage you'd find in a clogged heart, Detroit Medical Center Doctor Mahir Elder took out vial full of plaque of an artery in a patient's leg. It was the result of peripheral arterial disease.

"This is a very critical disease that is obstructing blood supply to the feet," Dr. Mahir Elder, medical director of endovascular medicine at the DMC Cardiovascular Institute and assistant program director of interventional fellowship at WSU School of Medicine, told Ivanhoe.

Between eight and ten-million people in the U.S. have P.A.D. Every year it costs 200,000 their limbs.

"Oh, I was fearful of amputation," Joe Kalish, who suffers from peripheral arterial disease, told Ivanhoe.

Joe Kalish has been struggling with P.A.D. for more than a decade.

"I'd walk from the bedroom to the living room and i had to sit down. My legs would just ache," Joe said.

But recently he took part in the connect-two trial led in part by doctor Elder. It's testing the ocelot, a device giving doctors a new view inside vessels.

"It uses ultrasound technology as it swipes in a 360 degree motion and subsequently giving us a three dimensional image," Dr. Elder said. "It is a game changer because now we can identify the vessel anatomy while we're inside the vessel."

The doctor said these images help him stay in the middle of the vessel while he shaves away the buildup or blasts it with a laser. The more center he is the better chances it won't close up again.

"The trial has shown that the patients are getting better results right away," Dr. Elder said.

As for Joe, his circulation's back and his pain is almost completely gone.

"It's great. It's like a child doing his first steps all over again that's how great it makes me feel." Joe said.

The connect two trial testing the ocelot is now closed, but, while the technology awaits FDA approval hospitals that took part in the study are allowed to continue treating patients with the ocelot.

RESEARCH SUMMARY

BACKGROUND: Peripheral arterial disease (P.A.D.) is a disease in which plaque builds up in the arteries that carry blood to your head, organs, and limbs. Plaque is made up of fat, cholesterol, calcium, fibrous tissue, and other substances in the blood.

When plaque builds up in the body's arteries, the condition is called atherosclerosis. Over time, plaque can harden and narrow the arteries. This limits the flow of oxygen-rich blood to your organs and other parts of your body. (Source: www.nhlbi.nih.gov)

P.A.D. PROBLEMS: People with diabetes are at greater risk for severe PAD and are five times more likely to have an amputation.

  • The risk of limb loss due to PAD increases with age.
  • People 65 or older are two to three times more likely to undergo amputation.
  • Men with PAD are twice as likely to undergo an amputation as women who have PAD.
  • Certain racial and ethnic groups are at increased risk of amputation (i.e., African Americans, Hispanic Americans, Native Americans), as they are at increased risk for diabetes and cardiovascular disease.

(Source: www.amputee-coalition.org)

THE OCELOT: CONNECT II is a multi-center, non-randomized global clinical study evaluatIing Ocelot, the first-ever interventional device that allows physicians that treat PAD to drill through totally blocked arteries in the legs while using an integrated camera to see from inside the artery.

  • Ocelot is aptly named to honor the cat that possesses excellent night vision.
  • Traditionally, physicians had only an X-ray to see outside an artery; but with the help of Ocelot they're able to see from inside it.
  • Using two-dimensional X-rays is like using a printed map to guide the procedure.
  • You can look ahead of time to plan your route and try and predict what roadblocks you might face. (Source: Detroit Medical Center)

INTERVIEW

Dr. Mahir Elder, Medical Director Director of Endovascular Medicine and Assistant Program Director of Interventional Fellowship at WSU school of medicine, talks about viewing vessels from the inside out and how it's helping stop amputations.

What is PAD?

Dr. Elder: Peripheral arterial disease is a disease process that affects the arteries mainly in the lower extremity which is the legs. It affects over 25 million Americans and hundreds of millions worldwide and it is a slow blockage of the arterial system. If you can imagine the vessel as a pipe and the blood supply flows through the pipe to the critical origins and so what tends to happen is it is a slow, plaque buildup throughout the whole vessel to the point where the vessel is occluded and there is no blood supply attending distal to the feet. What happens is that as a slow progression occurs, some patients will have symptoms. What makes peripheral arterial disease so critical is not every patient will have symptoms. The typical symptoms we see are patients that have leg pain upon walking that is relieved with rest. This can occur in a lot of patients and a lot of times, they think it is their back or they think that it is their bones or a lot of patient dismisses it as maybe arthritis. But this is a very critical disease that is obstructing the blood supply to the feet. Worst case scenario when the blockages get really severe, it ends up with gangrene and once gangrene sets in, that can in extreme situations lead to amputation of the limbs.

How many amputations occur every year due to PAD?

Dr. Elder: It is over 200,000 amputations that occur annually in this country. Worldwide, it is even much larger. Our goal of identifying peripheral arterial disease is to prevent amputation. Part of the reason why there is a lot of amputations is that the disease itself is not diagnosed until it is really late in the stage. So catching it and diagnosing it early is very critical, but also helps in prevention and treatment with the process.

What is the buildup?

Dr. Elder: Some of the material is a hyperplasia plaque, calcium in a number of critical areas. These are blockages that occurred to block the vessel and what we did is, we used a special device to shave off the plaque and open up the blockage.

Is it similar to what you would see in a blockage in the heart?

Dr. Elder: Correct. It is very similar to what you would have in blockages in the heart as well as in the neck. These blockages are buildup of cholesterol and calcium plaque buildup that ends up obstructing the blood supply to the area that it is intended to supply.

Are people more prone to this genetically or it is something that can develop in anyone?

Dr. Elder: It could basically develop in almost anyone; anywhere that has a blood supply. The higher risk patients are patients that smoke, as well as uncontrolled diabetes. Hypertension is another risk factor coupled with these risk factors they compound to even greater risk of having this disease. We all have some type of fat streak buildup that is in the vessels. It starts at 4 weeks of life. It slowly progresses. For some patients it will progress much quicker depending on the risk factors that they have.

What was the traditional treatment if you caught it early or even if you caught it late?

Dr. Elder: If it is diagnosed, typically there is an open bypass where they will open up the leg and do a vessel bypass either using an artificial graft or the vein in the leg. The artificial grafts tend not to stay open very long. There is an alternative which is a minimally invasive procedure where we go in with a catheter, about the size of a dime and open up the blockage through various equipment such as shaving it off or with laser or with a drill. Some of the other equipment we use are lasers to dissolve the material. We also use a small little drill that breaks up the calcium and allows us to open up the blockage. We have various equipment all done without any scalpel, without any cutting. It is basically done through a small IV line about the size of a dime or a pen. There is no cutting. There are no stitches involved in the entire procedure.

Is that the Connect II trial?

Dr. Elder: the Connect II is a trial that we use to use ultrasound technology and going through the blockages. These are the vessels that have been occluded for a long time, for many years and we try to break up the blockage. The Connect II trial helped to use ultrasound to see if ultrasound-guided can help us maintain to be in the center of the vessel without popping out. The thought process behind it is if we stay inside the center of the vessel; the vessel is more likely to stay open rather than re-occluding within a year.

Is there a risk of developing PAD again?

Dr. Elder: With patients who have peripheral arterial disease on one leg, the odds are it occurs in a second leg. They are mirror image. In addition, if there is a blockage in the leg, you have a much higher risk of having a blockage inside the heart. They are all connected; almost through like a pipe system throughout the whole cardiovascular system. The risk of having a blockage in one area, it is highly likely of having it elsewhere.

How is the Ocelot different than this?

Dr. Elder: There are many minimally invasive techniques that we use to open up the blockage. The Ocelot is an ultrasound technology where we use to maintain the center of the vessel. When we are trying to open up a blockage that has been shut down for a very long time, getting through the blockage is one obstacle, but also maintaining inside the vessel where we do not go outside the vessel. The ultrasound helps guide us so we maintain the center of the vessel. This long-term in theory is supposed to help maintain patency of the vessel a much longer time period. It is almost like a siren and what it does is it uses ultrasound technology as it swipes in a 360 degree motion and subsequently giving us a 3-dimensional image.

As it's giving you that image, it is clearing the blockage as well?

Dr. Elder: That gives us guidance. It is almost like a preview of where we are going and we use different techniques to break through the blockage, but it gives us almost like a visual aspect of the vessel inside the vessel.

How helpful is that when you are trying to clear these blockages and shave them?

Dr. Elder: It not only decreases the length of time for the procedure, but also helps maintain the vessel location, so we are inside it. It is going to maintain the patency or help decrease the length of time for the procedure itself and get a better outcome.

Is this the second phase of the trial?

Dr. Elder: Yeah, it is. Phase 1 was very successful. We are down to Phase 2 and this will be almost a standard practice in almost all patients that have critical limb ischemia with a chronic totally occluded vessel.

Is this a game changer?

Dr. Elder: It is going to change a number of things. First, most of chronic total occluded vessels are not treated. It is going to allow us to treat vessels that we normally would not treat. It is going to help maintain the vessel patency as well as prevention of amputation in the future.

What have you seen in the trial in the patients you have treated?

Dr. Elder: Preliminary, the trial has shown that the patients are getting better results right away. Angiographically, the results look terrific. We immediately can see the results during the procedure and the results afterwards when patients follow up in the clinic they have all been very satisfactory.

Have you seen any recurrence in any of the patients that you have used Ocelot on?

Dr. Elder: It is still early to determine how long, if the patency is going to change, but so far, we have not seen recurrence.

Does that give you hope?

Dr. Elder: It does. It does allow us to potentially maintain the patency. In particular, the vessels that we tend to use this on are the superficial femoral artery and that vessel has a high risk of re-occluding. Any equipment that is helpful in maintaining the vessel patency at a much longer period is going to be helpful long term in the treatment of this disease.

Do you see it mainly in the legs?

Dr. Elder: Blockage inside the heart tends to show up with chest pain and we try to catch that early and the majority of patients will have chest pain. In peripheral arterial disease, only 35% to 40% of the patients will have symptoms. Most of the patients will have a blockage and unfortunately what tends to happen is that the symptoms do not show up until very late in the stage and then the patients either have gangrene or they have critical limb ischemia. That is really late in the process. By screening early and treating it early, you are allowing yourself to fix the problem before it becomes a really critical problem.

Are there any tips for being able to spot some of the signs?

Dr. Elder: All patients that have diabetes or who are smokers are encouraged to be screened. The screening process is a very simple procedure where they check ankle brachial index. That is basically the blood pressure in the arm and in the leg and they do a comparison. If the pressure is different, it is a sign that there might be a blockage. Having proper screening is one aspect. The second aspect is treatment. The treatment options are either doing a surgical procedure, which is the traditional way of handling it. We do bypass of the vessel through an artificial graft or the vein or what is more popular now, endovascular procedure, where there is no cutting and there is no artificial equipment that is left inside the body.

Do you recommend any lifestyle changes to reduce the risk?

Dr. Elder: There are a number of things, behavioral modifications that have to take place. The first of which is smoking cessation. Patients really need to stop smoking. It is the #1 risk factor for peripheral arterial disease as well as coronary artery disease. By quitting smoking, you help not only future progression, but also the disease process itself. Second would be diabetes. If the patient is a diabetic, it is strongly encouraged that they tightly control their diabetes. Hemoglobin A1c is a factor that is used to measure the average of the glucose level in the diabetic patients for about 3 months, which is lifespan of the red blood cell. We like that number way under 7. If we can control the diabetes, we can control the disease process. The last thing which is under emphasized is ambulatory exercise. By doing exercise, you also, not only increase the blood supply, but you also prevent the vessels from occluding. Exercise not only helps with the coronary in helping the heart, but it is really good on the legs. We highly recommend an exercise program.

Besides smoking and diabetes, are there any demographics that are more at risk for PAD than others?

Dr. Elder: Patients that have family history have a higher risk because most likely it is related to like cholesterol inside the family history. As far as demographic, it is probably equal across the board. If, smoking and diabetes and hypertension were removed as variables, it affects almost everybody.

What I tell patients is that there is as a very general rule, there are 4 major arteries on each side of the leg that can be occluded. It is not just 1 artery or 2 arteries. It is basically 8 to 10 that can be occluded and that is all from the hip down as a general very soft way of looking at peripheral arterial disease. It is very important that the symptoms are related to screening. If you screen and we notice that there is a blockage in that area, then the best process is actually to look for it. An angiogram can quickly tell if there is a blockage. Unfortunately, there is still amputation and occlusion of the vessels occur without taking the angiogram. Our objective is to identify the disease, do an angiogram where we can see where the blockage is and discuss appropriate treatment.

Patients who are at risk that amputation, where it is normally?

Dr. Elder: It tends to start off in basic amputation, midfoot and that is half of your foot. If that does not resolve the matter or if there is progression, they start off below the knee and then above the knee. There is a huge difference. Losing a limb is not just the psychology of not able to get around and the quality of life. It has been proven that these patients that lose a limb within 5 years have about 30% to 50% mortality. There is something systemic that takes place that increases their mortality after having an amputation.

Do you think this will be a standard of care?

Dr. Elder: I think it will be. I think in the future what is going to happen is we are going to use the ultrasound technology like Ocelot to make sure we are exactly where we need to be in the vessel and it will help us with one of our many tools to help prevent and treat peripheral arterial disease.

Any one of 11 sites in the world?

Dr. Elder: Right now in the country, we are 1 of 11 sites and preliminary results looks pretty good. The final results will come out, I think the trial is closing very soon, so will have the data to go onto the next phases.

Is there something patients should never ignore when it comes to pain?

Dr. Elder: A leg pain is not always arthritis. Leg pain should not be dismissed. In my world because I am an endovascular specialist and we deal a lot with peripheral arterial disease, leg pain may suggest angina for the legs. It is very important with all patients that if they have leg pain, in particular, leg pain when you exercise or when you walk that is relieved with rest; that is very suggestive of arterial occlusion and this is something that needs to be treated and identified immediately. I always tell my patients that the best way to fix a problem is to actually prevent it in the future. The best way is prevention. Once you identify if you have the disease process, you need to focus on measures such as exercise, such as diet control, and behavior modifications to prevent it from returning.

Are there any PAD myths that you hear from patients or that are out there?

Dr. Elder: One of the things that tend to occur is that people think that if you have peripheral arterial disease that you have to have an amputation. There is an alternative to amputation and there is an endovascular way of fixing it without having to do surgery. We have many times saved many limbs. I think at our center, we saved over 2000 limbs in the last 4 to 5 years. These are patients that were scheduled for either amputation within the year and subsequently with the treatment we either delayed amputation and provided a better quality of life or even prevented it at all. This is a huge benefit for the patients; not only because of saving a limb, but it is the psychological aspect and the mortality benefit of preventing a limb amputation. 

FOR MORE INFORMATION, PLEASE CONTACT:

Silvia Zoma
Public Relations and Marketing Account Manager
Harper University Hospital
(313) 745-7637
szoma@dmc.org

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