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KDMC First in Region to Use New Limb-Saving Device that Cuts Through Hard Plaque

Vascular and endovascular surgeon Omran Abul-Khoudoud, M.D., and a team of support staff at King’s Daughters Medical Center are first in the region to treat patients with a new minimally invasive plaque-busting device called the Diamondback 360˚TM Orbital Atherectomy System.

Approved in August 2007 by the FDA, the Diamondback 360˚ system, made by Minnesota-based Cardiovascular Systems, Inc., is the first device specifically developed to cut through hardened plaque to restore blood flow in the arteries of the lower leg or below the knee. The Diamondback 360˚ uses a diamond-coated rotary device mounted on a flexible wire to “sand” away plaque inside the leg arteries of patients suffering from peripheral artery disease (PAD).

According to representatives from Cardiovascular Systems Inc., the nearest hospitals to King’s Daughters that are using the Diamondback 360˚ are in Lexington, Ky., Beckley, W.Va., and Cincinnati, Ohio.

PAD is a life-threatening condition where fatty material, called plaque, builds up inside the walls of the arteries that carry blood from the heart to the legs. The build-up of plaque causes the arteries to harden and narrow – a condition called atherosclerosis. This reduces blood flow to the legs and feet. Many people with this condition suffer from critical limb ischemia (CLI), the most severe form of peripheral artery disease. CLI commonly is found in people with diabetes. Amputation is a frequent "treatment" for patients with totally obstructed leg arteries.

Hardened plaque has been a difficult challenge for physicians trying to restore blood flow in the legs. The problem is three-fold: first, finding an atherectomy system strong enough to cut through the stone-like blockage; second, keeping surrounding tissue safe during the process; and third, preventing material from breaking loose and traveling downstream to cause blockages at another site. However, the Diamondback 360˚ is specially designed to address these challenges.

The new system uses a diamond-coated sanding crown that is advanced through the leg artery to the site of the blockage. Like a dentist’s drill, the device “orbits” or spins to gently sand through the hardened plaque. As the speed increases, the orbiting crown enlarges the opening by “sanding” or removing the plaque against the artery walls, leaving a smooth surface behind.

When Dr. Abul-Khoudoud was contacted by representatives from Cardiovascular Systems Inc., he knew he wanted to try the Diamondback 360˚ system. “Other treatment options rarely have been able to remove the calcium ‘wall,’ which has reduced our ability to treat an entire group of patients,” Dr. Abul-Khoudoud said. “This is a new tool to help patients with severe peripheral artery disease who in the past may have been told that invasive surgery, amputation or living with the pain was their only option.”

Dr. Abul-Khoudoud was very pleased with the outcomes of his first three cases using the Diamondback, and he quickly scheduled more patients for a procedure with the new device.

Vascular and endovascular surgeon Alexander Hou, M.D., and interventional radiologist Wes Lewis, M.D., also began treating patients with the Diamondback 360˚. Other vascular specialists at King’s Daughters are expected to begin using it soon.

“The device is weighted asymmetrically, so it shakes up and down the faster it goes,” explained Dr. Hou. “It’s like an unbalanced tire on your car – it causes more vibrations as it gains speed. The vibrations are controlled so that the crown of the device enlarges the passageway in the vessel.”

“The dust-like particles created by the procedure are smaller than red blood cells, so there is minimal risk of forming clots further down the vessel,” said Dr. Lewis. He said other rotary systems have collection baskets for the dislodged particles, and require the physician to periodically remove the device to clean out the baskets. This adds to the procedure time.

According to the National Institutes of Health, between eight and 12 million Americans have peripheral artery disease. Like clogged arteries in the heart, blocked arteries in the lower body also raise the risk of heart attack and stroke. Risk factors for PAD include having diabetes, current or past smoking history, age greater than 50 years, high blood pressure, obesity, abnormal cholesterol, and family history. One in three people with diabetes who are age 50 or older are likely to have PAD.

“Peripheral artery disease still is largely underrecognized by patients,” Dr. Abul-Khoudoud said. “As a result, patients often attribute their leg pain to getting older, muscle cramps or arthritis, and the disease often goes undiagnosed. Most patients suffering from the disease experience worsening pain in their legs that limits their activities. The disease can progress to cause non-healing wounds, ulcers and infections that can lead to gangrene and amputation. Also, about 90 percent of these patients have coronary artery disease, greatly increasing their risk of heart attack and stroke.

“People should have leg pain evaluated by their physician,” Dr. Abul-Khoudoud continued. “There are treatments now available to save limbs affected by peripheral artery disease.”

King’s Daughters vascular program includes two vascular/endovascular surgeons, a cardiothoracic surgeon who specializes in vascular disease, two interventional radiologists and eight peripheral vascular specialists. To find out more about these physicians, visit online at kdmc.com or call 1-888-377-KDMC (5362).

Peripheral Artery Disease (PAD) Facts

  • According to the National Institutes of Health, between 8 and 12 million Americans have PAD.
  • Among adults age 65 and older, 12 to 20 percent have PAD.
  • In the U.S., approximately 85 percent of all amputations occur in people over age 60.
  • One in three people over age 50 with diabetes is likely to have PAD.
  • Each year, more than 160,000 lower-limb amputations are performed. Of all lower-limb amputations, more than 60 percent of them occur among people with diabetes.
  • Ninety percent of people with PAD also have coronary artery disease that can lead to heart attacks and strokes.
  • 60 percent of people who receive an amputation have never had a diagnostic imaging study to determine if blood flow could be restored.

Diagnosing Peripheral Artery Disease

  • Medical history to review risk factors and symptoms associated with PAD.
  • Physical examination of the legs and feet
  • Ankle-brachial index test – blood pressure is taken in the arm and ankle, and a ratio is calculated to find out if blood flow to the legs is within normal ranges.
  • If ankle-brachial ratio is abnormal, other tests may be ordered, such as ultrasound, CT, MRI or angiography.

Treatment Options for Peripheral Artery Disease

  • For mild cases, medication and changes in lifestyle may stop or reverse the progression of disease.
  • Orbital atherectomy (Diamondback 360˚) is the latest technological advancement available for people with critical limb ischemia. It can be used on both hardened and softer plaques.
  • Balloon angioplasty and stenting, where a balloon is inflated at the site of the blockage to compress it against the artery wall; and a metal stent is embedded at the site to hold the artery open.
  • Directional atherectomy uses small cutting devices to drill through plaque, with an attached basket to collect the debris and prevent it from causing blockages lower in the vessel.
  • Laser atherectomy which uses laser energy to burn away plaque and restore blood flow.
  • Some patients benefit from open surgical bypass, similar to heart bypass, where a surgeon makes a deep incision on the affected leg and uses vein grafts to create new routes for blood to flow around a totally blocked artery.
  • Amputation is done as a treatment of last resort to save the patient from a life-threatening infection or to remove part of the body that is “dead” and no longer receives a blood supply.

Many factors determine which treatment option is best, such as the patient’s overall health and whether they have other complicating conditions, the placement and size of the blockage, and the calcification/hardness of the plaque.

All of these procedures are performed at King’s Daughters Medical Center.

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