Thursday, May 21, 2009

Peripheral Arterial Disease of the Legs - Overview

What is peripheral arterial disease of the legs?

Peripheral arterial disease (PAD) is narrowing or blockage of arteries that results in poor blood flow to your arms and legs. When you walk or exercise, your leg muscles do not get enough blood and you can get painful cramps.

Peripheral arterial disease is also called peripheral vascular disease. This topic focuses on peripheral arterial disease of the legs, the area where it is most common.

What causes PAD?

The most common cause is the buildup of plaque on the inside of arteries. Plaque is made of extra cholesterol, calcium, and other material in your blood. Over time, plaque builds up along the inner walls of the arteries, including those that supply blood to your legs.

If plaque builds up in your arteries, there is less room for blood to flow. Every part of your body needs blood that is rich in oxygen. But plaque buildup prevents that blood from flowing freely and starves the muscles and other tissues in the lower body.

This process of plaque buildup usually happens at the same time throughout the body. It is called atherosclerosis or hardening of the arteries. If you have this problem in your legs, you most likely will have it in the arteries that supply blood to your heart and brain. This increases your chance of having a heart attack or stroke.

Plaque builds up bit by bit over a lifetime, but symptoms often do not start until after age 65. High cholesterol, high blood pressure, and smoking make you more likely to get atherosclerosis and peripheral arterial disease.

What are the symptoms?

Many people who have PAD do not have any symptoms.

But if you do have symptoms, you may have a tight, aching, or squeezing pain in the calf, thigh, or buttock. This pain, called intermittent claudication, usually happens after you have walked a certain distance. For example, your pain may always start after you have walked a block or two or after a few minutes. The pain goes away if you stop walking. As PAD gets worse, you may have pain in your foot or toe when you are not walking.

How is PAD diagnosed?

Your doctor will talk with you about your symptoms and past health and will do a physical exam. During the exam, your doctor will check your pulse at your groin, behind your knee, on the inner ankle, and on the top of your foot. Your pulse shows the strength of blood flow. An absent or weak pulse in these spots is a sign of PAD. Your doctor may also look at the color of your foot when it is higher than the level of your heart and after exercise. The color of your foot can be a clue to whether enough blood is getting through your arteries.

You will likely have a test that compares the blood pressure in your legs with the blood pressure in your arms. This test is called an ankle-brachial index. A test called an arterial Doppler ultrasound may be done to check the blood flow in your arteries.

Blood tests to check your cholesterol and blood sugar can tell whether you may have other problems related to PAD, such as high cholesterol and diabetes.

How is it treated?

One of the most important things you can do for PAD is to quit smoking. If you need help quitting, talk to your doctor about programs and medicines that can help you stop. These can increase your chances of quitting forever.

There are also products that gradually wean you off nicotine. These include nicotine patches, chewing gums, nasal sprays, inhalers, and lozenges. These treatments help people have better success in the long term.1

Your doctor may tell you to eat healthy foods and to get more exercise. You may need to take aspirin and medicines to lower your cholesterol and control your symptoms. If you have diabetes, you will need to carefully control your blood sugar.

Combined, these measures can help control your symptoms and reverse the blockage of your arteries. Keeping your arteries open can help lower your risk of heart attack and stroke. And it may also improve the quality and length of your life.

If your leg pain does not get better after a few months of treatment, your doctor may prescribe a medicine called cilostazol (Pletal) to help with the pain when you walk.

If you still do not get better, you may need a procedure called angioplasty or bypass surgery to open narrowed arteries or reroute blood flow around them. These treatments are usually used for severe peripheral arterial disease.

In rare cases, advanced PAD can cause tissues in the leg or foot to die because they do not get enough oxygen as a result of poor blood flow. If this happens, part of the leg or foot must be removed (amputated). This is more common in people who also have diabetes.

Wednesday, May 20, 2009

Pervasis Therapeutics Presents Promising Preclinical Data for its Minimally Invasive Cell Therapy

Study Findings Show Treatment with PVS-10200 Following Angioplasty and Stent Placement for Peripheral Artery Disease in a Porcine Model Reduces Intimal Area and Enhances Vascular Repair

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Pervasis Therapeutics, Inc., a biotechnology company pioneering biologically active cellular therapies to treat vascular and other serious diseases, today announced new preclinical data for the Company’s minimally invasive cell therapy, PVS-10200. Results from the preclinical study found that treatment with PVS-10200 (tissue engineered allogeneic endothelial cells) following an intervention for peripheral arterial disease (PAD) resulted in a statistically significant increased lumen area, reduced intimal area, and decreased occlusion compared to control. These data were presented in an oral presentation today at EuroPCR, the official congress of the European Association of Percutaneous Cardiovascular Interventions in Barcelona, Spain.

In this preclinical study, researchers evaluated treatment with ultrasound-guided percutaneous (needle delivered) administration of PVS-10200 to the outside of porcine (pig) femoral arteries immediately following angioplasty and stent placement. Animals in the control group received angioplasty and stents with no further treatment (sham standard of care control). A third group was treated with injection of matrix alone. A total of 36 femoral arteries were evaluated in the study and evaluations were conducted at 30 and 90 days following treatment. At 90 days, PVS-10200 treated arteries had significantly decreased intimal area (3.3 ± 0.4 mm²) compared to control (6.2 ± 0.5 mm², P<0.05) and increased lumen area (20.4 ± 0.7 mm²) compared to control (16.1 ± 0.9 mm² P<0.05). After 90 days, PVS-10200 treated arteries had a 50 percent decrease in percent occlusion compared to sham control (P<0.05). Treatment with the gelatin matrix alone did not differ significantly from the sham control.

“Restenosis, or narrowing of the arteries, following procedural treatment for PAD occurs frequently and is associated with a number of vascular complications and re-interventions,” added Helen M. Nugent, Ph.D., co-founder and vice president, research and development at Pervasis and co-author of the study. “PVS-10200 provides endothelial-based factors to the injured artery, which regulates the inflammatory response within the blood vessel and promotes natural healing. Results from this study indicate that PVS-10200 may offer a novel therapeutic option that can effectively reduce the intimal area and reduce occlusion, and therefore limit restenosis following treatment for PAD.”

“We are pleased to present this compelling preclinical data for PVS-10200,” stated Frederic Chereau, president and chief executive officer of Pervasis Therapeutics. “Treatment with drug-eluting stents has shown no benefit within the peripheral vasculature. There continues to be a significant unmet medical need and a large market potential for new therapies to effectively address common complications related to vascular intervention. Based on the encouraging results seen in this study, we are initiating a Phase 2 trial to further evaluate the safety and efficacy of PVS-10200 in treating interventions for PAD.”

Pervasis has demonstrated proof-of-concept for this novel cellular approach in two Phase 2 trials with Vascugel®, the Company’s first cellular treatment developed using its proprietary technology platform, in patients with end-stage renal disease receiving arteriovenous (AV) access for hemodialysis. The two studies, known as V-HEALTH, showed that perivascular placement of Vascugel® at the time of AV access creation resulted in higher patency rates, extended time to first intervention and greater lumen diameter at six months. Results also showed that treatment with Vascugel® was safe with fewer thrombic events, early complications and interventions than compared to placebo. Additionally, positive efficacy trends were shown in various other secondary endpoints.

About Peripheral Artery Disease

Peripheral arterial disease (PAD) affects approximately 8 million Americans according to the American Heart Association and is characterized by the build up of fatty deposits on the inner lining of the artery walls. Over time, the build up of fatty deposits restricts blood flow primarily in the arteries leading to the kidneys, arms, legs, stomach and feet. PAD becomes more common as a person ages and by age 65, about 12 to 20 percent of the population has the disease. People with PAD have a four to five times higher risk of heart attack and stroke compared to those who do not have the disease. Treatment often begins with lifestyle changes, including smoking cessation, diet and exercise. Medication is often used along with lifestyle changes to treat PAD. Some patients require additional intervention to help manage the disease and these patients may undergo angioplasty, stent placement or have surgery to help treat the narrowed artery. Restenosis is a large problem for patients following treatment for PAD and to date, drugs have had limited success in treating restenosis.

About PVS-10200

PVS-10200 is a minimally invasive cell therapy currently being developed by Pervasis to treat interventions for PAD and other vascular applications. The Company’s proprietary technology platform harnesses the power of the endothelium to promote natural healing to repair and restore vascular function following an intervention, such as angioplasty, stent placement, peripheral and coronary bypass, and AV access placement for patients with end-stage renal disease. By supplementing the existing endothelium, PVS-10200, an allogeneic endothelial cell treatment, may regulate the inflammatory response and promote natural healing in the vasculature. PVS-10200 may represent a therapeutic advance in treating any vascular intervention and has the potential to become an off-the-shelf, standard-of-care treatment.

About Pervasis Therapeutics, Inc.

Pervasis Therapeutics, Inc. is a clinical-stage cell-based biotechnology company pioneering biologically active products to treat vascular and other serious diseases. The Company has developed a novel, allogeneic endothelial cell therapy that repairs and restores vascular function after injury by mimicking the body’s natural healing process. Pervasis believes its proprietary cell therapy may become the standard of care to promote natural healing following any vascular intervention. Pervasis is also exploring broader indications for its groundbreaking technology in non-vascular applications, such as bone and joint repair, wound healing and inflammation. Pervasis is a privately held company with funding from Flagship Ventures, Polaris Venture Partners, and Highland Capital Partners. For more information, please visit

Tuesday, May 19, 2009

Peripheral Arterial Disease - Clinically

Peripheral arterial disease is characterized by a gradual reduction in blood to the extremities secondary to atherosclerosis. In diabetes, the pattern of atherosclerotic occlusion typically shows a propensity toward the infrapopliteal vessels. Additionally, impairment of the microcirculation manifests in diminished vasoreactivity and a functional ischemia that is not always correctable with surgery. However, when a nonhealing wound is complicated by peripheral arterial disease, revascularization is paramount to wound healing. Revascularization can be accomplished through traditional bypass surgery or newer endovascular interventions, such as angioplasty and stenting. These less invasive techniques of revascularization offer the advantages of quicker recovery and lower morbidity but durability may be compromised. Ultimately, the choice of revascularization procedure should be based on the clinical characteristics of the atherosclerotic lesion along with the individual patient history.

Monday, May 18, 2009

10 million people in the U.S. suffer from lower-limb peripheral arterial disease

According to iData Research, an international medical device & dental market research firm, an estimated 10 million people in the U.S. suffer from lower-limb Peripheral Arterial Disease (PAD), with less than 20% of these diagnosed by a physician.
As early detection increases and more patients seek treatment, the U.S. market for peripheral vascular treatment will grow to an estimated $4.7 billion by 2015.

PAD is the formation of plaque in arterial blood vessels of the outer circulatory system. This causes damage to the arterial wall, which increases the risk of stroke. In 2008, over 4 million individuals in the U.S. had symptoms indicative of PAD, such as persistent leg cramping, numbness, fatigue and severe pain.

"Of people aged 50 to 69 with a history of smoking or diabetes, approximately 30% will manifest PAD," says Kamran Zamanian PhD., CEO of iData Research, "This will drive sales for PAD treatment devices, particularly for devices such as stents and stent-grafts, and complementary and alternative products, like embolic protection and atherectomy devices."

In 2008, the largest segment in the U.S. market for peripheral vascular devices was for stents, which represented 28.7% of the overall treatment market. The stent market will grow at double digit rates through 2015, led by an increase in early diagnoses. The U.S. government and the medical community have taken an active role in improving awareness of PAD among physicians and the general population.

iData Research provides market intelligence reports on the peripheral vascular device market, for the U.S., Europe and Japan. Watch the iData movie at:

Friday, May 15, 2009

Peripheral arterial disease overlooked

United Press International


NEW YORK, Apr 29, 2009 (UPI via COMTEX) -- Peripheral arterial disease of the legs is often overlooked even in patients with known heart disease under a cardiologist's care, U.S. researchers say.

Dr. Issam D. Moussa of New York Presbyterian Hospital/Weill Cornell Medical Center said the study involved nearly 800 patients with heart disease who were to undergo coronary angiography -- an examination of the blood vessels or chambers of the heart -- and/or intervention and were either at least 70 years old, or between the ages of 50-69 and had a history of diabetes and/or tobacco use.

Researchers determined if patients had peripheral arterial disease by calculating the Ankle-Brachial Index, the ratio of the blood pressure in the lower legs to blood pressure in the arms. Patients also answered questionnaires on peripheral arterial disease awareness and functional status.

The study, published in the May issue of Catheterization and Cardiovascular Interventions, showed that approximately 1 of 6 patients had previously unrecognized peripheral arterial disease, despite being under the care of a cardiovascular specialist. The researchers point out that this includes only those with previously undiagnosed peripheral arterial disease and does not represent the total prevalence of peripheral arterial disease in patients with heart disease, which is actually much higher.


Stroke Risk Of Peripheral Artery Disease Cut With Aspirin

A new study suggests that aspirin may cut the risk of stroke in patients with peripheral artery disease.

Although aspirin is effective in the prevention of cardiovascular events in patients with symptomatic coronary heart disease and cerebrovascular disease, its effect in patients with peripheral artery disease (PAD) has been uncertain.

To determine the effect of aspirin on cardiovascular event rates in patients with PAD, lead researcher Dr Jeffrey S. Berger, of the University of Pennsylvania, Philadelphia conducted a meta-analysis to evaluate available evidence from randomized controlled trials of aspirin therapy, with or without dipyridamole (an antiplatelet agent), that reported cardiovascular event rates.

"Results of this meta-analysis demonstrated that for patients with PAD, aspirin therapy alone or in combination with dipyridamole did not significantly decrease the primary end point of cardiovascular events, results that may reflect limited statistical power," wrote the authors.

Even though aspirin use is associated with a statistically nonsignificant decrease in the risk of a group of combined cardiovascular events but is associated with a significant reduction in the risk of one of these events, nonfatal stroke.

"Larger prospective studies of aspirin and other antiplatelet agents are warranted among patients with PAD in order to draw firm conclusions about clinical benefit and risks," the authors added.

The study appears in the issue of JAMA.


Wednesday, May 13, 2009

What is peripheral vascular disease?

Great article on

Peripheral vascular disease (PVD) refers to diseases of the blood vessels (arteries and veins) located outside the heart and brain. While there are many causes of peripheral vascular disease, doctors commonly use the term peripheral vascular disease to refer to peripheral artery disease (peripheral arterial disease, PAD), a condition that develops when the arteries that supply blood to the internal organs, arms, and legs become completely or partially blocked as a result of atherosclerosis.

Tuesday, May 12, 2009

About Peripheral Arterial Disease


PAD is a common circulation problem in which the arteries that carry blood to the legs or arms become narrowed or clogged. This interferes with the normal flow of blood, sometimes causing pain, but often causing no symptoms at all. The most common cause of PAD is atherosclerosis, often called "hardening of the arteries." Atherosclerosis is a gradual process in which cholesterol and scar tissue build up, forming a substance called "plaque" that clogs the blood vessels. In some cases, PAD may be caused by blood clots that lodge in the arteries and restrict blood flow. Left untreated, this insufficient blood flow will lead to limb amputation in some patients.
In atherosclerosis, the blood flow channel narrows from the buildup of plaque, preventing blood from passing through as needed, restricting oxygen and other nutrients from getting to normal tissue. The arteries also become rigid and less elastic, and are less able to react to tissue demands for changes in blood flow. Many of the risk factors-high cholesterol, high blood pressure, smoking and diabetes-may also damage the blood vessel wall, making the blood vessel prone to diffuse plaque deposits.

PAD Symptoms
The most common symptom of PAD is called claudication, which is leg pain that occurs when walking or exercising and disappears when the person stops the activity.
Other symptoms of PAD include: numbness and tingling in the lower legs and feet, coldness in the lower legs and feet, and ulcers or sores on the legs or feet that don't heal.
Many people simply live with their pain, assuming it is a normal part of aging, rather than reporting it to their doctor.

PAD is a disease of the arteries that affects 10 million Americans.
PAD can happen to anyone, regardless of age, but it is most common in men and women over age 50.
PAD affects 12-20 percent of Americans age 65 and older.

PAD Treatments

Often PAD can be treated with lifestyle changes. Smoking cessation and a structured exercise program are often all that is needed to alleviate symptoms and prevent further progression of the disease.

Angioplasty and stenting
Interventional radiologists pioneered angioplasty and stenting, which was first performed to treat peripheral arterial disease. Using imaging for guidance, the interventional radiologist threads a catheter through the femoral artery in the groin to the blocked artery in the legs. Then he or she inflates a balloon to open the blood vessel where it is narrowed or blocked. In some cases this is then held open with a stent, a tiny metal cylinder. This is a minimally invasive treatment that does not require surgery, just a nick in the skin the size of a pencil tip.

PAD Fast Facts

Many people mistake the symptoms of PAD for something else.

PAD often goes undiagnosed by healthcare professionals.

People with PAD are at higher risk for heart attack and stroke.

Left untreated, PAD can lead to gangrene and amputation.

If you smoke, you have an especially high risk for PAD.

If you have diabetes, you have an especially high risk for PAD.

People with high blood pressure or high cholesterol are at risk for PAD.

PAD is easily diagnosed in a simple, painless way.

You can take control by leading a heart-healthy lifestyle and following the recommendations of your healthcare professional.

Most cases of PAD can be managed with lifestyle changes and medication.

Thursday, May 7, 2009

Screening for peripheral arterial disease


We screen for peripheral arterial disease (PAD), more commonly known as hardening of the arteries, by using the ankle-brachial index (ABI). This screening is painless, quick, and non-invasive. It will identify most cases of peripheral arterial disease.

What you can learn
The ankle-brachial index measures the ratio between the pressure in your arms and that in your legs. This ratio indicates how well blood flows to the legs. A ratio of less than 0.90 indicates plaque buildup and possible peripheral arterial disease. A ratio of 0.90 or greater is considered normal.

The screening is simple and painless. After removing your socks and shoes, you will have pressure cuffs placed around your upper arms and ankles. A small ultrasound device will then measure the systolic blood pressures in your limbs.

Who should have peripheral arterial disease screening
Anyone who has risk factors for PAD should have this screening. Are you at risk? Find out.

How often to get screened
This is a personal decision based on your risk factors and previous screening results. Many of our customers have an annual screening as part of their regular healthcare regimen.

How to prepare

Wear a short-sleeved shirt or blouse.

Do not wear pantyhose.

Tuesday, May 5, 2009

Putting your best foot forward

Diabetes Watch
Focusing on preventive foot care in hemodialysis patients
by: Zahid Ahmad, MD - Article May 2009

With changes in overall care, mortality in the dialysis patient population has improved. But comorbid conditions have limited the impact. One such area that remains under the radar for patients with diabetes and end-stage renal disease is morbidity and mortality related to peripheral vascular disease and foot care.

For the most part, at this stage, foot care attracts attention only after a problem has already arisen. There are no screening protocols in dialysis centers to identify the problem earlier on. As a result, preventive strategies to reduce morbidity and mortality related to this issue remains unaddressed. The magnitude of this problem is unrealized until you add to the equation that the majority of hemodialysis patients are diabetics as well. Currently, there is a high-risk of lower extremity amputations in hemodialysis patients.

Early risk factors for diabetic foot complications may be disregarded, and this may lead to amputation-a failure for both the patient and physician. Diabetic foot complications, including amputation, add significantly to the morbidity and mortality of the patient with diabetes and CKD. However, of all the long-term complications of diabetes, foot complications may be the most preventable.

And diabetic foot examinations reduce the risk of amputation. For two decades, the United States Department of Health and Human Services (DHHS) has used health promotion and disease prevention objectives to improve the health of the American people. The overall goal for diabetes in Healthy People 2010 is, "Through prevention programs, reduce the disease and economic burden of diabetes and improve the quality of life for all persons who have or are at risk for diabetes." A specific objective contained within this goal targets a 55% reduction in the rate of lower extremity amputations in persons with diabetes. This would amount to 1.8 lower extremity amputations per 1,000 patients with diabetes per year, down from 4.1 per 1,000 patients that occurred in 1997, according to DHHS. Several clinical studies in the nondialysis diabetic population have shown that coordinated programs to screen for high-risk feet and to provide regular foot care decreased lower extremity amputation rates. In a controlled study, 45 hemodialysis patients were assigned to intensive education and care management that included preventive foot care, and 38 HD patients were assigned to usual care. Over the 12-month follow-up period, there were no amputations in the study group while there were five lower extremity amputations and two finger amputations in the control group.

The American Diabetes Association says that "all individuals with diabetes should receive a thorough foot examination at least once yearly to identify high-risk foot conditions." The ADA goes on to recommend more frequent evaluation for people with one or more risk factors and a visual foot inspection at every visit with a health care professional for diabetic patients with neuropathy.

Preventive foot care for hemodialysis patients is lost in efforts and time spent to provide care in other much politicized areas of care. But ignoring prevention in this area leads to significant morbidity and mortality. There are no randomized controlled trials of intensive education and care management versus usual care of feet in diabetic dialysis patients. Nonetheless, diabetic dialysis patients are likely to benefit from examination of the foot as part of the routine dialysis care. Given the fact that prevention can be easily done in a hemodialysis center by nursing staff, there is little reason not to introduce it. Three times a week contact between hemodialysis nurses and patient is a potential opportunity to assess risks, educate, and provide early intervention for foot issues in the dialysis population. Simple measures such as routine foot screening and education for this high risk population can prevent ulcer-initiating events and detect small ulcers when they may heal with proper intervention. Preventive strategies should include protocol- based strategy for referral to a specialist. Computerized networks should allow this to happen seamlessly and effortlessly to the benefit of all involved in hemodialysis care. In this regard, all involved in medical care of hemodialysis patients can no longer afford to ignore the importance of preventive care of hemodialysis patients.."

Dr. Ahmad is assistant professor of medicine at University of Oklahoma, specializing in interventional nephrology in the Section of Nephrology & Hypertension.

Sunday, May 3, 2009

Foot Exams For Diabetics

According to estimates, more than 86,000 amputations of the lower leg or foot are performed on diabetics in the United States each year. More than 70 percent of these amputations are caused by infected foot ulcers, many of which can be prevented with routine foot exams. When a primary care doctor or podiatrist examines a patients foot, the patient is checked for nerve sensations, skin abnormalities, swelling, drainage, and foot deformities that may place excessive pressure on the affected area (i.e., bunions or hammertoes). Diabetics require these exams because their condition typically leads to decreased feeling in the extremities and circulation problems. Diabetics at high risk for ulcers should be checked every two to three months.
Self-care may not be the best option for diabetics when it comes to their health, unless directed by a podiatrist. At SHENANDOAH PODIATRY, we've seen the results of what happens when foot problems are left untreated or are only self-treated. A better avenue of defense is to see a foot specialist. If you suffer from diabetes and notice foot ulcers, or if your feet hurt for any reason, and you don't have a podiatrist, we would be happy to schedule an appointment for you.

Dedicated To Your Healthy Feet,
Dr. Jennifer Feeny

P.S. All diabetics should have their feet professionally examined at least once a year.

For more information visit our website

Saturday, May 2, 2009

Diseased leg arteries may trigger heart attack, stroke

Diseased leg arteries may trigger heart attack, stroke
2009-04-29 12:53:58
New York, April 29 (IANS) Early detection of peripheral arterial disease (PAD) can help prevent the loss of lower limbs and possibly heart attack or stroke.

PAD is a condition in which plaque blocks arteries of the leg, restricting blood flow and impairs one's ability to walk or exercise. It affects eight million people in the US.

Coronary artery disease (CAD) is prevalent in patients with PAD, which is under-diagnosed in the primary care setting. But a new study found that it is often overlooked even in patients with known heart disease under a cardiologist's charge.

Led by Issam D. Moussa of New York Presbyterian Hospital, the study involved 800 patients with ischemic heart disease (reduced blood flow to the heart) who were to undergo coronary angiography and/or intervention. They were either at least 70 years old, or between the ages of 50 and 69 and had a history of diabetes mellitus and/or tobacco use.

Researchers determined if patients had PAD by calculating the Ankle-Brachial Index, the ratio of the blood pressure in the lower legs to blood pressure in the arms. The Ankle-Brachial Index is normally the first test administered to patients in cases where PAD is suspected.

Patients also answered questionnaires on PAD awareness and functional status. The results showed that approximately one out of six patients had previously unrecognised PAD, despite being under the care of a cardiovascular specialist.

Researchers point out that this includes only those with previously undiagnosed PAD and does not represent the total prevalence of PAD in patients with heart disease, which is actually much higher, said a Presbyterian release.

'The combination of physician's lack of awareness and lack of symptoms among patients results in failure to diagnose PAD, even in patients who are at high risk,' the researchers stated.

The study is slated for publication in the May issue of Catheterisation and Cardiovascular Interventions.